RU208841U1 - Device for temporary balloon occlusion of the infrarenal aorta - Google Patents

Abstract

The utility model relates to medicine, namely to surgery, and can be used to perform temporary balloon occlusion of the infrarenal aorta to prevent bleeding during delivery of patients with placenta ingrowth into a uterine scar after a previous caesarean section. The device for temporary balloon occlusion of the infrarenal aorta contains an elongated tubular element, inside which two non-communicating channels are made along the length. The first of which has a constant diameter along its length is designed to accommodate a wire conductor and is made with radially arranged holes in the wall of the tubular element to communicate the cavity of this channel with the external environment. The outlet of the second channel is made in the form of a hole in the wall of the tubular element for supplying a liquid agent and inflating the balloon to a spherical shape. The balloon is located at a distance from the free end of the tubular shape of the element, and this end is made in the form of a spout with a rounded tip, forming a blank wall for the first channel. Said radial openings of the first channel are made on the other side of the balloon. There is a node located at the other end of the tubular shape of the element with two independent ports for communicating each with the corresponding channel. The port communicated with the first channel for injecting the contrast agent is made with a two-way stopcock for closing the first channel in one position after the contrast agent is injected and preventing it from flowing out. On the outer surface of the cylinder in the middle there is a radiopaque mark for orientation when it is located. And the radial openings of the first channel, indicated in the amount of five, used for contrasting the aorta, are located along a spiral circle of the tubular shape of the element. The technical result of the utility model is to simplify the design of a balloon catheter used for complete occlusion of a blood vessel to improve the safety of occlusion and the accuracy of the location of the balloon catheter in the blood vessel. 2 w.p. f-ly, 3 ill.

Description

The utility model relates to medicine, namely to surgery.

The utility model considers a device for temporary balloon occlusion of the infrarenal aorta to prevent bleeding during delivery of patients with placenta ingrowth into a uterine scar after a previous caesarean section.

Applicable terms:

Infrarenal (subrenal) abdominal aorta - from the renal arteries to the division of the aorta into the arteries of the legs (iliac). From this department departs the artery to the large intestine (inferior mesenteric).

Occlusion is a violation of the patency (obturation) of hollow anatomical formations due to damage to their walls, as well as ensuring the sealing of the pleural cavity in case of penetrating wounds (“occlusive dressing”).

Transradial access - access for the introduction of a catheter, carried out using the radial artery.

A catheter is a medical product in the form of a hollow tube designed to connect natural channels, body cavities, vessels with the external environment in order to empty them, introduce drugs (diagnostic, therapeutic), rinse, or pass surgical instruments through them. The process of inserting a catheter is called catheterization.

Placenta ingrowth is a pathology of its attachment, caused by pathological invasion of the trophoblast in the area or over the entire area of the placental site with penetration beyond the region of the basal plate into the myometrium (Heller DS "Placenta accreta and percreta", "Surgical Pathology Clinics", 2013, 6(1), pp. 181-197). Delivery of women with placenta ingrowth is very often accompanied by profuse, life-threatening bleeding, ends with organ-removing hysterectomy (Saveleva G. M., Kurtser M. A., Breslav I. Yu. “Ingrown placenta (placenta accreta) in patients with a scar on the uterus after caesarean section Clinical and morphological comparison", "Obstetrics and Gynecology" 2015, No. 11, pp. 41-45).

The etiology of placenta accreta is not fully understood. One of the main hypotheses is that the disturbed structure of the uterine wall, especially in the area of the scar, leads to a change in its decidualization, pathological invasion of the anchor villi and deep trophoblast infiltration (Jauniaux E., Collins S., Burton GJ "Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging", Am. J. Obstet. Gynecol, 2018, No. 218, pp. 75-87). The latter does not receive para-autocrine signals necessary to stop the invasion, and penetrates into the thickness of the myometrium, up to the serous cover and bladder wall (Robert MS, Kelli DB "Placenta accreta spectrum: accreta, increta, and percreta" "Obstetrics and Gynecology Clinics of North America, 2015, 42(2), pp. 381-402).

To reduce blood loss, an incision in the uterus and extraction of the fetus are carried out in an area uncompromised by placenta ingrowth. A benign or corporal caesarean section is preferred. Access is made from a lower median incision on the skin, bypassing the navel on the left. After extraction of the fetus, the umbilical cord is clenched and immersed in the uterus, the placenta is not removed. The incision on the uterus is sutured (Kurtser M. A., Breslav I. Yu., Latyshkevich O. A., Grigoryan A. M. “Temporary balloon occlusion of the common iliac arteries in patients with a scar on the uterus after cesarean section and placenta accreta. Advantages and possible complications", "Obstetrics and Gynecology", 2016, No. 12, pp. 70-75; Chandraharan E., Rao S., Belli AM "The Triple-P procedure as a conservative surgical alternative to peripartum hysterectomy for placenta percreta", "Inter. J. Gynaecol. Obstetrics", 2012, 117(2), pp. 191-194; Silver RM, Fox KA, Barton JR "Center of excellence for placenta accrete", "Am. J. Obstetrics Gynecol." 2015 , 212(5), pp. 561-568.

Methods for reducing the volume of circulating blood in the uterus include: ligation of the uterine, ovarian arteries; ligation of the internal iliac arteries (Kurtser M. A., Breslav I. Yu., Latyshkevich O. A., Grigoryan A. M. “Temporary balloon occlusion of the common iliac arteries in patients with a uterine scar after cesarean section and placenta accreta. Advantages and possible complications”, “Obstetrics and Gynecology”, 2016, No. 12, pp. 70-75); the imposition of compression sutures on the uterus; embolization of uterine arteries; balloon occlusion of the internal or common iliac arteries (D'Souza DL, Kingdom JC, Amsalem H. "Conservative management of invasive placenta using combined prophylactic internal iliac artery balloon occlusion and immediate postoperative uterine artery embolization", "Can. Association Radiol.", J 2015, 66(2), pp. 179-184; Tskhai V. B., Yametov P. K., Brezhneva N. V. “The effectiveness of methods of X-ray endovascular occlusion of arterial vessels in reducing intraoperative blood loss in pregnant women with placenta previa”, “ Obstetrics and Gynecology", 2015, 10, pp. 5-10; Mei Y., Zhao H., Zhou H., Jing H., Lin Y. "Comparison of infrarenalaortic balloon occlusion with internal iliac artery balloon occlusion for patients with placenta accrete", "BMC Pregnancy Childbirth", 2019, 19(1), pp. 147-147; Chen M., Lv B., He G., Liu X. "Internaliliac artery balloon occlusion during cesarean hysterectomy in women with placenta previa accrete", "Int. J. Gynaecol. Obstet.", 2019, Apr., 145(1), pp. 110-115 ; Zhou X., Sun X., Wang M., Huang L., Xiong W. “The effectiveness of prophylactic internal iliac artery balloon occlusion in the treatment of patients with pernicious placenta previa coexisting with placenta accrete”, J. “Matern. Fetal Neonatal Med., 2019, 9, р. 1-6).

Balloon catheters are well known and are used to treat a variety of blood vessel conditions. There are two main types of balloon catheters known in this field, the balloon catheter for expansion, used to treat narrowed or stenotic parts of the vessel and restore blood flow (for example, balloon catheters for angioplasty), and balloon catheters for occlusion, used to temporarily block flow from a segment of the vessel. when a liquid is poured into it (for example, a drug, a contrast enhancer or a flushing material) (US 7182755, 5368567).

Thus, a PTA (percutaneous transluminal angioplasty) balloon catheter, preferably of a high-pressure type, is used to perform occlusion of blood vessels, which can be inserted using a wire (WO 2014113257, A61M25/00, publ. 24.07.2014). This catheter is taken as a prototype.

The catheter has the property of injecting a liquid (contrast-enhancing material and/or drug) into the treated area of the vessel through a special opening, proximal to the balloon element. Liquid injection can be performed simultaneously with inflation or deflation of the balloon, or while the balloon remains inflated. A number of radiopaque markers (preferably two or more) may be present to determine the working length of the balloon and facilitate balloon insertion. In some embodiments, a single lumen is used, at least in part, for both the transfer and dispersion of liquids ("infusion") and the passage of a guide wire. In some such embodiments, a valve mechanism is used to maintain selective lumen operability such that liquids will be dispersed primarily or only through the proximal dispersion port rather than the distal guide wire outlet. In one example, the catheter terminates in a tip, optionally an atraumatic tip with a check valve, embedded in the lumen of the guidewire distal to the injection port to allow infusion of fluids with or without a guidewire.

Structurally known balloon catheter is a long element of round shape in cross section, made of polymeric material with flexibility, or rigid inelastic polymer. The body of the element has two channels, one of which runs along the entire length of the element and is open; it is used to pass the wire (wire conductor) with the end of the wire exiting through the open end of this channel. This channel is also used to supply the solution to exit through the side radial holes in the element (while keeping the wire in the channel if the channel diameter is larger than the wire diameter, or after removing the wire). The diameter of this channel in the end part of the element (nose behind the balloon) is made equal to the diameter of the wire and, in fact, forms a seal to prevent the solution from escaping through this end or to control the volume of the solution escaping through this end. The second channel is passed parallel to the first one, is deaf and has an outlet through a radial hole into the area of the inflatable balloon of spherical shape, which is located on the element at a distance from the open end of the first channel. When an agent is injected into it, the balloon inflates, leading to its abutment against the vessel wall and occlusion. As an option, the balloon can be made in the form of a non-inflatable ball or a ball made of a material with low elasticity.

At the other end of the element, a valve assembly is mounted, having two independent communications: with the first channel for controlling the wire and supplying the solution, and with the second channel for supplying the agent in order to inflate the balloon when used as a balloon.

This balloon catheter is used as follows:

1) leading the guidewire into a luminal blood vessel (such as a vein or artery, optionally a coronary, peripheral, or dialysis target vessel);

2) delivery of the balloon catheter into the lumen of the vessel along the wire guide to the selected target;

3) inflating the balloon to cover at least partial occlusion of the luminal vessel at the target;

4) administering a liquid (eg liquid or suspended drug or contrast enhancing medium) through a lateral radial opening in the first infusion port such that little or no liquid passes behind the balloon.

In some embodiments, steps 3 and 4 are performed simultaneously and/or overlapping.

The disadvantage of this balloon catheter lies, firstly, in the complexity of manufacturing an elongated element, in which both channels are made profiled and with a variable diameter. In principle, such an element can be performed, but such an implementation is not technologically justified. Secondly, structurally, the catheter is designed in such a way that the element is introduced into the cavity of the blood vessel through the initial introduction of the wire guide into this vessel beyond the place where occlusion should be performed, and then the element is strung with the open end on the wire and pushed along the wire inside the blood vessel to the predetermined location of the balloon. Such an operation requires increased accuracy of movements and accuracy so as not to damage the wall of the vessel. At the same time, for the sake of safety and avoiding damage, constant monitoring of the movement (achieved by reading the movement of radiopaque marks) of the structure should be carried out. But, this control by radiopaque marks is carried out only for the element and in order to determine its position in the vessel. And the introduction of the wire into the vessel takes place without external control, which is a complex and unsafe operation.

In addition, this catheter is designed for the introduction of drugs into the cavity of the blood vessel with full or partial occlusion. Therefore, it is performed both with an inflatable balloon and with a non-inflatable balloon, that is, with a rigid spherical balloon. In principle, in this patent, the catheter is used as an instrument for the treatment of blood vessels, i.e. for injecting liquid into the treated area through a special hole, proximal to the balloon element, for the introduction of liquids, such as a contrast enhancing material and/or a drug. Liquid injection can be performed simultaneously with inflation or deflation of the balloon. Fundamentally for the injection of the drug solution is to reduce the blood flow in the treated vessel to exclude ischemia. The issue of complete blockade of the passage section of the blood vessel is not considered in the patent. Moreover, when treating a vessel with a medicinal solution, it is assumed not only to spray the vessel wall in the area before the balloon, but also after the balloon (through the open end of the element), that is, in the area of the vessel filled with blood. For this purpose, the conductor wire is used as a regulator of the flow section of the narrowed end of the element, in the area behind the cylinder.

The present utility model is aimed at achieving a technical result of simplifying the design of a balloon catheter used for complete occlusion of a blood vessel to improve the safety of occlusion and the accuracy of the balloon catheter in the blood vessel.

This technical result is achieved by the fact that in the device for temporary balloon occlusion of the infrarenal aorta, containing an elongated tubular element, inside which two non-communicating channels are made along the length, the first of which is designed to accommodate a wire guide and which is made with radially arranged holes in wall of the tubular form of the element for communicating the cavity of this channel with the external environment, and the outlet of the second channel is made in the form of an opening in the wall of the tubular form of the element for supplying a liquid agent and inflating the balloon to a spherical shape formed on this element, while the said balloon is located at a distance from of the free end of the tubular form of the element, and the indicated radially located openings of the first channel are made on the other side of the container, as well as a node located at the other end of the tubular form of the element, containing two independent ports for communicating each with the corresponding channel, located behind the balloon made of latex, the free end of the tubular element is made in the form of a spout with a rounded tip, forming a blank wall for the first channel, the first channel along its entire length to the blank wall is made of constant cross section, which is larger than the transverse size of the wire conductor, the port communicated with the first channel for injecting a contrast agent, is made with a two-way stopcock for closing the first channel in one position after injecting the contrast agent and preventing it from flowing out, on the outer surface of the balloon in the middle there is a radiopaque mark for orientation when it is located, and the radial holes indicated in the amount of five of the first channel, used for contrasting the aorta, are arranged in a spiral around the circumference of the tubular element.

The liquid balloon inflation agent may be a mixture of saline and contrast medium at a 1:1 dilution.

Preferably, the elongated tubular member has a diameter corresponding to 5F.

Preferably, the device contains five holes of the first channel used for contrasting the aorta and arranged in a spiral.

These features are essential and are interconnected with the formation of a stable set of essential features sufficient to obtain the desired technical result.

This utility model is illustrated by a specific example of execution, which, however, is not the only possible one, but clearly demonstrates the possibility of achieving the required technical result.

In FIG. 1 - General view of the device for temporary balloon occlusion of the infrarenal aorta;

fig. 2 is a longitudinal section of the device according to FIG. 1 in its end part (balloon formation zone);

fig. 3 is a section A-A according to FIG. 2.

According to this utility model, a new device is considered for performing temporary balloon occlusion of the infrarenal aorta to prevent bleeding during delivery of patients with placenta ingrowth into a uterine scar after a previous caesarean section.

The utility model considers the design of a double-lumen balloon catheter (also called a "balloon on a guidewire").

By inflating the balloon of the device located at the end of the catheter, the infrarenal aorta is occluded, which leads to a decrease in perfusion (blood filling) of organs and tissues located below the level of the renal arteries. A decrease in blood supply will favorably affect the visualization of the surgical field and the almost bloodless extraction of an abnormally ingrown placenta into the wall of the uterus and nearby organs (bladder, intestines).

In the general case, the constructive of the claimed utility model consists in the fact (Fig. 1 and 2) that inside the elongated tubular shape of the element 1 along the length there are two non-communicating channels 2 and 3 (Fig. 3). The first channel 2 is designed to accommodate a wire conductor (not shown) and is made with at least two holes 4 in the wall of the tubular shape of the element 1 to communicate the cavity of this channel with the external environment. This channel 2 is also used to supply the contrasting agent and output it dosed into the cavity of the vessel. The device is intended to be used through the radial artery. The length of the course from the place of entry into the patient's vessel and to the final location is very long. This determines the length of element 1.

The outlet of the second channel 3 is made in the form of a hole 5 in the tubular wall of the element 1 for supplying a liquid agent and inflating the latex balloon 6 formed on this element to a spherical shape. The hole in the wall of the element, used to inject the mixture of saline and contrast agent into the balloon, exits the balloon exactly in the middle for uniform opening of the balloon (Fig. 2).

The position and size of the channels in the body of the element can vary widely, but these parameters constitute the technical essence of the claimed utility model. The first channel can be made larger than the second channel in diameter and located centrally along the longitudinal axis of the element. Or both channels are located offset relative to the longitudinal axis of the element (Fig. 3). The same applies to the transverse dimensions of the channels and their cross-sectional shapes.

The body of the catheter, that is, the elongated tubular shape of the element, can be made of a flexible polymer material such as latex or similar in properties. The cylinder can be technologically made in the form of a separate part and fixed on the body of the element. During operation, the body of the element can be flexibly and resiliently deformed, changing its shape along the length, but not in the transverse direction. To maintain the element in a certain positional position, a conductor wire with a bending strength higher than that of the element body is used. And the balloon is made with the ability, when inflated, to take the form of a ball like an air one.

The balloon is located at a distance from the free end 7 of the tubular shape of the element. The free end of the tubular shape of the element located behind the balloon made of latex is made in the form of a spout 8 with a rounded tip, forming a blank wall for the first channel (Fig. 2). When a wire guide is inserted into the cavity of this channel, this guide rests against a blank wall and allows you to move the catheter inside the vessel to a predetermined place where the balloon will be inflated. The spout, in fact, is a guiding device that adapts to the shape and structure of the vessel, allowing non-traumatic advancement of the catheter. On the outer surface of the cylinder in the middle there is a radiopaque mark for orientation when it is located in the vessel (the mark is not shown in the figures).

Said radial holes 4 of the first channel 2 are made on the other side of the balloon 6. These holes of the first channel, used for contrasting the aorta, are located around the circumference of the tubular shape of the element. The holes are located around the entire circumference of the catheter element body. Five holes are preferred. It is not advisable to use the number of holes more than five or six, because. they are located on a limited area of the catheter, which can affect the strength of the device. Less than three should not be done, tk. in this case, a uniform versatile distribution of the contrast agent may not be ensured, which will not make it possible to assess the tightness of the catheter to the aortic walls. Hole diameter - 1.0 mm. The holes are arranged in a spiral, up to the cylinder attachment point, at a distance of 4 mm from each other. This allows, by introducing a contrast agent against the background of an inflated balloon, to clearly see the degree of obturation (overlap) of the aortic lumen.

At the other end of the tubular form of the element, a node 9 is mounted, containing two independent ports 10 and 11 for communicating each with the corresponding channel.

The first channel 2 along its entire length up to the blank wall is made of constant cross section, which is larger than the transverse size of the wire conductor. The port communicated with the first channel for injecting a contrast agent is made with a two-way cock for closing the first channel in one position after the contrast agent is injected and preventing it from flowing out.

Double-lumen balloon catheter is designed for temporary occlusion of the infrarenal aorta. Delivery method - transradial. To do this, a puncture a.radialis (radial artery) is performed on the left according to a well-established and widely known technique. By means of a guidewire (size 0.035 inches) introduced into the lumen of the first channel 2 of the catheter, the device is delivered and installed below the orifices of the renal arteries. The introduction of a contrast agent through the first channel of the catheter makes it possible to assess the level of the catheter location, for which five perforations are located on the catheter itself along its diameter above the balloon attachment point (the number of holes was established as optimal during tests to improve the accuracy of visual assessment of the position of the device in the vessel). The first channel runs through the entire catheter, ending at the tip. After the operator is satisfied that the catheter is positioned correctly, by injecting a mixture of saline and contrast agent in a 1:1 ratio with a syringe, the mixture is injected through one port to open the balloon element of the catheter. Re-injection of the contrast agent into the second port (for the first channel) allows assessing the adequacy of the catheter location, the absence of the contrast agent in the antegrade direction and its "stagnation" above the balloon location area, indicating complete blockage of the artery lumen. The data obtained during angiography indicate the absence of blood flow below the area of the balloon (infrarenal aorta), which will allow obstetrician-gynecologists to remove the placenta without blood loss and suture the incision in the uterus as soon as possible. The time of a single exposure of the balloon is limited by the resulting ischemia of the lower extremities. To prevent ischemic damage to the lower extremities, the time the balloon catheter is in the open state is limited to 10 minutes, after which the previously injected mixture of saline and contrast agent should be released from the catheter. If necessary, the balloon catheter can be re-inflated. The total exposure time of the balloon catheter should not exceed 120 minutes.

The device in the part of the body has a diameter corresponding to 5F (1.6 mm) (where F - (french) is the size of the catheter used in endovascular surgery; 1 french corresponds to 0.33 mm), the tip of the catheter is straight, blindly ends (sealed). The length of the catheter is 125 cm, which allows it to be used from a radial approach using the left a.radialis (radial artery). The catheter has two channels. The first 2 - for the introduction of the conductor and stiffening the catheter during the introduction to prevent bending and breaking of the product and the introduction of a contrast agent. The second 3 is for injecting a mixture of a contrast agent and saline to inflate the balloon 6. For the introduction of a conductor and a contrast agent, there are two corresponding ports 10 and 11 at the end of the catheter, each leading to its own channel. The port for injecting a contrast agent is supplemented with a two-way stopcock, which allows you to close the lumen of the catheter after injecting the mixture and preventing it from leaking out. The tip is rounded to reduce injury to the vessel. The tip does not have a through hole, the conductor rests against the wall of the lumen from the inside and pushes the catheter. The catheter is inserted simultaneously with the conductor. At a distance of 15 mm from the sealed tip of the catheter, a balloon 6 made of latex is located, which allows it to be opened by injecting a mixture of saline and a contrast agent at a 1:1 dilution with a conventional Luer-type syringe, without pressure on the aortic wall. When opened, the balloon has a diameter corresponding to 30 mm. When opened, the balloon takes the form of a ball. Strictly in the middle of the balloon there is a radiopaque mark (not shown in the figures) for orientation when it is located. At a distance of 15 mm from the proximal part of the balloon catheter along its entire circumference there are perforations 4 in the amount of 5 (five) for contrasting the aorta.

The claimed double-lumen balloon catheter has a simple design, with sufficient manufacturability, allows you to control block the flow area of the blood vessel, safety when the catheter is inserted into the vessel and when it is located in the vessel. These properties are provided by optimizing the layout of the device and the withdrawal of the wire conductor from the contact zone with the vessel. The spiral arrangement of the openings for the release of the contrast agent makes it possible to distribute the contrast agent across the aorta and around the catheter in a local zone narrow in width, which makes it possible to quickly and, most importantly, accurately assess the tightness of the catheter to the aortic walls.

Claims (3)

1. A device for temporary balloon occlusion of the infrarenal aorta, containing an elongated tubular element, inside which two non-communicating channels are made along the length, the first of which is designed to accommodate a wire guide and which is made with radially arranged holes in the wall of the tubular form of the element for communication the cavity of this channel with the external environment, and the outlet of the second channel is made in the form of an opening in the wall of the tubular shape of the element for supplying a liquid agent and inflating the balloon to a spherical shape formed on this element, while the said balloon is located at a distance from the free end of the tubular shape of the element, and said radial openings of the first channel are made on the other side of the container, as well as a node located at the other end of the tubular shape of the element, containing two independent ports for communicating each with the corresponding channel, characterized in that located behind the made from latex with a balloon, the free end of the tubular shape of the element is made in the form of a spout with a rounded tip, forming a blank wall for the first channel, the first channel along its entire length to the blank wall is made of a constant cross section, which is larger than the transverse size of the wire conductor, the port communicated with the first channel for injection of a contrast agent, is made with a two-way stopcock for closing the first channel in one position after injection of a contrast agent and preventing its leakage outward, on the outer surface of the balloon in the middle there is a radiopaque mark for orientation when it is located, and the radial holes of the first channel indicated in the amount of five, used for contrasting the aorta, are arranged in a spiral around the circumference of the tubular shape of the element. 2. The device according to claim. 1, characterized in that the liquid agent for balloon inflation is a mixture of saline and a contrast agent in a dilution of 1:1. 3. The device according to claim. 1, characterized in that the elongated tubular element has a diameter corresponding to 5F.

Images