The inventive subject matter relates generally to foam-in place apparatus, and more specifically to foam-in-place apparatus adapted to immobilize portions of the body or other physical objects, and methods of making and using such apparatus.
Emergency medical technicians (E.M.T.) are often called to accident scenes in which a person has sustained a bodily injury that should be immobilized. For example, when a patient has a potential head, neck or spinal cord injury, an E.M.T. performs roughly the following procedure. First, the E.M.T. applies a cervical collar, which is a device that is wrapped around the patient's neck to keep the patient's neck midline. Next, the patient is transferred onto a rigid spine board. This is typically performed by rolling the patient on one side, placing the board under the patient, then rolling the patient back onto the board. At this point, the E.M.T. places a “head immobilizer” around the patient's head and cervical collar to prevent any side-to-side motion of the patient's head or neck during transport to an emergency medical facility. If such motion occurs, permanent physical damage could result.
A head immobilizer typically is a cardboard or plastic device, which needs to be unfolded, assembled, and then taped to the spine board in order to be effective. Current head immobilizers are cumbersome devices, which are difficult for the E.M.T. to work with, particularly while the E.M.T. is wearing his or her protective gloves. More importantly, they are extremely time-consuming to use, which places the patient at even more risk of permanent damage or death.
Another problem that exists with current head immobilizers is that, while taping the head immobilizer to the spine board, the E.M.T. usually is forced to reach underneath the board. Often, this results in the E.M.T.'s protective gloves becoming torn on glass or other obstacles or debris located under the board. In addition, because of the difficulty of handling tape with the protective gloves on, and because of the risk of exacerbated injury if the process of securing the head immobilizer takes too long, the E.M.T. may remove his or her gloves during the process. Obviously, torn or removed protective gloves place the E.M.T. at a much greater risk of being exposed to blood or other bodily fluids. Yet another problem with current methods of injury immobilization is that, the more tape that is used in order to immobilize the patient, the more time it will take hospital personnel to remove the head immobilizer, so that they can fully care for the injury.
Techniques for immobilizing other areas of the body (e.g., joints, hands, feet, limbs, shoulders, etc.) also suffer from problems similar to the problems encountered with head and neck immobilization. In addition, medical professionals are sometimes forced to manipulate injured body parts to apply current immobilization devices. This manipulation can further injure the patient.
Besides the medical industry, other industries also continue to develop ways of immobilizing objects in a manner that the objects are less likely to become damaged. For example, a wide variety of packaging technologies have been developed to secure objects being shipped in shipping containers. Often, these packaging technologies require the use of extensive external equipment, which limits their use to companies that have sufficient manufacturing facilities. These technologies are not portable, and thus are generally unavailable to the average person.
Various embodiments of the inventive subject matter, described in detail herein, involve new and novel methods and apparatus adapted to immobilize a body part or other physical structure, and a method of manufacturing the apparatus. Embodiments of the invention have several significant advantages over prior art methods.
First, various embodiments of the apparatus are easy for E.M.T. to use to immobilize a body part while the E.M.T. is wearing protective gloves. Further various embodiments of the apparatus can immobilize a body part more completely and quickly than the head immobilizer system that has been used in the past. Further, various embodiments of the apparatus can immobilize a body part completely, while still being quick and easy to remove.
The base 102 can be formed from a rigid, semi-rigid or flexible material. In an embodiment, the base 102 is formed from cardboard, which allows the device 100 to retain its shape, and also facilitates properly positioning the device on a spine board or other support structure. The size of the base 102 depends on the size of the body part it is intended to immobilize, and the size of the surface that the base 102 is to be secured to. For example, when the device is designed to be secured to a spine board in order to immobilize a head, spine or neck, the base has have a width of approximately 18 inches, and a height of approximately 15 inches, in an embodiment, although the base can be wider, narrower, shorter, or taller, as well.
In an embodiment, the device 100 includes two flexible bags 104, each of which include an interior cavity into which immobilizing foam is deployable. The interior cavity is defined by an inside surface of the flexible bag 104. In an embodiment, bags 104 can be positioned on either side of a patient's head when the device 100 is secured to a spine board, and the patient is laid upon the spine board. In other embodiments, the device 100 includes only one bag, or includes more than two bags.
In other embodiments, the base 102 and bags 104 are relatively positioned in a manner that they can function to effectively immobilize other body parts. In still other embodiments, the base 102 and bags 104 are pre-attached or attachable to a rigid or semi rigid support structure other than a spine board. The support structure can be substantially flat, or can be contoured or molded in a manner that it loosely conforms to a body part to be immobilized. In still another embodiment, a splint is provided that does not include an attached base. Instead, in an embodiment, the flexible bag has significant rigidity to provide support for the foam as it is forming.
Flexible bags 104 are formed from plastic or any other flexible material that is capable of substantially retaining the immobilizing foam during activation of the device. In an embodiment bags 104 are airtight. In another embodiment, bags 104 are not airtight, but are nonetheless capable of substantially retaining the foam. For example, bags 104 include one or more perforated or vented portions (not shown), in an embodiment, which enable gaseous by-products to be vented from the bags 104 during formation of the foam.
In an embodiment, the one or more flexible bags are shaped to at least partially contour to a body part intended to be at least partially immobilized. In other words, in an embodiment, the one or more flexible bags have dimensions that are proportional to the dimensions of a body part intended to be at least partially immobilized. For example, but not by way of limitation, if the splint is intended to immobilize an entire leg, at least one of the flexible bags would have a length proportional to the length of a leg. Alternatively, if the splint is intended to immobilize a finger, the length of at least one of the flexible bags would be substantially shorter.
Flexible bags 104 are attached to base 102 using an adhesive, in an embodiment. In another embodiment, flexible bags 104 include areas that are attachable using a penetrating securing device (e.g., a nail, rivet, screw, staple, hook, or other device). Desirably, these areas do not extend into the cavity into which the immobilizing foam is deployed. In still other embodiments, flexible bags 104 are attached to base 102 using a non-permanent securing device, such as a hook-and-loop (e.g., Velcro) type fastener, a snap, hook, clip, button, or other such device.
In an embodiment, a foam precursor package 106, also referred to herein as a “reactant container,” is positioned within each flexible bag 104 during manufacture of the device 100. Desirably, the foam precursor package 106 is attached to a portion of the bag, in order to stabilize the precursor package and to make sure that it is located in a predictable position. The predictable position can be indicated by a marking (e.g., a circle or other shape) on the top surface of the flexible bag 104, to make it easy for the user to identify the location of the foam precursor package 106.
In addition, foam precursor package 400 includes one or more separation mechanisms 418, in an embodiment, which separate first and second chambers 414, 416 from a mixing chamber 420. Separation mechanism 418 can be a perforation, frangible barrier or other separation mechanism. Separation mechanism 418 can be readily broken or deflected. Accordingly, when the foam precursor package 400 is physically agitated or “activated,” the separation mechanism 418 functions to enable the first and second foam precursors 410, 412 to at least partially exit the first and second chambers 414, 416, respectively, and to combine within mixing chamber 420.
When the foam precursors 410, 412 are combined, they function to produce a reaction, which results in formation of a foam. During the reaction, the foam expands to fill the interior cavity of the flexible bag or bags (e.g., bags 104, 204, 304, 2104, 2204, (
In an embodiment, the foam precursors 410, 412 include two chemicals, where each chemical is held in separation from the other chemical within the foam precursor package 400, prior to activation. When these two chemicals are pre-heated and combined, they expand and produce a foam, which rapidly sets and solidifies.
Polyurethane foam is produced from the combination of the first chemical 410 and the second chemical 412, in one embodiment. In other embodiments, the polyurethane foam is produced from the combination of more than two foam precursor components.
The first chemical 410 includes a member of the isocyanate family with a functionality in a range of 2.0-2.9 (e.g., a diisocyanate), including but not limited to a polymeric MDI, in one embodiment. The second chemical includes a polyol, in one embodiment, including but not limited to a polyether polyol. In another embodiment, the second precursor component includes a polyurethane foam resin.
Various additives may be included in the second chemical, in one embodiment. In alternate embodiments, additives are included in the first precursor component or in both the first and second precursor components. In one embodiment, additives are selected from a group of additives that includes a blowing agent precursor, a surfactant (i.e., a cell control agent), a catalyst, a cross-linker, and a flame retardant. In other embodiments, more, fewer, or additional additives can be included with either or both the first and second chemicals.
The term “Part A” is used herein to refer to the first chemical (e.g., including a diisocyanate) and any additives mixed with the first chemical. The term “Part B” is used herein to refer to the second chemical (e.g., including a polyol) and any additives mixed with the second chemical. In one embodiment, additives are mixed only with the second chemical. In other embodiments, additives are mixed with both chemicals. In still other embodiments, a portion of the polyol may be “pre-reacted” with the isocyanate component to form a “prepolymer” as Part A, which may then be reacted with the Part B component during device activation. In still another embodiment, a “Part C” component may be present, which may include, for example, a catalyst, a flame retardant, and/or another combination of additives. The Part C component may be held in separation from the Part A and Part B components until the device is activated.
When Part A and Part B are combined, various blowing agent precursors combine to generate a chemical blowing agent, which aids in the production of the foam. In one embodiment, the blowing agent is carbon dioxide (CO2). The CO2 may be generated, for example, by the reaction of diisocyanate in Part A with water (H2O) as a blowing agent precursor in Part B, in one embodiment. In alternate embodiments, other chemical blowing agents can be generated through the reaction of Part A and Part B. Alternative physical blowing agents include, but are not limited to, chlorinated fluorocarbons (CFC), hydro chlorofluorocarbons (HCFC), hydro fluorocarbons (HFC), and hydrocarbons such as pentane or butane, for example, but not by way of limitation.
In other embodiments, other chemicals are used as the foam precursors, and/or one or more than two chemicals are used. Desirably, the foam precursors have a property that, when combined, they produce a foam that can readily fill the flexible bag (e.g., bag 104, 204, 304, 2104, 2204, (
In an embodiment, a foam precursor package is formed from two flexible sheets that are selectively sealed to form the first and second chambers. In various other embodiments, a foam precursor package may be formed from one flexible sheet (e.g., folded over and selectively sealed), one or more substantially rigid substrates, a syringe device (e.g., a multiple chamber syringe), a substantially rigid canister, and/or one or more other materials or components.
Referring back to
The layers 110 are attached to the base 102 and/or bags 104 in such a manner that, when activation occurs, the insulator layers 110 are disposed between the flexible bags 104 and the patient's body part or the other physical object. In another embodiment, the flexible bags 104 are formed from a material and/or have a thickness that provides the desired thermal protection, without the use of insulator layers 110.
In an embodiment, the device 100 also includes one or more securing straps 112 and fasteners 114. The securing straps 112 and fasteners 114 are stabilization mechanisms, which perform the function of holding the patient still in relation to the flexible bags 104 and foam, before, during, and/or after activation. For example, if the device is used to immobilize a patient's head, the flexible bags 104 and the foam within them provide a snug nest in which the patient's head rests. One securing strap 112 can be secured across the patient's forehead, and another securing strap 112 can be secured across the patient's chin. Both straps 112 can be removably secured to fasteners 114, so that the patient's head is held securely within the nest provided by the flexible bags 104 and foam.
In an embodiment, a first end of a strap 112 is either permanently or removably attached to a fastener 114 on a first region of flexible bag 104 or base 102, and a second end of the strap 112 is removably attached to another fastener 114 on a second region of flexible bag 104 or base 102. In an embodiment, the attachment between strap 112 and fastener 114 include a hook-and-loop type of attachment mechanisms. Alternatively, the attachment is made using a snap, hook, clasp, frictional, or other type of attachment mechanisms. In still other embodiments, types of stabilization mechanisms other than straps are used.
In an embodiment, the device 100 includes an adhesive surface on the back side of the base 102.
The method begins, in block 602, by pre-heating the foam precursors to a temperature sufficient to ensure that the desired reaction will occur when the chemicals are combined. In an embodiment, the foam precursor package is integrated with the device (e.g., located within the flexible bags) prior to use. In this embodiment, the entire device can be pre-heated, or the portion of the device that includes the foam precursor package can be inserted into a heating unit.
In an embodiment, pre-heating storage unit 710 is receives power from a 112 volt power source. As such, unit 710 is able to receive power from a vehicle battery or other similar source. In alternate embodiments, unit 710 can be battery powered or powered through other sources.
In other embodiments, other types of pre-heating storage units are used in conjunction with the immobilizing device. For example, if the foam precursor package is not integrated with the device, a pre-heating storage unit can be a small, heatable chamber adapted to contain and heat the foam precursor packages separately from the main part of the device. Alternatively, the pre-heating storage unit can be configured to accept the entire device, in a folded or unfolded position. In still other embodiments, the foam precursors are not pre-heated prior to activation.
Referring again to
Referring again to
After affixing the device to the support structure, the portion of the patient to be immobilized is placed in proximity to the device, in block 610.
Once the patient is properly positioned, the foam precursor package or packages are activated, and the foam precursors are combined, in block 612, in order to react and fill the flexible bags with foam. In an embodiment, the foam precursors are combined by the user physically agitating (e.g., squeezing or pressing down) on a foam precursor package (e.g., package 400,
In an embodiment, the bags only partially contour around the patient's body part. This facilitates easy removal of the device from the body part from.
Referring again to
The next figures illustrate inflation of the flexible bags during activation.
In an embodiment, in block 2006, the foam precursor package is formed, including the first and second foam precursor chambers. The chambers are filled with the appropriate foam precursor chemicals. In an embodiment, the foam precursor packages are inserted into and fixed within the flexible bags, in block 2008. As described previously, in other embodiments, the foam precursor packages are not integrated within the flexible bags, but instead are insertable into the bags or attachable to the bags.
The flexible bags are attached to the base portion, in block 2010. For example, the flexible bags are attached using an adhesive, in an embodiment. In other embodiments, the flexible bags are attached using another permanent, semi-permanent or other attachment mechanism.
The insulator sheets are attached to the base or to the flexible bags, in block 2012. The base is folded, in an embodiment, and the device is packaged for distribution. The method then ends.
In another embodiment, the device is attached to the support structure prior to distribution or use. In this embodiment, the base is attached to the support structure using an adhesive or other permanent, semi-permanent or other attachment mechanism. Alternatively the flexible bags can be attached directly to the support structure, using an adhesive or other permanent, semi-permanent or other attachment mechanism.
Various embodiments have been described of apparatus adapted to immobilize a portion of the body, along with descriptions of methods of using such apparatus, and methods for making such apparatus. Embodiments of the invention described above enable body parts, such as a patient's head, neck, spine and other parts to be immobilized and secured.
Other applications would be obvious, based on the description. For example, embodiments of the invention can be used to immobilize other portions of a patient's body, or other physical structures, for that matter. Further, embodiments of the invention can be used in conjunction with other support structures besides a rigid spine board.
For example, a support structure and immobilizing device can be adapted from embodiments described herein to provide immobilization of a foot, knee, leg, torso, shoulder, arm, elbow, wrist, hand, finger, and/or virtually any other body part. For example, but not by way of limitation,
Besides body parts, embodiments of the invention also can be used to immobilize other types of physical structures. For example, but not by way of limitation, embodiments of the invention can be used to immobilize items within a shipping container. In such an embodiment, one or more immobilization devices, of various embodiments, can be placed in a shipping container in proximity to one or more objects being immobilized. Each immobilization device can be activated before or after being placed in the shipping container.
Although the support structure described herein is a substantially flat spine board, in other embodiments, other substantially flat support structures can be used, or support structures can be pre-contoured or contourable in a manner that they can be loosely contoured to the portion of the body or the other physical structure being immobilized. Other modifications, which would be apparent to those of skill in the art, could be made to various embodiments to achieve the same results.
While the foregoing examples of dimensions and ranges are considered typical, various embodiments of the invention are not limited to such dimensions or ranges. Various dimensions of the portions of the device and the support structure depend on the portion of the body or other structure being immobilized.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement that is calculated to achieve the same purpose may be substituted for the specific embodiments shown. In addition, the arrangement of various steps of use and manufacture can be done in the order shown, or in a different order. Many adaptations of the invention will be apparent to those of ordinary skill in the art. Accordingly, this application is intended to cover any adaptations or variations of the invention. It is manifestly intended that this invention be limited only by the following claims and equivalents thereof.
This application claims benefit to provisional application No. 60/492,354, filed on Aug. 4, 2003.
Number | Date | Country | |
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60492354 | Aug 2003 | US |