Electrochemical pump drug delivery device of implantable medical equipment

Abstract

The invention discloses an electrochemical pump dosing device of implantable medical equipment, which comprises an outer cavity, an inner cavity and a stimulating electrode, and is characterized in that the inner cavity is positioned in the outer cavity, and liquid medicine is arranged in the inner cavity; the stimulating electrode is communicated with the inner cavity and comprises a plurality of medicine release ports for releasing medicine liquid; a medicine supply part and electrolyte are arranged in the outer cavity, and the medicine supply part is used for electrolyzing the electrolyte and generating gas to press the inner cavity to shrink, so that the medicine liquid in the inner cavity is conveyed to the medicine release opening; the electrochemical pump drug delivery device of the implantable medical equipment has the requirements of miniaturization and controllable drug delivery, and solves the problems that the drug coated on the surface of the electrode cannot be precisely controlled and the existing precise drug delivery system cannot be miniaturized.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates to an electrochemical pump drug delivery device for implantable medical devices. Background Technology

[0002] Implantable medical devices are precise interventions for severe functional impairments. Their core function is to bypass damaged tissue and directly stimulate nerves or organs to restore key functions. Major implantable medical devices include cochlear implants, pacemakers, and neuromodulation implants. The cochlear implant (CI) is an effective treatment for severe to profound sensorineural hearing loss, and has helped over one million deaf people regain their hearing. During cochlear implantation surgery, doctors insert a thin, flexible electrode approximately 24 mm long, with an average cross-sectional area of ​​only 2 mm². 2 The cochlea is located in the scala tympani of the cochlea. The structure of the human cochlea is extremely delicate and complex. During electrode insertion, damage to the delicate structures of the cochlea can easily occur. This may not only lead to the loss of residual hearing, but may also cause infection to spread along the electrode carrier and enter the cerebrospinal fluid through the wound, causing serious central nervous system complications.

[0003] Because the inner ear is a closed system, and the electrodes can directly reach the inner ear during cochlear implantation, local drug delivery to the inner ear using cochlear implant electrodes as drug carriers has become a recent research hotspot. The electrode consists of electrode contacts, electrode wires, and a silicone matrix. According to relevant research reports both domestically and internationally, improvements to cochlear implant electrodes mainly include electrode surface coatings, silicone matrix, and drug-loaded conductive polymer coatings on electrode contacts. In drug-loaded cochlear implants with electrode coatings as described above, the drug is often attached to the electrode in a solid form and delivered to the cochlea via passive diffusion to achieve the therapeutic purpose. Because drug delivery is passive, the drug delivery process is uncontrollable; and since the drug delivery is a one-time event, the dosage is limited, making long-term therapeutic effects impossible.

[0004] For cochlear implants containing a drug reservoir, a drug delivery microcatheter, a drug release port, a drug delivery power system, and a control system, the drug reservoir is often expandable and relies on its own contraction to provide the power for drug delivery. However, because the drug reservoir is in direct contact with human tissue, and tissue proliferation after implantation can encapsulate the reservoir, its expandability decreases or even disappears, leading to drug delivery failure. Expandable drug reservoirs are often made of polymer materials and are in direct contact with human tissue, posing a risk of drug leakage. In addition to relying on the contraction of the drug reservoir, drug delivery can also be powered or enhanced by mechanisms such as tympanic membrane vibration and stapedius muscle reflex, but these also suffer from insufficient power, instability, and lack of controllability. This type of passive drug delivery power makes it difficult to ensure the stability of the drug flow rate, which has a significant impact on the pressure stability of the inner ear. Large pressure fluctuations can affect inner ear function and even cause damage to the inner ear structure.

[0005] In summary, existing drug delivery systems suffer from problems such as uncontrollable drug delivery. Against this backdrop, there is an urgent need to find a new method that is easy to control and can achieve precise drug release. Summary of the Invention

[0006] To address the aforementioned problems, the technical solution of this invention is as follows: an electrochemical pump drug delivery device for implantable medical devices, comprising an outer cavity, an inner cavity, and a stimulation electrode, wherein... The inner cavity is located within the outer cavity, and the inner cavity contains a medicinal solution; The stimulating electrode is connected to the inner cavity, and the stimulating electrode includes a plurality of drug release ports for releasing the drug solution; The outer cavity is provided with a drug supply device and an electrolyte. The drug supply device is used to electrolyze the electrolyte and generate gas to compress the inner cavity to contract, thereby delivering the drug solution in the inner cavity to the drug release port.

[0007] Preferably, the device further includes a stimulator connected to the drug supply unit to supply power to the drug supply unit.

[0008] Preferably, the drug supply component includes at least one electrolytic element, which includes a positive electrode plate and a negative electrode plate. The positive electrode plate is connected to the positive terminal of the power supply in the stimulator, and the negative electrode plate is connected to the negative terminal of the power supply in the stimulator.

[0009] Preferably, a flexible membrane is provided between the outer cavity and the outer wall of the inner cavity, the flexible membrane preventing the exchange of electrolyte and drug solution.

[0010] Preferably, the top of the outer cavity is covered with an end cap, and the top of the inner cavity is fixed with a first sealing ring, which is embedded in the end cap.

[0011] Preferably, the inner cavity is made of a flexible material.

[0012] Preferably, the inner cavity is provided with a drainage tube and a drug delivery tube, one end of the drainage tube is located inside the inner cavity, the other end of the drainage tube extends out of the inner cavity and is connected to the drug delivery tube, and the end of the drug delivery tube away from the inner cavity is connected to the stimulation electrode.

[0013] Preferably, the distance between a segment of the drainage tube located within the inner cavity along its own length and the bottom of the inner cavity is defined as the first distance, and the distance between a segment of the drainage tube located within the inner cavity along its own radial direction and the peripheral wall of the inner cavity is defined as the second distance, wherein the first distance is greater than the second distance.

[0014] Preferably, a sample feeding device is provided at the end of the outer cavity away from the inner cavity, and the sample feeding device is used to replenish the electrolyte into the outer cavity.

[0015] Preferably, the sample feeding component includes a sample feeding port cover, a sample feeding port flange, and a second sealing ring; the sample feeding port flange is fixed to the bottom of the outer cavity, the sample feeding port flange has a stepped groove in the middle, and the stepped groove has an internal threaded hole in the middle; the sample feeding port cover is threaded to the internal threaded hole and abuts against the bottom of the stepped groove; the second sealing ring is clamped between the sample feeding port cover and the bottom of the stepped groove.

[0016] The beneficial effects of this invention are as follows: 1. The electrochemical pump drug delivery device for implantable medical devices of the present invention comprises an inner cavity for holding a drug solution and an outer cavity for holding an electrolyte solution. A drug delivery element within the outer cavity electrolyzes the electrolyte solution and generates gas, thereby compressing the inner cavity to contract and deliver the drug solution within the inner cavity to the release port of the stimulating electrode, achieving precise drug delivery. This drug delivery device does not require significant modifications to implantable medical devices, especially cochlear implant systems, thus ensuring compatibility with existing implantation procedures and meeting miniaturization requirements. Simultaneously, it utilizes existing electrical stimulation systems to achieve electrical signal transmission and controlled drug release for implantable medical devices, enabling precise control of the drug delivery rate and dosage. Furthermore, drug delivery can be stopped at any time when not needed, combining miniaturization and controllable drug delivery requirements. This solves the problems of inaccurate drug release from electrode surfaces and the inability to miniaturize existing precision drug delivery systems.

[0017] 2. The electrochemical pump drug delivery device of the implantable medical device of the present invention effectively ensures the airtightness and safety of the drug delivery device by setting a first sealing ring at the top of the inner cavity and a second sealing ring at the bottom of the outer cavity. By setting the positional relationship between the drainage tube and the bottom of the inner cavity, the bottom of the inner cavity is prevented from prematurely blocking the lower port of the drainage tube during the compression of the inner cavity, further improving the safety of drug delivery. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the electrochemical pump drug delivery device of an implantable medical device according to a specific embodiment of the present invention. Figure 2 This is a schematic cross-sectional view of the electrochemical pump drug delivery device of an implantable medical device according to a specific embodiment of the present invention; Figure 3 This is a partially enlarged view of the electrochemical pump drug delivery device of an implantable medical device according to a specific embodiment of the present invention; Figure 4 This is a partial structural schematic diagram of the electrochemical pump drug delivery device of an implantable medical device according to a specific embodiment of the present invention. Figure 5 This is a partial structural schematic diagram of the electrochemical pump drug delivery device of an implantable medical device according to a specific embodiment of the present invention.

[0019] Explanation of reference numerals in the attached figures: 1. Outer cavity; 2. Electrolyte; 3. Drug solution; 4. Inner cavity; 5. Drainage tube; 6. First sealing ring; 7. Drug head; 8. Drug delivery tube; 9. Negative electrode plate; 10. Positive electrode plate; 11. Second sealing ring; 12. Sample dispensing port cap; 13. Sample dispensing port flange. Detailed Implementation

[0020] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0021] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0022] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0023] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0024] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0025] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0026] See Figure 1 and Figure 2 An electrochemical pump drug delivery device for implantable medical devices includes an outer cavity 1, an inner cavity 4, and a stimulating electrode (not shown in the figure). The inner cavity 4 is located inside the outer cavity 1 and contains a drug solution 3. The stimulating electrode is connected to the inner cavity 4 and includes several release ports (not shown in the figure) for releasing the drug solution 3. The outer cavity 1 contains a drug supply element and an electrolyte 2. The drug supply element electrolyzes the electrolyte 2 and generates gas to compress the inner cavity 4, thereby delivering the drug solution 3 in the inner cavity 4 to the release ports of the stimulating electrode.

[0027] Furthermore, it also includes a stimulator (not shown in the figure), which is connected to the drug delivery device and supplies power to it. The stimulator can be a stimulator for a cochlear implant or for other implantable medical devices, which will not be elaborated here.

[0028] See Figure 2The drug supply unit includes at least one electrolytic element. Further, the electrolytic element includes a positive electrode 10 and a negative electrode 9. The positive electrode 10 is connected to the positive terminal of the stimulator's power supply, and the negative electrode 9 is connected to the negative terminal of the stimulator's power supply, thereby providing power to the drug supply unit, achieving electrolysis, and generating gas. It should be noted that an appropriate number of electrolytic elements can be configured according to actual needs. Optionally, the positive and negative electrode sheets are made of platinum-iridium alloy.

[0029] When the electrodes of the electrolytic element are energized, the electrolyte 2 generates gas under electrolysis. In a specific embodiment, physiological saline is selected as the electrolyte 2, and the chemical reaction that occurs during its electrolysis is as follows: Anode (positive electrode) reaction: 2Cl - (aq) → Cl2(g) + 2e - In this process, chloride ions (Cl) - At the anode, it loses electrons and is oxidized into chlorine gas (Cl2).

[0030] Cathode (negative electrode) reaction: 2H₂O + 2e - → H2(g) + 2OH - (aq) At the cathode, water molecules gain electrons and are reduced, thus decomposing into hydrogen gas (H2) and hydroxide ions (OH-). - ).

[0031] Overall reaction equation: 2NaCl(aq) + 2H2O(l) → 2NaOH(aq) + H2(g) + Cl2(g) Through electrolysis, physiological saline ultimately produces sodium hydroxide (NaOH), hydrogen (H2), and chlorine (Cl2). Since Cl2 is soluble in water and reacts with NaOH to produce NaCl and NaClO, the generation of H2 is the main cause of the expansion of the volume of the substance inside the outer cavity 1, thereby compressing the inner cavity 4.

[0032] Furthermore, the outer cavity can be made of titanium alloy, and the inner cavity 4 can be made of flexible material. Preferably, the flexible material can be selected from one or more of silicone, rubber, polyolefins, polyacrylic acid, polyester, polyether, polylactic acid, and cellulose, and can deform under external pressure to allow the gas generated by the electrolyte 2 to compress the inner cavity 4 and contract, thereby delivering the drug solution 3 in the inner cavity 4 to the drug release port of the stimulation electrode.

[0033] Furthermore, a flexible membrane is provided between the outer wall of the outer cavity 1 and the outer wall of the inner cavity 4. The flexible membrane prevents the electrolyte 2 and the drug solution 3 from exchanging, thus ensuring the safety and stability of the electrolyte 2 and the drug solution 3.

[0034] It should be noted that the drug delivery device can also be equipped with an intelligent control system, which can adjust the release rate and total amount of drug solution 3 as needed, so as to further achieve precise, timed and quantitative delivery of drug solution 3.

[0035] See Figure 1 , Figure 2 and Figure 4 The outer cavity 1 is capped with an end cap, and the inner cavity 4 is fixed with a first sealing ring 6, which is embedded in the end cap. A drainage tube 5 and a drug delivery tube 8 are provided on the inner cavity 4. One end of the drainage tube 5 is located inside the inner cavity 4, and the other end extends outside the inner cavity 4 and is connected to the drug delivery tube 8. The end of the drug delivery tube 8 away from the inner cavity 4 is connected to the stimulating electrode to deliver the drug solution 3 to the stimulating electrode. In one embodiment, a drug delivery head 7 is provided on the other end of the drainage tube 5, and the drainage tube 5 is connected to the drug delivery tube 8 through the drug delivery head 7.

[0036] Furthermore, the distance between the portion of the drainage tube 5 located within the inner cavity 4 along its length and the bottom of the inner cavity 4 is defined as the first distance, and the distance between the portion of the drainage tube 5 located within the inner cavity 4 along its radial direction and the peripheral wall of the inner cavity 4 is defined as the second distance, where the first distance is greater than the second distance. Considering that during the delivery of the drug solution 3 under gas compression within the inner cavity 4, the bottom of the drainage tube 5 may come into contact with the bottom of the inner cavity 4, causing blockage at the lower end of the drainage tube 5 and affecting the delivery of the drug solution 3, the above-mentioned design minimizes the risk of blockage at the bottom of the drainage tube 5, thereby further improving the delivery effect of the drug solution 3. Optionally, the drainage tube can be made of platinum-iridium alloy or stainless steel.

[0037] See Figure 2 , Figure 3 as well as Figure 5 An electrolyte 2 is added to the outer cavity 1 at the end furthest from the inner cavity 4. The electrolyte 2 is supplied to the outer cavity 1. The electrolyte 2 includes a sample inlet cap 12, a sample inlet flange 13, and a second sealing ring 11. The sample inlet flange 13 is fixed to the bottom of the outer cavity 1. A stepped groove is provided in the middle of the sample inlet flange 13, and an internally threaded hole is provided in the middle of the stepped groove. The sample inlet cap 12 is threaded into the internally threaded hole and abuts against the bottom of the stepped groove. The second sealing ring 11 is clamped between the sample inlet cap 12 and the bottom of the stepped groove. When electrolyte 2 needs to be added, it is added through the sample inlet cap 12.

[0038] Furthermore, the materials of the first sealing ring 6 and the second sealing ring 11 can be selected from one or more of silicone, rubber, polyolefins, polyacrylic acid, polyester, polyether, polylactic acid, and cellulose. Optionally, the sample dispensing cap and sample dispensing flange can be made of titanium alloy.

[0039] By setting the first sealing ring 6 and the second sealing ring 11, the outer cavity 1 and the inner cavity 4, and the inner cavity 4 and the drainage tube 5 are sealed tightly, effectively preventing loosening and air leakage, and ensuring the airtightness and safety of the device.

[0040] In summary, this invention, by setting up an inner cavity 4 containing the drug solution 3 and an outer cavity 1 containing the electrolyte 2, utilizes a drug supply element within the outer cavity 1 to electrolyze the electrolyte 2 and generate gas, thereby compressing the inner cavity 4 to contract and deliver the drug solution 3 from the inner cavity 4 to the release port of the stimulating electrode, achieving precise drug delivery. This drug delivery device does not require significant modifications to implantable medical devices, especially cochlear implant systems, thus ensuring compatibility with existing implantation surgeries and meeting miniaturization requirements. Simultaneously, it utilizes existing electrical stimulation systems to achieve electrical signal transmission and controlled drug release for implantable medical devices, enabling precise control of the drug delivery rate and dosage. Furthermore, drug delivery can be stopped at any time when not needed, combining miniaturization and controllable drug delivery requirements. It also solves the problems of inaccurate drug release from electrode surfaces and the inability to miniaturize existing precision drug delivery systems.

[0041] Finally, it should be noted that the above preferred embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail through the above preferred embodiments, those skilled in the art should understand that various changes can be made to it in form and detail without departing from the scope defined by the claims of the present invention.

Claims

1. An electrochemical pump drug delivery device for implantable medical devices, characterized in that, It includes an outer cavity, an inner cavity, and stimulation electrodes, among which, The inner cavity is located within the outer cavity, and the inner cavity contains a medicinal solution; The stimulating electrode is connected to the inner cavity, and the stimulating electrode includes a plurality of drug release ports for releasing the drug solution; The outer cavity is provided with a drug supply device and an electrolyte. The drug supply device is used to electrolyze the electrolyte and generate gas to compress the inner cavity to contract, thereby delivering the drug solution in the inner cavity to the drug release port.

2. The electrochemical pump drug delivery device for implantable medical devices according to claim 1, characterized in that, It also includes a stimulator, which is connected to the drug supply unit and supplies power to the drug supply unit.

3. The electrochemical pump drug delivery device for implantable medical devices according to claim 2, characterized in that, The drug supply device includes at least one electrolytic element, which includes a positive electrode plate and a negative electrode plate. The positive electrode plate is connected to the positive terminal of the power supply in the stimulator, and the negative electrode plate is connected to the negative terminal of the power supply in the stimulator.

4. The electrochemical pump drug delivery device for implantable medical devices according to claim 1, characterized in that, A flexible membrane is provided between the outer cavity and the outer wall of the inner cavity, which prevents the electrolyte and the drug solution from being exchanged.

5. The electrochemical pump drug delivery device for implantable medical devices according to claim 1, characterized in that, The top of the outer cavity is covered with an end cap, and the top of the inner cavity is fixed with a first sealing ring, which is embedded in the end cap.

6. The electrochemical pump drug delivery device for implantable medical devices according to claim 1, characterized in that, The inner cavity is made of a flexible material.

7. The electrochemical pump drug delivery device for implantable medical devices according to claim 1, characterized in that, The inner cavity is provided with a drainage tube and a drug delivery tube. One end of the drainage tube is located inside the inner cavity, and the other end of the drainage tube extends out of the inner cavity and is connected to the drug delivery tube. The end of the drug delivery tube away from the inner cavity is connected to the stimulation electrode.

8. The electrochemical pump drug delivery device for implantable medical devices according to claim 7, characterized in that, The distance between a segment of the drainage tube located within the inner cavity along its own length and the bottom of the inner cavity is defined as the first distance, and the distance between a segment of the drainage tube located within the inner cavity along its own radial direction and the peripheral wall of the inner cavity is defined as the second distance, wherein the first distance is greater than the second distance.

9. The electrochemical pump drug delivery device for implantable medical devices according to claim 1, characterized in that, A sample feeding device is provided at the end of the outer cavity away from the inner cavity, and the sample feeding device is used to replenish the electrolyte into the outer cavity.

10. The electrochemical pump drug delivery device for implantable medical devices according to claim 9, characterized in that, The sample feeding component includes a sample feeding port cap, a sample feeding port flange, and a second sealing ring; the sample feeding port flange is fixed to the bottom of the outer cavity, and a stepped groove is provided in the middle of the sample feeding port flange, and an internal threaded hole is provided in the middle of the stepped groove; the sample feeding port cap is threaded to the internal threaded hole and abuts against the bottom of the stepped groove; the second sealing ring is clamped between the sample feeding port cap and the bottom of the stepped groove.

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