Patent Description:
The introduction of modern technology in the medical field has led to great changes in the practice of medicine. Although medical equipment and machinery have evolved greatly due to gains in technology, many of the traditional implements used by medical professionals have remained nearly unchanged. For example, surgeons make wide use of traditional scalpels, scissors, forceps, and other hand-held devices. However, even these basic and traditional tools may be improved upon. For example, increasing demands on medical professionals has created the need for lighter and stronger tools. Composite materials have been applied to tool handles to address some of these needs. In particular, some tubular composite handles have been produced with holes disposed throughout to save weight. However, the use of composite materials in surgical tool handles has been limited to rigid, tubular handles which are generally used on tools, such as manipulators, without any moving parts. Furthermore, these tubular composite designs are often complex and difficult to manufacture. Accordingly, there is a need for lightweight, flexible handles that may be used with moving parts and are easily manufactured.

Reference is made to the documents <CIT>, <CIT>, <CIT> and <CIT> which have been cited as representative of the state of the art.

It will be appreciated that the scope is in accordance with the appended claims.

The present disclosure relates generally to devices, systems, and methods relating to handles formed of composite materials. In some implementations, a handle apparatus for a surgical instrument is provided. The handle apparatus may include a base component comprising a foldable strip of a first composite material that is bendable to form opposing sides of the handle apparatus. The base component may be sized and arranged to be grasped and squeezed by a hand during a surgical procedure. The base component may include a first grip having a proximal end and a distal end, a second grip having a proximal end and a distal end, and a flexible portion bendable to form an arcuate shape. The flexible portion may extend from the proximal end of the first grip to the proximal end of the second grip. The base component also may include a fastening mechanism connecting the distal end of the first grip to the distal end of the second grip.

In some implementations, the first grip and the second grip are formed from a second composite material that is different from the first composite material. The first grip and the second grip may be formed from the first composite material. In some implementations, the flexible portion has a first flexibility and the first and second grips have a second flexibility, wherein the first flexibility is greater than the second flexibility. A width of the first and second grips may be greater than a width of the flexible portion.

In some implementations, the fastening mechanism is one of a screw, bolt, brad, clip, rivet, or adhesive bond. The handle apparatus may further include a first hole disposed in a central portion of the flexible portion, and may include a tool adaptor which passes through the first hole. In some implementations, the first composite material comprises a plurality of fibers that may be bent around the first hole.

In some implementations, an actuation handle apparatus for a surgical instrument may include a handle and a tool adaptor. The handle may include a base component of a composite material. The base component may include a relatively more flexible region forming a flexible portion of the base component. The more flexible region may be bent in a U-shape and may have a first end and a second end. The base component may also include a relatively less flexible first grip extending from the first end of the more flexible region in a distal direction. The first grip may have a distal end portion. The base component may also include a relatively less flexible second grip extending from the second end of the more flexible region in a distal direction. The second grip may have a distal end portion. A fastening mechanism may connect the distal end portion of the first grip to the distal end portion of the second grip. The tool adaptor may be arranged to hold a working end of an actuatable surgical tool in a manner such that compression of the first and second grips axially displaces the tool adaptor.

In some implementations, the first grip and the second grip are formed from a different composite material than the more flexible region. A width of the first and second grips may be greater than a width of the more flexible region. In some aspects, a thickness of the first and second grips may be greater than a thickness of the more flexible region. In some implementations, the fastening mechanism is one of a screw, bolt, brad, clip, rivet, or adhesive bond. Depending on the implementation, the first and second grips may comprise one or more gripping features. For example, the first and second grips may have rounded outer edges. In some implementations, the actuation handle apparatus further comprises a first hole in the more flexible region, and the tool adaptor may extend from the fastening mechanism through the first hole.

In some implementations, a method of forming a handle is provided. The method may include forming a strip from a composite material having a first end section and a second end section, wherein the composite material comprises a plurality of fibers. The method also may include heating a section of the sheet; bending the sheet such that the first end section and the second end section are in physical contact; and securing the first end section to the second end section.

In some implementations, the method also may include securing the first end section to the second end section with one of a screw, bolt, brad, clip, or rivet. A first hole may be formed in the first end section and a second hole may be formed in the second end section. In some implementations, the method further may include passing a tool adaptor through a third hole and securing the tool adaptor to one or both of the first and second end sections.

In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the accompanying drawings and the following detailed description.

The accompanying drawings illustrate implementations of the devices and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure.

The accompanying drawings may be better understood by reference to the following detailed description.

For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the implementations illustrated in the drawings. Specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one implementation may be combined with the features, components, and/or steps described with respect to other implementations of the present disclosure. For example, although explanatory references are made to "surgical tools," other applications are included within the scope of the present disclosure. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.

The present disclosure relates generally to devices, systems, and methods relating to handles for hand-held tools. In particular, the present disclosure relates to surgical tool actuation handles. According to the implementations described herein, the handles may be formed from composite materials and may be configured for use with surgical tools. The handles described herein may offer benefits that cannot be obtained using conventional handles.

For example, the handles described herein may be operable for use with instruments having moving parts. In some implementations, the rigidity and flexibility of the handles described herein may be varied depending on the application of the handles. For example, the handles may be configured with a sufficient amount of rigidity to fully control the handles and attached devices as well as perform precise operations with the handles and attached devices. The handles described herein may also exhibit a range of flexibility, which may allow the handles to be used with tools requiring moving parts, for example, to actuate a forceps. Having some flexibility may also allow the handles to have a more ergonomic feel for a user. In some implementations, the rigidity and flexibility of the composite handles of the present disclosure may be variable. This variable flexibility may be accomplished through the use of different materials throughout the handles and in particular, through the use of composite materials. Furthermore, the use of composite materials may allow for tailored anisotropic behavior of the handles, allowing for a balance of rigidity and flexibility. The thickness and width of various components may also allow for variation of rigidity and flexibility in the handles of the present disclosure. The range of rigidity and flexibility may be helpful for using the handles with tools with non-moving parts, tools with moving parts, and/or tools requiring delicate care.

In addition, the handles of the present disclosure may be light due to the method by which they are formed as well as the composite materials used in their construction. This lightness may help to prevent user fatigue as well as improving manual precision as less motor units may be recruited to perform a task. Furthermore, the handles described in the present disclosure may include a limited number of constituent parts that are easily formed and assembled. Furthermore, the handles of the present disclosure may require a minimum number of machining steps in their production.

Furthermore, the present disclosure may provide techniques for manufacturing composite handles with holes while maintaining the integrity of composite materials, and in some cases, even strengthening the composite materials around the holes. As another advantage, the handles of the present disclosure may be inexpensive to produce and assemble, allowing them to be used once and discarded. This may protect medical professionals and patients while keeping costs low.

<FIG> illustrates a side view of an exemplary surgical tool actuation handle apparatus <NUM>. The surgical tool actuation handle apparatus <NUM> may include a handle <NUM> and a tool adaptor <NUM>. The handle <NUM> may include a base component <NUM> and a fastener <NUM>. The base component <NUM> may include a flexible portion <NUM>, a first grip <NUM>, a second grip <NUM>, a first end portion <NUM>, a second end portion <NUM>, and a hole <NUM>. In some implementations, the surgical tool actuation handle apparatus <NUM> is produced by using a base component <NUM> in the shape of a foldable strip, bending the base component <NUM> onto itself, fastening the first and second end portions <NUM>, <NUM> of the base component <NUM> with the fastener <NUM>, and adding the tool adaptor <NUM>. The base component will be described further herein.

The flexible portion <NUM> of the base component <NUM> may be configured to bend to allow the first and second end portions <NUM>, <NUM> to be placed in physical contact. Accordingly, the flexible portion may bend, for example, within a range of <NUM> degrees to <NUM> degrees. In some implementations, the flexible portion may form an arcuate shape when bent. In some implementations, the flexible portion may bend more than <NUM> degrees to allow the end portions <NUM>, <NUM> to come into contact with each other. In some implementations, the flexible portion <NUM> allows the first grip <NUM> and the second grip <NUM> to move closer together when pressure is applied to the surgical tool actuation handle apparatus <NUM>. In some implementations, the flexible portion <NUM> comprises a composite material. In some implementations, the composite material is a pre-impregnated (prepreg) carbon or mixed fabric material. Additionally or alternatively, the composite material may include glass fibers, reinforced plastic, thermoplastics, epoxies, and other materials. The first and second grips <NUM>, <NUM> may also be formed out of composite material. In some implementations, the first and second grips <NUM>, <NUM> are less flexible than the flexible portion <NUM>. In some implementations, this difference in flexibility is due to the thickness or width of the material of the constituent parts. For example, the thickness of the first and second grips <NUM>, <NUM> may be greater than the thickness of the flexible portion <NUM>. In another example, the thickness of the first and second grips <NUM>, <NUM> and the flexible portion <NUM> is the same, but the first and second grips <NUM>, <NUM> have a width that is less than the width of the flexible portion <NUM>. In other implementations, the flexible portion <NUM> has a similar thickness and width as the first and second grips <NUM>, <NUM>, but the flexible portion <NUM> is more flexible than the first and second grips <NUM>, <NUM> because it is formed from a more flexible material. Furthermore, by choosing the composite material mix, the bending stiffness of the flexible portion <NUM> and the grips <NUM>, <NUM> may be tailored independently.

The curvature of various components of the surgical tool actuation handle apparatus <NUM> may affect its stiffness. For example, curving the first and second grips <NUM>, <NUM> (e.g., by applying tension to the surgical tool actuation handle apparatus <NUM> during the joining of the first and second end portions <NUM>, <NUM>) may cause the stiffness of the first and second grips <NUM>, <NUM> to be increased. This technique may allow for greater stiffness without adding weight by increasing the thickness of various components.

The first and second grips <NUM>, <NUM> may include gripping features to aid a user in gripping the surgical tool actuation handle apparatus <NUM>. For example, the first and second grips <NUM>, <NUM> may include gripping features such as raised portions, ridges, pitted areas, holes formed therethrough, among other features. The gripping features may be formed during the shaping of the base component <NUM> of the composite handle. Additionally or alternatively, gripping features may be added after the first and second end portions <NUM>, <NUM> are fastened together. In some implementations, the first and second grips <NUM>, <NUM> and other portions of the handle are formed by cutting the composite materials, for example, by a water jet.

The first and second grips <NUM>, <NUM> may be connected to the flexible portion <NUM> at their proximal ends <NUM>, <NUM>. Furthermore, the first grip <NUM> may be connected to the first end portion <NUM> at a distal end <NUM>, and the second grip <NUM> may be connected to the second end portion <NUM> at a distal end <NUM>. In some implementations, the first and second end portions <NUM>, <NUM> may include fastening mechanisms such as holes, adhesive bonds, and welded joints. Other fastening mechanisms are also contemplated. In some implementations, fastening mechanisms of the first and second end portions <NUM>, <NUM> may correspond, such as having matching holes. The fastener <NUM> may include any kind of fastening mechanism. Furthermore, the fastener <NUM> may include additional fastening mechanisms such as screws, bolts, clips, and/or adhesive bonds that may be added to the fastening mechanisms of the first and second end portions <NUM>, <NUM>. In the example of <FIG>, the fastener <NUM> includes a bolt that passes through holes in the first and second end portions <NUM>, <NUM>. Other examples of fastening mechanisms are shown in <FIG>.

Still referring to <FIG>, the surgical tool actuation handle apparatus <NUM> may be actuated by pressing the first and second grips <NUM>, <NUM> together in directions <NUM> and <NUM>. This motion may decrease the radius of the flexible portion <NUM>, which in turn may cause a longitudinal expansion of the surgical tool actuation handle apparatus <NUM> and associated axial motion in directions <NUM> and <NUM>.

A tool adaptor <NUM> may be included in the surgical tool actuation handle apparatus <NUM>. The tool adaptor <NUM> may be passed through the hole <NUM> in the flexible portion <NUM> and extend between the grips <NUM>, <NUM> to the fastener <NUM>. In some implementations, the tool adaptor <NUM> is affixed to the flexible portion <NUM> of the surgical tool actuation handle apparatus <NUM>. In some implementations, the tool adaptor <NUM> may be a connector or shaft that connects to the body of a tool, such as a scalpel blade or a manipulator. In some implementations, the tool adaptor <NUM> may connect to a movable portion or the working end of a tool, such as the blades on scissors or the actuators on forceps. The tool adaptor <NUM> may be used with other articulable surgical tools. The tool adaptor <NUM> may be affixed to the first and second end portions <NUM>, <NUM> and/or the fastener <NUM>. The motion of the surgical tool actuation handle apparatus <NUM> in directions <NUM> and <NUM> as a result of squeezing or compressing the first and second grips <NUM>, <NUM> in the lateral directions <NUM>, <NUM> may be used to actuate tools with moving parts, such as scissors and forceps, for example. In some implementations, the tool adaptor <NUM> includes an inner shaft and an outer shaft, with the inner shaft extending through the hole <NUM> to the fastener <NUM>. In <FIG>, only the inner shaft is shown. The outer shaft may be fixed to the flexible portion <NUM> and may have a lumen in which the inner shaft may slide. Accordingly, when a user squeezes the actuation handle apparatus <NUM> in the lateral directions <NUM>, <NUM>, the outer shaft, connected to the flexible portion <NUM> moves in the axial direction <NUM> relative to the inner shaft which is connected to the fastener <NUM>. In so doing, the outer shaft and the inner shaft axially displace relative to each other. This may actuate a tool, such as a forceps, for example.

<FIG> illustrate exemplary base components <NUM> that may be included in a surgical tool actuation handle apparatus <NUM>. In some implementations, the base component <NUM> is a single strip comprising one or more composite materials that is shaped, bent, and fastened with a fastener <NUM> to form handle <NUM>. The base component <NUM> shown in <FIG> may include a flexible portion <NUM>, first and second grips <NUM>, <NUM>, and first and second end portions <NUM>, <NUM>, as shown in <FIG>.

In <FIG>, a base component <NUM> is depicted which may comprise prepreg carbon or mixed fabric composite material. In some implementations, the first and second end portions <NUM>, <NUM> of the base component <NUM> are rounded. A hole <NUM> may be formed in the flexible portion <NUM> of the base component <NUM>. This hole <NUM> may allow for greater flexibility of the flexible portion <NUM>, as well as providing access for a tool adaptor <NUM> or other components.

<FIG> shows a base component <NUM> with a flexible portion <NUM> and a hole <NUM> formed in the center of the flexible portion <NUM>. In some implementations, the flexible portion <NUM> may comprise a different material than the rest of the base component. For example, the flexible portion <NUM> may be formed with glass fibers, while the rest of the base component <NUM> comprises prepreg carbon composite material without glass fibers. The use of different materials for the flexible portion <NUM> may allow it to be more flexible and achieve greater curvature.

<FIG> shows a base component <NUM> that includes a flexible portion <NUM> with a width W<NUM>. In some implementations, width W<NUM> is smaller than a width W<NUM> of other portions of the base component <NUM> such as the grips <NUM>, <NUM>. In particular, the width W<NUM> of the flexible portion <NUM> may be narrowed by removing two trapezoid shaped portions of the base flexible portion <NUM>. In other implementations, the width W<NUM> of the flexible portion <NUM> may be narrowed by removing portions of the flexible portion <NUM> with curved edges, elliptical shapes, rectangular shapes, or other shapes. The edges of the flexible portion <NUM> may be cut with a tool such as a water jet to decrease the width W<NUM> of the flexible portion <NUM>. In some implementations, the width W<NUM> of the flexible portion <NUM> may be narrowed in such a way as to impart a desired amount of flexibility to the surgical tool actuation handle apparatus <NUM>.

<FIG> shows a base component <NUM> having a narrowed flexible portion <NUM> with width W<NUM> and narrowed first and second end portions <NUM>, <NUM> with widths W<NUM>. The narrowing of the flexible portion <NUM> and the first and second end portions <NUM>, <NUM> may serve to define a first grip <NUM> and a second grip <NUM> therebetween, that have larger widths W<NUM>. In some implementations, the first and second grips <NUM>, <NUM> may allow a user to grasp and manipulate the surgical tool actuation handle apparatus <NUM>. Furthermore, the larger width W<NUM> of the first and second grips <NUM>, <NUM> in relation to other widths W<NUM>, W<NUM> of the base component <NUM> may afford more rigidity to the first and second grips <NUM>, <NUM>. In some implementations, the greater flexibility of the flexible portion <NUM> and first and second end portions <NUM>, <NUM> as compared to lesser flexibility of the first and second grips <NUM>, <NUM> allows for greater precision in manipulating the surgical tool actuation handle apparatus <NUM>.

<FIG> illustrate steps in the method of forming a handle <NUM> according to an implementation of the present disclosure. A bent base component <NUM> is shown in <FIG> that includes a flexible portion <NUM>, first and second grips <NUM>, <NUM>, and first and second end portions <NUM>, <NUM>. In the example of <FIG>, the first and second grips <NUM>, <NUM> are aligned to form a U-shape so that the flexible portion <NUM> has been bent. In some implementations, the handle <NUM> is not fully formed until the first and second end portions <NUM>, <NUM> are fastened together with a fastener <NUM>.

<FIG> shows a handle <NUM> with the base component <NUM> bent onto itself and first and second end portions <NUM>, <NUM> joined together by a fastener <NUM>. The flexible portion <NUM> may be bent with a greater curvature in <FIG> than in <FIG>. In some implementations, the first and second grips <NUM>, <NUM> form a triangular shape that is wider at the proximal ends <NUM>, <NUM> of the grips <NUM>, <NUM> (e.g., where the grips <NUM>, <NUM> connect to the flexible portion <NUM>) than the distal ends <NUM>, <NUM> of the first and second grips <NUM>, <NUM>. Although not shown, the handle <NUM> may be further modified. For example, the first and second grips <NUM>, <NUM> may be further shaped or cut to a desired shape, such as having rounded edges. The grips <NUM>, <NUM> may also be modified to include gripping features such as raised or lowered portions. Furthermore, a hole <NUM> may be drilled or cut into the flexible portion <NUM>, and a tool adaptor <NUM> such as that depicted in <FIG> may be added to the handle <NUM>.

<FIG> show cross sectional views of the handle <NUM>. <FIG> is a cross-section taken through the lines 3C-3C in <FIG>. In some implementations, one or more lateral edges of the handle <NUM>, including the first and second grips <NUM>, <NUM>, are bent or curved laterally. This lateral curvature may help to add rigidity to various portions of the handle <NUM> without adding extra material and may help to minimize the overall weight of the handle <NUM>. In other implementations, portions of the handle <NUM> may be formed from different materials or have different thicknesses. Variation in the curvature, thickness, and material of the handle <NUM> may help to fine tune the amount of rigidity and flexibility needed to perform different functions. Lateral curvature may be imparted to various portions of the handle <NUM> before or after the first and second end portions <NUM>, <NUM> are joined together. Although <FIG> show lateral curvature in the first and second grips <NUM>, <NUM>, lateral curvature may also be imparted to other portions of the handle <NUM>, including the flexible portion <NUM> and the first and second end portions <NUM>, <NUM>.

<FIG> shows a cross section of the handle <NUM> with the first and second grips <NUM>, <NUM> having lateral curvature at the edges, but not the middle of the first and second grips <NUM>, <NUM>. The curvature of <FIG> may help to round the edges of the first and second grips <NUM>, <NUM> to provide a comfortable grip for the user while increasing rigidity of the handle. <FIG> shows a cross section of the handle <NUM> with the first and second grips <NUM>, <NUM> having lateral curvature across the width of the first and second grips <NUM>, <NUM>. <FIG> shows a cross section of the handle <NUM> with first and second grips <NUM>, <NUM> that are not curved in a lateral direction.

<FIG> illustrates several examples of fastening mechanisms that may be used to form the fastener <NUM> of a composite handle, such as that depicted in <FIG> and <FIG>. In particular, one or more fastening mechanisms may be disposed around or between a first end portion <NUM> and a second end portion <NUM> of a base component <NUM>. In the example of <FIG>, various fastening mechanisms are shown in conjunction to the first end portion <NUM>, although it will be understood that corresponding fastening mechanisms may be applied to a second end portion <NUM>.

In one implementation shown in <FIG>, one or more holes <NUM> are disposed in the second end portion <NUM>. The hole(s) <NUM> may be sized and arranged to receive a screw, bolt, brad, clip, rivet, or other fastening device to be passed therethrough to fasten the end portions <NUM>, <NUM> together. Although shown as round or elliptical in the example of <FIG>, the one or more holes <NUM> may be square, rectangular, hexagonal, or have other shapes to accommodate different types of fastening devices.

In another implementation shown in <FIG>, an adhesive bond <NUM> is disposed on a surface of the first end portion <NUM>. This adhesive may be a composite adhesive, cement, or plastic. In some implementations, the adhesive bond is a composite bonding mechanism such as melting or fusing which may be used to fasten together the first and second end portions <NUM>, <NUM>.

In another implementation shown in <FIG>, a side interface <NUM> is disposed in one or both of the first and second end portions <NUM>, <NUM>. This may allow a fastening device to be passed from the side to the middle of the first and second end portions <NUM>, <NUM>. The side interface <NUM> may allow for the quick installation or removal of a fastening device.

In another implementation shown in <FIG>, a hole reinforcement <NUM> is disposed on the first or second end portions <NUM>, <NUM>. In some implementations, the hole reinforcement <NUM> prevents a fastening mechanism from breaking through a portion of the first or second end portions <NUM>, <NUM>. The hole reinforcement <NUM> may be used in conjunction with another fastening device, such as a screw, bolt, clip, or rivet. The hole reinforcement <NUM> may allow for a more narrow first or second end portion <NUM>, <NUM> than would be possible without reinforcement. The reinforcement of material around a hole is further discussed in reference to <FIG>.

In another implementation shown in <FIG>, an end interface <NUM> is provided. Like the side interface <NUM>, the end interface <NUM> may allow for a fastening device to be clipped into the first and/or second end portion <NUM>, <NUM>. Along with the side interface <NUM>, the end interface <NUM> may allow for the use of removable fasteners on the surgical tool actuation handle apparatus <NUM>.

In another implementation shown in <FIG>, various combinations of fastening mechanisms are used. For example, a combination fastening device <NUM> may include an adhesive bond disposed around a hole. Such a combination may provide additional fastening strength. Other combinations are possible, including combining a side interface <NUM> and an end interface <NUM>, reinforcing side interfaces <NUM> and end interfaces, <NUM>, among others.

<FIG> show exemplary techniques for forming a hole in a composite handle. <FIG> shows a portion of a base component <NUM> including a plurality of fibers <NUM>. In some implementations, composite materials include fibers <NUM> that may be aligned in various directions throughout the material. In the example of 5A, the fibers <NUM> are aligned perpendicular to a longitudinal axis of the base component (i.e., in a vertical direction in <FIG>). The fibers <NUM> may include materials such as glass, carbon, metal, or other fibers. In some cases, the fibers <NUM> lend strength on the composite material. Forming holes in conventional composite devices may cause problems because fibers are generally cut when the holes are formed, weakening the composite material. This problem is addressed by the present disclosure by forming holes without cutting through fibers <NUM> or with minimal cutting or breaking of fibers.

<FIG> shows a hole <NUM> which has been formed in a portion of the base component <NUM>. This hole may be the hole <NUM> of <FIG> and <FIG>, and/or the hole <NUM> of <FIG>. In some implementations, a prepreg carbon composite material is used in the base component <NUM> which may include aligned fibers <NUM>. Like <FIG>, the fibers <NUM> are aligned vertically in <FIG>. The process of forming the hole <NUM> may include heating the composite material. A pointed device such a punch or die is used to form a hole <NUM> in the heated composite material. In some implementations, the formation of the hole bends the fibers <NUM> around the hole. The formation of the hole <NUM> during the curing process of the composite material may aid in bending the fibers <NUM> around the hole <NUM>. In some implementations, the bent fibers <NUM> may lend additional strength to the hole <NUM> and act a self-reinforcement mechanism to protect the material around the hole <NUM> from damage due to movement of a fastener or other device extending through the hole <NUM>.

<FIG> is an illustration of a portion of the base component <NUM> with a composite material that includes fibers <NUM> that are aligned parallel with a longitudinal axis of the base component <NUM> (i.e., in the horizontal direction). As in <FIG>, the formation of the hole <NUM> may allow for the bending of fibers <NUM> around a hole <NUM> without cutting them.

<FIG> is an illustration of a portion of the base component <NUM> with a composite material that includes fibers <NUM> that are aligned both vertically and horizontally. The fibers <NUM> around the hole <NUM> may be bent or formed around the hole <NUM>, lending additional strength to the base component <NUM>.

<FIG> is a flowchart of a method for forming a composite handle according to implementations of the present disclosure. The method is generally referred to by the reference number <NUM>. It is understood that additional steps may be provided before, during, and after the steps of method <NUM>, and that some of the steps described may be replaced or eliminated in other implementations of the method. In particular, <NUM>, <NUM>, <NUM>, and <NUM> may be performed simultaneously or in various sequences as discussed below. In some embodiments, the steps may be performed in a different order than provided below.

At <NUM>, the method <NUM> may include forming a base component out of composite material with a central portion, grips, and end portions. In some implementations, the base component is that depicted in <FIG>. The central portion, grips, and end portions may be the flexible portion <NUM>, first and second grips <NUM>, <NUM>, and first and second end portions <NUM>, <NUM>, respectively, as depicted in <FIG>, <FIG>. The base component may be formed from prepreg carbon composite material. All or a portion of the composite material may be uncured at <NUM>. In some implementations, the base component may be formed from a strip of material comprising a single composite material with a uniform thickness throughout. Alternatively, the base component may include a second material for the grips and/or the central portion. This may allow the stiffness of various parts of the tool to be more precisely controlled. In particular, by choosing a mix of materials, the bending stiffness of the central portion and the rigidity of the grips may be tailored independently.

At <NUM>, the method <NUM> may include placing the base component into a heatable die. In some implementations, the heatable die applies a desired form to the base component by applying heat and pressure to the base component. In some implementations, the heatable die is an autoclave or oven.

At <NUM>, the method <NUM> may include imparting curvature to the base component. In some implementations, the central portion of the base component may be curved, as shown in <FIG>. Although not shown, the base component may also be curved in a direction perpendicular to its longitudinal axis and may appear curled or cupped along its length. The amount of curvature applied to the base component may be chosen to impart a specific amount of stiffness to the central portion and/or the grips.

At <NUM>, the method <NUM> may include forming holes in the base component. These holes may be formed in the central portion, the end portions, or other locations therebetween. These holes may include hole <NUM> of <FIG> and <FIG>, the holes <NUM> of <FIG>, and/or the hole <NUM> of <FIG>. In some implementations, composite fibers around the holes may be bent around the holes during their formation, such as shown in <FIG>. This may provide reinforcement to the area around the holes and afford the composite material greater strength than would be achieved by cutting through composite fibers while forming the holes.

At <NUM>, the method <NUM> may include curing the composite material. In some implementations, the composite material is cured with heat from the heated die. In other implementations, the composite material is cured with ultraviolet light or chemical reactions that may or may not involve heat. The composite material may be cured after the composite material has been formed into a desired shape. Curing the composite material may include hardening epoxy within the composite material, fusing fibers together within the composite material, and/or adding a stiff coat to the exterior of the composite material.

At <NUM>, the method <NUM> may include bending the base component so that the grips are adjacent to each other. In some implementations, pressure is applied with the heated die. In other implementations, the pressure is applied by devices after the base component has been removed from the die.

At <NUM>, the method <NUM> may include fastening the end portions of the base component together. In some implementations, the end portions are modified before they are fastened together with features such as holes, adhesives, and reinforcements. These modifications may be made during any of <NUM>, <NUM>, and <NUM>, for example. The end portions may be fastened together by any of the methods described in reference to <FIG>, including fusing, melting, and the use of mechanical fasteners and adhesives. Other systems and techniques are also contemplated. At this point, the basic shape of the composite handle is formed.

At <NUM>, the method <NUM> may include adding features to the grips. These features may include the gripping features as discussed previously. Additionally, one or more layers of a coating such as laminate may be applied to the grips. This may aid in gripping as well as modifying the flexibility of the handles. In some cases, adding features to the grips may increase the thickness of the grips as compared to the thicknesses of the central portion and the end portions. The difference in thicknesses may cause differences in flexibility, allowing for greater variation in flexibility across the base component.

At <NUM>, the method <NUM> may optionally include shaping various portions of the formed composite handle. For example, the grips may be shaped by narrowing portions of the composite handle around the grips to create a more ergonomic shape. The grips may also be shaped with rounded edges. This shaping may be accomplished by a water jet or other cutting device. Furthermore, the central portion of the composite handle may be narrowed to increase the flexibility of the composite handle. Adaptions for tools such as holes and adhesive bonds may also be added to the composite handle.

At <NUM>, the method <NUM> may include connecting a tool adaptor to the composite handle. In some implementations, the tool adaptor may be the tool adaptor <NUM> of <FIG>. This tool adaptor may connect the composite handle to a tool face such as a manipulator, forceps, clamp, or scissors. In some implementations, the tool adaptor moves a portion of the tool when the handle is actuated by a user. In some cases, this actuation may be accomplished by pressing the grips of the composite handle together. This motion may close the blades on a pair of scissors or bring the ends of a pair of forceps together, for example.

The surgical tool actuation handle apparatus <NUM> as described herein offers advantages such as being lightweight, having variable flexibility, being suitable for use on surgical instruments with moving parts, being easily manufactured and assembled, and being suitable for disposable use.

Claim 1:
A handle apparatus (<NUM>) for a surgical instrument comprising:
a base component (<NUM>) comprising a foldable strip of a first composite material that is bendable to form opposing sides of the handle apparatus, the base component being sized and arranged to be grasped and squeezed by a hand during a surgical procedure, the base component comprising:
a first grip (<NUM>) having a proximal end and a distal end (<NUM>);
a second grip (<NUM>) having a proximal end and a distal end (<NUM>);
a flexible portion (<NUM>) bendable to form an arcuate shape, the flexible portion extending from the proximal end of the first grip to the proximal end of the second grip;
a first hole (<NUM>) disposed in a central portion of the flexible portion;
a fastening mechanism (<NUM>) connecting the distal end of the first grip to the distal end of the second grip via first and second end portions (<NUM>, <NUM>) connected to the respective distal ends (<NUM>, <NUM>) of the first and second grips (<NUM>, <NUM>); and
characterised in that
the flexible portion (<NUM>) has a first flexibility and the first and
second grips have a second flexibility, and the first flexibility is greater than the second flexibility; and
in that the base component (<NUM>) comprises a single strip bent to form the first grip (<NUM>), the second grip (<NUM>), the flexible portion (<NUM>), the first end portion (<NUM>), and the second end portion (<NUM>).