Potential guide intrathecal implantation catheter real-time positioning system

Abstract

The invention discloses a real-time positioning system for implanting a catheter in a potential guiding sheath. The real-time positioning system comprises a positioning electrode plate, a potential guiding instrument and a guide wire body which are electrically connected. The positioning electrode plate comprises an adhesive tape adhered to the body of a patient and a plurality of electrode plates arranged on the adhesive tape; the potential guiding instrument comprises a shell, positive and negative electrodes, a current change display and a voltage and current regulator are arranged on the shell, and a current signal receiver and a signal amplifier are arranged in the shell; the guide wire body comprises an insulating sleeve and a metal guide wire arranged in the insulating sleeve, the front end and the rear end of the insulating sleeve are closed, and a plurality of through holes are formed in the side wall; the head end of the metal guide wire is exposed, and the other part is wrapped by the insulating layer. The positioning electrode plate and the wire guide body are respectively connected with positive and negative electrodes to form a closed loop. The problems that in the implantation operation process of an intrathecal infusion system, the position of the catheter needs to be adjusted in a perspective mode repeatedly, real-time monitoring cannot be achieved, and the developing quality is not high are solved, the operation precision and efficiency are improved, and the X-ray exposure amount of a patient is reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices and relates to a real-time positioning system for an implanted catheter in a potential-guided sheath. Background Art

[0002] Intrathecal drug infusion system implantation refers to the use of minimally invasive surgery to implant an intrathecal catheter into the subarachnoid space and establish a corresponding drug infusion system (port or electronic infusion pump) under the skin to deliver drugs directly to the subarachnoid space, so that the drugs can directly act on the spinal pain center, thereby achieving the purpose of pain control. The intrathecal drug infusion system mainly consists of two parts: one is the intrathecal catheter, and the other is the drug pump system. Drugs can be infused into the subarachnoid space for a long time.

[0003] In the process of intrathecal catheter implantation in the prior art, a C-arm machine is always required for repeated fluoroscopy and positioning, which has obvious defects: (1) X-ray fluoroscopy is required during the operation, which has a large amount of radiation. During each positioning process, the on-site operating doctor needs to avoid radiation at any time, which invisibly increases the operation time and makes the operation inefficient; (2) The machine equipment is large in size, has a low degree of freedom, lacks certain operational convenience, and is difficult to monitor the guidewire trajectory in real time; (3) The imaging quality is not high and the positioning accuracy is low, which affects the treatment effect after catheter implantation, resulting in low overall accuracy and efficiency of the operation. Summary of the invention

[0004] The present invention is aimed at the above-mentioned problems and provides a real-time positioning system for implanting a catheter within a potential-guided sheath. By utilizing the property of human body fluids as electrical conductors, a positioning electrode plate, a guide wire body and a potential guide instrument that can form a closed loop are designed. By capturing the current differences inside and outside the body at different positions, accurate positioning during the catheter implantation process is achieved.

[0005] The design principle of the present invention is as follows: the positioning electrode plate is attached to the patient's posterior spine along the longitudinal direction of the human body. In order to reduce the contact resistance, a conductive paste needs to be applied between the positioning electrode plate and the skin; the wire body enters the body through an incision, and the body fluids of the human body form a current loop. There is a fixed potential difference between the metal probe of the wire body and the positioning electrode plate outside the body. When the wire head gradually approaches an electrode sheet, the amount of body fluids flowing through the current decreases (that is, the resistance decreases), and the current gradually increases. When the wire head moves to the bottom of the positioning electrode plate, the human body resistance is the smallest and the output current is the largest. The current change is sampled and amplified by the potential guide instrument to drive the current change display, indicating that the wire head is located just below the positioning electrode sheet, thereby achieving real-time and accurate positioning of the wire head.

[0006] To achieve the above object, the present invention adopts the following technical solution:

[0007] The potential-guided intrathecal catheter real-time positioning system provided by the present invention has the following technical features: it comprises an electrically connected positioning electrode plate, a potential-guided instrument and a guide wire body.

[0008] The positioning electrode plate includes a sticky adhesive strip pasted on the patient's body and a plurality of electrode sheets arranged on the sticky adhesive strip; the potential guide instrument includes a shell, on which positive and negative electrodes, a current change display, a voltage and current regulator are arranged, and a current signal receiver and a signal amplifier are arranged in the shell; the guide wire body includes an insulating sleeve and a metal guide wire arranged therein, the front and rear ends of the insulating sleeve are closed, and a plurality of through holes are arranged on the side wall; the head end of the metal guide wire is exposed, and the rest is covered by an insulating layer. The positioning electrode plate and the guide wire body are respectively connected to the positive and negative electrodes to form a closed loop.

[0009] Preferably, in the potential-guided intrathecal catheter real-time positioning system provided by the present invention, the sticky adhesive strip is a sticky silicone strip, and a conductive paste is applied between the sticky silicone strip and the skin to reduce contact resistance.

[0010] Preferably, in the potential-guided intrathecal catheter real-time positioning system provided by the present invention, the number of electrode sheets is 13. Each positioning electrode sheet corresponds to a convex or concave part of the spine, which can prevent it from slipping and realize the previous positioning during the catheter implantation process.

[0011] Preferably, in the potential-guided intrathecal catheter real-time positioning system provided by the present invention, the current change display is a sensitive galvanometer or an electronic digital display. The sensitive galvanometer indicates the current change by the degree of pointer deflection, and the electronic digital display indicates the current change by displaying the current value in real time.

[0012] Preferably, in the potential-guided sheath implant catheter real-time positioning system provided by the present invention, the insulating sleeve of the guide wire body is a silicone sleeve, and a plurality of through holes are arranged on the side wall of the front end portion of the silicone sleeve. Silicone is a commonly used material in the medical field, has high biocompatibility, and is suitable for implantation in the body; the through holes serve as body fluid inflow holes, connecting the external positioning electrode plate and the internal guide wire body to form a closed loop, and generating a potential difference between the two.

[0013] Preferably, in the real-time positioning system for implanting a catheter within a potential-guided sheath provided by the present invention, both ends of the metal guide wire are fixedly connected to the inner wall of the silicone sleeve, and the tail end is provided with an electrode connector to be connected to the electrode of the potential-guided instrument.

[0014] Preferably, in the potential-guided intrasheath implant catheter real-time positioning system provided by the present invention, the portion other than the tip of the metal guide wire is insulated by an enameled layer, leaving only the tip of the metal wire exposed.

[0015] Preferably, in the potential guidance sheath implant catheter real-time positioning system provided by the present invention, a handle is provided on the potential guidance instrument housing.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The potential-guided intrathecal catheter real-time positioning system is small in size and portable in design. It achieves positioning by detecting current changes and has no electromagnetic radiation. This avoids the risk of X-ray radiation to doctors on site and eliminates the risk of radiation damage to patients multiple times during the catheter implantation process. It is undoubtedly beneficial to both doctors and patients.

[0018] The potential guidance in the present invention detects the different insertion paths of the metal guide wire probe in the body, samples and amplifies the changes in the weak current flowing through the patient's body, and converts it into changes in the deflection angle of the pointer of the sensitive ammeter, thereby achieving precise positioning of the guide wire probe, improving surgical accuracy and efficiency, improving surgical treatment effects, and enhancing the patient's comfort experience in using the intrathecal pump. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a structural schematic diagram of a real-time positioning system for implanting a catheter in a potential-guided sheath;

[0020] Figure 2 It is a schematic diagram of the internal structure of the potential guide instrument;

[0021] Figure 3 This is a schematic diagram of the usage status of the real-time positioning system for implanting a catheter within the potential-guided sheath. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical solution and advantages of the embodiment of the present invention clearer, the technical solution of the embodiment of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, not all of the embodiments. Based on the described embodiment of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] according to Figure 1 The potential-guided intrathecal catheter real-time positioning system 100 comprises an electrically connected positioning electrode plate 1, a potential-guided instrument 2, and a guide wire body 3. The positioning electrode plate 1 is set on the patient's body, and the guide wire body 3 is inserted into the human body. The two are respectively connected to the positive and negative electrodes of the potential-guided instrument 2, forming a closed loop under the conductive connection of the human body fluid.

[0024] The positioning electrode plate 1 includes an adhesive strip 11 pasted on the patient's body and a plurality of electrode sheets 12 arranged on the adhesive strip; the adhesive strip 11 is an adhesive silicone strip, and when in use, a conductive paste is applied between the adhesive silicone strip and the skin to reduce contact resistance. There are 13 electrode sheets, and each positioning electrode sheet corresponds to a protrusion or depression of the spine, which can prevent it from slipping and can achieve the previous positioning during the catheter implantation process.

[0025] Combination Figure 1 and Figure 2 The potential guide instrument 2 is approximately a rectangular parallelepiped, including a shell 21, a handle 22 is set on the top of the shell for easy carrying, a positive electrode 23, a negative electrode 24, a current change display 25, a voltage regulator 26 and a current regulator 27 are set on the front face, and a current signal receiver 28, a signal amplifier 29 and a controller are set inside.

[0026] The housing 21 is made of plastic or stainless steel; the positive electrode 23 and the negative electrode 24 are respectively used as connection ports for positioning the electrode plate 1 and the guide wire body 3, so as to realize the electrical connection between the potential guide instrument 2 and the positioning electrode plate 1 and the guide wire body 3. The current change display 25 can be a sensitive galvanometer or an electronic digital display. The sensitive galvanometer realizes the current change indication through the deflection degree of the pointer, and the electronic digital display indicates the current change by displaying the current value in real time. In the specific embodiment of the present invention, a sensitive galvanometer is selected.

[0027] The voltage regulator 26 and the current regulator 27 are used to adjust the output voltage of the guide wire body. According to the individual physical differences of different patients, different potential differences between the probe and the positioning electrode are set, thereby adjusting different current parameters flowing through the human body and obtaining different sensitive ammeter driving currents, making the deflection angle of the sensitive ammeter pointer more sensitive and improving the positioning accuracy.

[0028] The current signal receiver 28 receives the current value of the guide wire body 3 in the process of moving in the body in real time. The signal amplifier 29 amplifies the current value according to a predetermined ratio and displays it through the current change display 25.

[0029] The guide wire body 3 includes an insulating sleeve 31 and a metal guide wire 32 disposed therein. The insulating sleeve 31 is closed at both ends, and a plurality of through holes 311 are disposed on the side wall of the front end; the head end of the metal guide wire 32 is exposed, and the rest of the metal guide wire 32 is covered by an enamel layer 321, that is, the part outside the head end of the metal guide wire is insulated, and only the head end of the metal wire is left exposed.

[0030] Preferably, the insulating sleeve 31 is a silicone sleeve, and a plurality of through holes 311 are arranged on the side wall of the silicone sleeve. Silicone is a commonly used material in the medical field, has high biocompatibility, and is suitable for implantation in the body; the through holes serve as body fluid inflow holes, connecting the external positioning electrode plate and the internal guide wire body to form a closed loop, and generating a potential difference between the two.

[0031] In terms of fixation, both ends of the metal guide wire 32 are fixedly connected to the inner wall of the silicone sleeve, and the tail end is provided with an electrode connector to be connected to the electrode of the potential guide instrument.

[0032] The use method or principle of the potential-guided intrathecal catheter real-time positioning system of the present invention is as follows:

[0033] Combination Figure 3 , the positioning electrode plate 1 is pasted on the patient's posterior spine along the longitudinal direction of the human body. In order to reduce the contact resistance, a conductive paste needs to be applied between the positioning electrode plate and the skin. Each positioning electrode piece can correspond to the protrusion or depression of the spine as needed.

[0034] The guide wire body 3 and the positioning electrode plate 1 are connected to the negative pole and the positive pole respectively, and the head end of the guide wire body is inserted into the human spine from the incision. The human body fluid flows into the space between the sleeve and the metal guide wire through the through hole on the guide wire body insulating sleeve 31. The human body fluid is a conductor. In this way, there is a fixed potential difference between the metal probe and the positioning electrode plate outside the body, and the current loop is formed by the human body fluid.

[0035] The wire body enters the human spinal canal from the incision. When the head of the wire body gradually approaches the first electrode, the amount of body fluid flowing through the current decreases (i.e., the resistance decreases), and the current gradually increases. When the head of the wire body moves to the bottom of the positioning electrode plate, the human body resistance is the smallest and the output current is the largest. This current change is sampled and amplified by the potential guide instrument, and the angle of deflection of the sensitive ammeter pointer is driven to be the largest, indicating that the wire head movement position is just below the first positioning electrode, thereby achieving real-time and accurate positioning of the wire head. Similarly, when the wire head is pushed forward, the output current of the potential guide instrument will change from small to large in the process of the wire head moving toward the second positioning electrode. The potential guide instrument will amplify this changing current and drive the sensitive ammeter pointer to deflect. When the sensitive ammeter pointer deflects at the largest angle, it means that the wire head movement position is just below the second positioning electrode. By analogy, the precise positioning of the wire head movement position at all positioning electrode positions can be achieved.

[0036] The present invention overcomes the problems of repeated fluoroscopic adjustment of the catheter position, inability to monitor in real time, and low imaging quality during the implantation of the intrathecal infusion system, thereby improving surgical accuracy and efficiency and reducing the patient's X-ray exposure.

[0037] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A potential-guided intrathecal catheter real-time positioning system, characterized in that: It includes an electrically connected positioning electrode plate, a potential guide and a guide wire body, Wherein, the positioning electrode plate comprises an adhesive strip adhered to the patient's body and a plurality of electrode sheets arranged on the adhesive strip; The potential guide instrument comprises a shell, on which positive and negative electrodes, a current change display, and a voltage and current regulator are arranged, and inside the shell a current signal receiver and a signal amplifier are arranged; The guide wire body comprises an insulating sleeve and a metal guide wire arranged therein, wherein the front and rear ends of the insulating sleeve are closed, and a plurality of through holes are arranged on the side wall of the front half; the head end of the metal guide wire is exposed, and the rest of the metal guide wire is covered by an insulating layer. The positioning electrode plate and the guide wire body are respectively connected to the positive and negative electrodes to form a closed loop.

2. The potential-guided intrathecal catheter real-time positioning system according to claim 1, characterized in that: in, The sticky adhesive strip is a sticky silicone strip, and conductive paste is smeared between the sticky silicone strip and the skin.

3. The potential-guided intrathecal catheter real-time positioning system according to claim 1, characterized in that: in, The number of the electrode sheets is 13.

4. The potential-guided intrathecal catheter real-time positioning system according to claim 1, characterized in that: in, The current change display is a sensitive ammeter or an electronic digital display.

5. The potential-guided intrathecal catheter real-time positioning system according to claim 1, characterized in that: in, The insulating sleeve is a silicone sleeve, and a plurality of through holes are arranged on the side wall of the front end portion of the silicone sleeve.

6. The potential-guided intrathecal catheter real-time positioning system according to claim 5, characterized in that: in, Both ends of the metal guide wire are fixedly connected to the inner wall of the silicone sleeve, and the tail end is provided with an electrode connector.

7. The potential-guided intrathecal catheter real-time positioning system according to claim 1, characterized in that: in, The portion other than the tip of the metal guide wire is insulated by an enamel layer.

8. The potential-guided intrathecal catheter real-time positioning system according to claim 1, characterized in that: in, A handle is arranged on the housing of the potential guidance instrument.

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