Patent Description:
The invention pertains to a combination surgical kit for performing hand surgeries such as an endoscopic ligament release surgery, carpal tunnel release, plantar fasciotomy, gastroc release, cubital tunnel release, and tarsal tunnel release surgery, and similar surgical procedures on anatomic members.

Hand surgery is a common medical procedure in the United States and throughout the world. During surgeries such as endoscopic ligament release surgery, carpal tunnel release, plantar fasciotomy, gastroc release, cubital tunnel release, and tarsal tunnel release, the hand/wrist of the patient is positioned on an operating table whereupon various surgical instruments are employed to achieve the desired surgical goal. Conventionally, the medical staff assisting the surgeon will discern the surgical instruments required for a scheduled patient surgery, have them sterilized at a central processing area and once received back, position them in the sterile field in the operating room. The surgeon thereafter will employ the staff-gathered sterilized instruments during various stages of the hand surgery procedure.

Different surgical interventions on the various internal parts of the hand and wrist generally may require certain instruments common to all such surgeries. However, customized surgical instruments may also be required which are specifically adapted to perform each different intricate specific surgical procedure. It is conventionally left up to the surgical support staff to discern both the common and customized surgical instruments to gather, sterilize, and position in the operating room, in anticipation of the surgeon needing them during a schedule procedure. Should the support staff err in selection of the instruments needed for a particular surgery, the required instruments must be retrieved during the surgery for the surgeon.

A further consideration is the positioning of the surgical site, therefore the static positioning of the hand and wrist of the patient during the length of the procedure must be ensured. Should a patient move their arm or hand during the surgical procedure, the results can be catastrophic, potentially leading to further tissue damage. Conventionally, table stands with straps or retaining members are employed for such a purpose. Such stands and straps must also be sterilized in advance of the procedure to maintain the sterile field during the surgery.

For specialized surgery to the hand and wrist, it is important that the hand and wrist of the patient be restrained to prevent movement. Additionally, for a quick and successful surgery it is important that the correct sterilized surgical instruments needed for the particular procedure be present in the operating room and ready for use by the surgeon. This is important when transitioning procedures from the operating room with ready access to sterilization services to procedure rooms and office clinics where such services might not be readily available.

<CIT> discloses a surgical tray adapted to support a portion of a patient's body in a recess of the surgical tray. A wrist restraint is arranged in the recess to position and immobilise the patient's wrist in the recess. The surgical tray further comprises compartments, slots, and foam islands to position tools and accessories.

The forgoing examples of related art as to surgical kits including customized instruments to the task and hand restraints, and limitations related therewith, are intended to be illustrative and not exclusive, and they do not imply any limitations on the invention described and claimed herein. Various limitations of the related art will become apparent to those skilled in the art upon a reading and understanding of the specification below and the accompanying drawings.

The device herein provides a solution to the shortcomings of conventional surgery to and through the hand and wrist, which rely on staff to discern the instruments required, sterilize the instruments, and pre-position the instruments. The device provides a customized set of instruments adapted to perform the specific surgery on a patient in a single container. Additionally, the container includes a hand restraint for the hand of the patient on which the surgery will be performed. Still further, a drape cloth conventionally employed by most surgeons is also included.

Each container may be labeled for the specific surgery to which it, and the instruments, and hand mount within are adapted. Provided sterile in a sealed envelope or box or both, the resulting surgical kit is customized with the instruments required for the specific surgery to be performed, thereby alleviating mistakes by inexperienced surgical staff in surgical preparations. Further, the hand and wrist restraint can be formed for a single hand, or, may be configured to provide a mount to either hand of the patient thereby alleviating another issue which can arise should the correct restraint not be provided in advance.

With respect to the above description, before explaining at least one preferred embodiment of the herein disclosed combination surgical kit and hand restraint in detail, it is to be understood that the disclosed surgical system herein is not limited in its application to the details of construction and to the arrangement of the components in the following description or illustrated in the drawings. The examples described herein are capable of other embodiments and of being practiced and carried out in various ways which will be obvious to those skilled in the art. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for designing of other structures, methods and systems for carrying out the several purposes of the present disclosed customized surgical kit with hand restraint The invention, however, is defined in the appended claims.

The objects features, and advantages of the present invention, as well as the advantages thereof over existing prior art, which will become apparent from the description to follow, are accomplished by the improvements described in this specification and hereinafter described in the following detailed description which fully discloses the invention, but should not be considered as placing limitations thereon.

In some aspects, a combination surgical kit includes a plurality of sterile tools for a medical procedure, the plurality of tools comprising a first set of tools and a second set of tools; and a hand positioning tray device. The hand positioning tray may include a bottom tray configured to hold the first set of tools, a middle tray configured to hold the second set of tools, and a top tray comprising a recess configured to receive a patient's hand for the medical procedure.

The first set of tools can include one or more selected from the group consisting of: guides, a retrograde blade, and a combination probe and rasp instrument. The combination probe and rasp instrument can include two different surgical tools extending from respective opposing ends of a centrally located handle. The second set of tools can include one or more selected from the group consisting of: a scalpel blade, a pair of scissors, forceps, a dilator and elevator tool, or a retractor. The bottom tray can include a plurality of recesses configured to receive each of the first set of tools. The middle tray can include a plurality of recesses configured to receive each of the second set of tools. The top tray can include a recess dimensioned to receive the patient's hand. The top tray can include a first elevated portion to support a patient's wrist. The first elevated portion can include a roll of bandages. The top tray can include a strap configured to be positioned over and restrain the patient's hand.

In some examples, a hand positioning tray device can include a bottom tray configured to hold a first set of tools, a middle tray configured to hold a second set of tools; and a top tray comprising a recess configured to receive a patient's hand for a medical procedure. The first set of tools can include one or more selected from the group consisting of: guides, a retrograde blade, and a combination probe and rasp instrument. The combination probe and rasp instrument can include two different surgical tools extending from respective opposing ends of a centrally located handle. The second set of tools can include one or more selected from the group consisting of: a scalpel blade, a pair of scissors, forceps, a dilator and elevator tool, or a retractor. The bottom tray can include a plurality of recesses configured to receive each of the first set of tools. The middle tray can include a plurality of recesses configured to receive each of the second set of tools. The top tray can include a recess dimensioned to receive the patient's hand. The top tray can include a first elevated portion to support a patient's wrist. The first elevated portion can include a roll of bandages or esmark for positioning the patient's wrist. The top tray can include an elastomer strap configured to be positioned over and restrain the patient's hand.

In some aspects of the disclosure (not claimed), a method of positioning a hand for a medical procedure can include providing a hand positioning device comprising a top tray, the top tray comprising a substantially flat surface and an elevated portion; positioning a patient's wrist on the elevated portion of the top tray; and positioning a patient's hand on the substantially flat surface of the top tray. The method can further include securing the patient's hand to the top tray by positioning a strap of the top tray over the patient's hand. The method can further include positioning a plurality of tools in a bottom tray. The plurality of tools can include guides, a retrograde blade, and a combination probe and rasp instrument. The combination probe and rasp instrument can include two different surgical tools extending from respective opposing ends of a centrally located handle. The hand positioning device can further include a middle tray. The method can further include positioning a plurality of tools in the middle tray. The plurality of tools can include a scalpel blade, a pair of scissors, forceps, a dilator and elevator tool, or a retractor.

The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate some, but not the only or exclusive, examples of embodiments and/or features of the invention. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than limiting. In the drawings:.

Other aspects of the present invention will be more readily understood when considered in conjunction with the accompanying drawings, and the following detailed description, neither of which should be considered limiting.

Embodiments disclosed in this section or elsewhere in this application relate to devices and methods for positioning a patient's hand for minimally invasive tissue visualization and access, including endoscopic procedures.

Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

Where a range of values is provided, it is understood that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention.

Certain ranges are presented herein with numerical values being preceded by the terms "about," "around," and "approximately. " These terms are used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

In this description, the directional prepositions of up, upwardly, down, downwardly, front, back, top, upper, bottom, lower, left, right and other such terms refer to the nose engagement device as it is oriented and appears in the drawings and are used for convenience only; they are not intended to be limiting or to imply that the device has to be used or positioned in any particular orientation.

Now referring to the examples of <FIG>, there can be seen in <FIG> an overhead view of one example of the surgical kit device <NUM> herein which includes a polymeric mount <NUM>. The mount <NUM> may be formed of a material which may be sterilized by conventional methods such as PETG, Polyesters, Fluoropolymers, high temperature thermoplastics, silicone, PGA, polypropylene, and similar polymeric materials.

As shown in the examples of the device <NUM>, a recessed area <NUM> adapted in shape to accommodate the hand and wrist of a patient, may be formed into one, or opposing surfaces of the mount <NUM>. The material forming the mount <NUM> may be of a denier which will allow for a comfortable positioning of the hand of a patient in the recessed area <NUM> for the duration of the surgical procedure. Silicone for example can be formed in a denier which slightly compresses under weight and would allow for a cradling engagement of a hand in the recessed area <NUM> and soft comfortable support. Silicone is also adapted to undergo the heat of conventional steam sterilization or other sterilization so that the mount <NUM> can be packaged in a sealed container such as a plastic envelope (not shown) to maintain the sterility of the instruments engaged with the mount <NUM> and the mount <NUM> itself.

In certain examples, pre-engaged to the mount <NUM> are one or a plurality of restraints such as the depicted elastic or strap restraints <NUM>. At least one end of each restraint <NUM> may be connected to the surface of the mount <NUM> by a removable connector <NUM>. In examples, such connectors may be snaps, buttons, magnets, screws, or other separable removable connectors <NUM> as one skilled in the art may employ such as any from the <NUM> GRAINGER catalog. If the restraints <NUM> are elastic, then the connector <NUM> may be fixed since the restraints <NUM> may be stretched to insert the hand of a patient into the recessed area <NUM> and thereafter removed therefrom. The restraints <NUM> so positioned may be adapted to contact and restrain the hand and wrist of a patient, within the recessed area <NUM> for the duration of the surgical procedure. The hand of the patient is thus secured from moving which as noted can have catastrophic consequences during a procedure with scalpels and other surgical instruments being employed. While not shown, the mount <NUM> itself may be secured to the surgical table using conventionally available straps and the like for such securement.

Additionally shown in <FIG>, are the inclusion of removable engaged surgical instruments <NUM> which may be engaged to the mount <NUM> as a kit. Each kit of instruments <NUM> may include a plurality of specific instruments <NUM> which are employed by surgeons for a specific surgery. Such as shown may include a guide, pick-ups, blade or scalpel, release blades, elevators, or other instruments specifically employed in an individual specific surgical procedure.

The device <NUM> with a kit of instruments <NUM> specific to a surgical procedure, may be labeled on the exterior as to the procedure or procedures the device <NUM> with the included kit of instruments <NUM> is adapted to perform. The surgical support staff thus need only find the device <NUM> labeled on the exterior with indicia indicating the particular device <NUM> chosen matches the surgical procedure for which it is being chosen.

Shown in <FIG> is an example of the device <NUM> having thumb recesses <NUM> on opposing sides of the recess for the palm and fingers of the hand of a patient. This example of the device <NUM>, thus on a single surface of the mount <NUM>, provides for fixed positioning of either the right hand or left hand of a patient within the recess <NUM> in the mount <NUM>. Restraints <NUM> may also be provided to secure and hold either hand in the recess <NUM> and in a fixed position for the duration of the procedure.

Shown in <FIG>, is another example of the device <NUM> herein adapted for either the right or left hand of the user. As depicted, a second recess <NUM> is formed into a rear surface <NUM> of the mount <NUM> for the opposite hand of the recess <NUM> formed into the front surface <NUM> of the mount <NUM>. The restraints <NUM> can be moveable between the front surface <NUM> and rear surface <NUM>, or simply provided engaged to both surfaces. Removable connectors <NUM> are employed unless the restraints are elastic wherein they may be in fixed engagement to the mount <NUM>.

In examples of the device <NUM> shown, a drape cloth <NUM> may be included. The drape cloth <NUM> may be in a fixed engagement to the mount <NUM> on one end. Alternatively, the drape cloth <NUM> may be removably adhered to the mount <NUM> such as with a separable adhesive <NUM>.

<FIG> illustrates an exploded view of an example of a hand/wrist positioning surgical kit or device <NUM>. The hand/wrist positioning surgical kit <NUM> can include a top tray <NUM>, a middle tray <NUM>, and a bottom tray <NUM>. The three trays can be configured to fit within one another. The bottom tray <NUM> can receive the middle tray <NUM>. The bottom tray <NUM> and/or the middle tray <NUM> can receive the trop tray <NUM>. Other configurations may include only one tray or two trays, such as a bottom tray <NUM> and top tray <NUM>. Some configurations may include more than three trays configured to fit together or nest within one another. The top tray <NUM> may be configured as a handhold, dimensioned to receive a patient's hand in the correct position. The top tray <NUM> may be positioned on a table, such as a medical examination table. The top tray <NUM> may be used to securely position and hold a patient's hand in place for a medical procedure. The middle tray <NUM> and/or bottom tray <NUM> can also hold a variety of tools or instruments for use in the medical procedure.

In some configurations, the lip or edge of the bottom tray <NUM> may have a first groove or recess <NUM> to receive a middle tray <NUM>. The middle tray <NUM> can include a protrusion or edge that can fit into the corresponding first groove <NUM> of the bottom tray <NUM>. Similarly, the lip or edge of the bottom tray <NUM> may have a second groove or recess <NUM> to receive the top tray <NUM>. The top tray <NUM> can also have a protrusion or edge that can fit into the corresponding second groove <NUM> of the bottom tray <NUM>. The second groove or recess <NUM> may be positioned above the first groove or recess <NUM>. The second groove or recess <NUM> may have a longer length and/or width than the length and/or width of the first groove or recess <NUM>. In some configurations, the middle tray <NUM> can include a groove to receive the top tray <NUM>. The top tray <NUM> can include a protrusion or edge that can fit into the corresponding groove of the middle tray <NUM>.

In some configurations, the bottom tray <NUM> may have a series of inwardly extending protrusions or projections configured to receive or support a bottom surface of the middle tray <NUM> and/or the top tray <NUM>. Similarly, in some configurations, the middle tray <NUM> may have a series of inwardly extending protrusion or projections configured to receive or support a bottom surface of the top tray <NUM>. The middle tray <NUM> and/or top tray <NUM> may be interference fit with the bottom tray <NUM>. The middle tray <NUM> may also be interference fit with the top tray <NUM>. The middle tray <NUM> and/or top tray <NUM> have protrusions or features that create an interference fit with the bottom tray <NUM>. In some configurations, the bottom tray <NUM> may have protrusions of features that create an interference fit with the received middle tray <NUM> and/or top tray <NUM>. Each of the trays may be made of a semi-rigid material.

<FIG> illustrates an example of a bottom tray <NUM> of the hand/wrist positioning surgical kit <NUM> of <FIG>. The bottom tray <NUM> may hold or store a plurality of a variety of instruments. For example, the bottom tray <NUM> illustrated in <FIG> includes two guides <NUM>, a retrograde blade <NUM>, and a combination probe or rasp instrument <NUM>. The surface of the bottom tray <NUM> may include a series of customizable recesses to receive the individual instruments. These recesses can securely hold the individual instruments in place, particularly when the hand/wrist positioning surgical kit <NUM> is moved. The recesses can also separate the individual instruments to hold them apart from one another. As described herein, the middle tray <NUM> may be received by the bottom tray <NUM>. The recesses of the bottom tray <NUM> may allow the instruments to rest below the surface of the bottom tray <NUM>, such that the middle tray <NUM> does not come into contact with the instruments when positioned within the recesses of the bottom tray <NUM>. Additionally, the recesses can be shaped and dimensioned to not only receive each instrument, but also to allow a user to easily grip and remove each instrument from the corresponding recess.

<FIG> illustrates an example of a middle tray <NUM> of the hand/wrist positioning surgical kit <NUM> of <FIG> and <FIG>. Similar to the bottom tray <NUM>, the middle tray <NUM> may hold a plurality of a variety of instruments. For example, the middle tray <NUM> illustrated in <FIG> includes a plurality of instruments <NUM>, such as scalpel blades, scissors, forceps, dilator or elevator tool, and retractors. Also similar to the bottom tray <NUM>, the middle tray <NUM> may have a series of recesses that can be customizable to receive individual instruments. As discussed herein, the middle tray <NUM> may be received by the bottom tray <NUM>. Similarly, the middle tray <NUM> may receive the top tray <NUM>.

<FIG> illustrates a top tray <NUM> of the hand/wrist positioning surgical kit <NUM>. <FIG> illustrates the top tray <NUM> with a roll <NUM> positioned thereon for positioning the hand and wrist. <FIG> illustrates the hand/wrist positioning top tray <NUM> with a hand/wrist <NUM> positioned thereon. The top tray <NUM> may be used as a mount to position and restrain a hand/wrist <NUM> in place for a procedure, as shown in <FIG>. The top tray <NUM> may have a hand recess <NUM>. The hand recess <NUM> may be dimensioned to receive and position the patient's hand <NUM>. The patient's hand <NUM> may be positioned palms up on the top tray <NUM> of the kit <NUM>, with the patient's hand within the hand recess <NUM>. The top tray <NUM> can include a strap <NUM>, which may be elastic or elastomer, to restrain the hand <NUM> in position within the hand recess <NUM>. The strap <NUM> may be positioned over the top surface of the hand <NUM>, as illustrated in <FIG>. The strap <NUM> can be positioned over the fingers of the patient's hand <NUM>. The strap <NUM> may be adjustable such that the length can be adjusted depending on the size of the patient's hand <NUM>. The position of the strap <NUM> may also be adjustable along the length of the top tray <NUM>, such that the strap <NUM> can be adjusted depending on the size of the patient's hand <NUM>.

The trop tray <NUM> may also have one or more elevated portions or protrusions <NUM>. The one or more elevated portions <NUM> can be positioned at the proximal end of the top tray <NUM>. The one or more elevated portions <NUM> may be configured to position and stabilize the patient's wrist. The one or more elevated portions <NUM> can have a recess <NUM> positioned there between. The recess <NUM> may receive a roll <NUM>, as shown in <FIG> and <FIG>. The roll <NUM> may be a roll of bandages or esmark bandages. The elevated portions <NUM> may be sloped for comfort of the patient, to allow the patient's wrist to be supported by the one or more elevated portions <NUM> and to allow the patient's hand <NUM> to rest within the hand recess <NUM>. The top tray <NUM> can also have a second elevated portion <NUM>, which can be positioned at the distal end of the top tray <NUM>. The second elevated portion <NUM> can act to barrier or to form the hand recess <NUM>. The second elevated portion <NUM> can act to position and retain the patient's hand <NUM> within the hand recess <NUM>. The hand recess <NUM> may be a substantially flat surface between the one or more elevated portions <NUM> at one end of the top tray <NUM> and the second elevated portion <NUM> at the other end of the top tray <NUM>.

In examples, the combination probe or rasp instrument <NUM> illustrated in the bottom tray in <FIG> may be a dual sided medical instrument. The handle may be substantially straight and sized for gripping by the fingers and hands of a surgeon. The handle may be formed in a unitary structure with both the rasp positioned at a first end and a probe positioned at an opposite end. In examples, the handle may be formed independently of the two different instruments extending from opposite ends thereof such as by forming it of a plastic or polymeric material or of metal, which is adapted at both ends to operatively engage with the chosen surgical instruments.

In examples, at a first end of the formed handle portion extends a first instrument having a proximal end adapted to engage the handle and having a distal end configured as the surgical instrument such as a probe. At the opposite second end of the handle may extend the second instrument from a proximal end thereof adapted to engage the second end of the handle. The second instrument may extend to a distal end on which the second instrument is formed, such as a probe.

In examples of the device, a central portion of the first instrument and a central portion of the second instrument, extend from the ends of the handle at an angle substantially between approximately <NUM> to <NUM> degrees, such as between <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, relative to a central axis of the handle. By substantially is meant plus or minus <NUM> percent, <NUM> percent, <NUM> percent, <NUM> percent, <NUM> percent, or <NUM> percent.

In examples, this angled extension allows for the surgeon using one of the instruments extending from the handle to position the second instrument out of the way of his hand and arm as it will extend at the angle away from the handle opposite that of the first instrument.

For example, a single surgical instrument which include a first surgical tool such as a rasp on a first end and a second surgical tool such as a probe at the second end, may therefore allow the surgeon the ability to accomplish two tasks without having to change instruments.

Referring now to the drawings in <FIG>, there is seen in <FIG>, one example of the device <NUM> herein formed in a unitary structure of material such as stainless steel. As shown, the device <NUM> may have a centrally positioned handle <NUM> which as shown is substantially planar and adapted for compression holding between the fingers and thumb of the user. At a first end of the handle may extend a first surgical tool, and at an opposing end of the handle <NUM> extends a second surgical tool.

The first surgical tool may include a rasp <NUM> positioned at the distal end of a first projecting member <NUM>. The proximal <NUM> end of the first projecting member <NUM> is engaged to the first end of the handle <NUM>. The second surgical tool includes a probe <NUM>, positioned at the distal end of a second projecting member <NUM>. The proximal end of the second projecting member <NUM> is engaged to <NUM> the second end of the handle <NUM>.

In examples of the device <NUM> herein, both the first projecting member <NUM> and the second projecting member <NUM> may extend from their respective engagements to the handle <NUM> ends, at opposing angles. Currently, in the example, the angle of extension relative to the central axis of the handle <NUM> (<FIG>) is between <NUM> to <NUM> degrees with an angle of between substantially <NUM>-<NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, <NUM> to <NUM> degrees, or <NUM> to <NUM> degrees.

Shown in <FIG>, an example of device <NUM> is shown with the rasp <NUM> extending from the handle <NUM> engaged with the first projecting member <NUM> at a first end. Also shown is the probe <NUM> at the distal end of the second projecting member <NUM> extending from the opposite end of the handle <NUM>. As shown, the first and second projecting members extend in opposite directions at an angle between <NUM>-<NUM> degrees.

In this example, the handle <NUM> may be formed independent of the two surgical tools extending from opposite ends thereof. As shown, the centrally located handle is formed in a cylindrical shape which ridges on opposing sides of recesses extending along the handle <NUM>. This combination of ridges and recesses provides enhanced gripping of the handle and more comfort during use.

Claim 1:
A combination surgical kit (<NUM>) comprising:
a plurality of tools for a medical procedure, the plurality of tools comprising a first set of tools and a second set of tools; and
a hand/wrist positioning tray device;
characterised in that the hand/wrist positioning tray device comprises:
a bottom tray (<NUM>) configured to hold the first set of tools;
a middle tray (<NUM>) configured to hold the second set of tools; and
a top tray (<NUM>) comprising a recess (<NUM>) and an elevated portion (<NUM>),
wherein the recess (<NUM>) is configured to receive a patient's hand for the medical procedure,
wherein the elevated portion (<NUM>) is configured to support a patient's wrist for the medical procedure.