Abstract:
After intervention of the vessels in the groin, a routine procedure is to apply pressure by a sand bag to prevent bleeding. 
     The device of the present invention is a better solution for this problem. It consists of a wrap which covers the groin area to support a specifically shaped pressure balloon when it is inflated. The balloon is inside a cover and the pressure inside it can easily be changed and monitored. A mesh inside a plastic tube may help to watch for bleeding. By using this wrap, a patient no longer need be motionless, and may even be allowed to stand if needed.

Description:
FIELD OF THE INVENTION 
     This invention relates to the post-catheterization . prevention of bleeding from a wound created as a consequence of inserting a catheter, or other similar device, into a vessel. More particularly, it relates to preventing bleeding from a wound proximate a person&#39;s groin. 
     BACKGROUND AND SUMMARY OF THE INVENTION 
     One of the common concerns in cardiac catheterization and related interventions is the problem of bleeding after catheterization of a vessel. This well known and familiar problem may even need corrective surgery in extreme cases. 
     A commonly used method of preventing such complication is quite primitive, and may be ineffective in some instances. That method is to position a sand bag in the area over a pressure bandage. In general, it may be considered a rather crude and uncomfortable method since, 1) it does not apply an appropriate amount of pressure all the time, 2) the sand bag may slide and/or fall, 3) the patient must be kept practically motionless to avoid dislocation of the sand bag, and 4) the patient is usually told not to raise the head over 15 degrees. Insofar as the applicant is aware, no other method has replaced the sand bag to any significant degree. 
     This problem has led to the applicant&#39;s creation of a much better alternative, which the applicant has named the D. Device. This device affords much easier use, gives much better pressure control, and is more comfortable for the patient. Not only can the patient move more, but it is believed that he/she may be discharged earlier from the hospital. 
     Briefly, the device is designed to prevent bleeding after catheterization of a groin vessel in connection with any of a number of different interventions, such as angiography for the heart, brain, arteries, etc., during which a vessel, such as an artery, has to be entered for diagnostic or treatment purposes. Naturally, the resulting wound has tendency to bleed. 
     The device comprises a main wrap, made preferably from tough synthetic fabric, which wraps around both the lower abdomen and the upper thighs to give support for the application of pressure to the groin by a specially shaped inflatable balloon contained within the wrap. The pressure inside the balloon can be monitored by a gauge, which can also have a safety alarm to indicate if the pressure inside the balloon drops. Another wrap, made preferably from a thin layer of non-irritating, soft, disposable material matching the shape of the main wrap may cover the skin under the main wrap to prevent contamination. Means are also provided so that bleeding which may occur after the device has been placed on the person can be seen by an observer. Further detail of the invention, and other features, will be seen as the description proceeds. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a front view of a wrap used in the invention. 
     FIG. 2 is a front view showing the wrap in use on a person. 
     FIG. 3 is a front view of a balloon and cover used in the invention. 
     FIG. 4 is a fragmentary front view of the cover of FIG. 3 showing further detail. 
     FIG. 5 is a front view showing the general application of the balloon and cover to the person&#39;s body, including an alarm associated with the balloon. 
     FIG. 6 is a front view of the alarm of FIG. 5 showing more detail. 
     FIG. 6A is a fragmentary front view of a portion of the alarm of FIG. 6 showing better detail. 
     FIG. 7 is a front view of an inner wrap that may also be used in the invention. 
     FIG. 8 is a traverse cross-sectional view in the direction of arrows 8--8 in FIG. 3. 
     FIG. 9 is a more enlarged view of the alarm of FIG. 6. 
     FIG. 10 is a transverse cross-sectional view in the direction of arrows 10--10 in FIG. 9. 
     FIG. 11 is a top view of another part that may be used in the invention. 
     FIG. 12 is a transverse cross-sectional view in the direction of arrows 12--12 in FIG. 11. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     FIG. 1 shows the front view of a wrap 20 and its general appearance when opened and spread on a table. It has several areas containing Velcro™. The soft parts 22, 24, 26, 28 of the Velcro™ are shown with straight lines, while the rough parts 30, 32, 34 are shown with dots. Parts 22, 24 are on the front face of wrap 20 as it appears in FIG. 1, and parts 30, 28 on the back face so that when wrap 20 is worn as shown in FIG. 2, the end containing soft part 22 will match and stick to part 30 to tighten the upper portion of the wrap around the lower abdomen, very much like a girdle or a belt. Part 24 will match with part 32 to wrap around the right upper thigh. Part 28 will match with part 34 to wrap around the left upper thigh. These will altogether hold the wrap tight in place. 
     Part 26 shown in FIG. 1 is a soft Velcro™ part and is disposed so that the back of a cover of a balloon, to be described next, will be in contact with, and stick to, it. The purpose of this part 26 is to allow adjustment of the position of the balloon and cover to the wrap in order to fit different patients. FIG. 2 gives a general idea of how wrap 20 will look when it is worn and in place on a patient&#39;s body. 
     FIG. 3 shows a balloon 36 inside a fabric pocket 38 of a cover 40 having straps 42, 44 extending from its corners and designed to wrap around the lower abdomen and the right thigh. The broken area in the upper strap 42 that goes around the abdomen is intended to show the disrupted piece. The lower strap 44 is to fit the upper part of the right thigh. The general appearance of balloon 36 is shown, along with its connection 46 to an inflating part 48 as well as a tube 50 to be connected to an alarm, to be described later. 
     Tube 50 is at one lengthwise end of balloon 36, and a further tube 52, leading to connection 46, is at the opposite lengthwise end. The two tubes 50, 52 protrude from pocket 38. 
     In order to best fit and adapt to the shape and anatomy of the groin area and to mainly cover the area most liable for bleeding and hematoma, balloon 36 has an almost rhomboid shape, although it may have a different shape such as a circular or sausage-type shape, such different shapes not being shown in a drawing. As seen in FIGS. 3 and 5, balloon 36 tapers toward each lengthwise end so that it is noticeably wider in the middle than at its ends. As seen in FIG. 8, balloon 36 has a flat face 54 toward wrap 20, and an opposite angled face 56 toward the groin. Face 56 has a vertex that is to be situated in the groove of the groin line and that divides face 56 into an abdomen-confronting face portion and a thigh-confronting face portion. 
     Cover 40 is preferably a soft non-stretchable material to resist stretching. The cover of a regular blood pressure cuff is representative of such materials. Cover 40 has two faces: one to face the area of the groin, and the other containing a rough part 54 of Velcro™ to coincide and fit the matching part 26 on wrap 20 to hold the cover and balloon in place. Cover 40 can also be attached to wrap 20 by way of a couple of snaps. The balloon and its cover can be made from transparent plastic to allow observation of possible bleeding. 
     Wrap 20 is made from a durable, strong, but rather soft, fabric (similar to the synthetic fabric of many handbags and soft suitcases) designed to wrap around the lower abdomen and waist area with extensions to wrap around the upper parts of the thighs. This wrapping procedure can be achieved with the use of Velcro™ shown here and/or snaps and belt-like systems or the application of shoe tie types of techniques. The idea is to hold wrap 20 rather tightly in place to stand against pressure. When wrap 20 is held tight, then its strong non-stretchable fabric material will allow application of the force over the vessels and the adjacent areas where it is needed. The balloon&#39;s shape adapts to the shape of the groin area, and it should be strong enough to hold pressures of up to 250-300 mm of mercury. 
     With inflation of the balloon, the pressure will build up to be applied to the side of the vessel on the puncture side. This pressure can be monitored by connecting this part via tube 50 to the regular blood pressure monitor used in hospitals and offices or by a gauge designed for this job which is shown in FIGS. 6, 9, and 10, and which has a safety alarm part to indicate if the pressure drops. A small snap will allow the tube to be closed and the inflating device to be removed during transfers. 
     The alarm 60 comprises a small cylindrical box 61 having an accordion-type balloon 62 connected to balloon 36. This accordion balloon 62 will work against a circular coiled spring 64 inside box 61 and is separated by the flat, circular end plate of a cap 66 plate covering the lower end of spring 64. With a rise in the pressure inside balloon 36, this small accordion balloon 62 will be inflated, and distended and pressurized, and the pressure and distention will push cap 66 against spring 64. 
     Cap 66 is connected to a metal piece 68 which acts as a gauge. The gauge is to move against a scale 70 to show the relative amount of the pressure inside the balloon. If the pressure inside the balloon drops for any reason, i.e., perforation or leakage, spring 64 will push the metal piece 68 to connect its two metal terminals 72, 73 to terminals 74, 75 to complete an electric circuit and an electric buzzer 76 to sound. The circuit is powered by a battery 78. A control knob 80 comprising a screw 82 can be turned to position the top of spring 64 to adjust the level of pressure that will cause the alarm signal to sound. Turning control knob 80 also adjusts the pressure scale. 
     FIG. 7 shows the front view of an inner wrap 84 and its general appearance when opened and spread on a table. It is very similar to wrap 20 mentioned earlier. It is designed to be used under the outside wrap 20 to prevent contamination of the skin and the spread of dirt and germs. Wrap 84 is a layer of thin, non-irritating, soft synthetic disposable material, with a cut very similar to the wrap 20 so as to fit inside it. In order to keep wrap 84 in place when used, it has lines of gluey or sticky areas that are covered and protected by a covering plastic or paper that will be removed to expose the gluey areas at the time of use. The gluey areas are 86, 88, and 90. 
     When wrap 84 is worn, area 86 will match and stick to the back part of an area 92 after the upper part of the wrap has been wrapped around the lower abdomen. Area 88 will match and stick to an area 94 after the lower right part of the wrap has been wrapped around the right upper thigh. Area 90 will match and stick to an area 96 after the lower right part of the wrap has been wrapped around the left upper thigh. 
     Wrap 84 has a rectangular area 98 to register with part 26 of main wrap 20. Area 98 can be cut open and folded to the upper and lower sides (or torn) to make a window through which part 54 can touch part 26 of wrap 20 to hold balloon 36 in place. If wrap 84 is used to cover the area under the balloon, then there will be no need to have this window opened. 
     Wrap 84 may consist of a sheet of plastic to prevent oozing of the blood or liquids outside of the wrap. It may be designed to attach inside of the outside wrap by way of snaps, gluey surfaces, or clips, etc., before its use. The sizes, relative shapes, color, and materials of wrap 20 may vary to match different people&#39;s size and body structure as well as the amount of the pressure needed for the job to be done. The shape of the balloon and its cover may be modified to fit the anatomy of the groin area in different people with different groin anatomy, and it could be wider or have a longer diagonal along the femoral artery to cover the lower part of the abdomen for the patients whose perforation of vessels is done over and above the groin areas. 
     Some parts of this wrap such as the cover for the left groin and the left thigh may be eliminated when the wrap is made to be used for right groin procedures, and vice versa. Further support can be achieved for higher pressure by adding hard plastic or metal sheets to the wall of the area over the groin to enable it to stand higher pressure. The shape of these sheets may be oval or quadrilateral with mild curvature in center to match the shape of the balloon. These hard sheets may be permanent parts of the structure of the wrap or inserted inside a pocket over the groin area in the wall of the wrap when needed. 
     In some models, the area over the wounded vessel can be made from transparent plastics to give the chance of watching for bleeding. In such cases, the Velcro™ part 54 will be removed from the area. 
     FIGS. 11 and 12 show a clear transparent plastic tube 100 with 5 by 10 mm outside size and about 2 by 5 mm inside opening and 25 to 30 cm length, designed to resist pressure and to hold a hydrophilic cotton yarn or mesh 102 inside. One end of this mesh will be positioned directly over the wound area, and the tube will extend to other end to be exposed for observation outside of the wrap. This mesh is to absorb the blood if it oozed and carry along inside the tube to allow the blood to be noted and bleeding to be observed. 
     When properly placed in the area after a procedure, i.e., cardiac catheterization, the balloon will be over the artery which was intervened and then, after inflation, it will put the appropriate pressure desired in the area to prevent oozing of the blood. The pressure is easily controlled and it can be checked by a gauge. A mesh inside a plastic cover to be located under the balloon may help to notice bleeding, with absorption of the blood by the mesh and discoloration of its white color when contaminated with blood. 
     Further support when needed can be provided with the use of a hard piece of plastic or metal located over the balloon and inside a pocket in the wrap, or in the space between the wrap and the balloon. 
     The balloon 36 inside cover 40 may be enough to work in some cases alone without an outer wrap 20. A soft disposable cover may be made to cover this piece in order to prevent contamination. 
     In summary then, the disclosed balloon 36 and its cover 40 may be said to comprise a face 56 that confronts the person&#39;s groin line and portions of the person&#39;s abdomen and thigh on either side of the groin line. The vertex 58 fits into the groin, dividing this face 56 into an abdomen-confronting portion and a thigh-confronting portion. The balloon and cover have a length extending between tubes 50 and 52, a thickness that extends in the direction of pressure application to the underlying wound, and a width that is transverse to both the length and thickness.