Alternating charges to inhibit adsorption to surfaces exposed to biological materials

By placing insulating electrodes near the surface of implantable medical devices, an alternating electric field is used to inhibit the accumulation and adsorption of biofilm, thus solving the problem of biocontamination on the surface of implantable medical devices and extending the service life of the devices.

CN113597324BActive Publication Date: 2025-11-11RAMBAM MEDTECH LTD +2
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Patent Information

Application Number
CN202080021747.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-03-18
Filing Date
2020-03-16
Publication Date
2025-11-11
Estimated Expiration
2040-03-16

AI Technical Summary

Technical Problem

Existing technologies are insufficient to effectively suppress bioadsorption and biocontamination on the surface of implantable medical devices, leading to a shortened lifespan of the devices.

Method used

By placing insulating electrodes near the surface of an implantable medical device, an alternating electric field is used to inhibit the accumulation and adsorption of biofilms. An alternating charge is generated by a power source and regulator to prevent current flow. The electrodes are insulated from the surface and the biological medium.

Benefits of technology

It effectively inhibits the accumulation and adsorption of biofilm on the surface of implantable medical devices, reduces biological pollution, and extends the service life of the devices.

✦ Generated by Eureka AI based on patent content.

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Abstract

A system and / or method is disclosed to suppress adsorption and / or biofouling on a surface in a biological medium by means of an alternating electric field. For example, one or more insulating electrodes may be disposed near the surface. For example, insulation may limit the current between the biological medium and the electrodes, and / or between the surface and the electrodes, and / or between the plurality of electrodes. In some embodiments, the alternating charge near the surface may suppress the accumulation of multiple biofilms and / or adsorption onto the surface. For example, the system may be used to suppress fouling of an implantable medical device (e.g., a catheter).
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Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 819,693, filed March 18, 2019, with the information contained herein by reference. Technical Field

[0003] In some embodiments, the present invention relates to a method and system for suppressing adsorption and / or biocontamination of a surface, and particularly, but not exclusively, to processes that prevent implantable medical devices from being damaged by bioadsorption and / or biocontamination. Background Technology

[0004] U.S. Patent No. 8,951,241 discloses "a medical device,"... "which includes a functional unit (C) for permanent or temporary placement in the urogenital tract of a human or animal body. The functional unit has at least one conductive portion. After the functional unit is placed in the urogenital tract, a power source (G) provides a current to the conductive portion. In this way, bacterial growth on the functional unit can be reduced."

[0005] International Patent Application Publication No. WO2012007332(A1), entitled "Apparatus and Method for Reducing the Risk of Occlusion and Restenosis after Stent Implantation," discloses "a medical device for permanent or temporary support of a blood vessel wall,"... "The device includes an implantable tubular stent (3) having at least one conductive portion, and a power source (2, 4, 5, 6) operable to provide a voltage or current to said conductive portion after the stent is implanted in a blood vessel of a human or animal. In this way, the risk of vascular occlusion, stenosis, or restenosis can be reduced. In a preferred embodiment, a small surface current density in the range of 10-10000 nA / mm² is generated, penetrating the surrounding body material. Means for supplying energy to the stent through the skin and through the blood vessel wall are also disclosed."

[0006] Background technologies include: U.S. Patent Application Publication No. 2012150171(A1) - Controlling the formation of coagulants; U.S. Patent Application Publication No. 2008281250(A1), entitled "Self-cleaning catheter for clinical implantation"; U.S. Patent Application Publication No. 2012197063(A1), entitled "System and method for removing material from the vessel wall"; and works by Soojin Shim, Seok Hoon Hong, Yongsug Tak, and Jeyong. Published in Biocontamination, 2011, 27:2, 217-224, Digital Object Identifier: 10.1080 / 08927014.2011.554831, Preventing Pseudomonas aeruginosa adhesion by electric current; US Patent No. 7,150,814 (B1), entitled Preventing surface adsorption in microchannels by applying electric current in pressure-induced flow; US Patent No. 6,939,345 (B2), entitled Method for reducing restenosis in the presence of endovascular stents; US Patent No. 5,154,165 (A), entitled Medical device; US Patent No. 201,430,9579 (A1), entitled Balloon catheter method for reducing restenosis by irreversible electroporation.

[0007] Some embodiments of the present invention are described herein by way of example only and with reference to the accompanying drawings. Referring now to the drawings in detail, it is important to emphasize that the details shown are by way of example and for the purpose of illustrative discussion of embodiments of the invention. In this regard, the description taken in conjunction with the drawings will make it clear to those skilled in the art how embodiments of the invention can be practiced. Summary of the Invention

[0008] According to one aspect of some embodiments of the present invention, an implantable device is provided, comprising: a surface configured to contact at least one body part within the body; a first electrode disposed near the surface; an electrical insulator to suppress current between the body part and the first electrode; a power source; and a regulator connected to the power source to the first electrode to regulate a charge on the first electrode.

[0009] According to some embodiments of the present invention, a shortest path between the first electrode and the surface is sealed within the interior of the implantable device and away from the body component, and is also sealed away from the surface.

[0010] According to some embodiments of the present invention, a shortest path between the first electrode and the surface is not in fluid communication with the body component and is not in fluid communication with the surface.

[0011] According to some embodiments of the present invention, the implantable device further includes: a second electrode connected to the regulator for carrying a charge opposite to that of the first electrode, wherein the second electrode is electrically insulated from the surface and from the body component.

[0012] According to some embodiments of the present invention, the implantable device further includes: a second electrode connected to the regulator for carrying an opposite charge relative to the first electrode, wherein the second electrode is located away from the first electrode.

[0013] According to some embodiments of the present invention, the regulator and the power supply configuration are used to generate a current of less than 0.01 amperes.

[0014] According to some embodiments of the present invention, the surface is non-conductive.

[0015] According to some embodiments of the present invention, the surface is conductive.

[0016] According to one aspect of some embodiments of the present invention, a method for suppressing adsorption onto a surface is provided, comprising: providing a charge source electrically insulated from the surface; adjusting a charge on the charge source; and keeping the charge source close to the surface.

[0017] According to some embodiments of the invention, the holding step includes holding the charge sources within a geometry, and sealing a shortest path between the charge sources to prevent fluid communication with the surface.

[0018] According to some embodiments of the invention, the adjustment ratio is between 50 and 1000 Hz.

[0019] According to some embodiments of the present invention, the method further includes: placing the surface in contact with living tissue in vivo, wherein the charge source is isolated from the living tissue.

[0020] According to some embodiments of the present invention, the method further includes placing the surface in contact with a bodily fluid outside the body, wherein the charge source is isolated from the bodily fluid.

[0021] According to one aspect of some embodiments of the present invention, a catheter assembly is provided, comprising: a distal portion configured for insertion into a living body; an inner lumen located within the distal portion; an electrode located within the distal portion adjacent to the inner lumen and electrically insulated from the inner lumen; a power source; and a charge regulator electrically connected between the electrode and the power source for generating an alternating charge on the electrode.

[0022] According to some embodiments of the present invention, the power supply, regulator and electrode configuration are used to generate the alternating charge in a wall portion of the inner cavity at a frequency of 50 Hz to 1 kHz.

[0023] According to some embodiments of the present invention, the electrode is held within 5 mm of the inner cavity.

[0024] According to some embodiments of the present invention, the electrode is held within a wall of the inner cavity.

[0025] According to some embodiments of the invention, the electrode is sealed to prevent communication with an internal fluid within the cavity.

[0026] According to some embodiments of the present invention, the catheter assembly further includes: a second electrode connected to the regulator for carrying a charge opposite to the alternating charge on the electrode, wherein the second electrode is electrically insulated from the lumen.

[0027] According to one aspect of some embodiments of the present invention, an apparatus for suppressing adsorption on a surface is provided, comprising: a first electrode disposed close to the surface; an electrical insulator for suppressing current between the surface and the first electrode; a power source; and a regulator connected to the power source to the first electrode to regulate a charge on the first electrode.

[0028] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials to those described herein may be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including its definitions, shall prevail. Furthermore, materials, methods, and embodiments are illustrative only and not intended to impose necessary limitations. Attached Figure Description

[0029] Some embodiments of the present invention are described herein by way of example only and with reference to the accompanying drawings. Referring now to the drawings in detail, it is important to emphasize that the details shown are by way of example and for the purpose of illustrative discussion of embodiments of the invention. In this regard, the description taken in conjunction with the drawings will make it clear to those skilled in the art how embodiments of the invention can be practiced.

[0030] In the attached diagram:

[0031] Figure 1 This is a block diagram of a system for inhibiting adsorption and / or biocontamination in a system according to an embodiment of the present invention;

[0032] Figure 2This is a block diagram of a system having a single electrode according to an embodiment of the present invention;

[0033] Figure 3 This is a flowchart of a method for suppressing adsorption on a surface according to an embodiment of the present invention;

[0034] Figure 4 This is a perspective view of a medical tube (e.g., a catheter) according to an embodiment of the present invention;

[0035] Figure 5A This is a close-up perspective view of a system for preventing adsorption according to an embodiment of the present invention;

[0036] Figure 5B This is a close-up cross-sectional view of a system for preventing adsorption according to an embodiment of the present invention;

[0037] Figure 6 A cross-section of a catheter according to an embodiment of the present invention is shown;

[0038] Figures 7A-7D This is a schematic diagram illustrating a possible concept of inhibiting adsorption according to some embodiments of the present invention;

[0039] Figure 8A An example is shown of a conduit including an external electric field source according to an embodiment of the present invention;

[0040] Figure 8B An example is shown of a catheter including an implanted electric field source according to an embodiment of the present invention;

[0041] Figure 9A A matrix of cells and debris forming a fibrous sheath is shown;

[0042] Figure 9B This shows an intraluminal catheter occlusion;

[0043] Figure 9C A fibrin tail is shown;

[0044] Figure 9D A blood clot was observed in one wall;

[0045] Figure 10A A piezoelectric device is shown on the lateral side of an artery according to an embodiment of the present invention;

[0046] Figure 10B A piezoelectric device is shown on the inner side of an artery according to an embodiment of the present invention;

[0047] Figure 11 This is a schematic diagram of a cross-section of a catheter used in an exemplary experimental demonstration according to an embodiment of the present invention;

[0048] Figure 12These are images demonstrating an exemplary experiment according to an embodiment of the present invention; and

[0049] Figure 13 This is an image of an experimental result according to an embodiment of the present invention. Detailed Implementation

[0050] In some embodiments, the present invention relates to a method and system for suppressing adsorption and / or biocontamination of a surface, and particularly, but not exclusively, to processes that prevent implantable medical devices from being damaged by bioadsorption and / or biocontamination.

[0051] Overview

[0052] One aspect of some embodiments of the present invention relates to suppressing adsorption and / or biofouling on a surface in a biological medium by means of an alternating electric field. For example, one or more insulating electrodes may be disposed near the surface. For example, insulation around the electrodes may prevent current flow between the biological medium and the electrodes. For example, insulation around the electrodes may prevent current flow between the surface and the electrodes. For example, insulation around the electrodes may prevent current flow between the electrodes. In some embodiments, alternating charges near the surface may suppress the accumulation of multiple biofilms and / or adsorption onto the surface.

[0053] One aspect of some embodiments of the present invention relates to methods and / or systems for preventing biocontamination of implantable medical devices (e.g., catheters). In some embodiments, the system may include one or more electrodes positioned close to a surface of the device that comes into contact with biological media, bodily fluids, and / or tissues. Optionally, the electrodes are insulated from the body and / or the surface. Optionally, a power source and / or a regulator is used to generate an alternating electric field near the surface to suppress adsorption. Optionally, the power source may include an implantable battery and regulator and / or an external battery and regulator and / or a piezoelectric device. Specific Implementation

[0055] Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not necessarily limited in its application to the details of the construction and / or arrangement of the components and / or methods illustrated in the following description and / or the drawings and / or examples. The invention can have other embodiments or can be practiced or implemented in a wide variety of ways.

[0056] Now refer to the attached diagram. Figure 1This is a block diagram of a system for suppressing adsorption and / or biofouling in a system according to an embodiment of the present invention. In some embodiments, one or more electrodes 102a, 102b are insulated from insulators 104a, 104b and / or positioned close to a surface 106 in contact with a biological medium 108. Optionally, the electrodes are alternately charged with positive and / or negative charges. For example, the electrodes may be connected to a power supply 110 and a regulator 112. Because the electrodes 102a, 102b are insulated from each other and / or from the medium 108, there may be little or no current between the electrodes 102a, 102b and / or in the medium 108.

[0057] In some embodiments, a surface 106 may include a facet of an object into which the electrodes 102a, 102b are embedded. For example, an electrode 102a, 102b may be embedded in a wall of a catheter. Optionally, the electrodes 102a, 102b may suppress adsorption to an inner surface and / or an outer surface of the catheter. In some embodiments, a first electrode 102a may be within 0.5 mm of the surface and / or between 0.5 and 1 mm of the surface and / or between 1 and 2 mm of the surface and / or between 2 and 5 mm of the surface and / or between 5 and 20 mm of the surface and / or between 20 and 100 mm of the surface 106. Alternatively or additionally, the system may include a second electrode 102b. Optionally, the shortest path between the second electrode 102b and the surface 106 may pass through the device without passing through the biological medium 108. For example, the electrodes 102a, 102b may have opposite polarities. For example, the second electrode 102b may be within 0.5 mm of the surface and / or between 0.5 and 1 mm of the surface and / or between 1 and 2 mm of the surface and / or between 2 and 5 mm of the surface and / or between 5 and 20 mm of the surface and / or between 20 and 100 mm of the surface and / or further away. Alternatively or additionally, the second electrode 102b may be in electrical contact with the medium 108 and / or the surface 106. In some embodiments, the insulation may block between the electrodes 102a and 102b, such that there is no conductive path between the two electrodes 102a and 102b. Alternatively or additionally, the insulation may block between the medium 108 and one or both of the electrodes 102a and / or 102b. Alternatively or additionally, the insulation may block between the surface 106 and one or both of the electrodes 102a and / or 102b. Optionally, a monolithic insulating material insulates between one or both of the electrodes 102a and / or 102b and / or the electrodes and / or the medium 108 and / or the surface 106. In some embodiments, one of the electrodes 102a and 102b may be in electrical contact with the medium 108 and / or the surface 106.

[0058] In some embodiments, a power source 110 and / or the regulator 112 may include a battery and / or a generator and / or a piezoelectric device and / or a printed circuit board (PCB). Optionally, the power source 110 and / or the regulator 112 may be implanted in a subject and / or may be external to the subject.

[0059] In some embodiments, the protected surface 106 may include a surface of an implantable device and / or a catheter. Alternatively or additionally, the surface 106 may be external to a person. For example, the surface may be part of a laboratory apparatus that comes into contact with a biofilm-prone medium 108 and / or a conduit and / or a pump.

[0060] Figure 2 This is a block diagram of a system having a single electrode according to an embodiment of the present invention. Optionally, Figure 1 The system may have a single electrode 202 (e.g., an alternating charge source [e.g., including a power supply 210 and / or an oscillator 212]). Optionally, the electrode 202 is located close to the surface 206 in contact with the biological medium 208. For example, the electrode 202 may generate an alternating electric field that protects the surface 206 from biofilms and / or other sources of contamination. Alternatively or additionally, the electrode 202 is insulated from the protected surface 206 and / or the biological medium 208 by an insulator 204.

[0061] Figure 3 This is a flowchart of a method for suppressing adsorption on a surface according to an embodiment of the present invention. For example, the method can be combined with... Figure 1 and / or Figure 2The system is used in conjunction with the above. In some embodiments, a charge source 310 is provided. Optionally, the charge is regulated 312 to produce a regulated charge. For example, the charge 312 may be alternated between frequencies between 100 and 500 Hz and / or between 10 and 100 Hz and / or between 1 and 10 Hz and / or between 500 Hz and 4 kHz and / or between 4 kHz and 20 kHz and / or between 20 kHz and 500 kHz. Optionally, the intensity of the charge may range between ±0.5 and ±2 volts and / or between ±0.1 and ±0.5 volts and / or between ±2 and ±5 volts and / or between ±0.01 and ±0.1 volts and / or between ±5 and ±20 volts and / or between ±0.01 and ±0.1 volts. Optionally, the oscillation of the charge may take the form of a square wave and / or a sine wave and / or a complex shape and / or a random shape. In some embodiments, the charge will be retained 302 near a surface, for example, the charge may be conducted to an electrode near the surface. In some embodiments, a surface in contact with the biological medium may be exposed to an alternating field. Optionally, the field may prevent adsorption to the surface and / or protect the surface from the influence of biofilms. For example, the surface may include a surface of an implantable medical device and / or a tube through which a biological fluid passes and / or a surface exposed to the biological fluid. Optionally, there may be little or no current flow there. For example, the charge source may be insulated from the surface and / or the biological fluid.

[0062] Figure 4 This is a perspective view of a medical tube (e.g., a catheter) according to an embodiment of the present invention. In some embodiments, an adsorption inhibition system is included in the catheter, for example, to prevent contamination of the tube 406. For example, wires and / or electrodes can To extend along the tube 406. Optionally, the electrode is insulated and / or not in contact with the wall of the tube 406. The fluid inside the tube 406 and / or the fluid outside the tube 406. In some embodiments, the electrode can reach and / or Or it may be shaped to prevent adsorption at the distal end of the tube 406.

[0063] Optionally, tube 406 includes multiple cavities (e.g., including a suture wing and / or a partition cavity to separate port 414) connected by a hub and / or a bushing 418. For example, the adsorption suppression system may include elements built into the bushing 418, such as those shown in the unfolded view of region B. Figure 5A And / or 5B.

[0064] In some embodiments, a surface protected from adsorption (e.g., a surface of medical tube 406) may be made of a polymeric material, such as silicone, polyurethane (PUR), vinyl, latex, silicone elastomer-coated latex and / or hydrophilic polymer-coated latex, rubber and / or polytetrafluoroethylene (PTFE) (Teflon)-coated latex and / or more. Optionally, the surface may be coated or uncoated with materials such as silver alloy coating (antimicrobial) and / or antibiotics and / or preservatives and / or other materials. Optionally, tube 406 may have an outer diameter ranging from 3f to 23f. The medical tube may include one to three or more lumens for material transfer between the outside of the tube and the body cavity.

[0065] Various types of medical “tubes,” including catheters, urinary catheters, and / or stents, can be inserted into a patient, for example, to deliver medication and / or guide bodily fluids (e.g., blood, urine, etc.). These devices typically have a shortened lifespan due to blockage over time. Blockage may result from activation of the body's clotting system. In some embodiments, a system according to the invention can be used to suppress such blockage.

[0066] Figure 5A and 5B yes Figure 4 A close-up view of Part B, showing a perspective view and a sectional view according to an embodiment of the invention. Optionally, a power source 510 (e.g., a battery) and / or a regulator (e.g., an A / C generator 512 and / or a processor 520) is located outside the conduit (e.g., in the bushing 418 and / or a suture flap of the conduit). Electrodes 502a, such as wires connected to the A / C generator 512, are optionally generated through the tube 406 of the conduit. For example, the wires are connected to the A / C generator 512 to generate an alternating electric field on an exposed surface of the tube 406. For example, the field and / or system may be based on... Figures 1 to 3 The system and / or method described herein.

[0067] In some embodiments, electrodes (e.g., 1 to 5 wires 502a on each side, see...) Figure 5A The electrodes are sealed within the wall of tube 406. Optionally, the electrodes are not exposed (e.g., electrically insulated from) an inner and / or outer surface of tube 406. Optionally, the electrodes are connected to a regulator (e.g., an oscillator 512 and / or a controller 520, which may include, for example, a printed circuit board (PCB) device). For example, the regulator may be connected to a power source 510 (e.g., a battery) and / or control the frequency, amplitude, and / or voltage variation of each electrode. Optionally, the voltage variation may be periodic and / or random. In some embodiments, the voltage variation will occur on conductors 502a, 502b carrying opposite charges (e.g., see...). Figure 6An alternating electric field is induced between the electrodes. The current between the electrodes can be optionally very small and / or negligible.

[0068] Figure 6 A cross-section of a catheter according to an embodiment of the present invention is shown (e.g., through a...). Figure 4 (Cross-section of the wire DD). Optionally, wires 502a and 502b extend along the length of the tube 406. Optionally, wires 502a and 502b are charged with alternating current. For example, wire 502a on one side of the tube 406 has opposite polarity to wire 502b extending along the other side of the tube 406. For example, the tube 406 includes three medical lumens (one main lumen 416a and / or two secondary lumens 416b, 416c). Optionally, electrodes (e.g., wires 502a, 502b) are embedded in the wall of the catheter (e.g., the interior of the wall having a surface exposed to biological media).

[0069] Figures 7A-7D This is a schematic diagram illustrating a possible concept of inhibiting adsorption according to some embodiments of the present invention. For example, a fluid can be as follows: Figure 7A The illustration includes a surface 724 and / or polar molecules 722a, 722b. Without limiting the invention to a theoretical conceptualization, in some embodiments, various types of electrical connections (e.g., the poles of a polarized molecule 722a, 722b can be oriented and / or attracted to a surface 724 having opposite charges, for example, as shown) Figure 7B The illustrated and / or nonpolar molecule can become polarized and / or be attracted to a charge, for example by van der Waals forces, to facilitate an adhesion process between molecules (e.g., enzymes, proteins, and / or a foreign body similar to an implant). In some embodiments, an alternating voltage on a surface 724 (e.g., a medical tube) can create an alternating repulsive state between molecules 722a, 722b in the surface and the surrounding fluid (e.g., blood). In this way, the molecules 722a, 722b can approach the surface (e.g., blood). Figure 7B (as shown) and remove (e.g.) Figure 7C (as shown), but can be suppressed from forming a stable bond with the surface and / or retaining the solution (e.g. Figure 7D (As shown). Optionally, the oscillation rate of the charge will be related to the time required for a molecule 722a to rotate (e.g., between 1 / 10 and 1 time and / or between 1 and 10 time and / or between 10 and 100 time and / or between 100 and 1000 time). For example, in a conduit, this may suppress a contamination process. Alternatively, an alternating voltage may generate a reverse electric field, which may cause a rapid reversal in the direction in which molecules move toward each other, thereby suppressing their binding.

[0070] Figure 7AA schematic conceptualization depicts a situation where there is no charge at the surface 724 (e.g., an electrode near the surface 724 is not activated). Optionally, the molecules 722a, 722b are not of interest to them. For example, according to some embodiments of the invention, no charge can be sensed during a phase of the AC mode.

[0071] Figure 7B In another stage, the electrode and / or surface 724 may be loaded with a positive charge. The molecules 722a, 722b may be rotated and / or stretched such that a portion of the molecule carrying a negative charge is directed toward the positively charged electrode. A positively charged portion of the molecules 722a, 722b may leave the electrode while the negative charge may approach the electrode. In some cases, the attractive force between opposite charges is stronger than the repulsive force between like charges, for example because the positive portion of the molecules 722a, 722b is farther from the electrode than the negative portion. For example, the molecules 722a, 722b may begin to move toward the electrode and / or surface 724.

[0072] Figure 7C A conceptual diagram illustrating the charge reversal of an electrode is shown. When the charge of the electrode reverses (e.g., from positive to negative), a molecule 722a, 722b (e.g., directed to the negative portion of the positive electrode) is repelled. Possibly later, the molecule 722a, 722b will turn and / or begin to be attracted to the electrode. This may result in movement and / or rotation of the molecule 722a, 722b within the charge reversal region (e.g., according to the polarization change rate of the electrode). The rotation and / or extension and / or movement of the molecule 722a, 722b itself can suppress adsorption onto a surface 724.

[0073] Figure 7D This shows that the device returns to an uncharged state while adsorption has been avoided.

[0074] Figure 8A An example of a conduit according to an embodiment of the present invention includes an external electric field source (e.g., a power supply 810a and / or a regulator 812a). For example, an electrode 802 carries an alternating charge and / or an opposing electrode 802' is loaded with an opposite charge. For example, the electrodes 802, 802' may include lines extending along the length of a conduit 826. Optionally, in some embodiments, an electrode may be shaped to have a dominant effect at a specific location where blockage and / or contamination and / or film formation and / or adsorption are expected to occur. For example, an electrode may be shaped to have a dominant effect near the end 806 and / or near an opening of a conduit. For example, the electrodes 802, 802' may be twisted around the end 806 near the conduit 826 and / or have an increased surface area.

[0075] Figure 8B An example of a catheter including an implanted electric field source according to an embodiment of the present invention is shown. Optionally, in some embodiments, an electrode 802, 802' may be shaped to have a primary effect at a specific location where blockage and / or contamination and / or film formation and / or adsorption is expected to occur. For example, an electrode may be shaped to have a primary effect near the end 806 and / or near an opening of a catheter 826. Optionally, a power source 810b may include a piezoelectric generator. For example, movement of the object and / or internal body parts may result in the generation of electricity. For example, the power source may be rectified by a rectifier 828 and / or a capacitor 830 and / or regulated by a regulator 812b, for example, to generate an electric field that inhibits blockage and / or contamination and / or film formation and / or adsorption.

[0076] Figures 9A to 9D Various forms of adsorption and / or contamination of a catheter can be mitigated through some embodiments of the present invention. In some embodiments, blockage and / or adsorption and / or contamination are contemplated to begin from an outer surface and / or near an opening of a catheter. According to some embodiments of the invention, one or more electrodes will be positioned near an opening of a catheter. For example, the electrodes may be embedded in a wall of the catheter and / or insulated. Optionally, the electrodes may be located between 0.01 and 0.1 mm and / or between 0.1 and 1 mm and / or between 1 and 2 mm and / or between 2 and 5 mm and / or between 5 and 15 mm from a distal end of a catheter and / or an opening of a catheter.

[0077] Figure 9A The image shows a matrix of cells and debris forming a fibrin sheath 932 around one end of a catheter 926. This sheath 932 is a known cause of central venous stenosis and catheter failure.

[0078] Figure 9B An intraluminal catheter occlusion 934 is shown. For example, a blood clot adhering to the catheter wall and / or potentially blocking the tip of the catheter 926.

[0079] Figure 9C A fibrin tail 936 is shown. For example, cells and / or debris may extend from the tip of the catheter and / or be pulled inward. The material may block the opening in the lumen of the catheter 926.

[0080] Figure 9D A thrombus 938 is shown. For example, a thrombus 938 may form where the catheter 926 contacts or “rubs” against the wall of a natural lumen (e.g., the wall of a vein).

[0081] In some embodiments, a system according to the invention (e.g., any of the embodiments described herein) can be used as a urinary catheter (e.g., the system can inhibit infection and / or form a biofilm and / or adsorb bacteria onto the catheter) and / or other catheters (e.g., pneumothorax, epidural, subarachnoid, brachial tube, subcutaneous, venous, umbilical cord, tunnel center, peripherally inserted central catheter (PICC)) and / or implants, such as implantable ports, stents, tube implants, shunts, drainage tubes, and artificial valves.

[0082] Figure 10A A piezoelectric device 1010 is shown inside an artery 1042 according to an embodiment of the present invention.

[0083] Figure 10B A piezoelectric device 1010 is shown on the outer side of an artery 1042 according to an embodiment of the present invention. For example, a piezoelectric device 1010 may be triggered by pulsation of an artery 1042. For example, the device 1010 may suppress blockage of an artery 1042. For example, a piezoelectric ring forming an alternating charge may be disposed around and / or inside the artery 1042 (e.g., as a stent portion). Alternatively, the device may form a charge via a piezoelectric device, for example in response to pulsation when blood 1040 is pumped through the artery. Alternatively or additionally, the device may be connected to an external and / or internal power source (e.g., a battery and / or a regulator).

[0084] The various embodiments and aspects of the invention described above and claimed in the following claims are experimentally supported in the examples below.

[0085] Example

[0086] Referring now to the following examples, which, together with the above description, illustrate some embodiments of the invention in a non-limiting manner.

[0087] 1. Nine catheters 1226a, 1226b (see, for example, see...) Figure 12 ) is printed inside each catheter, with a central channel 1106 (see, for example, see...) Figure 11 )passing through all of each catheter 1226a, 1226b and the six additional electrode channels surrounding the central channel within their walls ( Figure 11 ).

[0088] 2. The six additional electrode channels open at a proximal end and have a closed "venous side" that seals the electrode channels, electrically insulates the electrode channels, and prevents contact between the electrodes and fluid and tissue surrounding the catheters 1226a, 1226b.

[0089] 3. Electrodes composed of metal wires 1102a and 1102b are inserted into the six electrode channels of these conduits.

[0090] 4. In five of the nine catheters used for testing, the electrodes are connected to an AC voltage generator 1112. These are the active catheters. The other four catheters are used as controls.

[0091] 5. The amplitude of the AC voltage applied to the electrode of the test conduit is 1 volt.

[0092] 6. Three wires 1102a in each group are connected to “-”, and the other three wires 1102b are connected to “+”. For example, three positive electrodes 1102b form a group on one side of the lumen of the catheter, while the remaining charged electrodes 1102a (negative electrodes) form a group on the opposite side of the lumen.

[0093] 7. In different experiments, the voltage generator reverses the voltage between "+" and "-" at frequencies of 20, 200 and 2000 Hz.

[0094] 8. All catheters were inserted into a larger tube 1242 that circulates fresh human blood using a peristaltic pump.

[0095] 9. The active catheter and control catheters 1126a and 1126b are arranged alternately.

[0096] 10. At the end of each experiment, the water flow through the conduit is measured, and the active conduit 1126a is compared with the control conduit 1126b.

[0097] In the exemplary test, the most positive result was observed at a frequency of 200 Hz, with four-fifths of the experimental active catheters showing significantly higher flow rates compared to the control catheter. A photograph of the catheter at the end of the test is included. Figure 12 The image shows the test catheter connected to the blue line and the control catheter without the line. Blood clots adhering to the opening of each control catheter are visible at the bottom. Less contamination is visible in the active catheter compared to the control.

[0098] Table 1 below and Figure 13 The results are described after the tube was exposed to blood for 43 hours. The blood was circulated between 5 minutes of stillness and 5 seconds of aspiration.

[0099]

[0100] Table 1 Test Results

[0101] Four of the five tested catheters (catheters 1, 3, 5, 7, and 9) of catheter 1226a showed significantly less adsorption and significantly more flow than the control catheters (2, 4, 6, and 8) of catheter 1226b.

[0102] generally

[0103] It is anticipated that during the patent term of this application, many related building technologies, artificial intelligence methods, computer user interfaces, and image acquisition devices will be developed, and the terminology of design elements, analysis programs, and user devices is intended to encompass all these new technologies.

[0104] As will be understood by those skilled in the art, some embodiments of the present invention may be embodied as systems, methods, or computer program products. Therefore, some embodiments of the present invention may take the form of a completely hardware implementation, a completely software implementation (including firmware, resident software, microcode, etc.), or an implementation combining software and hardware aspects, all of which may be referred to herein as "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer-readable media, on which computer-readable program code is embodied. Implementation of methods and / or systems according to some embodiments of the present invention may involve manually, automatically, or a combination thereof performing and / or completing selected tasks. Furthermore, according to the actual instruments and apparatus of some embodiments of the methods and / or systems of the present invention, several selected tasks may be implemented by hardware, software, or firmware and / or a combination thereof, for example, using an operating system.

[0105] For example, hardware for performing selected tasks according to certain embodiments of the invention can be implemented as a chip or circuit. As software, selected tasks according to certain embodiments of the invention can be implemented as multiple software instructions, executed by a computer using any suitable operating system. In one exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, may also be provided.

[0106] Any combination of one or more computer-readable media can be used in some embodiments of the present invention. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, device, or apparatus, or any suitable combination thereof. More specific examples (a non-exhaustive list) of computer-readable storage media include the following: an electrical connection having one or more wires, a portable computer floppy disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable optical disc read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof. In the context of this document, a computer-readable storage medium can be any tangible medium capable of containing or storing a program for use by or associated with an instruction execution system, device, or apparatus.

[0107] A computer-readable signal medium may include a propagated data signal embodying computer-readable program code, for example, in baseband or as part of a carrier wave. This propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium that is not a computer-readable storage medium and may communicate, propagate, or transmit a program for use by or in connection with an instruction execution system, apparatus, or device.

[0108] Program code embodied on a computer-readable medium and / or data used therefrom may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, radio frequency, or any suitable combination thereof.

[0109] Computer program code used to perform operations of certain embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, C++, or similar languages, and traditional procedural programming languages ​​such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or connected to an external computer (e.g., using an internet service provider via the internet).

[0110] Some embodiments of the present invention will now be described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It will be understood that each block in the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to create a machine such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, produce means for implementing the functions / behaviors specified by one or more blocks in the flowchart illustrations and / or block diagrams.

[0111] These computer program instructions may also be stored in a computer-readable medium that can direct a computer, other programmable data processing apparatus or other apparatus to operate in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture, including instructions that implement the functions / behaviors specified in the flowcharts and / or block diagrams.

[0112] Computer program instructions may also be loaded onto a computer, other programmable data processing apparatus or other apparatus to cause a series of operational steps to be performed on the computer, other programmable apparatus or other apparatus, thereby producing a computer-implemented process, such that the instructions that execute on the computer or other programmable apparatus provide a process for implementing the functions / behaviors specified in the flowchart and / or block diagram.

[0113] Some of the methods described in this article are typically designed for computers and may be infeasible or impractical for human experts to perform manually. Human experts wishing to perform similar tasks manually might use entirely different approaches, such as leveraging expert knowledge and / or the pattern recognition capabilities of the human brain, which would be far more efficient than manually completing the steps of the methods described in this article.

[0114] The term "about" as used in this article refers to ±20%.

[0115] The terms "including", "comprise", "contain", "have", and their conjugates mean "including but not limited to".

[0116] The term "composed of" means "including and limited to".

[0117] The term "substantially composed of" means that the composition, method, or structure may include additional ingredients, steps, and / or portions, provided that such additional ingredients, steps, and / or portions do not substantially alter the fundamental and novel characteristics of the claimed composition, method, or structure.

[0118] As used herein, the singular forms of “a,” “one,” and “the” include plural references unless the context explicitly specifies otherwise.

[0119] In this application, various embodiments of the invention can be represented using a range format. It should be understood that the use of a range format is for convenience and brevity only and should not be construed as a rigid limitation on the scope of the invention. Therefore, a description of a range should be considered as specifically disclosing all possible subranges and individual numerical values ​​within that range. For example, a description of a range, such as from 1 to 6, should be considered as specifically disclosing subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual numbers within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0120] Whenever a range of numbers is specified here, it means to include any referenced numbers (decimals or integrals) within the specified range. The phrases "range between the first and second indicated numbers" and "range from the first indicated number to the second indicated number" are used interchangeably here and mean to include the first and second indicated numbers as well as all fractions and integrals in between.

[0121] As used herein, the term "method" refers to the manner, means, techniques, and procedures for accomplishing a particular task, including but not limited to those known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry, and medicine, or those that can be readily developed from known manner, means, techniques, and procedures.

[0122] It should be understood that certain features of the invention, described for clarity in the context of individual embodiments, may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually, or in any suitable sub-combination, or suitably provided in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless an embodiment without these elements would be inoperable.

[0123] Although the invention has been described in conjunction with its specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is an object of the invention to encompass all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0124] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the same extent that each individual publication, patent, or patent application is specifically and individually identified and incorporated herein by reference. Furthermore, any reference or identification of any reference in this application should not be construed as an admission that such reference is prior art to the present invention. Where section headings are used, they should not be construed as necessarily limiting.

Claims

1. An implantable device, characterized in that: The implantable device includes: A distal tube having a non-conductive surface configured to contact at least one body part within the body; A first electrode is disposed near the non-conductive surface, the first electrode is embedded in a wall portion of the distal tube and extends along a length of the distal tube, wherein the first electrode is electrically insulated from a point on an inner surface of the distal tube, the point contacting an inner cavity of the distal tube, and the first electrode is electrically insulated from an outer surface of the distal tube, the outer surface contacting the at least one body component. The first electrode is positioned to generate an electric field in the cavity and is configured to prevent adsorption on the inner surface of the distal tube, the outer surface of the distal tube, or both, wherein the inner surface of the distal tube contacts the cavity and the outer surface of the distal tube. An electrical insulator is used to suppress the current between the body component and the first electrode; One power source; as well as A regulator is connected to the power supply to the first electrode, thereby regulating a charge on the first electrode. The first electrode is configured to generate an alternating electric field on the non-conductive surface to suppress adsorption onto the non-conductive surface.

2. The implantable device as claimed in claim 1, characterized in that: The shortest path between the first electrode and the non-conductive surface is sealed within the implantable device and away from the body component, and is also sealed away from the non-conductive surface.

3. The implantable device as described in claim 1, characterized in that: The shortest path between the first electrode and the non-conductive surface is not in fluid communication with the body component and is not in fluid communication with the non-conductive surface.

4. The implantable device as claimed in claim 1, characterized in that: The implantable device also includes: A second electrode, connected to the regulator, is used to carry a charge opposite to that of the first electrode, wherein the second electrode is electrically insulated from the non-conductive surface and from the body component.

5. The implantable device as described in any one of claims 1 to 3, characterized in that: The implantable device also includes: A second electrode, connected to the regulator, is used to carry an opposite charge relative to the first electrode, wherein the second electrode is located away from the first electrode.

6. The implantable device according to any one of claims 1 to 4, characterized in that: The regulator and the power supply are configured to generate a current of less than 0.01 amperes.

7. The implantable device as claimed in claim 1, characterized in that: The non-conductive surface comes into contact with living tissue in vivo, wherein the power source is isolated from the living tissue.

8. The implantable device as claimed in claim 1, characterized in that: The non-conductive surface is in contact with the body fluid outside the body, wherein the power source is isolated from the body fluid.

9. A catheter assembly, characterized in that: The catheter assembly includes: A distal portion is configured for insertion into a living body; An inner cavity located within the distal portion; A first electrode is embedded in a wall portion of the distal portion and extends along a length of the distal portion, wherein the first electrode is electrically insulated from a point on an inner surface of the distal portion, the point being in contact with the inner cavity, and the first electrode is electrically insulated from an outer surface of the distal portion, the outer surface being in contact with the living body. The first electrode is positioned to generate an electric field in the cavity and is configured to prevent adsorption on the inner surface of the distal portion, the outer surface of the distal portion, or both, wherein the inner surface of the distal portion contacts the cavity and the outer surface of the distal portion. One power source; and A charge regulator, electrically connected between the electrode and the power source, is used to generate an alternating charge on the electrode to suppress adsorption onto a non-conductive surface of the distal portion.

10. The catheter assembly as claimed in claim 9, characterized in that: The power supply, regulator, and first electrode are configured to generate the alternating charge in a wall of the inner cavity at a frequency of 50 Hz to 1 kHz.

11. The catheter assembly as claimed in claim 9, characterized in that: The first electrode is held within 5 millimeters of the cavity.

12. The catheter assembly as claimed in claim 9, characterized in that: The first electrode is held within a wall of the cavity.

13. The catheter assembly as claimed in claim 9, characterized in that: The electrode is sealed to prevent communication with an internal fluid within the cavity.

14. The catheter assembly as claimed in any one of claims 9 to 13, characterized in that: The catheter assembly also includes: A second electrode, connected to the regulator, is used to carry a charge opposite to the alternating charge on the first electrode, wherein the second electrode is electrically insulated from the cavity.

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