Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
1999-11-24
2002-08-20
Reip, David O. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S167000, C606S180000, C128S898000
Reexamination Certificate
active
06436116
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to surgical apparatus and procedures. More particularly, it relates to methods and apparatus for removing veins, such as, varicose veins and spider veins, in a venous system of a patient.
BACKGROUND OF THE INVENTION
Ten to fifteen percent of the population is plagued with varicose veins and spider veins. These veins have usually lost their ability to carry blood back to the heart and blood often accumulates in these veins. As a result, the veins may become swollen, distorted, and prominent. This condition is usually caused by inefficient or defective one-way valves which prevent blood from draining back through the vein.
A number of factors can contribute to the development of varicose veins and spider veins, including heredity, obesity, posture, standing or sitting for long periods of time, hormonal shifts, and excessive heat. Varicose veins may cause patients to experience various symptoms, such as, for example, aching, burning, swelling, cramping, and itching, while more serious complications of varicose veins can include thrombophlebitis, dermatitis, hemorrhage and ulcers. If these varicose veins are not treated, blood clots may form in the vein, and phlebitis or inflammation of the inside lining of the vein may occur. Even absent such symptoms, many patients seek medical treatment of varicose or spider veins for cosmetic reasons.
Various approaches have been developed to treat varicose veins. In less complicated cases, elevation of the legs and use of support hosiery may be sufficient therapy to stop or slow the progression of the varicose veins. Alternatively, a technique called “sclerotherapy” may be used to treat varicose veins. In this procedure, the affected veins are injected with a sclerosing solution, such as sodium tetradecyl sulfate or pilocainol. Approximately one injection of the solution is usually administered for every inch of the affected veins, and multiple injections may be administered during a treatment session. The sclerosing solution causes subsequent inflammation and sclerosis of the veins. The sclerosis results in localized scarring or closure of the veins, which forces rerouting of the blood away from the affected veins.
However, patients usually have to undergo two or more sclerotherapy treatments in order to alleviate the varicose and spider veins to a satisfactory degree. Other fine reddish blood vessels may also appear around the treated area, requiring further injections. Nevertheless, the sclerotherapy technique may not be a permanent or complete solution since the condition of the varicose and spider veins may reoccur within five years.
Sclerotherapy also has other potential complications, including browning splotches or bruising of the skin, formation of blood clots in the veins, inflammation, adverse allergic reactions, ulceration, phlebitis, anaphylactic overdose, ischemia, skin or fat necrosis, and peripheral neuropathy. Furthermore, sclerotherapy cannot be applied to the saphenous vein in the upper thigh region due to the risk of sclerosis of the deep veins. Thus, the sclerotherapy technique is often combined with an operative procedure, such as ligation of a portion of the saphenous vein.
Another technique to treat varicose veins is called stabavulsion phlebectomy with hooks. In this technique, one or more incisions are made in the skin of the patient, and a hook is inserted into the incision to grip or hook the veins to be removed. When the veins are grabbed, the veins are pulled through the surgical incision and severed. However, this procedure usually requires two surgeons to perform the procedure and takes about 2-3 hours. In addition, this procedure usually requires multiple incisions in the patient in order to hook the affected veins. Furthermore, it is often difficult to completely remove the entire affected veins using this procedure.
Varicose veins can also be removed by a procedure commonly referred to as “stripping.” To remove a saphenous vein using this stripping procedure, a large incision is made near the groin area of a patient and the saphenous vein is separated from the femoral vein. The saphenous vein is also usually dissected near the lower portion of the leg. Multiple large incisions are made along the leg in order to sever and ligate the tributary veins of the saphenous vein. A vein stripper, such as a wire, is then inserted into the lumen of the saphenous vein. The wire is then inserted through the saphenous vein to the groin incision and tied to the lower end of the vein. The wire is then removed through the groin incision to extract the vein. After the saphenous vein is completely removed from the leg, the large incisions along the leg are closed.
However, the stripping procedure is usually painful and often requires overnight hospitalization. In addition, numerous incisions are usually required to remove the saphenous vein and its branches which often leave permanent unsightly scars along the leg of a patient. Additionally, the large incisions create a risk of infection to the patient and may not heal properly, especially patients who have poor circulation in their extremities. There are also associated complications with this technique, such as, for example, blood loss, pain, infection, hematoma, nerve injury, and swelling.
SUMMARY OF THE INVENTION
In view of the above, the present invention provides methods and apparatus for removing undesired veins, such as, varicose and spider veins, in a venous system of a patient. The apparatus and methods of the present invention provide an efficient and minimally intrusive procedure to remove the undesired veins. The undesired veins can be completely removed with minimal scarring and without hospitalization. The methods and apparatus can also reduce operating time in the removal of the undesired veins, and the entire procedure can be performed by a single surgeon in less time than traditional procedures.
According to one aspect of the invention, a method for removing a vein includes making an incision through a skin layer of a patient, inserting a surgical instrument through the incision, visualizing the vein through the skin layer using a light source positioned subcutaneously and in proximity of the vein, and cutting the vein using the surgical instrument.
Embodiments of this aspect of the invention may include one or more of the following features.
Visualizing the vein includes directing light from the light source at the vein from underneath the vein or from a side of the vein.
In one illustrated embodiment, the surgical instrument is provided with the light source. The light source is a fiberoptic, e.g., a fiberoptic bundle.
The method further includes irrigating and tumescing a surgical region in proximity to the vein using the surgical instrument, and aspirating cut veinous tissue through the surgical instrument.
In another embodiment, visualizing the vein includes providing a second instrument including the light source, making a second incision through a skin layer of the patient, and inserting the second instrument through the incision. A surgical region in proximity to the vein is irrigated and tumesced using the second instrument.
According to another aspect of the invention, a method of visualizing a body structure includes positioning an illuminating device subcutaneously such that light is directed at the body structure, and observing the body structure through a skin layer of the patient overlying the body structure.
Embodiments of this aspect of the invention may include one or more of the following features.
Visualizing the body structure includes directing light from the illuminating device at the body structure from underneath the body structure or from a side of the body structure.
According to another aspect of the invention, a device for illuminating a body structure has a housing with a distal end configured for subcutaneous insertion into a patient's tissue and positioning in proximity of the body structure, a light path supported by the housing and configured for directing li
Grinberg Alexander D.
Long Michael A.
Sjostrom Douglas D.
Spitz Gregory A.
Fish & Richardson P.C.
Reip David O.
Smith & Nephew Inc.
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