The present invention generally relates to an apparatus, system, and method for supporting a patient for a medical procedure, and in particular for supporting a patient when positioned in a non-parallel or tilted position, such as in the Trendelenburg position.
When a patient is unconscious, disabled, or otherwise unable to move under their own power, there is difficulty in retaining patient positioning on a hospital bed or operating table. For example, when patients undergo surgery, it is often necessary to tilt the operating table on which the patient rests in order to gain access to the surgical area. Tilting the operating table results in the patient laying supine at an angle, wherein the patient's feet may be above the patient's head or the patient's head may be above the patient's feet. One such common positioning in surgery is the Trendelenburg position, where the patient is tilted at 15° to 45° and the patient's feet are elevated above the patient's head. When in the Trendelenburg position, it is difficult to maintain the patient's position upon the operating table. Current methods of maintaining patient positioning can cause injury to the patient or increase the patient's level of discomfort.
Furthermore, before, during, or after such a procedure, the patient may need to be re-positioned or transferred between surfaces, which can be difficult and time-consuming. Turning, positioning, transferring and/or boosting patient—types of “patient handling” activities—can result in injury to healthcare workers who push, pull, or lift the patient's body weight. For healthcare workers, the most prevalent cause of injuries resulting in days missed from work is overexertion or bodily reaction, which includes motions such as lifting, bending, or reaching and is often related to patient handling. These injuries can be sudden and traumatic, but are more often cumulative in nature, resulting in gradually increasing symptoms and disability in the healthcare worker.
Additionally, there is a risk of patient injury when turning, position, transferring, and/or boosting patients. Current methods of maintaining patient positioning on a support surface do not adequately hold the patient in place without a potential risk of injury to the patient. For patients who may be unconscious, disabled, or otherwise unable to move under their own power, any unintentional patient movement can cause injury or additional patient discomfort.
The present disclosure seeks to overcome certain of these limitations and other drawbacks of existing devices, systems, and methods, and to provide new features not heretofore available.
To understand the present invention, it will now be described by way of example, with reference to the accompanying drawings in which:
While this invention is capable of embodiment in many different forms, there are shown in the drawings, and will herein be described in detail, certain embodiments of the invention with the understanding that the present disclosure is to be considered as an example of the principles of the invention and is not intended to limit the broad aspects of the invention to the embodiments illustrated and described.
The disclosure relates to a system or apparatus for positioning a patient, including an inflatable patient support device, a pad configured to be placed over the device, and/or a pump or other air output for inflation of the device, as well as systems including one or more of such devices and methods utilizing one or more of such systems and/or devices. Various embodiments of the invention are described below. The system may be used for supporting, transferring, positioning, boosting, turning, and/or otherwise moving a patient on a support surface or between support surfaces.
Referring now to the figures, and initially to
The inflatable device 16 is flexible and foldable when in the non-inflated state. The inflatable device 16 is configured to be positioned on the support surface 12 so that a bottom surface 30 of the inflatable device 16 faces or confronts the support surface 12, and is supported by the support surface 12. For example, the bottom surface 30, as shown in
As shown in
The high-friction pad 18 is placed on top of the inflatable device 16 to provide a resting surface for a patient. In one embodiment, the high-friction pad 18 is smaller in size than the inflatable device 16, and is configured for only the upper body of the patient to lie on top of the high-friction pad 18. In another embodiment, the high-friction pad 18 may be of similar size as the inflatable device 16 and may be configured for the entire body of the patient to lie on top of the high-friction pad 18. The high-friction pad 18 is generally shown to include a first section 42 and a second section 44, separated by perforations 46, and arm wraps 48, which in some embodiments include openings 50. In the embodiment shown in
The inflatable device 16 generally includes an inflatable body 40 that defines the internal cavity configured to be inflated with air or another gaseous substance. Referring to
Additionally, the sheet material(s) of the top and bottom sheets 60, 62 may have properties that are desirable for a particular application. Some exemplary characteristics for a selected material include favorable breathability, durability, imagining compatibility, flammability, biocompatibility, pressure distribution profile, heat transmission, electrical conductivity, and cleaning properties. For example, if the inflatable device 16 is intended to be left beneath the patient for an extended period of time, the sheets 60, 62 may be breathable fabrics or other materials that have sufficient breathability to allow passage of heat and moisture vapor away from the patient, while also having sufficient resistance to air passage to retain inflation of the inflatable body 40. As another example, when the inflatable device 16 is used solely as a patient transfer device that is not left beneath a patient for an extended period of time, breathability may not be a primary concern when selecting a material for the sheets 60, 62. In such an embodiment, factors such as durability, ease of cleaning, liquid repellence, and cost may be properties of primary concern. Some examples of materials suitable for use in constructing the sheets 60, 62 that meet these criteria but do not provide a high degree of breathability include woven polyester and non-woven polypropylene. The material(s) of the top and bottom sheets 60, 62 may also include specific frictional properties, as described herein. Additionally, if the inflatable device 16 is designed to be breathable, the material of the top and bottom sheets 60, 62 may have greater permeability to water vapor (i.e., breathability) than its permeability to liquid or air. As an example, the top and/or bottom sheets 60, 62 may be formed of a material that is liquid repellant and/or impermeable and may have little to no air permeability, while being permeable to moisture vapor, such as polyester and/or nylon (polyamide). Some materials may further include an additive, such as coatings, laminates, and the like. For example, a coated nylon taffeta material is one example of a material which can provide these properties, and further, the coating on such a material may have a higher coefficient of friction than the sheet material itself, creating a configuration with a high-friction material (the coating) on one surface and a low-friction material (the sheet material with or without an additive) on the opposite side, as described in greater detail elsewhere herein. The additives to the material may provide one or more of the following: decreasing the static potential (as described below), increasing the coefficient of friction of the top sheet, and decreasing the coefficient of the bottom sheet.
In some embodiments, static electrical potential may form in the inflatable device 16 due to friction caused by airflow through the inflatable device 16, sliding between the top and bottom sheets 60, 62, and/or sliding the inflatable device 16 against the support surface 12. This static potential can create significant electrical shocks in some situations. In order to avoid this effect, an anti-static additive, such as carbon black powder or carbon fiber, may be applied to the top and bottom sheets 60, 62, either as a material additive or as a coating (e.g., a spray or brush-on coating). In another embodiment, the surfaces of the top and/or bottom sheets 60, 62 that face in towards the cavity may be laminated or coated with urethane, PVC, or other material having similar properties. Coating or covering the sheets 60, 62 with such materials may result in a reduction of the static discharge potential of the sheets 60, 62. In another example, conductive threads may be used in the stitching of the inflatable device 16 to ground the apparatus. Other static-reducing techniques may be used in other embodiments.
In one embodiment, the top and bottom sheets 60, 62 are both a nylon taffeta sheet material. The surfaces of the top and bottom sheets 60, 62 that face in towards the cavity may be coated with urethane. The top sheet 60 may have on its top face (outward facing) a urethane laminate additive. In a second preferred embodiment, the top and bottom sheets 60, 62 are both a nylon taffeta sheet material. The top surface of the bottom sheet 62 that faces in towards the cavity may have a PVC coating. The top sheet 60 may have on its top face (outward facing) a polyurethane additive. In other preferred embodiments other combinations of the above materials are used for the top and bottom sheets 60, 62. Materials such as these provide an additional benefit of imaging capability. With some materials and manufacturing processes, radiographic artifacts from the device may appear in and distort images. The materials and manufacturing processes selected for inflatable device 16 preferably will not present any radiographic artifact.
Still referring to
The high-friction pad 18 and, in some embodiments, an additional high friction material, help in maintaining the position of a patient 66 on a support structure 14, as depicted in
Now referring to
In other embodiments, the connection areas 80 are formed by stitching arranged in different shapes, and/or a different connection method (e.g., adhesive, sealing, etc.) is used instead of or in addition to the stitching. In general, the cavity is effectively unable to expand fully (or at all in some circumstances) during inflation at the location of or near each connection area 80, and the connection areas thereby act as inflation-limiting structures. The areas between the connection areas 80 form swells 84, as shown in
The fully inflated device 16 has a shape that is defined by the configuration of the edges 32-38 of the inflatable device 16, and the arrangement of the inflation-limiting structures, among other factors. The arrangement of the connection areas 80 (i.e., spacing, locations, and orientations with respect to each other) may influence the degree of inflation that occurs locally around each connection area 80, and the connection areas 80 may be arranged in various patterns to accomplish specific desired shapes and characteristics of the inflatable device 16 upon inflation.
For example, in the embodiment of
The connection areas 80 of the upper jogged structure are spaced at a distance from the head edge 32 that is greater than the space between the upper jogged structure and the next jogged structure. In this way, a larger swell is created near the head edge, which provides a head support portion for a patient on the inflatable device 16. The head portion is higher than the area of the first pattern 86. Likewise, the connection areas 80 in the second pattern 88 are spaced more closely to each other compared to the first pattern 86, which allows the swells 84 in the area of the first pattern 86 to inflate to a larger degree than in the area of the second pattern 88. In this configuration, the area of the first pattern 86 is slightly raised with respect to the area of the second pattern 88 when inflated, creating greater lift and support for the head and upper body of the patient 66 when resting on the inflated device 16.
In the embodiments of
Referring to
Referring to
As stated above, the passages 90 of the inflatable device 16 are intended to pass air between the bottom surface 30 of the inflatable device 16 and the support surface 12 upon which the inflatable device 16 sits. The effectiveness of these passages 90 in doing so is also impacted by the arrangement of the passages 90 in the bottom sheet 62. Several exemplary arrangements are shown in the figures, and described below. Generally, the passages 90 are arranged entirely, or more densely, in areas of the bottom sheet 62 that are in contact areas, where the bottom sheet 62 contacts the support surface 12 when the inflatable device 16 is inflated and supporting a patient. The inflatable device 16 may also have non-contact areas. In particular, when the inflatable device 16 is inflated, the connection areas 80 and the areas surrounding them are drawn in towards the cavity when inflated (due to the top sheet 60 and bottom sheet 62 being sewn together in these areas) and the bottom sheet 62 in these areas does not contact the surface. Accordingly, passages 90 positioned in this area would not be as effective for the intended purpose. Thus, it is preferred that all or most of the passages 90 are arranged in areas in between and spaced at a distance from the connection areas 80, which are the areas that are in contact with the surface when the device is inflated and supporting a patient.
The distribution of the passages 90 may vary depending on the desired performance of the inflatable device 16. In some embodiments, the passages 90 are more densely distributed in some portions of the inflatable device 16 relative to other portions of the inflatable device 16. The passages 90 in the embodiment illustrated in
The distribution of passages 90 is not limited to the specific arrangements shown in the embodiments of
In some embodiments, the top surface 28 of the inflatable device 16 has at least a portion formed of a high-friction or gripping material and the bottom surface 30 has at least a portion formed of a low-friction material. The high-friction material may be in the form of one or more pieces of high-friction sheet material connected to the high-friction material of the inflatable body 40 in a surface-to-surface, confronting relation to form a layered structure, in various embodiments. For example, the high friction material may be a knitted material, which can enhance comfort, and may be made of polyester and/or another suitable material. The material can then be treated with a high friction substance, such as a hot melt adhesive or appropriate plastic, which can be applied as a discontinuous coating to promote breathability. In another embodiment, both the top and bottom sheets 60, 62 are made from the low-friction material, such as by using a low-friction sheet material, and the high-friction material may be connected to at least the top sheet 60. For example, the high-friction material may be or include a coating applied to the inflatable body 40, such as a spray coating or silkscreen. This coating may be a polyurethane coating that is waterproof and/or breathable in one embodiment. In a further embodiment, the portion of the inflatable body 40 forming the high-friction material (e.g., top sheet 60) may be formed of the high-friction material, while the portion of the inflatable body 40 forming the bottom surface 30 (e.g., bottom sheet 62) may be formed of the low-friction material. It is noted that the high-friction material may form or cover the entire top surface 28 of the inflatable device 16 in one embodiment, or may only form or cover a portion of the top surface 28 in another embodiment, e.g., the low-friction material may form a portion of the top surface 28, with the edges of the high-friction material being recessed from the edges 32-38 of the inflatable device 16. Similarly, the low-friction material may form at least a portion of the bottom surface 30 of the inflatable device 16.
In some embodiments, the bottom surface 30 may also have at least a portion formed of a high-friction or gripping material. In this embodiment, the high-friction material is preferably positioned in the non-contact areas (e.g., the areas of the bottom sheet 62 that are not in contact with the support surface when the inflatable device 16 is inflated). In this way, the bottom sheet 62 has a desirable low friction quality when the inflatable device 16 is inflated and is being used to lift or otherwise maneuver the patient. However, when the inflatable device 16 is not inflated (i.e. is not being used to maneuver the patient) and the patient is laying on top of the inflatable device 16 on a support surface, the high friction material comes into contact with the surface and minimizes slipping and moving of the inflatable device 16 relative to the surface. Any of the high friction materials or additives described above with respect to use on the top surface 28 may also be used on the bottom surface 30. The inflatable device 16 may have a high friction material on the bottom surface 30 that is the same as that which is used on the top surface 28, or the high friction material on the bottom surface 30 may be different than that which is used on the top surface 28. In some embodiments, the high friction material may be a directional glide material, which allows relative movement between the material and an external element (i.e., the support surface, a sheet, a positioning member, etc.) in one or more certain directions and prevents relative movement in other directions.
As described in greater detail below, the low-friction material permits sliding of the inflatable device 16 in contact with the support surface 12. The high-friction material provides increased resistance to slipping or sliding of the patient 66 and/or the high-friction pad 18 on which the patient 66 may be lying, in contact with the inflatable device 16, and increased resistance to slipping of the inflatable device 16 on the support surface when it is not inflated (i.e., not being used for maneuvering of the patient), or a controlled relative movement between elements of the system by way of a directional glide material. The low-friction material may also have rip-stop properties and/or may have suitable structural strength and stability and other performance properties to form the primary structural component of the inflatable device 16. The high-friction and/or low-friction materials can also be treated with a water repellant, such as polytetrafluoroethylene (PTFE). In other embodiments, the high-friction and/or low-friction materials may include any combination of these components, and may contain other components in addition to or instead of these components.
Generally, the high friction material has a coefficient of friction that is higher than the coefficient of friction of the low friction material. In one embodiment, the coefficient of friction for the high-friction material is about 8 to 10 times higher than the coefficient of friction of the low friction material. In another embodiment, the coefficient of friction for the high-friction material is between 5 and 10 times higher, or at least 5 times higher, than the coefficient of friction of the low friction material. The coefficient of friction, as defined herein, can be measured as a direct proportion to the pull force necessary to move either of the materials in surface-to-surface contact with the same third material, with the same normal force loading. Thus, in the embodiments above, if the pull force for the high-friction material is about 8 to 10 times greater than the pull force for the low friction material, with the same contact material and normal loading, the coefficients of friction will also be 8 to 10 times different. It is understood that the coefficient of friction may vary by the direction of the pull force, and that the coefficient of friction measured may be measured in a single direction. For example, in one embodiment, the above differentials in the coefficients of friction of the high-friction material and the low friction material may be measured as the coefficient of friction of the low friction material based on a pull force normal to the side edges 36 and the coefficient of friction of the high-friction material based on a pull force normal to the head and foot edges 32, 34.
Additionally, the coefficient of friction of the interface between the high-friction material and the high-friction pad 18 is greater than the coefficient of friction of the interface between the low friction material and the support surface 12 (which may include a bed sheet). It is understood that the coefficients of friction for the interfaces may also be measured in a directional orientation, as described above. In one embodiment, the coefficient of friction for the interface of the high-friction material is about 8-10 times higher than the coefficient of friction of the interface of the low friction material. In another embodiment, the coefficient of friction for the interface of the high-friction material is between 5 and 10 times higher, or at least 5 times higher, than the coefficient of friction of the interface of the low friction material. It is understood that the coefficient of friction for the interface could be modified to at least some degree by modifying factors other than the inflatable device 16. For example, a high-friction material (e.g., substance or surface treatment) may be applied to the bottom surface of the pad 18, to increase the coefficient of friction of the interface, which may be done in addition to, or in place of, using the high-friction material on the inflatable device 16. An example of a calculation of the coefficients of friction for these interfaces is described in greater detail in U.S. Patent Application Publication No. 2012/0186012, published Jul. 26, 2012, which is incorporated by reference herein in its entirety and made part hereof, which calculation is made using a rip-stop nylon material as the low friction material and a knitted material treated with a hot melt adhesive as the high-friction material. The relative coefficients of friction of the high-friction material and the low friction material used in the example calculation are also described in the aforementioned publication.
Now referring to
A method of attachment of the arm wraps 48 is shown generally in
An alternative arm wrap 49 configuration and method of attachment of the arm wraps 49 is shown generally in
In some embodiments, the arm wrap 49 comprises two separate pieces: one attached to the first strap portions 51A and one attached to the second side portions 51B. In some embodiments, arm wrap 49 may be attached to the high-friction pad 18 by inserting both pieces, opposite the ends of strap portions 51A-B, between the high-friction pad 18 and the counterpart connection strips 112 on the bottom of the high-friction pad 18. In some embodiments, the pieces of the arm wraps 49 may then be sewn or otherwise attached to both the high-friction pad 18 and the counterpart connection strips 112. In still other embodiments, the arm wraps 49 may be sewn or otherwise attached directly to the bottom surface 79 of the high-friction pad 18, such that they are in contact with the inflatable device 16. In other embodiments, the arm wraps 49 may consists of a single, continuous piece of material, such that the arm wrap 49 is folded at the location of attachment to the high-friction pad 18, wherein the straps 51 extend from the central fold. In still other embodiments, the arm wraps 49 may have a different attachment mechanism, such a plurality of snaps or hook and loop fasteners, to attach to the high-friction pad 18.
To secure the patient's arm 72 with the arm wraps 49, the patient's arm 72 is placed between the first strap portion 51A and second strap portion 51B straps. The first strap portions 51A are then wrapped outwards and around the patient's arm 72 while the second strap portions 51B are wrapped inwards and around the patient's arm 72, such that the first strap portions 51A overlap with the second strap portions 51B. The first strap portions 51A connect to the corresponding second strap portions 51B to secure the patient's arm 72 in place. In the embodiment shown, securing strips 119 are used to attach the first strap portions 51A to the second strap portions 51B. When the patient's arm is strapped into arm wrap 49, the space between the straps 51 allows a healthcare provider to retain access to the patient's arm 72, such as shown in
The perforations 46 of the high-friction pad 18 allow a healthcare provider to remove the high-friction pad 18 while in use with a patient 66, as depicted in
The device, as shown in the embodiment of
Port opening 122 of port sock 21 has a retaining mechanism 124, which is provided in the form of an elastic ring. Side handles 126 (e.g., straps or tabs) are disposed at or along an edge of port opening 122 of port sock 21. Side handles 126 are configured to allow for pulling retaining mechanism 124 to stretch open port opening 122 so that an air output 130 can be inserted into port opening 122. Side handles 126 are also configured to allow for pulling retaining mechanism 124 to open port opening 122 for removal of the air output 130. Port sock 21 may also include side pouches 128 configured to engage with a specifically designed nozzle of air output 130, such as the nozzle shown in
A nozzle of an air output 130 which is configured to be disposed within port opening 122 is show in
Referring back to the alternative embodiment shown in
The inflatable device 16 may be configured in alternative arrangements, such as any of those described in U.S. patent application Ser. No. 15/594,195 entitled “Patient Transport Apparatus” and filed May 12, 2017, which is hereby incorporated by reference in its entirety.
All or some of the components of the system 10 can be provided in a kit, which may be in a pre-packaged arrangement. For example, the inflatable device 16 (deflated) and the high-friction pad 18 may be provided in a pre-folded arrangement or assembly, with the high-friction pad 18 positioned in confronting relation with the top surface 28 of the inflatable device 16, in approximately the same position that they would be positioned in use, and the inflatable device 16 and high-friction pad 18 be pre-folded to form a pre-folded assembly. This pre-folded assembly can be unfolded when placed beneath a patient. It is understood that different folding patterns can be used. The pre-folded inflatable device 16 and high-friction pad 18 can then be unfolded together on the support structure 14 to facilitate use of the system 10. Additionally, the inflatable device 16 and high-friction pad 18 can be packaged together, by wrapping with a packaging material to form a package, and may be placed in the pre-folded assembly before packaging. Other packaging arrangements may be used in other embodiments. In other embodiments, the system may also include the air pump 144.
It is understood that all embodiments of the inflatable device 16 shown and described herein may be utilized in the same or a similar method, with the same or similar functionality. As described above, the inflatable device 16 and high-friction pad 18 are placed underneath the patient 66. The system 10 may be used to transfer the patient to a support structure 14. Transfer of the patient is facilitated by inflating the inflatable device 16 to ease the burden on the patient handler and make the transfer easier, as described above. Once on the intended support structure, the inflatable device 16 may be deflated. The patient will then be resting on the support structure 14 above the deflated inflatable device 16 and the high-friction pad 18. The support structure 14 can then be manipulated to change the position of the patient 66, as described above, with the high-friction pad 18 acting to hold the patient 66 in place upon the inflatable device 16 and the high-friction pad 18.
Though the foregoing system 10, and the components thereof, are intended for single use and then disposal, the system 10 and any of the components thereof may be refurbished for reselling and reusing. Refurbishment of the device may include steps such as inspecting the device, removing foreign particles, stains, or odors by washing one or more surfaces of the device, repairing tears or damage to the device, repairing or supplementing the stitching, such as at the seams, replacing any elements or components such as the high-friction pad 18, replacing missing items from a kit, etc. Refurbishing may include decontaminating the system and/or any of the components such as by sterilization means, such as the use of gamma radiation, electron-beam radiation, X-ray radiation, Ethylene oxide (EtO), steam, such as through the use of an autoclave, or any combination thereof. And, refurbishing and reselling may include repackaging the system and elements thereof.
Several alternative embodiments and examples have been described and illustrated herein. A person of ordinary skill in the art would appreciate the features of the individual embodiments, and the possible combinations and variations of the components. A person of ordinary skill in the art would further appreciate that any of the embodiments could be provided in any combination with the other embodiments disclosed herein. It is understood that the invention may be embodied in other specific forms without departing from the spirit or central characteristics thereof. The present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein. The terms “first,” “second,” “top,” “bottom,” etc., as used herein, are intended for illustrative purposes only and do not limit the embodiments in any way. In particular, these terms do not imply any order or position of the components modified by such terms. Additionally, the term “plurality,” as used herein, indicates any number greater than one, either disjunctively or conjunctively, as necessary, up to an infinite number. Further, “providing” an article or apparatus, as used herein, refers broadly to making the article available or accessible for future actions to be performed on the article, and does not connote that the party providing the article has manufactured, produced, or supplied the article or that the party providing the article has ownership or control of the article. Accordingly, while specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention.
This application is a continuation of U.S. patent application Ser. No. 16/007,712, filed Jun. 13, 2018, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/518,668, filed Jun. 13, 2017, both of which are hereby incorporated by reference in their entireties.
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Prism Medical Company, 5300 Ergoglide Instructions, 2009, 2 pp. Maryland Heights, MO. |
Record of Oral Hearing held Dec. 14, 2015, Appeal No. 2015-007832, Reexamination Control No. 90/013,088, mailed Jan. 4, 2016. |
Romedic OneWaySlide, Handicare, Dec. 6, 2010. |
Soule Medical, Patient Positioning Systems Product Catalog, published Jan. 1, 2015, 63 pages. |
Stryker Operations/Maintenance Manual for Stryker Glide Lateral Air Transfer System, Model 3062, date unknown, 33 pages. |
Textbook of Palliative Nursing, Nov. 10, 2005, Oxford University Press, XP002740850, 1 page. |
Waverley Glen, One-Way Glide—The Grimstead Range of Transfer and Repositioning Aids, Ontario Canada, downloaded Jun. 11, 2012, 3 pages. |
Number | Date | Country | |
---|---|---|---|
20230240924 A1 | Aug 2023 | US |
Number | Date | Country | |
---|---|---|---|
62518668 | Jun 2017 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 16007712 | Jun 2018 | US |
Child | 18133034 | US |