This application claims benefit and priority of U.S. provisional application Serial No. 61/599,229 filed February 15, 2012.

FIELD OF THE INVENTION

The present invention relates to an inexpensive, easy-to-use pneumatic anti-shock device for use by doctors, nurses, paramedics and/or midwives.

BACKGROUND OF THE INVENTION

Hemorrhage from pelvic blood vessels after obstetric delivery remains the leading cause of maternal death worldwide. Most bleeding occurs postpartum and initial treatment includes uterotonic medications, such as oxytocin and misoprostol plus bimanual massage, but when bleeding is not postpartum or is not responsive to these treatments other approaches are needed. Because treatment will be most effective when initiated promptly, secondary treatment measures need to be readily available at the birth site. Aortic compression can be used to treat obstetric hemorrhage (or pelvic trauma) using an open hand, fist, or knee to compress the aorta against the underlying lumbar vertebrae.(l , 2) Prolonged compression is difficult, however, when personnel are limited and other interventions or transport are needed. Fortunately, circumferential abdominal-pelvic pressure (CAPP) can be provided with inflatable pneumatic anti-shock garments (PASG) or neoprene non-inflatable anti-shock garments (NASG). There are numerous case reports of successful use of PASG and NASG for obstetric and post-operative hemorrhage. Two pre/post intervention trials with NASG showed improved maternal outcomes. (3-5).

Pneumatic anti-shock garments (also called Military or Medical Anti-Shock Trousers) were developed in the early 1900's to treat shock in surgical and battlefield patients. They were routinely used to treat trauma patients in the United States until the mid-1980's, when studies revealed slightly decreased survival rates in trauma patients using anti-shock garments in urban pre-hospital settings with quick transport to a trauma center.(6) Randomized controlled trials of PASG use for obstetric hemorrhage do not exist. Pneumatic anti-shock garments have been shown to decrease distal aortic blood flow by up to 90% (7) at the level of the superior mesenteric artery. Additionally, circumferential abdominal-pelvic pressure devices (NASG or PASG) deliver direct pressure to pelvic compartment organs and smaller blood vessels. They can be used to treat pelvic bleeding from blunt or penetrating trauma, obstetric injury or bleeding from the legs while additional treatment is being performed or prepared for, and can provide definitive treatment if bleeding stops. The complication rate for PASG use is low, estimated as less than one per 100,000 cases. (8) However, commercially available PASG are expensive. NASG are less expensive but bulky and relatively difficult to clean.

There is a need for an inexpensive pneumatic circumferential abdominal pelvic pressure (CAPP) device, that can be easily available at all births, at home or in a facility, and that mid-level professionals and midwives can use with relatively short term training. SUMMARY OF THE INVENTION

An illustrative embodiment of the present invention provides an inexpensive pneumatic pressure device that comprises a flexible wrapping panel having a shape for circumferential wrapping around a patient's body part, such as the lower torso, leg, etc. The flexible panel includes releasable fastening elements for securing the wrapped panel around the patient's body part and further includes a pocket with an access opening through which an inflatable bladder is initially placed deflated in the pocket and then subsequently inflated after the panel is wrapped and secured around the patient's body part. The inflatable bladder can be easily inserted into and removed from the pocket via the access opening. In a particular illustrative embodiment of the invention, the wrapping panel comprises an un-impregnated and substantially inelastic

(substantially non-stretchable) relatively sturdy cloth that is permeable to air or gas.

The pocket can comprise a folded-over and sewn section of the panel when the panel comprises cloth material. The pocket includes a second access opening for receiving a valve of the inflatable bladder. The inflatable bladder can comprise a pneumatic tube, such as for example a bicycle tire tube with the usual valve. In use, a manual or other air pump, compressed air cartridge, compressed C0 ₂ cartridge, or other source of pressurized air or gas can be used to inflate the inflatable bladder after the panel is circumferentiallywrapped and secured around the patient's body part.

The invention also envisions a treatment kit including multiple such pneumatic pressure devices as described above for applying pressure to a patient's lower torso and each leg, if desired.

The present invention further envisions a method of applying pressure to a patient's body part by placing an inflatable bladder in the pocket of the flexible panel, placing the pocket of the flexible panel on the patient's body part, tightly circumferentially wrapping and securing the remainder of the flexible panel around the patient's body part, leaving a valve of the bladder accessible, and inflating the inflatable bladder in the pocket via the valve.

Another method embodiment envisions use of a ball, such as conventional sports ball (e.g. a soccer ball), as the inflatable bladder together with a covering that overlies the deflated ball on the abdomen and that can resist the pressure of the ball when it is inflated so that pressure is applied to the abdomen A method embodiment involves placing a deflated ball on a patient's abdomen, covering the ball on the abdomen in a manner that resists outward pressure of the ball when it is inflated, and inflating the ball using any source of pressurized gas such as an air pump, compressed air cartridge, C0 ₂ cartridge, or other device to inflate the ball.

The present invention is advantageous in that it provides inexpensive, easy-to-use pneumatic anti-shock devices that can be used in low-resource countries or geographical regions by mid- level trauma and obstetric providers for emergency hemorrhage and anti-shock treatment. The present invention is further advantageous in that it provides anti-shock devices that can be transported easily in difficult terrain by military personnel for emergency use in the care of wounded soldiers.

These and other advantages of the present invention will become more readily apparent from the following detailed description of the invention taken with the following drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic view of a circumferential pneumatic pressure device pursuant to an illustrative embodiment of the invention ready to be wrapped around the patent's abdomen and pulled over a leg, the other leg being similarly treated but omitted for clarity. Figures 2A and 2B are plan views of the outer side and inner side of the flexible abdomen panel of Figure 1, respectively, for wrapping around a patient's body part showing a pocket at one end of the rectangular-shaped panel with the pocket having a relatively large access opening for an inflatable bladder and a relatively small access opening for a valve of the inflatable bladder.

Figure 3 is a perspective view of the closed leg piece into which the patient's leg is inserted with the pocket tor the inflatable bladder and bladder itself shown in dashed lines.

Figures 3A and 3B are plan views of the outer side and inner side of the flexible leg panel of Figure 3, respectively.

Figure 4 is a schematic view of a circumferential pneumatic pressure device pursuant to another illustrative embodiment of the invention showing the inflatable bladder as comprising an inflatable ball with a pocket-less flexible panel ready to be wrapped around the patent's abdomen and the deflated ball as a covering. A pressure device of the type shown in Figure 1 is shown pulled over a leg, the other leg being similarly treated but omitted for clarity.

Figures 4A and 4B are plan views of the outer side and inner side of the flexible abdomen panel of Figure 4, respectively, for wrapping around a patient's body part.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an inexpensive pneumatic pressure device especially useful for circumferential abdominal-pelvic compression to decrease pelvic blood flow from trauma or obstetric delivery complications, although the pneumatic anti-shock device is not limited to such uses. Referring to Figure 1 , a circumferential pneumatic pressure device pursuant to an illustrative embodiment of the invention is shown with the abdominal piece (panel) in position ready to be wrapped around the patent's abdomen and a leg inserted into a leg piece. In particular, the pneumatic pressure device 10 for wrapping around the patent's abdomen is shown comprising a flexible wrapping panel 12 having a pocket 14 containing an inflatable bladder 16 shown in dashed lines since it is hidden inside the pocket 14. The panel pocket 14 containing the inflatable bladder 16 is initially positioned on the patient's abdomen as shown with a remaining length 15 of the flexible panel 12 extending outwardly and ready to be circumferentially tightly wrapped around the abdomen and secured as described below by the care provider.

The pneumatic pressure device 20 for enclosing the patent's leg is shown comprising a closed tubular (e.g. cylindrical) panel 22 having a pocket 24 containing an inflatable bladder 26 shown in dashed lines since it is hidden inside the pocket 24. The tubular panel 22 with the panel pocket 24 containing the inflatable bladder 26 is initially pulled over the patient's leg body part like a legging by the care provider. Although not shown for clarity, the other leg of the patient is similarly treated.

The pneumatic pressure device 10 for the patient's abdomen can be used sans the pneumatic pressure devices 20 for the patient's leg since the former alone has been found to decrease distal aortic blood flow in the pelvic region as much as it does with added leg compression. The optional pneumatic pressure devices 20 for the legs can be used concurrently with the pneumatic pressure device 10 perhaps to decrease venous pooling or their use may be deferred until more crucial emergency treatment has been carried out. The present invention envisions a treatment kit including the pneumatic pressure device 10 for abdominal aorta compression and two pneumatic pressure leg compression devices 20 so that the care provider will have a choice as to which to use in treating the patient.

Referring to Figures 2 A and 2B, the flexible panel 12 having a rectangular shape is illustrated having the pocket 14 at one end of the rectangular-shaped panel with the pocket having a relatively large access opening 14a for an inflatable bladder and a relatively smaller access opening 14b for the valve 16a of the inflatable bladder 16, which can comprise a mountain bike tire inner tube having a length of 26 inches and suitable diameter for purposes of illustration and not limitation. The access openings 14a and 14b can have length dimensions of 8 inches and 2 inches, respectively, for such an illustrative mountain bike tire inner tube. When the inner tube is placed through access opening 14a and spread out in the panel pocket, the air valve 16a of the inner tube will extend through the smaller access opening 14b of the pocket to provide access for the end fitting of a hand air pump.

The length and width of the abdomen-encircling panel 12 can be 90 inches and 14 inches, respectively, with a pocket depth of 15 inches for purposes of illustration and not limitation. The flexible leg-encircling tubular panel 22 can have a length and width of 60 inches and 24 inches, respectively, with a pocket depth of 12 inches with the same access opening lengths as abdomen- encircling panel 12 for the inflatable bladder 26 and its valve 26a for purposes of illustration and not limitation.

For purposes of further illustration and not limitation, the panels 12 and 22 can be made of cloth, such as light canvas, or other suitable material which is strong but does not stretch easily. For example, the wrapping panel can comprise an un-impregnated and substantially inelastic

(substantially non-stretchable) relatively sturdy cloth that is permeable to air or gas. The panel material should be strong enough to avoid failure (e.g. tearing) when the bladder 16 or 26 is inflated to for example 45 psi (3 BAR). However, if strong panel material is not available, extra wraps of the panel around the patient's body part can be made to reduce the chance of panel failure when the bladder is inflated.

For purposes of illustration and not limitation, Figures 2A and 2B are plan views of the outer side and inner side of an exemplary flexible abdomen-encircling panel 12, respectively, which are hemmed with a 2 cm total allowance around its periphery. In Figure 2A, a dashed line L is shown representing a fold line where the panel 12 is folded onto itself and sewn to form the pocket 14 with the exception of gaps that form the pocket access openings 14a, 14b, as shown in figure 2B. All seams are double-stitched for strength. After hemming and prior to folding, fastening loop strips 18 (e.g. VELCRO™ loop strips) are sewn onto the outer side of the panel 12 in positions shown for purposes of illustration so that the loop strips overlap and engage the fastening hook strips 19 when the panel 12 is wrapped tightly around the patient. The fastening hook strips 19 are sewn (double stitched) onto the panel 12 in positions shown to this end. Other fastening elements such as webbing straps or ties can be used in practice of the invention to secure the tightly wrapped abdomen-encircling panel 12, however.

In Figure 2B, the inner side of the folded panel 12 is shown wherein the inner side is placed against the patient's body part (e.g. abdomen). The pocket 14 is shown having access opening 14a through which the inflatable bladder 16 is introduced and removed from the pocket and access opening 14b in which the valve 16a of the inflatable bladder 16 resides when the panel is wrapped. Figure 3 is a perspective view of the tubular leg-encircling panel or piece 22 (after it is sewn shut in tubular shape) with the inflatable bladder 26 in pocket 24 shown in dashed lines in the panel pocket 24. For purposes of illustration and not limitation, the panel 22 is hemmed (double stitched) with a 2.5 cm allowance around its periphery. Figures 3A and 3B are plan views of the outer side and inner side of the flexible leg part 22 of Figure 3, respectively.

After hemming, ends of the fastening loop strips 28 (e.g. VELCRO™ loop strips) are sewn onto the end of the inner side 22a of the panel 22 in positions shown within the hemming allowance for purposes of illustration so as to leave free lengths of the fastening loop strips 28 to overlap and engage the fastening hook strips 29 when the part 22 is pulled over the patient's leg. The fastening hook strips 29 are sewn (double stitched) onto outer side 22b of the panel 22 in positions shown. Other fastening elements, such as webbing or ties, can be used in practice of the invention to secure the leg piece 22, however. The leg panel or piece 22 is then closed into a tubular (e.g. cylindrical) shape by sewing a seam from A - A' to B - B'

In Figure 3B, the pocket 24 can be formed by sewing (double stitched) a secondary pocket panel 22c onto the inner side 22a of the main panel 22 with the exception of gaps that form the access openings 24a and 24b for the inflatable bladder 26 and its valve 26a, respectively. Refer to details in Figure 3B.

An illustrative method embodiment of the present invention for applying compression to the patient's abdomen involves the care provider's placing a deflated bladder 16 in the pocket 14 of the flexible panel 12 and then placing the pocket 14 on the patient's abdomen, Figure 1. Then the remaining length 15 of the panel 12 is wrapped tightly and circumferentially around the abdomen and secured by engagement of the fastening elements 18, 19. The bladder valve 16a is left accessible through the opening 14b so that the bladder can be inflated. The inflatable bladder 16 then is inflated in the pocket 14 of the wrapped and secured panel 12 via bladder valve 16a using a hand air pump (not shown) or any other air pump until a desired pressure is achieved in the bladder, such as 45 psi (3BAR) for purposes of illustration and not limitation. The amount of compression of the abdomen is controlled by controlling the amount of inflation pressure of the bladder and can be varied to suit the needs and comfort of the patient. Inflation of the bladder is achieved by coupling an air pump end fitting (not shown) on the bladder valve 16a and pumping air into the bladder or by using a compressed air cartridge, compressed C0 ₂ cartridge or other pressurized gas source coupled to the bladder valve 16a. After use, the panels 12, 22 can be cleaned by laundering for reuse, while the bike tube can be cleaned in a mild bleach solution. The inflatable bladder such as the bike inner tube is easily replaced if needed.

An illustrative method embodiment of the present invention for applying compression to the patient's leg involves similar steps as described above for applying pressure to the abdomen.

Another method embodiment of the invention envisions use of a ball, such as conventional sports ball 16' as the inflatable bladder together with a covering 1 1 ' that overlies the deflated ball 16' on the abdomen, extends substantially around the abdomen, and can resist the pressure of the ball when it is inflated so that pressure is applied to the abdomen, Figure 4. The covering 1 1 ' can be made of any suitable material to this end which will resist the outward pressure of the ball 61 ' when inflated so as to apply pressure to the abdomen.

For purposes of illustration and not limitation, the covering 1 1 ' can be a wrapping panel 12' of the type described above sans the pocket. That is, a pocket-less, un-impregnated, permeable-to- air, substantially inelastic cloth wrapping panel 12' can be used. However, the covering 11 ' is not limited to a wrapping panel 12' as described since any covering 1 1 ' can be used that can be provided over the ball 16' on the abdomen to resist the outward pressure of the ball 16' when it is inflated so that pressure is applied to the abdomen.

For purposes of illustration and not limitation, Figure 4 is a schematic view of a circumferential pneumatic pressure device wherein the inflatable bladder comprises an inflatable ball 16' and wherein a covering 1 1 'in the form of a pocket-less wrapping panel 12' is provided over the ball 16' and resists outward pressure of the ball 16' when it is inflated so that pressure is applied to the abdomen of the patient. In Figure 4, the ball 16' in the deflated state is initially positioned on the patient's abdomen as shown with a length of the panel 12' overlying the deflated ball and with a remaining length 15' of the panel 12' extending outwardly and ready to be

circumferentially tightly wrapped around the abdomen and secured as described above by the care provider. The panel includes fastening loop strips 18' and fastening hook strips 19', Figures 4 A, 4B, that are engaged after the panel 12' is tightly wrapped around the abdomen. Any sturdy inflatable ball of spherical or other shape about 8 inches in diameter (or maximum dimension for an oblong ball) can be used for purposes of illustration and not limitation. A particularly useful ball 16' comprises a sports ball such as a soccer ball.

In this illustrative method embodiment, the deflated ball 16' is placed on the patient's abdomen and then the flexible pocket-less panel 12'is tightly wrapped around the abdomen and ball and secured by fastening elements 18', 19' with the valve 16a' near the top edge (as shown) or bottom edge of the wrapped panel 12' and accessible for inflation by a suitable air pump, compressed air cartridge, C0 ₂ cartridge, or other device to inflate the ball to apply pressure to the abdomen. After use, the covering 1 1 ' if cloth can be cleaned by laundering for reuse, while the ball 16' can be cleaned in a mild bleach solution. The inflatable ball is easily replaced if needed. An optional circumferential pressure device 20 of the type shown in Figure 1 is shown in Figure 4 pulled over a leg of the patient, the other leg being similarly treated but omitted for clarity.

Although the present invention has been described in detail hereabove with certain illustrative embodiments, those skilled in the art will appreciate that changes and modifications can be made in therein within the scope of the appended clams.

REFERENCES, which are incorporated herein by reference

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