Ultrasonic surgical instrument

专利摘要:
sealing arrangements for surgical instruments equipped with an ultrasonic motor. in general, several modalities are directed to ultrasonic surgical instruments that can be used in aqueous environments. instruments may include cutting a limb that is supported in a hollow sheath. various sealing arrangements are described to establish a substantially fluid-tight seal between the cutting member and the sheath.112012020112
公开号:BR112012020115B1
申请号:R112012020115-8
申请日:2011-02-09
公开日:2020-06-02
发明作者:Galen C. Robertson；Galen C Robertson；Kevin L. Houser；Kevin L Houser；Mark A. Neurohr；Mark A Neurohr
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

BACKGROUND [001] 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.
[002] Over the years, a variety of different types of cutting devices and trimmers equipped with an ultrasonic motor to perform surgical procedures have been developed. Some of these devices employ a rotary cutting instrument and other devices employ a reciprocating cutting element. For example, trimmers are widely used in arthroscopic surgery. These devices generally consist of a power supply, a drill, and a disposable end effector. The end effector commonly has an inner tube and an outer tube. The inner tube rotates in relation to the outer tube and will cut fabric with its sharp edges. The inner tube can rotate continuously or oscillate. In addition, this device may employ a suction channel that moves through the interior of the inner tube. For example, US Patent No. 4,970,354 issued to McGurk-Burleson, et al., Discloses a surgical cutting instrument equipped with a non-ultrasonic motor that comprises a rotary cutter for cutting material with a shearing action. It employs an internal cutting element that is rotatable inside an external tube.
[003] US Patent No. 3,776,238 issued to Peyman et al. features an ophthalmic instrument in which the tissue is cut by a carving action activated by the sharp end of an inner tube in motion against the inner surface of the end of an outer tube. US Patent No. 5,226,910 issued to Kajiyama et al. apprehension
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2/87 sits another surgical cutting instrument that has an inner element that moves in relation to an outer element to cut the tissue that enters through an opening in the outer element.
[004] US Patent No. 4,922,902 issued to Wuchinich et al. presents a method and device for endoscopic tissue removal using an ultrasonic cleaner. The device uses an ultrasonic probe that disintegrates the malleable tissue and aspirates it through a narrow hole. US Patent No. 4,634,420 issued 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 vibrates at an ultrasonic frequency in the lateral direction. The ultrasonic movement of the needle fragments the tissue into fragments. The pieces of fabric can be removed from the treatment area by aspiration through a conduit in the needle. US Patent No.
3,805,787 granted to Banko presents yet another ultrasonic instrument that has a probe that is protected with a shield to narrow the beam of ultrasonic energy radiated from the tip of the probe. In one embodiment, the shield extends beyond the free end of the probe to prevent the probe from coming into contact with the tissue. US 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. US Patent No. 6,984,220 issued to Wuchinich and US Patent Publication No. 2005/0177184 granted to Easley features ultrasonic dissection systems that provide combined longitudinal and torsional movement through the use of longitudinal-torsional resonators. US Patent Publication No. US 2006/0030797 A1 granted 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 transducer
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3/87 to supply ultrasonic energy signals to the transducer.
[005] Although the use of instruments equipped with an ultrasonic motor provides several advantages over drills, saws and other mechanically equipped instruments, the temperature rise in the bone or adjacent tissue due to frictional heating at the bone / tissue interface can still be a significant problem . Arthroscopic surgical tools include drilling devices, reciprocating trimmers and radio frequency (RF). Mechanical devices such as perforators and dressers create minimal tissue damage, but sometimes leave behind lines of roughness, which are undesirable. RF devices can create smoother cut lines and also excise large volumes of soft tissue; However, they tend to create more tissue damage than mechanical means. Therefore, it would be necessary to create a device that provides improved cutting accuracy while forming smooth cutting surfaces without creating excessive tissue damage.
[006] Arthroscopic surgery involves performing surgery on the joint space. To perform the surgery, the joints are commonly filled with a pressurized saline solution for distention and visualization. The ultrasonic instruments that can be used in these surgeries must withstand fluid pressure without generating leakage. However, conventional ultrasonic instruments generally experience significant forces during use. Current seals in ultrasonic devices are generally not robust enough to withstand this environment without leakage.
[007] It would be desirable to obtain an ultrasonic surgical instrument that overcomes some of the deficiencies of current instruments. Ultrasonic surgical instruments overcome many of these deficiencies.
[008] It would also be desirable to provide sealing provisions
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4/87 more robust for ultrasonic surgical instruments used to cut and coagulate in the aqueous environment of arthroscopic surgery.
[009] The aforementioned discussion is only intended to illustrate some of the disadvantages present in the field of the various modalities of the invention at the moment, and should not be taken as a denial of the scope of the claims.
SUMMARY [0010] Regarding a general aspect, an ultrasonic surgical instrument is provided that includes a compartment that operationally supports an ultrasonic transducer set. A blade can be attached to the ultrasonic transducer assembly and the hollow sheath can be attached to the compartment and extend axially around a portion of the blade. The instrument may also include a seal assembly to establish a seal between a portion of the blade and the hollow sheath. In various embodiments, the seal assembly may comprise a first annular seal portion that is attached to the blade. Two axial seal portions can extend axially beyond the first annular seal portion in opposite directions from the first annular seal portion. The axial sealing portions can be oriented in flexible sealing contact with corresponding portions of an inner wall of the hollow sheath.
[0011] In connection with another general aspect, an ultrasonic surgical instrument is provided that includes a compartment that operationally supports an ultrasonic transducer set. A blade can be attached to the ultrasonic transducer assembly and have an annular seal on a portion of it. The instrument may also include a hollow sheath comprising a first sheath segment and a second sheath segment that is fixable to the first sheath segment to form a substantial lumen
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5/87 hollow for receiving the portion of the blade therein. The first sheath segment and the second sheath segment can be configured in relation to each other to form an annular groove in the hollow tube to receive the annular seal in the sealing wood when said first hem segment and the second hem segment they are fixed together and the portion of the blade is received in said hollow lumen.
[0012] In connection with yet another general aspect, an ultrasonic surgical instrument is provided that includes a compartment that supports an ultrasonic transducer set in it. A blade can be attached to the ultrasonic transducer assembly and the hollow sheath can be attached to the compartment and extend axially around a portion of the blade. The instrument may also include a seal assembly to establish a seal between a portion of the blade and the hollow sheath. In various embodiments, the seal assembly may comprise an annular seal specifically attached to the blade and a first annular ring member projecting from an inner wall of the hollow sheath adjacent to the proximal end of the annular seal.
[0013] In connection with another general aspect, an ultrasonic surgical instrument is provided that can include a compartment that supports an ultrasonic transducer set in it. A blade can be attached to the ultrasonic transducer assembly. A hollow sheath can be attached to the compartment and extend axially around a portion of the blade. The instrument may also include an annular seal specifically attached to the blade portion. The annular seal may have an outer diameter that is greater than an inner diameter of the hollow sheath and additionally has a proximal side and a distal side so that when the portion of said blade is installed in the hollow sheath, a portion of the proximal side is in hitch
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6/87 seal with an internal hollow sheath wall.
[0014] In connection with yet another general aspect, a method is presented for creating a substantially fluid-tight seal between a blade of an ultrasonic surgical instrument and a hollow sheath of the instrument. Various forms of the method may include installing a seal on the cutting member, the seal having an annular groove in it and forming a portion of the hollow sheath into said annular groove in the seal.
FIGURES [0015] The innovative characteristics of the various non-limiting modalities are presented with particularity in the attached claims. The various non-limiting modalities, however, with regard to both the organization and the methods of operation, together with their additional objectives and advantages, can be better understood by reference to the description presented below, taken in conjunction with the drawings in attached, as explained.
[0016] Figure 1 is a schematic view of a non-limiting modality of a surgical control system;
[0017] Figure 1A is a perspective view of a non-limiting modality of the control system enclosure;
[0018] Figure 1B is a perspective view of another non-limiting embodiment of a control system enclosure arrangement;
[0019] Figure 2 is a cross-sectional view of a non-limiting drill bit;
[0020] Figure 3 is a partial cross-sectional view of an ultrasonic surgical drill that can be used with several non-limiting modalities;
[0021] Figure 4 is a cross-sectional view of a portion
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7/87 of a non-limiting modality of tapered part of the instrument; [0022] Figure 5 is a partial exploded view of the set of a non-limiting modality of tapered part of the instrument;
[0023] Figure 6 is a partial cross-sectional view of a non-limiting modality of a tapered piece of the surgical instrument;
[0024] Figure 7 is a perspective view of the non-limiting modality of the surgical instrument drill in Figure 6;
[0025] Figure 8 is a partial cross-sectional view of another non-limiting modality of surgical instrument drill;
[0026] Figure 9 is a partial cross-sectional view of another non-limiting surgical instrument drill;
[0027] Figure 10 is a perspective view of the surgical instrument drill modality shown in figure 9;
[0028] Figure 11 is a partial exploded view of a non-limiting coupling assembly mode for coupling a motor to the transducer assembly;
[0029] Figure 12 is a side view of a thin plate element and a driving shaft arrangement of a non-limiting coupling assembly;
[0030] Figure 13 is an end view of the non-limiting thin plate element embodiment of Figure 12;
[0031] Figure 14 is a side view of a non-limiting thin plate element and drive shaft arrangement and another non-limiting coupling assembly mode;
[0032] Figure 15 is an end view of the non-limiting thin plate element embodiment of Figure 14;
[0033] Figure 16 is a partial cross-sectional view of another non-limiting modality of surgical instrument drill;
[0034] Figure 17 is a partial perspective view of a motion 870190093144, of 09/18/2019, p. 11/97
8/87 non-limiting quality of blade and external sheath;
[0035] Figure 18 is a partial perspective view of the non-limiting blade modality shown in Figure 17;
[0036] Figure 19 is a partial bottom perspective view of the blade of figures 17 and 18;
[0037] Figure 20 is a side view of a portion of another non-limiting blade embodiment;
[0038] Figure 21 is a side view of a portion of another non-limiting blade embodiment;
[0039] Figure 22 is a partial perspective view of a distal end of another non-limiting blade and outer sheath arrangement;
[0040] Figure 23 is a partial perspective view of a distal end of another non-limiting blade and outer sheath arrangement;
[0041] Figure 23A is a side view of a portion of the external sheath non-limiting embodiment shown in Figure 23;
[0042] Figure 24 is a side view of a portion of another non-limiting blade embodiment;
[0043] Figure 25 is a side view of a portion of another non-limiting blade embodiment;
[0044] Figure 26 is a partial perspective view of the blade non-limiting modality of figure 25 within a distal end of another non-limiting outer sheath modality;
[0045] Figure 27 is a side view of a portion of another non-limiting embodiment of the blade;
[0046] Figure 28 is a partial perspective view of the blade non-limiting modality of figure 27 within a distal end of another non-limiting outer sheath modality;
[0047] Figure 29 is an end view of a cross section
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9/87 partial salt of the non-limiting blade and outer sheath modalities of figure 28;
[0048] Figure 30 is a side view of a portion of another non-limiting blade embodiment;
[0049] Figure 31 is a partial perspective view of the blade non-limiting modality of figure 30 within a distal end of another non-limiting outer sheath modality;
[0050] Figure 32A illustrates a first rotational position of the blade non-limiting mode of figures 30 and 31 within the outer sheath mode of figure 31;
[0051] Figure 32B illustrates a second rotational position of the non-limiting blade mode of figures 30 and 31 within the external sheath mode of figure 31;
[0052] Figure 32C illustrates a third rotational position of the blade mode of figures 30 and 31 within the external sheath mode of figure 31;
[0053] Figure 32D illustrates a fourth rotational position of the blade mode of figures 30 and 31 within the external sheath mode of figure 31;
[0054] Figure 33 is a perspective view of a portion of another non-limiting blade embodiment;
[0055] Figure 34 is a partial perspective view of the blade modality of figure 33 within a non-limiting outer sheath modality;
[0056] Figure 34A is a partial perspective view of another non-limiting modality of blade and outer sheath;
[0057] Figure 35 is a perspective view of a portion of another non-limiting blade embodiment;
[0058] Figure 36 is a partial cross-sectional view of another non-limiting modality of ultrasonic surgical instrument;
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10/87 [0059] Figure 36A is a partial cross-sectional view of a portion of an instrument tapered piece of another non-limiting surgical instrument embodiment of the present invention;
[0060] Figure 37 is a partial perspective view of a distal end of the non-limiting blade and outer sheath arrangement of Figure 36;
[0061] Figure 38 is a cross-sectional view of distal portions of the blade and outer sheath modalities represented in the cutting fabric of Figure 37;
[0062] Figure 39 illustrates the use of the surgical instrument modality in figure 36 in conjunction with performing a discectomy;
[0063] Figure 40 shows the additional use of the surgical instrument modality of figure 36 in conjunction with performing a discectomy;
[0064] Figure 41 is a side elevation view of the surgical instrument modality in Figure 36 with a retractable safety sheath mounted on it;
[0065] Figure 42 is a partial perspective view of the modality of retractable safety sheath illustrated in figure 41 beginning to be retracted from a closed position;
[0066] Figure 43 is another partial perspective view of the retractable safety sheath modality illustrated in figures 41 and 42 with the safety sheath retracted in an open position;
[0067] Figure 44 is another partial perspective view of the retractable safety sheath modality illustrated in figures 41 to 43 with the retractable safety sheath in an open position;
[0068] Figure 45 is a side elevation view of modalities of a portion of the outer sheath and safety sheath illustrated in figures 41 to 44 with the safety sheath shown in transPetition section 870190093144, of 09/18/2019, pg. 14/97
11/87 versal in an open position;
[0069] Figure 46 is a perspective view of a portion of another non-limiting blade embodiment;
[0070] Figure 47 is a side view of a portion of another hollow outer sheath arrangement and blade of another non-limiting embodiment;
[0071] Figure 48 is a cross-sectional view of another non-limiting blade modality;
[0072] Figure 49 is a cross-sectional view of another non-limiting blade modality;
[0073] Figure 50 is a cross-sectional view of another non-limiting blade modality;
[0074] Figure 51 is a cross-sectional view of another non-limiting blade modality;
[0075] Figure 52 is a partial cross-sectional view of another non-limiting modality of blade and outer sheath;
[0076] Figure 53 is another partial cross-sectional view of the blade and external sheath modality of Figure 52 interacting with body tissue;
[0077] Figure 54 is a cross-sectional view of the blade and outer sheath arrangement shown in Figures 52 and 53 interacting with body tissue;
[0078] Figure 55 is a partial perspective view of another non-limiting external sheath modality;
[0079] Figure 56 is a partial perspective view of another non-limiting external sheath modality;
[0080] Figure 57 is a partial cross-sectional view of the external sheath modality of figure 56 supporting another non-limiting blade modality;
[0081] Figure 58 is a partial perspective view of another moPetition 870190093144, of 09/18/2019, p. 15/97
12/87 non-limiting quality of the external sheath;
[0082] Figure 59 is a cross-sectional view of another non-limiting modification of the outer sheath and blade;
[0083] Figure 60 illustrates an angle between the cutting edges formed in a non-limiting external sheath modality;
[0084] Figure 61 is a perspective view of another non-limiting external sheath modality;
[0085] Figure 62 is a cross-sectional view of the blade and outer sheath modality of figure 61;
[0086] Figure 63 is a perspective view of another non-limiting external sheath modality;
[0087] Figure 64 is a cross-sectional view of the blade and outer sheath modality of figure 63;
[0088] Figure 65 is a perspective view of another non-limiting external sheath modality;
[0089] Figure 66 is a cross-sectional view of the blade and outer sheath modality of figure 65;
[0090] Figure 67 is an end view in cross section of another non-limiting arrangement of blade and outer sheath;
[0091] Figure 68 is a partial lateral cross-sectional view of the blade and outer sheath arrangement of figure 67;
[0092] Figure 69 is a partial side view of a distal end portion of the blade and outer sheath arrangement of figures 67 and 68;
[0093] Figure 70 is a side view of a non-limiting modality of drill compartment fixed to the blade and outer sheath arrangement of figures 67 to 69;
[0094] Figure 71 shows a method of using the surgical instrument modality in figure 70;
[0095] Figure 72 shows another method of using the modality of
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13/87 surgical instrument of figure 70;
[0096] Figure 73 shows another method of using the surgical instrument modality in figure 70;
[0097] Figure 74 is a partial lateral cross-sectional view of another non-limiting surgical instrument;
[0098] Figure 75 is a perspective view of a portion of the blade and outer sheath arrangement employed with the surgical instrument modality shown in Figure 74;
[0099] Figure 76 is an end view of the blade and outer sheath arrangement of Figure 75;
[00100] Figure 77 is an end view in cross section of the blade and sheath arrangement of figures 75 and 76;
[00101] Figure 78 is a side view of another non-limiting modality of an ultrasonic surgical instrument;
[00102] Figure 79 is a partial cross-sectional view of a non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00103] Figure 80 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00104] Figure 81 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00105] Figure 82 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
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14/87 [00106] Figure 83 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality, before being wrinkled in the correct position;
[00107] Figure 84 is a partial cross-sectional view of the sealing mode of figure 83 after being furrowed in the correct position;
[00108] Figure 85 is a partial cross-sectional view of another non-limiting sealing modality between a two-piece hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00109] Figure 86 is an exploded partial cross-sectional view of another non-limiting sealing modality between another two-piece hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00110] Figure 87 is a partial perspective view of a portion of the hollow sheath modality in figure 86;
[00111] Figure 88 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00112] Figure 89 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00113] Figure 90 is a partial cross-sectional view of another non-limiting sealing modality between a hollow sheath and a waveguide portion of an ultrasonic implement modality;
[00114] Figure 91A is an illustration representing a position
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15/87 initial of two cutting edge modalities preparing to cut rigid fabric;
[00115] Figure 91B is a second position of the cutting edges and fabric of Figure 91A;
[00116] Figure 91C is a third position of the cutting edges and fabric of figures 91A-B;
[00117] Figure 91D is a fourth position of the cutting edges and fabric of figures 91A-C;
[00118] Figure 92 is a perspective view of a portion of a non-limiting mode of cutting blade and cushion;
[00119] Figure 92A is a partial cross-sectional view of a portion of the blade and cushion modality of figure 92 installed inside an internal sheath of a non-limiting surgical instrument modality;
[00120] Figure 93 is a cross-sectional view of a portion of the blade and cushion modality of Figure 92 in a non-limiting surgical instrument modality;
[00121] Figure 94 is a perspective view of a portion of another non-limiting modality of cutting blade and cushion;
[00122] Figure 95 is a cross-sectional view of a portion of the blade and cushion modality of Figure 94 in a non-limiting surgical instrument modality;
[00123] Figure 96 is a partial perspective view of a portion of a non-limiting embodiment of the blade and outer sheath;
[00124] Figure 97 is a cross-sectional view of the blade and outer sheath arrangement of Figure 96;
[00125] Figure 98 is a partial rear perspective view of a portion of the blade and outer sheath arrangement of Figure 97;
[00126] Figure 99 is a partial rear perspective view of a portion of another non-limiting modality of blade and sheath
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External 16/87;
[00127] Figure 100 is a partial perspective view of another non-limiting external sheath modality;
[00128] Figure 101 is an end view in cross section of the outer sheath modality of figure 100 supporting a cutting blade modality therein; and [00129] Figure 102 is a perspective view of a portion of another non-limiting blade embodiment.
DESCRIPTION [00130] The owner of this application also has 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:
[00131] US patent application No. ___________ serial, entitled
ULTRASONICALLY POWERED SURGICAL INSTRUMENTS WITH ROTATING CUTTING IMPLEMENT, Attorney's summary n ° END6688USNP / 090341;
[00132] US Patent Application No. __________ Series, entitled
METHODS OF USING ULTRASONICALLY POWERED SURGICAL INSTRUMENTS WITH ROTATABLE CUTTING IMPLEMENTS, Lawyer Summary No. END6689USNP / 090342;
[00133] US Patent Application No. ___________ from Seri and, entitled
ULTRASONIC SURGICAL INSTRUMENTS WITH ROTATABLE BLADE AND HOLLOW SHEATH ARRANGEMENTS, Precedent No. n ° END6691USNP / 090344;
[00134] US Patent Application No. ________________ Serial, entitled ROTATABLE CUTTING IMPLEMENT ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS, Lawyer Summary END6692USNP / 090345;
[00135] US Patent Application No. __________________ Series, inti
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17/87 titled ULTRASONIC SURGICAL INSTRUMENTS WITH PARTIALLY ROTATING BLADE AND FIXED PAD ARRANGEMENT, Lawyer Summary No. END6693USNP / 090346;
[00136] US Patent Application No. ___________________ Serial, entitled DUAL PURPOSE SURGICAL INSTRUMENT FOR CUTTING AND COAGULATING TISSUE, Attorney Summary No. END6694USNP / 090347;
[00137] US Patent Application No. _____________________ Serial, entitled OUTER SHEATH AND BLADE ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS, Attorney Summary No. END6695USNP / 090348;
[00138] US Patent Application No. ___________________ Serial, entitled ULTRASONIC SURGICAL INSTRUMENTS WITH MOVING CUTTING IMPLEMENT, Lawyer Summary No. END6687USNP / 090349; and [00139] US Patent Application No. ________________ Serial, entitled ULTRASONIC SURGICAL INSTRUMENT WITH COMB-LIKE TISSUE TRIMMING DEVICE, Attorney Summary No. END6686USNP / 090367.
[00140] Several modalities are directed to devices, systems, and methods for tissue treatment. Numerous specific details are demonstrated to provide a complete understanding of the general structure, function, manufacture, and use of the modalities, as described in the specification and illustrated in the attached drawings. It will be understood by those skilled in the art, however, that the modalities can be practiced without these specific details. In other instances, operations, components, and well-known elements have been described in detail so as not to obscure the modalities described in the specification. Those skilled in the art will understand that the modalities described and illustrated in the presence
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18/87 and the invention are non-limiting examples, and therefore it can be understood that the specific structural and functional details presented in the present invention may be representative and do not necessarily limit the scope of the modalities, the scope of which is defined solely by the claim attached.
[00141] The reference from the beginning to the end of the specification of several modalities, some modalities, a modality, or the modality, or similar, means that an attribute, structure, or characteristics described together with the modality is included in at least one modality. Therefore, the appearance of phrases in various modalities, in some modalities, in one modality, or in the modality, or similar, in places from beginning to end of the specification are not necessarily all referring to the same modality. In addition, the particular attributes, structures, or characteristics can be combined in any suitable way in one or more modalities. Therefore, the particular attributes, structures, or features illustrated or described in conjunction with a modality can be combined, in whole or in part, with the structures of the attributes, or features of one or more other modalities without limitation.
[00142] Several modalities are directed to enhanced ultrasonic surgical systems configured to result in tissue dissection, cutting and / or coagulation during surgical procedures as well as cutting implements and sealing attributes thus employed. In one embodiment, an ultrasonic surgical instrument device is configured for use in open surgical procedures, but has applications in other types of surgery, such as laparoscopic, endoscopic, and robotically assisted procedures. Versatile use is facilitated by the selective use of ultrasonic energy and the selective rotation of the cutting / coagulation implement.
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19/87 [00143] It should be recognized that the terms proximal and distal are used in the present invention with reference to a clinician holding a drill set. Thus, an end actuator is distal to the proximal drill set. It should be further recognized that, for the sake of convenience and clarity, spatial terms such as top and bottom can also be used in the present invention in relation to the clinician holding the cable assembly. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
Surgical Systems [00144] FIG. 1 schematically illustrates a non-limiting modality of a surgical system 10. Surgical system 10 can include an ultrasonic generator 12 and a surgical instrument set 100 that can include a one-piece ultrasonic instrument
110. As will be discussed in further detail below, the ultrasonic generator 12 can be connected by a cable 14 to an ultrasonic transducer assembly 114 of the one-piece ultrasonic instrument 110 by a slip ring assembly 150 located in a portion of the housing 102 of the surgical instrument set 100. In one embodiment, system 10 additionally includes a motor control system 20 that includes a power supply 22 that is coupled to a control module 24 by a cable 23 to supply, for example, 24VDC to that. The engine control module 24 may comprise a control module produced by the National Instruments of Austin, Texas, USA, 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
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20/87 tion 22 can be additionally coupled to a motor driver 26 by cable 25 to supply 24VDC to that as well. The motor starter 26 may comprise a National Instruments produced motor starter. The control module 24 can also be coupled to the motor driver 26 by cable 27 to supply power to this. A conventional foot pedal 30 or other control key arrangement can be attached to the control module 24 by a cable 31. As will be discussed further in detail below, the ultrasonic surgical instrument 100 may include an engine 190 that has an associated encoder 194 thereby. The engine 190 may comprise an engine produced by National Instruments under Model No. CTP12ELF10MAA00. Encoder 194 may comprise an encoder manufactured by U.S. Digital of Vancouver, Washington, USA, 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 the cable 33. The surgical system 10 can also include a computer 40 that can communicate via an Ethernet cable 42 with the engine control module 24.
[00145] As can also be seen in figure 1, in several modalities, the engine control system 20 is housed in a housing 21. To facilitate a comfortable portability of the system, several components can be attached to the engine control system 20 removable cable connectors. For example, the foot pedal wrench 30 can be attached to a removable cable connector 37 by cable 35 to facilitate quick attachment of the foot pedal to the control system 20. An alternating current supply can be supplied to the power supply 22 by a conventional cable / plug 50 that is attached to a removable cable connector 54 that is attached to cable 52. The component
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21/87 operator 40 may have a cable 60 that is attached to the removable cable connector 62 that is attached to the cable 42. Encoder 194 may have an encoder cable 70 that is attached to a removable connector 72. Similarly, the 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 cable 32 and connector 72 can be attached to motor driver 26 by cable 33. Therefore, the Cable connector 72 serves to couple the encoder 194 to the control module 24 and the motor 190 to the motor starter 26. The cables 70 and 74 can be housed in a common sheath 76.
[00146] In an alternative mode, the ultrasonic generator 12 and the control system 20 can be housed in the same housing 105. See figure 1A. In yet another embodiment, the ultrasonic generator 12 can communicate electrically with the engine control system 20 via a jumping cable 107. This arrangement can share a data link as well as a common means of supplying energy (cord 50). See figure 1B.
[00147] In several modalities, 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 each can be integrated with the ultrasonic generator 12 or can be supplied as a separate circuit module electrically coupled to the ultrasonic generator 12 (shown in dashed line to 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 understand any suitable device that generates signals suitable for programming the operation of the generator 12 in a known manner. Still
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22/87 with reference to figure 1, cable 14 may comprise multiple electrical conductors for the application of electrical energy to positive (+) and negative (-) electrodes of an ultrasonic transducer assembly 114, as will be further discussed in detail below.
[00148] Various forms of ultrasonic generators, ultrasonic generator modules, and signal generator modules are known. For example, these devices are featured in US Patent Application Serial No. 12 / 503,770, commonly owned, entitled Rotating Transducer Mount For Ultrasonic Surgical Instruments, filed on July 15, 2007, hereby incorporated by reference, in its wholeness. Other devices are presented in one or more of the following US patents, all of which are incorporated herein 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. 6,633.23 4 (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 (Apparatu s and Method for Altering Generator Functions in an Ultrasonic Surgical System); US patent No. 6,977,495 (Detection Circuitry for Surgical l Handpiece System); US patent No. 7,077,853 (Method for Calculation ng 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).
Surgical Instruments [00149] As can be seen in Figure 2, an ultrasonic surgical instrument drill 100 can comprise a housing 102 housing the motor 190, encoder 194, the slip ring set 150 and the one-piece ultrasonic surgical instrument 110. Compartment 102 can be supplied in two or more parts that are fixed together by fasteners such as screws, pressure devices, etc. and it can be manufactured from, for example, polycarbonate material. The motor 190 may comprise, for example, a stepper motor produced by National Instruments under Model No. CTP12ELF10MAA00. However, other motors can be used to perform, for example, gross rotational movement of a one-piece ultrasonic surgical instrument 110 in relation to compartment 102 in the order of 1-6000 rpm. The encoder 194 converts the mechanical rotation of the motor rod 192 into electrical pulses that provide speed and other motor control information to the control module 24.
[00150] The one-piece ultrasonic surgical instrument 110 may comprise a surgical instrument that is produced and sold by Ethicon Endo-Surgery under Model No. HP054. However, other ultrasonic instruments can be used successfully. It will be understood that the term single piece for use in the present invention means that the ultrasonic surgical instrument can be used effectively as an ultrasonic surgical instrument alone, separately from use with surgical instrument 100. As illustrated in more 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
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24/87 ca in mechanical energy that results in vibrational movement 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 of 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 cylinder 118, which in turn is mounted to the compartment at another zero point of movement 122. A horn 124 can also be fixed at 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 motionless node when the ultrasonic transducer assembly 114 is directed at a maximum current at the transducer resonant frequency. However, the current that provides maximum movement will vary with each instrument and is a value stored in the instrument's non-volatile memory so that the system can use it.
[00151] The parts of the ultrasonic instrument 110 can be designed so that that combination will oscillate on the same resonant frequency. In particular, the elements can be tuned so that the resulting length of each of these elements is half the wavelength or a multiple of it. The longitudinal movement back and forth is amplified as the diameter closest to the blade 200 of the acoustic installation horn 124 decreases. Therefore, the horn 124 as well as the blade / coupler can be shaped and sized to amplify the movement of the blade and provide ultrasonic vibration in
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25/87 resonance with the rest of the acoustic system, which produces the maximum forward and backward movement of the horn end of the acoustic installation 124 next to blade 200. A 20 to 25 micron movement in the ultrasonic transducer assembly 114 can be amplified by horn 124 in a blade movement of about 40 to 100 microns.
[00152] When power is applied to the ultrasonic instrument 110 by operating the foot 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 the user. When a relatively high cutting energy is applied, the blade 200 can be designed to move longitudinally in the range of about 40 to 100 microns at the ultrasonic vibratory rate. This ultrasonic vibration of the blade 200 will generate heat as the blade contacts the tissue, i.e., 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 those smaller than a millimeter in diameter. The cutting efficiency of blade 200, as well as the degree of hemostasis, will vary with the level of drive 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.
[00153] As can be seen in figure 2, the ultrasonic instrument 110 is supported inside compartment 102 by a rear drive adapter 130 and a distal drill adapter 134. The rear drive adapter 130 is assumed
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26/87 rotated inside the compartment 102 by a proximal bearing 132 and is non-rotatable coupled to the output shaft 192 of the motor 190. See figure 2. The rear drive adapter 130 can be pressed against the compartment 112 of the ultrasonic instrument 110 or, for example, be fixed to the compartment 112 by fastening screws or adhesive. The distal handpiece adapter 134 can be pressed against a distal end 113 of the drill housing 112 or otherwise be secured to it by clamping screws or adhesive. The distal drill adapter 134 is pivotally supported in housing 102 by a distal bearing 136 which is mounted within housing 102.
[00154] When energy is applied to the mechanism 190, the mechanism 190 applies a gross rotational movement to the drill 110 to cause the ultrasonic surgical instrument 110 and the blade 200 to rotate around the central axis A-A. For use in the present invention, the term gross rotational motion must be distinguished from the torsional ultrasonic motion ”that can be obtained when using an inhomogeneously formed ultrasonic blade. The term gross rotational movement, instead, encompasses rotational movement that is not generated only by the operation of the ultrasonic transducer assembly 114.
[00155] To supply power to the ultrasonic instrument 110 from the ultrasonic generator 12, a slip ring assembly 150 can be employed. As can be seen in figure 2, the conductors 151 and 152 are coupled to the ultrasonic transducer assembly 114 and extends through a hollow rod portion 132 of the back piece drive adapter 130. The hollow rod portion 132 is fixed to the drive rod 192 of the motor 190 and is free to rotate within the slip ring assembly 150. A first contact
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27/87 internal 154 is fixed to the hollow shaft portion 132 for rotational travel around the axis A-A. The first internal contact 154 is positioned for rotational contact with a fixed external contact 156 within the slip ring assembly 150. The contacts 154 and 156 can be supplied in the 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 encoder 194 and form the cable of the encoder 70. Rotation of the motor stem 192 results in the rotation of the rear drive adapter 130 and the ultrasonic instrument 110 attached thereto around the AA axis. The rotation of the driving 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 due to the contact or electrical communication between the internal contact 154 and the external contact 156. Those signals are transmitted to the ultrasonic transducer assembly 114 by conductors 151 and 152. In alternative embodiments, the slip ring assembly may employ the use of conventional pogo pins that engage in concentric ring contact. Other slip ring arrangements can also be employed.
[00156] Various embodiments also include a protection piece 160 that can be removably attached to the distal end 103 of compartment 102 by locks 161. See figure 5. One or more wedge elements 162 can be positioned between the distal end 103 and the tapered part 160 to facilitate coaxial attachment between compartment 102 and the tapered part 160. The tapered part 160 can be produced from, for example, stainless steel or polycarbonate. In various embodiments, the distal end 202 of the blade 200 extends through a second hollow coupler 210 that
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28/87 is seated within the inner sheath seal 212. The inner sheath seal 212 may comprise, for example, polytetrafluoroethylene (PTFE ”), and serves to establish a substantially fluid-tight and / or air-tight seal between the second coupler 210 and the tapered part 160. Also in the embodiment of figure 4, an inner sheath 220 may be attached to the hollow coupling segment 210 by, for example, welding or the hollow coupling segment 210 may comprise an integral portion of the inner sheath 220. In one embodiment, the blade / torque pin element 216 can extend transversely through the blade element 200 and the hollow coupling segment 210 to facilitate movement of the inner sheath 220 with the blade element 200. One or more cushions vented silicone tubes 214 can be seated at the end of the shaft 200 to acoustically isolate the blade 200 from the inner sheath 220. The blade element 200 may have a proximal end 201 that is threaded internally and adapted to separably engage the threaded portion of coupler 126. To facilitate the tightening of blade 200 to coupler 126, a tightening hole 108 (figure 2) can be provided through housing 102 to allow a tool (for example , Allen wrench) is inserted through it into a hole 131 in the drive adapter of the back piece 130 to prevent rotation of the ultrasonic surgical instrument 110 and the coupler 126 attached to it. Once the blade 200 has been bolted to coupler 126, the user can remove the Allen wrench or other tools from holes 108 and 131 and insert into a threaded plug (not shown) in hole 108 to prevent fluids / debris from entering in compartment 102 through it.
[00157] Also in various modalities, an outer sheath 230 can be aligned coaxially with the inner sheath 220 and blade element 200 and be attached to a distal end 163 of the piece
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29/87 tapered 160 by, for example, welding, brass welding, overmoulding, or pressure adjustment. As can be seen in figure 4, a suction port 240 can be attached to the tapered part 160 to connect with the hollow outer sheath 230. A flexible tube 242 can be attached to the suction port 240 and communicates with a receptacle collection tube 243 which is coupled to a vacuum source, usually shown as 244. Therefore, the outer sheath 230 forms a suction path that extends around the inner sheath 220 that begins at the distal end of the outer sheath 230 and exits through the suction port 240. Those skilled in the art will recognize that alternative suction paths are also possible. In addition, in alternative embodiments, the inner sheath 220 is omitted.
[00158] Various modalities of the surgical system 10 provide the ability to selectively apply an ultrasonic axial movement to the blade 200 as well as gross rotational movement to the blade 200. If desired, the physician can simply activate the ultrasonic transducer assembly 114 without activating the motor 190 In such cases, instrument 100 can be used in ultrasonic mode simply as an ultrasonic instrument. The frequency ranges for longitudinal ultrasonic movement can be in the order of, for example, 30 to 80 kHz. Similarly, the physician may wish to activate the motor 190 without activating the ultrasonic transducer assembly 114. Therefore, the gross rotational movement will be applied to the blade 200 in the rotation mode, without the application of the longitudinal ultrasonic movement to it. The gross rotational speeds can be, for example, in the order of 16000 rpm. In other applications, the physician may wish to use the instrument 100 in both ultrasonic and rotational modes with the blade 200 experiencing a longitudinal ultrasonic movement from the transducer assembly 114 and gross rotational movement from the motor. The oscillatory movement, for example, 2 to 10 revolutions per
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30/87 cycle (720 to 3600 degrees) or continuous unidirectional rotation can be achieved. Those skilled in the art will readily recognize that various modalities of the surgical system 10 can be effectively employed in conjunction with arthroscopic applications as well as other surgical applications.
[00159] At least one non-limiting mode can additionally include a control arrangement 170 in compartment 102. See figure 2. Control arrangement 170 can communicate with control module 24 via a 17-conductor cable. Control 170 can include a first button 172 to activate / deactivate a dual mode that includes ultrasonic mode ”and rotational mode. In these arrangements, control module 24 can be pre-programmed to provide a pre-set amount of gross rotational movement to blade 200. Control arrangement 170 may additionally include a second button 174 to activate / deactivate rotational mode without activating the ultrasonic mode to cut without hemostasis. The control arrangement 170 may also include a third button 176 to activate / deactivate a coagulation mode with the motor 190 driving in a pre-established rotational orientation and then parking or deactivating, thus exposing the ultrasonic blade surface at the distal end of the outer sheath 240 as will be further discussed in detail below. Also in this module, the ultrasonic transducer set 114 can be equipped with a motor to provide spot coagulation or in an alternative modality, the doctor can simply activate a spot coagulation button 77 that activates the ultrasonic transducer set 114 for a period of pre-set time of, for example, five seconds. The control arrangement can additionally include a button 178 to switch between the ultrasonic and rotational modes. According to several non-limiting modalities,
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31/87 any combinations of the aforementioned functions / modes can be combined and controlled by one or more buttons without deviating from the character and scope of the various non-limiting modalities presented in the present invention as well as their equivalent structures. [00160] Those skilled in the art will understand that the housing element 102 and the mounting adapters 130 and 134 can be configured to functionally support several different types and formats of ultrasonic drills in that which can be used independently of the surgical instrument 100. Therefore , the control system 20 and instrument 100 can be supplied in kit form without the ultrasonic drill 110 to allow the buyer to install his existing ultrasonic drill there without deviating from the character and scope of the various non-limiting modalities presented in the present invention as well as their respective equivalent structures.
[00161] Figures 6 and 7 illustrate another surgical instrument 300 with the same numbers previously used to describe the various modalities discussed above being used to designate equal components. In these embodiments, the surgical instrument 300 includes a compartment 302 that houses a transducer assembly 314 that is attached to an ultrasonic horn 324. The ultrasonic horn 324 can be coupled to the proximal end 201 of the blade 200 in the manner described above. The ultrasonic horn 324 can be swiveled inside the compartment 302 by a distal bearing 336. A tapered part 160 can be fixed to the compartment 302 by locks 161 in the manner described above.
[00162] In this embodiment, the ultrasonic transducer set 314 has magnets 316 built-in or otherwise attached to it to form an integral motor rotor, generally designated as 320. A motor stator ring 330 is mounted inside compartment 302
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32/87 as shown. Conductors 332 and 334 are attached to the motor stator ring 330 and pass through the common sheath 76 to be attached to the motor cable 33 in the control system 20 as described above. A hollow rod 340 extends through the motor rotor 320 to form a passage for conductors 151 and 152. Conductors 151 and 152 are coupled to the ultrasonic transducer assembly 314 and an internal contact 154. The internal contact 154 is attached to a hollow rod portion 340 that pivots extending in a slide ring assembly 150 that is supported within housing 302. The hollow stem 340 is pivotally supported within housing 302 by a proximal bearing 342. The ring assembly Sliding type 150 is fixed (i.e., non-rotating) within compartment 302 and includes a fixed external contact 156 that is coupled to conductors 157 and 158 that form a generator cable 14 as described above. When power is supplied to the motor stator 330, rotor 320 and integral ultrasonic transducer 314 are rotated about axis A-A. The ultrasonic signals from the ultrasonic generator 12 are transferred to the internal contact 154 through the rotary contact or electrical communication between the internal contact 154 and the external contact 156. These signals are transmitted to the ultrasonic transducer set 314 by conductors 151 and 152. The surgical instrument 300 may include a control arrangement of the type described above and used in the various modes described above. A suction can be applied between the blade 200 and the outer sheath 230 through port 240. A collection receptacle 243 and a 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 blade to the fabric as will be discussed further below.
[00163] Figure 8 illustrates another 400 surgical instrument,
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33/87 Similar numbers previously used to describe the various modalities discussed above are used to designate similar components. In these embodiments, the surgical instrument 400 includes a compartment 302 that houses an ultrasonic transducer set 314 that is attached to an ultrasonic horn 324. The ultrasonic horn 324 can be coupled to the proximal end 201 of the blade 200 in the manner described above. The ultrasonic horn 324 can be swiveled within the compartment 302 by a distal bearing 336. A tapered part 160 can be attached to the compartment 302 in the manner described above.
[00164] In this embodiment a brushed motor 410 is integrally attached to the ultrasonic transducer set 314. For use in the present invention integrally attached means directly attached to, or otherwise formed with, the ultrasonic transducer set 314 to move with it. The term integrally fixed as used with reference to the attachment of the brushed motor 410 to the ultrasonic transducer set 314 does not cover those configurations, the ultrasonic transducer set being fixed to the motor by means of an actuated rod arrangement. Also in this mode, magnets 426 are provided in a ring of stator 420 that is fixed inside compartment 302. Conductors 432 and 434 extend through a hollow rod 340 which is fixed to the brushed motor 410. The hollow rod 340 is supported in a rotary mode inside housing 302 by proximal bearing 342. Motor conductor 432 is attached to a first internal motor contact 436 and motor conductor 434 is attached to a second internal motor contact 438. The first and second contact contacts internal motor 436 and 438 are supported on the hollow rod portion 340 that extends into a slip ring assembly, generally referred to as 450. The slip ring assembly 450 is fixed (i.e., non-rotating) within the housing
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302 and includes a first external motor contact 440 which is coupled to conductor 441 and a second external motor contact 442 which is coupled to conductor 443. Conductors 441 and 443 form the motor cable 74 as described above. When the doctor wishes to apply a gross rotational movement to the ultrasonic transducer set 314 and finally to the blade 200, the doctor causes energy to be supplied to the brushed motor 410 from motor driver 26. [00165] Also in this mode, the conductors 151 and 152 are attached to the ultrasonic transducer assembly 314 and extends through the hollow stem 340 to be coupled to the internal transducer contact 154 which is attached to the hollow stem 340. The slip ring assembly 450 includes a fixed external transducer contact 156 which is coupled to conductors 157 and 158 that form the generator cable 14 as described above. When power is supplied to brushed motor 410, motor 410, ultrasonic transducer assembly 314, and motor stem 340 are rotated about axis A-A. The ultrasonic signals from the ultrasonic generator 12 are transferred to the internal contact 154 via the rotational sliding contact or electrical communication between the internal contact 154 and the external contact 156. These signals are transmitted to the ultrasonic transducer set 314 by conductors 151 and 152. Surgical instrument 400 may include a control arrangement of the type described above and be used in the various modes described above. It will be understood that the instrument 400 can be used in rotation mode, ultrasonic mode, rotation and ultrasonic mode (dual mode), or coagulation mode as described above. A suction can be applied between the blade 200 and the outer sheath 230 through port 240. A collection receptacle 243 and a 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 laminaPetição 870190093144, of 18/09/2019, p. 38/97
35/87 to the fabric as will be further discussed below.
[00166] Figures 9 to 13 illustrate another surgical instrument 500, similar numbers used previously to describe the various modalities discussed above are used to designate similar components. In these embodiments, the surgical instrument 500 includes a compartment 302 that houses a transducer assembly 530 that is attached to an ultrasonic horn 324. The ultrasonic horn 324 can be coupled to the proximal end 201 of the blade 200 in the manner described above. The ultrasonic horn 324 can be swiveled within the compartment 302 by a distal bearing 336. A tapered part 160 can be attached to the compartment 302 in the manner described above.
[00167] This embodiment includes a motor 510 which can comprise a stepper motor of the type and construction described above, and can have an encoder portion associated with it that communicates with the control module 24 as described above. Motor 510 can receive power from motor driver 26 through conductors 511 and 512 comprising a motor cable 74 that extends through the common sheath 76. Motor 510 has a hollow motor rod 520 attached to it that extends through of a slip ring assembly 150. The hollow drive shaft 520 is pivotally supported within housing 302 by a proximal bearing 342. The slip ring assembly 150 is fixed (i.e., non-rotating) within housing 302 and includes a fixed external contact 156 that is coupled to conductors 157 and 158 that form a generator cable 14 as described above. An internal contact 154 is mounted on the hollow drive shaft 520 and is in electrical contact or communication with the external contact 156. Conductors 151 and 152 are attached to the internal contact 154 and extend through the hollow drive shaft 520 to be coupled to the Ultrasonic transducer set Petition 870190093144, of 09/18/2019, p. 39/97
36/87 co 530.
[00168] In various modalities, to facilitate the assembly and also to acoustically isolate the motor from the 530 ultrasonic transducer assembly, the hollow drive shaft 520 can be removably coupled to the 530 ultrasonic transducer stack by a coupling assembly, in general designated as 540. As can be seen in Figures 9, 11, and 12, coupling assembly 540 may include a thin plate element 542 which is attached to a distal end 521 of the hollow drive shaft 520. The thin plate element 542 can be produced from a material that has a relatively low hardness in the axial direction and has a high hardness in the rotation. See figure 12. For example, thin plate element 542 can be produced from 0.020 cm (0.008 inches) thick from Aluminum 7075-T651 and can be attached to the distal end 521 of the hollow drive shaft 520 by, for example. example, a pressure fit or strong welding. The coupling assembly 540 may additionally include a proximal end mass or flange portion 531 of the ultrasonic transducer assembly 530. The proximal end mass 531 may comprise, for example, a flange made from stainless steel which is attached to the assembly 530 ultrasonic transducer by, for example, a screw connection or other connection. As can be seen in figure 11, the end mass 531 has an orifice 532 sized to receive the thin plate element 542 therein. In various embodiments, the thin plate element 542 can be sized to be pressed into hole 532, so that rotation of the thin plate element 542 around the AA axis will cause the ultrasonic transducer assembly 530 to rotate around of the AA axis. In other embodiments, a separate pressure plate (not shown) or pressure rings (not shown) or pressure features (not shown) can be provided to retain
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37/87 the thin plate element 542 in non-rotating engagement with the end mass 531 of the ultrasonic transducer assembly 530. These arrangements serve to minimize the transmission of acoustic vibrations to the motor of the ultrasonic transducer assembly.
[00169] Figures 14 and 15 illustrate an alternative thin plate element 542 'that can be employed. In this embodiment, the thin plate element 542 'has a plurality of radial notches 544 provided therein to form the radial projections 546. The orifice 532 would be formed by notches (not shown) to accommodate the radial projections 546 therein. This arrangement can reduce the moment force applied to axis 520. By using thin plate elements 542 and 542 'the amount of acoustic vibrations that are transferred from the ultrasonic transducer assembly 530 to the drive shaft 520 can be minimized.
[00170] 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. When the clinician wishes to power the ultrasonic transducer set 530, energy is supplied from the ultrasonic generator 12 to the fixed contact 156 on the slip ring set 150. The energy is transmitted to the ultrasonic transducer set 530 by virtue of the rotational sliding contact. or electrical communication between internal contact 154 and external contact 156. These signals are transmitted to the ultrasonic transmitter set 530 by conductors 151 and 152. The surgical instrument 500 may include a control arrangement of the type described above and be used in the various described above. It will be understood that the instrument 400 can be used in rotation mode, ultrasonic mode, rotation and ultrasonic mode (dual mode), or coagulation mode as described above. A suction can be applied between the blade 200 and the outer sheath 230 through the port
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240. A collection receptacle 243 and a 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 blade to the fabric as will be further discussed below.
[00171] Figure 16 illustrates another surgical instrument 600, similar numbers used previously to describe the various modalities discussed above are used to designate similar components. In these embodiments, the surgical instrument 600 includes a compartment 302 that houses a transducer set 314 that is attached to an ultrasonic horn 324. In this embodiment, the transducer set 314 and ultrasonic horn 324 are attached to a PZT 602 compartment that is supported pivotally inside the compartment 302 by a distal bearing 336. The ultrasonic horn 324 can be coupled to the proximal end of the blade 200 in the manner described above. A tapered part 160 can be secured to compartment 302 by locks 161 in the manner described above. [00172] This modality includes a 510 engine that can comprise a stepper motor of the type and construction described above. The motor 510 may have an encoder associated therewith which communicates with the control module 24 (figure 1) as described above. Motor 510 can receive power from motor driver 26 (figure 1) through conductors 511 and 512 comprising motor 74 which extends through common sheath 76. Motor 510 has a hollow motor rod 520 attached to it. extends through a slip ring assembly 150. The hollow drive shaft 520 is pivotally supported within housing 302 by a proximal bearing 342.
[00173] The slip ring assembly 150 is fixed (that is, non-rotating) within compartment 302 and includes a fixed external contact
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156 which is coupled to conductors 157 and 158 that form a generator cable 14 as described above. An internal contact 154 is mounted on the hollow rotating drive shaft 520 and is in electrical contact or communication with the external contact 156. Conductors 151 and 152 are attached to the internal contact 154 and extend through the hollow drive shaft 520 to be coupled to the ultrasonic transducer set 314. In various modalities, to facilitate assembly and also to acoustically isolate the motor 510 from the ultrasonic transducer set 314, the hollow drive shaft 520 can be removably coupled to the PZT 602 compartment by a coupling set , in general designated as 540. Coupling assembly 540 may include a thin plate element 542 which is attached to a distal end 521 of the hollow drive shaft 520. As discussed above, the thin plate element 542 can be produced from of a material that has a relatively low hardness in the axial direction and a high hardness in rotation. The PZT compartment 602 has an end portion 604 that has an orifice 603 sized to receive a thin plate element 542 therein. In various embodiments, the thin plate element 542 can be sized to be pressed into orifice 603, so that rotation of the thin plate element 542 around the AA axis will cause the PZT 602 housing and the transducer assembly ultrasonic 314 and ultrasonic horn 324 rotate about the AA axis. In other embodiments, a separate pressure plate (not shown) or pressure rings (not shown) or pressure features (not shown) can be provided to retain thin plate element 542 in non-rotating engagement with the proximal end portion 604 and the PZT compartment 602. This embodiment can also employ the end plate element 542 'as discussed above.
[00174] When power is supplied to the 510 motor, the action axis
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40/87 namento 520 rotates around the A-A axis, which also causes the PZT 602 housing and ultrasonic transducer assembly 314 to rotate about the A-A axis. When the clinician wishes to power the ultrasonic transducer set 314, energy is supplied from the ultrasonic generator 12 to the fixed contact 156 on the slip ring assembly 150. The energy is transmitted to the ultrasonic transducer set 314 by virtue of the rotational sliding contact or electrical communication between internal contact 154 and external contact 156. These signals are transmitted to the ultrasonic transducer set 314 by conductors 151 and 152. The surgical instrument 500 may include a control arrangement of the type described above and be used in the various described above. It will be understood that the instrument 400 can be used in rotation mode, ultrasonic mode, rotation and ultrasonic mode (dual mode), or coagulation mode as described above. A suction can be applied between the blade 200 and the outer sheath 230 through port 240. A collection receptacle 243 and a 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 blade to the fabric as will be discussed further below.
[00175] In an effort to reduce the overall size of the 302 compartment employed in each of the 300, 400, 500, and 600 instruments, the ultrasonic transducer sets employed in each of those respective instruments could be replaced with a half-transducer wave that physically has a shorter length.
Ultrasonic Blade and Sheath Modes [00176] Current arthroscopic tools include perforators, reciprocating trimmers, and devices equipped with a radio frequency (RF) engine. Mechanical devices such as perforators and apa
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41/87 operators tend to create minimal tissue damage, but can sometimes leave behind irregular lines that are not desirable. Blades equipped with a radio frequency motor can leave smoother lines behind and also excise large volumes of soft tissue. However, these devices can create more damage to soft tissue than purely mechanical instruments. The various modalities of non-limiting surgical instruments described above provide many advantages over surgical instruments equipped with an RF motor as well as conventional mechanical trimmers that employ a rotary tissue cutting element. As will be discussed in more detail below, additional advantages can be obtained by using the exclusive and innovative blade and sheath configurations of various non-limiting modalities.
[00177] Figures 17 to 21 illustrate a blade shape 200 and outer sheath 230 that can be used in conjunction with the various surgical instruments described above. As can be seen in these figures, the blade 200 can have a distal end portion 700 and the outer sheath 230 can have a distal end portion 720. The blade 200 can be produced from, for example, titanium and the outer sheath 230 can be produced from, for example, poly (ether-ether-ketone) (PEEK), Ultem®, or stainless steel. As discussed above, blade 200 may have a waveguide or proximal end portion that is configured to be threaded or otherwise attached to an ultrasonic horn 324 (figures 6 to 10 and 16) in a known manner. The distal end portion 700 of the blade 200 may have a curved tip portion 702 formed therein. The curved tip 702 can have an arcuate top segment 704 that has a cutting edge 706 formed on each side side 705. The cutting edges 706 can end distally at a common and substantially sharp distal end 708
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42/87 da. The pointed distal end 708 may be relatively blunt or the pointed distal end 708 may have a relatively sharp tip. As can be seen in figure 20, the pointed distal end 708 can curve inwards along the central axis A-A of the blade. As can be seen in figure 19, in various embodiments, the cutting edges 706 may not intersect with each other but may be separated by a center portion 707. As can be seen in figure 20, the blade 200 may have a portion reduced neck 710 protruding distally from a waveguide or proximal blade portion 712. A knot 714 can be established in the area where the neck portion 710 protrudes from the proximal portion 712.
[00178] As can be seen in figure 17, the outer sheath 230 also has a distal end portion 720 that has a window or opening 722 formed thereon to expose the distal end portion 700 of the blade 200. As can be seen further in 17, the outer sheath 230 may comprise a hollow cylinder having a substantially blunt end 724. In various embodiments, the window 722 extends to half the circular cross section of the sheath 230. This window configuration forms an arcuate protrusion 725 that extends around the blunt end 724. In various embodiments, the outer sheath 230 can be produced from, for example, poly (ether-ether-ketone (PEEK), Ultem®, or stainless steel. To avoid metal contact with metal between the cutting edges 706 at the distal end portion 700 of the blade 200 and the protrusion 725, a polymer bumper 726 can be fixed, for example, by adhesive or a T slot around the protrusion 724. Consu See figure 17. The 726 bumper can be made from, for example, Teflon®, silicone or other reduced or low-friction material. The 726 bumper can be dimensioned to produce an en
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43/87 interference shank, for example, t, 0.0127 cm (0.005 inches) with the cutting edges 706 and the distal pointed end 708.
[00179] In use, as the blade 200 is rotated around the axis AA inside the outer sheath 230 and introduced into the fabric, the fabric is removed from the window 722 by suction means applied between the inner sheath 220 (figure 4) , and the outer sheath 230 as described above. The removed fabric part of the window 722 is then cut as the cutting edges 706 are rotated beyond the bumper 726 and the cut fabric can pass between the inner sheath 220 and outer sheath 230 and out through the suction port 240 (figures 4, 6 to 10, and 16) to the collection receptacle 243 (figures 4, 6 to 10, and 16).
[00180] In another embodiment, an axial suction passage 730 can be provided through the neck portion 710 of the blade 200. See figure 20. The axial suction passage 730 can communicate with a transverse suction passage 732 in the area of the knot 714. Therefore, the cut fabric can pass through passages 730 and 732 and out between the inner sheath 220 and the outer sheath 230 and out through the suction port 240 (figures 4, 6 to 10, and 16) to the collection receptacle 243 (figures 4, 6 to 10, and 16). Fig. 21 represents an alternative embodiment with two outlet passages 734 and 736 communicating with axial pass 730 and extending at an angle thereafter. In various embodiments, outlet passages 734 and 736 can extend from axial pass 730 at an angle 738 of, for example, forty-five (45) degrees. This arrangement serves to reduce impedance and energy loss during ultrasonic activation, which may otherwise have resulted from the water that was extracted through window 722 in the outer sheath 230.
[00181] In use, the doctor may decide to rotate the blade 200 inside the outer sheath 230 without applying ultrasonic movement to it. The month
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44/87 doctor may also decide to apply ultrasonic motion to the rotating blade or the physician may wish to apply ultrasonic motion to a parked (non-rotating) blade to use the portion of the slide exposed in window 722 to coagulate tissue.
[00182] Figure 22 illustrates the use of blade 200 in conjunction with an outer sheath 230 that has a distal end portion 750 that includes a prominent segment being projected in distal position 752. In various embodiments, the prominent segment 752 can be a W-arched width comprising approximately ten (10) to thirty (30) percent of the circumference of the distal end portion 750 of the outer sheath 230. The prominent segment 752 can protrude distally from the end of the distal end portion 750 of the sheath 230 in a length L that can be approximately 0.635 cm (0.25 inches), for example. In alternative embodiments, a low-friction bumper or guard (not shown) can be applied to the sides 753 of the prominent segment 752 if desired. These modalities can operate in a similar way to the previous modality. However, this modality has the additional ability to cut fabric with the exposed tip. As with other modalities, the doctor can apply gross rotational movement to the 200 slide without ultrasonic movement or with ultrasonic movement. In another alternative use method, exposed tip 708 and partially exposed cutting edges 706 can be used to cut fabric when the blade is not being rotated or vibrated.
[00183] Figures 23 to 24 illustrate another non-limiting modality of blade and outer sheath. In this embodiment, the blade 200 has a distal end portion 760 that is substantially similar to the distal end portion 700 of the blade configuration described above. However, the distal blade portion 760 does not engage inter
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45/87 at the same degree, so that the blade tip 762 does not cross with the central axis A-A. See figure 24. As can be seen in figure 23, the window 722 'on the distal end portion 720 of the outer sheath 230 does not extend the entire distance from an end wall 725 to the blunt end 724. Therefore, in this In this embodiment, the blunt point 724 comprises a point that extends more than 90 ° but less than 180 ° (i.e., angle A in figure 23A is greater than 90 ° but less than 180 °).
[00184] Figures 25 and 26 represent another non-limiting blade modality. In this embodiment, blade 200 'can be substantially similar to blade 200 or any of the other blades described herein. In this embodiment, the distal end 700 'has a rough upper surface 705'. This rough surface 705 'creates higher frictional forces between the distal end portion 700' of the blade 200 'and the fabric to extract it from within the window 722' in the distal end portion 720 of the outer sheath 230 (figure 26) . When pulling more fabric from within window 722, the main cutting edge 706 'of blade 200' may have a higher probability of cutting the fabric cleanly. In various embodiments, for example, the rough surface may be formed by protrusions or the upper surface may be coated with a hard material such as diamond or the like.
[00185] Figures 27 to 29 illustrate another non-limiting blade modality. In this embodiment, blade 200 ”can be substantially similar to blade 200 described above. In these embodiments, the distal ends 700 "have a series of cutting teeth 707 that extend outwardly from the surface 705" to pull and cut fabric as the blade 200 "is rotated inside the outer sheath 230.
[00186] Figures 30 and 31 and 32A to 32D illustrate another non-limiting modality of blade and outer sheath. When using multiple
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46/87 instruments that employ a rotating blade inside the outer sheath, it was realized that the tissue can be expelled from the sheath window as the blade rotates on it. This can lead to reduced cutting speeds as the fabric is not captured properly and kept between the cutting edges. Blade 800 of this modality addresses these potential disadvantages.
[00187] As can be seen in figure 30, blade 800 can be substantially the same as blade 200 except for the differences observed in the present invention. In particular, blade 800 may include a neck portion 803 that ends at a distal end portion 810. The distal end portion 810 may have a slightly curved tip 812. A series of teeth 817 may be provided on at least one side side 813 or 815 of the distal end portion 810. In the embodiment shown in figures 32A to 32D, teeth 817 and 819 are formed on the side sides 813 and 815, respectively, of the distal end portion 810. The distal end portion 810 it additionally has a slightly domed top portion 821. In the embodiment shown in figures 30 to 32D, teeth 817 comprise relatively sharp points that define a series of arched openings 823 with each other. The teeth 819 may also comprise relatively sharp points that have a series of arcuate openings 825 with each other. As shown in figure 30, an axial suction passage 805 can be provided through the neck portion 803 of the blade 800. The axial suction passage 805 can communicate with a transverse suction passage 807 in the area of node 808. Therefore, the cut tissue can pass through passages 805 and 807 and out between the inner sheath (not shown) and the outer sheath 850 and out through the suction port to a collection receptacle in the manner described earlier in this document. Other suction path arrangements can
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47/87 also be employed correctly.
[00188] The outer sheath 850 can be substantially similar to the outer sheath 230 described above and has a distal sheath tip 852 attached thereto which has a window or opening 854 formed thereon to expose the distal end portion 810 of the blade 800. See figure 31. The outer sheath 850 may comprise a hollow cylinder produced from, for example, stainless steel. In various embodiments, the window 854 extends approximately half the circular cross section of the sheath 850 and forms a blade opening 858 therein. The distal end of the sheath 852 can be produced from metal such as stainless steel, so that a relatively sharp cutting edge 860 extends around the blade opening 858. For the purpose of explanation, the sharp cutting edge 860 has a first side cutting edge portion 862 and a second side cutting edge portion 864.
[00189] Figures 32A to 32D illustrate a sequential rotation of the blade 800 inside the outer sheath 850. Returning first to figure 32A, the blade 800 is shown being rotated counterclockwise CCW. As shown in that figure, the cutting teeth 817 on the first side side 813 of the blade 800 are positioned for the shear of tissue (not shown) between the teeth 817 and the first cutting edge portion 862 of the cutting edge 860. When in that position, the arched openings 823 between the teeth 817 are exposed to collectively form a first lateral suction path 870 between the blade 800 and the distal sheath tip 852 to allow the tissue to be extracted from it to be applied through the suction passage 805 (figure 30). As the rotational sequence continues, the domed upper portion 821 of blade 800 covers opening 854 at the distal sheath tip 852 so that there are no exposed suction paths for tissue to enter opening 854.
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48/87 as the blade continues through its rotation, figure 32C illustrates arched openings 825 between the teeth 819 that collectively form a second lateral suction path 872 between the second portion of the cutting edge 864 and the blade 800 to allow the fabric is extracted from it. As the blade 800 continues to rotate in the CCW direction, a third suction path 874 is exposed to allow the fabric to be extracted further through opening 854. Therefore, this arrangement allows for sequential opening of suction paths from one side side of the opening of blade 858 to the other, for an even easier cut of fabric. In use, the physician may decide to rotate the blade 800 into the outer sheath 850 without applying ultrasonic motion to it. The physician may also decide to apply ultrasonic motion to the rotating blade, or the physician may wish to apply ultrasonic motion to a parked (non-rotating) slide in order to use the portion of the slide exposed in aperture 854 to coagulate tissue.
[00190] Figures 33 and 34 illustrate another modality of blade 880 that can be substantially the same as blade 200 except for the observed differences. In particular, the blade 880 may include a wire guide or proximal portion 882 that terminates at a distal cut portion 884. The proximal portion 882 of the blade 880 may be configured to be threadably attached, or otherwise, to a ultrasonic horn of any of the various modalities discussed above. The cutting portion of distal tissue 884 may have opposite arcuate channels 886 and 888 formed therein. The first arcuate channel 886 can define a first cutting edge 890 and the second arcuate channel 888 can define a second cutting edge 892. This blade mode can be used in conjunction with any of the outer sheath configurations described above. In the embodiment shown, the hollow outer sheath 900 is used and may be similar to the sheath
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230 for example, and included a distal sheath tip 901 which has a prominent rounded or blunt portion 902 and a window 904. The hollow outer sheath 900 can be produced from, for example, stainless steel and the distal sheath tip 901 can be produced from a metal such as stainless steel. The window 904 forms an arched cutting edge 906 that cooperates with the cutting edges 890 and 892 on the blade 880 to break the fabric as the blade 880 is rotated within the outer sheath 900 in the various ways described above. In at least one embodiment, the proximal portion 882 of the blade 880 can be dimensioned in relation to the hollow outer sheath 900 so that a gap is provided between them to allow suction to be applied to it in the manner described above, for example. As you can see in figure 34, as the blade 880 rotates (represented by the arrow R), the arched channels 886 and 886 define openings 894 and 896 between the distal end 884 of the blade 880 and the walls of the distal sheath tip 901 for allow the fabric to be extracted therein by the suction (represented by the arrow S) applied to the area between the inner wall of the outer sheath 900 and the neck 882 of the blade 800. It will also be understood that the blade 880 can be rotated counterclockwise or clockwise or be selectively oscillated between these rotational directions and still effectively cut the fabric extracted from it. Figure 34A represents an alternative sheathed tip 901 'which is produced from a metallic material such as stainless steel, which has a series of serrated cutting teeth 905' formed on each cutting edge 890 'and 892 '.
[00191] Figure 35 represents another type of blade 910 that can be substantially the same as blade 200 except for the differences noted below. In particular, the blade 910 may include a waveguide portion 912 that terminates at a tissue cut portion
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50/87 of the distal 914. The proximal portion 912 of the blade 910 can be configured to be screwed on, or otherwise, to an ultrasonic horn of any of the various modalities discussed above. The distal tissue cutting portion 914 may have opposite channels 916 formed therein which cooperate to define a first cutting edge 920 and a second cutting edge 922. This blade modality can be used in conjunction with any of the various described outer sheath configurations above and is designed to rotate only in an R direction for fabric cutting purposes. As with the modality described above, the arcuate channels 916 define openings between the fabric cutting portion 914 of the blade 910 and the inner walls of the distal sheath tip to allow the fabric to be extracted therein as suction is applied to the area between the proximal portion 912 and the inner wall of the outer sheath.
[00192] Figure 36 illustrates another surgical instrument 2000 and similar numbers, used previously to describe the various modalities discussed above, are used to designate similar components. In these modalities, the surgical instrument 2000 includes a compartment 302 that houses an ultrasonic transducer set 314 that is fixed to an ultrasonic horn 324. In this modality, the ultrasonic transducer set 314 and the ultrasonic horn 324 can be swiveled within the compartment 302 in a known manner. Electrical control signals can be supplied to the ultrasonic transducer set 314 from an ultrasonic generator 12 by conductors 151 and 152. Activation of the ultrasonic generator 12 will cause the ultrasonic transducer set 314 to apply an ultrasonic motion to the ultrasonic horn 324. In this modality, a hollow external sheath 2010 is coupled to the ultrasonic horn 324 to receive ultrasound movement
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51/87 unique of that. For example, in various embodiments, the external sheath 2010 can be coupled to the ultrasonic horn 324 by a threaded connection or other suitable closing arrangement.
[00193] This modality includes a rotating blade 2020 that is rotatably supported inside the outer sheath 2010 and is coupled to a motor 510 supported inside compartment 302. The motor 510 may, for example, comprise a stepper motor of type e construction described above. The motor 510 may have an encoder associated therewith which communicates with a control module 24 (figure 1) as described above. The 2020 blade may have a hollow distal portion 2022 and a solid proximal portion 2024. See figure 36A. The solid proximal portion 2024 can be attached to the drive shaft of the motor 520 by a threaded connection or other suitable connection. The drive shaft of the motor 520 can be swiveled inside the compartment 302 by a proximal bearing 342. When control signals are provided to the motor 510, the drive shaft 520 rotates around the AA axis which also takes the blade 2020 to rotate around the AA axis inside the outer sheath 2010.
[00194] As can be seen additionally in figure 36A, the hollow outer sheath 2010 is supported within the hollow tapered part 160 which has a suction port 240 in it. A flexible tube 242 can be attached to the suction port 240 and communicate with a collection receptacle 243 which is coupled to a suction source, usually represented as 244. The hollow sheath 2010 can be supported within the tapered part 160 by a proximal seal 2013 and a distal seal 2015 which are located on each side of the suction port 240, as shown in figure 36A, and which serves to establish fluid proof seals between them. The hollow sheath 2010 is provided with at least one opening of the proximal sheath 2014 registered with the suction port 240 between the proximal seal 2013 and the ve
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52/87 distal portion 2015. In addition, the hollow distal portion 2022 of the blade 2020 is swiveled within the hollow sheath 2010 by at least one proximal blade seal 2025 and a distal blade seal 2027. At least one blade discharge 2028 can be provided through the hollow portion 2022 of blade 2020 between the proximal blade seal 2025 and the distal blade seal 2027 for discharge into at least one proximal sheath opening 2014. [00195] Also in several embodiments, the the distal end portion 2011 of the hollow outer sheath is closed and at least one opening or window 2012 is provided thereto to expose a cutting portion of distal fabric 2025 from the blade 2020. In at least one embodiment the window 2012 comprises an elongated slit and the cutting portion of distal tissue also comprises an elongated slot 2026 in blade 2020 (figures 37 and 38). Therefore, suction can be applied from the suction source 244 to the hollow portion of the blade 2020 through port 240, the proximal sheath opening 2014 and the blade discharge port 2028. As the distal openings 2026 and 2012 coincide, the T fabric can be extracted in the hollow distal portion 2022 of the blade 2020 as shown in figure 38. The separate portions of T 'fabric can pass through the hollow distal portion 2022 of the blade 2020 and out through opening 2028 and 2014 and inward collection receptacle 243.
[00196] In use, the doctor can activate the 2020 rotary blade to cut and evacuate tissue. When bleeding is found, the doctor can activate the 314 ultrasonic transducer set to send ultrasonic movements to the 2010 outer sheath for the purpose of coagulation. For example, spinal fusion surgeries require the removal of disc material due to a variety of unhealthy conditions. The material is often hardened and requires a lot of strength with conventional instrumentation to decompose the disc and remove
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53/87 its fragments. Once the disc material is removed, the end plates need to be broken to reveal the fresh surfaces to fuse the plates in each cage. The plates also need to be formatted to provide a good fit with the type of cage being used. Conventional instrumentation generally requires great surgeon strength very close to critical structures. In other embodiments, the motor can be coupled to rotate an ultrasonic transducer set and the blade can be attached to the ultrasonic transducer set as described above, so that the blade rotates and can have ultrasonic motion applied to it.
[00197] The use of surgical instrument 2000 described above can be particularly advantageous when performing, for example, a discectomy as shown in figures 39 and 40. As can be seen in these illustrations, the external sheath 2010 can be inserted in disk D The 2020 rotary blade can be used to scrape small disc parts and suction them out. This arrangement eliminates the need for repeated insertion / removal of surgical tools. The device can also be used to prepare the end plates of vertebrae. In the embodiment shown in figures 41 to 45, the rotary cutting blade 2020 has a series of serrated teeth 2021 formed on at least one side of the distal opening system 2026 to assist in cutting tissue extraction through the opening 2012 in the outer sheath 2010 Also in this modality, a 2040 retractable safety guard is movably mounted on the outer sheath 2010 and is selectively movable from a closed position, substantially covering the opening 2012 in the outer sheath 2010, to an open position exposing the opening 2012 ( figures 43 and 44). This arrangement covers teeth 2021 on blade 2020 during insertion and removal of the outer sheath 2010 adjacent to ner
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54/87 vitals and other important tissues. To facilitate the movement of the 2040 safety sheath in the 2010 external sheath, a 2042 thumb control tab (figures 41 and 45) can be formed at the end of the 2040 safety sheath to allow the physician to apply sliding actuating forces to this. In addition, in various embodiments, a protrusion of retainer 2044 can be formed in the safety sheath 2040 to engage at least one detent or groove 2046 provided in the external sheath 2010 to retain the safety sheath 2040 in a corresponding open or closed position. For example, one holder or groove 2046 may correspond to a closed position (the safety sheath 2040 covering the opening 2012) and another holder or groove 2046 'may correspond to a partially open position (with a portion of the opening 2012 being exposed) and another holder or groove 2046 ”can correspond to a completely open position (with the 2012 opening being exposed completely).
[00198] Figures 46 to 51 illustrate a 940 blade that has an approximately straight 942 cut portion of distal tissue. This blade configuration can reduce increases in impedance and potential energy when the 940 blade is used in an aqueous environment compared to impedance and power requirements for several other blade configurations when used in that environment. That is, these relatively straighter blade designs may require less energy to operate in an aqueous environment. The blade 940 may have a round or blunt distal end 944 and a groove 946 that forms cutting edges 947 and 948 to cut fabric when blade 940 is used in conjunction with an outer sheath 230, as described above. The groove may have a length L of, for example, 2.54 cm (one (1) inch). The blade 942 may also have a suction passage 730 of the type and construction described above.
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As shown in figure 47, a bumper or block 726 of the type and construction described above can be used around the exposed distal end portion 720 of the outer sheath 230. Figures 48 to 51 show alternative cross-sectional shapes of a blade 940 in which juices formatted differently 946 are employed.
[00199] Figures 52 to 55 show another type of non-limiting blade and sheath. This modality employs a hollow external sheath 950 that can be fixed to a tapered end piece or to the ultrasonic transducer set of any of the surgical instruments described above by any suitable fixation method or connection arrangement. As can be seen in figure 55, the outer sheath 950 has a round or blunt end piece portion 952 and a rectangular shaped window or opening 954. In one embodiment, for example, the rectangular shaped window 954 has a width W which is approximately a quarter of the circumference of the 950 hollow outer sheath and a length of approximately 0.635 cm (0.25 inches). The sheath 950 can be produced from, for example, stainless steel.
[00200] This modality also employs a 960 blade that can be used in conjunction with any of the surgical instrument modalities described above and others. For example, a proximal portion or waveguide of the blade can be configured to attach to the ultrasonic horn or drive shaft portion of the instrument motor by a threaded connection or other connection. As can be seen in Figures 52 to 54, the blade 960 has a pair of radially opposed sharp cutting edges 962 formed therein that serves to cut T fabric that is extracted from the window 954 of the outer sheath 950. In various embodiments, the blade 960 can be produced from, for example, titanium and be dimensioned in relation to the base
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56/87 outer ring 950 so that a gap C is provided between the inner wall 951 of the outer sheath 950 and the tips of the radially opposite sharp cutting edges 962. See figure 54. In some embodiments, for example, the gap C can approximately 0.0025 cm (0.001 inches). In this embodiment, blade 960 can be produced from, for example, titanium and have a flattened distal end 964. In use, when the gross rotary movement of blade 960 in any of the various ways described above and suction is applied within of the hollow outer sheath 950, the T fabric is extracted through the window 954 and captured between the blade 960 and the inner wall 951 of the outer sheath 950. This action isolates the T fabric long enough to cut, when, for example, the device is employed in an aqueous environment as will be discussed further in detail below. In some embodiments, cutting edges 962 can be serrated. In other embodiments, cutting edges 962 are not serrated.
[00201] Figure 57 shows another non-limiting blade and sheath modality. This modality employs a 970 hollow outer sheath that can be attached to the tapered part or ultrasonic transducer set of any of the various instruments described above. As can be seen in Figure 56, outer sheath 970 has a rounded or blunt end portion 972 and an elongated window or opening 974 that forms a blade access hole 976 in end portion 972 and two radially opposite side window portions 978. In one embodiment, for example, with the outer diameter of the outer sheath 970 being approximately 0.399 cm (0.157 inches), the diameter of the 976 blade access hole may be approximately 0.318 cm (0.125 inches). The side window portions 978 can each have a width W of approximately 0.229 cm (0.090 inches) and a length L of approximately
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57/87 0.635 cm (0.25 inches). Other window sizes / configurations can be used. The 970 sheath can be produced from, for example, stainless steel.
[00202] This modality also employs a 980 blade that has a waveguide or proximal portion that is configured by attaching to the ultrasonic horn or motor drive shaft of any of the various surgical instrument modalities described above 324 by a threaded connection or another suitable connection. In various embodiments, the blade 980 may be substantially the same as the blade 960 described above (with sharp cutting edges 982 radially opposite), except that the blade 980 has a distal round or substantially blunt portion 984 protruding out through the hole blade access plate 976 on outer sheath 970. See figure 57. In various embodiments, blade 980 can be produced from, for example, titanium and be dimensioned in relation to outer sheath 970, so that a gap is provided between the inner wall 971 of the outer sheath 970 and the radially opposite sharp edged cutting edges 962. In some embodiments, for example, the clearance may be approximately 0.0025 cm (0.001 inches). In use, when the pivoting motion is applied to the blade 980 in any of the various ways described above and suction is applied inside the hollow outer sheath 970, the fabric is extracted through the window portions 978 and captured between the blade 980 and the inner wall 971 of outer sheath 970. This action isolates the fabric long enough to cut when, for example, the device is used in an aqueous environment as will be discussed further in detail below. Also, in this modality, when the 980 blade is equipped with an ultrasonic motor, the doctor can use the distal tip portion 984 for ablation of fibrous tissue stain or for stain coagulation purposes. In some modalities
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58/87 des, the cutting edges 982 can be serrated. In other embodiments, cutting edges 982 are not serrated.
[00203] Figure 59 shows another non-limiting blade and sheath modality. This modality employs a hollow outer sheath 990 that can be attached to the tapered end piece or ultrasonic transducer assembly of any of the surgical instruments described above by any suitable fixation method or connection arrangement. As can be seen in figure 58, the outer sheath 990 has a round or blunt end portion 992 and an elongated rectangular shaped window or opening 994. In one embodiment, for example, the rectangular shaped window 994 has a width W that is approximately 0.254 cm (0.100 inches) and a length of approximately 0.635 cm (0.25 inches). The sheath 990 can be produced from, for example, a polyamide or similar material that does not result in the heating of a blade 1000 from contact with it. The window 994 can be defined by cutting edges 995 and 997. As can be seen in figure 60, the edges 995 and 997 can be provided with an angle B to each other. In some embodiments, angle B can be approximately 110 degrees.
[00204] These modalities also employ a blade 1000 that has a waveguide or proximal portion that is configured to be attached to the ultrasonic horn or motor drive shaft of any of the surgical instruments described above or others by a threaded connection or other arrangement proper. As can be seen in figure 59, the blade 1000 may have a pair of radially opposed sharp cutting portions 1002 formed therein which serve to cut fabric that is extracted from inside the window 994 in the outer sheath 990. In various embodiments, the blade 1000 it can be produced from, for example, titanium. Cutting portions 1002
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59/87 of the blade 1000 may have sharp cutting angles 1003 formed therein. In some embodiments, the cutting angles 1003 can be serrated. In other embodiments, the cutting angles 1003 are not serrated. The cutting portions 1002 can be dimensioned in relation to the outer sheath 990 to establish a shearing action of fabric between the cutting angles 1003 and the cutting edges 995 and 996 of the window opening 994 as the blade 1000 is rotated or swung back and forth inside the outer sheath 990. The blade 1000 can be dimensioned in relation to the outer sheath 990 to create a slip fit with each other that would otherwise prevent the fabric from being captured between these two components. The 990 blade can rotate back and forth (arrow D) or rotate in a single direction (arrow E) and if desired to be activated ultrasonically as discussed above. See figure 59. In use, when the gross spinning motion is applied to blade 1000 in any of the various ways described above, and suction is applied within the hollow outer sheath 990, T fabric is extracted through window 994 and captured between the blade 1000 and the inner wall 999 of the outer sheath 990. This action isolates the fabric long enough to cut when, for example, the device is used in an aqueous environment as will be discussed further in detail below.
[00205] Figure 62 shows another non-limiting modality of blade and sheath. This modality employs a 1010 hollow outer sheath that can be attached to a tapered part or ultrasonic transducer assembly of any of the surgical instruments described above by any suitable attachment method or connection arrangement. As can be seen in figure 61, the outer sheath 1010 can have a round or blunt end piece portion 1012 and an elongated rectangular shaped window or opening 1014.
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In one embodiment, for example, window 1014 has a first wedge or recessed edge 1016 and a second wedge or recessed edge 1018 to define an opening 1019 that can have a width W ”that is approximately 0.254 cm (0.100 inches). Window 1014 can be approximately 0.635 cm (0.25 inches) long. The sheath 1010 can be produced from, for example, stainless steel.
[00206] These modalities also employ a 1020 blade that has a waveguide or proximal portion that is configured for attachment to the ultrasonic horn or motor drive shaft of any of the surgical instruments described above or others by a threaded connection or other connection proper. As can be seen in Figure 62, the blade 1020 may have a pair of radially opposite sharp cutting portions 1022 and 1024 formed therein. The blade 1020 can be produced from, for example, titanium and have relatively sharp cutting edges 1025 formed in each of the cutting portions 1022 and 1024. In some embodiments, the cutting edges 1025 can be serrated. In other embodiments, the cutting edges 1025 are not serrated. The cutting portions 1022 and 1024 can be dimensioned in relation to the outer sheath 1010 to establish a shearing action of fabric between the recessed edges 1016 and 1018 and the cutting edges 1025 as the blade 1020 is rotated or oscillated within the sheath outer 1010. These arrangements form a relatively small area located to reduce contact problems between the blade and the outer sheath and also to facilitate a cutting effect on the fabric. In use, when the pivoting motion is applied to blade 1020 in any of the various ways described above and suction is applied inside the hollow outer sheath 1010, the tissue is extracted through opening 1019 and captured between blade 1020 and the inner wall 1011 outer sheath
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1010. This action isolates the fabric long enough to cut when, for example, the device is used in an aqueous environment as will be discussed further in detail below. [00207] Figure 64 shows another non-limiting blade and sheath modality. This modality employs a hollow 1030 outer sheath that can be attached to a tapered part or ultrasonic transducer set of any of the surgical instruments described above. As can be seen in figure 63, the outer sheath 1030 may have a rounded or blunt end portion 1032 and an elongated rectangular shaped window or opening 1034. This embodiment may additionally include a pair of sharp cutting inserts 1036 and 1038 The cutting insert elements 1036 and 1038 can be produced from, for example, tempered stainless steel and can be fixed within the hollow sheath 1030 by, for example, welding. Window 1034 can have a width W ”that is approximately 0.254 cm (0.100 inches) and a length of approximately 0.635 cm (0.25 inches). The 1030 sheath can be produced from, for example, stainless steel.
[00208] These modalities also employ a 1040 blade that has a waveguide or proximal portion that is configured to be attached to the ultrasonic horn or motor drive shaft of any of the surgical elements described here or others by a threaded connection or other connection proper. As can be seen in figure 64, the blade 1040 has a pair of radially opposed cutting portions 1042 formed therein that have relatively sharp cutting edges 1043. In some embodiments, cutting edges 1043 can be serrated. In other embodiments, the cutting edges 1043 are not serrated. In several embodiments, the blade 1040 can be produced from, for example, titanium and can be dimensioned in relation to the cutting insert elements 1036 and
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1038 to establish a tissue shearing action between the sharp cutting edges 1043 and the cutting portions 1042 as the blade 1020 is rotated or oscillated within the hollow outer sheath 1030. The outer diameter of the blade 1020 is less than the diameter outer sheath 1030 to provide clearance for blade 1040 during operation. The only instance of contact would be between the cutting portions 1042 of the blade 1040 and the insertion elements 1036 and 1038 along the window opening 1034 with the fabric being pulled by the suction.
[00209] Figure 66 shows another non-limiting blade and sheath modality. This modality employs a hollow 1110 outer sheath that can be attached to the tapered part or ultrasonic transducer set of any of the surgical instruments described above by any suitable fixation method or connection arrangement. As can be seen in figure 65, the outer sheath 1110 can be a round or blunt end portion 1112 and an elongated rectangular shaped window or opening 1114. In this embodiment, the side edge portions 1116 and 1118 of window 1114 are minted or lowered inward. Window 1014 can be a width W ”that is approximately 0.254 cm (0.10 inches) and a length of approximately 0.635 cm (0.25 inches).
[00210] These modalities also employ an 1120 blade that has a waveguide or proximal portion that is configured to be attached to the ultrasonic horn or motor drive shaft of any of the surgical instrument modalities described above or others by a threaded connection or another suitable connection arrangement. As can be seen in figure 66, the blade 1120 has a pair of radially opposite cutting portions 1122 formed therein that have relatively sharp cutting edges 1023. In some embodiments, cutting edges 1023 can be serrated. In or
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63/87 other modes, the cutting edges 1023 are not serrated. In several embodiments, the blade 1020 can be produced from, for example, titanium and be dimensioned in relation to the recessed edges 1116 and 1118 to establish a fabric shearing action between the sharp cutting edges 1023 and the cutting portions 1122 as the blade 1120 is rotated or swung. This arrangement defines a greater clearance C1 between the cutting portions 1122 of the blade 1120 and the inner wall 1111 of the sheath 1110. To form a shearing action of fabric between the side edges 1116 and 1118 and the cutting portions 1122, a clearance C2 which is less than C1 is provided.
[00211] Figures 67 to 69 show another non-limiting modality of blade and sheath. This modality employs a hollow external sheath 1210 that can be attached to the tapered part or ultrasonic transducer set of any of the surgical instruments described above. The hollow outer sheath 1210 has a distal end portion 1212 that includes an upper opening 1214 and a lower opening 1215 which serve to define the arcuate side portions 1216 and 1218. The distal end portion 1212 may additionally have a closed end 1219 that extends between side portions 1216 and 1218.
[00212] This modality additionally comprises a blade 1220 that has a waveguide or proximal portion that is configured to be attached to the ultrasonic transducer set of any of the surgical instruments described above. The blade 1220 additionally has a distal end portion 1221 which has a cavity 1222 which serves to define a pair of arcuate cutting portions above the arcuate side portions 1224 and 1226 that extend above the arcuate side portions 1216 and 1218 of the hollow sheath 1210 One, both, or none of the cutting portions 1224 and 1226 may have serrated teeth 1227. As shown in the figure
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67, cavity 1222 has a cross-sectional shape that resembles approximately C flat bottom. However, cavity 1222 may have other cross-sectional shapes. At least one suction pass 1230 can be provided through blade 1220 as shown. The suction port can communicate with a suction source (not shown).
[00213] In several embodiments, the blade 1220 can be produced from, for example, titanium and can be dimensioned in relation to the distal end portion 1212 of the hollow sheath 1210, so that the bottom portion 1232 of the blade 1220 is extend downward beyond the sides 1216 and 1218 of the end portion 1212. Similarly, the cutting edges of the arcuate side portions 1224 and 1226 extend above sides 1216 and 1218 as shown in figure 67. The exposed bottom portion 1232 of the blade 1220 can be used, for example, to coagulate tissue, while cutting edges 1224 and 1226 can be used to cut and separate tissue.
[00214] The proximal end 1211 of the hollow sheath 1210 protrudes from a cable compartment 1240 as shown in figure 70. The cable compartment 1240 houses an ultrasonic transducer assembly, a motor, and a slip ring assembly as described above and is coupled to a control system 10. The cable compartment 1240 may include a selector switch 1241 that allows the physician to choose between a first ultrasonic mode 1242, and a second trimmer mode 1244, and a third injection mode 1246. The mechanism switch 1241 communicates with control system 10 to automatically orient blade 1220 in a desired rotational orientation. For example, to employ device 1200 in ultrasonic mode 1242, the physician changes the selector switch 1241 to the position of ultrasonic mode 1242 (shown as action 1250 in figure 71). When in the first ultrasonic configuration
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1242, the engine will rotate blade 1220 to the position shown in figures 67 and 68 (shown as action 1252 in figure 71) and then park the blade in that position to expose the bottom portion 1232 of blade 1220 through the hollow sheath 1210 (shown as action 1254 in figure 71). When in that position, the ultrasonic transducer assembly is activated to allow the bottom portion 1232 to be used to achieve hemostasis (shown as action 1257 in figure 71). More particularly, when in ultrasonic mode 1242, the physician can orient the bottom portion 1232 against the bleeding tissue and then apply firm pressure to the tissue (shown as action 1256 in figure 71) with the exposed portion 1232 of the blade 1220. The doctor then activates the ultrasonic transducer set to achieve hemostasis (shown as action 1258 in figure 71). In alternative modalities, the device 1200 can be supplied with a series of keys / buttons as described above that communicate with a control system so that the activation of a key can start the rotation. The activation of another switch can initiate the rotary oscillation and the activation of another switch can, in cooperation with the control system, rotate the blade to the ultrasonic position and park it, and consequently activate the ultrasonic transducer set or in other modalities , the ultrasonic transducer assembly can be activated by yet another separate switch. All of these alternative arrangements are within the scope of the various non-limiting modalities presented in the present invention and their respective equivalent structures.
[00215] Figure 72 illustrates the use of device 1200 when in trimmer mode 1244. In particular, selector switch 1241 is moved to trim position 1242 (shown as action 1260 in figure 72). When in that position, the motor continuously rotates the blade 1220 inside the hollow outer sheath 1210 (shown as action 1262 in fig.
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66/87 to 72). In other modes, the motor swivels the blade 1220 back and forth inside the outer sheath 1210 or in other modes, the selector switch can be moved to yet another position where the swivel oscillation is initiated. In any case, the doctor can then contact the tissue with the rotating or oscillating blade (1220) to have the tissue trimmed and evacuated through the suction passage 1230 (shown as action 1264 in figure 72).
[00216] Figure 73 illustrates the use of device 1200 when in injection mode 1246. In particular, selector mode 1241 is moved to injection position 1246 (shown as action 1270 in figure 73). When in that position, blade 1220 is held in a parked position (shown as action 1272 in figure 73). The doctor can then orient the slide in a desired position and then inject the desired medication (shown as action 1274 in figure 73). A form of medicine that can be injected, for example, can comprise a cell-generating drug sold under the trademark Carticel. However, other drugs and medications can be used. The injection action can be performed by orienting the blade 1220 in a position within the outer sheath 1210 so that the drug passage 1284 that extends through the blade 1220 is exposed through the outer sheath 1210 to allow the drug to be advantageously applied to the adjacent site. The medicine can then be injected by activating a 1280 pump that communicates with a 1282 medicine source. See figure 70. In various embodiments, device 1200 can have an injection trigger 1249 that communicates with pump 1280 in a way that activating the 1249 injection trigger will cause the 1280 pump to inject medicine out of the 1284 passage (figure 68). In alternative modalities, the medication can be injected manually
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67/87 mainly by, for example, a syringe in a port (not shown) that communicates with the passage of medicine 1284 on slide 1220.
[00217] Figures 74 to 77 show another non-limiting modality of surgical instrument 1300. The device 1300 can include any of the drill devices 300, 400 and 500 as described above. For example, device 1300 may include a drill 300 that incorporates the difference noted below. The drill 300 includes a blade 200 that has a waveguide or proximal portion that is attached to an ultrasonic transducer assembly that, when activated, applies ultrasonic motion to the blade 200. The blade 200 can also be rotated by the motor arrangement contained within drill bit 300 as described above. The blade 200 can be extended through an inner sheath 1320 projecting from the drill 300. The blade 200 is free to be vibrated and rotated selectively within the inner sheath 1320. One or more sealing elements 1322 can be provided between the blade 200 and inner sheath 1320 to prevent fluids and fabric from entering the area between inner sheath 1320 and blade 200. Sealing elements 1322 can be produced from, for example, silastic silicone.
[00218] The device 1300 may additionally include an outer sheath 1330 that is movably received in the inner sheath 1320. The outer sheath 1330 can be dimensioned in relation to sheath 1320 so that the suction tube 1350 can extend between a portion the inner sheath 1320 and a portion of the outer sheath 1330. The suction tube 1350 can be communicated with a suction source generally shown as 1352. See figure 74. As can be seen in figures 74 to 77, the outer sheath 1330 may include a swing arm portion 1332 projecting distally from end portion 1331 to outer sheath 1330. The arm
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68/87 oscillating 1332 may be relatively straight (figure 75) or may have a slightly curved distal end 1334 (figure 76). As can be seen in figure 76, the distal end 1334 can have a sharp cutting surface 1336 therein. As can also be seen in figures 74 to 76, in some embodiments, the blade 200 may have a curved blade tip 1360 that has a pair of side cutting edges 1362 formed therein. In other embodiments, the blade tip 1360 can be straight. In some embodiments, the blade 200 can be rotated in the various ways discussed above. In other embodiments, the blade 200 cannot rotate. In these modalities, for example, the physician may choose not to activate the motor to rotate the blade or the drill may comprise a drill that does not include a motor to rotate the blade.
[00219] In use, the swing arm portion 1332 can cover portions of the distal end 1360 of the blade 200. In one mode of use, the outer sheath 1330 is retained in position with the swing arm portion 1332 covering the rear side of the blade 200 as shown in figure 74. This arrangement leaves the curved blade tip 1360 exposed. When in this position, for example, the curved blade tip 1360 can be used to cut through the tissue, such as the meniscus. In a second mode of operation, the swing arm portion 1332 is in motion.
[00220] In the embodiment shown in figures 74 to 77, a suction tube 1350 is used to extract loose tissue from the blade tip 1360 and also remove small sections of tissue transected during the cut. In other embodiments, suction could occur in the annular space between sheaths 1320 and 1330. Still in other embodiments, blade 200 may have a suction path (not shown) that extends through it, which ultimately communicates with a source suction as described above. This suction trajectory would come out of the blade 200 most likely at the node at the proximal end. 72/97
69/87 badly. In other embodiments, no suction is used.
[00221] In some embodiments, the swing arm portion 1332 can be permanently retained in position against blade 200. In still other embodiments, a slippery low-friction block (not shown) can be mounted on swing arm portion 1332 so the block to contact blade 200. In other embodiments, a clearance of 0.005 cm (0.002 ”) - 0.025 cm (0.010”) can be provided between the swing arm portion 1332 and the blade 200. In other embodiments, the swing arm 1332 extends around the length of the curved portion of the blade 200 so that the entire blade 200 is covered on the rear side.
[00222] The various non-limiting modalities described earlier in this document can be used effectively in conjunction with a variety of different surgical applications and are particularly well suited for cutting and coagulating tissue in the aqueous environment of arthroscopic surgery. In these applications, however, if the fluid passes between the blade or waveguide and the inner sheath, the fluid can enter the compartment and damage its components. Various sealing arrangements are known for use with surgical instruments equipped with an ultrasonic motor. For example, US Patent No. 5,935,144 and US Patent No. 5,944,737, the descriptions of which are incorporated herein by reference in their respective totalities, each has various sealing arrangements for use with ultrasonic instruments in the traditional laparoscopic surgery environment. and open surgery (ie, non-aqueous environments). However, the various non-limiting modalities discussed below employ improved sealing arrangements that may be better suited for use in aqueous environments.
[00223] More particularly and with reference to figure 78, an ultrasonic device 1400 is shown which includes a compartment
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1402 which rotatably supports a set of ultrasonic transducer 1404 therein. For example, the ultrasonic transducer assembly 1404 can be rotatably supported within compartment 1402 with a series of bearings (not shown). An ultrasonic horn 1406 can be coupled to the ultrasonic transducer assembly 1404 and an ultrasonic implement 1410 is attached to it by conventional means that can typically comprise a threaded arrangement. For use in the present invention, the term ultrasonic implement can encompass any of the cutting element and blade described herein. The portion of the ultrasonic implement 1410 that is coupled to the ultrasonic horn 1406 may be referred to as a waveguide portion 1412. The waveguide 1412 may comprise an integral portion of the ultrasonic implement 1410 or may comprise a separate component attached thereto. example, through a threaded connection. In the embodiment described in figure 78, the ultrasonic implement 1410 extends through a hollow outer sheath 1420. The outer sheath 1420 and the distal end of the ultrasonic implement 1410 can be configured in any of the various blade and sheath configurations described earlier in this document. as well as others.
[00224] As can also be seen in figure 78, a proximal rod 1430 is attached to the ultrasonic transducer assembly 1404. Attached to the proximal rod 1430 is a drive gear 1432 that is in engagement with a drive gear 1434 coupled to an output rod 1436 from a 1440 motor. Ultrasonic electrical signals and motor control signals can be provided from control system 10 via a set of slip rings 1450 of the type and construction described above. The device 1400 can additionally comprise the various control button arrangements described above, so that the device
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71/87 positive can be used in an ultrasonic mode, a non-ultrasonic mode (for example, rotational trimming mode) and a combination of these modes. Unlike the various instruments described above, the 1440 motor is not coaxially aligned with the ultrasonic transducer assembly.
[00225] Figure 79 shows a non-limiting modality of a seal assembly 1470 that can be used between the waveguide or proximal portion 1412 of the ultrasonic implement 1410 and the outer sheath 1420. The seal 1470 comprises an annular element that can be made from silicone or other materials such as Ultem® and is overmolded or otherwise sealingly attached to waveguide 1412 in an N-knot. Seal 1470 may have a first annular portion 1472 which is molded in waveguide 1412 in an N-node and two axial seal portions 1474 and 1476 that extend axially in opposite axial directions beyond the first annular portion 1472 and which are separated by a groove 1478. Groove 1478 can allow the two axial seal portions 1474 and 1476 flex slightly with respect to each other in sealing contact with the outer sheath 1420. The first narrower annular seal portion 1472 can prevent the development of overheating provided endo a wider contact area with the seal 1470 contacting the outer sheath 1420.
[00226] Figure 80 shows a non-limiting modality of a seal 1480 that can be used between the waveguide or proximal portion 1412 of the ultrasonic implement 1410 and the outer sheath 1420. The seal 1480 comprises an annular element that can be produced from silicone or other materials, such as Ultem® and is overmolded or otherwise sealed to the waveguide 1412 in an N-knot. The seal 1480 can be arranged to be in a boundary position with a ring anu support
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72/87 inwardly extending hearth 1490 formed in outer sheath 1420. Seal 1480 is located distally from support ring 1490. When hydrostatic pressure develops within the distal end of outer sheath 1420, seal 1480 it is forced against the support ring 1490 thus increasing the resistance of the seal. The outer sheath 1420 can be produced from, for example, stainless steel.
[00227] Figure 81 shows a non-limiting embodiment of a seal 1500 that can be used between the waveguide portion 1412 of the blade 1410 and the outer sheath 1420. The seal 1500 comprises an annular element that can be produced from made of silicone or other materials, such as Ultem® and is overmolded or otherwise sealingly attached to waveguide 1412 in a N-knot. Seal 1480 can be arranged to be received within an annular groove 1423 provided in outer sheath 1420. The outer sheath 1420 can be produced from, for example, stainless steel.
[00228] Figure 82 shows a non-limiting embodiment of a seal 1510 that can be used between the waveguide or proximal portion 1412 of the ultrasonic implement 1410 and the outer sheath 1420. The seal 1510 comprises an annular element that can be produced from silicone or other materials such as Ultem® and is overmolded from the otherwise sealed seal to the waveguide 1412 in a N-knot. The seal 1510 can be an inner flap portion 1512 that is molded into the waveguide 1412 in an N node and two sealing portions 1514 and 1516 that extend axially in opposite directions beyond the inner portion 1512 and that are separated by a groove 1518. The axial portions 1514 and 1516 are dimensioned to extend into a groove 1520 provided in outer sheath 1420. As can be seen in figure 82, groove 1520
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73/87 has an inward projecting ring 1522 sized to extend into the groove 1518 in the seal 1510. In the illustrated embodiment, the ring 1522 has an angled slope 1524 formed therein that allows the seal 1510 to slide over it during assembly, and then be locked in place. The outer sheath 1420 can be produced from, for example, Ultem®.
[00229] Figures 83 and 84 show a non-limiting modality of a seal 1530 that can be used between the waveguide or proximal portion 1412 of the ultrasonic implement 1410 and the outer sheath 1420. The seal 1530 comprises an annular element that can be made from silicone or other materials such as Ultem® and is overmoulded or otherwise sealed to the waveguide 1412 in a N-knot. The seal 1530 can have a groove 1532 in it as shown in the figure 83. The outer sheath 1420 is then furrowed to compress the seal 1530 as shown in figure 84. The outer sheath 1420 can be furrowed evenly around the entire circumference, or it can be furrowed in discontinuous locations. For example, four evenly spaced ruffles (for example, at 90 degree intervals) can be used. In these embodiments, the outer sheath 1420 can be produced from, for example, stainless steel.
[00230] Figure 85 shows a portion of an outer sheath 1540 that has a proximal axial portion 1542 and a distal axial section 1544 that are adapted to be interconnected together, for example, by welding, pressure adjustment, threading or fitting. As can be seen in figure 85, the distal axial section 1544 has a groove portion 1546 dimensioned to engage a portion of an annular seal 1550 that is overmolded or otherwise sealingly installed on the waveguide or proximal portion 1412 of the implement. ultrasonic probe on a N node. Therefore, when fixed
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74/87 together, the proximal axial section 1542 and the distal axial section 1544 serve to capture and compress a portion of the seal 1550 with each other. In alternative embodiments, the groove portion 1546 may be provided in the proximal axial section 1542 or each section 1542 and 1544 may have a groove segment therein which cooperates to accommodate the annual seal 1550 therein.
[00231] Figure 86 shows a portion of an outer sheath, generally designated as 1560 that consists of two side halves 1562 and 1564. Each side half 1562 and 1564 has a semi-annular groove segment 1566 formed therein. See figure 87. The semi-annular groove segments 1566 form an annular groove 1568 sized to receive an annular seal 1570 that is overmolded or otherwise attached to the waveguide or proximal portion 1412 when the side halves 1562 and 1564 are joined together to form the hollow outer sheath 1560. By creating a two-piece outer sheath 1560, the seal 1570 can have much greater interference with the outer sheath 1560, than it could have in general if the waveguide 1412 needed to be pushed under the outer sheath 1560 during the assembly process. The two outer sheath halves 1562 and 1564 can be joined together by welding, pressure adjustment or other suitable methods. Therefore, the seal 1570 can be installed first on the waveguide 1412. Consequently, the two halves 1562 and 1564 can be joined around the waveguide 1412 so that the seal 1570 is captured within the groove 1568. The halves 1562 and 1564 are then closed together in that position.
[00232] Figure 88 shows a non-limiting embodiment of a seal 1580 that can be used between the waveguide portion 1412 of the ultrasonic implement and the outer sheath 1420. The seal 1580 comprises an annular element that can be produced at
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75/87 from silicone or other materials, such as Ultem®, and is overmolded or otherwise sealingly attached to the waveguide or proximal portion 1412 in an N-node. The 1580 seal can be held in place by a proximal ring 1590 and distal ring 1592. The proximal ring 1590 may comprise an integral portion of outer sheath 1420 or may comprise a separate component which is pressed against outer sheath 1420 or otherwise secured thereto. The distal ring 1592 can be glued, snapped together, or otherwise fixed to the outer sheath 1420. The distal ring 1592, in the installation, can provide compression on the seal 1580. This would increase the force between the seal 1580 and the wave 1412, further decreasing the movement of fluid beyond the seal 1580. Rings 1590 and 1592 may comprise split annular rings or rings without slits. Furthermore, as can be seen in figure 88, rings 1590 and 1592 can be dimensioned in relation to waveguide 1412 so that the amount of clearance C is provided between them.
[00233] Figure 89 shows a non-limiting modality of a seal 1600 that can be used between the waveguide or proximal portion 1412 of an ultrasonic implement 1410 and the outer sheath 1420. The seal 1600 comprises an annular element that can be made from silicone or other materials such as Ultem® and overmoulded or otherwise sealed to the waveguide 1412 in an N-knot. The seal 1600 can be an outside diameter that is greater than the inside diameter of the outer sheath 1420. The seal 1600 may additionally have a proximal side 1602 and a distal side 1604. When assembled, the outer portion of the proximal side 1602 of the seal 1600 contacts the inner wall 1421 of the outer sheath 1420 in a sealing manner. , when the hydrostatic pressure P increases on the distal side of seal 1600, the seal
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76/87 tion 1600 is additionally propelled to make contact with the outer sheath 1420, thus creating a better seal between the waveguide 1412 and the outer sheath 1420.
[00234] Figure 90 shows a non-limiting embodiment of a seal 1610 that can be used between the waveguide or proximal portion 1412 of the blade and the outer sheath 1420. The seal 1610 comprises an annular element that can be produced from made of silicone or other materials such as Ultem® and is overmolded or otherwise attached to the outer sheath 1420 as shown. In this embodiment, an annular groove 1620 can be provided on the waveguide 1412 to receive a sealing portion 1610 therein. In alternative modes, no groove is provided. It will be further understood that the seals shown in figures 79 to 82 can similarly be attached to the outer sheath instead of to the waveguide or proximal portion of the cutting blade or implement as illustrated without deviating from the character and scope of the various non-limiting modalities presented in the present invention and their respective equivalents. In addition, it will be understood that the various sealing modalities described herein can be used effectively with any of the surgical instrument modalities described above. That is, the various non-limiting sealing arrangements presented in the present invention and their respective equivalent structures can be effectively employed to achieve a seal between the ultrasonic blade or waveguide and the corresponding inner sheath. In those embodiments that employ an inner sheath and an outer sheath, but suction is not applied between them, the various non-limiting sealing arrangements presented in the present invention and their equivalents can also be employed effectively to achieve a substantially fluid-tight seal between the bai
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77/87 internal and external lines. In still other non-limiting modalities, the seal can be used between an ultrasonic blade and an external sheath, while the ultrasonic blade does not engage in gross rotational movement in relation to the external sheath. In these embodiments, the seal can be rigidly attached to the ultrasonic blade and outer sheath. In still other non-limiting modalities, the ultrasonic sheet can oscillate within the outer sheath. For example, the ultrasonic blade can oscillate through a 90 degree arc (45 degrees on either side of a central axis). In these embodiments, the seal can be rigidly attached to the outer sheath and ultrasonic sheet by, for example, adhesive, crimping, etc. The sealing material may comprise an elastic or similar rubber material that can accommodate the deformation of the seal in a range of about 45 degrees. In these modalities, the extension experienced by the seal can help return the blade to a neutral position of zero degrees (in alignment with the central axis).
[00235] Several of the modalities described above employ rotating blades that serve to trim fabric between sharp edges formed in the blade and edges of the surrounding outer sheath. Although these arrangements are very effective in cutting most fabrics, hard fabric, such as tendon fabric for example, can be difficult to cut effectively because it tends to slip between the blade and the outer sheath. This problem is similar to the problems encountered when scissors are used to cut through hard material such as leather, for example. In short, the scissor blades separate and the material is not cut. This phenomenon is shown graphically in figures 91A to D. As can be seen in these figures, two 1700 cutting blades are used to cut through hard T fabric. As the 1700 blades move inward towards the T fabric, the telaT moves between the 1700 blades and
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78/87 causes them to separate.
[00236] In various blade and sheath modalities shown in the present invention, it may be advantageous to minimize the amount of clearance between the cutting portion of the outer sheath and the cutting edge (s) of the blades. For example, it may be desirable to maintain an amount of clearance between the cutting portion of the outer sheath and the cutting edge (s) on the blades within the range of 0.0025 cm (0.001 ”) to 0.0127 cm (0.005 ”). In other non-limiting modalities, one cutting edge or portion is harder than the other cutting portion. For example, the cutting edge (s) on the blades may be harder than the cutting portion of the outer sheath or vice versa. The engine can then be activated with no ultrasound to achieve a gap of approximately zero between the cutting edges / portion. In addition to these approaches or in place of these approaches, other modalities may employ a structure to tilt at least a distal portion of the blade into an off-center arrangement within the outer sheath while still facilitating the blade's rotation therein. More particularly and with reference to figures 92 and 93, a blade 200 of the type and construction described above is shown, which extends through an outer sheath set 3000. In the embodiment shown, the outer sheath set 3000 is used in conjunction with a surgical instrument 3001 that can be constructed in any of the ways described above to selectively apply the gross rotational movement of the blade 200 as well as selectively apply ultrasonic motion to it.
[00237] In the embodiment shown in figure 93, the blade 200 extends axially through an inner sheath 3020 that is mounted within a portion of the instrument compartment 3010. The outer sheath assembly 3000 is attached to the instrument compartment 3010 and has a distal tip 3002 that has a window or open
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79/87 ture 3004 on that. As discussed above, window 3004 allows the tissue to be extracted from within a tip cavity 3006 formed within the distal tip portion 3002. Suction can be applied to the tip cavity 3006 through a suction port 3007 in the portion of distal tip 3002 of the outer sheath assembly 3000 that communicates with a suction source 244. In these embodiments, the blade 200 is somewhat flexible and can be produced from, for example, titanium. In addition, the waveguide portion or proximal portion of the blade 200 extends through a pad 3030 that is mounted inside the inner sheath 3020 at the location of the N-node. In various embodiments, the inner sheath 3020 can be produced from material that is substantially rigid and resistant to bending. For example, the inner sheath 3020 can be produced from Ultem or similar materials. The 3030 cushion can be produced from, for example, Ultem® and be retained in a non-rotating manner within the inner sheath 3020 for example, by stainless steel.
[00238] As can be seen in figures 92A and 93, the waveguide or proximal portion 701 of the blade 200 extends through an orifice 3032 in the cushion 3030. The center line CL-CL of the orifice of the cushion 3032 is displaced (this ie, not coaxial with) of the central axis AA defined by the outer sheath 3000. The pad hole 3032 is dimensioned in relation to the proximal portion 701 of the blade 200 to allow the proximal portion 701 to rotate freely in this, and still serves to tilt the portion the distal end 700 of the blade 200 off the center axis AA of the outer sheath 3000 so that the distal end that cuts the fabric 705 of the blade 200 is retained in non-rotating contact with the cutting edge 3005 defined by the window opening 3004 In some embodiments, for example, the blade 200 can be tilted off the center by a distance that can be as much as 0.076 cm (0.030 ”). Because of the distal end that cuts through the tissue 705 of the
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80/87 blade 200 is tilted in this way, the distal end 705 resists the forces encountered when cutting the fabric, which may otherwise cause the cutting edges 706 at the distal end 705 to move away from the cutting edge 3005 of the opening. window 3004.
[00239] Figures 94 and 95 illustrate another embodiment in which a proximal portion 701 of blade 200 extends coaxially through the pad 3040 which can be produced from, for example, silastic silicone or Ultem® and can be retained within the sheath external 3020, for example, by a slip adjustment. As with the above modality, pad 3040 can be located at node N along the waveguide or proximal portion of blade 200. However, distal portion 711 (that is, the portion of blade 200 that extends distally from the pad 3040) is slightly arched to tilt the distal fabric cutting edge 705 of the blade 200 into the cutting edge 3005 of the window opening 3004. For example, the distal portion 711 of the blade 200 can be arched approximately 0.076 cm (0.030 inches) away from the center (distance OS in figure 95). This arrangement causes the distal fabric cutting edge 705 of the blade 200 to resist forces when there is cutting of hard fabric which may otherwise cause the cutting edges 706 on the blade 200 to depart from the cutting edge 3005 of the window opening 3004.
[00240] Figures 96 to 97 show another non-limiting embodiment of the outer sheath 3040 and blade 200. In this embodiment, the tip of the distal outer sheath 3050 is used. The tip of the distal outer sheath 3050 can be produced from metal such as stainless steel and has a proximal bearing portion 3052 that extends to an open distal end 3062 of the outer sheath 3060. The outer sheath 3060 can be produced from, for example, stainless steel and can be fixed to the tip of the distal outer sheath 3050 by fasteners, adhesives, etc. The proximal end
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3062 of the outer sheath 3060 is attached to a portion of an instrument compartment as described above. The instrument can comprise many of the various instrument modalities described in detail above that provide gross rotational movement of the blade 200 as well as ultrasonic movements thereto.
[00241] The waveguide or proximal portion 701 of the blade 200 can be attached to an ultrasonic horn (not shown) and extends through an inner sheath 3070 in the various ways described above. The proximal portion 701 of the blade 200 can be swiveled within the inner sheath 3070 by a pad 3040 as described above. A distal portion 711 of blade 200 swivels through a lumen 3054 at the tip of the distal outer sheath 3050. See Figure 97. A window 3056 is formed at the tip of the distal outer sheath 3050 to expose the distal cutting edge of 705 fabric of blade 200. As with various embodiments described above, window 3056 can define at least one cutting edge 3057 that interacts with the distal swiveling fabric cutting end of blade 200 to cut fabric extracted from within window 3056 In this embodiment, the OD outer diameter of the tissue-cutting distal end portion 705 of the blade 200 at the point where the distal end 705 of the blade 200 projects distally into the window opening 3056 is greater than the ID inner diameter of the blade. lumen 3054. In some embodiments, for example, the diameter of the inner lumen ID may be approximately 0.356 cm (0.140 ”) and the blade OD may be approximately 0.381 cm (0.150”). This arrangement results in interference between the distal tissue cutting end 705 of the blade 200 and the distal outer sheath tip 3050. In this arrangement, the distal portion 711 of the blade 200 essentially comprises a fixed cantilever bundle that results in the distal end of cutting lamia fabric 705
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82/87 on 200 that is being pushed down (figure 97) by the tip of the distal outer sheath 3050.
[00242] In the modalities shown in figures 92 to 97, it may be desirable to provide an amount of clearance between the distal end 3058 of the distal outer sheath tip 3050 and the curved tip portion 702 of the blade 200. This clearance C is illustrated in the figure 97. This clearance allows for unimpeded ultrasonic movement of the blade 200. However, it may be desirable to minimize that clearance C to reduce suction losses around the curved tip portion 702 which can delay the ability of the device to cut tissue.
[00243] Also, to facilitate the extraction of tissue from inside the 3056 window opening, a suction must be applied inside the distal outer sheath tip 3050 from a suction source (not shown) in the various ways described above. In this embodiment, for example, a suction path 3080 is provided at the end of the distal outer sheath 3050 as shown in figures 97 and 98. Seal 3090 is seated on distal portion 711 of blade 200 to establish a fluid-tight seal on a point where the distal portion 711 of the blade 200 exits the outer sheath 3070. See figure 97. Also in this embodiment, the distal end 3072 of the inner sheath 2070 extends into an opening 3055 in the bearing portion 3052 of the sheath tip distal external 3050 to provide rigid support for this. As can be seen in figure 98, the suction path 3080 forms a discontinuity in the support surface of the inner sheath 3057 defined by opening 3055. Figure 99 shows an alternative distal outer sheath tip 3050 'with the suction path 3080' it does not extend into the opening 3055 'that supports the distal end 3072 of the inner sheath 3070.
[00244] Various ultrasonic instruments that employ a dis
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83/87 position of rotating cutting element and outer sheath also face the challenge of deformation of the blade and outer sheath due to heat and high contact forces between those two components. Deformation of the distal tip portion of the outer sheath can be reduced by changing the tip material to metal, but this can result in the undesirable effect of damaging the blade through abrasion, which can ultimately result in broken blades and service life. extremely limited blade. Sheath tip blade abrasion damage can occur due to metal-to-metal contact between the blade and the sheath tip. This condition can be exacerbated when cutting hard tissues such as tendon and the like. As discussed above, these hard fabrics can skew the cutting edges away from each other and forcing the cutting edge or face of the blade in contact with the scabbard, thus resulting in abrasion.
[00245] Various non-limiting modalities described above in the present invention and their equivalents can employ a thin friction reduction material inside the tip cavity formed within the distal tip portion of the outer sheath or, in alternative modalities, a low friction block or friction reducer can be affixed inside the tip cavity to protect the blade. An exemplary embodiment is shown in figures 100 and 101. As can be seen in those figures, the outer sheath 900 'described above has a 3100 friction-reducing polymer block or coating. In various embodiments, the distal tip portion 902' of sheath 900 'can be produced from metal such as stainless steel and the block or material for reducing friction 3100 can be produced from, for example, polyimide, carbon-filled polyimide, Teflon®, Teflon-Ceramics, etc. In those modalities in which a block is employed, the block can be attached within the tip portion 902 'by,
Petition 870190093144, of 09/18/2019, p. 87/97
84/87 for example, adhesive or a prism joint arrangement. The 3100 block is preferably configured to match the corresponding blade geometry. For example, as shown in figure 101, a blade 3110 that can be substantially similar to the blade 200 described above, has a distal end portion 3112 that has a central portion 3114 that separates two cutting faces 3116 and 3118. The cutting faces 3116 and 3118 have an arched shape and have cutting edges 3120 formed on each edge thereof. In that embodiment, the polymeric block 3100 also has a top surface shaped in a similar arcuate shape 3101. The advantage of this concept is that it maintains a hard metal cutting edge (for example, stainless steel), which is advantageous for cutting hard fabric. It also protects the wide cutting faces 3116 and 3118 of the blade 200 when the block 3100 is produced from softer materials that can otherwise withstand the forces applied to the blade. In addition or alternatively, the inner wall 903 'of the tip portion 902' can be coated with a friction reducing coating 3130 of the type described above. The coating 3130 may comprise a separate component that is held in place by means of adhesive or may comprise a deposition coating that is directly adhered to the inner surface 903 'of the tip portion 902'. For example, a Teflon® material can be applied to portions of the inner wall 903 'through vapor deposition. Portions of tip 902 'where coating is not required can be masked using known masking techniques, prior to exposing tip 902' to vapor deposition processes.
[00246] Figure 102 shows a 3112 'fabric cutting blade end that can be coated with a low-friction and relatively hard material to increase hardness and reduce friction. In particular, as can be seen in that figure, at least the portions of the
Petition 870190093144, of 09/18/2019, p. 88/97
85/87 cutting faces 3116 'and 3118' are coated with coating material 3130. In some embodiments, for example, the coating material may comprise coating materials such as titanium nitride, diamond-like coating, chrome nitride, Graphit iC ™, etc. The 3060 'blade can be used in conjunction with an external sheath tip that is produced from metal (for example, stainless steel) to prevent abrasion of the blade and eventual breakage of the blade. In alternative embodiments, the cutting edge of the entire distal tissue of the blade can be coated with the coating material 3130.
[00247] The devices described here can be designed to be discarded after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps to disassemble 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.
[00248] Preferably, the various modalities described here will be processed before surgery. First, a new instrument or use
Petition 870190093144, of 09/18/2019, p. 89/97
86/87 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 be done in any number of ways known to those skilled in the art, including beta or gamma radiation, ethylene oxide and / or steam.
[00249] In several modalities, an ultrasonic surgical instrument can be provided to a surgeon with a waveguide and / or end effector already functionally coupled with a transducer of the surgical instrument. In at least one modality, the surgeon, or doctor, can remove the ultrasonic 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. This system can remove the need for the surgeon, or another doctor, to mount a waveguide and / or end effector to the ultrasonic surgical instrument. After the ultrasonic surgical instrument has been used, the surgeon, or another doctor, can place the ultrasonic instrument in a sealable package, and the package can be transported to a sterilization facility. In the sterilization installation, the ultrasonic instrument can be disinfected, and the worn parts can be discarded and replaced, while the reusable parts can be sterilized and used again. Consequently, the ultrasonic instrument can be
Petition 870190093144, of 09/18/2019, p. 90/97
87/87 reassembled, tested, placed in a sterile packaging, and / or sterilized after being placed inside a packaging. Once sterilized, the ultrasonic surgical instrument can be used again. [00250] 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 claims are intended to cover all such modifications and variations.
[00251] All published US Patents and US Patent applications and US Patent Applications referred to in this specification are hereby incorporated by reference in their entirety, but only to the extent that the incorporated material does not conflict with the definitions , statements, or other existing described material presented 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 (6)
[1]
1. Ultrasonic surgical instrument (100) comprising: a compartment (102), a set of ultrasonic transducers (114) supported in the compartment (102);
a blade (200) coupled to the ultrasonic transducer assembly (114);
a hollow sheath (1420) coupled to the compartment (102) and extending axially around a portion of the blade (200); and a seal assembly (1470) to establish a seal between a portion of the blade (200) and the hollow sheath (1420), the seal assembly (1470) comprising:
a first annular seal portion (1472) attached to the blade; characterized by the fact that two axial seal portions (1474,1476) extend axially beyond the first annular seal portion (1474) in opposite axial directions from the first annular seal portion (1472) and in flexible seal contact with corresponding portions of an inner wall (1421) of the hollow sheath (1420).
[2]
2. Ultrasonic surgical instrument, according to claim 1, characterized by the fact that it still comprises an annular groove (1478) between the axial sealing portions (1474,1476).
[3]
3. Ultrasonic surgical instrument, according to claim 2, characterized by the fact that a portion of the hollow sheath (1420) extends into the annular groove (1478).
[4]
4. Ultrasonic surgical instrument according to claim 2, characterized by the fact that the two axial sealing portions (1474,1476) extend into a corresponding annular sheath groove (1520) formed in the hollow sheath (1420) .
[5]
5. Ultrasonic surgical instrument, according to the king
Petition 870190093144, of 09/18/2019, p. 92/97
2/2 vindication 4, characterized by the fact that it still comprises a ring portion (1522) that protrudes inwardly into the sheath groove (1518) of the inwardly protruding ring portion that has an angled side portion (1524 ) formed therein for sliding coupling with at least one of the axial sealing portions (1474,1476) during the installation of the blade (200) in the hollow sheath (1420).
[6]
6. Ultrasonic surgical instrument, according to claim 1, characterized by the fact that the first annular seal portion (1472) is fixed to the blade (200) in a knot on the blade.

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同族专利:

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公开号 | 公开日

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WO2011100321A2|2011-08-18|

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JP2013519436A|2013-05-30|

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US9649126B2|2017-05-16|

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EP2533712B1|2017-11-01|

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US20110196398A1|2011-08-11|

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WO2011100321A3|2011-11-10|

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BR112012020115A2|2018-07-17|

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US10117667B2|2018-11-06|

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AU2011215909B2|2015-07-09|

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US20190053822A1|2019-02-21|

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EP2533712A2|2012-12-19|

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CN102843982B|2015-11-25|

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US20150123348A1|2015-05-07|

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CN102843982A|2012-12-26|

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US20150250495A1|2015-09-10|

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CA2788685A1|2011-08-18|

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US8951272B2|2015-02-10|

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AU2011215909A1|2012-08-23|

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JP5813668B2|2015-11-17|

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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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US12/703,866|2010-02-11|

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US12/703,866|US8951272B2|2010-02-11|2010-02-11|Seal arrangements for ultrasonically powered surgical instruments|

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