Blood pressure sensing guide wire device and manufacturing method thereof

Abstract

The invention relates to a blood pressure sensing guide wire device and a manufacturing method thereof. The blood pressure sensing guide wire device comprises a near end part; the far-end part is bonded with the joint part of the near-end part to form a complementary spiral structure; a hollow stranded wire is correspondingly arranged in the far-end part, and the hollow stranded wire is formed by stranding a plurality of strands of metal wires; the tip part comprises another section of hollow stranded wire formed by stranding a plurality of strands of metal wires, one end of the hollow stranded wire is correspondingly connected to the far end of the far-end part, and the other end of the hollow stranded wire is correspondingly connected with a ball head; the pressure sensor is arranged between the two sections of hollow stranded wires in the far-end part; opposite through holes are formed in the two sides of the position, corresponding to the pressure sensor, of the far-end part; and the optical fiber is arranged in the hollow stranded wire, is connected to the pressure sensor and extends towards the near end. The characteristics that the near end of the guide wire has high rigidity and the far end of the guide wire has high flexibility are achieved, the overall structural design is simple and ingenious, and practicability is high.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to an improved guide wire device for measuring blood pressure and a manufacturing method thereof. Background Art

[0002] The blood pressure sensing guidewire is a soft and slender medical device commonly used in clinical medical diagnosis and treatment. During interventional cardiac surgery and diagnosis, the blood pressure sensing guidewire is widely used to evaluate intravascular hemodynamic parameters, such as the blood flow reserve fraction (FFR).

[0003] However, traditional blood pressure sensing guidewires are usually made of a single material, which makes it difficult to simultaneously meet the requirements of flexibility, pushing performance, and torque transmission. In addition, the connection method between different materials also directly affects the performance and reliability of the guidewire. In clinical use, traditional blood pressure sensing guidewires are inconvenient. Therefore, it is necessary to propose an improvement measure to solve the above technical problems. Summary of the invention

[0004] The present invention provides a blood pressure sensing guide wire device and a manufacturing method thereof, which are used to solve the technical problems raised in the above-mentioned background technology.

[0005] In order to achieve the above object, the present invention adopts the following technical scheme: a blood pressure sensing guide wire device of the present invention comprises proximal part; The distal part is bonded with the joint of the proximal part to form a complementary spiral structure; a hollow stranded wire is correspondingly arranged inside the distal part, and the hollow stranded wire is formed by twisting a plurality of metal wires; The tip portion includes another section of hollow stranded wire formed by twisting multiple strands of metal wires, one end of the hollow stranded wire is correspondingly connected to the distal end of the distal portion, and the other end of the hollow stranded wire is correspondingly connected to a ball head; The pressure sensor is arranged between two sections of hollow twisted wires in the distal part; through holes are provided on both sides of the distal part corresponding to the pressure sensor; The optical fiber, disposed inside the hollow stranded wire, is connected to the pressure sensor and extends toward the proximal end.

[0006] Preferably, the tip portion further comprises a spring, wherein the spring is arranged outside the hollow stranded wire, one end of the spring corresponds to the connection with the ball head, and the other end of the spring corresponds to the connection with the distal end of the distal portion.

[0007] Preferably, the torsion direction of the two sections of hollow stranded wire on the distal portion is the same; the torsion direction of the spring is opposite to the torsion direction of the hollow stranded wire.

[0008] Preferably, the joints between the proximal portion and the distal portion are cut and processed to have complementary spiral structures, and the joints between the distal portion and the proximal portion are bonded by adhesive to form complementary spiral structures.

[0009] Preferably, the surface of the distal portion is processed to form a series of laser marks with predetermined shapes and intervals, and the density and depth of the laser marks gradually increase from the proximal end to the distal end.

[0010] Preferably, when the laser score is a spiral structure, the rotation direction of the laser score is opposite to the torsion direction of the hollow stranded wire.

[0011] Preferably, the proximal portion is made of MP35N alloy; the distal portion is made of a nickel-titanium alloy tube; and the metal wire of the hollow stranded wire is a stainless steel wire.

[0012] Preferably, the adhesive is a soldering material.

[0013] Preferably, the surface of the guide wire is coated with a hydrophilic coating.

[0014] A method for manufacturing the blood pressure sensing guide wire device as described above of the present invention comprises the following steps: Step 1: providing an MP35N alloy tube as the proximal part and a nickel-titanium alloy tube as the distal part; Step 2: Perform spiral cutting at the joint of the two metal pipes to form a complementary spiral structure; Step 3: The MP35N alloy tube and the nickel-titanium alloy tube are embedded together through a spiral structure, and the two metal tubes are firmly bonded using an adhesive; Step 4: laser scoring is performed on the surface of the nickel-titanium alloy tube to form a predetermined scoring pattern; and through holes with two sides penetrating the corresponding positions on the surface of the nickel-titanium alloy tube are processed; Step 5: Twisting multiple strands of metal wires to form a hollow stranded wire, and inserting the hollow stranded wire into the nickel-titanium alloy tube; Step 6: Connect the optical fiber to the pressure sensor and place them inside the hollow stranded wire so that the pressure sensor is located at the through hole and the optical fiber is extended toward the proximal end; Step 7: Making a flexible tip portion, twisting multiple metal wires into a hollow stranded wire as a tip structure, and inserting one side of the tip structure into the distal end of the nickel-titanium alloy tube; Step 8: Surface treatment of the guide wire.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention optimizes the material combination by using MP35N alloy in the proximal part of the guide wire and nickel-titanium alloy in the distal part of the guide wire, so as to give full play to the characteristics of the two materials and meet the performance requirements of different parts.

[0016] Second, the present invention connects nickel-titanium alloy and MP35N alloy together by adopting a spiral cutting and interlocking method, and uses tin or other alternative methods for bonding, thereby ensuring the firmness and conductivity of the connection.

[0017] 3. The present invention performs laser scoring on the surface of the nickel-titanium alloy tube to give the distal end of the guide wire variable flexibility, thereby achieving a gradual change in the flexibility of the distal end of the guide wire and improving the control performance.

[0018] Fourth, the present invention can improve the torque transmission capability of the guidewire and the overall strength of the guidewire by adding a hollow stranded wire inside the guidewire, thereby further improving the control performance.

[0019] 5. The present invention also improves the guide wire tip structure by using a tip of a multi-strand metal wire twisted wire to make it softer and reduce the stimulation to the blood vessel wall while maintaining good pushing performance.

[0020] 6. The present invention realizes that the guidewire has higher rigidity and torque transmission capability at the proximal end and good flexibility and navigation performance at the distal end. Its overall structural design is simple and ingenious, with excellent performance and low manufacturing cost. It does not require internal hole expansion of the nickel-titanium alloy tube, thus reducing processing steps and costs and having strong practicality. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic diagram of the overall assembly of the blood pressure sensing guide wire device of the present invention; Figure 2 is a detailed schematic diagram of the distal portion of the blood pressure sensing guidewire device of the present invention; Figure 3 is a partial schematic diagram of the distal end portion when the laser scoring of the present invention is a ring structure; Figure 4 is a partial schematic diagram of the distal end portion when the laser scoring of the present invention is a spiral structure; Figure 5 It is a schematic diagram of the connection structure between the proximal part and the distal part of the present invention.

[0022] In the figure: 1, proximal part; 2, distal part; 21, through hole; 22, laser scoring; 3, hollow stranded wire; 4, tip part; 5, optical fiber; 6, spring; 7, pressure sensor; 8, ball head; DETAILED DESCRIPTION

[0023] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments 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.

[0024] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "page", "bottom", "inside", "outside", "clockwise", "counterclockwise", "coaxial", "bottom", "one end", "top", "the other end", "one side", "front", "two ends", "both sides" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0025] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0026] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed", "provided with", etc. should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be internal communication between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0027] Reference is now made to the accompanying drawings, wherein the purpose of each illustration is only to show certain exemplary embodiments and is not intended to limit the present invention. In each of the drawings, the same reference numerals represent the same or corresponding parts. The dimensions and proportions in each of the drawings are also only for illustration and should not be interpreted as limiting the present invention, and these dimensions may be exaggerated relative to the actual product. Example 1

[0028] See also Figures 1 to 5This embodiment provides a blood pressure sensing guide wire device with variable flexibility and improved connection structure, including proximal part 1; The distal part 2 is bonded to the joint part of the proximal part 1 to form a complementary spiral structure; a hollow stranded wire 3 is correspondingly arranged inside the distal part 2, and the hollow stranded wire 3 is formed by twisting a plurality of metal wires; The tip portion 4 includes another section of hollow stranded wire 3 formed by twisting multiple strands of metal wires, one end of the hollow stranded wire 3 is correspondingly connected to the distal end of the distal portion 2, and the other end of the hollow stranded wire 3 is correspondingly connected to a ball head 8; The pressure sensor 7 is arranged between the two hollow strands 3 in the distal part 2; through holes 21 are provided on both sides of the distal part 2 corresponding to the pressure sensor 7; The optical fiber 5 is disposed inside the hollow stranded wire 3, connected to the pressure sensor 7 and extends toward the proximal end.

[0029] The proximal part 1 and the distal part 2 are both tubular parts with the same diameter. The proximal part 1 is made of MP35N alloy, which has high rigidity and excellent torque transmission performance, and is convenient for doctors to accurately control the guide wire. The distal part 2 is made of nickel-titanium alloy tube, which has superelasticity and good flexibility, and is suitable for passing through curved blood vessel paths.

[0030] In order to reliably connect the proximal part 1 of the MP35N alloy and the distal part 2 of the nickel-titanium alloy, the joints of the proximal part 1 and the distal part 2 are cut and processed with complementary spiral structures, and the joints of the distal part 2 and the proximal part 1 are bonded by adhesive to form complementary spiral structures. The device forms a complementary spiral structure by adopting a spiral interlocking method at the joint of the two metals, so that the two parts can be tightly interlocked together. The adhesive is a soldering material, which can specifically use tin or other suitable adhesive materials, and the two metals are bonded together by a soldering process to enhance the firmness and conductivity of the connection. It is worth noting that the specific parameters of the spiral cutting of the joints of the proximal part 1 and the distal part 2 can be designed according to actual needs to ensure the reliable connection of the proximal part 1 and the distal part 2.

[0031] The present guidewire device specifically uses two sections of hollow stranded wires 3, and the torsion direction of the two sections of hollow stranded wires 3 is the same. The multiple strands of metal wires used to make the hollow stranded wires 3 are all stainless steel wires, and a hollow channel is formed in the hollow stranded wires 3. The present guidewire device can enhance the torque transmission capability of the guidewire, increase the energy passing capacity of the product, make the torsion synchronization better, ensure the control accuracy, and provide internal support, improve the overall strength of the guidewire, and prevent the nickel-titanium alloy tube from excessive deformation when bending. The hollow stranded wire 3 of the tip portion 4 can better improve the softness of the tip.

[0032] The present guidewire device also has a flexible design for its distal portion 2, and the surface of the distal portion 2 (i.e., the nickel-titanium alloy tube) is processed with laser notches 22 to form a series of laser notch patterns of predetermined shapes and spacings, such as an annular structure or a spiral structure. The density and depth of the laser notches 22 gradually increase from the proximal end to the distal end, and the density and depth of the notches change along the length of the guidewire, giving the distal portion 2 variable flexibility and realizing a flexibility gradient. It is worth noting that when the laser notches 22 are a spiral structure, the rotation direction of the laser notches 22 can be opposite to the torsion direction of the hollow strand 3, thereby better ensuring the torque transmission capability of the guidewire.

[0033] The pressure sensor 7 is preferably an optical pressure sensor. The pressure sensor 7 is connected to an optical fiber 5, which is correspondingly arranged inside the hollow stranded wire 3 and extends toward the proximal end to transmit a pressure signal through the internal space of the hollow stranded wire 3. It is worth noting that a sealing ring may be correspondingly arranged around one side of the optical fiber 5 close to the pressure sensor 7, and the sealing ring may be correspondingly sealed and bonded to the inner wall of the hollow stranded wire 3. By providing the sealing ring, the liquid in the tubular component can be better prevented from being conducted to the more proximal area of ​​the guide wire.

[0034] The tip portion 4 may also include a spring 6, which is arranged outside the hollow strand 3 of the tip portion 4, one end of the spring 6 corresponds to the ball head 8, and the other end of the spring 6 corresponds to the distal end of the distal portion 2. By forming the tip portion 4 with the hollow strand 3 plus the spring 6, the traditional core wire and spring structure are replaced, thereby improving the flexibility of the tip and reducing the risk of damage to the blood vessel wall, while maintaining sufficient pushing performance to ensure the advancement of the guidewire in a complex blood vessel path. It is worth noting that the torsion direction of the spring 6 can be opposite to the torsion direction of the hollow strand 3, so as to better enhance the torque transmission capability of the guidewire, so that no matter which side the guidewire deflects, it will be consistently transmitted to the ball head 8.

[0035] The guidewire device uses MP35N alloy in the proximal part 1 of the guidewire and nickel-titanium alloy in the distal part 2, and uses spiral cutting to connect the two dissimilar metals together, combined with tin or other alternative methods for bonding. This design achieves that the guidewire has high rigidity and torque transmission capability at the proximal end, and good flexibility and navigation performance at the distal end. In addition, by laser scoring the surface of the nickel-titanium alloy tube, the distal part 2 of the guidewire is given variable flexibility; and a layer of hollow stranded wire is added inside it to enhance the torque transmission and overall strength of the guidewire; the tip part 4 also uses a stranded wire structure formed by twisting multiple strands of metal wires to replace the traditional core wire and spring structure, to achieve a softer tip while maintaining sufficient pushing performance.

[0036] The proximal end of the spring 6 and the distal end of the distal part 2 can be connected by brazing, welding, bonding, etc. The distal end of the spring 6 and the ball head 8 can also be connected by brazing, welding, bonding, etc. The ball head 8 is a hemispherical structure, which can specifically be a welding ball end. The ball head 8 and the hollow stranded wire 3 can also be connected by brazing, welding, bonding, etc. The shape of the through hole 21 can be circular or elliptical or other shapes. By setting the through hole 21, the liquid can flow into the interior of the tubular component along the through hole 21 and contact the pressure sensor 7, so as to measure the blood pressure when the guide wire is pushed through the blood vessel.

[0037] The surface of the guide wire may also be coated with a hydrophilic coating, that is, the proximal part 1, the distal part 2, the ball head 8, the hollow strand 3 of the tip part 4 and the spring 6 may be coated with a hydrophilic coating on the surface to facilitate advancement in the blood vessel. Example 2

[0038] This embodiment provides a method for manufacturing the blood pressure sensing guide wire device described in Embodiment 1, which specifically comprises the following steps: Step 1: providing an MP35N alloy tube as the proximal part 1 and a nickel-titanium alloy tube as the distal part 2; Step 2: Perform spiral cutting at the joint of the two metal pipes to form a complementary spiral structure; Step 3: The MP35N alloy tube and the nickel-titanium alloy tube are embedded together through a spiral structure, and the two metal tubes are firmly bonded using tin or other suitable adhesives; the adhesive is a soldering material, and the two metals are bonded using a soldering process; Step 4: laser scoring is performed on the surface of the nickel-titanium alloy tube to form a predetermined scoring pattern; and through holes 21 with two sides penetrating the nickel-titanium alloy tube are processed at corresponding positions on the surface of the nickel-titanium alloy tube; Step 5: Twisting multiple strands of metal wires to form a hollow stranded wire 3, and inserting the hollow stranded wire 3 into the interior of the nickel-titanium alloy tube; Step 6: Connect the optical fiber 5 and the pressure sensor 5 and place them inside the hollow stranded wire 3, so that the pressure sensor 5 is located at the through hole 21, and extend the optical fiber 5 toward the proximal end; Step 7: making a flexible tip portion 4, twisting multiple strands of metal wire into another section of hollow stranded wire 3 as a tip structure, and inserting one side of the tip structure into the distal end of the nickel-titanium alloy tube; Step 8: Treat the guide wire surface and apply a hydrophilic coating if necessary.

[0039] The proximal portion 1 can be mounted on a connector or a handle for use. The optical fiber 5 can also be attached to the handle, and the other end of the optical fiber 5 can be connected to a signal conditioner or an interferometer. The signal conditioner can be connected to a display or other device via a cable, so as to facilitate real-time observation and use by users.

[0040] The guidewire device has good control performance. The high rigidity of the proximal part 1 and the high flexibility of the distal part 2 make the guidewire have excellent control performance and facilitate passing through complex blood vessel paths. The tip safety is also high. The soft tip part 4 reduces the stimulation to the blood vessel wall and reduces the risk of complications. When in use, the doctor pushes the guidewire device into the patient's blood vessel and uses the pressure sensor 7 to measure the pressure in the blood vessel.

[0041] The present invention uses MP35N alloy and nickel-titanium alloy at the proximal and distal ends of the guidewire, respectively, and uses spiral cutting and adhesive bonding to reliably connect the two dissimilar metals, giving the guidewire the characteristics of high rigidity at the proximal end and high flexibility at the distal end. Combined with the internal hollow stranded wire and the improved tip structure, the torque transmission capability and control performance of the guidewire are improved, while the risk of damage to the blood vessels is reduced. The blood pressure sensing guidewire device of the present invention has a simple structure, excellent performance, and low manufacturing cost, and is suitable for interventional cardiac surgery and diagnosis.

[0042] The above-described embodiments only express a certain implementation mode of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the patent scope of the present invention. It should be pointed out that, for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be based on the attached claims.

Claims

1. A blood pressure sensing guide wire device, characterized in that: include proximal part (1); The distal part (2) is bonded to the joint portion of the proximal part (1) to form a complementary spiral structure; a hollow stranded wire (3) is correspondingly arranged inside the distal part (2), and the hollow stranded wire (3) is formed by twisting a plurality of metal wires; The tip portion (4) comprises another section of hollow stranded wire (3) formed by twisting a plurality of metal wires, one end of the hollow stranded wire (3) being correspondingly connected to the distal end of the distal portion (2), and the other end of the hollow stranded wire (3) being correspondingly connected to a ball head (8); The pressure sensor (7) is arranged between the two hollow strands (3) in the distal portion (2); through holes (21) are provided on both sides of the distal portion (2) corresponding to the pressure sensor (7); The optical fiber (5) is disposed inside the hollow stranded wire (3), connected to the pressure sensor (7) and extends toward the proximal end.

2. A blood pressure sensing guide wire device according to claim 1, characterized in that: The tip portion (4) further comprises a spring (6), wherein the spring (6) is arranged outside the hollow strand (3), one end of the spring (6) is correspondingly connected to the ball head (8), and the other end of the spring (6) is correspondingly connected to the distal end of the distal portion (2).

3. A blood pressure sensing guide wire device according to claim 2, characterized in that: The torsion direction of the two sections of the hollow stranded wire (3) on the distal portion (2) is the same; the torsion direction of the spring (6) is opposite to the torsion direction of the hollow stranded wire (3).

4. A blood pressure sensing guide wire device according to claim 1, characterized in that: The joints between the proximal part (1) and the distal part (2) are cut and processed to have complementary spiral structures, and the joints between the distal part (2) and the proximal part (1) are bonded by adhesive to form complementary spiral structures.

5. A blood pressure sensing guide wire device according to claim 1, characterized in that: The surface of the distal portion (2) is processed to form a series of laser marks (22) of predetermined shapes and spacings, and the density and depth of the laser marks (22) gradually increase from the proximal end to the distal end.

6. A blood pressure sensing guide wire device according to claim 5, characterized in that: When the laser notch (22) is a spiral structure, the rotation direction of the laser notch (22) is opposite to the twisting direction of the hollow stranded wire (3).

7. A blood pressure sensing guide wire device according to claim 1, characterized in that: The proximal part (1) is made of MP35N alloy; the distal part (2) is made of a nickel-titanium alloy tube; and the metal wire of the hollow stranded wire (3) is a stainless steel wire.

8. A blood pressure sensing guide wire device according to claim 4, characterized in that: The adhesive is a soldering material.

9. A blood pressure sensing guide wire device according to claim 1, characterized in that: The surface of the guide wire is correspondingly coated with a hydrophilic coating.

10. A method for manufacturing a blood pressure sensing guide wire device according to any one of claims 1 to 9, characterized in that: The following steps are involved: Step 1: providing an MP35N alloy tube as the proximal portion (1) and a nickel-titanium alloy tube as the distal portion (2); Step 2: Perform spiral cutting at the joint of the two metal pipes to form a complementary spiral structure; Step 3: The MP35N alloy tube and the nickel-titanium alloy tube are embedded together through a spiral structure, and the two metal tubes are firmly bonded using an adhesive; Step 4: laser scoring the surface of the nickel-titanium alloy tube to form a predetermined scoring pattern; and processing through holes (21) with two sides penetrating at corresponding positions on the surface of the nickel-titanium alloy tube; Step 5: Twisting multiple strands of metal wires to form a hollow strand (3), and inserting the hollow strand into the nickel-titanium alloy tube; Step 6: After connecting the optical fiber (5) and the pressure sensor (5), the optical fiber (5) is arranged inside the hollow stranded wire (3), so that the pressure sensor (5) is located at the through hole (21) and the optical fiber (5) is extended toward the proximal end; Step 7: making a flexible tip portion (4), twisting a plurality of metal wires into a hollow strand (3) as a tip structure, and inserting one side of the tip structure into the distal end of the nickel-titanium alloy tube; Step 8: Surface treatment of the guide wire.

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