Patent Application
20050021068
This invention relates to surgical instruments and their use. Specifically, the invention relates to surgical instruments used for removing blood vessels, particularly diseased and unsightly varicose veins, or other tubular structures, from the body.
Varicose veins have a multitude of undesirable features. It is estimated that about 80 million people in the USA at any one time suffer from some form of varicose venous disease. Significantly diseased varicose veins cause considerable pain, especially while the afflicted person is standing, and they are also unsightly as they bulge while the person is standing, which is due to the valvular incompetence of the vein. Varicose veins are a condition for which many patients annually seek a surgical remedy. It is not at all uncommon for a patient to enter a physician's office with very painful superficial thrombophlebitis, and sometimes it is possible for pulmonary emboli to occur from above-knee greater saphenous vein (GSV) thromboses. It is also possible with very superficial, high-pressure, large, varicose veins that a patient might suffer an inconsequential skin abrasion (usually near the shin), and then the vein will open and could threaten a patient's life from exanguination, for example, while the patient is asleep.
Long-standing incompetent varicose veins may cause a steady buildup of iron in the subcutaneous fat layers and skin of the lower leg, resulting in permanent staining of the tissues, known as hemosiderosis. As this condition progresses the subcutaneous tissues become woody and hard and take on a rust colored appearance. This can result in substantial local pain, embarrassment and unsightly rust-colored skin depressions from fat necrosis. As the circumstances advance, the skin, especially over and above the medial malleolus and the anteromedial lower shin, is apt to break down and infection is prone to set in. Advanced venous stasis ulcers can be difficult to resolve. Varicose veins may be secondary to sapheno-femoral valve regurgitation, common femoral valve regurgitation or to incompetent perforators.
It is in the best interests of the patient to prevent progression from early varicose veins to advanced complicated varicose veins and stasis ulcer formation. Provided that it is established that the patient has sapheno-femoral valve incompetence, and consequent GSV regurgitation, documented, for example, by venous color flow, duplex Doppler studies performed with and without a Valsalver maneuver, then a long, or GSV, stripping is a good procedure that can prevent most of the advanced complications from developing over time. As used herein, “stripping” means removal of all or part of the GSV. As described below, removing, or stripping, the GSV means to literally pull it out of the body.
The known method for removal of the greater saphenous vein (“GSV”) typically involves exposing it with an incision in the groin area, and delivering the GSV at its junction with the common femoral vein, just below the inguinal ligament. Once delivered, the GSV is ligated in continuity and is then exposed in front of the medial malleolus at the ankle, and the GSV at the ankle is also ligated in continuity and divided. A flexible plastic stripper endovenous cable is then passed through the GSV and is variably threaded to the groin section of the GSV. On occasions it is not possible to pass the stripper endovenous cable through the GSV due to knots and snarls within the GSV. Secondary incisions then become necessary and the process is repeated, thus removing sections of the GSV at a time. Once at the groin, a ligature is passed around the GSV and loosely tied to prevent excessive blood loss. At this time the GSV is now divided and the terminal expansion of the stripper endovenous cable is passed out of the vein. At this time the second ligature is firmly tied around the stripper endovenous cable. A stripper head is now attached to the stripper endovenous cable and the head is pulled through the leg to secure the endovenous cable in the GSV as the GSV is stripped.
In the known method of Babcock/Meyer, the stripper head is similar to a mushroom in shape and comes in three sizes, large, medium and small. Typically, the medium size is selected for removal of the GSV. The stripper head is fitted into the groin incision and the vein is then serially avulsed from the leg from a longitudinal pull from the ankle incision where the endovenous cable is attached to some form of a handle. The GSV bunches up against the leading surface of the stripper bead. In order to reduce bleeding as the vein is stripped the leg may be either compressed with a firm ACE bandage around the leg before the strip is performed or local pressure can be applied as the stripper head passes down the leg. Once that is done the two or more incisions are closed with sutures and the patient is sent home after several recovery hours with an ACE bandage around the leg.
Three or four days later the patient usually visits the doctor's office and the ACE wrap is removed. More commonly than not, the leg has significant ecchymoses, cords of contained hematomas down the line where the veins were stripped and usually the patient has a painful, swollen leg. The bruising often takes several weeks to resolve as does the discoloration from the post-operative hemorrhage that usually occurs. Sometimes it is necessary to return the patient to the operating room to surgically release pressurized (and potentially painful) hematomas.
Prior art stripping techniques involved using rings to locate branches. These ringed instruments are passed blindly from above down under the skin and next to the vein from the groin incision. Once a substantial branch is located by observing pulling of the skin, a local incision is made and the branch may be tied.
Other prior art involves non-stripping procedures. Such procedures include radio frequency ablation, laser ablation and sclerotherapy. The former two procedures produce clots in the varicosed vein by heat, the latter by invoking clot formation with pro-coagulant chemicals. Each procedure has the potential to produce pulmonary embolism. The main problem with these techniques is centered around the continued existence of the varicosed vein. In all of these techniques there may be significant pain, risk of pulmonary embolism and recurrence or recannelization of the veins. Also, the vein remains in situ and can remain unsightly. A significant number of patients using these alternate techniques revert to traditional stripping technique of Babcock/Meyers.
Prior art techniques also involve inversion stripping. In this situation, the endovenous cable is passed as before through the vein but no stripper head is attached. Rather, the vein is simply tied to the endovenous cable before the expansion. The vein is now pulled out of the leg and inverts on itself as it does so; it is literally peeled out of the body. The main problem with this technique is that as the vein inverts, the bulky, large tubular part of the vein, which lies in the groin and thigh must fit inside the smaller, less bulky part of the vein in the calf area. Sometimes, it is impossible for the inversion technique to continue and the vein is simply torn apart and the stripping stops. That immediately results in bleeding and necessitates an additional incision to locate the unstripped vein portion, which must be retrieved and stripped. Thus while invagination stripping is less traumatic that the Babcock/Meyers method, it is less effective in facilitating successful stripping of varicose veins. For this reason the Babcock/Meyers stripping procedure has become the procedure of common use, but the main problems with the Babcock/Meyers procedure are (1) trauma, and (2) postoperative bleeding and its complications.
The traumatic component of the Babcock/Meyers technique can be easily understood by understanding how the stripper head is designed. It is similar to a toadstool shape with a cone-like trailing end but a flat or blunt leading end that must be pulled through the patient's tissues. Pulling such a blunt ended instrument through the patient's leg from the groin to the ankle, although the head holds the crumpling vein, remains quite traumatic and considerable force is required to pull the flat cone down the full length of the leg. As larger stripper heads are selected, the pulling force required rises substantially. The reverse is obviously also true. The smaller head, however, runs a risk that the vein will flow over the head and not be stripped.
At least these two concerns, trauma and hemorrhage, of the simple Babcock/Meyers technique should be addressed and solved.
The present invention addresses the above problems by using, among other things, a smaller and more streamlined stripper head without significant risk of the vein flowing over the head and into the body during stripping. This smaller stripper head substantially diminishes the trauma associated with removing the vein. As used herein with respect to the invention, “vein” includes all tubular body structures, unless a specific structure, such as the GSV, is identified.
The present invention improves upon the prior art by providing relatively simple surgical instruments for stripping veins from a body.
The preferred embodiment of the invention comprises three main parts: an endovenous cable for placement into the vein, a stripper head for helping to retain the endovenous cable in the vein and preventing the vein from backing up into the body as it is stripped, and a handle to pull the endovenous cable and stripper head through the body.
The endovenous cable is preferably a solid plastic rod, although any suitable endovenous cable for passing through the vein and assisting in stripping the vein may be used. The endovenous cable has a first end and a second end and each end preferably has an expansion in the form of a flat, oval-shaped section.
The stripper head is preferably a low-profile, streamlined structure and has a leading edge and a smooth outer surface. Rounded edges connect the leading edge to the outer surface. The stripper head also has an inner cavity for receiving part of the vein as it is stripped, and a slot for attaching the stripper head to an expansion of the endovenous cable.
The handle can be any suitable structure for pulling the endovenous cable and stripper head out of the body, thereby stripping the vein. Preferably, the handle is plastic and has a central slot for receiving an expansion of the endovenous cable.
Also disclosed herein is a method of using the device and a novel endovenous cable, stripper head and handles that may be used to practice the invention.
Referring now to the drawings where the purpose is to describe preferred embodiments of the invention and not to limit same,
At each end 1b, 1c, respectively, of endovenous cable 1 are expansions 2, 3. Expansions 2, 3 take the general shape of an oval in plan view, and are preferably egg-shaped when viewed in three dimensions. Each expansion 2, 3 is about 3 mm+/−1 mm wide at the widest point. Expansions 2, 3 are about 0.5 cm long and are designed to attach to either the stripper head or the handle by being received in a suitable receptacle or slot. Each expansion 2, 3 preferably has the same dimensions so that they are interchangeable, although they may be of different shapes or sizes. Once in place in a receptacle or slot in either the handle or the stripper head, they cannot be easily removed by longitudinal force. They could possibly be removed, however, by slipping the expansion 2 or 3 laterally with respect to the slot in either the handle or the stripper head, if removal is a desired feature.
Referring now to
Stripper head 4 has a lateral slot 6 that will accept an expansion 2 or 3 of endovenous cable 1 and retain the expansion in place inside stripper head 4. Any suitable structure for attaching stripper head 4 to endovenous cable 1 may be used, however. Expansion 2 or 3 and slot 6 are simply an easy way to make the attachment.
Leading edge 4a of stripper head 4 has a rounded edge 5a and a preferably smooth outer surface 6a. Edge 5a makes it much less traumatic as stripper head 4 is pulled through a patient's leg tissues. Much less force will be required due to the streamlined leading edge and smaller size of stripper head 4. This is possible in part because of internal cavity 7 designed to receive the vein thus preventing it from flowing over the smaller profile stripper head of the invention.
On the trailing end 5 of stripper head 4 is a cylindrical projection 8. Projection 8 is a structure for attaching a surgical drain to stripper head 4 and any suitable structure may be used. As shown, trailing end 8 is cylindrical, has an outer surface 8a and one or more raised circumfrential chevrons 8b. Projection 8 is designed to receive and temporarily retain a drain 9 of sufficient length to extend down (preferably) the entire length of the leg if the GSV is being stripped. Thus, in the preferred embodiment, as stripper head 4 is pulled down the leg stripping a vein, stripper head 4 will also pull a surgical drain, such as drain 9, into the precise space in the body from which the vein is being stripped. Previous to this invention, such automatic drain placement was not possible. Once placed in position, drain 9 is then simply exterorized at a convenient location and the ankle and groin incisions are closed in the routine fashion. Such a drain makes subcutaneous hematomas, extensive bruising and ecchymoses much less unlikely.
Prior art handles only faster to an end of the endovenous cable. This means as the stripper head is pulled past (i.e., below) the knee when the GSV is removed, the endovenous cable outside of the body is now quite long and is well past the foot. As the stripping continues the handle gets even further away from the operative site. This can be undesirable and potentially dangerous. The application of force with this system is poorly controlled with respect to proximity to the patient. The advantage a moveable handle provides is that a surgeon doing the stripping, for the first time, can now stand close to the distal incision, which is at the ankle for GSV removal, during the entire procedure. First, a segment of vein in the thigh is avulsed. The surgeon can then release the grip on the handles and slide the handle up the endovenous cable and thus closer to the patient's ankle and then continue pulling. This provides better and safer control.
The vein stripping instrument of the present invention thus provides multiple functions that have not before been available. The present invention provides one or more of the following: a one size fits all stripper head (although different sizes may be used) with a vein trapping feature (the internal cavity), reduced tissue trauma (due to the size and sloping streamlined edges), and preferably provides a solution for the problem of postoperative hemorrhage (the ability to attach a trailing drain to the device, preferably to the stripper head to drain any post operative hemorrhage) with or without an ACE bandage.
Having now described preferred embodiments of the invention, modifications and variations to the present invention may be made by those skilled in the art. The invention is thus not limited to the preferred embodiments, but is instead set forth in the following claims and legal equivalents thereof.
This application claims priority to U.S. Provisional Application Ser. No. 60/478,474, filed Jun. 12, 2003. The disclosure of U.S. application Ser. No. ______, filed Jun. 7, 2004, entitled SURGICAL DRAINS to John C. Opie, Stephen J. Joyce, and Thomas Izdebski, is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60478474 | Jun 2003 | US |
