Adhesive body securing device

Abstract

An adhesive body securing device capable of securing a patient to a medical furnishing during a medical procedure without the need for conventional securing devices 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 second side of the adhesive body securing device is disposed upon a medical furnishing and at least the torso region of a patient is disposed upon the first side of the adhesive body securing device. In some embodiments, a second releasably-adhesive component is disposed upon the second side of the foam member.

Description

[0001] Adhesive Body Securing 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 securing devices for a patient's body to restrict movement thereof and / or to relieve pressure points during medical procedures. More particularly, the present disclosure relates to an adhesive body securing device which is suitable for medical purposes.

[0006] BACKGROUND OF THE INVENTION

[0007] The medical field is replete with medical furnishings upon which patients (e.g., people receiving medical treatments / procedures, disabled individuals, rehabilitating individuals, elderly individuals, animals in veterinary hospitals, etc.) can lie upon. Such medical furnishings can include, but are not limited to, gurneys, operating tables, stretchers, medical cots, surgical tables, examination tables, therapeutic tables, chiropractic tables, hospital beds, inversion tables, dental chairs, veterinary operating 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, such medical furnishings tend to be relatively uncomfortable for patients and can even result in minor injuries (e.g., muscle soreness, contusions, bed sores, etc.), particularly when a patient encounters prolonged exposure upon such medical furnishings. 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 have numerous negative effects on a patient, including discomfort, skin irritation, sores, etc. In addition, such material tends to become slippery when exposed to moisture, which can result in undesirable movement of a patient, or even the patient falling off the medical furnishing, such as during a medical procedure.

[0009] Attempts have been made to alleviate the negative effects associated with medical furnishings. For example, in the area of surgical procedures, many hospitals utilize a disposable body pad consisting of a memory foam, which typically has a width approximately equivalent to the width of the operating table and a length which is at least equal to the length of a patient's torso, and often has a length which is greater than the length of the patient's entire body. Such conventional disposable body pad of memory foam tends to be relatively soft and at least partially breathable (i.e., allows for air flow), which can help alleviate some of the negative effects associated with the covering material of medical furnishings. In another example, US 8,464,720 to Pigazzi et al. describes a method of minimizing injuries caused by pressure on portions of a body of a patient in a Trendelenburg position on a surgical operating table, which utilizes a viscoelastomeric memory foam which provides a greater cushioning effect than the cushioned covering of the surgical operating table, and can also provide a small degree of grip (i.e., a greater coefficient of friction than the surgical operating table covering material), which can reduce some of the slipperiness experienced by a patient during a surgical procedure (e.g., when a patient perspires). Unfortunately, even with the use of such conventional disposable body pads, patients remain susceptible to undesirable movement during medical procedures (which can impair or complicate such procedures, and can result in injuries), as well as to falling off a given medical furnishing (which can result in injury or even death). Accordingly, despite the use of such conventional disposable body pads, patients must often additionally be secured to medical furnishings during medical procedures.

[0010] Attempts have been made to secure patients to medical furnishings, namely in the form of straps, belts, harnesses, braces, clamps and the like (i.e., conventional securing devices). In general, medical furnishings will often include one or more sets of such conventional securing devices. For example, in the case of straps, each set of straps typically comprises two strap portions and metallic fastening members, wherein one end of each strap portion is permanently secured to the medical furnishing (typically located on each side of the furnishing), and wherein the opposing distal ends hang free and typically further comprise mating fastening members. Thus, after a patient has been disposed upon a medical furnishing, the free ends of such conventional securing devices are brought together around the patient, and then secured with the fastening members (typically comprising buckling or tensioning elements) to firmly confine the patient upon the given medical furnishing.

[0011] Unfortunately, such conventional securing devices have numerous deficiencies. For example, in the case of straps, such straps can be relatively lengthy and, since they are free-hanging, can interfere with the use of a medical furnishing, can become buried beneath sheets or beneath the patient, can become tangled in the various components of the furnishing, can interfere with (i.e., obstruct) a particular medical procedure, can cause injury to the patient (e.g., skin irritation, scrapes, contusions, mental anguish, etc.), and can even cause injuries (e.g., an impact injury) to the medical provider (e.g., EMT, nurse, doctor, dentist, veterinarian, therapist, etc.). In addition, the general design of such conventional securing devices typically requires two medical providers to conduct the securing action, and also requires the medical providers to inconveniently reach over the patient to fasten the securing devices. Furthermore, since each patient tends to have different dimensions, conventional securing devices must be inconveniently re-adjusted for each use. Moreover, such conventional securing devices can tend to feel overly-confining to a patient, which can cause significant discomfort and / or mental distress. In addition, in the case of straps, since one end of each strap tends to be 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.

[0012] Another negative attribute of conventional disposable body pads is that such pads tend to be inherently flammable. Due to the nature and equipment utilized in many medical procedures, the potential for a fire is a very real risk. Fire retardant chemicals could be applied to such conventional disposable body pads, but typically are not, because such chemicals often are not considered to be safe (e.g., due to respiration, skin contact, allergic reactions, etc.), and add to the cost of such pads.

[0013] Thus, there is a need for an inventive medical securing device in the form of an adhesive body securing device which is relatively soft, relatively breathable (i.e., allows for air flow), which can conform to a patient's body shape, and which can eliminate the need for conventional securing devices. There is also a need for an inventive medical securing device which can relieve pressure points. There is also a need for an inventive medical securing 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 medical securing device which does not cause an injury to a medical provider or to the patient. There is also a need for an inventive medical securing device which does not require multiple medical personnel to secure a patient thereto. There is also a need for an inventive medical securing device which does not require the act of medical personnel reaching over the patient. 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 body pads with conventional securing devices. There is also a need for an inventive medical securing device which is optionally reusable. There is also a need for an inventive medical securing device which is bacteriostatic or antimicrobial (which can include antibacterial, antifungal and / or antipathogenic). There is also a need for an inventive medical securing device which can be sterilized. There is also a need for an inventive medical securing device which is inherently fire resistant. There is also a need for an inventive medical securing device which is biodegradable. There is also a need for an inventive medical securing device which utilizes green technology.

[0014] SUMMARY OF THE INVENTION

[0015] In response, the invention of the present disclosure solves one or more of the problems and / or needs discussed above.

[0016] The inventive medical securing device of the present disclosure takes the form of an adhesive body securing device for securing a patient (i.e., persons receiving medical treatments / procedures, disabled persons, rehabilitating persons, elderly persons, animals receiving veterinary procedures, etc.) to a medical furnishing (i.e., gurneys, operating tables, stretchers, medical cots, surgical tables, examination tables, therapeutic tables, chiropractic tables, hospital beds, inversion tables, dental chairs, veterinary operating tables, etc.), such as during a medical procedure.

[0017] In some preferred embodiments, the inventive adhesive body securing device generally comprises a foam member (e.g., a foam layer, foam pad, foam mat, etc.), preferably a polyurethane foam member, having a major first external surface (i.e., a body contacting surface) and an opposing major second external surface (i.e., a medical furnishing contacting surface), and a releasably-adhesive component disposed upon at least a portion of a first external surface of the foam member (wherein such surface is intended to contact a patient during a medical procedure). In such embodiments, the first releasably-adhesive component will preferably comprise an adhesiveness that is sufficient for the inventive adhesive body securing device to withstand the forces exerted by a patient during a medical procedure, but which also allows a medical provider to remove the inventive adhesive body securing device from the patient thereafter without causing any negative effects to the patient (e.g., skin irritation, skin tears, etc.).

[0018] In some embodiments, the inventive adhesive body securing device of the present disclosure can further comprise a second releasably-adhesive component disposed upon at least a portion of the second external surface of the foam member (wherein such surface is intended to contact a medical furnishing), such that the inventive adhesive body securing device can be securely and releasably attached to the medical furnishing during a medical procedure. In such embodiments, the second releasably-adhesive component will preferably comprise an adhesiveness that is sufficient for the inventive adhesive body securing device to adhered to the medical furnishing without dislodging therefrom during use, but which also allows a medical provider to remove the inventive adhesive body securing device from the medical furnishing thereafter without damaging the medical furnishing, without damaging the integrity of the device, and to optionally clean and sterilize the device or dispose of the device after use.

[0019] Advantageously, the inventive adhesive body securing device eliminates the need for conventional securing devices. In some preferred embodiments, the inventive adhesive body securing device does not interfere with the use of a given medical furnishing. In some preferred embodiments, the inventive adhesive body securing device does not interfere with a particular medical procedure. In some preferred embodiments, the inventive adhesive body securing device does not cause an injury to a medical provider during a medical procedure. In some preferred embodiments, the inventive adhesive body securing device does cause an injury to a patient during a medical procedure. In some preferred embodiments, the inventive adhesive body securing device does not require multiple medical personnel to secure a patient thereto. In some preferred embodiments, the inventive adhesive body securing device does not require the act of medical personnel reaching over the patient during use of the device.

[0020] In some preferred embodiments, the inventive adhesive body securing device comprises a desired softness, which can be equivalent to the softness of conventional body pads. In some preferred embodiments, the inventive adhesive body securing device can have a desired breathability (i.e., air flow), which can be equivalent to the breathability of conventional body pads. In some preferred embodiments, the inventive adhesive body securing device can substantially conform to a patient's body shape profile. In some preferred embodiments, the inventive adhesive body securing device can relieve pressure points of a patient during a medical procedure. In some preferred embodiments, the inventive adhesive body securing device can provide greater comfort for a patient during use as compared to conventional body pads in conjunction with conventional securing devices.

[0021] In some preferred embodiments, the inventive adhesive body securing device can be disposable. In some preferred embodiments, the inventive adhesive body securing device can be reusable. In some preferred embodiments, the inventive adhesive body securing device comprises bacteriostatic or antimicrobial (which can include antibacterial, antifungal and / or antipathogenic) properties. In some preferred embodiments, the inventive adhesive body securing device can be sterilized. In some preferred embodiments, the inventive adhesive body securing device is inherently fire resistant. In some preferred embodiments, the inventive adhesive body securing device is biodegradable. In some preferred embodiments, the inventive adhesive body securing device comprises green technology.

[0022] In some preferred embodiments, an adhesive body securing device for releasably securing a patient to a medical furnishing comprises a foam member and a first releasably- adhesive component, wherein the adhesive body securing device comprises a first side and an opposing second side, wherein the foam member also comprises a first side and an opposing second side of which each correspond to the first side and the second side of the adhesive body securing device, respectively, wherein the first releasably-adhesive component is at least partially disposed upon the first side of the foam member, wherein the second side of the adhesive body securing device is disposed upon a medical furnishing during use, and wherein at least the torso region of a patient is disposed upon the first side of the adhesive body securing device during use.

[0023] 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.

[0024] 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 aspects, wherein the first releasably-adhesive component comprises a polyurethane-based viscoelastomeric thermoset polymer. In some further aspects, the polyurethane-based viscoelastomeric thermoset polymer of the first releasably-adhesive component is the product of a reaction media comprising:

[0025] 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, and

[0026] 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.

[0027] In some aspects of this embodiment, the adhesive body securing device further comprises a second releasably-adhesive component, wherein 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 thermoset polymer or a silicone based releasably-adhesive polymer. In other aspects, the wherein the second releasably-adhesive component comprises a polyurethane-based viscoelastomeric thermoset polymer. In some further aspects, the polyurethane-based viscoelastomeric thermoset polymer of the second releasably-adhesive component is the product of a reaction media comprising:

[0028] A. about 2 wt% to about 10 wt% isocyanate prepolymer,

[0029] 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

[0030] 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.

[0031] In some aspects of this embodiment, the adhesive body securing device is bacteriostatic. In other aspects of this embodiment, the adhesive body securing device is sterilizable (i.e., capable of being sterilized). In other aspects of this embodiment, the adhesive body securing device is fire resistant. In other aspects of this embodiment, the adhesive body securing device is cleansable and reusable

[0032] In some preferred embodiments, a method of using an adhesive body securing device comprises:

[0033] A. providing a foam member having a first side and an opposing second side; B. providing a first releasably-adhesive component;

[0034] C. disposing the first releasably-adhesive component upon the first side of the foam member to form an adhesive body securing device having a first side and an opposing second side;

[0035] D. disposing the second side of the adhesive body securing device upon a medical furnishing; and

[0036] E. disposing at least the torso region of a patient upon the first side of the adhesive body securing device; wherein the foam member is suitably sized for placement upon a medical furnishing and for accommodating at least the torso region of a patient, 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 securing 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.

[0037] In some aspects of this embodiment, the method further comprises:

[0038] A. providing a second releasably-adhesive component; and

[0039] 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.

[0040] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] 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:

[0042] Fig. 1A is a perspective view showing a non-limiting exemplary inventive adhesive body securing device of the present disclosure having a major first side and an opposing major second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side;

[0043] Fig. IB is a side view of Fig. 1A taken along Line A-A;

[0044] Fig. 1C is a perspective view showing a non-limiting exemplary inventive adhesive body securing device of the present disclosure having a major first side and an opposing major second side, and comprising a foam member and a first releasably-adhesive component disposed upon the first side, wherein the second side of the medical securing device is disposed upon a medical furnishing, and wherein a patient's body is disposed upon the first side and is releasably attached thereto via the first releasably-adhesive component;

[0045] Fig. 2A is a perspective view showing a non-limiting exemplary inventive adhesive body securing 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;

[0046] Fig. 2B is a side view of Fig. 2A taken along Line B-B;

[0047] Fig. 2C is a perspective view showing a non-limiting exemplary inventive adhesive body securing 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 second side of the adhesive body securing device is disposed upon and releasably adhered to a medical furnishing via the second releasably-adhesive component, and wherein a patient is disposed upon and releasably adhered to the first side via the first releasably-adhesive component; and

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

[0049] TEST METHODS

[0050] Adhesiveness Test

[0051] 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).

[0052] 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.

[0053] 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.

[0054] 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.

[0055] The procedure is then repeated two (2) additional times for a total of three (3) test iterations.

[0056] 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).

[0057] Cohesiveness Test

[0058] The cohesiveness of a releasably-adhesive component (e.g., the first releasably-adhesive component 130 and the second releasably-adhesive component 150) 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.

[0059] 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.

[0060] The procedure is repeated two (2) additional times, for a total of three (3) test iterations

[0061] 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

[0062] 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).

[0063] Foam Indentation Force Deflection (IFD) Test

[0064] 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.

[0065] Foam Air Flow Test

[0066] 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).

[0067] Foam Tensile Strength Test

[0068] 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).

[0069] Foam Tear Strength Test

[0070] 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

[0071] 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 (%).

[0072] DEFINITIONS

[0073] 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.

[0074] 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.

[0075] 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.

[0076] As used herein with respect to foam, the term "cell" refers to a cavity contained in a foam.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] As used herein, the term "patient" refers to a human or an animal undergoing a medical procedure.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] As used herein, the term "surfactant" refers to a chemical component that affects the surface tension of fluids.

[0091] 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.

[0092] 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.

[0093] DETAILED DESCRIPTION - Best Mode(s) - Industrial Applicability

[0094] The invention is generally directed to a securing device for a patient to restrict movement thereof and / or to relieve pressure points during medical procedures. In some preferred embodiments, the present disclosure relates to an adhesive body securing 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 securing device comprises a foam member and at least one releasably-adhesive component disposed upon at least one external surface of the foam member.

[0095] In some embodiments, the inventive adhesive body securing device can be useful for, among other things, reducing or eliminating injuries to patients from pressure points during a medical procedure. In some embodiments, the inventive adhesive body securing device can be useful for, among other things, reducing or eliminating injuries to patients from impacts during a medical procedure. In some embodiments, the inventive adhesive body securing 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 securing device can be useful for, among other things, restricting movement of a patient's body during a medical procedure. In some embodiments, the inventive adhesive body securing device can be useful for, among other things, positioning a patient's body during a medical procedure. In some embodiments, the inventive adhesive body securing device can be useful for, among other things, securing a patient's body, (e.g., to a medical furnishing) during a medical procedure.

[0096] In some embodiments, the inventive adhesive body securing device of the present disclosure can comprise a first releasably-adhesive component disposed upon a first major external surface of the foam member wherein such surface is intended to contact at least a portion of a patient's body, such that the patient can be securely and releasably attached to the adhesive body securing device. In such embodiments, the first releasably-adhesive component will preferably comprise an adhesiveness that is sufficient for the adhesive body securing device to withstand the forces exerted by a patient's body during a medical procedure without the patient dislodging from the device, but which thereafter also allows a medical provider to remove the adhesive body securing device from the patient 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.

[0097] In some embodiments, the inventive adhesive body securing device of the present disclosure can further comprise a second releasably-adhesive component disposed upon an opposing second major external surface which is distal to the first surface of the foam member wherein such surface is intended to contact a medical furnishing, such that the adhesive body securing device can be securely and releasably attached to the medical furnishing. In such embodiments, the second releasably-adhesive component will preferably comprise an adhesiveness that is sufficient for the medical securing device to withstand the forces exerted by a patient's body 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 securing device from the medical furnishing without damaging the medical furnishing or 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 securing 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 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.

[0100] 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. 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 securing 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 showing non-limiting embodiments of an inventive adhesive body securing device 100.

[0102] With particular reference to Figs. 1A-1C, in some preferred embodiments, an inventive adhesive body securing device 100 of the present disclosure is shown generally in the form of a substrate, layer, pad, mat, etc. for, inter alia, securing a patient to the device 100 without the need for external securing means (e.g., conventional securing devices) and relieving pressure points of the patient during a medical procedure or process. The inventive adhesive body securing device 100 has a major first side or surface 101 (which may also be referred to as a top side, a body contacting side, or a first external side or surface) and an opposing major second side or surface 102 (which may also be referred to as a bottom side, a medical furnishing contacting side, or a second external side or surface) distal to the first side 101.

[0103] The adhesive body securing device 100 comprises a foam member 110 having a first side 111 (which corresponds to the first side 101 of the adhesive body securing device 100) and an opposing second side 112 (which corresponds to the second side 102 of the adhesive body securing device 100) distal to the first side 111. Accordingly, the foam member 110 generally defines the shape and dimensions of the adhesive body securing device 100. The inventive adhesive body securing device 100 also comprises a first releasably-adhesive component 130 disposed at least partially upon the first side 111 of the foam member 110.

[0104] The first side 101 of the inventive adhesive body securing device 100 is intended to face towards, and be releasably attached to, a patient (e.g., skin, fur, etc.) during a medical procedure, and the second side 102 is intended to be disposed upon a medical furnishing during such medical procedure. Procedurally, the inventive adhesive body securing device 100 is positioned / aligned upon a medical furnishing at a desired location such that the second 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 it is generally in contact with the medical furnishing. Then a patient is disposed upon the first side 101 of the inventive adhesive body securing device 100 such that at least a portion of the patient's body is adhesively secured to the device 100. Upon completion of a desired medical procedure, the patient and the adhesive body securing device 100 can be separated by exerting a removal force sufficient to overcome the adhesive force of the first releasably-adhesive component 130, and then the adhesive body securing device 100 can be removed from the medical furnishing. In some preferred embodiments, this can all be accomplished while maintaining a sterile field. Afterwards, the adhesive body securing device 100 can be disposed of, or can be cleaned and sterilized for further use.

[0105] Continuing with Figs. 1A-1C, as referenced above, the inventive adhesive body securing device 100 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. In some preferred embodiments, a thermoset foam may be more desirable than a thermoplastic foam since thermoset foams tend to be more resilient than thermoplastic foams. 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.). 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 1 bf (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).

[0106] The foam member 110 (and thus the inventive adhesive body securing device 100) of this first embodiment can comprise any shape as may be desired, but will typically be generally rectangular (i.e., cuboid). However, it should be understood that the foam member 110 can comprise any other shape (ovular, diamond, body silhouette, random, etc.) without departing from the scope of the invention. Preferably, the shape of the foam member 110 will be suitable to substantially extend to or beyond the outer perimeter of the patient's whole body, or a portion thereof (e.g., from the neck to the feet of a human patient, or along the entire length of the patient's body, but not including the patient's arms, or the perimeter of the patient' torso, etc.) (though it need not be), depending upon the medical procedure or process being performed.

[0107] The foam member 110 (and thus the inventive adhesive body securing device 100) also comprises dimensions. In general, the foam member 110 is suitably sized for placement upon a medical furnishing and for accommodating at least the torso region of a patient, such that at least the torso region of a patient can be disposed upon the top side of the adhesive body securing device during use. Preferably, the dimensions will be suitable to substantially extend to or beyond the outer perimeter of the patient's body, or a portion thereof (e.g., a length which extends the entire length of a patient's body, or a length measuring from the neck to the feet of a human patient, or the length of a patient's torso region, etc.), depending upon the medical procedure or process being performed. In some embodiments, the width of the adhesive body securing device 100 can be approximately equivalent to the width of a particular medical furnishing, though it need not be. By way of example only, in some aspects where the foam member 110 comprises a rectangular (i.e., cuboid) shape, the foam member 110 can have a length of about 20 inches (50.8 cm) to about 90 inches (228.6 cm) and a width of about 10 inches (25.4 cm) to about 50 inches (127.0 cm). 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).

[0108] 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 a patient and / or resist tearing of the foam member 110 during use and during removal of the patient from the adhesive body securing device 100 and removal of the adhesive body securing device 100 from the medical furnishing.

[0109] The foam member 110 (and in some instances, the inventive adhesive body securing device 100) 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 Ibf, 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 I bf or greater than 200 I bf 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, each of which is briefly discussed below. 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 or more of the properties discussed above.

[0111] In general, suitable foams have a cellular structure, with cells defined by cell membranes and struts. The struts are formed at the intersection of cell membranes, with the cell membranes covering interconnecting cellular windows between the struts. Such foams may further contain cell orifices within the membranes that can provide doorways into adjoining cells. Accordingly, the foam may define a plurality of open cells and / or closed cells which are separated from one another by cell membranes and struts. Cell sizes may be in the range of about 10 microns to about 1,000 microns as measured by ASTM D3576. However, it should be understood that foams having cell sizes that are less than 10 microns or greater than 1,000 microns can also be utilized for the foam member 110 of the present invention without departing from the scope of the invention. In some aspects, a "fine" foam can have foam cell sizes in the range of about 10 microns to about 500 microns, such as about 20 microns to about 300 microns. In other aspects, a "coarse" foam can have foam cell sizes in the range of about 500 microns to about 1,000 microns. The specific number and size of cells can be determined by the foam formulation, as well as the processing parameters selected.

[0112] In addition, suitable foams may be substantially closed-celled, substantially open- celled, or a combination thereof. In some aspects, the foam which forms the foam member 110 can have an open cell structure of about 25% or greater, such as about 50% or greater, or 75% or greater, as measured by using a gas pycnometer according to ASTM D2856, Method C. In other aspects, the foam can have a closed-cell content of at least about 25%, such as at least about 50% or at least about 75%, which can help improve resiliency and / or compression resistance.

[0113] By way of a non-limiting example only, a suitable foam for the foam member 110 can include an elastomeric thermoset foam, such as a thermoset polyurethane foam. An exemplary process for producing a thermoset polyurethane foam begins with preparing a thermoset foam formulation. The thermoset foam formulation can include a polyol component, a surfactant component, a blowing agent component, a crosslinking component, or a combination thereof. The thermoset foam formulation can optionally include a solvent (for example, if used for reacting a solid or semi-solid product) or the polyol component without the solvent (for example, if used for reacting a liquid product. However, the final product will typically be a solid foamed polymer. One or more catalysts can also be utilized in the production of a thermoset foam, such as chlorohydrins in the presence of tertiary amine catalyst (which can be blocked with different acids in order to yield delay action catalysts). By delay action catalysts it is meant that the catalysts will not be substantially active on the initial stages of the polymerization process thereby allowing for the polymerizing mass to freely flow, such as to completely fill a mold, for example.

[0114] The polyol component of the thermoset foam formulation can include a polyether polyol and a copolymer polyol. For example, the thermoset foam formulation could comprise about 50 parts per one hundred parts polyol (pphp) of a first polyol (e.g., polyether polyol) in the polyol component, about 50 pphp of a second polyol (e.g., copolymer polyol) in the polyol component, about 3.0 pphp to about 3.5 pphp water as a blowing agent component, about 0.60 pphp surfactant (e.g., a silicon surfactant) as a surfactant component, about 0.70 pphp crosslinking agent (e.g., diethanolamine) as a crosslinking component, or a combination thereof. For example, the polyol component of the thermoset foam formulation could include polyols for making a high resilient (HR) foam product.

[0115] Other suitable polyols that can be utilized in the thermoset foam formulation can include natural oil polyols or polyols obtained from renewable natural resources such as vegetable oils. Natural oils consist of triglycerides of saturated and unsaturated fatty acids. One natural oil polyol suitable for use as a polyol can include castor oil, which is a natural triglyceride of ricinoleic acid. Other natural oils may need to be chemically modified to introduce sufficient hydroxyl content to make them useful in the production of polyurethane polymers. There are two chemically reactive sites that can be considered when attempting to modify natural oil or fat into a useful polyol: 1) the unsaturated sites (double bonds), and 2) the ester functionality. Unsaturated sites present in oil or fat can be hydroxylated via epoxidation followed by ring opening or hydroformylation followed by hydrogenation. Alternatively, trans-esterification can also be utilized to introduce OH groups into natural oil and fat.

[0116] The chemical process for the preparation of natural polyols using the epoxidation route involves a reaction mixture that requires epoxidized natural oil, a ring opening acid catalyst and a ring opener. Epoxidized natural oils include epoxidized plant-based oils (i.e., epoxidized vegetable oils) and epoxidized animal fats. The epoxidized natural oils may be fully or partially epoxidized and such oils can include soybean oil, corn oil, sunflower oil, olive oil, canola oil, sesame oil, palm oil, rapeseed oil, tung oil, cotton seed oil, safflower oil, peanut oil, linseed oil, and the like, and combinations thereof. Animal fats for epoxidation may include fish oil, tallow and lard. These natural oils are triglycerides of fatty acids which may be saturated or unsaturated with various chain lengths from C12 to C24. Such acids can include, for example, 1) saturated, such as, lauric, myristic, palmitic, steric, arachidic or lignoceric acid; 2) mono-unsaturated, such as, palmitoleic or oleic acid, and 3) polyunsaturated, such as, linoleic, linolenic, or arachidonic acid. Partially or fully epoxidized natural oil may be prepared when reacting peroxyacid under suitable reaction conditions. Examples of peroxyacids that can be utilized in the epoxidation of oils have been described in WO 2006 / 116456 Al, which is hereby incorporated herein by reference in in a manner that is consistent herewith. Ring opening of the epoxidized oils with alcohols, water and other compounds having one or multiple nucleophilic groups can also be utilized. Depending on the reaction conditions, oligomerization of the epoxidized oil can also occur. Ring opening yields natural oil polyol that can be used for the manufacture of polyurethane products. In the hydroformylation / hydrogenation process, the oil is hydroformylated in a reactor filled with a hydrogen / carbon monoxide mixture in the presence of a suitable catalyst (e.g., cobalt or rhodium) to form an aldehyde which is hydrogenated in the presence of cobalt or nickel catalyst to form a polyol. Alternatively, natural oil and fat polyols can be produced by trans-esterification with a suitable poly-hydroxyl containing substance using an alkali metal or alkali earth metal base or salt as a transesterification catalyst. Natural oil or, alternatively, any partially hydrogenated oil can be utilized in the transesterification process. Examples of such oils include, but are not limited to, soybean oil, corn oil, cottonseed oil, peanut oil, castor oil, sunflower oil, canola oil, rapeseed oil, safflower oil, fish oil, seal oil, palm oil, tung oil, olive oil, and the like, and combinations thereof. Multifunctional hydroxyl compounds can also be utilized, such as lactose, maltose, raffinose, sucrose, sorbitol, xylitol, erythritol, mannitol, and the like, and combinations thereof.

[0117] Useful polyester polyols include those produced when a dicarboxylic acid is reacted with an excess of a diol. For example, adipic acid, phathalic acid, or phthalic anhydride can be reacted with ethylene glycol or butanediol to form a polyester polyol. Alternatively, a lactone can be reacted with an excess of diol, such as the reaction of caprolactone with propylene glycol, for example.

[0118] When making flexible polyurethane foam, carboxylic acids are normally added to the polyurethane formulation to inhibit the catalytic activity of the tertiary amine and prevent a relatively fast increase in viscosity, which can allow for a more efficient foam fabrication operation (e.g., mold-filling, particularly in cases where molds with complex shapes and geometries are needed). This approach allows for the filling of small cavities and voids, which can minimize the number of defective foam products. Acids most commonly used for this purpose are monoacids such as acetic acid, propionic acid, butanoic acid, hexanoic acid, 2-ethylhexanoic acid, and the like, and combinations thereof. Other acids commonly used in applications that require emission minimization can include carboxylic acids containing functional groups able to react with isocyanate to render the carboxylic acid immobilized in the polyurethane polymer. Examples of such acids include glycolic acid, gluconic acid or any other acids containing isocyanate reactive groups. In addition, carboxylic diacids, triacids and polyacids can also be utilized. Such acids include malonic, maleic, succinic, glutaric, adipic, pimelic, suberic, azelaic, sebacic, phthalic, isophthalic and therephthalic. Other suitable acids include those disclosed in U.S. Pat. Nos. 6,432,864 and 6,525,107 (which are hereby incorporated herein by reference in a manner that is consistent herewith) for the preparation of polyurethane foams. These acid-blocked amine catalysts are typically made by combining a tertiary amine with an acid prepared from an organic cyclic anhydride and a glycol. The amount of tertiary amine catalyst blocked with an acid can range from about 0.1 pphp to about 20 pphp of the thermoset foam formulation.

[0119] Suitable cell stabilizers (forming a portion or all of the surfactant component of the thermoset foam formulation) can include, but are not limited to, silicon surfactants, anionic surfactants, or a combination thereof. If desired, the cell stabilizer can be devoid of any acyl group and can include silicon surfactant, such as, polyalkylsiloxane, polyoxyalkylene polyol- modified dimethylpolysiloxane, alkylene glycol-modified dimethylpolysiloxane, or a combination thereof. For example, a silicon surfactant can include an acyl group. If desired, the cell stabilizer can be an anionic surfactant, such as a salt of a fatty acid, a salt of a sulfuric acid ester, a salt of a phosphoric acid ester, a salt of a sulfonic acid, or a combination thereof. For example, the thermoset foam formulation and / or the polyurethane composition can include cell stabilizers at a suitable predetermined amount, such as about 0.1 pphp to about 20 pphp of the thermoset foam formulation.

[0120] Suitable crosslinking agents (which can form a portion of, or all of, the crosslinking component) can include, but are not limited to, low-molecular weight compounds containing at least two moieties, such as hydroxyl groups, primary amino groups, secondary amino groups, other active hydrogen-containing groups that are reactive with an isocyanate group, or a combination thereof. For example, the crosslinking agent can be a polyhydric alcohol (e.g., a trihydric alcohol, such as, glycerol or trimethylolpropane), a polyamine, or a combination thereof. In one example having polyamine as the crosslinking agent, the crosslinking agent can be diethyltoluenediamine, chlorodiaminobenzene, diethanolamine, diisopropanolamine, triethanolamine, tripropanolamine, 1,6-hexanediamine, or a combination thereof. In another example having diamine as the crosslinking agent, the crosslinking agent can include twelve or fewer carbon atoms. In another example where the crosslinking agent(s) is blended, such as a low molecular weight crosslinker, the polyol component can build hardness and promote faster demolding. In another example, the amount and / or concentration of the crosslinking agent(s) can be increased or decreased, thereby respectively increasing or decreasing hardness. The amount of crosslinking agents typically ranges from about 0.10 pphp to about 20 pphp of the thermoset foam formulation.

[0121] The thermoset foam formulation can further include chain extenders, pigments, fillers, flame retardants, auxiliary urethane gelling catalysts, auxiliary urethane blowing catalysts (e.g., bis-dimethylaminoethyl ether) in addition to the blowing component (e.g., at about 0.12 pphp), transition metal catalysts, and the like, and combinations thereof. The thermoset foam formulation can also include further components that are added through any suitable procedures and / or at any suitable portion of the foam producing process, for example, as part of the thermoset foam formulation.

[0122] Suitable chain extenders include, but are not limited to, compounds having a hydroxyl or amino functional group, such as, glycols, amines, diols, water, or a combination thereof. For example, the chain extender can be ethylene glycol, diethylene glycol, propylene glycol, dipropylene glycol, 1,4-butanediol, 1,3-butanediol, 1,5-pentanediol, neopentyl glycol, 1,6-hexanediol, 1,10-decanediol, 1,12-dodecanediol, ethoxylated hydroquinone, 1,4-cyclohexanediol, N-methylethanolamine, N-methylisopropanolamine, 4-aminocyclohexanol, 1,2-diaminoethane, 2,4-toluenediamine, or a combination thereof. The amount of chain extenders typically ranges from about 0.10 pphp to about 20 pphp of the thermoset foam formulation.

[0123] Suitable pigments include, but are not limited to, organic pigments, inorganic pigments, or a combination thereof. The pigments permit coloring (e.g., to match a color grade), concealing (e.g., to conceal yellowing), or a combination thereof. In one example comprising an organic pigment, the pigment can be an azo / diazo dye, a phthalocyanine, dioxazine, carbon black, or a combination thereof. In another example comprising an inorganic pigment, the pigment can be titanium dioxide, iron oxide, chromium oxide, or a combination thereof. The amount of pigments typically ranges from about 0.01 pphp to about 20 pphp of the thermoset foam formulation.

[0124] Suitable fillers can increase the density and load bearing properties of polyurethane foams. For example, the filler can include barium sulfate, calcium carbonate, or a combination thereof. The amount of filler can typically range from about 0 pphp to about 20 pphp of the thermoset foam formulation. Suitable flame retardants can reduce the flammability of polyurethane foams. For example, the flame retardant can be a chlorinated phosphate ester, a chlorinated paraffin, a melamine powder, or a combination thereof. Accordingly, the thermoset foam formulation and / or a polyurethane composition can include a flame retardant at a suitable amount, such as about 0 pphp to about 20 pphp of the foam formulation.

[0125] The thermoset foam formulation also can also include an isocyanate component, which forms the backbone of the polyurethane composition. Preferably, the amount of the isocyanate component will be based upon an NCO index. The NCO index is the number of equivalents of the isocyanate, divided by the total number of equivalents of active hydrogen, multiplied by 100 (e.g., based upon an NCO index being [NCO / (OH+NH)]*100). Accordingly, the polyurethane composition can include the NCO index being within a predetermined range. For example, the predetermined range can between about 70 and about 500. In one example, the NCO index range can be between about 70 and about 115 to produce flexible foams.

[0126] The thermoset foam formulation can also include one or more blowing agents. A blowing agent component can forms cells in a polyurethane matrix by having low boiling points and being vaporized during the exothermic polymerization reaction. The blowing agent component can include any suitable blowing agent. Suitable blowing agents include, but are not limited to, carbon dioxide, chlorofluorocarbons, hydrogenated fluorocarbons, hydrogenated chlorofluorocarbons, fluoroolefins, chlorofluoroolefins, hydrofluoroolefins, hydrochlorofluoro olefins, acetone, low-boiling hydrocarbons (for example, cyclopentane, isopentane, n-pentane, or a combination thereof), or a combination thereof. Other suitable blowing agents include, but are not limited to, compounds that react with isocyanate compounds to produce a gas (e.g., water). Suitable blowing agents can also be inert such that they do not decompose or react during the polymerization reaction. Desirably, the thermoset foam formulation can include a blowing agent at a suitable amount. Suitable amounts include, but are not limited to, about 0 (water-blown) to about 80 pphp. In embodiments that are water-blown, the isocyanate component reacts, thereby forming carbon dioxide.

[0127] The isocyanate component can include any suitable organic isocyanate compound. Suitable organic isocyanate compounds include, but are not limited to, hexamethylene diisocyanate (HDI), phenylene diisocyanate (PDI), toluene diisocyanate (TDI), 4, 4'-diphenylmethane diisocyanate (MDI), isophoronediisocyanate (IPDI), and the like, and combinations thereof. For example, the isocyanate component can include 2,4-TDI, 2,6-TDI, or a combination thereof. In another example, the isocyanate component 17 can include MDI, such as, a mixture of about 60% 4,4'-MDI and / or a stoichiometric amount along with other isomeric and analogous higher polyisocyanates. Other suitable isocyanates includes those isocyanates shown and described in U.S. Pat. No. 4,394,491, which is hereby incorporated herein by reference in a manner that is consistent herewith.

[0128] A base polyol in the polyol component reacts with the isocyanate to produce the polyurethane composition. Suitable base polyols are shown and described in WO 03 / 016373 Al, WO 01 / 58976 Al, WO 04 / 060956 Al, WO 03 / 016372 Al, and WO 03 / 055930 Al, each of which are hereby incorporated herein by reference in a manner that is consistent herewith. Suitable base polyols include, but are not limited to, polyether polyols. For example, the polyether polyols can be poly(alkylene oxide) polymers, such as, polyethylene oxide), polypropylene oxide), and / or copolymers with terminal hydroxyl groups derived from polyhydric compounds (e.g., diols and triols). In example, the base polyol can be, or can include, triols having a molecular weight between about 4,500 and about 6,000 and / or diols having a molecular weight between about 2,000 and about 4,000. In one example, the diols and triols utilized can be ethylene glycol, propylene glycol, 1,3-butanediol, 1,4- butanediol, 1,6-hexanediol, neopentyl glycol, diethylene glycol, dipropylene glycol, pentaerythritol, glycerol, diglycerol, trimethylol propane, other suitable low molecular weight polyols, and the like, and combinations thereof. In another example, the base polyol can include polyhydroxy-terminated acetal resin, hydroxy-terminated amine, hydroxylterminated polyamine, and the like, and combinations thereof. In another example, the base polyol can be, or can include, polyalkylene carbonate-based polyols, phosphate-based polyols, and the like, and combinations thereof. The amount of polyol can typically range from about 20 pphp to about 100 pphp (one single polyol) of the thermoset foam formulation.

[0129] For example, the base polyol can be a single high molecular weight polyether polyol. In another example, the base polyol can be a mixture of high molecular weight polyether polyols, each having a different molecular weight or different chemical composition. In another example, the base polyol can include di-functional and tri-functional materials, such as, but not limited to, polyethylene glycol, polypropylene glycol, glycerol-based polyether triols, trimethylolpropane-based polyether triols, other similar ester-free compounds or mixtures, and the like, and combinations thereof. In another example, the base polyol can be end-capped with ethylene oxide (e.g., at greater than about 75% primary hydroxyl groups) with a capping range between about 10% and about 20%. In another example, the base polyol can include an ester-free polyol component at a concentration, by weight, of at least about 50%, wherein the ester-free polyol component includes one or more polyether polyols.

[0130] Additionally or alternatively, the polyol component can include copolymer polyols. The copolymer polyols can form, by weight, up to about 20% of the total polyol content (the total polyol content being based upon the amount of the base polyol, the copolymer polyol, and any other polyols in the polyurethane composition). The copolymer polyols improve polyurethane foam formed by the polyurethane composition of the thermoset foam formulation by increasing resistance to deformation of the polyurethane foam, thereby increasing load-bearing properties of a polyurethane foam. For example, the copolymer polyol can be, or can include a graft polyol, a polyurea-modified polyol, and the like, and combinations thereof.

[0131] A suitable graft polyol can be any suitable graft polyol. For example, the graft polyol can be prepared by copolymerizing vinyl monomers (for example, styrene and acrylonitrile) with a suitable starting polyol. In one example, the starting polyol can be, or can include, glycerol-initiated triol, end-capped with ethylene oxide (e.g., at about 80% to about 85% primary hydroxyl groups). In this example, the graft polyol can include copolymer grafted to the starting polyol, homopolymers of the vinyl monomers, and the starting polyol (unaltered). In another example, the graft polymer can include styrene or acrylonitrile at a concentration, by weight, between about 5% and about 45%.

[0132] A suitable polyurea-modified polyol can be formed by the reaction of a diamine and a diisocyanate in the presence of the starting polyol. In this embodiment, the polyurea- odified polyol includes polyurea dispersion. Such polyurea modified-polyol can be, or can include, polyisocyanate poly addition (PIPA) polyols, for example, formed in-situ from a reaction of the isocyanate and an alkanolamine in the starting polyol.

[0133] Once the thermoset foam formulation has been prepared, the constituents can be blended for a predetermined duration with a predetermined mixer (e.g., a mechanical mixer), at a predetermined blade rotation speed (e.g., about 6000 revolutions per minute), for a predetermined amount of time, such as at least about 10 second, or at least about 30 seconds, or at least about 60 seconds, or more.

[0134] The process continues, such as with the blended polyurethane composition being poured, for example, by pouring it into a pre-heated mold. In such example, the pre-heated mold can be at a predetermined temperature (e.g., about 55° C to about 70° C), and the polyurethane composition can remain in the pre-heated mold for a predetermined duration (e.g., at least about 4 minutes).

[0135] The process continues, such as with the polyurethane composition being cured. Among other things, curing of the polyurethane composition will be dependent upon the components of the thermoset foam formulation, and any catalyst composition.

[0136] The process can then end with the cured polyurethane composition being removed from the pre-heated mold as a flexible foam member 110, or can be cut to desired dimensions to form the foam member 110.

[0137] By way of a non-limiting example only, another suitable foam for the foam member 110 can include an elastomeric thermoplastic foam. In general, a foam having a low density and low bending modulus can provide enhanced softness and flexibility. A thermoplastic elastomer can also be added to enhance softness, flexibility and elasticity. In addition, a foam can be formulated and processed to exhibit a higher or lower compression set, as may be desired (such as to provide greater support, or to relieve pressure points, for example).

[0138] A thermoplastic foam can also have desirable basis weights and / or densities. For example, the foam can have a density in the range of about 0.01 g / cc to about 0.5 g / cc or greater. Furthermore, densification of the foam at some point after the formation process can be employed to enhance functionality for specific applications.

[0139] A non-limiting exemplary thermoplastic foam which can form the foam member 110 can be made of at least one polymer that can be heated, formed and cooled repeatedly. The starting material used in the thermoplastic foam formulation can include at least one suitable base resin which could include a single thermoplastic polymer, a blend of thermoplastic polymers, or a blend of thermoplastic and non-thermoplastic polymers. Examples of base resins suitable for use in the thermoplastic foam formulation include styrene polymers, such as polystyrene or polystyrene copolymers or other alkenyl aromatic polymers, polyolefins including homo or copolymers of olefins, such as polyethylene, polypropylene, polybutylene, etc., polyesters, such as polyalkylene terephthalate, and combinations thereof. For example, in some aspects, a suitable base resin includes STYRON 685D polystyrene resin available from Dow Chemical Company, having a place of business located in Freeport, Texas, USA.

[0140] Coagents and compatibilizers can also be utilized for blending such resins. Additionally, crosslinking agents can also be employed to enhance mechanical properties, foamability, and expansion. Such crosslinking may be accomplished by utilizing several means, including the use of electron beams or by chemical crosslinking agents such as organic peroxides.

[0141] It is suitable to utilize base resins which provide effective foamability, softness and flexibility. In general, resins having branched polymer chains tend to be more foamable. As such, flexibility, softness, and foamability can be manipulated by utilizing several means, including the use of polymer side groups, the incorporation of chains within the polymer structure to prevent polymer crystallization, the lowering of the glass transition temperature, the lowering of a given polymer's molecular weight distribution, the adjusting of melt flow strength and viscous / elastic properties including elongational viscosity of the polymer melt, the use of block copolymerization, the blending of polymers, the use of polyolefin homopolymers and copolymers including low (such as linear low), medium and high-density polyethylene and polypropylene which are normally made using Ziegler-Natta or Phillips catalysts and are relatively linear as well as those that can be engineered with elastic and crystalline areas, the use of syndiotactic, atactic and isotactic polypropylenes including those made using metallocene-based catalysts as well as blends of such and other polymers, and the use of olefin elastomers.

[0142] In some applications, it is suitable to utilize resins which provide foam composites that are soft and / or extensibly elastic. Softness and extensibility can be manipulated using several means, including the use of ethylene and a-olefin copolymers, particularly those made using either Ziegler-Natta or a metallocene catalyst such as metallocene catalyzed polyolefins, the use of polyethylene cross-linked with a-olefins and various ethylene ionomer resins, and the use of ethyl-vinyl acetate copolymers with other polyolefin-type resins.

[0143] Common modifiers for various polymers can also be reacted with chain groups to obtain suitable functionality. This includes the use of alkenyl aromatic polymers and ionomer resins. Suitable alkenyl aromatic polymers include alkenyl aromatic homopolymers and copolymers of alkenyl aromatic compounds and copolymerizable ethylenica I ly unsaturated comonomers including minor proportions of non-alkenyl aromatic polymers and blends thereof.

[0144] Thermoplastic base resins could also contain blends of other polymers with the thermoplastic polymers, such as natural and synthetic organic polymers including cellulosic polymers, methyl cellulose, polylactic acids, polyvinyl acids, polyacrylates, polycarbonates, starch-based polymers, polyetherimides, polyamides, polymethylmethacrylates, and copolymer / polymer blends.

[0145] In some preferred aspects, the thermoplastic foam formulation could include a polyurethane base resin, such as hydrophilic urethane prepolymer. Examples of suitable hydrophilic urethane prepolymers include isocyanate terminated or capped polyoxyalkylene ethers including polyoxyethylene polyol prepolymers. Other examples of suitable prepolymers are described in US Patent No. 4,137,200 to Woods et al., US Patent No. 4,209,605 to Hoy et al., US Patent No. 2,993,013 to Wolfe, Jr., and U.S. Patent No. 3,805,532 to Kistner, each of which is incorporated herein by reference in a manner that is consistent herewith. General procedures for the preparation of such prepolymers are described by J. H. Saunders and X. C. Frisch in Polyurethanes Chemistry and Technology, Interscience Publishers, John Wiley & Sons, New York, Vol. XVI, Part 2, High Polymer Series, published in 1987, "Foam Systems" pages 7-26, and "Procedures for the Preparation of Prepolymers" pages 26 et seq., each of which is incorporated herein by reference in a manner that is consistent herewith.

[0146] In some aspects, the thermoplastic foam formulation can comprise toluene diisocyanate (TDI) base resin that is terminated with polyethylene polyol, such as with less than 6% of the available unreacted NCO groups and a component functionality of 2 or less, such as TREPOL available from Rynel Ltd., Inc., having a place of business located in Boothbay, Maine, USA. In other aspects, the base resin can include HYPOL 2000 / 3000 grade prepolymers, available from Dow Chemical Co. which are water-activated polymeric liquid polyurethanes based on TDI. In general, a hydrophilic prepolymer is activated by the aqueous phase for polymerization upon mixing.

[0147] In addition to the base resin polymers discussed above, the thermoplastic foam formulation can also include at least one thermoplastic elastomer. For example, in some aspects, the thermoplastic foam formulation can comprise up to about 95-percent base resin by weight of the foam formulation (wt%), such as about 50 wt% to about 95 wt%, or about 50 wt% to about 80 wt% base resin and at least about 5 wt% thermoplastic elastomer, such as about 5 wt% to about 50 wt%, or about 20 wt% to about 50 wt% thermoplastic elastomer. In some aspects, the thermoplastic foam formulation can comprise substantially equal amounts of base resin and thermoplastic elastomer.

[0148] Suitable thermoplastic elastomers include, but are not limited to, rubbers, including natural rubber, styrene-butadiene rubber (SBR), polybutadiene, ethylene propylene terpolymers, and vulcanized rubbers including TPVs, rubber-modified polymers such as styrene elastomers, ethylene elastomers, butadiene, polybutylene resins, diblock, triblock, tetrablock, or other multi-block thermoplastic elastomeric and / or flexible copolymers such as polyolefin-based thermoplastic elastomers including random block copolymers including ethylene a-olefin copolymers, block copolymers including hydrogenated butadiene- isoprene-butadiene block copolymers, stereoblock polypropylenes, graft copolymers including ethylene-propylene-diene terpolymer or ethylene-propylene-diene monomer (EPDM), ethylene-propylene random copolymers (EPM), ethylene propylene rubbers (EPR), ethylene vinyl acetate (EVA), and ethylene-methyl acrylate (EMA), and styrenic block copolymers including diblock and triblock copolymers such as styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene-butadiene-styrene (SIBS), styrene- ethylene / butylene-styrene (SEBS), or styrene-ethylene / propylene-styrene (SEPS). For example, the thermoplastic foam formulation can utilize KRATON, a thermoplastic elastomer available from Kraton Polymers, having a place of business located in Houston, Texas, U.S.A. In another example, the thermoplastic foam formulation can utilize VECTOR SIS and SBS thermoplastic elastomer available from Dexco, a division of ExxonMobil Chemical Company, having a place of business located in Houston, Texas, U.S.A. In still another example, the thermoplastic foam formulation can utilize SEPTON SEBS thermoplastic elastomer available from Kuraray America, Inc., having a place of business located in New York City, New York, U.S.A.

[0149] Additional suitable thermoplastic elastomers can include blends of thermoplastic elastomers with dynamic vulcanized elastomer-thermoplastic blends, thermoplastic polyether ester elastomers, ionomeric thermoplastic elastomers, thermoplastic elastic polyurethanes such as LYCRA polyurethane available from E. I. Du Pont de Nemours, having a place of business located in Wilmington, Delaware, U.S.A., and ESTANE available from Noveon, Inc., having a place of business located in Cleveland, Ohio, U.S.A., thermoplastic elastic polyamides, including polyether block amides such as PEBAX polyether block amide available from Atofina Chemicals, Inc., having a place of business located in Philadelphia, Pennsylvania, U.S.A., thermoplastic elastic polyesters such as HYTREL available from E. I. Du Pont de Nemours Company, and ARNITEL available from DSM Engineering Plastics, having a place of business located in Evansville, Indiana, U.S.A., and single-site or metallocene- cata lyzed polyolefins having a density of less than about 0.89 grams / cubic centimeter such as AFFINITY metallocene polyethylene resins available from Dow Chemical Company, and combinations thereof.

[0150] As used herein, a tri-block copolymer has an ABA structure where the A represents several repeat units of type A, and B represents several repeat units of type B. As mentioned above, several examples of styrenic block copolymers are SBS, SIS, SIBS, SEBS, and SEPS. In these copolymers, the A blocks are polystyrene and the B blocks are the rubbery component. Generally, these triblock copolymers have molecular weights that can vary from the low thousands to hundreds of thousands and the styrene content can range from 5% to 75% based on the weight of the triblock copolymer. A diblock copolymer is similar to the triblock but is of an AB structure. Suitable diblocks include styrene-isoprene diblocks, which have a molecular weight of approximately one-half of the triblock molecular weight and having the same ratio of A blocks to B blocks. Diblocks with a different ratio of A to B blocks or a molecular weight larger or greater than one-half of triblock copolymers may be suitable for improving the thermoplastic foam formulation for producing low-density, soft, flexible, and absorbent foam utilizing polymer extrusion.

[0151] In some aspects, it may be particularly beneficial to include a thermoplastic elastomer having a high diblock content and high molecular weight as part of the thermoplastic foam formulation to extrude a low-density, soft, flexible, resilient, and absorbent thermoplastic foam. For example, the thermoplastic elastomer may have a diblock content between about 50 wt% and about 80 wt% of the total thermoplastic elastomer weight.

[0152] KRATON thermoplastic elastomers can function as a discontinuous phase in styrenic- based foams and further function as cell-opener generators when used in small amounts. However, in larger amounts, the cell-opener effect may be somewhat secondary compared to the resiliency, flexibility, elasticity, absorbency and softness imparted. The thermoplastic foam formulation can also include blowing agents to aid in the foaming process and to help form a foamable melt. Blowing agents are compounds that decompose at extrusion temperatures to release large volumes of gas, volatile liquids such as refrigerants and hydrocarbons, ambient gases such as nitrogen and carbon dioxide, water, and the like, and combinations thereof. Both physical and chemical blowing agents, including both inorganic and organic physical blowing agents, can be used to create or enhance foaming.

[0153] Suitable inorganic physical blowing agents include water, nitrogen, carbon dioxide, air, argon, and helium. Suitable organic blowing agents include hydrocarbons such as methane, ethane, propane, butanes, pentanes, hexanes, and the like. Aliphatic alcohols and halogenated hydrocarbons including various Freon and fluorocarbons such R-134A can also be used (although their use may be avoided for environmental reasons). Endothermic and exothermic chemical blowing agents which are typically added at the extruder hopper include azodicarbonamide, paratoluene sulfonyl hydrazide, azodiisobutyro-nitrile, benzene sulfonyl hydrazide, P-toluene sulfonyl hydrazide, barium azodicarboxylate, sodium bicarbonate, sodium carbonate, ammonium carbonate, citric acid, toluene sulfonyl semicarbazide, dinitroso-pentamethylene-tetramine, phenyltetrazole sodium borohydride, and the like.

[0154] In addition, mixtures and combinations of various physical and chemical blowing agents can be used to control cell structure. Blowing agent activators can also be added to lower the decomposition temperature / profile of such chemical blowing agents. Such blowing agent activators include metals in the form of salts, oxides, or organometallic complexes.

[0155] Blowing agents can be added directly to the thermoplastic foam formulation or, alternatively, can be added after the melt has been heated to a temperature at or above its glass transition temperature or melting temperature. The inlet for a blowing agent, such as in an extrusion process (not shown), is typically between the metering and mixing zones. The blowing agent is then mixed thoroughly with the melted polymer at a sufficiently elevated pressure to prevent melt expansion. For example, a blowing agent can be added to the thermoplastic foam formulation in an amount between about 1 wt% and about 10 wt%.

[0156] Other additives can also be included in the thermoplastic foam formulation to enhance various properties. For example, a nucleating agent, or nucleant, can be utilized to improve foam gas bubble formation and to obtain desired fine open-cell structure. Examples of suitable nucleants include talc, magnesium carbonate, nanoclay, silica, calcium carbonate, blends of citric acid and sodium bicarbonate, coated citric acid / sodium bicarbonate particles, silica, barium stearate, diatomaceous earth, titanium dioxide, pulverized wood, clay, calcium stearate, stearic acid, salicylic acid, fatty acids, metal oxides, modified nucleant complexes, and combinations thereof. An example of a commercially available nucleant is a nanoclay available under the trade name CLOISITE® 20A, available from Southern Clay Products, Inc., having a place of business located in Gonzales, Texas, U.S.A. Various thermoplastic polymers may also be used for such purposes.

[0157] Nucleants are typically dry blended or added with the polymer concentrate. The amount of nucleant will vary based upon several parameters, including the cell structure desired, foaming temperature, pressure, polymer composition, and type of nucleating agent utilized. For example, a nucleant can be added to the thermoplastic foam formulation in an amount between about 0.1 wt% and about 5 wt%. Typically, as the amount of nucleant increases, the cell density likewise increases.

[0158] Still other additives that can be utilized include surface active agents (i.e., surfactants). Surfactants may be utilized to control properties such as surface tension, foam formation, and wettability.

[0159] In general, while forming the foam composite, the bubble walls may tend to drain due to factors such as gravity and capillary forces. Such drainage often thins the walls before the cell struts, or ribs, are sufficiently hardened, which in turn can result in cell collapse. La Place and Young proposed that capillary pressure at the junction of two or more struts tends to be lower, thereby creating flow from the membrane to the struts and, consequently, thinning the cell membrane. With a sufficient amount of surfactant molecules arranged preferentially to migrate to the surface of the film membrane, the presence of surfactant at the membrane's thin film surfaces may provide resistance to drainage of the molten plastic. If the film layer is sufficiently thick, such as in a foam cell membrane, it can be further stabilized by an ionic double layer of molecules resulting from orientation of ionic surfactants. Both nonionic and ionic surfactants can exhibit another stabilizing force if the membrane is sufficiently thin. This can be accomplished through alignment of surfactant tails to create a bi-layer structure, such as that found in biological cells, which are held together by Van der Waals forces, thus stabilizing the foam cell membrane. Further discussion can be found in Polymeric Foams, edited by Daniel Klempner and Kurt Frisch, Hanser Publishers, 1991, Foam Extrusion, edited by S. T. Lee, Technomic Publishing Co., Inc., 2000, Polymeric Foams, edited by S.T. Lee and N.S. Ramesh, CRC Press, 2004, and Polymeric Foams and Foam Technology, 2nd Edition, edited by Daniel Klempner and Vahid Sendijarevic, 2004, each of which is incorporated herein by reference in a manner that is consistent herewith.

[0160] While not intending to be limited to a particular theory, it is believed that a surfactant also provides resistance to diffusion of gas from a foam cell to the surroundings, which aids in resisting collapse. The reduced gas permeability due to the drainage resistance is related to the degree that a surfactant can pack into a foam cell's film surface and might explain the difference between the performances of the various surfactants. This reduced rate of diffusion allows sufficient cooling for strut formation to prevent coalescence. The surfactant does not necessarily need to completely prevent drainage, but rather can slow it sufficiently so that cell struts are substantially cooled and hardened, thereby preventing cell coalescence. In general, surfactants which tend to be highly mobile in the melt, highly surface active, and / or can pack tightly to help prevent membrane drainage will typically provide superior cell stabilization.

[0161] Suitable surfactants for the absorbent composite can be single-component or multi-component surfactants. A multi-component surfactant is a combination of two or more surfactants. It has been found that certain multi-component surfactants can achieve equal or better foam formation at a lower dosage than certain single-component surfactants. For example, in some aspects, foams utilizing a multi-component surfactant have densities comparable to foams made with over three times the amount of a singlecomponent surfactant. Since surfactant tends to be a costly additive, the use of certain multi-component surfactants can result in foam composites having comparable foam properties at a lower cost than foams which include higher amounts of single-component surfactant.

[0162] Surfactants can be added at various locations in the foam-making process, such as directly in the thermoplastic foam formulation, in the composition during the foaming process, and / or as a post-treatment after formation of the foam composite. For example, a surfactant can be added to the thermoplastic foam formulation in a gaseous phase, such as through the use of a blowing agent (e.g., supercritical carbon dioxide). Examples of suitable surfactants include cationic, anionic (including alkylsulfonates), amphoteric, and nonionic surfactants. Exemplary surfactants include SCHERCOPOLTM OMS- NA, a disodium momooleamido MEA sulfosuccinate, available from Scher Chemicals, Inc., having a place of business located in Clifton, New Jersey, U.S.A., and PLURONIC F68, a polypropylene glycol non-ionic surfactant which is a block copolymer of propylene oxide and ethylene oxide, available from BASF Corporation. Other examples include HOSTASTAT HS-1, available from Clariant Corporation, having a place of business located in Winchester, Virginia, U.S.A., EMEREST 2650, EMEREST 2648, and EMEREST 3712, each available from Cognis Corporation, having a place of business located in Cincinnati, Ohio, U.S.A., and DOW CORNING 193, available from Dow Corning Corporation, having a place of business located in Midland, Michigan, U.S.A. Alkyl sulfonates can also be suitable as a surfactant, although use of this class of surfactants in certain applications may be limited because of product safety concerns. However, some combinations of surfactants offer benefits where an alkyl sulfonate is added at a substantially lower level in conjunction with another surfactant to yield good foaming and wettability.

[0163] The amount of surfactant utilized will vary depending upon the particular surfactant, as well as the properties desired. For example, the surfactant can be utilized in the thermoplastic foam formulation in an amount between about 0.05 wt% and about 10 wt%, such as between about 0.1 wt% and about 5 wt%. In one particular example, the surfactant can be a multi-component surfactant utilized in the thermoplastic foam formulation in an amount between about 0.05 wt% and about 8.0 wt%, such as between about 0.1 wt% and about 3.0 wt%.

[0164] Various other additives such as lubricants, acid scavengers, stabilizers, colorants, adhesive promoters, fillers, smart-chemicals, foam regulators, various UV / infrared radiation stabilizing agents, antioxidants, flame retardants, smoke suppressants, anti-shrinking agents, thermal stabilizers, rubbers (including thermosets), anti-statics, permeability modifiers, and other processing and extrusion aids including mold release agents, antiblocking agents, and the like can also be added to the thermoplastic foam formulation.

[0165] Still other additives that can be utilized include cellulosic fibers (e.g., wood fibers) and / or superabsorbents to enhance bodily fluid (e.g., water, blood, etc.) absorption.

[0166] In one non-limiting exemplary embodiment, the foam can comprise a thermoplastic foam derived from a thermoplastic foam formulation comprising about 50 wt% to about 95 wt% alkenyl aromatic base resin, about 10 wt% to about 50 wt% thermoplastic elastomer which has a styrenic block copolymer content of about 50 wt% to about 80 wt% of the elastomer, about 0.05 wt% to about 10 wt% surfactant, and about 0 wt% and about 10 wt% blowing agent.

[0167] Once the desired ingredients of the thermoplastic foam formulation have been determined, the materials can be added together and prepared to be formed in a foammaking process, including those foam-making processes known by persons having ordinary skill in the art. For example, various continuous plastic extrusion processes known in the art can be utilized to produce the foam. Other suitable foam-making processes known in the art include injection molding, batch processes, and air-forming processes.

[0168] In general, the materials can be heated such that the materials form a molten foam melt, at which time the materials can form a substantially homogeneous mixture. In some aspects, the materials are suitably heated to a temperature between about 100 °C and about 500 °C to create the foam melt. Such foam melt can then be foamed to create cells within the melt using suitable foaming techniques known to persons having ordinary skill in the art. Once formed, the foam melt can then be processed, such as with an extrusion process, and cooled to form a foam member 110.

[0169] In some aspects, continuous plastic extrusion processes known in the art can be utilized to produce a foam member 110. In the case of such extrusion processes, a tandem screw-type extruder can be utilized. This type of extruder may be considered particularly suitable in some aspects because it has the ability to provide tight control of extrusion temperatures to produce open-cell foams. With tandem extruders, the first extruder section typically contains several zones including: feed and conveying, compression, melting, metering and mixing zones and the second extruder section often contains a cooling zone and a shaping zone prior to the discharge. The first extruder is typically hopper loaded with the base resin(s) and thermoplastic elastomer(s), as well as any other optional additives. Techniques known in the art for accomplishing this include using dry / blend / metering equipment and / or having the components incorporated into a pelletized polymer concentrate such as in a master batch. The components of the thermoplastic foam formulation are then heated in the extruder to form a plasticized or melt polymer system, often with zoned temperature control using an extruder's cooling / heating systems. The foamable melt is then typically cooled to a lower temperature to control the desired foam cell structure. In the case of tandem extruders, the cooling is typically accomplished in the second extruder which is connected downstream of the first extruder through a heated cross-over supply pipe. In the case of single extruders, cooling is typically accomplished upstream of the discharge orifice. Often cooling / heating systems with process temperature control loops are incorporated to tightly control foam bubble nucleation / growth within the gas-laden melt. The optimum cooling temperature is typically at or slightly above the glass transition temperature or melting point of the melt.

[0170] The melt is then extruded through a die to a lower pressure (typically atmospheric or a vacuum) to cause thermodynamic instability and foaming which then cools and crystallizes the plastic to form a stabilized foam which then solidifies to form a web or layer. Often circular, annular or slit dies, including curtain dies, and the like are used, often with a mandrel, to shape and draw the web to the desired gauge, shape and orientation with foam expansion and cooling.

[0171] Various equipment configurations using such extrusion can be used to manufacture a foam member 110 of the present invention. In addition, various specialized equipment can be employed upstream of specially designed dies to enhance mixing, cooling, cellular structure, metering, and foaming. Such equipment includes static mixers, gear pumps, and various extruder screw designs, for example. Stretching equipment, including roller nips, tenters, and belts, may also be used immediately downstream of the discharge to elongate cellular shape to enhance absorbency. Microwave irradiation for cross-linking, foaming activation, and mechanical means can also be used to enhance foam properties. Foam contouring, shaping (e.g. patterning, perforating, etc.) and the like, using thermoforming, and other such thermal processes, including thermal bonding, can be used to control shaping, flexibility, softness, aesthetics, and absorbent swelling.

[0172] Open-cell formation can be regulated by elevated processing pressures and / or temperatures, as well as by using additives such as nucleating agents, chemical blowing agents, and low additions of immiscible polymers, and / or surfactants which can control both cell density and cell structure. Particular base resins are also sometimes used to broaden the foaming temperature to make open-cell foam. For example, the open-cell level of a polystyrenic-based foam can be facilitated by adding small amounts of various immiscible polymers to the thermoplastic foam formulation, such as by adding polyethylene or ethylene / vinyl acetate copolymer, to create interphase domains that cause cell wall rupture. In another example, ethylene-styrene interpolymers can be added to alkenyl aromatic polymers to control open-cell quality and improve surface quality and processability. In still another example, small amounts of polystyrene-based polymers can be added to polyolefin-based foams to increase open-cell content. The open-cell content and microporous cell membrane uniformity can also be controlled by regulating the polymer system components and crystallization initiating temperature.

[0173] In addition to those discussed above, other suitable foams may also be available commercially. For example, foams which retain bulk thickness after hydraulic needling (i.e., resilient foams) include RYNEL 562-B medical grade polyurethane and RYNEL 562-D medical grade polyurethane, both available from Rynel Ltd., Inc., a division of Mblnlycke Health Care AB, having a place of business located in Gothenburg, Sweden. Other suitable foam layers include MINICELL STD crossed-linked polyethylene, available from Voltek, a division of Sekisui America Corporation, having a place of business located in Lawrence, Massachusetts, U.S.A., latex foams such as those described in US Patent No. 6,627,670 to Mork et al., which is incorporated herein by reference in a manner that is consistent herewith, High Internal Phase Emulsion (HIPE) foams such as those described in US Patent No. 5,260,345 to DesMarais et al., which is incorporated herein by reference in a manner that is consistent herewith, and extruded thermoplastic foams such as those described in US Patent No. 7,358,282 to Krueger et al. and US Patent No. 6,071,580 to Bland et al., each of which is incorporated herein by reference in a manner that is consistent herewith.

[0174] In addition to the above, secondary post-treatment processes can be performed to provide or enhance desirable properties including, inter alia, perforating, softening, flexibility, absorbency, cellular orientation, aesthetics, and the like. This can be accomplished through numerous techniques known in the art including mechanical needling and other mechanical perforation, stretching and drawing, calendaring or creping, brushing, scarfing, buffing / sanding, and thermoforming / shaping. Often a foam surface skin may form during extrusion, which can later be skived or sliced off, needle-punched, brushed, scraped, buffed, scarved, sanded, or perforated to remove the barrier, or portions thereof. Mechanical, hydraulic, thermal, or laser perforation can also be utilized. Mechanical, laser, and / or hydraulic micro-serrations can also be employed (e.g., to enhance permeability). In addition, application of a surfactant after the foaming process or needling process may further be utilized to afford a desired wettability.

[0175] Processes can be utilized for making open-cell foams, low-density foams, absorbent foams, and soft, resilient, elastomeric foams. Some examples of such processes are described in US Patent No. 5,962,545 to Chaudhary et al., US Patent No. 5,728,406 to Halberstadt et al., and US Patent No. 6,451,865 to Migchels et al., each of which is incorporated herein by reference in a manner that is consistent herewith.

[0176] Plasticizing agents are sometimes used as cell openers in producing foams. When used as cell openers, such plasticizing agents are added to the thermoplastic foam formulation in minor amounts, such as described in U.S. Patent No. 6,071,580 to Bland et al., which is incorporated herein by reference in a manner that is consistent herewith. More particularly, the plasticizing agent can act to increase cell expansion to produce a high expansion ratio. When cells expand, membranes between cells thin and can become unstable, rupture, and can thereby create porous connections between cells. In addition, when thermoplastic polymer cools and with volumetric contraction with crystallization, thin portions of the membrane can rupture enough to create additional connections or pores between cells, thereby creating open cells.

[0177] Although plasticizing agents act as softeners, the addition of plasticizing agents makes foaming to low densities more difficult. For example, in a high density, essentially closed-cell, non-absorbing foam containing a plasticizing agent and thermoplastic elastomer and an additive such as a surfactant, plasticizing agents can lower polymer melt viscosities and lead to increasing melt drainage which causes foaming difficulties with cell collapse, such as described in U.S. Patent No. 6,653,360 to Gupta, which is incorporated herein by reference in a manner that is consistent herewith.

[0178] There is a wide range of plasticizing agents available. The desired properties for selecting a plasticizing agent includes not only its softening ability, but also temperature stability upon extrusion, resistance to migration, cost, odor, biodegradability, and manufacturing and consumer safety. Typical plasticizing agents include citrates, phthalates, stearates, fats and oils. It is known that glycerol fatty acids, such as glycerol monostearate, stabilize cells by reducing the rate of gas diffusion from the cell.

[0179] Accordingly, in some aspects, a plasticizing agent can be included in the thermoplastic foam formulation. A plasticizing agent is a chemical agent that imparts flexibility, stretchability and workability. The type of plasticizing agent has an influence on foam gel properties, blowing agent migration resistance, cellular structure, including fine cell size and number of open cells. Typically, desirable plasticizing agents are of low molecular weight (e.g., less than 1,000). The increase in polymer chain mobility and free volume caused by incorporation of a plasticizing agent typically results in a Tgdecrease, and plasticizing agent effectiveness is often characterized by this measurement. Petroleumbased oils, fatty acids, and esters are commonly used and act as external plasticizing agents or solvents because they do not chemically bond to the polymer, yet remain intact in the polymer matrix upon crystallization.

[0180] The plasticizing agent increases cell connectivity by thinning membranes between cells to the point of creating porous connections between cells, thus the plasticizing agent increases open-cell content. If desired, a plasticizing agent can be included in the thermoplastic foam formulation in an amount of about 0.5 wt% to about 10 wt%, such as about 1 wt% and about 10 wt%. Such plasticizing agent should be gradually and carefully metered in increasing concentration into the thermoplastic foam formulation during the foaming process as too much plasticizing agent added at once can create cellular instability, resulting in cellular collapse.

[0181] Other examples of suitable plasticizing agents can include polyethylene, ethylene vinyl acetate, mineral oil, palm oil, waxes, esters based on alcohols and organic acids, naphthalene oil, paraffin oil, and combinations thereof. A commercially available plasticizing agent is a small-chain polyethylene that is produced as a catalytic polymerization of ethylene, which is often referred to in the art as a "wax" because of its low molecular weight. An example of such low-density, highly branched polyethylene "wax" is EPOLENE C- 10 available from Eastman Chemical Company, having a place of business located in Kingsport, Tennessee, U.S.A.

[0182] Still other examples of plasticizing agents include acetyl tributyl citrate, acetyl triethyl citrate, p-tert-butylphenyl salicylate, butyl stearate, butylphthalyl butyl glycolate, dibutyl sebacate, di-(2-ethylhexyl) phthalate, diethyl phthalate, diisobutyl adipate, diisooctyl phthalate, diphenyl-2-ethylhexyl phosphate, epoxidized soybean oil, ethylphthalyl ethyl glycolate, glycerol monooleate, monoisopropyl citrate, mono-, di-, and tristearyl citrate, triacetin (glycerol triacetate), triethyl citrate, and 3-(2-xenoyl)-l,2-epoxypropane. Continuing with Figs. 1A-1C, as referenced above, the inventive adhesive body securing device 100 also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 111 of the foam member 110 (and thus upon the first side 101 of the adhesive body securing device 100 ). The purpose of the first releasably-adhesive component 130 is to attach a patient to the adhesive body securing device 100, such as 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 securing device 100 to keep a patient secured to the adhesive body securing device 100 during a medical procedure and to substantially withstand reasonable forces exerted by a patient's body during a medical procedure, but which also allows a medical provider to release the patient from the adhesive body securing device 100 thereafter without injuring the patient and without damaging the integrity of the device 100. It should be appreciated that a medical provider could choose to invert the adhesive body securing device 100 of this aspect without departing from the scope of the invention, in which case the purpose of the first releasably-adhesive component 130 would attach the adhesive body securing device 100 to a medical furnishing rather than being attached to a patient, although that is not the intended preferred use of the inventive adhesive body securing device 100 of this embodiment.

[0183] In this embodiment, the first releasably-adhesive component 130 will preferably comprise an adhesiveness that is sufficient for the adhesive body securing device 100 to restrict movement of a patient's body disposed upon the device 100 during a medical procedure, such as to eliminate the need for conventional securing devices, such as straps, belts, harnesses, braces or other external securing devices.

[0184] Virtually any suitable releasably-adhesive component can be utilized upon the first side 101 of the inventive adhesive body securing device 100. Several non-limiting exemplary adhesives suitable for use as a first releasably-adhesive component 130 are discussed below. For example, a polyurethane-based releasably-adhesive polymer (e.g., a polyurethane-based viscoelastomeric releasably-adhesive thermoset 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 (i.e., adhesion, tackiness, etc.) of the first releasably-adhesive component 130 will at least somewhat depend on the properties of the particular adhesive body securing device 100 and its intended use; however, the adhesiveness will typically range from about 0.3 seconds per inch (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.

[0185] 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 is 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 111 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 (as measured by the Cohesiveness Test upon a patient upon removal of the adhesive body securing 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 securing device 100 from a from a patient. 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 patient. In some preferred aspects, the first releasably-adhesive component 130 (and the adhesive body securing device 100 ) can be intentionally detached and reattached to the patient 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.

[0186] The first releasably-adhesive component 130 can be applied to the first side 111 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 111 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.

[0187] 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, each of which is briefly discussed below. 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. Continuing with the embodiment of Figs. 1A-1C, 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 111 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.

[0188] Continuing with the embodiment of Figs. 1A-1C, in some aspects, an optional grid element (not shown) can be disposed between the first-releasably-adhesive component 130 and the first side 111 of the foam member 110, or upon the second side 112 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.

[0189] Referring now to Figs. 2A-2C, a further embodiment of the inventive adhesive body securing device 100 of the present disclosure is shown. The adhesive body securing device 100 has a major first side 101 and an opposing major second side 102 distal to the first side 111.

[0190] The adhesive body securing device 100 comprises a foam member 110 having a major first side 111 (which corresponds to the first side 101 of the adhesive body securing device 100) and an opposing major second side 112 (which corresponds to the second side 102 of the adhesive body securing device 100) distal to the first side 111. Accordingly, the foam member 110 generally defines the shape and dimensions of the adhesive body securing device 100. The adhesive body securing device 100 of this embodiment also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 111 of the foam member 110, wherein the first side 111 of the foam member 110 is intended to face towards a patient during use, such that the patient's body contacts and becomes attached to the adhesive body securing device 100 via the first releasably-adhesive component 130. The adhesive body securing device 100 of this embodiment further comprises a second releasably-adhesive component 150 disposed upon at least a portion of the second side 112 of the foam member 110, wherein the second side 112 of the foam member 110 is intended to face towards a medical furnishing when in use, such that the adhesive body securing device 100 contacts and becomes attached to the medical furnishing via the second releasably-adhesive component 150, without the need for conventional securing devices.

[0191] Procedurally, the inventive adhesive body securing device 100 of this embodiment is positioned / aligned upon a medical furnishing at a desired location such that the second 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 second releasably-adhesive component 150 is generally in contact with (and thus adheres to) the medical furnishing. Then, a patient is disposed upon the first side 101 of the inventive adhesive body securing device 100 such that the first releasably-adhesive component 130 is generally in contact with (and thus adheres to) the patient, thus attaching the patient's entire body, or portion thereof (e.g., the patient's torso), to the adhesive body securing device 100. Upon completion of a desired medical procedure, the patient can be removed from the adhesive body securing device 100 by exerting a removal force sufficient to overcome the adhesive force of the first releasably-adhesive component 130, and then the adhesive body securing device 100 can be removed from the medical furnishing by exerting a removal force sufficient to overcome the adhesive force of the second releasably-adhesive component 150. In some preferred embodiments, this can all be accomplished while maintaining a sterile field. Afterwards, the adhesive body securing device 100 can be disposed of, or can be cleaned and sterilized for further use.

[0192] As referenced above, the inventive adhesive body securing device 100 of this embodiment as shown in Figs. 2A-2C 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 embodiment of Figs. 1A-1C, wherein such description is hereby incorporated herein by reference in its entirety in a manner that is consistent herewith.

[0193] As referenced above, the inventive adhesive body securing device 100 of this embodiment as shown in Figs. 2A-2C also comprises a first releasably-adhesive component 130 disposed upon at least a portion of the first side 111 of the foam member 110 (and thus upon the first side 101 of the adhesive body securing device 100 ). The purpose of the first releasably-adhesive component 130 is to generally contact and adhere to a patient's body such that the patient can be securely and releasably attached to the adhesive body securing device 100 (and thus ultimately to the medical furnishing) during use. In such embodiments, the first releasably-adhesive component 130 will preferably comprise an adhesiveness that is sufficient for the adhesive body securing device 100 to keep a patient secured to the device 100 during a medical procedure and to substantially withstand reasonable forces exerted by a patient's body during a medical procedure, but which also allows a medical provider to release the patient from the adhesive body securing device 100 thereafter without injuring or irritating such patient's contacting surface (e.g., skin, hair, fur, etc.) and without damaging the integrity of the device 100.

[0194] In this embodiment, the first releasably-adhesive component 130 will preferably comprise an adhesiveness that is sufficient for the adhesive body securing device 100 to restrict movement of a patient's body disposed upon the device 100 during a medical procedure, such as to eliminate the need for conventional securing devices, such as straps, belts, harnesses, braces or other external securing devices.

[0195] Suitable first releasably-adhesive components 130, as well as properties thereof, processes, examples, etc. have been described above with respect to the embodiment of Figs. 1A-1C, wherein such description is hereby incorporated herein by reference in its entirety in a manner that is consistent herewith.

[0196] Continuing with Figs. 2A-2C, the inventive adhesive body securing device 100 of this embodiment further comprises a second releasably-adhesive component 150 disposed upon at least a portion of the second side 112 of the foam member 110 (and thus upon the second side 102 of the adhesive body securing device 100). The purpose of the second releasably-adhesive component 150 is to attach the adhesive body securing device 100 of this embodiment to a medical furnishing, such as for use during a medical procedure. In such embodiments, the second releasably-adhesive component 150 will preferably comprise an adhesiveness that is sufficient for the adhesive body securing device 100 to withstand the forces exerted by a patient's body 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 securing device 100 from the medical furnishing thereafter without damaging the medical furnishing or damaging the integrity of the device 100.

[0197] Virtually any suitable releasably-adhesive component can be utilized upon the second side 102 of the inventive adhesive body securing device 100 of this embodiment. Several non-limiting exemplary adhesives suitable for use as a second releasably-adhesive component 150 are discussed below. For example, a polyurethane-based releasably- adhesive polymer or a silicone-based releasably-adhesive 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 securing 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.

[0198] 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.

[0199] 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 is 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 112 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 securing 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 securing 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 securing device 100. In some preferred aspects, the second releasably-adhesive component 150 (and the adhesive body securing 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.

[0200] The second releasably-adhesive component 150 can be applied to the second 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 second 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 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.

[0201] 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, each of which is further discussed below. 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 or more of the preferred properties set forth herein.

[0202] Continuing with the embodiment of Figs. 2A-2C, 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.

[0203] Continuing with the embodiment of Figs. 2A-2C, in some aspects, an optional grid element (not shown) can be disposed between the first-releasably-adhesive component 130 and the first side 111 of the foam member or between the second releasably-adhesive component 150 and the second side 112 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.

[0204] As referenced above, in some preferred embodiments, the adhesive body securing 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 securing device 100 can be securely adhered to a patient (and in some embodiments to a medical furnishing) 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 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 securing 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 securing 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 securing device 100 to a medical furnishing. In another example, the degree of adhesiveness (within the adhesiveness range) for adhering the adhesive body securing device 100 to a medical furnishing may be the same as, or comparatively higher than, the degree of adhesiveness for adhering the adhesive body securing device 100 to a patient's contacting surface.

[0205] 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 securing 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 securing device 100 from a patient 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.).

[0206] 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.

[0207] 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 securing 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.

[0208] 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 securing device 100.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] 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. 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.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] 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.

[0217] 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 securing 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.

[0218] 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.

[0219] 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.

[0220] 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 securing 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 securing device 100.

[0221] 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 securing 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.

[0222] 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.

[0223] 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.

[0224] 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.

[0225] 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.

[0226] 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 securing 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).

[0227] 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.

[0228] 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.

[0229] 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.

[0230] 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 securing device 100.

[0231] 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 securing 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.

[0232] As referenced above, in some preferred embodiments, the adhesive body securing 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 securing device 100 can be securely adhered to a patient and / or medical furnishing 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 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 securing 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 securing 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 securing device 100 to a medical furnishing. In another example, the degree of adhesiveness (within the adhesiveness range) for adhering the adhesive body securing device 100 to a medical furnishing may be the same as, or comparatively higher than, the degree of adhesiveness for adhering the adhesive body securing device 100 to a patient's contacting surface.

[0233] 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. The structure of a typical silicone polymer is as follows:

[0234] The silicate resin (i.e., the MQ resin) is a solid particle supplied in a hydrocarbon solvent. The MQ name derives from the fact that its structure consists of a core of three- dimensional Q-units (SiO4 / 2) surrounded by a shell of M-units (MesSiOi^). The resin also contains a low level of silanol functionality on the surface. The ratio of M:Q is typically in the range of 0.6-1.2:1.

[0235] Suitable silicone-based releasably-adhesive polymers can be produced by blending a specified ratio of a MQ resin and siloxane polymer together in a hydrocarbon solvent. Heating the mixture to promote a condensation reaction between the available silanol functionality on the resin and polymer can further enhance the initial cohesive strength of the polymer. The ratio of resin to polymer is an important formulation detail when trying to optimize the balance of performance properties for a given silicone-based releasably-adhesive polymer.

[0236] Although most silicone-based releasably-adhesive polymers will exhibit pressure sensitive behavior immediately after solvent removal, further crosslinking is typically performed to reinforce the adhesive network. The level of additional crosslinking will depend on the intended application needs of the polymer's construction. There are two basic cure systems available for silicone-based releasably-adhesive polymers: peroxide catalyzed free-radical cure and platinum catalyzed silicon hydride to vinyl addition cure. The majority of commercial silicone-based releasably-adhesive polymers employ the use of a peroxide catalyzed free-radical reaction to achieve additional crosslink density.

[0237] Curing of these types of polymers is typically accomplished via multi-zoned ovens due to the use of non-specific peroxides. Solvent removal is first required at lower temperatures (i.e., about 60°C to about 90°C) to ensure the peroxide does not inadvertently cure the solvent in the polymer matrix, which would result in reduced adhesive performance and poor temperature stability. At elevated temperatures (i.e., about 130°C to about 200°C), the catalyst decomposes to form free radicals, which primarily attack the organic substituents along the polymer chains to extract protons and generate free radicals. The free radicals then combine to form crosslinks as shown by the following general reaction mechanism:

[0238]

[0239] The main benefit of the peroxide catalyzed system is the ability to control properties by addition level of peroxide used. For example, a range of 0 weight percent (wt%) to about 4 wt% peroxide has been found to be suitable. The additional curing with the peroxide can result in a more tightly crosslinked polymer. An increase in cohesive strength, as evidenced by performance in shear tests, is also generally observed. However, such increase in cohesive strength is typically accompanied by a slight decrease in adhesiveness. One suitable peroxide cured silicone-based releasably-adhesive polymer for use as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150 of the adhesive body securing device 100 can include a polydimethylsiloxane peroxide cure polymer, which comprises suitable adhesiveness and releasability properties, and which further has a non-volatile content of about 57%. Such polydimethylsiloxane peroxide cure polymer can be formulated by adding a solvent solution of benzoyl peroxide (BPO) in an amount to yield 0, 1, 2, or 4 wt% BPO per silicone solids. Such formulation can be subsequently diluted with additional solvent to reach a final solids content of about 50 wt%.

[0240] Some of the disadvantages of peroxide catalyzed systems can include the handling of volatile solvents, the generation of peroxide by products, the requirement of sophisticated curing ovens, and a need for the priming of certain substrates to improve adhesive anchorage upon a surface to which the polymer is applied.

[0241] As an alternative to the peroxide catalyzed system, silicone-based releasably-adhesive polymers can utilize a platinum catalyzed addition cure in which a silicon hydride reacts with a silicon vinyl to form a crosslink site. This chemistry is analogous to the typical solvent-based and solventless platinum catalyzed silicone release coating systems used for release liners of organic adhesive compositions. The curing of this type of silicone-based releasably-adhesive polymers can be accomplished in a single-zone oven at lower overall temperatures (i.e., about 100°C to 150°C), even though these systems are supplied in hydrocarbon solvents. As the solvent evaporates, the platinum catalyzed reaction occurs without any generation of byproducts, which can be seen as follows:

[0242] One suitable platinum cured silicone-based releasably-adhesive polymer for use as the first releasably-adhesive component 130 and / or the second releasably-adhesive component 150 of the adhesive body securing device 100 can include a polydimethylsiloxane platinum cure polymer, which comprises suitable adhesiveness and releasability properties, and which further has a non-volatile content of about 41%. Such polydimethylsiloxane platinum cure polymer can be formulated by adding a platinum catalyst and a silicone-hydride (Si H ) crosslinker to the vinyl-functional polymer in an amount to yield 0.5, 1.0, or 1.5 wt% The ability of the system to be cured at a single, lower temperature offers benefits that are not seen with a peroxide catalyzed system. These benefits include faster line speeds (or cure time), lower sensitivity to temperature variation, the ability to use substrates with lower thermal stability (polyethylene, polypropylene, etc.) and no generation of volatile byproducts. Another benefit of the platinum catalyzed silicone system is the fact that it does not inherently need the hydrocarbon solvent for anything other than viscosity control. The peroxide catalyzed system not only requires solvent for viscosity control, but the solvent also keeps the peroxide dissolved within the adhesive bath prior to coating on a surface. Accordingly, this advantage of the platinum catalyzed system allows for the ability to manufacture solventless platinum catalyzed silicone-based releasably-adhesive polymers.

[0243] The invention of the present disclosure also includes a method of using the inventive adhesive body securing device 100. The method of using the adhesive body securing device 100 comprises:

[0244] A. providing a foam member 110 having a first side 111 and an opposing second side 112;

[0245] B. providing a first releasably-adhesive component 130;

[0246] C. disposing the first releasably-adhesive component 130 upon the first side 111 of the foam member 110 to form an adhesive body securing device 100 having a first side 101 and an opposing second side 102;

[0247] D. disposing the second side 102 of the adhesive body securing device 100 upon a medical furnishing; and

[0248] E. disposing at least the torso region of a patient upon the first side 101 of the adhesive body securing device 100 which becomes adhesively attached thereto; wherein the foam member 110 is suitably sized for placement upon a medical furnishing and for accommodating at least the torso region of a patient, wherein the first side 111 and the second side 112 of the foam member 110 correspond to the first side 101 and the second side 102 of the adhesive body securing 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.

[0249] In some aspects of this embodiment, the method further comprises:

[0250] A. providing a second releasably-adhesive component 150; and

[0251] B. disposing the second releasably-adhesive component 150 upon the second side 112 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 adhesive body securing device is adhesively attached to the medical furnishing.

[0252] The present invention may be better understood with reference to the following examples.

[0253] EXAMPLES

[0254] Example 1

[0255] 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 29 inches (73.7 cm) and a width of about 20 inches (50.8 cm). Accordingly, the foam member 110 had a major first side 111 and an opposing major second side 112.

[0256] 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.

[0257] While still in liquid form, a quantity of the reaction media was applied to substantially the entire first side 111 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.

[0258] In addition, while still in liquid form, a quantity of the reaction media was applied to substantially the entire second side 112 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.

[0259] Accordingly, a non-limiting example of an inventive adhesive body securing device 100 of the present disclosure was formed having a first side 101 (which was presented as a top or upward-facing side) and a second side 102 (which was presented as bottom or downward -fa ci ng side). The adhesive body securing device 100 of this Example 1 was similar to that shown in Figs. 2A-2B.

[0260] The adhesiveness of the first side 101 of the adhesive body securing 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 101 of the adhesive body securing device 100 (i.e., the first releasably-adhesive component 130) was determined to be about 10 seconds / inch (sec / in).

[0261] Similarly, the adhesiveness of the second side 102 of the adhesive body securing 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 102 of the adhesive body securing device 100 (i.e., the second releasably-adhesive component 150) was determined to be about 10 seconds / inch (sec / in).

[0262] An operating table was provided which was capable of inclining up to 45° in each lengthwise direction. With the operating table in a horizontal position, the adhesive body securing device 100 of this Example 1 was then placed upon the top side of the operating table such that the second releasably-adhesive component 150 disposed upon the second side 102 became in contact with the covering material of the top side of the operating table. More particularly, one lengthwise edge of the adhesive body securing device 100 was disposed at the approximate location of where a patient's neck and shoulders region would be during use of the operating table, and the remainder of the adhesive body securing device 100 then extended down the length of the operating table in the direction toward where a patient's feet would be located.

[0263] A test subject (i.e., a person) then donned a sleeveless hospital gown such that the skin of the test subject's back side and arms was exposed. With the assistance of several individuals, and with the test subject's legs together and arms positioned against the sides of their torso, the test subject was generally centered with, and then disposed in a supine position upon the top side 101 of the adhesive body securing device 100, such that the person's skin was in direct contact with the first releasably-adhesive component 130 disposed upon the top side 101, and such that the device 100 generally extended from the upper shoulders of the test subject to about the mid-thigh area (hamstrings) of the test subject. Care was taken so that the hospital gown was draped over the sides of the operating table, such that substantially no material of the hospital gown was in contact with the adhesive body securing device 100.

[0264] The test subject reported initially feeling the adhesive body securing device 100 conforming to their body (i.e., a slight sinking-in feeling). The test subject also reported that it was very difficult to generally move upon the adhesive body securing device 100, including difficulty in rolling back and forth, difficulty raising their arms and hands, and difficulty trying to sit up.

[0265] With the test subject remaining in a supine position, the operating table was then tilted to a 45° angle such that the test subject's head was above the test subject's feet (similar to a reverse Trendelenburg position, except at a greater angle). After several minutes, the operating table was placed back into a horizontal position. The test subject reported that they could feel the pull of gravity while in the angled position, but at no time while at an angle did they feel themselves detaching from the adhesive body securing device 100 or from the operating table.

[0266] With the test subject remaining in a supine position, the operating table was then tilted to a -45° angle such that the test subject's head was below the test subject's feet (similar to a Trendelenburg position, except at a greater angle). After several minutes, the operating table was placed back into a horizontal position. The test subject again reported that they could feel the pull of gravity while in the angled position (except in the opposite direction from the first tilting session), but at no time while at an angle did they feel themselves detaching from the adhesive body securing device 100 or from the operating table.

[0267] With assistance from the aforementioned individuals, the test subject's arms were detached from the adhesive body securing device 100 using a lifting and bending at the elbow motion, and then the test subject was slightly rolled and lifted off the adhesive body securing device 100, wherein the adhesive body securing device 100 remained attached to the operating table fully intact. 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, and no residual polymer from the first releasably-adhesive component 130 was observed on the test subject's skin.

[0268] Finally, the adhesive body securing device 100 was removed from the operating table by grasping one end and then pulling at an angle in a type of peeling motion. Upon removal, the adhesive body securing 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 operating table was inspected for any residual polymer from the second releasably-adhesive component 150, but none was observed. Accordingly, the inventive adhesive body securing device 100 successfully functioned as intended.

[0269] Example 2

[0270] The adhesive body securing device 100 from Example 1 was placed onto a concrete floor in a laid flat configuration, such that the 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 top side 101 of the adhesive body securing device 100 until a flame could be observed rising from the adhesive body securing device 100 (about 10 seconds). The torch flame was then removed from the adhesive body securing device 100, and it was observed that the flame emanating from the device 100 immediately extinguished on its own.

[0271] A 12 inch by 12 inch sample of a conventional disposable body pad consisting of memory foam and having a thickness of about 1 inch was then provided. The conventional pad 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 pad. A flame could be observed rising from the conventional pad material within about 1 second of exposure to the torch flame. The torch flame was removed from the conventional pad after several seconds, and it was observed that the conventional pad continued to burn. The flame was ultimately extinguished using a fire extinguisher.

[0272] This Example 2 successfully demonstrates that the adhesive body securing device 100 of the present disclosure possesses fire resistant properties, particularly as compared to conventional disposable body pads comprising memory foam.

[0273] 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. 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 securing device for releasably securing a patient to a medical furnishing, comprising a foam member and a first releasably-adhesive component; wherein the adhesive body securing 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 securing device, respectively; wherein the first releasably-adhesive component is at least partially disposed upon the first side of the foam member; wherein the second side of the adhesive body securing device is disposed upon a medical furnishing during use; and wherein at least the torso region of a patient is disposed upon and adhesively attached to the first side of the adhesive body securing device during use.

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

3. The adhesive body securing 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 securing device of claim 1, wherein the foam member comprises an indentation force deflection of about 5 Ibf to about 200 Ibf.

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

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

10. The adhesive body securing device of claim 9, 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.

11. The adhesive body securing 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 second side of the adhesive body securing device is adhesively attached to the medical furnishing during use.

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

15. The adhesive body securing 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 securing device of claim 1, wherein the adhesive body securing device is bacteriostatic.

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

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

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

20. A method of using an adhesive body securing 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 securing device having a first side and an opposing second side;D. disposing the second side of the adhesive body securing device upon a medical furnishing; andE. disposing at least the torso region of a patient upon the first side of the adhesive body securing device which becomes adhesively attached thereto; wherein the foam member is suitably sized for placement upon a medical furnishing and for accommodating at least the torso region of a patient; 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 securing 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 adhesive body securing device is adhesively attached to the medical furnishing.

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