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EP4554492A1 - Instrument chirurgical à butée de tissu intégrée - Google Patents

Instrument chirurgical à butée de tissu intégrée

Info

Publication number
EP4554492A1
EP4554492A1 EP24752161.0A EP24752161A EP4554492A1 EP 4554492 A1 EP4554492 A1 EP 4554492A1 EP 24752161 A EP24752161 A EP 24752161A EP 4554492 A1 EP4554492 A1 EP 4554492A1
Authority
EP
European Patent Office
Prior art keywords
end effector
tissue stop
surgical instrument
tissue
closed configuration
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
Application number
EP24752161.0A
Other languages
German (de)
English (en)
Inventor
William D. Dannaher
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cilag GmbH International
Original Assignee
Cilag GmbH International
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US18/415,073 external-priority patent/US20250025198A1/en
Application filed by Cilag GmbH International filed Critical Cilag GmbH International
Publication of EP4554492A1 publication Critical patent/EP4554492A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
    • A61B17/282—Jaws
    • A61B2017/2825—Inserts of different material in jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs

Definitions

  • a variety of surgical instruments include an end effector having a blade element that vibrates at ultrasonic frequencies to cut and/or seal tissue (e.g., by denaturing proteins in tissue cells). These instruments include piezoelectric elements that convert electrical power into ultrasonic vibrations, which are communicated along an acoustic waveguide to the blade element. The precision of cutting and coagulation may be controlled by the surgeon’s technique and adjusting the power level, blade edge, tissue traction and blade pressure.
  • ultrasonic surgical instruments include the HARMONIC ACE® Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades, all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examples of such devices and related concepts are disclosed in U.S. Pat. No. 5,322,055, entitled “Clamp Coagulator/Cutting System for Ultrasonic Surgical Instruments,” issued June 21, 1994, the disclosure of which is incorporated by reference herein; U.S. Pat. No.
  • ultrasonic surgical instruments may include a cordless transducer such as that disclosed in U.S. Pub. No. 2012/0112687, entitled “Recharge System for Medical Devices,” published May 10, 2012, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2012/0116265, entitled “Surgical Instrument with Charging Devices,” published May 10, 2012, the disclosure of which is incorporated by reference herein; and/or U.S. Pat. App. No. 61/410,603, filed November 5, 2010, entitled “Energy- Based Surgical Instruments,” the disclosure of which is incorporated by reference herein. [0006] Additionally, some ultrasonic surgical instruments may include an articulating shaft section. Examples of such ultrasonic surgical instruments are disclosed in U.S.
  • FIG. 1 depicts a perspective view of an exemplary surgical instrument having one example of an end effector
  • FIG. 2 depicts a side elevational view of the end effector of the instrument of
  • FIG. 1 in a closed configuration
  • FIG. 3 depicts a perspective view of the end effector of FIG. 2, in an open configuration
  • FIG. 4 depicts a perspective view of the end effector of FIG. 2, in a closed configuration
  • FIG. 5 depicts a side elevational view of another example of an end effector for incorporation into the instrument of FIG. 1, in a closed configuration
  • FIG. 6 depicts a side elevational view of the end effector of FIG. 5 with a first exemplary tissue stop applied thereto, in a closed configuration
  • FIG. 7 depicts a perspective view of the tissue stop of FIG. 6;
  • FIG. 8 depicts a cross-sectional view of the tissue stop of FIG. 6 taken along line8-
  • FIG. 9 depicts a side elevational view of the end effector of FIG. 5 with a second exemplary tissue stop applied thereto, in an open configuration
  • FIG. 10 depicts a side elevational view of the end effector of FIG. 5 with the second tissue stop of FIG. 9 applied thereto, in a closed configuration
  • FIG. 11 depicts a front elevational view of the end effector of FIG. 5 with an exemplary deflectable flap of the second tissue stop of FIG. 9 abutting an exemplary clamp arm of the end effector;
  • FIG. 12 depicts a perspective view of the second tissue stop of FIG. 9 showing an exemplary interior chamfered area, an exemplary series of cut-outs, and an exemplary fluid associated with the deflectable flap of FIG. 11 of the second tissue stop of FIG. 10.
  • proximal and distal are defined herein relative to a human or robotic operator of the surgical instrument.
  • proximal refers the position of an element closer to the human or robotic operator of the surgical instrument and further away from the surgical end effector of the surgical instrument.
  • distal refers to the position of an element closer to the surgical end effector of the surgical instrument and further away from the human or robotic operator of the surgical instrument.
  • FIGS. 1-4 illustrate an exemplary ultrasonic surgical instrument (100). At least part of each instrument (100) may be constructed and operable in accordance with at least some of the teachings of U.S. Pat. No. 5,322,055; U.S. Pat. No. 5,873,873; U.S. Pat. No. 5,980,510; U.S. Pat. No. 6,325,811; U.S. Pat. No. 6,773,444; U.S. Pat. No. 6,783,524; U.S. Pub. No. 2006/0079874; U.S. Pub. No. 2007/0191713; U.S. Pub. No. 2007/0282333; U.S. Pub. No.
  • instrument (100) is operable to cut tissue and seal or weld tissue (e.g., a blood vessel, etc.) substantially simultaneously. It should also be understood that instrument (100) may have various structural and functional similarities with the HARMONIC ACE® Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears, and/or the HARMONIC SYNERGY® Ultrasonic Blades. Furthermore, instrument (100) may have various structural and functional similarities with the devices taught in any of the other references that are cited and incorporated by reference herein.
  • FIG. 1 illustrates an exemplary ultrasonic surgical instrument (100) that is configured to be used in open surgical procedures.
  • Instrument (100) of this example comprises a handle assembly (120), a shaft assembly (130), and an end effector (140).
  • Handle assembly (120) comprises a body (122) including a finger grip ring (124) and a pair of buttons (126).
  • Instrument (100) also includes a clamp arm assembly (150) that is pivotable toward and away from body (122).
  • Clamp arm assembly (150) includes a shank (152) with a thumb grip ring (154). Thumb grip ring (154) and finger grip ring (124) together provide a scissor grip type of configuration.
  • Shaft assembly (130) comprises an outer sheath (132) extending distally from body (122).
  • a cap (134) is secured to the distal end of sheath (132).
  • end effector (140) comprises an ultrasonic blade (142) and a clamp arm (144).
  • Ultrasonic blade (142) extends distally from cap (134).
  • Clamp arm (144) is an integral feature of clamp arm assembly (150).
  • Clamp arm (144) includes a clamp pad (146) facing ultrasonic blade (142).
  • Clamp arm assembly (150) is pivotally coupled with outer sheath (132) via a pin (156).
  • Clamp arm (144) is positioned distal to pin (156); while shank (152) and thumb grip ring (154) are positioned proximal to pin (156).
  • clamp arm (144) is pivotable toward and away from ultrasonic blade (142) based on pivoting of thumb grip ring (154) toward and away from body (122) of handle assembly (120). It should therefore be understood that an operator may squeeze thumb grip ring (154) toward body (122) to thereby clamp tissue between clamp pad (146) and ultrasonic blade (142) to transect and/or seal the tissue.
  • one or more resilient members are used to bias clamp arm (144) to the open configuration shown in FIG. 3.
  • such a resilient member may comprise a leaf spring, a torsion spring, and/or any other suitable kind of resilient member.
  • an ultrasonic transducer assembly (112) extends proximally from body (122) of handle assembly (120). Transducer assembly (112) is coupled with a generator (116) via a cable (114). Transducer assembly (112) receives electrical power from generator (116) and converts that power into ultrasonic vibrations through piezoelectric principles.
  • Generator (116) may include a power source and control module that is configured to provide a power profile to transducer assembly ( 112) that is particularly suited for the generation of ultrasonic vibrations through transducer assembly (112).
  • generator (116) may comprise a GEN 300 sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio.
  • generator (116) may be constructed in accordance with at least some of the teachings of U.S. Pub. No. 2011/0087212, entitled “Surgical Generator for Ultrasonic and Electrosurgical Devices,” published April 14, 2011, the disclosure of which is incorporated by reference herein. It should also be understood that at least some of the functionality of generator (116) may be integrated into handle assembly (120), and that handle assembly (120) may even include a battery or other on-board power source such that cable ( 114) is omitted. Still other suitable forms that generator (116) may take, as well as various features and operabilities that generator (116) may provide, will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • Ultrasonic vibrations that are generated by transducer assembly (112) are communicated along an acoustic waveguide (138), which extends through shaft assembly (130) to reach ultrasonic blade (142).
  • Waveguide (138) is secured within shaft assembly (130) via a pin (not shown), which passes through waveguide (138) and shaft assembly (130). This pin is located at a position along the length of waveguide (138) corresponding to a node associated with resonant ultrasonic vibrations communicated through waveguide (138).
  • ultrasonic blade (142) when ultrasonic blade (142) is in an activated state (i.e., vibrating ultrasonically), ultrasonic blade (142) is operable to effectively cut through and seal tissue, particularly when the tissue is being clamped between clamp pad (146) and ultrasonic blade (142).
  • waveguide (138) may be configured to amplify mechanical vibrations transmitted through waveguide (138).
  • waveguide (138) may include features operable to control the gain of the longitudinal vibrations along waveguide (138) and/or features to tune waveguide (138) to the resonant frequency of the system.
  • the distal end of ultrasonic blade (142) is located at a position corresponding to an anti-node associated with resonant ultrasonic vibrations communicated through waveguide (138), in order to tune the acoustic assembly to a preferred resonant frequency f 0 when the acoustic assembly is not loaded by tissue.
  • the distal end of ultrasonic blade (142) is configured to move longitudinally in the range of, for example, approximately 10 to 500 microns peak-to-peak, and in some instances in the range of about 20 to about 200 microns at a predetermined vibratory frequency f o of, for example, 55.5 kHz.
  • transducer assembly (112) of the present example When transducer assembly (112) of the present example is activated, these mechanical oscillations are transmitted through the waveguide to reach ultrasonic blade (102), thereby providing oscillation of ultrasonic blade (102) at the resonant ultrasonic frequency.
  • the ultrasonic oscillation of ultrasonic blade (142) may simultaneously sever the tissue and denature the proteins in adjacent tissue cells, thereby providing a coagulative effect with relatively little thermal spread.
  • an electrical current may also be provided through ultrasonic blade (142) and/or clamp pad (146) to also seal the tissue.
  • buttons (126) may activate buttons (126) to selectively activate transducer assembly (112) to thereby activate ultrasonic blade (142).
  • two buttons (126) are provided - one for activating ultrasonic blade (142) at a low power and another for activating ultrasonic blade (142) at a high power.
  • a foot pedal may be provided to selectively activate transducer assembly (112).
  • Buttons (126) of the present example are positioned such that an operator may readily fully operate instrument (100) with a single hand.
  • buttons (126) may be located at any other suitable positions.
  • instrument (100) may be configured in numerous other ways as will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • at least part of instrument (100) may be constructed and/or operable in accordance with at least some of the teachings of any of the following, the disclosures of which are all incorporated by reference herein: U.S. Pat. No. 5,322,055; U.S. Pat. No. 5,873,873; U.S. Pat. No. 5,980,510; U.S. Pat. No. 6,325,811; U.S. Pat. No. 6,783,524; U.S. Pub. No.
  • FIGS. 5-12 show an exemplary alternative end effector (1140) that may be used in place of end effector (140).
  • End effector ( 1140) of this example is substantially similar to end effector ( 140) described above.
  • end effector ( 1140) includes an ultrasonic blade (1142) extending from a guide (1138), a clamp arm (1144), and a clamp pad (1146).
  • Ultrasonic blade (1142), clamp arm (1144), and clamp pad (1146) of this example are substantially similar to ultrasonic blade (142), clamp arm (144), and clamp pad (146), respectively.
  • Guide (1138) may also encompass a guide style element, similar to acoustic waveguide (138), a distal pipe, or any other element generally holding, guiding, or projecting ultrasonic blade (1142) outwardly towaids an engagement with clamp arm (144) and clamp pad (1146).
  • ultrasonic blade (1142) distally projects relative to guide (1138).
  • Ultrasonic blade (1142) extends from a proximal end (1158) outwardly away from guide (1138) to terminate at a distal end (1160).
  • clamp pad (1146) extends from a proximal end (1162) to a distal end (1164).
  • Proximal end (1158) of ultrasonic blade (1142) and proximal end (1162) of clamp pad (1146) are both disposed generally proximate guide (1138).
  • a proximal clamp pad surface (1165) of clamp pad (1146) is exposed at proximal end (1162), generally facing guide (1138).
  • a proximal clamp arm surface (1163) is generally facing guide (1138) and in some versions of end effector (1140) sized to generally align with proximal clamp pad surface (1165).
  • a pad retention feature (1167) is provided as a projection located at proximate end (1162) of clamp pad (1146) to prevent clamp pad (1146) from sliding proximally off or out of placement with respect to clamp arm (1144).
  • Pad retention feature (1167) is disposed within end effector (1140) to abut proximal clamp pad surface (1165) and thereby prevent displacement of clamp pad (1146).
  • Guide (1138), ultrasonic blade (1142), clamp pad (1146), and clamp arm (1144) cooperate to define a gap (1166) when end effector (1140) is in the closed configuration.
  • Clamp arm (1144) includes a gap surface (1145) extending generally orthogonally from gap surface (1165) of clamp pad (1146) and proximal clamp arm surface (1163). Gap (1166) facilitates clearance between acoustic waveguide (138) and clamp arm (1144) when end effector (1140) is in a closed configuration.
  • a tissue stop (1170) may be provided on or around guide (1138) to prevent tissue from traveling into gap (1166) and overstuffing end effector (1140) with tissue, past the length of ultrasonic blade (1142). Tissue stop (1170) may also be used to provide a visual indication to the user as to where the tissue should be placed within end effector (1140) prior to a closure stroke. Tissue stop (1170) may also be used as an atraumatic heat shield to enable end effector (1140) to self -contain heat from ultrasonic blade (1142) and thereby prevent unintended thermal spread to nearby critical anatomical structures.
  • Tissue stop (1170) of the present disclosure includes a generally circular or continuous wall (1171).
  • Wall (1171) may be formed into a cone or shcath-likc structure around guide (1138), and sized and positioned to prevent tissue from pressing beyond tissue stop (1170) and into gap (1166) and when end effector (1140) moves from the open configuration to the closed configuration with tissue therebetween.
  • wall (1171) of tissue stop (1170) may resemble a U-shaped or shroud type of extension off guide (1138) extending over proximal end (1158) of ultrasonic blade (1142).
  • Wall (1171) of tissue stop (1170) may include a profile that abuts either gap surface (1145) of clamp pad (1146), gap surface (1165) of clamp arm (1144), or both, when end effector (1140) is in the closed configuration.
  • Wall (1171) includes an exterior surface (1180) and an interior surface (1182).
  • tissue stop (1170) defines an interior channel (1168) there through.
  • the proximal end (1162) of clamp pad (1146) is disposed in interior channel (1168) when end effector (1140) is in the closed configuration.
  • Tissue stop (1170) further includes a leading surface.
  • the leading surface of tissue stop (1170) is located distally of proximal end (1162) of clamp pad (1146) when end effector (1140) is in the closed configuration.
  • the proximal end (1162) of clamp pad (1146) is disposed in interior channel (1168) when end effector ( 1140) is in the closed configuration.
  • Some versions of wall (1171) of tissue stop (1170) may include a stepped configuration, with a portion of wall (1171) being referred to as a first wall (1172) having a first leading surface (1173) and a portion of wall (1171) being referred to as a second wall (1174) having a second leading surface (1175).
  • the leading surface described above may be embodied in one or both of first leading surface (1173) and second leading surface (1175).
  • First wall (1172) and second wall (1174) define a stepped portion (1176). As shown in FIG. 7, first wall (1172) is sized and positioned to partially encircle ultrasonic blade (1142), with second wall (1174) continuing this partial encirclement.
  • Second wall (1174) defines a notch (1178), wherein notch (1178) sized to receive pad retention feature (1167) therein when end effector (1140) is in the closed configuration.
  • a chamfered edge (1184) may be provided at the transition between exterior surface (1180) of wall (1171) and second leading surface (1175) of second wall (1174). Inasmuch as second wall (1174) generally abuts clamp arm (1144) when end effector (1140) is in the closed configuration, chamfered edge (1184) further facilitates tissue stop (1170) pressing onto and abutting clamp arm (1144) as end effector (1140) transitions from the open configuration to the closed configuration.
  • wall (1171) of tissue stop (1170) defines a pocket (1183) therein.
  • Pocket (1183) is sized to receive a portion of another element of instrument (100) for locking tissue stop (1170) in place.
  • a portion of shaft assembly (130) may extend into pocket (1183) to lock tissue stop (1170) in place.
  • guide (1138) is entirely encircled by wall (1171) of tissue stop (1170) without another feature or element of end effector (1140) abutting guide (1138) within tissue stop (1170). Thus, guide (1138) passes through tissue stop (1170) free of an abutment therein.
  • tissue stop (1170) may be over-molded onto guide (1138), or an acoustic waveguide used in place or in conjunction with guide (1138), or on cap (134) to provide a snug fit and additional friction to secure tissue stop (1170) into end effector (1140). Over- molding may also reduce costs and provide the desired ability to fine-tune the tolerances and shape to facilitate first wall (1172) and second wall (1174) fitting as desired with respect to distal end (1164) of clamp pad (1146).
  • first wall (1172), second wall (1174), and notch (1178) are sized and configured to fit complementarily with the profile formed by proximal clamp arm surface (1 163), proximal clamp pad surface (1165), gap surface (1145), and pad retention feature (1167).
  • second wall (1174) moves into an abutment with clamp arm (1144).
  • first wall (1172) moves into a backstop style orientation with respect to clamp pad (1146), with first leading surface (1173) facing and stopping any tissue that would be moving in a proximal direction toward gap (1166).
  • tissue stop (1170) may provide a heat shield with respect to ultrasonic blade (1142) to prevent unintended thermal spread to nearby tissue or anatomical structures.
  • Other versions of the described tissue stop (1170) may have different profiles or features.
  • a second exemplary tissue stop referred to as a tissue stop (1184), includes a pair of deflectable flaps (1186).
  • deflectable flaps (1186) and wall (1171) are formed from the same material in and include generally the same thickness throughout the length of wall (1171). In other versions of tissue stop (1184), deflectable flaps (1186) are formed from the same material as the rest of wall (1171), but with a reduced thickness to allow additional flexibility in deflectable flaps (1186) as these elements pass or cam over clamp arm (1144) as end effector (1140) proceeds through its closing stroke to move into the closed configuration.
  • deflectable flaps (1186) may further include an interior chamfered area (1188) to aid in camming or slidably abutting deflectable flaps (1186) over clamp pad (1146) and clamp arm (1144) in the direction of Arrow A.
  • other versions of deflectable flaps (1186) may include a different material from that which the rest of wall (1171) is comprised.
  • deflectable flaps (1186) may be formed from a first material (1191), while the remainder of tissue stop (1184) may be formed from a second material (1193), whereby first material (1191) is more flexible than second material (1193).
  • delectable flaps (1186) may define one or more slits (1192) extending entirely through deflectable flaps (1186) to allow for more flexibility of each deflectable flap (1186) during the closing stroke.
  • Deflectable flaps (1186) may also include one or more cut out portions (1 194) to aid in flexibility, wherein cut out portions (1194) are not entirely cut through deflectable flaps (1186), but a portion of the material is removed to reduce stiffness.
  • Slits (1192) and/or cut out portions (1194) may be curved or s- shaped or may be generally parallel with clamp pad (1146) while in the closed configuration to allow for greater flexibility in the deflection of deflectable flaps (1186).
  • Deflectable flaps (1186) may incorporate atraumatic geometry such as smooth curves should inadvertent tissue contact occur.
  • Deflectable flaps (1186) may be formed such that a portion of deflectable flaps (1186) remain distal of proximal end (1162) of clamp pad (1146) through the range of motion between the open configuration and the closed configuration of end effector ( 1140). [00053] Similar to tissue stop (1170), once tissue stop (1184) moves into the closed configuration, deflectable flaps (1186) cam or otherwise slide or travel over the portion of clamp arm (1144) proximate proximal end (1162) of clamp pad (1146). This provides for containing heat from ultrasonic blade (1142) as well and reducing inadvertent overstuffing of end effector (1140) with tissue. As shown in FIG. 11, deflectable flaps (1186) may include a slight interference fit with clamp arm (1144), which allows deflectable flaps (1186) to deflect out of the way as clamp arm (1144) and ultrasonic blade (1142) move through its closure stroke.
  • deflectable flaps (1186) determine how long these elements will act as a tissue stop relative to the open and close stroke of clamp arm (1144). Extending the length of deflectable flaps (1186) in turn extends the time those elements act as a tissue stopping device.
  • deflectable flaps (1186) include a leading surface (1190). Leading surface (1190) may be formed with a particular radius. In some version of leading surface (1190), the radius is configured to match proximal end (1162) of clamp pad (1146).
  • leading surface (1190) ensures deflectable flaps (1186) do not travel past proximal end (1162) of clamp pad (1146) to maintain the tissue stopping functionality. Further this radius on leading surface (1190) and smooth curvature on other surfaces or deflectable flaps (1186) provide atraumatic geometry should any tissue inadvertently contact tissue stop (1 184).
  • leading surface (1190) of tissue stop (1184) is located distally of proximal end (1162) of clamp pad (1146) when end effector (1140) is in the closed configuration.
  • tissue stop (1170, 1184) are shaped to abut clamp arm (1144) when end effector (1140) is in the closed configuration. Some versions of tissue stop (1170, 1184) are shaped to abut clamp pad (1146) when end effector (1140) is in the closed configuration. Some versions of tissue stop (1170, 1184) are shaped to abut gap surface (1145) when the end effector is in the closed configuration. Some versions of tissue stop (1170, 1184) are shaped to abut proximal clamp arm surface (1163) when the end effector is in the closed configuration. Some versions of tissue stop (1170, 1184) are shaped to abut proximal clamp pad surface (1165) when the end effector is in the closed configuration.
  • tissue stop (1170, 1184) an elastomeric material is used.
  • the elastomeric material may measure between 30 and 90 (inclusive) on the Shore A hardness scale.
  • distal pipe may be lubricated prior to assembly. This preassembly lubrication may utilize medical grade lubricants such as sodium stearate or silicone fluid.
  • distal pipe may be formed from a self-lubricating elastomer such as Nusil MED1-4855 Liquid silicone rubber. Nusil MED1-4855 Liquid silicone rubber is a self-lubricating injection moldable elastomer with high lubrication properties and is suitable for over-molding.
  • a surgical instrument comprising: (a) a shaft; and (b) an end effector located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration, wherein the end effector comprises: (i) a guide, (ii) an ultrasonic blade extending distally from the guide and operable to treat tissue with ultrasonic energy, (iii) a clamp arm movable relative to the ultrasonic blade, (iv) a clamp pad disposed on the clamp arm and extending from a proximal end to a distal end, (v) a tissue stop encircling the guide, wherein the tissue stop includes a leading surface, wherein the leading surface of the tissue stop is located distally of the proximal end of the clamp pad when the end effector is in the closed configuration.
  • Example 4 The surgical instrument of any one or more of Examples 1 through 3, wherein the clamp arm includes a proximal clamp arm surface, wherein the tissue stop abuts the proximal clamp arm surface when the end effector is in the closed configuration.
  • clamp pad includes proximal clamp pad surface, wherein the tissue stop abuts the proximal clamp pad surface when the end effector is in the closed configuration.
  • tissue stop includes a first portion and a second portion, wherein the second portion extends from the first portion, wherein the first portion extends entirely around the ultrasonic blade, wherein the second portion extends partially around the ultrasonic blade.
  • the end effector comprises further comprises; (a) a pad retention feature proximate the clamp pad, wherein the pad retention feature is configured to prevent the clamp pad from sliding proximally therebeyond; and (b) a notch defined by the tissue stop, wherein a portion of the pad retention feature is disposed within the notch when the end effector is in the closed configuration.
  • tissue stop includes a pair of deflectable flaps, wherein the ultrasonic blade is disposed between the pair of deflectable flaps.
  • tissue stop includes a deflectable flap, wherein a portion of the deflectable flap remains distal of the proximal end of the clamp pad through the range of motion between the open configuration and the closed configuration.
  • Example 15 The surgical instrument of any one or more of Examples 1 through 14, wherein the pair of deflectable flaps abut the clamp arm throughout the entire range of motion between the open configuration and the closed configuration.
  • a surgical instrument comprising: (a) a shaft; and (b) an end effector located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration, wherein the end effector comprises: (i) an ultrasonic blade extending from a guide and operable to treat tissue with ultrasonic energy, (ii) a guide, wherein the ultrasonic blade extends distally from the guide, (iii) a clamp arm movable relative to the ultrasonic blade, (iv) a clamp pad disposed on the clamp arm and extending from a proximal end to a distal end, (v) a tissue stop defining an interior channel, wherein the guide is disposed in the interior channel, wherein the proximal end of the clamp pad is disposed in the interior channel when the end effector is in the closed configuration.
  • the end effector comprises further comprises: (a) a pad retention feature proximate the clamp pad, wherein the pad retention feature is configured to prevent the clamp pad from sliding proximally thcrcbcyond; and (b) a notch defined by the tissue stop, wherein a portion of the pad retention feature is disposed within the notch when the end effector is in the closed configuration.
  • tissue stop includes a pair of deflectable flaps, wherein the ultrasonic blade is disposed between the pair of deflectable flaps, wherein the pair of deflectable flaps abut the clamp arm when the end effector is in the closed configuration.
  • Example 19 The surgical instrument of any one or more of Examples 16 through 18, wherein the pair of deflectable flaps are formed from a first material, wherein the remainder of the tissue stop is formed from a second material.
  • a surgical instrument configured to apply ultrasonic energy to tissue disposed therein, the surgical instrument comprising: (a) a shaft; and (b) an end effector located at a distal end of the shaft, wherein the end effector is selectively movable between an open configuration and a closed configuration, wherein the end effector comprises: (i) an ultrasonic blade extending from a guide and operable to treat tissue with ultrasonic energy, (ii) a guide, wherein the ultrasonic blade extends distally from the guide, (iii) a clamp arm movable relative to the ultrasonic blade, (iv) a clamp pad disposed on the clamp arm and extending from a proximal end to a distal end, (v) a pad retention feature proximate the clamp pad, wherein the pad retention feature is configured to prevent the clamp pad from sliding proximally therebeyond, (vi) a tissue stop encircling the guide, (vii) a notch defined by the tissue stop, wherein
  • Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a clinician immediately prior to a procedure.
  • reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
  • versions described herein may be sterilized before and/or after a procedure.
  • the device is placed in a closed and sealed container, such as a plastic or TYVEK bag.
  • the container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
  • the radiation may kill bacteria on the device and in the container.
  • the sterilized device may then be stored in the sterile container for later use.
  • a device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Dentistry (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un instrument chirurgical comprenant un effecteur situé à l'extrémité distale d'une tige et pouvant être déplacé sélectivement entre une configuration ouverte et une configuration fermée. L'effecteur comprend un guide sur lequel s'étend une lame ultrasonore (1142) et un bras de serrage doté d'un tampon de serrage (1146) et mobile par rapport à la lame ultrasonore. L'effecteur comprend en outre une butée de tissu (1184) entourant le guide et présentant une surface d'attaque. La butée de tissu est configurée pour empêcher un tissu de se déplacer de manière proximale au-delà du tampon de serrage pendant une course de fermeture. Dans certaines versions, une surface avant de la butée de tissu empêche le tissu de se déplacer de manière proximale. La butée de tissu peut comprendre une paire de rabats béquillables (1186) dotée de la surface avant, les rabats béquillables venant en butée contre le bras de serrage ou d'autres caractéristiques de l'effecteur pendant une course de fermeture.
EP24752161.0A 2023-07-17 2024-07-15 Instrument chirurgical à butée de tissu intégrée Pending EP4554492A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202363514011P 2023-07-17 2023-07-17
US18/415,073 US20250025198A1 (en) 2023-07-17 2024-01-17 Surgical instrument with integrated tissue stop
PCT/IB2024/056858 WO2025017462A1 (fr) 2023-07-17 2024-07-15 Instrument chirurgical à butée de tissu intégrée

Publications (1)

Publication Number Publication Date
EP4554492A1 true EP4554492A1 (fr) 2025-05-21

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WO (1) WO2025017462A1 (fr)

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