Thrombus rotary cutting catheter system suitable for multiple lesions

Abstract

The invention discloses a thrombus rotary cutting catheter system suitable for multiple lesions, and belongs to the technical field of interventional medical instruments. The system includes a catheter assembly and a powered handle assembly. A composite tool bit, an integrated spiral star-shaped grinding head, a rotary cutting tool bit and a flexible scraper tool bit are arranged at the head end of the catheter assembly and can be selectively used according to thrombus properties; a spiral steel cable with a spiral blade is arranged in the catheter and used for power transmission and thrombus delivery. A driving device, a thrombus outflow pipeline and a guide wire assembly are arranged in the power handle assembly, and the scraper is controlled to be opened and closed through the flexible scraper trigger button. Through the design of the integrated composite tool bit structure, the built-in guide wire and the waste liquid channel, efficient removal of multiple types of thrombus is achieved, catheter replacement in an operation is avoided, and operation continuity and safety are improved. The system is a disposable consumable, is compact in structure, is simple and convenient to operate, and is suitable for interventional therapy of peripheral blood vessel and other thrombotic diseases.

Description

Technical Field

[0001] This invention belongs to the field of interventional medical device technology, specifically relating to a thrombus resection catheter system suitable for multiple lesions. Background Technology

[0002] With the improvement of people's living standards and the increasing trend of population aging, the incidence of thrombotic diseases is rising year by year. Thrombus formation can block blood vessels, leading to obstructed blood flow. In mild cases, it can cause tissue ischemia and dysfunction, while in severe cases, it can lead to organ necrosis or even death. Currently, the treatment of peripheral vascular embolism mainly relies on interventional surgery. Common surgical tools include thrombus aspiration catheters, rotary cutting catheters, and plaque ablation catheters.

[0003] In current techniques, different catheters are required to treat thrombi of different types. For example, fresh thrombi are suitable for use with rotary cutting catheters or negative pressure aspiration catheters; while calcified plaques or old thrombi require catheters with abrasive functions. In actual surgery, patients may have multiple types of thrombi in their blood vessels, and doctors often need to change catheters multiple times, which not only prolongs the operation time and increases patient suffering, but also increases the complexity and risk of the operation.

[0004] Furthermore, existing thrombectomy devices typically rely on large, external power sources. These devices are bulky, inconvenient to carry, and expensive, and are difficult to replace quickly in case of malfunction during surgery, thus affecting the surgical process. Some catheters are also less effective at removing firmly attached wall thrombi, easily leaving residual thrombi and increasing the risk of re-embolism.

[0005] Therefore, there is an urgent need to develop an integrated thrombus removal system that combines multiple functions and is applicable to multiple lesion types, in order to improve surgical efficiency, reduce operational complexity, reduce patient suffering, and have good economic and portability. Summary of the Invention

[0006] In view of the above-mentioned shortcomings in the prior art, the present invention aims to provide a thrombus removal catheter system suitable for multiple lesions, which solves the problem of frequent catheter replacement due to the variety of thrombus types in the prior art, while improving thrombus removal efficiency, reducing surgical risks, and simplifying the operation process.

[0007] To achieve the above objectives, the present invention provides a thrombectomy catheter system suitable for multiple lesions, including a catheter assembly and a power handle assembly; The catheter assembly includes a catheter body and a spiral steel cable. The head end of the catheter body is provided with a composite cutter head, which includes a spiral star-shaped grinding head, a rotary cutting head, and a flexible scraper head. The tail end of the catheter body is connected to the power handle assembly. The power handle assembly includes a handle housing and a flexible scraper trigger button, and a drive device is provided inside the handle housing; The head end of the spiral steel cable passes through the conduit body and is fixedly connected to the composite cutter head, while the tail end is connected to the drive device; the flexible scraper trigger button is fixedly connected to the conduit body, and the flexible scraper trigger button pushes the conduit body to move, opening or closing the flexible scraper head.

[0008] This invention provides a thrombectomy catheter system suitable for multiple lesions, comprising a catheter assembly and a power handle assembly. The catheter tip integrates a composite blade head, which includes a spiral star-shaped grinding head, a rotary cutting head, and a flexible scraper head, with power transmitted via a spiral steel cable. The flexible scraper head is mechanically opened and closed by pushing the catheter body through a trigger button, achieving an integrated design of the three blade heads and avoiding intraoperative catheter replacement. The mechanical scraper control structure is simple and reliable, facilitating single-handed operation and improving surgical efficiency.

[0009] Furthermore, the composite blade also includes a fixing seat located at the head end of the catheter body. The fixing seat has a cylindrical hollow structure, and the tail end of the fixing seat contacts the head end of the catheter body. The head end of the fixing seat is fixedly provided with the flexible scraper head. The flexible scraper head includes two spaced-apart first fixing rings and second fixing rings, and a plurality of flexible scraper blades are provided between the first fixing rings and the second fixing rings. The first fixing ring is fixedly connected to the head end face of the fixing seat, and a first transmission step is provided on the outer end face of the second fixing ring. The spiral star-shaped grinding head is connected to the head end of the spiral steel cable, and a second step that cooperates with the first transmission step is provided on the tail end face of the spiral star-shaped grinding head. The rotary cutting head includes a rotary cutting cylinder with a hollow cylindrical structure. The head end face of the rotary cutting cylinder is fixedly connected to the tail end face of the spiral star-shaped grinding head. Two rotary cutting holes communicating with the interior are symmetrically arranged on the outer circumference of the rotary cutting cylinder. The inner diameters of the first and second fixing rings are larger than the outer diameter of the rotary cutting cylinder; when the flexible scraper head is opened, the first and second fixing rings are sleeved on the rotary cutting cylinder, the first transmission step cooperates with the second step, and the multiple flexible scraper blades are pressed open.

[0010] The composite cutter head adopts a stacked structure: the fixed base serves as the base, and the flexible scraper is positioned by two fixing rings; the spiral star-shaped grinding head is connected in series with the rotary cutting head, and the scraper opens by compression through a stepped engagement. The rotary cutting cylinder has a rotary cutting hole and rotates in conjunction with the grinding head. The operation of each cutter head does not interfere with each other and can be used individually or in combination.

[0011] Furthermore, the spiral steel cable located inside the catheter body is provided with spiral blades. The rotation of the spiral steel cable drives the spiral blades to rotate, forming a delivery effect similar to a "screw pump", which pushes the thrombus fragments towards the tail end of the catheter body, thereby realizing the active delivery of thrombus fragments and reducing the risk of blockage.

[0012] Furthermore, the handle housing is provided with a thrombus outflow tube inside. The bottom end of the thrombus outflow tube is located outside the handle housing and is connected to the waste fluid collection bag. The tail end of the catheter body is connected to the top end of the thrombus outflow tube, which facilitates collection by the waste fluid collection bag and forms a closed waste fluid discharge channel.

[0013] Furthermore, the driving device includes a power supply, a switch button, and a motor that are electrically connected to each other and disposed inside the handle housing; the output end of the motor is provided with a transmission mechanism, the transmission mechanism including a driving gear and a driven gear that mesh with each other, the driving gear being fixedly connected to the output end of the motor, and the driven gear being fixedly connected to the spiral steel cable.

[0014] Furthermore, the tail end of the spiral steel cable passes through the thrombus outflow pipe and is fixedly connected to the driven gear. A sealing ring is provided between the spiral steel cable and the thrombus outflow pipe to prevent blood from seeping into the handle housing along the steel cable and to prevent blood from contaminating the drive device.

[0015] Furthermore, the device includes a guidewire assembly, which includes a guide member disposed inside the handle housing. The guide member contains a guidewire that passes through the spiral steel cable, the flexible scraper head, the rotary cutting head, and the spiral star-shaped grinding head, enabling the guidewire to pass through the entire thrombectomy procedure. The guidewire guides the composite cutting head to accurately reach the lesion site.

[0016] Furthermore, the guide includes a cylindrical section, a conical section, and a tubular section that are integrally formed. The cylindrical section is connected to the side wall of the handle housing, and a channel for the guide wire to pass through is provided inside the cylindrical section, the conical section, and the tubular section.

[0017] Furthermore, both of the aforementioned rotary cutting holes are elliptical in structure, and the edges of each rotary cutting hole are ground to form a rotary cutting edge. Under the high-speed rotation of the rotary cutting cylinder, a shearing effect is formed. The elliptical rotary cutting hole can increase the cutting area and improve the thrombus uptake.

[0018] Furthermore, the thrombectomy catheter system is a single-use, integrated consumable that is discarded entirely after use and cannot be reused, thus completely preventing the spread of microorganisms between patients.

[0019] The beneficial effects of this invention are as follows: This invention provides a thrombus resection catheter system suitable for multiple lesions, which integrates three functions: resection, grinding, and scraping, to achieve efficient removal of thrombi of different natures, avoid frequent catheter changes during the operation, shorten the operation time, and reduce patient suffering; it adopts an integrated handheld design, which is compact in structure, flexible in operation, and low in cost, and is suitable for interventional treatment of various thrombotic lesions such as peripheral blood vessels. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of a thrombolysis catheter system suitable for multiple lesions.

[0021] Figure 2 This is a schematic diagram of the open flexible scraper head in a composite cutter head.

[0022] Figure 3 This is a schematic diagram of the closed flexible scraper head in a composite cutter head.

[0023] Figure 4 This is a side view of the composite cutter head.

[0024] The components include: 1. Catheter assembly; 2. Power handle assembly; 3. Catheter body; 4. Spiral steel cable; 5. Composite blade; 6. Spiral star-shaped grinding head; 7. Rotary cutting head; 701. Rotary cutting cylinder; 702. Rotary cutting hole; 8. Flexible scraper head; 801. First fixing ring; 802. Second fixing ring; 803. Flexible scraper blade; 9. Handle housing; 10. Flexible scraper trigger button; 11. Fixing base; 12. First transmission step; 13. Second step; 14. Spiral blade; 15. Thrombus outflow tubing; 16. Power supply; 17. Switch button; 18. Motor; 19. Driving gear; 20. Driven gear; 21. Sealing ring; 22. Guide component; 23. Guide wire. Detailed Implementation

[0025] The specific embodiments of the present invention are described below to enable those skilled in the art to understand the present invention. However, it should be understood that the present invention is not limited to the scope of the specific embodiments. For those skilled in the art, various changes are obvious as long as they are within the spirit and scope of the present invention as defined and determined by the appended claims. All inventions utilizing the concept of the present invention are protected.

[0026] refer to Figures 1-4 As shown, the present invention provides a thrombectomy catheter system suitable for multiple lesions, including a catheter assembly 1 and a power handle assembly 2; the catheter assembly 1 includes a catheter body 3 and a spiral steel cable 4, the catheter body 3 is about 1200mm in total length and about 3.0mm in outer diameter, is made of PBAX material and is covered with a super-slippery anticoagulant coating.

[0027] The power handle assembly 2 includes a handle housing 9 and a flexible scraper trigger button 10. A drive device is disposed within the handle housing 9. The handle housing 9 is approximately 120mm long and 40mm wide, conforming to an ergonomic grip design. The drive device is disposed within the handle housing 9.

[0028] The head end of the catheter body 3 is provided with a composite cutter head 5, which includes a fixed base 11, a spiral star-shaped grinding head 6, a rotary cutting head 7, and a flexible scraper head 8; the tail end of the catheter body 3 is connected to the handle housing 9.

[0029] Specifically, as a specific structural design of the composite cutter head 5, the fixing seat 11 has a cylindrical hollow structure. The tail end of the fixing seat 11 contacts the head end of the guide tube body 3. The head end of the fixing seat 11 is fixedly provided with the flexible scraper head 8. The flexible scraper head 8 includes two spaced-apart first fixing rings 801 and second fixing rings 802. Multiple flexible scraper blades 803 are provided between the first fixing rings 801 and the second fixing rings 802. The first fixing ring 801 is fixedly connected to the head end face of the fixing seat 11, and the outer end face of the second fixing ring 802 is provided with a first transmission step 12.

[0030] The tail end face of the spiral star-shaped grinding head 6 is provided with a second step 13 that cooperates with the first transmission step.

[0031] The rotary cutting head 7 includes a hollow cylindrical rotary cutting cylinder 701. The head end face of the rotary cutting cylinder 701 is fixedly connected to the tail end face of the spiral star-shaped grinding head 6. Two rotary cutting holes 702, communicating with the interior, are symmetrically arranged on the outer circumference of the rotary cutting cylinder 701. Preferably, both rotary cutting holes 702 are elliptical in structure, and the edges of each rotary cutting hole 702 are ground to form a rotary cutting edge. Under the high-speed rotation of the rotary cutting cylinder 701, a shearing effect is generated. The elliptical structure of the rotary cutting hole 702 can increase the cutting area and improve the thrombus uptake.

[0032] The inner diameter of the first fixing ring 801 and the second fixing ring 802 is larger than the outer diameter of the rotary cutting cylinder 701; when the flexible scraper head 8 is opened, the first fixing ring 801 and the second fixing ring 802 are sleeved on the rotary cutting cylinder 701, the first transmission step cooperates with the second step 13, and the multiple flexible scraper blades 803 are pressed open.

[0033] The spiral steel cable 4 is made of nickel-titanium alloy and has continuous spiral blades 14 on its surface. The head end of the spiral steel cable 4 passes through the conduit body 3 and is welded and fixed to the spiral star-shaped grinding head 6 in the composite cutter head 5. The tail end is connected to the drive device. The flexible scraper trigger button 10 is fixedly connected to the conduit body 3. The flexible scraper trigger button 10 pushes the conduit body 3 to move, opening or closing the flexible scraper head 8.

[0034] As one specific embodiment of the internal structure of the handle housing 9, the handle housing 9 is made of PC material and integrates a drive device, a thrombus outflow tube 15, and a guidewire assembly. Specifically, the drive device includes a power supply 16, a switch button 17, and a motor 18 that are electrically connected to each other and disposed inside the handle housing 9; the output end of the motor 18 is provided with a transmission mechanism, which includes a driving gear 19 and a driven gear 20 that mesh with each other. The driving gear 19 is fixedly connected to the output end of the motor 18, and the driven gear 20 is fixedly connected to the spiral steel cable 4.

[0035] The handle housing 9 has a thrombus outflow conduit 15 inside. The bottom end of the thrombus outflow conduit 15 is located outside the handle housing 9 and communicates with a waste fluid collection bag. The tail end of the catheter body 3 is connected to the top end of the thrombus outflow conduit 15, facilitating collection by the waste fluid collection bag and forming a closed waste fluid discharge channel. The tail end of the spiral steel cable 4 passes through the thrombus outflow conduit 15 and is fixedly connected to the driven gear 20. A sealing ring 21 is provided between the spiral steel cable 4 and the thrombus outflow conduit 15. The sealing ring 21 prevents blood from seeping into the handle housing 9 along the steel cable and prevents blood from contaminating the drive device.

[0036] The guidewire assembly includes a guide member 22 disposed inside the handle housing 9. The guide member 22 includes an integrally formed cylindrical section, a conical section, and a cylindrical section. The cylindrical section is connected to the side wall of the handle housing 9. A channel for the guide wire 23 to pass through is provided inside the cylindrical section, the conical section, and the cylindrical section. The guide wire 23 is disposed inside the guide member 22 and passes through the spiral steel cable 4, the flexible scraper head 8, the rotary cutting head 7, and the spiral star-shaped grinding head 6, so that the guide wire 23 can pass through the entire thrombectomy procedure. The guide wire 23 guides and ensures that the composite cutting head 5 accurately reaches the lesion site.

[0037] The entire thrombectomy catheter system is a single-use, integrated consumable that is discarded after use and cannot be reused, thus completely preventing the spread of microorganisms between patients.

[0038] The method of using a thrombectomy catheter system suitable for multiple lesions in this invention includes: Step 1, Preoperative preparation: Connect the thrombus outflow tubing 15 to the waste fluid collection bag, insert a 0.014-inch guidewire 23 through the guide 22, and flush the catheter assembly 1 and the thrombus outflow tubing 15 with normal saline. Step 2, guidewire 23 placement: Guidewire 23 is placed into the target vessel lesion site under the guidance of imaging equipment; Step 3, Catheter Advancement: Push the composite blade 5 at the tip of catheter assembly 1 along guidewire 23 to the proximal end of the thrombus, and fix guidewire 23 after confirming the position; Step 4, Start the rotary cutting: Press the switch button 17, the motor 18 starts, the composite cutter head 5 starts to rotate, and pushes the catheter assembly 1 forward at a rhythm of 2mm each time. Fresh thrombus is cut by the rotary cutter head 7, and calcified plaque is ground by the star-shaped burr head. Step 5: Scrape off the attached thrombus: If the angiography shows that there is residual attached thrombus, push the flexible scraper trigger button 10 to open the flexible scraper blade 803 in the flexible scraper head 8, and gently scrape back and forth to remove the thrombus from the blood vessel wall. Step 6, Thrombus Removal: The cut thrombus fragments are transported backward with the rotation of the spiral steel cable 4 and enter the waste liquid collection bag through the thrombus outflow pipe 15. Step 7, Exit and Cleanup: After the thrombus is removed, turn off the power 16, slowly withdraw the catheter along the guidewire 23, and dispose of the waste bag and used components.

[0039] In summary, the thrombectomy catheter system of the present invention, applicable to multiple lesions, allows for the switching of different blades to remove thrombi according to different types during surgery, eliminating the need for frequent catheter changes, saving surgical time, reducing patient suffering, increasing thrombectomy efficiency, accelerating surgical progress, and reducing patient discomfort.

Claims

1. A thrombolysis catheter system suitable for multiple lesions, characterized in that, Includes conduit assembly and power handle assembly; The catheter assembly includes a catheter body and a spiral steel cable. The head end of the catheter body is provided with a composite cutter head, which includes a spiral star-shaped grinding head, a rotary cutting head, and a flexible scraper head. The tail end of the catheter body is connected to the power handle assembly. The power handle assembly includes a handle housing and a flexible scraper trigger button, and a drive device is provided inside the handle housing; The head end of the spiral steel cable passes through the conduit body and is fixedly connected to the composite cutter head, while the tail end is connected to the drive device; the flexible scraper trigger button is fixedly connected to the conduit body, and the flexible scraper trigger button pushes the conduit body to move, opening or closing the flexible scraper head.

2. The thrombolysis catheter system suitable for multiple lesions according to claim 1, characterized in that, The composite blade also includes a fixing seat located at the head end of the catheter body. The fixing seat has a cylindrical hollow structure. The tail end of the fixing seat contacts the head end of the catheter body. The head end of the fixing seat is fixedly provided with the flexible scraper head. The flexible scraper head includes two spaced-apart first fixing rings and second fixing rings. Multiple flexible scraper blades are provided between the first fixing rings and the second fixing rings. The first fixing ring is fixedly connected to the head end face of the fixing seat. A first transmission step is provided on the outer end face of the second fixing ring. The spiral star-shaped grinding head is connected to the head end of the spiral steel cable, and a second step that cooperates with the first transmission step is provided on the tail end face of the spiral star-shaped grinding head. The rotary cutting head includes a rotary cutting cylinder with a hollow cylindrical structure. The head end face of the rotary cutting cylinder is fixedly connected to the tail end face of the spiral star-shaped grinding head. Two rotary cutting holes communicating with the interior are symmetrically arranged on the outer circumference of the rotary cutting cylinder. The inner diameters of the first and second fixing rings are larger than the outer diameter of the rotary cutting cylinder; when the flexible scraper head is opened, the first and second fixing rings are sleeved on the rotary cutting cylinder, the first transmission step cooperates with the second step, and the multiple flexible scraper blades are pressed open.

3. The thrombolysis catheter system suitable for multiple lesions according to claim 2, characterized in that, Helical blades are provided on the helical steel cable located inside the conduit body.

4. The thrombolysis catheter system suitable for multiple lesions according to claim 1, characterized in that, The handle housing has a thrombus outflow tube inside, the bottom end of which is located outside the handle housing and connected to a waste fluid collection bag, and the tail end of the catheter body is connected to the top end of the thrombus outflow tube.

5. The thrombolysis catheter system suitable for multiple lesions according to claim 4, characterized in that, The driving device includes a power supply, a switch button, and a motor that are electrically connected to each other and disposed inside the handle housing; the output end of the motor is provided with a transmission mechanism, the transmission mechanism including a driving gear and a driven gear that mesh with each other, the driving gear being fixedly connected to the output end of the motor, and the driven gear being fixedly connected to the spiral steel cable.

6. The thrombolysis catheter system for multiple lesions according to claim 5, characterized in that, The tail end of the spiral steel cable passes through the thrombus outflow pipe and is fixedly connected to the driven gear. A sealing ring is provided between the spiral steel cable and the thrombus outflow pipe.

7. The thrombolysis catheter system for multiple lesions according to claim 1, characterized in that, The device includes a guide wire assembly, which includes a guide member disposed inside the handle housing. The guide member contains a guide wire that passes through the spiral steel cable, the flexible scraper head, the rotary cutting head, and the spiral star-shaped grinding head.

8. The thrombolysis catheter system for multiple lesions according to claim 7, characterized in that, The guide includes a cylindrical section, a conical section, and a tubular section that are integrally formed. The cylindrical section is connected to the side wall of the handle housing. The cylindrical section, the conical section, and the tubular section are provided with a channel for the guide wire to pass through.

9. The thrombolysis catheter system for multiple lesions according to claim 2, characterized in that, Both of the rotary cutting holes are elliptical in structure, and the edges of each rotary cutting hole are ground to form a rotary cutting edge.

10. The thrombolysis catheter system suitable for multiple lesions according to any one of claims 1 to 9, characterized in that, The thrombus cutting catheter system is a single-use, integrated consumable.

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