Adhesive body appendage protection device

Abstract

An adhesive body appendage protection device capable of protecting a body appendage of a patient during a medical procedure, such as from pressure points and impact injuries comprises a foam member having a first side and a second side, and a first releasably-adhesive component at least partially disposed upon the first side thereof. During typical use, the first side of the device is disposed upon a medical furnishing and a body appendage is disposed upon the second side of the device. In some embodiments, a second releasably-adhesive component is disposed upon the second side of the foam member. In such embodiments, the device further protects the appendage by securing the appendage to the medical furnishing without the need for conventional securing devices.

Description

[0001] Adhesive Body Appendage Protection Device

[0002] CROSS-REFERENCE TO RELATED APPLICATION

[0003] This application claims priority to US Provisional Patent Application No. 63 / 668,750 entitled "Medical Securing Devices" filed in the United States Patent and Trademark Office on 08 July 2024 (08.07.2024), which is hereby incorporated herein by reference in its entirety.

[0004] TECHNICAL FIELD

[0005] The present disclosure relates to protection devices for a patient's body appendages to restrict movement thereof and / or to relieve pressure points and / or to protect from impacts during medical procedures. More particularly, the present disclosure relates to adhesive body appendage protection devices which are suitable for medical purposes.

[0006] BACKGROUND OF THE INVENTION

[0007] The medical field utilizes a variety of medical furnishings upon which patients (e.g., people receiving medical treatments / procedures, disabled individuals, rehabilitating individuals, elderly individuals, animals in veterinary hospitals, etc.) can place various body appendages for medical procedures (e.g, hand surgery, foot surgery, knee replacements, rehabilitations, etc.). Such medical furnishings can include, but are not limited to, stirrups, operating tables, surgical tables, examination tables, therapeutic tables, chiropractic tables, hospital beds, dental chairs, veterinary tables, and the like.

[0008] Although such medical furnishings tend to have a cushioned covering, the cushioning effect of such covering (if present) is typically minimal. As a result, a patient's appendage can experience discomfort and even injuries during a medical procedure (e.g., pressure points, undesirable movements, impact injuries, etc.).

[0009] In addition, the covering material for such medical furnishings tends to be a material that can be easily wiped clean of contamination (e.g., perspiration, blood, etc.) and / or quickly disinfected between uses. Accordingly, such covering material typically consists of a plastic, most typically vinyl (or a material having similar properties). As a result, such covering material tends to be non-breathable, which causes, inter alia, the accumulation of body heat and perspiration between the patient and the covering, which can also result in negative effects to a patient's appendage.

[0010] Attempts have been made to secure patients' appendages to medical furnishings, namely in the form of straps, belts, harnesses, braces, clamps and the like (i.e., conventional securing devices). However, such conventional securing devices can be cumbersome, can be uncomfortable for the patient, can cause injuries to the appendage (skin irritation, scrapes, contusions, mental anguish, etc.), and can potentially obstruct a medical procedure. In addition, in the case of straps, since one end of such straps is often permanently fastened to the medical furnishing, such straps cannot be removed (such as for cleaning, or to use the medical furnishing without such conventional securing devices). Moreover, such conventional securing devices often become contaminated, and are typically not bacteriostatic, antimicrobial or sterilizable.

[0011] Thus, there is a need for an inventive appendage protection device which is relatively soft, relatively breathable (i.e., allows for air flow), which can conform to a patient's appendage shape. There is also a need for an inventive appendage protection device which can relieve pressure points. There is also a need for an inventive appendage protection device which will not interfere with the use of a given medical furnishing or a particular medical procedure. There is also a need for an inventive appendage protection device which does not cause an injury to the patient. There is also a need for an inventive appendage protection device which is not cumbersome to utilize. There is also a need for an inventive medical securing device which can provide greater comfort for a patient during use as compared to conventional securing devices. There is also a need for an inventive appendage protection device which can eliminate the need for conventional securing devices. There is also a need for an inventive appendage protection device which is optionally reusable. There is also a need for an inventive appendage protection device which is bacteriostatic or antimicrobial (which can include antibacterial, antifungal and / or antipathogenic). There is also a need for an inventive appendage protection device which can be sterilized. There is also a need for an inventive appendage protection device which is inherently fire resistant. There is also a need for an inventive appendage protection device which is biodegradable.

[0012] There is also a need for an inventive appendage protection device which utilizes green technology.

[0013] SUMMARY OF THE INVENTION

[0014] In response, the invention of the present disclosure solves one or more of the problems and / or needs discussed above. More particularly, the invention is directed to an adhesive body appendage protection device which is capable of protecting a body appendage of a patient during a medical procedure, such as from pressure points and impact injuries, and which comprises a foam member suitably sized and shaped to accommodate a patient's body appendage, and having a first side and a second side, and further comprising first releasably-adhesive component at least partially disposed upon the first side of the foam member. During typical use, the first side of the device is disposed upon a medical furnishing and a body appendage is disposed upon the second side of the device. In some embodiments, a second releasably-adhesive component is disposed upon the second side of the foam member. In such embodiments, the device further protects the appendage by securing the appendage to the medical furnishing without the need for conventional securing devices.

[0015] In some preferred embodiments, an adhesive body appendage protection device for protecting a body appendage of a patient when disposed upon a medical furnishing comprises a foam member and a first releasably-adhesive component, wherein the adhesive body appendage protection device comprises a first side and an opposing second side, wherein the foam member comprises a first side and an opposing second side which each correspond to the first side and the second side of the adhesive body appendage protection device, respectively, wherein the foam member is sized and shaped to accommodate a body appendage of a patient, wherein the first releasably-adhesive component is at least partially disposed upon the first side of the foam member, wherein the first side of the adhesive body appendage protection device is disposed upon a medical furnishing during use such that the first releasably-adhesive component is in contact with the medical furnishing, and wherein at the patient's body appendage is disposed upon the second side of the adhesive body appendage protection device during use.

[0016] In some aspects of this embodiment, the foam member comprises a polyurethane foam. In other aspects of this embodiment, the foam member comprises a density of about 1.2 lb / ft3to about 10 lb / ft3. In other aspects of this embodiment, the foam member comprises an indentation force deflection of about 5 I bf to about 200 Ibf. In other aspects of this embodiment, the foam member comprises a tensile strength that is greater than about 8 psi. In other aspects of this embodiment, the foam member comprises a tear strength that is greater than about 1.3 lbf / in.

[0017] In some aspects of this embodiment, the first releasably-adhesive component comprises an adhesiveness of about 0.3 sec / in to about 600 sec / in. In some further aspects, the first releasably-adhesive component comprises a polyurethane-based releasably- adhesive polymer or a silicone based releasably-adhesive polymer. In other further aspects, the first releasably-adhesive component comprises a polyurethane-based viscoelastomeric thermoset polymer. In some further aspects, the polyurethane-based releasably-adhesive component is the product of a reaction media comprising:

[0018] A. about 2 wt% to about 10 wt% isocyanate prepolymer,

[0019] B. about 35 wt% to about 75 wt% polyols comprising about 1 wt% to about 65 wt% straight chain linking diols and about 3 wt% to about 50 wt% crosslinking polyols, and

[0020] C. about 10 wt% to about 60 wt% plasticizer comprising about 10 wt% to about 50 wt% epoxidized triglyceride plasticizer and 0 wt% to about 40 wt% viscosity reducing plasticizer.

[0021] In some aspects of this embodiment, the second releasably-adhesive component is at least partially disposed upon the second side of the foam member. In some further aspects, the second releasably-adhesive component comprises an adhesiveness of about 0.3 sec / in to about 600 sec / in. In some further aspects, the second releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone based releasably-adhesive polymer. In other further aspects, the second releasably-adhesive component comprises a polyurethane-based viscoelastomeric thermoset polymer. In some further aspects, the polyurethane-based viscoelastomeric thermoset polymer is the product of a reaction media comprising:

[0022] A. about 2 wt% to about 10 wt% isocyanate prepolymer,

[0023] B. about 35 wt% to about 75 wt% polyols comprising about 1 wt% to about 65 wt% straight chain linking diols and about 3 wt% to about 50 wt% crosslinking polyols, and C. about 10 wt% to about 60 wt% plasticizer comprising about 10 wt% to about 50 wt% epoxidized triglyceride plasticizer and 0 wt% to about 40 wt% viscosity reducing plasticizer.

[0024] In some aspects of this embodiment, the adhesive body appendage protection device is bacteriostatic. In other aspects of this embodiment, the adhesive body appendage protection device is sterilizable (i.e., capable of being sterilized). In other aspects of this embodiment, the adhesive body appendage protection device is fire resistant. In other aspects of this embodiment, the adhesive body appendage protection device is cleansable and reusable.

[0025] In some preferred embodiments, a method of using an inventive adhesive body appendage protection device comprises:

[0026] A. providing a foam member having a first side and an opposing second side;

[0027] B. providing a first releasably-adhesive component;

[0028] C. disposing the first releasably-adhesive component upon the first side of the foam member to form an adhesive body appendage protection device having a first side and an opposing second side;

[0029] D. disposing the first side of the adhesive body appendage protection device upon a medical furnishing such that the first releasably-adhesive component contacts the medical furnishing; and

[0030] E. disposing a patient's body appendage upon the second side of the adhesive body appendage protection device; wherein the foam member is suitably sized and shaped for accommodating the patient's body appendage, wherein the first side and the second side of the foam member correspond to the first side and the second side of the adhesive body appendage protection device, respectively, and wherein the first releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone based releasably-adhesive polymer, each having an adhesiveness of about 0.3 sec / in to about 600 sec / in. In such embodiments, the adhesive body appendage protection device protects the patient's appendage against, inter alia, pressure points and impact injuries due to undesirable movements of the appendage during a medical procedure.

[0031] In some aspects of this embodiment, the method further comprises:

[0032] A. providing a second releasably-adhesive component; and B. disposing the second releasably-adhesive component upon the second side of the foam member; wherein the second releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone based releasably-adhesive polymer, each having an adhesiveness of about 0.3 sec / in to about 600 sec / in. In such aspects, the adhesive body appendage protection device further protects the patient's appendage by securing the appendage to the medical furnishing without the need for conventional securing devices.

[0033] Numerous other features and advantages of the present invention will appear from the following description. In the description, reference is made to exemplary embodiments of the invention. Such embodiments do not represent the full scope of the invention. Reference should therefore be made to the claims herein for interpreting the full scope of the invention. In the interest of brevity and conciseness, any ranges of values set forth in this specification contemplate all values within the range and are to be construed as support for claims reciting any sub-ranges having endpoints which are real number values within the specified range in question. By way of a hypothetical illustrative example, a disclosure in this specification of a range of from 1 to 5 shall be considered to support claims to any of the following ranges: 1-5; 1-4; 1-3; 1-2; 2-5; 2-4; 2-3; 3-5; 3-4; and 4-5.

[0034] BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The foregoing and other features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims and accompanying drawings where:

[0036] Fig. 1A is a perspective view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side;

[0037] Fig. IB is a side view of Fig. 1A taken along Line C-C;

[0038] Fig. 1C is a top view showing an array of various non-limiting exemplary inventive adhesive body appendage protection devices of the present disclosure, each having a first side and a second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side;

[0039] Fig. ID is a top view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side, wherein the first side of the adhesive body appendage protection device is disposed upon and releasably adhered to a medical furnishing via the first releasably-adhesive component, and wherein a patient's appendage in the form of a torso is disposed upon the second side;

[0040] Fig. IE is a top view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side, wherein the first side of the adhesive body appendage protection device is disposed upon and releasably adhered to a medical furnishing via the first releasably-adhesive component, and wherein a patient's appendage in the form of an arm and hand are disposed upon the second side;

[0041] Fig. IF is a top view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side, wherein the first side of the adhesive body appendage protection device is disposed upon and releasably adhered to a medical furnishing via the first releasably-adhesive component, and wherein a patient's appendage in the form of a leg is disposed upon the second side;

[0042] Fig. 2A is a perspective view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member, a first releasably-adhesive component disposed upon the first side, and a second releasably-adhesive component disposed upon the second side;

[0043] Fig. 2B is a side view of Fig. 2A taken along Line D-D;

[0044] Fig. 2C is a top view showing an array of various non-limiting exemplary inventive adhesive body appendage protection devices of the present disclosure, each having a first side and a second side, and comprising a foam member, a first releasably-adhesive component disposed upon the first side, and a second releasably-adhesive component disposed upon the second side;

[0045] Fig. 2D is a top view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member, a first releasably-adhesive component disposed upon the first side, and a second releasably-adhesive component disposed upon the second side; wherein the first side of the adhesive body appendage protection device is disposed upon and releasably adhered to a medical furnishing via the first releasably-adhesive component, and wherein a patient's appendage in the form of a torso is disposed upon and releasably adhered to the second side via the second releasably-adhesive component;

[0046] Fig. 2E is a top view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member, a first releasably-adhesive component disposed upon the first side, and a second releasably-adhesive component disposed upon the second side; wherein the first side of the adhesive body appendage protection device is disposed upon and releasably adhered to a medical furnishing via the first releasably-adhesive component, and wherein a patient's appendage in the form of an arm and a hand are disposed upon and releasably adhered to the second side via the second releasably-adhesive component;

[0047] Fig. 2F is a top view showing a non-limiting exemplary inventive adhesive body appendage protection device of the present disclosure having a first side and a second side, and comprising a foam member, a first releasably-adhesive component disposed upon the first side, and a second releasably-adhesive component disposed upon the second side; wherein the first side of the adhesive body appendage protection device is disposed upon and releasably adhered to a medical furnishing via the first releasably-adhesive component, and wherein a patient's appendage in the form of a leg is disposed upon and releasably adhered to the second side via the second releasably-adhesive component; and

[0048] Fig. 3 is a perspective view showing a testing apparatus for the Adhesiveness Test.

[0049] Repeated use of reference characters in the present specification and drawings is intended to represent the same or analogous features or elements of the present invention. It should be understood that the drawings herein are not intended to be drawn to scale, but rather are drawn to show particular elements of the invention.

[0050] TEST METHODS

[0051] Adhesiveness Test

[0052] The adhesiveness of a releasably-adhesive component 690 (e.g., the first releasably-adhesive component 130, the second releasably-adhesive component 150, or other adhesive composition) is measured in accordance with the following test procedure, or equivalent. Unless otherwise stated, the test results herein are expressed in units of seconds per inch (sec / in).

[0053] With reference to Fig. 3, the testing apparatus 600 includes a sixty-degree (60°) incline plane 610 having a planar major front side 611, an opposing planar major back side 612 distal to the front side 611, a top side 613 disposed between the front side 611 and the back side 612, an opposing bottom side 614 distal to the top side 613, and two (2) lateral sides 615. The incline plane 610 is rectangular and comprises a rigid solid material (e.g., stainless steel, a sheet of plywood, plastic, etc.) having a length of 24 inches (61.0 cm), a width of 20 inches (50.8 cm), and a thickness of % inch (1.0 cm). The incline plane is attached to a bracing assembly 620 constructed essentially of 2 inch by 2 inch (5.1 cm x 5.1 cm) wooden boards or equivalent such that the incline plane 610 is securely disposed at a 60° lengthwise angle, as measured from the horizontal. The testing apparatus 600 also comprises a clamping element 630 disposed upon the front side 611 of the incline plane 610 proximate to the top side 613 thereof. The purpose of the clamping element 630 is to retain a test sample against the planar front side 611 of the incline plane 610 during use. The testing apparatus 600 additionally comprises a tray member 640 adapted to receive a marble 650 which is disposed adjacent to the front side 611 and bottom side 614 of the incline plane 610, and which has a length of at least about 20 inches (50.8 cm), such that the tray member 640 generally aligns with the width of the incline plane 610. Accordingly, the testing apparatus 600 further includes a glass spherical marble 650 having a diameter of 1 inch (2.5 cm) and a weight of 20.0 grams ± 1.0 grams. The testing apparatus 600 further includes a standard stopwatch 660.

[0054] Procedurally, the testing apparatus 600 is placed onto a suitable solid, flat and level horizontal surface. A test sample 670 is then prepared by providing a release liner 680 having a length of about 8 inches (20.3 cm) to about 22 inches (55.9 cm) and a width of about 2 inches (5.1 cm) to about 12 inches (30.5 cm). The release liner 680 comprises 120 gauge PET (polyethylene terephthalate), such as Part No. F-10067 available from Griff Paper & Film, having a place of business located in Fallsington, Pennsylvania 19054, USA. A releasably-adhesive component 690 is then placed upon essentially an entire side the release liner 680 at a desired thickness (typically ranging from about 0.1 mm to about 25 mm), thus forming the test sample 660. This can be accomplished by: 1) adhesively applying a prefabricated releasably-adhesive component 690 to the release liner 680, or 2) by applying a liquid or semi-liquid adhesive composition to the release liner 680 and then allowing it to dry or cure in-situ into a releasably-adhesive component 690 disposed upon release liner 680.

[0055] The test sample 670 is then placed upon the front side 611 of the incline plane 610 (such that the release liner 670 faces and is in contact with the front side 611 of the incline plane 610) by clamping one lengthwise end of the test sample 670 into the clamping element 630 such that the opposing distal lengthwise end of the test sample 670 faces toward, and is proximate to, the tray member 640. The marble 650 is then disposed upon the test sample 670 proximate to the clamping element 630 (i.e., proximate to the top end of the test sample 670) and then held in position (typically with a finger) using minimal pressure, and a mark (or equivalent) is made on the incline plane 610 or the test sample 670 to designate the starting position of the marble 650. The marble 650 is then released while simultaneously starting the stopwatch 660. The marble 650 is then allowed to roll down the test sample 670. The stopwatch 660 is stopped when the marble 650 detaches from the test sample 670 and falls into the tray member 640 (marking the point of detachment if it occurs prior to the distal lengthwise end of the test sample 670). The stopwatch 660 time (in seconds) is then recorded, and the distance the marble 650 traveled prior to detachment is measured (in inches) and also recorded.

[0056] The procedure is then repeated two (2) additional times for a total of three (3) test iterations.

[0057] The sum of the three (3) stopwatch 660 times (from the three (3) test iterations) is calculated and recorded. Likewise, the sum of the three (3) distance measurements (from the three (3) test iterations) is calculated and recorded. The adhesiveness of the test sample 670 is then calculated by dividing the sum of the time (in seconds) by the sum of the distance (in inches). The resulting adhesiveness is expressed in units of seconds per inch (sec / in).

[0058] Cohesiveness Test

[0059] The cohesiveness of a releasably-adhesive component (e.g., the first releasably-adhesive component 130, the second releasably-adhesive component 150, or other adhesive composition) can be tested by determining the amount of residual adhesive composition which remains on a surface after being contacted by such releasably-adhesive component. The test procedure utilizes a platen which is a solid polished nickel cylinder weighing 20.0 grams and having a flat, planar contact surface area of 1.76 cm2.

[0060] A test sample of the releasably-adhesive component which has dimensions large enough to test three (3) untested areas of the sample (e.g., at least about 1.5 cm x 1.5 cm) is laid flat on a solid, flat and level surface. The platen is then placed onto an untested surface portion of the test sample with the contact surface of the platen in contact with the releasably-adhesive component. The platen is then allowed to remain in contact with the test sample for 15 seconds. The platen is then separated from the test sample, and the contact surface of the platen is carefully visually inspected for residual adhesive composition. The amount of residual adhesive composition disposed upon the platen's contact surface is then recorded as a percentage (%) of coverage of the platen's contact surface.

[0061] The procedure is repeated two (2) additional times, for a total of three (3) test iterations

[0062] The average of the three (3) test iterations is then calculated and recorded. The cohesiveness is then calculated by subtracting the average of the three (3) test iterations from 100%. The resulting cohesiveness is expressed as a percent (%). Foam Density Test

[0063] The density of a foam member 110 can be tested in accordance with ASTM D3574-A or equivalent. Unless otherwise stated, the test results herein are expressed in units of pounds per cubic foot (lb / ft3).

[0064] Foam Indentation Force Deflection (IFD) Test

[0065] The density of a foam member 110 can be tested in accordance with ASTM D3574-B1 or equivalent. Unless otherwise stated, the test results herein are expressed in units of pounds-force (Ibf). It should be understood that the term "Indentation Load Deflection" or "ILD" can be used interchangeably with the term "Indentation Force Deflection" or "IFD", respectively.

[0066] Foam Air Flow Test

[0067] The air flow of a foam member 110 can be tested in accordance with ASTM D3574-G or equivalent. Unless otherwise stated, the test results herein are expressed in units of cubic feet per minute (cfm).

[0068] Foam Tensile Strength Test

[0069] The tensile strength of a foam member 110 can be tested in accordance with ASTM D3574-E or equivalent. Unless otherwise stated, the test results herein are expressed in units of pounds per square inch (psi).

[0070] Foam Tear Strength Test

[0071] The tear strength of a foam member 110 can be tested in accordance with ASTM D3574-F or equivalent. Unless otherwise stated, the test results herein are expressed in units of pounds-force per inch (lbf / in). Foam Elongation Test

[0072] The elongation of a foam member 110 can be tested in accordance with ASTM D3574-E or equivalent. Unless otherwise stated, the test results herein are expressed in units of percent (%).

[0073] DEFINITIONS

[0074] It should be noted that, when employed in the present disclosure, the terms "a" and "an" are intended to mean "at least one" of any stated features, elements, integers, steps, components, or groups and are not intended to be limited to only one of such features, elements, integers, steps, components, or groups thereof, except where specifically stated as such. In addition, use of the phrase "at least one" is not intended to render other uses of the terms "a" or "an" to be limited to only one of a feature, element, integer, step, component, or group.

[0075] 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, components, or groups, and are not intended to preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof.

[0076] As used herein, the term "foam member" refers to a foam mass (e.g., substrate, layer, pad, mat, etc.) in a generally solid form which exhibits elastic and / or rebound properties and which generally does not disperse or break apart upon application of a reasonable mechanical force thereto as would be understood by a person having ordinary skill in the art.

[0077] As used herein with respect to foam, the term "cell" refers to a cavity contained in a foam.

[0078] As used herein with respect to foam, the term "cell connectivity" refers to a circumstance wherein at least one wall of a cell membrane of a foam surrounding a cell has orifices, pores or apertures that connect to an adjacent cell, such that an exchange of fluid (i.e., gasses and / or liquids) is possible between such adjacent cells.

[0079] As used herein with respect to foam, the term "closed cell" refers to a cell in a foam wherein the cell membrane surrounding the cavity is not broken and has all membranes intact. As used herein, the term "catalytic amount" is a term of art which is recognized by persons having ordinary skill in the art and refers to an amount that is enough to obtain a desired response or result.

[0080] As used herein with respect to adhesive components, the terms "cohesive" and "cohesiveness" refer to the ability of an adhesive component (e.g., a polymer) to return to its original innate form upon subjection and subsequent removal of a stretching or compression force and to resist the separation and deposition of the adhesive component onto the surface of a previously adhered object.

[0081] As used herein, the term "effective amount" is a term of art which is recognized by persons having ordinary skill in the art and refers to the amount required to obtain a desired response or result.

[0082] As used herein, the terms "elastomer," "elastomeric," and "elastic" are used interchangeably and refer to material having elastomeric or rubbery properties, and are generally capable of recovering their shape after deformation when a deforming force is removed.

[0083] As used herein with respect to foam, the term "foam formulation" refers to the base constituent (e.g., resin, polymer, etc.) and any additives that are combined and used in the foam-making process.

[0084] As used herein, the term "medical" refers to and includes the medical field, surgical field, dental field, veterinary field, therapy / therapeutic field, chiropractic field, acupuncture field, tattoo field, and the like.

[0085] As used herein, the term "medical furnishing" refers to any furnishing upon which a patient resides during a medical procedure performed on the patient, including but not limited to, operating tables, surgical tables, examination tables, therapeutic tables, chiropractic tables, veterinary operating tables, stretchers, gurneys, medical cots, hospital beds, dental chairs, and the like, and any attachments thereto, and which further includes any coverings upon such furnishings which may be utilized during a medical procedure. As used herein, the term "medical provider" refers to any individual who may be involved with the provision of a medical procedure and any preparation and cleanup relating to such medical procedure.

[0086] As used herein with respect to foam, the term "open-cell" refers to any cell in a foam that has at least one broken or missing membrane or an orifice or aperture in a membrane such that it is in communication with a neighboring cell.

[0087] As used herein, the term "patient" refers to a human or an animal undergoing a medical procedure.

[0088] As used herein, the term "polymer" generally includes but is not limited to, homopolymers, copolymers, including block, graft, random and alternating copolymers, terpolymers, etc., and blends and modifications thereof. Furthermore, unless otherwise specifically limited, the term "polymer" shall include all possible molecular geometrical configurations of the material. These configurations include, but are not limited to isotactic, syndiotactic and atactic symmetries.

[0089] As used herein with respect to adhesive components, unless otherwise stated, the composition of a polymer is considered to be generally equivalent to the composition of the polymeric reaction media.

[0090] As used herein with respect to adhesive components, the terms "reaction media" and "polymeric reaction media" refer to a polymer formula and any additives that are combined and used in the polymer-making process. The term "uncured" refers to a reaction media in a liquid state prior to a reaction of the constituents thereof. The term "partially-cured" refers to a reaction media in a liquid or semi-liquid state wherein a reaction of the constituents has commenced, but prior to completion of the reaction. The term "cured" refers to a completed reaction of a reaction media.

[0091] As used herein, the term "surfactant" refers to a chemical component that affects the surface tension of fluids.

[0092] As used herein, the term "thermoplastic" describes a material that softens and / or flows when exposed to heat, and then substantially returns to a hardened condition when cooled to room temperature. As used herein, the term "thermoset" refers to a material that is capable of becoming permanently cross-linked, and the physical form of the material cannot be changed by heat without a breakdown of chemical bonds.

[0093] As used herein with respect to adhesive components, the terms "viscoelastomeric" and "viscoelastic" can be used interchangeably to refer to a substance having viscous and elastic properties and which exhibits viscous flow, fluidic displacement and elastic properties (as opposed to densifying compressive elastic properties) to return to its original innate form upon subjection and subsequent removal of a stretching or compressive force. These terms may be defined with additional language in the remaining portions of the specification.

[0094] DETAILED DESCRIPTION - Best Mode(s) - Industrial Applicability

[0095] The invention is generally directed to a protection device for a patient's appendage to restrict movement thereof and / or to relieve pressure points and / or to protect from impacts during medical procedures. As used herein, the term "appendage" refers to a member of a patient's body (i.e., body part) which includes a patient's torso and which generally extends, directly or indirectly, from the patient's torso (e.g., torso, head, neck, arm, hand, finger, wrist, elbow, shoulder, leg, foot, toe, ankle, knee, hip, etc.). In some preferred embodiments, the present disclosure relates to an adhesive body appendage protection device which is suitable for medical purposes, and which eliminates the need for conventional securing devices (e.g., straps, belts, harnesses, braces, clamps, etc.). In general, the inventive adhesive body appendage protection devices herein comprise a foam member and at least one releasably-adhesive component disposed upon at least one external surface of the foam member.

[0096] In some embodiments, the inventive adhesive body appendage protection device can be useful for, among other things, reducing or eliminating injuries to a patient's appendage from pressure points during a medical procedure. In some embodiments, the inventive adhesive body appendage protection device can be useful for, among other things, reducing or eliminating injuries to a patient's appendage from impacts during a medical procedure. In some embodiments, the inventive adhesive body appendage protection device can be useful for, among other things, enhancing the comfort of a patient during a medical procedure. In some embodiments, the inventive adhesive body appendage protection device can be useful for, among other things, restricting movement of a patient's appendage during a medical procedure. In some embodiments, the inventive adhesive body appendage protection device can be useful for, among other things, positioning a patient's appendage during a medical procedure. In some embodiments, the inventive adhesive body appendage protection device can be useful for, among other things, securing a patient's appendage, (e.g., to a medical furnishing) during a medical procedure.

[0097] In some embodiments, the inventive adhesive body appendage protection device of the present disclosure can comprise a first releasably-adhesive component disposed upon a first major external side or surface of a foam member wherein such surface is intended to contact a medical furnishing, such that the adhesive body appendage protection device can be securely and releasably attached to the medical furnishing. In such embodiments, the first releasably-adhesive component will preferably comprise an adhesiveness that is sufficient for the adhesive body appendage protection device to withstand the forces exerted by a patient's appendage during a medical procedure without dislodging the device from the medical furnishing, but which thereafter also allows a medical provider to remove the adhesive body appendage protection device from the medical furnishing without damaging the medical furnishing or damaging the integrity of the device. In some embodiments, the inventive adhesive body appendage protection device of the present disclosure can further comprise a second releasably-adhesive component disposed upon an opposing second major external side or surface of the foam member which is distal from the first side, wherein such surface is intended to contact at least a portion of a patient's appendage, such that the appendage can be securely and releasably attached to the adhesive body appendage protection device, and thus to the medical furnishing. In such embodiments, the second releasably-adhesive component will preferably comprise an adhesiveness that is sufficient for the adhesive body appendage protection device to withstand the forces exerted by a patient's body appendage during a medical procedure without the patient dislodging from the device or from the medical furnishing, but which thereafter also allows a medical provider to remove the patient's appendage from the adhesive body appendage protection device without injuring the patient or irritating the contacting surface (e.g., skin, hair, fur, etc.) of the patient, and without damaging the integrity of the device.

[0098] In some embodiments comprising both a first releasably-adhesive component and a second releasably-adhesive component, the first releasably-adhesive component and the second releasably-adhesive component can comprise the same type of adhesive composition, and each can have substantially the same degree of adhesiveness. In other embodiments, the first releasably-adhesive component and the second releasably-adhesive component can comprise the same type of adhesive composition, but each can have a different degree of adhesiveness (e.g., the adhesiveness of the first releasably-adhesive component may be greater than or less than the adhesiveness of the second releasably-adhesive component). In yet other embodiments, the first releasably-adhesive component and the second releasably-adhesive component can comprise different types of adhesive compositions, but each can have substantially the same degree of adhesiveness. In still other embodiments, the first releasably-adhesive component and the second releasably-adhesive component can comprise different types of adhesive composition, and each can have a different degree of adhesiveness (e.g., the adhesiveness of the first releasably-adhesive component may be greater than or less than the adhesiveness of the second releasably-adhesive component). It should be appreciated that the thickness of the first releasably-adhesive component and the second releasably-adhesive component can also have an effect on the adhesiveness of the respective adhesive compositions. Typically, an adhesive component having a relatively greater thickness will tend to exhibit a greater adhesiveness than the same adhesive component having a relatively lesser thickness because, among other things, a greater thickness can generally provide for more surface area contact. Accordingly, the first releasably-adhesive component and the second releasably-adhesive component of the inventions of the present disclosure can have the same thickness or a different thickness without departing from the scope of the invention.

[0099] In some embodiments, the first releasably-adhesive component and / or the second releasably-adhesive component can be applied to a foam member to form the inventive adhesive body appendage protection device while in a prefabricated form (i.e., formed prior to applying the adhesive component to a foam member). In such embodiments, the first releasably-adhesive component and / or the second releasably-adhesive component can be cut to size (if desired), and then disposed onto the foam member, wherein such adhesive component will then be adhered to the foam member via an adhesive bonding. In other embodiments, the first releasably-adhesive component and / or the second releasably-adhesive component can be applied to the foam member while in a liquid or semi-liquid state (e.g., an uncured or partially cured polymer reaction media) and then allowed to dry or cure in-situ to form the adhesive component. Such liquid or semi-liquid adhesive component can be applied to a foam member using techniques known to persons having ordinary skill in the art, including but not limited to, casting, molding, pouring, coating, brushing, rolling, spraying, printing, and the like, and combinations thereof. In such in-situ curing, the adhesive component will then be adhered to the foam member via chemical bonding, as well as adhesive bonding, and thus may exhibit a greater adhesion to the foam member as compared to applying the adhesive component in a prefabricated form. Although several exemplary embodiments of the present invention will be described herein, it should be understood that the disclosed embodiments are intended merely as non-limiting examples of the invention that may be embodied in various forms. Therefore, specific details disclosed herein, such as relating to structure, function, and the like, are not to be interpreted as limiting in any manner whatsoever, but rather only as one of numerous example bases for claims and / or teaching persons having ordinary skill in the art to variously employ the present invention in virtually any appropriately detailed structure or circumstance.

[0100] Accordingly, in the interest of brevity and conciseness, descriptions herein may be substantially directed to a non-limiting exemplary form of the inventive adhesive body appendage protection device that is for use by human patients in a surgical setting. However, it should be understood that the invention of the present disclosure can be utilized by humans and animals alike, and in a variety of settings, including but not limited to, surgical settings, hospital settings, medical clinic settings, dental settings, veterinary settings, physical therapy settings, chiropractic settings, acupuncture settings, nursing home settings, tattoo parlor settings, and the like.

[0101] To gain a better understanding of the present invention, attention is directed to Figs. 1A-3 for exemplary purposes directed to non-limiting embodiments of an inventive adhesive body appendage protection device 100.

[0102] With particular reference to Figs. 1A-1F, in some preferred embodiments, an inventive adhesive body appendage protection device 100 of the present disclosure is shown generally in the form of a substrate, layer, pad, mat, etc. for, inter alia, relieving pressure points of a particular body appendage of a patient and / or protecting such appendage from impact injuries during a medical procedure. The inventive adhesive body appendage protection device 100 has a major first side 102 and an opposing major second side 104 distal to the first side 102.

[0103] The adhesive body appendage protection device 100 comprises a foam member 110 having a major first side 112 (which corresponds to the first side 102 of the adhesive body appendage protection device 100) and an opposing major second side 114 (which corresponds to the second side 104 of the adhesive body appendage protection device 100) distal to the first side 112. Accordingly, the foam member 110 generally defines the shape and dimensions of the adhesive body appendage protection device 100. Accordingly, the first side 112 and second side 114 of the foam member 110 correspond to the first side 102 and second side 104 of the inventive adhesive body appendage protection device 100, respectively.

[0104] The adhesive body appendage protection device 100 also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 112 of the foam member 110, wherein the first side 112 of the foam member 110 (which generally defines the first side 102 of the adhesive body appendage protection device 100) is intended to face towards, and be releasably attached to, a medical furnishing during use, and wherein an appendage of a patient is intended to be disposed upon the second side 114 of the foam member 110 (which generally defines the second side 104 of the adhesive body appendage protection device 100) to protect the appendage during a medical procedure.

[0105] Procedurally, the inventive adhesive body appendage protection device 100 of this embodiment is positioned / aligned upon a medical furnishing at a desired location such that the first side 102 of the device 100 faces toward the medical furnishing (typically downward, though it need not be) and then the device 100 is disposed onto the medical furnishing such that the first releasably-adhesive component 130 is generally in contact with (and thus adheres to) the medical furnishing. Then a desired appendage of a patient is disposed upon the second side 104 of the inventive adhesive body appendage protection device 100. Upon completion of a desired medical procedure, the patient's appendage can be removed from the adhesive body appendage protection device 100 (or the patient can be entirely removed from the medical furnishing), and then the adhesive body appendage protection device 100 can be removed from the medical furnishing by exerting a removal force sufficient to overcome the adhesive force of the first releasably-adhesive component 130. In some preferred embodiments, this can all be accomplished while maintaining a sterile field. Afterwards, the adhesive body appendage protection device 100 can be disposed of, or can be cleaned and sterilized for further use.

[0106] Continuing with Figs. 1A-1F, as referenced above, the inventive adhesive body appendage protection device 100 of this embodiment comprises a foam member 110. In some preferred embodiments, the foam member 110 can comprise a polyurethane foam, such as a thermoset polyurethane foam or a thermoplastic polyurethane foam, for example. Additional discussion regarding thermoset foams and thermoplastic foams is disclosed in US Provisional Patent Application No. 63 / 668,750 to Kriesel et al. entitled "Medical Securing Devices", to which this application claims priority, and which has been incorporated herein by reference in a manner that is consistent herewith. However, it should be understood that other types of foams (including open-celled foams, closed-cell foams and combinations thereof) can also be suitable without departing from the scope of the invention (e.g., neoprene foams, rubber foams, etc.).

[0107] Preferably, the foam utilized for the foam member 110 is a medical grade foam, though it need not be. Preferably, the foam utilized for the foam member 110 is biodegradable, though it need not be. Preferably, the foam utilized for the foam member 110 can be sterilized (e.g., with gamma radiation), though it need not be. In some preferred embodiments, the foam member 110 can comprise a high resiliency (HR) foam, although a viscoelastic foam can also be suitable, as well as other thermoset foams and thermoplastic foams, without departing from the scope of the invention. For example, one non-limiting exemplary viscoelastic foam suitable for the present invention may be a polyurethane foam made by mixing polyhydroxy polyol with toluene diisocyanate utilizing foam manufacturing methods as are known in the art. For example, toluene diisocyanate may be used in combination with polyester polyols and / or polyether polyols to make viscoelastic foam (e.g., memory foam). In another example, a high resiliency (HR) foam designated as B-25565-710, available from Premier Foam Inc., having a place of business located in Newnan, Georgia, 30263, USA, can provide a suitable foam for use in a foam member 110 of the present invention. The B-25565-710 foam is a high resiliency (HR) foam that can have a density of about 2.62 lb / ft3(as measured by ASTM D3574-A), a 4 inch 25% Indentation Force Deflection (IFD) of about 63.1 Ibf (as measured by (ASTM D3574-B1), and an air flow of greater than about 2.5 cfm (as measured by ASTM D3574-G). In another example of the present invention, a high resiliency (HR) neoprene foam rubber foam designated as 2130SFB NFR Sponge Biodegradable Foam, available from Bergad Specialty Foams, can provide a suitable foam for use in a foam member 110 of the present invention. The 2130SFB NFR foam is a high resiliency (HR) foam that can have a density of about 1.8-2.3 lb / ft3(as measured by ASTM D3574-A), an Indentation Force Deflection (IFD) of about 26.0-34.0 Ibf (as measured by (ASTM D3574-B1), an air flow of greater than about 2.3 cfm (as measured by ASTM D3574-G), a tensile strength of greater than about 12 psi (as measured by ASTM D3574-E), a tear strength of greater than about 1.5 lbf / in (as measured by ASTM D3574-F), and an elongation of greater than about 85% (as measured by ASTM D3574-E). The foam member 110 (and thus the inventive adhesive body appendage protection device 100) of this embodiment will preferably have a shape that accommodates a particular appendage. However, the foam member 110 can comprise any shape as may be desired, (rectangular, square, circular, ovular, diamond, appendage silhouette, random, etc.) without departing from the scope of the invention. Preferably, the shape will be suitable to substantially extend to or beyond the outer perimeter of the appendage (though it need not be), depending upon the medical procedure or process being performed.

[0108] The foam member 110 (and thus the inventive adhesive body appendage protection device 100) of this embodiment also comprises dimensions. Preferably, the dimensions will be suitable to substantially extend to or beyond the outer perimeter of the particular appendage (though they need not be), depending upon the medical procedure or process being performed. By way of example only, in some aspects where the foam member 110 comprises a rectangular shape, the foam member 110 can have a length of about 3 inches (7.6 cm) (e.g., for a toe) to about 40 inches (101.6 cm) (e.g., for a leg) and a width of about 1 inch (2.5 cm) (e.g., for a finger) to about 20 inches (50.8 cm) (e.g., for a hip). However, it should be understood that the foam member 110 can comprise lesser or greater dimensions without departing from the scope of the invention. In addition, the dimensions need not be uniform across the entire length and / or width of the foam member 110 (e.g., for shapes that are not rectangular or square).

[0109] The foam member 110 also comprises a thickness. Preferably, the thickness of the foam member 110 will be about Vs inch (0.3 centimeters) to about 3 inches (7.6 cm). However, it should be understood that the thickness can be less than Vs inch or greater than 3 inches without departing from the scope of the invention. It should also be understood that the thickness need not be uniform without departing from the scope of the invention, and can optionally comprise a three-dimensional topography (e.g., an egg crate topography, a patterned topography, etc.) without departing from the scope of the invention. While there is no particular upper limit to the thickness, the foam member 110 will preferably have a minimum thickness that can suitably at least partially relieve pressure points of an appendage, suitably protect the appendage from impact injuries and / or resist tearing of the foam member 110 during use and during removal of the patient from the adhesive body appendage protection device 100 and removal of the adhesive body appendage protection device 100 from the medical furnishing. The foam member 110 (and in some instances, the inventive adhesive body appendage protection device 100) of this embodiment can also comprise a variety of properties. For example, in some preferred embodiments, the foam member 110 can comprise a density of about 1.2 pounds per cubic foot (lb / ft3) to about 10 lb / ft3, as measured by ASTM D3574-A. However, it should be understood that the foam member 110 can have a density that is less than 1.2 pounds per cubic foot (lb / ft3) or greater than 10 lb / ft3without departing from the scope of the invention. In some preferred embodiments, the foam member 110 can comprise an Indentation Force Deflection (IFD) of about 5 pounds- force (Ibf) to about 200 I bf, as measured by ASTM D3574-B1. However, it should be understood that the foam member 110 can have an IFD that is less than 5 Ibf or greater than 200 Ibf without departing from the scope of the invention. In some preferred embodiments, the foam member 110 can comprise an air flow that is 0 or greater, more preferably greater than about 1 cubic foot per minute, and most preferably greater than about 2 cubic feet per minute (cfm), as measured by ASTM D3574-G. In some preferred embodiments, the foam member 110 can comprise a tensile strength that is greater than about 8 pounds per square inch (psi), as measured by ASTM D3574-E. However, it should be understood that the foam member 110 can have a tensile strength that is less than 8 psi without departing from the scope of the invention. In some preferred embodiments, the foam member 110 can comprise a tear strength that is greater than about 1.3 pounds-force per inch (lbf / in), as measured by ASTM D3574-F. However, it should be understood that the foam member 110 can have a tear strength that is less than 1.3 lbf / in without departing from the scope of the invention. In some preferred embodiments, the foam member 110 can comprise an elongation that is greater than about 50 percent (%), as measured by ASTM D3574-E. However, it should be understood that the foam member 110 can have an elongation that is less than 50% without departing from the scope of the invention.

[0110] In some preferred embodiments, the foam member 110 can be a thermoset foam or a thermoplastic foam, such as a high resilient (HR) polyurethane foam or a viscoelastic polyurethane foam, for example. However, it should be understood that a variety of other foams can be suitable for use as the foam member 110 without departing from the scope of the invention. Preferably, such foams will suitably comprise one of more of the properties discussed above. Continuing with Figs. 1A-1F, the inventive adhesive body appendage protection device 100 also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 112 of the foam member 110 (and thus upon the first side 102 of the adhesive body appendage protection device 100). The purpose of the first releasably-adhesive component 130 is to attach the adhesive body appendage protection device 100 to a medical furnishing, such as for use during a medical procedure. In such embodiments, the first releasably-adhesive component 130 will preferably comprise an adhesiveness that is sufficient for the adhesive body appendage protection device 100 to withstand the forces exerted by a patient's appendage disposed upon the device 100 during a medical procedure without dislodging the device 100 from the medical furnishing upon which the device 100 is attached, but which also allows a medical provider to remove the device 100 from the medical furnishing thereafter without damaging the medical furnishing or damaging the integrity of the device 100. It should be appreciated that a medical provider could choose to invert the adhesive body appendage protection device 100 of this embodiment without departing from the scope of the invention, in which case the first releasably-adhesive component 130 would attach the patient's appendage rather than being attached to a medical furnishing, although that is not the intended preferred use of the adhesive body appendage protection device 100 of this embodiment.

[0111] Virtually any suitable releasably-adhesive component can be utilized upon the first side 102 of the inventive adhesive body appendage protection device 100 of this embodiment. Several non-limiting exemplary adhesives and chemistries thereof suitable for use as a first releasably-adhesive component 130 are discussed in US Provisional Patent Application No. 63 / 668,750 to Kriesel et al. entitled "Medical Securing Devices", to which this application claims priority, and which has been incorporated herein by reference in a manner that is consistent herewith. For example, a releasably-adhesive polyurethane-based polymer or a releasably-adhesive silicone-based polymer can be utilized, though it need not be (i.e., a different adhesive composition can be suitably utilized). The desired adhesiveness of the first releasably-adhesive component 130 of this embodiment will at least somewhat depend on the properties of the particular adhesive body appendage protection device 100 and its intended use; however, the adhesiveness will typically range from about 0.3 sec / in to about 600 sec / in, as measured by the Adhesiveness Test, such as about 0.5 sec / in to about 300 sec / in, or about 1 sec / in to about 100 sec / in, more preferably about 1.5 sec / in to about 20 sec / in, as measured by the Adhesiveness Test.

[0112] In some preferred aspects, the adhesiveness of the first releasably-adhesive component 130 substantially does not diminish over time, such as over at least about six (6) months, or over at least about twelve (12) months, or over at least about twenty-four (24) months, or longer. In some preferred aspects, the first releasably-adhesive component 130 can be substantially transparent. In some preferred aspects, the first releasably-adhesive component 130 can be viscoelastomeric, which can, inter alia, enhance pressure point relief for a patient and / or can better withstand reasonable (i.e., typical) forces exerted by the patient during a medical procedure. In some preferred aspects, the first releasably-adhesive component 130 comprises a flexibility generally equivalent to the foam member 110 such that it can flex in tandem with the first side 112 of the foam member 110 with minimal or no restriction to the foam member 110 during use. In some preferred aspects, the first releasably-adhesive component 130 comprises a cohesive stretch at least equivalent to that of the foam member 110, such that the first releasably-adhesive component 130 can stretch in tandem with the foam member 110 with minimal or no restriction to the foam member 110. In some preferred aspects, the first releasably-adhesive component 130 comprises a cohesiveness such that the adhesive component 130 leaves no more than a trace (i.e., miniscule) amount, more preferably no amount, of residual adhesive (e.g., as measured by the Cohesiveness Test) upon a medical furnishing upon removal of the adhesive body appendage protection device 100 therefrom and / or such that the adhesive component 130 returns to its original (i.e., innate) form upon removal of the adhesive body appendage protection device 100 from a from a medical furnishing. In some preferred aspects, the first releasably-adhesive component 130 is bacteriostatic or antimicrobial (which can include antibacterial, antifungal and / or antipathogenic). In some preferred aspects, the first releasably-adhesive component 130 is sterilizable (e.g., with gamma radiation) without any noticeable, more preferably without any detectable, degradation to the adhesive properties of the adhesive component 130. In some preferred aspects, the first releasably-adhesive component 130 will not leak any of its compositional constituents (e.g., plasticizer, etc.) onto the medical furnishing. In some preferred aspects, the first releasably-adhesive component 130 (and the adhesive body appendage protection device 100 ) can be intentionally detached and reattached to the medical furnishing multiple times (such as 5 times, or 10 times, or 20 times, or more) without any noticeable, more preferably without any detectable, diminution of the adhesiveness thereof. In some preferred aspects, the first releasably-adhesive component 130 is fire resistant. In some preferred aspects, the first releasably-adhesive component 130 can be cleaned of any contamination (e.g., dust, debris, dirt, lint, body fluids, etc.) via washing techniques, including washing / rinsing with water, washing / wiping with a water / detergent solution and / or autoclaving to fully restore the adhesiveness properties of the first releasably-adhesive component 130. In some preferred aspects, the first releasably-adhesive component 130 comprises substantially no volatile organic compounds (VOC's). In some preferred aspects, the first releasably-adhesive component 130 is biodegradable. In some aspects, the first releasably-adhesive component 130 can be considered green technology and / or is environmentally friendly.

[0113] The first releasably-adhesive component 130 can be applied to the first side 112 of the foam member 110 using techniques known to persons having ordinary skill in the art, including but not limited to, casting, molding, pouring, coating, brushing, rolling, spraying, printing, and the like, and combinations thereof, and can be applied to at least a portion of the first side 112 of the foam member 110 as a continuous or discontinuous layer or coating, or it can be applied in a variety of patterns, without departing from the scope of the invention. The thickness of the applied first releasably-adhesive component 130 will typically range from about 0.1 millimeters (mm) to about 5 mm, depending upon the type of adhesive composition. However, it should be understood that the thickness can be greater than 5 mm without departing from the scope of the invention.

[0114] In some preferred embodiments, the first releasably-adhesive component 130 can be a polyurethane-based viscoelastomeric thermoset polymer or a silicone-based thermoset polymer, for example. However, it should be understood that virtually any releasably-adhesive composition can be suitable for use as the first releasably-adhesive component 130 without departing from the scope of the invention. Preferably, such releasably-adhesive compositions will suitably comprise one or more of the preferred properties set forth herein. For example, such releasably-adhesive compositions will preferably have an adhesiveness of about 0.3 seconds per inch (sec / in) to about 600 sec / in, as measured by the Adhesiveness Test.

[0115] Continuing with the embodiment of Figs. 1A-1F, to preserve the adhesiveness of the first releasably-adhesive component 130 (as well as other properties thereof) prior to use, it may be desirable to apply a removable protective barrier layer (not shown) upon the major external surface of the first releasably-adhesive component 130. Such protective barrier layer will preferably comprise an adhesive attraction to the first releasably-adhesive component 130 that is less than the adhesive attraction of the first releasably-adhesive component 130 to the first side 112 of the foam member 110 to prevent detachment of the first releasably-adhesive component 130 from the foam member 110 upon removal of the optional protective barrier layer. Suitable protective barrier layers include those known to persons having ordinary skill in the art, such as silicone coated substrates, polyvinyl chloride (PVC) films, paraffin coated substrates, polytetrafluoroethylene (PTFE) coated substrates, and the like, which generally tend to be less adhesively compatible with the adhesive components herein than most other materials.

[0116] Continuing with the embodiment of Figs. 1A-1F, in some aspects, an optional grid element (not shown) can be disposed between the first-releasably-adhesive component 130 and the first side 112 of the foam member 110, or upon the second side 114 of the foam member 110. Preferably, the grid element can be detected by a scanning device (e.g., X-ray, MRI, CT-scan, etc.) such that it is viewable upon a readout from such scanning device. The purpose of the optional grid element is to assist with the mapping of a patient's body. Such grid element can be electronic, printed (e.g. lead printing, RFID, etc.) or physical (e.g., metallic wires), and will typically be in the style of a checkered grid, although other styles can also be utilized without departing from the scope of the invention.

[0117] Referring now to Figs. 2A-2F, a further embodiment of the inventive adhesive body appendage protection device 100 of the present disclosure is shown. The adhesive body appendage protection device 100 of this embodiment has a major first side 102 and an opposing major second side 104 distal to the first side 102.

[0118] The adhesive body appendage protection device 100 comprises a foam member 110 having a generally planar major first side 112 and an opposing generally planar major second side 114 distal to the first side 112. Accordingly, the foam member 110 generally defines the shape and dimensions of the adhesive body appendage protection device 100.

[0119] The adhesive body appendage protection device 100 of this embodiment also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 112 of the foam member 110, wherein the first side 112 of the foam member 110 (which generally defines the first side 102 of the adhesive body appendage protection device 100) is intended to face towards, and be releasably attached to, a medical furnishing during use.

[0120] The adhesive body appendage protection device 100 of this embodiment further comprises a second releasably-adhesive component 150 disposed upon at least a portion of the second side 114 of the foam member 110, wherein the second side 114 of the foam member 110 (which generally defines the second side 104 of the adhesive body appendage protection device 100), is intended to face towards a patient's appendage when in use such that the patient's appendage contacts and becomes attached to the adhesive body appendage protection device 100 via the second releasably-adhesive component 150, and thus also to the medical furnishing without the use of conventional securing devices (e.g., straps, belts, harnesses, braces, clamps, etc.).

[0121] Procedurally, the inventive adhesive body appendage protection device 100 of this embodiment is positioned / aligned upon a medical furnishing at a desired location such that the first side 102 of the device 100 faces toward the medical furnishing (typically downward, though it need not be) and then the device 100 is disposed onto the medical furnishing such that the first releasably-adhesive component 130 is generally in contact with (and thus adheres to) the medical furnishing. Then a desired appendage of a patient is disposed upon the second side 104 of the inventive adhesive body appendage protection device 100 such that the second releasably-adhesive component 150 is generally in contact with (and thus adheres to) the patient, thus attaching the patient's appendage to the adhesive body appendage protection device 100, and thus to the medical furnishing without the need for conventional securing devices. Upon completion of a desired medical procedure, the patient's appendage can be removed from the adhesive body appendage protection device 100 by exerting a removal force sufficient to overcome the adhesive force of the second releasably-adhesive component 150, and then the adhesive body appendage protection device 100 can be removed from the medical furnishing by exerting a removal force sufficient to overcome the adhesive force of the first releasably-adhesive component 130. In some preferred embodiments, this can all be accomplished while maintaining a sterile field. Afterwards, the adhesive body appendage protection device 100 can be disposed of, or can be cleaned and sterilized for further use.

[0122] As referenced above, the inventive adhesive body appendage protection device 100 of this embodiment as shown in Figs. 2A-2F comprises a foam member 110. Suitable foam members 110, as well as properties thereof, processes, examples, etc. have been described above with respect to the embodiments of Figs. 1A-1F, wherein such description is hereby incorporated herein by reference in its entirety in a manner that is consistent herewith.

[0123] Continuing with Figs. 2A-2F, the inventive adhesive body appendage protection device 100 of this embodiment also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 112 of the foam member 110 (and thus upon the first side 102 of the adhesive body appendage protection device 100). The purpose of the first releasably-adhesive component 130 is to attach the adhesive body appendage protection device 100 to a medical furnishing, such as for use during a medical procedure. In such embodiments, the first releasably-adhesive component 130 will preferably comprise an adhesiveness that is sufficient for the adhesive body appendage protection device 100 to withstand the forces exerted by a patient's appendage disposed upon the device 100 during a medical procedure without dislodging the device 100 from the medical furnishing upon which the device 100 is attached, but which also allows a medical provider to remove the adhesive body appendage protection device 100 from the medical furnishing thereafter without damaging the medical furnishing or damaging the integrity of the device 100.

[0124] Suitable first releasably-adhesive components 130, as well as properties thereof, processes, examples, etc. have been described above with respect to the embodiments of Figs. 1A-1F, wherein such description is hereby incorporated herein by reference in its entirety in a manner that is consistent herewith.

[0125] Continuing with Figs. 2A-2F, the inventive adhesive body appendage protection device 100 of this embodiment further comprises a second releasably-adhesive component 150 disposed upon at least a portion of the second side 114 of the foam member 110 (and thus the second side 104 of the adhesive body appendage protection device 100). The purpose of the second releasably-adhesive component 150 is to generally contact and adhere to a patient's appendage, such that the appendage can be securely and releasably attached to the adhesive body appendage protection device 100, and ultimately to the medical furnishing, during use. In such embodiments, the second releasably-adhesive component 150 will preferably comprise an adhesiveness that is sufficient to secure the patient's appendage to the inventive adhesive body appendage protection device 100 during use, but which also allows the appendage to be removed from the adhesive body appendage protection device 100 thereafter without damaging or irritating the patient's contacting surface (e.g., skin, hair, fur, etc.) and without damaging the integrity of the device 100.

[0126] In this embodiment, the second releasably-adhesive component 150 will preferably comprise an adhesiveness that is sufficient for the adhesive body appendage protection device 100 to restrict movement of a patient's appendage disposed upon the device 100 during a medical procedure to eliminate the need for conventional securing devices, such as straps, belts, harnesses, braces, clamps, or other external protection devices.

[0127] Virtually any suitable releasably-adhesive component can be utilized upon the second side 104 of the inventive adhesive body appendage protection device 100 of this embodiment. Several non-limiting exemplary adhesives and chemistries thereof suitable for use as a second releasably-adhesive component 150 are discussed in US Provisional Patent Application No. 63 / 668,750 to Kriesel et al. entitled "Medical Securing Devices", to which this application claims priority, and which has been incorporated herein by reference in a manner that is consistent herewith. For example, a releasably-adhesive polyurethane-based polymer or a releasably-adhesive silicone-based polymer can be utilized, though it need not be (i.e., a different adhesive composition can be suitably utilized). The desired adhesiveness of the second releasably-adhesive component 150 of this embodiment will at least somewhat depend on the properties of the particular adhesive body appendage protection device 100 and its intended use; however, the adhesiveness will typically range from about 0.3 sec / in to about 600 sec / in, as measured by the Adhesiveness Test, such as about 0.5 sec / in to about 300 sec / in, or about 1 sec / in to about 100 sec / in, more preferably about 1.5 sec / in to about 20 sec / in, as measured by the Adhesiveness Test. In some embodiments, the second releasably-adhesive component 150 can be the same as the first releasably-adhesive component 130. In other embodiments, the second releasably-adhesive component 150 can be different than the first releasably-adhesive component 130.

[0128] In some aspects of this embodiment, the first releasably-adhesive component 130 and the second releasably-adhesive component 150 can comprise the same type of adhesive composition, and each can have substantially the same degree of adhesiveness. In other aspects, the first releasably-adhesive component 130 and the second releasably-adhesive component 150 can comprise the same type of adhesive composition, but each can have a different degree of adhesiveness (e.g., the adhesiveness of the first releasably-adhesive component 130 may be greater than or less than the adhesiveness of the second releasably-adhesive component 150). In yet other aspects, the first releasably-adhesive component 130 and the second releasably-adhesive component 150 can comprise different types of adhesive compositions, but each can have substantially the same degree of adhesiveness. In still other aspects, the first releasably-adhesive component 130 and the second releasably-adhesive component 150 can comprise different types of adhesive composition, and each can have a different degree of adhesiveness (e.g., the adhesiveness of the first releasably-adhesive component 130 may be greater than or less than the adhesiveness of the second releasably-adhesive component 150). It should be appreciated that the thickness of the first releasably-adhesive component 130 and the second releasably-adhesive component 150 can also have an effect on the adhesiveness of the respective adhesive compositions. Typically, an adhesive component having a relatively greater thickness will tend to exhibit a greater adhesiveness than the same adhesive component having a relatively lesser thickness because, among other things, a greater thickness can generally provide for more surface area contact. Accordingly, the first releasably-adhesive component 130 and the second releasably-adhesive component 150 of this embodiment can have the same thickness or a different thickness without departing from the scope of the invention.

[0129] In some preferred aspects of this embodiment, the adhesiveness of the second releasably-adhesive component 150 substantially does not diminish over time, such as over at least about six (6) months, or over at least about twelve (12) months, or over at least about twenty-four (24) months, or longer. In some preferred aspects, the second releasably- adhesive component 150 can be substantially transparent. In some preferred aspects, the second releasably-adhesive component 150 can be viscoelastomeric, which can, inter alia, enhance pressure point relief for a patient and / or better withstand reasonable (i.e., typical) forces exerted by the patient. In some preferred aspects of this embodiment, the second releasably-adhesive component 150 comprises a flexibility generally equivalent to the foam member 110 such that it can flex in tandem with the second side 114 of the foam member 110 with minimal or no restriction to the foam member 110 during use. In some preferred aspects, the second releasably-adhesive component 150 comprises a cohesive stretch at least equivalent to the foam member 110 such that it can stretch in tandem with the foam member 110 with minimal or no restriction to the foam member 110. In some preferred aspects, the second releasably-adhesive component 150 comprises a cohesiveness such that the adhesive component 150 leaves no more than a trace (i.e., miniscule) amount, more preferably no amount, of residual adhesive upon a medical furnishing upon removal of the adhesive body appendage protection device 100 therefrom and / or such that the adhesive component 150 returns to its original (i.e., innate) form upon removal of the adhesive body appendage protection device 100 from a medical furnishing. In some preferred aspects, the second releasably-adhesive component 150 is bacteriostatic or antimicrobial (which can include antibacterial, antifungal and / or antipathogenic). In some preferred aspects, the second releasably-adhesive component 150 is sterilizable (e.g., with gamma radiation) without any noticeable, more preferably without any detectable, degradation to the adhesive properties of the adhesive component 150. In some preferred aspects, the second releasably-adhesive component 150 will not leak any of its compositional constituents (e.g., plasticizer, etc.) onto or into the medical furnishing during use of the adhesive body appendage protection device 100. In some preferred aspects, the second releasably- adhesive component 150 (and the adhesive body appendage protection device 100) can be intentionally detached and reattached to the same or different medical furnishing multiple times (such as 5 times, or 10 times, or 20 times, or more) without any noticeable, more preferably without any detectable, diminution of the adhesiveness thereof. In some preferred aspects, the second releasably-adhesive component 150 is fire resistant. In some preferred aspects, the second releasably-adhesive component 150 can be cleaned of any contamination (e.g., dust, debris, dirt, lint, body fluids, etc.) via washing techniques, including washing / rinsing with water, washing / wiping with a water / detergent solution and / or autoclaving to fully restore the adhesiveness properties of the second releasably- adhesive component 150. In some preferred aspects, the second releasably-adhesive component 150 comprises substantially no volatile organic compounds (VOC's). In some preferred aspects, the second releasably-adhesive component 150 is biodegradable. In some aspects, the second releasably-adhesive component 150 can be considered green technology and / or is environmentally friendly.

[0130] The second releasably-adhesive component 150 can be applied to the second side 114 of the foam member 110 using techniques known to persons having ordinary skill in the art, including but not limited to, casting, molding, pouring, coating, brushing, rolling, spraying, printing, and the like, and combinations thereof, and can be applied to at least a portion of the second side 114 of the foam member 110 as a continuous or discontinuous layer or coating, or it can be applied in a variety of patterns, without departing from the scope of the invention. The thickness of the applied second releasably-adhesive component 150 will typically range from about 0.1 mm to about 5 mm, depending upon the type of adhesive composition. However, it should be understood that the thickness can be greater than 5 mm without departing from the scope of the invention.

[0131] In some preferred aspects, the second releasably-adhesive component 150 can be a polyurethane-based thermoset polymer or a silicone-based thermoset polymer, for example. However, it should be understood that virtually any releasably-adhesive composition can be suitable for use as the second releasably-adhesive component 150 without departing from the scope of the invention. Preferably, such releasably-adhesive compositions will suitably comprise one of more of the preferred properties set forth herein. For example, such releasably-adhesive compositions will preferably have an adhesiveness of about 0.3 seconds per inch (sec / in) to about 600 sec / in, as measured by the Adhesiveness Test.

[0132] Continuing with the embodiments of Figs. 2A-2F, to preserve the adhesiveness of the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150 (as well as other properties thereof) prior to use, it may be desirable to apply a removable protective barrier layer (not shown) upon the major external surface of the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150. Such protective barrier layer will preferably comprise an adhesive attraction to the releasably-adhesive component 130,150 that is less than the adhesive attraction of the releasably-adhesive component 130,150 to the foam member 110 to prevent detachment of the releasably-adhesive component 130,150 from the foam member 110 upon removal of the protective barrier layer. Suitable protective barrier layers include those known to persons having ordinary skill in the art, such as silicone coated substrates, polyvinyl chloride (PVC) films, paraffin coated substrates, polytetrafluoroethylene (PTFE) coated substrates, and the like, which generally tend to be less adhesively compatible with adhesive components herein than most other materials.

[0133] Continuing with the embodiment of Figs. 2A-2F, in some aspects, an optional grid element (not shown) can be disposed between the first-releasably-adhesive component 130 and the first side 112 of the foam member or between the second releasably-adhesive component 150 and the second side 114 of the foam member. Preferably, the grid element can be detected by a scanning device (e.g., X-ray, MRI, CT-scan, etc.) such that it is viewable upon a readout from such scanning device. The purpose of the optional grid element is to assist with the mapping of a patient's body. Such grid element can be electronic, printed (e.g. lead printing, RFID, etc.) or physical (e.g., metallic wires), and will typically be in the style of a checkered grid, although other styles can also be utilized without departing from the scope of the invention.

[0134] As referenced above, in some preferred embodiments, the adhesive body appendage protection device 100 of the present disclosure can comprise a polyurethane-based releasably-adhesive polymer (e.g., a polyurethane-based viscoelastomeric releasably-adhesive thermoset polymer) for use as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150. Such polymers can comprise releasable adhesiveness such that the adhesive body appendage protection device 100 can be securely adhered to a medical furnishing (and in some embodiments to a patient's appendage) during a medical procedure without the device 100 becoming dislodged during the medical procedure, and can then be removed from the patient and / or medical furnishing thereafter via an application of a sufficient removal force to overcome the adhesive force of the adhesive polymer without injuring or irritating the patient's contact surface (e.g., skin, hair, fur, etc.), without damaging the medical furnishing, and without damaging the integrity of the adhesive body appendage protection device 100. The degree of adhesiveness of such polymers can be adjusted within the given adhesiveness range discussed above via manipulation of certain constituents of the polymers within prescribed ranges (discussed further below). For example, the degree of adhesiveness (within the adhesiveness range) for adhering the adhesive body appendage protection device 100 to a patient's appendage contacting surface may be the same as, or comparatively lower than, the degree of adhesiveness for adhering the adhesive body appendage protection device 100 to a medical furnishing. In another example, the degree of adhesiveness (within the adhesiveness range) for adhering the adhesive body appendage protection device 100 to a medical furnishing may be the same as, or comparatively higher than, the degree of adhesiveness for adhering the adhesive body appendage protection device 100 to a patient's appendage contacting surface.

[0135] Suitable polyurethane-based releasably-adhesive polymers are thermoset polymers, and also exhibit, inter alia, cohesiveness and viscoelastomeric properties (in their cured form). Such cohesiveness substantially prevents separation of the polymer from itself (e.g., transference of polymer to a patient or medical furnishing) upon removal of the adhesive body appendage protection device 100 from the patient and / or medical furnishing. Accordingly, such polymers tend to leave no more than a trace amount, more preferably no amount, of visually observable residual polymer upon a contacting surface upon removal of the adhesive body appendage protection device 100 from a patient's appendage and / or medical furnishing. In other words, the total amount of polymer by weight of the polymer component remains substantially constant over time, including after use. In addition, the unique cohesiveness of such polymers allows the polymeric component to substantially return to its original innate form. In other words, such polymers can substantially return to the same overall shape profile the polymer had upon curing, despite any deformation of the polymer during use or removal of an item previously attached to the polymer, such as due to the application of external forces (e.g., pressing into the polymer, pulling away from the polymer, flexing the polymer, stretching the polymer, etc.).

[0136] In some preferred embodiments, suitable polyurethane-based releasably-adhesive polymers (in their cured form) can comprise substantially no volatile organic compounds (VOC's). Thus, the total amount of polymer by weight remains substantially constant over time. Accordingly, such polymers may be considered green technology and / or are environmentally friendly.

[0137] In some preferred embodiments, suitable polyurethane-based releasably-adhesive polymers (in their cured form) can be cleansable (also referred to herein as "washable"), and thus reusable over time. Such cleansing may be desirable when dust or other contaminants accumulate upon the surface of the adhesive polymer. Desirably, such cleansing of the adhesive polymer component can be accomplished by washing with water, or with a solution of water and a detergent (e.g., a solution of tap water and DAWN dish detergent, available from Procter & Gamble Company, having a place of business located in Cincinnati, Ohio, USA). Such cleansing typically results in a substantial return to the polymer's original adhesiveness. Accordingly, an inventive adhesive body appendage protection device 100 of the present disclosure comprising such adhesive polymers can be utilized for multiple uses over time while substantially providing optimal adhesive effectiveness for each such use. In some preferred embodiments, suitable polyurethane-based releasably-adhesive polymers (in their cured form) can be bacteriostatic or antimicrobial (which can include antibacterial, antifungal and / or antipathogenic). Accordingly, such adhesive polymers can be ideal for uses involving hygienic and / or sanitary conditions, such as medical uses. Preferably, such bacteriostatic or antimicrobial properties remain optimally effective throughout multiple uses of the adhesive body appendage protection device 100.

[0138] In some embodiments, suitable polyurethane-based releasably-adhesive polymers (in their cured form) can be fire resistant. Accordingly, such adhesive polymers can be ideal for uses involving high heat, flames and / or electrical conditions, such as for medical uses.

[0139] Such polyurethane-based releasably-adhesive polymers can typically be formed via the preparation and subsequent curing of a thermosetting reaction media. In one non-limiting exemplary embodiment, the reaction media can comprise (based on the total reaction media weight) about 2 percent by weight (wt%) to about 10 wt% isocyanate prepolymer, about 35 wt% to about 75 wt% polyols comprising about 1 wt% to about 65 wt% (based on the total reaction media weight) straight chain linking polyols and about 3 wt% to about 50 wt% (based on the total reaction media weight) crosslinking polyols, and about 10 wt% to about 60 wt% plasticizer comprising about 10 wt% to less than about 50 wt% (based on the total reaction media weight) epoxidized triglyceride plasticizer and about 0 wt% to about 40 wt% (based on the total reaction media weight) viscosity reducing plasticizer, preferably an ester plasticizer. Typically, the resulting viscoelastomeric thermoset releasably-adhesive polymer will be formed from a substantially uniform admixture of the reaction media constituents.

[0140] As referenced above, the reaction media and the resulting polyurethane-based viscoelastomeric thermoset releasably-adhesive polymers are substantially free from VOC's. As a result, the weight of the reaction media and the weight of the resulting polymers (i.e., upon curing the reaction media) remain substantially constant. Accordingly, the "wt%" values of each constituent referenced above can alternatively be expressed in terms of total "polymer" weight (rather than total reaction media weight), without departing from the scope of the invention. Of course, it should be understood that when expressing the constituents in terms of wt% based on total "polymer" weight, such components have actually been combined and reacted to form the polymer thereof. In the interest of brevity, the "wt%" of the polymer constituents will typically be expressed in terms of total reaction media weight herein.

[0141] In some versions of the polyurethane-based viscoelastomeric thermoset releasably-adhesive polymers, the straight chain polyols and the crosslinking polyols used to form the polymers can each comprise repetitive oxygen groups. In other versions, the straight chain polyols and the crosslinking polyols can each comprise repetitive ether groups. In still other versions, the straight chain polyols and the crosslinking polyols can each comprise hydroxyl groups, desirably wherein two (2) of the hydroxyl groups are terminal hydroxyl groups. In some preferred versions, the straight chain polyols and the crosslinking polyols can each comprise a polyether having a molecular weight of about 1,000 to about 20,000, such as about 1,000 to about 10,000. In some versions, the straight chain polyols and crosslinking polyols can be present in a straight chain polyol to crosslinking polyol weight ratio of about 1:3 to about 3:1, such as about 1:2 to 2:1, or about 7:13 to about 13:7, to provide desired viscoelastic, cohesive and adhesive attributes.

[0142] In some versions of the polyurethane-based releasably-adhesive polymers, the plasticizer is desirably uniformly dispersed and cohesively bound throughout the interior portion of the inventive polymer. In some versions, such polymers comprise epoxidized triglyceride plasticizer. In some versions, such polymers comprise epoxidized triglyceride plasticizer and an optional viscosity reducing plasticizer (e.g., an ester plasticizer, etc.).Accordingly, such polymers can comprise an epoxidized triglyceride plasticizer to viscosity reducing plasticizer weight ratio of about 1:0 to about 1:1, such as about 6:1 to about 1:3, or about 3:1 to about 1:2, to provide a workable reaction media viscosity.

[0143] As noted above, some preferred polyurethane-based releasably-adhesive polymers may be derived from a thermosetting reaction media comprised of a substantially uniform admixture of an isocyanate prepolymer, prescribed amounts of polyols (e.g., polyether diols and polyether triols) and a carefully controlled amount of select plasticizers. The isocyanate prepolymer in combination with a controlled amount of polyols in the form of straight chain diols and crosslinking polyols (preferably crosslinking triols) provides a thermoset infrastructure for effectively housing the plasticizing components in a form which results in a unique stabilized, releasably-adhesive, cohesive, and viscoelastic (i.e., viscoelastomeric) thermoset polymer having bacteriostatic or antimicrobial attributes and fire resistant attributes, while also permitting a restorative cleansability function via conventional washing and / or autoclaving techniques. In addition, the cohesiveness attributes of such polymers substantially prevent plasticizer leakage, even at relatively high plasticizer loadings (i.e., greater than about 10 wt% of the total reaction media weight), and further result in leaving little to no residual polymer upon a previously attached item.

[0144] A highly effective thermosetting reaction media for preparing such polyurethane-based releasably-adhesive polymers comprises a prepolymer, polyols and plasticizer. More particularly, the reaction media comprises (i) a prepolymer (e.g., a polyol reacted with an isocyanate), preferably a diisocyanate prepolymer (e.g., methylene diphenyl diisocyanate (MDI)), ranging from about 2 wt% to about 10 wt% of the total reaction media weight; (ii) polyols, ranging from about 35 wt% to about 75 wt% of the total reaction media weight, wherein the polyols include straight chain linking polyols (preferably diols) and crosslinking polyols (preferably triols); and (iii) plasticizer, ranging from about 10 wt% to about 60 wt% of the total reaction media weight, wherein the plasticizer includes an epoxidized triglyceride plasticizer in an amount of about 10 wt% to less than about 50 wt% of the total reaction media weight, such as about 10 wt% to about 45 wt% of the total reaction media, or about 10 wt% to less than 45 wt% of the total reaction media weight, and optionally a reaction media viscosity-reducing plasticizer, preferably an ester plasticizer, in an amount of about 0 wt% to about 40 wt% of the total reaction media weight. Such polymers can also optionally comprise additional components including, but not limited to, additional plasticizers, catalysts, initiators, colorants (e.g., dyes), UV inhibitors, antioxidants, and the like, as would be known to persons having ordinary skill in the art.

[0145] The thermosetting reaction media (and thus the resulting polyurethane-based releasably-adhesive polymers) comprises a quantity of prepolymer which forms the backbone of the polymer. Such prepolymer will typically be present in an amount of about 2 wt% to about 10 wt% of the total reaction media weight, such as about 3 wt% to about 9 wt%, or about 4 wt% to about 8 wt% of the total reaction media weight. Suitable prepolymers can comprise polyurethane prepolymers, which can include ring-opening species of a hardener (e.g., amines, amides, mercaptans, anhydrides, isocyanates including polyisocyanates (such as a diisocyanate), etc.). Suitable polyisocyanates include, but are not limited to, aromatic diisocyanates (e.g., diphenylmethane diisocyanate, methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), etc.) and aliphatic diisocyanates (e.g., hexamethylene diisocyanate (HDI), isophorone diisocyanate (I PDI), etc.) in a conventional prepolymer form. An example of a suitable polyurethane prepolymer is a methylene diphenyl diisocyanate (MDI) designated as ELASTOCAST TQZ-P23, available from BASF Corporation, having a place of business located in Florham Park, New Jersey, USA.

[0146] The thermosetting reaction media (and thus the resulting polyurethane-based releasably-adhesive polymers) also comprises a total quantity of polyols (diols and higher order polyols), typically ranging from about 35 wt% to about 75 wt% of the total reaction media weight, such as about 38 wt% to about 65 wt%, or about 40 wt% to about 55 wt% of the total reaction media weight. More particularly, the polyols include straight chain polyols and crosslinking polyols. Typically, the straight chain polyols will be in the form of diols (e.g., a diol having two terminal reactive groups), and the crosslinking polyols will be in the form of triols or higher (e.g., having two terminal reactive groups and one or more additional reactive groups). For the purpose of brevity, the description herein will primarily exemplify triols as the crosslinking polyols.

[0147] The diol (i.e., straight chain polyol) and triol (i.e., crosslinking polyol) components of the reaction media are typically liquid at room temperature (i.e., about 21°C) and generally have a molecular weight of about 1,000 to about 20,000, such as about 1,000 to about 15,000, or about 1,000 to about 10,000. The adhesiveness and cohesiveness of the resulting releasably-adhesive and cohesive thermoset viscoelastomeric polymers depend upon using a controlled polyol balance within the thermosetting reaction media. Typically, the amount of diols and triols (preferably reacted in the presence of an effective amount of plasticizer within the reaction media) can suitably fall within a diol to triol weight ratio of about 1:3 to about 3:1, such as about 1:2 to 2:1, or about 7:13 to about 13:7, to provide the desired viscoelastic, adhesive, cohesive, releasability, cleansability, bacteriostatic and / or antimicrobial attributes for effective use herein (while also inhibiting bleeding of plasticizer). The content and type of polyols can have an effect upon imparting the necessary thermoset polymeric infrastructure for obtaining such attributes. Accordingly, when the weight ratio of diols to triols deviates outside a range of about 1:3 to about 3:1, the desired adhesiveness, cohesiveness and releasability attributes of the resultant polymers may begin to diminish. Thus, a controlled balance within the cited ranges with respect to the straight chain diols and the crosslinking triols can provide an effective reaction media for preparing the releasably-adhesive and cohesive thermoset viscoelastomeric polymers uniquely possessing the viscoelastic, adhesiveness, cohesiveness, releasability, cleansability, and bacteriostatic or antimicrobial features for the inventive adhesive body appendage protection device 100 of the present disclosure (i.e., first releasably-adhesive component 130 and / or second releasably-adhesive component 150). Such polymers have also been discovered herein to be resistant to gamma radiation, thus making them sterilizable. Such polymers have also been discovered herein to be fire resistant.

[0148] In general, the diol component of such releasably-adhesive and cohesive viscoelastomeric thermoset polymers can provide straight chain infrastructure formation and sufficient crosslinkage disruption to permit for a highly effective intermolecular plasticizer attraction and alignment, thus providing for an unusually high and effective loading of the viscoelastic, adhesive, cohesive and bacteriostatic or antimicrobial contributing plasticizer co-factors. Typically, the straight chain diol can be provided by a polyether diol having a molecular weight suitably ranging from about 1,000 to about 10,000, such as about 1,000 to about 8,000, or about 2,000 to about 6,000, and preferably having two (2) terminal reactive groups (e.g., hydroxyl groups). Such polyether diol can be suitably present in an amount ranging from about 1 wt% to about 65 wt% of the total reaction media weight, such as about 5 wt% to about 55 wt%, or about 10 wt% to about 45 wt% of the total reaction media weight. An example of a suitable diol is a 2-functional polyether diol designated as ELASTOCAST C-4057, available from BASF Corporation.

[0149] In general, the crosslinking polyol component of such polyurethane-based releasably-adhesive polymers can provide sufficient crosslinkage infrastructure to the polymers, and can contribute to the cohesiveness, releasability and stability attributes thereof. In some versions, the crosslinking polyol can be provided by a polyether triol having a molecular weight suitably ranging from about 1,000 to about 10,000, such as about 2,000 to about 8,000, or about 3,000 to about 7,000, and preferably having three (3) reactive groups (e.g., hydroxyl groups) wherein two (2) of the reactive groups are terminal reactive groups. Such polyether triol can be suitably present in an amount ranging from about 3 wt% to about 50 wt% of the total reaction media weight, such as about 10 wt% to about 45 wt%, or about 20 wt% to about 40 wt% of the total reaction media weight. An example of a suitable polyether triol is a 3-functional polyether triol designated as ELASTOCAST C-4018, available from BASF Corporation.

[0150] The adhesiveness properties of such polyurethane-based releasably-adhesive polymers can be tailored to fit the need for any given purpose, such as to attach a patient to the inventive adhesive body appendage protection device 100, or to attach the device 100 to a medical furnishing. Accordingly, the thermosetting reaction media may be properly formulated so as to impart a desired degree of adhesiveness for adherence and restriction of movement, while still retaining the desired cohesiveness of the resulting polymer. For example, in general, increasing the diol to triol ratio (i.e., increasing the diol content relative to the triol content) will result in an increased adhesiveness of such polymers. Conversely, decreasing the diol to triol ratio (i.e., increasing the triol content relative to the diol content) will generally result in an increased cohesiveness of such polymers. Thus, controlling the diol to triol weight ratio within the range of about 3:1 to about 1:3 for example can result in polymers having a desired adhesiveness and cohesiveness for the adhesion to, and subsequent release from, the inventive adhesive body appendage protection device 100.

[0151] Such polyurethane-based releasably-adhesive polymers also comprise a total quantity of plasticizers typically ranging from about 10 wt% to about 60 wt% of the total reaction media weight, such as about 15 wt% to about 55 wt%, or about 20 wt% to an adhesive body appendage protection device 100 bout 50 wt% of the total reaction media weight. More particularly, the plasticizer includes a triglyceride plasticizer, and can optionally further include a process aid plasticizer (i.e., reaction media viscosity reducing plasticizer). Preferably, the triglyceride plasticizer is an epoxidized triglyceride plasticizer, and the optional viscosity reducing plasticizer, if present, is typically an ester plasticizer. The plasticizer components of the thermoset reaction media are desirably liquid at room temperature (i.e., about 21°C). Typically, the weight ratio of triglyceride plasticizer to optional viscosity reducing plasticizer can suitably fall within a prescribed weight ratio range of about 1:0 to about 1:1, such as about 6:1 to about 1:3, or about 3:1 to about 1:2, to provide a workable reaction media viscosity, and to help provide the desired viscoelastic, adhesiveness, cohesiveness, releasability, cleansability, bacteriostatic and / or antimicrobial attributes of the resulting polymer, which can be utilized as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150. The content and type of plasticizers can have an effect upon imparting the desired polymer attributes. Thus, a controlled amount of triglyceride plasticizer (e.g., epoxidized triglyceride plasticizer) and optional viscosity reducing plasticizer (e.g., ester plasticizer) within the prescribed range can provide an effective reaction media for preparing a releasably-adhesive and cohesive thermoset viscoelastomeric polymer uniquely possessing the desired compositional attributes for use herein. Desirably, the plasticizer component is uniformly dispersed and cohesively bound throughout the thermosetting reaction media (along with the other polymerizable thermosetting components) and will tenaciously remain uniformly dispersed within the resultant cured polymer in a highly cohesive and stabilized (i.e., resistance to plasticizer bleeding) form.

[0152] Suitable triglyceride plasticizers for preparing such polyurethane-based releasably-adhesive polymers preferably include epoxidized triglyceride plasticizers. Epoxidized triglyceride plasticizers, such as epoxidized animal oils and epoxidized vegetable oils, are particularly effective as a plasticizer component in the thermosetting viscoelastomeric reaction media. Amongst the suitable epoxidized triglyceride plasticizers, epoxidized vegetable oils (e.g., soybean, castor, corn, cottonseed, peri Ila, safflower, linseed, tall, etc.) can be particularly effective. Such triglyceride plasticizers can be suitably present in an amount that is less than about 50 wt% of the total reaction media weight, such as less than about 45 wt%, or about 10 wt% to less than about 50 wt%, or about 10 wt% to less than about 45 wt% of the total reaction media weight. For example, epoxidized soybean oil can provide a highly suitable triglyceride plasticizer to form such releasably-adhesive and cohesive thermoset viscoelastomeric polymers.

[0153] Such polyurethane-based releasably-adhesive polymer can also optionally comprise a suitable reaction media viscosity reducing plasticizer. In general, those plasticizers which are suitable as plasticizing agents for the plasticization of polyvinyl chlorides can be utilized as viscosity reducing plasticizers for the reaction media. Exemplary viscosity reducing plasticizers include, but are not limited to, ester plasticizers. Such ester plasticizers are especially effective as an optional additional plasticizer component in the thermosetting reaction media. Suitable ester plasticizers typically have a relatively low molecular weight, typically less than about 750, or less than about 500, and can include, but are not limited to, the condensation products of alcohols (e.g., Ci-Cio alcohols, such as C2-C6 alcohols) and dicarboxylic acids (e.g., C2-C12 dicarboxylic acids, such as C4-C8 dicarboxylic acids). In addition, amongst the more fluid ester plasticizers, such as diester plasticizers for example, are the lower dialkyl esters of dicarboxylic acids, such as dialkyl esters having alkyl groupings of less than 12 carbon atoms, such as Ci-Cs dialkyl ester groupings of sebacates, adipates, phthalates, isophthalates, maleates, azelates, glutarates, etc.

[0154] In some aspects, the polar strength (often referred to as "dipole moment") of such ester plasticizers depends, to a certain degree, upon the alcohol condensation reactant chain length, which can also have an effect upon the adhesiveness characteristics of the resulting cured polymer. For example, non-epoxidized plasticizers having a relatively high dipole moment (e.g., dibutyl sebacate, having a dipole moment of 2.48 debyes (D), as compared to epoxidized plasticizers having a dipole moment near 0 D) can be effective in retaining the desired properties of the polymerizate while also providing a thermosetting reaction media exhibiting a reduced working viscosity, which is particularly effective for use in permeating porous interstices or other structures of the foam member 110. Suitable ester plasticizers can have a dipole moment of greater than about 1.5 D, such as greater than about 2.0 D. Typically, the ester plasticizers can be suitably present in an amount ranging from about 0 wt% to about 40 wt% of the total reaction media weight, such as about 1 wt% to about 30 wt%, or about 2 wt% to about 20 wt% of the total reaction media weight. For example, dibutyl sebacate can optionally provide a highly suitable ester plasticizer to form such releasably-adhesive and cohesive thermoset viscoelastomeric polymers.

[0155] In some aspects, the incorporation (within the ranges prescribed herein) of the optional relatively low molecular weight ester plasticizer in combination with the triglyceride plasticizer (e.g., epoxidized triglyceride plasticizer) can be utilized herein to provide an easier fabricating form (e.g., for casting, coating, molding, injecting, pouring, spraying, printing, etc.) of the uncured polymer mix by lowering the viscosity of the reaction media without adversely affecting the desirable features of such polyurethane-based releasably-adhesive polymers. For example, the addition of polar ester plasticizers, or substitution of the triglyceride plasticizers with polar ester plasticizers, can effectively reduce the viscosity of the reaction media while still maintaining a desired level of adhesiveness and cohesiveness of the resulting polymer, as well as providing for excellent releasability and stability properties. Including a viscosity reducing plasticizer (e.g., an ester plasticizer) having a fluid consistency at room temperature (i.e., about 21 °C) and having a relatively low molecular weight (e.g., less than about 750) in the reaction media can contribute to ideal working viscosities during the initial curing stages, rendering the reaction media to be more effective for forming the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150 of the present disclosure. Inclusion of an optional viscosity reducing plasticizer can be particularly desirable where uncured reaction media is first applied to the foam member 110 in a substantially liquid form, and then cured in situ, to form a tenacious bonding between the foam member 110 and the resulting first releasably-adhesive component 130 and / or second releasably-adhesive component 150.

[0156] As referenced above, the plasticizer component is desirably uniformly incorporated into the thermosetting reaction media (along with the other polymerizable thermosetting reactants) and will tenaciously remain uniformly dispersed within the resultant polyurethane-based releasably-adhesive polymers in a highly cohesive and stabilized form. The straight chain diols and crosslinking triols, in cooperative combination with the plasticizer, create a thermoset viscoelastomeric polymeric structure possessing a high degree of cohesiveness and releasable adhesiveness which is desirable for the inventive adhesive body appendage protection device 100 of the present disclosure. Controlling the amount of triglyceride plasticizer and optional ester plasticizer (along with the prescribed amounts of straight chain diols and crosslinking polyols) can thus effect the properties of the resulting polyurethane-based releasably-adhesive polymers. For example, if the amount of plasticizer is excessively high (i.e., outside the range prescribed herein), the resultant polymer will tend to lose its desired cohesiveness and will then tend to distort (i.e., may not return to its original innate form as when initially formed), and / or will tend to bleed plasticizer. (However, in certain instances, increasing the triol content can partially arrest such plasticizer bleeding, but such triol increase will then tend to decrease the adhesiveness of the polymer).

[0157] Such polyurethane-based releasably-adhesive polymer can also optionally comprise additional constituents including, but not limited to, catalysts, initiators, other additional plasticizers, colorants, UV inhibitors, antioxidants, and the like, as would be known to persons having ordinary skill in the art. For example, the polymerization of the thermosetting reaction media can be carried out in the presence of a catalyzing amount (defined above) of a catalyst (e.g., a slow-acting catalyst or a heat-activated catalyst) to control the curing rate of the reaction media. Suitable catalysts can include tertiary amines, tertiary phosphines, strong bases (e.g., alkali, alkaline earth metal hydroxides, alkoxides, phenoxides, etc.), acidic metal salts of strong acids, metal chelates, metal alcoholates, metal phenolates, organic acid salts, organo metallic derivatives, etc. An example of a suitable catalyst is a slow-acting organobismuth catalyst available under the trade name COSCAT 83 (available from Vertellus Holdings LLC, having a place of business located in Zeeland, Michigan, USA). Another example of a suitable catalyst is a heat-activated tin thioglycolate catalyst available under the trade names FOMREZ CATALYST UL-29 and FOMREZ CATALYST UL-54 (each available from Galata Chemicals, having a place of business located in Jersey City, New Jersey, U.S.A.). It has been discovered herein that a blend of catalysts can also be beneficial in some embodiments. For instance, in one non-limiting example, a blend of COTIN 430 (a dioctyltin carboxylate available from Cambrex Company, having a place of business located in Itasca, Illinois, USA) and FOMREZ CATALYST UL-54 was utilized with the reaction media to provide improved benefits.

[0158] Procedurally, an exemplary suitable polyurethane-based releasably-adhesive polymers can be prepared from a thermosetting reaction media homogeneously loaded with plasticizer(s) which includes a triglyceride plasticizer (preferably an epoxidized triglyceride plasticizer, such as epoxidized vegetable oil) as well as optionally a viscosity reducing plasticizer, coupled with a carefully measured amount of straight chain diols and crosslinking polyols (to create the necessary bridging between the crosslinks), and an isocyanate prepolymer (e.g., diisocyanate, such as aliphatic, aromatic, heterocyclic, etc., polyisocyanates, cycloaliphatic isocyanates and arylaliphatic isocyanates), and optionally in the presence of an appropriate catalyst (e.g., preferably a relatively slow acting catalyst). The reaction media desirably contains the necessary plasticizer loading specifically adapted to provide a curable reaction media, which upon curing, produces such releasably-adhesive and cohesive thermoset viscoelastomeric polymers having a unique polymerizate structure effectively loaded with polar oriented plasticizers uniformly and homogeneously distributed throughout such polymers' entire thermoset mass, intertwined therewithin, and supported by the flexible plasticizer-entrapping, thermoset polymerizate structure. Under the most effective thermosetting and fabricating conditions, the thermosetting polymerizate reactants and the plasticizers are collectively provided in the reaction media as liquids at room temperature (i.e., about 21 °C) without necessitating the use of any solvents, other chemical dispersion aids or elevated temperatures, in order to homogeneously disperse the reaction media components. Accordingly, this allows the thermosetting reaction to be effectively conducted at room temperature.

[0159] The crosslinked polymeric structure of such polyurethane-based releasably-adhesive polymer provides an ideal infrastructure for effectively harboring plasticizer components in a viscoelastic, releasably-adhesive, cohesive and stabilized (i.e., substantially no plasticizer bleeding) polymeric form, while also providing bacteriostatic or antimicrobial properties and cleansability / reusability properties, as well as a resistance to melting when subjected to heat, and a resistance to fire when subjected to a flame. Desirably, the plasticizer is uniformly incorporated throughout the reaction media containing the polymerizable components, and remains uniformly dispersed within the resultant polymer in a highly cohesive form, thus preventing leakage of the plasticizers therefrom.

[0160] From a molecular infrastructure standpoint, the unique combination of straight chain and crosslinking reactants and plasticizer types in the amounts prescribed herein creates suitable polyurethane-based releasably-adhesive polymers for use as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150. The appropriate control of straight chain diol and crosslinking polyol reactants appears to create long chain polarized sites ideal for powerful cohesive polar entrapment of the plasticizer while also aligning polarized plasticizer components in a powerful adhesive and cohesive positioning within the resulting polymer. The polarized molecular alignment of the plasticizer cofactor within the polymeric infrastructure contributes to a highly cohesive structure which maintains its molecular integrity when subjected to forces which effect separation of the polymer from a contacting surface. The plasticizer appears to also be a major contributing factor in the polymer's unique viscoelastomeric properties. As a result, such polyurethane-based releasably-adhesive polymer possesses a host of unique and superior properties (e.g., adhesiveness, cohesiveness, releasability, stability, cleansability, reusability, bacteriostatic, melting resistance, fire resistance, etc.) over other adhesive compositions, thus make such polymer ideal for use as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150 of the inventive adhesive body appendage protection device 100.

[0161] It has been discovered herein that such non-limiting exemplary releasably-adhesive, cohesive, viscoelastomeric thermoset polyurethane polymer as described above can be particularly effective as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150 of the inventive adhesive body appendage protection device 100 of the present disclosure. Furthermore, it has been discovered herein that such polymer meets essentially all of the preferred properties set forth above.

[0162] As referenced above, in some preferred embodiments, the adhesive body appendage protection device 100 of the present disclosure can comprise a silicone-based releasably-adhesive polymer for use as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150. Such polymers can comprise releasable adhesiveness such that the adhesive body appendage protection device 100 can be securely adhered to a medical furnishing and optionally a patient's body appendage during a medical procedure without the device 100 becoming dislodged during the medical procedure, and can then be removed from the patient's appendage and the medical furnishing thereafter via an application of a sufficient removal force to overcome the adhesive force of the polymer without injuring or irritating the patient's contact surface (e.g., skin, hair, fur, etc.), without damaging the medical furnishing, and without damaging the integrity of the adhesive body appendage protection device 100. The degree of adhesiveness of such silicone-based polymers can be adjusted within a given adhesiveness range via manipulation of certain constituents of the polymers (e.g., the amount of peroxide or platinum catalyst) within prescribed ranges. For example, the degree of adhesiveness (within the adhesiveness range) for adhering the adhesive body appendage protection device 100 to a patient's contacting surface may be the same as, or comparatively lower than, the degree of adhesiveness for adhering the adhesive body appendage protection device 100 to a medical furnishing. In another example, the degree of adhesiveness (within the adhesiveness range) for adhering the adhesive body appendage protection device 100 to a medical furnishing may be the same as, or comparatively higher than, the degree of adhesiveness for adhering the adhesive body appendage protection device 100 to a patient's contacting surface. The composition of suitable silicone-based releasably-adhesive polymers can be based on a polymer filled system. The two main components that dictate the performance of the polymer are a high molecular weight, linear siloxane polymer and a highly condensed, silicate tackifying resin (hereinafter referred to as an "MQ resin"). Commercially available silicone-based releasably-adhesive polymers utilize either a polydimethylsiloxane polymer or polydimethyldiphenylsiloxane co-polymer that may contain silanol or vinyl functionality at the polymer chain ends.

[0163] The invention of the present disclosure also includes a method of using the inventive adhesive body appendage protection device 100. The method of using the adhesive body appendage protection device 100 comprises:

[0164] A. providing a foam member 110 having a first side 112 and an opposing second side 114;

[0165] B. providing a first releasably-adhesive component 130;

[0166] C. disposing the first releasably-adhesive component 130 upon the first side 112 of the foam member 110 to form an adhesive body appendage protection device 100 having a first side 102 and an opposing second side 104;

[0167] D. disposing the first side 102 of the adhesive body appendage protection device 100 upon a medical furnishing such that the first releasably-adhesive component 130 contacts and adhesively attaches to the medical furnishing; and

[0168] E. disposing a patient's body appendage upon the second side 104 of the adhesive body appendage protection device 100; wherein the foam member 110 is suitably sized and / or shaped for accommodating the patient's body appendage, wherein the first side 112 and the second side 114 of the foam member 110 corresponds to the first side 102 and the second side 104 of the adhesive body appendage protection device 100, respectively, and wherein the first releasably-adhesive component 130 comprises a polyurethane-based releasably-adhesive polymer or a silicone based releasably-adhesive polymer, each having an adhesiveness of about 0.3 sec / in to about 600 sec / in. In such embodiments, the adhesive body appendage protection device 100 protects the patient's appendage against, inter alia, pressure points and impact injuries due to undesirable movements of the appendage during a medical procedure.

[0169] In some aspects of this embodiment, the method further comprises: A. providing a second releasably-adhesive component 150; and B. disposing the second releasably-adhesive component 150 upon the second side 114 of the foam member 110; wherein the second releasably-adhesive component 150 comprises a polyurethane-based releasably-adhesive polymer or a silicone based releasably-adhesive polymer, each having an adhesiveness of about 0.3 sec / in to about 600 sec / in, and wherein the patient's body appendage is adhesively attached to the second side of the adhesive body appendage protection device during use. In such aspects, the adhesive body appendage protection device 100 further protects the patient's appendage by securing the appendage to the medical furnishing without the need for conventional securing devices.

[0170] The present invention may be better understood with reference to the following examples.

[0171] EXAMPLES

[0172] Example 1

[0173] A sheet of B-25565-710 thermoset foam (available from Premier Foam Inc., having a place of business located in Newnan, Georgia, USA, 30263) was provided. The foam had a thickness of about 1 inch (2.5 cm). A rectangular foam member 110 in the form of a pad was cut from the foam sheet, such that the foam member 110 had a length of about 12 inches (30.5 cm) and a width of about 4 inches (10.2 cm), which was intended to be utilized with a patient's forearm body appendage. The foam member 110 had a major first (bottom) side 112 and an opposing major second (top) side 114.

[0174] A polyurethane-based viscoelastomeric thermoset releasably-adhesive polymer reaction media was prepared. The reaction media comprised 7.05 wt% (based on the total reaction media weight) ELASTOCAST TQZ-P23 methylene diphenyl diisocyanate, 15.75 wt% ELASTOCAST C-4057 2-functional polyether diol, 41.14 wt% ELASTOCAST C-4018 3-functional polyether triol, 35.01 wt% epoxidized soybean oil, 0.11 wt% COSCAT 83 slow- acting organobismuth catalyst, 0.23 wt% heat-activated tin thioglycolate catalyst FOMREZ CATALYST UL-29, 0.53 wt% TINUVIN B 75 UV inhibitor (available from BASF Corporation), and 0.18 wt% neon green dye blend.

[0175] While still in liquid form, a quantity of the reaction media was applied to substantially the entire first side 112 of the foam member 110, and allowed to fully cure, thus forming a first releasably-adhesive component 130. The first releasably-adhesive component 130 had a thickness of approximately 0.5 mm.

[0176] In addition, while still in liquid form, a quantity of the reaction media was applied to substantially the entire second side 114 of the foam member 110, and allowed to fully cure, thus forming a second releasably-adhesive component 150. The second releasably-adhesive component 150 also had a thickness of approximately 0.5 mm.

[0177] Accordingly, a non-limiting example of an inventive adhesive body appendage protection device 100 of the present disclosure was formed having a first side 102 and an opposing second side 104. The adhesive body appendage protection device 100 of this Example 1 was generally similar to those shown in Figs. 2A-2C.

[0178] The adhesiveness of the first (bottom) side 102 of the adhesive body appendage protection device 100 was determined by testing a sample of the first releasably-adhesive component 130 in accordance with the Adhesiveness Test set forth above. The adhesiveness of the first side 102 of the adhesive body appendage protection device 100 (i.e., the first releasably-adhesive component 130) was determined to be about 10 seconds / inch (sec / in).

[0179] Similarly, the adhesiveness of the second (top) side 104 of the adhesive body appendage protection device 100 was determined by testing a sample of the second releasably-adhesive component 150 in accordance with the Adhesiveness Test set forth above. The adhesiveness of the second side 104 of the adhesive body appendage protection device 100 (i.e., the second releasably-adhesive component 150) was also determined to be about 10 seconds / inch (sec / in).

[0180] An examination table was provided having a vinyl-like covering material disposed upon the top side. The adhesive body appendage protection device 100 of this Example 1 was then placed upon the top side of the examination table such that the first releasably-adhesive component 130 disposed upon the first side 102 of the device 100 became in contact with the covering material of the examination table.

[0181] A test subject (i.e., a person) then placed the bottom side of their forearm upon the top side 104 of the adhesive body appendage protection device 100, such that the test subject's skin was in direct contact with the second releasably-adhesive component 150 disposed upon the top side 104 of the device 100, and such that the device 100 generally extended from the test subject's wrist to their elbow.

[0182] The test subject reported initially feeling the adhesive body appendage protection device 100 conform to their forearm (i.e., a slight sinking-in feeling). The test subject also reported that it was very difficult to generally move their forearm upon the adhesive body appendage protection device 100, including difficulty with trying to rotate their forearm right and left, difficulty with trying to roll their forearm back and forth, and difficulty trying to raise their forearm from the device 100.

[0183] With assistance from another individual, the test subject's forearm was detached from the adhesive body appendage protection device 100 using a sufficient removal force to overcome the adhesive force of the device via a lifting motion which started at the elbow and continued toward their wrist. The test subject reported that the removal process felt "sticky", but that the experience did not cause any pain. In addition, no skin irritation was observed upon the test subject's forearm, and no residual polymer from the second releasably-adhesive component 150 was observed on the test subject's skin. Upon removal of the patient's forearm, it was further observed that the adhesive body appendage protection device 100 remained attached to the operating table fully intact.

[0184] Finally, the adhesive body appendage protection device 100 was removed from the examination table by grasping one end and then pulling at an angle in a type of peeling motion. Upon removal, the adhesive body appendage protection device 100 was inspected for any tears or other detrimental effects, but none were observed (i.e., the device 100 remained intact). In addition, the covering material of the examination table was inspected for any residual polymer from the first releasably-adhesive component 130, but none was observed.

[0185] Accordingly, the inventive adhesive body appendage protection device 100 successfully functioned as intended.

[0186] Example 2

[0187] The adhesive body appendage protection device 100 of Example 1 was placed onto a concrete floor in a laid flat configuration, such that the first (bottom) side 102 thereof was in contact with the concrete floor. A torch was then provided which produced a flame having a temperature of about 2,000 °F. The torch flame was then directed into the second (top) side 104 of the adhesive body appendage protection device 100 until a flame could be observed rising from the adhesive body appendage protection device 100 (about 10 seconds). The torch flame was then removed from the device 100, and it was observed that the flame emanating from the device 100 immediately extinguished on its own.

[0188] A 12 inch by 12 inch sample of a conventional memory foam having a thickness of about 1 inch was then provided. The conventional foam material was then placed upon the concrete floor (in a different location) in a laid flat configuration. The same torch flame was then directed to the top side of the conventional foam. A flame could be observed rising from the conventional foam material within about 1 second of exposure to the torch flame. The torch flame was removed from the conventional foam material after several seconds, and it was observed that the conventional foam material continued to burn. The flame was ultimately extinguished using a fire extinguisher.

[0189] This Example 2 successfully demonstrates that the adhesive body appendage protection device 100 of the present disclosure comprising a releasably-adhesive component possesses fire resistant properties, particularly as compared to conventional memory foam.

[0190] It will be appreciated that details of the foregoing examples, given for purposes of illustration, are not to be construed as limiting the scope of the present invention. Although only a few exemplary embodiments of the present invention have been described in detail above, persons having ordinary skill in the art will readily appreciate that many modifications are possible in the examples without materially departing from the novel teachings and advantages of this invention. For example, features described in relation to one example may be incorporated into any other example of the invention.

[0191] Accordingly, all such modifications are intended to be included within the scope of the present invention, which is defined in the following claims and all equivalents thereto. Further, it is recognized that many embodiments may be conceived that do not achieve all of the advantages of some embodiments, particularly of the preferred embodiments, yet the absence of a particular advantage shall not be construed to necessarily mean that such an embodiment is outside the scope of the present invention. As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense.

Claims

CLAIMSWhat is claimed is:

1. An adhesive body appendage protection device for protecting a body appendage of a patient when disposed upon a medical furnishing, comprising a foam member and a first releasably-adhesive component; wherein the adhesive body appendage protection device comprises a first side and an opposing second side; wherein the foam member comprises a first side and an opposing second side which each correspond to the first side and the second side of the adhesive body appendage protection device, respectively; wherein the foam member is sized and shaped to accommodate a body appendage of a patient; wherein the first releasably-adhesive component is at least partially disposed upon the first side of the foam member; wherein the first side of the adhesive body appendage protection device is disposed upon and adhesively attached to a medical furnishing during use; and wherein the body appendage is disposed upon the second side of the adhesive body appendage protection device during use.

2. The adhesive body appendage protection device of claim 1, wherein the foam member comprises a polyurethane foam.

3. The adhesive body appendage protection device of claim 1, wherein the foam member comprises a density of about 1.2 lb / ft3to about 10 lb / ft3.

4. The adhesive body appendage protection device of claim 1, wherein the foam member comprises an indentation force deflection of about 5 I bf to about 200 Ibf.

5. The adhesive body appendage protection device of claim 1, wherein the foam member comprises a tensile strength that is greater than about 8 psi.

6. The adhesive body appendage protection device of claim 1, wherein the foam member comprises a tear strength that is greater than about 1.3 lbf / in.

7. The adhesive body appendage protection device of claim 1, wherein the first releasably-adhesive component comprises an adhesiveness of about 0.3 sec / in to about 600 sec / in.

8. The adhesive body appendage protection device of claim 7, wherein the first releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone-based releasably-adhesive polymer.

9. The adhesive body appendage protection device of claim 7, wherein the first releasably-adhesive component comprises a polyurethane-based viscoelastomeric thermoset polymer.

10. The adhesive body appendage protection device of claim 9, wherein the polyurethane-based releasably-adhesive component is the product of a reaction media comprising:A. about 2 wt% to about 10 wt% isocyanate prepolymer,B. about 35 wt% to about 75 wt% polyols comprising about 1 wt% to about 65 wt% straight chain linking diols and about 3 wt% to about 50 wt% crosslinking polyols, andC. about 10 wt% to about 60 wt% plasticizer comprising about 10 wt% to about 50 wt% epoxidized triglyceride plasticizer and 0 wt% to about 40 wt% viscosity reducing plasticizer.

11. The adhesive body appendage protection device of claim 1, further comprising a second releasably-adhesive component, wherein the second releasably-adhesive component is at least partially disposed upon the second side of the foam member; and wherein the body appendage is and adhesively attached to the second side of the adhesive body appendage protection device during use.

12. The adhesive body appendage protection device of claim 11, wherein the second releasably-adhesive component comprises an adhesiveness of about 0.3 sec / in to about 600 sec / in.

13. The adhesive body appendage protection device of claim 12, wherein the second releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone-based releasably-adhesive polymer.

14. The adhesive body appendage protection device of claim 12, wherein the second releasably-adhesive component comprises a polyurethane-based viscoelastomeric thermoset polymer.

15. The adhesive body appendage protection device of claim 14, wherein the polyurethane-based viscoelastomeric thermoset polymer is the product of a reaction media comprising:A. about 2 wt% to about 10 wt% isocyanate prepolymer,B. about 35 wt% to about 75 wt% polyols comprising about 1 wt% to about 65 wt% straight chain linking diols and about 3 wt% to about 50 wt% crosslinking polyols, andC. about 10 wt% to about 60 wt% plasticizer comprising about 10 wt% to about 50 wt% epoxidized triglyceride plasticizer and 0 wt% to about 40 wt% viscosity reducing plasticizer.

16. The adhesive body appendage protection device of claim 1, wherein the adhesive body appendage protection device is bacteriostatic.

17. The adhesive body appendage protection device of claim 1, wherein the adhesive body appendage protection device is sterilizable.

18. The adhesive body appendage protection device of claim 1, wherein the adhesive body appendage protection device is fire resistant.

19. The adhesive body appendage protection device of claim 1, wherein the adhesive body appendage protection device is cleansable and reusable.

20. A method of using an adhesive body appendage protection device, comprising:A. providing a foam member having a first side and an opposing second side;B. providing a first releasably-adhesive component;C. disposing the first releasably-adhesive component upon the first side of the foam member to form an adhesive body appendage protection device having a first side and an opposing second side;D. disposing the first side of the adhesive body appendage protection device upon a medical furnishing such that the first releasably-adhesive component contacts and adhesively attaches to the medical furnishing; andE. disposing a patient's body appendage upon the second side of the adhesive body appendage protection device; wherein the foam member is suitably sized and shaped for accommodating the patient's body appendage; wherein the first side and the second side of the foam member correspond to the first side and the second side of the adhesive body appendage protection device, respectively; and wherein the first releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone based releasably-adhesive polymer, each having an adhesiveness of about 0.3 sec / in to about 600 sec / in.

21. The method of claim 20, further comprising:A. providing a second releasably-adhesive component; andB. disposing the second releasably-adhesive component upon the second side of the foam member; wherein the second releasably-adhesive component comprises a polyurethane-based releasably-adhesive polymer or a silicone-based releasably-adhesive polymer, each having an adhesiveness of about 0.3 sec / in to about 600 sec / in; and wherein the patient's body appendage is adhesively attached to the second side of the adhesive body appendage protection device during use.

Images