A rapid exchange guide wire

Abstract

This invention provides a rapid-exchange guidewire, comprising a head end, a temperature and pressure measuring section, a main body section, a connector section, and a sensor. The head end is connected to the main body section via the temperature and pressure measuring section, the outer surface of which has a groove. The sensor is disposed in the groove and includes a sensor chip. The sensor chip includes a diaphragm, and two resistors with resistances varying with pressure and / or temperature are respectively provided on the front and back sides of the diaphragm. The two resistors are connected and three wires are led out. The connector section includes an insulating tube and three spaced conductive components. These three wires extend through the main body section into the insulating tube, exit from an opening, and are respectively soldered to the corresponding three conductive components. This guidewire structure achieves temperature and pressure measurement functions while ensuring a minimal proximal size, without hindering the smooth insertion and sliding of other instruments, successfully realizing rapid exchange.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a quick-exchange guidewire. Background Technology

[0002] In urological surgeries, guidewires are widely used as a crucial auxiliary and emergency medical device. Typically, the guidewire is pre-placed in the ureter as a protective guide and does not obstruct the working channels of surgical instruments. During surgery, in the event of sudden complications such as ureteral perforation, medical staff can quickly insert a ureteral stent along the guidewire to achieve urine drainage, thereby effectively ensuring surgical safety.

[0003] However, existing traditional guidewires have relatively limited functionality. For example, traditional guidewires typically lack temperature monitoring capabilities, leading to a high reliance on the physician's subjective clinical experience for intraoperative assessment of the local environment. This lack of objective, real-time data support can easily result in clinical misjudgments, significantly increasing surgical risks.

[0004] Furthermore, some existing guidewire solutions with detection functions are limited by their structural design, typically featuring electronic structures such as chips at the proximal end of the guidewire. This proximal chip structure physically hinders the insertion and sliding of other instruments, preventing the guidewire from achieving the rapid exchange operations urgently needed in clinical practice, severely restricting the continuity and flexibility of surgical procedures. Summary of the Invention

[0005] The technical problem solved by this invention is that traditional guidewires lack temperature monitoring, leading to high surgical risks, and existing detection guidewires cannot be quickly exchanged due to proximal structural limitations.

[0006] To solve the above-mentioned technical problems, the present invention provides a fast-exchange guidewire, comprising: A quick-change guidewire includes a head end, a temperature and pressure measuring section, a main body section, a connector section, and a sensor. The proximal end of the head end and the distal end of the main body section are connected via the temperature and pressure measuring section, the outer surface of which has a groove. The sensor is disposed in the groove and includes a sensing chip. The sensing chip includes a diaphragm, a first resistor located on the front of the diaphragm, and a second resistor located on the back of the diaphragm. The resistance values ​​of both the first and second resistors change with pressure and / or temperature. The connector section includes an insulating tube and conductive components. The distal end of the insulating tube is connected to the proximal end of the main body section via a stainless steel sleeve. The conductive components include a first conductive component, a... The second and third conductive components are distributed at intervals from the far end to the near end of the insulating tube and are wrapped around the insulating tube. The first end of the first resistor leads out a first wire, the second end of the first resistor is connected to the first end of the second resistor and leads out a second wire, and the second end of the second resistor leads out a third wire. The first wire, the second wire, and the third wire extend from the temperature and pressure measuring section through the main body section into the insulating tube and are respectively led out from the three openings of the insulating tube, and are respectively welded to the first conductive component, the second conductive component, and the third conductive component.

[0007] Optionally, during temperature and pressure measurement, the connector segment is connected to the connector, which includes a signal sampling module. The signal sampling module includes a first signal sampling point, a second signal sampling point, and a third signal sampling point. The first conductive component, the second conductive component, and the third conductive component are respectively connected to the first signal sampling point, the second signal sampling point, and the third signal sampling point.

[0008] Optionally, during temperature and pressure measurement, the connector housing includes an upper cover and a lower cover, which are fixed by rotation via a fixed shaft.

[0009] Optionally, during temperature and pressure measurement, the signal sampling module further includes a power supply, a voltage detection component, a third resistor, and a fourth resistor. The first, second, third, and fourth resistors are connected end-to-end in sequence. The high-voltage end of the power supply is connected to the first signal sampling point and then connected between the first and fourth resistors via a first wire. The low-voltage end of the power supply is connected to the third signal sampling point and then connected between the second and third resistors via a third wire. One end of the voltage detection component is connected to the second signal sampling point and then connected between the first and second resistors via a second wire. The other end of the voltage detection component is connected between the third and fourth resistors to form a Wheatstone bridge structure.

[0010] Optionally, during temperature and pressure measurement, the signal sampling module also includes a calculation module and a communication module. The calculation module is used to calculate the temperature and pressure based on the measurement results of the voltage detection device, and transmit the calculation results to the host computer through the communication module.

[0011] Optionally, the head end includes a mandrel, which is covered by a spring tube, and the mandrel and spring tube are joined by welding.

[0012] Optionally, the mandrel is made of nickel-titanium wire.

[0013] Optionally, the outer diameter of the mandrel gradually increases from the distal end to the proximal end.

[0014] Optionally, the coating of the spring tube is a PTFE coating.

[0015] Optionally, the outer surface of the temperature and pressure measuring section is made of stainless steel.

[0016] Optionally, the conductive sleeve is a copper sleeve.

[0017] Optionally, the first, second, and third wires are disposed inside the polymer tube.

[0018] Optionally, the polymer tube is made of one or a combination of PEEK, PI.

[0019] Optionally, the outer surface of the polymer tube is a stainless steel tube, and the outer surface of the stainless steel tube is a spring tube.

[0020] Optionally, the first, second, and third conductors are encapsulated in a stainless steel tube, the outer surface of which is a spring tube.

[0021] Alternatively, the insulating tube may be a stainless steel tube with an insulating coating.

[0022] Optionally, the connector segment also includes insulating sleeves distributed on the intervals between conductive components and covering the insulating tube.

[0023] Compared with the prior art, the technical solution of the present invention has the following beneficial effects: In the rapid-exchange guidewire provided by this invention, the resistance value within the sensing chip changes with pressure and / or temperature. Three wires are led out to the connector section for connection to a detachable connector, thereby achieving temperature and pressure measurement functions. Due to the detachable connector design, the proximal end of the guidewire does not require the integration of large electronic components, allowing for a smaller outer diameter (e.g., less than 0.1 mm). This structural design satisfies the clinical need for objective temperature and pressure monitoring while ensuring that the proximal guidewire size does not obstruct the insertion and sliding of other instruments, thus facilitating rapid guidewire exchange. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of the fast-exchange guidewire according to an embodiment of the present invention; Figure 2 This is a cross-sectional schematic diagram of the head end, temperature and pressure measuring section, and main body section of the quick-exchange guidewire according to an embodiment of the present invention; Figure 3 This is a cross-sectional schematic diagram of the main body segment of the quick-exchange guidewire according to an embodiment of the present invention; Figure 4 This is for Figure 3 A cross-sectional view along plane AA; Figure 5 is a schematic diagram of the connector segment of the quick-exchange guidewire according to an embodiment of the present invention; Figure 6 This is a schematic diagram of the connector structure according to an embodiment of the present invention; The component designations are as follows: 1-Head end 2-Temperature and pressure measurement section 3-Main Body Section 4-Connector Section 5-Connectors 11-Spring tube 12-mandrel 13- Stainless Steel Pipe 21-Sensing Chip 22-Spring tube 23-Polymer Tube 24- Stainless Steel Pipe 25-Three wires 30-Stainless Steel Sleeve 31-Insulating tube 32-Conductive Components 3201 - First Conductive Component 3202 - Second Conductive Component 3203 - Third Conductive Component 33-Insulating sleeve 41-Signal Sampling Module 4101 - First signal sampling point 4102 - Second signal sampling point 4103 - Third signal sampling point 42-Limiting Groove 43-Limiting Groove 501-Top Cover 502-bottom cover 503-Fixed Shaft Detailed Implementation

[0025] As mentioned in the background technology, existing traditional guidewires do not have temperature detection capabilities, and due to structural limitations at the proximal end of the guidewire, rapid exchange operations cannot be achieved.

[0026] To solve the above-mentioned technical problems, the present invention provides a quick-exchange guidewire, the structure of which includes: a head end, a temperature and pressure measuring section, a main body section, a connector section, and a sensor. The proximal end of the head end and the distal end of the main body section are connected through the temperature and pressure measuring section, the outer surface of which is provided with a groove. The sensor is disposed in the groove and includes a sensing chip. The sensing chip includes a diaphragm, a first resistor located on the front side of the diaphragm, and a second resistor located on the back side of the diaphragm. The resistance values ​​of the first and second resistors change with pressure and / or temperature. The connector section includes an insulating tube and conductive components. The distal end of the insulating tube is connected to the proximal end of the main body section through a stainless steel sleeve. The electrical components include a first conductive component, a second conductive component, and a third conductive component. These components are spaced apart along the far end to the near end of the insulating tube and are wrapped around it. A first wire leads out from the first end of the first resistor. The second end of the first resistor is connected to the first end of the second resistor and leads out from there a second wire. A third wire leads out from the second end of the second resistor. The first, second, and third wires extend from the temperature and pressure measuring section through the main body section into the insulating tube and emerge from three openings in the insulating tube, respectively, and are welded to the first, second, and third conductive components, respectively. Therefore, since the resistance values ​​of both the first and second resistors change with pressure and / or temperature, the guide wire can simultaneously perform temperature and pressure measurement functions. Furthermore, through the design of the connector section, the near-end outer diameter of the guide wire can be made small (e.g., less than 0.1 mm), thereby enabling rapid exchange of the guide wire.

[0027] To make the above-mentioned objectives, features, and beneficial effects of the present invention more apparent and understandable, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] The terms “first,” “second,” “third,” “fourth,” etc. (if present) in the specification, claims, and drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a particular order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms “comprising” and “having,” and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus. Additionally, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as they are shown in the figures, with upward or upper directions pointing towards the top of the corresponding figure and downward or lower directions pointing towards the bottom of the corresponding figure.

[0029] In the terminology used in this article, "proximal" or "tail" refers to the end that is closest to the doctor during use. "Distal" or "anterior" refers to the end that is furthest from the entrance site within the body cavity, i.e., the end furthest from the doctor, i.e., the insertion end.

[0030] The full length of the guidewire is not shown in the attached diagram below. The length of the guidewire can be varied as needed, but typical guidewire lengths range from 30 to 800 centimeters (cm).

[0031] The technical solution of the present invention is as follows Figures 1 to 6 As shown. The structure of the fast-exchange guidewire in this embodiment of the invention is as follows: Figure 1 As shown in Figure 5.

[0032] The structure of the quick-exchange guidewire includes: head end 1, temperature and pressure measuring section 2, main body section 3, connector section 4, and sensor.

[0033] The proximal end of the head end 1 and the distal end of the main body section 3 are connected by a temperature and pressure measuring section 2, and the outer surface of the temperature and pressure measuring section 2 is provided with a groove.

[0034] The sensor is disposed in the groove. The sensor includes a sensing chip 21, which includes a diaphragm, a first resistor located on the front side of the diaphragm, and a second resistor located on the back side of the diaphragm.

[0035] The connector segment 4 includes an insulating tube 31 and conductive components 32. The distal end of the insulating tube 31 is connected to the proximal end of the main body segment 3 via a stainless steel sleeve 30. The conductive components 32 include a first conductive component 3201, a second conductive component 3202, and a third conductive component 3203. The first conductive component 3201, the second conductive component 3202, and the third conductive component 3203 are distributed at intervals along the distal end to the proximal end of the insulating tube 31 and cover the insulating tube 31. Figure 5A As shown.

[0036] In another embodiment of the invention, the connector segment 4 further includes an insulating sleeve 33, which is distributed on the intervals of the conductive components 32 and covers the insulating tube 31. Figure 5B As shown.

[0037] Furthermore, the resistance values ​​of both the first and second resistors change with pressure and / or temperature.

[0038] Furthermore, a first wire is led out from the first end of the first resistor, a second wire is led out from the second end of the first resistor, and a third wire is led out from the second end of the second resistor; the first wire, the second wire, and the third wire extend from the temperature and pressure measuring section 2 through the main body section 3 into the insulating tube 31 and are led out from the three openings of the insulating tube 31 respectively, and are respectively welded to the first conductive component 3201, the second conductive component 3202, and the third conductive component 3203.

[0039] On the one hand, the first and second resistors, as sensitive elements, change their resistance values ​​with variations in the pressure and / or temperature of the surgical environment. Therefore, the guidewire does not require an additional complex probe structure; by acquiring the resistance change signals of the first and second resistors and performing data calculations, high-precision temperature and pressure measurement functions can be simultaneously achieved on a single guidewire body.

[0040] On the other hand, unlike traditional guidewires with a chip structure at the proximal end, this invention eliminates redundant volume at the proximal end through the compact structure design of the connector segment 4. This feature allows for a significant reduction in the proximal outer diameter of the guidewire (e.g., less than 0.1 mm), thereby avoiding physical interference when inserting and sliding other surgical instruments (such as stents) along the guidewire, ensuring smooth and rapid exchange of the guidewire during surgery.

[0041] Furthermore, during temperature and pressure measurements, connector segment 4 and... Figure 6The connector 5 shown is connected to a signal sampling module 41, which includes a first signal sampling point 4101, a second signal sampling point 4102, and a third signal sampling point 4103. The first conductive component 3201, the second conductive component 3202, and the third conductive component 3203 are respectively connected to the first signal sampling point 4101, the second signal sampling point 4102, and the third signal sampling point 4103.

[0042] Furthermore, the structure of connector 5 in this embodiment of the invention is as follows: Figure 6 As shown, the housing of connector 5 includes an upper cover 501 and a lower cover 502, which are fixed by rotation via a fixed shaft 503. The lower cover 502 of connector 5 includes a limiting groove 42 and a limiting groove 43. The inner diameter of the grooves at the limiting grooves 42 and 43 is reduced so that the connector segment 4 can be stably fitted therein.

[0043] Furthermore, in another embodiment of the present invention, the connector 5 may also be fixed by rotation or other fixing methods.

[0044] Furthermore, during temperature and pressure measurement, the signal sampling module 41 also includes a power supply, a voltage detection component, a third resistor, and a fourth resistor. The first resistor, the second resistor, the third resistor, and the fourth resistor are connected end to end in sequence. The high-voltage end of the power supply is connected to the first signal sampling point 4101 and then connected between the first resistor and the fourth resistor through the first wire. The low-voltage end of the power supply is connected to the third signal sampling point 4103 and then connected between the second resistor and the third resistor through the third wire. One end of the voltage detection component is connected to the second signal sampling point 4102 and then connected between the first resistor and the second resistor through the second wire. The other end of the voltage detection component is connected between the third resistor and the fourth resistor to form a Wheatstone bridge structure.

[0045] In this sensor chip 21, the first and second resistors form a Wheatstone half-bridge. These two resistors are connected to an external third and fourth resistor via first, second, and third wires, forming a pressure-measuring Wheatstone bridge. Under pressure within the human body, the resistance values ​​of the first and second resistors change with the pressure, thus changing the voltage between them. The voltage detection device measures the difference between this voltage and the voltage between the third and fourth resistors, thereby measuring the pressure within the body's tissues or cavities. Similarly, under temperature within the human body, the resistance values ​​of the first and second resistors change with the temperature, allowing for the measurement of the temperature within the body's tissues or cavities.

[0046] Furthermore, the signal sampling module 41 also includes a calculation module and a communication module. The calculation module is used to calculate the temperature and pressure based on the measurement results of the voltage detection device, and transmit the calculation results to the host computer through the communication module.

[0047] In existing technologies, modules similar to the signal sampling module 41 that perform signal measurement, sampling, and transmission are typically located at the proximal end of the guidewire and are integrated with it. Due to mechanical limitations of such modules—that is, their outer diameter is much larger than the guidewire diameter—rapid guidewire exchange is not possible. For example, during urological surgery, if ureteral perforation occurs, using a traditional guidewire requires first withdrawing the guidewire and then placing a ureteral stent to drain the urine; however, using the rapid-exchange guidewire of this invention, because its proximal structure is the connector segment 4, meaning its outer diameter is the same as or similar to the distal portion of the guidewire, the required medical device can be directly and rapidly inserted along the rapid-exchange guidewire.

[0048] Furthermore, such as Figure 2 As shown, the tip 1 includes a mandrel 12, which is covered by a spring tube 11. The mandrel 12 and the spring tube 11 are joined by welding, preferably by ball-head welding, so that the distal end of the tip 1 forms a ball-head structure to avoid puncture damage to the patient.

[0049] Furthermore, the mandrel 12 is made of nickel-titanium wire, preferably ground nickel-titanium wire. The outer diameter of the mandrel 12 gradually increases from the distal end to the proximal end, ensuring that the distal end of the mandrel 12 is sufficiently flexible to prevent damage to the patient's ureter or other internal tissues or cavities.

[0050] Furthermore, the coating of the spring tube 11 is a PTFE coating.

[0051] Furthermore, the length of the head tip 1 is in the range of 20 to 80 millimeters (mm). Preferably, the length of the head tip 1 is 50 millimeters (mm).

[0052] Furthermore, such as Figure 2 and Figure 3 As shown, the outer surface of the temperature and pressure measuring section 2 is a stainless steel tube 13. Pressure and / or temperature changes in tissues or cavities within the human body are transmitted to the internal sensor via the grooves in the stainless steel tube 13, thereby achieving pressure and / or temperature measurement. Simultaneously, the stainless steel tube 13 serves as a fixed connection, linking the head end 1 to the main body section 3.

[0053] Furthermore, such as Figure 3 As shown, three wires 25 are arranged inside the polymer tube 23. Figure 4 This is for Figure 3 A cross-sectional view along plane AA. Figure 4 As shown more clearly, three wires 25 are disposed inside the polymer tube 23, and the exterior of the polymer tube 23 is a stainless steel tube 24. It should be noted that... Figure 4 The material or structure covering the stainless steel pipe 24 is omitted.

[0054] Furthermore, the polymer tube 23 is made of a material with high strength and good smoothness. Preferably, the material of the polymer tube 23 includes one or a combination of PEEK and PI.

[0055] Furthermore, the polymer tube 23 is surrounded by a stainless steel tube 24, and the stainless steel tube 24 is surrounded by a spring tube 22. The stainless steel tube 24 is used to shield external magnetic field interference to ensure temperature measurement accuracy. During signal processing, pressure measurement uses differential calculation by subtracting two resistors, which can directly cancel common-mode interference; while temperature measurement is based on the addition of two resistors, which is easily affected by current fluctuations caused by magnetic fields. Therefore, stainless steel tubes 24 are sleeved on the outside of each conductor for electromagnetic shielding to ensure the accuracy of temperature measurement.

[0056] Furthermore, the insulating tube 31 is made of a high-hardness insulating material. Preferably, the insulating tube 31 is a stainless steel tube with an insulating coating.

[0057] In another embodiment of the present invention, the three wires 25 are not placed inside the polymer tube 23, but are directly encapsulated in the stainless steel tube 24, and the outside of the stainless steel tube 24 is a spring tube 22.

[0058] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. A quick-exchange guidewire, characterized in that, It includes the head end, temperature and pressure measurement section, main body section, connector section, and sensor. The proximal end of the head end and the distal end of the main body segment are connected by the temperature and pressure measuring segment, and the outer surface of the temperature and pressure measuring segment is provided with a groove. The sensor is disposed in the groove. The sensor includes a sensing chip. The sensing chip includes a diaphragm, a first resistor located on the front side of the diaphragm, and a second resistor located on the back side of the diaphragm. The resistance values ​​of the first resistor and the second resistor both change with pressure and / or temperature. The connector segment includes an insulating tube and conductive components. The distal end of the insulating tube is connected to the proximal end of the main body segment through a stainless steel sleeve. The conductive components include a first conductive component, a second conductive component, and a third conductive component. The first conductive component, the second conductive component, and the third conductive component are distributed at intervals along the distal end of the insulating tube to the proximal end of the insulating tube and are covered on the insulating tube. A first wire is led out from the first end of the first resistor, a second end of the first resistor is connected to the first end of the second resistor and a second wire is led out from it, and a third wire is led out from the second end of the second resistor; The first wire, the second wire, and the third wire extend from the temperature and pressure measuring section through the main body section into the insulating tube and are respectively led out from the three openings of the insulating tube, and are respectively welded to the first conductive component, the second conductive component, and the third conductive component.

2. The quick-exchange guidewire according to claim 1, characterized in that, When measuring temperature and pressure The connector segment is connected to the connector, and the connector includes a signal sampling module, which includes a first signal sampling point, a second signal sampling point, and a third signal sampling point. The first conductive component, the second conductive component, and the third conductive component are respectively connected to the first signal sampling point, the second signal sampling point, and the third signal sampling point.

3. The quick-exchange guidewire according to claim 2, characterized in that, The connector housing includes an upper cover and a lower cover, which are rotatably fixed by a fixed shaft.

4. The quick-exchange guidewire according to claim 2, characterized in that, When measuring temperature and pressure The signal sampling module further includes a power supply, a voltage detection component, a third resistor, and a fourth resistor. The first resistor, the second resistor, the third resistor, and the fourth resistor are connected end-to-end in sequence. The high-voltage end of the power supply is connected to the first signal sampling point and then connected between the first resistor and the fourth resistor via the first wire. The low-voltage end of the power supply is connected to the third signal sampling point and then connected between the second resistor and the third resistor via the third wire. One end of the voltage detection component is connected to the second signal sampling point and then connected between the first resistor and the second resistor via the second wire. The other end of the voltage detection component is connected between the third resistor and the fourth resistor, thus forming a Wheatstone bridge structure.

5. The quick-exchange guidewire according to claim 4, characterized in that, The signal sampling module also includes a calculation module and a communication module. The calculation module is used to calculate the temperature and pressure based on the measurement results of the voltage detection device, and transmit the calculation results to the host computer through the communication module.

6. The quick-exchange guidewire according to claim 1, characterized in that, The head end includes a mandrel, which is covered by a spring tube, and the mandrel and the spring tube are joined together by welding.

7. The quick-exchange guidewire according to claim 6, characterized in that, The mandrel is made of nickel-titanium wire.

8. The quick-exchange guidewire according to claim 6, characterized in that, The outer diameter of the mandrel gradually increases from the distal end to the proximal end.

9. The quick-exchange guidewire according to claim 6, characterized in that, The coating of the spring tube is a PTFE coating.

10. The quick-exchange guidewire according to claim 1, characterized in that, The outer surface of the temperature and pressure measuring section is made of stainless steel.

11. The quick-exchange guidewire according to claim 1, characterized in that, The conductive sleeve is a metal copper sleeve.

12. The quick-exchange guidewire according to claim 1, characterized in that, The first wire, the second wire, and the third wire are disposed inside the polymer tube.

13. The quick-change guidewire according to claim 12, characterized in that, The polymer tube is made of one or a combination of PEEK and PI.

14. The quick-change guidewire according to claim 12, characterized in that, The polymer tube is surrounded by a stainless steel tube, and the stainless steel tube is surrounded by a spring tube.

15. The quick-exchange guidewire according to claim 1, characterized in that, The first wire, the second wire, and the third wire are encapsulated in a stainless steel tube, the outside of which is a spring tube.

16. The quick-exchange guidewire according to claim 1, characterized in that, The insulating tube is a stainless steel tube with an insulating coating.

17. The quick-exchange guidewire according to claim 1, characterized in that, The connector segment also includes an insulating sleeve, which is distributed on the intervals of the conductive components and covers the insulating tube.

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