Hemostasis therapeutic compression system, apparatus and methods of use

Abstract

The invention is directed to a hemostasis therapeutic compression system including an apparatus and system to stop bleeding and assist recovery at a wound location. The hemostasis therapeutic compression apparatus includes a bladder having a transparent portion to visualize the bleeding wound location as well as having one side with an interface pressure sufficient to stop bleeding at the wound site, and the wrap has as an elongated tab as part of a hook and loop portion for self-application by the user or patient. The hemostasis therapeutic compression apparatus includes compression not just on the bleeding wound site but alongside the site for increased and faster recovery and less complications. The transparent portion of the bladder may be in the shape of a circle, oval, kidney, elongated kidney, square, rectangle, "U", "C", and other known shapes depending on the size and location of the bleeding wound site on the limb.

Description

HEMOSTASIS THERAPEUTIC COMPRESSION SYSTEM, APPARATUS AND METHODS OF USERELATED APPLICATIONS

[0001] The present application claims priority from provisional application Serial No. 63 / 662,746 filed June 21 , 2024 and entitled “Hemostasis Therapeutic Compression System, Apparatus and Methods of Use”, and as a continuation-in-part from U.S. Serial No 18 / 285,853 filed October 5, 2023, based on PCT Application Serial No. PCT / US22 / 024121 based on provisional application Serial No. 63 / 171541 filed April 6, 2021, and entitled "Arm Therapeutic Compression System, Apparatus and Methods of Use", the entire contents of which are hereby incorporated herein by reference for all purposes.BACKGROUND OF THE INVENTIONI. Field of the Invention

[0002] The subject invention is directed generally to a system for applying compression to a punctured area or open wound, and more particularly, to a system for applying compression to obtain hemostasis such as controlling bleeding at the site. The system includes at least one therapeutic compression apparatus, such as a wrap having a partially transparent bladder and an inflation means for the bladder with the apparatus capable of applying compression to a body location and a pump connected to the inflation means and optionally a bandage material over the wound site.II. Background of the Related Art

[0003] Hemostasis the state of controlling bleeding from a wound, puncture or other opening in the skin. The wound could be a needle puncture or scalpel or blade cut such as during a medical procedure or could be a trauma such as during an accident or battle. Each of these wounds requires control of the bleeding while not stopping circulation of the surrounding area or even the extremities of the human.

[0004] For example, when a catheter or the like is inserted into a blood vessel percutaneously to perform treatment or examination, it is necessary to remove the catheter and then stop bleeding at the puncture site. There are certain known hemostatic devices used to perform hemostasis placed or attached so as to be wrapped around a portion of a puncture site of for example an arm or a leg and compress the puncture site to be hemostatic. Such conventional hemostatic devise may include an band wound around an arm or leg limb having a puncture site, and a balloon that is installed inside the band and can be expanded or contracted. The puncture site to be hemostatic can be compressedby the expanded balloon. Such a hemostatic device can stop the puncture site by the balloon pressing the puncture site with a pressing force of an appropriate size. However conventional hemostatic devices use a large amount of inflation or pressure to compress the puncture site, such as 100 mmHg or greater. This amount of pressure can have complications such as reducing or stopping circulation in the area adjacent to the site or even farther for the wound site causing numbness, tingling, and even necrosis or amputation. A need exists for a compression wrap that can control bleeding using a pressure less than 100-200 mmHg and to reduce or prevent complications.

[0005] Loss of blood is a major cause of death in emergency situations in which the injured person is alone or medical assistance is not immediately available. The use of a touriquet to stop blood loss from an injured arm or leg is a well-known technique for preventing death in these situations. In general, for emergency use where the victim is alone, the victim must be able to apply the tourniquet to his or her own arm or leg and occlude blood flow using only one hand. Tourniquets of the prior art generate inward radial compression on the limb by being put into high levels of circumferential tension when wrapped around the limb. As the pressure on the limb increases, the friction between the strap and the limb also increases, causing the underlying soft tissue to move with the strap as it is drawn tight. This tends to draw soft tissues underlying the strap into the ratchet or buckle device, pinching the soft tissue and creating a region of very high localized pressure which will cause unnecessary injury. This effect may also create high shearing stresses in the underlying soft tissues, increasing the probability of nerve and tissue injury. Friction between the strap and the limb may also create regions of low pressure by preventing tension from being distributed evenly in the strap around the entire limb circumference, and as a result, arterial blood may still flow through these low-pressure regions although overall strap tension is very high. In general, the application of uneven or non-uniform application of pressure around the limb leads to the need for unnecessarily high overall tourniquet pressures to reliably and predictably stop arterial blood flow, and this need for unnecessarily high pressure increases the probability of a range of unnecessary injuries to nerves, muscles and the limb. Necrosis can occur if the interface pressure applied by a tourniquet is too high, which while stopping the immediate bleeding wound then causes the surrounding tissue to die due to lack of blood flow. This is a serious complication with any tourniquet or compression wrap when in use.

[0006] In the related art, it has been known to use tourniquets to stop blood flow from traumatic injuries. A tourniquet is generally a tightly tied band applied around a body part (for example, a bandage tightened around an arm or a leg by twisting) in an attempt to arrest bleeding by forcibly compressing a blood vessel. A tourniquet is typically applied as a last resort method when bleeding cannot be controlled through alternative methods and the amount of blood loss is likely to cause death in seconds to minutes.Animal attacks as well as trauma from exploding devices and gunshot wounds results in a high incidence of life and limb-threatening injuries. Exsanguination from peripheral vascular injury is the primary preventable cause of death in field trauma and has been well documented in literature regarding current war trauma. Blood loss from non-fatal injuries to arms and legs also can contribute to morbidity to kidneys, liver and other vital organs due to hypotension. The loss of significant amounts of blood also increases the rate of consumption of blood products from the blood bank. Multiple extremity wounds can also complicate triage. It is axiomatic that there is a “platinum 5 minutes” for major vascular injury. Even with quick triage, it often takes hours to transport casualties to a medical center, and even if the distance is small, the hazardous nature of the injury locations frequently prevents medical personnel from quickly reaching the wounded. Hence the need for individuals to have a readily available tourniquet that is safe and effective.

[0007] Some improvements have been made in the field of tourniquets however current conventional devices suffer from a number of disadvantages which include: not being easily visible; being complicated or difficult to use; not being quickly or easily accessible; and not being conveniently located. Further as stated the use of too much interface pressure on the wound site, such as about 100 mm Hg or less can cut off blood flow completely resulting in necrosis and even amputation of a limb.

[0008] Further, the use of a tourniquet in many emergency situations, including many recreational activities, such as hiking, rock climbing and camping, imposes a weight restriction on the tourniquet. Simply stated, if a tourniquet is too bulky or has an excessive weight, the potential user, such as a hiker, will not pack and carry the tourniquet with them. Therefore, there is a need of a relatively small and light-weight tourniquet that can be easily packed and carried, and subsequently used at remote locations, if necessary, and using less pressure to reduce or prevent complications. Accordingly, there is a need for an emergency, light-weight tourniquet that provides improved radial pressure to the wounded limb, thereby restricting blood flow to the limb. Furthermore, there is a need for such a tourniquet that can be applied by the victim using one hand.

[0009] Another use for a compression wrap is during hemodialysis, which is the treatment for kidney problems where blood is put through a filter outside a patient's body, cleaned, and then returned to the patient in essence performing the function of the kidneys. It is done either at a hospital, dialysis facility or at home, though most typically at a dialysis facility. The patient generally has to travel to a hospital or a dialysis facility three days a week and undergoes the treatment for 3-7 hours per day. The number of patients being treated at home for dialysis is increasing and such patients may have treatment for 4-7 days a week. More than 661,000 Americans alone have kidney failure and of those about 468,000 are treated through hemodialysis.

[0010] Treatment of dialysis typically involves the use of two needle sites, one with the bloodbeing removed from the patient to run through the dialysis machine to "clean” the blood and then a second needle site where the blood is returned into the patient. Generally, these two needle sites are either together on the forearm or upper arm, spaced apart by a couple of inches or more.

[0011] At some point the patient may have to undergo a minor surgery to insert or create a fistula to provide direct access to the bloodstream. The fistula may include an artery and vein joined together under the skin in an arm which can then be used for hemodialysis for years. Another option is a graft wherein a plastic tube is used to join an artery and vein under the skin. However, a graft does not last as long and will need to be redone and there is a higher risk of infection and bleeding after the hemodialysis treatment.

[0012] Whether a puncture site for a needle or a fistula or graft, each of these access sites have a tendency to bleed immediately after the treatment when the needle is removed, as well as a day or so afterward. The access site has to be observed for bleeding, redness, pus, and swelling. The current way to deal with bleeding immediately after the hemodialysis treatment is to place a piece of gauze on the site and press with the fingers for 10 minutes. This pressure is typically applied by a trained professional medical staff person such as a dialysis technician or nurse at the dialysis facility taking time away from other tasks by the professional. It is recommended to apply firm pressure over the exact bleeding site, use gauze and two fingers or thumb. It is not recommended to use a towel absorbent cloth, as this will make it difficult to see where the fistula is bleeding from. The medical staff such as the dialysis technician or nurse is best suited to apply pressure and control bleeding versus the patient himself or herself.

[0013] In 20 17, the United States government paid, on average, $248 per dialysis treatment compared to $ 1,041 per treatment with private insurance. In 2018 US Medicare spent $81 billion for people with kidney disease (National Kidney, 2020). One of the complications that occurs with hemodialysis is bleeding control from the access site which is a major complication following each dialysis session. Bleeding control is typically accomplished through manual control by the patient or the trained professional medical staff such as a dialysis technician or nurse. A piece of gauze is placed on the needle access site and then held by fingers or a thumb. Certain aids such as clamps with chitosan dressings may also be applied however they can be painful and tend to slip causing further bleeding and discomfort as well as swelling. The clamps have a very high pressure which may cause bruising and further swelling and pain to the patient. In contrast the manual control lacks consistent pressure as a human being is applying the pressure or compression, is time consuming for the medical staff and may be a waste of precious time for the medical staff who instead could be performing otherprocedures.

[0014] Further, bleeding may occur in between dialysis sessions at the needle access site requiringvisits by the patient to urgent care or even an emergency room at a cost of approximately $10,000 per visit. Moreover, infection can occur at the needle access site if the bleeding is uncontrolled and continues either immediately after the hemodialysis treatment or at home or work in between treatment sessions. It is estimated that there are nearly 21,000 annual complications in regard to hemodialysis therapy and vascular access complications account for 16 -25% of hospital admissions. Thus, a need exists for an apparatus to control bleeding both immediately after the hemodialysis treatment and in between treatment sessions for the patient with at home or at work or school. In certain cases, death can result from dialysis vascular access hemorrhaging and it is estimated that dialysis patients may die of fatal hemorrhaging approximately 0.5% though records of death from these causes are likely to be under reported.

[0015] A further need exists for such an apparatus that can be applied by the patient themself without medical staff or a professional involved. If hemodialysis treatment occurs at home without professional medical staff present the potential for bleeding and swelling increases. Thus a need exists for an apparatus to reduce or stop bleeding immediately after the hemodialysis treatment as well as reduce swelling and bleeding in between treatment sessions which apparatus or system can be applied by the patient themselves without a professional medical staff person such as a dialysis technician or a nurse. It is estimated that the current manual compression immediately after a hemodialysis treatment (a dialysis technician or nurse placing gauze on the needle access site and pressing with his / her fingers or thumb for 15 minutes) results in about 39 hours of bleeding control per patient per year based on 15 minutes with patients attending 3 weekly sessions per year, equaling about 156 sessions per year and 39 hours of bleeding control. Therefore the time cost based on salary of the professional medical staff engaged in this manual compression to control bleeding may cost about $1,365 per / patient based on an annual salary of a nurse in the range of about $80,000.

[0016] If compression bandaging is used to attempt to control bleeding after a hemodialysis treatment or in between treatment sessions, current known compression bandaging, also called wrapping, involves the application of several layers of padding and short-stretch bandages to the involved areas. Soft-stretch bandages are preferred over long-stretch bandages (such as those normally used to treat sprains), as the long-stretch bandages cannot produce the proper therapeutic tension necessary to safely reduce lymphedema or swelling and may in fact end up producing a tourniquet effect. The short-stretch bandages enhance the pumping action of the lymph vessels by providing increased resistance for them to push against. This encourages lymphatic flow and helps to soften fluid-swollen areas of the needle site post- dialysis treatment. However, compression wraps applied to the needle site post-dialysis treatment have a problem of obscuring the needle siteto check for bleeding. Thus, a need exists for a compression wrap applied to the needle site after a dialysis treatment which provides visual access to the needle site to check for bleeding.

[0017] Known methods for swelling and lymphedema treatment, like compression bandaging, have several disadvantages. The bandaging is time consuming and the effectiveness is limited to the skill of the provider. In some instances, bandages can be applied too tightly or too loosely and may slip from their intended position, decreasing their effectiveness, such as on the ann. When this occurs, bandages must be taken off and reapplied, further increasing the time of application and decreasing the consistency of application of the therapy.

[0018] The effectiveness of many ofthe current compression therapies is limited by the application of current products. Because current compression therapy is done either with manual wraps or electromechanical systems, they require either a skilled medical professional to apply and / or the need for the patient to be stationary for extended periods of time. Although bandages can be worn by patients and self-administered, they are very difficult for the patient to put on and pose a challenge for unskilled medical professionals to apply consistently and effectively.

[0019] Thus, a need exists for an apparatus and method of use to treat bleeding after hemodialysis treatment at the needle site or access site. This apparatus needs to be applied by a patient without the direction of a medical trained professional such as a dialysis technician or nurse to free up the medical staff s time and use. A need exists for an apparatus and method of use to visually observe the needle access site for any bleeding while applying compression and pressure to control the bleeding and reduce or eliminate swelling at the site and surrounding limb, such as an arm. The patient’s mind, as well as medical professionals, will be at ease with visualization ofthe needle access site post-dialysis treatment to monitor bleeding and bruising.

[0020] Again, the current compression therapy isdonc either with a dialysis technician or nurse placing two fingers or a thumb on gauze placed over the access or needle site for 10-15 minutes, then placing a bandage over the site and sending the patient home. A need exists for a new system to treat bleeding post-dialysis treatment and / or post-catheterization to reduce swelling and bleeding while having visualization of the needle access site. A further need exists for compression not just on the needle site but also on the area surrounding the needle site to assist in recovery such as reduced swelling, and stopping the bleeding at the needle site once the needle is removed. Compression on the arm localized around the needle site and extending around the circumference of the side or even entire arm will assist in recovery and may decrease bleeding and bruising at the needle site as well as having other advantages known for compression therapy such as sore muscles and skin tenderness and other advantages.

[0021] A need exists for a compression device including a single size or multiple which can be usedinstead of a tourniquet so can visualize the bleeding with a transparent or partially transparent potion. A need exists to be able to visualize the wound site as well as inflate the bladder as much as needed, while still being lower than conventional known bladders such that we can control and / or stop the bleed without high pressure. In certain methods of the inventive compression device use a gauze or bandage portion can be applied to the wound site under the compression device for additional localized pressure and hemostasis assistance. In certain methods a bandage with a bolster such as a bolter dressing may be placed on the wound site under the compression device for additional localized pressure and hemostasis assistance. Further, the inventive compression apparatus is beneficial compared to conventional known tourniquet that have no control on the pressure level and in certain instances if applied on a leg the leg becomes ischemic due to for example current pressures of 130-140 mm Hg for tourniquets versus the inventive hemostasis therapeutic compression apparatus of about 40-80 or preferably 60-70 for local bleeding.

[0022] Further, a need exists for a hemostasis therapeutic compression apparatus having a shape to reduce or prevent the device slipping on the skin surface within applied. The inventive apparatus fills this need with certain shapes such as extensions, bumps or the like which act like short legs or anchors from preventing any slippage on the limb when in use.

[0023] Another need exists for not one single bladder over the wound site as employed on conventional compression apparatus for hemostasis but instead a bladder portioned around the transparent portion which one side that stiffer than other side at a set interface pressure while the other portion of the bladder compresses at a lower interface pressure allowing some blood flow to avoid necrosis but still assist in reducing and stopping bleeding at the wound site including reducing swelling along the wound site. A need exists for a hemostasis therapeutic compression apparatus having a bladder such as partitioned like a river or maze having one interface pressure and then one transparent or translucent portion of the bladder having an interface pressure sufficient to reduce of stop bleeding at the wound site, such as about 40-90 mm Hg. Again, the circumferential compression and then more localized compression at the wound site assists in hemostasis and reduces or prevent complications. A further need exists for a hemostasis therapeutic compression apparatus including a bladder compressing an artery to get hemostasis but not just plugging the artery hole and instead seals or closes the arterial hole with localized bulk and may include gauze or bandage on the site under the clear bladder.

[0024] Certain compression devices are known which may include an inflation means capable of providing constant static pressure for a period of time as well as providing intermittent varying pressure for a prior oftime, but the currently known devices are bulky as the inflation means or pump is an integral part of the wrap mechanism. A need exists for an apparatus with a constant compression or pressure level to control bleeding and swelling at a needle access site afterhemodialysis treatment and in between treatment sessions. A further need exists for such a compression devices or apparatus to include a check valve to prevent both over-inflation and to also seal and prevent deflation while the user engages in activities or rests in place. A need exists for a hemostasis therapeutic compression system including a compression apparatus having an integrated valve to maintain the level of compression and prevent deflation of a bladder, and preferably a self-sealing valve. A need exists for a hemostasis therapeutic compression system including a relief valve for immediate deflation of the compression or pressure within the bladder.

[0025] A further need exists for a system including an inflation means which is less bulky than known systems. A further need exists for a tourniquet that can be applied by the user themselves, especially when in a remote location alone, to reduce or stop bleeding at the wound site while still allowing blood flow to reduce or prevent numbness, pain, tissue damage, occluding of the blood vessel, or even necrosis. Another need exists for a hemostasis therapeutic compression apparatus which when inflated applies circumferential compression through the inflated bladder to skin and tissue surrounding the wound site while applying higher and more localized compression and interface pressure at the wound site so that hemostasis is achieved at the wound site without complications.

[0026] The apparatuses, methods, assemblies and systems of the subject invention provide benefits and advantages that may overcome a number of problems with respect to known compression technologies, particularly the problems that arise due to the difficulty of applying current manual compression or current compression wrap technologies.SUMMARY OF THE INVENTION

[0027] The subject invention is directed to a hemostasis therapeutic compression system and methods of use. The hemostasis therapeutic compression system includes a hemostasis therapeutic compression apparatus including an air bladder that has a transparent or translucent bladder portion over the wound site for visualization of any bleeding issues. The hemostasis therapeutic compression apparatus also includes an inflation means wherein the inflation means is less bulky than known inflation means. The inflation means includes at least two settings of constant inflation or pressure. An optional setting may befor varying or intermittent inflation or pressure. The inventive hemostasis therapeutic compression system may optionally include at least one sensor, such as a motion sensor, pressure sensor, blood pressure sensor, tannometer sensor, or other sensors to monitor use of the inventive system by the patient and / or medical professionals. The inventive system includes a portion of the compression bladder near to but not limited to the wound site, such as around the side and back of the arm so as to aid in recovery post-dialysis. The inventive system may also include a relief valve to prevent overinflation as well as a release valve to deflate the inflated bladder. The system includes different therapeutic compression apparatus such as but not limited to an apparatusfor use on a limb such as an arm or leg or other body part.

[0028] The hemostasis therapeutic compression apparatus includes a connecting means such as a loop and hook material in order to wrap the hemostasis therapeutic compression apparatus around the limb, such as an arm or leg, of the user. The inventive hemostasis therapeutic compression apparatus includes a portion of the hook material including an elongated tab configured to connect to an adhesive such as tape allowing the user to place the hemostasis therapeutic compression apparatus on the arm by himself or herself. Alternatively, the at least one bladder may be integral with the connecting means or wrap. One or more connecting means may be operatively associated along the first and second peripheral edges of the therapeutic compression apparatus for securing it around the limb.

[0029] The at least one bladder may be adapted and configured to form a set pressure or compression level when the at least one bladder is filled. The bladder includes a portion which is translucent or transparent for visualization of the wound site. The translucent or transparent portion of the bladder may be in the shape of a -'U", kidney or elongated kidney, oval, circle, rectangle or any other known shapes. The at least one bladder may also include a plurality of fluid chambers. The hemostasis therapeutic compression apparatus, as part of the inventive system, may further comprise at least one means for adjusting pressure coupled to the at least one bladder for controlling an amount of pressure or compression level supplied to the treatment site.

[0030] The subject invention is also directed to a bladder assembly for a compression apparatus for providing pressure to a limb to cause hemostasis at a wound site, whether as part of a surgical procedure or as a tourniquet outside of a medical facility during an emergency situation. The bladder assembly comprises at least one bladder having first and second flexible walls secured to one another about a peripheral edge thereof to form an air pocket with certain welds in a predetermined pattern and location inward of the peripheral edge connecting the first and second walls to one another to define a plurality of chambers within the bladder. A portion of the bladder is transparent or translucent to visualize the wound site and the portion has one side in contact with the skin of the limb and wound site having an interface pressure sufficient when inflated to reduce and / or stop bleeding at the wound site, and the other side of the transparent or translucent bladder has a pressure which is lower as this side is facing away from the skin, however together the interface pressure on the skin is in an amount of about 40-90 mm Hg.

[0031] An inflation means for inflating the bladder such as the air pocket through at least one inflation port may be provided in the first wall of the bladder assembly. The inflation means may be detachable from the at least one inflation port. At least one pressure valve may be operatively associated with the inflation means for controlling an amount of pressure within the bladder and theair pocket within the bladder. The inflation port includes a check value so as to maintain a given pressure within the bladder of the therapeutic compression apparatus. The inflation port may be universal in that it is configured to be capable of connecting to and accepting a plurality of inflation sources and inflation means such as a manual pump, mechanical pump, electrical pump, battery- operated pump, static pump, intermittent pump, pneumatic pump, negative pressure source and other variations. The therapeutic compression apparatus may also include a release valve which when activated by a user releases the air within the air bladder to deflate and release the pressure on the arm of the patient.

[0032] The bladder is connected to an inflation port including a valve configured so that when the valve is in the closed position the pressure profile and / or compression profile is maintained at the then current pressure and / or compression level. The valve is configured so that when it is in the open position the fluid, such as air, flows from the inflation means into the bladder and if not connected to an inflation means then the fluid escapes from the bladder and it is deflated. The valve may be self-sealing or it may be connected to a means to open and close it with for example a level, knob, screw or other opening and closing means.

[0033] A method of the invention includes the therapeutic compression system including a therapeutic treatment apparatus used to treat swelling and bleeding at a wound site or a needle access site for the patient after hemodialysis or a surgery, by applying the wrap around a limb by a patient and inserting an inflation means into an inflation port and inflating the bladder within each of the primary wrap and if applicable secondary wrap and maintaining a certain pressure to treat the swelling or bleeding at the needle access site.

[0034] Another embodiment of the present invention includes a system according to the invention includes a pressure mechanism having a flexible member for attachment to a limb and an air chamber which may be pumped up into a desired pressurized state, a separate relatively small pre-filled air bladder, an absorbent foam, sponge or dressing coupled to the pre-filled air bladder. Optionally a suction conduit may be coupled to a source of negative pressure (suction) and in fluid communication with the absorbent foam, sponge or dressing. In a preferred embodiment, the pre-filled air bladder, the absorbent foam, sponge or dressing and the suction conduit are formed together as a unit.

[0035] In one embodiment a disk 455 having an indentation or cut-out for a needle lying on the skin of the patient at the needle access site is placed on the skin prior to tire therapeutic compression apparatus being placed on the patient wherein the disk may be a foam, gauze or other material. The disk 455 assists in keeping the needle from moving while the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is placed on the arm 600 and closed via the hook and loop means 122, 222, 322, 422 and 124, 224, 324, 424 and the bladder 102, 202, 302, 402 inflated. At a later time theneedle is then removed from under the activated and inflated inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400. The disk 455 also assists in controlling bleeding once the needle is removed from the patient’s arm. The disk 455 could include a gauze portion as well as other medicines to prevent infection at the needle access site.

[0036] According to one aspect of the invention, the hemostasis therapeutic compression apparatus is adapted to wrap around an arm or leg and over a pre-filled air bladder in order to secure the pre-filled air bladder and the foam, sponge or dressing to a wound site on the arm or leg. The bladder when inflated has a transparent or translucent portion that is in contact with the wound site and has an interface pressure of about 40-90 mm Hg, preferably about 50-70 mm Hg so as to reduce and / or stop bleeding at the wound site. Other portions of the inflated bladder are within the wrap to apply pressure on tissue around the wound site and assist in recovery from trauma or a surgical procedure including reducing swelling which may be around the wound site due to the trauma on the skin. For example, if the individual is in an accident or suffers an injury there may be a bleeding wound site and that wound site and surrounding skin and tissue may swell up so that the inflated bladder would reduce and stop of the bleeding at the wound site via interface pressure (about 40-90 mmHg) on the bleeding wound site while the surrounding swollen skin and tissue would have lower compression pressure to reduce the swelling through therapeutic compression application. The line welds of the wrap create a predetermined pattern and pressure levels when inflated based on the area of the wrap in contact with the limb beyond just the wound site. The wrap also includes a securing means such as shapes around the transparent or translucent portion of the bladder to prevent or reduce slippage and movement of the inflated inventive hemostasis therapeutic compression apparatus on the limb or body part. If used as a tourniquet such as to treat a trauma, then the interface pressure may need to be higher such as 100-140 mmHg on the wound site and surrounding skin and tissue area.

[0037] One of the methods of the invention include locating the pre-filled air bladder and foam, sponge or dressing over a bleeding needle access site on an arm, wrapping the inventive hemostasis therapeutic compression apparatus around a limb with the transparent and / or translucent portion of the bladder located over the pre-filled air bladder connected to an absorbent portion (“PFAB”), sponge or dressing, and fastening the hemostasis therapeutic compression apparatus in place with the connecting means such as hook and loop fasteners or other types. When the apparatus is properly located and affixed to the lower arm or upper arm or leg, the bladder is inflated, preferably to so that the portion of the transparent and / or translucent bladder in contact with the bleeding wound site has an interface pressure of about 40-90 mm Hg, preferably about 50-70 mm Hg.

[0038] In another embodiment the system includes one or more sensors to monitor movement ofthe therapeutic compression apparatus, pressure levels, blood pressure of the patient, tonometry of the target limb, or other sensor data.

[0039] These and other aspects of the contacts of the subject invention will become more readily apparent from the following description taken in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use the apparatuses of the subject invention, preferred embodiments thereof will be described in detail herein below with reference to the drawings, wherein:

[0041] FIG. 1 is an embodiment of the present invention including a lower arm hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of an elongated kidney shape in use on a patient including two pieces of gauze on each of the two wound locations, here needle access sites with the needles removed and bladder in an inflated activated state;

[0042] FIG. 2 is another view of one embodiment of the present invention including a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of an elongated kidney showing the outer view which could be used on a left lower arm or a leg depending on size of the user’s leg;

[0043] FIG. 3 view of one embodiment of the present invention including a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of an elongated kidney showing the outer view which could be used on a right lower arm or a leg depending on size of the user’s leg;

[0044] FIG. 4 is a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a kidney for use on the left upper arm or forearm of a user or a leg depending on size of the user’s leg;

[0045] FIG. 5 is a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a kidney for use on the right upper arm or forearm of a user or a leg depending on size of the user’s leg;

[0046] FIG. 6 is a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a circle and a longer length of the bladder and hook and loop closure means approximately 6 inches long for use on the lower arm or upper arm or forearm or leg of a user and including an extended portion of the tab for self-application with adhesives such as common tape;

[0047] FIG. 7 is further embodiment of a hemostasis therapeutic compression apparatus including atransparent portion of the air bladder in the shape of a circle with indentations to form a cross-like shape when inflated and a longer length of the bladder and hook and loop closure means approximately 8 inches long for use on either the lower arm or upper arm or forearm or leg of a user and including an extended portion of the tab for self-application with adhesives such as common tape;

[0048] FIG. 8 is a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a circle and a longer length of the bladder and hook and loop closure means approximately 10 inches long for use on either the lower arm or upper arm or forearm or leg of a user and including an extended portion of the tab for self-application with adhesives such as common tape;

[0049] FIG. 9 is a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a circle and a longer length of the bladder and hook and loop closure means approximately 12 inches long for use on either the lower arm or upper arm or forearm or leg of a user and including an extended portion of the tab for self-application with adhesives such as common tape;

[0050] FIG. 10 is blown up exploded view of FIG. 7;

[0051] FIG. 11 is a perspective view of FIG. 7 also including a release button and not including the valve cap and connector;

[0052] FIG. 12 is a top view of FIG. 8 also including a release button;

[0053] FIG. 13 is a back view of a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a circle and for use on the lower arm or upper arm or forearm or the leg of a user with the bladder in an activated inflated state;

[0054] FIGs. 14A-C is an embodiment of an inflation means of the present invention with FIG.14A a front view of the inflation means, FIG. 14B an exploded view of the inflation means of FIG. 14A, and FIG. 14C a blown up view of the vent button assembly;

[0055] FIGs. 15A-G are blown up view of portions of the vent button assembly of FIG. 14C which is part of the inflation means of FIGs. 14A and 14B including FIG. 15G is a cross-section view of the inventive inflation means hand pump pressure control;

[0056] FIGs. 16A and 16B are an exploded cross-section view of a further embodiment of the inflation port as part of the present invention;

[0057] FIG. 17 is an embodiment of the present invention (such as FIGs. 6-12) including an arm hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a circle in use on a patient post-hemodialysis treatment including a foam disc having a cut out configured for placement of the needle when the therapeutic compression apparatus is placed andwrapped on the arm two and the bladder in an inflated activated state;

[0058] FIG. 18 is an embodiment of the present inventive system including a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of an elongated kidney for use on the right lower arm or the leg of a user, an inflation means including a hand pump and a gauge, a piece of gauze, and a pre-filled air bladder;

[0059] FIGs. 19A and 19B are further embodiments of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a square for use on the upper arm or a leg of a user of FIG. 19A and shape of a rectangle for use on the lower arm or a leg of a user of FIG. 19B;

[0060] FIG. 20 is a further embodiment of a hemostasis therapeutic compression apparatus including a transparent portion of the air bladder in the shape of a “U” for use on the upper or lower arm or a leg of a user.

[0061] FIG. 21 is a further embodiment of a hemostasis therapeutic compression apparatus including different thickness of the transparent bladder a securing means to prevent slippage of the present invention on a user when the body part moves;

[0062] FIGs. 22 and 23 are opposite sides of FIG. 21 with FIG. 22 the top view and FIG. 23 the bottom view having contact with the user’s skin when worn on a body part;

[0063] FIGs. 24-26 are side views of FIG. 21 and 23 with FIG. 24 a side view of FIG 21 in a noninflated state, FIG. 25 a side view of FIG. 21 with only the transparent bladder inflated, and FIG. 26 a side view of FIG. 23 with only the transparent bladder inflated, each Figure with the valve cap held in the inflation port;

[0064] FIG. 27 is an exploded side view of FIG. 21 in an inflated state showing the difference between the portion of the inflated transparent bladder having a larger portion on the skin contact side 404b;

[0065] FIG. 28 is a top view of FIG. 21 in an inflated state;

[0066] FIG. 29 is a further embodiment of a hemostasis therapeutic compression apparatus; and

[0067] FIG. 30 is a further embodiment of a hemostasis therapeutic compression apparatus.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068] Preferred embodiments of the subject invention are described below with reference to the accompanying drawings, in which like reference numerals represent the same or similar elements. One of ordinary skill in the art would appreciate that while the apparatuses discussed herein relate to compression therapy of the upper arm or lower arm or leg, the scope of the invention is not limited to those exemplary applications and may be sized and shaped for the anatomical portion for whichhemostasis compression therapy is needed such as by way of example as part of a surgical procedure, catheterization, or dialysis treatment at a needle access site once the needle is removed from the patient’s skin or as a tourniquet in an emergency situation within or outside of a medical facility.

[0069] The subject invention provides compression to a patient or user limbs, including the extremities, including for example, the arm of a user post-dialysis treatment or radial or femoral arty post-cardiac catheterization or other body parts, in a manner that is simpler, less bulky, more practical, more mobile, and more convenient than current systems. Any limb or body part may be compressed by the instant system including a hemostasis therapeutic compression apparatus such as for instance a foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, hand, fingers, neck, head or the like depending on the treatment or need for compression at such location.

[0070] The subject invention provides system for providing compression and reducing and / or preventing swelling and bleeding at a wound site, such as for example a needle access site after hemodialysis treatment and removal of the two needles, or post-cardiac catheterization, or in a trauma or emergency situation. The system is provided in in a manner that allows for consistent measuring of the pressure supplied, as well as safe, comfortable, more practical, more mobile, convenient, effective, and self-application by the patient.

[0071] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either both of those included limits are also included in the invention. Any such range may be estimated to be lower or higher by at least + of 10%.

[0072] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited.

[0073] It must be noted that as used herein and in the appended claims, the singular forms "a", "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a stimulus" would include a plurality of such stimuli and reference to "the signal" would include reference to one or more signals and equivalents thereof known to those skilled in theatl, and so forth. The publications discussed herein are provided solely fortheir disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may differ from the actual publication dates which may need to be independently confirmed.

[0074] Referring now to FIG. I, there is illustrated the inventive hemostasis therapeutic compression system and apparatus in use on the needle access sites on a lower arm of a patient after hemo-dialysis treatment. The inventive hemostasis therapeutic compression system and apparatus 100 has been placed on the user arm 600, lower arm between the wrist 605 and elbow 610, above the needle access sites over two pieces of absorbent dressing, such as gauze 504A, 504B, and the needles have been removed and the inventive hemostasis therapeutic compression apparatus 100 inflated and activated. The transparent portion 104 of the bladder 102 shows the location of the needle access sites and the absorbent dressing, gauze 504A and 504B, so that the external bleeding can be monitored at the needle access sites after removal of the needles. This is an example of visualization of lower arm needle access sites which may bleed immediately after the hemo-dialysis treatment or in between treatment sessions. In other patients the needle access sites may be on the upper arm or on the leg or even groin area. Also shown is the bladder 102 inflated on the sides of the lower arm adjacent to the needle access sites. The inflation port 112 is closed by the self-sealing valve as shown in FIGs. 16A-B, and the valve cap 113 can deflate the inflated bladder 102 by pushing down on the self-sealing valve. Once the bladder is inflated in the inventive hemostasis therapeutic compression apparatus the inventive inflation means cannot overinflate and instead inflates to a sufficient interface pressure to assist and create hemostasis, typically at interface pressure on the needle access site of 60 mm-Hg though many other pressures may be employed from 10 mm-Hg to under or about 100 mm-Hg. Either arm may be used and depending on how long this patient has been undergoing hemo-dialysis treatment, there may be multiple fistulas or grafts that stop working and others placed on the other arm or placed on the upper arm after the lower arm locations stop working.

[0075] FIGs. 2 and 3 show an exemplary embodiment of the inventive system including a hemostasis therapeutic compression apparatus 100 for use on the lower arm or forearm of a patient including an elongated kidney shaped transparent portion of the air bladder to allow visual observation of the needle access sites after the hemodialysis treatment. Not shown in these FIGs. are the inflation means 150 and a connecting means 160 between the inflation means 150 and the inflation port 112 on the inventive hemostasis therapeutic compression apparatus. In some embodiments the inflation means may be a manual hand pump, foot pump, mechanical pump, electrical pump, battery-operatedpump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any combination thereof or any other known or developed source of inflation so as to provide a certain pressure within the hemostasis therapeutic compression apparatus so to provide compression in use by the patient or user. In some embodiments the inflation means is connected to the hemostasis therapeutic compression apparatus by a hose or tube as the connecting means 160. In some embodiments the inflation means is connected to a retaining means such as a belt or wrap to be worn by the user where an automatic pump is employed for intermittent pressure and inflation followed by deflation.

[0076] The hemostasis therapeutic compression apparatus 100 (and other embodiments shown as 200, 300 and 400) may be comprised of a bladder 102, 202, 302, 402 such as a compression bladder either integrally formed in the hemostasis therapeutic compression apparatus 100, 200, 300, 400 or the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is configured for the bladder to be inserted (not shown) within the hemostasis therapeutic compression apparatus 100, 200, 300, 400. The hemostasis therapeutic compression apparatus 100, 200, 300, 400 is configured and adapted to wrap around a patient's limb such as in for instance an arm 600 or lower arm or upper arm or leg though other limbs may be included as well such as a leg, calf, knee, foot, ankle, thigh, torso, arm, neck or any other limbs. The hemostasis therapeutic compression apparatus 100, 200, 300, 400 is not limited to the limbs or body parts listed above but could be any body part such as without limitation a foot, ankle, calf, lower leg, knee, thigh, groin, hip, leg, buttocks, torso, stomach, chest, shoulder, arm, elbow, hand, wrist, neck, head or the like and any combinations thereof. As shown in FIGs. 1-3 the hemostasis therapeutic compression apparatus 100 is a lower arm apparatus (sometimes referred to as the forearm apparatus) having a transparent portion of the bladder 104 in the shape of an elongated kidney, whereas the hemostasis therapeutic compression apparatus 200 is an upper arm apparatus as shown in FIGs. 1-3 with the transparent portion of the bladder 204 in the shape of a kidney.

[0077] The hemostasis therapeutic compression apparatus 100 is a wrap member with a proximal end portion 107 (top as oriented in FIGs. 1-3 closer to the elbow 610 of the user) and opposed distal end portion 109 (bottom as oriented in FIGs. 1-3 closer to the wrist 605 of the user) which is configured and adapted to conform around a patient's lower arm and provide compression through the inflation of bladder 102. The top portion 107 and lower portion 109 of the hemostasis therapeutic compression apparatus 100 are configured to curve closer to the wrist 605 and / or elbow 610 to fit better or more snuggly on the user when in use.

[0078] The hemostasis therapeutic compression apparatus 200 as shown in FIGs. 4-5 is a wrap member with a proximal end potion 207 (top as oriented in FIGs. 4-5 closer to the shoulder 615 of theuser) and opposed distal end portion 209 (bottom as oriented in FIGs. 4-5 closer to the elbow 610 of the user) which is configured and adapted to conform around a patient’s upper arm and provide compression through the inflation of bladder. The top portion 207 and lower portion 209 of the hemostasis therapeutic compression apparatus 200 are configured to curve closer to the shoulder 615 and / or elbow 610 to fit better or more snuggly on the user when in use. The top portion 207, 307 of the hemostasis therapeutic compression apparatus 200, 300, 400 is curved to configure along the elbow 210 if worn on the lower arm or nearer the shoulder 615 if worn on the upper arm. The bottom portion 209, 309 of the hemostasis therapeutic compression apparatus 200, 300, 400 is curved to configure along the wrist 605 if worn on the upper arm or nearer the elbow 605 if worn on the upper arm. In another embodiment the upper arm apparatus 200, 300, 400 is configured so that it can be turned upside down by the user to make it easier to close the hook and loop portion whether on the right upper arm or left upper arm.

[0079] In this embodiment the hemostasis therapeutic compression apparatus 100, 200, 300, 400 (as shown in exploded detail in FIG. 10) includes an outer sheet 301a and inner sheet 301b which are made out of a nylon laminated polyurethane sheet which are configured and adapted to be RF welded together such as along and via the weld lines 116, 216, 316, 416 which for the boundary of the bladder 102, 202, 302, 402 as well as the compression points and the location of the line welds 116, 216, 316, 416 affect the pressure on the skin both at the needle access site and on the arm adjacent to the needle access site or even around the whole arm area under the wrap when applied and the bladder inflated. However, any other suitable materials which are weldable or otherwise joined while being airtight can be used. Continuous peripheral weld lines 116, 216, 316, 416 form an airtight boundary of integrally formed bladder 102, 202, 302, 402. In this exemplary embodiment, bladder 102, 202, 302, 402 is a single continuous bladder throughout however, it is envisioned that the hemostasis therapeutic compression apparatus 100, 200, 300, 400 could have an independent bladder either separately inflatable or inflatable through a one-way valve or other desired inflation / deflation configuration and even multiple connected or not connected and separate bladders are possible and envisioned in the inventive hemostasis therapeutic compression apparatus.

[0080] In this embodiment, hook and loop fasteners 124, 224, 324, 424 (the hook component) are provided along the edge of inner sheet and outer sheets (as shown in exploded view of FIG. 10) in order to ease adjustment and secure the hemostasis therapeutic compression apparatus 100, 200, 300, 400 on a patient's limb such as for example an arm and more specifically either a lower arm or an upper arm or a leg of a user, by connecting to soft material such as doe skin or other stretchable material 122, 222, , 322, 422. It is envisioned that the hemostasis therapeutic compression apparatus 100, 200, 300, 400 can include hook and loop fasteners 124, 224, 324, 424connecting to stretchable material 122, 222, 322, 422, but also could be secured to a patient's arm, leg or other body part by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means. Further, it is also envisioned that hook and loop closures systems 122, 124, 222, 224, 322, 324, 422, 424 can be replaced by material similar to that of an wrist strap, elbow strap, shoulder strap, arm strap, hip strap, leg strap, calf strap, ankle strap, or any other type of strap (including those described below) and be welded / sewn / attached to bladder for improved comfort. Further, there are a number of air holes 108, 208, 308 to allow for breathing of the skin area below the hemostasis therapeutic compression apparatus 100, 200, 300, 400 such as to reduce sweating and rashes.

[0081] Referring now to FIGS. 2-13 and 18-20, in these embodiments the hemostasis therapeutic compression apparatus 100, 200, 300, 400 has a bladder integral within outer sheet 101a, 201a, 301a and inner sheet 101b, 201b, 301b, with the location and desired preconfigured compression gradient profile obtained cost-effectively. A number of different embodiments of bladder configurations can be used in the hemostasis therapeutic compression apparatus 100, 200, 300, 400 such as those configurations described above. FIGS. 2-13 and 18-20 show various inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 having bladder 102, 202, 302, 402, with a plurality of line welds 116, 216, 316, 416 therein. Linear weld lines 116, 216, 316, 416 allow for better compression along the body part of a user. This increased tension can generate a more effective compression in order to reduce or stop bleeding at a wound site, such as during surgery or an emergency procedures outside a medical facility at a needle access site while also preventing slippage down the body part arm and securing the transparent bladder portion 104, 204, 304, 404 over the wound site. The interface pressure at the wound site has to be sufficient to stop or control bleeding at the wound site without causing necrosis or other complications if blood flow is stopped completely in the arteries or veins around the wound site. By way of example, an interface pressure on the skin at a wound site of about 40-90 mmHg, preferably about 50-70 mmHg reduces or stops bleeding at a wound site without occluding the arteries and veins around the wound site, thus avoiding complications like numbness, the feeling of pins and needles, or more serious complications such as necrosis or even amputation if blood flow is stopped long enough. However, when used as a tourniquet such as to treat a trauma, then the interface pressure may need to be higher such as 100-140 mmHg on the wound site and surrounding skin and tissue area.

[0082] When the inventive hemostasis therapeutic compression apparatus is used as part of a surgical procedure such as dialysis or any catheterization, once the needle is removed the wound site has to have interface pressure applied in order to reduce and stop the bleeding, while still maintaining blood flow within the vessel (vein or artery) under the skin. Linear weld lines 116, 216, 316, 416 located laterallyalong the arm 600 or a leg create a ribbed portion, which keeps the inflated profile of hemostasis therapeutic compression apparatus 100, 200, 300, 400 compact and compressing arteries and veins surrounding the wound site without occluding them or cutting off blood flow completely. This additional compression beyond just on the bleeding wound site assists with hemostasis and recovery around the wound site such as reducing swelling of the surrounding skin and tissue. The combination of circumferential compression applied to the skin and tissue surrounding the wound site and then more localized compression at the wound site in an amount sufficient to obtain hemostasis such as interface pressure of about 40-90 mmHg results in faster and more efficient hemostasis with less complications. For example, when applied to a needle site, the arterial hole at the needle site is closed and sealed with the inventive hemostasis therapeutic compression apparatus versus other known hemostasis devices.

[0083] It can be appreciated that depending on the location of the hemostasis therapeutic compression apparatus 100, 200, 300, 400, different pressure levels or compression levels may be utilized. Other possible pressure profile may be imagined based upon the geometric location of the linear welds 116, 216, 316, 416. For example, in the hemostasis therapeutic compression apparatus 300, depending on the location of the limb to be compressed, such as the upper arm area, the linear welds 216 may be in different geometric configurations than those shown in FIGS. 2-5 for therapeutic compression apparatus 200, 300, 400 for use on the lower or upper arm area compared to the line welds 316, 416 on FIGs. 6-12 and further compared to FIGS. 21-30. Further, the compression profile and / or pressure profile may be based on the pressure level from the inflation means alone, or combined with the overall shape of the bladder 102, 202, 302, 402 and the overall shape of the translucent or transparent portion of the air bladder which is configured to be placed over the needle access site.

[0084] The hemostasis therapeutic compression apparatus 100, 200, 300, 400 includes a portion of the bladder 100, 202, 302, 402 which is translucent ortransparent 104, 204, 304, 404. This translucent or transparent portion 104, 204, 304, 404 ofthe bladder 2102, 02, 302, 402 is connected to the other portion of the air bladder 102, 202, 302, 402 via openings 105, 205, 305 shown in the Figures. The location of the openings 105, 205, 305 may vary in width and height also depending on the shape oftransparent portion 104, 204, 304, 404 and the embodiment depending on the application to the lower arm or upper arm or leg when in use.

[0085] This translucent ortransparent portion 104, 204, 304, 404 of the bladder, 202, 302, 402 is configured to be placed over the wound site for a trauma or for example over the needle access site after cardiac catheterization or hemodialysis treatment so the user or medical staff can visually observe any external bleeding through the gauze or bandage applied over the needle access site once the needle is removed. The translucent or transparent portion 104, 204, 304, 404 of thebladder 102, 202, 302, 402 may beconfigured in various shapes as shown in the Figures including without limitation a rectangle, square, kidney, elongated kidney, "U", “C”, oval, circle or any other known shape. FIGs. 1-3 and 18 show the translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 in the shape of an elongated kidney. FIGs. 4-5 show the translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 in the shape of a kidney. In the embodiment shown in FIGs. 6-13, 17, and 21-30 the hemostasis therapeutic compression apparatus 200, 300, 400 shows the translucent or transparent portion 204, 304, 404 in the shape of a circle (FIGs. 7 and 21-30 have additional indents to form the shape of a cross within the circle) and are configured for the lower arm and upper arm and leg, though could be used on other body parts. FIG. 19A shows the translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 in the shape of a square and FIG. 19B in the shape of a rectangle. FIG. 20 shows another embodiment of the hemostasis therapeutic compression apparatus 350 in this configuration for the lower arm, with the translucent or transparent portion 354 of the bladder 302 in the shape of a •’U". Other known shapes may be employed.

[0086] The translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 of the inventive hemostasis therapeutic compression apparatus is configured to apply pressure or compression at the wound site for trauma or a needle access site during and after a surgical procedure to control external bleeding and reduce or eliminate swelling of the arm or leg area around the needle access site as well as the arm or leg area overall while maintaining sufficient blow flow within the vessel. The pressure or compression is kept constant through the inflation means in this embodiment though intermittent pressure is also envisioned and in other embodiments which may mimic the pulsing of blood through the vessel or other intermittent ranges.

[0087] The inflation means may be a hand pump as shown in FIGs. 14-15 and 18B. In the embodiment as shown in FIG. ISBthe inflation means is a device 150 which is a manual pump capable of attaching to inflation port 112, 212, 312, 412 to inflate bladder within the hemostasis therapeutic compression apparatus 100, 200, 300, 400 though other pneumatic pumps may be employed. As shown in FIG. 18B the inflation means 150 is a is a hand manual pump 400 including a bulb 420 for manually pumping of air fluid and a hand dial 410 including a check valve within. A number or variety' of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. Asseen in FIGs. 16A and 16B which is a close up view of a valve 290 incorporated into therapeutic compression apparatus 200 in the inflation port 212 to allow a userto selectively deflate bladder 202 ofthe hemostasis therapeutic compression apparatus 200. Further, a check valve (not shown) or relief valve (not shown) is incorporated with either inflation means 150 or bladder 202 to prevent over-inflation once a maximum pressure is detected. Examples of relief valves are described in U.S. Pat. No. 7,276,037 and U.S. Pat. No. 7,850,629, the disclosures of which are incorporated by reference in their entirety. In another embodiment not shown it can be appreciated that other mechanical or automatic inflation pump (not shown) can also be attached to inflation port 212 to inflate and deflate bladder 202 within the hemostasis therapeutic compression apparatus 200 to provide pulsating pressure to a user's limb.

[0088] The inventive therapeutic system includes an inventive self-sealing means connected to the bladder 102, 202, 302, 402 so as to maintain the constant compression profile and / or pressure profile when the inflation means 150 is either disconnected from the hemostasis therapeutic compression apparatus 100, 200, 300. 400 or the inflation means stops providing additional inflation or pressure. In the embodiment shown the self-sealing means is a valve 290 in the inflation port 112, 212, 312, 412. The self-sealing means valve 290 within the inflation port 112, 212, 312, 412 is shown in more detail in FIGs. 16A-B which is a cut-away ofthe inflation port 212, the valve 290 is located within a housing 214, the housing being tubing or for instance a luer. In this embodiment the housing 214 is a plastic female luer but other materials can be employed such as metal, polymers, or rubbers and other housing means can be employed. The valve 290 as shown in FIGS. 16A-B includes a V-notch 291 in the top proximal portion ofthe valve 290 though other shapes of notches or other apertures and openings may be employed. The V-notch 291 in this embodiment assists in movement of the fluid from the male luer 161 (fluid flowing from the inflation means 150) into the inflation port 112, 212, 312, 412 and into the bladder 102, 202, 302, 402. The bottom distal portion ofthe valve 290 is in a shape as shown such as a plug where the top portion 291 is thinner than the bottom distal portion and has a location 292 which abuts and seals the inflation port when it rests along the top portion 299 of the indent 293 in the lower portion ofthe housing 209. When the two portions 292 and 299 are connected or touching, the inflation port 112, 212, 312, 412 is sealed and the fluid within the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is sealed within the bladder 102, 202, 302, 402 and thus the pressure and compression within is sealed and if applicable the gradient compression profde and / or gradient pressure profile is maintained. As seen in FIGS. 14A-14B, the housing 214 has a circumference which expands in a lower distal portion to house the valve 290. The shape as shown is not limiting and any other shapes may be employed, as longas some portion of the valve 290 touches a portion of the housing 214 so as to create a sealing means and maintain the pressure and fluid within the inflated therapeutic compression apparatus 100, 200, 300, 400. Again other shapes may be employed such that the functionality is created for a sealing means. The bottom distal portion 295 of the housing 214 in this embodiment then narrows or tapers so that when the valve 290 is pushed down by the male luer 161 the bottom of the valve 290 rests on top of 295 and the fluid passes around the outer circumference of the valve 290 and also through the V-notch 291 and flows into the bladder 102, 202, 302, 402 via the opening or aperture 294. The outer circumference of the bottom distal portion of the valve 290 is slightly smaller than the inner circumference of the bottom distal portion 293 of the housing 214 so that the fluid can flow from the inflation means 150 through the hose 160 through the slip luer 161 through the inflation port 112, 212, 312, 412 and into the bladder 102, 202, 302, 402.

[0089] FIG. 16A shows the inflation of the hemostasis therapeutic compression apparatus 200 with the male slip luer 161 inserted within the housing 214 of the inflation port 112, 212, 312, 412 (the optional cap 113, 213, 313, 413 is open and off to the side) and pushes down on the valve 290 so that the valve 290 bottom rests on the bottom distal portion 295 of the housing 214 which is referred to as the open position for the valve 290. The fluid represented by the downward arrow in the middle of the male slip luer 161 flows into the housing 214 and past the valve 290 and into the bladder 202 as shown by the arrow direction in the bottom of the figure. The fluid will continue to flow into the bladder 102, 202, 302, 402 until such time as the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is in the appropriate inflated state. The user then removes the male slip luer 161 inserted from the housing 214 of the inflation port 212 (as shown in FIG. 16B) and the valve 290 moves in an upward direction so that the valve 290 bottom distal portion 292 touches the corresponding shape of the top portion 299 of the indent 293 in the lower portion of the housing 214. The two portions 292 and 299 are connected or touching thereby sealing the inflation port 212 and the fluid within the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is maintained at the level prior to the inflation means 150 being disconnected to therapeutic compression apparatus 100, 200, 300, 400. The fluid is represented by the upward arrow in the middle of the housing 214 flowing from the bladder 202 and into the bottom portion of the indented housing 293 is sealed by the valve 290. The inflation means 150 could be a manual pump 400 as well and any other static or intermittent inflation means. When the bladder 102, 202, 302, 402 is deflated by the user the valve 290 will again be pushed down by the male slip luer 161 but no fluid or inflation will be employed at that time so that the fluid flows out of the inflation port past the valve 290 and the deflated state will be maintained. The valve 290 can be manually pushed down to deflate by inserting the male slip luer 161 or by aste or other extending portionofthe cap 113, 213, 313, 413 or by any other appliance to push the valve 290 in a downward direction. In this embodiment the valve 290 is self-sealing but other sealing means can be employed such as any moveable lever, screw, switch, stop cock, or other mechanical means to seal the inflation port and maintain the fluid within.

[0090] FIGs. 14A-C and FIGs. 15A-G show an inventive vent button assembly connected to tire hand bulb 420 tube 160 or hose. FIG. 14A is the inflation means 150 of this embodiment of the present invention including the hand bulb 420 including at least one check valve 421 and preferably two check valves 422, a vent button assembly 170, tube 160 or hose, and male luer slip 161. The vent button assembly 170 includes a vent 172 and a pressure relief valve assembly 180 which in this embodiment is configured to target the maximum bladder pressure at a range of approximately 80-140 mm-Hg which corresponds to an interface pressure on the patient at the transparent bladder portion 104, 204, 304, 404 when placed over the needle access site in a range of about 50-70 mm-Hg, preferably about 55-65 mm-Hg interface pressure. The vent 172 assembly also includes a button 172 which when depressed releases the pressure within and deflates the bladder 102 202, 302, 402. The bulb 420 contains a check valve at each end 421 , 422, so that when the bulb 420 is squeezed air is forced out of the front of the bulb 420. When the bulb 420 is released, air is pulled into the bulb 420 through the rear checkvalve 421. When the hand bulb 420 is connected to a pressurized bladder 102, 202, 302, 402, the 170 vent button assembly will allow air flow out of the bladder 102, 202, 302, 402 when the button 174 is depressed.

[0091] FIGs. 14B and 15A-G show in more detail the inventive pressure relief valve assembly 180 configured to target the bladder 102, 202, 302, 402 interface pressure at about 55-65 mm-Hg. The inventive pressure relief valve assembly 180 includes an umbrella valve 185 to regulate the maximum air pressure that can be delivered from the bulb 420 to the bladder 102, 202, 302, 402. At low pressure the umbrella valve 185 remains closed and air flow is directed straight through the bulb 420 into and through the valve assembly 180, through the valve housing 181 and into the bladder 102, 202, 302, 402. Once the pre-determined maximum pressure is reached, such as by way of example only an interface pressure 55- 65 mm-Hg (or any other determined pressure in the range of 40-80 mm-Hg interface pressure), tire umbrella valve 185 opens and air from any further additional bulb 410 cycles (more hand pumps of the bulb 420) is directed out ofthe valve housing 181 via at least one vent slot 183 (183a, 183b as shown in FIG. 15G) and not into the bladder 102, 202, 302, 402. Air flows out ofthe valve housing 181 through at least one and preferably multiple vent slots (183a, 183b, around the outer diameter of the top plug 186). The top plug 186 is slightly recessed into the valve housing 181 so that a silo is created. The bottom plug 187 is sealed with an O-ring 188 to prevent air leakage out ofthe valve housing 181 on the bottom side of the vent assembly 180. 184 shows the ports to the underside of the umbrella valve 185. The umbrella valve 185 is chosen for height (185a, 185b) and durometer of material, such as silicone or other polymersor plastics, based on the pre-determined interface pressure selected as when this blow off pressure is exceeded the umbrella valve 185 flexes and directs excess pressure out of the vent slot 183 (or slots 183a, 183b, 183c, 183d, etc.) and therefore the pre-determined maximum interface pressure for the needle access site is not exceeded which if exceeded could cause complications based on impediment of blood flow through the vessels under the skin. As shown in FIG. 15G, the measurement of the heigh of the umbrella valve (185a, 185b) is calculated and set dependent on the pre-determined interface pressure selected for such therapeutic compression apparatus based on the target compression needed for the body part. This inventive safety feature of the inventive therapeutic compression system decreases complications following by way of example dialysis treatment at the needle access site and surrounding the needle access site which complications from compression include cutting off blood circulation, compartment syndrome, thrombosis, aneurism or even necrosis. The inventive safety feature also assist in obtaining and maintain hemostasis at a bleeding wound site in a trauma situation.

[0092] As shown in FIGs. 1 and 17, once the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is secured around a patient's arm, bladder 102, 202, 302, 402 is inflated and not able to shift out of place via the compression of the inflated bladder 102, 202, 302, 402, thus increasing comfort and reducing fitting issues on the patient. It will be appreciated that the chambers of the bladder 102, 202, 302, 402 may be filled by air, fluid or other known means of inflation. It will also be appreciated that the bladder 102, 202, 302, 402 can be arranged to receive air and be inflated using a manual pumping bulb or can be inflated by an electric air pump (not shown) which can use batteries or AC wall current to pump air into the chamber(s). The inflation port 112, 212, 312, 412 of the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is universal in that it can connect to a multiple of different types of inflation means. Any known source of air or fluid may be employed whether manual, mechanical, electrical, battery-operated or any other power sourced pump or pressure creator. The inflation means 150 may be a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. The inflation means 150 is connected to the hemostasis therapeutic compression apparatus 100, 200, 300, 400 via a tube 160 or hose. Any other known connecting means may be employed. The embodiments shown in FIGs. 14 and 18 include a tube 160 connected to the handheld manual pump 400. The tube 160 is connected to the hemostasis therapeutic compression apparatus 100, 200, 300, 400, by inserting, for instance a male luer slip 161, into the inflation port 112, 212, 312, 412. The inventive therapeutic system includes an inventive sealing means connected to the bladder 102, 202, 302, 402 so as tomaintain the constant compression profile and / or pressure profile when the inflation means 150 is either disconnected from the hemostasis therapeutic compression apparatus 100, 200, 300, 400 or the inflation means stops providing additional inflation or pressure. In the embodiment shown the sealing means is a cap 113, 213, 313, 413 which is inserted onto or into the inflation port 112, 212, 312, 412. The sealing means also includes a valve 290 within the inflation port 112, 212, 312, 412. As shown in FIGs. 16A-B which is a cut-away of the inflation port 212, the valve 290 is located within a housing 214, the housing being tubing or for instance a luer. In this embodiment the housing 214 is a plastic female luer but other materials can be employed such as metal, polymers, or rubbers and other housing means can be employed. The valve 290 as shown in FIGS. 14A and 14B includes a V-notch 291 in the top proximal portion ofthe valve 290 though other shapes of notches or other apertures and openings may be employed. The V-notch 291 in this embodiment assists in movement of the fluid from the male luer 161 (fluid flowing from the inflation means 150) into the inflation port 112, 212, 312, 412 and into the bladder 102, 202, 302, 402. The bottom distal portion of the valve 290 is in a shape as shown in FIGS. 16A-16B such as a plug where the top portion 291 is thinner than the bottom distal portion and has a location 292 which abuts and seals the inflation port when it rests along the top portion 299 ofthe indent 293 in the lower portion ofthe housing 209. When the two portions 292 and 299 are connected or touching, the inflation port 112, 212, 312, 412 is sealed and the fluid within the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is sealed within the bladder 102, 202, 302, 402 and thus the pressure and compression within is sealed and if applicable the compression profile, gradient compression profile and / or gradient pressure profile is maintained. As seen in FIGS. I6A-164B, the housing 214 has a circumference which expands in a lower distal portion to house the valve 290. The shape as shown in FIGs. 164A- 16B is not limiting and any other shapes may be employed, as long as some portion ofthe valve 290 touches a portion ofthe housing 214 so as to create a sealing means and maintain the pressure and fluid within the inflated therapeutic compression apparatus 100, 200, 300, 400. Again other shapes may be employed such that the functionality is created for a sealing means. The bottom distal portion 295 ofthe housing 214 in this embodiment then narrows or tapers so that when the valve 290 is pushed down by the male luer 161 the bottom of the valve 290 rests on top of 295 and the fluid passes around the outer circumference of the valve 290 and also through the V-notch 291 and flows into the bladder 202 via the opening or aperture 294. The outer circumference ofthe bottom distal portion ofthe valve 290 is slightly smaller than the inner circumference ofthe bottom distal portion 293 of the housing 209 so that the fluid can flow from the inflation means 150 through the hose 160 through the slip luer 161 through the inflation port 112, 212, 312, 412 and into the bladder 102, 202, 302, 402.

[0093] The inflation means 150 may apply pressure constantly in a static status or may apply pressure intermittently though static may be preferred, for example by applying 20 mm-Hg, 25 mm-Hg, 30 mm-Hg, 35 mm-Hg, 40 mm-Hg, 45 mm-Hg, 50 mm-Hg, 55 mm-Hg, 60 mm-Hg, 65 mm-Hg, 70 mm-Hg, 75 mm-Hg, 80 mm-Hg, 90 mm-Hg, 60 mm-Hg, 75 mm-Hg, 80 mm-Hg, 90 mm-Hg, 100 mm-Hg or other known pressure levels, depending on the treatment plan, level of bleeding, and the target limb of the patient. There could also be multiple pressure levels within the pump so there is varying pressure during treatment. In one embodiment of the present invention the interfacial pressure on the wound site may be between 40-90 mm Hg, preferably about 60 mmHg thereby requiring between 40-120 mm-Hg pressure from the inflation source into the bladder in order to maintain the interface pressure on the wound site of about 50-70 mm-Hg. The interfacial pressure on the wound site or needle access site must be sufficient to stop external bleeding, such as once the needle is removed post-surgical procedure or for example dialysis treatment, while maintaining blood flow within the vessel so as to prevent complications such as circulation cut off, swelling, edema, bruising, compartment syndrome, thrombosis, aneurism or even necrosis or loss or amputation of limb. The pressure in the rest of the bladder, not the transparent portion 104, 204, 304, 404 in contact with the wound site, may be less than about 40- 80 mmHg as the lower interface pressure maintains blood flow in the arteries and veins while assisting in the reduction and stopping of bleeding from the wound site and assist in recovery and reducing complications post-trauma, surgical or medical procedures.

[0094] The inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400, may be comprised of both non-elastic and elastic materials, semi-rigid, laminates, polymers, doeskin, stretchable, or other materials sufficient to provide the interface compression of about 30-90 mmHg. The inner layer (301b as shown in FIG. 10) of the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is non-elastic and is preferably made of a wicking, non- hook and loop compatible material, so as to pull perspiration and other unwanted moisture away from the limb, such as by way of example the arm area or leg area around the needle access site being treated. The non-hooking material against the patient's skin also reduces irritation, which may be caused from a hooking material. In certain embodiments through holes 108, 208, 308, 408 are included to allow air on the limb and reduce sweating. The outer layer (301a as shown in FIG. 10) has at least a portion which is hook compatible in order for the connecting tabs 122, 124, 222, 224, 322, 422, 324, 424 to be secured at the peripheral edge of the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 around the arm, shoulder, elbow, wrist, leg, groin, ankle, or other limb. For example, the hemostasis therapeutic compression apparatus 100, 200, 300, 400, may be comprised of two layers of elastomeric material with the air bladder 102, 202, 302, 402 affixed between these twolayers by nylon threads or other suitable fastening means. The dimensions of the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 are configured to provide coverage and compression on one or more wound sites and may be in the range of about 2 inches to about 24 inches in width to wrap around the circumference of an arm, shoulder, elbow, wrist, hip, thigh, knee, calf, able, foot or other body part and if or example over the chest or stomach of a user would need to be longer in the range of 2-6 feet or longer depending on the individual’s dimensions, and a length of about 1 inch to about 18 inches to correspond to the length of a wrist, lower arm, forearm, upper arm, bicep, elbow, shoulder, thigh, knee, calf, able, foot or other body part and if or example over the chest or stomach of a user would need to be longer in the range of 1-3 feet or other body part. The depth is in a range of about 1 mm to about 100 mm depending on the inflation and pressure and compression profile of the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 and the body part being compressed over the wound site or needle access site. Other dimensions of length, width and depth may be employed. The translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 may have circular radius of about 1 mm to about 500 mm and in other shapes have a length of about 2 mm to about 1000 mm and a width of about 2 mm to about 1000 mm and depth (when inflated) of about 1 mm to about 500 mm. Other dimension of length, width and depth may be employed for the translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402.

[0095] The patient, if completing dialysis at home can apply and secure and inflate the inventive hemostasis therapeutic compression system and apparatus on his or her own. The patient places an absorbent dressing on the needle access site over the needle still within the arm. The absorbent dressing may be gauze, bandages, foam (such as a disk 455 shown in FIG. 17), PF AB or other materials. The patient may put an adhesive such as tape on the extended tab 325, 425 (as shown in FIGs. 6-12 and 21-30) and tapes the extended tab 325, 425 to his or her arm. The patient then wraps the hemostasis therapeutic compression apparatus 100, 200, 300, 400 around the arm making sure the transparent bladder portion 104, 204, 304, 404 is over the needle access site(s) to allow visualization and monitor for external bleeding. Next the patient can remove the tape from his or her arm. The patient then inflates the bladder 102, 202, 302, 402 via the inflation means 150, such as by inserting the luer 161 within the inflation port 112, 212, 312, 412 and squeezing the hand bulb 420 repeatedly until such time as the bladder 102, 202, 302, 402 is fully inflated and compression is felt on the needle access site and on the arm adjacent to the site or even on the entire circumference of the arm at that area, or shoulder, elbow or wrist are of the inventive hemostasis therapeutic compression apparatus is located on the shoulder, elbow or wrist part of the arm. The patient or user activates the manual hand pump 420 and stops at the decided pressurelevel and removes the male luer slip 161 and depending on which embodiment of the inventive hemostasis therapeutic compression apparatus is employed there is either a self-sealing valve 290 or the patient inserts the cap 113, 213, 313, 413 into the inflation port 112, 212, 312, 412. Finally, the patient or a medical provider removes the needle from below the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400. Once the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is secured around a patient's limb such as for instance an arm 600, the inflated bladder 102, 202, 302, 402 is not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient. The hemostasis therapeutic compression apparatus 100, 200, 300, 400 does not shift or slip down the user’s limb when in use due to the shape of the overall apparatus, the compression level throughout the bladder as it applies compression not just at the wound site or needle access site in the transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 but continues throughout the bladder, as well as the extensions 420 as shown in FIGs. 21-30. The extensions 420 are a further securing means on the hemostasis therapeutic compression apparatus 100, 200, 300, 400 and are in the shape of curves as shown in FIGs. 21-29 or points in FIG. 30, though many other shapes could be employed as long as they assist the hemostasis therapeutic compression apparatus 100, 200, 300, 400 in staying secured on the original location on the limb when in use. The user thus has increased mobility compared to current known hemostasis devices where the inflation means is integral to the apparatus and weighs down the device. Using the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 compression may be applied to the wound site or needle access site for a period of time to stop externally bleeding which is dependent on the patient (thin blood, clotting parameters, and other variants) and can be from a period of about 15 minutes to hours. The inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 may be adjusted via the hook and loop securing means 122, 124, 222, 224, 322, 422, 324, 424 if the compression feels too tight to the patient or user or too loose, as well as the pressure adjusted to reduce or increase the interface pressure level.

[0096] The inflation means 150 could include a means to monitor or regulate the inflation. The inflation means 150 could include programming such that the bladder 102, 202, 302, 402 is inflated and deflated to a set pressure at intervals or at set times throughout the day or night when the compression apparatus is in use worn on the patient. In another embodiment of the present invention, if the hemostasis therapeutic compression apparatus has two separate bladders (not shown but for instance bladders 202a and 202b) then there may be two separate inflation ports 212 (e.g. 212a and 212b not shown) that are each connected to either the same or different inflation means, and the pressure levels of the first bladder 202a and the second bladder 202b could be the same or have different pressurelevels. For instance, by way of example only, the inflation means could be set to 40 mm-Hg forthe first bladder 202b and set to 60 mm-Hg forthe second bladder 202b, or each could vary and the inflation means be set to inflate, deflate, inflate, etc. throughout the day as described above.

[0097] In one embodiment of the invention, the inflation means includes a manual pump(as shown in FIGI SB) and the dial includes graphics of pressure amount such as "35, "45’, "55' and "65" or lettering such as "A", "B", "C", "D" which each would correspond to a certain pressure such as 35 mm-Hg, 45 mm-Hg, 55 mm-Hg and 65 mm-Hg. The specific pre-determined pressure to correspond with the graphic is endless and not limited by the examples herein.

[0098] Further, the hemostasis therapeutic compression apparatus 100, 200, 300, 400 may be deflated by a button or a switch 130, 230, 330, 430 to deflate the bladder 102, 202, 302, 402 and thus release the pressure and / or compression profile as shown in FIG.s 11-12. Each embodiment may also include the release button 130, 230, 330, 430 though not shown here. Other release mechanism may also be employed beyond a button such as a switch, valve, or other release means.

[0099] FIGs. 2-5 and 19A-B and 20 show different shapes of the present invention depending on the limb to be applied on, such as rectangular or square of the overall inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400. In each the transparent portion 104, 204, 304, 404 is also in different shapes depending on the wound site or needle-access site to be covered so as to reduce and stop bleeding at those sites. Figs. 6-12 and 21-30 show a longer rectangular overall shape of multiple embodiments of the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400. The length of each embodiment is dependent on the limb to be applied on and the wound site and the width shown in these embodiments by way of example only are smaller than the respective length shown but other embodiments not shown may be much wider again dependent on the limb to be applied on and the wound site length and width.

[0100] The transparent portion 104, 204, 304, 404 or translucent portion of the bladder 102, 202, 302, 402 as shown in FIGs. 21-30 have different profiles when inflated as shown in FIGs. 25-27. The inner side 404b is in direct contact with the skin and wound site and has an interface pressure of about 40-90 mmHg, preferably about 50-70 mmHg so as to reduce and stop bleeding at the wound site. By way of example, the inner side 404b is made from a material that is more flexible than the material used for the outer side 404a as the inner side 404b pushes down on the bleeding wound site to close up and seal the wound such as a needle access site after the needle is removed. In one embodiment the inner side 404b is made from a Thermoplastic Polyurethane having a thickness of about 0.2-0.4 mm with a tolerance of about .015 + / - .002 or .33mm+ / -.07mm. Other thickness may be used depending on the shape of the translucent or transparent portion 104, 204, 304, 404 to cover the wound site, such as a larger kidney, square, rectangle and the mathematical “area” being coveredby the inner side 104b, 204b, 304b, 404b. While in one embodiment thermoplastic polyurethane is used other materials not limited to Thermoplastic Elastomer or Thermoplastic Copolyester and other suitable materials may be used making sure such materials are biocompatible with a bleeding wound site. In one embodiment the outer side 404a is made from a Polyvinyl Chloride having a thickness of about 0.1 -0.3 mm with a tolerance of about .010+ / -.002 or ,2mm+ / -.06mmas. The outer side 404a is not in contact with skin or the bleeding wound site and is more rigid compared to the inner side 404b. Other thickness may be used depending on the shape of the translucent or transparent portion 104, 204, 304, 404 to cover the wound site, such as a larger kidney, square, rectangle and the mathematical “area” being covered by the inner side 104b, 204b, 304b, 404b, though in general PVC is a cheaper material and may be preferred. While in one embodiment Polyvinyl Chloride is used other materials not limited to Polyethylene, Polypropylene, Polyesters and other suitable materials may be used. In an embodiment where the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is used as a tourniquet over a larger wound site than a needle access site such as a trauma due to a stabbing or gunshot or car accident by way of example, the interface pressure may need to be larger than 40-90 mmHg and thus the inner side 404b material may be a different thickness than stated above and different material other than a Thermoplastic Polyurethane so that other materials and thickness may be employed depending on the location of the wound site and dimensions such as area of the bleeding wound site.

[0101] The inventive system may be included in a kit including a hemostasis therapeutic compression apparatus 100, 200, 300, 400, an inflation means 150 and a connecting means such as a tube 160. The kit may also include gauze 500A-B, 450 and bandages, or PF AB 460 or a foam disk 455 for the user to apply over the wound site or for example a needle access site immediately after the hemodialysis treatment or in between treatments sessions if bleeding occurs. An exemplary embodiment of the system or kit is shown in FIGs. 18A-D. The kit may also include various wound dressings and / or bandages (500A-B and 450) which may include adhesive for placement on the skin of the user. The PFAB 460, wound dressings and / or bandages may be disposed of on a more frequent basis and the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is applied in conjunction or combination with the wound dressings and / or bandages. In one embodiment the hemostasis therapeutic compression apparatus 100, 200, 300, 400 is used over or on top of the wound dressing applied to the skin. In an embodiment where the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 and inflation means 150 is used as a tourniquet based on a trauma due to a stabbing or gunshot or hiking (puncture, animal bite, rock or tree injury, etc.) or car accident by way of example, the kit may include multiple wound dressings and / or bandages (500A-B and 450) and PFABs 460 so as to apply onto the bleeding wound siteunder the translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 within the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400. It is possible for a kit to be specific for hikers, bicyclists and other outdoor and indoor sports for use as a tourniquet due to injuries including the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 and wound dressings and / or bandages (500A-B and 450) and PFABS 460 as well as inflation means 150 along with for example iodine or other antibiotic to immediately apply to the wound site outdoors.

[0102] The system may also include other sensor such as a tonometer, which is a device pressed into the skin to measure the amount of force required to make an indent in the tissue. The resulting measurement can help gauge the degree of firmness or fibrosis (tissue scarring) under the skin, which is a consequence of loss of blood circulation. Such a tonometer could be applied to the patient's skin under the hemostasis therapeutic compression apparatus 100, 200, 300, 400 and measure the firmness or fibrosis at such treatment site on the limb of the patient. Such a tonometer could be connected to the inflation means via Bluetooth or other digital means and provide feedback to the patient and medical staff as discussed above. A pulsometer could also be employed to measure the pulse near the needle access site to ensure sufficient and adequate blood flow for the vessel is maintained, while still stopping the external bleedings at the needle access site. Other sensors may be employed depending on the needs of the patient and user.

[0103] In another embodiment, the inventive therapeutic compression system has sensors that measure the positioning and movement of the hemostasis therapeutic compression apparatus 100, 200, 300, 400. Such sensors could be interpreted to give readouts (via the interface, a plug-in to a computer, or sent to an app) to the user or clinician as to the compliance, activity (pedometer to measure steps, stairs climbed, etc.), and give advice / alerts to improve the treatment. In one embodiment the sensors would be able to measure skin fibrosis and adjust the level of compression required to improve bleeding or swelling reduction or a pulsometer to release compression and swelling if the vessel is being cut off and circulation impeded. These sensors listed are not limiting and any other known or future developed sensors could be employed with the inventive system.

[0104] The sensors described above are non-limiting and could be non-digital or digital means may also be employed. A motorized pump and digital display may be used. The valve may include digital or electric means to change or modify pressure at a set rate or intervals or based on feedback from the monitoring means. The system may include various sensors and monitors. Other sensors could be time set for instance if the system was rented so that the system would stop working once the sensor triggered that the rental days or rental hours had expired. In this instance,the sensor could be reset if additional rental time was purchased.

[0105] The inventive therapeutic compression system may be used for post-medical treatment such as surgery or dialysis to control or reduce external bleeding and swelling at the needle access site. In use the hemostasis therapeutic compression apparatus 100, 200, 300, 400 may be placed by the patient, practitioner or care-giver on the chosen limb, such as for instance the lower arm, upper arm, wrist, groin, thigh, calf, ankle, leg and even two or more apparatus may be employed on different limbs where multiple needle access sites are located on the patient. The hemostasis therapeutic compression apparatus 100, 200, 300, 400 is fastened around the limb of the patient in this example over the needle access site, absorbent dressing, and needle itself. The patient, practitioner or caregiver fastens or secures the fastening tabs 122, 124, 222, 224, 322, 324, 422, 424 up or down to the arm or leg. If there are additional optional straps located on the proximal end of the apparatus the first strap should be closed or secured in a tight fashion so that the hemostasis therapeutic compression apparatus 100, 200, 300, 400 fits snugly but not too tight and the second strap should be closed or secured in a tight fashion so that the hemostasis therapeutic compression apparatus 100, 200, 300, 400 fits snugly but not too tight. The patient, practitioner or care-giver then removes the cap 113, 213, 313, 413 from the inflation port 112, 212, 312, 412 located on the hemostasis therapeutic compression apparatus 100, 200, 300, 400 thus opening, namely the female slip luer housing 214. The patient, practitioner or care-giver then selects a pressure amount of value on the dial of the inflation means 150 depending on the treatment and whether the patient or if no dial provided starts the inflation means, such as squeezing the hand bulb 420. Once pressure amount or value is chosen on the dial (or set to one pressure such as 60 mm-Hg where there is no dial and only one given pressure amount as shown in FIGs. 14A-C), the corresponding umbrella valve or switch is activated such that the pressure is thereafter maintained (closed position) or modified so as to maintain the pressure as it changes with the activity or altitude when in use). The patient, practitioner or care-giver then inserts an end of the tube 160 portion such as the male luer slip 161 into the inflation port 1 12, 212, 312, 412 on the hemostasis therapeutic compression apparatus 100, 200 300, uses the hand pump 420, and the air or fluid is increased to inflate the bladder 102, 202, 302, 402 and thus achieve a desired pressure amount or valve. Again this inflation means may be a hand pump, electric pump, battery-operated pump, remote controlled pump, air pump, gas pump, or any other known inflation means. A number or variety of inflation means can be employed so as to provide a certain pressure within the bladder so to provide compression in use by the patient, practitioner or care-giver. Depending on the inflation means 150 employed such inflation means may be removed and the cap 113, 213, 313, 413 replaced and the pressure will not decrease except as noted in position or the inflation port may be self-sealing as shown in FIGs. 16A-B. At any point inuse the patient, practitioner or care-giver can deflate the bladder by either inserting the cap 113, 213, 313, 413 so it depresses the valve spring and thus release the air or fluid in the bladder 102, 202, 302, 402 and decrease the pressure, or the patient, practitioner or care-giver can reinsert the inflation means and select the "Deflate" or “Release" on the dial if so provided and the corresponding umbrella valve will be in the open position so as to release the air or fluid in the bladder and decrease the pressure until a deflated state is achieved for the bladder and the hemostasis therapeutic compression apparatus. In another embodiment a release button 130, 230, 330 configuration is within the air bladder 102, 202, 302, 402 as shown in FIGs. 11-12 which can immediately release the pressure within the air bladder 102, 202, 302, 402. The hemostasis therapeutic compression apparatus 100, 200, 300, 400 can be reinflated and deflated over and over again when in use.

[0106] When in use due to a trauma, the method is the same though additional wound dressing and / or bandages and / or medical tape may be employed due to the severity of the bleeding at the wound site such as due to an injury, accident, stabbing, gun shot or other causes of trauma. The tab 125, 225, 325, 425 may be used by the individual themselves if alone during a traumatic event as the individual can use medical or regular tape included in the kit to fasten the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 to the limb and then only needs to use one hand to wrap the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 around the limb and connect it via the hook and loop means 122, 124, 222,224, 322, 324, 422, 424. The user then takes the inflation means 150 and inflates the bladder 102, 202, 302, 402 making sure the translucent or transparent portion 104, 204, 304, 404 is located over the bleeding wound site so as to apply sufficient interface pressure to reduce and / or stop the bleeding. Assuming the kit includes wound dressings and / or bandages the user could place those over the bleeding wound site prior to applying the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 over the limb. Once inflated the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 then reduces and / or stops the bleeding at the wound site giving the user time to get to a medical facility or for responders to get to the user such as EMTs or other first responders.

[0107] The method of use of the inventive system has been illustrated and described with respect to specific embodiments thereof, which embodiments are exemplary and illustrative ofthe principles ofthe invention and are not intended to be exclusive or otherwise limiting embodiments. For instance, while in the foregoing embodiments the hemostasis therapeutic compression apparatus 100, 200, 300, 400 are described as having inflatable bladders, the hemostasis therapeutic compression apparatus 100, 200, 300, 400 may additionally include integrally formed or attached (e.g., by adhesive, radio-frequency welding, etc.) compression members that are not configured for inflation and / or deflation. For instance, additional compression members may beimplemented using any of a variety of preformed and / or prefilled cushioning materials such as foam cushions and / or air, gel, or other fluid filled non-inflatable cushions, provided such compression members generate sufficient compression in combination with integral compression bladders. Further, while particular shapes, sizes, and materials have been described for purposes of illustration, it will be recognized that any of a variety of shape or size can be used, and the materials described are not exclusive but merely illustrative. Also, as noted above, while the bladder shown is inflated with air, it will be appreciated that any other fluid or medium such as liquid or gel can be used. Moreover, as also noted, it will be understood that bladders may be configured to have multiple pneumatically independent and / or pneumatically coupled bladder sections, and may also be configured to have various contours or lobulations. The inventive therapeutic compression system described herein can be used for any suitable condition treatable by compression therapy and the like. For example, the inventive system including a hemostasis therapeutic compression apparatus 100, 200, 300, 400 in accordance with the present invention can be used for compression of the venous system for the treatment of swelling and bleeding posthemodialysis treatment, post-cardiac catheterization or other catheterization procedures, and the like.

[0108] As stated herein, the possible hemostasis therapeutic compression apparatus 100, 200, 300, 400 to be used in the inventive system are only limited to the target limbs or body parts to be compressed or subject to pressure treatments in order to reduce and treat swelling and bleeding (even including lymphedema, CVI, DVT or any other medical issue). For instance, the hemostasis therapeutic compression apparatus could be for a foot, ankle, calf, lower leg, knee, thigh, groin, hip, buttocks, torso, stomach, back, shoulder, chest, arm, elbow, wrist, hand, neck, head, or the like and any combinations thereof. The inventive system of the instant invention described herein solves many problems with the prior art and in the industry and treatment of patients.

[0109] The hemostasis therapeutic compression apparatus 100, 200, 300, 400 may be applied on the patient's body part by the patient without the need or requirement of a skilled care-giver as required by current devices and apparatus and most notably by the user when outside of a medical facility such as when dealing with a trauma such as an injury (sport related or otherwise), accident, criminal activity or natural disaster. It further is capable of maintaining sufficient effective pressure such as interface pressure to reduce and stop bleeding at the wound site without overpressure complications, maintaining compression and the like. The inventive hemostasis therapeutic compression apparatus controls external bleeding at the wound site such as a needle access site post-dialysis or post-catheterization treatment with consistent and constant compression and pressure that is more reliable than manual compression. The medical staff such as nurses cando other tasks and the patient has ease of mind by having visualization of the needle access site to monitor for external bleeding. The patient using the inventive therapeutic compression system and apparatus also has mobility since a medical staff doesn’t have to hold down a dressing at the needle access site while the patient sits in a chair or in bed. Further the inventive therapeutic compression system and apparatus doesn’t slip or move based on the extended compression within the bladder 102, 202, 302, 402 beyond just the translucent or transparent portion 104, 204, 304, 404 over the needle access site as additional lower pressure is applied surrounding the wound site to a portion of the arm or leg. The pressure however from the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is just what is needed to stop or control bleeding and not too high to cause bruising or other complications at the needle access site or on the arm itself. Thus complications such as swelling, pins and needles feeling, numbness, cutting off blood circulation, compartment syndrome, thrombosis, aneurism or even necrosis are reduced or prevented by the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400.

[0110] The inventive therapeutic compression system also reduces the problem of lack of mobility in that the inflation means is not integral to the hemostasis therapeutic compression apparatus 100, 200, 300, 400 and instead the patient or user can walk about and go to work, school, recreational activities while the external bleeding and swelling at the wound site or needle access site is reduced or eliminated. The compression is held constant with the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 versus a human being applying pressure, such as a medical professional, by pressing down with a finger or hand on tire needle access site once the needle is removed from the patient’s arm and the pressure varies as the medical professional gets tired from pressing down. The inventive system includes an inflation means which is less bulky than known systems and does not require a human being trained professional medical staff to manually apply pressure and compression to the wound site or needle access site after trauma or a medical treatment or procedure. The inventive system and apparatus can be used by the patient or user in between treatment sessions and thus the user can return to life activities sooner than with known compression systems, prophylaxis systems and other treatment systems which limit the user's ambulation both within and outside the home due to power constraints (electrical, mechanical, battery, manual, etc.) on the system. The inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is also compact and smaller being able to fit under clothes on the patient and out of public view. However, the transparent portion 104, 204, 304, 404 of the bladder allows visualization of the wound site or needle access site when in view. Further, the inventive system may include one or more sensors to measure the user's limb in regard to pressure on the skin, motion of the limb, blood pressure, tannometer sensor, GPS sensor, and thelike while the system is in use. Such sensors may be connected to the inflation means so as to regulate the pressure from the inflation means and either increase or decrease the current pressure level(s). Such sensors may also be connected to a database and possibly accessible to a medical professional and / or the user in real time or as saved over time.[Oi l 1] The inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is reusable thereby reducing costs to a dialysis center and to the patient, as well as the inflation means 150 being reusable. Additionally the system incudes multiple sponges or foam or prefabricated air bladders (PF AB as disclosed in Applicant's co-owned patents and pending applications) 46Q with optional adhesive to adhere the PFAB to the user's skin, which may be disposable or reusable depending on the materials. Additional gauze or bandages 500a, 500b, 450 may also be included in the system or kit as well as iodine or other antibiotic liquids to apply onto the wound such as when outdoors and the apparatus is used due to a trauma.

[0112] The safety features of the inventive therapeutic compression system and apparatus include check valves so ensure pressure and compression is not too high causing complications at the wound site or needle access site post-dialysis or post-catheterization treatment. For example, the inflation means as shown in FIGs. 14A-C and 15A-G include an umbrella valve 185 chosen for height and durometer of material, such as silicone or other polymers or plastics, based on the pre-determined interface pressure selected as when this blow off pressure is exceeded the umbrella valve 185 flexes and directs excess pressure out of the vent slot 183 (or slots 183a, 183b, 183c, 183d, etc.) and therefore the pre-determined maximum interface pressure for the needle access site is not exceeded which if exceeded could cause complications based on impediment of blood flow through the vessels under the skin. Therefore, the inventive therapeutic compression system decreases complications following dialysis or catheterization treatment at the needle access site and surrounding the needle access site which complications from compression include cutting off blood circulation, compartment syndrome, thrombosis, aneurism, or even necrosis and amputation.

[0113] Another embodiment of the present invention not shown includes an assembly according to the invention includes a pressure mechanism having a flexible member for attachment to a limb and an air chamber which may be pumped up into a desired pressurized state, a separate relatively small pre-filled air bladder, an absorbent foam, sponge or dressing coupled to the prefilled air bladder. Optionally a suction conduit may be coupled to a source of negative pressure (suction) and in fluid communication with the absorbent foam, sponge or dressing. In a preferred embodiment, the PFAB, the absorbent foam, sponge or dressing and the suction conduit are formed together as a unit. According to one aspect of the invention, the flexible member of the pressure mechanism is adapted to wrap around an arm and over the pre-filled air bladder in orderto secure the pre-filled air bladder and the foam, sponge or dressing to a wound or ulcer in the extremity. Thus, the flexible member is provided with some fixation structure such as a hook and loop closure mechanism. An air pumping mechanism is preferably coupled to the air chamber of the pressure mechanism in order to inflate the air chamber to a pressurized state. The air chamber of the pressure mechanism is preferably designed to apply pressure along a predefined area (e.g., the lower arm or upper arm over the needle access site)as opposed to around an entire limb.

[0114] According to another aspect of the invention not shown, the suction conduit is located either between the PF AB 460 and the absorbent foam, sponge or dressing which is adhered to the small air bladder, or the PF AB 460 is formed as a donut with a central opening and the suction conduit extends through the central opening. By coupling the suction conduit to a source of negative pressure, exudate from the bleeding needle access site is sucked through the foam, sponge or dressing into the suction conduit. One of the methods of the invention not shown include locating the PF AB 460 and foam, sponge or dressing over a bleeding needle access site on an arm 600, wrapping the flexible member of the pressure mechanism around a limb with the air chamber located over the PFAB / absorbent foam, sponge or dressing, and fasteningthe pneumatic pressure mechanism in place with the fixation structure. When the apparatus is properly located and affixed to the lower arm, upper arm, leg or two or more wrap such as one located on each of the lower arm and upper arm at the same time, the air chamber is inflated, preferably to about 100-150 mm Hg overall so as to apply interface pressure of about 40-90 mm Hg on the wound side via the inner side 104b, 204b, 304b, 404b in contact with the wound site, thereby applying pressure to the limb via the overall bladder 102, 202, 302, 402 and more specifically via the PFAB on thew wound first under the inflated translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402. The suction apparatus over the wound site and under the inflated translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302, 402 is activated by turning on the source of negative pressure, and exudate from the needle access site is pulled through the absorbent foam, sponge or dressing into the suction conduit.

[0115] Other embodiments for the present invention are not shown but have the advantages of reducing and / or eliminating external bleeding at the wound site or needle access site both immediately after application of the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 over thew traumatic wound site or after the medical procedure such as by way of example hemodialysis treatment or catheterization, or for a time in between treatment sessions. The patient can apply the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400, 350 by himself or herself without the aid or time spent by a trained medical professional staff such as a dialysis technician or operating room nurse. The inventive therapeutic compressions apparatus 100,200, 300, 400, 300 includes a translucent or transparent bladder portion 104, 204, 304, 404 allowing for visual observation for any external bleeding occurring at the bleeding wound site or for example needle access site once the needle is removed following the hemodialysis treatment or catheterization procedure. The compression or pressure level remains constant along the overall bladder 102, 202, 302, 402 to reduce or eliminate bleeding and swelling on the limb post-trauma or medical procedure, both at or near the wound site and the surrounding skin and tissue. The inventive therapeutic compressions apparatus 100, 200, 300, 400 and method of use reduce complications following a traumatic event or medical procedures such as reducing, eliminating or preventing swelling, edema, circulation cut off, bruising, compartment syndrome, thrombosis, aneurism or even necrosis or loss or amputation of limb if the pressure is too high on the skin or tissue. Other advantages are found through the inventive system, apparatus, method and kit.

[0116] FIGs. 21-31 are another embodiment of the present invention including edges 420 of the bladder 402 which are shaped to assist in reducing or preventing slippage of the inventive apparatus 400 on the skin of the user. This advantage fills a need in the field for maintaining the location of the device once applied to the user’s skin or limb. The edges or extensions 420 may be in different shapes sufficient to secure or anchor or assist the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 to stay secure on the limb once applied without slippage or movement on the limb when the user is ambulatory and moving. Further, in these embodiments as shown the transparent portion 404 of the bladder 402 is configured of material so that one side is more expandable 404b in contact with the wound site and extends further when inflated compared to the other outer side 404a, resulting in reduced or prevention of bleeding and assistance in hemostasis. This fills a need in the field.

[0117] Further, the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 in use has an inflated translucent or transparent portion 104, 204, 304, 404 of the bladder 102, 202, 302 402 which is configured such that when inflated compresses an artery at the bleeding wound site to obtain and maintain hemostasis and the inventive hemostasis therapeutic compression apparatus 100, 200, 300, 400 is not plugging the artery hole but is instead sealing and / or closing the arterial hole. The sealing and / or closing of for example a needle access site such as an arterial hole is closed and sealed by the inventive system including a localized bulk such as gauze or bandage on the wound site under the inflated clear bladder portion 104, 204, 304, 404. Compared to current known hemostasis devices which do not close or seal the wound site, the inventive hemostasis compression apparatus 100, 200, 300, 400 fills a need in the field and is thus more advantageous than other devices.

[0118] While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that variouschanges and / or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein. There have been described and illustrated herein several embodiments of an intermittent pressure apparatus and a method of installing and operating same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular shapes and sizes of inflatable bladders, transparent or translucent or clear 1 portions of the air bladder, and straps have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well. It will also be understood that while Velcro and adhesive means have been disclosed for helping to secure the hemostasis therapeutic compression apparatus 100, 200, 300, 400 to the limb, other types of attachments such as hooks, snaps, or waps may be used. In addition, it will be appreciated that while the fluid conduit may be detachably connected to the bladders using mating threaded portions or bayonet locks, other means of attachment known in the art may be used. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims

CLAIMSWe claim:

1. A hemostasis therapeutic compression apparatus for use on bleeding wound site on a limb comprising: a wrap having an inner sheet and an outer sheet joined together by welds and lines to create a bladder; the bladder including a transparent portion configured to be worn over the bleeding wound site on a user’s limb allowing visualization of the bleeding wound site wherein a portion of the transparent bladder when inflated causes hemostasis compression at the bleeding wound site; the wrap including a securing means to secure the wrap to the user’s limb wherein a portion of the securing means is elongated and configured to allow the user to self-apply the wrap when in use; an inflation port connected to the bladder; an inflation means connected to the inflation port; and wherein the bladder is configured to apply compression not only on the bleeding wound site but circumferentially on the limb around the bleeding wound site when inflated.

2. The hemostasis therapeutic compression apparatus of claim 1 wherein an interface pressure of the inflated transparent portion of the bladder is higher than an interface pressure of the remainer of the inflated bladder.

3. The hemostasis therapeutic compression apparatus of claim 1 wherein the transparent portion of bladder is inflated such that a side in contact with the bleeding wound has an interface pressure of from about 40 mmHg to about 200 mm Hg.

4. The hemostasis therapeutic compression apparatus of claim 3 wherein the interface pressure is from about 50 mmHg to about 80 mm Hg.

5. The hemostasis therapeutic compression apparatus of claim 3 wherein the interface pressure is about 60 mmHg.

6. The hemostasis therapeutic compression apparatus of claim 1 wherein the inflation means is selected from the group consisting of manual pumps, static pumps, electrical inflation pumps, battery inflation pumps, gas powered inflation pumps, static pneumatic compression pumps, and the combinations thereof and the inflation means for the at least one bladder is selected from the group consisting of air, gas, fluid or combinations thereof.

7. The hemostasis therapeutic compression apparatus of claim 1 wherein the inflation port is a self-sealing inflation port configured to prevent deflation of the bladder and includes a check valve.

8. The hemostasis therapeutic compression apparatus of claim 1 further comprising an elbow connector, a check valve and a valve cap wherein the valve cap is capable of releasing a pressure created by the inflation means within the bladder.

9. The hemostasis therapeutic compression apparatus of claim 1 further comprising a pressure sensor operatively connected to the inflation means to protect from over inflation and wherein the check valve is set to open at a predetermined pressure or a user selectable pressure.

10. The hemostasis therapeutic compression apparatus of claim 1 wherein the wrap further includes a release valve or button for release of pressure within the inflated bladder.

11. The hemostasis therapeutic compression apparatus of claim 1, wherein the bladder is an air bladder configured to provide a first compression level at the wound site and a second compression level on the limb.

12. The hemostasis therapeutic compression apparatus of claim 1, wherein the inflation means includes a real-time pressure measurement mechanism.

13. The hemostasis therapeutic compression apparatus of claim 1, wherein the wrap includes a pulsometer configured to measure the pulse of a target vessel in the area of the bleeding wound site.

14. The hemostasis therapeutic compression apparatus of claim 1 wherein the transparent portion of the bladder is in the shape of a circle, cross, oval, kidney, elongated kidney, square, rectangle, “U”, “C” or the like shapes.

15. The hemostasis therapeutic compression apparatus of claim 1 further comprising an umbrella valve within the inflation means configured to prevent overinflation of the bladder on the wound location.

16. The hemostasis therapeutic compression apparatus of claim 1, wherein the wrap includes an inner sheet of wicking material and an outer sheet partially elastic or having an elastic portion configured to securely wrap around the limb of the user prior to and after inflation of the bladder.

17. The hemostasis therapeutic compression apparatus of claim 1 further comprising an elastic portion connected to the wrap the elastic portion configured to stabilize and maintain the wrap on the limb of the user when the at least one bladder is inflated and the user is moving.

18. The hemostasis therapeutic compression apparatus of claim 1 wherein a proximal portion, distal portion or both the proximal and distal portions of the wrap are shaped to stabilize and maintain the wrap on the limb of the user when the at least one bladder is inflated and the user is moving.

19. A method of applying compression pressure to a bleeding wound site on a limb of a user to obtain hemostasis, comprising: placing a dressing over the bleeding wound site on the limb of a user; placing a wrap on the dressing and the limb, wherein the wrap includes (a) a bladder having an inflation port with the bladder having a transparent portion configured to allow visualization of the bleeding wound site and (b) a securing means to secure the wrap to the user’s limb wherein a portion of the securing means is elongated and configured to allow the user to self-apply the wrap when in use; securing the wrap on the limb with the transparent portion of the bladder over the bleeding wound site and dressing; connecting an inflation means to the inflation port on the wrap;activating the inflation means and inflating the bladder; and monitoring bleeding at the wound site via the transparent portion of the bladder.

20. The method of claim 19 further including the step of deflating the inflated bladder by opening a release valve or button on the wrap and releasing a pressure within the at least one bladder once bleeding has reduced or stopped due to hemostasis.21 . A hemostasis therapeutic compression system configured to control external bleeding at a wound site on a limb of a user, comprising: at least one wrap having an inner sheet and an outer sheet joined together by welds and lines to create an at least one bladder with the at least one bladder including a transparent portion configured to be worn over the bleeding wound location on a user’s limb allowing visualization of the bleeding wound site wherein a portion of the transparent bladder when inflated causes hemostasis compression in an amount of about 40 mmHg to about 90 mmHg interface pressure at the bleeding wound site; the at least one wrap including a securing means to secure the wrap to the user’s limb wherein a portion of the securing means is elongated and configured to allow the user to self-apply the wrap; a universal self-sealing inflation port connected to the at least one bladder; an inflation means connected to the universal inflation port; and an absorbent dressing selected from the group of bandages, gauze, foam, PF AB and the like; wherein the at least one bladder is configured to apply compression not only on the bleeding wound site but circumferentially on the limb around the bleeding wound site when inflated.

22. The hemostasis therapeutic compression system of claim 21 wherein the absorbent dressing is a foam disk including a center opening and a slit on the radius of the disk configured to accommodate a needle at the wound site where the bleeding wound site is a needle-access site.

23. The hemostasis therapeutic compression system of claim 21 wherein an interface pressure of the inflated transparent portion of the at least one bladder is higher than an interface pressure of the remainer of the inflated at least one bladder.

24. The hemostasis therapeutic compression system of claim 21 wherein the transparent portion of the at least one bladder is inflated such that a side in contact with the bleeding wound has an interface pressure of from about 40 mmHg to about 200 mm Hg.

25. The hemostasis therapeutic compression system of claim 21, wherein the wrap includes a pulsometer configured to measure the pulse of a target vessel in the area of the bleeding wound site.

26. The hemostasis therapeutic compression system of claim 21 wherein the transparent portion of the at least one bladder is in the shape of a circle, cross, oval, kidney, elongated kidney, square, rectangle, “U”, “C” or the like shapes.

27. The hemostasis therapeutic compression system of claim 21 further comprising an elastic portion connected to the wrap the elastic portion configured to stabilize and maintain the wrap on the limb of the user when the at least one bladder is inflated and the user is moving.

Images