Abstract:
A surgical restraint device includes an elongate strap member having a widened pad end and an attachment end. An adhesive layer is affixed to one side of the widened pad end that is formed of a hypoallergenic material for selective engagement to skin of a patient. A peel-off layer releasably covering the adhesive layer to selectively expose the adhesive layer before use. At least one aperture formed in the attachment end accepts engagement to a hooking member presented on a surgical patient support structure.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 62/263,448, entitled “POSITIONING ATTACHMENT FOR A PATIENT” and filed Dec. 4, 2015. The entire disclosure of which is hereby incorporated by reference for all purposes. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Field of the Invention 
         [0003]    The field of art disclosed herein generally pertains to patient surgical restraining devices, and more particularly to immobilizing portions of a patient&#39;s body to a surgical support surface during surgery. 
         [0004]    Description of the Related Art 
         [0005]    Often a patient who is placed onto an operating table is positioned in a predetermined way on the table to allow for surgical intervention. This position must be maintained during the surgery with very little motion to the body parts. 
         [0006]    Patient position restraining systems are of multiple varieties. Some are silicone based pads that allow for a body part to have limited specific point of pressure to avoid decubitus. Some are foam based to allow a similar alteration of pressure on a body part to prevent compression and ulceration or damage to the skin in long or even short procedures. 
         [0007]    Retaining straps may be used along the patient&#39;s body to secure the patient to the underlying table. Often the patient is moved aggressively or the table may be tilted. In these situations, there is a need to protect the body with straps so that the patient does not literally fall from the operating table. Although there are soft and malleable cushion straps that can be used, often high tension materials are used so that firm pressure can be applied to a sometimes massive torso to allow for firm fixation. In this situation if there is any change in body position, the pads or foams that are positioned under the straps may become dislodged and friction skin damage may occur. 
         [0008]    In any situation where there is patient motion during the case, the initial positions of the arms, legs, and/or bony prominences may change and thus potentially altering the ability to protect the body part with non sticky foam cushions. Even in the cases of the vacuum positioning system which custom forms to the body or body part, alterations can occur with resultant changes in the pressure that the body parts experience. 
         [0009]    In situations in which a body part such as the arm has to be pulled to one side of the body, foam straps are applied with underlying cords of non woven or cloth attachments straps. These have a significant ability to strangulate the body part during a procedure regardless of the foam used. This is often worse in a morbidly obese individual with a more difficult limb to control. In a debilitated or older individual with poor skin, even minor abrasions can result in full skin sloughs. 
         [0010]    In the morbidly obese individual, multiple skin flaps are the rule rather than the exception. The skin must be pulled to one side to allow for the surgery to take place without contamination and with maximum visibility. Conventionally, this situation is dealt with by tape that is attached to the patient skin to allow for an attachment to the pannus. The other side of the tape may be then attached with tension to the side of the bed. Similar skin tension is necessary when dealing with surgeries below the breast or around the neck or lower face. 
         [0011]    In situations in which there is traction applied to an extremity through a traction device, such as during wrist, shoulder or ankle arthroscopy, the attachment points are again related to straps and a mobile silicone or foam based attachment. 
         [0012]    Prior inventors have addressed the above problems. Representative prior U.S. patents are listed below. 
         [0013]    In Patent U.S. Pat. No. 3,845,757, a pre-gelled intensive care electrode is formed from two layers of soft, conformable foam material having a rigid plastic supporting layer between the foam layers. A conductive connector is in contact with an open-celled spongy material filled with an electrolyte, which provides means for connecting the electrode to monitoring devices and measuring the electrical impulses from a patient&#39;s skin. The biomedical monitoring electrode is held in place on the patient&#39;s skin by means of a hypo-allergenic pressure sensitive adhesive. 
         [0014]    Patent U.S. Pat. No. 4,016,869 discloses a signal collector system, in particular for electrical body signals, consisting of at least one electrode and a contact paste, which is to be introduced, at the applicating location, intermediate the body and the electrode. The electrode provides for the extensive avoidance of the effect of the forces and twisting moments which attack it in its applied condition by forming on the body a homogeneous contact paste and adhesive with a conductive substance having a salve or syrup like consistency for the electrode. 
         [0015]    In Patent U.S. Pat. No. 4,008,721, a tape form electrode is provided which is usable for transmission of electrical signals into the human body through the skin. The electrode is of a construction so that it can be applied to the skin to secure good electrical contact therewith and remain in place for many days despite normal movement and the normal activities of the subject such as perspiring, and washing. The construction utilizes a porous backing material which has an adhesive layer on one side thereof and over the adhesive layer a second layer which has incorporate therein a quantity of finely divided silver metal. The composition construction is of a thickness and selection of materials such that it readily “breaths” thereby permitting escape of normal amounts of perspiration from the skin of the subject. The adhesive is normally “dry” and is activated at the time of application by a suitable solvent. 
         [0016]    Patent U.S. Pat. No. 3,911,906 discloses an electrode device for establishing an electrical connection between electromedical apparatus and the skin of the human anatomy comprising a composite electrode body for self-adhering engagement with a substantial surface area of the skin to establish the electrical connection throughout substantially the entire engaged area of the skin without the use of conductive pastes, gels or other liquids, such as solvents or the like, the composite electrode body being porous and hypoallergenic and including a carrier layer and a thin flexible layer of pressure sensitive adhesive material having fine electrically conductive particles dispersed throughout providing a tacky skin-engaging surface the particles being provided in an amount sufficient to effect the electrical connection with the engaged area of the skin through the layer by particle to particle contact while permitting the skin-engaging surface of the layer to remain tacky prior to skin engagement. A removable sheet having a release surface engaging the tacky skin-engaging surface of the layer is operable to be separated therefrom prior to application without substantially reducing the tackiness thereof. 
         [0017]    In Patent U.S. Pat. No. 4,066,078, an improved combination electrode for use in medical applications requiring monitoring and stimulation is provided preferably having an electrical current conductor including a connector in addition to a skin-interfacing film wherein this film may have adhesive, plastic and hydrophilic properties such as may reside in an electrically conductive, polymeric composition. 
       SUMMARY OF THE INVENTION 
       [0018]    In another aspect, the present disclosure provides a device for immobilizing a portion of a patient. The device includes a patch having an adhesive gel surface suitable for adhering to the skin of the patient. 
         [0019]    In one aspect of the present innovation, a surgical restraint device includes an elongate strap member having a widened pad end and an attachment end. In another aspect of the present innovation, a surgical restraint device includes multiple elongate strap members having a widened pad end and an attachment end. An adhesive layer is affixed to one side of the widened pad end that is formed of a hypoallergenic material for selective engagement to skin of a patient. A peel-off layer releasably covers the adhesive layer. At least one aperture formed in the attachment end to accept engagement to a hooking member presented on a surgical patient support structure. 
         [0020]    In another aspect of the present innovation, a surgical restraint device provides for multiple attachment points to the skin in an attempt to capture and control the position of the body part. The surgical restraint device allows for positioning of these individual attachment points in varied distances and tensions to the strap in order to vary the vector force of tension on the skin. 
         [0021]    In another aspect of the present innovation, the primary surgical restraint device is attached to an area adjacent to the body. 
         [0022]    In another aspect of the present innovation, an adhesive eye patch includes an inner covering shaped to encircle an orbit of a patient&#39;s eye and comprising an extending tab for manually grasping and peeling the inner covering away from a patient&#39;s face and comprising an aperture sized to encompass a patient&#39;s eye. An intermediate eye protective layer is attached to an outer side of the inner covering to cover the aperture and formed of a material that is protective or noninteractive with the patient&#39;s eye. An over covering is peripherally attached to the outer side of the inner covering around and overtop of the intermediate eye protective layer. An adhesive layer is at least intermittently adhered around an inner periphery of an inner side of inner covering to adhere to skin around a patient&#39;s eye. A peel-off layer is releasably covering the adhesive layer before adhering to the face of the patient. 
         [0023]    In another aspect of the present innovation, an adhesive eye patch is made of multiple points of contact with the eyelid instead of one continuous area of adherent material. This allows for less potential damage to the eyelid with removal of the patch. Also without a continuous area of adherent material there is more potential to harm the eye if the adherent material is inadvertently applied to the cornea. 
         [0024]    These and other features are explained more fully in the embodiments illustrated below. It should be understood that in general the features of one embodiment also may be used in combination with features of another embodiment and that the embodiments are not intended to limit the scope of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0025]    The description of the illustrative embodiments can be read in conjunction with the accompanying figures. It will be appreciated that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements are exaggerated relative to other elements. Embodiments incorporating teachings of the present disclosure are shown and described with respect to the figures presented herein, in which: 
           [0026]      FIG. 1  illustrates a front view of an example patient positioning device including an adhesive pad attached to strap for attachment to a surgical platform for fixation, according to one or more embodiments; 
           [0027]      FIG. 2  illustrates an isometric detail view of the example patient positioning device of  FIG. 1  having a pull-off protective cover being removed from a pad end, according to one or more embodiments; 
           [0028]      FIG. 3  is an isometric detail view of a portion of the patient positioning device of  FIG. 1 , with an end turned up to reveal a gel sticky surface of the pad end, according to one or more embodiments; 
           [0029]      FIG. 4  illustrates a front side view of the example patient positioning device of  FIG. 1  having the gel stick surface of the pad end adhered to a chest of a patient and with an excess segmented portion strap selectively detached, according to one or more embodiments; 
           [0030]      FIG. 5  illustrates a front view of an example patient positioning device including frangible, tracks formed in a pad end, according to one or more embodiments; 
           [0031]      FIG. 6  illustrates a front view of the example patient positioning device of  FIG. 5  with the frangible tracks opened to expandingly separate fingers of the pad end, according to one or more embodiments; 
           [0032]      FIG. 7  illustrates a side view of two example patient positioning devices of  FIG. 1  positioning an arm of a patient to other parts of the patient, according to one or more embodiments; 
           [0033]      FIG. 8  illustrates a side view of the example patient positioning devices of  FIG. 1  adhered to a chin of a patient to expose a neck portion thereby allowing an unimpeded view of an intended surgical site, according to one or more embodiments; 
           [0034]      FIG. 9  illustrates a top isometric view of a patient having a large abdomen, obscuring a surgical site at waist level; 
           [0035]      FIG. 10  illustrates a top isometric view of the patient of  FIG. 9  having the example patient positioning devices of  FIG. 1  retracting the abdomen away from the operative site, according to one or more embodiments; 
           [0036]      FIG. 11  illustrates a top side view of an example pair of adhesive eye patches applied to a patient, according to one or more embodiments; 
           [0037]      FIG. 12  is a rear view the example adhesive eye patch, according to one or more embodiments; 
           [0038]      FIG. 13  is an side exploded side view of the example adhesive eye patch of  FIG. 10 , according to one or more embodiments; and 
           [0039]      FIG. 14  illustrates a side view of a patient secured with the example patient positioning devices of  FIG. 1  and the example adhesive eye patch of  FIG. 10 , according to one or more embodiments. 
       
    
    
     DETAILED DESCRIPTION 
       [0040]    In one aspect, the present disclosure provides a silicone type of protectant with an adhesive pad that can attach to a body part in the operating room. This can allow for control of the body and manipulation of the body part without skin damage from straps or tape. 
         [0041]    In another aspect, the straps may be attached to the gel pad so that the body part may be manipulated into a better position while allowing the silicone to protect the skin area in question by acting as another layer of protective medium. 
         [0042]    In another aspect, the straps may be attached to the bed with an adjustable hook and loop assembly method or some other potential securing method including iterating using glue, buttons, belt buckle like attachments. 
         [0043]    In another aspect, the straps may be adjusted during the case but are not sterile at the attachment points to the bed. Another iteration may include a suitable sterile gel matrix that allows for use in the operating field. 
         [0044]    In an exemplary embodiment, one surface of the pad has an adhesive gel applied thereto. The gel is designed to adhere to the skin, and is preferably initially covered with a tear-away covering. Suitable adhesive gels are well known. The adhesion strength can be altered by suitable choice of materials, according to the intended application. The strap end of the device is provided with fasteners such as soft loops/stiff hooks, adhesive material knots, eyelets, etc., so that it can be wrapped around a fixture and secured in place. The pad is preferably divided into parallel sections, which can be splayed when desired to distribute the adhesive traction over a larger area of the patient. 
         [0045]    Similarly, an eye patch embodies the principles of the aspects of the present innovation can be used to immobilize the eyelid. The eye patch comprises an outer layer, a protective material, and an inner layer provided with a pull tab. Adhesive dots and an adhesive line are applied to the reverse of the inner layer. A release material might initially cover the adhesive. 
         [0046]    Turning now to the Drawings, the detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts with like numerals denote like components throughout the several views. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well known structures and components are shown in block diagram form in order to avoid obscuring such concepts. 
         [0047]    Referring to the  FIG. 1 , in an exemplary embodiment of a patient positioning device  100  that includes a strap  102  having a widened pad end  104  at one end and an elongate attachment end  106 . Apertures  108  formed along the length of the attachment end  106  provide an opening for hooking to a fixed structure, such as to a surgical support structure. 
         [0048]      FIG. 2  illustrates a peel-off protective covering layer  110  being removed from one side of the widened pad end  104  of the patient positioning device  100  to expose a hypoallergenic adhesive layer  112  which comprises a gel sticky surface providing sufficient adherence in sheer to be secured to the skin. The gel sticky surface readily allows removal from the skin when pulled away from the skin.  FIG. 3  illustrates that the strap  102  is formed of a flexible material to conform to the shape of the patient. In one or more embodiments the strap  102  is formed from a resilient material. In one or more embodiments the strap  102  is formed of an inelastic material. 
         [0049]      FIG. 4  illustrates that the example patient positioning device  100  having the pad end  104  adhered to a chest portion of a patient  114 . The attachment end  106  includes transverse grooves  116  that facilitate manual separation of an excess distal length  118  of the attachment end  106  that is not needed. 
         [0050]      FIG. 5  illustrates that the example patient positioning device  100  can include frangible, tracks  120  formed in a pad end  104  that are initially unbroken to provide a unitary pad end  104 .  FIG. 6  illustrates the example patient positioning device  100  with the frangible tracks  120  opened to expandingly separate fingers  122  of the pad end  104 . 
         [0051]      FIG. 7  illustrates two example patient positioning devices  100  positioning an arm  124  of a patient  114  to other parts of the patient  114 .  FIG. 8  illustrates the example patient positioning device  100  adhered to a chin  126  of a patient  116  to expose a neck portion  128  thereby allowing an unimpeded view of an intended surgical site. An inflatable pillow  130  under the neck also supports the patient  114 .  FIG. 9  illustrates a patient  114  having a large abdomen  132 , obscuring a surgical site  134  at waist level.  FIG. 10  illustrates the example patient positioning device  100  retracting the abdomen  132  away from the operative site  134 . 
         [0052]      FIG. 11  illustrates an example pair of adhesive eye patches  1100  applied to each eye of a patient  1102 , removable by pulling on a tab  1104  extending from one edge.  FIGS. 12-13  illustrate that the adhesive eye patch  1100  includes an inner covering  1106  shaped to encircle an orbit of a patient&#39;s eye and comprising the extending tab  1104  for manually grasping and peeling the inner covering away from a patient&#39;s face and having an aperture  1108  sized to encompass a patient&#39;s eye. An intermediate eye protective layer  1110  is attached to an outer side of the inner covering  1106  to cover the aperture  1108  and is formed of a material that is protective or noninteractive with the patient&#39;s eye. An over covering  1112  ( FIG. 12 ) is peripherally attached to the outer side of the inner covering  1106  around and overtop of the intermediate eye protective layer  1110 . An adhesive layer  1114  is at least intermittently adhered around an inner periphery of an inner side of inner covering  1106  to adhere to skin around a patient&#39;s eye. A peel-off layer  1116  releasably covers the adhesive layer  1114  before adhering to the face of the patient. In an exemplary embodiment, the adhesive layer  1114  comprises a series of space apart adhesive dots  1118  positioned for adhering above the patient&#39;s eye and an arcing line  1120  of adhesive positioned for adhering below a patient&#39;s eye.  FIG. 14  illustrates a patient  1400  secured with the example patient positioning device  100  and the example adhesive eye patch  1100 . 
         [0053]    All publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated as incorporated by reference. It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
         [0054]    It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a “colorant agent” includes two or more such agents. 
         [0055]    Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred materials and methods are described herein. 
         [0056]    References within the specification to “one embodiment,” “an embodiment,” “embodiments”, or “one or more embodiments” are intended to indicate that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. The appearance of such phrases in various places within the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Further, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not other embodiments. 
         [0057]    It is understood that the use of specific component, device and/or parameter names and/or corresponding acronyms thereof, such as those of the executing utility, logic, and/or firmware described herein, are for example only and not meant to imply any limitations on the described embodiments. The embodiments may thus be described with different nomenclature and/or terminology utilized to describe the components, devices, parameters, methods and/or functions herein, without limitation. References to any specific protocol or proprietary name in describing one or more elements, features or concepts of the embodiments are provided solely as examples of one implementation, and such references do not limit the extension of the claimed embodiments to embodiments in which different element, feature, protocol, or concept names are utilized. Thus, each term utilized herein is to be given its broadest interpretation given the context in which that terms is utilized. 
         [0058]    As will be appreciated by one having ordinary skill in the art, the methods and compositions of the invention substantially reduce or eliminate the disadvantages and drawbacks associated with prior art methods and compositions. 
         [0059]    It should be noted that, when employed in the present disclosure, the terms “comprises,” “comprising,” and other derivatives from the root term “comprise” are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, and are not intended to preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof. 
         [0060]    As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. 
         [0061]    While it is apparent that the illustrative embodiments of the invention herein disclosed fulfill the objectives stated above, it will be appreciated that numerous modifications and other embodiments may be devised by one of ordinary skill in the art. Accordingly, it will be understood that the appended claims are intended to cover all such modifications and embodiments, which come within the spirit and scope of the present invention.