Absorbable pace-making lead

Abstract

The invention belongs to the field of medical instruments, and particularly relates to an absorbable pace-making wire, which comprises a chest wall penetrating steel needle, a magnesium metal wire, a zinc film coated electrode, a single-strand wire, a coil and a curved needle, the magnesium metal wire is mounted at one end of the chest wall penetrating steel needle, and the zinc film coated electrode is mounted at one end of the magnesium metal wire; one end of the zinc film wrapped electrode is provided with the single-strand wire and the coil, one end of the single-strand wire and one end of the coil are provided with the curved needle, the magnesium metal wire is wrapped by a layer of absorbable material film (such as polycaprolactone material), and the electrode part of the magnesium metal wire in contact with the cardiac muscle is not provided with a polymer coating and is only wrapped by zinc foil. According to the invention, a temporary cardiac pacing effect can be achieved after an operation, and slow degradation and absorption can be gradually realized by a human body in about one year. Complication and secondary operation are avoided, performance is improved by means of innovative materials, electric signal transmission is guaranteed through structure optimization, and a better choice is provided for temporary pacing in cardiac surgery.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to an absorbable pacing lead. Background Art

[0002] In cardiac surgery, cardiac pacing technology is essential to maintain the normal heart rhythm of patients, and cardiac pacing wires are the key components to achieve this technology. Currently, existing cardiac pacing wires face many problems in clinical applications.

[0003] Traditional cardiac pacing wires are accompanied by a series of complications in postoperative treatment, whether they are removed or left in place. Removing the wire may cause risks such as bleeding, while leaving the wire in place can easily lead to retrograde infection, chronic inflammation and other problems, seriously affecting the patient's postoperative recovery. If a second operation is required to remove the wire, it will not only cause additional physical pain to the patient, but will also significantly increase medical expenses and increase the patient's financial burden. Summary of the invention

[0004] The purpose of the present invention is to provide an absorbable pacing lead, which effectively solves the complications existing in the prior art, reduces medical risks and costs, and at the same time improves the safety and effectiveness of cardiac pacing, providing a better solution for temporary cardiac pacing in cardiac surgery.

[0005] To achieve the above-mentioned object, the present invention provides the following technical solutions: an absorbable pacing lead, comprising a chest wall piercing steel needle, a magnesium metal lead, a zinc film wrapped electrode, a single strand and a coil, and a curved needle, wherein one end of the chest wall piercing steel needle is installed with a magnesium metal lead, and one end of the magnesium metal lead is installed with a zinc film wrapped electrode, one end of the zinc film wrapped electrode is installed with a single strand and a coil, and one end of the single strand and the coil is installed with a curved needle;

[0006] The magnesium metal wire replaces the traditional steel wire and is used for the electrical signal transmission of the pacing wire. In order to prevent the loss of electrical information, an insulating polymer coating is provided on the surface of the magnesium metal wire, such as a polycaprolactone film or a polycaprolactone plus polylactic acid mixed film. In order to prevent the magnesium metal wire from being corroded and breaking prematurely, the position where the magnesium metal wire contacts the myocardium is wrapped with corrosion-resistant zinc foil. On the one hand, the transmission of electrical signals can be guaranteed. On the other hand, zinc is also an absorbable material that is safe for the human body. The thickness is only 0.01-0.02MM and it can be completely absorbed in about a year.

[0007] Preferably, the magnesium metal conductor uses magnesium metal wire as the conductor.

[0008] Preferably, the zinc film wrapped electrode is made of magnesium wire wrapped zinc foil.

[0009] Preferably, a hole is provided at one end of the chest wall piercing steel needle, and a folding groove is provided at one quarter of the side surface of the chest wall piercing steel needle.

[0010] Preferably, the single strand and the coil are made of absorbable material and are spring-shaped.

[0011] Compared with the prior art, the present invention has the following beneficial effects: the present invention adopts bioabsorbable materials to make the main wire structure, which can be naturally degraded in the body after completing the temporary pacing function in cardiac surgery, without the need for secondary surgery to remove it, effectively avoiding complications such as retrograde infection, tissue adhesion, bleeding, etc. caused by traditional wire removal or retention, and significantly reducing the medical risks and physical pain of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a schematic structural diagram of the main body of the present invention.

[0013] Figure 2 It is a three-dimensional schematic diagram of the chest wall piercing steel needle of the present invention.

[0014] Figure 1 In: 1. Steel needle for piercing the chest wall; 2. Magnesium metal wire; 3. Zinc film wrapped electrode; 4. Single strand wire and coil; 5. Curved needle. DETAILED DESCRIPTION

[0015] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0016] according to Figure 1-Figure 2As shown, it includes a chest wall piercing steel needle 1, a magnesium metal wire 2, a zinc film wrapped electrode 3, a single-strand wire and a coil 4, and a curved needle 5. One end of the chest wall piercing steel needle 1 is installed with a magnesium metal wire 2, and one end of the magnesium metal wire 2 is installed with a zinc film wrapped electrode 3, one end of the zinc film wrapped electrode 3 is installed with a single-strand wire and a coil 4, and one end of the single-strand wire and the coil 4 is installed with a curved needle 5. The outer diameter of the chest wall piercing steel needle 1 is 0.86 mm and the length is 8.8 cm. One end of the chest wall piercing steel needle 1 has a hole, and the hole is used to clamp the magnesium metal wire, which is convenient for removing the sharp part of the needle tip after the cardiac pacing magnesium metal wire surgery is completed, so that the remaining part can be smoothly inserted into the pacemaker. A folding groove is left at one quarter of the side surface of the chest wall piercing steel needle 1. The magnesium metal wire 2 uses magnesium metal wire as the wire. The magnesium metal wire 2 A polymer material is used as the wrapping insulation layer of magnesium metal. The magnesium metal here can be pure magnesium wire or magnesium-zinc alloy. The magnesium metal wire 2 replaces the traditional 316 steel wire and is used for the electrical signal transmission of the pacing wire. In order to prevent the loss of electrical information, an insulating polymer coating is arranged on the surface of the magnesium metal wire 2, such as a polycaprolactone film or a polycaprolactone plus polylactic acid mixed film. At the position where the magnesium wire contacts the myocardium, in order to prevent the magnesium wire from being corroded and breaking prematurely, a corrosion-resistant zinc foil is used for wrapping. On the one hand, the conduction of electrical signals can be guaranteed. On the other hand, zinc is also an absorbable material that is safe for the human body. The thickness is only 0.01-0.02MM and it can be completely absorbed in about one year. The zinc film wrapped electrode 3 is made of magnesium wire wrapped in zinc foil to prevent premature corrosion and breakage. An ultra-thin zinc foil with a thickness of 0.01MM can be selected, and the number of wrapped layers can be controlled to control the degradation time. The coating layer of the magnesium metal wire 2 is made of polycaprolactone. Because polycaprolactone is a degradable material, or a mixed material of polycaprolactone and polylactic acid is used, or other degradable polymer materials are used. The polycaprolactone coating acts as insulation, so that the current of the pacemaker can be connected to the sinoatrial node through the magnesium wire, so that leakage does not occur. The single-strand wire and coil 4 are made of absorbable material and are spring-shaped, which can prevent the pacing wire from slipping. If the process is to be simplified, pure magnesium wire can also be directly used here, which is simple to process and has a firm connection.

[0017] The tail end of the steel needle 1 that penetrates the chest wall has a clamping hole, which can clamp the magnesium metal wire 2. The zinc film wrapped electrode 3 can wrap the connection part between the single-strand coil 4 and the magnesium metal wire 2. The magnesium wire exposed on the surface directly contacts the muscle or blood, so that the magnesium wire produces unpredictable oxidation damage. The tip of the curved needle 5 is a round needle, and the tail of the needle has a clamping hole, which can clamp the single-strand coil 4. The inner layer of the magnesium metal wire 2 is made of magnesium or magnesium-zinc alloy. In actual use, the elongation of pure magnesium or magnesium-zinc alloy can reach 15%-30%, and can be stretched to 0.3MM. This diameter is more in line with the thickness of the indwelling pacing wire after clinical cardiac surgery. However, the elongation of magnesium-calcium alloy is low, and it is difficult to stretch to 0.3MM, and calcium metal is easy to present small blocks in the alloy. In repeated tests, the author broke in small calcium metal blocks. Therefore, the author believes that magnesium-calcium alloy is not suitable for this purpose.

[0018] There is a needle clamping hole at the tail end of the chest wall piercing needle 1, which can clamp the magnesium metal wire 2, thereby preventing the tail end of the chest wall piercing needle 1 from falling off from one end of the magnesium metal wire 2. During installation, the magnesium metal wire 2 is placed inside the tail end of the chest wall piercing needle 1, and then the tail end of the chest wall piercing needle 1 is plastically deformed by a pressure needle and cold-clamped. One end of the chest wall piercing needle 1 is installed and arranged with one end of the magnesium metal wire 2. The tips of the chest wall piercing needle 1 and the curved needle 5 are both in the shape of puncture needles. An easy-to-break groove is left at one-quarter of the needle body of the chest wall piercing needle 1, which is convenient for removing the sharp part of the needle tip after the cardiac pacing magnesium metal wire surgery is completed, so that the remaining part of the chest wall piercing needle 1 can be smoothly inserted into the pacemaker, and one end of the curved needle 5 is in the shape of a puncture needle, so that the curved needle 5 and the single-strand coil 4 can be smoothly inserted into the epicardium in the human body. The curved needle 5 is made of stainless steel and is exposed. After the cardiac pacing magnesium metal wire is sutured, one end of the curved needle 5 passes through the myocardial surface, and the curved needle 5 is cut off and thrown away. During the use of the cardiac pacing magnesium metal wire, current will pass through, and the current will produce an electrolytic reaction that causes the magnesium wire and the magnesium metal wire to break. The polycaprolactone coating and zinc film wrapped electrode setting can prevent the magnesium wire and the magnesium metal wire from breaking, thereby protecting the magnesium wire and the magnesium metal wire.

[0019] Degradable materials are intended to provide temporary support for the healing process of patients or damaged tissues, and then gradually degrade. Iron, magnesium, zinc and their alloys are currently the three absorbable metal families, and magnesium-based alloys have the fastest development and the largest amount of experimental data in basic research and translational research. The research and development of magnesium alloy medical products is currently focused on bone fixation materials, vascular stents, porous magnesium tissue engineering materials and plastic repair materials. The present invention can use the new biodegradable biomedical magnesium alloy material as a temporary pacing wire in cardiac surgery, avoiding the complications of removing or retaining temporary pacing wires and the risk of secondary surgery, thereby reducing medical costs.

[0020] The applicant also conducted an experiment on the degradation of pure magnesium wire, and concluded that: when pure magnesium wire was dissolved in physiological saline under 5V direct current, with magnesium wire as the anode and stainless steel as the cathode, it was found that the magnesium wire decomposed in one minute, while when pure magnesium wire was dissolved in physiological saline under 5V direct current, with magnesium wire as the anode and stainless steel as the cathode, it was found that the pure magnesium wire did not decompose and bubbles were generated.

[0021] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An absorbable pacing lead wire, comprising a chest wall piercing steel needle (1), a magnesium metal wire (2), a zinc film wrapped electrode (3), a single strand wire and a coil (4), and a curved needle (5), characterized in that: A magnesium metal wire (2) is installed at one end of the chest wall piercing steel needle (1), and a zinc film wrapped electrode (3) is installed at one end of the magnesium metal wire (2), a single strand wire and a coil (4) are installed at one end of the zinc film wrapped electrode (3), and a curved needle (5) is installed at one end of the single strand wire and the coil (4); The magnesium metal wire (2) can replace the traditional 316 steel wire and can be used for the conduction of electrical signals of the pacing wire. In order to prevent the loss of electrical information, a polymer coating having an insulating effect, such as a polycaprolactone film or a polycaprolactone plus polylactic acid mixed film, is provided on the surface of the magnesium metal wire (2). In order to prevent the magnesium metal wire (2) from being corroded and breaking prematurely, a corrosion-resistant zinc foil can be used to wrap the position where the magnesium metal wire (2) contacts the myocardium. On the one hand, the conduction of electrical signals can be ensured. On the other hand, zinc is also an absorbable material that is safe for the human body. The thickness is only 0.01-0.02 mm and it can be completely absorbed in about one year.

2. The absorbable pacing lead according to claim 1, characterized in that: The magnesium metal conductor (2) uses magnesium metal wire as the conductor.

3. The absorbable pacing lead according to claim 1, characterized in that: The zinc film wrapped electrode (3) is made of zinc foil wrapped with magnesium wire.

4. The absorbable pacing lead according to claim 1, characterized in that: A hole is provided at one end of the chest wall piercing steel needle (1), and a folding groove is provided at one quarter of the side surface of the chest wall piercing steel needle (1).

5. The absorbable pacing lead according to claim 1, characterized in that: The single strand and the coil (4) are made of absorbable material and are in a spring shape.

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