Micro-intervention magnetic control diagnosis and treatment catheter

Abstract

The invention relates to the technical field of medical instruments, and discloses a micro-intervention magnetic control diagnosis and treatment catheter which is characterized in that a magnetic ring and a first flexible catheter are connected to form a continuous body, and a detection electrode for detection is arranged in the first flexible catheter and the magnetic ring in a penetrating manner; during detection, the magnetic action is generated between external magnetic field equipment and the magnetic ring, the first flexible catheter is controlled through the magnetic action to move in a complex and limited environment (blood vessels or tissues), addressing of suspected diseased regions can be accurately achieved, the stability during operation is improved through cooperation of magnetic force, and the detection accuracy is improved. The diagnosis and treatment efficiency of the diseased region is further improved; meanwhile, a conveying pipe and an optical fiber are arranged in the first flexible catheter in a penetrating mode and are used for drug delivery and phototherapy of local diseased regions respectively, and the first flexible catheter is used for being matched with the detection electrode to jointly achieve precise treatment of the diseased regions.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a micro-interventional magnetic control diagnosis and treatment catheter. Background Art

[0002] As an important part of modern medicine, micro-interventional surgery shows broad application prospects in clinical treatment. Guided by advanced imaging equipment, local treatment is achieved by directly acting on the lesion site through a thin-diameter catheter or treatment probe, avoiding the large-area trauma of traditional surgery. In tumor diseases, micro-interventional surgery can precisely destroy tumor tissues while protecting surrounding normal tissues, improving the treatment effect. For cardiovascular diseases, it can quickly restore blood flow and relieve the symptoms of patients. However, micro-interventional surgery highly depends on interventional tools. Currently, the guide wires or catheters in interventional surgery usually rely on doctors' clinical experience in operation, with a relatively high operation difficulty. During the detection process, precise control of their movement paths cannot be achieved, and the stability is relatively low. Summary of the Invention

[0003] The purpose of the present invention is to provide a micro-interventional magnetic control diagnosis and treatment catheter, which is used to solve the problems of large movement control difficulty, low stability, and single function of guide wires or catheters in micro-interventional surgery in the prior art.

[0004] To achieve the above purpose, an embodiment of the present application provides a micro-interventional magnetic control diagnosis and treatment catheter, including: a first flexible catheter, a magnetic ring, and a detection electrode;

[0005] One axial side of the magnetic ring is connected to the first flexible catheter, so that the magnetic ring and the first flexible catheter form a continuous body, and the length direction of the continuous body has a first end and a second end arranged oppositely;

[0006] The detection electrode passes through the first flexible catheter and the magnetic ring in sequence from the second end, and extends out from the first end.

[0007] In some embodiments of the present application, the micro-interventional magnetic control diagnosis and treatment catheter has a first direction extending along the length direction of the continuous body, and the magnetic ring includes a first magnetic ring and a second magnetic ring arranged at intervals along the first direction;

[0008] The micro-interventional magnetic control diagnosis and treatment catheter further includes a second flexible catheter connected between the first magnetic ring and the second magnetic ring, and the second magnetic ring is connected to the first flexible catheter on one side close to the second end;

[0009] The detection electrode passes through the first flexible catheter, the second magnetic ring, the first flexible catheter, and the first magnetic ring in sequence from the second end, and extends out from the first end.

[0010] In some embodiments of the present application, the micro-interventional magnetically controlled diagnostic and therapeutic catheter further includes a head shell disposed at the first end, and the head shell is connected to a side of the first magnetic ring away from the second end;

[0011] The detection electrode passes through the first magnetic ring and enters the head shell. The head shell has a hollow portion connected to the outside. The detection electrode is accommodated in the hollow portion at a side away from the second end.

[0012] In some embodiments of the present application, the micro-interventional magnetically controlled diagnostic and therapeutic catheter also includes a delivery tube. Along the first direction, the delivery tube passes through the first flexible catheter, the second magnetic ring, the second flexible catheter, the first magnetic ring in sequence from the second end and enters the head shell, and the side of the delivery tube away from the second end is accommodated in the hollow portion.

[0013] In some embodiments of the present application, the micro-interventional magnetically controlled diagnostic and therapeutic catheter also includes an optical fiber. Along the first direction, the optical fiber passes through the first flexible catheter, the second magnetic ring, the second flexible catheter, the first magnetic ring from the second end in sequence and enters the head shell; the head shell is a light-transmitting structural component.

[0014] In some embodiments of the present application, the optical fiber is arranged colinearly with the axial center line of the continuum; there are multiple detection electrodes, and the delivery tube and the multiple detection electrodes are arranged around the optical fiber at intervals.

[0015] In some embodiments of the present application, along the first direction, a first channel is penetrated in the first flexible conduit, and a second channel is penetrated in the second flexible conduit; the detection electrodes are sequentially penetrated in the first channel and the second channel.

[0016] In some embodiments of the present application, the detection electrode extends from the second magnetic ring and extends to the second end, so that the detection electrode at least partially extends into the first channel toward the second end;

[0017] The first channel has a conductive plugging piece on one side away from the first end, and the detection electrode extends into a cavity between one end of the first channel and the conductive plugging piece to form a conductive cavity, which is used to store liquid conductive medium.

[0018] In some embodiments of the present application, the micro-interventional magnetically controlled diagnostic and therapeutic catheter further includes a columnar fixing member, and the columnar fixing member is coaxially disposed through the inner cavities of the first magnetic ring and the second magnetic ring;

[0019] The columnar fixing member has a plurality of third channels for the detection electrodes to pass through, and the plurality of third channels are arranged at intervals around the axial center line of the columnar fixing member.

[0020] In some embodiments of the present application, a fourth channel is provided inside the head housing, and the detection electrode passes through the fourth channel after extending from the first magnetic ring;

[0021] The hollowed-out portion includes a slot hole communicating with the side of the fourth channel away from the first magnetic ring, and one end of the detection electrode extending from the fourth channel is received in the slot hole.

[0022] Compared with the prior art, a micro-interventional magnetic control diagnosis and treatment catheter according to an embodiment of the present invention has the beneficial effects that: in this solution, a magnetic ring and a first flexible catheter are connected to form a continuum, and a detection electrode for detection is passed through the first flexible catheter and the magnetic ring; during detection, by means of the magnetic force generated between an external magnetic field device and the magnetic ring, the first flexible catheter can be controlled to move in a complex and restricted environment (blood vessel or tissue) through this magnetic force, and the addressing of a suspected lesion site can be accurately achieved. Through the cooperation of magnetic forces, the stability during operation is improved, and at the same time, through internal diagnostic and treatment devices such as detection electrodes, delivery tubes (for drug administration), and optical fibers (for phototherapy), the diagnostic and treatment efficiency of the lesion site is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic diagram of the overall structure of the continuum according to the first embodiment of the present invention;

[0024] Figure 2 It is an exploded schematic diagram of the overall structure of the continuum according to the first embodiment of the present invention;

[0025] Figure 3 It is a schematic diagram of the structures of the first flexible catheter and the second flexible catheter according to the first embodiment of the present invention;

[0026] Figure 4 It is a schematic diagram of the installation relationship among the first magnetic ring, the second magnetic ring, and the columnar fixing member according to the first embodiment of the present invention;

[0027] Figure 5 It is another perspective schematic diagram of the installation relationship among the first magnetic ring, the second magnetic ring, and the columnar fixing member according to the first embodiment of the present invention;

[0028] Figure 6 It is a schematic diagram of the overall structure of the continuum according to the second embodiment of the present invention;

[0029] Figure 7 It is a schematic diagram of a partially cross-sectioned continuum according to the first embodiment of the present invention;

[0030] Figure 8 It is a schematic diagram of the cross-sectional structure of the head housing according to the first embodiment of the present invention.

[0031] In the figure, 1 is the first flexible catheter; 11 is the first channel; 111 is the conductive cavity; 12 is the conductive plugging member; 13 is the second optical fiber hole;

[0032] 2 is the magnetic ring; 21 is the first magnetic ring; 22 is the second magnetic ring; 3 is the detection electrode;

[0033] 4 is the second flexible catheter; 41 is the second channel; 42 is the third optical fiber hole; 5 is the head housing; 51 is the fourth channel; 52 is the slot hole; 53 is the protrusion; 54 is the first optical fiber hole;

[0034] 6 is the delivery tube; 7 is the optical fiber; 8 is the columnar fixing member; 81 is the third channel; 82 is the fourth optical fiber hole; 9 is the first end; 10 is the second end; X is the first direction. Detailed implementation manners

[0035] The following combines the drawings and embodiments to further describe in detail the specific implementation manners of the present invention. The following embodiments are used to illustrate the present invention, but are not used to limit the scope of the present invention.

[0036] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", etc. are based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present invention. It should be understood that the present invention uses the terms "first", "second", etc. to describe various information, but these information should not be limited to these terms, and these terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present invention, the "first" information may also be referred to as the "second" information, and similarly, the "second" information may also be referred to as the "first" information.

[0037] Such as Figures 1 - 8As shown in the figure, an embodiment of the present application provides a micro-interventional magnetic control diagnosis and treatment catheter, including a first flexible catheter 1, a magnetic ring 2, and a detection electrode 3; one axial side of the magnetic ring 2 is connected to the first flexible catheter 1, so that the magnetic ring 2 and the first flexible catheter 1 form a continuous body; the first flexible catheter 1 in this solution is prepared by 3D printing technology, and its printing raw material is: prepared by mixing alcohol-soluble aniline black (mass fraction 0.03%) and PDMS (99.97%; SE 1700, Dow Corning) evenly and then performing vacuum degassing for 10 minutes, and then using a 3D printer for printing. The printed product is cured at 70°C for 1 hour to obtain the first flexible catheter 1; in the magnetic field driving design, when the external magnetic field direction is the same as or close to the magnetization direction of the magnet, the control effect of the magnetic field on the magnet is the most significant, and more precise control can be achieved; the magnetic ring 2 in this solution is selected as an axially magnetized magnetic ring 2. As the magnet responding to the external magnetic field, the magnetization direction is consistent with the axis of the continuous body. The magnetic force generated under the action of the external magnetic field can drive the continuous body to move more flexibly in a complex and restricted environment (blood vessel or tissue), so that the first end 9 of the continuous body exhibits strong stability and directivity; as Figure 1 shown, a first end 9 and a second end 10 are oppositely arranged in the length direction of the continuous body; the detection electrode 3 passes through the first flexible catheter 1 and the magnetic ring 2 in sequence from the second end 10 and extends out from the first end 9.

[0038] In the specific use of this embodiment, medical staff control the precise and flexible movement of the continuous body in blood vessels or tissues through the magnetic force between the external magnetic field and the magnetic ring 2, so that the continuous body drives the detection electrode 3 to move quickly and sensitively, and the end of the detection electrode 3 extending out from the first end 9 detects biochemical markers at the lesion site when it reaches the lesion site. The type of the detection electrode 3 is determined by the biochemical markers of the disease. Taking the detection of tumor characteristics as an example, the present invention detects physiological analytes such as pH, hydrogen peroxide, potassium ions, glutathione, and glucose in the microenvironment, and then realizes the detection and analysis of the lesion site.

[0039] Preferably, a hydrogel layer can be cured on the surface of the first flexible catheter 1 in this solution, which can better reduce the frictional resistance of the continuous body when passing through blood vessel living tissues (improve the safety during interventional surgery); specifically, the preparation process is as follows: the first flexible catheter 1 is immersed in an ethanol solution of 10wt% benzophenone for 5 minutes and then dried at room temperature for 2 hours; then it is put into a solution containing 1%wt Irgacure-2959 (photoinitiator) and 20%wt N,N-dimethylacrylamide for ultraviolet cross-linking for 1 hour; then washed with water to remove the uncrosslinked hydrogel polymer, and a hydrogel layer can be cured on the surface of the first flexible catheter 1.

[0040] In some embodiments of the present application, such asFigure 1 , Figure 2 As shown in Figure 2 , the micro-interventional magnetic control diagnosis and treatment catheter has a first direction X extending along the length of the continuum. The magnetic ring 2 includes a first magnetic ring 21 and a second magnetic ring 22 arranged at intervals along the first direction X. The micro-interventional magnetic control diagnosis and treatment catheter further includes a second flexible catheter 4 connected between the first magnetic ring 21 and the second magnetic ring 22 (the second flexible catheter 4 is made of the same material and prepared in the same way as the first flexible catheter 1, and will not be elaborated here; the surface of the second flexible catheter 4 is also coated with a layer of hydrogel layer, and its preparation method has been described above and will not be elaborated here). The second magnetic ring 22 is connected to the first flexible catheter 1 near the second end 10. In this solution, the first magnetic ring 21, the second flexible catheter 4, the second magnetic ring 22, and the first flexible catheter 1 are all bonded by a photocuring resin adhesive to connect and fix the above-mentioned multiple components, and then form a continuum. Preferably, a layer of PDMS (polydimethylsiloxane) layer, that is, silicone oil, a polyorganosiloxane with a chain structure of different degrees of polymerization, can be coated on the surfaces of the first magnetic ring 21 and the second magnetic ring 22. During preparation, the first magnetic ring 21 and the second magnetic ring 22 are directly soaked in silicone oil (in an environment of 60 °C) to obtain the first magnetic ring 21 and the second magnetic ring 22 with a PDMS layer coated on their surfaces. The PDMS layer has good chemical inertness, which can help isolate harmful substances on the surfaces of the first magnetic ring 21 and the second magnetic ring 22, thereby reducing damage to the human body (PDMS is harmless to the human body and will not cause immune reactions or toxic reactions, which makes it widely used in application scenarios that need to contact the human body, such as medical devices). The detection electrode 3 passes through the first flexible catheter 1, the second magnetic ring 22, the first flexible catheter 1, and the first magnetic ring 21 in sequence from the second end 10 and extends out from the first end 9.

[0041] In this embodiment, the magnetic ring 2 is divided into a first magnetic ring 21 and a second magnetic ring 22 arranged at intervals along the first direction X. The N pole of the first magnetic ring 21 corresponds to the S pole of the second magnetic ring 22, so that the magnetic field distribution on the continuum presents in sequence from the first end 9 to the second end 10: N-S, N-S (or S-N, S-N) arrangement. When the magnetic force of the external magnetic field acts on this continuum, the movement of this continuum can be controlled more precisely (multiple N-S or S-N are arranged in sequence, so that no matter whether the external magnetic field acts on the first magnetic ring 21 or the second magnetic ring 22, the continuum can be driven to move, making the control of the movement of the continuum by the external magnetic field more sensitive and efficient). In this solution, the more the number of magnetic rings 2 arranged at intervals along the first direction X on the continuum, the more beneficial it is to the sensitivity of the control of the movement of the continuum. However, the more the number of magnetic rings 2, the greater the rigidity of this continuum will be synchronously (not conducive to the sensitive movement and turning of the continuum in the blood vessel living tissue). In this solution, it is preferred to have two magnetic rings 2 (the first magnetic ring 21 and the second magnetic ring 22).

[0042] In some embodiments of the present application, such as Figure 1 shown, the micro-interventional magnetic control diagnosis and treatment catheter further includes a head housing 5 provided at the first end 9 (also prepared by 3D printing technology, and the original printing material is photosensitive resin), and the head housing 5 is connected to the side of the first magnetic ring 21 away from the second end 10 (connected by a photocuring resin adhesive); as Figure 2 shown, the detection electrode 3 passes through the first magnetic ring 21 and enters the head housing 5. There is a hollow portion in the head housing 5 that communicates with the outside. The side of the detection electrode 3 away from the second end 10 is accommodated in the hollow portion, and the end of the detection electrode 3 extending from the first magnetic ring 21 is placed in the hollow portion. When the continuum reaches the lesion site, it is convenient for the detection electrode 3 to contact the tissue fluid in the blood vessel or tissue, and is used for the detection and analysis of biochemical markers.

[0043] The head housing 5 in this solution is used to protect the end of the detection electrode 3 extending from the first magnetic ring 21. In order to reduce the friction generated when the continuum moves in the blood vessel or tissue, the head housing 5 is set to an arrowhead-like structure from the first end 9 to the second end 10 (as Figure 8 shown), which helps to reduce the frictional resistance when the continuum moves in the blood vessel or tissue; or the head housing 5 is set to a circular outer shell, as Figure 6 shown. The setting of the circular outer shell can prevent the continuum from damaging the tissue or blood vessel wall during movement; in order to enable the end of the detection electrode 3 extending into the head housing 5 to contact the tissue fluid in the blood vessel or tissue, a hollow portion communicating with the outside is provided on the head housing 5, and the end of the detection electrode 3 extending from the first magnetic ring 21 is placed in the hollow portion, so as to ensure effective contact between the detection electrode 3 and the tissue fluid, and is used for the detection and analysis of biochemical markers.

[0044] In some embodiments of the present application, the micro-interventional magnetic control diagnosis and treatment catheter further includes a delivery tube 6. Along the first direction X, the delivery tube 6 sequentially passes through the first flexible catheter 1, the second magnetic ring 22, the second flexible catheter 4, the first magnetic ring 21 from the second end 10 and enters the head housing 5. The side of the delivery tube 6 away from the second end 10 is accommodated in the hollow portion; the end of the delivery tube 6 extending from the first magnetic ring 21 is placed in the hollow portion, so that the drug delivered through the delivery tube 6 can be delivered outward from the hollow portion to achieve the effect of targeted drug delivery to the lesion site; the setting of the delivery tube 6 is used to enable the continuum to have the ability to deliver drugs to the lesion site, realize the synchronous detection and treatment of the lesion site, integrate the detection and treatment functions, expand the diagnosis and treatment functions of the continuum, and improve the clinical application of the continuum in disease diagnosis and treatment.

[0045] In some embodiments of the present application, such as Figure 2As shown, the micro-interventional magnetic control diagnosis and treatment catheter further includes an optical fiber 7. Along the first direction X, the optical fiber 7 sequentially passes through the first flexible catheter 1, the second magnetic ring 22, the second flexible catheter 4, the first magnetic ring 21 from the second end 10 and enters the head housing 5. The head housing 5 is a light-transmitting structural member. Different types of laser light sources are connected to the end of the optical fiber 7. The laser light source emitted by the optical fiber 7 is emitted outward through the light-transmitting head housing 5, so as to realize phototherapy for the diseased part and cooperate with the delivery tube 6 to realize the synchronous progress of local drug delivery and phototherapy, and further improve the treatment effect on the diseased part.

[0046] In some embodiments of the present application, the optical fiber 7 is arranged collinearly with the axial center line of the continuum; there are multiple detection electrodes 3, and the delivery tube 6 and the multiple detection electrodes 3 are arranged at intervals around the optical fiber 7; the detection electrodes 3 in this solution can be selected accordingly according to the items to be detected. Taking the detection of tumor diseases as an example in this solution: the detection electrodes 3 include a reference electrode, a potassium ion electrode, a glutathione electrode, a pH electrode, a hydrogen peroxide electrode and a counter electrode, a glucose electrode, and are used to detect 5 physiological analytes such as pH, hydrogen peroxide, potassium ion, glutathione, and glucose in the tumor characteristic microenvironment.

[0047] Among them, the preparation process of each electrode is as follows:

[0048] Reference electrode: The bare electrode (gold wire electrode, diameter about 0.1 mm, length 3 mm) is repeatedly immersed in the conductive silver paste of Ag / AgCl to form a layer of Ag / AgCl conductive layer on the electrode surface, and dried at room temperature for 12 h to form a reference electrode.

[0049] Potassium ion electrode: The bare electrode is repeatedly immersed in the carbon nanotube isopropanol slurry. After a carbon nanotube structure is formed on the surface, a potassium ion selective permeable membrane (the membrane solution is composed of a mixture (200 mg) of valinomycin (2%, w / w), sodium tetraphenylborate (0.5%), polyvinyl chloride (32.7%, w / w) and diisooctyl sebacate (64.7%, w / w)) dissolved in 700 μl of cyclohexanone) is coated on its surface to form a potassium ion electrode.

[0050] Glutathione electrode: The bare electrode was repeatedly immersed in the glutathione-sensitive paste (dispersed 2 mg of carbon nanotubes in 30 mL of isopropyl alcohol; added 500 μL of 3,4-ethylenedioxythiophene to the dispersed solution under stirring, then added 5 mL of an aqueous solution of cobalt sulfonated phthalocyanine (10 mM / L); subsequently, slowly added 2 mL of an aqueous solution of chloroauric acid (25 mM / L) to initiate a chemical polymerization reaction; further stirred at room temperature for 24 hours, and there was no obvious aggregation in the solution; finally, centrifuged the solution at 10000 rpm for 15 min, and washed it 3 times with ultrapure water and isopropyl alcohol respectively to obtain the glutathione-sensitive paste), so that a glutathione-sensitive nano-layer was formed on the electrode surface, and finally dried at room temperature for 12 h to form the glutathione electrode.

[0051] pH electrode: The bare electrode was immersed in a hydrochloric acid solution containing aniline (where the aniline concentration was 0.1 M and the hydrochloric acid concentration was 1 M), and a pH-sensitive polyaniline layer was formed on the surface of the gold wire by cyclic voltammetry for 40 cycles; then rinsed with deionized water to remove the excess solution, and dried overnight at room temperature to form the pH electrode.

[0052] Hydrogen peroxide electrode and counter electrode: The bare electrode was immersed in a hydrochloric acid solution containing aniline (where the aniline concentration was 0.1 M and the hydrochloric acid concentration was 1 M), and a pH-sensitive polyaniline layer was formed on the surface of the gold wire by cyclic voltammetry for 40 cycles. Then rinsed with deionized water to remove the excess solution, and dried overnight at room temperature to form the pH electrode. The bare electrode was immersed in a platinous sulfite solution, and a layer of platinum nanoparticles was formed on the bare electrode by multi-step current step method for 20 min. Then rinsed with deionized water to remove the excess solution, and dried overnight at room temperature to form the hydrogen peroxide electrode and counter electrode.

[0053] Glucose electrode: 2 mM of 3-mercaptopropionic acid was dropped on the surface of the cleaned bare electrode and incubated for 12 h to allow the thiol groups to self-assemble on the gold surface. The electrode surface was washed with distilled water, and then 2 mM of 2-mercaptoethanol solution was dropped on the electrode surface and incubated for 30 min. Subsequently, a solution of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (10 mg / mL) and N-hydroxysuccinimide (15 mg / mL) with a volume ratio of 1:1 was dropped on the electrode surface and incubated for 45 min. The solution was prepared with 2-(N-morpholino)ethanesulfonic acid buffer at 10 mM pH 5. 3 μL of 100 mg / mL PEI-Fc solution was dropped, and after incubation for 4 hours, the electrode was cleaned with deionized water, then incubated in 2.5% glutaraldehyde for 45 min, and finally 4 μL of glucose oxidase solution (15 mg / mL) was added to the electrode surface and dried in a refrigerator at 4 °C for 12 h; the glucose electrode was formed.

[0054] In some embodiments of the present application, such as Figure 3As shown in the figure, along the first direction X, a plurality of first channels 11 are provided through the first flexible catheter 1, and a plurality of second channels 41 matching the number of the first channels 11 are provided through the second flexible catheter 4. The detection electrode 3 is sequentially inserted into the first channels 11 and the second channels 41 from the second end 10. The inner diameters of the first channels 11 and the second channels 41 match the outer diameter of the detection electrode 3. At the same time, a group of the first channels 11 and the second channels 41 are reserved for the penetration of the delivery tube 6, that is, a plurality of detection electrodes 3 and the delivery tube 6 are inserted into the corresponding first channels 11 and second channels 41. The integration and integration of a plurality of detection electrolytes and the delivery tube 6 are realized through the first flexible catheter 1 and the second flexible catheter 4; the plurality of detection electrodes 3 and the delivery tube 6 and the corresponding first channels 11 and second channels 41 can be fixedly connected by gluing to ensure that the delivery tube 6 and the detection electrode 3 do not move relative to each other in the first channels 11 and the second channels 41; such as Figure 3 A second optical fiber hole 13 and a third optical fiber hole 42 are coaxially arranged in the first flexible catheter 1 and the second flexible catheter 4, and the optical fiber 7 is sequentially inserted into the second optical fiber hole 13 and the third optical fiber hole 42 from the second end 10.

[0055] In some embodiments of the present application, in order to further improve the flexibility of the continuum in blood vessels or tissues (reduce the self-rigidity of the continuum) so that the continuum can move better in blood vessels or tissues, the arrangement of the detection electrode 3 is optimized in this solution; such as Figure 7As shown, the length of the detection electrode 3 is set to be relatively short, that is, the detection electrode 3 only penetrates through the head housing 5, the first magnetic ring 21, the second flexible catheter 4, the second magnetic ring 22, and a part of the first flexible catheter 1; that is, after the detection electrode 3 extends from the first end 9 towards the second end 10 and extends out of the second magnetic ring 22, only a small section of the detection electrode 3 extends into the first channel 11 provided in the first flexible catheter 1. A conductive plugging member 12 is provided on the side of the first channel 11 away from the first end 9 (the conductive plugging member 12 and the inner wall of the first channel 11 are sealed with sealant). The first channel 11 between the conductive plugging member 12 and the end of the detection electrode 3 extending into the first channel 11 forms a conductive cavity 111. The conductive cavity 111 is filled with a liquid conductive medium (such as a metal liquid, an electrolyte solution, etc.) for realizing the electrical connection between the detection electrode 3 and the conductive plugging member 12. The conductive plugging member 12 is electrically connected to an external wire. The outer diameter of the detection electrode 3 is set to match the inner diameter of the first channel 11 (which can reliably seal the side of the first channel 11 close to the first end 9), so that the liquid conductive medium is restricted in the conductive cavity 111 and used to supply power to the detection electrode 3; since only a short distance of the detection electrode 3 exists in the first flexible catheter 1 (powered by the liquid conductive medium), the flexibility of the first flexible catheter 1 is further improved (compared with the case where the first channel 11 is completely filled with the detection electrode 3), which helps to improve the flexibility of the continuum when moving in blood vessels or tissues and reduce the damage to blood vessels or tissues.

[0056] In some embodiments of the present application, such as Figure 2 , Figure 4 , Figure 5 As shown, the micro-interventional magnetic control diagnosis and treatment catheter further includes a columnar fixing member 8 (prepared in the same way as the head housing 5, both are made by 3D printing, and the printing raw material is photosensitive resin). The columnar fixing member 8 coaxially penetrates through the inner cavities of the first magnetic ring 21 and the second magnetic ring 22 (fixed by bonding with photocuring resin). The outer diameter of the columnar fixing member 8 matches the inner diameters of the first magnetic ring 21 and the second magnetic ring 22. A third channel 81 for passing the detection electrode 3 and the delivery tube 6 is provided in the columnar fixing member 8 (the number of the third channels 81 is the same as the sum of the numbers of the detection electrode 3 and the delivery tube 6). A fourth optical fiber hole is also provided at the center of the columnar fixing member 8 (for allowing the optical fiber 7 to pass through). A plurality of third channels 81 are arranged at intervals around the fourth optical fiber hole.

[0057] In this embodiment, the columnar fixing member 8 is arranged so that when the multiple detection electrodes 3 pass through the first magnetic ring 21 and the second magnetic ring 22, each detection electrode 3 will not contact each other, and the detection electrode 3 will not contact the first magnetic ring 21 and the second magnetic ring 22; the columnar fixing member 8 is arranged to physically isolate the multiple detection electrodes 3 and the detection electrode 3 and the first magnetic ring 21 and the second magnetic ring 22, ensuring that the detection electrodes 3 and the detection electrodes 3 and the first magnetic ring 21 and the second magnetic ring 22 will not be interfered by contact, and the normal operation of the detection electrode 3 will not be affected.

[0058] In some embodiments of the present application, Figure 5 , Figure 8 As shown, a protrusion is provided on the side of the head shell 5 facing the first magnetic ring 21 (the outer diameter of the protrusion is the same as the inner diameter of the first magnetic ring 21, and during assembly, the protrusion is directly inserted into the inner cavity of the first magnetic ring 21 and is fixedly connected to the first magnetic ring 21 by gluing), and a first optical fiber hole 54 is coaxially provided in the protrusion and the head shell 5. After the optical fiber 7 extends out from the first magnetic ring 21, it is passed through the first optical fiber hole 54. A through hole (not numbered in the figure) connected to the hollow part is provided at the end of the first optical fiber hole 54 away from the first magnetic ring 21, so that the laser light source emitted by the optical fiber 7 can better irradiate the lesion site and be used for phototherapy; the optical fiber 7 in this solution is also fixedly connected to the first optical fiber hole 54, the second optical fiber hole 13, and the third optical fiber hole 42 by gluing; as shown Figure 5 and Figure 8 As shown, a plurality of fourth channels 51 are further provided in the protruding portion and the head shell 5 (the number of the fourth channels 51 is the same as the sum of the number of the detection electrodes 3 and the delivery tubes 6); the detection electrodes 3 and the delivery tubes 6 are respectively provided in the corresponding fourth channels 51 after extending from the first magnetic ring 21, and the plurality of fourth channels 51 are arranged at intervals around the first optical fiber hole 54; in this solution, the hollow portion provided on the head shell 5 includes a plurality of slots 52 (such as Figures 1 - 5 As shown, a plurality of slots 52 are arranged at intervals around the circumference of the head shell 5, and each slot 52 is arranged on the extension line of the fourth channel 51 in the first direction X, so that the fourth channel 51 and the corresponding slot 52 are connected, and the detection electrode 3 and the delivery tube 6 extend from the fourth channel 51 into the slot 52 to achieve contact with the tissue fluid in the blood vessel or tissue for biochemical marker detection and local drug delivery.

[0059] The working process of the present invention is as follows: medical staff control the movement of the continuum in blood vessels or tissues through an external magnetic field, so that under the control of magnetic force, the continuum is driven to quickly reach the lesion site, and biochemical markers of the lesion site are detected through the detection electrode 3; local drug delivery is carried out to the lesion site through the delivery tube 6, and different types of laser light sources are applied to perform phototherapy on the lesion site through the optical fiber 7, so as to realize the synchronous detection and treatment of the lesion site.

[0060] In summary, the embodiment of the present invention provides a micro-interventional magnetically controlled diagnosis and treatment catheter. In this solution, the magnetic ring 2 and the first flexible catheter 1 are connected to form a continuum, and the detection electrode 3 for detection is disposed in the first flexible catheter 1 and the magnetic ring 2; during detection, a magnetic force is generated between the external magnetic field device and the magnetic ring 2, and then the first flexible catheter 1 is controlled to move in a complex and restricted environment (blood vessels or tissues) through this magnetic force, and the addressing of the suspected lesion site can be accurately achieved. Through the cooperation of magnetic forces, the stability during operation is improved, and thus the diagnosis and treatment efficiency of the lesion site is improved; at the same time, a delivery tube 6 and an optical fiber 7 are also disposed in the first flexible catheter 1, which are respectively used for local drug delivery and phototherapy of the lesion site, and are used in cooperation with the detection electrode 3 to jointly achieve the precise treatment of the lesion site.

[0061] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the technical principle of the present invention, several improvements and substitutions can be made, and these improvements and substitutions should also be regarded as the protection scope of the present invention.

Claims

1. A micro-interventional magnetically controlled diagnostic and therapeutic catheter, characterized in that: It comprises: a first flexible catheter (1), a magnetic ring (2), and a detection electrode (3); One axial side of the magnetic ring (2) is connected to the first flexible conduit (1), so that the magnetic ring (2) and the first flexible conduit (1) form a continuous body, and the length direction of the continuous body has a first end (9) and a second end (10) arranged opposite to each other; The detection electrode (3) passes through the first flexible catheter (1) and the magnetic ring (2) in sequence from the second end (10) and extends out from the first end (9).

2. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 1, characterized in that: The micro-interventional magnetically controlled diagnostic and therapeutic catheter has a first direction (X) extending along the length direction of the continuum, and the magnetic ring (2) comprises a first magnetic ring (21) and a second magnetic ring (22) arranged at intervals along the first direction (X); The micro-interventional magnetically controlled diagnostic and therapeutic catheter further comprises a second flexible catheter (4) connected between the first magnetic ring (21) and the second magnetic ring (22), wherein the second magnetic ring (22) is connected to the first flexible catheter (1) at a side close to the second end (10); The detection electrode (3) passes through the first flexible conduit (1), the second magnetic ring (22), the first flexible conduit (1), the first magnetic ring (21) in sequence from the second end (10), and extends out from the first end (9).

3. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 2, characterized in that: The micro-interventional magnetically controlled diagnostic and therapeutic catheter further comprises a head shell (5) disposed at the first end (9), and the head shell (5) is connected to a side of the first magnetic ring (21) away from the second end (10); The detection electrode (3) passes through the first magnetic ring (21) and enters the head shell (5); the head shell (5) has a hollow portion connected to the outside, and the detection electrode (3) is accommodated in the hollow portion on the side away from the second end (10).

4. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 3, characterized in that: The micro-interventional magnetically controlled diagnostic and therapeutic catheter also includes a delivery tube (6). Along the first direction (X), the delivery tube (6) passes through the first flexible catheter (1), the second magnetic ring (22), the second flexible catheter (4), the first magnetic ring (21) in sequence from the second end (10) and enters the head shell (5). The side of the delivery tube (6) away from the second end (10) is accommodated in the hollow portion.

5. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 4, characterized in that: The micro-interventional magnetically controlled diagnostic and therapeutic catheter also includes an optical fiber (7). Along the first direction (X), the optical fiber (7) passes through the first flexible catheter (1), the second magnetic ring (22), the second flexible catheter (4), the first magnetic ring (21) in sequence from the second end (10) and enters the head shell (5); the head shell (5) is a light-transmitting structural component.

6. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 5, characterized in that: The optical fiber (7) is arranged colinearly with the axial center line of the continuum; there are a plurality of detection electrodes (3), and the delivery tube (6) and the plurality of detection electrodes (3) are arranged at intervals around the optical fiber (7).

7. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 2, characterized in that: Along the first direction (X), a first channel (11) is penetrated in the first flexible conduit (1), and a second channel (41) is penetrated in the second flexible conduit (4); the detection electrode (3) is sequentially penetrated in the first channel (11) and the second channel (41).

8. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 7, characterized in that: The detection electrode (3) extends from the second magnetic ring (22) and toward the second end (10), so that the detection electrode (3) at least partially extends into the first channel (11) on the side facing the second end (10); The first channel (11) has a conductive plugging member (12) on a side away from the first end (9), and the detection electrode (3) extends into a cavity between one end of the first channel (11) and the conductive plugging member (12) to form a conductive cavity (111), and the conductive cavity (111) is used to store a liquid conductive medium.

9. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 6, characterized in that: The micro-interventional magnetically controlled diagnostic and therapeutic catheter further comprises a columnar fixing member (8), wherein the columnar fixing member (8) is coaxially disposed through the inner cavities of the first magnetic ring (21) and the second magnetic ring (22); The columnar fixing member (8) has a plurality of third channels (81) for the detection electrode (3) to pass through, and the plurality of third channels (81) are arranged at intervals around the axial center line of the columnar fixing member (8).

10. The micro-interventional magnetically controlled diagnostic and therapeutic catheter according to claim 3, characterized in that: The head shell (5) has a fourth channel (51) in it, and the detection electrode (3) extends from the first magnetic ring (21) and is then inserted into the fourth channel (51); The hollow portion comprises a slot (52) connected to a side of the fourth channel (51) away from the first magnetic ring (21); one end of the detection electrode (3) extends out of the fourth channel (51) and is accommodated in the slot (52).

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