Tissue excision instrument
The end effector assembly of the tissue resection device addresses the challenges of tissue removal and fluid management by using a rotating or vibrating distal cutting tip within the tissue resection device, enhancing the efficiency and clarity of the surgical site.
Patent Information
- Application Number
- JP2021070149
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-04-20
- Filing Date
- 2021-04-19
- Publication Date
- 2025-06-13
- Estimated Expiration
- 2041-04-19
AI Technical Summary
Existing tissue resection instruments face challenges in efficiently removing tissue from internal surgical sites, such as the uterus, while maintaining a clear visual working space and effective fluid management.
The end effector assembly of the tissue resection device includes an outer shaft with a window, a drive wire, and a distal cutting tip. The drive wire is configured to rotate or vibrate the distal cutting tip relative to the outer shaft, facilitating tissue removal and fluid outflow through a designed outflow path.
This configuration enhances the efficiency of tissue resection by ensuring effective cutting and removal of tissue, while also maintaining clear fluid outflow, thereby improving the visibility and accessibility of the surgical site.
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Abstract
Description
Technical Field
[0001] The present disclosure generally relates to the field of tissue resection. In particular, the present disclosure relates to a tissue resection instrument configured to facilitate the resection and removal of tissue from an internal surgical site, such as the uterus.
Background Art
[0002] Background Art Tissue resection can be performed endoscopically within an organ such as the uterus by inserting an endoscope (or hysteroscope) into the uterus and introducing a tissue resection instrument into the uterus through the endoscope (or hysteroscope). For such endoscopic tissue resection procedures, it is often desirable to inflate the uterus with a fluid, such as saline, sorbitol, or glycine. The inflow and outflow of fluid during the procedure maintains the uterus in an inflated state, flushes tissue and other debris out of the uterus, and maintains a visible working space.
Summary of the Invention
Means for Solving the Problems
[0003] As used herein, the term "distal" refers to the portion that is described as being farther from the user, while the term "proximal" refers to the portion that is described as being closer to the user. Further, to the extent not inconsistent, any or all of the aspects described herein may be used in combination with any or all of the other aspects described herein.
[0004] Provided in accordance with aspects of the present disclosure is an end effector assembly for a tissue resection device that includes an outer shaft, a drive wire, a distal cutting tip, a hub housing, and a driver. The outer shaft defines a proximal end portion and a distal end portion. The distal end portion of the outer shaft defines a window therethrough. The drive wire extends through the outer shaft and defines a proximal end portion and a distal end portion. The distal cutting tip is disposed within the outer shaft and engages the distal end portion of the drive wire. The distal cutting tip at least partially overlaps the window. The hub housing engages the proximal end portion of the outer shaft. The driver is disposed within the hub housing and engages the proximal end portion of the drive wire. The driver is configured to be rotationally driven relative to the hub housing, thereby rotating the drive wire and the distal cutting tip within and relative to the outer shaft. The driver defines an internal lumen and at least one lateral opening disposed in communication with the internal lumen. An outflow path is defined to pass around the outer shaft and the drive wire from the window, into the interior of the hub housing, through at least one lateral opening, and through the internal lumen.
[0005] In one aspect of the present disclosure, the outer shaft includes a cutting edge surrounding the window. The cutting edge defines a plurality of cutting teeth.
[0006] In another aspect of the present disclosure, the distal cutting tip defines an opening that communicates with the window in at least one rotational direction of the distal cutting tip relative to the outer shaft. In such an aspect, the outflow path can be further defined to pass from the window through the opening, around the outer shaft and the drive wire, into the interior of the hub housing, through at least one lateral opening, and through the internal lumen. Additionally, or alternatively, the distal cutting tip can include a plurality of teeth disposed along both sides of the opening.
[0007] In yet another aspect of the present disclosure, the proximal extension extends proximally from the hub housing and defines an interior that is in fluid communication with the inner lumen such that the outflow path is further defined from the inner lumen to the inner proximal extension. In such an aspect, the proximal extension can further define an outflow opening and further define an outflow path from the interior of the proximal extension through the outflow opening.
[0008] Another end effector assembly of a tissue resection device provided in accordance with an aspect of the present disclosure includes an outer shaft, a driver wire, a distal cutting tip, a hub housing, and a driver. The outer shaft defines a proximal end portion and a distal end portion that define a window therethrough. The drive wire extends through the outer shaft and defines a proximal end portion and a distal end portion. The proximal end portion of the drive wire includes a longitudinally extending segment and a finger disposed at an angle to the longitudinally extending segment. The distal cutting tip is disposed within the outer shaft, engages the distal end portion of the drive wire, and at least partially overlaps the window. The hub housing engages the proximal end portion of the outer shaft. The driver is disposed within the hub housing and defines a longitudinally extending slot and a transverse slot disposed in communication with the longitudinally extending slot at an angle thereto. The longitudinally extending slot is configured to receive the longitudinally extending segment of the drive wire, and the transverse slot is configured to receive the finger of the drive wire, thereby engaging the driver with the proximal end portion of the drive wire. The driver is configured to be rotationally driven relative to the hub housing, thereby rotating the drive wire and the distal cutting tip within and relative to the outer shaft.
[0009] In one aspect of the present disclosure, the finger is disposed at an angle of approximately 90 degrees to the longitudinally extending segment, and the transverse slot is disposed at an angle of approximately 90 degrees to the longitudinally extending slot.
[0010] In another aspect of the present disclosure, the outer shaft includes a cutting edge surrounding the window. The cutting edge defines a plurality of cutting teeth.
[0011] In yet another aspect of the present disclosure, the distal cutting tip defines an opening that communicates with the window in at least one rotational direction of the distal cutting tip relative to the outer shaft. In such an aspect, the distal cutting tip may include a plurality of teeth disposed along both sides of the opening.
[0012] In yet another aspect of the present disclosure, an adhesive between the longitudinally extending slot and at least one of the longitudinally extending segment or the transverse slot and the finger further secures the engagement of the driver with the proximal end portion of the drive wire.
[0013] In yet another aspect of the present disclosure, the driver is overmolded around the proximal end portion of the drive wire, thereby defining a longitudinally extending slot that receives the longitudinally extending segment and a transverse slot that receives the finger, and engaging the driver around the proximal end portion of the drive wire.
[0014] In another aspect of the present disclosure, the driver defines first and second transverse openings on either side of any one of the longitudinally extending slots and is disposed to communicate with the inner lumen of the driver.
[0015] Another end effector assembly of a tissue resection device provided in accordance with an aspect of the present disclosure includes an outer shaft, a drive wire, a distal cutting tip, a hub housing, a driver, and a connector. The outer shaft defines a proximal end portion and a distal end portion that define a window therethrough. The drive wire extends through the outer shaft and defines a proximal end portion and a distal end portion. The distal cutting tip is disposed within the outer shaft, engages the distal end portion of the drive wire, and at least partially overlaps the window. The hub housing engages the proximal end portion of the outer shaft. The driver is disposed within the hub housing and is configured to be rotationally driven relative to the hub housing. The connector couples the proximal end portion of the drive wire to the driver, whereby rotation of the driver relative to the hub housing rotates the drive wire and the distal cutting tip within and relative to the outer shaft.
[0016] In one aspect of the present disclosure, the outer shaft includes a cutting edge surrounding the window. The cutting edge defines a plurality of cutting teeth.
[0017] In another aspect of the present disclosure, the distal cutting tip defines an opening that communicates with the window in at least one rotational direction of the distal cutting tip relative to the outer shaft. In such an aspect, the distal cutting tip may include a plurality of teeth disposed along both sides of the opening.
[0018] In yet another aspect of the present disclosure, the connector engages the proximal end portion of the drive wire in a first manner and engages the driver in a second, different manner.
[0019] Also provided in accordance with aspects of the present disclosure is an end effector assembly for a tissue resection device including an outer shaft, a drive wire, and a distal cutting tip. The outer shaft has a proximal end portion and a distal end portion defining a window therethrough. The drive wire extends through the outer shaft and includes a cylindrical body and a distal end portion defining a semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface. A semi-cylindrical notch is defined within the planar top surface. The distal cutting tip is disposed within the outer shaft and at least partially overlaps the window. The distal cutting tip has a semi-cylindrical lumen defined by the semi-cylindrical bottom surface and an open top. The distal end portion of the drive wire is at least partially received within the semi-cylindrical lumen of the distal cutting tip, wherein the semi-cylindrical bottom surface of the distal end portion of the drive wire engages in substantial mating engagement with the semi-cylindrical bottom surface of the distal cutting tip. The drive wire is configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft.
[0020] In one aspect of the present disclosure, the distal cutting tip includes a plurality of teeth extending along a portion of its length. The plurality of teeth includes a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on an opposite, second side of the semi-cylindrical lumen.
[0021] In another aspect of the present disclosure, the distal end of the distal end portion of the drive wire does not extend distally beyond the first teeth of each of the first and second sets of teeth. Alternatively or additionally, the distal end of the distal end portion of the drive wire is positioned proximal to the plurality of teeth.
[0022] In yet another aspect of the present disclosure, the drive wire includes a transition portion disposed between the cylindrical body and the distal end portion. The transition portion includes a curved surface. In such an aspect, the semi-cylindrical notch may include a transition portion defined within the transition portion of the drive wire. The transition portion of the semi-cylindrical notch is defined by a curved bottom surface.
[0023] In yet another aspect of the present disclosure, the distal end portion of the drive wire includes a chamfered distal surface.
[0024] Another end effector assembly of a tissue resection device provided in accordance with the present disclosure includes an outer shaft, a drive wire, and a distal cutting tip. The outer shaft defines a proximal end portion and a distal end portion that define a window therethrough. The drive wire extends through the outer shaft and includes a surface that is at least partially cylindrical. The distal cutting tip is disposed within the outer shaft and at least partially overlaps the window. The distal cutting tip defines a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open top. The distal cutting tip further includes a slot defined through the semi-cylindrical bottom surface. The distal end portion of the drive wire is at least partially received within and engaged within the semi-cylindrical lumen of the distal cutting tip. The at least partially cylindrical surface extends at least partially within the slot. The drive wire is configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft.
[0025] In one aspect of the present disclosure, the drive wire includes a cylindrical body and the distal end portion of the drive wire defines a semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface. The semi-cylindrical bottom surface functions as at least a partially cylindrical surface that extends at least partially within the slot.
[0026] In another aspect of the present disclosure, the drive wire includes a transition portion disposed between the cylindrical body and the distal end portion.
[0027] In yet another aspect of the present disclosure, the planar upper surface of the distal end portion of the drive wire is recessed with respect to the open upper portion of the distal cutting tip.
[0028] In yet another aspect of the present disclosure, the distal cutting tip includes a plurality of teeth extending along a portion of its length. The plurality of teeth includes a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on an opposite second side of the semi-cylindrical lumen.
[0029] Yet another end effector assembly of a tissue resection device provided in accordance with an aspect of the present disclosure includes an outer shaft, a drive wire, and a distal cutting tip. The outer shaft has a proximal end portion and a distal end portion that define a window therethrough. The drive wire extends through the outer shaft and defines a cylindrical configuration. The distal cutting tip is disposed within the outer shaft and at least partially overlaps the window. The distal cutting tip defines a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open upper portion. The drive wire extends distally within the distal cutting tip at a distance of 20% or less of the length of the distal cutting tip and is engaged therein. The drive wire is configured to drive rotation or vibration of the distal cutting tip with respect to the outer shaft.
[0030] In one aspect of the present disclosure, the drive wire extends distally within the distal cutting tip at a distance of 17% or less of the length of the distal cutting tip. In another aspect, the drive wire extends distally within the distal cutting tip at a distance of 15% or less of the length of the distal cutting tip.
[0031] In another aspect of the present disclosure, the distal cutting tip includes a plurality of teeth extending along a portion of its length. The plurality of teeth includes a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on an opposite second side of the semi-cylindrical lumen.
[0032] In yet another aspect of the present disclosure, the distal end of the drive wire is proximally spaced from the plurality of teeth.
[0033] In yet another aspect of the present disclosure, the drive wire is engaged within the cutting tip by a butt weld or a lap weld. The present invention provides, for example, the following. (Item A1) An end effector assembly of a tissue resection device, An outer shaft defining a proximal end portion and a distal end portion, wherein the distal end portion of the outer shaft defines a window therethrough, and the outer shaft; A drive wire extending through the outer shaft and including a cylindrical body and a distal end portion defining a semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface, wherein a semi-cylindrical notch is defined within the planar top surface; A distal cutting tip disposed within the outer shaft and at least partially overlapping the window, the distal cutting tip defining a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open top; The distal end portion of the drive wire is at least partially received within the semi-cylindrical lumen of the distal cutting tip, wherein the semi-cylindrical bottom surface of the distal end portion of the drive wire engages in a substantially mated state with the semi-cylindrical bottom surface of the distal cutting tip, and the drive wire is configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft. An end effector assembly. (Item A2) The distal cutting tip includes a plurality of teeth extending along a portion of its length, the plurality of teeth including a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on a second opposite side of the semi-cylindrical lumen. The end effector assembly according to the above item. (Item A3) The distal end of the distal end portion of the drive wire does not extend distally beyond the first teeth of each of the first and second sets of teeth. The end effector assembly according to any of the above items. (Item A4) The end effector assembly according to any of the above items, wherein the distal end of the distal end portion of the drive wire is positioned proximal to the plurality of teeth. (Item A5) The end effector assembly according to any of the above items, wherein the drive wire includes a transition portion disposed between the cylindrical body and the distal end portion, and the transition portion includes a curved surface. (Item A6) The end effector assembly according to any of the above items, wherein the semi-cylindrical notch includes a transition portion defined within the transition portion of the drive wire, and the transition portion of the semi-cylindrical notch is defined by a curved bottom surface. (Item A7) The end effector assembly according to any of the above items, wherein the distal end portion of the drive wire includes a chamfered distal surface. (Item A8) An end effector assembly of a tissue resection device, An outer shaft defining a proximal end portion and a distal end portion, wherein the distal end portion of the outer shaft defines a window therethrough, and the outer shaft; A drive wire extending through the outer shaft, the drive wire including at least a partially cylindrical surface; A distal cutting tip disposed within the outer shaft and at least partially overlapping the window, the distal cutting tip defining a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open top, and the distal cutting tip further including a slot defined through the semi-cylindrical bottom surface; and a distal cutting tip. The end effector assembly, wherein the distal end portion of the drive wire is at least partially received within the semi-cylindrical lumen of the distal cutting tip, wherein the at least partially cylindrical surface engages in a state of extending at least partially within the slot, and the drive wire is configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft. (Item A9) The drive wire includes a cylindrical body, and a distal end portion of the drive wire defines a semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface, the semi-cylindrical bottom surface being at least partially cylindrical surface extending into the slot, the end effector assembly according to any of the above items. (Item A10) The drive wire includes a transition portion disposed between the cylindrical body and the distal end portion, the end effector assembly according to any of the above items. (Item A11) The planar top surface of the distal end portion of the drive wire is recessed relative to the open upper portion of the distal cutting tip, the end effector assembly according to any of the above items. (Item A12) The distal cutting tip includes a plurality of teeth extending along a portion of its length, the plurality of teeth including a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on a second opposite side of the semi-cylindrical lumen, the end effector assembly according to any of the above items. (Item A13) An end effector assembly of a tissue resection device, An outer shaft defining a proximal end portion and a distal end portion, the distal end portion of the outer shaft defining a window therethrough, the outer shaft and, A drive wire extending through the outer shaft and defining a cylindrical configuration, the drive wire and, A distal cutting tip disposed within the outer shaft and at least partially overlapping the window, the distal cutting tip defining a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open upper portion, and, The drive wire extends distally within the distal cutting tip at a distance of 20% or less of the length of the distal cutting tip and engages therein, the drive wire being configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft, the end effector assembly. (Item A14) The end effector assembly according to any of the above items, wherein the drive wire extends distally within the distal cutting tip at a distance of 17% or less of the length of the distal cutting tip. (Item A15) The end effector assembly according to any of the above items, wherein the drive wire extends distally within the distal cutting tip at a distance of 15% or less of the length of the distal cutting tip. (Item A16) The end effector assembly according to any of the above items, wherein the distal cutting tip includes a plurality of teeth extending along a portion of its length, and the plurality of teeth includes a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on a second opposite side of the semi-cylindrical lumen. (Item A17) The end effector assembly according to any of the above items, wherein the distal end of the drive wire is spaced proximally from the plurality of teeth. (Item A18) The end effector assembly according to any of the above items, wherein the drive wire is engaged within the cutting tip by a butt weld or a lap weld. (Item B1) An end effector assembly of a tissue resection device, An outer shaft defining a proximal end portion and a distal end portion, wherein the distal end portion of the outer shaft defines a window therethrough, and the outer shaft; A drive wire extending through the outer shaft and including a cylindrical body and a distal end portion defining a semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface; A distal cutting tip disposed within the outer shaft and at least partially overlapping the window, the distal cutting tip defining a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open top. The distal end portion of the drive wire is at least partially received within the semi-cylindrical lumen of the distal cutting tip, wherein the semi-cylindrical bottom surface of the distal end portion of the drive wire engages in a substantially mated state with the semi-cylindrical bottom surface of the distal cutting tip, and the drive wire is configured to drive rotation or vibration of the distal cutting tip with respect to the outer shaft, an end effector assembly. (Item B2) The distal cutting tip includes a plurality of teeth extending along a portion of its length, the plurality of teeth including a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on a second, opposite side of the semi-cylindrical lumen, the end effector assembly according to any of the above items. (Item B3) The distal end of the distal end portion of the drive wire does not extend distally beyond the respective first teeth of the first and second sets of teeth, the end effector assembly according to any of the above items. (Item B4) The distal end of the distal end portion of the drive wire is positioned proximal to the plurality of teeth, the end effector assembly according to any of the above items. (Item B5) The drive wire includes a transition portion disposed between the cylindrical body and the distal end portion, the transition portion including a curved surface, the end effector assembly according to any of the above items. (Item B6) The semi-cylindrical notch includes a transition portion defined within the transition portion of the drive wire, the transition portion of the semi-cylindrical notch being defined by a curved bottom surface, the end effector assembly according to any of the above items. (Item B7) The distal end portion of the drive wire includes a chamfered distal surface, the end effector assembly according to any of the above items. (Item B8) The drive wire includes a semi-cylindrical notch defined within the planar upper surface, the end effector assembly according to any of the above items. (Item B9) The end effector assembly according to any one of the above items, wherein the planar upper surface of the distal end portion of the drive wire is recessed with respect to the open upper portion of the distal cutting tip. (Item B10) The end effector assembly according to any one of the above items, wherein the drive wire extends distally within the distal cutting tip at a distance of 20% or less of the length of the distal cutting tip. (Item B11) The end effector assembly according to any one of the above items, wherein the drive wire extends distally within the distal cutting tip at a distance of 15% or less of the length of the distal cutting tip. (Item B12) The end effector assembly according to any one of the above items, wherein the drive wire is engaged within the cutting tip by welding. (Item B13) A tissue resection device, comprising: A handpiece; The end effector assembly according to any one of the above items, wherein the end effector assembly is configured to releasably engage with the handpiece. (Item B14) The tissue resection device according to any one of the above items, further comprising a hub assembly configured to releasably engage with the handpiece, wherein when the end effector assembly is releasably engaged with the handpiece, the outer shaft is fixed to the handpiece and the drive wire is operably coupled to a motor of the handpiece. (Item B15) The tissue resection device according to any one of the above items, wherein the hub assembly includes an RFID chip therein, and the RFIC chip is configured to be read by an RFID reader of the handpiece to enable identification of the end effector assembly. (Abstract) The end effector assembly of the tissue resection device includes an outer shaft that defines a window, a drive wire that extends through the outer shaft, and a distal cutting tip disposed within the outer shaft. The drive wire includes a cylindrical body and a distal end portion that defines a semi-cylindrical configuration, the semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface in which a semi-cylindrical notch is defined. The distal cutting tip at least partially overlaps the window and has a semi-cylindrical lumen defined by the semi-cylindrical bottom surface and an open top. The distal end portion of the drive wire is at least partially received and substantially mates with the semi-cylindrical surface within the semi-cylindrical lumen. The drive wire is configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft. BRIEF DESCRIPTION OF THE DRAWINGS
[0034] Various aspects and features of the present disclosure are described below with reference to the drawings, and in each of several figures, like reference numerals indicate the same or corresponding elements.
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DETAILED DESCRIPTION OF THE INVENTION
[0035] Generally, referring to FIGS. 1 and 23, a tissue resection instrument 10 provided in accordance with the present disclosure and configured to excise tissue includes an end effector assembly 100 and a handpiece assembly 200. The tissue resection instrument 10 is adapted to be connected to a control unit (not shown) via a cable 300 to provide power and control functions to the tissue resection instrument 10, although the tissue resection instrument 10 may alternatively or additionally include a power source, such as a battery, and / or a control unit disposed within the handpiece assembly 200. The tissue resection instrument 10 is further adapted to be connected to a fluid management system (not shown) via an outflow tube (not shown) connected to an outflow port 400 for applying suction to remove fluid, tissue, and debris from the surgical site through the tissue resection instrument 10. The control unit and the fluid management system may be integral with each other, coupled to each other, or separated from each other.
[0036] The tissue resection instrument 10 may be configured as a disposable device that is discarded after use or sent to the manufacturer for reprocessing, a reusable device that can be cleaned and / or sterilized for repeated use by the end user, or a partially disposable and partially reusable device. With respect to a partially disposable and partially reusable configuration, the handpiece assembly 200 may be configured as a washable / sterilizable, reusable component, while the end effector assembly 100 is configured as a disposable, discardable / reprocessable component. In any of the above configurations, the end effector assembly 100 is configured to releasably engage with the handpiece assembly 200 to facilitate the discard / reprocessing of any disposable components and the cleaning and / or sterilization of any reusable components. Further, by enabling a releasable engagement between the end effector assembly 100 and the handpiece assembly 200, interchangeable use of different end effector assemblies, such as end effector assemblies of different lengths, configurations, etc., with the handpiece assembly 200 becomes possible.
[0037] Continuing to refer to FIG. 1, the end effector assembly 100 includes an outer shaft 120, a drive wire 140, a hub assembly 160, a drive assembly 180 (FIG. 5), and an RFID chip 190 (FIG. 5). Referring also to FIGS. 2-5, 8, and 9, the outer shaft 120 includes a proximal end portion 122 and a distal end portion 124 that defines at least partially closed distal end 126 and a lateral window 128 disposed adjacent to the at least partially closed distal end 126. The window 128 provides lateral access into the interior of the outer shaft 120 through its sidewalls and may be surrounded by a cutting edge 129a that extends around at least a portion of the outer perimeter of the window 128 to facilitate cutting of tissue entering the outer shaft 120 through the window 128. The cutting edge 129a can define a serrated configuration that includes a plurality of cutting teeth 129b extending along the longitudinal sides of the cutting window 128, or can define any other suitable configuration. In an embodiment, the cutting teeth 129b are arcuate in configuration to conform to the tubular shape of the outer shaft 120.
[0038] The outer shaft 120 can be formed as a single monolithic piece of material or can be formed from multiple pieces that are formed separately and subsequently joined together. For example, the outer shaft 120 can include an elongate cylindrical body portion 121a and a distal tip portion 121b (including at least partially closed distal end 126, window 128, and cutting edge 129a) that are joined together by laser welding or any other suitable method. The outer shaft 120 can be formed from stainless steel or other suitable materials. The outer shaft 120 can define an outer diameter of about 0.085 inches or less in an embodiment, about 0.075 inches or less in other embodiments, and about 0.065 inches or less in still other embodiments. The outer shaft 120 can define an inner diameter of about 0.070 inches or less in an embodiment, about 0.060 inches or less in other embodiments, and about 0.050 inches or less in still other embodiments. As used herein, "about" takes into account generally accepted tolerances and variations in the art, including but not limited to tolerances in materials, manufacturing, environment, use, and measurement.
[0039] Referring to FIGS. 1-7, drive wire 140 is rotatably disposed within outer shaft 120 and includes a body 142 (FIG. 7) and a distal end portion 144. The proximal end portion 143a of body 142 of drive wire 140 is bent to define a finger 143b that facilitates engagement of the proximal end portion 143a of drive wire 140 within distal driver 184 of drive assembly 180, as detailed below, although other engagement configurations are contemplated. The distal end portion 144 of drive wire 140 is at least partially received within and engaged with distal cutting tip 150.
[0040] Referring to FIGS. 6 and 7, body 142 of drive wire 140 defines a cylindrical configuration having a substantially circular cross-section with an outer diameter of about 0.045 inches or less in one embodiment, about 0.035 inches or less in other embodiments, and about 0.025 inches or less in still other embodiments. Instead of defining a circular cross-sectional configuration, material is removed from the distal end portion 144 of drive wire 140 such that the distal end portion 144 defines a semi-circular cross-sectional configuration having a semi-cylindrical (semi-circular cross-section) bottom surface 145a and a planar top surface 145b. A transition section 146a that defines an angled transition surface 146b is disposed between body 142 and the distal end portion 144 of drive wire 140 and defines a tapered transition between the arcuate outer surface of body 142 and the planar top surface 145b of the distal end portion 144. Drive wire 140 can be formed as a solid rod of material, such as stainless steel, although other suitable materials and / or configurations are contemplated.
[0041] Continuing with reference to FIGS. 6 and 7, as described above, the distal end portion 144 of the drive wire 140 is received and engaged at least partially within the distal cutting tip 150. The distal cutting tip 150 includes a semi-cylindrical body 152 that defines a semi-cylindrical lumen 154. The distal cutting tip 150 can be formed from any suitable material, such as stainless steel, and can be formed by machining or other methods. The semi-cylindrical body 152 defines a semi-cylindrical bottom surface 155a, a planar top surface 155b, an open proximal end 155c, and a at least partially closed distal end 155d. The planar top surface 155b is defined by first and second side walls 156 that are spaced apart from each other to define an elongated opening 157 that provides access to the semi-cylindrical lumen 154 along its length. The open proximal end 155c similarly provides access to the semi-cylindrical lumen 154.
[0042] The first and second side walls 156 can project from the planar top surface 155b (and / or define a valley that is recessed therebetween) and define a plurality of cutting teeth 158 that extend along a portion of the length of the first and second side walls 156. Referring temporarily to FIG. 10, the cutting teeth 158 can be complementary to the cutting teeth 129b such that in one direction of the cutting tip 150 within the outer shaft 120, the surfaces defined by the cutting teeth 158 and the cutting teeth 129b are completely aligned with each other and appear, for example, as a set of teeth. In an embodiment, similar to the cutting teeth 129b, the cutting teeth 158 are configured to be arcuate to conform to the tubular shape of the outer shaft 120 (since the cutting teeth 158 are disposed radially inward of the cutting teeth 129b, the radius defined by the cutting teeth 158 is smaller than the radius defined by the cutting teeth 129b).
[0043] Returning to FIGS. 6 and 7, in embodiments, the cutting tip 150 can define an outer diameter of about 0.070 inches or less, in other embodiments about 0.060 inches or less, and in still other embodiments about 0.050 inches or less (e.g., of the semi-cylindrical body 152). The inner diameter of the cutting tip 150 (e.g., of the semi-cylindrical lumen 154) can be about 0.055 inches or less in embodiments, about 0.045 inches or less in other embodiments, and about 0.035 inches or less in still other embodiments. Referring also to FIGS. 10 - 12, the annular clearance defined between the outer diameter of the cutting tip 150 and the inner diameter of the outer shaft 120 can be about 0.001 inches to about 0.006 inches in embodiments, and about 0.003 to about 0.004 inches in other embodiments.
[0044] Referring again to FIGS. 6 and 7, as described above, the distal end portion 144 of the drive wire 140 is at least partially received within and engaged with the distal cutting tip 150. More specifically, the distal end portion 144 of the drive wire 140 is received within the semi-cylindrical lumen 154 such that the semi-cylindrical bottom surface 145a on the outside of the distal end portion 144 of the drive wire 140 complementarily mates with the semi-cylindrical inner surface of the cutting tip 150 that defines the semi-cylindrical bottom of the semi-cylindrical lumen 154. In this position, the planar upper surface 145b of the distal end portion 144 of the drive wire 140 can be coplanar with the upper surface 155b (defined by the side wall 156) of the cutting tip 150. To fix the distal end portion 144 of the drive wire 140 within the distal cutting tip 150 at this position, the abutting edges of the planar upper surface 145b and the upper surface 155b (defined by the side wall 156) can be welded (e.g., by laser welding) or otherwise attached to each other on both sides. The location of the attachment, e.g., welding, can be proximal to the cutting teeth 129b, 158 and / or any other suitable location(s).
[0045] Referring further to FIGS. 10 - 12, drive wire 140 is configured to rotate or vibrate within and relative to inner shaft 120, thereby rotating or vibrating distal cutting tip 150 relative to window 128. More specifically, inner shaft 140 is configured to rotate or vibrate between a first open position (FIG. 10), a second partially closed position (FIG. 11), and a third closed position (FIG. 12). In the first position, as shown in FIG. 10, cutting teeth 129b, 158 are aligned with each other and elongated aperture 157 is aligned with window 128 to allow maximum fluid communication therebetween. In the second position, as shown in FIG. 11, cutting teeth 129b, 158 are offset from each other (only teeth 158 on one side of distal cutting tip 150 are exposed) and elongated aperture 157 is offset from window 128 to allow only partial fluid communication therebetween. In the third position, as shown in FIG. 12, cutting teeth 129b, 158 are either offset from each other by approximately 180 degrees or in any other suitable position such that cutting teeth 158 are not exposed. Similarly, elongated aperture 157 and window 128 are either offset from each other by approximately 180 degrees or in any other suitable position such that fluid communication therebetween is substantially blocked. For a rotational embodiment, drive wire 140 can rotate in a single direction from the first position to the second position, the third position, and back to the first position (and can rotate continuously to repeat the same). For a vibrational embodiment, drive wire 140 can rotate in a first direction from the first position to the second position, the third position, and then in a second reverse direction from the third position to the second position, back to the first position (after which it can similarly return to the first direction or continue to the third position in the second direction before returning to the first position and repeat the same). Other vibration patterns and / or combinations of rotation and vibration (e.g., where multiple rotations are performed before switching directions) are also contemplated.
[0046] Referring to FIGS. 10 and 13 - 15, in the embodiment, either or both of the proximal and distal surfaces 128a, 128b of the outer shaft 120 that define the longitudinal boundaries of the window 128 may define a plane "P1" that is at an angle "α" (perpendicularly in the orientation shown in FIG. 13) with respect to a plane "P2" that extends perpendicular to the longitudinal axis of the outer shaft 120. The plane "P1" defined by the proximal and / or distal surfaces 128a, 128b may be angled longitudinally away from the window 128 (e.g., the proximal surface 128a is angled proximally away from the window 128 in the radially outward direction and / or the distal surface 128b is angled distally away from the window 128 in the radially outward direction). The angle "α" may be, in one embodiment, from about 25 degrees to about 55 degrees, in other embodiments, from about 30 degrees to about 50 degrees, and in other embodiments, from about 35 degrees to about 45 degrees. Alternatively, as shown in FIGS. 16 and 17, either or both of the proximal and distal surfaces 128a, 128b of the outer shaft 120 may define a plane that extends perpendicular to the longitudinal axis of the outer shaft 120. In any of the above embodiments, the distal cutting tip 150 extends distally beyond the window 128 and it can be facilitated to restrain the distal cutting tip 150 within the outer shaft 120. Additionally or alternatively, one or more of the most proximal cutting teeth 158 of the distal cutting tip 150 may be disposed at least partially proximal to the window 128.
[0047] In the embodiments of FIGS. 10 and 13 - 15, the distal end 126 of the outer shaft 120 is partially closed in that the distal end 126 does not extend a full 180 degrees but rather extends 180 degrees minus "α" degrees. In contrast, in the embodiments of FIGS. 16 and 17, the distal end 126 of the outer shaft 120 is fully closed in that it extends a full 180 degrees (e.g., "α" is equal to about 0 degrees).
[0048] Turning to FIG. 18, in the embodiment, rather than providing teeth, both the outer shaft 1120 and the distal cutting tip 1150 can each define a substantially planar cutting edge 1129, 1158. In such an embodiment, the distal ends 1126, 1155d of the outer shaft 1120 and the distal cutting tip 1150 respectively may be only partially closed and may include respective U-shaped openings 1121, 1151 defined therein. The cutting edges 1129, 1158 can extend around the U-shaped openings 1121, 1151, or the U-shaped openings 1121, 1151 can be defined by a blunt surface.
[0049] As shown in FIG. 19, in other embodiments, rather than both including teeth, one of the outer shaft 2120 and the distal cutting tip 2150, for example, the distal cutting tip 2150, can define a substantially planar cutting edge 2158, while the other of the outer shaft 2120 and the distal cutting tip 2150, for example, the outer shaft 2120, defines teeth 2129. The reverse configuration is also contemplated.
[0050] Referring to FIGS. 1-5, as described above, the end effector assembly 100 includes an outer shaft 120, a drive wire 140, a hub assembly 160, and a drive assembly 180. The end effector assembly 100 further includes an RFID chip 190 captured between a retaining cap 170 of the hub assembly 160 and a proximal extending portion 164 of the hub housing 161 of the hub assembly 160, as will be described in detail below.
[0051] The hub assembly 160 includes a hub housing 161 having a distal body portion 162 and a proximal extending portion 164 configured to engage with each other via, for example, snap fit or other suitable engagement. Further referring temporarily to FIG. 23, with the end effector assembly 100 engaged with the handpiece assembly 200, the proximal extending portion 164 of the hub housing 161 extends into the handpiece assembly 200, while the distal body portion 162 substantially abuts against the handpiece assembly 200 and extends distally therefrom. The proximal extending portion 164 of the hub housing 161 further defines an outflow opening 165 through its side wall that is configured to be in fluid communication with an internal bore (not shown) of the handle housing 210 of the handpiece assembly 200 when the end effector assembly 100 engages therewith.
[0052] Returning to FIGS. 1 - 5 and FIG. 9, the distal body portion 162 of the hub housing 161 is fixedly disposed around the proximal end portion 122 of the outer shaft 120, and the outer shaft 120 extends distally therefrom. The drive wire 140 extends through the outer shaft 120 as described above and extends proximally through the distal body portion 162 of the hub housing 161 into the proximal extending portion 164 of the hub housing 161, and the drive assembly 180 is operably coupled to the finger 143b of the proximal end portion 143a of the body 142 of the drive wire 140.
[0053] The hub assembly 160 further includes an O - ring 166 configured to engage around the proximal extending portion 164 of the hub housing 161 distal to the outflow opening 165 (see FIG. 20). The O - ring 166 is configured to establish a liquid - tight seal against the interior of the handle housing 210 of the handpiece assembly 200 (see FIG. 23) when the end effector assembly 100 engages therewith to prevent fluid from moving distally after exiting the outflow opening 165.
[0054] The hub assembly 160 further includes an outer shell 168 that is positioned around the distal body portion 162 of the hub housing 161 and configured to engage with it, for example, by snap-fit engagement or any other suitable method. The cantilever engagement finger 169 extends proximally from the outer shell 168 of the hub housing 161 and proximally from the distal body portion 162 of the hub housing 161 when the outer shell 168 engages therearound. The engagement finger 169 is configured to engage within a corresponding opening 218 (not shown) defined within the handle housing 210 of the handpiece assembly 200 (see FIG. 23), enabling releasable engagement between the end effector assembly 100 and the handpiece assembly 200 (FIG. 23).
[0055] Continuing to refer to FIGS. 1 - 5, the retaining cap 170 of the hub assembly 160 is configured for snap-fit or other suitable engagement with the proximal end portion of the proximal extension portion 164. The retaining cap 170 defines a longitudinal lumen 174 that extends therethrough. The retaining cap 170 further defines a pocket 178 that is configured to receive an RFID chip 190 therein. When the retaining cap 170 engages with the proximal extension portion 164, for example, by snap-fit, the open end of the pocket 178 is blocked by the proximal face of the proximal extension portion 164, thereby capturing the RFID chip 190 therein.
[0056] The drive assembly 180 is configured to operably couple a drive rotor (not shown) of the handpiece assembly 200 (see FIG. 23) to the drive wire 140, whereby rotation of the drive rotor drives rotation and / or vibration of the drive wire 140, thereby driving rotation and / or vibration of the distal cutting tip 150 within and relative to the outer shaft 120. The drive assembly 180 specifically includes a proximal driver 182, a distal driver 184, and a biasing spring 186, such as a coil compression spring. Additionally, the drive assembly 180 may include a gearing (not shown) configured to amplify or attenuate the output rotation of the drive wire 140 relative to the input rotation received from the drive rotor of the handpiece assembly 200 (FIG. 23).
[0057] Referring to FIG. 7, the distal driver 184 of the drive assembly 180 includes a proximal body portion 185a, a distal body portion 185b, and a collar 185c disposed between the proximal and distal body portions 185a, 185b, respectively. A seal 189 can engage annularly around the collar 185c. The seal 189 is configured to establish a liquid-tight seal across an annular gap between the distal driver 184 and the distal body portion 162 of the hub housing 161 to prevent flow of fluid within the annular gap proximally beyond the seal 189 (see FIG. 20). The distal driver 184 further includes a lumen 185d extending therethrough in part. The proximal body portion 185a of the distal driver 184 further includes a proximal leg 185e extending proximally therefrom. At least a portion of the proximal leg 184e defines a non-circular cross-sectional configuration, such as a semi-circular, rectangular, or other polygonal configuration. Additionally, the lumen 185d is open at the proximal leg 185e, such that, for example, the proximal leg 185e defines an open portion in communication with the lumen 185d.
[0058] Referring also to FIG. 21, the distal body portion 185b of the distal driver 184 of the drive assembly 180 is configured to receive and engage with the finger portion 143b of the proximal end portion 143a of the body 142 of the drive wire 140. More specifically, the distal body portion 185b defines a longitudinally extending slot 185f that communicates with a lateral slot 185g. The lateral slot 185g is configured to receive the finger portion 143b, while the longitudinally extending slot 185f is configured to receive a portion of the body 142 of the drive wire 140 that extends distally from the finger portion 143b. The finger portion 143b can be disposed at substantially a right angle to the body 142 or at any other suitable angle, and thus the lateral slot 185g can be disposed at substantially a right angle to the longitudinally extending slot 185f or at any other suitable angle. This right-angle engagement facilitates torque transmission and provides axial fixation between the distal driver 184 and the drive wire 140. Further, an adhesive (e.g., epoxy) disposed within the lateral slot 185g and / or the longitudinally extending slot 185f (and / or on the finger portion 143b and / or the body 142) can be utilized to facilitate the engagement between the distal driver 184 and the drive wire 140. Instead of, or in addition to, the detailed lateral finger (and adhesive) engagement described above, in an embodiment, the distal driver 184 is overmolded around the proximal portion 143a of the body 142 of the drive wire 140 to fix the distal driver 184 and the drive wire 140 to each other.
[0059] As shown in FIG. 22, instead of engaging the drive wire 140 directly with the distal driver 184, a connector 3143 can be provided to engage the drive wire 140 with the distal driver 184. The drive wire 140 can be connected to the connector 3143 by snap-fit engagement, adhesive (with or without engagement of the lateral fingers as detailed above), press-fit engagement, heat staking, combinations thereof, or any other suitable method. The connector 3143 can then be connected to the distal drive 184 by spin welding, overmolding, heat staking, combinations thereof, or any other suitable method. The connector 3143 can be formed from metal, such as stainless steel, plastic, or can include both plastic and metal parts.
[0060] Referring to FIG. 20, the distal driver 184 defines a flow path therethrough. More specifically, the distal body portion 185b of the distal driver 184 defines lateral openings 185h that are opposite each other on both sides thereof and communicate with the lumen 185d of the distal driver 184. In this way, fluid, tissue, and debris that are drawn proximally through the window 128 (FIGS. 10-12) and through the outer shaft 120 (around the drive wire 140) to the distal body portion 162 of the hub housing 161 are further drawn through the lateral openings 185h into the lumen 185d.
[0061] Referring to FIGS. 4, 5, 20, and 21, the proximal driver 182 of the drive assembly 180 includes a proximal body portion 183a and a distal body portion 183b. The proximal body portion 183a includes an external collar 183c disposed annularly around it. The proximal body portion 183a further includes a proximal opposing cavity 183d having at least a portion thereof with a non-circular cross-sectional configuration, such as an eight-point star or other polygonal configuration, which is configured to at least partially receive the drive rotor of the handpiece assembly 200 (FIG. 23) in a fixed rotational direction. The distal body portion 183b defines a distal opposing cavity 183e having at least a portion thereof with a non-circular cross-sectional configuration, such as a semi-circular, rectangular, or other polygonal configuration. A longitudinally extending slot 183f (FIG. 21) defined through the sidewall of the distal body portion 183b communicates with the distal opposing cavity 183e. The distal opposing cavity 183e of the distal body portion 183b of the proximal driver 182 is configured to slidably receive the proximal leg 185e of the distal driver 184 in a fixed rotational direction due to its non-circular and at least partially complementary configuration.
[0062] As shown in FIGS. 20 and 21, the slot 183f extending in the longitudinal direction of the proximal driver 182 is disposed in fluid communication with the lumen 185d of the distal driver 184, whereby fluid, tissue, and debris can be aspirated from the lumen 18d, through the longitudinally extending slot 183f, and further through the outflow opening 165 of the proximal extension portion 164 of the hub housing 161 in at least some rotational directions of each of the proximal and distal drivers 182, 184 relative to the hub housing 164. The fluid, tissue, and debris aspirated through the outflow opening 165 of the proximal extension portion 164 of the hub housing 161 can further pass through an outflow path defined through the handle housing 210 (FIG. 23) of the handpiece assembly 200 and ultimately be aspirated into a collection container (not shown) through the outflow port 400 (FIG. 23) and an outflow tube (not shown). As will be appreciated, aspiration can also be provided through the outflow path defined above. More specifically, the outflow tube (not shown) is configured to connect to the outflow port 400 and thereby connect the outflow port 400 to a fluid management system (not shown). The fluid management system includes a vacuum source for establishing aspiration through the tissue resection instrument 10, as well as an outflow tube for facilitating the removal of fluid, tissue, and debris from the surgical site, and may also include a collection reservoir, such as a collection canister, for the collection of the removed liquid, tissue, and debris. Instead of or in addition to a vacuum source for establishing aspiration through the tissue resection instrument 10 and the outflow tube, a vacuum may be created through and via a pressure differential between the surgical site and the outflow path.
[0063] Referring again to FIGS. 4, 5, 20, and 21, the biasing spring 186 is disposed around the proximal body portion 185a of the distal driver 184 and includes a distal end that abuts the collar 185c of the distal driver 184. The biasing spring 186 includes a proximal end that is configured to abut the distal end of the distal body portion 183b of the proximal driver 182. In this way, the biasing spring 186 biases the proximal driver 182 in the proximal direction relative to the distal driver 184. The complementary features on the proximal driver 182 and the retaining cap 170 mate at this more proximal position of the proximal driver 182 to rotatably lock the proximal and distal drivers 182, 184 relative to the retaining cap 170 and the hub housing 161, and as a result, the drive wire 140 can be rotatably fixed relative to the outer shaft 120 at this position. When the end effector assembly 100 engages the handpiece assembly 200 (FIG. 23), a drive rotor (not shown or other portion) of the handpiece assembly 200 is received, for example, at least in part by its complementary configuration, within the proximal facing cavity 183d of the proximal body portion 183a of the proximal driver 182 in its fixed rotational direction. When the driver rotor is inserted into and reaches the bottom within the proximal facing cavity 183d, further insertion of the end effector assembly 100 biases the proximal driver 182 distally through and relative to the retaining cap 170 against the bias of the biasing spring 186, thereby displacing the proximal driver 182 distally relative to the retaining cap 170 and displacing the complementary features, thereby rotatably unlocking the proximal and distal drivers 182, 184 from the retaining cap 170 and the hub housing 161. Thus, when the end effector assembly 100 engages the handpiece assembly 200, the drive wire 140 is unlocked from the outer shaft 120 and is permitted to rotate relative thereto.
[0064] Referring to FIGS. 21 and 23, with the end effector assembly 100 engaged with the handpiece assembly 200 as detailed above, the RFID chip 190 of the end effector assembly 100 is disposed in vertical alignment with an RFID transceiver (not shown) of the handpiece assembly 200, enabling the RFID transceiver to read / write data from / to the RFID chip 190 and / or, for example, read / write data from / to a control unit via a cable 300.
[0065] Data stored in the RFID chip 190 of the end effector assembly 100 may include an item number, e.g., an SKU number, a manufacturing date, a manufacturing location, e.g., a location code, a serial number, a number of uses (which may be updated by writing data from the RFID transceiver 290 to the RFID chip 190), a home / initial position of the drive wire 140, a rotation type (rotation vs. vibration), an RPM setting (default, high, medium, low), a maximum RPM, pressure setting information, vacuum setting information, efflux setting information, calibration information, and / or an encryption key(s). Additional or alternative data is also contemplated.
[0066] Referring generally to FIGS. 1 - 5, 10 - 12, 20, 21, and 23, with the end effector assembly 100 engaged with the handpiece assembly 200 as detailed above, the tissue resection instrument 10 is ready for use. During use, a motor (not shown) of the handpiece assembly 200 is actuated to drive the rotation of the drive rotor. Upon actuation of the motor, suction is established through the tissue resection instrument 10, for example, by actuating a vacuum source of a fluid management system, either with a head start, a delay, or independently of the actuation of the motor.
[0067] When the motor is operated in either a rotational or oscillatory manner, the rotation of the drive rotor is driven, whereby the rotation of the proximal driver 182 is driven, and further, the rotation of the distal driver 184 is driven, whereby the drive wire 140, and thus the distal cutting tip 150, is rotated or oscillated relative to the outer shaft 120. The rotation or oscillation of the distal cutting tip 150 relative to the outer shaft 120, together with the suction applied through the outer shaft 120, causes tissue to be drawn through the cutting window 128 and cut by the distal cutting tip 150 and / or the cutting edge 129a, and together with fluid and debris, (around the drive wire 140) through the outer shaft 120, the drive assembly 180, through the output opening 165 of the proximal extending portion 164 of the hub housing 161, and proximally sucked to the outflow port 400 through the outflow path of the handpiece assembly 200, enabling it to be output to the collection reservoir of the fluid management system.
[0068] Referring to FIG. 23, as an alternative to the handpiece assembly 200 configured for manual grasping and operation during use, the tissue resection instrument 10 may alternatively be configured for use in a robotic surgical system, where the handle housing 210 is configured to engage the robotic arm of the robotic surgical system. The robotic surgical system can utilize various robotic elements to assist the surgeon and enable remote operation (or partial remote operation). More specifically, various robotic arms, gears, cams, pulleys, electric motors, and mechanical motors, etc., can be used for this purpose and can be designed with the robotic surgical system to assist the surgeon during the surgical or therapeutic process. The robotic surgical system can include a remotely operable system, an automated robotic surgical system, a remotely robotic surgical system, a remotely articulated robotic surgical system, a wireless surgical system, a modular or selectively configurable remotely operated surgical system, etc.
[0069] A robotic surgical system can be used with one or more consoles adjacent to the operating room or located at a remote location. In this case, one team of surgeons or nurses prepares the patient for surgery, and another surgeon (or group of surgeons) can configure a robotic surgical system that uses the surgical devices disclosed herein while remotely controlling the surgical devices via the robotic surgical system. As can be appreciated, a highly skilled surgeon can perform multiple operations at multiple locations without leaving their remote console, which can be economically advantageous and beneficial for the patient or a series of patients.
[0070] The robotic arm of a robotic surgical system is typically coupled by a controller to a pair of master handles. The handles can be moved by a surgeon to generate corresponding movements of the working end of any type of surgical instrument (e.g., end effector, gripper, knife, scissors, camera, fluid delivery device, etc.) that can complement the use of the tissue resection device described herein. The movement of the master handles can be scaled such that the working end has a corresponding movement that is different from, smaller than, or larger than the movement performed by the hand of the surgeon operating it. The scale factor or gear ratio can be adjustable so that the operator can control the resolution of the working end of the surgical instrument(s).
[0071] Turning to FIGS. 24-26, another configuration of the distal end portion 3144 of the drive wire 3140, the distal cutting tip 3150, and the engagement therebetween is shown. Except where specifically distinguished below, the distal end portion 3144 of the drive wire 3140, the distal cutting tip 3150, and the engagement therebetween may be the same as any of the embodiments detailed above. The distal end portion 3144 of the drive wire 3140 does not define a circular outer periphery, but rather material has been removed therefrom such that the distal end portion 3144 defines a semi-cylindrical (semi-circular in cross-section) bottom surface 3145a and a planar top surface 3145b. A transition section 3146a that defines a curved transition surface 3146b is disposed between the body 3142 of the drive wire 3140 and the distal end portion 3144 of the drive wire 3140, defining a smooth transition between the arcuate outer surface of the body 3142 and the planar top surface 3145b of the distal end portion 3144.
[0072] The distal end portion 3144 of the drive wire 3140 further includes a semi-cylindrical notch 3145c that is defined therein and that is open to both the distal end of the distal end portion 3144 of the drive wire 3140 and the planar top surface 3145b, whereby the planar top surface 3145b branches into surface portions on both sides of the semi-cylindrical notch 3145c. The semi-cylindrical notch 3145c defines a substantially constant diameter along the distal end portion 3144 and further includes a transition portion whose depth (along the curved bottom surface) gradually decreases in the distal-to-proximal direction, defining a smooth transition from within the semi-cylindrical notch 3145c to the exterior of the body 3142 of the drive wire 3140.
[0073] The distal end portion 3144 of the drive wire 3140 is at least partially received within and engaged with the distal cutting tip 3150. More specifically, the distal end portion 3144 of the drive wire 3140 is received within the proximal portion of the semi-cylindrical lumen 3154 such that the semi-cylindrical bottom surface 3145a on the outside of the distal end portion 3144 of the drive wire 3140 complementarily mates with the semi-cylindrical inner surface of the cutting tip 3150 that defines the semi-cylindrical bottom of the semi-cylindrical lumen 3154. Further, at least a portion of the distal end face of the distal end portion 3144 of the drive wire 3140, e.g., the chamfered surface 3148, is proximal to the cutting teeth 3158 of the distal cutting tip 3150, and / or the distal end face of the distal end portion 3144 of the drive wire 3140 does not extend distally beyond the most proximal teeth 3158 on both sides of the distal cutting tip 3150. The branched planar upper surface 3145b of the distal end portion 3144 of the drive wire 3140 may be coplanar with the upper surface 3155 (defined by the side walls 3156) of the cutting tip 3150.
[0074] The more proximal positioning of the distal end portion 3144 of the drive wire 3140 relative to the cutting tip 3150 maximizes the open volume within the portion of the semi-cylindrical lumen 3154 beneath the cutting teeth 3158, increasing the amount of tissue, fluid, and debris that can be received therein. The semi-cylindrical notch 3145c extending proximally from the portion of the semi-cylindrical lumen 3154 beneath the cutting teeth 3158 provides additional open volume to facilitate the proximal flow of tissue, fluid, and debris through the outer shaft 3120 around the distal end portion 3144 of the drive wire 3140. Further, the distal end of the distal end portion 3144 of the drive wire 3140 may define the chamfered surface 3148 to facilitate the proximal flow of tissue, fluid, and debris from the semi-cylindrical lumen 3154 to the semi-cylindrical notch 3145c and / or around the distal end portion 3144 of the drive wire 3140.
[0075] Referring to FIGS. 27-29, another configuration of the distal end portion 4144 of the drive wire 4140, the distal cutting tip 4150, and the engagement therebetween is shown. Except where specifically distinguished below, the distal end portion 4144 of the drive wire 4140, the distal cutting tip 4150, and the engagement therebetween can be similar to any of the embodiments detailed above. The distal end portion 4144 of the drive wire 4140 is similar to the distal end portion 3144 (FIGS. 24-26) of the drive wire 3140, except that the distal end portion 4144 does not include a semi-cylindrical notch. The distal end portion 4144 of the drive wire 4140 is received within the proximal portion of the semi-cylindrical lumen 4154 of the cutting tip 4150 such that the semi-cylindrical bottom surface 4145 outside the distal end portion 4144 of the drive wire 4140 complementarily mates with the semi-cylindrical inner surface of the cutting tip 4150 that defines the semi-cylindrical bottom of the semi-cylindrical lumen 4154. Further, at least a portion of the distal end surface of the distal end portion 4144 of the drive wire 4140, e.g., the chamfered surface 4148, is proximal to the cutting teeth 4158 of the distal cutting tip 4150, and / or the distal end surface of the distal end portion 4144 of the drive wire 4140 does not extend distally beyond the most proximal teeth 4158 on both sides of the distal cutting tip 4150.
[0076] Referring to FIGS. 30-32, another configuration of the distal end portion 5144 of the drive wire 5140, the distal cutting tip 5150, and the engagement therebetween is shown. Except where specifically distinguished below, the distal end portion 5144 of the drive wire 5140, the distal cutting tip 5150, and the engagement therebetween can be similar to any of the embodiments detailed above.
[0077] The distal cutting tip 5150 includes a semi-cylindrical body 5152 that defines a semi-cylindrical lumen 5154. The semi-cylindrical body 5152 defines a semi-cylindrical bottom surface 5155a, a planar top surface 5155b defined by first and second side walls 5156 spaced apart from each other to define an elongated mouth 5157 providing access to the semi-cylindrical lumen 5154, an open proximal end 5155c, and at least partially closed distal end 5155d. The distal cutting tip 5150 further defines a slot 5159 that extends longitudinally through the semi-cylindrical bottom surface 5155a on the opposite side of the elongated mouth 5157. The slot 5159 has an open proximal end at the proximal end of the distal cutting tip 5150.
[0078] The distal end portion 5144 of the drive wire 5140 is at least partially received within and engaged with the distal cutting tip 5150. More specifically, the distal end portion 5144 of the drive wire 5140 is received within the semi-cylindrical lumen 5154 such that at least a portion of the semi-cylindrical bottom surface 5145a of the distal end portion 5144 of the drive wire 5140 extends within the slot 5159 of the distal cutting tip 5150. In this way, the distal end portion 5144 of the drive wire 5140 is permitted to seat further within the distal cutting tip 5150, such that the planar top surface 5145b of the distal end portion 5144 of the drive wire 5140 is not coplanar with the top surface 5155b (defined by the side walls 5156) of the cutting tip 5150, but is recessed with respect to the top surface 5155b. Accordingly, the open volume within the semi-cylindrical lumen 5154 is increased, thereby increasing the amount of tissue, fluid, and debris that can be received therein.
[0079] Turning to FIGS. 33-35, another configuration of the drive wire 6140, the distal cutting tip 6150, and the engagement therebetween is shown. Except where specifically distinguished below, the drive wire 6140, the distal cutting tip 6150, and the engagement therebetween can be the same as any of the embodiments detailed above.
[0080] The drive wire 6140 does not include a distal end portion from which material has been removed, but rather defines a cylindrical configuration relative to its distal end. The outer diameter of the drive wire 6140 generally approximates (e.g., within 10%) the inner diameter of the semi-cylindrical lumen 6154 of the distal cutting tip 6150. The distal end of the drive wire 6140 extends to or minimally into the semi-cylindrical lumen 6154 of the distal cutting tip 6150 and engages the distal cutting tip 6150 by welding (e.g., overlap welding or butt welding) at a position spaced proximally from the cutting teeth 6158 of the distal cutting tip 6150. More specifically, in an embodiment, the distal end of the drive wire 6140 extends within the semi-cylindrical lumen 6154 of the distal cutting tip 6150 a distance of 20% or less of the length of the distal cutting tip 6150, in other embodiments a distance of 17% or less of the length of the distal cutting tip 6150, and in yet other embodiments a distance of 15% or less of the length of the distal cutting tip 6150. Thus, the open volume within the semi-cylindrical inner cavity 6154 of the distal cutting tip 6150 is maximized.
[0081] Although some embodiments of the present disclosure are shown in the drawings, the present disclosure is intended to be as broad as is acceptable in the art and the specification is to be read accordingly, and thus the present disclosure is not intended to be limited to these embodiments. Accordingly, the above description should not be construed as limiting, but rather as merely illustrative of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the appended claims.
[0082] The foregoing disclosure has been described in some detail by way of illustration and example, but it will be apparent that certain changes and modifications can be practiced within the scope of the appended claims for purposes of clarification or understanding.
Claims
1. An end effector assembly for a tissue resection device, the end effector assembly comprising: an outer shaft defining a proximal end portion and a distal end portion, the distal end portion of the outer shaft defining a window therethrough; an outer shaft; a drive wire extending through the outer shaft, the drive wire including a cylindrical body and a distal end portion defining a semi-cylindrical configuration including a semi-cylindrical bottom surface and a planar top surface; a drive wire; a distal cutting tip disposed within the outer shaft, the distal cutting tip at least partially overlapping the window, the distal cutting tip defining a semi-cylindrical lumen defined by a semi-cylindrical bottom surface and an open top; a distal cutting tip; comprising the distal end portion of the drive wire is at least partially received within the semi-cylindrical lumen of the distal cutting tip and engaged with the semi-cylindrical bottom surface of the distal end portion of the drive wire that substantially mates with the semi-cylindrical bottom surface of the distal cutting tip, the drive wire being configured to drive rotation or vibration of the distal cutting tip relative to the outer shaft; the distal cutting tip includes a plurality of teeth extending along a portion of its length, the plurality of teeth including a first set of teeth disposed on a first side of the semi-cylindrical lumen and a second set of teeth disposed on a second opposite side of the semi-cylindrical lumen; An end effector assembly, wherein the distal end of the distal end portion of the drive wire does not extend distally beyond the respective first teeth of the first set of teeth and the second set of teeth.
2. The end effector assembly according to claim 1, wherein the distal end of the distal end portion of the drive wire is positioned proximal to the plurality of teeth.
3. The drive wire includes a transition portion disposed between the cylindrical body and the distal end portion, the transition portion including a curved surface. The end effector assembly according to claim 1.
4. A semi-cylindrical notch is defined within the planar top surface, The semi-cylindrical notch includes a transition portion defined within the transition portion of the drive wire, the transition portion of the semi-cylindrical notch being defined by a curved bottom surface. The end effector assembly according to claim 3.
5. The end effector assembly according to claim 1, wherein the distal end portion of the drive wire includes a chamfered distal surface.
6. The end effector assembly according to claim 1, wherein the drive wire includes a semi-cylindrical notch defined within the planar upper surface.
7. The end effector assembly according to claim 1, wherein the planar upper surface of the distal end portion of the drive wire is recessed relative to the open upper portion of the distal cutting tip.
8. The end effector assembly according to claim 1, wherein the distance measured from the location where the drive wire is first received within the semi-cylindrical lumen to the most distal end of the drive wire is 20% or less of the length of the distal cutting tip.
9. The end effector assembly according to claim 1, wherein the distance measured from the location where the drive wire is first received within the semi-cylindrical lumen to the most distal end of the drive wire is 15% or less of the length of the distal cutting tip.
10. The end effector assembly according to claim 1, wherein the drive wire is engaged within the distal cutting tip by welding.
11. A tissue resection device, the tissue resection device comprising: a handpiece; an end effector assembly according to any one of claims 1 to 10; and wherein the end effector assembly is configured to releasably engage with the handpiece.
12. The tissue resection device according to claim 11, wherein the end effector assembly further includes a hub assembly configured to releasably engage with the handpiece, and when the end effector assembly is releasably engaged with the handpiece, the outer shaft is fixed relative to the handpiece and the drive wire is operably coupled to a motor of the handpiece.
13. The tissue resection device according to claim 12, wherein the hub assembly includes an RFID chip therein, and the RFID chip is configured to be read by an RFID reader of the handpiece to enable identification of the end effector assembly.
Citation Information
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