Absorbable pacing lead

Abstract

The present invention belongs to the field of medical devices, and specifically relates to an absorbable pacing lead, comprising a transthoracic steel needle, a magnesium metal wire, a zinc film-wrapped electrode, a single-stranded wire and coil, and a curved needle. The magnesium metal wire is mounted at one end of the transthoracic steel needle, and the zinc film-wrapped electrode is mounted at one end of the magnesium metal wire. The single-stranded wire and coil is mounted at one end of the zinc film-wrapped electrode, and the curved needle is mounted at one end of the single-stranded wire and coil. The magnesium metal wire is coated with a layer of absorbable material film (such as a polycaprolactone material), but an electrode portion of the magnesium metal wire in contact with the myocardium has no polymer coating and is only wrapped with zinc foil. The present invention can provide temporary cardiac pacing after surgery, and can be gradually slowly degraded and absorbed by the human body in approximately one year. This avoids complications and secondary surgery, improves performance by using innovative materials, and ensures electrical signal transmission by means of structural optimization, providing a superior option for temporary pacing in cardiac surgery.

Description

An absorbable pacing lead Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to an absorbable pacing lead. Background Technology

[0002] In cardiac surgery, cardiac pacing technology is crucial for maintaining a patient's normal heart rhythm, and cardiac pacing leads are a key component for achieving this. Currently, existing cardiac pacing leads face numerous challenges in clinical application.

[0003] Traditional cardiac pacing leads, whether removed or left in place, are associated with a range of complications post-operatively. Lead removal can lead to risks such as bleeding, while leaving the lead in place can easily cause retrograde infection and chronic inflammation, severely impacting the patient's post-operative recovery. If a second surgery is required to remove the lead, it not only causes additional physical pain for the patient but also significantly increases medical costs, adding to their financial burden. Summary of the Invention

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

[0005] To achieve the above objectives, the present invention provides the following technical solution: an absorbable pacing lead, comprising a steel needle penetrating the chest wall, a magnesium metal wire, a zinc film-wrapped electrode, a single-strand wire and a coil, and a bent needle. One end of the steel needle penetrating the chest wall is fitted with a magnesium metal wire, and one end of the magnesium metal wire is fitted with a zinc film-wrapped electrode. One end of the zinc film-wrapped electrode is fitted with a single-strand wire and a coil, and one end of the single-strand wire and the coil is fitted with a bent needle.

[0006] The magnesium metal wire replaces the traditional steel wire for electrical signal transmission in the pacing lead. To prevent the loss of electrical information, an insulating polymer coating, such as a polycaprolactone film or a polycaprolactone and polylactic acid mixture film, is applied to the surface of the magnesium metal wire. At the contact point between the magnesium metal wire and the myocardium, corrosion-resistant zinc foil is used to wrap the magnesium metal wire to prevent corrosion and premature breakage. This ensures the transmission of electrical signals, and zinc is also an absorbable and safe material for the human body. The thickness is only 0.01-0.02 mm, and it can be completely absorbed in about one year.

[0007] Preferably, the magnesium metal conductor is made of magnesium metal wire.

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

[0009] Preferably, one end of the steel needle that pierces the chest wall has a hole, and a folding groove is left at one-quarter of the side surface of the steel needle.

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

[0011] Compared with the prior art, the beneficial effects of the present invention are: the present invention uses bioabsorbable materials to make the main lead 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, and bleeding caused by traditional lead removal or retention, and significantly reducing the medical risks and physical pain of patients. Attached Figure Description

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

[0013] Figure 2 is a three-dimensional schematic diagram of the steel needle for penetrating the chest wall according to the present invention.

[0014] In Figure 1: 1. Steel needle through the chest wall; 2. Magnesium metal wire; 3. Electrode wrapped with zinc film; 4. Single strand wire and coil; 5. Curved needle. Detailed Implementation

[0015] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0016] As shown in Figures 1 and 2, the device includes a steel needle 1 for piercing the chest wall, a magnesium metal wire 2, a zinc film-coated electrode 3, a single-strand wire and a coil 4, and a bent needle 5. One end of the steel needle 1 is fitted with the magnesium metal wire 2, and the other end is fitted with the zinc film-coated electrode 3. The other end of the zinc film-coated electrode 3 is fitted with the single-strand wire and the coil 4, and the other end is fitted with the bent needle 5. The outer diameter of the steel needle 1 is 0 mm. The steel needle 1, measuring 0.86mm in diameter and 8.8cm in length, has a hole at one end for clamping the magnesium metal lead. This hole facilitates the removal of the sharp tip after the magnesium metal lead implantation procedure, allowing the remaining portion to be easily inserted into the pacemaker. A folding groove is located on one-quarter of the side surface of the steel needle 1. The magnesium metal lead 2 uses magnesium wire as the conductor, with a polymer material used as the insulating layer. This magnesium can be pure magnesium wire or a magnesium-zinc alloy. The magnesium metal lead 2 replaces the traditional 316 steel wire for electrical signal transmission in the pacing lead. To prevent electrical signal loss, an insulating polymer coating, such as a polycaprolactone film or a polycaprolactone and polylactic acid mixture, is applied to the surface of the magnesium metal lead 2. At the point where the magnesium wire contacts the myocardium, corrosion-resistant zinc foil is used to prevent corrosion and premature breakage of the magnesium wire. This ensures signal transmission, and zinc is an absorbable and safe material for the human body. The thickness is only 0.01-0. The 0.02mm thickness is approximately 0.01mm and can be completely absorbed in about a year. The zinc-coated electrode 3 is made of magnesium wire wrapped with zinc foil to prevent premature corrosion and breakage. Ultra-thin zinc foil of 0.01mm thickness can be selected, and the degradation time can be controlled by adjusting the number of wrapping layers. The coating layer of the magnesium metal lead 2 is made of polycaprolactone, which is biodegradable. Alternatively, a mixture of polycaprolactone and polylactic acid, or other biodegradable polymers, can be used. The polycaprolactone coating provides insulation, allowing the pacemaker's current to connect to the sinoatrial node through the magnesium wire without leakage. The single-strand wire and coil 4 are made of absorbable material and are spring-shaped to prevent slippage of the pacing lead. For simplified manufacturing, pure magnesium wire can also be used here, which is simple to process and provides a strong connection.

[0017] The steel needle 1, inserted through the chest wall, has a clamping hole at its end to clamp the magnesium metal wire 2. The zinc-coated electrode 3 can cover the connection between the single-strand coil 4 and the magnesium metal wire 2. The exposed magnesium wire directly contacts muscle or blood, potentially causing unpredictable oxidation damage. The curved needle 5 has a round tip and a clamping hole at its end to hold the single-strand coil 4. The inner layer of the magnesium metal wire 2 is made of magnesium or a magnesium-zinc alloy. In practical use, pure magnesium or magnesium-zinc alloys can achieve an elongation of 15%-30%, stretching to 0.3 mm, a diameter suitable for pacing leads placed after clinical cardiac surgery. Magnesium-calcium alloys, however, have a lower elongation, making it difficult to stretch to 0.3 mm. Furthermore, calcium metal in the alloy tends to form small lumps; in repeated experiments, the wires broke due to these small calcium metal lumps. Therefore, the author believes that magnesium-calcium alloys are unsuitable for this application.

[0018] The steel needle 1 has a clamping hole at its tail end, which can clamp the magnesium metal wire 2, thus preventing the tail end of the steel needle 1 from detaching from one end of the magnesium metal wire 2. During installation, the magnesium metal wire 2 is placed inside the tail end of the steel needle 1, and then the tail end of the steel needle 1 is plastically deformed by a pressure needle for cold clamping fixation. One end of the steel needle 1 is installed with one end of the magnesium metal wire 2. The tips of both the steel needle 1 and the bent needle 5 are needle-shaped.

[0019] The needle 1 has a brittle groove at one-quarter of its length to facilitate the removal of the sharp needle tip after the magnesium lead implantation procedure.

[0020] Partially, this allows the remaining portion of the steel needle 1, which pierces the chest wall, to be smoothly inserted into the pacemaker. One end of the curved needle 5 is needle-shaped, allowing it, along with the single-strand coil 4, to be smoothly inserted into the epicardium within the body. The curved needle 5 is made of stainless steel and is exposed. After the cardiac pacing magnesium metal lead is sutured, one end of the curved needle 5 passes through the surface of the myocardium, and the curved needle 5 is cut off and discarded. During use, current flows through the cardiac pacing magnesium metal lead, and this current can cause an electrolytic reaction that can lead to breakage of the magnesium wire or magnesium metal lead. The polycaprolactone coating and zinc film covering of the electrodes prevent breakage of the magnesium wire or magnesium metal lead, thus protecting it.

[0021] Biodegradable materials are designed 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 families of absorbable metals, with magnesium-based alloys showing the fastest development and the most abundant experimental data in both basic and translational research. Research and development of magnesium alloy medical products currently focuses on bone fixation materials, vascular stents, porous magnesium tissue engineering materials, and orthopedic repair materials. This invention enables the use of novel biodegradable biomedical magnesium alloy materials as temporary pacing leads in cardiac surgery, avoiding complications and the risk of secondary surgeries associated with removing or leaving temporary pacing leads, and reducing medical costs.

[0022] The applicant also conducted an experiment on the degradation of pure magnesium wire, and found that: when pure magnesium wire was dissolved in physiological saline under 5V DC power with magnesium wire as the anode and stainless steel as the cathode, the magnesium wire decomposed in one minute. However, when pure magnesium wire was dissolved in physiological saline under 5V DC power with magnesium wire as the anode and stainless steel as the cathode, the pure magnesium wire did not decompose and bubbles were generated.

[0023] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An absorbable pacing lead, comprising a steel needle penetrating the chest wall (1), a magnesium metal lead (2), a zinc-coated electrode (3), and a single strand. Wire and coil (4), bent needle (5), characterized in that: One end of the steel needle (1) that penetrates the chest wall is equipped with a magnesium metal wire (2), and one end of the magnesium metal wire (2) is equipped with a zinc film-wrapped electrode (3). One end of the zinc film-wrapped electrode (3) is equipped with a single strand wire and a coil (4), and one end of the single strand wire and the coil (4) is equipped with a bent needle (5). The magnesium metal wire (2) can replace the traditional 316 steel wire and can be used for electrical signal transmission in pacing leads. In order to prevent the loss of electrical information, a polymer coating with 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). At the position where the magnesium metal wire (2) contacts the myocardium, in order to prevent the magnesium metal wire (2) from being corroded and prematurely broken, corrosion-resistant zinc foil can be used to wrap it. On the one hand, it can ensure the transmission of electrical signals. 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 wire (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 magnesium wire wrapped with zinc foil.

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

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

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