Distal sealing end effector with spacers

Description

BACKGROUND

The present invention relates to surgical instruments and, in various circumstances, to surgical sealing and transecting instruments.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of instances of the invention taken in conjunction with the accompanying drawings, wherein:

FIG. 1 illustrates a perspective view of a surgical instrument comprising a handle and an end effector assembly;

FIG. 2 illustrates a cross-section of the surgical instrument of FIG. 1 showing the internal working components of the handle and showing the end effector assembly in a closed configuration;

FIG. 3 illustrates a perspective view of an end effector assembly of the surgical instrument of FIG. 1;

FIG. 4 illustrates a top view of tissue;

FIG. 5 illustrates a top view of the tissue of FIG. 4 showing a segment transected and sealed along an axis B-B by the end effector assembly of FIG. 3;

FIG. 6 illustrates a top view of the tissue of FIG. 4 showing two segments transected and sealed along the axis B-B by the end effector assembly of FIG. 3;

FIG. 7 illustrates a top view of a jaw member of the end effector assembly of FIG. 3;

FIG. 8 illustrates a top view of a jaw member of the end effector assembly of FIG. 3;

FIG. 9 illustrates a top view of a jaw member of the end effector assembly of FIG. 3;

FIG. 10 illustrates a partial top view of a jaw member of the end effector assembly of FIG. 3;

FIG. 11 illustrates a partial top view of a jaw member of the end effector assembly of FIG. 3;

FIG. 12 illustrates a partial top view of a jaw member of the end effector assembly of FIG. 3;

FIG. 13 illustrates a partial top view of a jaw member of the end effector assembly of FIG. 3; and

FIG. 14 illustrates a partial top view of a jaw member of the end effector assembly of FIG. 3.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a surgical system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, an element of a system, device, or apparatus that “comprises,” “has,” “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.

The terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up”, and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the person of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein can be used in numerous surgical procedures and applications including, for example, in connection with open surgical procedures. As the present Detailed Description proceeds, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein can be inserted into a body in any way, such as through a natural orifice, through an incision or puncture hole formed in tissue, etc. The working portions or end effector portions of the instruments can be inserted directly into a patient's body or can be inserted through an access device that has a working channel through which the end effector and elongated shaft of a surgical instrument can be advanced.

Turning to the Drawings wherein like numerals denote like components throughout the several views, FIG. 1 depicts an electrosurgical device 10 for use in various surgical procedures. The device 10 may include a handle assembly 80 and an end effector assembly 20. In certain instances, the device 10 may include a shaft 12 which has a distal end 14 dimensioned to mechanically engage with the end effector assembly 20 and a proximal end 16 (FIG. 2) which mechanically engages the handle assembly 80. As illustrated in FIG. 1, the end effector assembly 20 can be attached to the distal end 14 of shaft 12 and may include a pair of opposing jaw members 22 and 24; the handle assembly 80 can be attached to the proximal end 16 of shaft 12 and may include internally-disposed activating mechanisms, e.g., a movable handle 82 and a drive assembly 70, which mechanically cooperate to impart movement of the jaw members 22 and 24 from an open configuration wherein the jaw members 22 and 24 are disposed in a spaced relation relative to one another, to a clamping, closed, or approximated configuration wherein the jaw members 22 and 24 cooperate to grasp tissue therebetween, for example.

It is envisioned that the device 10 may be designed such that it is fully or partially disposable depending upon a particular purpose or to achieve a particular result. For example, end effector assembly 20 may be selectively and releasably engageable with the distal end 14 of the shaft 12 and/or the proximal end 16 of the shaft 12 may be selectively and releasably engageable with the handle assembly 80. In either of these two instances, the device 10 would be considered “partially disposable”, i.e., a new or different end effector assembly 20 (or end effector assembly 20 and shaft 12) selectively replaces the old end effector assembly 20 as needed.

FIGS. 1 and 2 are taken from U.S. Pat. No. 7,473,253, entitled VESSEL SEALER AND DIVIDER WITH NON-CONDUCTIVE STOP MEMBERS, which issued on Jan. 6, 2009. FIGS. 1 and 2 illustrate exemplary operating elements and internal-working components of the handle assembly 80 which for the purposes of the present disclosure are generally described herein. The specific functions and operative relationships of these elements and the various internal-working components are described in more detail in U.S. Pat. No. 7,083,618, entitled VESSEL SEALER AND DIVIDER, which issued on Aug. 1, 2006. The entire disclosure of U.S. Pat. No. 7,083,618, entitled VESSEL SEALER AND DIVIDER, which issued on Aug. 1, 2006, is hereby incorporated by reference herein in its entirety. In addition, the entire disclosure of U.S. Pat. No. 7,473,253, entitled VESSEL SEALER AND DIVIDER WITH NON-CONDUCTIVE STOP MEMBERS, which issued on Jan. 6, 2009, is hereby incorporated by reference herein in its entirety. In addition, the entire disclosure of U.S. Pat. No. 7,491,201, entitled TISSUE SEALER WITH NON-CONDUCTIVE VARIABLE STOP MEMBERS AND METHOD OF SEALING TISSUE, which issued on Feb. 17, 2009, is hereby incorporated by reference herein in its entirety. In addition, the entire disclosure of U.S. Pat. No. 7,267,677, entitled VESSEL SEALING INSTRUMENT, which issued on Sep. 11, 2007, is hereby incorporated by reference herein in its entirety.

Referring again to FIGS. 1 and 2, the handle assembly 80 may include the movable handle 82 and a fixed handle 84. The movable handle 82 may include an aperture 89 defined therethrough which enables a user to grasp and move the handle 82 relative to the fixed handle 84, for example. In certain instances, the movable handle 82 can be selectively moveable about a pivot 87 from a first position relative to the fixed handle 84 to a second position in closer proximity to the fixed handle 84 which, as explained below, may impart relative movement of the jaw members 22 and 24 relative to one another.

In certain instances, the handle assembly 80 may house the drive assembly 70 which cooperates with the movable handle 82 to impart movement of the jaw members 22 and 24 from an open configuration wherein the jaw members 22 and 24 are disposed in spaced relation relative to one another, to a clamping, approximated, or closed configuration wherein the jaw members 22 and 24 cooperate to grasp tissue therebetween. In certain instances, the handle assembly 80 can generally be characterized as a four-bar mechanical linkage, for example, which may be composed of the following elements: movable handle 82, a link 73, a cam-like link 76 and a base link embodied by fixed pivot points 75 and 77.

Movement of the handle 82 may activate the four-bar linkage which, in turn, may actuate the drive assembly 70 for imparting movement of the opposing jaw members 22 and 24 relative to one another to grasp tissue therebetween. Other drive assemblies for moving at least one of the jaw members 22 and 24 relative to the other one of the jaw members 22 and 24 are contemplated by the present disclosure. In certain instances, one of the jaw member 22 and 24 can be fixed relative to the shaft 12 such as, for example, the jaw member 22; in such instances, the jaw member 24 can be movable relative to the jaw member 22 between the open configuration and the closed, clamped, or approximated configuration by advancing and retracting a reciprocating member which is operably coupled to the jaw member 24 and the movable handle 82, for example. The operation of the various working components of the drive assembly 70 are explained in detail in the above-mentioned U.S. Pat. No. 7,083,618, for example. Once the tissue is grasped between opposing jaw members 22 and 24, electrosurgical energy can be supplied to the jaw members 22 and 24 through an electrosurgical interface 110 disposed within the handle 84 as explained in more detail the above-mentioned U.S. Pat. No. 7,083,618, for example. In various instances, as illustrated in FIG. 1, the device 10 may include a trigger 86 which reciprocates a cutting member 60 disposed within the end effector assembly 20. Once a tissue seal is formed, the user can activate the trigger 86 to transect the sealed tissue.

Referring to FIG. 3, the device 10 may comprise an end effector assembly 20′ which may replace the end effector assembly 20. The end effector assembly 20′ can be similar in many respects to the end effector assembly 20. In certain instances, the end effector assembly 20′ may include jaw members 22′ and 24′ which are similar in many respects to the jaw members 22 and 24, respectively. For example, the jaw members 22′ and 24′ can be operable to capture tissue in a similar manner to the jaw members 22 and 24. In certain instances, as illustrated in FIG. 3, the end effector assembly 20′ may extend along a curved path. In result, distal ends 25 and 27 of the jaw members 22′ and 24′, respectively, may deviate to the right or to the left from a longitudinal axis A-A, as illustrated in FIG. 3, for example.

In certain instances, each of the jaw members 22′ and 24′ may include an electrically conductive sealing surface 35 dispose on an inner-facing surface 30 thereof and an insulator 34. It is envisioned that the electrically conductive surfaces 35 cooperate to seal tissue held therebetween upon the application of electrosurgical energy. In certain instances, the electrically conductive sealing surfaces 35 may also include a pinch trim which facilitates secure engagement of the electrically conductive surfaces 35 to the insulators 34 and also simplifies the overall manufacturing process, for example. In certain instances, a least one of the electrically conductive surfaces 35 of the jaw members, e.g., 22′, may include a longitudinally-oriented channel 36 defined therein which may extend longitudinally along a length of the jaw member 22′, for example. It is envisioned that the channel 36 facilitates longitudinal reciprocation of the cutting member 60. In certain instances, the elongate slot 36 may include a distal end 28; the cutting member 60 can be advanced distally through the elongate slot 36 up to the distal end 28.

In use, a clinician may place the end effector assembly 20′ and close the jaws members 22′ and 24′ around a tissue bite to be acted upon, for example, by pivoting the movable handle 82, as described above. Once the tissue bite is secure between the jaw members 22′ and 24′, energy may flow between the electrically conductive surfaces 35 and through the captured tissue. The provision of energy may be accomplished in any suitable way. See, for example, U.S. Patent Publication No. 2011/0087216 A1, entitled SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, and filed Oct. 1, 2010, the entire disclosure of which is hereby incorporated by reference herein.

Referring to FIGS. 3-6, in certain instances, the end effector assembly 20′ may be configured to seal and transect or cut a large tissue 200 such as, for example, Mesentery tissue. As illustrated in FIGS. 4-6, the end effector assembly 20′ may seal and transect the large tissue 200 in segments along an axis B-B, for example. In certain instances, the jaw members 22′ and 24′ can be large jaw members suitable for sealing and transecting large segments tissue to reduce the total number of segments to be sealed and transected by the device 10 in order to seal and transect the large tissue. In certain instances, the jaw members 22′ and 24′ may each comprise any length selected from a range of about 15 mm, for example, to about 30 mm, for example. In certain instances, the jaw members 22′ and 24′ may each comprise a length of about 20 mm, for example. Other ranges for the lengths of the large jaw members 22′ and 24′ are contemplated by the present disclosure.

In certain instances, the end effector assembly 20′ may be configured to seal and transect small tissue, for example. In such instances, the jaw members 22′ and 24′ can be small jaw members suitable for sealing and transecting the small tissue. For example, in certain instances, the jaw members 22′ and 24′ may each comprise any length selected from a range of about 5 mm, for example, to about 10 mm, for example. Other ranges for the lengths of the small jaw members 22′ and 24′ are contemplated by the present disclosure.

Referring again to FIG. 3, in certain instances, at least one jaw member 22′ and/or 24′ may include one or more stop members 50 which may limit the movement of the two opposing jaw members 22′ and 24′ relative to one another. In certain instances, the stop members 50 may extend from the sealing surface or tissue contacting surface 35 a predetermined distance according to the specific material properties (e.g., compressive strength, thermal expansion, etc.) to yield a consistent and accurate gap distance between the two opposing jaw members 22′ and 24′. In certain instances, the gap distance maintained by the stop members 50 between opposing sealing surfaces 35 may range from about 0.001 inches, for example, to about 0.005 inches, for example. In certain instances, the gap distance may range from about 0.002 inches, for example, to about 0.003 inches, for example.

In certain instances, the stop members 50 can be made from one or more electrically insulative or non-conductive materials such as, for example, parylene, nylon and/or ceramic. It is envisioned that the stop members 50 may be disposed on one or both of the jaw members 22′ and 24′ in various configurations and arrangements to prevent short circuiting of the jaw members 22′ and 24′ and/or enhance the gripping characteristics of the jaw members 22′ and 24′ during sealing and transecting, for example. In certain instances, the stop members 50 may comprise various shapes and geometries such as, for example, a cylindrical shape and/or a circle-like cross-section. It is envisioned that the stop members 50 can be substantially equal in size; however, one or more of the stop members 50 may be dimensioned larger or smaller than the other stop members, for example.

In certain instances, the stop members 50 can be molded onto the jaw members 22′ and 24′ (e.g., over-molding, injection molding, etc.), stamped onto the jaw members 22′ and 24′ or deposited onto the jaw members 22′ and 24′, for example. Stamping is defined herein to encompass virtually any press operation known in the trade, including but not limited to: blanking, shearing, hot or cold forming, drawing, bending, and coining. In certain instances, the stop members 50 can extend from one or both of the electrically conductive surfaces 35 of the jaw members 22′ and 24, for example. In certain instances, the stop members 50 can be attached to the electrically conductive surfaces 35 in a snap-fit manner, for example. Alternatively, the stop members 50 can be molded onto the electrically conductive surfaces 35, for example. Alternatively, the stop members 50 can be adhered to the electrically conductive surfaces 35 by any suitable adhesive, for example. Other techniques for positioning the stop members 50 with respect to the electrically conductive surfaces 35 are contemplated by the present disclosure.

In certain instances, the stop members 50 can be created by thermally spraying a ceramic material onto the surface of the jaw member 22′ and 24′ to form the stop members 50, for example. Several thermal spraying techniques are contemplated which involve depositing a broad range of heat resistant and insulative materials on the electrically conductive surfaces 35 to create stop members 50 such as High velocity Oxy-fuel deposition and plasma deposition, for example.

Referring to FIG. 7, an exemplary embodiment of the jaw member 22′ is illustrated. For illustration purposes, the following disclosure describes the construction and features of the jaw member 22′. For conciseness and clarity of disclosure, a detailed description of the construction and features of the jaw member 24′ is omitted, it being understood that the jaw member 24′ may comprise the same, or a similar, construction and features as the jaw member 22′. In certain instances, as illustrated in FIG. 7, the electrically conductive surface 35 of the jaw member 22′ may include a distal electrically conductive region 202 and a proximal electrically conductive region 204. In certain instances, the proximal electrically conductive region may comprise a plurality of the stop members 50 which can be disposed on the proximal electrically conductive region 204 and may interrupt energy flow between the proximal electrically conductive region of the jaw member 22′ and a corresponding electrically conductive region of the jaw member 24′. In certain instances, the proximal electrically conductive region 204 can be bifurcated into a first proximal electrically conductive region 204a and a second proximal electrically conductive region 204b by the passing of the elongate slot 36 therethrough, as illustrated in FIG. 7. In certain instances, the stop members 50 can be disposed onto the first proximal electrically conductive region 204a and the second proximal electrically conductive region 204b, for example. In certain instances, the distal electrically conductive region 202 can be defined by the lack or absence of interrupters that interrupt energy flow to or from the electrically conductive surface 35 of the distal electrically conductive region 202, for example. In certain instances, the distal electrically conductive region 202 can be defined by the lack or absence of stop members on the electrically conductive surface 35 of the distal electrically conductive region 202, for example.

In certain instances, as illustrated in FIG. 7, the distal electrically conductive region 202 can be an uninterrupted electrically conductive region permitting uninterrupted energy flow between the distal electrically conductive region 202 of the jaw member 22′ and a corresponding uninterrupted electrically conductive region of the jaw member 24′ through the tissue captured therebetween, for example. In certain instances, as illustrated in FIG. 5, a sealed and transected segment of tissue such as, for example, the tissue 200 may comprise a distal end portion 206 which can be subject to significant tension forces due, in part, to its terminal position. In certain instances, the uninterrupted flow of energy between the distal electrically conductive region 202 of the jaw member 22′ and the corresponding uninterrupted electrically conductive region of the jaw member 24′ may provide a sufficiently secure seal at the distal end portion 206 to prevent or significantly reduce bleeding by creating an uninterrupted seal at the distal end portion 206. In certain instances, the uninterrupted seal may significantly reduce the instance of a fracture at the distal end portion 206 post sealing which may prevent or significantly reduce the instance of renewed bleeding, for example.

In certain instances, the surface area of the distal uninterrupted electrically conductive region 202 can be about one quarter, for example, of the surface area of the proximal interrupted electrically conductive region 204. The reader will appreciate that the surface area of the distal uninterrupted electrically conductive region 202 can determine the size, quality, and/or shape of the seal at the distal end portion 206 of the tissue 200. In certain instances, the surface area of the distal uninterrupted electrically conductive region 202 can be about one third, for example, of the surface area of the proximal interrupted electrically conductive region 204. In certain instances, the surface area of the distal uninterrupted electrically conductive region 202 can be about one half, for example, of the surface area of the proximal interrupted electrically conductive region 204. In certain instances, the surface area of the distal uninterrupted electrically conductive region 202 can be equal, or at least substantially equal, to the surface area of the proximal interrupted electrically conductive region 204, for example. In certain instances, the ratio of the surface area of the distal uninterrupted electrically conductive region 202 to the surface area of the proximal interrupted electrically conductive region 204 may be any value selected from a range greater than or equal to about one fifth, for example, and less than or equal to about one, for example.

Referring to FIGS. 7-9, in certain instances, the surface 35 of the jaw member 22′ may extend between a proximal end 26 and a distal end 31. In certain instances, the distal uninterrupted electrically conductive region 202 may comprise a length L1 extending proximally from the distal end 31; and the proximal interrupted electrically conductive region 204 may comprise a length L2 extending distally from the proximal end 26 and residing proximal to the length L1, for example. In certain instances, the lengths L1 and L2 may extend along an axis L-L which can be aligned with the elongate slot 36, for example. In certain instances, the ratio of the length L1 to the length L2 can be any value selected from a range greater than or equal to about one fifth, for example, and less than or equal to about two, for example. In certain instances, the length L1 can be about one half, for example, of the length L2. In certain instances, the length L1 can be about one quarter, for example, of the length L2. In certain instances, as illustrated in FIG. 7, the length L1 can be about one fifth, for example, of the length L2.

Referring to FIGS. 10 and 11, in certain instances, the distal uninterrupted electrically conductive region 202 can be defined by a circular perimeter 212, for example. It is envisioned that the circular perimeter 212 may encompass the distal uninterrupted electrically conductive region 202. In certain instances, the circular perimeter 212 may have a radius comprising a length that is about double the distance between the distal end 28 of the elongate slot 36 and the distal end 31 of the electrically conductive surface 35, for example. In certain instances, the circular perimeter 212 may encompass a distal portion 214 of the elongate slot 36, as illustrated in FIG. 10, for example. In certain instances, as illustrated in FIG. 11, the distal end 31 of the electrically conductive surface 35 may be located on the circular perimeter 212, for example. In certain instances, the circular perimeter 212 may have a radius comprising a length that is about triple the distance between the distal end 28 of the elongate slot 36 and the distal end 31 of the electrically conductive surface 35, for example. In certain instances, the circular perimeter 212 may have a radius comprising a length that is about quadruple the distance between the distal end 28 of the elongate slot 36 and the distal end 31 of the electrically conductive surface 35, for example.

Referring to FIGS. 12 and 13, in certain instances, the first proximal electrically conductive region 204a may include a peripheral point on an outer perimeter 217 of the electrically conductive surface 35 on a first lateral side of the elongate slot 36 such as, for example, peripheral point 216. In certain instances, the second proximal electrically conductive region 204b may include a peripheral point on the outer perimeter 217 on a second lateral side, opposite the first lateral side, of the elongate slot 36 such as, for example, peripheral point 218. In certain instances, the distal uninterrupted electrically conductive region 202 can be defined by a circular perimeter 220, for example. It is envisioned that the circular perimeter 220 may encompass the distal uninterrupted electrically conductive region 202. In certain instances, the circular perimeter 220 may have a diameter comprising a length that is equal, or at least substantially equal, to the distance between the peripheral point 216 and the peripheral point 218, for example. In certain instances, the circular perimeter 220 may encompass the distal end 28 of the elongate slot 36, as illustrated in FIG. 12. In certain instances, the circular perimeter 220 may encompass the distal end 31 of the electrically conductive surface 35, as illustrated in FIG. 13. In certain instances, as illustrated in FIG. 13, the distal end 31 of the electrically conductive surface 35 may be located on the circular perimeter 220, for example. In certain instances, the circular perimeter 220 can be tangential to the outer perimeter 217 of the electrically conductive surface 35, for example.

Referring to FIG. 14, in certain instances, the jaw member 22′ may include an outer perimeter 227 which may include a peripheral point on the first lateral side of the elongate slot 36 such as, for example, peripheral point 226. In certain instances, the outer perimeter 227 may also include a peripheral point on the second lateral side of the elongate slot 36 such as, for example, peripheral point 228. In certain instances, the distal uninterrupted electrically conductive region 202 can be defined by a circular perimeter 230, for example. It is envisioned that the circular perimeter 230 may encompass the distal uninterrupted electrically conductive region 202. In certain instances, as illustrated in FIG. 14, the circular perimeter 230 may have a diameter comprising a length that is equal, or at least substantially equal, to the distance between the first peripheral point 226 and the second peripheral point 228, for example. In certain instances, as illustrated in FIG. 14, the circular perimeter 230 may encompass the distal end 31 of the electrically conductive surface 35. In certain instances, as illustrated in FIG. 14, the circular perimeter 230 may encompass the distal end 28 of the elongate slot 36. In certain instances, as illustrated in FIG. 14, the circular perimeter 230 can be tangential to the outer perimeter 227 of the jaw member 22′.

The devices disclosed herein can be designed to be disposed of 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 the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can 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.

Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

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 materials 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.

While this invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.