Patent Description:
Nerves can be transected for a variety of reasons. Whether the nerve is transected deliberately or by accident, repair of the nerve can be facilitated if a nerve end is cut and free of frayed or damaged areas, or randomly extending axons and tissue. Clean nerve ends can be easier to coapt to other nerve ends or grafts and can promote alignment of the axons from each terminal nerve end. Also, nerve ends that are to be capped or covered can be easier to manipulate and development of neuromas can be minimized if the nerve end is free of randomly extending axons.

In order to obtain a clean cut nerve end, it may be necessary to resection the nerve tissue some distance away from the terminal end, to remove damaged or non-viable tissue at the terminal nerve end. Resection of nerve tissue can be difficult. If done incorrectly it can result in a new terminal nerve end that is crushed, frayed, or that has multiple transection lines caused by the cutting implement making multiple passes or sawing across the tissue. Properly bracing the circumference of the nerve in the area of transection can minimize such damage to the one or more new terminal nerve ends. There are devices that can be used to support a nerve, while a cutting implement is used to transect the nerve. Often these devices do not entirely brace the full circumference and secure the position of the nerve, thus, allowing the nerve to roll or turn during the cutting process. This can necessitate excessive force being applied by the cutting implement in order to hold the nerve while it penetrates the tougher outer epineurium. This force can crush the softer internal nerve tissues. Alternatively, a cutting implement may have to be passed through the tissue more than once to incrementally sever the nerve tissue, which can result in a frayed nerve end.

If the resected nerve end is to be coapted to, or inserted into, a graft or implant, the nerve must be measured in vivo, so that an appropriately-sized graft can be selected. It has been demonstrated that when obtaining sizes of nerves during surgical procedures, the measurements are usually inaccurate. Nerve tissue is soft and pliable and does not often have a defined diametric shape. As such, it can be difficult to visually estimate the size of a nerve or obtain an accurate measurement of the diameter when the nerve is placed on a flat measuring surface.

Every manipulation and change of equipment or tools that must be made during surgery takes time and increases the opportunities for error. Devices and surgical tools that have multiple functions are desirable, as they can reduce the number of manipulations necessary to complete a procedure.

<CIT> describes a tissue measuring and suturing device. <CIT> describes a multi-ringed separator for tubular organs. <CIT> describes surgical forceps for anastomosis. <CIT> illustrates a wire connector. <CIT> describes surgical forceps. <CIT> describes a frenotomy method and apparatus. <CIT> describes forceps with v-shaped grasping tips. <CIT> describes surgical forceps including a belt blade reverser mechanism. <CIT> describes forceps. <CIT> describes surgical forceps. <CIT> describes a needle holder and suture cutter surgical instrument.

In accordance with the subject invention, the problem of measuring the diameter of a nerve and transecting the nerve to obtain a clean nerve end for coaptation or capping procedures is solved by the use of a single sizing forceps instrument.

The sizing forceps can surround a nerve in the area to be transected providing peripheral bracing of the nerve. The sizing forceps can also secure the position of the nerve, to minimize sliding or rolling of the nerve during the transecting process. This allows the nerve to be cut in a single stroke or at least with minimal strokes. The sizing forceps can also have multiple apertures of different diameters in the head end. The nerve diameter can be determined by selecting the appropriately sized aperture that encloses but does not pinch, constrict, or otherwise damage the nerve tissue. The correctly selected aperture can also be used to brace an area of the periphery of the nerve without crushing or damaging the nerve.

Specific embodiments of a sizing forceps have two pivoting members, each member having a handle portion and a jaw portion, where the combined jaw portions form the head end. A pivot point located between the handle portion and the jaw portions allows the pivoting members to rotate, in relation to one another, around the pivot point. The jaw portion of each pivoting member can have multiple diameter semi-circular cut-outs. When the handle portions are brought together through rotation around the pivot point, the jaw portions are simultaneously brought together so the semi-circular cut-outs are aligned to form the multiple diameter apertures in the head.

Advantageously, the jaw portions align across and make contact with surfaces between the semi-circular cut-outs on each jaw portion. This inhibits the jaw portions from coming any closer together and maintains the diameters of the multiple apertures. Thus, regardless of the amount of force applied to the handle portions, the jaw portions will maintain alignment and the prescribed aperture diameters. Chamfering of select edges can also inhibit pinching of the nerve tissue.

Once the correct aperture size has been determined and a nerve is braced and secured therein, the nerve can be cut. The blade used should be surgically sharp, straight, and free of defects on the cutting edge. The nerve can be cut by several techniques using the sizing forceps. The nerve extending out from either side of an aperture can be transected by placing the blade along an outside edge of the head end and slicing transversely across the aperture. There can also be a slicing slot within the head end. A slicing slot can longitudinally bisect the jaw portions, thereby bisecting each aperture. A blade passed through the slicing slot will cut across a nerve in one of the apertures.

The head portion can be angled or slanted on the handle portion to provide easier access to a nerve, particularly a nerve in vivo, where other tissues can obstruct access. The edges of the head portion can also be rounded, curved, flattened, or otherwise smoothed to inhibit abrasion of tissues that the head contacts.

Advantageously, the embodiments of the subject invention do not require excessive force to be applied against the jaw portions. As long as the jaw portions can be closed and their faces aligned against each other, nerve tissue within an aperture can be measured and cut. This can enable the sizing forceps to be manufactured from any of a variety of materials, including materials amenable to being disposable or recyclable.

In order that a more precise understanding of the above recited invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. The drawings presented herein may not be drawn to scale and any reference to dimensions in the drawings or the following description is specific to the embodiments disclosed. Any variations of these dimensions that will allow the subject invention to function for its intended purpose are considered to be within the scope of the subject invention.

The subject invention provides a surgical tool for sizing and assisting with transection or cutting of tissue. In specific embodiments, the subject invention provides sizing forceps, or similar devices, for use in measuring the diameter of a nerve and bracing and holding an area of the nerve in place for transection.

The subject invention is particularly useful in the field of surgical nerve repair, including nerve grafting or nerve coaptation procedures, where the non-viable or damaged tissue of a nerve needs to be removed prior to a procedure.

In the description that follows, a number of terms used with regard to surgical repair of tissues are utilized. In order to provide a clear and consistent understanding of the specification and claims, including the scope to be given such terms, the following definitions are provided.

The terms "nerve" and "nerve tissue" as used herein are merely for literary convenience. The embodiments of the subject invention are not limited to use with only nerve tissue and can be utilized with other tissues, such as, for example, blood vessels and tendons.

Further, reference is made throughout the application to the "proximal end" and "distal end. " As used herein, the proximal end is that end placed nearest to the nerve tissue or the patient during use. For example, the head portion is at the proximal end of the sizing forceps. Conversely, the distal end of the device is that end closest to the surgeon during use. For example, the handle portion is at the distal end of the sizing forceps.

As used in the specification and in the claims, the singular for "a," "an" and "the" include plural referents unless the context clearly dictates otherwise.

Reference will be made to the attached figures on which the same reference numerals are used throughout to indicate the same or similar components. With reference to the attached figures, which show certain embodiments of the subject invention, it can be seen in <FIG> that a sizing forceps <NUM> comprises first member <NUM> and a second member <NUM>, each having a handle portion <NUM> with a proximal end <NUM> and a distal end <NUM>. At the proximal end of the handle portion of each member there are attached a lower jaw <NUM> and an upper jaw <NUM> that are cooperatively engaged to come together and form a head portion <NUM> with one or more apertures <NUM> for receiving a nerve without pinching, constricting, or otherwise damaging the nerve tissue. Each of these general components can have one or more sub-components, which will be discussed in detail below.

The first member <NUM> and the second member <NUM> can be joined so that they can be simultaneously manipulated to control the opening and closing of the handle portion <NUM> and the head portion <NUM>. In one embodiment, the first member has a first handle <NUM> and a lower jaw <NUM> and the second member <NUM> has a second handle <NUM> and an upper jaw <NUM>. In an alternative embodiment, the first member has a first handle <NUM> and an upper jaw <NUM> and the second member <NUM> has a second handle and a lower jaw <NUM>. As will be discussed below, a biasing member can be utilized to hold the handles together or apart, which can determine whether the jaws are maintained in an opened or closed position. A person with skill in the art would be able to determine the appropriate arrangement of the handles and the jaws and whether a biasing element is required. Such variations are within the scope of this invention.

The first member has a first outer side <NUM> from the handle portion to the head portion. The first member also has a first inner side <NUM> that extends from the handle portion to the head portion, but includes a joint area <NUM> between the handle portion and the head portion, at which the first member rotates against the second member. Likewise, the second member <NUM> has second outer side <NUM> from the handle portion to the head portion. The second member also has a second inner side <NUM> that extends from the handle portion to the head portion, but includes a joint area <NUM> between the handle portion and the head portion, at which the second member rotates against the first member.

When the first member <NUM> and the second member <NUM> are rotatably connected, as discussed below, the first handle <NUM> and the second handle <NUM> constitute the handle portion <NUM> that can be manipulated to bring the lower jaw <NUM> and the upper jaw <NUM> together. In one embodiment, the handle portion has a scissors-like configuration, as shown for example, in <FIG> and <FIG>. This embodiment has a first handle <NUM>, to which the lower jaw <NUM> can be attached, and a second handle <NUM>, to which the upper jaw <NUM> can be attached, the members being configured as left and right symmetrical with each other and pivotally attached by a joint member <NUM> at their proximal ends <NUM>. Joint members are known in the art and allow rotation about a common axis <NUM>, as shown, for example, in <FIG>. When the first handle and second handle are squeezed together, along a longitudinal line <NUM>, which is illustrated in <FIG> and <FIG>, the motion can bring the lower jaw and upper jaw, at the proximal ends of the respective members, into contact. <FIG> and <FIG> show non-limiting examples of an embodiment where the handle members come together at the longitudinal line <NUM>.

In another embodiment, the first handle <NUM> and the second handle <NUM> are pivotally connected with a joint member <NUM> at their proximal ends <NUM> and are urged apart by a compression spring or other biasing member <NUM>. It can be beneficial for the handle members of the handle portion <NUM> to be curved, as shown, for example, in <FIG>, to facilitate rotation of the handle portions and the jaws. The upper jaw and lower jaw can be connected to the first handle and second handle, respectively, such that when the handle members are squeezed towards each other, or towards the longitudinal line <NUM> of the handle portion, the jaws are separated. When the members are not squeezed, the biasing member forces the handle members apart, which brings the jaws together, as shown for example in <FIG>. Other handle types could also be utilized. Thus, any configuration of the handle portion <NUM> that provides control over the opening and closing of the upper jaw and lower jaw is within the scope of this invention.

When the first member <NUM> and the second member <NUM> are rotatably connected, the lower jaw <NUM> and the upper jaw <NUM> constitute a head portion <NUM>. In general, the head portion <NUM> can operate in tandem with the handle members, as discussed above, so that the jaws can come together along all or at least some portion of the lengthwise extent <NUM> of the head portion. Preferably, the jaws do not cross or pass each other, but are aligned along the lengthwise extent. <FIG>, <FIG>, and <FIG> illustrate examples of the lengthwise extent <NUM> of a head portion. The alignment of the head portion <NUM> relative to the handle portion <NUM> can be variable, to accommodate use of the sizing forceps <NUM> in different situations. In one embodiment, the head portion can be aligned with the handle portion, such that the longitudinal line <NUM> of the handle portion is coplanar, collinear, or otherwise in-line with the lengthwise extent <NUM> of the head portion. <FIG>, <FIG>, <FIG>, and <FIG> illustrate non-limiting examples of this embodiment.

In another embodiment, the head portion <NUM> is angled relative to the handle portion <NUM>, such that the lengthwise extent <NUM> of the head portion is angled or bent relative to the longitudinal line <NUM> of the handle portion. <FIG>, <FIG>, <FIG>, and <FIG> illustrate non-limiting examples of this embodiment. In one embodiment, the head portion is angled, relative to the handle portion, between approximately <NUM>° and approximately <NUM>°. In a particular embodiment, the head portion is angled, relative to the handle portion, between approximately <NUM>° and approximately <NUM>°. In one specific embodiment, the head portion is angled, relative to the handle portion, at approximately <NUM>°, one example of which is shown in <FIG> and <FIG>. In another specific embodiment, the head portion is angled, relative to the handle portion, at approximately <NUM>°, which is shown, by way of example in <FIG>. The ability to determine alternative angles for the head portion is within the capability of one of ordinary skill in the art and such variations are within the scope of this invention.

When placing the head portion around a nerve, the jaws are separated by the handle members and the lower jaw can be positioned approximately perpendicular to the length of the nerve and slid around the nerve so that the nerve is between the upper jaw and the lower jaw. The shape of the upper and/or the lower jaw can facilitate the procedure of sliding the jaw around the nerve. In one embodiment, the edges and surfaces of the upper and lower jaws are beveled or smoothed to reduce sharp or rough edges and encourage sliding of the nerve over those surfaces. In a further embodiment, the upper jaw and lower jaw are tapered towards the proximal end <NUM>, so that the proximal end of the head portion <NUM> is narrower or has a smaller diameter than the distal end of the head portion. By way of example, <FIG> shows a first diameter, D<NUM>, at the distal end <NUM> of the head portion and a second diameter, D<NUM>, at the terminal proximal end <NUM> of the head portion. It can be seen that, in this example, D<NUM> is larger than D<NUM>, indicating a smaller diameter at the proximal end. Alternatively, the diameter of D1 and D2 are the same or approximately the same.

The boundary that separates the head portion <NUM> and handle portion <NUM> can be the joint area <NUM>. In one embodiment, the joint area comprises two surfaces <NUM>, which are located on the first inner side <NUM> of the first member <NUM> and the second inner side <NUM> of the second member <NUM>. The joint area can also include a joint member <NUM>, which can be on either or both surfaces, that rotatably connects the handle members <NUM> and <NUM>, where the handle portions come together at the common axis <NUM> to rotate against each other. <FIG> shows a non-limiting example of a joint area. In one embodiment, the surfaces <NUM> are recessed or narrower than the handle and the jaws, as shown, for example, in <FIG>. The narrowness allows the handle members and upper and lower jaws to overlap, when the handle members are connected by the joint member <NUM> at the common axis <NUM>. The recessed surface can extend out from the joint member a sufficient distance to allow the handle members and jaws to rotate without being impinged upon by material or surfaces around the recessed surface. The use of a joint area and a joint member to form a pivotal connection is known in the art. A person having skill in the art will be able to determine the appropriate dimensions for recessed surface that will allow proper rotation around the joint member. Such variations in the configuration of a joint area are within the scope of the subject invention.

As mentioned previously, the head portion <NUM> includes the lower jaw <NUM> and the upper jaw <NUM>, which pivot by the rotation of their respective handle members on a joint member <NUM>. While the invention is described herein with reference to the upper jaw and the lower jaw, it should be understood that these terms are not intended to confer any order or specific placement in structural orientation. The upper jaw could just as readily be used in a position below or to the side of the lower jaw described herein, and vice versa. Thus, reference to upper jaw and lower jaw are for descriptive purposes and are not intended to limit the invention or its use in any way.

In one embodiment, the lower jaw <NUM> has a first face <NUM> and at least one notch <NUM> within the first face. In one embodiment, the first face is a substantially flat surface, whereby an imaginary plane across the flat surface will be parallel to the lengthwise extent <NUM>, as shown, for example, in <FIG>. This can urge the lower jaw and the upper jaw to align with each other, as shown in the example in <FIG> and <FIG>. The flat alignment of the upper and lower jaw can also inhibit one or the other jaw from sliding past the other if excessive force is applied to the handle members.

In a further embodiment, the first face is interrupted by at least one notch <NUM> that is cut, molded, or otherwise formed transverse to the lengthwise extent <NUM> of the lower jaw, such that the notch further opens onto the side edges <NUM> of the jaw, which is shown, for example, in <FIG> and <FIG>. In other words, the at least one notch can be perpendicular to the lengthwise extent. The at least one notch within the lower jaw opens onto the first face, which breaks or divides the first face into smaller interstitial faces <NUM>. In a further embodiment, there are two or more notches <NUM> within the lower jaw. In a specific embodiment, there are five notches within the lower jaw that interrupt the first face, wherein the notches open onto the first face, forming multiple interstitial faces <NUM>, as shown, for example, in <FIG>.

The at least one notch in the lower jaw can have any circumferential shape. Multiple notches in a lower jaw could also have different circumferential shapes. It can be preferable, though not required, for the shape to be curved, which can be more conforming to the shape of a nerve and beneficial for cutting. In one embodiment, the notches are substantially semi-circular, as shown by way of example in <FIG> and <FIG>. In another embodiment, the notches are semi-oval, or U-shaped, wherein the long axis can be either parallel or perpendicular to the lengthwise extent <NUM>, as shown in the example in <FIG> and <FIG>. In yet another embodiment, the notches are semi-ovate, such as shown, for example, in <FIG>. Other curved shapes could also be used, including but not limited to, semi-ovate, multi-curved or waved, hyperbolic, or other curved or semi-curved forms.

In another embodiment, the circumferential shape of a notch has at least one straight side. By way of example, a notch could have an arch-type circumference, where the sides are parallel and straight and the bottom or closed end <NUM> is rounded. A notch could also be square or rectangular, where there are no curved edges. Furthermore, the notches can have the same or different circumferential shapes.

In another embodiment, the lower jaw has two or more notches, each of different size diameters. In a specific embodiment, shown, by way of example, in <FIG> and <FIG>, the lower jaw has five notches <NUM>, which open onto the first face <NUM> and side edges <NUM>. In a further specific embodiment, the notches have a semi-circular circumferential shape and are graduated in size from the largest at the distal end <NUM> of the lower jaw to the smallest size at the proximal end <NUM> of the lower jaw. In one embodiment, the diameters of the notches range from between approximately <NUM> (<NUM> inch) to approximately <NUM> (<NUM> inch). In one specific embodiment, the diameters of the semi-circular notches are approximately <NUM> (<NUM> inch), <NUM> (<NUM> inch), <NUM> (<NUM> inch), <NUM> (<NUM> inch) and <NUM> (<NUM> inch), an example of which is shown in <FIG>. Alternatively, a specific embodiment has notches ranging in size from approximately <NUM>, approximately <NUM>, approximately <NUM>, approximately <NUM>, and approximately <NUM>.

In a further embodiment, a notch <NUM> has a beveled, chamfered, filleted, sloping, or smoothed edge where it opens onto the side edge <NUM>. This can inhibit fraying, cutting or other injury to a tissue positioned across the notch.

When the first handle <NUM> of the handle portion <NUM> is joined to the second handle <NUM> of the handle portion at the joint area <NUM>, the upper jaw <NUM> can aligned with the lower jaw. <FIG>, <FIG>, and <FIG> illustrate the alignment of the upper jaw with the lower jaw. In one embodiment, the upper jaw <NUM> has a second face <NUM> and at least one pairing notch <NUM> within the second face. In one embodiment, the first face is a substantially flat surface, whereby an imaginary plane across the flat surface will be parallel to the lengthwise extent <NUM>, as shown, for example, in <FIG>. As mentioned above, this can urge the upper jaw and the low jaw to align with each other. This can also direct force applied to the handle member to the first face <NUM> and the second face <NUM>, whereby the flat surfaces and the alignment of the upper and lower jaw can inhibit one or the other jaw from sliding past the other if excessive force is applied to the handle members.

In a further embodiment, the second face <NUM>, similarly to the first face <NUM>, is interrupted by at least one pairing notch <NUM> that is cut, molded or otherwise formed to be transverse to the lengthwise extent <NUM> of the lower jaw, such that the pairing notch further opens onto the side edges <NUM> of the jaw, which is shown, for example, in <FIG>. In other words, the at least one pairing notch can be perpendicular to the lengthwise extent. The at least one pairing notch within the upper jaw opens onto the second face, which breaks or divides the second face into smaller second interstitial faces <NUM>. In a further embodiment, there are two or more pairing notches <NUM> within the lower jaw. In a specific embodiment, there are five notches within the upper jaw that interrupt the second face, wherein the notches open onto the second face, forming multiple second interstitial faces <NUM>, as shown, for example, in <FIG>. In one embodiment, when the lower jaw <NUM> is aligned with the upper jaw <NUM>, as discussed above, the interstitial faces <NUM> of the first face can align with the interstitial faces <NUM> of the second face <NUM>. In a further embodiment, the notches <NUM> in the lower jaw will align with or "pair-up" with the pairing notches <NUM> in the upper jaw, to form apertures <NUM> within the head portion. The nerve tissue within an aperture can be supported while held in place for transecting. Furthermore, selecting the correct aperture size can also help determine the diameter of the nerve tissue.

As with the lower jaw, the at least one pairing notch in the upper jaw can have any circumferential shape. Ideally, the circumferential shape of a pairing notch can complement, cooperate with, or otherwise be operable with a notch <NUM> it pairs with in the lower jaw. Multiple pairing notches in the upper jaw could also have different circumferential shape. It can be preferable, though not required, for the circumferential shape to be curved, which can be more conforming to the shape of a nerve and beneficial for cutting. The circumferential shapes that can be utilized for a notch <NUM> in a lower jaw <NUM> have been discussed above and are reasserted here with regard to the circumferential shapes of a pairing notch <NUM> in an upper jaw.

In another embodiment, the upper jaw has two or more notches, each of different size diameters. In a specific embodiment, shown, by way of example, in <FIG>, the upper jaw <NUM> has five pairing notches <NUM>, which open onto the first face <NUM> and side edges <NUM>. In a further specific embodiment, the pairing notches have a semi-circular circumferential shape and are graduated in size from the largest at distal end <NUM> of the upper jaw to the smallest size at the proximal end <NUM> of the upper jaw. In still further specific embodiment, the pairing notches <NUM> align with the notches <NUM> to form circular apertures, as shown, for example, in <FIG> and <FIG>. In one embodiment, the diameters of the pairing notches range from between approximately <NUM> (<NUM> inch) to approximately <NUM> (<NUM> inch). In one specific embodiment, the diameters of the semi-circular notches are approximately <NUM> (<NUM> inch), <NUM> (<NUM>. 157inch), <NUM> (<NUM>. 118inch), <NUM> (<NUM> inch) and <NUM> (<NUM> inch). Alternatively, a specific embodiment has notches ranging in size from approximately <NUM>, approximately <NUM>, approximately <NUM>, approximately <NUM>, and approximately <NUM>.

In a further embodiment, a pairing notch <NUM> has a beveled, chamfered, filleted, sloping or smoothed edge where it opens onto the side edge <NUM>. This can inhibit fraying, cutting or other injury to a tissue positioned across the pairing notch or within an aperture.

In another embodiment, the upper jaw <NUM> can have a second face <NUM>, but not have pairing notches. This provides for a smooth, continuous second face that can be aligned with the interstitial faces <NUM> of the first face <NUM>. <FIG> illustrates one non-limiting example of an upper jaw without pairing notches. With this embodiment, the side edges <NUM> of the second face of the upper jaw can be aligned with the side edges <NUM> of the lower jaw. As with the pairing notches, the side edges at or near the second face can be beveled, chamfered, filleted, sloped, or smoothed to inhibit injury to a tissue that it contacts. The second face <NUM> can be positioned over the notches <NUM> within the lower jaw without concern for precise alignment with the notches. This embodiment can be advantageous for sizing forceps <NUM> intended for repeated use and sterilization. Over time, any surgical tool can experience wear from use and repeated sterilization. With this embodiment, the sizing forceps can have a longer usable life, as long as the upper jaw <NUM> and the lower jaw <NUM> can be sufficiently aligned.

The lower jaw <NUM> and the upper jaw <NUM> together form the head portion <NUM> of a sizing forceps <NUM>. When the jaws are brought together, the interstitial faces <NUM> and the second interstitial faces <NUM> come together and there is formed at least one aperture <NUM> within the head portion. Preferably, there is more than one aperture in a head portion, where the apertures have different diameters. <FIG> illustrate one embodiment of a sizing forceps having five apertures of graduated sizes. Different diameters of nerve tissue can be secured and held in place by using the correct size aperture.

When the interstitial faces <NUM> and the second interstitial faces <NUM> come together, they can form a seal between the apertures <NUM> in the head portion <NUM>. To inhibit tissue within the apertures from becoming pinched between the interstitial faces, the edges of the interstitial faces within the apertures can be indented, such that they have a chamfered, beveled, filleted, sloped, or otherwise recede from the aperture. The indented edges <NUM> can inhibit tissue within the aperture from being pinched when the interstitial faces come together. <FIG> illustrates a non-limiting embodiment of interstitial faces with indented edges <NUM>.

When nerve grafts are being implanted, it can be necessary to select a graft having a diameter similar to the in vivo nerve end. It has been shown that visual size determinations are often incorrect. Utilizing measuring devices with a flat surface, such as rulers, also does not give an accurate measurement of diameter. With a sizing forceps of the subject invention, the sizes or diameters of the apertures can be used to measure the diameter of a nerve placed therein.

The head portion can have a plurality of apertures <NUM> that can be used to measure the diameter of a nerve. Each aperture can open onto the side edges of the upper jaw and lower jaw, such that the direction of an aperture is transverse to the lengthwise extent <NUM> of the lower jaw. In one embodiment, a head portion has between two and eight apertures where the apertures have diameters that range from between approximately <NUM> (<NUM> inch) to approximately <NUM> (<NUM> inch). In a further embodiment, a head portion has between three and seven apertures, where the apertures have diameters that range between approximately <NUM> (<NUM> inch) and approximately <NUM> (<NUM> inch). In a still further embodiment, a head portion has between four and six apertures, where the diameters of the apertures range between approximately <NUM> (<NUM> inch) and approximately <NUM> (<NUM> inch). In a particular embodiment, the head portion has five apertures, where the apertures have diameters that range from between approximately <NUM> (<NUM> inch) to approximately <NUM> (<NUM> inch). In one specific embodiment, the head portion has five apertures, where the diameters of the apertures <NUM> are approximately <NUM> (<NUM> inch), <NUM> (<NUM> inch), <NUM> (<NUM> inch), <NUM> (<NUM> inch) and <NUM> (<NUM> inch). Alternatively, a specific embodiment has notches ranging in diameter from approximately <NUM>, approximately <NUM>, approximately <NUM>, approximately <NUM>, and approximately <NUM> and any diameter in a range between any two of the listed diameters.

There are many situations in which a nerve has to be cut or severed. It may be necessary to remove tissue from a nerve end to reach viable, vascularized tissue or a section of nerve may need to be removed from one area to be coapted to a nerve in another area. Regardless of the reason, the method by which the nerve is severed can affect the success of the procedure and the quality of healing and regeneration of nerve tissue. The sizing forceps of the subject invention can be helpful in providing support to a nerve by holding it within an aperture. When the nerve tissue is to be severed, the cutting implement can be placed along one of the side edges and slid along the side edge to provide a clean, precise cut across the nerve.

In one embodiment, and in accordance with the present claimed invention, the head portion has a slicing slot <NUM> through which a cutting implement <NUM>, such as, for example, a surgical grade safety blade or scalpel, such as, by way of example, the one shown in <FIG>, can be passed through to sever a nerve at a point within an aperture. In one embodiment, the lower jaw <NUM> is traversed by a first part <NUM> of the slicing slot that bisects the notches, as shown, for example, in <FIG>. In a further embodiment, the upper jaw <NUM> is traversed by a second part <NUM> of the slicing slot that bisects the pairing notches. When the upper jaw and lower jaw are rotated and the faces aligned, as described above, the first part of the slicing slot and the second part of the slicing slot are also aligned to create a full slicing slot through the head portion.

A slicing slot can extend through the head portion, in the same direction as the lengthwise extent <NUM>. In one embodiment, the slicing slot extends through the head portion in a direction transverse to the direction of the notches <NUM> and the pairing notches <NUM>, discussed above. The slicing slot can extend through the head portion, going through the upper jaw <NUM> and the lower jaw <NUM>, and opening onto the proximal end <NUM> of the upper jaw and the lower jaw. <FIG> illustrates an example of this embodiment. In a further embodiment, the length of a slicing slot, in the direction of the lengthwise extent <NUM>, is between approximately <NUM> (<NUM> inch) and <NUM> (<NUM> inch) and the width of a slicing slot, in a direction transverse to the lengthwise extent, is between approximately <NUM> (<NUM> inch) and approximately <NUM> (<NUM> inch). Furthermore, the width of a slicing slot, in a direction perpendicular to the lengthwise extent, can be between approximately <NUM> (<NUM>") and approximately <NUM> (<NUM>"). In a specific embodiment, the length of a slicing slot is approximately <NUM> (<NUM>") and the width of a slicing slot is approximately <NUM> (<NUM>").

In an alternative embodiment, the slicing slot <NUM> extends entirely through the upper jaw <NUM>, but terminates within the lower jaw <NUM> at a point below the notches <NUM>. Thus, with this embodiment, the slicing slot does not extend through the entire head portion <NUM>. Specifically, it does not extend entirely through the lower jaw. In one embodiment, the slicing slot terminates at the bottom or closed end <NUM> of the notches. In another embodiment, the slicing slot terminates beyond the closed end of the notches, such that a cutting implement <NUM> will pass entirely through one or more notches in the lower jaw. In one embodiment, the slicing slot terminates between approximately <NUM> (<NUM> inch) and approximately <NUM> (<NUM> inch) below the closed end of one or more notches.

The nerve tissue within an aperture <NUM> can be supported along the length of the aperture. The slicing slot <NUM> can be advantageously narrow, providing only sufficient space for a cutting implement to pass through the slicing slot in the upper jaw and, possibly, the lower jaw. To facilitate insertion of a cutting implement, an insert port <NUM> can be fashioned on the outside of the upper jaw <NUM>. The insert port can be a shallow, depressed area on either side of the outside of the sliding slot that is wider than the slicing slot. The insert port can be used to guide or direct a cutting implement into the slicing slot. In one embodiment, the edges of the insert port are chamfered, beveled, filleted, sloped, or otherwise wider than the remaining length of the slicing slot. The insert port can extend along all or at least some part of the length of the slicing slot. <FIG> is a cross-sectional view, taken along line <NUM> in <FIG>, showing an insert port <NUM> that is wider than the slicing slot. <FIG> is a similar cross-sectional view showing that the insert port may not extend along the entire length of the slicing slot.

The slicing slot can extend into the lower jaw, such that it bisects the lower jaw or, alternatively, terminates just below the notches in the lower jaw. In a further embodiment, the slicing slot in the lower jaw can also have an insert port <NUM>, similar to that in the upper jaw. <FIG> illustrates a non-limiting example of a lower jaw having an insert port. The insert port in the lower jaw can provide additional guidance to a cutting implement as it traverses through an aperture <NUM>.

These features of a slicing slot allow the nerve to be cut anywhere along the aperture and obtain a non-frayed end. In one embodiment, the slicing slot is centered between the side edges <NUM> of the lower jaw and the side edges <NUM> of the upper jaw <NUM>. In an alternative embodiment, the slicing slot is off-center between the side edges <NUM> of the lower jaw and the side edges <NUM> of the upper jaw, an example, of which, is shown in <FIG>.

Surgical procedures involving nerve tissue can obtain improved results if viable, healthy nerve tissue is used. This can necessitate incrementally removing non-viable or unhealthy nerve tissue. When removing nerve tissue, obtaining a clean, non-frayed nerve end for use can improve procedure outcomes and provide better healing. If nerve grafts are being utilized, it can be preferable for the graft and the nerve being repaired to have similar diameters. The sizing forceps embodiments of the subject invention can be used to provide an effective method for fixing a nerve in place, measuring the diameter of the nerve, and providing an efficient and effective procedure for cutting nerve tissue to provide a non-frayed end.

Claim 1:
A sizing forceps (<NUM>) comprising:
a first member (<NUM>) having:
a first handle portion (<NUM>) with a first outer side (<NUM>) and a first inner side (<NUM>),
a lower jaw (<NUM>) at one end of the first handle portion (<NUM>) with a first face,
two or more notches (<NUM>) within the lower jaw (<NUM>), where the two or more notches (<NUM>) open onto the first face, the first outer side (<NUM>) and the first inner side (<NUM>), and
a first part (<NUM>) of a slicing slot that is transverse to the two or more notches (<NUM>) so as to bisect each of the two or more notches (<NUM>);
a second member (<NUM>) having:
a second handle portion (<NUM>) with a second outer side (<NUM>) and a second inner side (<NUM>),
an upper jaw (<NUM>) at one end of the second handle portion (<NUM>) with a second face,
two or more pairing notches (<NUM>) within the upper jaw (<NUM>), where the two or more pairing notches (<NUM>) open onto the second face, the second outer side (<NUM>) and the second inner side (<NUM>), and
a second part (<NUM>) of the slicing slot that is transverse to the two or more pairing notches (<NUM>) so as to bisect each of the two or more pairing notches (<NUM>); and
a joint area (<NUM>) at which the first handle portion (<NUM>) is rotatably connected to the second handle portion (<NUM>);
such that the handle portions (<NUM>), when manipulated along a longitudinal line (<NUM>) to rotate at the joint area (<NUM>), bring the lower jaw (<NUM>) into alignment with the upper jaw (<NUM>), along a lengthwise extent (<NUM>), so that the first face is against the second face, thereby forming a head portion (<NUM>) in which the notches (<NUM>) and pairing notches (<NUM>) come into alignment so as to form two or more apertures (<NUM>) within the head portion (<NUM>), and in which the first part (<NUM>) of the slicing slot and the second part (<NUM>) of the slicing slot come into alignment so as to form the slicing slot (<NUM>) bisecting each aperture (<NUM>).