A suture-free epicardial temporary pacemaker lead set

Abstract

The present invention relates to a suture-free epicardial temporary pacemaker lead kit, which is used for installing a temporary pacemaker after cardiac surgery. Generally, the temporary pacing lead can be removed when there is no need for pacing for 72 consecutive hours after surgery. The pacemaker lead can also be removed after the patient's condition stabilizes and improves, which should not exceed one month. If the lead is not removed, it is very likely to cause infection, and even a debridement operation may be required. Due to various reasons, it is still common for the pacemaker lead to be temporarily unable to be removed. In this case, another thoracotomy is often required, which not only increases the pain and burden of the patient, but also is a hidden danger causing medical disputes. The beneficial effects of the present invention: the use of the present invention can easily connect the pacemaker lead to the epicardium without suture, and when removing the pacemaker lead, it is only necessary to pull out the fixed line inserted into the left end of the lead to easily pull the lead out of the body, effectively solving the problem that the pacemaker lead is difficult to remove during surgery.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a suture-free epicardial temporary pacemaker lead set, which is used for installing a temporary pacemaker after cardiac surgery. Background Art

[0002] A pacemaker is an electronic therapeutic device implanted in the body. It consists of a pulse generator and a metal wire connected to it. The pulse generator emits electrical pulses powered by a battery. These pulses are conducted through the wire electrodes to stimulate the myocardium touched by the electrodes, causing the heart to become excited and contracted, thereby achieving the purpose of treating heart dysfunction caused by certain arrhythmias.

[0003] After open-heart surgery, various types of arrhythmias, conduction block, bradycardia, and heart rhythm disturbances often occur. Implanting a temporary epicardial pacemaker is an effective treatment option to overcome the low cardiac output syndrome caused by the aforementioned symptoms. It also plays an important role in managing complications such as postoperative arrhythmias and improving hemodynamics early on. Currently, intraoperative placement of temporary epicardial pacing leads and the use of temporary pacemakers are considered effective methods for preventing arrhythmias and maintaining hemodynamic stability after cardiac surgery. Furthermore, for cardiovascular patients who require temporary pacing treatment when transvenous pacemaker lead implantation is difficult, such as with vascular occlusion, tricuspid atresia, post-tricuspid valve replacement surgery, lead inability to pass, and repeated dislocation of transvenous electrode leads, the use of temporary epicardial pacing is an irreplaceable method.

[0004] Currently, epicardial temporary pacemaker leads used during open cardiac surgery are made of metal and consist of a braided guidewire with a suture needle. Examples include the Medtronic Capsure Epi-4965 monopolar steroid lead and the Capsure Epi-496817 bipolar steroid lead. Traditional epicardial temporary pacemaker lead placement involves suturing the negative lead directly to the avascular myocardium of the anterior right ventricle, and the anode lead directly to the epicardium of the right ventricle. The two leads are spaced at least 2 cm apart. Atraumatic sutures are used to secure and stop bleeding, depending on the presence of bleeding. Once testing parameters are satisfactory and there is no diaphragmatic irritation, the pacemaker lead is passed under the costal margin, secured to the body surface, and then connected to the pulse generator. Generally, the temporary pacemaker lead can be removed after 72 consecutive hours without pacing. Alternatively, the lead can be removed after the patient's condition stabilizes and improves, for a maximum of one month. Failure to remove the lead can lead to infection and may even require debridement.

[0005] When removing a temporary epicardial pacemaker lead after the patient has recovered, if the lead is accidentally left in the body for various reasons, it may irritate wound healing and even cause local infection, resulting in varying degrees of adverse effects on the patient. Removal of a temporary epicardial pacemaker lead requires simply cutting the retaining sutures on the surface of the body and gently removing the lead with sustained force. Due to the lead's location and the myocardial distortion and high suture forces often associated with suturing, removal may result in complications such as lead breakage, arrhythmias, intraventricular epistaxis, and cardiac tamponade. Therefore, when removing a temporary pacemaker lead, apply even force and remove slowly, carefully monitoring the patient's response. Close observation for bleeding or cardiac tamponade should be performed for 24 hours after removal. For various reasons, temporary pacemaker lead removal can sometimes be difficult, often requiring further thoracotomy. This not only increases the patient's pain and burden but also poses a potential risk of medical disputes. It can be seen that the most critical step after surgical epicardial temporary pacemaker implantation is to remove the epicardial temporary pacemaker electrode wire. However, when removing the pacemaker wire, it is often encountered that the wire is adhered to the epicardial tissue or the wire is tightly sutured to the epicardium and difficult to remove. At this time, if the wire is forcibly pulled out, it is very likely to cause cardiac bleeding, endangering the patient's life, and thoracotomy is performed to stop the bleeding. Summary of the Invention

[0006] The purpose of the present invention is to overcome the deficiencies of the above-mentioned prior art and to provide a suture-free epicardial temporary pacemaker lead kit. When using the present invention, since no suture is required between the lead and the myocardium or epicardium, the pacing lead can be easily removed when the pacemaker is removed. This effectively solves the problem of being unable to remove the pacemaker lead during surgery while slowly applying force, and the problem of cardiac bleeding that may endanger the patient's life due to forcible pulling on the lead.

[0007] In order to achieve the above-mentioned purpose, the technical solution adopted by the present invention is: a suture-free epicardial temporary pacemaker lead set, including a lead, a fixing wire, and a catheter assembly. The middle main body of the lead is a soft conductive wire with an insulating layer on the outer surface. The insulating layer of the lead used as the anode lead is red, and the insulating layer of the lead used as the cathode lead is black. The insulating layer of the lead is provided with white size scale markings. The right end of the conductive wire is fixedly connected to a skin needle for passing through the skin. The left end of the conductive wire is connected to a single ball rack, which is woven from nickel-titanium memory alloy wire. The single ball rack is elliptical in its natural state, and can be slender when pulled by the conductive wire. The left end of the single ball rack is connected to a puncture needle, and the left end of the puncture needle is connected to an expansion ring folded from nickel-titanium memory alloy wire. The expansion ring is slender when not subject to external force, and can be stretched to an elliptical ring when subjected to external force. The above-mentioned single ball rack and expansion ring have the function of controlling the puncture needle to penetrate into the myocardium or epicardium. The middle main body of the fixed line is a thin steel wire. When used with the anode wire, the surface of the thin steel wire is coated with a red insulating layer. When used with the cathode wire, the surface of the thin steel wire is coated with a black insulating layer. The surfaces of the two colors of thin steel wires are both made with white scale lines. The right end of the thin steel wire is connected to a skin-piercing needle for passing through the skin. The left end of the thin steel wire is fixedly connected to the right end of a double-ball rack. The double-ball rack is woven from nickel-titanium memory alloy wire. The double-ball rack is dumbbell-shaped when not subjected to external force and is dumbbell-shaped when subjected to external force. When pulled with force, the entire double-ball rack can be stretched into a slender strip. When external force presses the small ball on the right side of the double-ball rack to make it thinner and longer, the small ball on its left side will also become thinner and longer at the same time. The outside of the catheter assembly is a catheter, and a pull wire is passed through the catheter. After the pull wire passes through the two ends of the catheter, each is fastened to a cylindrical rubber head. The outer diameter of the rubber head is smaller than the inner diameter of the catheter. When the skin-piercing needle at the right end of the fixed line is inserted into the rubber head on one side of the catheter and then the rubber head on the other side of the catheter is pulled, the skin-piercing needle can be led out from the other side of the catheter.

[0008] The method of use of the present invention is as follows: when installing the epicardial lead after thoracotomy, the expansion ring and the puncture needle at the leftmost end of the lead are inserted into the hollow needle, and then the hollow needle is penetrated into and out of the epicardium or myocardium, and the expansion ring is penetrated out of the epicardium or myocardium by the guiding effect of the hollow needle, while the puncture needle is retained in the epicardium or myocardium, the expansion ring is expanded into an elliptical ring with the left hand, and then the double ball rack at the left end of the fixing wire is compressed into a slender strip with the right hand, and then the expansion ring is penetrated, and then the left and right hands are relaxed. At this time, the expansion ring is just clamped in the middle of the double ball rack, and the puncture needle cannot move under the combined action of the double ball rack and the single ball rack, so that the puncture needle is fixed to the epicardium or myocardium; then the skin-piercing needle at the right end of the lead wire and the fixing wire is penetrated out of the human abdominal epidermis, the scale lines on the lead wire and the fixing wire are observed, and the excess lead wire and fixing wire in the human body are pulled out and fixed to the body surface, and finally the skin-piercing needle at the right end of the anode lead and the cathode lead is connected to the pacemaker, thus completing the installation of the pacing lead. To remove the pacemaker lead, simply release the lead and fixation wire from the body's surface. Then, slowly pull the fixation wire from outside the body. The double-ball holder, under the combined force of the pull and the resistance of the expansion ring, slightly expands the expansion ring, simultaneously stretching the double-ball holder itself. This allows the double-ball holder to be easily pulled out of the expansion ring and out of the body. The left end of the lead, now freed from the restraint of the double-ball holder, can also be easily removed. If resistance is encountered when initially pulling the fixation wire, the rubber tip of the catheter assembly and the pull wire can be used to guide the transdermal needle at the right end of the fixation wire through the catheter. The catheter can then be pushed into the body along the path of the thin steel wire in the middle of the fixation wire until it strikes the double-ball holder. At this point, gently pull the thin steel wire from outside the body. The combined force of the catheter's push and the wire's pull will cause the double-ball holder to gradually contract into a long, thin strip, gradually pulling out of the expansion ring and into the catheter. The double-ball holder and catheter can then be pulled out of the body together, and the lead, freed from the restraint of the double-ball holder, can be removed.

[0009] The beneficial effects of the present invention are as follows: the present invention can be used to easily connect a pacemaker lead to the myocardium or the epicardium without suturing. Since there is no suturing between the lead and the myocardium or the epicardium, there is little resistance when removing the pacemaker lead. The lead can be easily pulled out of the body by simply pulling out the fixing wire at the leftmost end of the lead. This effectively solves the problem of difficult removal of the pacemaker lead during surgery and the problem of cardiac bleeding that may endanger the patient's life due to forcible pulling of the lead. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 Schematic diagram of the wire in its natural state.

[0011] Figure 2 This is a schematic diagram of the expansion ring and single ball bracket at the left end of the conductor being subjected to external force.

[0012] Figure 3Schematic diagram of the fixed line in its natural state.

[0013] Figure 4 This is a schematic diagram of the left end of the fixed line being pulled by external force.

[0014] Figure 5 Schematic diagram of the double ball rack after the expansion ring is inserted.

[0015] Figure 6 A schematic diagram of the catheter assembly.

[0016] Explanation of the accompanying reference numerals: In the figure, 1. guide wire, 2. fixing wire, 3. catheter assembly, 1.1. conductive wire, 1.2. percutaneous needle, 1.3. single ball rack, 1.4. puncture needle, 1.5. expansion ring, 2.1. thin steel wire, 2.2. percutaneous needle, 2.3. double ball rack, 3.1. catheter, 3.2. pull wire, 3.3. rubber head. DETAILED DESCRIPTION

[0017] A sutureless epicardial temporary pacemaker lead set includes a lead 1, a fixing wire 2, and a catheter assembly 3. The middle main body of the lead 1, from mark G to H, is a stainless steel conductive wire 1.1 coated with an insulating layer on the surface, with a length of 300 mm and a core diameter of 0.5 mm. The insulating layer of the conductive wire 1.1 connected to the anode of the pacemaker is red, and the insulating layer of the conductive wire 1.1 connected to the cathode of the pacemaker is black. The insulating layer of the conductive wire 1.1 is provided with white size scale lines. The right end of the conductive wire 1.1 is fixedly connected to a skin needle 1.2 from mark H to K for passing the lead 1 out from under the skin. The left end of the conductive wire 1.1 is connected to a single ball rack 1.3 from mark G to C. The single ball rack 1.3 is composed of a 0.2 mm diameter needle. The single ball rack 1.3 is woven from nickel-titanium memory alloy wire of meters. The single ball rack 1.3 is elliptical in its natural state, with a major axis of 4 mm and a minor axis of 2 mm. The single ball rack 1.3 can be slender when pulled by the conductive wire 1.1. The left end of the single ball rack 1.3 is connected with a puncture needle 1.4 from mark C to B. The puncture needle 1.4 is 10 mm long and 0.6 mm in diameter. The left end of the puncture needle 1.4 is welded with an expansion ring 1.5 folded from nickel-titanium memory alloy wire from mark B to A. The diameter of the alloy wire is 0.3 mm. The expansion ring 1.5 is slender when not subject to external force and is 5 mm long. The expansion ring 1.5 can be stretched into an elliptical ring when subjected to external force; the middle main body of the fixed line 2 is a stainless steel wire from mark F to M. A thin steel wire 2.1 having a diameter of 0.5 mm and a length of 700 mm. The thin steel wire 2.1 used in conjunction with the anode wire 1 is coated with a red insulating layer, and the thin steel wire 2.1 used in conjunction with the cathode wire 1 is coated with a black insulating layer. Both colors of thin steel wire 2.1 have white scale lines on the outer surface of the insulating layer. The right end of the thin steel wire 2.1 is connected to a skin-piercing needle 2.2 marked from M to N for passing through the skin. The left end of the thin steel wire 2.1 is fixedly connected to a double ball rack 2.3 marked from F to D. The double ball rack 2.3 is woven from a nickel-titanium memory alloy wire with a diameter of 0.2 mm. The double ball rack 2.3 is dumbbell-shaped when not subjected to external force, and the major axis of each ball is 4 mm and the minor axis is 2 mm. When subjected to external force, the entire double ball rack 2.3 can be stretched into a slender strip. When the external force presses the small ball on the right side of the double ball rack 2.3 to make it thinner and longer, the small ball on its left side will also become thinner and longer at the same time. The outside of the catheter assembly 3 is a catheter 3.1. The inner hole diameter of the catheter 3.1 is 1.2 mm and the length is 300 mm. A pull wire 3.2 is passed through the catheter 3.1. The pull wire 3.2 passes through the two ends of the catheter 3.1 and is fastened to a cylindrical rubber head 3.3. The outer diameter of the rubber head 3.3 is smaller than the inner diameter of the catheter 3.1. When the skin-piercing needle 2.2 at the right end of the fixed line 2 is inserted into the rubber head 3.3 on one side of the pull wire 3.2 and then the rubber head 3.3 on the other side of the pull wire 3.2 is pulled, the skin-piercing needle 2.2 can be removed from the catheter 3.During use, the left end of the guidewire 1 is inserted into the epicardium or myocardium from the puncture needle 1.4 marked B to C. The midpoint of the double-ball holder 2.3 at the left end of the fixing wire 2, marked point E, is trapped within the expansion ring 1.5 at the left end of the guidewire 1, preventing the guidewire 1 from moving in the epicardium. When the double-ball holder 2.3 is removed, the expansion ring 1.5 automatically returns to its long strip shape, allowing easy removal from the epicardium or myocardium.

Claims

1. A sutureless epicardial temporary pacemaker lead set, characterized by: Including wires , a fixing wire and a catheter assembly, wherein the middle main body of the wire is a soft conductive wire coated with an insulating layer, the right end of the conductive wire is fixedly connected to a skin-piercing needle, the left end of the conductive wire is connected to a single-ball rack, the left end of the single-ball rack is connected to a puncture needle, and the left end of the puncture needle is connected to an expansion ring folded from a nickel-titanium memory alloy wire; the middle main body of the fixing wire is a thin steel wire, the right end of the thin steel wire is connected to a skin-piercing needle, and the left end of the thin steel wire is fixedly connected to the right end of a double-ball rack; the outside of the catheter assembly is a catheter, a pull wire is passed through the catheter, and the pull wire passes through both ends of the catheter and is fastened to a cylindrical rubber head; The single ball rack is woven from nickel-titanium memory alloy wire. The single ball rack is elliptical in its natural state and becomes a thin strip when pulled by the conductive wire. The expansion ring is in the shape of a thin strip when not subject to external force, and can be expanded into an elliptical ring when subjected to external force; The double-ball rack is woven from nickel-titanium memory alloy wire. When not subject to external force, the double-ball rack is dumbbell-shaped. When pulled by external force, the entire double-ball rack can be stretched into a slender strip. When external force presses the small ball on the right side to make it thinner and longer, the small ball on its left side will also become thinner and longer at the same time.

2. The sutureless epicardial temporary pacemaker lead kit according to claim 1, characterized in that: When the wire is used as an anode wire, the insulating layer of the conductive wire is red; when used as a cathode wire, the insulating layer of the conductive wire is black; and there are white size scale markings outside the insulating layer.

3. The sutureless epicardial temporary pacemaker lead kit according to claim 1, characterized in that: The outer surface of the thin steel wire is coated with a red insulating layer when used in conjunction with an anode wire, and is coated with a black insulating layer when used in conjunction with a cathode wire. White scale lines are formed on the surfaces of all insulating layers.

4. The sutureless epicardial temporary pacemaker lead kit according to claim 1, characterized in that: The outer diameter of the rubber head is smaller than the inner diameter of the catheter.

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