Patent Application
20210106380
Electrosurgical instruments utilize electrical energy for sealing tissue, and generally include a distally mounted end effector that can be configured for bipolar or monopolar operation. During bipolar operation, electrical current is provided through the tissue by active and return electrodes of the end effector. During monopolar operation, current is provided through the tissue by an active electrode of the end effector and a return electrode (e.g., a grounding pad) separately located on a patient's body. Heat generated by the current flowing through the tissue may form hemostatic seals within the tissue and/or between tissues, and thus may be particularly useful for sealing blood vessels, for example. The end effector of some electrosurgical devices may also include a cutting member that is movable relative to the tissue and the electrodes to transect the tissue.
Electrical energy applied by an electrosurgical device can be transmitted to the instrument by a generator coupled with the instrument. The electrical energy may be in the form of radio frequency (“RF”) energy, which is generally in the frequency range of approximately 300 kilohertz (kHz) to 1 megahertz (MHz). In use, an electrosurgical device can transmit lower frequency RF energy through tissue, which causes ionic agitation, or friction, in effect resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary is created between the affected tissue and the surrounding tissue, surgeons can operate with a high level of precision and control, without sacrificing un-targeted adjacent tissue. The low operating temperatures of RF energy is useful for removing, shrinking, or sculpting soft tissue while simultaneously sealing blood vessels. RF energy works particularly well on connective tissue, which is primarily comprised of collagen and shrinks when contacted by heat.
An example of an RF electrosurgical device is the ENSEAL® Tissue Sealing Device by Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio. Further examples of electrosurgical devices and related concepts are disclosed in U.S. Pat. No. 6,500,176 entitled “Electrosurgical Systems and Techniques for Sealing Tissue,” issued Dec. 31, 2002, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,112,201 entitled “Electrosurgical Instrument and Method of Use,” issued Sep. 26, 2006, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,125,409, entitled “Electrosurgical Working End for Controlled Energy Delivery,” issued Oct. 24, 2006, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,169,146 entitled “Electrosurgical Probe and Method of Use,” issued Jan. 30, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,186,253, entitled “Electrosurgical Jaw Structure for Controlled Energy Delivery,” issued Mar. 6, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,189,233, entitled “Electrosurgical Instrument,” issued Mar. 13, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,220,951, entitled “Surgical Sealing Surfaces and Methods of Use,” issued May 22, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,309,849, entitled “Polymer Compositions Exhibiting a PTC Property and Methods of Fabrication,” issued Dec. 18, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,311,709, entitled “Electrosurgical Instrument and Method of Use,” issued Dec. 25, 2007, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,354,440, entitled “Electrosurgical Instrument and Method of Use,” issued Apr. 8, 2008, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,381,209, entitled “Electrosurgical Instrument,” issued Jun. 3, 2008, the disclosure of which is incorporated by reference herein.
Additional examples of electrosurgical devices and related concepts are disclosed in U.S. Pat. No. 8,939,974, entitled “Surgical Instrument Comprising First and Second Drive Systems Actuatable by a Common Trigger Mechanism,” issued Jan. 27, 2015, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,161,803, entitled “Motor Driven Electrosurgical Device with Mechanical and Electrical Feedback,” issued Oct. 20, 2015, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2012/0078243, entitled “Control Features for Articulating Surgical Device,” published Mar. 29, 2012, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,402,682, entitled “Articulation Joint Features for Articulating Surgical Device,” issued Aug. 2, 2016, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,089,327, entitled “Surgical Instrument with Multi-Phase Trigger Bias,” issued Jul. 28, 2015, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 9,545,253, entitled “Surgical Instrument with Contained Dual Helix Actuator Assembly,” issued Jan. 17, 2017, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 9,572,622, entitled “Bipolar Electrosurgical Features for Targeted Hemostasis,” issued Feb. 21, 2017, the disclosure of which is incorporated by reference herein.
While various types of electrosurgical instruments have been made and used, it is believed that no one prior to the inventor(s) has made or used the invention described herein.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
For clarity of disclosure, the terms “proximal” and “distal” are defined herein relative to a surgeon, or other operator, grasping a surgical instrument having a distal end. The term “proximal” refers to the position of an element arranged closer to the surgeon, and the term “distal” refers to the position of an element arranged closer to the distal end of the surgical instrument and further away from the surgeon. Moreover, to the extent that spatial terms such as “upper,” “lower,” “vertical,” “horizontal,” or the like are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.
As used herein, the terms “about” and “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.
I. Exemplary Surgical Instrument System
A. Exemplary Surgical Instrument Having RF Cuff
As shown in
As shown best in
Grip portion (24) of surgical instrument (12) of the present example has a generally rectangular, tab-like body configured to be gripped by an operator between two or more digits, such as a thumb and a finger, for example. Cannula shaft (22) extends distally from a distal end of grip portion (24), and a suction conduit port (34) is coupled to a proximal end of grip portion (24). Suction conduit port (34) is configured to couple with suction conduit (90), to thereby fluidly couple suction source (14) with surgical instrument (12). In the present example, port (34) has a barbed configuration to promote a secure fit with suction conduit (16), which may be elastomeric. It should be understood that various other types of port configurations may be employed in other examples. As seen in
As shown best in
In use, an operator may selectively vary the amount of suction applied at open distal end (26) of cannula shaft (22) by adjusting the amount of vent opening (40) that is exposed to the ambient environment. For example, the operator may increase the amount of suction applied at open distal end (26) by closing more or all of vent opening (40) with a thumb or finger. Conversely, the operator may decrease the amount of suction applied at open distal end (26) by partially removing the thumb or finger from vent opening (40), thereby causing suction source (14) to draw air from the ambient environment through vent opening (40). Vent opening (40) may be configured such that fully exposing vent opening (40) to the ambient environment, by fully removing the thumb or finger from vent opening (40), causes suction at open distal end (26) to drop to zero. In the present example, vent opening (40) is formed with a teardrop shape, though vent opening (40) may be formed with various other suitable shapes in other examples. By way of example only, the teardrop shape (or some other elongate shape) may enable the operator to selectively vary the amount of suction at open distal end (26) of cannula shaft (22) based on the longitudinal position of the operator's thumb (or other finger) on vent opening (40).
Upper and lower surfaces (36, 38) of grip portion (24) may be configured to promote gripping of grip portion (24) by an operator. In particular, in the present example upper surface (36) provides a concave contour while lower surface (38) provides a series of ridges. By way of example only, an operator may grasp grip portion (24) by placing a thumb on upper surface (36) and the side of the index finger of the same hand on lower surface (38). The rectangular shape of grip portion (24) may provide the operator with substantial purchase on grip portion (24), while the configurations of surfaces (36, 38) may further secure the operator's grip. Surgical instrument (12) and its gripping and suction features may be further configured in accordance with one or more teachings of U.S. Pat. App. No. 62/512,830, entitled “Navigable Suction Instrument With Coaxial Annular Sensor,” filed May 31, 2017, the disclosure of which is incorporated by reference herein.
As shown in
Positive electrodes (54) of RF cuff (50) are electrically isolated from negative electrodes (56), such that an electrical coupling between any one positive electrode (54) with any one negative electrode (56) is established only when the positive and negative electrodes (54, 56) simultaneously electrically couple with the same conductive medium, such as tissue, as described below. In the present example, positive electrodes (54) are electrically coupled to a first annular conductive member (58) of cuff (50), and negative electrodes (56) are electrically coupled to a second annular conductive member (60) of cuff (50). Annular conductive members (58, 60) are arranged at a proximal end of cuff body (52) and are electrically isolated from one another. First annular conductive member (58) is electrically coupled to a first electrical lead (62), and second annular conductive member (60) is electrically coupled to a second electrical lead (64).
In the present example, electrical leads (62, 64) are arranged externally of cannula shaft (22) and are housed within wire (20) that electrically couples electrodes (54, 56) with generator (18). In some versions, electrical leads (62, 64) may be arranged within and extend proximally through cannula lumen (30), or be integrated within a sidewall of cannula shaft (22), for example. In such configurations, surgical instrument (12) may include an electrical connector (not shown) arranged on a proximal portion of instrument (12), such as on or near grip portion (24) for example. Such an electrical connector may function to electrically couple surgical instrument (12) with generator (18) via an external cable or wire, similar to wire (20) for example. In other examples, generator (18) may be in the form of a battery (not shown) housed within a body of surgical instrument (12) such that no external wires or electrical connectors are required. Other suitable ways in which generator (18) may be configured, and other suitable ways in which generator (18) may be coupled with electrodes (54, 56), will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that a switch (e.g., button on grip portion (24), footswitch, button on generator (18)) may be provided to enable the operator to selectively activate and deactivate electrodes (54, 56) as needed.
Electrodes (54, 56) of the present example are shown in the form of elongate rectangular members arranged in a single ring extending about a circumference of cuff body (52) and cannula distal end (26). In other examples, electrodes (54, 56), may be provided with various other suitable shapes and arranged in various other suitable configurations. For instance, though not shown, cuff (50) may include multiple rings of electrodes (54, 56), each ring having a circumferentially alternating arrangement of positive and negative electrodes (54, 56). Alternatively, or in addition, cuff (50) may include one or more rings of one or more positive electrodes (54), and one or more adjacent rings of one or more negative electrodes (56), such that each ring has a single polarity, with the different rings being longitudinally spaced apart from each other. In such a configuration, electrode polarities would alternate in an axial direction rather than, or in addition to, a circumferential direction.
As shown in
While RF cuff (50) is described herein as a component of suction instrument (12), it should be understood that RF cuff (50) may be incorporated into various other surgical instruments. For instance, and by way of example only, RF cuff (50) with or without its cylindrical body (52) may be provided on catheters, dilation catheters, guide catheters, guide wires, and any other suitable surgical instrument having an elongate body on which a circumferential arrangement of electrodes (54, 56) of cuff (50) may be applied. Accordingly, the teachings provided herein are not limited to suction instruments and operations per se. Other suitable instruments and procedures in which the teachings herein may be applied will be apparent to those of ordinary skill in the art. By way of example only, such instruments and procedures may include those disclosed in U.S. Pat. Pub. No. 2017/0273747, entitled “Apparatus and Method for Treatment of Ethmoid Sinus,” published Sep. 28, 2017, the disclosure of which is incorporated herein; U.S. Pat. Pub. No. 2017/0119414, entitled “Fluid Communication Features for Eustachian Tube Dilation Instrument,” published May 4, 2017, the disclosure of which is incorporated herein; U.S. Pat. Pub. No. 2017/0056632, entitled “Dilation Catheter with Expandable Stop Element,” published Mar. 2, 2017, the disclosure of which is incorporated herein; U.S. Pat. No. 9,155,492, entitled “Sinus Illumination Lightwire Device,” issued Oct. 13, 2015, the disclosure of which is incorporated by reference herein; and U.S. Pat. Pub. No. 2011/0004057, entitled “Systems and Methods for Transnasal Dilation of Passageways in the Ear, Nose or Throat,” published Jan. 6, 2011, the disclosure of which is incorporated by reference herein.
B. Exemplary Method of Using Surgical Instrument System
The ethmoid sinus (ES) includes ostia (not shown) for providing fluid communication to and from the cells of the ethmoid sinus (ES) and the nasal cavity. For instance, ostia may provide fluid paths for cells within the anterior ethmoid sinus (AES), cells within the posterior ethmoid sinus (PES), and the ethmoid bulla (EB). In some instances, suprabullar cells of the ethmoid sinus (ES) drain into the ethmoid bulla (EB). Some suprabullar cells may drain directly into the retrobullar space (RBS). The ethmoid bulla (EB) may itself provide fluid communication with the nasal cavity via one or more ostia, such that the ethmoid bulla (EB) may provide a fluid communication path between the other ethmoid sinus (ES) cells (that drain into the ethmoid bulla (EB)) and the nasal cavity. For instance, the ethmoid bulla (EB) may provide fluid communication through an ostium at the retrobullar space (RBS). The fluid communication paths provided by ostia may allow the entry of air and liquids (e.g., medications); while also allowing drainage of mucus. In some instances, the ostia may become blocked, may become functionally closed due to mucosal thickening, or may otherwise not provide sufficient fluid communication. In addition, or in the alternative, the configuration of the retrobullar space (RBS) may impede flow through the ostium of the ethmoid bulla (EB).
The anatomy of the ethmoid sinus (ES) may make it impractical to perform a dilation procedure on ostia of the ethmoid sinus (ES) using a dilation catheter to improve fluid communication within the ethmoid sinus (ES). This may lead some physicians to perform an ethmoidectomy, which is an invasive procedure that involves removal of ethmoid sinus (ES) portions (e.g., tissue and bone) using an instrument such as a debriding instrument. This kind of procedure may be somewhat crude an inelegant, resulting in removal of significant amounts of mucosa that might otherwise benefit the patient. Ethmoidectomy procedures may also have risks of inadvertent damage to optic nerves, damage to orbital muscles, damage to olfactory bulbs, damage to other anatomical structures, and even leakage of cerebrospinal fluid. Even in successful ethmoidectomies, the patient may need to return for several follow-up debridements. It may therefore be desirable to improve fluid communication from within the ethmoid sinus (ES) to the nasal cavity without resorting to a procedure like an ethmoidectomy. In some instances, this may involve the formation of an opening in one or more cells of the ethmoid sinus (ES) using a surgical instrument.
In the present example shown in
As shown in
While surgical instrument system (10) is shown in
II. Exemplary Combinations
The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
A surgical instrument, comprising: (a) an elongate body configured to be inserted through the nasal cavity of a patient; and (b) a plurality of electrodes spaced circumferentially about an exterior of the elongate body, wherein the electrodes are configured to deliver bipolar RF energy to tissue for sealing the tissue.
The surgical instrument of Example 1, wherein the elongate body is rigid.
The surgical instrument of any of the preceding Examples, wherein the elongate body comprises a shaft defining a lumen.
The surgical instrument of Example 3, wherein the shaft includes a straight portion and a bent portion.
The surgical instrument of any one or more of Examples 3 through 4, wherein the surgical instrument further comprises a grip portion, wherein the shaft extends distally from the grip portion.
The surgical instrument of any one or more of Examples 3 through 5, wherein a proximal end of the surgical instrument is configured to operatively couple with a suction source, wherein the surgical instrument is operable to draw fluid proximally through the lumen with suction provided by the suction source.
The surgical instrument of any of the preceding Examples, wherein the surgical instrument is operable to draw fluid proximally through a distal end of the surgical instrument with suction and simultaneously deliver bipolar RF energy via the electrodes to tissue for sealing the tissue.
The surgical instrument of any of the preceding Examples, wherein the electrodes are arranged at a distal end of the elongate body.
The surgical instrument of any of the preceding Examples, wherein the electrodes are arranged circumferentially with alternating polarities.
The surgical instrument of any of the preceding Examples, wherein the electrodes include a first set of electrodes having a first polarity and a second set of electrodes having a second polarity, wherein the electrodes of the first set are electrically isolated from the electrodes of the second set.
The surgical instrument of any of Example 10, wherein the electrodes of the first set are electrically coupled with a first electrical lead, wherein the electrodes of the second set are electrically coupled with a second electrical lead, wherein the first and second electrical leads are configured to electrically couple with a power source.
The surgical instrument of any of the preceding Examples, wherein the electrodes are provided by a cuff that encircles the elongate body.
The surgical instrument of Example 12, wherein the cuff is arranged at a distal end of the elongate body.
The surgical instrument of any of the preceding Examples, wherein the plurality of electrodes includes at least four electrodes.
A surgical system, comprising: (a) the surgical instrument of claim 1, wherein the surgical instrument includes a lumen; (b) a suction source operatively coupled with the surgical instrument, wherein the suction source is operable to apply suction to the surgical instrument for drawing fluid proximally through the lumen; and (c) a power source operatively coupled with the surgical instrument, wherein the power source is operable to energize the electrodes with bipolar RF energy for sealing tissue.
A surgical instrument, comprising: (a) an elongate body configured to be inserted through the nasal cavity of a patient; and (b) first and second electrodes arranged at a distal end of the elongate body, wherein the first and second electrodes are configured to deliver bipolar RF energy to tissue for sealing the tissue.
The surgical instrument of Example 16, wherein the elongate body comprises a shaft having a lumen and an open distal end, wherein the first and second electrodes are spaced circumferentially about the open distal end.
The surgical instrument of Example 17, wherein the surgical instrument is operable to draw fluid proximally through the lumen with suction.
A surgical instrument, comprising: (a) a rigid shaft configured to be inserted through the nasal cavity of a patient, wherein the rigid shaft has an open distal end and a lumen, wherein the surgical instrument is operable to draw fluid proximally through the open distal end and the lumen with suction; and (b) at least one electrode provided on an exterior of the rigid shaft, wherein the at least one electrode is configured to deliver RF energy to tissue for sealing the tissue.
The surgical instrument of Example 19, wherein the at least one electrode comprises a plurality of electrodes, wherein the electrodes are configured to deliver bipolar RF energy to tissue for sealing the tissue.
III. Miscellaneous
It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
By way of example only, versions described herein may be sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15797091 | Oct 2017 | US |
| Child | 17128276 | US |
