# Patent

## Title
Device and method for control of hemorrhage

## Abstract

A junctional and truncal tourniquet and a hip-girdling pelvic sling device for maintaining a desired amount of tension surrounding a person's hips and pelvis to securely support and stabilize a pelvis that has been fractured and for securing a pressure applying device to a person so that blood vessel-occluding pressure can be applied. Areas of mating types of fastener material such as mating hook-bearing fastener material and loop pile fastener material are arranged on the device to enable a strap to be secured at various effective lengths to provide a wide range of adjustability. The device may include inflatable bladders, stays, and a chin support and may be wrapped around a patient's neck as a cervical support collar, or around the torso to occlude blood vessels proximal to an injury on a limb.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of application Ser. No. 13/489,293, filed Jun. 5, 2012, entitled DEVICE AND METHOD FOR STABILIZATION OF A FRACTURED PELVIS OR AN INJURED NECK, and claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 61/522,910 filed Aug. 12, 2011, entitled JUNCTIONAL/TRUNCAL/POINT TOURNIQUET—PELVIC BINDER COMBINATION DEVICE.


BACKGROUND OF THE INVENTION
The present invention relates to emergency treatment and control of hemorrhage in places where compression is needed but a tourniquet is not desired, and where control by compression is difficult.
Serious injuries, as in military conflict or automobile collisions, for example, often result in hemorrhage. Two types of hemorrhage that are not addressed well by currently available products are non-tourniquetable compressible hemorrhage and noncompressible hemorrhage.
Internal bleeding due to a fractured pelvis can easily result in death. Rapidly reducing a fracture of a pelvis decreases mortality substantially, and devices are known for reducing a fracture and stabilizing the fractured pelvis in emergency situations, so that a patient can be transported to a hospital or other treatment facility. Stabilization of the pelvis within the first hour after a fracture occurs is critical and may often determine whether the patient lives or dies.
Bleeding can often be stopped on a hemorrhaging wound if direct pressure is applied, but a tourniquet often cannot be used when the wound is either not on an extremity or is too close to the torso for effective tourniquet use. For a non-compressible hemorrhaging wound, direct pressure is not possible or not effective, so one must occlude the vasculature proximal to the injury site. It is common that wounds in the junctional or torso area occur in polytrauma patients, where the bleeding wound is not the only injury. In cases where pelvic fracture is also present, the pelvis should be reduced to a controlled compression level in order to prevent internal exsanguination.
Krieg, et al., U.S. Pat. Nos. 6,554,784 and 7,008,389 disclose devices which can be used to encircle the hips of an injured person and provide a proper amount of hoop tension to urge the parts of a person's fractured pelvic ring toward a normal relationship and thus reduce internal bleeding at the site or sites of fracture.
Ward, U.S. Patent Application Publication Document No. US 2010/0179586 discloses a belt system with inflatable bags attached and adjustable in position, for use in control of hemorrhage in regions of the body where it is difficult to apply conventional compression, but different operators may adjust the belt to different levels of tightness. If stabilization of a pelvic fracture is desired at the same time as arterial hemorrhage control through the bladder, the reduction force to the pelvis may be excessive or the force applied to achieve hemostasis may be inadequate.
Spencer, U.S. Patent Application Publication Document No. US 2010/0152770 discloses a belt system with a screw-in component to provide point pressure. The circumferential compression force of the belt is not controlled, and the screw is fixed in position in the belt. In addition, there is no force or pressure gauge so the arterial compression force cannot be controlled.
Perkins, U.S. Patent Application Publication Document No. US 2010/0100120 discloses apparatus that provides point pressure via a screw, but there is no force or pressure gauge, so arterial compression force cannot be controlled.
SUMMARY OF THE INVENTION
The present invention, as defined by the claims which form a part of the disclosure herein, provides an answer to the aforementioned need for a way to provide pressure to occlude blood vessels or compress a wound, and in one embodiment may embody a device for encircling a pelvis that has been fractured, reducing the fracture, and stabilizing the pelvis by providing a predefined amount of encircling tension. The device will control junctional hemorrhage (groin and axilla) in a tactical environment by applying pressure proximal to or directly over a major arterial bleed.
The present disclosure describes a combination of a binder such as a belt-like device which controls the circumferential compression force to a predefined level, and a harness or similar support system useful in other places on a person, combined with one, two or more point pressure devices which when activated may either occlude vessels or compress a wound. In one embodiment the device is secured using a spring controlled buckle mechanism, which guides the user to a controlled baseline circumferential force. This controlled baseline force ensures that inflation of the point pressure devices will achieve a consistent and desired tissue compression depth for occlusion of the artery. In one embodiment the belt incorporates a flat non-repositionable inflatable backing bladder to provide an additional and customizable force level.
As a first aspect of a device as disclosed herein, a wide belt-like main body of a device for stabilizing a fractured pelvis has a pair of opposite end portions, one of which carries a buckle, and the other of which has an inner end of a strap member attached thereto. The strap member is arranged to extend through the buckle and to be doubled back to extend toward the end of the main body to which its inner end is attached. Fastener material is present in locations providing a wide range of adjustment of the effective lengths to provide a wide range of adjustability.
In one embodiment of the device disclosed herein, fastening material such as VelcroTM hook-bearing fastener material is provided on an outer end portion of the strap, and material such as VelcroTM loop-bearing fastener material is provided along an intermediate portion of the strap.
In one embodiment of the device, a surface of the main body of the device, at the end from which the strap extends, is securely and matingly receptive to hook-bearing fastener material such as VelcroTM hook-bearing fastener material located on the outer end portion of the strap.
In one embodiment of the device disclosed herein, material of much of the outer face of the end portion of the main body of the device is receptive to fastener material of the VelcroTM hook-bearing type, and an area of hook-bearing fastener material of the VelcroTM type is also located on the end portion, where it can engage and grip the loop-bearing fastener material on the intermediate portion of the strap when the strap is doubled back alongside itself and pulled through the buckle far enough for the device to fit around the pelvic area of a relatively slender injured person with the necessary amount of tension.
In one embodiment of the device disclosed herein one or more inflatable bladders may be included in the main body, to provide additional somewhat localized pressure, either as a pelvis-stabilizing device or to assist in closing and supporting tissue around an open wound.
One embodiment of the device described herein includes point pressure devices that can be held by the belt-like portion of the device, either directly over a wound or proximal to the wound to occlude the proximal vessels and stop or control bleeding.
The foregoing and other features of the invention will be more readily understood upon consideration of the following detailed description of the invention taken in conjunction with the accompanying drawings.



BRIEF DESCRIPTION OF THE SEVERAL DRAWINGS
FIG. 1 is an isometric view of a pelvis-stabilizing device that is an exemplary embodiment of an aspect of the present invention.
FIG. 2 is a front elevational partially cutaway view of the pelvis-stabilizing device shown in FIG. 1, showing the device extending around the pelvic area of a person and showing a portion of the skeleton of the person to illustrate the proper location of the device during use.
FIG. 3 is a top plan view of the pelvis-stabilizing device shown in FIGS. 1 and 2, under tension and with the strap shown secured so as to maintain tension to keep the buckle engaged while the device is fastened around a person of a minimum size for use of the device.
FIG. 4 is an isometric front view of end portions of the main body of the pelvis-stabilizing device shown in FIGS. 1-3, illustrating the device secured and under tension at a small circumference, as if to fit a slender person.
FIG. 5 is an isometric view of a buckle useful as a part of the pelvis-stabilizing device shown in FIGS. 1-4.
FIG. 6 is a sectional view of the buckle shown in FIG. 5, taken along line 6-6 of FIG. 5, with the buckle in a relaxed condition.
FIG. 7 is a view similar to FIG. 6, but showing the condition of the buckle when subjected to a predetermined tension to cause the buckle to engage a strap that is a part of the pelvis-stabilizing device shown in FIGS. 1-4.
FIG. 8 is a view similar to FIG. 4 showing the pelvis-stabilizing and supporting device under tension so that the buckle engages the strap, at a larger circumference than that shown in FIG. 4, as if properly in place on a larger person.
FIG. 9 is a view similar to FIG. 8, showing the pelvis-stabilizing and supporting device with the strap under tension and engaged by the belt at yet a larger circumference than that shown in FIG. 8, as if properly secured in place on a yet larger person.
FIG. 10 is a view similar to FIG. 9, showing the pelvis-stabilizing and supporting device with the strap under tension and engaged by the buckle as if properly secured in place around a person of yet larger circumference, near the maximum for the size of the device.
FIG. 11 is an isometric view of an alternative embodiment of the pelvis-stabilizing device shown in FIGS. 1-10, which may also be used as a cervical collar for the protection of a person's neck.
FIG. 11A is a sectional view taken along line A-A in FIG. 11.
FIG. 12 is an isometric view of the main body portion of a pelvis-stabilizing device which is another alternative embodiment of the device shown in FIGS. 1-10.
FIG. 13 is an isometric view of the main body portion of a pelvis-stabilizing device which is yet a further alternative embodiment of the device shown in FIGS. 1-10.
FIG. 14 is a perspective view showing the pelvis-stabilizing device shown in FIGS. 11 and 11A in use as a cervical collar to support a person's neck.
FIG. 15 is a perspective view of a pelvis-stabilizing device which is yet another alternative embodiment of the device shown in FIGS. 1-10, which may also be used as a cervical collar to support a person's neck.
FIG. 16 is a perspective view of the pelvis-stabilizing device shown in FIG. 15 in use as a cervical collar to support a person's neck.
FIG. 17 is a view of an end portion of the main body of a pelvis-stabilizing and neck-supporting device similar to that shown in FIG. 15 and incorporating a chin rest, shown in a non-deployed position with respect to the body portion of the pelvis-stabilizing and neck supporting device.
FIG. 18 is a view similar to FIG. 17, showing the chin rest in a deployed position.
FIG. 19 is a perspective view of the pelvis-stabilizing and neck supporting device shown in FIGS. 17 and 18 in use as a cervical collar to support a person's neck.
FIG. 20 is an isometric view of a junctional and truncal point tourniquet and pelvis-stabilizing device that is an exemplary embodiment of one aspect of the present invention.
FIG. 21 is an isometric view of another junctional and truncal point tourniquet and pelvis-stabilizing device that is an exemplary embodiment of one aspect of the present invention, in which a main body is of a minimal width.
FIG. 22 is an isometric view of the main body portion of a device such as that shown in FIG. 21, together with an inflatable bladder attached to the main body portion of the device.
FIG. 23 is a front elevational view of the junctional and truncal point tourniquet and pelvis-stabilizing device shown in FIG. 21, together with an inflatable bladder attached to the main body portion of the device, in use on a pelvic area of a person.
FIG. 24 is a side elevational view showing how a junctional and truncal point tourniquet and pelvis-stabilizing device shown in FIG. 20 might be used on a person in a selected one of three different possible positions to stabilize a fractured pelvis.
FIG. 25 is a front view of the junctional and truncal and point tourniquet and pelvis-stabilizing device shown in FIG. 20 in use, with a pair of inflatable point pressure exerting members located so as to occlude a person's femoral arteries.
FIG. 26 is a front view of the junctional and truncal and point tourniquet and pelvis-stabilizing device shown in FIG. 21 in use, with a pair of inflatable point pressure exerting members located so as to occlude a person's femoral arteries.
FIG. 27 is a front elevational view showing the device shown in FIG. 21 applied around a patient's upper torso, so as to occlude an axillary artery.
FIG. 28 is an isometric view of the device shown in FIGS. 21, 22, and 26, rolled into a compact configuration for packaging.
FIG. 29 is an isometric view of an inflatable pressure application device such as the ones shown in FIGS. 20, 21, 24, 25, and 26 in a deflated condition.
FIG. 30 is an isometric view of the device shown in FIG. 29 in an inflated condition and inverted.
FIG. 31 is a sectional view taken along line 31-31 in FIG. 29.
FIG. 32 is a sectional view taken along line 31-31 of FIG. 29, but showing the flexible bladder in a inflated condition.



DETAILED DESCRIPTION OF EMBODIMENTS
Referring first to FIGS. 1-4 of the drawings which form a part of the disclosure herein, a pelvis supporting and stabilizing device 12 for stabilizing a fractured pelvis, hereinafter often called a pelvic sling, is shown in FIG. 1 ready for application to a person to provide stabilization and support for a fractured pelvic ring by encircling the hip region of a person. A main body portion 14 is of strong flexible material and has the general shape of a wide belt. A buckle 16 is attached to a first end portion 18 of the main body 14 by a small loop of a strap 20 of strong fabric such as woven webbing, permanently attached to the first end portion 18, as by being sewn securely to it. As used herein the term “permanently attached” means that removal and reattachment are not easily accomplished by a user and cannot be accomplished readily without use of equipment such as that needed for initial manufacture. The fabric of the strap 20 also defines a large loop 22, attached to the first end portion 18 so that it can be used as a handle by a person applying the pelvic sling 12 to an injured person, as will be explained more fully presently.
A central portion of the main body 14 may be covered on an exterior face by a sheet 24 of low friction flexible plastic material which will be exposed on the posterior side of a person on whom the pelvic sling 12 is in use, facilitating movement of such person on a backboard or other support.
At a second end portion 26, opposite the first end portion 18, an inner end 28 of an elongate flexible strap 30 is permanently attached to the main body 14, as by being sewn, riveted, or thermally or sonically welded securely to the second end portion 26 of the main body 14. The strap 30 extends longitudinally away from the second end portion 26, generally aligned with the longitudinal axis 32 of the main body 14. An outer end portion 34 of the strap 30 may include a loop 36 of strong fabric such as Nylon webbing attached to an intermediate portion 38 of the strap 30, which may be of heavier and consequently slightly stiffer, yet still flexible, webbing. The loop 36 may be securely sewn or otherwise permanently attached to the intermediate portion 38 of the strap 30. The loop 36 is thus available for use as a handle to pull the strap 30 away from the buckle 16, as will be explained more fully presently.
Pairs of holes 40 may be defined in the intermediate portion 38 of the strap 30. The holes 40 of each pair are aligned with each other transversely across the width 42 of the strap 30 and loop 36, which may be about two inches, for example. Adjacent pairs of holes 40 may be evenly spaced apart longitudinally of the strap 30 at a pitch 44 of for example, 0.625 inch, so as to permit the effective circumference of the pelvic sling 12 to be adjusted in increments small enough to provide a desirable amount of tension in the pelvic sling 12 encircling a person's hips to stabilize a fractured pelvis.
The main body portion 14 may be of laminated fabric, and may include a central layer of padding material (not shown), between an inner layer 46 of a comfortably soft yet strong fabric such as a Nylon tricot material, on the side of the main body 14 intended to be placed against a person, and an exterior layer 48 of a strong fabric such as a tricot material of Nylon or another synthetic material brushed to produce a nap of fiber loops that can act as a fastener material of a first kind, such as a loop-bearing fastener material capable of being engaged matingly by a fastener material of a second kind, such as a hook-bearing flexible fastener material such as that well known under the trademark Velcro. As used herein, the terms “loop-bearing fastener material” and “hook-bearing fastener material” will refer to fastener material that functions similarly to the VelcroTM combination of loop-pile fabric and “thistle-cloth” to stick removably together. Thus, for example, such loop-bearing fastener material is a first kind of flexible fastener material and such hook-bearing material is a second kind of flexible fastener material that can matingly engage the first kind of flexible fastener material.
A binding 49 may be provided around the exterior margin of the main body 14, and an adhesive may also be used to keep the inner and exterior layers 46 and 48 together with the central layer.
An exterior side 50 of the intermediate portion 38 of the strap 30 may be covered by a layer of a flexible loop-bearing fastener material 52, securely attached to the strap 30, as by being sewn to the webbing. Such loop-bearing fastener material 52 ideally may be present along the entire exterior side or face 50 of the strap 30, the side that is exposed in the same general direction as the exposed face of the exterior layer 48, from a point abutting the outer end portion 34 to the second end portion 26 of the main body 14, and may be present on the inner end 28 of the strap 30.
A piece of hook-bearing fastener material 54 may be securely attached to the exterior side 50 of the outer end portion 34 of the strap 30, as by being sewn to the webbing material forming the loop 36. Thus the area hook-bearing fastener material 54 may abut against the loop-bearing fastener material 52 on the exterior side 50 of the intermediate portion 38 of the strap 30.
At least one area 58 of hook-bearing fastener material is located on the second end portion of the main body 14. Advantageously, each area 58 may be a narrow, elongate piece of hook-bearing fastener material with a width 60 less than the width 42 of the strap 30, and a length 62, extending generally parallel with the longitudinal axis 32 of the main body portion 14. Such elongate areas 58 may be separated laterally from one another by a distance 64. For example, where the width 42 of the strap 30 is two inches, the width 60 of each area 58 may be about 0.75 inch, and the distance 64 between areas 58 may be about one inch. The length 62 may be as great as can be accommodated in the second end portion 26 and thus may be, for example, in the range of about 5 inches to about 7.3 inches, depending on the size of the pelvic sling 12. As will be understood in light of subsequent explanation, the foregoing dimensions are not critical, but the relationships of the width 60 and the distance 64 with the width 42 of the strap 30 can provide significant functional advantages.
As may be seen in FIG. 2, when the pelvic sling 12 is properly in place on an injured person, it encircles the person's hips and buttocks at the level of the greater trochanters 66 and the symphysis pubis, with the main body portion 14 extending around the posterior of the person. The first and second ends 18 and 26 extend forward around the person's body and toward each other at the anterior side of the abdomen, with the strap 30 extending through the buckle 16 and doubled back toward the second end portion 26 of the main body portion 14, along the exterior of the pelvic sling 12. Although the pelvic sling 12 is shown consistently in one orientation herein, it is to be understood that it may be symmetrical in shape, about the central longitudinal axis 32, and thus can just as well be placed on a person with the buckle 16 and strap 30 oriented oppositely with respect to the person.
When the pelvic sling 12 is properly in place there is a prescribed amount of tension maintained in the main body portion 14 as it encircles the injured person, so that a fracture 70 in the pelvic ring is reduced. That is, the portions of the fractured bone are held together and stabilized by the tension in the pelvic sling 12. This tension is maintained by engagement of the buckle 16 with the strap 30. The desired amount of tension exerted on the buckle 16 by the strap 30 causes a portion of the buckle 16 to move, exposing pins 72 which extend through the ones of a pair of holes 40. As shown in FIGS. 2, 3, and 4, the outer, or pulled end, part 80 of the intermediate portion 38 of the strap 30 extends along the second end portion 26 of the main body 14, parallel with the outer surface of the exterior layer 48 when the device 12 is adjusted to a nearly minimum circumference. The loop-bearing fastener material 52 on the exterior side 50 of the strap 30 is aligned with and in mating contact with one of the areas 58 of hook-bearing fastener material, as shown in FIG. 2, so that the hook-bearing material 58 is matingly engaged with the loop-bearing fastener material 52 on the strap 30. Mating engagement of the fastener materials 58 and 52 is sufficient to maintain the tension in a portion 74 of the strap 30 between the inner end 28 and the buckle 16 to keep the pins 72 engaged in the holes 40 and thus keep the strap 30 engaged with the buckle 16.
The buckle 16 may be substantially similar to the buckle described in U.S. Pat. No. 7,008,389. Thus, as shown in FIGS. 5, 6, and 7, the buckle 16 includes two main parts, a rigid frame 82 and a sliding block 84. One side of the frame 82 is secured to the first end portion 18 of the main body portion 14 by a small loop of the fabric of the strap 20. The sliding block 84 is moveable relative to the buckle frame 82 in the directions indicated by the arrow 86. The strap 30 may extend through the opening defined by the frame 82, sliding along the contact surface of the curved face 87 of the sliding block 84 when the strap 30 is pulled to tighten the pelvic sling 12 about a person's pelvis. A pair of holes 88 are defined in the sliding block 84, and the pins 72 extend into the holes 88, with their ends preferably flush with the face 87 when the buckle 16 is not in tension. When a pair of holes 40 in the strap 30 then move into alignment with the holes 88 in the sliding block 84 the sliding block 84 is moved leftward toward the position shown in FIG. 6, so that the pins 72 protrude from the holes 88 and can extend through the holes 40, thus engaging the strap 30 and preventing it from moving relative to the buckle 16, apart from any differences in size between the pins 72 and the holes 40.
FIGS. 6 and 7 show a spring 90 positioned around one of the pins 72. An identical spring 90 may be used on the other pin 72. The springs 90 are compressed significantly when the sliding block 84 is in its fully extended position, as shown in FIG. 5, so that substantial force must be applied to the buckle 16 by tension in the straps 20 and 30 before the sliding block 84 begins to move relative to the buckle frame 82. Internal springs 90 are compressed further as the sliding block 84 moves leftward toward the position shown in FIG. 6 when there is sufficient tension in the strap 30. Flanges 92 on the buckle frame 82 are engaged by lips 94 on the sliding block 84 when the sliding block 84 is in the fully extended position as shown in FIGS. 5 and 6, thus withstanding the compressive force in the springs 90.
As the sliding block 84 moves leftward toward the position shown in FIG. 2 from the position shown in FIG. 6, the lips 94 ride up and over the tops of the ramps 96 beneath the flanges 92, so that movement of the sliding block 84 may create an audible click as the sliding block 84 moves along the pins 72 and the pins extend into the holes 40, indicating to the user that the buckle 16 is engaged with the strap 30. Thereafter the inwardly directed elastic force in the sides of the sliding block 84 presses the lips 94 against the ramps 96 and helps to keep the pins 72 engaged in the holes 40, so that a slightly lower amount of tension in the portion 80 of the strap between the pins 72 and the loop 36 is sufficient to keep the sliding block in the leftwardly depressed position, once the pins 72 have become engaged in the holes 40 as shown in FIGS. 2 and 4.
As the strap 30, when the outer end 34 is pulled away from the buckle 16, passes over the curved face 87 of the sliding block, when the predetermined tension is applied to the buckle 16 by the strap 30, the sliding block 84 moves, further compressing the springs 90 and allowing the pins 72 to extend from the holes 88 and proceed through the holes 40, preventing further movement of the strap 30 around the sliding block 84. The holes 40 in the strap 30 may have a slightly larger diameter than the largest transverse dimension of the pins 72, so that engagement of the pins 72 in the holes 40 occurs easily and smoothly at the desired tension in the strap 30. Thus, as described in previously mentioned U.S. Pat. No. 7,008,389, when the proper amount of tension has been reached in the portion of the pelvic sling 12 wrapped around an injured person, the buckle 16 will engage the strap 30, and so long as tension in the pulled portion 80 of the strap 30 extending beyond the buckle 16 is not greatly reduced, the pins 72 will remain engaged in the holes 40. It will be understood that the buckle 16 could be constructed to include only one pin 72 or more than two pins 72 and that the strap 30 could be provided with compatibly located holes 40.
Once the pins 72 have engaged the holes 40, tension should be substantially maintained in the outer or pulled portion 80 of the strap 30, and the pulled portion 80 should be moved toward the person on whom the pelvic sling is being used and should be pressed against the outer end portion 26 of the main body 14 to engage the two mating kinds of fastener material with one another to retain the strap 30 at the desired location.
It would be possible to use other buckles (not shown), instead of the buckle 16, so long as such buckles can sense a predetermined amount of tension and engage the strap 30 in response.
As a result of the locations and sizes of the areas of hook-bearing fastener material 54 and 58 and the loop-bearing fastener material 52 on the exterior face 50 of the strap 30, the portion 80 of the strap 30 extending outside the buckle 16 and being pulled by a person applying the pelvic sling 12 to an injured person is able to be securely held by the combination of hook-bearing fastener material and loop-bearing fastener material at any effective circumference of the pelvis stabilizing pelvic sling device 12 at which the pins 72 of the buckle 16 may be engaged in a pair of holes 40 along the strap 30. Thus, as shown in FIGS. 2, 3, and 4, with the effective circumference of the pelvic sling 12 at or near a minimum, the area of hook-bearing fastener material 58 aligned centrally along the second end portion 26 of the main body is engaged with a confronting portion of the loop-bearing fastener material 52 on the exterior side 50 of the strap 30. An available area of hook-and-loop fastener engagement is thus equal to the area of the hook-bearing fastener material 58 of one of the 3 strips shown in FIG. 1, and the mated fastener materials can hold the outer, or pulled end, portion 80 of the strap 30 securely enough to maintain enough tension in that portion 80 of the strap 30 so that the pins 72 of the buckle remain exposed beyond the sliding block 84 and engaged in the holes 40 of the strap 30.
In FIG. 8, the pelvis-stabilizing pelvic sling 12 is shown in tension as when in place on a person having a larger girth, and the loop-bearing fastener material 52 of the intermediate portion 38 of the strap 30 is not aligned with the area of hook-bearing fastener material 58. Instead, as shown in FIG. 8 the hook-bearing fastener material 54 mounted on the loop 36 of the outer end portion 34 is engaged with the loop-bearing fabric of the exterior layer 48 of the outer end portion 26 of the main body 14 on each side of the centrally located area of hook-bearing fastener material 58. As previously mentioned the fabric of the exterior layer 48 functions as loop-bearing fastener material. Accordingly, engagement of the area of hook-bearing fastener material 54 with the fabric 48 maintains sufficient tension in the outer, or pulled, portion 80 of the strap 30 to keep the pins 72 of the buckle 16 engaged in a pair of holes 40 in the strap 30, to maintain the proper amount of tension in the pelvic sling 12 to support and stabilize a person's fractured pelvis. It will be apparent that the loop 36 could be located slightly differently with the same position of the strap 30 with respect to the buckle, as shown in broken line. Thus the hook-bearing fastener material 54 could engage the fabric of the exterior layer 48 largely between two of the areas 58 of hook-bearing fastener material, overlapping somewhat on each of the areas 58, rather than by straddling a single area 58.
As shown in FIG. 9, with the pelvis-stabilizing pelvic sling 12 in place under proper tension on a somewhat larger person than in FIG. 8, the hook-bearing fastener material 54 on the loop 36 at the outer end 34 of the strap 30 may be engaged with loop-bearing fastener material 52 at the inner end 28 of the strap 30 where it is attached to the second end portion 26 of the main body 14 and may also be engaged with the fiber loops of the fabric of the exterior layer 48 of the outer end portion 26, to the extent that the area of hook-bearing fastener material 54 extends beyond the inner end portion 28 of the strap 30.
As may be seen in FIG. 10, with the pelvis-stabilizing pelvic sling 12 under the proper amount of tension to stabilize and support a fractured pelvis in an even larger person, the hook-bearing fastener material 54 on the loop 36 at the outer end of the strap 30 can mate securely with the loop-bearing fastener material 52 on the portion 74 of the strap 30 between the second end portion 26 of the main body 14 and the buckle 16. The mated hook-bearing fastener material 54 and loop-bearing fastener material 52 securely maintain sufficient tension in the strap 30 as it is engaged with the buckle 16 to keep the pins 72 engaged in a pair of holes 40 in the strap 30.
Thus by referring to FIGS. 4, 8, 9, and 10, it may be seen that, regardless of the circumference of the person on whom the device 12 is being used, within a relatively wide range of different circumferences, application of the device 12 is very straightforward. As a result of the availability and locations of the areas of flexible fastener material of two mating kinds, located on the second end portion 26 of the main body 14, on the strap 30, and on the loop 36, the outer, or pulled end, portion 80 of the strap 30 that extends beyond the buckle 16 can be fastened securely enough to maintain tension in the strap 30 to act against the sliding block 84 and thus maintain engagement of the buckle 16 with the pins 72 in any of the pairs of holes 40 along the part of the strap 30 extending beyond the second end portion 26 of the main body 14.
As the inner end portion 28 of the strap 30 is permanently attached to the second end portion 26 of the main body 14, adjustment of the pelvic sling 12 to provide the required amount of compression of the pelvis of an injured person is accomplished by pulling the strap 30 through the buckle 16, without first having to assemble any parts of the device. The pelvic sling 12 is placed around the hips of an injured person suspected of having a broken pelvis by sliding the main body portion 14 beneath the hips of the injured person. With the person lying in a supine position, the exterior side of the main body 14, the side shown in FIG. 1, should be downward. This permits the low friction plastic sheet 24 to slide easily along a surface of a backboard or other surface on which the person is resting, and exposes the necessary portions of the pelvic sling 12 so that it can be fastened.
Proper application of the pelvic sling 12 to an injured person thus can be accomplished simply and rapidly. First the sling should be placed at the level of the greater trochanters 66 and symphysis pubis, and the loop 36 and strap 30 must be passed through the opening in the frame 82 of the buckle 16 and around the curved face 87 of the sliding block 84. The pelvic sling can be tightened around a person by pulling the strap 30 and the buckle 16 in opposite directions, using the large loop 22 as a handle to pull toward the patient's left, as shown by the arrow 76, and, by using the large loop 36 as a handle, pulling the outer end 34 of the strap 30 in the opposite direction when the strap 30 extends through the buckle 16 and is doubled back toward the injured person's right side, as indicated by the arrow 78 in FIG. 2. The strap 30 is thus pulled through the buckle 16 until sufficient tension is achieved to move the sliding block 84 and allow the pins 72 to become engaged in a pair of holes 40 in the strap 30. While maintaining tension in the outer portion 80 of the strap 30 against the buckle 16, the flexible fastener materials can be engaged in one of the several alignments as described above to retain the tension in the strap 30 relative to the buckle 16 and thus to keep the pins 72 engaged in the holes 40 of the strap 30 at any effective circumference of the pelvic sling 12 at which the pins 72 are able to become engaged in a pair of holes 40.
Thus, engagement of the loop-bearing fastener material 52 of the strap 30 with the hook-bearing material in the areas 58 on the second end portion gives a first range of smallest available effective circumferences of the pelvic sling 12. Engagement of the fabric of the outer layer 48 of the second end portion of the main body 14 gives a second range of available, somewhat larger effective circumferences of the pelvic sling 12. Finally, engagement of the area 54 of hook-bearing fastener material of the outer end 34 of the strap with the loop-bearing fastener material 52 on the intermediate portion 38 of the strap 30 gives a third range of available effective circumferences, and the adjacent parts of the ranges overlap each other.
The pelvic sling 12 is made from a minimal number of components, and preferably of materials which are, except for the springs 90, radiolucent, and is ready for application as manufactured.
The pelvic sling 12 may be provided in various sizes. A normal size pelvic sling 12 may have a length 98 of its main body of, for example, 24 inches, and larger and smaller sizes may be provided for use with very slender or very large persons. For a normal size pelvic sling 12 the length of the strap 30 combined with the extent of the loop 36 may be similar to or slightly shorter than the main body length 98.
While the description above has described the use of hook-bearing fastener material and loop-bearing fastener material, other two-component flexible fastener systems could also be used by similar placement of areas of the two matable fastener kinds on the strap 30 and a second end portion of a main body 14.
Referring next to FIGS. 11 and 11A, a pelvic sling 112 may also be used as a cervical support, hereinafter simply called a cervical collar, that can be wrapped around a patient's neck, as will be explained presently. The pelvic sling 112 is in many ways similar to the pelvic sling 12, and so like reference numbers will be used with like components of the pelvic sling 112. The pelvic sling 112 includes an inflatable bladder 114 in a central portion of the main body 14, where it may be located between two fabric layers 48 and 46. A fill tube 120 communicating with the bladder 114 may be provided on the outer side of the pelvic sling 112 at the first end portion 18 of the main body portion 14. A suitable fill fitting 122 may be provided on the fill tube 120 to permit temporary attachment of a squeeze bulb (not shown) or connection to another source of air to inflate the bladder 114. The fill fitting 122 may include a check-valve or other closure to maintain inflation of the bladder as required.
A piece of loop-bearing fastener material 123 may be provided on the second end portion 26 of the main body 14 as shown in FIG. 11, to supplement the loop-bearing nature of the fabric layer 48 if desired, to provide for secure engagement with the hook-bearing material 54 on the loop 36 at the outer end portion 34 of the strap 30.
A pair of elongate stays 124 and 126 are attached to the main body portion 14, as by strips 128 and 130 of strong fabric such as nylon webbing material sewn to the outer layer 48 of fabric of the main body portion 14. The strips 128 and 130 of fabric might also be attached by other means such as thermal welding or adhesives, if more practical. The stays 124 and 126 are spaced apart from each other along the length of the main body 14 and may reside near or even overlapping the respective opposite ends of the bladder 114, as may be seen in FIG. 11A. The stays 124 and 126 may be narrow and elongate, and are held where they extend transversely across the length of the main body 14, parallel with each other, where they can provide support along the opposite sides of a patient's neck when the pelvic sling 112 is utilized as a cervical collar, as will be explained in greater detail presently.
Each of the fabric strips 128 and 130 may thus have a length equal to the width of the main body portion 14 of the pelvic sling 112 and a width, parallel with the length of the main body 14 of, for example, about two inches. Each stay 124 and 126 may each have a length enough less than the width of the main body portion 14 to permit the opposite ends of the pieces of fabric 128 and 130 to be fastened securely to the main body 14 to capture the stays 124 and 126.
Each stay 124 or 126 may have a width of, for example, about 0.5 inch (1.25 mm), although the specific dimensions are not critical. Each of the stays 124, 126 may be made of a suitable metal with sufficient thickness to provide firm support for the main body 14. For example the stays 124, 126 may be of sheet steel or sheet aluminum, or a suitable composite material such as a fiber-reinforced resin of ample strength, with some amount of flexibility and resiliency.
It should be understood also that there might be only one, or more than two stays 124 and 126. Also, the stays might extend diagonally and might not be parallel with one another, in different embodiments of the pelvic sling, and might be wider and less elongate, or in the nature of small plates of metal. In one version such stays or plates might be malleable enough to be bent to a desired configuration to help support a patient's neck or pelvis.
An area 132 of flexible fastener material of the second kind, such as hook-bearing flexible fastener material, may be provided on the loop 36 at the outer end of the strap member 30, facing in the same direction as the inner side of the strap member 30, and thus opposite the hook-bearing material 54 on the outer end portion of the strap member 30, to be used to fasten the outer end 34 of the strap member 30 to the intermediate portion 38 of the strap member 30. The area 132 of fastener material may, as shown in broken line in FIG. 11, be an extension of the area of 54 of hook-bearing flexible fastener material with one part thereof located as described with respect to the separate piece 132 so as to be exposed on the inner side of the strap member 30 at its outer end 34.
A flexible tension-bearing member of another sort, such as a flexible cord, or cable, might also be attached to the second end portion 26 and used with a suitable fastener of a different sort, such as a spool or hook, (not shown) in place of the buckle 16 on the first end portion 18 of the main body portion 14, to hold the main body around a patient's fractured pelvis. Another sort of fastener (not shown) might then be used together with the flexible tension-bearing member to secure the elongate main body portion 14 wrapped around the neck of a patient P.
A pelvic sling 140 that can also be used as a cervical collar is shown in FIG. 12, but with only a short portion of the strap member 30. The pelvic sling 140 is similar in most respects to the pelvic sling 112, and so will be described in detail only with respect to the significant differences. The principal difference in the pelvic sling 140 is that it includes three separate bladders, each somewhat smaller than the bladder 114 as illustrated in FIGS. 11 and 11A. A central bladder 142 is the largest of the three and is located in substantially the same position, centrally within the main body portion 14, as the bladder 114 is in the previously described pelvic sling 112. Two more, smaller, bladders 144 and 146 are located respectively in the first end portion 18 and the second end portion 26. The bladders 142, 144, and 146 may all be installed in the same general manner as is the bladder 114 shown in FIGS. 11 and 11A, and respective fill tubes and fill fittings (not shown), may be utilized to inflate each of the bladders 142, 144, and 146, or the bladders may be interconnected with each other and inflated through a single fill tube. The stays 124 and 126 and their associated retaining fabric pieces 128 and 130 are, as shown in FIG. 12, located similarly to their locations as in the pelvic sling 112 shown in FIGS. 11 and 11A and are between the central bladder 142 and the respective one of the end bladders 144 and 146.
A pelvic sling 150 is yet another embodiment of the pelvic sling, as shown in FIG. 13. The pelvic sling 150 is generally similar to the pelvic sling 140 shown in FIG. 12, except that it lacks the stays 124 and 126 and their associated fabric strips 128 and 130, and, as a result, there is room for the central bladder 152 and respective end bladders 154 and 156 to be somewhat larger and extend toward each other slightly more closely than the similar locations of the bladders 142, 144, and 146 of the sling 140. The bladders 142, 144, and 146 may be inflated when the pelvic sling 112 or 140 is used, taking care not to provide too much tension in the pelvic sling.
Referring next to FIG. 14, the pelvic sling 112 is shown as used as a cervical collar on a patient P. For use of the pelvic sling 112 as a cervical collar, the main body portion 14 is wrapped around the neck of the patient P. The device 112 is placed around the neck of the patient P with the buckle 116 extending beyond the first end 18 of the main body portion and toward the posterior of the patient on the patient's right hand side. The strap member 30 is extended around the main body portion and overlapped onto its own intermediate portion 38, and the outer end 34 of the strap member 30 is fastened to the intermediate portion 38 by mating interaction between the two types of fastener material. Thus when using the VelcroTM type hook-and-loop fastening materials described above, the piece of hook-bearing fastener material 132 on the outer end 34 of the strap member 30 mates securely with the loop-bearing fastener material 52 on the exterior side 50 of the intermediate portion 38 of the strap member 30. The second end portion 26 of the main body portion 14 of the pelvic sling 112 overlaps the first end portion 18 and can be positioned by the medical service provider applying the device 112 as a cervical collar to provide the needed support for the chin of the patient P. With the device ideally located the stays 124 and 126 extend vertically along the neck of the patient P, providing stiffness in a lateral direction with respect to the main body portion 14, that is, generally vertically along the neck of the patient P as shown in FIG. 14. Medical personnel can, if necessary, bend one or both of the stays 124, 126 to conform as desired to the patient's shoulders, neck, and head, and the device 112 can be placed on the neck of the patient P in the location deemed most appropriate to place the stays 124 and 126 where required, which may ordinarily be in a generally symmetrical arrangement with the stay 124 near the patient's left ear or jaw and the stay 126 near the patient's right ear or jaw. With the device wrapped around the neck of the patient P and the outer end 34 of the strap member 30 secured to the intermediate portion 38 of the strap 30 as shown in FIG. 14, the bladder 114 may be inflated as desired to provide support and to cause the interior layer 46 of fabric of the main body portion 14 to conform to and press against the neck of the patient P with a desired amount of pressure, by adjusting the extent of inflation of the bladder 114. Either the pelvic sling 140 or the pelvic sling 150 would also be applied to the support the neck of a patient P in the same manner shown in FIG. 14, with the exception of additionally having the optional use of the additional bladders 144, 146, 154, and 156 to modify the amount of support provided to the neck of patient P, and that in application of the pelvic sling 150 as a cervical collar the stays 124 and 126 are not available to provide support for the neck of the patient P as with the pelvic slings 112, and 140.
Referring next to FIGS. 15 and 16, a pelvic sling 160 is yet another embodiment of the pelvic sling shown in FIGS. 1-10 and is generally similar to the pelvic sling 12 except as will be described presently. The pelvic sling 160 is shown including a piece 123 of loop-bearing fastener material attached to the second end portion 126 of the main body portion 14. As with the pelvic slings 112, 140, and 150, an area of hook-bearing flexible fastener material 132 is attached to the interior side of the strap member 30 at its outer end 34.
On one side of the first end portion 18 a margin is shaped to define a concave-shaped chin receptacle part 162 spanning a distance 164 of several inches of the main body portion 14 of the pelvic sling 160 for use of the pelvic sling 160 as a cervical collar as shown in FIG. 16. The distance 164 may, for example, be in the range of 4-8 inches and more preferably in the range of about 5-7 inches when the pelvic sling 160 is straightened out into a flat condition as shown in FIG. 15. While an arcuate concave chin receptacle 162 is shown the shape may vary, so long as there is some concavity and opposite sides to receive and help to stabilize the chin of the patient P.
For the sake of simplicity, the pelvic sling 160 is shown in FIGS. 15 and 16 with the simple construction of the main body portion 14 similar to that shown in FIGS. 1-10, without showing any bladders or stays. It will be understood that in another embodiment including the concave margin defining the chin receptacle 162, one or more bladders might be included as shown in FIGS. 11, 11A, 12, and 13. Similarly, stays 124 and 126 might be included in the pelvic sling 160.
When the pelvic sling 160 is used as a cervical collar, as shown in FIG. 16, it can be placed under the chin of a patient P as shown in FIG. 16 to receive and assist in stabilizing the chin of the patient P as the body portion 14 is wrapped around the neck of the patient P and the outer end 34 of the strap member 30 is connected to the intermediate portion 38 of the strap member 30 by interaction of the hook-bearing fastener material in the area 132 with the loop-bearing fastener material 52 on the exterior side 50 of the intermediate portion 38 of the strap member 30, as shown in FIG. 16.
A pelvic sling 170, shown in FIGS. 17-19, is similar to the pelvic sling 160 shown in FIGS. 15 and 16, except with respect to its first end portion 18, where there is a moveable chin support piece 172 attached to the margin of the outer end portion 18 and aligned with the concave chin receptacle portion 162 of the margin of the outer end portion 18. As shown in FIG. 17, the outer end portion 18 is flat, as in FIG. 15, and the movable chin support piece 172 is in a retracted, or non-deployed, position lying closely alongside the interior face of the main body portion 14 of the pelvic sling 170. The moveable chin support piece 172 is attached to the margin of the end portion 18 by a pair of hinges 174 and 176 located near the opposite ends 178 and 180 of the moveable chin support piece 172. The hinges 174 and 176 have respective hinge axes 175 and 177 aligned with the locations on the concave chin rest margin portion 162 where each hinge is attached and interconnects the end portion 18 with the moveable chin support piece, and as a result the axes 175 and 177 of the hinges 174 and 176 are coplanar but not parallel, and diverge from each other by an obtuse angle, as seen in FIG. 17, when the end portion 18 lies flat.
The moveable chin support piece 172 may be of a somewhat stiff and self-supporting yet flexible material such as multiple layers of heavy laminated textile fabric, or a somewhat flexible yet fairly stiff synthetic plastics material, so that the moveable chin support piece is able to flex along with the end portion 18 and lie closely alongside it when the pelvic sling 170 incorporating such a moveable chin support piece 172 is applied as a pelvic sling with the moveable chin support piece 172 in the retracted, non-deployed position shown in FIG. 17. The hinges 174 and 176 may be, for example, short pieces of narrow strong textile fabric such as nylon webbing sewn to the concave portion 162 of the margin of the end portion 18 and to the concave inner margin of the moveable chin support piece 172. Alternatively, particularly if the moveable chin support piece 172 is of molded plastics material, the hinges 174 and 176 may be “live” plastic hinges with connected ears that can be sewn or otherwise fastened in well-known ways to the material of the outer end portion 18 and the chin support piece 172. Also instead of being permanently attached and moveable, the chin support piece 172 could be attached to the end portion 18 of the main body portion 14 by detachable fasteners, such as Velcro, snap fasteners, or buttons.
When it is desired to use the pelvic sling 170 as a cervical collar, the moveable chin support piece 172 can be deployed to the exterior side of the end portion 18. With the end portion 18 bent as shown in FIGS. 18 and 19 so as to fit around and conform to the neck of a patient P, the axes of rotation of the hinges 174 and 176 are no longer coplanar, but are oriented differently with respect to each other, so that the moveable chin support piece 172 is held in a nearly horizontal orientation extending outwardly from the outer end portion 18 with an upwardly concave curved shape, so that it can support and cradle the chin of the patient P as shown in FIG. 19. Thus when the pelvic sling 170 is used as a cervical collar as shown in FIG. 19 the moveable chin support piece 172 is deployed, and the main body portion 14 is placed on the neck of the patient P so it can support and cradle the chin of the patient P. The second end portion 26 of the pelvic sling 170, depending upon the size and circumference of the neck of the patient P, may provide more or less additional support beneath the moveable chin support piece 172, with the outer end 34 of the strap member 30 secured to the intermediate portion 38 of the strap member 30 by interaction between the area 132 of hook-bearing fastener material on the outer end 34 of the strap member with the loop-bearing fastener material 52 on the intermediate portion 38 of the strap member 30.
It will be understood that the main body portion 14 of the pelvic sling 170 might be constructed in any desired one of the various configurations shown in FIGS. 1-13, to include or not to include one or more inflatable bladders and transversely-oriented stays while still incorporating the moveable chin support piece 172.
Depending upon whether it is desired for the pelvic sling 170 to be able to be used only once or for more or fewer patients P, it will be understood that the moveable chin support piece 172 may also be made of various materials such as plastics, impregnated cloth or laminated paper, for example.
Referring next to FIGS. 20-32, a pelvic sling and junctional or truncal point pressure tourniquet 190 shown in FIG. 20 includes the ability to compress a blood vessel such as a femoral artery, iliac artery, brachial artery, axillary artery, carotid artery, abdominal aorta or subclavian artery, as well as being able to perform the functions of a pelvic sling as described above.
The pelvic sling and junctional or truncal point tourniquet 190 disclosed herein may also be used to provide perfusion support in low flow disease states such as hemorrhagic shock and cardiac arrest, as by applying pressure to limit blood flow to distal parts of a patient and thereby reducing the size of the portion of the body where artificially assisted circulation is in effect.
The pelvic sling and tourniquet 190 shown in FIG. 20 includes a main body portion 192 similar to the main body portion 14 of the device 12 shown in FIGS. 1-4, with the general shape of a wide belt. The main body portion 192 may be constructed of, for example, a pair of flexible, substantially inelastic sheets of strong loop-bearing flexible fastener material defining a wide central portion 194 with a width 196 of about 7 inches, for example, and a pair of tapered opposite end portions 198 and 200. Alternatively, the main body 192 may be of another strong cloth, such as a polyethylene fiber fabric, covered by the loop-bearing fastener material, and may include a padding layer of batting (not shown). A buckle 202, which may be similar to the buckle 16 of the device 12 shown in FIGS. 1-4, and which is therefore not described in detail here, is attached to the first end portion 198 of the main body 192, preferably by a pivoting connection. A loop 204 of strong webbing material may engage the buckle, and corresponding holes in that webbing material and in the first end 198 of the main body 192 may be interconnected by a fastener such as a short bolt 206. The holes in the first end portion 148 and the webbing material 204 attached to the buckle 202 may be suitably reinforced, as by the use of metal grommets.
At the second end portion 200 of the main body an inner end of an elongate flexible strap 30 similar to the strap member 30 of the pelvic slings 112, 140, 160, and 170 is permanently attached to the main body 192, as by being sewn, riveted, or thermally or sonically welded securely to the second end 200 of the main body 192. The strap 30 extends longitudinally away from the second end portion, generally aligned with the longitudinal axis of the main body portion 192. An outer end portion 34 of the strap 30 may include a loop 208 of strong fabric such as nylon webbing material covered by hook-bearing fastener material 210 on at least the outer face of the part adjacent to the outer face of the strap 30. The strap 30 may be of strong, inelastic flexible nylon webbing, and at least an intermediate portion 212 has a layer of loop-bearing flexible fastener material 213 securely attached to and extending along an outer face 214 of the strap.
The strap 30 is provided with pairs of holes 216 to interact with the buckle 202 as explained above in connection with the pelvic sling 12 and buckle 16, so that the main body portion 192 and the strap member 30 form a loop under tension when the buckle 202 is engaged with the strap member 30, to act as a support for application of pressure inward with respect to that loop.
In the central portion 194 of the main body 192, between the two layers of loop-bearing fastener material, is an inflatable bladder 220 similar to the bladder 114 of the pelvic sling 112 described above. The bladder 220 may be generally rectangular and of flexible sheet plastic, and may be referred to as a backing bladder. An inflation or fill tube 222 is connected to the bladder 220, and a valve 224, such as a luer activated valve, may be connected with the outer end of the tube 222. The bladder 220 may be inflated by the use of a small pump, such as a squeeze bulb 226 with an outlet tube 228 equipped with a corresponding connector such as a luer fitting 229 at its outer end. A valve 230 may be provided at the squeeze bulb or pump outlet, to provide for relieving pressure and exhausting fluid from within the bladder 220 when desired, and a pressure gauge 231 may also be connected with the squeeze bulb 228 or other pump to provide a medical caregiver a means of assessing force level.
A strip 232 of hook-bearing flexible fastener material, an inch in width, for example, extends along and is securely fastened to the main body portion on its outer face 234, so that the loop-bearing fastener material 213 on the outer face 214 of the strap 30 can mate with and be held against the outer face 234 of the main body portion when the strap 30 extends through the buckle 202 and is bent back alongside the main body 192 as shown in FIGS. 23 and 24.
A loop 240 of material such as Nylon webbing fits snugly around the strap 30. A face of the loop 240 on the inner side of the strap 30 is provided with an area 242 of loop-bearing fastener material, and a selectively inflatable point pressure application device 244 may be attached to the loop 240 on the inner side of the strap 30 by a corresponding area 246 of mating hook-bearing fastener material attached to the base of the point pressure device, as will be explained in greater detail below. The loop 240 may be slid along the strap 30 to a desired position between the end 200 of the main body 192 and the buckle 202 to attach the point pressure device 244 to the strap 30.
One or more point pressure devices 244 may also be attached removably to the inner face 248 of the main body portion 192 at any desired position, by mating interaction of the hook-bearing fastener material 246 on the base of the point pressure device with the loop-bearing fastener material on the inner face 248 of the main body portion 192. A point pressure device 244 could also be attached permanently, as by sewing or adhesive attachment, to a selected location on the inner face 248, as in the end portion 198.
The pelvic sling and truncal and junctional tourniquet 250 shown in FIG. 21 is generally similar to the device 190 shown in FIG. 20, except that the main body portion 252 of the device is narrower than the main body 192, and may have a uniform width 254 of about 3 inches, for example. With such a smaller width, the device 250 may lack an inflatable bladder within its main body 252, although its structure may otherwise be similar to the main body 192, thus including a pair of sheets of strong loop-bearing fastener material, fastened together, and having a strip 256 of hook-bearing fastener material attached to and extending along an outer face 258. Optionally, the main body may be of a strong fabric with loop-bearing fastener material attached to both sides. The pelvic slings 190 and 250 shown in FIGS. 20 and 21 have been demonstrated to effectively reduce pelvic fractures when applied at each of three different anatomical levels I, II, and III as shown in FIG. 24.
A selectively inflatable hemostatic point pressure application device 244 may also be removably attached to a loop 240 slidably disposed on the strap portion 30 of the pelvic sling and tourniquet 250, as with the device 190, and another such point pressure application device 244 may be attached removably in a selected location on to the inner face 256 of the main body portion 252 by mating interconnection of the fastener materials at a desired position along the length of the main body portion 252, although the smaller width 254 of the main body portion provides less choice of position.
Instead of the inflatable bladder contained within the main body portion 192 of the pelvic sling and tourniquet 190, the device 250 may be accompanied by a separate inflatable pressure device 260 having a length 262 of for example, about 13 inches, and a width 264 of, for example, about 7 inches, and containing a bladder 266 similar to the bladder 220 between a pair of layers of fabric each having an outer surface of loop-bearing flexible fastener material similar, for example, to that of the outside of the main body of the pelvic sling and tourniquet 190. A strip of hook-bearing fastener material 268 an inch in width, for example, extends longitudinally along a central axis on each side of the separate inflatable pressure device 260. A fill tube 270 is provided and may extend from one end of the inflatable bladder 266 and may be equipped with a connector and fill valve 224 such as the ones described above.
As may be seen in FIG. 28, the pelvic sling and truncal tourniquet 250 may be rolled tightly, together with a pair of point pressure devices 244, into a compact package that can be carried in a minimum amount of space, ready for use for emergency treatment of injured personnel, as in military operations where size and weight of emergency medical supplies may be critical.
A point pressure device 244, in one embodiment, as is shown in FIGS. 29-32, includes a baseplate portion 272, which may be molded of a strong, rigid plastics material, and an inflatable flexible bladder portion 274 having a peripheral rim 276 of a shape and size corresponding to the shape of the baseplate 272. The peripheral rim is fastened securely and hermetically sealed, as by an adhesive, or overmolding, or thermal welding, to a top surface of the baseplate 272. An inlet fitting such as a barbed nipple or spigot 278 extending radially out in the plane of the baseplate 272 defines a bore leading inward beyond the outer rim portion 276 of the bladder 274 and extending upward, opening through the top surface of the baseplate 272 to be able to inflate the bladder. While the baseplate 272 as shown is generally flat, it could be shaped to correspond to the bladder 274 to be more compact in a package. The hook-bearing fastener material 246 on the bottom of the point pressure device 244 may be, as shown in FIG. 20, a simple square, or may, as shown in FIG. 30, be shaped to conform more closely to the shape of the baseplate 272. A pressure limiting and relief valve 280 may be mounted in the base 272 as shown in FIGS. 30 and 31, to be sure that the bladder 274 doesn't fail because of overpressure, and to accommodate changes in ambient air pressure such as when a patient is airlifted, so that the bladder 274 does not become overextended or exert more than the desirable amount of pressure against a patient's body.
A suitable pressure relief valve 280, for example, has a cracking pressure of 21.8 pounds per square inch (150 kPa)±15 percent. Such a pressure relief valve might be press fitted into a boss 282 defined in the baseplate 272, or press fitted into a brass sleeve ultrasonically welded into the boss 282 in the baseplate, or ultrasonically welded directly into the boss in the baseplate, or the baseplate 272 could be over-molded onto the valve 280. Alternatively, a relief valve could be connected to the point pressure device 244 through tubing connected to the fill tube spigot 278.
The inflatable flexible bladder portion 274 of the point pressure device 244 is of a flexible material such as suitably strong and flexible plastics material molded in concentric pleats 286 arranged to unfold and allow a central part 288 to extend telescopically from the configuration shown in FIG. 29 to a height 290 as shown in FIG. 32 that is at least double and may be more than four times as great as the collapsed height 292 shown in FIG. 29, as a result of inflation and corresponding straightening of the concentric pleats 286. The central part 288, when the bladder 274 is extended, is the outer end of the bladder and is reinforced and thus stiffer than the expanded pleated portions 286 in order to be able to exert pressure firmly against a patient's body in a small area, such as a circular area with a diameter of about 2.2 inches, in a desired location, as to compress and hold a wound, or to exert pressure through a patient's tissue in order to compress and occlude a major blood vessel. In one embodiment of the inflatable point pressure device 244 the bladder portion 274 may have a collapsed height of about 0.6 inch and a diameter 294 of about 4 inches, with a wall thickness 296 of about 0.075 inch and a thickness of the central outer end parts 288 of about 0.25 inch. When extended, the height 290 may be about 3.0 inches. An inflation or fill tube mounted on the barbed spigot 278 may have a valve 224 of a luer activated type similar to that on the bladder 220, compatible with the squeeze bulb pump 226 described previously. Alternatively, a valve (not shown) compatible with use of a CO2 cartridge may be provided.
The inflatable point pressure device 244 or the separate inflatable pressure device 260 would be positioned between the belt 30 or the main body portion 192 or 252 and the patient, to apply pressure to a wound to be compressed or vasculature to be occluded. The bladders could be attached and positioned by various means such as being loosely sandwiched between the patient and belt, or being attached by hook-and-loop fasteners, clips, straps or the like.
Particularly where medical personnel need to limit blood flow to the legs, and regardless of whether a pelvic fracture exists or is suspected, to use the pelvic sling 190 or 250 the belt 30 would be tightened to a predetermined force dictated by a tension control mechanism such as the buckle 202 as described in greater detail above. This would provide a baseline force level. The operator would then activate one, two, or more separate inflatable pressure devices 260 or inflatable point pressure devices 244 to apply pressure to a wound or to press on the vasculature whose flow is to be limited or stopped.
One alternative to the inflatable bladder point pressure device 244 shown would be a screw system (not shown). The pelvic sling would have a series of threaded holes through the belt 30. Once the belt was tightened to the controlled minimum tension, with a rigid end piece positioned between the patient and belt a screw would be inserted into one of the holes and connected to the rigid end piece. As the screw was tightened, force would be directed down towards the patient and the treatment/occlusion target.
Since patients have different circumferences, the junctional and truncal tourniquets 190 or 250 provides for a means of adjusting the distance between inflatable point pressure devices 244. An inflatable point pressure device 244 on a pelvic sling and junctional and truncal tourniquet 190 or the like could be in a fixed position, possibly close to the buckle 202. The emergency caregiver could adjust the position of the pelvic sling 190 or 250 on the patient so that the point pressure device is in the ideal fixed location for treatment or occlusion. Then, the second inflatable point pressure device 244 could be positioned according to the patient size and shape. Alternatively, both point pressure devices 244 could be fixed or both adjustable.
If the point pressure device 244 is to be pre-fixed to the main body 192 or 252, this could be done with sewing, hook-and-loop, heat, adhesive, etc.
The separate pressure device 260 or the point pressure device 244 could be applied in the pelvic/groin/abdominal region as shown in FIGS. 23, 24, 25, and 26 to close and compress open wounds or occlude femoral vessels, iliac vessels or the aorta, or in the shoulder area as shown in FIG. 27 to treat or occlude carotid, axillary or subclavian vessels. If used in the shoulder area, the point pressure device may be fitted with a harness, a cup that cups the shoulder or a looping strap that goes around the shoulder which keeps the device from slipping away from the required location. With the device worn as shown in FIG. 27 the strap member 30 may extend from the buckle 202 and over the patient's shoulder to be secured in the desired position and arranged by engaging the loop-bearing fastener material on the strap 30 with the strip of hook-bearing fastener material 232 on the main body 252.
The bladder 220 and the inflatable pressure devices 244 and 260 may be inflated with the squeeze bulb 226 connected directly or via the tube 222 or 228. The pressure devices could instead be inflated via a syringe-like pump, or by an electrically powered air pump, that could include an ambient air pressure sensor and could inflate the bladder and pressure devices to a predetermined pressure. Alternatively, the pressure devices 244 and 260 could be fitted with ports allowing connection to a pressurized gas chamber such as a disposable 12 gram CO2 cartridge. If the pressure device 260 is fixed to the inside of the junctional or truncal point tourniquet 190 or 250 it may be desirable to have the inflation or fill tube extend through the junctional or truncal point tourniquet rather than around it, via a port through the belt (not shown) that connects the bladder to the source of inflation. The communication between a bladder and its inflation device could thus be via tubing or intimate interconnection.
The separate inflatable pressure device 260 could be of square, oval, circular, diamond or other shape to direct force directly inward from the main body 192 or 252. The composition of the bladder or fabric covering the actual bladder, as shown in FIGS. 22 and 23 could be a mostly non-elastic material such as loop-bearing fastener material, so that lateral stretch is reduced and force is directed controllably inward towards the patient.
The separate inflatable pressure device 260 could also have an attached rigid cup-like or otherwise protruding element (not shown) positioned between it and a patient to assist in focusing force. A rigid body at the bladder-patient interface results in maintaining a static surface area while force increases, thereby maximizing focused pressure.
To use the junctional and truncal point tourniquet and pelvis-stabilizing devices 190 and 250 in the pelvic or inguinal area, first insure the bladders 220 and 266 are deflated. If necessary, deflate them by attaching a squeeze bulb 226 and opening the valve 230. Next, position the point pressure devices 244 on the junctional and truncal point tourniquet as required by the patient's size and the caregiver's personal preference, such as having the two point pressure devices 244 on the wider portion of the main body 192 or 252, perhaps aligned with the backing bladder 220. Wrap the junctional and truncal point tourniquet device around the patient, aligned on a plane with or proximal to the injury site. The buckle 202 could be in the back or in the front of the patient depending upon caregiver preference and the condition of the patient.
Next, thread the holed strap 30 through the buckle 202 and double it back toward the second end 200 of the main body 192, so that the loop-bearing fastener material 213 on the portion of the strap member 30 that is doubled back faces toward the main body portion 192 or 252. If one of the inflatable point pressure devices 244 is on the sliding loop 240, slide the loop to the desired position along the strap member 30. Then, holding the buckle or the main body portion, pull the strap member 30 through the buckle 202 with enough force to cause the buckle 202 to click and engage the holes 216 in the belt member. Then holding the strap in the same position to keep the buckle 202 engaged in the holes in the strap, press the strap 30 down to the main body 192 or 252 to secure the loop-bearing fastener material 213 to the strip of hook-bearing fastener material 232.
Next ensure that the valve 230 in the squeeze bulb 226 is in the closed position and attach the pump connector fitting 229 to a luer connection 224 of one of the inflatable point pressure devices 244, and then inflate the point pressure device 244 as much as possible.
If necessary, to compress a wound or gain tension to improve the effectiveness of an inflatable point pressure device 244 inflate the backing bladder 220 in the main body 192 or a separate pressure device 260, as well.
For abdominal use of the junctional and truncal point tourniquet and pelvis-stabilizing devices 190 and 250, first ensure the bladders 220 and 266 are deflated as explained above. Position an inflatable point pressure device 244 in the center of the central portion 194 of the main body 192, over the backing bladder 220. Wrap the junctional and truncal point tourniquet 190 or 250 around the patient with the inflatable point pressure device 244 centered over the patient's umbilicus. Thereafter proceed as explained above with respect to pelvic or inguinal area use to tension the device around the patient and inflate the point pressure device 244, and, if necessary inflate the backing bladder 220 to obtain the desired result, such as occlusion of the abdominal aorta.
For use of the junctional and truncal point tourniquet and pelvis-stabilizing devices 190 and 250 to occlude the axillary artery or close a wound in the axilla prepare the device by ensuring the bladders 220 and 266 are deflated as explained previously and position one or more of the inflatable point pressure devices on the main body 192 or 252 or on the sliding loop 240 as explained above, and then wrap the junctional and truncal point tourniquet 190 or 250 around the patient, crossing under both shoulders. Align the inflatable point pressure device 244 on or proximal to an injury site and thread the end of the strap 30 through the buckle 202 and pull the outer end of the strap 30 until the buckle clicks and engages the holes 216 in the strap member 30. Retaining tension in the strap to keep the buckle 202 engaged, pass the outer portion of the strap 30 over the top of a shoulder of the patient, depending on the desired configuration, and press the strap against the outer face of the main body of the device to mate the loop-bearing fastener material 213 with the strip of hook-bearing material 232 or 256 on the main body 192 or 252 to secure the strap member 30 and retain the desired tension in the tourniquet 190 or 250. Depending upon the location of a wound or other factors that may be involved the device may be placed on the patient in various ways to accomplish the desired results. Once the tourniquet 190 or 250 is in the desired position the inflatable point pressure device or devices should be inflated, and if necessary, the backing bladder 220, or a separate inflatable pressure device 260 should be inflated.
In some cases one of the inflatable point pressure devices 244 or a separate inflatable pressure device 260 may be useful separately, in which case the bladder 266 or 274 should initially be deflated as explained above. The pressure device 244 or 260 should be placed over the injury site or proximal to it and secured in place with a suitable bandage, ensuring that the fill tube and its connection fitting or valve 224 is accessible, after which the inflatable pressure device 244 or 260 should be inflated.
The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow.

## Claims

1. A device for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) a belt-like flexible support member having a central portion and two opposite end portions;
(b) a tension-assuring connecting device arranged to secure the end portions to each other so as to form a loop and retain a predetermined tension in said support member, said connecting device being pivotally attached to one of said opposite end portions of said support member;
(c) an inflatable, controllably-expansible bladder associated with said support member so as to direct pressure inwardly from said loop; and
(d) an inflatable controllably-expansible point pressure application device attached removably at a selected location on said support member so as to direct pressure inwardly with respect to said loop at said selected location.

2. A device for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) a belt-like flexible support member having a central portion and two opposite end portions;
(b) a tension-assuring connecting device arranged to secure the end portions to each other so as to form a loop and retain a predetermined tension in said support member;
(c) an inflatable, controllably-expansible bladder associated with said support member so as to direct pressure inwardly from said loop; and
(d) an inflatable controllably-expansible point pressure application device attached removably at a selected location on said support member so as to direct pressure inwardly with respect to said loop at said selected location, and wherein said support member includes a strap that defines at least one hole and said tension-assuring connecting device includes a buckle that includes a base portion and a slide portion and has at least one pin projecting from the base portion, the slide portion having a contact surface and being mounted over the at least one pin and being movable relative to the base portion, and the slide portion being spring-biased toward a non-engaging position in which the at least one pin does not project beyond the contact surface of the slide portion, whereby the strap is free to slide freely over the contact surface until tension in the strap applies sufficient force to the slide portion to move the slide portion toward the base portion far enough for the at least one pin to project beyond the contact surface of the slide portion and engage said at least one hole in the strap, thereby establishing a position of the strap with respect to the buckle at a preselected tension level.

3. The device of claim 2 wherein the at least one hole includes a plurality of holes at respective spaced-apart locations in the strap between an outer end portion and an inner end of the strap.

4. A hemostatic pressure application device, comprising:
(a) a baseplate defining an inlet passage having an opening on a first side of the baseplate;
(b) an inflatable member attached to the baseplate on said first side thereof, the inflatable member having a reinforced , relatively inflexible contact pressure face portion and a relatively flexible extensible portion surrounding the pressure face portion and providing for expansion in a direction away from said first side of said baseplate to a height that is greater than an original height of said inflatable member;
(c) an inflation tube connected to said base plate and communicating with said inlet passage;
(d) a pressure-retaining valve connected with said inflation tube and arranged to retain fluid pressure within said inflatable member; and
(e) a connector associated with said inflation tube and arranged to conduct fluid under pressure into said inflation tube.

5. The pressure application device of claim 4 including a hand pump, the hand pump including a connector arranged to mate selectively and removably with said connector associated with said inflation tube, and said pump being operable selectively to direct fluid under pressure into said inflatable member and to release fluid from within said inflatable member.

6. The pressure applicator of claim 4 further including a pressure-limiting relief valve communicating with an interior of said inflatable member.

7. A device useful for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) an elongate main body portion having opposite first and second end portions and having an inner face including an area of a flexible fastener material of a first kind, and having an outer face including an area of a flexible fastener material of a second kind that is cooperative with the flexible fastener material of the first kind;
(b) a buckle attached to said first end portion of said main body portion;
(c) a flexible elongate strap having an inner end fixedly attached to said second end portion of said main body portion, the strap extending away from the main body portion and having an outer end portion opposite from said inner end thereof, the strap being of a size able to pass through the buckle and the buckle being adapted to engage the strap so as to interconnect the first and second end portions of the main body portion with each other, and the strap having an intermediate portion, located between the outer end portion of the strap and the second end portion of the main body, having an area of flexible fastener material of the first kind located on a first side of the strap and having an area of flexible fastener material of the second kind that is cooperatively matable with the flexible fastener material of the first kind, located on a second side of the outer end portion of the flexible elongate strap, the area of flexible fastener material of the second kind being capable of fastening the outer end portion of the flexible elongate strap to the main body portion by mating with the flexible fastener material of the first kind, to secure the device with the main body forming a loop able to be wrapped around a person and with the strap extending along the main body portion, so as to press a hemostatic pressure application device against a selected part of said person.

8. A device useful for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) an elongate main body portion having opposite first and second end portions and having an inner face including an area of a flexible fastener material of a first kind, and having an outer face including an area of a flexible fastener material of a second kind that is cooperative with the fastener material of the first kind;
(b) a buckle attached to said first end portion of said main body portion;
(c) a flexible elongate strap having an inner end fixedly attached to said second end portion of said main body portion, the strap extending away from the main body portion and having an outer end portion opposite from said inner end thereof, the strap being of a size able to pass through the buckle and the buckle being adapted to engage the strap so as to interconnect the first and second end portions of the main body portion with each other, and the strap having an intermediate portion, located between the outer end portion of the strap and the second end portion of the main body, having an area of flexible fastener material of the first kind located on a first side of the strap and having an area of flexible fastener material of the second kind that is cooperatively matable with the flexible fastener material of the first kind, located on a second side of the outer end portion of the flexible elongate strap, the area of flexible fastener material of the second kind being capable of fastening the outer end portion of the flexible elongate strap to the main body portion by mating with the flexible fastener material of the first kind, to secure the device with the main body forming a loop able to be wrapped around a person and with the strap extending along the main body portion, so as to press a hemostatic pressure application device against a selected part of said person, the device further including at least one selectively inflatable hemostatic pressure application device attached to said inner face of said main body portion by an area of said flexible fastener material of the second kind attached fixedly to said selectively inflatable hemostatic pressure application device and mated with said fastener material of the first kind on said inner face.

9. A device useful for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) an elongate main body portion having opposite first and second end portions and having an inner face including an area of a flexible fastener material of a first kind, and having an outer face including an area of a flexible fastener material of a second kind that is cooperative with the fastener material of the first kind;
(b) a buckle attached to said first end portion of said main body portion;
(c) a flexible elongate strap having an inner end fixedly attached to said second end portion of said main body portion, the strap extending away from the main body portion and having an outer end portion opposite from said inner end thereof, the strap being of a size able to pass through the buckle and the buckle being adapted to engage the strap so as to interconnect the first and second end portions of the main body portion with each other, and the strap having an intermediate portion, located between the outer end portion of the strap and the second end portion of the main body, having an area of flexible fastener material of the first kind located on a first side of the strap and having an area of flexible fastener material of the second kind that is cooperatively matable with the flexible fastener material of the first kind, located on a second side of the outer end portion of the flexible elongate strap, the area of flexible fastener material of the second kind being capable of fastening the outer end portion of the flexible elongate strap to the main body portion by mating with the flexible fastener material of the first kind, to secure the device with the main body forming a loop able to be wrapped around a person and with the strap extending along the main body portion, so as to press a hemostatic pressure application device against a selected part of said person, the device further including a selectively inflatable bladder defined in said main body portion and located centrally in said main body portion, between said opposite first and second end portions thereof.

10. A device useful for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) an elongate main body portion having opposite first and second end portions and having an inner face including an area of a flexible fastener material of a first kind, and having an outer face including an area of a flexible fastener material of a second kind that is cooperative with the fastener material of the first kind;
(b) a buckle attached to said first end portion of said main body portion;
(c) a flexible elongate strap having an inner end fixedly attached to said second end portion of said main body portion, the strap extending away from the main body portion and having an outer end portion opposite from said inner end thereof, the strap being of a size able to pass through the buckle and the buckle being adapted to engage the strap so as to interconnect the first and second end portions of the main body portion with each other, and the strap having an intermediate portion, located between the outer end portion of the strap and the second end portion of the main body, having an area of flexible fastener material of the first kind located on a first side of the strap and having an area of flexible fastener material of the second kind that is cooperatively matable with the flexible fastener material of the first kind, located on a second side of the outer end portion of the flexible elongate strap, the area of flexible fastener material of the second kind being capable of fastening the outer end portion of the flexible elongate strap to the main body portion by mating with the flexible fastener material of the first kind, to secure the device with the main body forming a loop able to be wrapped around a person and with the strap extending along the main body portion, so as to press a hemostatic pressure application device against a selected part of said person, the device including at least one additional selectively inflatable bladder located in a respective one of said end portions of said main body portion.

11. A device useful for stabilizing a fractured pelvis or controlling hemorrhage, or both, comprising:
(a) an elongate main body portion having opposite first and second end portions and having an inner face including an area of a flexible fastener material of a first kind, and having an outer face including an area of a flexible fastener material of a second kind that is cooperative with the fastener material of the first kind;
(b) a buckle attached to said first end portion of said main body portion;
(c) a flexible elongate strap having an inner end fixedly attached to said second end portion of said main body portion, the strap extending away from the main body portion and having an outer end portion opposite from said inner end thereof, the strap being of a size able to pass through the buckle and the buckle being adapted to engage the strap so as to interconnect the first and second end portions of the main body portion with each other, and the strap having an intermediate portion, located between the outer end portion of the strap and the second end portion of the main body, having an area of flexible fastener material of the first kind located on a first side of the strap and having an area of flexible fastener material of the second kind that is cooperatively matable with the flexible fastener material of the first kind, located on a second side of the outer end portion of the flexible elongate strap, the area of flexible fastener material of the second kind being capable of fastening the outer end portion of the flexible elongate strap to the main body portion by mating with the flexible fastener material of the first kind, to secure the device with the main body forming a loop able to be wrapped around a person and with the strap extending along the main body portion, so as to press a hemostatic pressure application device against a selected part of said person, the device including at least one additional selectively inflatable bladder removably attached to either said main body or said strap on an inner side at a selected location and inflatable to direct pressure against a person as required to compress a wound or occlude a blood vessel.

12. A method of controlling hemorrhage, comprising:
(a) applying a device having an elongate belt-like main body including opposite first and second end portions around a person in a position in a range of positions from a position aligned with the pelvis to a position including the neck;
(b) passing a strap permanently attached to and extending from the second end portion through a buckle attached to the first end portion and applying a predetermined amount of tension in the strap against the buckle, thereby urging the first and second end portions toward each other with a predetermined amount of tension in the main body;
(c) engaging the buckle to hold the strap and thereby retain the predetermined amount of tension in the main body;
(d) securing a portion of the strap that extends from and beyond the buckle so as to keep the buckle engaged, maintaining said predetermined amount of tension in the main body; and
(e) inflating a point pressure application device located either between said main body and the person or between said strap and the person and thereby applying sufficient pressure to the person to control flow in a major blood vessel.

13. The method of claim 12 wherein the step of securing a portion of the strap includes:
(a) matingly engaging a flexible fastener material of a first kind carried on an outer end portion of the strap with a flexible fastener material of a second kind located on the second end portion of the main body when the person has a circumference in a first range;
(b) matingly engaging the flexible fastener material of the first kind located on the outer end portion of the strap with flexible fastener material of the second kind located on a intermediate portion of the strap when the person has a circumference in a second range; and
(c) matingly engaging the fastener material of the second kind located on the intermediate portion of the strap with fastener material of the first kind located on the second end portion of the main body when the person has a circumference in a third range.