SE459472B - INTRAVENOEST FILTER AND DEVICE AND PROCEDURE FOR ORGANIZATION OF THE SAME BEFORE OPERATION - Google Patents

Abstract

An intravenous filter comprises a cylindrical holder (1) and a thromboembolus-trapping device in the form of a set of resilient pins (4) secured in the holder. Each pin has an L-shaped grip (5) on its free end. An apparatus for preoperative preparation of the filter comprises an applicator capsule (9) attached to a catheter (11), a guide element (8) comprising conical (20) and a cylindrical (19) portions, a threaded stylet (21) and a collet clamp (17, 18). Preoperative preparation of the filter comprises matching the cylindrical portion of the guide element with the capsule bringing the stylet up through the guide element capsule, catheter and collet, screwing the filter on to the thread, retracting the filter through the guide element into the capsule and removing the guide element. The tightened collet prevents unwanted rotation/unscrewing of the filter.

Description

20 25 30 35 459 472 2 One end of the springs is attached to the holder and the other, free end protrudes from the membrane, the free end of each spring being so pointed that it can attach the filter inside the walls of the lower half.

To secure the implantation of the filter in the lower half vein, a device is prepared for preparing the filter before surgery. The device partly comprises a control element, which consists of a cylindrical resp. a conical part. partly an applicator. son comprises a capsule for the placement of the filter, and a conductive catheter connected to the capsule. and partly a collet. The rod is arranged inside the catheter and the capsule and is fitted with a thread to hold the filter. partly a rod To assemble the filter, the rod is pushed both through the capsule and the catheter down the end that lacks a thread. Then the filter is screwed onto the bar, the conical part of the guide element is inserted into its cylindrical part so that the filter is folded. He joins the hole of the capsule with the heel of the cylindrical part and moves the filter further along an unpaved curve path into the capsule. wherein the filter for the capsule is lowered out of the control element. The assembly of the filter ends down that the rod is fixed by means of the clamping sleeve.

The main disadvantages of this filter are the following: on the one hand, the blood circulation in the lower half is blocked due to occlusion. induced by throne in the filter. which is due to the geonetric shape of the filter and the presence of tolt urnene on its proxinal surface. partly unreliable fixation of the filter inside the vein and partly of the construction of the filter. son causes the need to perform transcutaneous implantation surgically.

When using this known device and method for assembling the filter before the operation, the filter is arranged in the capsule of the applicator in such a way that implantation is ridiculed only through the inner right jugular vein (ie at the bottom 'retro-procedure'). In addition, a significant force is required for the filter to fold, and when it is moved into the capsule, there is a risk of the silicone membrane breaking, which can cause repeated throne embolism in the pulmonary artery.

An intravenous filter is also known, which includes a holder. inside which elastic fingers are attached in such a way that they form a net. At a certain distance from the hall, the fingers are united. but then they fall apart. Each free end of the fingers has a support element. The holder is provided with a hook or hook, which is intended for assembling the filter before implantation. and another hook is placed in the zone, where the elastic fingers disintegrate. Between these two attachments, the elastic fingers have a predetermined curvature. caused by the twisting of the fingers.

The filter is fixed inside the lower half with the help of the support elements at the free end of the fingers. The net. formed by the fingers, covers the opening of the lower half and prevents thrombus bolts from moving along it.

The proposed filter. which has a length of 7-12 cm, is bulky and comprises two 'dead' zones on the sections where the elastic fingers are fixed, which zones contribute to thrombus formation; the fixation of the filter inside the lower half by means of the support element is not reliable and can cause penetration of the venous wall and the peripheral perforated means of the vein.

For assembling the filter before surgery, a device is used which comprises a guide catheter, a system for inserting the catheter, a fixing hook and a retaining hook.

The retaining hook is inserted through the catheter, the hook on the filter holder is fixed and then the filter is pulled into the catheter, after which the filter is ready for operation.

The main object of the invention is to provide an intravenous filter as well as a device and a method for preparing it before the operation. which - by changing the construction of a device intended to prevent thromboembolism - makes it possible to eliminate penetration of the venous wall and the venous surrounding holding means during the fixation of the filter.

This object is achieved by inserting inside an intravenous filter for medical treatment and / or prophylaxis of pulmonary artery thromboembolism, comprising a central cylindrical holder and a device attached thereto, which is intended to prevent thromboembolism, and made in the form of a group of elastic fingers, one of which end is attached to the cylindrical holder and which can fix the filter in the walls of the lower hollow vein, the elastic fingers according to the invention are attached to the central cylindrical holder so that they form a cylindrical surface close to the cylindrical holder, which surface merges into a conical surface in the direction of the free ends of the elastic fingers, the free end of each elastic finger having an L-shaped hook, the tip of which is directed towards the cylindrical holder and located outside the conical surface.

Each L-shaped hook can be turned out from the intravenous filter and the elastic fingers can have different lengths. It is convenient to design each elastic finger with a variable cross-section along its entire length, the cross-section of the elastic finger at the section where it is fixed in the cylindrical holder being round, while the section adjacent to it the L-shaped hook, is flat and an intermediate section has a cross section with a round and a flat shape.

The elastic fingers and the cylindrical holder can be formed from one and the same biologically inactive material.

It has been found advantageous to select the number of elastic fingers based on the inner diameter of the inferior vena cava and on the ability of the intravenous filter to inhibit a life-threatening, minimum permissible size of thrombolum number of 10-16. , and selecting an object of the invention is also achieved by in a device for preparing the intravenous filter for surgery. which device comprises on the one hand a control element containing a cylindrical resp. a conical part. on the one hand, an applicator, which is provided with a capsule for inserting the intravenous filter, and on the other hand, one connected to the capsule. guiding catheter. secondly, a rod which is located inside the catheter and the capsule, and which comprises a thread for holding the intravenous filter. and on the other hand a clamping sleeve, which cooperates with the rod. the control element according to the invention is so designed. that together with the applicator's capsule it forms a releasable joint, the applicator's capsule coinciding with the cylindrical part of the guide element and having the same inner diameters.

The said object is further achieved in that the method for preparing the intravenous filter for surgery consists in passing the rod through the conductive catheter and the capsule, screwing the intravenous filter onto the rod and placing it into the capsule of the applicator. according to the invention, before screwing the intravenous filter, the cylindrical part of the guide element is joined to the capsule of the applicator, for the thread of the rod out through the guide element. screw on the intravenous filter, insert the intravenous filter into the capsule of the applicator through the conical and cylindrical parts of the guide element and remove the control element from the capsule.

This proposed technical solution makes it possible to reduce traumatic cases during surgery and shorten both the rehabilitation period for the sick. because the filter contributes to a more complete opening of the thrombus-damaged vein. The invention is described in more detail below with reference to some examples and accompanying drawings, in which: Fig. 1 shows a general view of an intravenous filter, according to the invention; Fig. 2 shows the same filter according to the arrow A in Fig. 1; Fig. 3 shows an elastic finger on an enlarged scale; Fig. 4 shows a section along the line IV-IV in Fig. 3: Fig. 5 shows a section along the line V-V in Fig. 3; Fig. 6 shows a longitudinal section of a device for preparing the intravenous filter for surgery according to the invention; Fig. 7 shows true device with the intravenous filter inserted into the capsule; and Fig. 8 shows the location of the intravenous filter in the inferior vena cava.

The intravenous filter proposed according to the invention for medical treatment and / or prophylaxis of pulmonary artery throne bone boli comprises a cylindrical cartridge 1 (Fig. 1), provided with a thread 2, and a stopping device 3 for throne bone boles. The stop device 3 comprises a group of elastic fingers 4. one end of which is fixed inside the cartridge. The number of elastic fingers is selected on the basis of the inner diameters of the inferior vena cava and on the ability of the intravenous filter to inhibit a minimum permissible size of tronbelbola dangerous to the patient's life. and selected in a number of l0-16 pieces. Fewer than 10 fingers do not ensure a reliable inhibition of throne body bolts, below a number exceeding 16 is impossible due to technical problems with the fixation of the fingers inside the cartridge with a diameter of no more than 3.2 mm.

Fig. 2 shows an embodiment of a filter down twelve elastic fingers, which number is almost optimal.

The fingers 4 in the vicinity of the cartridge 1 are arranged so as to form a section down a cylindrical surface (Fig. 1), which when the fingers 4 disintegrate, merges into a conical surface. The free end of each finger 4 is provided with an L-shaped hook 5 for holding the filter in the vein.

The L-shaped hook is facing the notch cartridge 1 and out from the conical surface. Each hook 5 is at a certain angle in relation to the axis of the filter as shown in Fig. 2. where the fingers of different lengths alternate down each other and form, for example, two rows. Each finger 4 has a varying section (Fig. 3).

The cross section 6 of the attachment part of the finger in the cartridge is round (Fig. 4). The section adjacent to the hook 5 has a flat cross section 7 (Fig. 5). the transition from the round (6) to the flat (7) cross section takes place gradually.

The cartridge 1 and the fingers 4 are made of a biologically identical inactive material. of whose properties are various well-known brands of stainless steel set down a nodule of elasticity in the order of 20500 kg / nnz. The use of one and true material for the manufacture of both the cartridge 1 and the fingers 4 eliminates any electrokenic process in the patient's body, which may result in destruction of the inserted intravenous filter.

A special device was used to prepare the intravenous filter for surgery. which comprises a control element 8 (Fig. 6) and an applicator. The applicator comprises on the one hand a capsule 9 for the placement of the intravenous filter 10. partly a down capsule 9 attached. conductive catheter 11, partly a rod 12, which is arranged inside the catheter 11 and the capsule 9 and which has a thread 13 to hold the filter 10. and partly a clamping sleeve 14. which interacts down the stub 15 of the catheter 11.

The guide element 8 down the capsule 9 forms a detachable coupling. by means of which the element 8 can be easily removed from the capsule 9.

The clamping sleeve 14 has a groove 16, which prevents rotation of the rod 12 during the operation. a tool cone 17 and a nut 18.

The guide element 8 comprises a cylindrical part 19 and a conical part 20. wherein the capsule 9 coincides with the cylindrical part 19 and has the same inner diameters.

Fig. 7 shows a device led to the filter 10 inserted in the capsule 9.

This was accomplished in the following manner. The free end of the rod 12 is inserted through the capsule 9 and the catheter 11 (Fig. 6.7), the cylindrical part 19 of the guide element 211 is joined to the open end of the capsule 9, the inner cavity 22 of the element 8 constituting the continuation of the inner cavity 22 of the capsule 9. The thread 13 of the rod 12 is 10 15 20 25 30 35 459 472 8 thereby located outside the end of the element 8. whereupon the filter 10 is screwed onto the cartridge 1. If the filter 10 is implanted via the right inner jugular vein or via the clavicle vein (not shown in the drawing), the hooks of the elastic fingers should be facing the conical part 20 of the guide element 8 below. the femoral veins, as shown in Fig. 6. next these hooks be turned away from the conical part of the guide element 8.

The rod 12 of the filter 10 is re-inserted through the conical 20 and cylindrical 19 parts of the guide element 8 and into the capsule 9 (Fig. 7) and takes up the guide element 8 of the capsule 9, after which nan down by means of the clamping sleeve 14 fixes the rod 12 during the operation.

Under local anesthesia after transcutaneous puncture in the clavicle or femoral vein before a cannula (not shown in the drawing) and under X-ray telecontrol before the applicator capsule 9 to the lower part of the trunk at the second vertebra of the lower back. With the help of the rod 12, the filter 10 is pushed out of the capsule 9 and during the subsequent movement of the applicator the fixation of the filter in the lower vena cava is ensured. By rotating a few turns in the counterclockwise direction of the clamping sleeve 14, the applicator separates from the implanted filter 10 and removes it from the vein together down the cannula. The cartridge 1 of the filter 10 is located down proximal to the hook 5, and they are fixed inside the cartridge 1. bent inwards and converging towards the center. the synthetic elastic fingers 4 form a locating zone for the sole. On top of the puncture wounds, lan puts an aseptic patch.

Fig. 8 shows the position of the filter 10 inside the lower hollow vein 24. the top of the conical surface of the fingers 4 and the cartridge 1 of the filter 10 being placed along the direction of the bloodstream, shown down the arrow B. Due to its shape, the L-shaped hook 5 penetrates only the inner surface 25 of the wall 26 of the vein 24 and does not penetrate it, neither during the operation itself nor during a long postoperative period.

During insertion of the single ball into the filter 10, the hook 5 does not move. 459 472 at the location of the thrombus body 27 in the filter 10 relative to the wall 26 of the vein 24, the sauce is made using known intravenous filters.

Use of the present invention makes it possible to perform X-ray endovascular prophylaxis of pulmonary artery throne bone boli by means of a slightly traumatic puncture procedure in extremely severely ill floating thrones along the vena cava. Use of the present intravenous filter true procedure and device for preparing it for implantation reduces the time for the surgical procedure down: inst 5-6 times, which also has a beneficial effect on the outcome of the disease, shortens the stay of the patients in the hospitals 4-5 times and preserves the working ability of the patients due to the absence of occlusion of the inferior vena cava and its penalties after implantation of the proposed filter.

Results of clinical trials down the proposed intravenous filter are shown in more detail below.

After diagnostic angiographic tests - angiopulmonography. retro- heart probe. or okavography was performed under local anesthesia a transcutaneous implantation of intravenous filters for prophylaxis and treatment of a nassive throne bone bolus in pulmonary artery in 39 patients down enbologene throne boser inside 1 femur and / or ocavasegents. of which retro procedure - 27 21 via the 6th and at the bottom an antegrade procedure 9. via 3. Among the operated patients were 17 women (43.6 \) and 22 (56.4 \) men aged from 19 to 82 years. implants via the left clavicle vein - right jugular vein - - 12 implants. via the right femoral vein - the left femoral vein - Depending on the diameter of the infrarenal part of the inferior vena cava. which is clarified at the bottom by operative retro- or ocavography. intravenous filters were implanted down the following dinension: - intravenous filter down diameter 23 now in 2 patients; intravenous filter down diameter 28 now in 23 patients: - intravenous filter down dianeters 32 un in low patients. 10 20 25 459 472 10 The angiographic procedure - transcutaneous implantation of an intravenous filter in operated patients - took 8-10 minutes and was performed during the final stage of diagnostic X-ray contrast tests - probing of the right canals of the heart. angiopulmonography and retro- or ocavography.

Prior to implantation, the intravenous filter was sterile treated by an autoclave procedure. The implant was sterilized in 6% hydrogen peroxide.

In order to study the condition of the okava segment, nan has done a control cavography during the period from 1 to 6 months. The performed analysis of the first and later results of an endovascular prophylaxis and medical treatment of pulmonary arterial thromboline testifies to a high reliability of the procedure for transcutaneous implantation of intravenous filters. During the period of our examinations, the recurrent pulmonary artery thromboline occurred in 2.51 of the operated patients. caused by an intraoperative error (incorrect fixation of the filter), which required re-implantation of the filter.

Postoperative deaths in the observed patients were 7.4%, which was due to sequelae or consequences of previous massive pulmonary artery throne bololias.

In the analysis of clinical angiographic and sectional data in 39 operated patients, nan has established that the intravenous filter is not enthroned. that the pressure gradient does not accumulate in the vena cava and that in 94.52 of the patients the main blood flow is not disturbed.

Claims (8)

10 15 20 25 30 ll 459 472 Patent claims 1. an intravenous filter for the medical treatment and / or prophylaxis of pulmonary arterial thromboembolism, comprising a central cylindrical holder (1) and a device (3) attached thereto, which is intended to prevent thromboembolism and which is designed in the form of a group of elastic fingers (4). one end of which is attached to the cylindrical holder (1) and which can fix the filter 1 to the walls (26) of the lower vena cava (24), characterized in that the elastic fingers (4) are attached to the central cylindrical the holder (1) so as to form a cylindrical surface near the cylindrical holder (1), which surface merges in a conical surface 1 towards the free ends of the elastic fingers, the free end of each elastic finger having an L- shaped hook, the tip of which is directed towards the cylindrical holder and located outside the conical surface. An intravenous filter according to claim 1, characterized in that each L-shaped hook (5) faces out from the axis of the intravenous filter. Il-at 3.; An intravenous filter according to claim 1 or 2, characterized in that the elastic fingers (4) have different lengths. 4. - intravenous filter according to any one of claims 1-3, characterized in that each elastic finger (4) has a variable cross-section. wherein the cross-section of the elastic finger at a section where it is attached to the cylindrical holder (1) is round (6), while a section adjacent to the L-shaped hook is flat (7) and an intermediate section has a cross section. with a round (6) and a plane (7) n e t e c k n a t shape. Intravenous filter according to one of Claims 1 to 4, characterized in that the elastic fingers (4) and the cylindrical holder (1) are made of one and the same biological inactive materials. Intravenous filter according to one of Claims 1 to 5, characterized in that the number of elastic fingers (4) is selected on the basis of the inner diameter of the inferior vena cava (24) and in the ability of the intravenous filter (10) to inhibit the patient's. life dangerous. minimum allowable size of thromboembol, preferably 10-16 pieces. The device for preparing the intravenous filter according to claim 1 for surgery. comprising on the one hand a control element (8), which has a cylindrical (19) and a comic (20) part. and an applicator, which is provided with a capsule (9) for inserting the intravenous filter (10). and one connected to the capsule (9). guide catheter (II), and a rod (12). which is located inside the catheter (II) and the capsule (9) and which comprises a thread (13) for holding the intravenous filter (10), and on the other hand a clamping sleeve (14), which cooperates with the rod (12), characterized in that the guide element (8) is designed so that it, together with the capsule (9) of the applicator, forms a releasable joint, the capsule (9) of the applicator coinciding with the cylindrical part (19) of the guide element (8) and having the same inner diameter. A method of preparing the intravenous filter according to claim 1 for surgery using the device according to claim 7, comprising passing the rod (12) through the guiding catheter (11) and the capsule (9). screw the intravenous filter (10) onto the rod (12) and place it into the capsule (9) of the applicator, characterized in that before the screwing of the intravenous filter (10) the cylindrical part (19) of the guide element (8) is joined to the appli - the catheter capsule (9), for the thread (13) of the rod (12) out through the guide element (8) and then screw on the intravenous filter (10), insert the intravenous filter (10) into the applicator capsule (9) through the guide element (8) ) conical (20) and cylindrical (19) parts and removes the guide element (8) from the capsule (9).