RU2766794C2 - Apparatus for loop endarterectomy - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment applied in vascular surgery and can be used in loop endarterectomy from peripheral vessels. The apparatus for loop endarterectomy comprises a ring with a cutting contour along the inner side thereof, connected with an extended retainer, placed at the opposite distal end whereof is a handle. The apparatus comprises a channel for supplying working fluid under pressure to the vessel treatment area, placed inside the extended retainer made for this purpose in the form of a hollow tube with holes formed at the opposite ends thereof: a hole at the side of the handle for intake of the liquid injected under pressure of 2 to 3 atm into the channel, and a hole at the proximal end of the retainer at the point of connection thereof with the ring for discharge of the injected liquid into the vessel treatment area.

EFFECT: use of the invention provides an increase in the effectiveness of deobliteration of vessel walls due to the structural elements of the claimed apparatus providing a possibility of imparting a joint increased force effect on the atherosclerotic plaque by means of a cutting contour and simultaneously by a liquid under pressure minimising the risk of injury to the vessel wall.

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Description

The invention relates to medical equipment and can be used in vascular surgery when performingloop endarterectomy, the essence of which consists in the removal of an atherosclerotic substrate with thrombotic masses using an instrument containing a working part in the form of a loop with certain design features. The specified surgical intervention is used mainly for revascularization of peripheral arteries with extended stenocclusive lesions.

Known tool "Vollmar Ring" - Volmar's ring stripper, the working part of the loop which is an oval, oriented to the cross section of the vessel at an angle of 45°, without a cutting edge, connected to a long holder, ending with a handle.

Due to the absence in the design of the cutting element of pathological foci at the mouth of the collateral branches, the frequency of postoperative complications is quite high, which is due to the unguaranteed result of endarterectomy, as well as the unpredictability of the instrument's behavior when it collides with obstacles in the process of advancing the instrument as a result of the loss of static stability due to the imperfection of the conductor part - tool holder.

A number of devices are also known with the presence of the cutting edge of the ring as the working part of the tool from the patent descriptions:

Russian Federation No. 140213 "Instrument for performing endarterectomy",

Russian Federation No. 2026018 "Endarterectomy instrument for restoring the patency of an arterial vessel",

RF № 2309687 "Savrasov's vascular instrument",

USA No. 2944552 "Surgical instrument",

USA No. 4559927 "Endarterectomy apparatus and process",

USA No. 6241745 "Apparatus and method for performing an endarterectomy"

with various modifications of loop structures used for mechanical deobliteration of arteries. In addition to the working contour in the form of a loop, they contain an extended holder connected to it, which has a handle at its opposite end.

Closest to the claimed invention for loop endarterectomy is a tool - ringstripper, known, for example, from the publication [Thrombendarterectomy from the external iliac artery / A. A. Fokin and others // Angiology and vascular surgery - 1996. - No. 1. - S. 107-112]. It is a working part in the form of a contour attached at an angle of 125-135 degrees to a rod with a handle. The inner edge of the contour at the point of its attachment to the rod is sharpened in order to be able to peel off the plaque from the wall of the arteries when the instrument is advanced inside the vessel.

However, loop mechanical instruments for endarterectomy, including the analogues listed above and the closest analogue, have disadvantages associated with a high risk of injury to the thinned vessel wall by the cutting surface of the loop. Especially high is the risk of perforation of the walls of blood vessels with calcification of arterial plaques with germination of the adventitious membrane and with tortuosity of the main vessels [Losev R.Z., Nikolenko V.N., Mikulskaya E.G. et al. Functional and anatomical prerequisites for revascularization of the femoral-popliteal arterial segment. Bulletin of Surgery. - 2008. - T. 167, No. 1. - S. 18-21].

The objective of the present invention is to increase the efficiency of loop endarterectomy with formed atherosclerotic plaques, including extended ones, and with any degree of calcification, including high, as well as to increase the safety of the operation, primarily by reducing trauma to the vessel walls.

The essence of the proposed device lies in the fact that in the loop endarterectomy device, containing a ring with a cutting contour along its inner side, connected to an extended holder, at the opposite distal end of which a handle is placed,

there is a channel for supplying working fluid under pressure to the treatment area of the vessel, located inside an extended holder, made for this in the form of a hollow tube, in which holes are formed at opposite ends: from the side of the handle - for inlet of fluid injected under pressure of 2-3 atm into the channel , and from the proximal end of the holder at the place of its connection with the ring - for the release of the injected liquid into the vessel processing zone.

In addition, a device with the above features is claimed, in which the hole for discharging the injected liquid is an extended cutout in the lower part of the holder, which is made on its edge.

A device is also claimed, in which the hole for discharging the injected liquid has a length along the holder of the order of 30 ± 5 mm and a width of the order of 1/3 of the circumference of the cross section of the holder.

In addition, a device is claimed that has a ring with a cutting contour of sizes 6, 8, 10 mm in diameter.

The technical result of the invention is aimed at more efficient deobliteration of the arteries, reduction of the operation time, formation of a smooth inner surface of the walls of the arteries during endarterectomy, which ultimately leads to a decrease in the need for the use of synthetic prostheses. The difference in the technical result lies in the fact that the claimed device, along with the mechanical action of the cutting contour of the ring, also uses the exfoliating effect of a liquid injected under pressure into the site of atherosclerotic plaque treatment . This makes it possible to level the tortuosity of the vessel, and also makes it possible to remove atherosclerotic plaques of not only low and medium, but also high calcification, including with a decrease in the risk of intraoperative complications, for example, perforation of the vessel wall.

An increased force effect on an atherosclerotic plaque by a cutting contour due to a liquid under a pressure of 2-3 atm accelerates its separation from the vessel wall, but does not allow injuring the vessel wall, protecting it like a “water curtain” between the layered substrate and the vessel wall, and also contributes to an increase in the quality of cleaning the vessel wall from the substrate by pouring the liquid into the treatment area.

The description of the claimed device is illustrated by a figure, the positions on which are indicated:

1 - ring,

2 - cutting contour of the ring,

3 - holder,

4 - handle,

5 - channel for supplying the working fluid,

6 - inlet hole,

7 - outlet hole,

8 - supercharger,

9 - adapter.

The inventive device for loop endarterectomy is a ring 1 with a cutting contour 2 along its inner side, connected to the proximal end of the extended holder 3. At the distal end of the holder 3 is a handle 4. Inside the holder 3 in the form of a hollow tube, a channel 5 is made for supplying the working fluid to the site of treatment of the vessel wall. The channel 5 has an opening 6 for the inlet of the injected liquid, located on the side of the handle 4, and an opening 7 for the release of the injected liquid into the treatment area of the vessel, located at the proximal end of the holder 3 near its connection with the ring 1. The hole 7 for the release of the injected liquid can be represented , in a particular case, in the form of an extended cut in the lower part of the holder 3 and is placed on the edge of the proximal side of the holder at the junction with the ring. The inlet hole 6 is made to ensure a tight connection of the fluid blower 8 under pressure of 2-3 atm. through adapter 9. The last two elements - supercharger 8 and adapter 9 are not parts of the proposed device and are presented in the description to illustrate the operation of the device.

The operation of the proposed device is as follows. After the formation of the arteriotomy hole, the end of the plaque is prepared for capture by the ring 1 of the proposed device. Then advance the ring 1 with the cutting contour 2 inside the treated area of the vessel, performing mechanical deobliteration. The liquid enters the channel 5, formed in the hollow holder, from the hole 6 for the inlet of the liquid into the inventive device. The fluid is supplied under pressure created by the supercharger, taken out of the limits of the proposed device. Hole 7 is made for release into the closed inner subadventitial space of the vessel with the creation of a hydraulic exfoliating effect on the atherosclerotic plaque. The liquid is released to the place of treatment under pressure from the outlet hole 7, made in the form of a cutout in the proximal end of the holder. The tool is advanced until the atherosclerotic plaque detaches from the vessel wall. Before removing the instrument from the vessel, it is rotated to fix the plaque on the working part of the device, usually by two turns. In conclusion, plastic arteriotomy is performed.

Example

An example of the proposed device can serve as a design with a working part in the form of a lamellar ring of a fixed diameter of 8 mm with a cutting edge along its inner side. The outer edge of the ring is rounded, which contributes to the atraumatic advancement of the proposed device along the wall of the artery. The diameter of the ring can be optimally selected from a number of standard sizes - 6 mm, 8 mm, 10 mm. It is selected according to the diameter of the operated vessel. The lamellar ring is fixed on the holder at an acute angle of 40° to its axis. The device holder is a hollow metal tube 450 mm long and 2 mm in diameter. The handle, located at the end of the holder, is made with the possibility of connection through a soft adapter, for example, a 14G catheter with a Luer cone socket, to a saline injector. The supercharger must provide a pressure of 2-3 atm. at the exit from the cutout in the wall of the hollow holder near the cutting part of the ring. Among a number of liquid agents, physiological saline is more often used, since it slowly dissociates in biological tissues and creates a hydrojet at the end of the holder and at the bottom of the ring. To prevent blocking the exit of the liquid when it is released from the channel along the lower part of the holder near the cutting edge of the ring, the outlet hole is made in the form of a cutout with a width of about 1/3 of the circumference of the cross section of the holder and a length of 32 mm. The device is made of stainless steel using laser welding along the fit contour of parts in accordance with GOST 28915-91. The device must be re-sterilized. Immediately before surgery, a sterile blower and adapter are attached to the claimed device.

Approbation of the device takes place in the prescribed manner, showing improved expected results.

Claims (4)

1. A device for loop endarterectomy, containing a ring with a cutting contour along its inner side, connected to an extended holder, at the opposite distal end of which a handle is placed, characterized in that a channel is made for supplying a working fluid under pressure to the treatment area of the vessel, located inside an extended holder, made for this in the form of a hollow tube, in which holes are formed at opposite ends: from the side of the handle - for the inlet of liquid injected under a pressure of 2-3 atm into the channel, and from the proximal end of the holder at the junction with the ring - for the outlet of the injected liquid into the treatment area of the vessel. 2. The device according to claim. 1, characterized in that the hole for discharging the injected liquid is an extended cutout in the lower part of the holder, which is made on its edge. 3. The device according to claim. 1, characterized in that the hole for discharging the injected fluid has a length along the holder of the order of 30±5 mm and a width of about 1/3 of the circumference of the cross section of the holder. 4. The device according to p. 1, characterized in that the ring with a cutting contour of sizes 6, 8, 10 mm in diameter.

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