RU2116051C1 - Surgical method for treating vein diseases - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves performing correction of ectatic portion of vein lumen by applying lumen check member being wire spring manufactured from metal possessing shape memory properties. The spring is a kind of meander bent as cylinder unclosed along its generatrix with wave translation direction being set along the cylinder. The check member is mounted on the whole ectatic portion of vein. EFFECT: enhanced effectiveness of treatment. 4 dwg

Description

 The invention relates to surgery and is intended to restore the lumen of pathologically dilated veins.

 There is the task of surgical treatment of pathological expansion of the veins (ectasia) to restore their normal diameter and, therefore, the normal physiological functioning of the vessels themselves and intravascular valves. The relevance of this task is determined by the extremely wide prevalence of venous diseases of various etiologies. It is enough to say that only patients with varicose veins of the lower extremities in the CIS countries, there are up to 35 million people [1]. It is believed that the main cause of ectasia of the veins of the lower extremities is the failure of the valves, the operation of which, in turn, depends on the transverse dimensions of the veins, their stability, i.e. return to original dimensions after lateral deformation, for example, as a result of increased hydraulic pressure. Thus, the treatment of many diseases of the veins is reduced to the restoration of their normal lumen.

 Known vein-preserving method of restoring the normal lumen of the ectasized deep veins of the lower extremities [2], including suturing the fascial vaginal membranes. Moreover, as a technical tool to facilitate the narrowing of the blood vessel during the operation, a lumen limiter is used in the form of a segment of a cylindrical tube cut along the generatrix of the cylinder. The disadvantage of this method is frequent postoperative recurrence of ectasia due to unrepaired tissue failure of the walls of the vein. The used tubular limiter acts as a mandrel when suturing the shells and does not carry a long-term reinforcing function.

 A known method of surgical treatment of insufficiency of valves of the deep veins of the lower extremities, the main action of which is the extravagant reinforcement of the walls of the ectazed vessel to restore normal clearance. At the valve localization site, a lumen limiter is applied to the ectasized section of the vein in the form of a spiral spring of elastic material with a given diameter and pitch. The greatest similarity of the technical nature of the specified method is selected as a prototype method.

 Known limiter of hollow organs in the form of a spiral spring of elastic material with a given diameter and pitch of the spiral. Worn on the corrected organ, the spiral serves as a reinforcing frame, preventing vasodilation. The specified lumen limiter is selected as a prototype of the proposed invention, a device.

 The disadvantage of this method is the complexity of the installation, due to the need for preliminary restriction of the mobilized area with turnstiles, displacement of blood from it to thin the veins and provide the possibility of applying a spiral lumen limiter. The spiral is put on by sequential winding, by rotating it around the vein with the inevitable danger of injury to adventitia (Fig. 3 a, b, c). Rigid preset spiral diameter, the absence of its transverse elasticity are the disadvantages of this limiter. To select the optimal size of the spiral, a thorough phlebographic examination is necessary. If the sizes of the spiral and the vessel do not match, the valve remains insolvent due to insufficient correction of the lumen of the vein and insufficient closure of the valve cusps or excessive compression of the walls with subsequent violation of the blood supply, dystrophic changes, the risk of stenosis and thrombosis. The latter circumstance contributes to the high lateral stiffness of the spiral. The operation has to be repeated.

 The objective of the invention, the method is to restore the lumen of the ectasized veins of the lower extremities with increased efficiency in the treatment of diseases caused by this pathology.

 The task of the invention is to create a lumen limiter of the hollow organs (in particular, veins of the lower extremities) with increased lateral elasticity, ease of installation, especially correction of the lumen of prolonged sections.

 In accordance with the first task in the known method of surgical treatment of veins, including the correction of the lumen of the ectasized area by extravasal application of a lumen limiter, a cylindrical shape-open lumen limiter made of metal with shape memory is used and this application is performed simultaneously on the entire ectazed section.

 In accordance with the second task in the known limiter of the lumen of hollow organs containing a cylindrical wire spring, the specified spring is made in the form of a meander rolled into a cylinder with the direction of translation of its waves longitudinally to the cylinder, and titanium nickelide with shape memory is used as the wire material.

 In FIG. 1 shows a lumen limiter in accordance with the invention; in FIG. 2 - linear scan of the translation of the meander longitudinally to the axis of the device; in FIG. 3 is a diagram of the stages of application of the lumen limiter of an ectasized vein in accordance with the prototype method; in FIG. 4 is a flow diagram of the application of a meander lumen limiter in accordance with the invention.

 The method is as follows.

 According to retrograde phlebography, the localization of the pathology (insolvent valve, ectasia of a vein or a combination of them) is established, the length and diameter of the veins in a dilated state and normal. Prepare a set of meander clearance limiters with a discrete set of values of the diameter of the device.

 They provide access to the vein to its peri-adventitial membrane and partial mobilization of it (without doping of small flowing branches that can be placed in the intervals of waves of the meander limiter). Measure the diameter of the vein in the wound while taking Valsalva and choose a lumen limiter with a diameter of 2 / 3-3 / 4 of the measured diameter of the vein. The limiter cooled under chloroethyl is deformed to a diameter exceeding the diameter of the vein during the administration of Valsalva, and simultaneously applied to the mobilized and taken on the turnstiles section. When the lumen limiter material is heated to the patient’s body temperature, the shape (diameter) of the latter is restored and the veins are gently squeezed to the required size.

 Thus, in contrast to the prototype method, less trauma occurs during mobilization of the vessel, installation of the device is simplified and accelerated, the risk of injury during installation is reduced (direct application, unlike wrap-up). Due to the adaptive dimensional ability of the implant, its preliminary selection is simplified.

 A simplified technique allows for the simultaneous correction of valve insufficiency and ectasia of the veins of adjacent areas.

 The lumen limiter used in the method (Fig. 1) is a meander-type wire structure 1 (Fig. 2), rolled into a cylinder longitudinally to the direction of translation of its waves (axis 2). The material of the wire is titanium nickelide with a shape memory effect of the TN-10 type. The length of the limiter, its diameter, wire thickness and the pitch of the meander are selected based on the specific characteristics of the vessel and its pathology. The manufacture of the proposed device is carried out using a template cylinder, on the outer surface of which along the contour of smooth bends of the meander in the direction along the axis of the template, pins are inserted into the body of the template, which serve as a support for bending the wire in a heated state, and is not difficult. Other manufacturing options are possible.

When using the proposed device operates as follows. Before applying to the dilated section of the vein (hollow organ), the device is cooled with a refrigerant (for example, chlorethyl) with a working temperature of less than 10 ^o C, the cylinder surface is deformed radially by compressive reinforcement until the gap in the generatrix exceeds or equal to the transverse size of the vein section. The device is applied to a vein with the coverage of the ectasized area. In the process of warming, the initial shape specified in the manufacture is restored, which leads to compression deformation (narrowing) of the vein walls and the restoration of its normal lumen.

The attainability of the technical result is due to a number of advantages of the proposed device compared to the prototype:
1. The uniformity of the compressive forces in the direction of travel. It is known that in devices using the mechanism of thermomechanical shape memory, this indicator is higher than in conventional elastic structures based on the elastic properties of metals. In practice, the stress level during deformation of a material with a shape memory of up to 6% remains constant, while, for example, steel has a proportional dependence of stress on deformation. In the prototype device, this means a high probability of inadequacy of the compressive effects of the device elements and the physiological characteristics of the vessel walls. In the proposed device, the restoration of the natural size of the vessel is achieved due to the indicated property of constancy of efforts in the form restoration and open design of the limiter.

 2. The convenience of applying the device simultaneously over the entire pathological section, due to the openness of the walls of the device, which, in turn, is determined by the configuration of the spring elements in the form of a "meander". In practice, it is possible to impose a limiter on any section of the site with minimal trauma, which is important in the treatment of concomitant diseases, for example, valve failure and ectasia of adjacent vein sections.

 3. Increased biocompatibility of the material used. It is known that, for example, titanium nickelide implants are minimally encapsulated and thus do not cause scar tissue reactions and possible stenosis of the restored hollow organ.

 These technical advantages of the proposed device-limiter of the lumen of the hollow organs in comparison with the prototype provide the expansion of operational capabilities when using it and increase the effectiveness of the therapeutic effect.

 Achievability of the technical result of the proposed inventions is confirmed by tests of the method and device on experimental animals and clinical applications conducted at the Siberian State Medical University, Tomsk Regional Clinical Hospital.

 Example 1

 Patient Yu., 56 years old, medical history N 1261. She was in the clinic from 01/27/94 to 02/25/94. The diagnosis is varicose veins of the lower extremities, ectasia of the large saphenous vein on the left, ectasia of the femoral vein immediately below the discharge of the deep femoral vein, valve insufficiency in this area.

 Under general anesthesia, a venectomy of the large saphenous vein was performed. The mobilized ectasized femoral vein was taken on the turnstiles (Fig. 4). The sterile lumen limiter (Fig. 1) (inner diameter 10 mm, length 70 mm, pitch 2 mm, material - titanium nickelide wire TN-10, diameter 0.4 mm) is cooled under chloroethyl and deformed in the radial direction to a size exceeding the transverse size of the ectasized vein while taking Valsalva (14 mm). In this state, a lumen limiter is placed on the vein. Under the influence of body temperature, the patient’s structure of the limiter, returning to the initial state of the form, pulled the vein walls to a normal diameter size (Fig. 4 b, c). Restored vein lumen. The device is fixed with two stitches for the final waves of the meander to the peri-adventitial tissues. The wound is sutured in layers.

 In the postoperative period, on the basis of retrograde phlebography, the restoration of the functional viability of the valves was established.

 Example 2

 Patient Sh., 33 years old, medical history N 3321. Was in the clinic from 03/10/94. The diagnosis is varicose veins of the right lower limb, expansion of veins in a large saphenous vein pool, and femoral vein valve insufficiency. The operation was completed on March 17, 94. The diseased saphenous vein is removed. A portion of the femoral vein was mobilized immediately below the discharge of the deep vein of the thigh, in the place of an insufficient valve, and taken to the turnstiles.

 Correction of the lumen of the vein and the concomitant restoration of the functional viability of the valve were made by a lumen limiter made of nickel-titanium wire with a diameter of 0.4 mm with shape memory made in the form of a meander folded into a cylinder with the direction of translation of its waves longitudinally to the cylinder. The limiter is 25 mm long, the inner diameter is 10 mm, and the pitch is 2 mm. In the cooled state, the limiter is opened in the radial direction to a size in the gap exceeding the size of the enlarged section of the vein during the administration of Valsalva (15 mm). The device is immediately and simultaneously installed on a mobilized section of a vein. Under the influence of tissue heat, the patient experienced a smooth restoration of the original shape (size) of the device and compression of the veins. The device is fixed to peri-adventitial tissues with sutures for the final waves of the meander. The wound is sutured in layers.

 In the postoperative period, on the basis of retrograde phlebography, the restoration of the functional viability of the valve in full was established.

Sources of information
1. Vedensky A.N. Varicose disease. - L .: Medicine, 1983, part 3, 143-145.

 2. Auth. St. USSR N 1253625.

Claims (1)

 A method for surgical treatment of vein diseases, including correction of the lumen of an ectasized section of a vein by extravasal application of a lumen limiter, characterized in that a wire spring of metal with shape memory is used as a lumen limiter, having the form of a meander folded into an open cylinder along the generatrix with the direction of wave translation cylinder, and impose it simultaneously at the entire ectazirovannym site.

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