Ultrasonic surgical instrument

专利摘要:
ultrasonic surgical instruments with partially rotating blade arrangement and fixed block. ultrasonic surgical instrument that supports an ultrasonically excitable blade and an outer sheath that can be selectively rotated relative to each other to bring a distal cutting edge of the blade into contact with at least one formed cutting surface and a distal end of the outer sheath. in some embodiments, the distal cutting tip may come into contact with two cutting surfaces located on opposite sides of an opening in the outer sheath through which the distal cutting tip protrudes. blocks of fabric can be attached to the cutting surfaces. various embodiments also include at least one suction lumen.
公开号:BR112012020296B1
申请号:R112012020296-0
申请日:2011-02-09
公开日:2020-06-02
发明作者:Galen C. Robertson；Galen C Robertson；Richard W. Timm；Richard W Timm；Craig T. Davis；Craig T Davis；Daniel J. Mumaw；Daniel J Mumaw；Matthew C. Miller；Matthewc Miller；William D. Dannaher；William D Dannaher；Jerome R. Morgan；Jerome R Morgan
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

Invention Patent Descriptive Report for ULTRASONIC SURGICAL INSTRUMENT.
BACKGROUND [0001] The present description refers, in general, to ultrasonic surgical systems and, more particularly, to ultrasonic systems that allow surgeons to perform tissue cutting and coagulation.
[0002] Over the years, a variety of different types of scalpels not equipped with an ultrasonic motor and shaving or waxing devices for performing surgical procedures have been developed. Some of these devices employ a rotary cutting instrument and other devices employ a reciprocating cutting element. For example, shavers are widely used in arthroscopic surgery. These devices generally consist of a power supply, a handpiece and an end actuator. The end actuator commonly has an inner and outer tube. The inner tube rotates in relation to the outer tube and will cut the fabric with its sharp ends. The inner tube can rotate continuously or oscillate. In addition, such a device may employ a suction channel that runs through the interior of the inner tube. For example, US Patent No. 4,970,354 to McGurk-Burleson, et al., Discloses a surgical cutting instrument not equipped with an ultrasonic motor that comprises a rotary cutter for cutting material by shear action. It employs an internal cutting element that is rotatable, contained in an external tube.
[0003] U.S. Patent No. 3,776,238 to Peyman et al. features an ophthalmic instrument in which the tissue is cut by a cutting action defined by the sharp end of an inner tube moving against the inner surface of the end of an outer tube. U.S. Patent No. 5,226,910 to Kajiyama et al. features other ins
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2/39 surgical cutting instrument that has an internal element, which moves in relation to an external element to cut tissue that passes through an opening in the external element.
[0004] U.S. Patent No. 4,922,902 to Wuchinich et al. presents a method and apparatus for endoscopic tissue removal using an ultrasonic cleaner. The device uses an ultrasonic probe that disintegrates malleable tissue and aspirates it through a narrow hole. U.S. Patent No. 4,634,420 to Spinosa et al. features an apparatus and method for removing tissue from an animal and includes an elongated instrument that has a needle or probe, which is vibrated at an ultrasonic frequency in the lateral direction. The ultrasonic movement of the needle breaks the tissue into fragments. Parts of tissue can be removed from the treatment area by aspiration through a conduit in the needle. U.S. Patent No.
3,805,787 for Banko presents yet another ultrasonic instrument that has a probe that is shielded to narrow the beam of ultrasonic energy radiated from the probe tip. In one embodiment, the shield extends beyond the free end of the probe to prevent the probe from coming into contact with the fabric. U.S. Patent No. 5,213,569 to Davis discloses a phacoemulsification needle that focuses on ultrasonic energy. The focusing surfaces can be chamfered, curved or faceted. U.S. patent No. 6,984,220 to Wuchinich and U.S. patent publication No. 2005/0177184 to Easley present ultrasonic tissue dissection systems that provide combined longitudinal and torsional movement through the use of torsional longitudinal resonators. U.S. Patent Publication No. 2006/0030797 A1 to Zhou et al. features an orthopedic surgical device that has a drive motor to drive an ultrasound transducer and horn. An adapter is provided between the drive motor and the transducer for
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3/39 ra provide ultrasonic energy signals to the transducer.
[0005] There is a need for a surgical instrument that can cut and remove tissue quickly and hemostatically in an arthroscopic environment.
[0006] The previously mentioned discussion is only intended to illustrate some of the disadvantages present in the field of the invention at the moment and should not be taken as a denial of the scope of the embodiments.
SUMMARY [0007] In general, several modalities are directed to an ultrasonic surgical instrument that includes a compartment that supports an external sheath. The outer sheath may have a distal blade opening in it that defines at least one cutting surface. The outer sheath can also have at least one suction lumen through which it communicates with the distal blade opening. A set of ultrasonic transducers can be supported by the compartment and can have a blade attached to it. The blade can extend through the outer sheath so that a distal tip of the blade extends into the blade opening. A portion of the tissue cut from the distal tip of the blade may protrude radially out of the blade opening. A motor can be supported by the compartment and attached to one of the sets of ultrasonic transducers and the external sheath for applying rotational movement so that the tissue cutting portion of the blade is placed in contact with a cutting surface in the outer sheath.
[0008] In conjunction with another general aspect of the present invention, a method of cutting fabric is presented. In one form, the method involves inserting a blade from a surgical instrument into a patient, the blade being attached to a source of movement
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4/39 ultrasonic and extends through an outer sheath so that a tissue cutting tip is exposed through a blade opening in the outer sheath. One blade and outer sheath is selectively rotatable over the others. The method may also include positioning the blade and the outer sheath so that the blade opening is adjacent to the target tissue in the patient and applying suction through the outer sheath to remove the target tissue into the blade opening. The method may also include oscillating one of the blade and the outer sheath with each other, so that the blade tissue cutting tip comes into contact and secures a portion of the target tissue extracted into the blade opening between the cutting tip and a cut surface on the outer sheath.
[0009] In conjunction with yet another general aspect of the present invention, an ultrasonic surgical instrument is provided that includes a compartment that supports an external sheath. The outer sheath may have a distal blade opening therein that defines at least one cutting surface. A set of ultrasonic transducers can be swiveled by the compartment. A blade can be attached to the ultrasonic transducer assembly and extend through the outer sheath so that a distal tip of the blade extends into the distal blade opening, with a tissue cutting portion extending radially out of the opening. distal lamina. A motor can be supported by the compartment and be coupled to the ultrasonic transducer assembly to apply rotational movement to it so that the tissue cutting portion of the blade is placed in contact with at least one cutting surface. The instrument may also include means for limiting the amount of torsion felt by the tissue cutting portion of said blade when in contact with the cutting surface.
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FIGURES [00010] The characteristics of several modalities are presented with particularity in the attached embodiments. The various modalities, however, with regard to both the organization and the methods of operation, together with additional objectives and advantages of the same, can be better understood with reference to the description presented below, considered together with the attached drawings as the follow.
[00011] Figure 1 is a schematic view of a non-limiting surgical control system modality of the present invention;
[00012] Figure 2 is a cross-sectional view of a non-limiting handpiece modality of the present invention;
[00013] Figure 3 is a partial cross-sectional view of an ultrasonic surgical handpiece that can be used with various non-limiting modalities of the present invention;
[00014] Figure 4 is a cross-sectional view of a portion of a non-limiting nozzle embodiment of the present invention;
[00015] Figure 5 is a partial exploded view of the whole of a non-limiting fastener nozzle embodiment of the present invention.
[00016] Figure 6 is a perspective view of a portion of the embodiment of a non-limiting outer sheath and distal sheath tip of the present invention with the tissue cutting tip of the blade in one position;
[00017] Figure 7 is another perspective view of the modality of the external sheath and tip of the distal sheath of figure 6 with the blade in another position;
[00018] Figure 8'A is a partial end view in cross section of the outer sheath and blade arrangement of figures 6 and 7
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6/39 with the blade in a central position;
[00019] Figure 8B is another partial end view in cross section of the outer sheath and blade arrangement of Figure 8A with the blade in a tissue cutting position;
[00020] Figure 8C is another partial end view in cross section of the outer sheath and blade arrangement of Figures 8A and 8B with the blade in another tissue cutting position;
[00021] Figure 9 is a partial end view in cross section of an embodiment of another external non-limiting sheath and blade of the present invention;
[00022] Figure 10 is a partial lateral cross-sectional view of another modality of non-limiting surgical instrument of the present invention;
[00023] Figure 11 is a partial side view in cross section of another type of surgical instrument that does not limit the present invention;
[00024] Figure 12 is a partial lateral cross-sectional view of another type of non-limiting surgical instrument of the present invention;
[00025] Figure 13 is a cross-sectional view of a portion of a non-limiting fastening nozzle of the surgical instrument of Figure 12;
[00026] Figure 14 is a partial end view in cross section of the external sheath and blade arrangement of the surgical instrument of Figures 12 and 13 with the external sheath in a tissue cutting position;
[00027] Figure 15 is another partial end view in cross section of the external sheath and blade arrangement of the surgical instrument of figures 12 and 13 with the external sheath in another tissue cutting position;
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7/39 [00028] Figure 16 is a partial lateral cross-sectional view of another type of non-limiting surgical instrument of the present invention;
[00029] Figure 17 is a cross-sectional view of a portion of a non-limiting fastening nozzle of the surgical instrument of Figure 16;
[00030] Figure 18 is a cross-sectional view of the external sheath and blade arrangement of the surgical instruments in Figures 16 and 17;
[00031] Figure 19 is a side view of a portion of the blade and sheath arrangement of figure 18;
[00032] Figure 20 is a perspective view of a portion of the blade and sheath arrangement of figures 18 and 19;
[00033] Figure 21 is a perspective view of a non-limiting tissue block embodiment of the present invention;
[00034] Figure 22 is a side elevation view of a non-limiting blade embodiment of the present invention;
[00035] Figure 23 is an end view in cross section of the surgical instrument of Figure 16 with a suction control system modality and a portion of a control system modality of the present invention shown in schematic form;
[00036] Figure 24 is a perspective view of a portion of the blade and sheath arrangement of Figure 23 with the blade in a first central position;
[00037] Figure 25 is a perspective view of a portion of the blade and sheath arrangement of Figure 24 with the blade in a tissue cutting position; and [00038] Figure 26 is a perspective view of a portion of the blade and sheath arrangement of Figures 24 and 25 with the blade in
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8/39 another fabric cutting position.
DESCRIPTION [00039] The owner of this application is also the owner of the following US patent applications that were filed on the same date as this application and which are hereby incorporated by reference in their respective totalities:
US patent serial number application No. __________, entitled ULTRASONICALLY POWERED SURGICAL INSTRUMENTS WITH ROTATING CUTTING IMPLEMENT, legal registration number END6688USNP / 090341;
US Patent Serial Number Application No. ________, entitled METHODS OF USING ULTRASONICALLY POWERED SURGICAL INSTRUMENTS WITH ROTATABLE CUTTING IMPLEMENTS, legal registration number END6689USNP / 090342;
US patent serial number application No. ________, entitled SEAL ARRANGEMENTS FOR ULTRASONICALLY POWERED SURGICAL INSTRUMENTS, legal registration number END6690USNP / 090343;
US patent serial number application ________, entitled ULTRASONIC SURGICAL INSTRUMENTS WITH ROTATABLE BLADE AND HOLLOW SHEATH ARRANGEMENTS, legal registration number END6691USNP / 090344;
US patent serial number application No. ________, entitled ROTATABLE CUTTING IMPLEMENT ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS, legal registration number END6692USNP / 090345;
US patent serial number application No. ________, entitled DUAL PURPOSE SURGICAL INSTRUMENT FOR CUTTING AND COAGULATING TISSUE, legal registration number END6694USNP / 090347;
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US patent serial number application No. __________, entitled OUTER SHEATH AND BLADE ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS, legal registration number END6695USNP / 090348;
US patent serial number no. __________, entitled ULTRASONIC SURGICAL INSTRUMENTS WITH MOVING CUTTING IMPLEMENT, legal registration number
END6687USNP / 090349; and
US patent serial number application ________, entitled ULTRASONIC SURGICAL INSTRUMENT WITH COMB-LIKE TISSUE TRIMMING DEVICE, legal registration number END6686USNP / 090367.
[00040] Before explaining in detail the various modalities of ultrasonic surgical instruments, it should be noted that the illustrative modalities are not limited, in their applications or their use, to the details of construction and arrangement of parts illustrated in the drawings and in the description in attachment. The illustrative modalities of the invention can be implemented or incorporated into other modalities, variations and modifications, and can be practiced or carried out in various ways. In addition, except where otherwise indicated, the terms and expressions used in the present invention were chosen for the purpose of describing illustrative modalities for the convenience of the reader and are not intended to limit them. It should also be considered that one or more of the modalities described below, expressions of modalities and examples can be combined with any one or more among the other modalities, expressions of modalities and examples.
[00041] Several modalities are directed to improved ultrasonic surgical systems and instruments configured to perform cutting tissue dissection and / or coagulation during the procedure.
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10/39 surgical procedures. In one embodiment, an ultrasonic surgical instrument apparatus is configured for use in open surgical procedures, but has applications in other types of surgery, such as laparoscopy, endoscopy and robot-assisted procedures. Versatile use is facilitated by the selective use of ultrasonic energy and selective rotation of the cutting / coagulation implement.
[00042] It should be recognized that the terms proximal and distal are used in the present invention with reference to a set of handpiece held by a clinician. In this way, an end actuator is distal to the most proximal handpiece assembly. It must be further recognized that, for the sake of convenience and clarity, spatial terms such as top and bottom are also used in the present invention in relation to the clinician holding the handpiece set. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
[00043] Figure 1 schematically illustrates a modality of a surgical system 10 of the present invention. The surgical system 10 can include an ultrasonic generator 12 and an ultrasonic surgical instrument set 100 which can include a self-contained ultrasonic instrument 110. As will be discussed in more detail below, the ultrasonic generator 12 can be connected by a cable 14 to a set of ultrasonic transducer 114 from the self-contained ultrasonic instrument 110 by a sliding ring assembly 150 located in a compartment portion 102 of the surgical instrument assembly 100. In one embodiment, system 10 additionally includes an engine control system 20 that includes a source power supply 22 which is coupled to the control module 24 by a cable 23 to a supply, for example, of 24 VDC thereof. The engine control module 24 can comprise a control module produced by National
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Instruments of Austin, Texas, under model No. NI cRIO-9073. However, other engine control modules can be used. Power supply 22 may comprise a power supply produced by National Instruments. However, other power supplies can be used correctly. The power supply 22 can be additionally coupled to a motor driver 26 by a cable 25 to also supply 24 VDC to it. Motor starter 26 may comprise a motor starter produced by National Instruments or others. The control module 24 can also be coupled to the motor starter 26 by a cable 27 to supply power to it. A conventional pedal 30 or other control key arrangement can be attached to the control module 24 by a cable 31. As will be discussed in more detail below, the ultrasonic surgical instrument 100 may include a motor 190 that has an encoder 194 associated with This one. As will be explained in more detail below, the motor 190 can be coupled to a torsional spring 300 which, in one embodiment, is coupled to the slip ring assembly 150. In one embodiment, the motor 190 can comprise a stepper motor produced by National Instruments under model No. CTP12ELF10MAA00. Encoder 194 may comprise an encoder produced by U.S. Digital of Vancouver, Washington under model No. E2-500-197-I-D-D-B. However, other engines and encoders can be used. The encoder 194 can be coupled to the motor control module 24 by an encoder cable 32 and the motor 190 can be coupled to the motor driver 26 by a cable 33. The surgical system 10 can also include a computer 40 that can communicate via an ethernet cable 42 with the motor control module 24.
[00044] As can be seen in figure 1, in several modalities, the engine control system 20 is housed in a housing 21. Pa
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12/39 To facilitate system portability, several components can be attached to the engine control system 20 by removable cable connectors. For example, pedal switches 30 can be attached to a removable cable connector 37 by a cable 35 to facilitate quick attachment of the pedal to the control system 20. AC power can be supplied to power supply 22 via a conventional cable / plug 50 which is attached to a removable cable connector 54 which is attached to cable 52. Computer 40 may have a cable 60 which is attached to removable cable connector 62 which is attached to cable 42. Encoder 194 may have an encoder cable 70 which is attached to a removable connector 72. Likewise, motor 190 may have a cable 74 that is attached to removable connector 72. Removable connector 72 can be attached to control module 24 by a cable 32 and connector 72 can be attached to motor starter 26 by a cable 33. In this way, cable connector 72 serves to secure encoder 194 to control module 24 and motor 190 to motor starter 26. Cables 70 and 74 can be accommodated in a common sheath 76.
[00045] In various embodiments, the ultrasonic generator 12 can include an ultrasonic generator module 13 and a signal generator module
15. See Figure 1. The ultrasonic generator module 13 and / or the signal generator module 15 can be integrated with the ultrasonic generator 12 or can be supplied as separate circuit modules electrically coupled to the ultrasonic generator 12 (shown in dashed line for illustrate this option). In one embodiment, the signal generator module 15 can be integrally formed with the ultrasonic generator module 13. The ultrasonic generator 12 can comprise an input device 17 located on a front panel of the generator console 12. The input device 17 can comprise any suitable device that generates signals suitable for programming the operation of the generator 12 in a known manner. Still with
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13/39 Referring to Figure 1, cable 14 can comprise multiple electrical conductors for applying electrical energy to the positive (+) and negative (-) electrodes of an ultrasonic transducer assembly 114 as will be discussed in greater detail below.
[00046] Various forms of ultrasonic generators, ultrasonic generator modules and signal generating modules are known. For example, such devices are presented in a US patent serial number application No. 12 / 503,770, entitled Rotating Transducer Mount For Ultrasonic Surgical Instruments, filed on July 15, 2007, which is hereby incorporated by reference, in its entirety. Other such devices are presented in one or more of the following US patents, all of which are incorporated by reference: US patent No. 6,480,796 (Method for Improving the Start Up of an Ultrasonic System Under Zero Load Conditions); US patent no.
6,537,291 (Method for Detecting a Loose Blade in a Handle Connected to an Ultrasonic Surgical System); US patent No. 6,626,926 (Method for Driving an Ultrasonic System to Improve Acquisition of Blade Resonance Frequency at Startup); US patent No. 6,633,234 (Method for Detecting Blade Breakage Using Rate and / or Impedance Information); US patent No. 6,662,127 (Method for Detecting Presence of a Blade in an Ultrasonic System); US patent No. 6,678,621 (Output Displacement Control Using Phase Margin in an Ultrasonic Surgical Handle); US patent No. 6,679,899 (Method for Detecting Transverse Vibrations in an Ultrasonic Handle); US patent No. 6,908,472 (Apparatus and Method for Altering Generator Functions in an Ultrasonic Surgical System); US patent No. 6,977,495 (Detection Circuitry for Surgical Handpiece System); US patent No. 7,077,853 (Method for Calculating Transducer Capacitance to Determine Transducer Temperature); US patent no.
7,179,271 (Method for Driving an Ultrasonic System to Improve Acquisition of Blade Resonance Frequency at Startup); and US patent no.
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7,273,483 (Apparatus and Method for Alerting Generator Function in an Ultrasonic Surgical System).
[00047] As can be seen in figure 2, an ultrasonic surgical instrument handpiece 100 can comprise a compartment 102 that houses the motor 190, the encoder 194, the slip ring assembly 150 and the self-contained ultrasonic surgical instrument 110. The compartment 102 can be supplied in two or more parts that are fixed together by fasteners such as screws, pressure characteristics, etc. and can be produced from, for example, polycarbonate, polyetherimide (GE Ultem®) or metals such as aluminum, titanium or steel. The motor 190 may comprise, for example, a stepper motor produced by National Instruments. However, other models can be used to effect, for example, gross rotational movement of the self-contained ultrasonic surgical instrument 110, relative to compartment 102 in the order of 1-6000 rpm. The encoder 194 converts the mechanical rotation of the motor shaft 192 to electrical pulses that provide speed and other motor control information to the control module 24.
[00048] The self-contained ultrasonic surgical instrument 110 may comprise a surgical instrument that is produced and marketed by Ethicon Endo-Surgery under model No. HP054. However, other ultrasonic instruments can be used correctly. It will be understood that the term self-contained for use in the present invention, means that the ultrasonic surgical instrument can be used effectively as an ultrasonic surgical instrument per se, separately from its use with the surgical instrument 100. As illustrated in greater detail in figure 3 , the ultrasonic surgical instrument 110 includes a compartment 112 that supports a set of piezoelectric ultrasonic transducer 114 to convert electrical energy into mechanical energy resulting in vi movement
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15/39 longitudinal cross-section of the ends of the transducer assembly 114. The ultrasonic transducer assembly 114 may comprise a stack of piezoelectric ceramic elements with a zero point movement located somewhere along the stack. The ultrasonic transducer assembly 114 can be mounted between two cylinders 116 and 118. In addition, a cylinder 120 can be attached to the cylinder 118, which in turn is mounted to the compartment at another zero point of movement 122. A horn 124 can also be fixed to the null point on one side and to a coupler 126 on the other side. A blade 200 can be attached to coupler 126. As a result, blade 200 will vibrate in the longitudinal direction at an ultrasonic frequency rate with the ultrasonic transducer assembly 114. The ends of the ultrasonic transducer assembly 114 achieve maximum movement with a portion of the stack constituting a non-moving node, when the ultrasonic transducer assembly 114 is activated at maximum current at the resonance frequency of the transducer. However, the current providing maximum movement will vary with each instrument and is a value stored in the instrument's non-volatile memory for the system to use.
[00049] The parts of the ultrasonic instrument 110 can be produced in such a way that the combination oscillates on the same resonant frequency. In particular, the elements can be adjusted so that the resulting length of each given element is half the wavelength, or a multiple of it. The back and forth movement is amplified as the diameter close to the blade 200 of the acoustic horn 124 decreases. In this way, the horn 124 as well as the blade / coupler can be shaped and sized so that they amplify the movement of the blade and provide ultrasonic vibration in resonance with the rest of the acoustic system, which produces maximum movement back and forth
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16/39 t from one end of the acoustic horn 124 next to blade 200. A 20 to 25 micron movement in the ultrasonic transducer assembly 114 can be amplified by horn 124 to a blade movement of about 40 to 100 microns.
[00050] When power is applied to the ultrasonic instrument 110 by operating the pedal 30 or other key arrangement, the control system 20 can, for example, cause the blade 200 to vibrate longitudinally at approximately 55.5 kHz, and the amount of longitudinal movement will vary proportionally with the amount of drive energy (current) applied, as selected by user adjustment. When relatively high cutting energy is applied, blade 200 can be designed to move longitudinally in the range of about 40 to 100 microns at the ultrasonic vibratory rate. Such ultrasonic vibration of the blade 200 will generate heat as the blade comes into contact with the fabric, that is, the acceleration of the blade 200 through the fabric converts the mechanical energy of the moving blade 200 into thermal energy in a very narrow and localized area. This localized heat creates a narrow coagulation zone, which will reduce or eliminate bleeding in small vessels, such as these smaller than a millimeter in diameter. The cutting efficiency of blade 200, as well as the degree of homeostasis, will vary with the level of trigger energy applied, the rate of cut or force applied by the surgeon to the blade, the nature of the type of tissue and the vascularity of the tissue .
[00051] As can be seen in figure 2, the ultrasonic instrument 110 is supported inside compartment 102 by a tail piece drive adapter 130 and a distal handpiece adapter 134. The tail piece drive adapter 130 is sustained rotating shape inside compartment 102 by a proximal bearing 132 and non-rotatingly coupled to the output shaft 192 of the
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17/39 motor 190. See figure 2. The tailpiece drive adapter 130 can be pressed into the housing 112 of the ultrasonic instrument 110. The distal handpiece adapter 134 can be pressed into a distal end 113 of the handpiece 112. The distal handpiece adapter 134 is pivotally supported in housing 102 by a distal bearing 136 which is mounted within housing 102.
[00052] When energy is applied to motor 190, motor 190 applies a gross rotational movement to handpiece 110 to cause the ultrasonic surgical instrument 110 and blade 200 to rotate around the central A-A axis. For use in the present invention, the term gross rotational movement must be specified differently from the torsional ultrasonic movement that can be achieved when used in a non-homogeneous formed ultrasonic blade. The term gross rotational movement, however, encompasses rotational movement that is not generated solely by the operation of the ultrasonic transducer set 114.
[00053] To supply the ultrasonic instrument 110 with the power of the ultrasonic generator 12, a slip ring assembly 150 may be employed. As can be seen in figure 2, conductors 151 and 152 are attached to the ultrasonic transducer assembly 114 and extend through a hollow rod portion 132 of the tail adapter drive adapter 130. The hollow rod portion 132 is attached to a torsional spring 300 which is attached to the drive shaft 192 of the motor 190. The hollow rod portion 132 is free to rotate within the slip ring assembly 150. A first internal contact 154 is attached to the hollow rod portion 132 for travel rotational around the AA axis. The first internal contact 154 is positioned for rotational contact with a fixed external contact 156 within the slip ring assembly 150. Contacts 154 and 156 can be supplied under the
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18/39 form of rings arranged concentrically. Conductors 157 and 158 are coupled to the fixed external contact 156 and form the generator cable
14. Conductors 191 and 193 are attached to the motor and form the motor cable 74 and conductors 195 and 197 are attached to the encoder 194 and form the encoder cable 70. Rotation of the driving shaft 192 results in the rotation of the driving adapter of the tail piece 130 and the ultrasonic instrument 110 attached to it about the AA axis. The rotation of the drive shaft of the motor 192 also results in the rotation of the internal contact 154. Ultrasonic signals from the ultrasonic generator 12 are transferred to the internal contact 154 by virtue of contact or electrical communication between the internal contact 154 and the external contact 156. These signals are transmitted to the ultrasonic transducer assembly 114 by conductors 151 and 152.
[00054] As indicated above, several embodiments employ a torsional spring 300 which is mounted between the output shaft 192 of the motor 190 and a distal shaft segment 301 which is attached to the tail piece drive adapter 130. However, other torsional springs 300 can be employed. For use in the present invention, the term torsional spring refers to these forms of springs that exert pressure along a path that is circular and must be distinguished from compression springs that exert forces in an axial direction. The purpose of the torsional spring 300 will be explained below.
[00055] Various embodiments can also include a distal clamp nozzle 160 which can be removably attached to the distal end 103 of compartment 102 by locks 161. See figure 5. One or more wedge members 162 can be positioned between the distal end 103 and the clamp nozzle 160 to facilitate coaxial attachment between housing 102 and the clamp nozzle 160. The clamp nozzle 160 can be produced from, for example, polycarbonate, polyetherimide (GE Ultem®) or metals such as aluminum, titanium or steel. In go
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19/39 In various embodiments, the distal end 202 of the blade 200 extends through a hollow coupling segment 210 that is seated within an inner sheath seal 212. The inner sheath seal 212 can serve to establish a substantially waterproof seal fluids and / or air proof between the coupling segment 210 and the fastener nozzle 160. Also in the embodiment of figure 4, an inner sheath 220 can be attached to the hollow coupling segment 210 by, for example, a threaded connection or the coupling segment hollow 210 may comprise an integral portion of the inner sheath 220. In one embodiment, a blade pin / torque member 216 may extend transversely through the blade member 200 and the hollow coupling segment 210 to facilitate movement of the inner sheath 220 with the blade member 200. One or more breather silicone cushions 214 can be seated around the blade 200 to acoustic isolate the blade 200 from the inner sheath 220. The blade member 2 00 can have a proximal end 201 which is internally threaded and adapted to remotely engage a threaded portion of coupler 126. To facilitate the firmness of blade 200 to coupler 126, a clamping hole 108 (figure 2) can be provided through compartment 102 to allow a tool (e.g. Allen key) to be inserted through it into a hole 131 in the tail piece drive adapter 130 to prevent rotation of the ultrasonic surgical instrument 110 and coupler 126 attached to it. Once blade 200 has been screwed to coupler 126, the user can remove the Allen key or other tool from holes 108 and 131 and insert a threaded plug (not shown) into hole 108 to prevent fluids / debris from entering the compartment 102 through it.
[00056] Also in various embodiments, an outer sheath 230 can be coaxially aligned with the inner sheath 220 and member
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20/39 of blade 200 and be fixed to a distal end 163 of basic piece 160 by, for example, welding or other suitable means. As can be seen in figure 4, a suction port 240 can be attached to the nozzle part 160 to communicate with the hollow outer sheath 230. A flexible tube 242 can be attached to the suction port 240 and communicate with a collection receptacle 243 which is coupled to a vacuum source, usually shown as 244. In this way, the outer sheath
230 forms a suction path extending around the inner sheath 220 that begins at a distal end of the outer sheath 230 and exits through the suction port 240. Those of ordinary skill in the art will understand that alternative suction paths are also possible. In addition, in alternative embodiments, the inner sheath 220 is omitted.
[00057] As can be seen in figures 6 and 7, a portion of distal tip 400 is shown that can be attached to the distal end
231 of the outer sheath 230. In various embodiments, the outer sheath 230 can be produced from, for example, aluminum, titanium, aluminum alloys, steels, ceramics, etc. The distal tip portion 400 can be attached to the distal end 231 of the outer sheath 230 by, for example, welding, adhesive, etc. As shown in figures 6 and 7, the distal tip portion 400 defines two cutting surfaces 402 and 404 that form the block surfaces for cutting on each side of a blade opening 410 formed therein.
[00058] Figure 8 illustrates a shape of the distal tissue cutting tip 250 that is formed or otherwise provided in the blade 200. As can be seen in the figure, the distal tissue cutting tip 250 has a pair of cutting edges. of fabric 252 and 254 formed therein. In several embodiments, blade 250 can be produced from, for example, titanium. In the embodiments shown in figures 6 and 7, a distal blade cover 260 can be attached to the distal end 251 of the tip
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21/39 cutting the distal tissue 250 from the blade 200. The distal blade cover 260 can be dimensioned to be swiveled within a nose cavity 412 formed in the distal tip portion 400 so that the blade 200 can oscillate to back and forth (represented by the arrow B in figures 6 and 7) around the longitudinal axis AA.
[00059] Various modalities of the surgical system 10 provide the ability to selectively apply ultrasonic motion to the 200 slide and also gross rotational motion to the 200 slide. In some embodiments, for example, the frequency rates for longitudinal ultrasonic motion may be in the order of, for example, 30-80 kHz. In a preferred method of use, the blade 200 swivels back and forth so that the fabric is brought together between the cutting edges 252 and 254 and the cutting surfaces 402 and 404 (figures 6 and 7). In various embodiments, blocks of fabric 270 made of, for example, polytetrafluoroethylene or similar materials can be attached to the cutting surfaces 402 and 404 by, for example, adhesives or other suitable fastening arrangements. In this way, the fabric can be brought together between cutting edges 252 and 254 and cutting surfaces 402 and 404 or fabric blocks 270. In use, blade 200 and fabric can both be momentarily stopped, with the blade applying force to the fabric , and block 270 providing a cutting board surface on the opposite side. In various embodiments, the ultrasonic actuation blade 200 can act with a desired amount of pressure and time on the tissue. In this way, the computer processor 40 of the control system can be programmed to cause the motor 190 to stop after the blade 200 has captured the tissue in block 270 for a predetermined dwell time. This can increase the amount of energy that is applied to the fabric, thereby potentially improving the cutting speed or
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22/39 hemostatic effect. In various modes, dwell times in the range of 5 ms to 10 ms can be used correctly, for example. The ultrasonic transducer assembly 114 can be activated to provide ultrasonic movement to the slide prior to tissue capture or immediately after the tissue has been captured between cutting edge 252 and 254 and tissue block 270.
[00060] During the cutting process, suction can be applied inside the outer sheath 230 by the suction source 244 so that the fabric is extracted inwards through the blade opening 410. As illustrated in figures 8A-8C, when the blade 200 is in a central position as shown in figure 8A, the T and “T 'fabric can be extracted into both sides 410R and 410L of the blade opening 410. When the blade 200 oscillates to hold the T fabric between the edge cutter 252 and tissue block 270 and is held in this cut position for the predetermined amount of dwell time, such dwell time allows another tissue T 'to be extracted into portion 410L of blade opening 410 as shown in figure 8B. Similarly, when blade 200 is swung to capture tissue T 'between cutting edge 254 and tissue block 270, and is held in this position for the predetermined dwell time, another tissue T can be extracted into portion 410R of the blade opening 410. It is believed that other devices that use a rotating blade for cutting tissue extracted into an opening in a sheath tend to expel tissue when it is being extracted into the opening. It is believed that the oscillating blade of various modalities of the present invention is faster when cutting fabric than one of continuous rotation because when the blade is stopped, the fabric has time to be extracted into an opposite side of the opening, thus making expulsion less likely when the blade is cutting.
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23/39 [00061] Another unique and innovative advantage provided by the present invention is the ability to control the amount of force that is generated at the blade / block interface. For example, the modality described above employs the torsional spring in combination with the stepper motor and encoder to control the amount of force applied to the blade / interface. Controlling the rotation of the motor beyond the point of contact of the blade / block results in displacement or loading of the torsional spring by a certain angle which results in the application of a predetermined amount of torsional force to the blade. For example, Force = [torsional spring rate] x [angular deflection] / [distance from the center of rotation to the blade edge]. Thus, in some non-limiting modalities, for example, a preferential force would be in the range of 6.67 to 22.24 N (1.5 to 5 lbs). In an alternative embodiment, motor 190 may comprise a servomotor and be used in connection with a suitable encoder. In yet another modality, the torsional spring can be omitted and the output shaft of the motor 192 can be connected directly to the drive adapter of the tail piece 130. In these modalities, the motor 190 comprises a servomotor that generates the desired amount of torque based on in the applied current. In yet another modality, the control system can measure the amount of impedance in the motor circuit to control the oscillation speed. When in contact with the fabric, the motor can run under a high load. Thus, in this mode, when the load exceeds a predetermined limit, the motor may have its speed reduced to allow the ultrasonic blade to cut through the tissue.
[00062] Figure 9 illustrates an alternative blade modality 200 '. As can be seen in that figure, the blade 200 'has a distal tip 250' which is formed with a pair of cutting edges of fabric 252 'and 254'.
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24/39 [00063] Figure 10 illustrates another embodiment of the surgical instrument 500 of the present invention that employs a handpiece 502. In this embodiment, handpiece 502 includes a compartment 302 that houses a transducer assembly 530 that is attached to a horn ultrasonic 324. The ultrasonic horn 324 can be coupled to the proximal end 201 of blade 200 by a threaded connection or other suitable connection. The ultrasonic horn 324 can be swiveled within the compartment 302 by a distal bearing 336. A catch nozzle 160 can be attached to the compartment 302 in the manner described above.
[00064] This modality includes a motor 510 that can comprise a stepper motor of the type and construction described above and can have an encoder portion 194 associated with it that communicates with the control module 24 (figure 1) through the cable 70 as was described above. Motor 510 can receive power from motor driver 26 (figure 1) through conductors 511 and 512 comprising motor cable 74 that extends through common sheath 76. Motor 510 has an output shaft 520 that can be supported rotatable inside the housing 302 by a first proximal bearing 521. The output shaft can be fixed to a torsional spring 540. Attached to the torsional spring 540 is a hollow drive shaft segment 550 that can be swiveled within the compartment 302 by a second proximal bearing 551. A distal portion 552 of the drive shaft segment 550 extends through a slip ring assembly 150. The slip ring assembly 150 is fixed (i.e. does not rotate) within the compartment 302 and includes a fixed external contact 156 that is attached to conductors 157 and 158 that form a generator cable 14 (figure 1) as described above. An internal contact 154 is mounted on the hollow drive shaft segment 550 and is in electrical contact or communicates
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25/39 tion with external contact 156. Conductors 151 and 152 are attached to internal contact 154 and extend through the hollow drive shaft 520 to be coupled to the ultrasonic transducer assembly 530.
[00065] This embodiment also employs an outer sheath 230 which may have a distal tip portion 400 attached to the distal end 231 thereof as described above. The blade may have a cutting tip of distal tissue 250 as described above. When power is supplied to motor 510, drive shaft 520 rotates around axis A-A, which also causes transducer assembly 530 to rotate around axis A-A. Due to the fact that the blade 200 is attached to the horn 324, it also rotates with the ultrasonic transducer assembly 530. As mentioned above, the torsional spring 540 in combination with the stepper motor 510 and encoder 190 controls the amount of force applied to the blade / block interface (ie, the amount of twist experienced by the tissue cutting portion of the blade when in contact with the block / cutting surface).
[00066] When the clinician wishes to supply power to the ultrasonic transducer set 530, power is supplied from the ultrasonic generator 12. (figure 1) to the fixed contact 156 on the slip ring set 150. Energy is transmitted to the ultrasonic transducer set 530 by due to a rotational sliding contact or electrical communication between internal contact 154 and external contact 156. These signals are transmitted to the ultrasonic transducer set 530 by conductors 151 and 152. Suction can be applied between blade 200 and outer sheath 230 through the port 240. A collection receptacle 243 and suction source 240 can be attached to port 240 by a tube 242. The distal end of the blade is exposed through a window at the distal end of the outer sheath 230 to expose the tissue cutting tip distal 250 from blade 200 to the fabric as I mentioned
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26/39 above. In this way, this modality can operate, unless otherwise specified, in the same way as the ultrasonic surgical instrument set 100 described above.
[00067] Figure 11 illustrates an alternative surgical instrument modality 500 'that is substantially similar in design and operation as the instrument 500 described above, except that this modality employs a torsional load cell 560 in place of torsional spring 540 and encoder 194 For example, a torsional load cell of the type produced by Futek Advanced Technologies of Irvine, California under model No. TRD300 as well as others can be used. As can be seen in figure 11, for example, the torsional load cell 560 can be attached to the output shaft 520 of the engine 510 as well as the segment of the hollow drive shaft 550. The torsional load cell 560 can communicate with the computer processor 40 by conductors 561 and 562 in a known manner to allow the clinician to control the motor 510 based on the amount of torque detected by the torsional load cell 560. In this way, the clinician can predetermine a desired amount of torque to be applied to blade 200 and then program the computer processor to provide the motor control signals appropriate to the motor to maintain such a level of torque.
[00068] Figures 12 and 13 illustrate another modality of surgical instrument 600 of the present invention that employs a handpiece
601. In this embodiment, the surgical instrument 600 includes a handpiece 601 that includes a compartment 602 that houses a transducer assembly 604 that is attached to an ultrasonic horn 606. The ultrasonic horn 606 can be attached to the proximal end 201 of the blade 200 by a threaded connection or other suitable connection. In other embodiments, the blade 200 can be integrally formed with the horn 606. The ultrasonic transducer set 604 and
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27/39 the ultrasonic horn 606 are mounted in a non-rotating manner inside compartment 602.
[00069] This modality includes a motor 610 that can comprise a stepper motor of the type and construction described above and can have an encoder portion 612 associated with it that communicates with the control module 24 through conductors 614 and 616 in the ways described above. Motor 610 can receive power from motor driver 26 through conductors 618 and 620 that extend through common sheath 76. Motor 610 is non-rotatingly supported inside compartment 602 and has an output shaft 630 that has a first drive gear 632 in this. The first drive gear 632 is interconnected by engagement with a second gear 636 which is mounted on a sheath drive shaft 634. The sheath drive shaft 634 can be supported in various modes for rotation within compartment 602. In the modalities shown in figures 12 and 13, the sheath drive shaft 634 is pivotally supported on a proximal bearing 640 and a distal bearing 642 (figure 13). A third drive gear 650 is attached to the distal end of the sheath drive shaft 634. The third drive gear 650 is interconnected by engagement with a sheath gear 652 mounted on the proximal end portion 662 of an outer sheath 660 rotationally around the blade 200 and is substantially coextensive to it. As can be seen in figure 12, the proximal end 662 of the outer sheath 660 may have a flange 664 formed therein that is swiveled within a portion of the concave part 670 formed by cooperative separators 672 in compartment 602. Such an arrangement prevents outer sheath 660 moves axially with respect to compartment 602 while allowing outer sheath 660 to rotate around
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28/39 of the A-A axis.
[00070] This embodiment also employs a 680 clamp nozzle which is relatively similar to the clamp nozzle arrangement described above. The clamp nozzle 680 can be removably attached to compartment 602 by screws 681 or other suitable closing arrangements. In this embodiment, the outer sheath 660 swivels through a passage 682 in the fastener nozzle 680. The proximal seal 684 and distal seal 686 swivelly support the outer sheath 660 inside the passage 682 while establishing a fluid-tight seal between itself. See figure 13. A suction port 240 can be provided on the clamping nozzle 690 and communicating through a flexible tube 242 with a collection receptacle 243 that is coupled to a vacuum source, usually shown as 244. The outer layer 660 it is dimensioned relative to the blade 200 so as to form a suction path 690 between the outer layer 660 and the blade 200. At least one suction opening 664 is provided through the outer sheath 660 at the location of the suction port 240 so that, while the outer sheath swivels through a predetermined range of arcuate movement, as will be discussed in more detail below, the suction opening 664 allows pieces of fabric to be drawn between the outer sheath 660 and the blade 200 through the passage 690 exit through suction passage 690 through opening 664 and port 240 to collection receptacle 243. An internal seal 668 is also provided between blade 200 and the rotating outer sheath 660 in a location that is proximal to the 664 suction opening as shown.
[00071] This modality may also employ the distal tip portion 400 of the type and construction described above as well as the distal cutting tip configurations 250 and 250 'as described above and illustrated in figures 8 and 9. However, in this embodiment, the
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29/39 blade tips 250 and 250 'are stationary and the distal tip portion 400 (and outer sheath 660) swivel back and forth to cut the T and T' fabric between the cutting edges 252 and 254 See figures 14 and 15. The outer sheath 660 can be swiveled in any of the various ways described above by controlling the performance of the 610 motor. Like the above described modes, the outer sheath 660 can be swiveled to a cutting position and held in that position for a predetermined dwell time. During the residence time, other tissue can be extracted into the opposite side of the blade opening. After the dwell time has expired, the blade can swivel to the other side of the blade opening to cut the other tissue for a similar dwell time, etc.
[00072] When the clinician wishes to supply power to the ultrasonic transducer set 530, power is supplied from the ultrasonic generator 12. (figure 1) to the fixed contact 156 on the slip ring set 150. Energy is transmitted to the ultrasonic transducer set 530 by virtue of a rotational sliding contact or electrical communication between internal contact 154 and external contact 156. These signals are transmitted to the ultrasonic transducer assembly 530 by conductors 151 and 152. A suction can be applied between blade 200 and outer sheath 230 through port 240. A collection receptacle 243 and suction source 240 can be attached to port 240 by a tube 242. The distal end of the blade is exposed through a window at the distal end of the outer sheath 230 to expose the cutting tip distal tissue 250 from blade 200 to the tissue as already mentioned above. In this way, this modality can operate, unless otherwise specified, in the same way as the ultrasonic surgical instrument set 100 described above.
[00073] Figures 16 to 26 illustrate another type of instrument
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30/39 surgical procedure 700 of the present invention. This embodiment can employ a handpiece 502 of the type and construction described above as well as any of the variations employing a rotating oscillating blade described above. In additional alternative embodiments, these suitable handpieces presented in the following commonly used US patent applications, previously incorporated herein by reference, may also be employed.
[00074] In various embodiments, the distal end 202 of the blade 200 can extend through a hollow coupling segment 210 that is seated within an inner sheath seal 212. See Figure 17. Inner sheath 220 can be attached to the segment hollow coupler 210 by, for example, a press setting, brazing, welding, threading, etc. or the hollow coupling segment 210 may comprise an integral portion of the inner sheath 220. In one embodiment, a blade pin / torque member 216 may extend transversely across the blade member 200 and the hollow coupling segment 210 to facilitate movement of the inner sheath 220 with blade member 200. One or more ventilated silicone cushions 214 can be seated around blade 200 to acoustically isolate blade 200 from inner sheath 220. Blade member 200 may have a proximal end 201 which is internally threaded and adapted to removably engage a threaded portion of coupler 126 in the various ways described above. In alternative embodiments, the proximal end 201 of the blade may be directly attached to the ultrasonic horn 324 or it may comprise an integral portion thereof.
[00075] This modality may employ an outer sheath 710 that is fixed to the fastener nozzle 160. In various embodiments, the outer sheath 710 can be manufactured from, for example, coextruded polyimide, or coated welded metal and be fixed to the fastener nozzle 160 by ,
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31/39 eg welding, adhesive, etc. The outer sheath 710 can be formed with a main lumen 712 and two block lumens 714 and 716 as shown in figure 18. As can be seen in figures 19 and 20, the distal end 750 of the outer sheath 710 has a rounded end 752 and a blade opening 754 communicating with the main lumen 712 through which blade 200 extends. The first block lumen 714 is defined by a first block protrusion 713 and the second block lumen 716 is defined by a second block protrusion 715 as shown in figure 18. The first block protrusion 713 and the second block protrusion 715 they are oriented relative to each other at an angle A as illustrated in figure 18. In the illustrated embodiment, angle A is approximately 135 degrees. As will be discussed below, angle A defines the arcuate path on which blade 200 can travel. In other embodiments, angle A may have different magnitudes.
[00076] As can be seen in figure 20, a first block of fabric 760 can be attached to the first protrusion of block 713 and a second block of fabric 770 can be attached to the second protrusion of block 715. In various embodiments, the blocks of fabric 760 and 770 can be manufactured from, for example, polytetrafluoroethylene or similar materials and have a serrated fabric grip surface 762 and 772 formed thereon. In alternative embodiments, the fabric surfaces 762 and 772 can be flat. Blocks 760 and 770 can be attached to the surfaces of blocks 713 and 715 respectively by, for example, interference fit, adhesives or mechanical closures. Block 760 can have at least one vacuum port 764 through which communicates with a corresponding first suction port 717 that extends through the first block surface 713 and into the first block lumen 714. Similarly, the second 770 tissue block can have at least one vacuum port
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32/39
774 through it that communicates with a corresponding second suction orifice 719 that extends through the second block surface 715 and into the second block lumen 716. Ports 764 and 774 can be of any suitable geometry such as holes, stars , rectangular spans, cross, etc.
[00077] As can be seen in figure 22, blade 200 has a proximal end 201 that can be attached to coupler 126 in the various ways described above. In alternative embodiments, the blade 200 can be integrally formed with the ultrasonic horn. The blade 200 additionally has an arcuate tissue cutting portion 780 formed therein. Other blade configurations can be employed. In several embodiments, the blade 200 can be manufactured from, for example, titanium, brass, aluminum or stainless steel.
[00078] As can be seen in figures 17 and 23, a first suction port 790 can be attached to the catch nozzle 160 and communicate with a suction control system 850 (figure 23) as will be further explained below. The first suction port 790 can communicate with the main lumen 712 to evacuate tissue and fluids from it through a flexible tube or hose 792 that is coupled to a first collection line 852 in the collection system 850. A second suction port 800 it can be attached to the catch nozzle 160 and communicate with the suction control system 850. The second suction port 800 can communicate with the first block lumen 714 to provide suction to it. The second suction port 800 communicates with a second collection line 854 in the collection system 850 via a second flexible tube or hose 802. A third suction port 810 can be attached to the catch nozzle 160 and communicate as a suction control system 850. The third suction port 810 can communicate with the second block lumen 716 to provide suction to it. The second suction port 810 communicates
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33/39 with a third collection line 856 in the collection system 850 through a third flexible tube or hose 812.
[00079] As can be seen further in figure 23, a first control valve 858 is coupled between the first collection line 854 and the collection receptacle 880 which is coupled to a suction source 890. The first control valve 858 can communicate with computer controller 40 in the first conductor control system 860. A second control valve 862 is coupled between the second collection line 854 and the collection receptacle 880 and communicates with computer controller 40 through the conductors 864. A third control valve 868 is coupled between the third collection line 856 and the collection vessel 880 and communicates with computer controller 40 through conductors 870.
[00080] Figures 24 to 26 illustrate a method of using the instrument 700. To start using the device, the distal end of the outer sheath 710 is inserted into the patient's body cavity with the tissue cutting portion 780 of the blade 200 positioned in the center of the window opening 754 as shown in figure 24. Consequently, the clinician can activate the ultrasonic transducer set 530 (figure 16) using the pedal (figure 1) or another key mechanism. The clinician can also activate the suction source with all three control valves 858, 862 and 868 in an open position to apply suction to main lumen 712 and first and second block lumens 714 and 716. However, in a preferred embodiment, only one of the control valves 862 and 868 for block lumens 714 and 716 are opened at a time, as will be discussed below. The clinician can then bring the distal end 750 of the outer sheath 710 into contact with the target tissue to allow the target tissue to be extracted into one or both of the tissue blocks 760 and 770. The tissue fibrils will be
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34/39 held in place by the tissue blocks 760 and 770 by vacuum through the suction ports 764 and 774. The clinician can then activate the engine 510 (figure 16) to rotate the blade 200 so that the tissue cutting portion 780 of this is rotated on the fabric in one of the tissue blocks 760 or 770. Figure 25 illustrates the tissue cutting portion 780 rotated to a position adjacent to the second tissue block 770 with the tissue omitted for clarity. The control system 10 will automatically, or at the clinician's control, retain the tissue cutting portion 780 in this position for a predetermined dwell time to ensure the transection of the fibrils / tissue. The dwell time can be, for example, approximately three (3) seconds. However, other residence times may be applied and may be dependent on the types of tissue to be transected.
[00081] Once the dwell time has expired, suction is discontinued for the block lumen in which the tissue cutting portion 780 of the blade 200 is in contact. In the example shown in figure 25, the control valve 868 will be moved to a breather position with the suction line 812 as well as the block lumen 716 having a breath into the atmosphere. This can be done automatically by the control system 10 or through manual keys (not shown) coupled to the control valve 868. The tissue cutting portion 780 can then be returned to the central position shown in figure 24 by activating the engine 510. This can be done automatically by the control system 10 or by manually activating manual keys (not shown) by the clinician. By rotating the tissue cutting portion 780 of the blade 200 to the center position and discontinuing suction to the block lumen 716 this will allow any tissue debris remaining in the tissue block 770 to be sucked through the main lumen 712. The system control can hold the blade tip 780 in the center position
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35/39 for a second predetermined dwell time to provide time for tissue debris to be evacuated through main lumen 712, line 792, line 852, valve 858 and into collection vessel 880. Consequently, since the second residence time has expired, the control system can open control valve 862 to apply suction to the lumen of block 714. In other modalities, once the clinician observes that block 770 is free of tissue debris, then the clinician can open the 862 control valve by manually activating a key (not shown).
[00082] When suction is applied to the block lumen 714, the fabric will be extracted into block 760. The fabric cutting tip 780 can then be rotated on this fabric in block 760 as shown in figure 26. The control system 10 it will automatically, or at the clinician's control, retain the tissue cutting portion 780 in this position for a third predetermined dwell time to ensure the transection of the fibrils / tissue. The third dwell time can be, for example, approximately three (3) seconds. However, other third residence times may be applied and may be dependent on the types of fabric to be transected.
[00083] Once the third dwell time has expired, suction is discontinued at the lumen of block 760. This can be achieved by moving the control valve 862 to a breather position where the suction line 802 as well as the lumen block 714 are breathed into the atmosphere. This can be done automatically by the control system 10 or by means of manual keys (not shown) coupled to the control valve 862. The tissue cutting portion 780 of the blade 200 can then be returned to the central position illustrated in figure 24 by activating the 510 engine. This can be done automatically by the control system 10
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36/39 or through manual activation of manual keys (not shown) by the clinician. By rotating the tissue cutting portion 780 of the blade 200 to the central position and discontinuing suction to the block lumen 714 this will allow any tissue debris remaining in the tissue block 760 to be sucked through the main lumen 712. The system control can hold the blade tip 780 in the center position for a second predetermined dwell time to provide time for tissue debris to be evacuated through main lumen 712, line 792, line 852, valve 858 and into the collection receptacle 880. Consequently, once the residence time has expired, the control system can then repeat the processes described above until the desired amount of tissue has been transected.
[00084] In several embodiments, the blade 200 is rotated back and forth quickly (for example, twenty (20) revolutions per minute (RPM), to achieve cutting speeds that can be comparable to cutting speeds commonly achieved when using current mechanical systems. In addition, however, the various embodiments of the present invention provide the added advantage of homeostasis. For example, if bleeding is found, the tissue cutting tip 780 of blade 200 can be kept stationary in the center of window 754 while it is activated (ie, receiving ultrasonic movement from the 530 transducer assembly) and then applied to the bleeding to cause hemostasis, the tip of the 780 slide can be rubbed over the bleeding area and then excised the tissue.
[00085] The devices described here can be designed to be discarded after a single use, or they can be designed for use multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of eta
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37/39 steps for disassembling the device, followed by cleaning or replacing particular parts, and subsequent reassembly. In particular, the device can be disassembled, in any number of particular parts or parts of the device can be selectively replaced or removed, in any combination. When cleaning and / or replacing particular parts, the device can be reassembled for subsequent use in a reconditioning facility or by a surgical team immediately before a surgical procedure. Those skilled in the art will appreciate that the reconditioning of a device can use a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present patent application.
[00086] Preferably, the various modalities described here will be processed before surgery. First, a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and the instrument are then placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays or high-energy electrons. The radiation kills bacteria on the instrument and the container. The sterile instrument can then be stored in a sterile container. The sterile container keeps the instrument sterile until it is opened at the medical facility. Sterilization can also be done in a number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, and / or steam.
[00087] In several modalities, an ultrasonic surgical instrument can be provided to a surgeon with a waveguide and / or end actuator already operationally coupled with a transducer
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38/39 of the surgical instrument. In at least one such modality, the surgeon, or another clinician, can remove the surgical instrument from a sterile package, plug the ultrasonic instrument into a generator, as described above, and use the ultrasonic instrument during a surgical procedure. Such a system can obviate the need for a surgeon or other clinician to mount a waveguide and / or end actuator to the ultrasonic surgical instrument. After the ultrasonic surgical instrument has been used, the surgeon, or another clinician, can place the surgical instrument in a sealed package, and the package can be transported to a sterilization facility. In the sterilization installation, the ultrasonic instrument can be disinfected, and any part used can be discarded and replaced while any reusable part can be sterilized and used again. Consequently, the ultrasonic instrument can be reassembled, tested, placed in a sterile package and / or sterilized after being placed in a package. Once sterilized, the reprocessed ultrasonic surgical instrument can be used again.
[00088] Although several modalities have been described here, many modifications and variations of those modalities can be implemented. For example, different types of end actuators can be employed. Also, where materials are developed for certain components, other materials can be used. The aforementioned description and the following embodiments are intended to cover all such modifications and variations.
[00089] All US patents and US patent applications, and US patent applications published and referred to in this specification are hereby incorporated by reference in their entirety, but only to the extent that the incorporated material does not come into contact.
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39/39 conflict with existing definitions, statements, or other descriptive material defined in this description. Accordingly, and as far as necessary, the description as explicitly stated herein replaces any conflicting material incorporated herein by way of reference. Any material, or portion thereof, that is deemed to be incorporated by reference in the present invention, but which conflicts with definitions, statements, or other description materials existing herein will be incorporated here only to the extent that no conflict will appear between the embedded material and the existing description material.

权利要求:
Claims (16)
[1]
1. Ultrasonic surgical instrument (100) characterized by the fact that it comprises:
a compartment (102), an outer sheath (230) supported by the compartment (102) and projecting out of that compartment (102), the outer sheath (230) having a distal blade opening (410) that defines the at least one cutting surface (402, 404);
an ultrasonic transducer assembly (114) supported by the compartment (102);
a blade (200) coupled to the ultrasonic transducer assembly (114) and extending through the outer sheath (230) so that a distal tip of the blade (200) extends into the distal blade opening (410) and being that a tissue cutting portion extends radially out of the distal blade opening (410); and a motor (190) supported by the compartment (102) and coupled to one of the ultrasonic transducer assembly (114) and the outer sheath (230) to apply rotary movement to the same or to the same, so that the cutting portion of blade fabric (200) is brought into contact with at least one cutting surface of the outer sheath (230).
[2]
2. Ultrasonic surgical instrument (100), according to claim 1, characterized by the fact that the outer sheath (230) has at least one suction lumen (242) through it that communicates with the opening of the distal blade ( 410).
[3]
3. Ultrasonic surgical instrument (100), according to claim 1 or 2, characterized by the fact that it also comprises a block of tissue (270) attached to each at least one cutting surface (402, 404).
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2/4
[4]
4. Ultrasonic surgical instrument (100), according to claim 3, characterized by the fact that each tissue block (270) has a tissue holding surface on it.
[5]
5. Ultrasonic surgical instrument (100), according to claim 2, characterized by the fact that the at least one suction lumen (242) comprises:
a main suction lumen (242) that extends through the outer sheath (230); and a block lumen that extends through the outer sheath (230) and communicates with at least one suction orifice through a corresponding surface among at least one cut surface (402, 404).
[6]
6. Ultrasonic surgical instrument (100), according to claim 5, characterized by the fact that it also comprises a block of tissue (270) on the corresponding surface among at least one cutting surface (402, 404) and that it has another suction port that communicates with the corresponding suction port among at least one suction port through the cutting surface (402, 404).
[7]
7. Ultrasonic surgical instrument (100) according to claim 2 or 3, characterized by the fact that at least one cutting surface (402, 404) comprises:
a first cutting surface on one side of the blade opening (410); and a second cutting surface on another side of the blade opening (410) and the application of rotating motion to one of the ultrasonic transducer and the outer sheath (230) places the tissue cutting portion of the blade (200) in contact with each of the first and second surfaces.
[8]
8. Ultrasonic surgical instrument (100), according to
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3/4 claim 7, characterized by the fact that the at least one suction lumen (242) comprises:
a first block lumen (714) that extends through the outer sheath (230) and communicates with at least one first suction orifice through the first cutting surface;
a second block lumen (716) that extends through the outer sheath (230) and communicates with at least a second suction orifice through the second cutting surface; and a main suction lumen (242) that extends through the outer sheath (230) and communicates with the blade opening (410).
[9]
9. Ultrasonic surgical instrument (100), according to claim 8, characterized by the fact that it also comprises a suction control system that communicates with the first and second block lumens (714, 716) and the lumen main suction valve (242).
[10]
10. Ultrasonic surgical instrument (100), according to claim 9, characterized by the fact that the suction control system comprises:
a suction source (244);
a collection receptacle (243) that communicates with the suction source (244);
a first suction supply line coupled to the collection receptacle (243) and the first block lumen (714);
a second suction supply line coupled to the collection receptacle (243) and the second block lumen (716);
a main suction supply line coupled to the collection receptacle (243) and the main suction lumen (242);
a first valve on the first suction supply line;
Petition 870190093137, of 09/18/2019, p. 45/51
4/4 a second valve on the second suction supply line; and a third valve on the main suction supply line.
[11]
11. Ultrasonic surgical instrument (100), according to claim 1 or 2, characterized by the fact that the distal tip of the blade (200) has an arcuate shape.
[12]
12. Ultrasonic surgical instrument (100) according to claim 7, characterized in that the tissue cutting portion of the blade (200) has a first cutting edge of fabric corresponding to the first cutting surface and a second cutting edge fabric cutter corresponding to the second cut surface.
[13]
13. Ultrasonic surgical instrument (100), according to claim 12, characterized by the fact that the first and second cutting edges are blind edges.
[14]
14. Ultrasonic surgical instrument (100), according to claim 1, characterized by the fact that it still comprises:
a means for limiting the amount of twisting (300) suffered by the tissue cutting portion of the blade (200) when in contact with the cutting surface (402, 404).
[15]
15. Ultrasonic surgical instrument (100), according to claim 14, characterized by the fact that the limiting means comprises:
a torsional spring (300) operably coupled to the motor (190) and the ultrasonic transducer assembly (114); or a torsional load cell (560) operably coupled to the motor (190) and the ultrasonic transducer (114).
[16]
16. Ultrasonic surgical instrument (100) according to claim 14, characterized by the fact that the motor (190) comprises a stepper motor with an encoder (194) operably coupled to it.

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同族专利:

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公开号 | 公开日

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CA2789428A1|2011-08-18|

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BR112012020296A2|2016-05-03|

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CN102843981A|2012-12-26|

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EP2533709A1|2012-12-19|

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JP2013519439A|2013-05-30|

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EP2533709B1|2015-03-25|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-07-30| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-03-31| B09A| Decision: intention to grant|

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2020-06-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/02/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US12/703,877|US8382782B2|2010-02-11|2010-02-11|Ultrasonic surgical instruments with partially rotating blade and fixed pad arrangement|

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US12/703,877|2010-02-11|

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PCT/US2011/024201|WO2011100332A1|2010-02-11|2011-02-09|Ultrasonic surgical instruments with partially rotating blade and fixed pad arrangement|

---