Space drill guide wire system

Abstract

The invention discloses a guide wire system of a space drill. The guide wire system comprises an amplitude-change pole, a conical free mass unit is connected with the amplitude-change pole, and the amplitude-change pole transmits vibration to the free mass unit; the collision module is in a cone shape and is connected with the free mass unit; the guide wire main body is connected with the collision module; during use, the amplitude-change pole transmits narrow-band periodic mechanical waves to the free mass unit serving as a space wave collector, and the free mass block does nonlinear motion and transmits vibration to the collision module after high-frequency periodic collision. According to the invention, the displacement amplitude of the guide wire head can be expanded from 10 [mu] m to the maximum non-linear motion of 1mm within the performance range of the piezoelectric transducer, the maximum amplification can reach 100 times, and the defect that the guide wire head in the prior art cannot penetrate through CTO calcification lesions with relatively high hardness can be effectively solved.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to a space drill wire guide system. Background Technology

[0002] CTO stands for Chronic Total Occlusion (CTO). This condition occurs when, on the basis of atherosclerotic lesions, a thrombus forms due to the rupture of a vulnerable plaque. Simultaneously, the thrombus undergoes organization, fibrosis, and calcium salt deposition, leading to complete occlusion of the coronary artery lumen for a duration exceeding 3 months.

[0003] Treatment for calcified toxin (CTO) lesions currently involves interventional procedures and medication. Interventional procedures utilize piezoelectric ultrasonic guidewires to penetrate the lesion and remove the calcifications. Specifically, a piezoelectric transducer generates longitudinal vibrations under a sinusoidal excitation voltage, which are amplified by an amplitude transformer and propagated through a waveguide mechanism to the distal end via the guidewire. The entire structure can be viewed as a resonant waveguide system, with typical parameters including a waveguide vibration frequency of 20-50 kHz and a displacement amplitude of 20-50 micrometers at the distal guidewire tip (the contact point with the CTO lesion). However, current devices of this type lack sufficient mechanical impact force to penetrate some of the harder CTO calcified lesions, resulting in a lower clinical success rate than desired. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by proposing a space drill wire guide system.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a space drilling guide wire system, comprising:

[0006] Amplitude lever;

[0007] A conical free mass unit is connected to the amplitude transformer, which transmits vibrations to the free mass unit.

[0008] A cone-shaped collision module is connected to the free mass unit;

[0009] The guide wire body is connected to the collision module;

[0010] In use, the amplitude transformer transmits narrowband periodic mechanical waves to the free mass unit, which acts as a spatial wave collector. After being subjected to high-frequency periodic impacts, the free mass block undergoes nonlinear motion and transmits the vibrations to the collision module.

[0011] As a further description of the above technical solution, it also includes a guide wire head. After being impacted, the guide wire collision module transmits mechanical waves to the guide wire body and the guide wire head, and the guide wire head acts on the target position.

[0012] As a further description of the above technical solution, a reset module is provided externally for the guide wire collision module.

[0013] As a further description of the above technical solution, the vibration frequency range of the amplitude rod is 15-100kHz, and the amplitude is 10-150μm.

[0014] As a further description of the above technical solution, the vibration frequency of the free mass element is 100-10000Hz, and the amplitude of the free mass element is 1-5mm.

[0015] As a further description of the above technical solution, the vibration frequency of the collision module is 20-1000Hz, and the amplitude of the collision module is 1-3mm.

[0016] As a further description of the above technical solution, the vibration frequency of the guide wire head is 20-1000Hz, and the amplitude range of the guide wire head is 0.05-2mm.

[0017] As a further description of the above technical solution, it also includes an ultrasonic coupling structure, wherein the guidewire body is connected to the ultrasonic coupling structure, the end of the guidewire body is connected to the free mass unit, and the other end of the free mass unit is fixed with the guidewire head.

[0018] As a further description of the above technical solution, both the free mass module and the collision module are conical structures and both weigh between 5 and 20g.

[0019] As a further description of the above technical solution, a rear cover plate is fixed to the other end of the amplitude rod away from the free mass unit, a plurality of piezoelectric ceramic plates are fixed between the rear cover plate and the end of the amplitude rod, an electrode plate is fixed between adjacent piezoelectric ceramic plates, and a prestressed bolt is fixed to the other side of the rear cover plate.

[0020] The present invention has the following beneficial effects:

[0021] 1. This invention, through the cooperation of a conical free mass unit, a conical collision module, a guide wire, and a guide wire head, can expand the displacement amplitude of the guide wire head from 10μm to a maximum of 1mm nonlinear motion within the performance range of the piezoelectric transducer, with a maximum amplification of up to 100 times. This can effectively solve the defect in the prior art where the guide wire head cannot penetrate CTO calcified lesions with high hardness. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the space drill guide wire system proposed in this invention;

[0023] Figure 2 This is a schematic diagram of the free mass unit and collision module proposed in this invention;

[0024] Figure 3 This is a schematic diagram of another embodiment of the space drill guide wire system proposed in this invention;

[0025] Figure 4 This is a schematic diagram showing the cooperation between the guide wire body, the free mass unit, and the collision module in another embodiment of the present invention;

[0026] Figure 5 This is a schematic diagram illustrating the motion law of the amplitude transformer, free mass block, and guide wire collision block proposed in this invention.

[0027] Legend:

[0028] 1. Amplitude bar; 2. Free mass unit; 3. Collision module; 4. Guide wire body; 5. Guide wire head; 6. Return spring; 7. Ultrasonic coupling structure; 8. Rear cover plate; 9. Piezoelectric ceramic sheet; 10. Electrode sheet; 11. Prestressed bolt. Detailed Implementation

[0029] 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 of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0030] Example 1

[0031] Reference Figure 1-3This invention provides an embodiment of a space drill guidewire system for breaking up chronic total occlusion (CTO) lesions in blood vessels to maintain vascular patency. The specific structure includes an amplitude transformer 1, one end of which is an ultrasonic transducer. Multiple piezoelectric ceramic plates 9 are disposed between the ultrasonic transducer and a rear cover plate 8, with electrode plates 10 positioned between adjacent piezoelectric ceramic plates 9. The end of the amplitude transformer 1 is fixed by a prestressed bolt 11. In this application, the piezoelectric ceramic plates 9, using the electrode plates 10 (i.e., piezoelectric transducers), generate longitudinal vibrations after an input excitation voltage. This vibration is then amplified by the amplitude transformer 1 and transmitted via a waveguide transmission mechanism through the guidewire body 4 to the distal guidewire tip 5 for breaking up the CTO. However, in current technology, while the guidewire tip 5 can break up softer CTO lesions, it lacks sufficient penetration for some harder CTO lesions, thus affecting the breaking up effect. The main influencing factor is that the piezoelectric ceramics in the existing technology can only withstand a limited excitation voltage, and the displacement amplitude that can be generated is limited, generally within 10μm. At the same time, the amplification factor of the amplitude transformer 1 is related to the area ratio of the main input and output terminals. In order to avoid lateral vibration, the amplification system generally cannot exceed 5.

[0032] For the reasons mentioned above, the existing guidewire tip 5 has insufficient mechanical impact force for CTO lesions with high rigidity, resulting in low penetration power, long penetration time, low efficiency, and a higher risk of complications.

[0033] This application incorporates a conical free mass unit 2 at one end of the amplitude transformer 1, which can be referenced. Figure 5 The lower curve is a schematic diagram of the amplitude law of the amplitude transformer 1. The amplitude transformer 1 vibrates at a frequency of 15-100kHz and moves with an amplitude of 10-150μm, generating and transmitting narrowband periodic mechanical waves. The amplitude transformer 1 can perform high-frequency periodic impacts on the free mass unit 2. After being impacted by the high-frequency periodic impacts of the amplitude transformer 1, the free mass unit 2 undergoes nonlinear motion. The free mass unit 2 can reduce the vibration frequency to 100-10000Hz, preferably 200-2000Hz, and amplify the amplitude to 1-5mm, preferably 2-3mm. (See reference...) Figure 5 The middle curve is a schematic diagram of the amplitude law of the free mass element 2.

[0034] A collision module 3 is provided at one end of the free mass unit 2. The distal end of the collision module 3 is connected to a guide wire body 4. The end of the guide wire body 4 passes through the collision module 3 and the axis of the free mass unit 2. After the collision module 3 undergoes nonlinear impact from the free mass unit 2, the frequency range of the impact module 3 is lower than that of the free mass unit 2, specifically 20-1000Hz, preferably 50-200Hz, and the amplitude is 1-3mm, preferably 1-2mm. (See reference...) Figure 5The upper curve is a schematic diagram of the amplitude law of the collision module 3. The guidewire body 4 transmits the mechanical wave of the collision module 3 to the guidewire head 5. Due to the impact on CTO calcified lesions, the vibration frequency of the guidewire head 5 after reaching the guidewire head 5 is 20-1000Hz, preferably 50-200Hz, and the amplitude is 0.05-2mm, preferably 0.5-1mm. As for the material selection of the guidewire body 4, it is preferably a nickel-titanium alloy, nickel-titanium based alloy, iron-based alloy, stainless steel, or cobalt-based alloy. The material selection of the guidewire head 5 is mainly stainless steel, and also includes imaging materials such as gold, platinum, tungsten, iridium, osmium, rhenium, palladium, tantalum, platinum alloy, platinum-tungsten alloy, platinum-iridium alloy, or platinum-nickel alloy, so as to ensure the conduction performance of the guidewire body 4 and the guidewire head 5.

[0035] In summary, this application, through the cooperation of the conical free mass unit 2, the conical collision module 3, the guide wire, and the guide wire head 5, can expand the displacement amplitude of the guide wire head 5 from 10μm to a maximum of 1mm nonlinear motion within the performance range of the piezoelectric transducer, with a maximum amplification of up to 100 times. This can effectively solve the defect in the prior art where the guide wire head 5 cannot penetrate CTO calcified lesions with high hardness.

[0036] refer to Figure 2 The free mass unit 2 and the collision module 3 are described in detail. Both are conical in shape, and the weight of both modules is between 5 and 20g. Their dimensions can be found in [the provided text]. Figure 2 The free mass unit 2 and collision module 3 of this application have a conical structure. Compared with the relatively simple stepped amplitude transformer 1, exponential amplitude transformer 1, catenary amplitude transformer 1, or other forms of composite amplitude transformer 1, the two, as a space wave gatherer, will converge broadband mechanical waves towards the focal region, which is more suitable for the transmission of broadband high-energy mechanical waves. At the same time, they will not concentrate stress, are less prone to metal fatigue, and have a more stable working state. In addition, the conical component is easier to machine during processing. It should be noted that the free mass unit 2 and collision module 3 are different from the amplitude transformer 1 that generates single-frequency or narrow-frequency ultrasonic arrays. They transmit broadband high-energy acoustic mechanical waves after collision. As for the material of the free mass unit 2 and collision module 3, a nickel-titanium alloy material with high hardness is preferably used. The amplitude transformer 1 is made of titanium alloy and aluminum and other metal materials. The piezoelectric ceramic sheet 9 is preferably made of piezoelectric materials such as PCT4 and PCT8, and the electrode sheet 10 is made of copper.

[0037] Furthermore, a reset module, preferably a reset spring 6, is fitted around the collision module 3. The reset spring 6 is used to reset the collision module 3 when it is subjected to high-frequency periodic impacts from the outside. The bottom end of the reset spring 6 is fixed to the outer casing of the device (not shown in the figure).

[0038] Example 2

[0039] refer to Figure 3 - Figure 4 This application provides a space drill guide wire system, which includes an amplitude transformer 1, an ultrasonic transducer at one end of the amplitude transformer 1, and a plurality of piezoelectric ceramic sheets 9 disposed between the ultrasonic transducer and the rear cover plate 8. The difference between the adjacent piezoelectric ceramic sheets 9 and the first embodiment is:

[0040] At the end of the amplitude transformer 1, the collision module 3 is replaced by an ultrasonic coupling structure. The distal end of the ultrasonic coupling structure is connected to the guide wire body 4, and the distal end of the guide wire body 4 is connected to the free mass unit 2. The distal end of the free mass unit 2 is connected to the collision module 3. That is, the original collision module 3 is replaced by the ultrasonic coupling structure 7, and the original guide wire head 5 is replaced by the collision module 3.

[0041] Through the above technical solution, the single-frequency or narrow-frequency vibration generated by the amplitude transformer 1 is transformed into a wide-band high-energy acoustic mechanical wave through the ultrasonic coupling mechanism, guide wire body 4, free mass unit 2 and collision module 3, so as to improve the penetration ability of hard calcified lesions and reduce the occurrence of complications.

[0042] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A space drill wire guide system, characterized in that, include: Amplitude lever; A conical free mass unit is connected to the amplitude transformer, which transmits vibrations to the free mass unit. A cone-shaped collision module is connected to the free mass unit; The guide wire body is connected to the collision module; In use, the amplitude transformer transmits narrowband periodic mechanical waves to the free mass unit, which acts as a spatial wave collector. After being subjected to high-frequency periodic impacts, the free mass block undergoes nonlinear motion and transmits the vibrations to the collision module.

2. The space drill guide wire system according to claim 1, characterized in that, It also includes a guide wire head. After being impacted, the guide wire collision module transmits mechanical waves to the guide wire body and the guide wire head, which acts on the target position.

3. The space drilling guide wire system according to claim 1, characterized in that, A reset module is provided externally for the guide wire collision module.

4. The space drilling guide wire system according to claim 1, characterized in that, The vibration frequency range of the amplitude transformer is 15-100kHz, and the amplitude is 10-150μm.

5. A space drilling guide wire system according to claim 1, characterized in that, The vibration frequency of the free mass element is 100-10000Hz, and the amplitude of the free mass element is 1-5mm.

6. A space drilling guide wire system according to claim 1, characterized in that, The vibration frequency of the collision module is 20-1000Hz, and the amplitude of the collision module is 1-3mm.

7. A space drill wire guide system according to claim 1, characterized in that, The vibration frequency of the guide wire head is 20-1000Hz, and the amplitude range of the guide wire head is 0.05-2mm.

8. A space drill wire guide system according to claim 1, characterized in that, It also includes an ultrasonic coupling structure, the guidewire body is connected to the ultrasonic coupling structure, the end of the guidewire body is connected to the free mass unit, and the other end of the free mass unit is fixed with the guidewire head.

9. A space drilling guide wire system according to claim 1, characterized in that, Both the free mass module and the collision module have a conical structure and weigh between 5 and 20g.

10. A space drill wire guide system according to claim 1, characterized in that, A rear cover plate is fixed to the other end of the amplitude transformer rod away from the free mass unit. Multiple piezoelectric ceramic plates are fixed between the rear cover plate and the end of the amplitude transformer rod. Electrode plates are fixed between adjacent piezoelectric ceramic plates. Prestressed bolts are fixed to the other side of the rear cover plate.

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