Customizable Pressure Offloading Cushioning Device
The subject invention is a device intended for use where support or restriction of motion of a body part is desired. The subject of the present invention is the formation of a network of lattice intrusions into the matrix of the device so that elements of the lattice can be removed to form a depression in the matrix of the device that conforms to the anatomy of the region that is being supported and positioned while offloading pressure.
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The nervous system of humans and higher animals is uniquely developed to perceive sensations that present a risk of harm to the being. One of those threats is prolonged pressure at a point of contact. Prolonged pressure or point pressure loading on the tissues is uncomfortable and may be painful. The transmission of a signal of discomfort or pain to the brain stimulates a counter signal from the brain to the skeletal muscles calling for some movement. This movement is intended to alleviate the pressure.
Prolonged point loading is deleterious and can lead to significant tissue damage and, in some cases, life-threatening injuries. Gravity places forces on the body to generate the sensation of mass. The body is prevented from sinking to the center of Earth by whatever structure it might be resting on. This is easy to relate to when one considers that, when standing, there is considerable pressure on the soles of the feet but almost none on the palms of the hand. Bony protrusions such as the point of the elbow, back of the head, hips, and knees are just some examples of places that typically end up being prominent contact points counteracting the force of gravity depending upon the position of the body. If the nervous system does not sense, or the body is unable to respond to the signals of prolonged pressure, an adverse situation can arise.
Prolonged pressure has a profound affect on the soft tissues. When blood vessels, muscle, subcutaneous fat, and skin are compressed between bone and an external surface it compromises the normal functions of that area. These opposing forces result in a cone-shaped pressure gradient (Pressure Ulcers-Guidelines for Prevention and Nursing Management, Second Edition). All of the tissue between the external surface and the skeletal anatomy is involved. However, the greatest tissue destruction is beneath the skin surface at the bony interface. If left undisturbed this decreased circulation to the area can drive the oxygen tension of the region into a state of hypoxia and eventually necrosis. The necrotic area can then rupture into a wound that begins inside the body and erodes to the outside. These are often referred to as “pressure injuries” (NPUAP, National Pressure Ulcer Advisory Panel).
Pressure injuries/ulcers are difficult to detect until they have eventually erupted to the outside skin. By that time there is considerable tissue damage that creates an ideal location for the establishment of an infection and, if left untreated, may become life threatening to the individual.
Normal healthy individuals are seldom afflicted with pressure injuries/ulcers because the sensation of point loading is a strong driver to change positions to offload the weight on the affected tissues. Medically compromised individuals are much more susceptible to the development of pressure injuries/ulcers. In many cases medically compromised individuals may lack the energy or strength to change positions. In other cases, they simply may not perceive the pressure on the affected tissues and thereby not have any urge to change positions. These are reasons why a main feature of skilled nursing of medically compromised individuals involves protection against the development of pressure injuries/ulcers. This medical condition is so prominent and dangerous to the health of compromised patients that there is a guideline for care givers for pressure injury/ulcer prevention (Pressure Ulcers-Guidelines for Prevention and Nursing Management, Second Edition).
Protecting patients from the development of pressure injuries/ulcers due to prolonged unrelieved pressure involves monitoring pressure points and making sure that persistent pressure contact does not occur. In some cases, this may be done by turning the patient to reposition body weight on a regular time schedule to allow for capillary refill time for good skin integrity. For example, the bony prominence of the hip may be a point where a pressure injury/ulcer may develop. By turning the patient from one side to the other on a regular basis can be successfully used to prevent tissue hypoxia from occurring. Scheduled repositioning is a normal program used in many long term care, and acute care facilities to prevent pressure injury/ulcer formation.
Studies indicate that comprehensive prevention programs are effective in reducing incidence rates and can be cost effective (Courtney H. Lyder, ND-Pressure Ulcer Prevention and Management). Thus, prevention is critical to reduce overall health costs (AHRQ, Agency for Healthcare Research and Quality-Preventing Pressure Ulcers in Hospitals, A Toolkit for Improving Quality of Care). In the U.S. 2.5 million patients develop pressure ulcers each year. Pressure ulcers cost $9.1-$11.6 billion per year to the US health care system. The cost of individual patient care ranges from $20,900 to $151,700 per pressure ulcer. Medicare estimated in 2007 that each pressure ulcer added $43,180 in costs to a hospital stay. More than 17,000 lawsuits are related to pressure ulcers annually. It is the second most common claim after wrongful death and greater than falls or emotional distress (Goebel et al, Clinical Practice Guidelines for pressure ulcer prevention can prevent lawsuits in older patients. JWOCN). In a study of the impact of compliance on medical malpractice awards: 35 Plaintiffs were awarded $14,418,770. Had health care defendants followed guidelines $11,389,989 might have been saved in 20 lawsuits in addition to the plaintiffs' pain and suffering from resulting pressure injuries/ulcers.
Turning a patient or offloading a pressure point is simplistic in concept but can be problematic in making sure that the patient remains in the desired position. Nursing care often use pillows or blankets rolled in such a way to “pack” in around the patient to assist in maintaining the desired position. Whilst these approaches have some utility they are not always useful for offloading the weight. In fact, in some cases pillows and blankets packed too tightly lead to the very complication that they were intended to alleviate. To better serve the patients needs and to facilitate offloading of pressure more uniformly, products such as the Global Medical Foam, Inc. (Langer, U.S. Pat. No. 6,360,388) positioning devices have been developed. These devices are cushioning for the body region and have unique designs that ensures a more even distribution of weight over the device. The devices are constructed of polyurethane foam with a solid foam core for rigidity surrounded by a softer foam layer uniquely cut so that it projects foam fingers outwardly from the core. The fingers compress and bend in such a way that the pressure loading is very evenly distributed over a much larger area of the body and the core center is intended to support the body weight. Moreover, because of the unique finger projects they can be wedged in place to very adequately and comfortably support patients in an offload position and in some cases can decrease the frequency for skilled nursing to assist in repositioning.
A wide variety of medical devices have been developed for pressure reduction/pressure redistribution. One such device by Mead et al (PCT/US 2008/074812) is a bladder that contains a combination of elastomeric foam and a light weight fluid wherein the fluid freely moves within the bladder to accommodate weight distribution and the foam prevents “bottoming out” of a part of the anatomy when it is used. In another product marketed by Sunrise Medical (Christofferson, et al, U.S. Pat. No. 7,146,666), the bladder is specially constructed to have internal baffles that allow air, as the support medium, to move somewhat freely through the device when it is used to cushion the patient. This device has advantages of being very lightweight and cushioning but does have some limitations in the true distribution of weight evenly over the device. In another invention, a wheelchair cushion with an anatomical support includes a patient interface layer of gel, a matrix panel and a foam base (Lampel, et al, U.S. Pat. No. 6,625,830). Although gels that are free to move aid in distribution of weight they have the limitation of being very poor support media and have a high potential for bottoming out and do not provide the offloading attribute thus potentially causing tissue interface pressure.
There are many examples of devices that have design features and material choices for aiding in the offloading of areas of the anatomy. Synthetic and natural rubberized materials are commonly used for this purpose primarily because they are generally soft to the touch and naturally provide some cushioning. Open and closed cell foams such as those formed of polyurethane are commonly used. Other foams are composed of natural latex or polyvinyl materials. Collectively these are elastomeric foams. All foams can be evaluated and given an RMA Value (Rubber Manufacturers of America) which relates to the cushioning or softness of the foam. Ideally the foam of choice is one that is constructed of sufficient elasticity, flexibility, conformability and etc. so that it distributes weight but does not bottom out when it is used to support the anatomy. In most cases the combination of device design and the cushioning index of the material used in its construction combine to provide some utility of design.
Offloading is a medical necessity to prevent pressure injury/ulcer formation. The repositioning of the body is effective for many patients. However, there are some patients where repositioning is not an option. Patients in prolonged traction, patients that are confined to lie on their back, side or stomach for some medical reason, or burns patients. Although regular scheduled repositioning may not be an option they are still susceptible to the formation of ulcers. In other cases, a patient may already have pressure induced, surgery induced or trauma induced wounds that need total offloading. In cases such as these it is imperative that support surfaces be such that they significantly redistribute the weight of the patient over a much broader tissue surface area. In addition, it may be necessary that the weight be totally offloaded from some portion of the anatomy. Special devices such as air bed mattresses are an example of devices that attempt to significantly redistribute weight but they may not totally offload weight from specific regions of the anatomy. In addition, these may be effective for the entire body, but they may not either be available, are too expensive, or they may be ineffective when only a portion of the anatomy needs offloading. Furthermore, many support devices come as one size fits all which is entirely unpractical in many cases. There is a need for devices that can be customized to offload and redistribute body weight pressure effectively particularly areas of specific anatomy. Such a customized device might be one that could be modified at bedside to fit a region of an arm, a leg, a backside or the head taking into account that arms, legs, feet, heads, and etc. vary in size and shape among the multitude of patients that may need such assistance. Such a device would be a customizable device in the sense that material could be selectively removed from the device so as to shape it to conform very specifically to the anatomy in need of support. Such a device furthermore could be conformable to totally offload the weight that might cause damage to specific anatomical sites. Such a device would be considerably different from existing art in the sense that the customizable features would enable the care giver to modify the device for the patient's specific needs. The invention described herein is a customizable device that is able to be very simply modified to conform in shape and utility to aid in the management of a patient's anatomy for the aim of providing comfort, and offloading to prevent the formation of pressure injuries/ulcers.
Several inventors have proposed improvements in support devices that are intended to better prevent pressure injuries from occurring. In one such improvement, Christofferson (Christofferson et al, U.S. Pat. No. 7,146,666) described a bladder which contained a fluid medium that was free to move within the bladder to conform to the contours of the anatomy. Such a device achieves very good contour to form conformation to the anatomy but it is not a good system for weight distribution and can not totally offload weight from a wound site if that is required.
Raburn et al (Raburn et al, U.S. Pat. No. 5,459,896) described a way of improving the cushioning support provided by polyurethane foam by describing the formation of a grid like pattern of channels into the anatomy-contact side of a foam device wherein the cuts specifically removed a portion of foam so that the grid projections of foam were totally independent and not touching adjacent projections. This relief of foam allowed the grid portions of foam to move independently but did not provide any ability to totally offload an area if needed nor did it provide any contour fitting of the device to conform to the anatomical shape of the supported anatomy.
Farley (Farley et al, U.S. Pat. No. 5,038,433) was substantially similar to the Raburn invention but provides more relief at the bottom of the channels so that moisture vapor and air more freely moves through the channels of the device. This is said to decrease the accumulation of body perspiration in the device.
All of these inventions substantially improved the weight distribution problem that is so necessary for the management of persons confined to prolonged sitting or reclined positioning. However, these devices address either pressure redistribution or contouring of the device but none of them address the totality of the needs for managing anatomical positioning, pressure re-distribution and total offloading for patients with restricted mobility. There has been a need for a device that provides weight re-distribution, positioning of the anatomy and a potential for total offloading of an anatomical area. Since all of these needs are prescribed by a medical needs of the individual patient, and often one with limited mobility, the ideal device would incorporate all of these requirements into a single device. In addition, due to the differences of the anatomical features that make individuals distinctive from one another, it makes sense that a composite of these features also have some degree of flexibility for “molding” the device to fit the individual.
The solution to this unmet need is a customizable cushioning support device that, in preparation for use, is able to be modified to more closely fit the anatomical surface area contours where positioning, weight redistribution, and offloading are needed to meet the care requirements of the patient to more comfortably stabilize the position where immobilization and/or support of the anatomy is desired. Such a device would have utility in clinical application in that it would allow the patient's care givers to shape the device to more precisely fit to the contours of the anatomy the device it is intended to contact. A predominate feature of such an invention would be ease of use, bedside adaptability to the patient's needs, functionality in positioning and support, and affordability. Foams, such as polyurethane and viscoelastic foams, are widely used in support devices of the nature used for positioning and weight distribution. However, these foams are homogeneous materials composed of either closed or open cells with varying degrees of compressibility due to their density and thickness. These materials have very limited utility in their raw manufactured form. To provide more useful devices for intended purposes developers have found that modifying the foam buns with cuts, coatings and designs substantially improve their utility for positioning, weight redistribution or offloading when used in the patient settings. The invention herein described is an improvement whereby foams such as polyurethane or viscoelastic can be milled to form a product that enables the patient and/or care giver the ability to easily modify its shape to conform to the anatomical features of the patient to provide positioning, weight redistribution and offloading of specific parts of the anatomy to aid in the prevention of pressure induced injuries/ulcers.
SUMMARY OF THE INVENTIONThe subject of this invention is a foam device such as a polyurethane or viscoelastic foam that has been manufactured in such a way that it is easily modified at the point of use, such as at the patient bedside, to provide positioning, weight redistribution and/or partial or total offloading of weight from a specific area of a patient's anatomy. The salient feature of the invention is the formation of small pillars of foam matrix in the foam bun where said small pillars of the foam matrix that are formed into the anatomical contact side of the device. The intention of the pillars of foam projecting from intact base portion of the device is to provide a lattice of closely adjoined structures that can be selectively decreased in length by the care giver to cause the formation of depression(s) in the matrix that conforms to the contours to the anatomical region where it will be used on the patient.
Polyurethane foam of a 1-5 pound per cubic foot density is an ideal soft material that can be easily formed at manufacturing to accomplish the desired features of the device. Polyurethane foam or other elastomeric foam provides uniformly soft homogeneous materials that are often used in mattresses, pillows, support, and positioning devices. Most of these devices are machine cut from large buns of foam. These machines use blades, compression points, and wires that are programmed to cut very precise shapes and sizes into the off-cuts in forming the finished device. Although foams are soft, pliable and elastic they are not easily cut or trimmed by hand with any degree of precision, particularly in the rushed clinical environment. Indeed, precision cutting and shaping of polyurethane foam from buns of foam requires sophisticated programmable machinery that is entirely impractical to house in the clinical environment. Although polyurethane foam is an ideal material that has been used extensively in support devices, its utility as a customizable device has traditionally been limited.
The present invention overcomes this limitation by adding manufactured intrusions or cuts that form a lattice array of pillars of matrix that sit upon the intact base of the foam during the manufacturing process. Although other manufacturers have introduced products that have grid patterns cut into the surfaces of their devices, no manufacture has considered the use of resulting protrusions of foam of the grid pattern for the purpose of customizing the device to the contours of the anatomy of the individual patient. Furthermore, the grid patterns in other inventions are excessively large (Raburn, et al, US 00D3945785) and too short to provide utility as a customizable device. The grid manufacturing of other inventions such as Raburn (Raburn, et al, U.S. Pat. No. 5,459,896) are accomplished by forming significantly wide channels in the matrix on the patient contact side of the matrix of the foam. These channels are intended for purposes such as ventilation of perspiration and to prevent shear injury when the patient moves. Since these structures are essentially dispersed they lack one of the benefits of intact foam, namely support. In other words, the structures do not benefit from the lateral support of adjacent structures. In some applications this might be beneficial to the patient but where the care needs prescribe support, weight distribution, offloading and positioning they are deficient. In the present invention the pillars are cut into the matrix to between 55% to 90% of the depth of the matrix into the anatomical contact side of the device. The cuts remove little or no matrix so that there are no channels formed between the pillars that stand on the intact base of the material. In addition, the lattice formation of pillars is constructed only in the appropriate area of the device that will substantially be in contact with the anatomic region of the patient. The importance of this feature is that the adjacent pillars provide lateral support to one another so that the overall affect is an action of intact unmodified foam thus providing precise positioning and offloading while maintaining overall weight redistribution.
In use the narrow pillars of matrix in the lattice array are intended to be partially or completely removed by simply pinching off the portion that needs to be removed. This selective action can be used to form a very precise depression in the foam that fits the contours of the anatomical region of the patient. These pillars are sufficiently narrow but long enough so that they can easily be grasped by the care giver, a process that would not be practical with larger protrusions of foam or with intact foam. By moving from pillar to pillar it is possible then to create a contoured depression in the support device that is an exact fit to the anatomical area that is in need of weight redistribution or total offloading. This procedure is one of picking the correct pillar for removal and then plucking out the correct amount of material that needs to be removed to create the customized support device. This “pick and pluck” procedure is repeated until a fully customized device is shaped by the care giver to fit the anatomy of the patient where it is intended to be used.
All of the devices of the invention are comprised of a cushioning support matrix such as a polyurethane foam or other such elastomeric foams. In all cases the foam may be generally cut to a size and overall shape suitable for its intended application. For example, a wheel chair cushion would be cut to a shape and form that is sufficient to fit in a wheel chair with sufficient thickness so that it would not be compressed so far that it bottoms out when used by a patient.
Elastomeric foam and in particular polyurethane foam is formed from stock buns that are then used as the raw material for the manufacturing of cushioning devices of this subject invention. These stock foam buns are then cut in any suitable manner to form the general dimensions of the finished device. Cutting is accomplished by the use of a foam cutting knife or wire fitted in a programmable foam cutting machine. This cutting of the raw shape could be accomplished by other methods that might commonly be employed for the cutting of such materials. If the intended use of the device were to be a wheel chair seat then the foam would be cut to an appropriate size to fit a wheel chair support. Usually such devices are then packages as is or have additional material added to them such as coatings or covers to make the finished device. In the case of the subject invention additional cuts made substantially through the foam matrix would be applied to the surface that is intended to make contact with the anatomy. These cuts would form a closely packed lattice array of pillars in the foam that stand on the intact base of the foam matrix.
The tightly packed lattice array of pillars of matrix are substantially made in the foam matrix on the patient contact side of the device. The grid-like distribution of pillars enables the patient or care giver the opportunity to decide where the customizing of the device is to occur. By picking and plucking away the pillars of matrix, it is easy to form a depression in the material that conforms to the anatomy of the patient surface that is targeted for support and offloading. The remaining intact portions of the pillars work in consort with neighboring pillars to act in a fashion similar to that expected of a solid matrix of material. In other word's there is not appreciable space between the pillars of matrix. This is particularly important for position of a region of the anatomy. The contiguous nature of the customized shape provides the necessary support, positioning and weight redistribution to aid in the avoidance of the formation of pressure injuries in the patient.
A variation of the theme is the formation of cushioning devices that are generally contoured by the foam cutting process to conform to the general anatomical shape that is intended for support. For instance, a device cut from polyurethane foam to form a flat bottom and sides but has a contoured top surface that conforms to the contours of the anatomy. One such device is formed so that it conforms to the back of the head and the cervical area. Once this shape is achieved then the entire top area of the device is cut partially the way to the bottom of the matrix to form the lattice array of foam pillars. Such a device is then more precisely modified to fit the patient by the selective removal of portions of the pillars of foam to form a depression that would specifically conform to the head and neck area. If some part of that anatomy require total offloading, then a significantly large part of the pillars in that specific region could be removed so that the device makes no contact with the anatomy in that specific anatomical region.
The utility of the invention was proven by making and testing several prototypes. Some examples of these prototypes include:
EXAMPLE 1A device that incorporates the features of the invention was developed by cutting a block of polyurethane foam into a block 9″×7″×1.5″ using a continuous programmable foam block cutter. The cut foam block from this process was then subjected to a secondary cutting operation that cut parallel cuts 0.5″ wide and 1.25″ deep across one surface of the foam. This process was repeated in a perpendicular direction to the first set of parallel cuts. The resulting appearance of one side of the foam was a cross hatching of pillars of foam 0.5″×0.5″ that extended into the foam 1.25″. Since the pillars were not cut entirely through to the opposite side of the foam the entire device remained intact. The other side of the foam was uniform without any evidence of cross hatching.
The utility of the device was demonstrated by customizing it to fit a 4″ diameter soft ball. The soft ball was placed in the center of the device and a felt pen was used to outline the edge of the area to be customized. The pillars within the marked area were then picked and plucked with the ones in the center being pinched off and removed at their bases and the ones out towards the perimeter being sequentially pinched off closer to the outer top surface. Once the customizing was complete a depression in the foam was created so that the soft ball would nestle into the depression with substantially uniform contact with pillars of foam. This customizing required only a few minutes to carry out and did not require any special equipment or machinery to complete.
EXAMPLE 2Essentially the same device was made as in example 1 except that the density of foam in this example was significantly lower than the first example. This created a softer support device that conformed to the desired shape but it was not sufficiently soft that bottoming out did not occur when it was tested.
EXAMPLE 3This device was cut in the same form as that in the first example device excepting that the size was approximately 12″×9″×3″ which was more conducive for use on an adult patient.
EXAMPLE 4Polyurethane foam was initially cut to form a shape with a contoured shape that would generally fit the contour of the neck and head region of a patient. The contoured block was generally 9″×7″×1.5″ in size. The anatomical contact side of the device had a series of cuts in a grid like fashion that extended from the surface into the matrix to 0.5″ from the bottom (66% of the depth). The device was placed in use to support and offload a baby's head by selectively removing portions of pillars in the central region of the foam to form a depression that precisely fit the head of the baby.
Claims
1. A cushioning device for the contours of an anatomical region that is conformable for purposes of supporting the position of the anatomical region by said device; by redistribution of the weight of the anatomical region by said device; by total offloading of weight to sub-regions of the anatomy supported by said device comprising; a foam assembly wherein a lattice of cuts are in said device to a partial depth of the matrix to form an array of adjoining pillars of matrix continuously joined to the intact base matrix whereby individual pillars of said device are manually adjusted to form a conforming depression in said device for the purpose of support, positioning, weight redistribution, offloading.
2. A cushioning device according to claim 1, wherein the device matrix is composed of polyurethane foam, viscoelastic foam, polyvinyl foam, natural and synthetic rubber.
3. A cushioning device according to claim 1, wherein the scoring of the lattice array is on the anatomical contact side of the device.
4. A cushioning device according to claim 1, wherein the lattice array of the device is scored on one side of the matrix to form pillars to a partial depth of the matrix where in the depth of the scoring ranges from 51% to 99% of the full depth; more preferably 60% to 95% of the depth; most preferably 65% to 90% of the depth of the device.
5. A cushioning device according to claim 1, wherein the pillars have a surface dimension that ranges from 0.1 cm square to 100 cm square; more preferably 0.5 cm square to 16 cm square; most preferably 1 cm square to 2 cm square.
6. A cushioning device according to claim 1, wherein the lattice array of the device is scored to a partial depth of the matrix by a mechanical process such as cutting.
7. A cushioning device according to claim 1, wherein the lattice array of the device is scored to a partial depth of the matrix by molding during the formation of the foam.
8. A cushioning device for the contours of an anatomical region that is conformable for purposes of supporting the position of the head and neck region of the anatomy by said device; by redistribution of the weight of the anatomical region by said device; by total offloading of weight to sub-regions of the anatomy supported by said device comprising; a foam assembly wherein a lattice of cuts are in said device to a partial depth of the matrix to form an array of adjoining pillars of matrix continuously joined to the intact base matrix whereby individual pillars of said device are manually adjusted to form a conforming depression in said device for the purpose of support, positioning, weight redistribution, offloading.
9. A cushioning device according to claim 8, wherein the device matrix is composed of polyurethane foam, viscoelastic foam, polyvinyl foam, natural and synthetic rubber.
10. A cushioning device according to claim 8, wherein the scoring of the lattice array is on the anatomical contact side of the device.
11. A cushioning device according to claim 8, wherein the lattice array of the device is scored on one side of the matrix to form pillars to a partial depth of the matrix where in the depth of the scoring ranges from 51% to 99% of the full depth; more preferably 60% to 95% of the depth; most preferably 65% to 90% of the depth of the device.
12. A cushioning device according to claim 8, wherein the pillars have a surface dimension that ranges from 0.1 cm square to 100 cm square; more preferably 0.5 cm square to 16 cm square; most preferably 1 cm square to 2 cm square.
13. A cushioning device according to claim 8, wherein the lattice array of the device is scored to a partial depth of the matrix by a mechanical process such as cutting.
14. A cushioning device according to claim 8, wherein the lattice array of the device is scored to a partial depth of the matrix by molding during the formation of the foam.
15. A cushioning device for the contours of an anatomical region that is conformable for purposes of supporting the position of the sacral and coccyx region of the anatomy by said device; by redistribution of the weight of the anatomical region by said device; by total offloading of weight to sub-regions of the anatomy supported by said device comprising; a foam assembly wherein a lattice of cuts are in said device to a partial depth of the matrix to form an array of adjoining pillars of matrix continuously joined to the intact base matrix whereby individual pillars of said device are manually adjusted to form a conforming depression in said device for the purpose of support, positioning, weight redistribution, offloading.
16. A cushioning device according to claim 15, wherein the device matrix is composed of polyurethane foam, viscoelastic foam, polyvinyl foam, natural and synthetic rubber.
17. A cushioning device according to claim 15, wherein the scoring of the lattice array is on the anatomical contact side of the device.
18. A cushioning device according to claim 15, wherein the lattice array of the device is scored on one side of the matrix to form pillars to a partial depth of the matrix where in the depth of the scoring ranges from 51% to 99% of the full depth; more preferably 60% to 95% of the depth; most preferably 65% to 90% of the depth of the device.
19. A cushioning device according to claim 15, wherein the pillars have a surface dimension that ranges from 0.1 cm square to 100 cm square; more preferably 0.5 cm square to 16 cm square; most preferably 1 cm square to 2 cm square.
20. A cushioning device according to claim 15, wherein the lattice array of the device is scored to a partial depth of the matrix by a mechanical process such as cutting.
21. A cushioning device according to claim 15, wherein the lattice array of the device is scored to a partial depth of the matrix by molding during the formation of the foam.
22. A cushioning device for the contours of an anatomical region that is conformable for purposes of supporting the position of the scrotum region of the anatomy by said device; by redistribution of the weight of the anatomical region by said device; by total offloading of weight to sub-regions of the anatomy supported by said device comprising; a foam assembly wherein a lattice of cuts are in said device to a partial depth of the matrix to form an array of adjoining pillars of matrix continuously joined to the intact base matrix whereby individual pillars of said device are manually adjusted to form a conforming depression in said device for the purpose of support, positioning, weight redistribution, offloading.
23. A cushioning device according to claim 22, wherein the device matrix is composed of polyurethane foam, viscoelastic foam, polyvinyl foam, natural and synthetic rubber.
24. A cushioning device according to claim 22, wherein the scoring of the lattice array is on the anatomical contact side of the device.
25. A cushioning device according to claim 22, wherein the lattice array of the device is scored on one side of the matrix to form pillars to a partial depth of the matrix where in the the depth of the scoring ranges from 51% to 99% of the full depth; more preferably 60% to 95% of the depth; most preferably 65% to 90% of the depth of the device.
26. A cushioning device according to claim 22, wherein the pillars have a surface dimension that ranges from 0.1 cm square to 100 cm square; more preferably 0.5 cm square to 16 cm square; most preferably 1 cm square to 2 cm square.
27. A cushioning device according to claim 22, wherein the lattice array of the device is scored to a partial depth of the matrix by a mechanical process such as cutting.
28. A cushioning device according to claim 22, wherein the lattice array of the device is scored to a partial depth of the matrix by molding during the formation of the foam.
29. A cushioning device for the contours of an anatomical region that is conformable for purposes of supporting the position of the torso region of the anatomy by said device; by redistribution of the weight of the anatomical region by said device; by total offloading of weight to sub-regions of the anatomy supported by said device comprising; a foam assembly wherein a lattice of cuts are in said device to a partial depth of the matrix to form an array of adjoining pillars of matrix continuously joined to the intact base matrix whereby individual pillars of said device are manually adjusted to form a conforming depression in said device for the purpose of support, positioning, weight redistribution, offloading.
30. A cushioning device according to claim 29, wherein the device matrix is composed of polyurethane foam, viscoelastic foam, polyvinyl foam, natural and synthetic rubber.
31. A cushioning device according to claim 29, wherein the scoring of the lattice array is on the anatomical contact side of the device.
32. A cushioning device according to claim 29, wherein the lattice array of the device is scored on one side of the matrix to form pillars to a partial depth of the matrix where in the the depth of the scoring ranges from 51% to 99% of the full depth; more preferably 60% to 95% of the depth; most preferably 65% to 90% of the depth of the device.
33. A cushioning device according to claim 29, wherein the pillars have a surface dimension that ranges from 0.1 cm square to 100 cm square; more preferably 0.5 cm square to 16 cm square; most preferably 1 cm square to 2 cm square.
34. A cushioning device according to claim 29, wherein the lattice array of the device is scored to a partial depth of the matrix by a mechanical process such as cutting.
35. A cushioning device according to claim 29, wherein the lattice array of the device is scored to a partial depth of the matrix by molding during the formation of the foam.
36. A cushioning device for the contours of an anatomical region that is conformable for purposes of supporting the extremity regions of the anatomy such as hand, elbow, arm, foot, leg by said device; by redistribution of the weight of the anatomical region by said device; by total offloading of weight to sub-regions of the anatomy supported by said device comprising; a foam assembly wherein a lattice of cuts are in said device to a partial depth of the matrix to form an array of adjoining pillars of matrix continuously joined to the intact base matrix whereby individual pillars of said device are manually adjusted to form a conforming depression in said device for the purpose of support, positioning, weight redistribution, offloading.
37. A cushioning device according to claim 36, wherein the device matrix is composed of polyurethane foam, viscoelastic foam, polyvinyl foam, natural and synthetic rubber.
38. A cushioning device according to claim 36, wherein the scoring of the lattice array is on the anatomical contact side of the device.
39. A cushioning device according to claim 36, wherein the lattice array of the device is scored on one side of the matrix to form pillars to a partial depth of the matrix where in the the depth of the scoring ranges from 51% to 99% of the full depth; more preferably 60% to 95% of the depth; most preferably 65% to 90% of the depth of the device.
40. A cushioning device according to claim 36, wherein the pillars have a surface dimension that ranges from 0.1 cm square to 100 cm square; more preferably 0.5 cm square to 16 cm square; most preferably 1 cm square to 2 cm square.
41. A cushioning device according to claim 36, wherein the lattice array of the device is scored to a partial depth of the matrix by a mechanical process such as cutting.
42. A cushioning device according to claim 36, wherein the lattice array of the device is scored to a partial depth of the matrix by molding during the formation of the foam.
Type: Application
Filed: May 23, 2016
Publication Date: Nov 24, 2016
Applicant: Global Medical Foam, Inc. (Lexington, OH)
Inventor: Victoria Aileen Langer (Mansfield, OH)
Application Number: 15/162,574
