Customizable pressure offloading cushioning device

Abstract

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.

Claims

1. A method for protecting a patient against pressure injury/ulcer formation, the method comprising steps of: providing a customizable cushioning device including a homogenous foam matrix with an anatomical contact side and a bottom side, the foam matrix having a depth defined by a distance between the anatomical contact side and the bottom side, the foam matrix having a lattice of cuts formed in the anatomical contact side and extending only partly through the depth of the foam matrix toward the bottom side and terminating at an intact base, the lattice of cuts defining an array of adjoined pillars attached to the intact base of the foam matrix, wherein an entirety of the lattice of cuts forms continuous cuts about each pillar at a surface of the anatomical contact side; determining an area of the foam matrix to be removed by pressure mapping the patient with sensors to form a conforming depression configured to accommodate contours of an anatomical region of the patient for purpose of at least one of support, positioning, weight redistribution, and offloading of weight of the anatomical region of the patient; and manually tearing away at least a portion of the pillars at the determined area of the foam matrix to form the conforming depression in the anatomical contact side of the foam matrix.

2. The method of claim 1, wherein the foam matrix is one of polyurethane foam, viscoelastic foam, polyvinyl foam, natural rubber, and synthetic rubber.

3. The method of claim 1, wherein the cut depth is from 51% to 99% of the depth of the foam matrix.

4. The method of claim 3, wherein the cut depth is from 60% to 95% of the depth of the foam matrix.

5. The method of claim 1, wherein each of the pillars has a cross-sectional area from 0.1 cm square to 100 cm square.

6. The method of claim 5, wherein each of the pillars has a cross-sectional area from 0.5 cm square to 16 cm square.

7. The method of claim 6, wherein each of the pillars has a cross-sectional area from 1 cm square to 2 cm square.

8. The method of claim 1, wherein each of the pillars contacts adjacent ones of the pillars and there are no channels formed therebetween, the adjacent ones of the pillars thereby providing lateral support.

9. The method of claim 1, wherein the step of manually tearing away the pillars includes pinching off by a user the portion of the pillars at the determined area to form the conforming depression.

10. The method of claim 9, wherein one of the pillars at the determined area is pinched off at the intact base, and another of the pillars at the determined area is pinched off at a location between the intact base and the anatomical contact side.

11. The method of claim 1, wherein the anatomical contact side is contoured during formation of the foam matrix and prior to the step of manually tearing way the pillars to form the conforming depression, the anatomical contact side configured to generally conform to the contours of the anatomical region of the patient.

12. The method of claim 1, wherein the anatomical region includes a head and a neck of the patient.

13. The method of claim 12, wherein the conforming depression is configured to receive an ear of the patient where the head is placed on the anatomical contact side of the customizable cushioning device.

14. The method of claim 1, wherein the foam matrix is generally block shaped.

15. The method of claim 1, wherein the foam matrix is approximately 9-12 inches in length by 7-9 inches in width by 1.5-3 inches in depth.

16. A cushioning device for protecting a patient against pressure injury/ulcer formation, the cushioning device having been customized according to the method of claim 1.

17. The method of claim 1, wherein the lattice of cuts defining the array of adjoined pillars attached to the intact base of the foam matrix form continuous cuts about a circumference of each pillar from the surface of the anatomical contact side to the intact base.

18. The method of claim 1, wherein a portion of the anatomical contact side has a curved surface.

19. The method of claim 1, wherein the step of manually tearing away the pillars includes pinching off by a user the portion of the pillars at the determined area to form the conforming depression by tearing away the pillars at only a base of each pillar, leaving an intact base.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations and are not intended to limit the scope of the present disclosure.

(2) FIG. 1 is a perspective view of a device according to one embodiment of the disclosure.

(3) FIG. 2 is a perspective view of the device shown in FIG. 1, and further depicting a depression created by a selective removal of portions or all of selected pillars to confirm to an anatomical region of a patient.

(4) FIG. 3 is a perspective view of the device shown in FIG. 1, and further depicting a cutaway to illustrate independent pillars of foam supported on an intact base of matrix material.

(5) FIG. 4 is a side elevational view of the device shown in FIGS. 1-3, and further illustrating the device in operation according to the method of the present disclosure.

(6) FIG. 5 is a front perspective view of a pressure mapping display of a body of a patient that corresponds to the device shown in FIGS. 1-4.

(7) FIG. 6 depicts a method of protecting against pressure injury/ulcer formation by modifying the device shown in FIGS. 1-4.

DETAILED DESCRIPTION

(8) The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. In respect of the methods disclosed, the order of the steps presented is exemplary in nature, and thus, is not necessary or critical unless otherwise disclosed.

(9) FIG. 1 depicts a block of foam that has been cut into an appropriate shape for cervical support form. The upper portion of the device 1 illustrates the anatomy contact side of the device 1 with a lattice array 2 of cuts into the matrix 3 of the homogeneous foam 3 of the device 1. The independent pillars 4 of matrix 3 formed in the cutting process stand upon the intact base 5 of matrix 3 of the foam device 1. The overall shape of the device 1 in this depiction is appropriate for supporting the cervical region of the anatomy.

(10) FIG. 2 depicts a block of foam that has been cut into an appropriate shape of the device 1 for cervical support form. In particular, the device 1 further has a lattice array 2 cut into the foam from the anatomy contact side of the device 1. The device 1 has a homogeneous foam matrix 3 with an overall form for cervical support. The device 1 further has an independent pillar 4 of foam resting on the intact base 5 of the device 1. The intact base 5 of matrix 3 supports the pillars 4 of foam. A depression 6 in the construct is created by the selective removal of portions or all of selected pillars 4 to conform to an anatomical region of the patient.

(11) FIG. 3 illustrates the anatomy contact side of the device 1, and the intact base 5 of the device 1. A cut away 7 of the foam matrix 3 is shown to illustrate the independent pillars 4 of foam supported on the intact base 5 of matrix 3 material.

(12) FIG. 4 illustrates the preparation of the device 1 for use wherein the device 1 is an independent unmodified pillar 4 of matrix 3 sitting upon the intact base 5 of the device 1. The pillars 4 of foam may be manually shortened as to form a depression 6 in the matrix 3 appropriate for offloading and redistributing the weight of the patient's anatomy.

(13) FIG. 5 depicts a pressure map of a body of a patient, illustrating the areas of pressure where the body contacts a pressure mat.

(14) FIG. 6 illustrates a method of pressure mapping a patient to determine which area of the foam matrix to remove.

(15) All of the devices 1 of the invention are comprised of a cushioning support matrix 3 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.

(16) 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 1 of this subject invention. These stock foam buns are then cut in any suitable manner to form the general dimensions of the finished device 1. 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 1 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 1 are then packages as is or have additional material added to them such as coatings or covers to make the finished device 1. In the case of the subject invention additional cuts made substantially through the foam matrix 3 would be applied to the surface that is intended to make contact with the anatomy. These cuts would form a closely packed lattice array 2 of pillars 4 in the foam that stand on the intact base 5 of the foam matrix 3.

(17) The tightly packed lattice array 2 of pillars 4 of the foam matrix 3 are substantially made in the foam matrix 3 on a patient contact side 8 of the device 1. The grid-like distribution of pillars 4 enables the patient or care giver the opportunity to decide where the customizing of the device 1 is to occur. By picking and plucking away the pillars 4 of the foam matrix 3, it is easy to form the depression 6 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 4 to act in a fashion similar to that expected of a solid matrix 3 of material. In other word's there is no appreciable space between the pillars 4 of the foam matrix 3. 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.

(18) A variation of the theme is the formation of cushioning devices 1 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 1 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 1 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 1 is cut partially the way to the bottom of the foam matrix 3 to form the lattice array 2 of foam pillars 4. Such a device 1 is then more precisely modified to fit the patient by the selective removal of portions of the pillars 4 of foam to form a depression 6 that would specifically conform to the head and neck area. If some part of that anatomy requires total offloading, then a significantly large part of the pillars 4 in that specific region could be removed so that the device 1 makes no contact with the anatomy in that specific anatomical region.

(19) In certain embodiments, the customizable cushioning device 1 includes a homogenous foam matrix 3 with the anatomical contact side 8 and a bottom side 10. The foam matrix 3 of the customizable cushioning device 1 may have a depth defined by a distance between the anatomical contact side 8 and the bottom side 10. The foam matrix 3 may have a lattice of cuts 9 formed in the anatomical contact side 8 and extending only partly through the depth of the foam matrix 3 toward the bottom side 10. The lattice of cuts 9 may terminate at an intact base 5 and define an array 2 of adjoined pillars 4 attached to the intact base 5 of the foam matrix 3.

(20) In a further embodiment, as shown in FIG. 5, a body of a patient may be pressure mapped to reveal areas of high pressure and to allow one to determine an area of the foam matrix 3 to be removed. Once the body of the patient is pressure mapped, pieces of the foam matrix 3 may be manually removed to lower the amount of pressure exerted by the cushioning device 1 on the patient in operation, thereby militating against injury and the formation of ulcers. For example, in certain embodiments, the pressure mapping may be performed using a sensing mat (shown on the display 12 in FIG. 5) having a plurality of pressure sensors. In a further example, the body of the patient may abut the sensing mat to reveal areas of high pressure that could potentially cause injury. Data is communicated from the pressure sensors to a user interface, such as a monitor or touch screen, which in turn shows a pressure mapping display 12.

(21) The pressure mapping display 12 may graphically depict a pressure mapping grid 14 that has a plurality of boxes 16, which each may be assigned a pressure reading in mmHg. In a non-limiting example, the boxes 16 of the grid may correspond to individual pieces of the foam matrix 3. Thus, the pressure reading shown in each box 16, may correspond to an individual pillar 4 of the foam matrix 3. One of ordinary skill in the art may also select other types of the display 12 for graphically depicting the pressure mapping of the body of the patient, as desired.

(22) In a further example, data collected by the sensors may be accessed by the user via at least one personal computer or mobile appliance, such as a mobile phone or a tablet computer. In particular, the sensors may send the data to a web browser on the personal computer, or through a downloadable software application on the mobile phone or the personal computer. After reviewing the pressure readings in each box 16 of the mapping display 12, the user may then selectively remove portions of the pillars 4 of foam to form a depression 6 that would correspond to areas of high pressure. The greater the amount of pressure, the larger portions of foam pillars 4 that may be removed. The software application may further be configured to suggest to the user the amount of each pillar 4 to be removed in order to optimize the relief of pressure to the body of the patient in operation.

(23) In non-limiting examples, the patient may be anyone at risk for pressure injuries or already having the pressure injuries, anyone on life support, any bed bound patients that are compromised, any persons that are confined to long hours of sitting, a handicapped person with contractures, those with disabilities, burn victims, surgical patients, or patients undergoing dialysis. The system and method may also be used with other suitable patients, as desired.

(24) In particular embodiments, as shown in FIG. 6, a method 100 for protecting a patient against pressure injury or ulcer formation may include a first step 102 of providing the customizable cushioning device 1. In a second step 104, the user may pressure map the body of the patient to reveal areas of high pressure. In a third step 106, the user determines the areas of the foam matrix 3 to be removed, in order to form the conforming depression 6 configured to accommodate contours of an anatomical region of the patient. It should be appreciated that the conforming depression 6 advantageously facilitates redistribution and offloading of weight of the anatomical region of the patient, as set forth hereinabove. In a fourth step 108, the identified pieces of the foam matrix 3 may be removed, in order to form the conforming depression 6 configured to accommodate contours of the anatomical region of the patient. For example, the user may manually tear away at least a portion of the pillars 4 at the determined area of the foam matrix 3 to form the conforming depression 6 in the anatomical contact side 8 of the foam matrix 3. In a fifth step 110, the foam matrix of the cushioning device may be disposed adjacent and contact the body of the patient that was pressure mapped, in order to provide cushioning and support while also minimizing an opportunity for formation of pressure ulcers.

(25) The utility of the invention was proven by making and testing several prototypes. Some examples of these prototypes include:

Example 1

(26) A device 1 that incorporates the features of the disclosure 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 4 of foam 0.5″×0.5″ that extended into the foam 1.25″. Since the pillars 4 were not cut entirely through to the opposite side of the foam the entire device 1 remained intact. The other side of the foam was uniform without any evidence of cross hatching.

(27) The utility of the device 1 was demonstrated by customizing it to fit a 4″ diameter soft ball. The soft ball was placed in the center of the device 1 and a felt pen was used to outline the edge of the area to be customized. The pillars 4 within the marked area were then picked and plucked with the ones in the center being pinched off and removed at their bases 5 and the ones out towards the perimeter being sequentially pinched off closer to the outer top surface. Once the customizing was complete, a depression 6 in the foam was created so that the soft ball would nestle into the depression 6 with substantially uniform contact with pillars 4 of foam. This customizing required only a few minutes to carry out and did not require any special equipment or machinery to complete.

Example 2

(28) Essentially the same device 1 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 1 that conformed to the desired shape, and bottoming out did not occur when it was tested.

Example 3

(29) This device 1 was cut in the same form as that in the first example device 1 except that the size was approximately 12″×9″×3″, which was found to be more conducive for use on an adult patient.

Example 4

(30) Polyurethane 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 8 of the device 1 had a series of cuts 9 in a grid like fashion that extended from the surface into the matrix 3 to 0.5″ from the bottom (66% of the depth). The device 1 was placed in use to support and offload a baby's head by selectively removing portions of pillars 4 in the central region of the foam to form a depression 6 that precisely fit the head of the baby.

Example 5

(31) Often, where positioning a patient in the proper position, the patient may be positioned with the non-operative side on the surgical surface. Proper alignment, adequate stabilization and support of extremities with sufficient padding minimize integumentary, circulatory and musculoskeletal injury. However, even the most ideal techniques may result in tissue damage, where poorly designed positioning equipment is purchased and used. Additionally, it should be appreciated that the cushioning device 1 may be adapted to the accommodate the occipital bones, or earlobes of the patient. Furthermore, the cushioning device 1 may also be customized for different types of lines, necessary for medical equipment. For example, these lines may be run from the patient's neck or clavicle area to the machine. Depending on how many lines required for the surgical procedure, the cushioning device 1 may be customized to accommodate the lines as well the occipital bones and ear lobes of the patient.

Example 6

(32) Where the patient is brought to a hospital as a trauma patient with head injuries and internal bleeding, one may customize the cushioning device 1 to accommodate the head to alleviate any further swelling to the brain.

Example 7

(33) Patients recovering after lengthily surgery may experience fluid build-up in the back of the head, which increases pressure on the occipitals. Other cushioning devices, including gel cushioning devices, tend to bottom out or cause increased pressure, and do not provide true off-loading of pressure. However, the present cushioning device 1 is customized to support the patients' occipital bones and earlobes for pressure relief. The customizable cushioning device 1 subject to a pressure reading machine, provides pressure readings below 32 mmhg, which is well below the AHRQ government guidelines.

(34) While certain representative embodiments and details have been shown for purposes of illustrating the invention, it will be apparent to those skilled in the art that various changes may be made without departing from the scope of the disclosure, which is further described in the following appended claims.