Vein ablation device, system, kit and methods of use

Abstract

A vein ablation device, system, kit and methods of use include a body containing an activation means, a hollow housing needle, and a vein ablator including at least two end effectors. The at least two end effectors are housed within the hollow housing needle until activated by the activating means and then the tip of the vein ablator and the at least two end effectors extend out of the distal end of the hollow housing needle and rotate in a clockwise and counter-clockwise director and returns to within the hollow housing needle back and forth, ablating the vein.

Description

PATENT APPLICATION SUN-090-PCT VEIN ABLATION DEVICE, SYSTEM, KIT AND METHODS OF USE RELATED APPLICATIONS

[0001] The present application claims priority from US provisional application serial number 63 / 738,494 filed December 23, 2024 entitled “Vein Ablation Device, System, Kit 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 related to vein ablation including an inventive device as well as system with a compression apparatus, a kit, and methods of use for surgical procedures.II. Background of the Related Art

[0003] Varicose vein or spider veins are usually found in the legs and removal can take the form of compression therapy, chemicals and surgical procedures. Patients suffering from spider veins and / or varicpse veins may experience pain, itching, heaviness, aching, pressure, fatigue, restless or jittery legs, sleeplessness, and other symptoms. On one hand surgical treatments for leg vascular issues include sclerotherapy which is a medical procedure used to eliminate varicose veins and spider veins. Sclerotherapy typically involves an injection of a solution (generally a salt solution) directly into the vein. The solution irritates the lining of the blood vessel, causing it to collapse and stick together and the blood to clot. Post-operative procedures may require compression bandaging or stockings, both of which have the problems described above in regard to slippage down the thigh to the knee as well as cost and need for a skilled level of knowledges in order to properly bandage the sclerotherapy treatment area. A need exists for device which can ablate the target vein and also a system and kit for post-operative use which the user can apply themselves without a caregiver or medical professional. A need exists for a vein ablation device, system and kit to assist in healing and reduce pain, complications, risk of infection and the like.

[0004] The veins of the leg are divided into the superficial and deep systems according to their position relative to the fascia. The deep veins, which come together to form the popliteal and femoral veins lie within the fascia and are responsible for the venous return from the leg muscles. Dilated valveless sinusoids also lie within the fascia (more particularly in the soleus and gastrocnemius muscles). The sinusoids fill with blood when the leg is at rest.

[0005] The long saphenous vein which runs along the medial side of the leg from foot to groin and the short saphenous vein which runs at the back of the calf from foot to knee are the major vessels of the superficial venous system. These vessels lie outside the fascia and are responsible for the venous returnfrom the skin and subcutaneous fat. Compression on the long saphenous vein may be recommended in treatment of certain conditions whereas in other conditions there may be less compression recommendation on the long saphenous vein on the medial side of the leg and more compression recommended on the short saphenous vein of the leg which runs on the back portion of the leg, including the thigh. Communicating veins, sometimes called perforators because they perforate the deep fasciajoin the two systems. The perforators, like the other veins in the leg, contain valves that permit the flow of blood in one direction only, from the outer or superficial system inwards to the deep veins.

[0006] The venous pressure at the ankle of a subject who is lying supine is around 10 mmHg, but on standing this will rise considerably due to an increase in hydrostatic pressure (equivalent to the weight of a vertical column of blood stretching from the point of measurement to the right auricle of the heart). During walking, as the foot is dorsally flexed, the contraction of the calf muscle compresses the deep veins and soleal sinuses thereby emptying them of blood. As the foot is plantarly flexed, the pressure in the veins falls, the proximal valves close, and the veins are refilled by blood passing through the perforators from the superficial system. During this cycle, in a normal leg, the distal valves of the dee veins and the valves of the perforators will ensure that the expelled blood can go in only one direction- upwards, back to the heart.

[0007] Blockage or damage to the venous system will cause disruption to normal blood flow, which may manifest itself in a number of different ways according to the site and extent of the damage. If the valves in the superficial system are affected, venous return will be impaired and blood may accumulate in the veins causing them to become distended, leading to the formation of varicosities (varicose veins). Such varicosities may be located in the thigh, knee, calf, ankle or foot area of the user's leg. If the function of the perforator valves is impaired, the action of the calf muscle pump will tend to cause blood to flow in the reverse direction into the superficial system increasing the possibility of damage to the superficial vessels. Again, the 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. A need exists for a new system to treat such medical issues. There may be minimal blood flow upward into the thigh and the rest of the body, causing issues for the patient along the body including the thigh, calf, ankle and entire leg of the patient.

[0008] Following a deep vein thrombosis that results in complete or partial obstruction of a deep vein, the unrelieved pressures produced by the calf muscle pump on the perforator valves may cause these to become incompetent. If this occurs, there will be a large rise in the pressure in the superficial system, which may force proteins and red cells out of the capillaries and into the surrounding tissue. Here, the red cells break down releasing a red pigment that causes staining of the skin, an early indicator of possible ulcer formation. The ulcer formation can be in any part of thebody, including the leg, groin, thi h, knee, calf, ankle and foot.

[0009] Venous leg ulcers are generally shallow and red in color. The skin surrounding the ulcer is frequently discolored due to the staining described previously. Incompetent perforating vein valves can also cause malleolar venules to become dilated and appear as fine red threads around the ankle as well as the thigh, knee, calf or foot are of the leg or any area of the leg. This condition, called ankle flair, is also diagnostic of a venous ulcer. The condition may also be seen on the thigh, including the inner medial thigh area or outer lateral thigh area, or around the knee or groin area of the patient's body.

[0010] Arteries transport oxygen replenished blood from the heart to the rest of the body. Veins return oxygen depleted blood back to the heart. When the veins in the lower extremities of the body have difficulty transporting blood back to the heart, a condition develops called chronic venous insufficiency (CVI), also known as chronic venous disease (CVD). CVI. Most commonly occurs as the result of a blood clot in the deep veins of the legs, a disease known as deep vein thrombosis (DVT). CVI also results from pelvic tumors and vascular malformations, and sometimes occurs for unknown reasons. When a person is standing or sitting, blood in the veins of the legs flows in an upward direction. When the person walks, the calf muscles and muscles in the feet contract to squeeze the veins and push the blood upward. To keep the blood flowing upward and prevent it from flowing downward, the veins contain one-way valves. CVI occurs when these valves become damaged and allow the blood to leak back downward in the opposite direction. Such valve damage may occur as the result of aging, extended sitting or standing, or a combination of aging and reduced mobility. When the veins and valves become weakened and the blood does not properly flow up to the heart, blood pressure in the veins of the lower extremities can stay elevated for long periods of time, leading to CVI. This-condition is more common in older individuals, and if not properly treated, can lead to burst capillaries, local tissue inflammation, internal tissue damage, varicose veins, ulcers, and open sores on the skin’s surface. The burst capillaries can be seen on the patient's leg including the thigh, knee and groin.

[0011] CVI can diminish the capacity of the venous system and increase the workload of the lymphatic system in the affected area. The lymphatic system must then transport larger volumes of water and protein to reduce the fluid load in the affected tissues of the legs, a situation which is especially difficult for patients with lymphedema, varicose veins, and other lower extremity pathology.

[0012] Varicose and spider veins affect men as well as women and impact the quality of life for a large segment of the population. Excess weight, age, family history, pregnancy, hormonal birth control, hormone therapy, prolonged sitting or standing, prior DVT and venous valve dysfunction / reflux are allknown to increase risk of varicose veins and spider veins. These risk factors lead to increased pressure in the veins known as venous hypertension. The increased pressure from venous hypertension causes the veins close to our skin to stretch and become varicose. Varicose veins are larger and may bulge and appear rope-like. They often appear on the calf, the back of the leg or inside the thigh. Spider veins are closer to the surface of the skin and look more like thin spider webs. Varicose vein changes can be asymptomatic, but are also associated with symptoms of variable degrees. Varicose veins can be associated with leg swelling, heaviness, itching and burning, which typically occurs over the day. This creates a state of constant inflammation in the legs, which ultimately damages the skin. In very advanced cases, ulcers can develop in the lower leg around the ankles. They can also be associated with bleeding of fragile veins close to the skin and blood clots.

[0013] One non-surgical option often used to help prevent or treat the leg extremity pathologies discussed above is the use of compression stockings. Compression stockings help prevent leg fatigue, ankle and foot swelling, spider veins, and varicose veins. They improve circulation in the legs, especially when used in conjunction with frequent exercise and leg elevation. Compression stockings maintain pressure on the legs while allowing for normal ambulation. Increasing pressure in the tissues beneath the skin reduces excess leakage of fluid from the capillaries and increases absorption of tissue fluid by the capillaries and lymphatic vessels. In addition, the increased pressure decreases the size of the veins, which causes the blood to flow faster and helps prevent it from pooling.

[0014] Compression stocking tightness typically varies between 15-50 mm HG. The tightness of a given stocking depends on its particular configuration-and class. For example, stockings having a compression pressure of 15-20 mm HG are considered light compression stockings. Class I stockings are 20-30 mm Hg, class II stockings are 30-40 mm Hg, and Class II stockings are 40-50 mm Hg. While such compression stockings are a commonly utilized non-invasive treatment of leg pathology, the issues they present are numerous. Wearing a tightly fitting stocking can be tedious or time consuming to put on, and may require help from another person if the wearer is injured, elderly, or has some form of disability. Any tight-fitting stocking to be worn on the thigh area has a harder time being put on as the user has to pull the tight-fitting stocking over the foot, ankle, calf, knee and finally up to the thigh area. Again, due to the shape of the thigh, these tight-fitting stockings will slip down the thigh at some point due to the user walking or moving about.

[0015] In addition, the pressure applied by the stocking generally stays relatively constant during use without any option of increasing or decreasing the tightness level. As compression stockings are repeatedly worn, they lose elasticity and thus tightness over time. Once such prescribed elasticity and tightness is lost, the stocking is of little or no value, and needs to be replaced on account of itslooseness, which requires buying a new pair to obtain the desired pressure. Further, given the shape of the thigh, the top or upper portion of the stocking must be very tight in order to prevent slippage down the thigh, which can in turn lead to complications of its own due to the excessive tightness. Typical compression stockings are also non-absorbent so require an additional wound dressing on the target area of the ulcer to be applied and then the compression stocking is pulled up over the target limb or extremity. A need exists for a pre-formed absorbent wound dressing in the shape of the target limb or extremity to be applied or placed over the ulcer either alone or as part of a wound dressing compression system.

[0016] Medical hosiery represents a useful and convenient method of applying compression to normal shaped legs in order to prevent the development or recurrence of leg ulcers and varicose veins. However, these stockings are of limited value in the treatment of active ulceration, being difficult to apply over dressings. In such situations compression bandages currently represent the treatment of choice. Compression bandages apply a pressure to the limb that is directly proportional to bandage tension but inversely proportional to the radius of curvature of the limb to which it is applied. This means, therefore, that a bandage applied with constant tension to a limb of normal proportions will automatically produce graduated compression with the highest pressure at the knee. This pressure will gradually reduce up the thigh as the circumference increases.

[0017] As can be readily appreciated, it is cumbersome and difficult to apply uniform tension to the compression bandage as it is applied to the treated limb, and thus this is accomplished only by highly skilled caregivers. Moreover, once secured to the treated limb, care and attention must be given to ensure that the bandage does not slip or become displaced as this will lead to multiple layers forming, which in turn may lead to localized areas of high pressure, which can place the patient in direct risk of skin necrosis. Further, as most compression dressings are non-absorbent, the provider must apply two layers of dressing, first an absorbent wound dressing and then a compression dressing, requiring even more skill for both dressing applications.

[0018] Mechanical compression treatments have also been proposed. An exemplary compression device is described in U. S. Pat. No. 5,031,604 to Dye. As generally described at col. 2, lines 33 et seq., an arrangement of chambers are provided that circumscribe the leg. An active pneumatic control system controls the pressure in the chambers to squeeze the leg near the ankle and then squeeze sequentially upward toward the knee in order to move blood from the extremity toward the heart. As noted in col. 4, lines 20-59 of U. S. Pat. No. 6,488,643 to Tumey et al., the mechanically produced compression levels may produce ischemic (i.e., localized tissue anemia) not noted at similar compression levels obtained through bandaging. It may also produce cuffing (i.e., a reduction in leg pulsatile blood flow). The pneumatic control system is also bulky and heavy, which severely limits the mobility of the patient duringtreatment. Moreover, the pneumatic control system fails to provide a mechanism to ensure that excessive pressure, which can cause necrosis, is not applied to the treated limb. These limitations have resulted in most mechanical compression devices being contraindicated for patients exhibiting DVT. Consequently, those skilled in the art have to date avoided such mechanical compression devices for the treatment of venous ulcers or edema of the extremities.

[0019] Co-owned U. S. Pat. No. 7,276,037, which is hereby incorporated by reference herein in its entirety, discloses an apparatus for applying compression therapy to an extremity of the human body, such as a portion of the human leg. The device includes a flexible member and an air bladder chamber. The flexible member is adapted to wrap around the extremity to secure the air bladder chamber to the extremity. An air pumping mechanism is operated to inflate the air bladder chamber to a pressurized state. One or more fluid-filled pressurized members are provided, each separate and distinct from the flexible member and the air bladder chamber and thus readily moveable relative to the flexible member and the air bladder chamber. The pressurized member(s) is operably disposed between the extremity and the flexible member whereby it applies increased localized pressure to the extremity during use. Preferably, the air bladder chamber is substantially longer in a first dimension than in a second dimension orthogonal thereto such that it can extend longitudinally along the extremity to cover a relatively long and narrow portion of the extremity. The position of the air chamber can be readily adapted to apply local pressure to desired body parts (such as a certain venous channel). The pressurized member(s) can be positioned during use such that it covers a venous ulcer (or other treatment sites) and applies increased localized pressure to the treatment site in order to promote healing.

[0020] In general the known compression devices 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 period of time, but the currently known devices are bulky as the inflation means or pump is an integral part of the wrap mechanism. Such known compression devices are limiting as the patient cannot walk or function in work, school or otherwise wearing bulky leg, foot, thigh or other limb wrap. Further, certain known compression devices only allow for varying intermittent pressure if directly connected to an electrical power source, thereby further limiting the use by the patient as he or she is literally tethered to a wall outlet. Moreover, known compression devices or apparatus lack 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 wound dressing 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.

[0021] Further, sequential compression may assist in therapies for varicose and spider veins, lymphedema, CVT, CVI, DVT and the like. Having multiple bladders within a compression apparatus isknown but a need exists for a streamlined inflation means to feed each bladder and a controlling mechanism so that each bladder is inflated sequentially. Another need exists for a separate foot bladder from the lower leg bladder and / or the upper leg or thigh bladder, so that each bladder has a separate is compression level, and again, coordinated sequential compression or pressure when inflated. Further a need exists where each of the separate bladders has a SSI of at least about 12 or greater.

[0022] Known methods for 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. 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. Further, when the compression bandaging is on the foot area of the leg. the bandaging bunches up when in the shoes of the individual, the bandage gets moist due to the heat of the foot in a shoe and when walking, the exudate soils the individuals sock or bedsheet, or clothes or couch when in use. Due to the anatomy and structure of the foot the current known bandages and wound dressings are inadequate to maintain securement on the sole of the foot or the top of the arch of the foot without adding multiple thickening of the bandage and wound dressing. Further, compression dressing is typically non-absorbent so therefore the patient has leakage or oozing from the wound such as a foot ulcer, that leaks onto bed sheets or clothes. Thus a need exists for an absorbent foot wound dressing to apply to the patient or user’s foot whether the ulcer is on the bottom or top of the foot and applied more easily than current wound dressings and maintains securement on the foot longer than conventional known wound dressings.

[0023] The effectiveness of many of the current compression therapies and wound dressings such as bandages is also 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 stockings and / or 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. Again though, the stockings and / or bandages will slip down the ankle and bunch up under the arch or along the sole of the foot once the user walks or moves around.

[0024] From a lifestyle and economics view, most visits to medical professionals such as clinicians are for venous wound care are for everyday dressing changes and not for monitoring the progress of the wound, thereby causing increased costs (to the patient, the insurance company and even loss of other billable time for the medical provider) and time management of all involved. This creates a large burden to health care system due to medical professionals such as clinicians basically removing and reapplying compression bandages every few days for patients resulting in lost opportunity to do other procedures andcost to the insurance companies, Medicare, and the patient’s co-pays every few days for weeks, months or even years on end. For the medical professional who is tasked with removing and then applying a new compression bandage, he or she will cut off and remove the typically soaked foul smelling bandage with debris flying around and leaking liquids, pus, blood and the like, then cleaning off the exudating and foulsmelling wound site and finally having to wrap the new replacement compression bandage around and around the wound site. This is a messy, odorous and arduous procedure which the clinical or medical professional may repeat ever few days for every single patient, over and over again for weeks, months or even years. Further, the patient has multiple burdens on his or her time to travel to and from the medical office every few days, economic costs and notably reduced quality of life as not able to engage in every day activities such as bathing and the like.

[0025] The current treatment for varicose veins and spider veins if compression therapy doesn’t work or the patient wishes to not have the veins present, is sclerotherapy and / or endovenous ablation.Sclerotherapy is a procedure where the doctor injects a chemical in the affected veins, which closes off the veins in the area. After sclerotherapy the veins may typically fade in a few weeks or months.However, multiple treatments may be needed to truly “fade” the veins. This procedure can be performed for symptomatic small veins close to the skin or for cosmetic reasons. Spider veins may also employ laser treatments consisting of multiple sessions or procedures as needed. For larger, bulging veins endovenous ablation may be used where a doctor inserts a device into the vein and applies heat or glue to close the vein. Blood is thereby redirected to healthy veins under endovenous ablation. Again however, it may take months for the veins to fade and repeated procedures may be necessary. Symptom relief can be felt days to weeks after the endovenous ablation procedure. Varicose veins close to the skin are removed through small incisions in a different procedure of mini-phlebectomy. Lastly, surgical ligation and stripping involves refluxing veins that are not amenable or have previously failed endovenous ablation therapies. This procedure must be performed in an operating room and is more invasive.

[0026] Another current treatment is stab therapy which has complications as well and requires, under anesthesia, a series of small incisions made in the skin near the varicose veins or bulges. Then a specialized hook and clamp are used to remove the vein through these incisions, often in sections requiring many many incisions followed by multiple locations that need to be stitched up and sealed, each location which may be subject to infection. The patient may also experience complications from the anesthesia in addition to swelling after the treatment, pain once the anesthesia wears off, infection, numbness and again the pins and needles feeling, as well as other surgical complications.

[0027] In known methods of current treatment of sclerotherapy, a sclerosing solution is injected into the abnormal veins of the involved leg. The patient's leg is then compressed with either stockings or bandages that they wear usually for two weeks after treatment. Complications, while rare, include venousthromboembolism, visual disturbances, allergic reaction, thrombophlebitis, skin necrosis, and hyperpigmentation. If the sclerosing agent is injected properly into the vein, there is no damage to the surrounding skin, but if it is injected outside the vein, tissue necrosis and scarring can result. Most complications occur due to an intense inflammatory reaction to the sclerotherapy agent in the area surrounding the injected vein. In addition, there are systemic complications that are now becoming increasingly understood. These occur when the sclerosing solution travels through the veins to the heart, lung and brain.

[0028] Specifically when targeting varicose veins and spider veins below the knee, such as on the calf, ankle and foot areas, sclerotherapy is done at the targeted location via a needle insertion of the sclerofluid, such as chemicals or foam. Due to the location of the nerves at those area near the veins, the patient may experience pain, itchiness, swelling, pains and needles, numbness and other complications as well as infection. Multiple sessions have to be scheduled as the targeted area can only be accessed for a short period of time given the pain experienced by the patient.

[0029] Alternatively, laser therapy can be used to destroy and shrink varicose veins and spider veins. Laser therapy uses heat to damage the inside of the vein thereby destroying it. There are known problems with laser therapy, notably the fact that patients can feel the heat during the treatment, describing it as a burning sensation. Based on the pain threshold of the patient there may need to be multiple shorter treatment sessions scheduled for laser therapy. Further, the skin surrounding the areas of varicose veins and spider veins can have changes in pigment meaning the surrounding skin may become darker as a result of laser therapy. This is particularly problematic with treatments on the face or if multiple areas on the legs are being treated. Unfortunately, even skilled medical professionals may not know which patients or skin types may be affected by hypopigmentation.

[0030] Further, prior art invented by the same instant inventor disclosed for example in U. S. Pat. No. 8,617,144, the disclosure of which is incorporated herein by reference in its entirety', occlude the vein at the saphenous vein junction by tying the vein off with one or more sutures which causes complications and other issues during the method to ablate the target vein via that inventive device including protuberances or projections such as barbs to ablate the varicose vein. A need exists for a device and method to treat varicose veins and spider veins by ablating the varicose or target veins which reduces complications while maintaining or increasing efficacy and recovery time by the patient. Further a need exists for a system including a pre-formed wound dressing, a bolster or off loader, and a therapeutic compression apparatus once the vein has been ablated using the inventive device.

[0031] All current known treatment apparatus, devices, bandages, stockings and hosiery have the problems of stability (no slippage), maintaining sufficient effective pressure without overpressure complications, maintaining compression and the like. Further all known apparatus, devices, bandages,stockings and hosiery, though especially the current treatment inelastic apparatus and devices are only capable of a SSI of no higher than about 10-12 so that a need exists for a therapeutic compression apparatus having a SSI of above about 12, preferably about 15-25. The subject invention provides an alternative to known tight-fitting therapeutic elastic garments, which cause patients discomfort and are bulky and impractical to wear in daily life, and lose their elasticity as well as have slippage down the leg, and therefore their effectiveness over time as well as inelastic garments and apparatus with a SSI of less than about 10-12, as well as various procedures which may have to be performed multiple times in order to fade varicose and / or spider veins and treat DVT and CVI. The inventive vein ablation device, system, kit and methods of use can treat spider veins and varicose veins better and more effectively than currently known sclerotherapy, laser or endovenous ablation.

[0032] A need exists for a vein ablation device, system and kit including a pre-formed absorbent wound dressing in the shape of a target limb or extremity as part of a wound dressing compression system such as an ankle and / or foot. Such a pre-formed absorbent wound dressing is easier to place on the ulcer or surgical site wound and lasts longer than common bandages and wound dressings. The pre-formed absorbent wound dressing is part of a wound dressing compression system including a therapeutic compression apparatus having a sufficient SSI or greater than 12 applied over the preformed absorbent wound dressing. Other uses for the inventive system and kit may be envisioned.

[0033] Treatment and ablation of spider veins and varicose veins is critical to the lifestyle, physical and mental health of individuals. Individuals living with spider veins and varicose veins typically experience poor quality of life because of pain, itching, heaviness, aching, pressure, fatigue, restless or jittery legs., disruption to work and leisure activities, sleep disturbance, depression, and pain. The inventive vein ablation device, system, kit and methods of use may alleviate or promote healing of these problems resulting in a better lifestyle for the individual, reduced medical costs, reduced complications, and possibly better physical and mental health. A need exists for a device that disrupts the vein architecture and ablates the vein by disrupting the architecture, interrupting blood flow and collapsing or closing the target vein such as a varicose vein or spider vein. A need exists for such a treatment done under local anesthesia so therefore less complicated than endoveaous vein surgery and more effective than current sclerotherapy, laser treatment and radio frequency treatments. Other uses for the inventive vein ablation device, system, kit and methods of use may be envisioned.

[0034] A need exists for a vein ablation device, system and kit to ablates varicose and / or spider veins located on the legs and other parts of the body where the treatment is complete in one session and has less complications than known devices such as laser treatment, Radio frequency treatment and other surgeries. A need exists for a system including a vein ablation device and a therapeutic compression garments or apparatus post-treatment or surgery such as on a thigh or lower leg or foot,or including multiple compression apparatus. For instance, a thigh compression garment could be used in conjunction with a lower leg compression apparatus such as that described (and incorporated herein as reference) in U. S. 9,033,906 and U. S. 7,967,766 and U. S. 7,559,908 and U. S. Serial No.13,444,600 and U. S. Serial No. 16 / 328,718 and therefore the user could wear two separate therapeutic compression apparatus on the entire leg and could also include an optional knee wrap. In this instance the user could have one pressure level on the inventive thigh therapeutic compression apparatus whereas a calf compression garment could have a second pressure level and both compression garments are connected to one pneumatic pump configured to have multiple pressure outlets. Such a need exists for such a system. Further such incorporated therapeutic compression apparatus such as the co-owned Aero-Wrap® have a SSI of above about 12, preferably about 15-25.

[0035] The subject invention provides an alternative to known tight-fitting therapeutic elastic garments, which cause patients discomfort and are bulky and impractical to wear in daily life, and lose their elasticity as well as have slippage down the leg, and therefore their effectiveness over time as well as inelastic garments and apparatus with a SSI of less than about 10-12, as well as various procedures which may have to be performed multiple times in order to fade varicose and / or spider veins. The inventive vein ablation device, system, kit and methods of use can treat spider veins and varicose veins better and more effectively than currently known sclerotherapy or endovenous ablation. A further need exists for a vein ablation device, system and kit including a pre-formed absorbent wound dressing in the shape of a target limb or extremity as part of a wound dressing compression system such as an ankle and / or foot. Such a pre-formed absorbent wound dressing is easier to place on the ulcer or surgical site wound and lasts longer than common bandages and wound dressings. The pre-formed absorbent wound dressing is part of a wound dressing compression system including a therapeutic compression apparatus having a sufficient SSI or greater than 1 applied over the preformed absorbent wound dressing. Other uses for the inventive system and kit may be envisioned.SUMMARY OF THE INVENTION

[0036] The subject invention is directed to an inventive vein ablation device, system, kit and methods of use to treat spider veins and / or varicose veins, typically on a target limb or extremity such as a foot, ankle, calf, thigh, knee, leg, torso, chest, shoulder, arm, wrist, hand, neck or any other limb. The inventive vein ablation device includes a handle, a hollow needle that houses the vein ablator including at least two end effectors configured to ablate the target vein. The inventive system or kit includes the inventive vein ablation device and one or more pre-formed absorbent wound dressings, one or more bolsters or off loaders, and one or more therapeutic compression apparatus each having at least one bladder and depending on target limb may have two, three or more bladders, all connected to one inflation means and each apparatus having a check valve in an inflation port on theI Iapparatus capable of maintaining the pressure within the inflated bladder when the inflation means is disconnected to the apparatus. Each therapeutic compression apparatus has a SSI of at least about 1 or greater. The system may include at least one sensor, such as a motion sensor, pressure sensor, blood pressure sensor, tonometer sensor, or other sensors to monitor use of the inventive system by the patient and / or medical professionals. In use, the inventive vein ablation is placed in the target vein, activated and the vein ablated through destruction via the end effectors rotating back and forth in this embodiment out of the distal end of the needle, followed by placement of the bolster or off loader along the ablated vein if used, then a pre-formed absorbent wound dressing on the target limb or extremity, secured, and followed by the therapeutic compression apparatus placed over the preformed absorbent wound dressing with the apparatus being secured and then inflated via the inflation means. The pre-formed wound dressing may also include a dressing which is impregnated with an additive such as silver or zinc oxide. The system, kit and method may also include a wound bolster or other elevating apparatus such as a pre-filled bladder in combination with an absorbent foam or other material adhered to the wound site.

[0037] A method of the invention includes inserted the tip of the hollow needle into the target vein (or barrel rolling the vein), activating the device wherein the tip of the rotating end comes out of the hollow needle to scrape or remove the target vein via the end effectors, then the tip is retracted back into the hollow needle after a series of rotations and the needle removed from the vein. Not being bound by theory, the target vein’s architecture is disrupted or damaged with the blood flood interrupted such that the vein closes and is absorbed. The system is used to treat spider veins, varicose veins as well as to treat CVI, DVT and / or lymphedema bas well as in use together with or after sclerotherapy for example, including applying the bolster dressing to the limb of a patient such as with an adhesive and then applying a compression housing or liner or stocking over the bolster dressing followed by applying a pre-formed wound dressing and a therapeutic compression garment or dressing over both the elastic housing or liner and the bolster dressing. If a thigh or lower leg therapeutic compression apparatus / garment is used as the inflatable wrap, then the method includes applying the therapeutic compression apparatus / garment around a limb by a patient and inserting an inflation means into an inflation port and inflating the one or multiple bladders within the therapeutic compression apparatus and maintaining a certain pressure or compression profile along the medial saphenous vein and / or the lateral saphenous vein or lower leg, or to treat the CVI, DVT and / or lymphedema or assist in healing post-ablation surgery such as sclerotherapy, laser, RE surgery or the like.

[0038] The inventive vein ablation device may be a sterile, single patient use, disposable device for use primarily in the patient’s legs to eliminate visible spider and small varicose veins though other uses maybe employed. The inventive vein ablation device includes multiple needle and contained end-effector sizes, typically housed in range of 18 gauge, 16 gauge and 14 gauge hollow surgical needles though other size needles may be employed as well as other end effector and other hollow housings. The inventive vein ablation device is currently disclosed in a manual hand cycled version and a motorized electric battery powered version though other versions may be employed including electric powered and other manual powered versions.

[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 device and system of the subject invention, and how to employ the methods of use, preferred embodiments thereof will be described in detail herein below with reference to the drawings, wherein:

[0041] FIG. 1 is one embodiment of the present invention of a vein ablation device which is manual hand-cycle operated;

[0042] FIG. 2 is an exploded view of FIG. 1;

[0043] FIG. 3 A is a side view of the twister assembly within the present invention of FIG. 1, with FIG. 3B being an exploded view of 3A, and FIG. 3C being a close up view of the portion “A” of FIG. 3C showing the tip assembly;

[0044] FIG. 4A is a close-up view of the distal portion of the tip of FIG. 2, with FIG. 4B being a front view of one embodiment of the end-effector and FIG. 4C being a side perspective view of the end -effector of FIG. 1 and 4B;

[0045] FIG. 4D is a side perspective view of the twister of FIG. 1, with FIG. 4D being a side view of FIG. 4C, and FIG. 4E is a cut-away view of the twister of FIG. 4C;

[0046] FIG. 5 is a side view of the front portion of FIG. 1 where the end effectors are activated and extending out of the distal end of the needle including a close-up view of the distal end of the tip;

[0047] FIG. 6 is a cut-away view of the present invention of FIG. 1;

[0048] FIG. 7 is an exploded view of another embodiment of the present invention being battery operated; and

[0049] FIG. 8A is a side perspective view of another embodiment of the present invention including a push trigger activating means and FIG. 8B is a cut-away view of FIG. 8A.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] Preferred embodiments of the subject invention are described below with reference to theaccompanying drawings, in which like reference numerals represent the same or similar elements. One of ordinary skill in the art would appreciate that while the device, system and kit discussed herein relate to vein ablation of the leg, the scope of the invention is not limited to those exemplary applications and may be sized and shaped for the anatomical portion for which vein ablation is needed.

[0051] The subject invention provides system and kit with the inventive vein ablation device including a pre-formed wound dressing used alone or with compression (via a therapeutic compression apparatus) to a patient's limbs, including the extremities, including for example, the foot, ankle and / or leg of a user, 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 subject to the vein ablation procedure using the inventive vein ablation device then combined with a pre-formed wound dressing alone or by the instant system including a therapeutic compression apparatus such as for instance a foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, band, fingers, neck, head or the like.

[0052] The subject invention provides a system and kit which may also include a pre-filled air bladder off loader or bolster which may also include a sponge or otherwise absorbent component. 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 of the wound dressing, compression therapy apparatus and pre-filled air bladder off loader or bolster.

[0053] The subject invention includes methods of use such as one method whereby the distal end 112, 212, 312 of the needle 110,210, 310 of the inventive vein ablation device 100, 200, 300 is inserted just under the skin and above the visible varicose or spider vein in an out-patient procedure using local anesthetic. The trigger 158, 258 in one embedment of the inventive vein ablation device 100, 200 is then cycled and the end effector 117, 217, 317 which in one embodiment of the inventive vein ablation device 100, 200, 300 are sharp star components then advance and spin out of the distal end 112, 212, 312 of the needle 110, 210, 310 resulting in the destruction of the target vein. The trigger 158, 258 may be cycled multiple times as judged by the surgeon or health care provider user and upon removal from the leg the inventive vein ablation device 100, 200, 300 may then be applied in a new location during the single patient procedure. The “scratching” of the veins by the inventive method using the inventive vein ablation device 100, 200, 300 permanently destroys the varicose or spider vein therefore disrupting blood flow resulting in improved cosmetic appearance and decreased or eliminated pain, swelling, bulges, throbbing and other known symptoms of varicose and / or spider veins as well as eliminate or reduce CVI, DVT and related vein complications. Other method of use and other embodiments of the inventive vein ablation device 100, 200, 300 may be employed.

[0054] 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 limitof 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 of those included limits are also included in the invention. 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.

[0055] 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 the art, and so forth.

[0056] The publications discussed herein are provided solely for their 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. Co-owned pending applications and issued patents listed herein are all incorporated in their entireties including Serial No. PCT / US2024 / 010513 entitled “Pre-formed Absorbent Wound Dressing, Therapeutic Compression System, and Methods of Use” filed January 5, 2024, Serial No. 63 / 425,183 filed November 14, 2022 entitled “Inelastic Therapeutic Compression Apparatus, System and Methods of Use” and as a continuation-in-part from U. S. application Serial No. 17 / 608,323 filed November 2, 2021 and entitled " Therapeutic Compression System and Methods of Use" based on application Serial No. PCT / US2020 / 31227 filed May 2, 2020, based on application Serial No. 62 / 842,165 filed May 2, 2019, and PCT / US2023 / 037286 entitled “Elasticinelastic Therapeutic Compression Apparatus, System, And Methods Of Use” filed November 14, 2023, and PCT / US2023 / 79854 entitled “Multiple Bladder Therapeutic Compression Apparatus, System, And Methods Of Use” filed November 15, 2023, and U. S. provisional application Serial No. 63 / 802,342 filed May 8, 2025 entitled “Method For Retrograde Sclerotherapy, System, Kit, And Saphenous Vein Ablator”, and U. S Serial No. 63 / 785,976 Entitled “Saphenous Vein Ablator And Method For Sclerotherapy” filed April 9, 2025, and PCT / US25 / 41961 entitled “Pre-formed Absorbent Wound Dressing With Bladder, Compression System, and Methods of Use” filed August 14, 2025.

[0057] The inventive vein ablation device 100, 200, 300 is used to treat varicose veins as well as other veins, primarily in the legs but other body parts may be targeted as well, by surgically traumatizing the veins resulting in shutting down blood flow and improving aesthetics. The inventive vein ablation device 100, 200300 in this embedment is a sterile single-use disposable device that comes with different needle gauges though reusable version may be employed, typically requiring sterilization between uses. Under local anesthesia a hollow needle 110, 210, 310 is inserted under the skin at a shallow angle above the varicose area of the vein. The inventive vein ablation device trigger 158, 258, 356 in the body assembly or handle 150, 250, 350 is cycled by the physician to advance and retract a spiked end-effector 117, 217, 317 to abrade and disrupt the target vein or blood vessel. The end effectors (spikes in this embodiment) 117, 217, 317 also rotate as they advance and retract into the needle 110, 210, 310. The spiked end effector 117, 217, 317 lies below flush within a hollow housing needle 110, 210, 310. When the trigger mechanism in the handle 150, 250, 350 is cycled, the ablator assembly tip 122, 222, 322 and end effectors 117, 217, 317 are pushed out of the aperture or opening 113, 213, 313 at the distal end 112, 212, 312 of the hollow housing needle 110, 210, 310 and rotates. Rotation of the end effectors 117, 217, 317 is caused by a helical guide path on an internal mechanism which houses the end effector 117, 217, 317. A tension spring 159, 259, 359 then pulls the mechanism back to the below flush resting position within the hollow housing needle 110, 210, 310. Upon return the end effector 117, 217, 317 is rotated again in the opposite direction. The insertion, activation, and retraction may be repeated within the same location and the inventive ablation device 100, 200, 300 may be inserted within the same target vein or vessel multiple times in different locations to abrade, disrupt and interrupt the blood flow within the target vein so that the vein architecture is destroyed and absorbed. The components include a trigger cycling mechanism which is mechanically based as shown in FIG. 2 (manual mechanical in FIG. 8A-B but a different embodiment of the push activation instead of a trigger), which is motorized as shown in FIG.7. The spiked end effector 117, 217, 317 is housed in a hollow housing needle 110, 210, 310 which hollow housing needle 110, 210, 310 may be in the range of 5-30 gauge, including one embodiment in 14 gauge and another embodiment in 16 gauge and a further embodiment in 18 gauge.

[0058] The hollow needle 110, 210, 310 may be comprised of any biocompatible material such as metals including stainless steel, titanium, nitinol, as well as others applicable metals or plastics. The hollow housing needle 110, 210, 310 needs to be strong with a thin wall as it is inserted percutaneously at a shallow angle into the skin during the inventive method so certain metals are preferred such as titanium or stainless steel, with certain biocompatible plastics a possibility but not optimal. The hollow housing needle 110, 210, 310 extends from the body or handle assembly 150, 250, 350 approximately 2 to 10 inches, preferably about 2.5 inches to about 4 inches based on the insertion at a shallow angle so it cannot be too short while also maintaining a position over a target vein so it cannot be too long. While theembodiments shown are single use devices, it is envisioned that a reusable embodiment could be employed with high temperature autoclavable plastics to be reusable. After use the inventive ablation device 100, 200, 300 would have parts of the patient’s veins, blood, tissue and skin in the end effectors 117, 217, 317 and in the hollow housing needle 110, 210, 310 which would have to cleaned out and removed then sterilized for next use. Further, an autoclaveable body or handle assembly 150, 250, 350 could include a snap-in single patient disposable needle 110, 210, 310 with ablator 121, 122, 221, 222, 321, 322 and end effectors 117, 217, 317 pre-loaded so that the body or handle assembly 150, 250, 350 is reused but the hollow housing needle 110, 210, 310 and the ablator assembly 121, 122, 221, 222, 321, 322 and end effectors 117, 217, 317 within the hollow needle 110, 210, 310 are used, then replaced over and over again as those would be disposable. Other methods of sterilization and reuse could be employed.

[0059] Referring now to FIG. 1 and 7 and 8A-B, an inventive vein ablation surgical device 100, 200, 300 is shown which includes a hollow housing needle 110, 210, 310 operatively associated therewith the body or handle assembly 150, 250, 350. The ablator assembly 121, 122, 221, 222, 321, 322 is preferably configured and adapted to be advanced on the proximal end from within the body or handle assembly 150, 250, 350 and the end effector 117, 217, 317 advance out of the opening or aperture 113, 213, 313 on the distal end 112, 212, 312 of the hollow housing needle 110, 210, 310 with repeated advance and withdrawal until the target vein is destroyed and ablated, though the entire inventive device 100, 200, 300 is operated for one patient use. In this embodiment the inventive vein ablation device 100, 200, 300 is a single use device though reusable devices may be employed with sufficient sterilization and other processes for reusability. The hollow housing needle 110, 210, 310 is also preferably configured and adapted and provided with a 2.4 mm needle or a 5 mm needle preferably about 10-30 gauge. The body or handle assembly 150, 250, 350 is preferably configured and adapted to receive, operate, and release the disposable hollow housing needle 110, 210, 310 regardless of whether a 2.4 mm needle is provided for insertion percutaneously under direct visualization when inserted into the target vein during the inventive method procedures, with preferred gauge hollow housing needles 110, 210, 310 in the range of about 10 gauge to about 26 gauge, preferably about 12 gauge to about 18 gauge. In this manner, the inventive vein ablation surgical device 100, 200, 300 allows for treatment of spider veins and / or varicose veins through vein ablation as well as improved appearance and alleviation or ending of symptoms associated with such veins.

[0060] As shown in FIG. 2 and 7 and 8B, needle assembly includes a hollow housing needle 110, 210, 310, and a needle hub 111, 211, 311 longitudinally fixed to the body or handle assembly 150, 250, 350. Also shown is an end effector 117, 217, 317 operatively associated within the hollow housing needle 110, 210, 310. The ablator assembly 121, 122, 221, 222, 321, 322 includes an endeffector 117, 217, 317 located on a body of the ablator assembly 121, 221, 321 as in this embedment the end effector 117, 217, 317 has an opening 119, 219, 319 to place them on the body 121, 221, 321 of the ablator assembly which has a smaller diameter than the ablator tip 122, 222, 322. As shown in greater detail in FIG. 3A-C and 4A, the body 121, 221, 321 of the ablator assembly has a distal tip 122, 222, 322 that is slightly rounded or pointed as it is inserted into or barrel rolled at the target vein, though other shapes may be employed. The proximal end of the ablator body 121, 221, 321 is inserted within an opening or aperture 124, 224, 324 in the distal hub 125, 225, 325 of a rear bushing 130, 230, 330. The rear bushing 130, 230, 330 has a proximal portion extending out 131, 231, 331 that is inserted within an opening or aperture 132, 232. 332 on the rod 135, 235, 335 which rod 135, 235, 335 has a distal end that is inserted within an opening or aperture 113, 213, 313 in the rotator or rotating mechanism 115, 215, 315 (twister). The end effectors 117, 217, 317 are separated by bushings 123, 223, 323 in these embodiments but other separating means may be employed. The ablator assembly 121, 122, 221, 222, 321, 322 and the end effector 117, 217, 317, and the bushings 123, 223, 323 must be comprised of biocompatible materials and in this embodiment are metals such as stainless steel, titanium, nitinol and the like, though it is envisioned they could be plastics and other biocompatible materials with sufficient strength to ablate, destroy, and disrupt the target vein architecture. On the proximal end of the end effector assembly 117, 217, 317 is a rotating mechanism 115, 215, 315. in this embodiment a “twister” 115, 215, 315 which operates to rotate and twist the ablator end effectors 117, 217, 317 once they are extended and pushed out of the aperture or opening 113, 213, 313 of the distal end 112, 212, 312 of the hollow housing needle 110, 210, 310. The hollow housing needle 110, 210, 310 and ablator assembly 121, 122, 221, 222, 321, 322 with end effectors 117, 217, 317 are selectively longitudinally translatable relative to one another and relative to needle hub 111, 211, 311 and body or handle assembly 150, 250, 350 via user manipulation of the body or handle assembly 150, 250, 350 via the triggers 158, 258 or push activation mechanism 356.

[0061] The hollow needle 110, 210, 310 includes a sharpened distal tip portion 112, 212, 312, a needle shaft having an inner surface which defines a hollow lumen through which the tip 122, 222, 322 of the ablator assembly and ablating end effectors 117, 217, 317 longitudinally translates. The hollow housing needle shaft 110, 210, 310 extends from one point defined by needle hub 111, 211, 311, and into the interior of the handle assembly 150, 250, 350 and on the distal end 112, 212, 312 through which the ablators or ablating end effectors 117, 217, 317 extend, rotate and finally retract. The tip 122, 222, 322 of the ablator 121, 221, 321 and end effector 117, 217, 317 is normally just below flush of the lower portion of the tip 112, 212, 312 of the hollow needle 110, 210, 310 and in one embodiment about .19 behind the needle tip 112, 212, 312. When the trigger 158, 258 (or pushmechanism 356) is fully depressed the end effector 117, 217, 317 rotates forward and extends about 0.5 to about 1.5 inches beyond the needle tip 112, 212, 312, preferably about 0.8 to about 1 inch, most preferred about 0.9 inch. The total end effector stroke is about 0.5 to about 1.5 inch, preferably about 1 inch though other lengths could be employed.

[0062] As shown, rotator or rotating member 115, 215, 315 is coupled to a trigger 158, 258 of body or handle assembly 150, 250. In this manner, trigger 158, 258 is activated to push the ablator tip 122, 222, 322 and end effector 117, 217, 317 out from the hollow housing needle 110, 210, 310 at the aperture or opening 113, 213, 313 and then further to rotate thereby rotating the ablators 117, 217, 317 in a clockwise and counter-clockwise manner so as to ablate or otherwise destroy the target vein. Certain embodiments of such rotational limits may be employed not limited to those shown in the Figures for 115, 215, 315. Various other structure facilitation of rotation of end effectors 117, 217, 317 together independent of the body or handle assembly 150, 250, 350, as well as longitudinal advancement 117, 217, 317. all by user manipulation of handle assembly 150, 250 may be employed.

[0063] As shown in FIGS. 1-2 and 5-8B-18, body or handle assembly 150, 250, 350 includes a housing 150, 250A, 150, 250B, 350 for storing and protecting the components thereof including the rotator or rotating mechanism 115, 215, 315 for rotating the end effectors 117, 217, 317. In this embodiment as shown in FIG. 2, 3A-B, 4D-F, and 6-8B, the rotator or rotation mechanism 115, 215, 315 is shown as a twister but other embodiments and rotation hubs may be employed. The length of the rotator or rotating mechanism 115, 215, 315 depends on the rotation and strength required and the length of the hollow housing needle 110, 210, 310. As shown in these non-limiting embodiments, the rotator or rotating mechanism 115, 215, 315, includes grooves 114, 214, 314 for the rotation of the end effector 117, 217, 317 in a clockwise and counter-clockwise rotation or direction.

[0064] The handle or body 150, 250, 350 includes a trigger 158, 258 which allows the surgeon or medical provider to activate the rotation mechanism 115, 215, 315 to activate the vein ablator assembly 121, 122, 221, 222, 321, 322 and end effectors 117, 217, 317 out of the hollow housing needle opening 113, 213, 313. The handle or body 150, 250, 350 also includes various springs 159, 259, 359 connected or secured by spring pins 145, 248, 345 and links 140, 240, 340 connected or secured by pins 147, 247, 347, for actuating and activating end effector 117, 217, 317 out of the hollow housing needle 110, 210, 310 and out of the distal end 112, 212, 312 opening 113, 213, 313 as well as rotating the end effector 117, 217, 317 so that each end effector 117, 217, 317 can ablate or destroy the target vein into which the distal end 112, 212, 312 has been inserted through the skin or fascia.

[0065] The handle or body assembly 150, 250, 350 further includes a crank assembly and a primaryreturn spring 159, 259, 359 (or as shown in embodiment of Fig. 2 multiple springs 159) for biasing the ablator assembly 121, 122, 221, 222, 321, 322 proximally and trigger 158, 258 distally toward the configuration so that the end effector assembly 117, 217, 317 is extended relative to the hollow housing needle 110, 210, 310 and activated. Handle assembly or body 150, 250, 350 also includes an arm slide for manipulating as well as various levers and slides and latches. The rotating mechanism or rotator 115, 215, 315 in this embodiment includes a molded hub 116, 216, 316 with a circular rear groove that allows the distal end 116, 216, 316 to fit into a driver 140, 240, 340 and rotate freely while axially affixing the distal end hub 116, 216, 316 and driver 140, 240, 340 together. A pin or pivot link 143, 243, 343 affixed to the right body or handle 150B, 250B, 350B fits into the spiral groove 114, 214, 314 on the rotating mechanism or twister 115, 215, 315 and constrains it to rotate clockwise and counterclockwise when driven back and forth by the driver 140, 240, 340, though other mechanisms and components may be employed. Further one or a set of springs 159, 259, 359 such as extension springs are connected to a drive link 141, 241, 341 or other ty pes of linkage to provide automatic return of the advanced and extended ablator assembly 121, 122, 221, 222, 321, 322 and end effectors 117, 217, 317.When the trigger 158, 258 is pulled by the user’s index finger into the body assembly or handle 150, 250, 350 the ablator assembly 121, 122, 221, 222, 321, 322 and constrained end effectors 117, 217, 317 advance from below flush in the hollow housing needle 110, 210, 310 and rotate clockwise until the full stroke is achieved. When index finger pressure is released the extension springs 159, 259, 359 return the trigger 158, 258 (and the push mechanism 356) to its full outward position. The returns the 121, 122, 221, 222, 321, 322 and end effectors 117, 217, 317 fully back into the hollow housing needle 110, 210, 310 while the end effectors 117, 217, 317 rotate counter-clockwise. While one shape of the end effector 117, 217, 317 is shown in the Figures (FIG. 4B up close) as a star shape or spiked shape, any other shape may be employed as long as configured to ablate or destroy the target vein once inserted therein or barrel rolled vein.

[0066] The manual version as shown in FIG. 1-6 and 8A-B has the end effectors 117, 217, 317 deployed by pulling the trigger 158, 258 back with the index finger. The end effectors 117, 217, 317 returns within the hollow needle 110, 210, 310 by releasing finger pressure and allowing the internal extension springs 159, 259, 359 to pull it back into the hollow needle 110, 210, 310. The finger loop on the trigger 158, 258 is to manually assist the return springs 159, 259, 359 with the index finger going forward to fully bring the end effectors 117, 217, 317 into the hollow needle 110, 210, 310 for reinsertion, as the end effectors 117, 217, 317 may have portions of the ablated vein, skin, tissue and blood as he vein is being ablated. The drive mechanism includes various drive links 141, 241, 341 and trigger link(s) 157, 257, 357 to activate and actuate the rotating mechanism 115, 215, 315 as well as activate and advance the ablator assembly 121, 122, 221, 222, 321, 322 and end effectors 117,217, 317 from within the distal end 112, 212, 312 and opening or aperture 113, 213, 313 of the hollow housing needle 110, 210, 310. In the embodiment shown in FIG. 8A-B the trigger is instead a push mechanism 356 which is also connected to various drive links 341 and activating or trigger link(s) 357. Each of the links 141, 157, 242, 257, 341, 357 are held by various pins 145, 147, 245, 247, 345, 347 though other mechanism or connecting means or securing means may be employed.

[0067] As shown in FIG. 2 and 6-8B, the right body 150B, 250B, 350B and left body pieces 150A, 250A, 350A are plastic and sandwich together to house the internal mechanism and are held permanently together with molded crush pins or connected via insertion of the pins 151, 251, 351 (shown non-limiting in this embodiment on the left side piece 150A, 250A, 350A of the body or handle assembly) into the corresponding aperture or openings 152, 252, 353 (shown in this non-limiting embodiment on the right side piece 150B, 250B, 350B of the body or handle assembly) on the edges of the internal body or handle assembly pieces. The body or handle assembly 150, 250, 350 captures and holds the two bosses on a molded trigger 158, 258 (or push mechanism 356) that is free to pivot within the clockwise and counterclockwise stops on the body or handle assembly 150, 50, 350. In this non-limiting embedment a set of pins connect two or three flat sequential links 141, 157, 241, 257, 341, 357 to the trigger 158, 258, 356 to provide an angular sweep that fits within the body or handle assembly 150, 250, 350 while avoiding contact with other components. These links 141, 157, 241, 257, 341, 357 provide the required angular stroke to drive the in and out the ablator assembly 121, 122, 221, 222, 321, 322 and end effectors 117, 217, 317 from within the distal end 112, 212, 312 and opening or aperture 113, 213, 313 of the hollow housing needle 110, 10, 310 the prescribed distance. The link 141, 241, 341 farthest from the trigger 158, 258, 356 connects by a pin 145, 245, 345 to a driver 140, 240, 340 that has tabs protruding from each side that fit with clearance into linear handle grooves 181, 281, 381 thereby converting the angular sweep of this link 141, 241, 341 and constraining the driver 140, 240, 340 to travel in a linear path concentric with the hollow housing needle 110, 210, 310 diameter. The body or handle assembly 150, 250, 350 also incudes various supports such as a rib 183, 283, 383 to support the rotator or rotating mechanism 115, 215, 315 and prevent deflection. The body or handle assembly 150, 250, 350 also includes a slot 185, 285, 365 on the right body 150B, 250B, 350B to support and accept the right tab of the driver 140, 240, 340 allowing the driver 140, 240, 340 to move back and forth without rotation as well as in this embodiment two ribs 187, 287, 387 with top radii support the cylindrical body of the driver 140, 240, 340. Finally a curved rib 189, 289, 389 supports the pivot link 143, 243, 343. These embodiments are not limiting and other shapes, support, slots and apertures may be employed.

[0068] The body or handle assembly 150, 250, 350 may consist of plastic while the hollow housing needle 110, 210, 310 may be manufactured from stainless steel hypodermic tubing. The body or handle assembly 150, 250, 350 has a trigger 158, 258 (push trigger 356) that extends from its lower side forindex finger mechanism actuation and spring return as well as finger grips 153, 253, 353 for better support during activation. When the trigger 158, 58 (push trigger 356) is pulled backwards by the index finger an inner stainless rod (the ablator assembly 121, 122, 221, 222, 321, 322 and end effector 117, 217, 317) extends and rotates approximately 1” out of the hollow housing needle 110, 210, 310. When the trigger 158, 258 (push trigger 356) is released by the finger the rod / ablator assembly 121, 122, 221, 222, 321, 322 and end effector 117, 217, 317 returns below flush into the hollow housing needle 110, 210, 310 under extension spring load and rotates back in the opposite direction. The stainless steel rod is the ablator assembly 121, 122, 221, 222, 321, 322 containing a series of thin stainless steel “scratcher stars” in this embodiment or end effectors 117, 217, 317 with sharp points that are aligned axially with the rod / ablator assembly 121, 122, 221, 222, 321, 322 and are constrained to advance, retract and rotate with the rod / ablator assembly 121, 122, 221, 222, 21, 322 without contacting the inside diameter or shaft of the hollow housing needle 110, 210, 310. In this embodiment approximately five end effector 117, 217, 317 are sandwiched and spaced apart by small tubular bushings 123 in this embodiment comprised of stainless steel though other biocompatible materials may be used and any where from 2 to about 10 end effectors 117, 217, 317 may be employed. In one embodiment of the inventive method the angled sharp distal end 112, 212, 312 of the hollow housing needle 110, 210, 310 is inserted just under the skin and above the visible varicose or spider vein in an out-patient procedure using local anesthetic. The trigger 158, 258, 356 is then cycled and the ablator assembly 121, 122, 221, 222, 321, 322 and end effector 117, 217, 317 advance and spin out of the hollow housing needle 110, 210, 310 resulting in the destruction of the vein. The trigger 158, 258, 356 may be cycled multiple times as judged by the surgeon or medical provider user and upon removal from the leg the inventive vein ablation device 100, 00, 300 may then be applied in a new location during the single patient procedure. The “scratching” or ablation of the veins is intended to permanently destroy the varicose and / or spider vein therefore disrupting blood flow resulting in • improved cosmetic appearance.

[0069] As shown in FIG. 7, an electric activation mechanism is employed via a small electric motor 270 and integral planetary gear reduction 271 to cycle and rotate the rotator or rotating mechanism 215 thereby rotating and extending out the ablator assembly 221, 222 and end effector 217 in and out of the hollow housing needle 210. The trigger 258, when depressed in the motorized version, closes an electric switch 260 that powers the motor 270. This embodiment version eliminates the need for the user to cycle the trigger 258 multiple times during the inventive vein ablation device 200 use on a single vein.Depressing the trigger 258 into the body or handle assembly 250 actuates the switch 260 and causes the rotator or rotating mechanism 215 to cycle as well as continually advancing and returning the ablator assembly 221, 222 and end effector 217 into the hollow housing needle 210 rotating first clockwise and returning counter-clockwise until the trigger 258 is released.

[0070] The motorized and manual versions of the inventive vein ablation device 100, 200, 300 use many of the same components and appear very similar to each other and in these embodiments are sterile, single patient use disposable devices. The motorized version of the vein ablation device 200 includes a driver spring link 242 and trigger spring 244 as well as an internal rotating disk shape of the drive gear 246 that sightly protrudes from the top of the body or handle assembly 250. The drive gear 246 has a visible colored printed band at one location on its outer diameter to indicate when the rotator or rotating mechanism 215 is below flush and the tip 212 of the hollow housing needle 210 is fully exposed. The drive gear 246 is connected via a rivet 287. The trigger 258 can be actuated and released when the colored band becomes visible to let the surgeon or other medical provider user know that the inventive vein ablation device 200 is “armed” and the sharp needle tip 212 is ready for reinsertion. Both the motorized and manual versions of the inventive vein ablation device 100, 200, 300, as removed from their sterile barrier packaging in the inventive system and kit, are set in the armed state and ready for needle insertion. A silicone tube (not shown) would cover the sharp needle tip 112, 212, 312 on such device versions and must be removed prior to needle insertion of the inventive methods of use.

[0071] As shown in the embodiment of FIG. 7, a small 3 V electric motor 270 with integral planetary gearing 271 is housed within the body or handle assembly 250. The gearing 271 reduces the motor’s 270 shaft rotation rate to around 100 RPM and significantly increases output torque. The motor 270 is powered by a 3V button battery 263 that resides within the body or handle assembly 250 and fits into, and is sandwiched by, metal positive contact 261 and negative battery contact 265. Fine insulated wires are soldered to the battery contacts 261, 265 and connect the trigger actuated switch 260 to the motor 270. The output shaft from the gear reduced 271 motor 270 is affixed with a pinion gear 272 that mates with the drive gear 246 and further reduces the RPM by half in this embodiment. The drive gear 246 rotates a ' link 241 that is pinned 247 to the same molded driver 240 used in the manual version of the inventive ' vein ablation device 100, 300. The cycles and rotation advances the ablator assembly 221, 222 and end effector 217 in and out of the hollow housing needle 210. Instead of the shown trigger 258 any type of low voltage electric button or switch could be used if it is positioned for index finger actuation. While a button may be more practical and effective than a switch as it can be easily turned off with a release of finger pressure many other types of activation mechanism may be employed on the body or handle assembly 250 for use by the surgeon or medical provider user. The gearing 246 in the motor 270 provides a lot of torque so manual assistance in getting the eventual vein, blood, and tissue loaded end effector 217 completely within the hollow housing needle 210 as the target vein is destroyed, disrupted and ablate should not be required as is done with the finger loop of the rigger 258 as seen in the manual version of the vein ablation device 100, 300. Other components may be included in an electric version of the vein ablation device 200 beyond those shown in FIG. 7 and alsoother electrical means beyond a button battery 263 may be employed such as AC or DC power and other modes of power.

[0072] The inventive vein ablation device 100, 200, 300 in use destroys the target vein through the rotation of the end effectors 117, 217, 317 and then combined with the therapeutic compression apparatus placed on the target area after the inventive method, the blood and destroyed vein are absorbed into the body resulting in faded or removed spider veins and / or varicose veins. The patient thus has reduce or alleviated pain, itching, heaviness, aching, pressure, fatigue, restless or jittery legs, sleeplessness, and other symptoms. The combination of the system including the pre-formed wound dressing (with or without an integral bladder) alone or in combination with the therapeutic compression apparatus assists in post-surgical healing

[0073] The inventive vein ablation device 100, 200, 300 and system may be included in a kit including the inventive pre-formed absorbent wound dressing and a therapeutic compression apparatus, an inflation means, a retaining means such as a belt, and a connecting means such as a tube as well as a wound dressing including zinc oxide and a wound bolster including an adhesive, absorbent foam and a pre-filled bladder elevation apparatus or bolster. The inflation means may require a charger depending on the source of energy, such as an electric charger (not shown) for connecting to the USB port and the kit would include such a charger. Depending on the therapeutic compression apparatus in the kit, a stocking or sock or other layer between the patient's skins and the therapeutic compression apparatus may be included in addition to the inventive pre-formed absorbent wound dressing. Depending on the embodiment of the inflation means, a flexible cover may be included in the kit. Other devices or apparatus may be included in such a kit or for instance, replacement or spare connecting means such as tubes, spare batteries, spare USB cables and the like. The kit may also include various wound dressings and / or bandages. The wound dressings and / or bandages may be disposed of on a more frequent basis and the inventive therapeutic compression apparatus is applied in conjunction or combination with the wound dressings and / or bandages. In one embodiment the therapeutic compression apparatus is used over or on top of the inventive pre-formed wound dressing, over the wound dressing applied to the skin.

[0074] Optionally, the pre-formed absorbent wound dressing (with or without bladder) may include a drain port in fluid communication with the wicking layer to drain excessive exudate, serum or blood from the foot ulcer or wound site. Optionally another bladder or shell layer may be employed that is filled with a tiller material such as, for example, a gel that can be, for example, a silicon gel or polytetrafluoroethylene (PTFE). The gel-like substance may have a flow characteristic that allows the inventive pre-formed absorbent wound dressing conform to the contour of the wound site. Optionally, the inventive pre-formed absorbent wound dressing may include an indicator to show when the inventive pre-formed absorbent wound dressing has a level of exudate within and should be changed, or any other indicators such as moisture, filled capacity, temperature of the target limb, pulse rate at the target limb or a pressure measurement device having a digital readout for the target limb such as the ankle or foot or leg or knee or the like of the individual user. Non-limiting examples of indicators are moisture level sensors or pressure sensors or measurements devices include a micro-array of pressure sensors at different sites including the target ulcer or wound site and sites around the target ulcer or wounds site on the foot or leg or other limbs. Further, the pre-formed absorbent wound dressing may include one or more sensors to measure the user's target limb such as the leg and / or foot in regard to pressure on the skin, motion of the limb, blood pressure, pulse rate, tonometer sensor, GPS sensor, moisture level, Co2 level, and the like while the system is in use. 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. Additionally the system includes multiple of compression garments which each therapeutic compression apparatus may have separate active pressure levels at the same time or can vary over time and based on the user's activities.

[0075] The inventive vein ablation device 100, 200, 300 and system including the inventive preformed absorbent wound dressing (with or without bladder) also reduces the problem of lack of mobility in that the patient can walk about and go to work, school, recreational activities. The inventive system where including the therapeutic compression apparatus also includes inflation means which is not tethered to a wall outlet and instead is a main pump which is configured to either apply constant static pressure at one pressure level, or constant at static pressure at a choice of different pressure levels, or intermittent pressure at one level, or intermittent pressure at multiple pressure levels, or a choice of either constant static pressure level and intermittent pressure levels. The ability to switch between pressure levels and / or switch between coristant static pressure and intermittent pressure promotes a more effective treatment for CVI. DVT and / or lymphedema and other treatments. Another embodiment (not shown) may include a variety of sensors so that the pump on its own may adjust the pressure level or switch from intermittent pressure level (which the patient is sitting or the kg is elevated) to constant static pressure (when the patient is walking or running). Such sensors may be connected to a database accessible by a medical provider which could remotely adjust the pressure levels or status change from intermittent to constant or the reverse.

[0076] The inventive system may be used as a prophylaxis or as part of a treatment plan which is easy for the patient to use at home or work (outside a hospital setting or with the aid of a medically trained professional as noted above) which is ambulatory so that the patient can walk and return to life activities. The inventive system can be used as a prophylaxis for wound care and / or swelling in any body part. The inventive system can also be used in pre-operative and post-operativetreatments for many different surgeries including but not limited to vein ablation, sclerotherapy and many other surgical procedures regarding other libs or body parts which have exudating wounds as well as an increased risk of CVI and / or DVT. The inventive system 100, 200 can be easily administered by a patient in the home setting as well as a rehabilitation setting or nursing home setting.

[0077] The inventive vein ablation device 100, 200, 300 and system including the pre-formed absorbent wound dressing (with or without bladder) democratizes the wound health care in that the user can remove the wound dressing to engage in everyday activities such as bathing and does not need to travel to a medical professional every few days for removal of wound dressings and replacement. It allows the user to self-apply the inventive pre-formed absorbent wound dressing. Further, the user saves money in travel costs and co-pays as well as time with reduced visits to the medical professional. Notably the inventive pre-formed absorbent wound dressing is reusable saving money and time. The inventive pre-formed absorbent wound dressing provides measurable air to the target ulcer or wound site, a compression level that is maintainable throughout the treatment plan when employing the therapeutic compression apparatus, is capable of self-application by the patient including being able to remove the inventive pre-formed absorbent wound dressing and reuse it, and these needs are all met by the inventive pre-formed absorbent wound dressing whether alone or in combination with the system including a therapeutic compression apparatus and / or a wound dressing and / or an elevation apparatus or bolster. Notably, anyone can properly place the pre-formed absorbent wound dressing on the user in a more effective way than known conventional compression bandages, which exudating the ulcer and wound site and assisting in wound healing, and if using the optional bolster or therapeutic compression further reduce edema. This inventive pre-formed absorbent wound dressing’s ease of reapplication directly correlates to compliance by the patient with the treatment plan. The inventive pre-formed absorbent wound dressing assists in healing and reduction of complications by providing a multi-layer design which is comfortable, non-stick, absorbent, and has an outer backing layer that prevent strike through and vapor transfer so not occlusive to the target foot ulcer or wound site by reducing build up in Co2 or bacteria growth.

[0078] The vein ablation device 100, 200, 300 and system including the pre-formed absorbent wound dressing (with or without bladder) provides measurable air to the wound site, a compression level that is maintainable throughout the treatment plan, is capable of self-application by the patient including being able to remove the system and reuse it, and these needs are all met by the inventive pre-formed absorbent wound dressing alone or as part of the inventive wound dressing compression system.Notably, anyone can properly place the pre-formed absorbent wound dressing on the user in a more effective way than known conventional compression bandages, which reducing edema and assisting inwound healing.

[0079] The inventive vein ablation device 100, 200, 300 may be used in conjunction with sclerotherapy such as that disclosed in co-owned application U. S. provisional application Serial No. 63 / 802,342 filed May 8, 2025 entitled “Method For Retrograde Sclerotherapy, System, Kit, And Saphenous Vein Ablator”, and U. S Serial No. 63 / 785,976 Entitled “Saphenous Vein Ablator And Method For Sclerotherapy” filed April 9, 2025, the entirety of which is incorporated herein. By way of example, the target vein could be subject to the inventive methods as disclosed in the two co-owned applications and then the inventive vein ablation device 100, 200, 300 inserted within the target vein to employed the inventive method of vein ablation disclosed herein, with the system and kit then employed including placing a bolster or offloaded on the now ablated vein, then covered with a pre¬ formed wound dressing (with or without bladder) and then covered with a co-owned therapeutic compression apparatus.

[0080] The inventive vein ablation device 100, 200, 300 and methods of use solve many problems with current treatments for varicose and / or spider veins. The inventive vein ablation device 100, 200, 300 and methods of use reduce or eliminate such varicose and / or spider veins as well as reducing or eliminating swelling, pain, throbbing, bulges, itching, heaviness, aching, pressure, fatigue, restless or jittery legs, disruption to work and leisure activities, sleep disturbance, depression, and again overall pain. The inventive vein ablation device, system, kit and methods of use may al leviate or promote healing of these problems resulting in a better lifestyle for the individual, reduced medical costs, reduced complications, and possibly better physical and mental health.

[0081] 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 various changes and / or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein. 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 needles, handles, pre-formed absorbent wound dressings and their components have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well. 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.

[0082] Thus the inventive vein ablation device 100, 200, 300 and system, kit and methods of use solve many problems with current known apparatus, garments, systems and methods of use such as the problematic laser treatments, conventional sclerotherapy, radio frequency treatments and vein endoveanous treatments or surgeries. The inventive vein ablation device 100, 200, 300 and systemimproves and standardizes localized bolstering as well as the ability to distribute the pressure evenly across the underlying anatomy resulting in optimal compression and comfort to the user and reducing the appearance of spider veins and / or varicose veins while at the same time assisting in healing and reducing pain and risk of complications and infection compared to current standard apparatus and treatment of methods of use.

[0083] The inventive vein ablation device 100, 200, 300 and system results in vein destruction of the vein architecture thereby ablating the target vein or at the very least minimizing the appearance in the leg or other body part, and the system localizes compression post-ablation on the target vein, such as the saphenous vein. Studies show that the system improves pressure and compression on the ablated vein post-procedure. The patients and users have increased compliance with their treatment plan and therefore improved healing with less complications.

[0084] 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 various changes 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 the 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 ablators 117, 217, 317 have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well. 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

We claim:

1. A vein ablation device for use on an individual to treat varicose and spider veins, comprising: a hollow housing needle including a proximal end and a distal end wherein the distal end is configured to be capable of insertion into an individual’s skin and vein with the proximal end connected to a handle;a vein ablator housed within the hollow housing needle wherein the vein ablator has a distal end tip that when activated extends out of the distal end of the hollow housing needle and when deactivated returns to within the hollow housing needle; andan activating means contained within the handle that activates the vein ablator to extend out and return into the needle hollow housing,wherein the distal end of the vein ablator includes at least two end effectors configured to ablate a vein when inserted into the vein and capable of rotating in a clockwise and counter-clockwise direction to ablate the vein.

2. The vein ablation device of claim 1 wherein the needle hollow housing is selected from the group consisting of size 10 gauge to size 20 gauge needles.

3. The vein ablation device of any of the preceding claims wherein the activating means is a manual powered means or electrically powered means.

4. The vein ablation device of any of the preceding claims wherein the at least two end effectors are numbered between about 2 to about 10 end effectors.

5. The vein ablation device of any of the preceding claims wherein the at least two end effectors are selected from the shapes of stars, triangles, spikes, circles with spikes, squares with spikes, or any other shape capable of ablating a vein when inserted therein.

6. The vein ablation device of any of the preceding claims wherein 'the at least two end effectors are in the shape or stars or circles with spikes.

7. The vein ablation device of any of the preceding claims wherein the handle further includes finger grips and an activation means connected to an actuator selected from the group consisting of a button, trigger, pull or push rod, and combinations thereof.

8. The vein ablation device of any of the preceding claims further comprising a rotating mechanism configured so that the at least two end effectors rotate in a clockwise and counter-clockwise direction when extended out of the distal end of the hollow housing needle and returned to within the hollow housing needle.

9. The vein ablation device of claim 8 wherein the rotating mechanism is comprised of a cylindrical component including at least one grove configured so that a rod connected to the cylindrical component rotates on its distal end as connected to the at least two end effectors.

10. The vein ablation device of any of the preceding claims wherein the hollow housing needle and at least two end effectors are comprised of biocompatible metals or plastics.

11. An inventive vein ablation system comprising the vein ablation device of any of the preceding claims, a pre-formed wound dressing, and a therapeutic compression apparatus wherein the vein ablation device is deployed and the pre-formed wound dressing is configured to be placed over the target vein following deployment of the inventive vein ablation device, and the therapeutic compression apparatus is configured to be placed over the pre-formed wound dressing and activated to apply compression on the target vein.

12. The inventive vein ablation system of claim 11 further comprising at least one sensor configured to sense or monitor moisture, blood, pH, acidity, pressure, pulse, temperature and combinations thereof.

13. The inventive vein ablation system of any of the preceding claims further comprising a bolster or off loader including a pre-filled air bladder, and medicated bandages.

14. A method to ablate varicose and / or spider veins, comprising:inserting a distal end tip of a vein ablation device comprising (a) a hollow housing needle including a proximal end and a distal end wherein the distal end is configured as a tip to be capable of insertion into an individual’s skin and vein with the proximal end connected to a handle, (b) a vein ablator housed within the hollow housing needle wherein the vein ablator has a distal end tip that when activated extends out of the distal end of the hollow housing needle and when deactivated returns to within the hollow housing needle, and (c) an activating means contained within the handle that activates the vein ablator to extend out and return into the needle hollow housing as well as rotate in a clockwise and counter-clockwise direction, wherein the distal end of the vein ablator includes at least two end effectors configured to ablate a vein when inserted into the vein and capable of rotating in a clockwise and counter-clockwise direction to ablate the vein;activating the activating means within the handle such that the vein ablator extends out and rotates ablating the vein;removing the vein ablation device from one location on the target vein and inserting into a second location on the target vein and repeating the activation;removing the vein ablation device once the target vein has been ablated;placing a bolster or off loader over the target vein;placing a pre-formed wound dressing over the bolster or off loader;placing a therapeutic compression apparatus over the pre-formed wound dressing and activating the compression level in the therapeutic compression apparatus.

15. The method of claim 14 further comprising a sclerotherapy treatment prior to insertion of the distal tip of the vein ablation device into the target vein.

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