CN116036478A - Suture-free epicardial temporary pacemaker lead wire set - Google Patents

Abstract

The invention relates to a suture-free epicardial temporary pacemaker lead wire set which is used for installing a temporary pacemaker after cardiac surgery. Under the general condition, when continuous 72h after operation does not need to pace, the temporary pacing lead can be pulled out, and the pacemaker lead can be pulled out after the patient's condition is stable and improved, and the maximum time is not more than one month, and even debridement operation is needed if the lead is not pulled out, the infection is very easy to be caused. For various reasons, the situation that the pacemaker lead cannot be pulled out at one time still happens sometimes, and at the moment, the chest opening operation is often needed again, so that pain and burden of patients are increased, and the situation is a hidden danger causing doctor-patient disputes. The invention has the beneficial effects that: the invention can easily connect the pacemaker lead at the epicardium without sewing, and can easily pull the lead out of the body by pulling out the fixed wire inserted into the left end of the lead when the pacemaker lead is pulled out, thereby effectively solving the problem that the pacemaker lead is not easy to pull out in operation.

Description

Suture-free epicardial temporary pacemaker lead wire set

Technical Field

The invention belongs to the field of medical appliances, and particularly relates to a suture-free epicardial temporary pacemaker lead set which is used for installing a temporary pacemaker after cardiac surgery.

Background

The cardiac pacemaker is an electronic therapeutic instrument implanted in human body, and is formed from a pulse generator and metal wire connected with the pulse generator, and the pulse generator can be used for giving out electric pulse capable of being supplied by battery, and can be used for stimulating cardiac muscle contacted by electrode and making heart be excited and contracted so as to attain the goal of curing cardiac dysfunction resulted from certain arrhythmia.

After open heart surgery, various types of arrhythmia, conduction block, bradycardia, rhythm disorder and the like often occur, and the epicardial temporary cardiac pacemaker is an effective treatment means at the moment, can overcome the low cardiac output syndrome generated by the symptoms, and plays an important role in treating complications such as postoperative arrhythmia and the like and improving hemodynamics in early stage. Currently, placement of epicardial temporary pacing leads and the use of temporary pacemakers in surgery has been considered an effective method for preventing arrhythmias and maintaining hemodynamic stability after cardiac surgery. In addition, for cases where it is difficult to implant a pacemaker lead via a vein in cardiovascular medicine, such as via vein occlusion, tricuspid valve replacement, repeated dislocation of an electrode lead via a vein approach, etc., where temporary pacing treatment is required, epicardial temporary pacing treatment is also an irreplaceable method.

At present, an epicardial temporary pacemaker lead used in the open operation of cardiac surgery is made of metal, and is a braided lead wire with a suture needle, such as a monopolar hormone electrode capsule Epi-4965 and a bipolar hormone electrode Cap-sure Epi-496817 of Medtronic company in the United states. The traditional epicardium temporary pacemaker lead placing method is that the epicardium temporary pacemaker negative electrode lead is directly sutured on the myocardial layer of the non-vascular area of the front wall of the right ventricle, the anode electrode lead is directly sutured on the epicardium of the right ventricle, the distance between the two electrode leads is not less than 2 cm, the lead is sutured and fixed by adopting a non-invasive wire according to the conditions of bleeding and the like, hemostasis is carried out, after test parameters are satisfied and diaphragmatic muscle stimulation is not carried out, the pacemaker lead passes through the rib edge downwards and is sutured and fixed with the body surface and then is connected to the pulse generator. In general, when continuous 72 hours after operation do not need to be paced, the temporary pacing lead can be pulled out, and the pacemaker lead can be pulled out after the patient's condition is stable and improved, and the maximum time is not more than one month, and even debridement operation is needed if the lead is not pulled out, the infection is very easy to be caused.

When the epicardial temporary pacing lead is removed after the patient recovers, if the temporary pacing lead remains in the body due to various reasons carelessly, the wound may be stimulated to be disunion, even local infection and the like are caused, and the influence on the patient is caused to different degrees. When the epicardium temporary pacemaker lead is pulled out, only the fixed suture on the body surface is needed to be cut off, and the lead is held by hands to be pulled out slowly with continuous force. Because the lead retention position is special, and myocardial distortion or larger suturing force can be generated when suturing, lead fracture, arrhythmia and endocardial bleeding can occur during removal, and complications such as pericardium filling are caused, so that even force is applied during removal of the temporary pacemaker lead, the lead is slowly removed, the reflection of a patient is carefully observed, and whether bleeding or pericardium filling occurs is closely observed within 24 hours after removal. For various reasons, the situation that the pacemaker lead cannot be pulled out at one time still happens sometimes, and at the moment, the chest opening operation is often needed again, so that pain and burden of patients are increased, and the situation is a hidden danger causing doctor-patient disputes. It is seen that the most critical step after the surgical epicardial temporary pacemaker implantation operation is to pull out the epicardial temporary pacemaker electrode lead, but the situation that the lead is adhered to epicardial tissue or the lead is tightly sutured with epicardial tissue and is difficult to pull out is often encountered when the pacemaker lead is pulled out, and the situation that the lead is pulled out forcefully is likely to cause heart bleeding, endanger the life of a patient and is ineffectively used for thoracotomy hemostasis.

Disclosure of Invention

The invention aims to overcome the defects of the prior art, and provides a suture-free epicardial temporary pacemaker lead set, when the invention is used, the pacing lead can be easily pulled out when a pacemaker is removed because no suture is needed between the lead and cardiac muscle or epicardium, so that the problems that the pacemaker lead cannot be pulled out due to slow force in operation and the life of a patient is endangered due to cardiac hemorrhage possibly occurring when the lead is pulled by force are effectively solved.

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows: the utility model provides a suture-free epicardium temporary pacemaker lead suit, includes wire, fixed line, pipe subassembly, the middle main part of wire is a soft and outward facing insulating layer's conducting wire, and the insulating layer of its conducting wire of wire that uses as the positive pole wire is red, and the insulating layer of its conducting wire of wire that uses as the negative pole wire is black, all make white size scale marking outside the insulating layer of wire, the right-hand member fixedly connected with of wire is used for wearing out from the skin, the left end of wire is connected with a single ball frame, single ball frame is woven by nickel titanium memory alloy silk and forms, single ball frame takes the ellipse when being in natural state, single ball frame can take the form of long and thin strip when being pulled by the conducting wire, the left end of single ball frame is connected with a pjncture needle, the pjncture needle left end is connected with the expansion ring that forms by nickel titanium memory alloy silk, the expansion ring takes the long and thin strip when not receiving external force, can be strutted by oval ring, single ball frame has the expansion ring and the inflation effect of control heart muscle or the inflation needle in the heart muscle when rolling down; the middle main body part of the fixing wire is a thin steel wire, the outer surface of the thin steel wire is coated with a red insulating layer when the thin steel wire is matched with an anode wire, the outer surface of the thin steel wire is coated with a black insulating layer when the thin steel wire is matched with a cathode wire, white scale marks are formed on the surfaces of the thin steel wires with two colors, the right end of the thin steel wire is connected with a penetrating needle for penetrating out from the skin, the left end of the thin steel wire is fixedly connected with the right end of a double-ball frame, the double-ball frame is formed by braiding nickel-titanium memory alloy wires, the double-ball frame is dumbbell-shaped when the double-ball frame is not subjected to external force, the whole double-ball frame can be elongated into an elongated strip shape when the double-ball frame is pulled by external force, and the small balls on the right side of the double-ball frame are elongated when the small balls on the right side of the double-ball frame are pressed by external force, and the small balls on the left side of the small balls are also elongated and become long at the same time; the outside of pipe subassembly is a pipe, wear a stay wire in the pipe, respectively fastening connection has a cylindric rubber head after the stay wire is worn out from the both ends of pipe, the external diameter of rubber head is less than the internal diameter of pipe, and when the rubber head of one side of pipe is pricked to the rubber needle of penetrating of fixed line right-hand member, the rubber head of the other side of drawing the pipe again can be followed the rubber needle of penetrating the other side of pipe and drawn.

The application method of the invention comprises the following steps: when an epicardium lead is arranged after chest opening, an expansion ring and a puncture needle at the leftmost end of the lead are inserted into a hollow needle, then the hollow needle penetrates into and out of the epicardium or the myocardium, the expansion ring is penetrated out of the epicardium or the myocardium by utilizing the guiding function of the hollow needle, meanwhile, the puncture needle is retained in the epicardium or the myocardium, the expansion ring is expanded by using the left hand to form an elliptical ring shape, a double-ball frame at the left end of a fixed line is compressed into an elongated strip shape by using the right hand and then penetrates into the expansion ring, and then the left hand and the right hand are relaxed, at the moment, the expansion ring is exactly clamped in the middle part of the double-ball frame, and the puncture needle cannot float under the combined function of the double-ball frame and the single-ball frame, so that the puncture needle is fixed on the epicardium or the myocardium; and then the skin penetrating needle at the right ends of the lead and the fixed wire penetrates out of the human abdomen epidermis, the scale marks on the lead and the fixed wire are observed to pull out the redundant lead and the fixed wire in the human body to fix the lead and the fixed wire on the body surface, and finally the skin penetrating needle at the right ends of the anode lead and the cathode lead is connected with the pacemaker, so that the installation of the pacing lead is completed. When the pacemaker lead is required to be pulled out, the lead and the fixing wire are only required to be fixed on the body surface, and then the fixing wire is slowly pulled out of the body, so that the double-ball frame can prop open the expansion ring a bit under the condition of being subjected to pulling force and expansion ring resistance, and meanwhile, the double-ball frame is pulled to be thin and long, so that the double-ball frame can be easily pulled out of the expansion ring until the pacemaker lead is pulled out of the body, and the left end of the lead at the moment can be easily pulled out of the body because the constraint of the double-ball frame is lost. If resistance is encountered when the fixing wire is pulled at the beginning, a rubber head and a pull wire on the catheter assembly can be used for leading a skin penetrating needle at the right end of the fixing wire into and out of the catheter, then the catheter is pushed into the body along the track of the thin steel wire in the middle of the fixing wire until the thin steel wire is propped against the double-ball frame, at the moment, the thin steel wire is pulled slightly in vitro, the double-ball frame gradually contracts to be changed into a slender strip shape under the combined action of the pushing force of the catheter and the pulling force of the thin steel wire, the double-ball frame gradually pulls out of the expansion ring and simultaneously enters the catheter, then the double-ball frame and the catheter can be pulled out of the body together, and finally the wire which is out of the constraint of the double-ball frame is pulled out of the body.

The invention has the beneficial effects that: the invention can easily connect the pacemaker lead at the myocardial or epicardium without sewing, and has small resistance when pulling out the pacemaker lead, and the lead can be easily pulled out of the body by pulling out the fixing wire at the leftmost end of the inserted lead, thereby effectively solving the problem that the pacemaker lead is not easy to pull out in operation and the problem that the heart bleeding possibly occurs due to the force pulling of the lead endangers the life of patients.

Drawings

Fig. 1 is a schematic view of a wire in a natural state.

Fig. 2 is a schematic view of the expansion ring and the single-ball frame at the left end of the guide wire when external force is applied.

Fig. 3 is a schematic view of the fixing line in a natural state.

Fig. 4 is a schematic view of the left end of the fixing wire when being pulled by an external force.

Fig. 5 is a schematic view of a double ball cage inserted into an expansion ring.

Fig. 6 is a schematic view of a catheter assembly.

Reference numerals illustrate: in the figures, 1.1.lead, 2.fixed wire, 3.catheter assembly, 1.1.conductive wire, 1.2 percutaneous needle, 1.3 single balloon carrier, 1.4 puncture needle, 1.5 expansion loop, 2.1 thin wire, 2.2 percutaneous needle, 2.3 double balloon carrier, 3.1 catheter, 3.2 pull wire, 3.3 rubber head.

Detailed Description

The utility model provides a suture-free epicardial temporary pacemaker lead suit, includes wire 1, fixed line 2, pipe subassembly 3, the middle main part of wire 1 is a stainless steel conducting wire 1.1 that the outward scribbles the insulating layer from mark G to H, length is 300 millimeters, the sinle silk diameter is 0.5 millimeter, and the conducting wire 1.1 that connects the pacemaker positive pole is red in its insulating layer, and the conducting wire 1.1 that connects the pacemaker negative pole is black in its insulating layer, all have white size scale mark outside the insulating layer of conducting wire 1.1, the right-hand member of conducting wire 1.1 is from mark H to K fixedly connected with a skin penetrating needle 1.2 for wear out wire 1 from subcutaneous, the left end of conducting wire 1.1 is connected a single ball frame 1.3 from mark G to C, the single ball frame 1.3 is formed by braiding nickel-titanium memory alloy wires with the diameter of 0.2 mm, the single ball frame 1.3 is elliptical in a natural state, the long axis is 4 mm, the short axis is 2 mm, the single ball frame 1.3 can be in an elongated strip shape when being pulled by a conductive wire 1.1, the left end of the single ball frame 1.3 is connected with a puncture needle 1.4 from a mark C to a mark B, the length of the puncture needle 1.4 is 10 mm, the diameter of the puncture needle is 0.6 mm, the left end of the puncture needle 1.4 is welded with an expansion ring 1.5 formed by folding the nickel-titanium memory alloy wires from the mark B to the mark A, the diameter of the alloy wires is 0.3 mm, the expansion ring 1.5 is in the elongated strip shape when not subjected to external force, the length of the expansion ring 1.5 mm can be expanded into an elliptical ring when the expansion ring is subjected to external force; the middle main body part of the fixing wire 2 is provided with a stainless steel thin steel wire 2.1 from a mark F to M, the diameter is 0.5 millimeter, the length is 700 millimeter, the outer surface of the thin steel wire 2.1, which is used in cooperation with an anode lead 1, is coated with a red insulating layer, the outer surface of the thin steel wire 2.1, which is used in cooperation with a cathode lead 1, is coated with a black insulating layer, white scale marks are respectively arranged on the outer surface insulating layers of the thin steel wires 2.1 with two colors, the right end of the thin steel wire 2.1 is connected with a skin penetrating needle 2.2 from the mark M to N for penetrating from the skin, the left end of the thin steel wire 2.1 is fixedly connected with a double ball frame 2.3 from the mark F to D, the double ball frame 2.3 is formed by braiding nickel-titanium memory alloy wires with the diameter of 0.2 millimeter, the long axis of each small ball is 4 millimeter when the double ball frame 2.3 is not subjected to external force, the whole double ball frame 2.3 is elongated to the long axis of the small ball when the small ball frame is subjected to external force, and the long ball frame is also elongated to the small ball frame is deformed to the long and the small ball frame is deformed when the small ball frame is deformed to the long when the small ball frame is deformed to the small ball frame; the outside of the catheter assembly 3 is a catheter 3.1, the diameter of an inner hole of the catheter 3.1 is 1.2 mm, the length of the inner hole is 300 mm, a pull wire 3.2 is penetrated in the catheter 3.1, the pull wires 3.2 are respectively fixedly connected with a cylindrical rubber head 3.3 after penetrating out from two ends of the catheter 3.1, the outer diameter of the rubber head 3.3 is smaller than the inner diameter of the catheter 3.1, and when a penetrating needle 2.2 at the right end of a fixed wire 2 is penetrated into the rubber head 3.3 at one side of the pull wire 3.2, the rubber head 3.3 at the other side of the pull wire 3.2 is pulled, so that the penetrating needle 2.2 can be led out from the other side of the catheter 3.1. When the device is used, the left end of the lead 1 penetrates into epicardium or cardiac muscle from the puncture needle 1.4 marked with B to C, the midpoint of the double-ball frame 2.3 at the left end of the fixed lead 2, namely the marked E point, is clamped in the expansion ring 1.5 at the left end of the lead 1, so that the lead 1 cannot move at the epicardium, and the expansion ring 1.5 automatically recovers to be long after the double-ball frame 2.3 is pulled out, so that the lead can be easily pulled out from the epicardium or cardiac muscle.

Claims (7)

1. A suture-free epicardial temporary pacemaker lead wire set, characterized by: the medical catheter comprises a wire, a fixed wire and a catheter assembly, wherein the middle main body part of the wire is a soft conductive wire with an insulating layer coated on the outer surface, the right end of the conductive wire is fixedly connected with a skin penetrating needle, the left end of the conductive wire is connected with a single ball frame, the left end of the single ball frame is connected with a penetrating needle, and the left end of the penetrating needle is connected with an expansion ring formed by folding nickel-titanium memory alloy wires; the middle main body part of the fixing wire is a thin steel wire, the right end of the thin steel wire is connected with a skin penetrating needle, and the left end of the thin steel wire is fixedly connected with the right end of a double-ball frame; the outside of pipe subassembly is a pipe, wear a stay wire in the pipe, the stay wire is worn out from the both ends of pipe and is connected with a cylindrical rubber head respectively fastening.

2. A suture-free epicardial temporary pacemaker lead wire set according to claim 1 wherein: when the lead is used as an anode lead, the insulating layer of the conductive wire is red, and when the lead is used as a cathode lead, the insulating layer of the conductive wire is black, and white size scale marks are arranged outside the insulating layer.

3. A suture-free epicardial temporary pacemaker lead wire set according to claim 1 wherein: the single ball frame is formed by weaving nickel-titanium memory alloy wires, is elliptical in nature and is in an elongated strip shape when being pulled by a conductive wire.

4. A suture-free epicardial temporary pacemaker lead wire set according to claim 1 wherein: the expansion ring is in an elongated strip shape when not subjected to external force, and can be expanded to be in an elliptical ring shape when subjected to external force.

5. A suture-free epicardial temporary pacemaker lead wire set according to claim 1 wherein: the outer surface of the thin steel wire is coated with a red insulating layer when being matched with an anode wire, the outer surface of the thin steel wire is coated with a black insulating layer when being matched with a cathode wire, and white scale marks are formed on the surfaces of all the insulating layers.

6. A suture-free epicardial temporary pacemaker lead wire set according to claim 1 wherein: the double-ball frame is formed by weaving nickel-titanium memory alloy wires, the double-ball frame is dumbbell-shaped when not subjected to external force, the whole double-ball frame can be elongated to be elongated and strip-shaped when being pulled by external force, and when the external force presses the small ball on the right side to enable the small ball to be thin and long, the small ball on the left side of the small ball can be thin and long at the same time.

7. A suture-free epicardial temporary pacemaker lead wire set according to claim 1 wherein: the outer diameter of the rubber head is smaller than the inner diameter of the guide pipe.

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