WO2026030641A1 - Vessel sealing device - Google Patents
Vessel sealing deviceInfo
- Publication number
- WO2026030641A1 WO2026030641A1 PCT/US2025/040196 US2025040196W WO2026030641A1 WO 2026030641 A1 WO2026030641 A1 WO 2026030641A1 US 2025040196 W US2025040196 W US 2025040196W WO 2026030641 A1 WO2026030641 A1 WO 2026030641A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- jaw
- cutting member
- instrument
- instrument body
- actuation handle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B2018/1452—Probes having pivoting end effectors, e.g. forceps including means for cutting
- A61B2018/1455—Probes having pivoting end effectors, e.g. forceps including means for cutting having a moving blade for cutting tissue grasped by the jaws
Definitions
- inventions are related to surgical systems and devices. Specifically, but not intended to limit the invention, embodiments of the invention are related to surgical devices for sealing, dividing and dissecting tissue during surgical procedures.
- Electrosurgical instruments for applying electrical energy to tissue are used widely in surgical procedures. Electrosurgical instruments used in vessel sealing rely on a combination of pressure and high frequency electrical energy applied to biological tissue to cut, coagulate, desiccate or seal tissue, for example, blood vessels.
- vessel sealing technology specifically focused small end effectors for micro-surgical procedures, including U.S. Patent No. 11 ,399,884 which describes a vessel sealing system that enables effective and safe vessel sealing of small caliber blood vessels at lower power outputs. Larger devices for sealing larger vessels have received comparatively less attention despite their wide use in general surgery. None of the prior art in this field addresses the unique circumstances presented with larger devices or enables similar safe and effective sealing of large vessels at lower power outputs.
- a tissue sealing and cutting instrument includes an instrument body having an instrument body handle, a shaft having a proximal end coupled to the instrument body, and a pair of opposing jaws movably coupled to a distal end portion of the shaft.
- a jaw actuation handle is movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween.
- the instrument includes a cutting member, e.g., a knife or other type of blade at least partially disposed in the shaft.
- a cutting member trigger is movably coupled to the instrument body and operatively coupled with a pinion rotatably mounted within the instrument body, the pinion also being operatively coupled to the cutting member, wherein moving the cutting member trigger towards the instrument body housing rotates the pinion to thereby distally advance the cutting member from a retracted position substantially proximal of the opposing jaws to an extended position between the opposing jaws to cut through tissue clamped therebetween, and wherein the jaw actuation handle interferes with and prevents rotation of the pinion, and the corresponding distal advancement of the cutting member, unless the jaw actuation handle is pivoted sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
- the cutting member trigger may be pivotably coupled to the housing body, such that the cutting member trigger may be pivoted angularly between a non-actuated position farthest from the instrument body handle, and a fully- actuated position closest to the instrument body handle, the pinion having corresponding non-actuated and fully-actuated rotational positions such that the cutting member is in the fully-retracted position when the pinion is in the nonactuated rotational position, and in the fully-extended position when the pinion is in the fully-actuated rotational position.
- the instrument includes a boss extending from a surface of the pinion that contacts a corresponding extended or protruding portion of the jaw actuation handle to prevent rotation of the pinion beyond the non-actuated rotational position unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
- the boss may have a curvilinear formation, with a first end that contacts the extended or protruding portion of the jaw actuation handle to prevent rotation of the pinion beyond the non-actuated rotational position unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position, wherein, once the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position, the boss prevents the extended or protruding portion of the jaw actuation handle from interfering with pinion as the pinion rotates from the non-actuated rotational position to the fully-actuated rotational position.
- the pinion is part of a rack and pinion assembly mounted in the instrument body, the instrument further including a cutting member actuator at least partially extending through the shaft, the cutting member actuator having a proximal end portion coupled to or integral with the rack, and a distal portion coupled to or integrally formed with the cutting member, such that movement of the cutting member trigger from the non-actuated position to the fully-actuated position translates the cutting member actuator relative to the shaft to move the cutting member from the fully-retracted position to the fully- extended position.
- These embodiments may further include a cutting member biasing element configured to move the cutting member trigger to, and/or maintain the cutting member trigger in, the non-actuated position, thereby moving the cutting member to, and/or maintaining the cutting member in, the fully- retracted position whenever a user is not actively moving the cutting member trigger to, and/or holding the cutting member trigger in, the fully-actuated position.
- a cutting member biasing element configured to move the cutting member trigger to, and/or maintain the cutting member trigger in, the non-actuated position, thereby moving the cutting member to, and/or maintaining the cutting member in, the fully- retracted position whenever a user is not actively moving the cutting member trigger to, and/or holding the cutting member trigger in, the fully-actuated position.
- the cutting member biasing element comprises a return spring positioned in-line with the rack, wherein the return spring is compressed by the rack as a user moves the cutting member trigger from the non-actuated position to the fully-actuated position, and wherein the return spring self-restores to a non-compressed state, thereby moving the respective rack, cutting member actuator, and cutting member proximally until the cutting member is in the fully-retracted position, with the pinion and cutting member trigger moving from the respective fully-actuated positions to nonactuated positions, respectively, when the user releases the cutting member trigger.
- the jaw actuation handle being pivotally coupled to the instrument body, wherein the jaw actuation handle may be pivoted angularly between a non-actuated position farthest from the instrument body handle, and a fully-actuated position closest to the instrument body handle, wherein the pair of opposing jaws are in the open position when the jaw actuation handle is in the non-actuated position, and in the approximate position when the jaw actuation handle is in the fully-actuated position.
- the instrument includes a jaw actuator at least partially extending through the shaft, the jaw actuator having a proximal end portion coupled to the jaw actuation handle, and a distal end portion coupled to the pair of opposing jaws, such that pivoting the jaw actuation handle from the non-actuated position to the fully-actuated position translates the jaw actuator proximally relative to the shaft from a most distal position relative to the shaft, with the pair of opposing jaws in the open position, to a most proximal position relative to the shaft, with the pair opposing jaws in the approximate position.
- a jaw actuation biasing element may be provided and configured to move the jaw actuation handle to, and/or maintain the jaw actuation handle in, the non-actuated position, thereby moving the opposing pair of jaws to, and/or maintaining the opposing pair of jaws in, the open position whenever a user is not actively moving the jaw actuation handle to, and/or holding the jaw actuation handle in, the fully- actuated position.
- the jaw actuation biasing element may be a return-spring positioned in-line with the jaw actuator, wherein the return-spring is compressed by the jaw actuator as a user moves the jaw actuation handle from the non-actuated position to the fully-actuated position, and wherein the return spring self-restores to a non-compressed state, thereby moving the jaw actuator back to the most distal position, with the jaw actuation handle moving from the fully-actuated position to the non-actuated position, respectively, when the user releases the jaw actuation handle.
- the opposing pair of jaws includes a first jaw and a second jaw, the first jaw comprising a channel extending along a length of the first jaw, and the second jaw comprising a channel extending along a length of the second jaw, the first and second jaw channels aligned with each other such that, when the jaws are in the approximate configuration, the first and second jaw channels together form a slot through which the cutting member travels.
- the first and second jaws have curved profiles along their lengths.
- the instrument body comprises an instrument body housing, with a first energy activation switch disposed on a first side of the instrument body housing, and a second energy activation switch disposed on a second side of the instrument body housing, wherein the first and second energy activation switches are configured and positioned on the respective first and second sides of the instrument body housing such that a user holding the instrument with a right hand or a left hand while squeezing the jaw actuation handle into the instrument body handle can use of thumb or other digit of the respective right hand or left hand to contact and activate one of the first and second energy activation switches without releasing the jaw actuation handle.
- activation of the first and/or second energy activation switches initiates delivery of energy from a generator coupled to the instrument to seal tissue clamped between the pair of opposing jaws.
- the instrument further includes a latching mechanism, the latching mechanism including a housing maze disposed within the instrument body, and a latch pin, the latch pin having one end coupled to the jaw actuation handle and another end configured to travel within the housing maze, wherein when a user a user moves the jaw actuation handle towards the instrument body handle sufficiently to move the pair of opposing jaws into the approximate position, the latch pin engages a structure of the housing maze to maintain the position of the jaw actuation handle, and thus maintain the jaws in the approximate position, even if the user releases the jaw actuation handle.
- the latching mechanism including a housing maze disposed within the instrument body, and a latch pin, the latch pin having one end coupled to the jaw actuation handle and another end configured to travel within the housing maze, wherein when a user a user moves the jaw actuation handle towards the instrument body handle sufficiently to move the pair of opposing jaws into the approximate position, the latch pin engages a structure of the housing maze to maintain the position of the jaw actuation
- the user may pull the jaw actuation handle further towards the instrument body handle, so that the latch pin is released from its engagement with the housing maze structure, and the pair of opposing jaws can return to the open position when the user releases the jaw actuation handle.
- FIG. 2 is a perspective end view of the generator cable connector of FIGS. 1A and 1B
- FIGS. 3A and 3B are side and perspective exploded views of the tissue sealing and cutting device of FIG. 1 .
- FIG. 5 is a partial perspective view of an opposite side view of the interface depicted in FIGS. 4A-C.
- FIG. 6 is an exploded side view of a latching mechanism of the tissue sealing and cutting device of FIG. 1 .
- FIGS. 7A and 7B are side views the latching mechanism depicted in FIG. 6
- FIGS. 8A-8C are respective side, top and perspective views of an energy activation assembly of the tissue sealing and cutting device of FIG. 1.
- FIGS. 9A-9C are side and top views of the pair of opposing jaws of the tissue sealing and cutting device of FIG. 1 .
- FIGS. 10A and 10B are cross-sectional partial views of the pair of opposing jaws depicted in FIGS. 9A-9C.
- FIGS. 11A-11C are cross-sectional partial and exploded views of the pair of opposing jaws depicted in FIGS. 9A-9C.
- FIGS. 12A-12D are perspective and exploded views of the first jaw depicted in FIGS. 9A-9C.
- FIGS. 13A and 13B are views of one of the jaws depicted in FIGS. 9A- 9C
- FIGS. 14A and 14B are side views of an alternative jaw embodiment.
- FIGS. 15 and 16 are perspective views of a cutting member stabilizing assembly, according to some embodiments.
- FIGS. 17 and 18 are enlarged views of selected components of the cutting member stabilizing assembly of FIGS. 15 and 16.
- FIGS. 19A and 19B are side and cutaway cross-sectional views of one of the jaws depicted in FIGS. 12A-D.
- FIGS. 20 and 21 are perspective views of an alternative jaw frame and a non-conductive insert.
- FIGS. 22A-C are top views of one of the jaws depicted in 9A-9C.
- FIG. 23 is a perspective view of an alternative instrument jaw assembly.
- FIG. 24 is a cross-section depicting the pivot pin connection features in the jaw assembly of FIG. 23.
- FIG. 25 is a partially cut-away top view of another alternative instrument jaw assembly that is similar the jaw assembly of the instrument of FIGS. 1A-1B.
- FIG. 26 is a cross-section depicting the pivot pin connection features in the jaw assembly of FIG. 25.
- FIGS. 27 and 28 are cut-away side views of an alternate embodiment of a tissue sealing and cutting instrument.
- FIGS. 29 and 30 are perspective views of a jaw link member deployed in an existing tissue sealing and cutting device.
- FIGS. 31 and 32 are perspective views of an alternative jaw link member deployed in the tissue sealing and cutting device of FIG. 31.
- Terms of orientation used herein such as “top,” “bottom,” “horizontal,” “vertical,” “longitudinal,” “lateral,” and “end” are used in the context of the illustrated embodiment. However, the present disclosure should not be limited to the illustrated orientation. Indeed, other orientations are possible and are within the scope of this disclosure. Terms relating to circular shapes as used herein, such as diameter, radius or arcuate, should be understood not to require perfect circular structures, but rather should be applied to any suitable structure with a cross-sectional region that can be measured from side-to-side.
- Conditional language used herein such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that some embodiments include, while other embodiments do not include, certain features, elements, and/or states. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment.
- the terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result.
- the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than or equal to 10% of the stated amount.
- the term “generally” as used herein represents a value, amount, or characteristic that predominantly includes or tends toward a particular value, amount, or characteristic.
- the term “generally parallel” can refer to something that departs from exactly parallel by less than or equal to 20 degrees. Where the term “about” is utilized before a range of two numerical values, this is intended to include a range between about the first value and about the second value, as well as a range from the first value specified to the second value specified.
- a device configured to are intended to include one or more recited devices. Such one or more recited devices can be collectively configured to carry out the stated recitations.
- a processor configured to carry out recitations A, B, and C can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.
- the terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth.
- the terms “some,” “certain,” and the like are synonymous and are used in an open-ended fashion.
- the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
- any ranges disclosed herein also encompass any and all overlap, subranges, and combinations thereof.
- Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ⁇ 5%, ⁇ 10%, ⁇ 15%, etc.). For example, “about 1 V” includes “1 V.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially perpendicular” includes “perpendicular.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.
- FIGS. 1A and 1B illustrate respective side views of a tissue sealing and cutting instrument 100 constructed in accordance with one embodiment of the disclosed inventions.
- the instrument 100 includes an instrument body 110 having an instrument body housing 200.
- the instrument body housing 200 has a first (right-handed) side 200a, and a second (left-handed) side 200b, lower portions of which together form an instrument body handle 220.
- the second side 200b of the instrument body housing 200 is partially removed in FIG. 1B to reveal interior components in instrument body 110.
- a jaw actuation handle 310 and a cutting member translation trigger 410 are each pivotably coupled to the instrument body 110.
- An elongated shaft 122 has a proximal end coupled to the instrument body 110.
- a pair of opposing jaws 700 including a first jaw 720 and second jaw 740, are movably coupled to a distal end portion of the shaft 122.
- a first energy activation contact switch 510a is located on an exterior surface of the first side 200a of the instrument body housing 200, and a second energy activation contact switch 510b is located on the second side 200b of the instrument body housing 200.
- the elongated shaft 122 has an inner shaft lumen 124 through which an elongate tubular cutting member actuator 440 and an elongate tubular jaw actuator 320 at least partially extend, with the cutting member actuator 440 being disposed over the jaw actuator 320.
- a proximal end portion of the cutting member actuator 440 is operatively coupled (i.e., mechanically linked) with the cutting member translation trigger 410, and a distal end of the cutting member actuator 440 is coupled to, or formed integrally with, a cutting member 450 (Fig. 1A).
- a proximal end of the jaw actuator 320 is operatively coupled (i.e., mechanically linked) to the jaw actuation handle 310, and a distal end of the jaw actuator 320 is coupled to the pair of opposing jaws 700.
- the jaw actuation handle 310 controls physical movement of the opposing pair of jaws 700 between an open configuration, as depicted in FIG. 9B, and a tissue clamping or “approximate” configuration, as depicted (without any tissue clamped between the jaws) in FIG. 9A.
- the jaw actuation handle 310 may be pivoted angularly between a non-actuated position, in which the jaw actuation handle 310 is farthest from the instrument body handle 220, and a fully-actuated position, in which the jaw actuation 310 handle is closest to the instrument body handle 220.
- Pivoting the jaw actuation handle 310 from the non-actuated position to the fully-actuated position pulls (translates) the jaw actuator 320 proximally along an axis 121 of the shaft 122 (FIG. 1A) from a most distal position relative to the shaft 122, with the pair of opposing jaws 700 in the open position, to a most proximal position relative to the shaft 122, with the pair opposing jaws 700 in the approximate position.
- the opposing pair of jaws 700 are biased to be in the open configuration by a return spring 330a positioned in-line with the jaw actuator 320.
- a return spring 330a positioned in-line with the jaw actuator 320.
- the jaw actuation handle 310 pulls (translates) the jaw actuator 320 proximately from the most distal position relative to the shaft 122 to the most proximal positional relative to the shaft 122, thereby compressing the return spring 330a, and moving the pair of opposing jaws 700 from the open configuration into the approximate configuration for engaging and clamping and sealing tissue (e.g., a blood vessel) located between the pair of opposing jaws 700.
- tissue e.g., a blood vessel
- the return spring 330a self-restores to its non-compressed configuration, thereby pushing (translating) the jaw actuator 320 distally relative to the shaft 122, moving the jaw actuation handle 310 away from the instrument body handle 220, and returning the pair of opposing jaws 700 to the open configuration.
- the spring 330a imposes a sufficient force on the jaw actuator 320 such that the pair of opposing jaws 700 “spring open” as soon as the user releases the jaw actuation handle 310.
- a load limiting spring 330b is also located in-line with the jaw actuator 320, and is pre-loaded (i.e. compressed) to a desired pull force for the jaw actuator 320 to thereby limit the compressive force applied to the tissue clamped between the opposing pair of jaws 700 and prevent over compression.
- the spring 330b may be pre- loaded in a range of 24-34 Ibf, although the specific pre-load force on the spring 330b will vary from embodiment to embodiment depending on the seal plate configuration and other factors.
- the load limiting spring 330b is preferably positioned in-line with the jaw actuator 320 to avoid off-axis loading.
- the cutting member trigger 410 is part of a cutting member translation assembly 400 configured to control translation of the cutting member 450 between a fully-retracted position that is substantially proximal of the opposing pair of jaws 700, and a fully-extended position between the opposing pair of jaws for cutting through tissue clamped therein.
- the cutting member translation assembly 400 includes a pinion 420 that is operatively coupled to the cutting member trigger 410, the pinion 420 having a raised surface boss 428 that interfaces with the jaw actuation handle 310 to prevent distal translation of the cutting member 450 from the fully-retracted position when the opposing pair of jaws 700 are in the open position.
- the cutting member 450 is shown in an extended or partially extended position in FIG. 1A, even though the opposing pair of jaws 700 are in the open position. However, it should be appreciated that the cutting member 450 is never extended, deployed or substantially visible when the opposing pair of jaws 700 are in the open position.
- the cutting member trigger 410 may be pivoted angularly between a non-actuated position, in which the cutting member trigger is farthest from the instrument body handle 220, and a fully-actuated position in which the cutting member trigger is closest to the instrument body handle 220, with the pinion 420 having corresponding non-actuated and fully-actuated angular positions, such that the cutting member 450 is in the fully-retracted position when the pinion 420 is in the non-actuated angular position, and in the fully-extended position when the pinion 420 is in the fully-actuated angular position.
- the pinion surface boss 428 has a curvilinear formation, with a first end 428a that contacts an extended or protruding portion 328 of the jaw actuation handle 310 to prevent rotation of the pinion 420 beyond the non-actuated angular position unless the jaw actuation handle 310 is moved sufficiently towards the instrument body handle 220 to move the pair of opposing jaws 700 into the approximate position and the extended/protruding portion 328 of the jaw handle 310 no longer interferes with the boss 428, so that the pinion 420 may rotate to advance the cutting member 450 distally.
- the curvilinear boss 428 prevents the extended or protruding portion 328 of the jaw actuation handle 310 from interfering with rotation of the pinion 420 as the pinion is rotated from the non-actuated position to the fully-actuated position.
- the cutting member 450 may be a knife or other type of blade configured to cut through and separate sealed tissue clamped between the opposing pair of jaws 700.
- the cutting member 450 may be a separate piece that is attached to the cutting member actuator 440, or may be an integrally formed portion of the cutting member actuator 400.
- the cutting member 450 may include a cutting electrode (not shown) instead of, or in addition to, a knife/blade.
- Such vessel sealers with a cutting electrode include those illustrated and described in U.S. Pat. Publication 2024/0058052, the teachings of which are incorporated by reference herein in its entirety.
- the energy activation switches 510a and 510b are part of a tissue sealing energy delivery assembly 500 configured to deliver tissue sealing energy from a power source (“generator”) 564 to the pair of opposing jaws 700 via an electrical cable 560 extending from within the instrument body handle 220 to a connector 562 that couples with the generator 564.
- the connector 562 is depicted connected to the generator 564 in FIG. 1A, and disconnected from the generator in FIG. 1B.
- energy activation contact switches 510a and 510b are positioned on respective sides 200a and 200b of the instrument body housing 200 to allow a user to easily extend the thumb (or other digit) of their right or left hand that is holding the instrument 100 and actively compressing (squeezing) the jaw activation handle 310 into the instrument body handle 220 and press the respective contact switch 510a or 510b into/against the instrument body housing 200 without releasing the jaw actuation handle 310.
- Activation of one (or both) of the first and/or second energy activation contact switches 510a and 510b initiates delivery of energy from the generator 564 (when connected to the instrument 100 via the cable connector 562) to seal tissue clamped between the pair of opposing jaws.
- the generator 564 (shown schematically in FIGS. 1A-1B) is configured to generate and deliver energy, typically radio-frequency (RF) energy, to the pair of opposing jaws 700 in accordance with a pre-programmed power algorithm suitable for sealing and/or cutting tissue.
- the generator 564 may be the same as, or similar to, the generators described in U.S. Patent No. 10,342,599 and U.S. Patent No. 9,039,694, each of which is incorporated herein by reference in its entirety.
- parameters for the power algorithm are stored within the generator. These parameters may include, but are not limited to, maximum voltage, maximum current, maximum power, impedance cutoff, dwell time, dwell power, and power ramp up and ramp down times.
- the parameters for the generator power algorithm may be stored, e.g., on an EPROM chip, within the cable connector 562 and/or sealing device handle 220, and transmitted to the power source 564 when the connection is established.
- the energy activation assembly 500 includes a pair of dome switches 520a and 520b underlying the energy activation contact switches 510a and 510b, respectively, such that dome switch 520a is activated when a user depresses contact switch 510a, and dome switch 520b is activated when a user depresses contact switch 510b.
- the dome switches 520a and 520b are each electrically coupled to a flexible circuit conductor 530, which in turn is coupled to a pair of circuit connectors 540 that are electrically connected (through cable 562) to connector pins 562c and 562d of the generator cable connector 562 (FIG. 2).
- dome switch 520a and 520b When the cable connector 562 is connected to the generator 564, and the generator 564 is activated for use in a procedure with the tissue sealing and cutting instrument 100, activation of either dome switch 520a and 520b “closes” an energy activation control circuit coupled to pins 562c and 562d within the generator 564 to thereby initiate delivery of power from the generator 564 to the pair of opposing jaws 700 in accordance with the pre-programmed power algorithm.
- the dome switches 520a and 520b are secured to respective sides of a switch chassis 550 composed of non-conductive material(s) that is mounted at the top interior surface of the instrument body housing 200.
- FIG. 2 depicts the end of the generator connector 562 at the end of cable 560 that extends from the instrument handle 220.
- pins 562e and 562f form a circuit that identifies the instrument type (e.g., manufacturer make and model) and/or operating parameters to the generator 564.
- Larger gage pins 562a and 562b are respective active and return (ground) terminals of the sealing energy circuit, and are electrically coupled to respective jaws 720 and 740 via cable 560 and additional wires that travel through the instrument body 110 and shaft lumen 124, respectively, to the jaws 720 ground (anode).
- a latch pin 340 and jaw actuation handle pin 335 are coupled to the jaw actuation handle 310.
- the latch pin 340 is configured to engage and travel in a housing maze 230 (FIG. 6) for more controlled movement of the pair of opposing jaws 700.
- the jaw actuation handle pin 335 is coupled to the instrument body housing 200, so that the jaw actuation handle 310 pivots (or rotates) about the actuation handle pin 335 (e.g., pivot point), which will be described in further detail below.
- the cutting member translation drive pinion 420 operatively couples the cutting member trigger 410 to the drive rack 430.
- the drive rack 430 is in turn coupled to the cutting member actuator 440 via a cutting member cap 442.
- the drive pinion 420 is configured to rotate about a drive pin 424, which is configured to pass through and translate within a cutting translation assembly slot 414, as best shown in FIG. 3B.
- the drive pinion 420 further comprises a drive pinion first gear 422 and a drive pinion second gear 426.
- the first gear 422 of the drive pinion 420 is configured to engage the cutting member trigger 410.
- the first gear 422 of the drive pinion 420 engages a trigger gear 412 of the cutting member trigger 410.
- the second gear 426 of the drive pinion 420 is configured to engage a drive rack gear 436 of the drive rack 430 that is coupled to the cutting member actuator 440.
- the trigger gear 412 moves the first gear 422 of the drive pinion 420, which in turns moves the second gear 426 of the drive pinion 420 that engages and moves the drive rack gear 436.
- Movement of the drive rack gear 436 in turn causes the cutting member actuator 440 to translate the cutting member 450 distally.
- the drive pinion first gear 422 is smaller than the drive pinion second gear 426, resulting in an increase distance ratio (approximately 2:1) of the drive rack gear 436 with respect to the drive pinion first gear 422.
- the first gear 422 and the second gear 426 of the drive pinion 420, and the trigger gear 412 are substantially circular, semi-circular, curved or arcuate, while the drive rack gear 436 is substantially linear.
- the cutting member trigger 410 further comprises a trigger pin 416, as shown in FIG. 3B.
- the trigger pin 416 is coupled to the instrument body housing 200 such that the cutting member trigger 410 rotates about the trigger pin 416.
- the instrument body housing 200 includes a rotatable nose cone “knob” portion 270 coupled to a rotation knob bushing 275 configured to rotate the shaft 122 and, thus, the opposing pair of jaws 700 (FIGS. 3A-3B).
- a rotation knob bushing 275 configured to rotate the shaft 122 and, thus, the opposing pair of jaws 700 (FIGS. 3A-3B).
- the knob 270 engages the rotation knob bushing 275, which engages and rotates the shaft 122 thereby rotating the pair of jaws 700, as shown by arrow 271 in FIG. 3A.
- the pair of electrical wires 570 coupled to the pair of jaws 700 are wrapped within the rotation knob bushing 275 to provide sufficient slack to allow the electrical wires 570 to rotate.
- the cutting member translation assembly 400 is in a “locked” position with the cutting member 450 in the fully-retracted position whenever the pair of jaws 700 are in the open position (FIG. 4A), and a “unlocked” position where the cutting member 450 is allowed to be advanced distally to the fully-extended position (FIGS. 4B and 4C) when the pair of jaws 700 are in the approximate position.
- FIG. 4A illustrates the cutting member translation assembly 400 in the locked position.
- the drive pinion 420 is shown transparent in FIGS. 3A and 3C, such that the outlines of the drive pinion 420 components (e.g., first gear 422 and second gear 426) are better appreciated.
- the jaw actuation handle 310 comprises an extension/protruding portion 328 (FIG. 4A) that interferes with the drive pinion boss 428.
- the pinion boss 428 have an arcuate or curvilinear shape or any other suitable configuration.
- the jaw actuation handle extension/protruding portion 328 interferes with the end point 428a of the boss 428 and prevents rotation of the drive pinion 420 when the jaw actuation handle 310 in not actuated by the user.
- FIG. 4B illustrates the cutting member translation assembly 400 in the unlocked position, in which distal translation of the cutting member 450 is permitted, but before the cutting member is moved to the fully-extended position.
- the jaw actuation handle 310 is moved proximately by the user towards the instrument body handle 220 in the direction shown by arrow “I”, the boss end 428a of the drive pinion 420 does not interfere with the extension 328 of the jaw actuation handle 310.
- movement the jaw actuation handle 310 in the direction of arrow “I” allows rotation of the drive pinion 420 about the drive pin 424 in the direction of arrow “II”, as shown in FIG. 4B.
- FIG. 4C depicts the cutting member translation assembly 400 when the cutting member 450 is in the fully-extended position between the closed jaws (not shown). As shown in FIG. 4C, the jaw actuation handle 310 is held in the proximal or pulled position so that the cutting member trigger 410 is pulled or moved to the proximal position as well.
- the cutting member trigger 410 is moved in an angular motion (shown by arrow “II” in FIG. 4C) by rotating about a pivot point at the trigger pin 416 until the cutting member trigger 410 is adjacent and abutting the jaw actuation handle 310.
- This action rotates the drive pinion 420 about the drive pin 424 and moves the drive rack 430 and extends the cutting member 450 while the pair of opposing jaws 700 are in the close or approximate position.
- the second gear 426 of the drive pinion 420 that engages and moves the drive rack gear 436 and drive rack 430, respectively, which in turn translated the cutting member actuator 440 to extend the cutting member 450 to the fully-extended position.
- FIG. 4B shows the drive rack 430 in a proximal position
- FIG. 4C shows the drive rack 430 is distal position
- a cutting member return spring 445 is configured to engage and exert a force on the drive rack 430 to translate the rack 430 from the distal position to the proximal position, thereby returning the cutting member 450 to the fully-retracted position, when the cutting member trigger 410 is released by the user.
- the cutting member 450 is biased to be in the retracted position due to the force exerted by the cutting member return spring 445.
- FIG. 5 illustrates a partial perspective view of the interface between the drive rack 430 and drive pinion 420 from an opposite side view of FIGS. 4A-4C.
- most components disposed inside the instrument body housing 200 and in proximity to the drive rack 430 are disposed proximally towards the instrument body handle 220.
- the drive rack 430 can translate the cutting member actuator 440 without interfering with the components.
- This arrangement of the components inside the instrument body housing 200 advantageously provides more space for the cutting member translation rack 430 to translate the cutting member actuator 440, and thus the cutting member 450.
- a user will first position the open jaws 720 and 740 around a portion of tissue (e.g., a blood vessel) to be sealed/divided. The user then moves (squeezes) the jaw actuation handle 310 towards - into the instrument body handle 220 to securely clamp the tissue portion between the jaws 720 and 740. While continuing to hold the jaw actuation handle 310 against (or close to) the instrument body handle 220, the user then presses one of the energy activation contact switches 510a or 510b to initiate delivery of sealing energy through the clamped tissue portion. An audible sound and/or visible light indicates that the delivery of power is complete, and that the clamped tissue portion has been sealed.
- tissue e.g., a blood vessel
- the user While continuing to hold the jaw actuation handle 310 against (or close to) the instrument body handle 220, the user uses a finger from their same hand holding the other handles to squeeze the cutting member translation trigger 410, thereby extending the cutting member 450 between the jaws to divide the sealed tissue. The user then releases the respective cutting member translation trigger 410 and jaw actuation handle 310, and the respective cutting member return spring 445 and jaw actuation return spring 330a return the cutting member to the fully-retracted position and the pair of opposing jaws 700 to the open position. The user then repositions the open jaws to another portion of tissue to be sealed and divided, repeating the process until the procedure is completed.
- FIG. 6 illustrates a side exploded view of a latching mechanism 800 within the instrument body 110.
- the latching mechanism 800 comprises the housing maze 230, which for illustration purposes is shown in the interior of the first side 200a of the instrument body housing 200 in FIGS. 6-7B. However, it should be appreciated that the housing maze 230 can be disposed, formed or defined in the second side 200b of the housing 200, or on both sides 200a and 200b.
- a latch pin 340 is coupled to the jaw actuation handle 310, and configured to engage and travel though the housing maze 230 to control movement of the pair of opposing jaws 700.
- a latch elongated member 350 is coupled to the jaw actuation handle 310 and to the latch pin 340. As the jaw actuation handle 310 pivots and rotates around the handle pin 335 (e.g., pulled towards the instrument body handle 220, as previously described), the latch pin 340 travels through the maze 230, which will be described in further detail below.
- FIGS. 7A-7B illustrate side views of the latching mechanism 800 of FIG. 6.
- the housing maze 230 is formed or defined by a plurality of extensions 232, 234, and 236 that protrude from an inner surface 202 of the instrument body housing 200.
- the extensions 232, 234, and 236 are molded into the inner surface 202 of the housing.
- the extensions 232, 234, and 236 may be formed by separate pieces coupled to the inner surface 202 of the housing 200.
- the extensions 232, 234, and 236 are formed in mirroring opposing pairs that extend inwardly from the inner surface 202 of each of the first and second sides 200a and 200b of the instrument body housing 200, defining a 3D housing maze 230.
- Each of the extensions 232, 234, and 236 comprises side walls 238.
- the side walls 238 of the extension are configured to limit or bound the movements of the latch pin 340 and the latch elongated member 350.
- the extensions 232, 234, and 236 and their side walls 238 define pathways, trails or tracks of the housing maze 230. As better appreciated in FIG.
- the housing maze 230 comprises a first pathway “A” and a second pathway “B” defined between the extensions 232, 234, and 236 and the inner surface 202 of the instrument body housing 200, where the latch pin 340 is configured to move and travel along the pathways.
- the latch elongated member 350 comprises a proximal portion 351 having a proximal end 352 coupled to the latch pin 340, and a distal portion 357 configured to be coupled to the jaw actuation handle 310.
- the proximal portion 351 comprises a first arm 354, and the distal portion 357 comprises a second arm 358.
- the latch elongated member 350 is formed of a metal or any other suitable elastic material configured to store elastic potential energy.
- the first and second arms 354 and 358) is configured to contact the side walls 238 of the extensions 232, 234, and 236 and exert spring elastic forces maintaining the proximal end 352 of the latch elongated member 350 and latch pin 340 within the paths of the housing maze 230.
- the latch elongated member 350 initially takes the pathway “A”, such that the latch pin 340 travels from a position “A1” to a position “A2” of the pathway “A”, as shown in FIG. 7B.
- the side wall 238 of the extension 234 holds the latch pin 340 in the position “A2”, thereby holding or latching the pair of opposing jaws 700 in their close approximate position, alleviating the user from apply continued force to the jaw actuation handle 310 and relieving user fatigue.
- the user When the user desires to unlatched the pair of opposing jaws 700 from in the approximate position, the user further pulls the jaw actuation handle 310 towards the instrument body handle 220 to release the latch pin 340 from the position “A2”.
- the latch pin 340 begins to travel the path “B” from the position “B1” towards the position “B2”, as shown in FIG. 7B, which opens the pair of opposing jaws 700.
- FIGS. 8A-8C illustrate perspective, side and top views of the components energy activation assembly 500 depicted in FIGS. 3A-B.
- the components of the energy activation assembly 500 are configured to activate and facilitate the delivery of tissue sealing energy to the pair of opposing jaws 700, and include the energy activation contact switches 510a and 510b.
- the second energy activation contact switch n 510b is shown as transparent in FIG. 8A in order to visualize further components (e.g., the flexible circuit 530) of the assembly 500.
- the energy activation assembly 500 further includes the pair of dome switches 520a (FIGS. 8C) and 520b (shown in FIGS. 8A-8B) underlying the respective housing surface contact switches 510a and 510b.
- the first and second energy activation contact switches 510a and 510b have inwardly extending posts 512a and 512b disposed substantially at a center of the respective dome switches 520a and 520b, such that, regardless of where the user presses or pushes the activation switches 510a or 510b, the respective post 512a or 512b will contact and activate the respective dome switch 520a or 520b, thereby substantially minimizing or eliminating activation “dead zones” associated with the contact switches 510a and 510b.
- the first and the second dome switches 520a and 520b are electrically coupled to the flexible circuit 530, such that the activation of either dome switch 520a or 520b will close the energy activation circuit (via pins 564c and 564d) to initiate the delivery of energy to the pair of opposing jaws 700 (via pins 562a and 562b).
- a pair of insulated wires extend from the pin connectors 562a and 562a through the cable 560, instrument body 110 and down/along the shaft 122 to delivery energy to the opposing pair of jaws 700, wherein one wire acts as the active conductor, and the other being the return conductor.
- FIGS. 9A-9B illustrate side views, and FIG. 9C illustrates a top view, of the pair of opposing jaws 700 of the tissue sealing and cutting instrument 100 of FIGS. 1A-1B.
- the pair of opposing jaws 700 are in the closed or approximate position, with the first jaw 720 and second jaw 740 positioned approximate each other and configured to hold and clamp tissue therebetween.
- the pair of opposing jaws 700 may have an overall envelope diameter 705 of no more than 8.0 millimeters when the first 720 and second 740 jaws are in the approximate position.
- the pair of opposing jaws 700 may have an envelope diameter 705 of less than 6.0 millimeters when the first 720 and second 740 jaws are in the approximate position.
- the pair of opposing jaws 700 are in the open position, with the first jaw 720 and second jaw 740 spaced apart from each other to allow the instrument to be maneuvered into a new position to place the jaws 720 and 740 around a blood vessel or other tissue portion to be treated.
- FIG. 9C illustrates a top view of pair of opposing jaws 700, depicting the curved, nonlinear configuration 701 of the pair of opposing jaws 700 to give each of the opposing jaws 700 a “Maryland” jaw shape.
- the pair of opposing jaws 700 are offset from the longitudinal axis 121 of the instrument 100.
- Each jaw has a proximal portion 7at has an elongated drive slot 730 therethrough, wherein the drive slots 730 of the opposing jaws 700 are aligned and configured to receive a drive pin 322 therethrough (FIG. 10A).
- the jaw drive slots 730 are curved and disposed at an angle with respect to the longitudinal axis 121 of the instrument shaft 122 such that the jaws travel in a desired trajectory relative to each other as the drive pin 322 travels through the slot from one end (jaws open) to the other end (jaws closed) of the slots 730.
- the jaw drive slots 730 may have any other suitable shape, such as elongated straight linear slot (not shown).
- FIGS. 10A-10B illustrate cross sectional views of the pair of opposing jaws 700.
- FIG. 10A shows the proximal portions 710 of the jaws 700 in a longitudinal cross-sectional view
- FIG. 10B shows a transversal cross- sectional view of the jaws 700.
- each jaw also comprises a pivot pin hole 732 (e.g., aperture, opening), wherein the respective pivot pin holes 732 are aligned and configured to accommodate a pivot pin 734 therethrough.
- the pivot pin holes 732 may have a round, cylindrical configuration or any other suitable shape configured to receive the pivot pin 734.
- the respective pivot pin holes 732 and pivot pin 734 are disposed distally from the jaw drive slots 730 and drive pin 322.
- the drive pin 322 extends through the respective slots, with each end of the drive pin 734 being fixedly attached to a respective split end of the jaw actuator 320, such that when the jaw actuator 320 translates or moves axially, the drive pin 322 travels within the jaw drive slots 730 to thereby move the jaws 720 and 740 about the pivot pin 734 between the open and approximate positions.
- This configuration advantageously allows the jaws 720 and 740 to be assembled separately, e.g., at the pivot pin 734, independent from the jaw actuator 320.
- the jaw actuator 320 may also be assembled separately. Then, the fully assembled pair of opposing jaws 700 are introduced into the jaw actuator 320 and coupled together with the drive pin 322.
- the pivot pin holes 732 are electrically isolated from the metal jaw frames 722 and 724.
- the pivot pin holes 732 may be composed of non-conductive material, may have a non-conductive coating, liner or layer.
- a non-conductive bushing 733 may be employed (FIG. 10B) to isolate the pivot pin holes 732 from the jaw frames 722 and 724.
- the pivot pin 734 (FIGS. 10A-10B) defines a pivot point and allows rotation of the pair of opposing jaws 700 relative to each other.
- the bushing 733 is fixedly attached (e.g., glued, welded, or the like) to the first jaw 720, such that the second jaw 740 rotates relative to the first jaw 720.
- the bushing 733 may be fixedly attached to the second jaw 740, so the first jaw 720 rotates relatively to the second jaw 740.
- the pivot pin 734 may be made of a metallic material and may include a coating, liner, or layer to minimize abrasive wear against the bushing 733.
- the pivot pin may be formed of a suitable non- conductive material such as, for example, a ceramic material.
- the jaws may be assembled with a non- conductive insert that surrounds and/or at least partially covers the respective pivot pin hole and drive slot.
- FIGS. 20 and 21 depict an alternative jaw 720’ having a conductive metal jaw frame 722’ in which a portion of the frame 722’ that includes a pivot pin hole 732’ and a drive pin slot 732’ has been configured to receive a non-conductive jaw frame insert 2000 that includes a laterally extending pivot pin hole portion 2032 and a laterally extending drive pin slot portion 2030 that extend the entire width of the jaw frame 722’.
- the insert 2000 is formed from ceramic material, anodized aluminum, or some other suitable non-conductive material, to electrically isolate the jaw frame 722’ from respective pivot and drive pins (not shown) passing through the pivot pin hole portion 2032 and drive pin slot portion 2030.
- the jaw frame insert 200 has a first side 2002 that, when the insert 200 is inserted into the jaw frame 722’, is substantively flush with the surface of the jaw frame 722’.
- the pivot pin hole portion 2032 and drive pion slot portions on a second side 2004 of the insert 2000 extend the entire width of the jaw frame 722’.
- the non- conductive insert 200 may be affixed to the jaw frame 722’, or it may be retained retained in the jaw frame 722’ by the jaw over-mold (not shown).
- FIGS. 11A-11C illustrate perspective and exploded views of the jaws 700 and jaw actuator 320.
- FIG. 11C depicts the jaw actuator 320 as having a flat elongated configuration but other configurations are possible that allow translation or axial movement of the actuator 320.
- the pair of opposing jaws 700 may include a pair of cam guide inserts 736 disposed over the drive pin 322, wherein the cam guide inserts 736 are configured to restrict or limit movement of the drive pin 322 within the jaw drive pin slots 730 to prevent splaying of the jaws 700.
- at least one of the cam guide inserts 736 comprises a recess 737 where the drive pin 322 is disposed.
- the recess 737 provides a bearing surface for the drive pin 322 as the jaws 700 are rotated between the open and approximate positions.
- the cam guide inserts 736 may be formed of stainless steel and press-fitted into the outer surface of the instrument shaft 122, forming a flush surface with the shaft 122.
- jaws 720 and 740 are provided with non- conductive over-molds 721 , 741 that partially cover the respective jaw frames 722, 742.
- the over-molds 721 , 741 are composed of a non-conductive polymeric material to electrically isolate the jaw frames 722, 742, which are composed of suitable conductive material (e.g., metal, alloys or the like).
- the over-molds 721 , 741 may further define and cover the pivot pin holes 732 to electrically isolate the pivot pin 734.
- FIGS. 12A-12D illustrate perspective and exploded views of the first jaw 720.
- jaw 740 is essentially a mirror image of jaw 720, and that the following description of jaw 720 applies equally to jaw 740.
- the over-mold 721 further defines the jaw pivot pin hole 732 and partially covers the jaw frame 722, while exposing a relatively narrow electrically conductive raised surface portion (“seal plate”) 723.
- the raised seal plate 723 has two elongate sides that extend nearly the entire length of the jaw 720, from a proximal end portion 731 proximate pivot pin hole 732, to a distal end of the jaw 743, with a channel or slot 725 disposed between the two seal plate sides through which the cutting member 450 (not shown) is advanced to cut sealed tissue clamped between the jaws.
- the cutting member channel 725 of first jaw 720, and the cutting member channel 725 of the second jaw 740 are aligned with each other such that, when the jaws 720, 740 are in the approximate configuration, the first and second jaw channels 725 together form a slot through which the cutting member 450 travels.
- a distal end portion 727 of the seal plate 723 wraps around the distal end of the cutting member slot 725, such that the two elongate sides of the raised seal plate 723 are continuous.
- the exposed seal plate surfaces may have an anti-stick coating applied to them, which also may be sandblasted, to help minimize sticking/adhesion of the tissue.
- the seal plate 723 tapers in width along the length of the jaw 720, from the proximal end portion 731 to the distal end tip 743.
- each side of the seal plate 723 is wider in a proximal portion 780 of the seal plate than in a distal portion 785 of the seal plate in order to better maintain a constant pressure (force per seal plate area) imposed on the tissue being clamped between the jaws 700.
- most to all of the tapering seal plate width reduction takes place between the proximal portion 780 and a middle jaw portion 783 of the seal plate.
- each side of the seal plate 723 may have a width (indicated as 783 in FIG. 22B) of approximately 0.040” in the proximal portion 780 of the seal plate, and a width of 0.025” (indicated as 787 in FIG. 22C) at both the middle portion 783 and the distal end portion 785 of the seal plate 723.
- all narrowing in the width of the seal plate 723 takes place entirely between the proximal portion 780 and the middle portion 783, with little to no further tapering between the middle portion 783 and the distal portion 785.
- the electrode mount 724 is coupled to the jaw frame 722 (FIG. 12D).
- the electrode mount 724 has a same length-width dimensions as, and underlies/supports the raised seal plate 723.
- the pair of electrical wires (described above in conjunction with the power activation assembly 500, includes a first insulated wire 1560 that passes through a strain relief channel 1900 in the jaw frame 722 (best seen in FIG. 19B), wherein the insulation 1562 is removed and an exposed portion of the wire 1563 is welded or otherwise electrically coupled to the jaw frame (not shown) distal to the strain relief passage 1900 to deliver electrical energy to the raised seal plate 723 via the jaw frame 722.
- the jaw frames 722 and 742 are electrically coupled to different wires that may be electrically connected to the generator 564 via the generator cable connector pins 562a and 562b (FIG. 2) through the cable 560, instrument body 110, and within/along the shaft 122, respectively, with one wire being the active conductor, and the other wire being the return conductor, so as to form a closed circuit including the respective jaw frame plates 722, 724, seal plates 723, and tissue clamped between the jaws 720, 740.
- the strain relief passage reduces or prevents the possibility of the wire-to-jaw frame weld from breaking due to proximal pulling tension on the wire 1560.
- the geometry of the channel 1900 results in any proximal pulling force on the wire 1560 being born by the wire itself, and not the weld, which is weaker than the wire 1560.
- FIGS. 22A are top views of a surface of one of the seal plates 700 of the instrument 100. depict eal plate width tapering along length of proximal portion of the seal plate.
- the jaw may be formed as a multi-piece jaw.
- a layer of plastic material may be positioned between the seal plate and the frame to act as a thermal barrier, effectively reducing thermal spread and improving thermal management during operation.
- the bottom surface of the seal plate may include a non-conductive coating, liner, or layer. This feature enhances electrical insulation and minimizes heat conduction.
- FIGS. 13 and 13B are side views of one of the opposing jaws 700 (jaw 720 or jaw 740), showing the side profile of the exposed raised seal plate 723 extending above the over-mold 721 , 741.
- the seal plate 723 extends by a gap 1302 above the top surface of the over-mold 721 , 724 directly adjacent to the seal plate 723 to expose a significant amount of the metal side(s) of the seal plate 723.
- the seal plate 723 has an arcuate top surface, wherein the broken line 1304 indicates the lowest edge of the top surface, and the solid line 1305 indicates the highest point along the arcuate top of the seal plate 723 relative to the top surface of the over-mold 721 , 741.
- the over-mold continues to decrease in height, including step downs 1306 1308 and 1310, as the over-mold surface extends farther away from the seal plate 723 (width-wise) towards the proximal end of the jaw 731 , to provide additional relief and ensure the seal plate 723, and not the over-mold 721 , 741 , is clamping the tissue.
- FIGS. 14A and 14B are side views of an alternative jaw 1400 in which the seal plate is electrically isolated from the jaw support structure.
- the surface of jaw 1400 includes a conductive seal plate 1423 substantially enclosed by an over-mold 1421.
- the height profile of the exposed side wall of the seal plate 1423 is significantly less (approximately 0.012” in some jaw embodiments) than in jaw 700.
- the over-mold 1421 otherwise has similar reductions in the over-mold height, including step downs 1404, 1406 and 1410, as the over-mold surface extends farther from the seal plate 1423 towards the proximal end of the jaw 1400.
- FIGS. 15-18 depict a cutting member stabilization clevis 1520 coupled to a dial end portion 441 of the cutting member actuator 440, in accordance with some embodiments of the tissue sealing and cutting instrument 100 of FIGS. 1A- 1B.
- the stabilization clevis 1520 includes first and second clevis arms 1502, 1504, which are welded or otherwise adhered to an interior wall 443 of the distal end portion 441 of the cutting member actuator 440.
- the clevis arms 1502 and 1504 extend distally from the actuator 440, with the cutting member 450 also extending distally from the actuator 440 through a gap between the clevis arms 1502 and 1504.
- the cutting member 450 is relatively thin, and the clevis arms 1502 and 1504 provide structural support to help to prevent buckling as the cutting member 450 is extended through sealed tissue clamped between the opposing jaws (not shown).
- Much of clevis arm 1504 is transparent in FIG. 16 to reveal the elongate cutting member 450 extending between the clevis 1502 and 1504 arms.
- the material comprising a inner wall of the distal end portion 457 of the cutting member 450 is removed to create a slot 459 to accommodate passage there through of the jaw pivot pin 734.
- the stabilizing clevis arms 1502 and 1506 have respective aligned openings 1506 flanking the slot 459 to also accommodate passage therethrough of the jaw pivot pin 734.
- a spacer boss/protrusion 1508 extends from a distal end portion of clevis arm 1504, distal of the jaw pivot pin openings 1506, through the opening 459, contacting clevis arm 1502 to maintain uniform spacing between the respective clevis arms 1502 and 1504. It will be appreciated that the spacer protrusion 1508 may alternatively be provided on clevis arm 1502.
- FIGS. 23-26 depict alternative arrangements for securing opposing jaw members (e.g., jaws 720, 740 of tissue sealing and cutting instrument 100) to a pivot pin (e.g., pivot 734 of the instrument 100).
- a pivot pin e.g., pivot 734 of the instrument 100.
- some of the arrangements for securing the opposing jaw members to the pivot pin may be employed in instrument 100, while other arrangements may be better suited for alternative sealing instruments having different jaw constructions than the jaws 720, 740 of instrument 100.
- the arrangements for securing the opposing jaw members to the pivot pin are described without reference to jaws 720 and 740 of instrument 100.
- jaw frame 2310 of jaw 2320 has a distal opening/aperture 2322 for receiving therethrough a jaw pivot pin 2308.
- a metallic pivot sleeve bearing (“support sleeve”) 2305 is inserted through the aperture 2322, and the pivot pin 2308 extends through the lumen of the pivot support (bearing) sleeve 2305.
- the ends of the pivot pin 2308 are secured (e.g., by welds 2331) to respective arms 2314 and 2316 of a jaw support clevis that sandwich the jaw frame members 2314 and 2316 approximate each other.
- the metallic support sleeve 2305 has a length configured to extend between jaw frame 2310 and jaw frame 2312 (of jaw 2340 - not shown) when the respective jaw frames are sandwiched between the clevis arms 2314 and 2316.
- the ends of the support sleeve 2305 abut or otherwise terminate proximate the respective clevis arms 2314 and 2316.
- the pivot pin 2308 is configured to form an interference fit within the lumen of the sleeve 2305, such that the support sleeve 2305 is fixed to the pivot pin 2308 and, in turn, to the clevis arms 2314 and 2316.
- the aperture 2322 though jaw frame 2310 has a slightly decreased diameter compared with the aperture 2322 though jaw frame 2312 such that the support sleeve 2305 is also secured to jaw frame 2310 by an interference fit (indicated by ref. no. 2348 in FIG. 24) (or by some other means such as a weld or adhesive bond), while jaw frame 2312 may freely rotate relative to the pivot pin 2308 and sleeve 2305, as indicated by the gap 2350 between the sleeve 2305 and the jaw frame 2314.
- This configuration beneficially reduces the amount of “play” between the jaws 2320 and 2340, minimizing or eliminating the possibility that the jaws become misaligned during a surgical procedure, while still allowing the jaws to be moved between open and closed configurations.
- FIGS. 25 and 26 depict another embodiment of a tissue sealing instrument jaw assembly, including a first jaw 2520 having a jaw frame 2510, and a second jaw 2540 (FIG. 26) having a jaw frame 2512. Proximal portions of the respective jaw frames 2510 and 2512 are coupled together by a metallic pivot sleeve bearing (“support sleeve”) 2505 that extends through aligned pivot pin apertures 2522 in the jaw frames 2510 and 2512.
- support sleeve diameter is configured so that the support sleeve slides through the aperture 2522 when the support sleeve is first inserted through the jaw frame apertures 2522 during the instrument assembly process.
- the support sleeve 2505 has a laterally extending collar or flange 2507 at one end that acts as a stop to limit further insertion of the sleeve 2505 through the aperture 2522.
- the support sleeve 2505 is inserted through the aperture 2522 of the lower jaw frame 2510 until the flange 2507 abuts and stops against a portion of over-mold material 2529, which is sandwiched between the support sleeve flange 2507 and the jaw fame 2510.
- the support sleeve 2505 is secured to the upper jaw frame using a swaging process in which the tubular wall of the sleeve 2505 is plastically deformed by a swaging tool to crimp (affix) the sleeve 2505 to the upper jaw frame 2512, such that the upper jaw frame is not rotatable relative to the support sleeve.
- the lower jaw frame 2510 is not affixed to the sleeve 2505, is may freely rotate relative to the sleeve 2505.
- a pivot pin 2708 is inserted through the support sleeve 2505, entering the sleeve lumen through the pivot pin aperture 2522 in the upper jaw frame 2512.
- the pivot pin has an enlarged head that abuts and stops against a portion of over-mold material 2529, which is sandwiched between the pivot pin head and the jaw fame 2512.
- the opposite end of the pivot pin 2708 is then welded to the support sleeve 2505.
- the pivot pin 2708 is also fixed at each end to respective arms of a jaw support clevis (not shown), so that the pivot pin 2708 is fixed to the clevis, the support sleeve 2505 is fixed to the pivot pin 2507 and to the upper jaw frame 2512 (from the swaging process).
- This configuration beneficially reduces the amount of “play” between the jaws 2520 and 2540, minimizing or eliminating the possibility that the jaws become misaligned during a surgical procedure, while still allowing the jaws to be moved between open and closed configurations.
- FIGS. 27 and 28 are cut-away side views of an alternate embodiment of a tissue sealing and cutting instrument 2800.
- instrument 2800 includes an instrument body 2810 having an instrument body handle (not shown), a shaft (not shown) having a proximal end coupled to the instrument body, and a pair of opposing jaws (not shown) movably coupled to a distal end portion of the shaft.
- the instrument 2800 includes a jaw actuation handle 2850 that is pivotally coupled to the instrument body 2810 and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle 2850 towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween.
- instrument 2800 further includes a jaw actuation handle return spring 2830 having a first end disposed in a spring well 2835 formed in the jaw actuation handle 2850, and a second end the abuts a solid wall 2832 structure in the instrument body 2810.
- the return spring 2830 is compressed by the jaw actuation handle 2850 as a user moves the handle 2850 towards the instrument body handle to manipulate (close) the opposing pair of jaws.
- the return spring 2830 self-restores to a non-com pressed state, thereby moving the jaw actuation handle 2850 back to an initial position away from the instrument body handle (opening the jaws) , when the user releases the jaw actuation handle 2850.
- FIGS. 29 and 30 are perspective views of a jaw link member 3000 deployed in an alternative tissue sealing and cutting device.
- the jaw link member 3000 includes first and second end cylindrical connector bosses 3002 and 3004.
- the first end connector boss 3002 is configured to press fit into a receiving aperture/opening 3005 of an instrument jaw 3020
- the second end cylindrical connector boss 3004 is configured to press fit into a receiving aperture/opening of a reciprocating jaw actuator (not seen) in order to rotate the jaw 3020 about a pivot pin (not seen) that rotatably connects jaw 3020 with a second jaw (not seen).
- a pivot pin not seen
- the first end connector boss 3002 may become uncoupled from (i.e., pull laterally out of opening 3005 of) the jaw 3020.
- FIGS. 31 and 32 are perspective views of an alternative jaw link member 3200 having first and second end cylindrical connector bosses 3202 and 3204.
- Jaw link member 3200 is essentially identical to jaw link member 3000 of FIGS. 29-30, except that the first end connector boss 3202 of jaw link member 3200 is provided with a tongue-shaped locking member 3207 that extends laterally from the connector boss 3202 towards the second connector boss 3204.
- the first end connector boss 3202 is maneuvered to insert the tongue-shaped locking member 3207 through the opening 3005 in jaw 3020.
- the jaw link member 3200 is then further maneuvered to insert the remaining body of the first end connector boss 3202 through the opening 3005, such that the tongue-shaped locking member 3207 extends laterally to overlap with a portion of the jaw 3020 to thereby secure the first end connector boss 3202 within the opening 3005 and prevent the possibility that the first end connector boss 3202 may become uncoupled from (i.e., pull laterally out of opening 3005 of) the jaw 3020.
- one or more acts, events, or functions of any of the algorithms, methods, or processes described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the algorithm).
- acts or events can be performed concurrently, e.g., through multithreaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.
- no element, feature, block, or step, or group of elements, features, blocks, or steps, are necessary or indispensable to each embodiment.
- any methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “positioning the jaws to grasp tissue to be sealed” include “instructing positioning the jaws to grasp tissue to be sealed.”
- a tissue sealing instrument comprising: an instrument body comprising an instrument body housing and an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; and a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein the instrument further comprises a first energy activation switch on a first side of the instrument body housing, and a second energy activation switch positioned on a second side of the instrument body housing, wherein the first and second energy activation switches are configured and positioned on the respective first and second sides of the instrument body housing such that a user holding the instrument with a right hand or a left hand while squeezing the jaw actuation handle into the instrument body handle can use of thumb or other digit of the respective right hand or left hand to contact and activate one of the first and second energy activation switches without releasing the jaw actuation handle.
- a tissue sealing instrument comprising: an instrument body comprising an instrument body housing and an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; and a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, the instrument further comprising a jaw actuation biasing element configured to move the jaw actuation handle to, and/or maintain the jaw actuation handle in, the non-actuated position, thereby moving the opposing pair of jaws to, and/or maintaining the opposing pair of jaws in, the open position whenever a user is not actively moving the jaw actuation handle to, and/or holding the jaw actuation handle in, the fully-actuated position.
- a tissue sealing and cutting instrument comprising: an instrument body having an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; and a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween and a latching mechanism, the latching mechanism including a housing maze disposed within the instrument body, and a latch pin, the latch pin having one end coupled to the jaw actuation handle and another end configured to travel within the housing maze, wherein when a user a user moves the jaw actuation handle towards the instrument body handle sufficiently to move the pair of opposing jaws into the approximate position, the latch pin engages a structure of the housing maze to maintain the position of the jaw actuation handle, and thus maintain the jaws in the
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Abstract
A tissue sealing and cutting instrument includes a jaw actuation handle movably coupled to the instrument body handle and configured to move a pair of opposing jaws disposed on a shaft extending from the instrument body from an open position to an approximate position for clamping tissue therebetween. A cutting member is disposed in the shaft in a retracted position, wherein the cutting member may be advanced distally to cut tissue clamped between the jaws by a cutting member translation assembly that includes a rack and pinion assembly mounted in the instrument body, wherein a portion of the jaw actuation handle interferes with and prevents rotation of the pinion, and corresponding distal advancement the cutting member, unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
Description
VESSEL SEALING DEVICE
[001] The disclosed inventions are related to surgical systems and devices. Specifically, but not intended to limit the invention, embodiments of the invention are related to surgical devices for sealing, dividing and dissecting tissue during surgical procedures.
BACKGROUND
[002] Electrosurgical instruments for applying electrical energy to tissue are used widely in surgical procedures. Electrosurgical instruments used in vessel sealing rely on a combination of pressure and high frequency electrical energy applied to biological tissue to cut, coagulate, desiccate or seal tissue, for example, blood vessels. Recent advances in vessel sealing technology specifically focused small end effectors for micro-surgical procedures, including U.S. Patent No. 11 ,399,884 which describes a vessel sealing system that enables effective and safe vessel sealing of small caliber blood vessels at lower power outputs. Larger devices for sealing larger vessels have received comparatively less attention despite their wide use in general surgery. None of the prior art in this field addresses the unique circumstances presented with larger devices or enables similar safe and effective sealing of large vessels at lower power outputs.
[003] The teachings of the following U.S. Patents and Publications are incorporated by reference herein in their entirety: U.S. Pat. No. 9,039,694 to Ross et al., U.S. Pat. No. 9,144,455 to Kennedy et al., 10,765,471 to Bucciaglia et al., U.S. Patent Publication 20240058052 to Schmaltz et al., U.S. Patent Publication 20240065716 to Steketee et al., and U.S. Patent Publication 20250213291 to Cole et al.
SUMMARY OF THE INVENTION
[004] In one embodiment of the disclosed inventions, a tissue sealing and cutting instrument includes an instrument body having an instrument body handle, a shaft having a proximal end coupled to the instrument body, and a pair of opposing jaws movably coupled to a distal end portion of the shaft. A jaw
actuation handle is movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween. The instrument includes a cutting member, e.g., a knife or other type of blade at least partially disposed in the shaft. A cutting member trigger is movably coupled to the instrument body and operatively coupled with a pinion rotatably mounted within the instrument body, the pinion also being operatively coupled to the cutting member, wherein moving the cutting member trigger towards the instrument body housing rotates the pinion to thereby distally advance the cutting member from a retracted position substantially proximal of the opposing jaws to an extended position between the opposing jaws to cut through tissue clamped therebetween, and wherein the jaw actuation handle interferes with and prevents rotation of the pinion, and the corresponding distal advancement of the cutting member, unless the jaw actuation handle is pivoted sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
[005] The cutting member trigger may be pivotably coupled to the housing body, such that the cutting member trigger may be pivoted angularly between a non-actuated position farthest from the instrument body handle, and a fully- actuated position closest to the instrument body handle, the pinion having corresponding non-actuated and fully-actuated rotational positions such that the cutting member is in the fully-retracted position when the pinion is in the nonactuated rotational position, and in the fully-extended position when the pinion is in the fully-actuated rotational position.
[006] In one such embodiment, the instrument includes a boss extending from a surface of the pinion that contacts a corresponding extended or protruding portion of the jaw actuation handle to prevent rotation of the pinion beyond the non-actuated rotational position unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
[007] The boss may have a curvilinear formation, with a first end that contacts
the extended or protruding portion of the jaw actuation handle to prevent rotation of the pinion beyond the non-actuated rotational position unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position, wherein, once the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position, the boss prevents the extended or protruding portion of the jaw actuation handle from interfering with pinion as the pinion rotates from the non-actuated rotational position to the fully-actuated rotational position.
[008] In various embodiments, the pinion is part of a rack and pinion assembly mounted in the instrument body, the instrument further including a cutting member actuator at least partially extending through the shaft, the cutting member actuator having a proximal end portion coupled to or integral with the rack, and a distal portion coupled to or integrally formed with the cutting member, such that movement of the cutting member trigger from the non-actuated position to the fully-actuated position translates the cutting member actuator relative to the shaft to move the cutting member from the fully-retracted position to the fully- extended position. These embodiments may further include a cutting member biasing element configured to move the cutting member trigger to, and/or maintain the cutting member trigger in, the non-actuated position, thereby moving the cutting member to, and/or maintaining the cutting member in, the fully- retracted position whenever a user is not actively moving the cutting member trigger to, and/or holding the cutting member trigger in, the fully-actuated position.
[009] By way of non-limiting example, the cutting member biasing element comprises a return spring positioned in-line with the rack, wherein the return spring is compressed by the rack as a user moves the cutting member trigger from the non-actuated position to the fully-actuated position, and wherein the return spring self-restores to a non-compressed state, thereby moving the respective rack, cutting member actuator, and cutting member proximally until the cutting member is in the fully-retracted position, with the pinion and cutting member trigger moving from the respective fully-actuated positions to nonactuated positions, respectively, when the user releases the cutting member
trigger.
[0010] In some embodiments, the jaw actuation handle being pivotally coupled to the instrument body, wherein the jaw actuation handle may be pivoted angularly between a non-actuated position farthest from the instrument body handle, and a fully-actuated position closest to the instrument body handle, wherein the pair of opposing jaws are in the open position when the jaw actuation handle is in the non-actuated position, and in the approximate position when the jaw actuation handle is in the fully-actuated position.
[0011] In such embodiments, the instrument includes a jaw actuator at least partially extending through the shaft, the jaw actuator having a proximal end portion coupled to the jaw actuation handle, and a distal end portion coupled to the pair of opposing jaws, such that pivoting the jaw actuation handle from the non-actuated position to the fully-actuated position translates the jaw actuator proximally relative to the shaft from a most distal position relative to the shaft, with the pair of opposing jaws in the open position, to a most proximal position relative to the shaft, with the pair opposing jaws in the approximate position. A jaw actuation biasing element may be provided and configured to move the jaw actuation handle to, and/or maintain the jaw actuation handle in, the non-actuated position, thereby moving the opposing pair of jaws to, and/or maintaining the opposing pair of jaws in, the open position whenever a user is not actively moving the jaw actuation handle to, and/or holding the jaw actuation handle in, the fully- actuated position. For example, the jaw actuation biasing element may be a return-spring positioned in-line with the jaw actuator, wherein the return-spring is compressed by the jaw actuator as a user moves the jaw actuation handle from the non-actuated position to the fully-actuated position, and wherein the return spring self-restores to a non-compressed state, thereby moving the jaw actuator back to the most distal position, with the jaw actuation handle moving from the fully-actuated position to the non-actuated position, respectively, when the user releases the jaw actuation handle.
[0012] In various embodiments, the opposing pair of jaws includes a first jaw and a second jaw, the first jaw comprising a channel extending along a length of
the first jaw, and the second jaw comprising a channel extending along a length of the second jaw, the first and second jaw channels aligned with each other such that, when the jaws are in the approximate configuration, the first and second jaw channels together form a slot through which the cutting member travels.
[0013] In various embodiments, the first and second jaws have curved profiles along their lengths.
[0014] In various embodiments, the instrument body comprises an instrument body housing, with a first energy activation switch disposed on a first side of the instrument body housing, and a second energy activation switch disposed on a second side of the instrument body housing, wherein the first and second energy activation switches are configured and positioned on the respective first and second sides of the instrument body housing such that a user holding the instrument with a right hand or a left hand while squeezing the jaw actuation handle into the instrument body handle can use of thumb or other digit of the respective right hand or left hand to contact and activate one of the first and second energy activation switches without releasing the jaw actuation handle. In some such embodiments, activation of the first and/or second energy activation switches initiates delivery of energy from a generator coupled to the instrument to seal tissue clamped between the pair of opposing jaws.
[0015] In various embodiments, each jaw of the opposing pair of jaws comprising a conductive seal plate, wherein a width of the seal plate varies along at least a portion of a length of the jaw, and wherein a width of the seal place at a proximal end portion of the jaw is greater than a width of the seal plate in a middle portion of the jaw.
[0016] In some embodiments, the instrument further includes a latching mechanism, the latching mechanism including a housing maze disposed within the instrument body, and a latch pin, the latch pin having one end coupled to the jaw actuation handle and another end configured to travel within the housing maze, wherein when a user a user moves the jaw actuation handle towards the instrument body handle sufficiently to move the pair of opposing jaws into the approximate position, the latch pin engages a structure of the housing maze to
maintain the position of the jaw actuation handle, and thus maintain the jaws in the approximate position, even if the user releases the jaw actuation handle. In such embodiments, the user may pull the jaw actuation handle further towards the instrument body handle, so that the latch pin is released from its engagement with the housing maze structure, and the pair of opposing jaws can return to the open position when the user releases the jaw actuation handle.
[0017] Other and further aspects and features of the disclosed inventions will be apparent from the following detailed specification and accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIGS. 1A and 1B are respective side views of a tissue sealing and cutting device coupled with a generator, according to one embodiment of the disclosed inventions, wherein the device housing is partially removed in FIG. 1B to reveal internal components.
[0019] FIG. 2 is a perspective end view of the generator cable connector of FIGS. 1A and 1B
[0020] FIGS. 3A and 3B are side and perspective exploded views of the tissue sealing and cutting device of FIG. 1 .
[0021] FIGS. 4A-C are side views of an interface disposed between respective actuation and cutting mechanisms of the tissue sealing and cutting device of FIG.
1
[0022] FIG. 5 is a partial perspective view of an opposite side view of the interface depicted in FIGS. 4A-C.
[0023] FIG. 6 is an exploded side view of a latching mechanism of the tissue sealing and cutting device of FIG. 1 .
[0024] FIGS. 7A and 7B are side views the latching mechanism depicted in FIG. 6
[0025] FIGS. 8A-8C are respective side, top and perspective views of an energy activation assembly of the tissue sealing and cutting device of FIG. 1.
[0026] FIGS. 9A-9C are side and top views of the pair of opposing jaws of the
tissue sealing and cutting device of FIG. 1 .
[0027] FIGS. 10A and 10B are cross-sectional partial views of the pair of opposing jaws depicted in FIGS. 9A-9C.
[0028] FIGS. 11A-11C are cross-sectional partial and exploded views of the pair of opposing jaws depicted in FIGS. 9A-9C.
[0029] FIGS. 12A-12D are perspective and exploded views of the first jaw depicted in FIGS. 9A-9C.
[0030] FIGS. 13A and 13B are views of one of the jaws depicted in FIGS. 9A- 9C
[0031] FIGS. 14A and 14B are side views of an alternative jaw embodiment.
[0032] FIGS. 15 and 16 are perspective views of a cutting member stabilizing assembly, according to some embodiments.
[0033] FIGS. 17 and 18 are enlarged views of selected components of the cutting member stabilizing assembly of FIGS. 15 and 16.
[0034] FIGS. 19A and 19B are side and cutaway cross-sectional views of one of the jaws depicted in FIGS. 12A-D.
[0035] FIGS. 20 and 21 are perspective views of an alternative jaw frame and a non-conductive insert.
[0036] FIGS. 22A-C are top views of one of the jaws depicted in 9A-9C.
[0037] FIG. 23 is a perspective view of an alternative instrument jaw assembly.
[0038] FIG. 24 is a cross-section depicting the pivot pin connection features in the jaw assembly of FIG. 23.
[0039] FIG. 25 is a partially cut-away top view of another alternative instrument jaw assembly that is similar the jaw assembly of the instrument of FIGS. 1A-1B.
[0040] FIG. 26 is a cross-section depicting the pivot pin connection features in the jaw assembly of FIG. 25.
[0041] FIGS. 27 and 28 are cut-away side views of an alternate embodiment of a tissue sealing and cutting instrument.
[0042] FIGS. 29 and 30 are perspective views of a jaw link member deployed in an existing tissue sealing and cutting device.
[0043] FIGS. 31 and 32 are perspective views of an alternative jaw link member deployed in the tissue sealing and cutting device of FIG. 31.
DETAILED DESCRIPTION
[0044] Various embodiments of the disclosed inventions are described hereinafter with reference to the figures. The figures are not necessarily drawn to scale, and the relative scale of select elements may have been exaggerated for clarity. It should also be understood that the description is intended to facilitate understanding of the illustrated embodiments and is not intended as an exhaustive description of the illustrated embodiments nor as a limitation on the scope of the appended claims. It should be further understood that an aspect or an advantage described in conjunction with a particular embodiment of the disclosed inventions is not necessarily limited to that embodiment and can be practiced in any other embodiments, even if not so illustrated.
[0045] Terms of orientation used herein, such as “top,” “bottom,” “horizontal,” “vertical,” “longitudinal,” “lateral,” and “end” are used in the context of the illustrated embodiment. However, the present disclosure should not be limited to the illustrated orientation. Indeed, other orientations are possible and are within the scope of this disclosure. Terms relating to circular shapes as used herein, such as diameter, radius or arcuate, should be understood not to require perfect circular structures, but rather should be applied to any suitable structure with a cross-sectional region that can be measured from side-to-side. Terms relating to shapes generally, such as “circular” or “cylindrical” or “semi-circular” or “semi-cylindrical” or any related or similar terms, are not required to conform strictly to the mathematical definitions of circles or cylinders or other structures, but can encompass structures that are reasonably close approximations.
[0046] Conditional language used herein, such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey
that some embodiments include, while other embodiments do not include, certain features, elements, and/or states. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment. Conjunctive language, such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
[0047] The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as the context may dictate, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than or equal to 10% of the stated amount. The term “generally” as used herein represents a value, amount, or characteristic that predominantly includes or tends toward a particular value, amount, or characteristic. As an example, in certain embodiments, as the context may dictate, the term “generally parallel” can refer to something that departs from exactly parallel by less than or equal to 20 degrees. Where the term “about” is utilized before a range of two numerical values, this is intended to include a range between about the first value and about the second value, as well as a range from the first value specified to the second value specified.
[0048] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B, and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry
out recitations B and C. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Likewise, the terms “some,” “certain,” and the like are synonymous and are used in an open-ended fashion. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
[0049] Any ranges disclosed herein also encompass any and all overlap, subranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 1 V” includes “1 V.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially perpendicular” includes “perpendicular.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.
[0050] FIGS. 1A and 1B illustrate respective side views of a tissue sealing and cutting instrument 100 constructed in accordance with one embodiment of the disclosed inventions. The instrument 100 includes an instrument body 110 having an instrument body housing 200. The instrument body housing 200 has a first (right-handed) side 200a, and a second (left-handed) side 200b, lower portions of which together form an instrument body handle 220. The second side 200b of the instrument body housing 200 is partially removed in FIG. 1B to reveal interior components in instrument body 110. A jaw actuation handle 310 and a cutting member translation trigger 410 are each pivotably coupled to the instrument body 110. An elongated shaft 122 has a proximal end coupled to the instrument body 110. A pair of opposing jaws 700, including a first jaw 720 and second jaw 740, are movably coupled to a distal end portion of the shaft 122. A first energy activation contact switch 510a is located on an exterior surface of the first side
200a of the instrument body housing 200, and a second energy activation contact switch 510b is located on the second side 200b of the instrument body housing 200.
[0051] Referring additionally to FIG. 3A, the elongated shaft 122 has an inner shaft lumen 124 through which an elongate tubular cutting member actuator 440 and an elongate tubular jaw actuator 320 at least partially extend, with the cutting member actuator 440 being disposed over the jaw actuator 320. As described below in greater detail, a proximal end portion of the cutting member actuator 440 is operatively coupled (i.e., mechanically linked) with the cutting member translation trigger 410, and a distal end of the cutting member actuator 440 is coupled to, or formed integrally with, a cutting member 450 (Fig. 1A). As described below in greater detail, a proximal end of the jaw actuator 320 is operatively coupled (i.e., mechanically linked) to the jaw actuation handle 310, and a distal end of the jaw actuator 320 is coupled to the pair of opposing jaws 700.
[0052] More particularly, the jaw actuation handle 310 controls physical movement of the opposing pair of jaws 700 between an open configuration, as depicted in FIG. 9B, and a tissue clamping or “approximate” configuration, as depicted (without any tissue clamped between the jaws) in FIG. 9A. As described below in greater, the jaw actuation handle 310 may be pivoted angularly between a non-actuated position, in which the jaw actuation handle 310 is farthest from the instrument body handle 220, and a fully-actuated position, in which the jaw actuation 310 handle is closest to the instrument body handle 220. Pivoting the jaw actuation handle 310 from the non-actuated position to the fully-actuated position pulls (translates) the jaw actuator 320 proximally along an axis 121 of the shaft 122 (FIG. 1A) from a most distal position relative to the shaft 122, with the pair of opposing jaws 700 in the open position, to a most proximal position relative to the shaft 122, with the pair opposing jaws 700 in the approximate position.
[0053] With further reference to FIGS. 4A-C, the opposing pair of jaws 700 are biased to be in the open configuration by a return spring 330a positioned in-line
with the jaw actuator 320. As a user pivots (squeezes) the jaw actuation handle 310 towards (into) the instrument body handle 220 from the non-actuated position to the fully-actuated position, the jaw actuation handle 310 pulls (translates) the jaw actuator 320 proximately from the most distal position relative to the shaft 122 to the most proximal positional relative to the shaft 122, thereby compressing the return spring 330a, and moving the pair of opposing jaws 700 from the open configuration into the approximate configuration for engaging and clamping and sealing tissue (e.g., a blood vessel) located between the pair of opposing jaws 700. When the user releases the jaw actuation handle 310, the return spring 330a self-restores to its non-compressed configuration, thereby pushing (translating) the jaw actuator 320 distally relative to the shaft 122, moving the jaw actuation handle 310 away from the instrument body handle 220, and returning the pair of opposing jaws 700 to the open configuration. Preferably, the spring 330a imposes a sufficient force on the jaw actuator 320 such that the pair of opposing jaws 700 “spring open” as soon as the user releases the jaw actuation handle 310.
[0054] As best seen in FIG. 1B and FIGS. 4A-C, a load limiting spring 330b is also located in-line with the jaw actuator 320, and is pre-loaded (i.e. compressed) to a desired pull force for the jaw actuator 320 to thereby limit the compressive force applied to the tissue clamped between the opposing pair of jaws 700 and prevent over compression. In various embodiments, the spring 330b may be pre- loaded in a range of 24-34 Ibf, although the specific pre-load force on the spring 330b will vary from embodiment to embodiment depending on the seal plate configuration and other factors. Notably the load limiting spring 330b is preferably positioned in-line with the jaw actuator 320 to avoid off-axis loading.
[0055] With continued reference to FIGS. 4A-C, the cutting member trigger 410 is part of a cutting member translation assembly 400 configured to control translation of the cutting member 450 between a fully-retracted position that is substantially proximal of the opposing pair of jaws 700, and a fully-extended position between the opposing pair of jaws for cutting through tissue clamped therein. As described below in greater detail, the cutting member translation assembly 400 includes a pinion 420 that is operatively coupled to the cutting
member trigger 410, the pinion 420 having a raised surface boss 428 that interfaces with the jaw actuation handle 310 to prevent distal translation of the cutting member 450 from the fully-retracted position when the opposing pair of jaws 700 are in the open position. For purposes of illustration only, the cutting member 450 is shown in an extended or partially extended position in FIG. 1A, even though the opposing pair of jaws 700 are in the open position. However, it should be appreciated that the cutting member 450 is never extended, deployed or substantially visible when the opposing pair of jaws 700 are in the open position.
[0056] More particularly, the cutting member trigger 410 may be pivoted angularly between a non-actuated position, in which the cutting member trigger is farthest from the instrument body handle 220, and a fully-actuated position in which the cutting member trigger is closest to the instrument body handle 220, with the pinion 420 having corresponding non-actuated and fully-actuated angular positions, such that the cutting member 450 is in the fully-retracted position when the pinion 420 is in the non-actuated angular position, and in the fully-extended position when the pinion 420 is in the fully-actuated angular position. The pinion surface boss 428 has a curvilinear formation, with a first end 428a that contacts an extended or protruding portion 328 of the jaw actuation handle 310 to prevent rotation of the pinion 420 beyond the non-actuated angular position unless the jaw actuation handle 310 is moved sufficiently towards the instrument body handle 220 to move the pair of opposing jaws 700 into the approximate position and the extended/protruding portion 328 of the jaw handle 310 no longer interferes with the boss 428, so that the pinion 420 may rotate to advance the cutting member 450 distally. The curvilinear boss 428 prevents the extended or protruding portion 328 of the jaw actuation handle 310 from interfering with rotation of the pinion 420 as the pinion is rotated from the non-actuated position to the fully-actuated position.
[0057] The cutting member 450 may be a knife or other type of blade configured to cut through and separate sealed tissue clamped between the opposing pair of jaws 700. The cutting member 450 may be a separate piece that is attached to the cutting member actuator 440, or may be an integrally formed
portion of the cutting member actuator 400. In alternative embodiments, the cutting member 450 may include a cutting electrode (not shown) instead of, or in addition to, a knife/blade. Such vessel sealers with a cutting electrode include those illustrated and described in U.S. Pat. Publication 2024/0058052, the teachings of which are incorporated by reference herein in its entirety.
[0058] With specific reference to FIGS. 1A-B and 3A-B, the energy activation switches 510a and 510b are part of a tissue sealing energy delivery assembly 500 configured to deliver tissue sealing energy from a power source (“generator”) 564 to the pair of opposing jaws 700 via an electrical cable 560 extending from within the instrument body handle 220 to a connector 562 that couples with the generator 564. For purposes of illustration, the connector 562 is depicted connected to the generator 564 in FIG. 1A, and disconnected from the generator in FIG. 1B. In particular, energy activation contact switches 510a and 510b are positioned on respective sides 200a and 200b of the instrument body housing 200 to allow a user to easily extend the thumb (or other digit) of their right or left hand that is holding the instrument 100 and actively compressing (squeezing) the jaw activation handle 310 into the instrument body handle 220 and press the respective contact switch 510a or 510b into/against the instrument body housing 200 without releasing the jaw actuation handle 310. Activation of one (or both) of the first and/or second energy activation contact switches 510a and 510b initiates delivery of energy from the generator 564 (when connected to the instrument 100 via the cable connector 562) to seal tissue clamped between the pair of opposing jaws.
[0059] The generator 564 (shown schematically in FIGS. 1A-1B) is configured to generate and deliver energy, typically radio-frequency (RF) energy, to the pair of opposing jaws 700 in accordance with a pre-programmed power algorithm suitable for sealing and/or cutting tissue. The generator 564 may be the same as, or similar to, the generators described in U.S. Patent No. 10,342,599 and U.S. Patent No. 9,039,694, each of which is incorporated herein by reference in its entirety. In some embodiments, parameters for the power algorithm are stored within the generator. These parameters may include, but are not limited to, maximum voltage, maximum current, maximum power, impedance cutoff, dwell
time, dwell power, and power ramp up and ramp down times. In alternate embodiments, the parameters for the generator power algorithm may be stored, e.g., on an EPROM chip, within the cable connector 562 and/or sealing device handle 220, and transmitted to the power source 564 when the connection is established.
[0060] As seen in FIGS. 3A and 3B, and with additional reference to FIGS. 8A- C, the energy activation assembly 500 includes a pair of dome switches 520a and 520b underlying the energy activation contact switches 510a and 510b, respectively, such that dome switch 520a is activated when a user depresses contact switch 510a, and dome switch 520b is activated when a user depresses contact switch 510b. The dome switches 520a and 520b are each electrically coupled to a flexible circuit conductor 530, which in turn is coupled to a pair of circuit connectors 540 that are electrically connected (through cable 562) to connector pins 562c and 562d of the generator cable connector 562 (FIG. 2). When the cable connector 562 is connected to the generator 564, and the generator 564 is activated for use in a procedure with the tissue sealing and cutting instrument 100, activation of either dome switch 520a and 520b “closes” an energy activation control circuit coupled to pins 562c and 562d within the generator 564 to thereby initiate delivery of power from the generator 564 to the pair of opposing jaws 700 in accordance with the pre-programmed power algorithm. The dome switches 520a and 520b are secured to respective sides of a switch chassis 550 composed of non-conductive material(s) that is mounted at the top interior surface of the instrument body housing 200.
[0061] FIG. 2 depicts the end of the generator connector 562 at the end of cable 560 that extends from the instrument handle 220. In addition to pins 562c and 562d, pins 562e and 562f form a circuit that identifies the instrument type (e.g., manufacturer make and model) and/or operating parameters to the generator 564. Larger gage pins 562a and 562b are respective active and return (ground) terminals of the sealing energy circuit, and are electrically coupled to respective jaws 720 and 740 via cable 560 and additional wires that travel through the instrument body 110 and shaft lumen 124, respectively, to the jaws 720 ground (anode).
[0062] As shown in FIGS. 3B, 6 and 7A-7B, a latch pin 340 and jaw actuation handle pin 335 are coupled to the jaw actuation handle 310. The latch pin 340 is configured to engage and travel in a housing maze 230 (FIG. 6) for more controlled movement of the pair of opposing jaws 700. The jaw actuation handle pin 335 is coupled to the instrument body housing 200, so that the jaw actuation handle 310 pivots (or rotates) about the actuation handle pin 335 (e.g., pivot point), which will be described in further detail below.
[0063] Referring now to FIGS. 3B and 4A-C, the cutting member translation drive pinion 420 operatively couples the cutting member trigger 410 to the drive rack 430. The drive rack 430 is in turn coupled to the cutting member actuator 440 via a cutting member cap 442. The drive pinion 420 is configured to rotate about a drive pin 424, which is configured to pass through and translate within a cutting translation assembly slot 414, as best shown in FIG. 3B. The drive pinion 420 further comprises a drive pinion first gear 422 and a drive pinion second gear 426. The first gear 422 of the drive pinion 420 is configured to engage the cutting member trigger 410. For example, the first gear 422 of the drive pinion 420 engages a trigger gear 412 of the cutting member trigger 410. The second gear 426 of the drive pinion 420 is configured to engage a drive rack gear 436 of the drive rack 430 that is coupled to the cutting member actuator 440. As such, when the cutting member trigger 410 is actuated (i.e. , moved proximately towards the jaw actuation handle 310 and instrument body handle 220) the trigger gear 412 moves the first gear 422 of the drive pinion 420, which in turns moves the second gear 426 of the drive pinion 420 that engages and moves the drive rack gear 436. Movement of the drive rack gear 436 in turn causes the cutting member actuator 440 to translate the cutting member 450 distally.
[0064] As show in FIG. 3B, the drive pinion first gear 422 is smaller than the drive pinion second gear 426, resulting in an increase distance ratio (approximately 2:1) of the drive rack gear 436 with respect to the drive pinion first gear 422. The first gear 422 and the second gear 426 of the drive pinion 420, and the trigger gear 412, are substantially circular, semi-circular, curved or arcuate, while the drive rack gear 436 is substantially linear. The cutting member trigger 410 further comprises a trigger pin 416, as shown in FIG. 3B. The trigger pin 416
is coupled to the instrument body housing 200 such that the cutting member trigger 410 rotates about the trigger pin 416.
[0065] The instrument body housing 200 includes a rotatable nose cone “knob” portion 270 coupled to a rotation knob bushing 275 configured to rotate the shaft 122 and, thus, the opposing pair of jaws 700 (FIGS. 3A-3B). For example, when the user turns the rotation knob 270 relative to the rest of the instrument body housing 200, the knob 270 engages the rotation knob bushing 275, which engages and rotates the shaft 122 thereby rotating the pair of jaws 700, as shown by arrow 271 in FIG. 3A. In some embodiments, the pair of electrical wires 570 coupled to the pair of jaws 700, are wrapped within the rotation knob bushing 275 to provide sufficient slack to allow the electrical wires 570 to rotate.
[0066] As described above, and shown in FIGS. 4A-4C, the cutting member translation assembly 400 is in a “locked” position with the cutting member 450 in the fully-retracted position whenever the pair of jaws 700 are in the open position (FIG. 4A), and a “unlocked” position where the cutting member 450 is allowed to be advanced distally to the fully-extended position (FIGS. 4B and 4C) when the pair of jaws 700 are in the approximate position.
[0067] In particular, FIG. 4A illustrates the cutting member translation assembly 400 in the locked position. The drive pinion 420 is shown transparent in FIGS. 3A and 3C, such that the outlines of the drive pinion 420 components (e.g., first gear 422 and second gear 426) are better appreciated. The jaw actuation handle 310 comprises an extension/protruding portion 328 (FIG. 4A) that interferes with the drive pinion boss 428. The pinion boss 428 have an arcuate or curvilinear shape or any other suitable configuration. As can be observed in FIG. 3A, the jaw actuation handle extension/protruding portion 328 interferes with the end point 428a of the boss 428 and prevents rotation of the drive pinion 420 when the jaw actuation handle 310 in not actuated by the user.
[0068] FIG. 4B illustrates the cutting member translation assembly 400 in the unlocked position, in which distal translation of the cutting member 450 is permitted, but before the cutting member is moved to the fully-extended position. As the jaw actuation handle 310 is moved proximately by the user towards the
instrument body handle 220 in the direction shown by arrow “I”, the boss end 428a of the drive pinion 420 does not interfere with the extension 328 of the jaw actuation handle 310. In particular, movement the jaw actuation handle 310 in the direction of arrow “I” allows rotation of the drive pinion 420 about the drive pin 424 in the direction of arrow “II”, as shown in FIG. 4B. Simultaneously, the second gear 426 of the drive pinion 420 engages the drive rack 430 and moves the drive rack gear 436 to thereby extend the cutting member 450 distally. FIG. 4C depicts the cutting member translation assembly 400 when the cutting member 450 is in the fully-extended position between the closed jaws (not shown). As shown in FIG. 4C, the jaw actuation handle 310 is held in the proximal or pulled position so that the cutting member trigger 410 is pulled or moved to the proximal position as well.
[0069] The cutting member trigger 410 is moved in an angular motion (shown by arrow “II” in FIG. 4C) by rotating about a pivot point at the trigger pin 416 until the cutting member trigger 410 is adjacent and abutting the jaw actuation handle 310. This action rotates the drive pinion 420 about the drive pin 424 and moves the drive rack 430 and extends the cutting member 450 while the pair of opposing jaws 700 are in the close or approximate position. For example, the second gear 426 of the drive pinion 420 that engages and moves the drive rack gear 436 and drive rack 430, respectively, which in turn translated the cutting member actuator 440 to extend the cutting member 450 to the fully-extended position. FIG. 4B shows the drive rack 430 in a proximal position, while FIG. 4C shows the drive rack 430 is distal position. A cutting member return spring 445 is configured to engage and exert a force on the drive rack 430 to translate the rack 430 from the distal position to the proximal position, thereby returning the cutting member 450 to the fully-retracted position, when the cutting member trigger 410 is released by the user. In other words, the cutting member 450 is biased to be in the retracted position due to the force exerted by the cutting member return spring 445.
[0070] FIG. 5 illustrates a partial perspective view of the interface between the drive rack 430 and drive pinion 420 from an opposite side view of FIGS. 4A-4C. As shown in FIG. 5, most components disposed inside the instrument body housing 200 and in proximity to the drive rack 430 are disposed proximally
towards the instrument body handle 220. As such, the drive rack 430 can translate the cutting member actuator 440 without interfering with the components. This arrangement of the components inside the instrument body housing 200 advantageously provides more space for the cutting member translation rack 430 to translate the cutting member actuator 440, and thus the cutting member 450.
[0071] It will be appreciated that a user will first position the open jaws 720 and 740 around a portion of tissue (e.g., a blood vessel) to be sealed/divided. The user then moves (squeezes) the jaw actuation handle 310 towards - into the instrument body handle 220 to securely clamp the tissue portion between the jaws 720 and 740. While continuing to hold the jaw actuation handle 310 against (or close to) the instrument body handle 220, the user then presses one of the energy activation contact switches 510a or 510b to initiate delivery of sealing energy through the clamped tissue portion. An audible sound and/or visible light indicates that the delivery of power is complete, and that the clamped tissue portion has been sealed. While continuing to hold the jaw actuation handle 310 against (or close to) the instrument body handle 220, the user uses a finger from their same hand holding the other handles to squeeze the cutting member translation trigger 410, thereby extending the cutting member 450 between the jaws to divide the sealed tissue. The user then releases the respective cutting member translation trigger 410 and jaw actuation handle 310, and the respective cutting member return spring 445 and jaw actuation return spring 330a return the cutting member to the fully-retracted position and the pair of opposing jaws 700 to the open position. The user then repositions the open jaws to another portion of tissue to be sealed and divided, repeating the process until the procedure is completed.
[0072] FIG. 6 illustrates a side exploded view of a latching mechanism 800 within the instrument body 110. The latching mechanism 800 comprises the housing maze 230, which for illustration purposes is shown in the interior of the first side 200a of the instrument body housing 200 in FIGS. 6-7B. However, it should be appreciated that the housing maze 230 can be disposed, formed or defined in the second side 200b of the housing 200, or on both sides 200a and
200b. A latch pin 340 is coupled to the jaw actuation handle 310, and configured to engage and travel though the housing maze 230 to control movement of the pair of opposing jaws 700. A latch elongated member 350 is coupled to the jaw actuation handle 310 and to the latch pin 340. As the jaw actuation handle 310 pivots and rotates around the handle pin 335 (e.g., pulled towards the instrument body handle 220, as previously described), the latch pin 340 travels through the maze 230, which will be described in further detail below.
[0073] FIGS. 7A-7B illustrate side views of the latching mechanism 800 of FIG. 6. As better appreciated in FIG. 7A, the housing maze 230 is formed or defined by a plurality of extensions 232, 234, and 236 that protrude from an inner surface 202 of the instrument body housing 200. In some embodiments, the extensions 232, 234, and 236 are molded into the inner surface 202 of the housing. Alternatively, the extensions 232, 234, and 236 may be formed by separate pieces coupled to the inner surface 202 of the housing 200. The extensions 232, 234, and 236 are formed in mirroring opposing pairs that extend inwardly from the inner surface 202 of each of the first and second sides 200a and 200b of the instrument body housing 200, defining a 3D housing maze 230. Each of the extensions 232, 234, and 236 comprises side walls 238. The side walls 238 of the extension are configured to limit or bound the movements of the latch pin 340 and the latch elongated member 350. The extensions 232, 234, and 236 and their side walls 238 define pathways, trails or tracks of the housing maze 230. As better appreciated in FIG. 7B, the housing maze 230 comprises a first pathway “A” and a second pathway “B” defined between the extensions 232, 234, and 236 and the inner surface 202 of the instrument body housing 200, where the latch pin 340 is configured to move and travel along the pathways.
[0074] As shown in FIG. 7A, the latch elongated member 350 comprises a proximal portion 351 having a proximal end 352 coupled to the latch pin 340, and a distal portion 357 configured to be coupled to the jaw actuation handle 310. The proximal portion 351 comprises a first arm 354, and the distal portion 357 comprises a second arm 358. The latch elongated member 350 is formed of a metal or any other suitable elastic material configured to store elastic potential energy. When the latch pin 340 travels through pathways of the housing maze
230 (FIG. 7B), the latch elongated member 350 (i.e. , the first and second arms 354 and 358) is configured to contact the side walls 238 of the extensions 232, 234, and 236 and exert spring elastic forces maintaining the proximal end 352 of the latch elongated member 350 and latch pin 340 within the paths of the housing maze 230. When the user moves or pulls the jaw actuation handle 310 towards the instrument body handle 220, the latch elongated member 350 initially takes the pathway “A”, such that the latch pin 340 travels from a position “A1” to a position “A2” of the pathway “A”, as shown in FIG. 7B. As such, the side wall 238 of the extension 234 holds the latch pin 340 in the position “A2”, thereby holding or latching the pair of opposing jaws 700 in their close approximate position, alleviating the user from apply continued force to the jaw actuation handle 310 and relieving user fatigue. When the user desires to unlatched the pair of opposing jaws 700 from in the approximate position, the user further pulls the jaw actuation handle 310 towards the instrument body handle 220 to release the latch pin 340 from the position “A2”. As such, the latch pin 340 begins to travel the path “B” from the position “B1” towards the position “B2”, as shown in FIG. 7B, which opens the pair of opposing jaws 700.
[0075] FIGS. 8A-8C illustrate perspective, side and top views of the components energy activation assembly 500 depicted in FIGS. 3A-B. The components of the energy activation assembly 500 are configured to activate and facilitate the delivery of tissue sealing energy to the pair of opposing jaws 700, and include the energy activation contact switches 510a and 510b. For illustration purposes, the second energy activation contact switch n 510b is shown as transparent in FIG. 8A in order to visualize further components (e.g., the flexible circuit 530) of the assembly 500. The energy activation assembly 500 further includes the pair of dome switches 520a (FIGS. 8C) and 520b (shown in FIGS. 8A-8B) underlying the respective housing surface contact switches 510a and 510b. As shown in FIGS. 8A-8C, the first and second energy activation contact switches 510a and 510b have inwardly extending posts 512a and 512b disposed substantially at a center of the respective dome switches 520a and 520b, such that, regardless of where the user presses or pushes the activation switches 510a or 510b, the respective post 512a or 512b will contact and activate the
respective dome switch 520a or 520b, thereby substantially minimizing or eliminating activation “dead zones” associated with the contact switches 510a and 510b. The first and the second dome switches 520a and 520b are electrically coupled to the flexible circuit 530, such that the activation of either dome switch 520a or 520b will close the energy activation circuit (via pins 564c and 564d) to initiate the delivery of energy to the pair of opposing jaws 700 (via pins 562a and 562b). As described in greater detail below, a pair of insulated wires (not shown) extend from the pin connectors 562a and 562a through the cable 560, instrument body 110 and down/along the shaft 122 to delivery energy to the opposing pair of jaws 700, wherein one wire acts as the active conductor, and the other being the return conductor.
[0076] FIGS. 9A-9B illustrate side views, and FIG. 9C illustrates a top view, of the pair of opposing jaws 700 of the tissue sealing and cutting instrument 100 of FIGS. 1A-1B. As shown in FIG. 9A, the pair of opposing jaws 700 are in the closed or approximate position, with the first jaw 720 and second jaw 740 positioned approximate each other and configured to hold and clamp tissue therebetween. In some embodiments, the pair of opposing jaws 700 may have an overall envelope diameter 705 of no more than 8.0 millimeters when the first 720 and second 740 jaws are in the approximate position. In some embodiments, the pair of opposing jaws 700 may have an envelope diameter 705 of less than 6.0 millimeters when the first 720 and second 740 jaws are in the approximate position. As shown in FIG. 9B, the pair of opposing jaws 700 are in the open position, with the first jaw 720 and second jaw 740 spaced apart from each other to allow the instrument to be maneuvered into a new position to place the jaws 720 and 740 around a blood vessel or other tissue portion to be treated. FIG. 9C illustrates a top view of pair of opposing jaws 700, depicting the curved, nonlinear configuration 701 of the pair of opposing jaws 700 to give each of the opposing jaws 700 a “Maryland” jaw shape.
[0077] The pair of opposing jaws 700 are offset from the longitudinal axis 121 of the instrument 100. Each jaw has a proximal portion 7at has an elongated drive slot 730 therethrough, wherein the drive slots 730 of the opposing jaws 700 are aligned and configured to receive a drive pin 322 therethrough (FIG. 10A).
The jaw drive slots 730 are curved and disposed at an angle with respect to the longitudinal axis 121 of the instrument shaft 122 such that the jaws travel in a desired trajectory relative to each other as the drive pin 322 travels through the slot from one end (jaws open) to the other end (jaws closed) of the slots 730. In alternative embodiments, the jaw drive slots 730 may have any other suitable shape, such as elongated straight linear slot (not shown).
[0078] FIGS. 10A-10B illustrate cross sectional views of the pair of opposing jaws 700. Particularly, FIG. 10A shows the proximal portions 710 of the jaws 700 in a longitudinal cross-sectional view, while FIG. 10B shows a transversal cross- sectional view of the jaws 700. As shown in FIGS. 9A-10B, each jaw also comprises a pivot pin hole 732 (e.g., aperture, opening), wherein the respective pivot pin holes 732 are aligned and configured to accommodate a pivot pin 734 therethrough. The pivot pin holes 732 may have a round, cylindrical configuration or any other suitable shape configured to receive the pivot pin 734.
[0079] As shown in FIGS. 9A-9B and 10A, the respective pivot pin holes 732 and pivot pin 734 are disposed distally from the jaw drive slots 730 and drive pin 322. As shown in FIG. 10A, the drive pin 322 extends through the respective slots, with each end of the drive pin 734 being fixedly attached to a respective split end of the jaw actuator 320, such that when the jaw actuator 320 translates or moves axially, the drive pin 322 travels within the jaw drive slots 730 to thereby move the jaws 720 and 740 about the pivot pin 734 between the open and approximate positions. This configuration advantageously allows the jaws 720 and 740 to be assembled separately, e.g., at the pivot pin 734, independent from the jaw actuator 320. The jaw actuator 320 may also be assembled separately. Then, the fully assembled pair of opposing jaws 700 are introduced into the jaw actuator 320 and coupled together with the drive pin 322.
[0080] In some embodiments, the pivot pin holes 732 are electrically isolated from the metal jaw frames 722 and 724. For example, the pivot pin holes 732 may be composed of non-conductive material, may have a non-conductive coating, liner or layer. Alternatively, a non-conductive bushing 733 may be employed (FIG. 10B) to isolate the pivot pin holes 732 from the jaw frames 722
and 724. The pivot pin 734 (FIGS. 10A-10B) defines a pivot point and allows rotation of the pair of opposing jaws 700 relative to each other. In some embodiments, the bushing 733 is fixedly attached (e.g., glued, welded, or the like) to the first jaw 720, such that the second jaw 740 rotates relative to the first jaw 720. Alternatively, the bushing 733 may be fixedly attached to the second jaw 740, so the first jaw 720 rotates relatively to the second jaw 740. In some embodiments, the pivot pin 734 may be made of a metallic material and may include a coating, liner, or layer to minimize abrasive wear against the bushing 733. In certain other embodiments, the pivot pin may be formed of a suitable non- conductive material such as, for example, a ceramic material.
[0081] In an alternative embodiment, the jaws may be assembled with a non- conductive insert that surrounds and/or at least partially covers the respective pivot pin hole and drive slot. By way of example, FIGS. 20 and 21 depict an alternative jaw 720’ having a conductive metal jaw frame 722’ in which a portion of the frame 722’ that includes a pivot pin hole 732’ and a drive pin slot 732’ has been configured to receive a non-conductive jaw frame insert 2000 that includes a laterally extending pivot pin hole portion 2032 and a laterally extending drive pin slot portion 2030 that extend the entire width of the jaw frame 722’. The insert 2000, is formed from ceramic material, anodized aluminum, or some other suitable non-conductive material, to electrically isolate the jaw frame 722’ from respective pivot and drive pins (not shown) passing through the pivot pin hole portion 2032 and drive pin slot portion 2030. The jaw frame insert 200 has a first side 2002 that, when the insert 200 is inserted into the jaw frame 722’, is substantively flush with the surface of the jaw frame 722’. As best seen in FIG. 21 , the pivot pin hole portion 2032 and drive pion slot portions on a second side 2004 of the insert 2000 extend the entire width of the jaw frame 722’. The non- conductive insert 200 may be affixed to the jaw frame 722’, or it may be retained retained in the jaw frame 722’ by the jaw over-mold (not shown).
[0082] FIGS. 11A-11C illustrate perspective and exploded views of the jaws 700 and jaw actuator 320. FIG. 11C depicts the jaw actuator 320 as having a flat elongated configuration but other configurations are possible that allow translation or axial movement of the actuator 320. As shown in FIGS. 11A-11C,
the pair of opposing jaws 700 may include a pair of cam guide inserts 736 disposed over the drive pin 322, wherein the cam guide inserts 736 are configured to restrict or limit movement of the drive pin 322 within the jaw drive pin slots 730 to prevent splaying of the jaws 700. As better appreciated in FIG. 11 C, at least one of the cam guide inserts 736 comprises a recess 737 where the drive pin 322 is disposed. The recess 737 provides a bearing surface for the drive pin 322 as the jaws 700 are rotated between the open and approximate positions. In certain embodiments, the cam guide inserts 736 may be formed of stainless steel and press-fitted into the outer surface of the instrument shaft 122, forming a flush surface with the shaft 122.
[0083] As shown in FIGS. 11B-11C, jaws 720 and 740 are provided with non- conductive over-molds 721 , 741 that partially cover the respective jaw frames 722, 742. The over-molds 721 , 741 are composed of a non-conductive polymeric material to electrically isolate the jaw frames 722, 742, which are composed of suitable conductive material (e.g., metal, alloys or the like). In some embodiments, the over-molds 721 , 741 may further define and cover the pivot pin holes 732 to electrically isolate the pivot pin 734.
[0084] FIGS. 12A-12D illustrate perspective and exploded views of the first jaw 720. It should be appreciated that jaw 740 is essentially a mirror image of jaw 720, and that the following description of jaw 720 applies equally to jaw 740. As shown in FIG. 12A, the over-mold 721 further defines the jaw pivot pin hole 732 and partially covers the jaw frame 722, while exposing a relatively narrow electrically conductive raised surface portion (“seal plate”) 723. In particular, the raised seal plate 723 has two elongate sides that extend nearly the entire length of the jaw 720, from a proximal end portion 731 proximate pivot pin hole 732, to a distal end of the jaw 743, with a channel or slot 725 disposed between the two seal plate sides through which the cutting member 450 (not shown) is advanced to cut sealed tissue clamped between the jaws. In particular, the cutting member channel 725 of first jaw 720, and the cutting member channel 725 of the second jaw 740 are aligned with each other such that, when the jaws 720, 740 are in the approximate configuration, the first and second jaw channels 725 together form a slot through which the cutting member 450 travels. A distal end portion 727 of the
seal plate 723 wraps around the distal end of the cutting member slot 725, such that the two elongate sides of the raised seal plate 723 are continuous. In some embodiments, the exposed seal plate surfaces may have an anti-stick coating applied to them, which also may be sandblasted, to help minimize sticking/adhesion of the tissue.
[0085] With additional reference to FIGS. 22A-C, the seal plate 723 tapers in width along the length of the jaw 720, from the proximal end portion 731 to the distal end tip 743. In particular, each side of the seal plate 723 is wider in a proximal portion 780 of the seal plate than in a distal portion 785 of the seal plate in order to better maintain a constant pressure (force per seal plate area) imposed on the tissue being clamped between the jaws 700. Notably, in some embodiments, most to all of the tapering seal plate width reduction takes place between the proximal portion 780 and a middle jaw portion 783 of the seal plate. For example, in some embodiments, each side of the seal plate 723 may have a width (indicated as 783 in FIG. 22B) of approximately 0.040” in the proximal portion 780 of the seal plate, and a width of 0.025” (indicated as 787 in FIG. 22C) at both the middle portion 783 and the distal end portion 785 of the seal plate 723. In other words, all narrowing in the width of the seal plate 723 takes place entirely between the proximal portion 780 and the middle portion 783, with little to no further tapering between the middle portion 783 and the distal portion 785.
[0086] Returning to FIGS. 12A-D, An electrode mount 724 is coupled to the jaw frame 722 (FIG. 12D). The electrode mount 724 has a same length-width dimensions as, and underlies/supports the raised seal plate 723. With additional reference to FIGS. 19A and 19B. the pair of electrical wires (described above in conjunction with the power activation assembly 500, includes a first insulated wire 1560 that passes through a strain relief channel 1900 in the jaw frame 722 (best seen in FIG. 19B), wherein the insulation 1562 is removed and an exposed portion of the wire 1563 is welded or otherwise electrically coupled to the jaw frame (not shown) distal to the strain relief passage 1900 to deliver electrical energy to the raised seal plate 723 via the jaw frame 722. It should be appreciated that the jaw frames 722 and 742 are electrically coupled to different wires that may be electrically connected to the generator 564 via the generator
cable connector pins 562a and 562b (FIG. 2) through the cable 560, instrument body 110, and within/along the shaft 122, respectively, with one wire being the active conductor, and the other wire being the return conductor, so as to form a closed circuit including the respective jaw frame plates 722, 724, seal plates 723, and tissue clamped between the jaws 720, 740. The strain relief passage reduces or prevents the possibility of the wire-to-jaw frame weld from breaking due to proximal pulling tension on the wire 1560. In particular, the geometry of the channel 1900 results in any proximal pulling force on the wire 1560 being born by the wire itself, and not the weld, which is weaker than the wire 1560.
[0087] FIGS. 22A are top views of a surface of one of the seal plates 700 of the instrument 100. depict eal plate width tapering along length of proximal portion of the seal plate.
[0088] In certain embodiments, the jaw may be formed as a multi-piece jaw. In this configuration, a layer of plastic material may be positioned between the seal plate and the frame to act as a thermal barrier, effectively reducing thermal spread and improving thermal management during operation. Furthermore, in certain additional embodiments, the bottom surface of the seal plate may include a non-conductive coating, liner, or layer. This feature enhances electrical insulation and minimizes heat conduction.
[0089] FIGS. 13 and 13B are side views of one of the opposing jaws 700 (jaw 720 or jaw 740), showing the side profile of the exposed raised seal plate 723 extending above the over-mold 721 , 741. As best seen in FIG. 13B, the seal plate 723 extends by a gap 1302 above the top surface of the over-mold 721 , 724 directly adjacent to the seal plate 723 to expose a significant amount of the metal side(s) of the seal plate 723. Notably, the seal plate 723 has an arcuate top surface, wherein the broken line 1304 indicates the lowest edge of the top surface, and the solid line 1305 indicates the highest point along the arcuate top of the seal plate 723 relative to the top surface of the over-mold 721 , 741. The over-mold continues to decrease in height, including step downs 1306 1308 and 1310, as the over-mold surface extends farther away from the seal plate 723 (width-wise) towards the proximal end of the jaw 731 , to provide additional relief
and ensure the seal plate 723, and not the over-mold 721 , 741 , is clamping the tissue.
[0090] Reducing the relative height of the over-mold to increase the side profile of the seal plate 723 (approximately 0.043” in one embodiment) is believed to be particularly beneficial in tissue sealing devices where the seal plate is not electrically isolated from the jaw structure (which then acts as a heat sink) for providing additional thermal energy generating contact with tissue clamped between the jaws.
[0091] In contrast to the over-mold profile on the jaw 700, FIGS. 14A and 14B are side views of an alternative jaw 1400 in which the seal plate is electrically isolated from the jaw support structure. The surface of jaw 1400 includes a conductive seal plate 1423 substantially enclosed by an over-mold 1421. As best seen in FIG. 14B, the height profile of the exposed side wall of the seal plate 1423 (indicated by the gap 1402) is significantly less (approximately 0.012” in some jaw embodiments) than in jaw 700. The over-mold 1421 otherwise has similar reductions in the over-mold height, including step downs 1404, 1406 and 1410, as the over-mold surface extends farther from the seal plate 1423 towards the proximal end of the jaw 1400.
[0092] FIGS. 15-18 depict a cutting member stabilization clevis 1520 coupled to a dial end portion 441 of the cutting member actuator 440, in accordance with some embodiments of the tissue sealing and cutting instrument 100 of FIGS. 1A- 1B. The stabilization clevis 1520 includes first and second clevis arms 1502, 1504, which are welded or otherwise adhered to an interior wall 443 of the distal end portion 441 of the cutting member actuator 440. The clevis arms 1502 and 1504 extend distally from the actuator 440, with the cutting member 450 also extending distally from the actuator 440 through a gap between the clevis arms 1502 and 1504. It will be appreciated that the cutting member 450 is relatively thin, and the clevis arms 1502 and 1504 provide structural support to help to prevent buckling as the cutting member 450 is extended through sealed tissue clamped between the opposing jaws (not shown). Much of clevis arm 1504 is transparent in FIG. 16 to reveal the elongate cutting member 450 extending
between the clevis 1502 and 1504 arms.
[0093] The material comprising a inner wall of the distal end portion 457 of the cutting member 450 is removed to create a slot 459 to accommodate passage there through of the jaw pivot pin 734. The stabilizing clevis arms 1502 and 1506 have respective aligned openings 1506 flanking the slot 459 to also accommodate passage therethrough of the jaw pivot pin 734. As best seen in FIGS. 17 and 18, a spacer boss/protrusion 1508 extends from a distal end portion of clevis arm 1504, distal of the jaw pivot pin openings 1506, through the opening 459, contacting clevis arm 1502 to maintain uniform spacing between the respective clevis arms 1502 and 1504. It will be appreciated that the spacer protrusion 1508 may alternatively be provided on clevis arm 1502.
[0094] FIGS. 23-26 depict alternative arrangements for securing opposing jaw members (e.g., jaws 720, 740 of tissue sealing and cutting instrument 100) to a pivot pin (e.g., pivot 734 of the instrument 100). It should be appreciated that some of the arrangements for securing the opposing jaw members to the pivot pin may be employed in instrument 100, while other arrangements may be better suited for alternative sealing instruments having different jaw constructions than the jaws 720, 740 of instrument 100. As such, the arrangements for securing the opposing jaw members to the pivot pin are described without reference to jaws 720 and 740 of instrument 100.
[0095] With reference to FIGS. 23 and 24, jaw frame 2310 of jaw 2320 has a distal opening/aperture 2322 for receiving therethrough a jaw pivot pin 2308. A metallic pivot sleeve bearing (“support sleeve”) 2305 is inserted through the aperture 2322, and the pivot pin 2308 extends through the lumen of the pivot support (bearing) sleeve 2305. The ends of the pivot pin 2308 are secured (e.g., by welds 2331) to respective arms 2314 and 2316 of a jaw support clevis that sandwich the jaw frame members 2314 and 2316 approximate each other. The metallic support sleeve 2305 has a length configured to extend between jaw frame 2310 and jaw frame 2312 (of jaw 2340 - not shown) when the respective jaw frames are sandwiched between the clevis arms 2314 and 2316. In particular, the ends of the support sleeve 2305 abut or otherwise terminate
proximate the respective clevis arms 2314 and 2316. The pivot pin 2308 is configured to form an interference fit within the lumen of the sleeve 2305, such that the support sleeve 2305 is fixed to the pivot pin 2308 and, in turn, to the clevis arms 2314 and 2316.
[0096] In particular, the aperture 2322 though jaw frame 2310 has a slightly decreased diameter compared with the aperture 2322 though jaw frame 2312 such that the support sleeve 2305 is also secured to jaw frame 2310 by an interference fit (indicated by ref. no. 2348 in FIG. 24) (or by some other means such as a weld or adhesive bond), while jaw frame 2312 may freely rotate relative to the pivot pin 2308 and sleeve 2305, as indicated by the gap 2350 between the sleeve 2305 and the jaw frame 2314. This configuration beneficially reduces the amount of “play” between the jaws 2320 and 2340, minimizing or eliminating the possibility that the jaws become misaligned during a surgical procedure, while still allowing the jaws to be moved between open and closed configurations.
[0097] FIGS. 25 and 26 depict another embodiment of a tissue sealing instrument jaw assembly, including a first jaw 2520 having a jaw frame 2510, and a second jaw 2540 (FIG. 26) having a jaw frame 2512. Proximal portions of the respective jaw frames 2510 and 2512 are coupled together by a metallic pivot sleeve bearing (“support sleeve”) 2505 that extends through aligned pivot pin apertures 2522 in the jaw frames 2510 and 2512. The support sleeve diameter is configured so that the support sleeve slides through the aperture 2522 when the support sleeve is first inserted through the jaw frame apertures 2522 during the instrument assembly process. The support sleeve 2505 has a laterally extending collar or flange 2507 at one end that acts as a stop to limit further insertion of the sleeve 2505 through the aperture 2522. In the illustrated embodiment, the support sleeve 2505 is inserted through the aperture 2522 of the lower jaw frame 2510 until the flange 2507 abuts and stops against a portion of over-mold material 2529, which is sandwiched between the support sleeve flange 2507 and the jaw fame 2510.
[0098] The support sleeve 2505 is secured to the upper jaw frame using a swaging process in which the tubular wall of the sleeve 2505 is plastically
deformed by a swaging tool to crimp (affix) the sleeve 2505 to the upper jaw frame 2512, such that the upper jaw frame is not rotatable relative to the support sleeve. However, the lower jaw frame 2510 is not affixed to the sleeve 2505, is may freely rotate relative to the sleeve 2505. Once the support sleeve 2505 is in place, a pivot pin 2708 is inserted through the support sleeve 2505, entering the sleeve lumen through the pivot pin aperture 2522 in the upper jaw frame 2512. The pivot pin has an enlarged head that abuts and stops against a portion of over-mold material 2529, which is sandwiched between the pivot pin head and the jaw fame 2512. The opposite end of the pivot pin 2708 is then welded to the support sleeve 2505. The pivot pin 2708 is also fixed at each end to respective arms of a jaw support clevis (not shown), so that the pivot pin 2708 is fixed to the clevis, the support sleeve 2505 is fixed to the pivot pin 2507 and to the upper jaw frame 2512 (from the swaging process). This configuration beneficially reduces the amount of “play” between the jaws 2520 and 2540, minimizing or eliminating the possibility that the jaws become misaligned during a surgical procedure, while still allowing the jaws to be moved between open and closed configurations.
[0099] FIGS. 27 and 28 are cut-away side views of an alternate embodiment of a tissue sealing and cutting instrument 2800. As with instrument 100 of FIGS. 1A- 1B, instrument 2800 includes an instrument body 2810 having an instrument body handle (not shown), a shaft (not shown) having a proximal end coupled to the instrument body, and a pair of opposing jaws (not shown) movably coupled to a distal end portion of the shaft. The instrument 2800 includes a jaw actuation handle 2850 that is pivotally coupled to the instrument body 2810 and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle 2850 towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween.
[00100] As best seen in FIG. 28, instrument 2800 further includes a jaw actuation handle return spring 2830 having a first end disposed in a spring well 2835 formed in the jaw actuation handle 2850, and a second end the abuts a solid wall 2832 structure in the instrument body 2810. The return spring 2830 is compressed by the jaw actuation handle 2850 as a user moves the handle 2850 towards the instrument body handle to manipulate (close) the opposing pair of
jaws. The return spring 2830 self-restores to a non-com pressed state, thereby moving the jaw actuation handle 2850 back to an initial position away from the instrument body handle (opening the jaws) , when the user releases the jaw actuation handle 2850.
[00101] FIGS. 29 and 30 are perspective views of a jaw link member 3000 deployed in an alternative tissue sealing and cutting device. The jaw link member 3000 includes first and second end cylindrical connector bosses 3002 and 3004. The first end connector boss 3002 is configured to press fit into a receiving aperture/opening 3005 of an instrument jaw 3020, and the second end cylindrical connector boss 3004 is configured to press fit into a receiving aperture/opening of a reciprocating jaw actuator (not seen) in order to rotate the jaw 3020 about a pivot pin (not seen) that rotatably connects jaw 3020 with a second jaw (not seen). Under certain operating conditions of the instrument, it is possible that the first end connector boss 3002 may become uncoupled from (i.e., pull laterally out of opening 3005 of) the jaw 3020.
[00102] FIGS. 31 and 32 are perspective views of an alternative jaw link member 3200 having first and second end cylindrical connector bosses 3202 and 3204. Jaw link member 3200 is essentially identical to jaw link member 3000 of FIGS. 29-30, except that the first end connector boss 3202 of jaw link member 3200 is provided with a tongue-shaped locking member 3207 that extends laterally from the connector boss 3202 towards the second connector boss 3204. During assembly of the instrument, the first end connector boss 3202 is maneuvered to insert the tongue-shaped locking member 3207 through the opening 3005 in jaw 3020. The jaw link member 3200 is then further maneuvered to insert the remaining body of the first end connector boss 3202 through the opening 3005, such that the tongue-shaped locking member 3207 extends laterally to overlap with a portion of the jaw 3020 to thereby secure the first end connector boss 3202 within the opening 3005 and prevent the possibility that the first end connector boss 3202 may become uncoupled from (i.e., pull laterally out of opening 3005 of) the jaw 3020.
[00103] The foregoing description and examples has been set forth merely to
illustrate the disclosure and are not intended as being limiting. Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects, embodiments, and variations of the disclosure. In addition, unless otherwise specified, none of the steps of the methods of the present disclosure are confined to any particular order of performance. Modifications of the disclosed embodiments incorporating the substance of the disclosure may occur to persons skilled in the art and such modifications are within the scope of the present disclosure. The language of the claims is to be interpreted broadly based on the language employed in the claims. The language of the claims is not to be limited to the non-exclusive embodiments and examples that are illustrated and described in this disclosure, or that are discussed during the prosecution of the application.
[00104] Certain features that are described in this disclosure in the context of separate implementations can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can be implemented in multiple implementations separately or in any suitable subcombination. Although features may be described herein as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.
[00105] While the methods and devices described herein may be susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but, to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an embodiment can be used in all other embodiments set forth herein.
[00106] Methods disclosed herein need not be performed in the order recited. Depending on the embodiment, one or more acts, events, or functions of any of the algorithms, methods, or processes described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the algorithm). In some embodiments, acts or events can be performed concurrently, e.g., through multithreaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. Further, no element, feature, block, or step, or group of elements, features, blocks, or steps, are necessary or indispensable to each embodiment. Additionally, any methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “positioning the jaws to grasp tissue to be sealed” include “instructing positioning the jaws to grasp tissue to be sealed.”
[00107] It should be appreciated that all possible combinations, subcombinations, and rearrangements of systems, methods, features, elements, modules, blocks, and so forth are within the scope of this disclosure. The use of sequential, or time-ordered language, such as “then,” “next,” “after,” “subsequently,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to facilitate the flow of the text and is not intended to limit the sequence of operations performed. Thus, some embodiments may be performed using the sequence of operations described herein, while other embodiments may be performed following a different sequence of operations.
[00108] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, and all operations need not be performed, to achieve the desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations.
Further, the operations may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described herein should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.
[00109] Embodiments of the disclosed inventions have been described in connection with the accompanying figures. Certain figures may be drawn and/or shown to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the embodiments disclosed herein. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, any methods described herein may be practiced using any device suitable for performing the recited steps.
NUMBERED EMBODIMENTS OF THE INVENTION
[00110] 1. A tissue sealing instrument, comprising: an instrument body comprising an instrument body housing and an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; and a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein the instrument further comprises a first energy activation switch on a first side of the instrument body housing, and a second energy activation switch positioned on a second side of the instrument body housing, wherein the first and second energy activation switches are configured and positioned on the respective first and second sides of the instrument body housing such that a user holding the instrument with a right hand or a left hand while squeezing the jaw actuation handle into the instrument body handle can
use of thumb or other digit of the respective right hand or left hand to contact and activate one of the first and second energy activation switches without releasing the jaw actuation handle.
[00111] 2. A tissue sealing instrument, comprising: an instrument body comprising an instrument body housing and an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; and a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, the instrument further comprising a jaw actuation biasing element configured to move the jaw actuation handle to, and/or maintain the jaw actuation handle in, the non-actuated position, thereby moving the opposing pair of jaws to, and/or maintaining the opposing pair of jaws in, the open position whenever a user is not actively moving the jaw actuation handle to, and/or holding the jaw actuation handle in, the fully-actuated position.
[00112] 3. The tissue sealing instrument of the above-numbered paragraph 2, wherein the wherein the jaw actuation biasing element comprises a jaw actuation return-spring disposed between the jaw actuation handle and a solid wall structure disposed in the instrument body.
[00113] 4. The tissue sealing instrument of the above-numbered paragraph 3, wherein a first end of the jaw actuation return spring is disposed in a spring well formed in the jaw actuation handle.
[00114] 5. The tissue sealing instrument of the above-numbered paragraphs 2 or 3, the instrument further comprising a jaw actuator at least partially extending through the shaft, the jaw actuator having a proximal end portion coupled to the jaw actuation handle, and a distal end portion coupled to the pair of opposing jaws, such that pivoting the jaw actuation handle towards the instrument body handle translates the jaw actuator proximally relative to the shaft to move the pair of opposing jaws from an open position to an approximate position, wherein the jaw actuation return-spring is positioned in-line with the jaw actuator such that the jaw actuation return-spring is compressed by the jaw actuator as a user moves the jaw actuation handle towards the instrument body handle, and wherein the
return spring self-restores to a non-compressed state, thereby moving the respective jaw actuator and jaw actuation handle to most distal positions relative to the instrument body handle when the user releases the jaw actuation handle.
[00115] 6. A tissue sealing and cutting instrument, comprising: an instrument body having an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; and a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween and a latching mechanism, the latching mechanism including a housing maze disposed within the instrument body, and a latch pin, the latch pin having one end coupled to the jaw actuation handle and another end configured to travel within the housing maze, wherein when a user a user moves the jaw actuation handle towards the instrument body handle sufficiently to move the pair of opposing jaws into the approximate position, the latch pin engages a structure of the housing maze to maintain the position of the jaw actuation handle, and thus maintain the jaws in the approximate position, even if the user releases the jaw actuation handle.
[00116] 7. The tissue sealing instrument of the above-numbered paragraph 6, wherein when the user pulls the jaw actuation handle further towards the instrument body handle, the latch pin is released from its engagement with the housing maze structure, such that the pair of opposing jaws can return to the open position when the user releases the jaw actuation handle.
[00117] Although the disclosed system, instrument and methods of their use for sealing and cutting tissue have been disclosed in the context of certain embodiments and examples, this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of systems, devices and methods
for sealing and cutting tissue. The scope of this disclosure should not be limited by the particular disclosed embodiments described herein.
Claims
1. A tissue sealing and cutting instrument, comprising: an instrument body having an instrument body handle; a shaft having a proximal end coupled to the instrument body; a pair of opposing jaws movably coupled to a distal end portion of the shaft; a jaw actuation handle movably coupled to the instrument body and operatively coupled with the pair of opposing jaws, wherein moving the jaw actuation handle towards the instrument body handle moves the pair of opposing jaws from an open position to an approximate position for clamping tissue therebetween; a cutting member at least partially disposed in the shaft; a cutting member trigger movably coupled to the instrument body; and a pinion rotatably mounted within the instrument body, the pinion operatively coupled to the cutting member trigger and to the cutting member, wherein moving the cutting member trigger towards the instrument body housing rotates the pinion to thereby distally advance the cutting member from a retracted position substantially proximal of the opposing jaws to an extended position between the opposing jaws to cut through tissue clamped therebetween, wherein the jaw actuation handle interferes with and prevents rotation of the pinion, and the corresponding distal advancement of the cutting member, unless the jaw actuation handle is pivoted sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
2. The tissue sealing and cutting instrument of claim 1 , wherein the cutting member trigger is pivotably coupled to the housing body, and wherein the cutting member trigger may be pivoted angularly between a non-actuated position farthest from the instrument body handle, and a fully-actuated position closest to the instrument body handle, the pinion having corresponding non-actuated and
fully-actuated rotational positions such that the cutting member is in the fully- retracted position when the pinion is in the non-actuated rotational position, and in the fully-extended position when the pinion is in the fully-actuated rotational position.
3. The tissue sealing and cutting instrument of claim 2, further comprising a boss extending from a surface of the pinion that contacts a corresponding extended or protruding portion of the jaw actuation handle to prevent rotation of the pinion beyond the non-actuated rotational position unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position.
4. The tissue sealing and cutting instrument of claim 3, the boss having a curvilinear formation, with a first end that contacts the extended or protruding portion of the jaw actuation handle to prevent rotation of the pinion beyond the non-actuated rotational position unless the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position, wherein, once the jaw actuation handle is moved sufficiently towards the instrument body handle to move the pair of opposing jaws into the approximate position, the boss prevents the extended or protruding portion of the jaw actuation handle from interfering with pinion as the pinion rotates from the nonactuated rotational position to the fully-actuated rotational position.
5. The tissue sealing and cutting instrument of claim 4, wherein the pinion is part of a rack and pinion assembly mounted in the instrument body, the instrument further comprising a cutting member actuator at least partially extending through the shaft, the cutting member actuator having a proximal end portion coupled to or integral with the rack, and a distal portion coupled to or integrally formed with the cutting member, such that movement of the cutting member trigger from the non-actuated position to the fully-actuated position translates the cutting member actuator relative to the shaft to move the cutting member from the fully-retracted position to the fully-extended position.
6. The tissue sealing and cutting instrument of claim 5, further comprising a cutting member biasing element configured to move the cutting member trigger to, and/or maintain the cutting member trigger in, the non-actuated position, thereby moving the cutting member to, and/or maintaining the cutting member in, the fully-retracted position whenever a user is not actively moving the cutting member trigger to, and/or holding the cutting member trigger in, the fully-actuated position.
7. The tissue sealing and cutting instrument of claim 6, wherein the cutting member biasing element comprises a return spring positioned in-line with the rack, wherein the return spring is compressed by the rack as a user moves the cutting member trigger from the non-actuated position to the fully-actuated position, and wherein the return spring self-restores to a non-compressed state, thereby moving the respective rack, cutting member actuator, and cutting member proximally until the cutting member is in the fully-retracted position, with the pinion and cutting member trigger moving from the respective fully-actuated positions to non-actuated positions, respectively, when the user releases the cutting member trigger.
8. The tissue sealing and cutting instrument of claim 1 , the jaw actuation handle being pivotally coupled to the instrument body, wherein the jaw actuation handle may be pivoted angularly between a non-actuated position farthest from the instrument body handle, and a fully-actuated position closest to the instrument body handle, wherein the pair of opposing jaws are in the open position when the jaw actuation handle is in the non-actuated position, and in the approximate position when the jaw actuation handle is in the fully-actuated position.
9. The tissue sealing and cutting instrument of claim 8, further comprising a jaw actuator at least partially extending through the shaft, the jaw actuator having a proximal end portion coupled to the jaw actuation handle, and a distal end portion coupled to the pair of opposing jaws, such that pivoting the jaw actuation handle from the non-actuated position to the fully-actuated position translates the jaw actuator proximally relative to the shaft from a most distal position relative to
the shaft, with the pair of opposing jaws in the open position, to a most proximal position relative to the shaft, with the pair opposing jaws in the approximate position.
10. The tissue sealing and cutting instrument of claim 9, further comprising a jaw actuation biasing element configured to move the jaw actuation handle to, and/or maintain the jaw actuation handle in, the non-actuated position, thereby moving the opposing pair of jaws to, and/or maintaining the opposing pair of jaws in, the open position whenever a user is not actively moving the jaw actuation handle to, and/or holding the jaw actuation handle in, the fully-actuated position.
11. The tissue sealing and cutting instrument of claim 10, wherein the jaw actuation biasing element comprises a return-spring positioned in-line with the jaw actuator, wherein the return-spring is compressed by the jaw actuator as a user moves the jaw actuation handle from the non-actuated position to the fully- actuated position, and wherein the return spring self-restores to a noncompressed state, thereby moving the jaw actuator back to the most distal position, with the jaw actuation handle moving from the fully-actuated position to the non-actuated position, respectively, when the user releases the jaw actuation handle.
12. The tissue sealing and cutting instrument of claim 1 , wherein the cutting member comprises a knife or blade having a distal edge configured to cut through sealed tissue.
13. The tissue sealing and cutting instrument of claim 1 , wherein the opposing pair of jaws includes a first jaw and a second jaw, the first jaw comprising a channel extending along a length of the first jaw, and the second jaw comprising a channel extending along a length of the second jaw, the first and second jaw channels aligned with each other such that, when the jaws are in the approximate configuration, the first and second jaw channels together form a slot through which the cutting member travels.
14. The tissue sealing and cutting instrument of claim 13, wherein the first and second jaws have curved profiles along their lengths.
15. The tissue sealing and cutting instrument of claim 1 , the instrument body comprising an instrument body housing, a first energy activation switch positioned on a first side of the instrument body housing, and a second energy activation switch positioned on a second side of the instrument body housing, wherein the first and second energy activation switches are configured and positioned on the respective first and second sides of the instrument body housing such that a user holding the instrument with a right hand or a left hand while squeezing the jaw actuation handle into the instrument body handle can use of thumb or other digit of the respective right hand or left hand to contact and activate one of the first and second energy activation switches without releasing the jaw actuation handle.
16. The tissue sealing and cutting instrument of claim 14, wherein activation of the first and/or second energy activation switches initiates delivery of energy from a generator coupled to the instrument to seal tissue clamped between the pair of opposing jaws.
17. The tissue sealing and cutting instrument of claim 1 , wherein each jaw of the opposing pair of jaws comprising a conductive seal plate, wherein a width of the seal plate varies along at least a portion of a length of the jaw, and wherein a width of the seal place at a proximal end portion of the jaw is greater than a width of the seal plate in a middle portion of the jaw.
18. The tissue sealing and cutting instrument of claim 1 , further comprising a latching mechanism, the latching mechanism including a housing maze disposed within the instrument body, and a latch pin, the latch pin having one end coupled to the jaw actuation handle and another end configured to travel within the housing maze, wherein when a user a user moves the jaw actuation handle towards the instrument body handle sufficiently to move the pair of opposing jaws into the approximate position, the latch pin engages a structure of the housing maze to maintain the position of the jaw actuation handle, and thus maintain the jaws in the approximate position, even if the user releases the jaw actuation handle.
19. The tissue sealing and cutting instrument of claim 18, wherein when the user pulls the jaw actuation handle further towards the instrument body handle, the latch pin is released from its engagement with the housing maze structure, such that the pair of opposing jaws can return to the open position when the user releases the jaw actuation handle.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202463678039P | 2024-07-31 | 2024-07-31 | |
| US63/678,039 | 2024-07-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2026030641A1 true WO2026030641A1 (en) | 2026-02-05 |
Family
ID=96989423
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2025/040196 Pending WO2026030641A1 (en) | 2024-07-31 | 2025-07-31 | Vessel sealing device |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2026030641A1 (en) |
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