Arterial stent fenestrating suturing device

Abstract

This invention discloses an arterial stent fenestration suture device. The suture device includes a handle, a slender delivery rod, and a composite anastomosis device. The composite anastomosis device has a U-shaped operating groove, with an anastomosis head and a staple seat respectively disposed on opposite sides of the U-shaped operating groove. The handle contains an operating trigger and a graded linkage reset mechanism connected to the operating trigger. The anastomosis head contains a ring-shaped blade and a staple pusher tube coaxially nested along its central axis. The front end of the staple pusher tube has a metal ring for mounting rigid staples. The graded linkage reset mechanism is configured to execute a two-stage timing control logic in response to the trigger's actuation displacement. It sequentially drives the blade to cut through the stent membrane, then retracts under the action of a reset spring to release space, and then drives the staple pusher tube to advance for staple insertion and suturing. This invention eliminates the risk of interference and deadlock between the cutting and suturing components in axial space, ensuring smooth integrated closed-loop operation, reducing operational difficulty, shortening preparation time, and improving the overall safety and efficiency of the surgery.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an arterial stent fenestration suture device, which is particularly suitable for pre-fenestration and suturing of covered stents before endovascular aortic repair surgery. Background Technology

[0002] In endovascular repair of lesions in the aortic arch or visceral region, fenestration of the covered stent is usually necessary before implantation to preserve blood flow to vital branches. Currently, the primary clinical procedure involves manual pre-fenestration performed externally by a surgeon using standard instruments on the operating table. This process generally involves cauterizing and cutting the stent graft opening with an electrocautery pen or scalpel, placing a metal ring for fixation, and then manually suturing the ring to achieve proper fenestration positioning. Because the opening diameter of the artificial blood vessel is very small, typically only 6 to 8 millimeters, manual suturing is time-consuming, labor-intensive, and requires a high degree of precision from the surgeon, thus prolonging preoperative preparation time.

[0003] Currently, there are instrument solutions in the industry that use integrated mechanical linkage for punching and suturing. However, these existing devices suffer from a systemic defect of unclear mechanical timing control. Under a single rigid drive operation, the cutting and suturing components are prone to interference and deadlock within the same axial space. Specifically, after cutting through the covering membrane, the cutting blade cannot effectively and quickly move backward, causing the blocked central space to be unable to be released, which in turn prevents the subsequent metal ring pushing and suturing / stacking actions from being executed smoothly downwards. This risk of interference and deadlock on the spatial axis limits the clinical practicality and operational success rate of such integrated fenestration instruments. Summary of the Invention

[0004] This invention solves the problems of cumbersome and time-consuming procedures in existing external artificial window opening, while overcoming the technical defects of existing mechanical linkage devices that are prone to spatial interference and deadlock in integrated operation of cutting and stitching components.

[0005] To achieve the above objectives, the present invention provides an arterial stent fenestration suture device, comprising a handle, a slender delivery rod, and a composite anastomosis device; The two ends of the slender delivery rod are respectively connected to the handle and the composite anastomosis device; The composite stapler has a U-shaped operating groove; The two opposite walls of the U-shaped operating groove are respectively provided with a matching head and a nail seat; The handle is equipped with an operating trigger and a graded linkage reset mechanism connected to the operating trigger. The anastomosis head is coaxially nested with an annular blade and a pusher tube along the central axis inside. The front end of the push pin tube is provided with a metal ring for installing rigid sew pins; The graded linkage reset mechanism is configured to execute two-stage timing control logic in response to the pulling displacement of the operating trigger; In the first stroke phase, the graded linkage reset mechanism drives the annular blade to move forward and cut through the support film; And when the cutting stroke ends, the stroke latching structure is triggered, and the annular blade retracts to the initial position under the action of the return spring and releases the central axial space; In the second stroke phase, the graded linkage reset mechanism releases the stroke lock on the pusher tube and drives the pusher tube to advance; The push pin tube presses against the metal ring, causing the rigid pin to penetrate the support membrane and undergo plastic deformation within the forming bending groove of the pin seat.

[0006] The technical solution provided by this invention brings the following beneficial effects: The arterial stent fenestration suture device provided in this application transforms the single, continuous trigger pull into a two-stage, sequential control logic of independent drilling, automatic blade retraction, and ring insertion suturing through an internal, tiered, and interconnected reset mechanism. This mechanism eliminates the risk of interference and deadlock between the cutting blade and the ring insertion suture mechanism on the same spatial axis. After the blade removes the waste membrane, it is instantly driven back by a reset spring, completely surrendering the axial central space to the surrounding nested stent pusher tube, ensuring smooth suturing. This suture device achieves an integrated closed loop of external fenestration and suturing, reducing the difficulty of manual operation for surgeons, shortening the preoperative artificial blood vessel preparation time, and improving the overall safety and efficiency of the surgery. Attached Figure Description

[0007] Figure 1 This is a schematic diagram of the overall structure of the arterial stent fenestration suture device provided in an embodiment of the present invention.

[0008] Figure 2 This is an internal cross-sectional view of the arterial stent fenestration suture device provided in an embodiment of the present invention.

[0009] Figure 3 This is a partially enlarged view of the internal firing assembly of the handle provided in an embodiment of the present invention.

[0010] Figure 4 This is a partial cross-sectional view of the composite stapler provided in an embodiment of the present invention.

[0011] Figure 5 This is a front view of the end face of the distal operating head of the composite stapler provided in an embodiment of the present invention.

[0012] Figure 6 This is a partial cross-sectional view of the internal micro-transmission mechanism of the composite anastomosis device provided in an embodiment of the present invention.

[0013] Figure 7 This is a partial enlarged view of the internal slider and limiting structure of the composite anastomosis device provided in the embodiment of the present invention.

[0014] Explanation of reference numerals in the attached figures: In the diagram: 100-Handle, 120-Operating trigger, 130-Graded linkage reset mechanism, 131-Reset spring, 140-Angle adjustment knob, 150-Timing cam plate, 151-First push rod, 152-Second push rod, 153-First driven pin, 154-Second driven pin, 160-First guide groove, 170-Second guide groove, 180-Stroke snap-fit ​​structure, 200-Slender conveying rod, 210-Axial transmission rod system, 220-Universal joint, 230-Flexible traction wire, 300-Composite stapler, 301-U-shaped operating groove, 310-Stabilizing head, 320-Stabilizer seat, 321-Supporting pad, 330-Annular blade, 331-Waste membrane collection cavity, 332-One-way barb, 340-Stabilizer tube, 350-Metal ring, 360-Rigid staple. Detailed Implementation

[0015] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0016] like Figure 1 and Figure 2 As shown, this invention provides an arterial stent fenestration suture device. The suture device has an overall clamp-like structure with a slender delivery rod, used for integrated artificial fenestration, ring placement, and suturing of an artificial covered stent on a preoperative sterile operating table. The basic structure of the suture device includes a handle 100, a slender delivery rod 200, and a composite anastomosis device 300. The slender delivery rod 200 has a tubular rigid or semi-rigid structure, with its two ends fixedly connected to the front end of the handle 100 and the base end of the composite anastomosis device 300, respectively. The interior of the slender delivery rod 200 is hollow to accommodate and arrange transmission components.

[0017] Combination Figure 4 and Figure 5 As shown, the composite anastomosis device 300 has an opening on its front side, forming a U-shaped operating groove 301 for receiving the arterial stent wall as it slides in. In use, the area of ​​the artificial blood vessel wall to be opened slides in laterally and lies flat within the U-shaped operating groove 301. The opposite walls of the U-shaped operating groove 301 are respectively provided with an anastomosis head 310 and a staple seat 320, which are arranged opposite each other on a common central axis. The anastomosis head 310 contains the main actuating components, while the staple seat 320 provides rigid support and a metal-formed reaction force base.

[0018] like Figure 2 and Figure 3As shown, the handle 100 includes an outer shell made of medical-grade high-strength engineering plastic. An operating trigger 120 is pivotally mounted inside the handle 100, and a graded linkage reset mechanism 130 is mechanically connected to the operating trigger 120 via gears and linkages. An axial transmission rod system 210 passes through the elongated delivery rod 200. The power output end of the graded linkage reset mechanism 130 is connected to the axial transmission rod system 210, and then extends from the axial transmission rod system 210 to the composite stapler 300, connecting to the internal specific execution components.

[0019] The anastomosis head 310 has two core actuating components coaxially nested within it: an inner annular blade 330 and an outer pusher tube 340. The annular blade 330 is a hollow cylinder with its distal edge machined into a sharp cutting edge. The inner diameter of the pusher tube 340 is slightly larger than the outer diameter of the annular blade 330, allowing the annular blade 330 to slide independently axially within the pusher tube 340. A metal ring 350, serving as the anchoring base for the suture, is pre-installed on the front end face of the pusher tube 340. Multiple rigid suture staples 360 are fixed in a circular array on the outer periphery of the metal ring 350. The tips of each rigid suture staple 360 ​​point perpendicularly towards the staple seat 320. To ensure the stability of the connection, an annular groove is provided on the inner wall of the front end of the pusher tube 340, and correspondingly, an elastic locking protrusion matching the annular groove is provided on the outer wall of the metal ring 350. Through this snap-fit ​​engagement, the metal ring 350 can be stably retained at the end of the push pin tube 340 before the suturing action is completed, thus preventing accidental detachment.

[0020] The core operation of this suture device relies on the two-stage timing control logic executed by the graded linkage reset mechanism 130. This logic ensures, through a mechanical structure, that the opening and suturing actions occur strictly and sequentially on the same axis, eliminating interference.

[0021] In the first stroke phase, when the trigger 120 is pulled back, the graded linkage reset mechanism 130, through internal rack and pinion transmission, independently drives the annular blade 330 to move forward against the tension of the reset spring 131. The sharp annular blade 330 presses and cuts through the support film clamped in the U-shaped operating groove 301, cutting out a standard circular window with a diameter in the range of 6 mm to 8 mm.

[0022] When the operating trigger 120 is pulled to a specific angle, causing the annular blade 330 to reach the set end point of the cutting stroke, the internal transmission system triggers the stroke locking structure 180. At this instant, the rigid constraint between the annular blade 330 and the forward drive chain is released, and the return spring 131 instantly releases its stored energy. Under the action of axial rebound force, the annular blade 330 instantly retracts back to its initial position inside the mating head 310. Through this retraction action, the axial space around the center of the cut hole is freed up.

[0023] In the second stroke phase, as the operating trigger 120 continues to be pulled backward, the cam or stop mechanism inside the graded linkage reset mechanism 130 switches, releasing the stroke lock on the pusher tube 340. At this time, the axial thrust is transferred and drives the peripheral pusher tube 340 forward. The end face of the pusher tube 340 rigidly presses the metal ring 350 downward in sync, causing the tips of the surrounding rigid sew pins 360 to directly penetrate the support film at the cut window edge.

[0024] After the rigid staple 360 ​​penetrates the covering film, its tip abuts against the surface of the staple seat 320 at the bottom. The surface of the staple seat 320 is machined with a shaped bending groove corresponding to the position of each rigid staple 360. The shaped bending groove has a symmetrical double-groove structure, its bottom is surface-hardened, and it is provided with a guide slope. When subjected to continuous pressure from above, the tips of the rigid staples 360 curl inward and close along the guide slope, undergoing a plastic deformation similar to the letter B. This deformation tightly clamps and holds the metal ring 350 and the support covering film, achieving a secure anchoring suture. The process is continuous, effectively preventing blood leakage and edge tearing.

[0025] In a preferred embodiment, to improve the initial cutting capability and filament breaking effect when cutting the coating, the cutting edge of the annular blade 330 is configured with a wavy toothed edge structure. This wavy toothed edge structure includes alternating, continuous crest teeth and trough teeth distributed along the circumference. Furthermore, the tips of the crest teeth are precision-machined and have a chamfered and polished structure. Through this design, the tips of the crest teeth can initially pierce the high-toughness polytetrafluoroethylene or polyester artificial vascular membrane using a point-piercing method, followed by smooth shearing with the oblique blade of the trough section, reducing the required initial cutting force.

[0026] To increase the operational flexibility of the stapler in complex environments, the composite stapler 300 is not rigidly fixed to the delivery rod. Instead, the composite stapler 300 is connected to the front end of the elongated delivery rod 200 via a universal joint 220. The stapler also includes an angle adjustment knob 140 located on the handle 100, and a flexible traction wire 230 passing through the interior of the elongated delivery rod 200 and connected to the universal joint 220. The angle adjustment knob 140 is configured to change the orientation angle of the front U-shaped operating groove 301 relative to the main shaft by winding or releasing the flexible traction wire 230. In a specific application example, the adjustment range of the orientation angle is set to... ,in The initial parallel angle indicates that the axis of the stapler coincides with the axis of the delivery rod; This is the maximum deflection angle. This structure allows for arbitrary adjustment of the anastomosis angle to accommodate the positioning requirements of artificial blood vessel branches with different orientations.

[0027] Combination Figure 6 and Figure 7 As shown in the microscopic internal structure, in order to rigidly mechanically solidify the two-stage logic in the main embodiment and improve reliability, the extended embodiment of this application introduces a rigid timing cam transmission structure. Specifically, the graded linkage reset mechanism 130 includes a timing cam plate 150 slidably disposed in the inner cavity of the handle, a first push rod 151 connecting the annular blade, and a second push rod 152 connecting the push pin tube. The timing cam plate 150 is mechanically connected to the operating trigger 120. When the operating trigger 120 is pulled, the timing cam plate 150 undergoes rigid translation along the linear direction of the handle axis.

[0028] A first driven pin 153 is fixedly disposed on the connecting seat extending rearward from the first push rod 151; a second driven pin 154 is fixedly disposed on the connecting seat extending rearward from the second push rod 152. A first guide groove 160 for sliding engagement of the first driven pin 153 and a second guide groove 170 for sliding engagement of the second driven pin 154 are precisely milled on the surface of the timing cam plate 150.

[0029] The topological shape of the guide groove determines the timing allocation of the mechanical logic. The first guide groove 160 includes a drive sloping groove section and a rapid rebound section that are sequentially and continuously distributed along the straight direction. The second guide groove 170 includes a delayed flat groove section and a pin-driving drive section that are sequentially and continuously distributed along the straight direction. The key timing synchronization point is that the starting position of the rapid rebound section and the ending position of the delayed flat groove section are aligned in the straight direction of the cam plate translation.

[0030] The rapid rebound section is configured as a straight groove structure parallel to the aforementioned straight direction. A travel latching structure 180 is provided at the junction of the drive inclined groove section of the first guide groove 160 and the rapid rebound section. This travel latching structure 180 is a one-way flap structure with a built-in torsion spring.

[0031] The working process under this extended mechanism is as follows: In the first stroke stage, the timing cam plate 150 translates, driving the inclined groove section to push the first driven pin 153 forward with a wedge force, causing the annular blade 330 to cut the hole. At this time, the second driven pin 154 is located in the delayed flat groove section, with zero force, and the pusher tube 340 remains stationary. When the hole is cut to the bottom, the first driven pin 153 is forced to slide over and pass the one-way flap structure, falling into the flat and unrestrained rapid rebound section. The one-way flap then resets to block its retreat. At this time, the return spring 131, which has accumulated deformation, releases energy, driving the first driven pin 153 to slide backward in the rapid rebound section, completing the retraction of the annular blade 330. When the annular blade 330 is completely retracted, as the operating trigger 120 continues to be pulled, the second driven pin 154 just exits the delayed flat groove section and enters the inclined nail driving section, where it is pushed forward to perform the subsequent stitching of the pusher tube 340. Based on the rigid trajectory setting of the cam slide, the uncertainty caused by mechanical motion friction is eliminated, ensuring that the timing of cutting and stitching is physically locked.

[0032] During external fenestration procedures, tiny pieces of membrane waste cut by the annular blade are easily attracted by static electricity or fall due to gravity, becoming hidden deep within the folds of the artificial blood vessel. If not cleaned in time and subsequently implanted into the human body, there is a risk of distal vascular embolism. Therefore, this embodiment adds a forced membrane waste recycling mechanism to the composite anastomosis device.

[0033] The waste film forced recycling mechanism includes a waste film collection cavity 331 and a supporting pad 321. The waste film collection cavity 331 is arranged coaxially in the hollow area inside the annular blade 330. Multiple annularly arranged unidirectional barbs 332 are machined on the inner cylindrical wall of the waste film collection cavity 331, and the tips of all unidirectional barbs 332 are inclined towards the deep interior of the waste film collection cavity 331.

[0034] On the opposing support side, the support pad 321 protrudes from the geometric center of the nail seat 320, with its top surface facing the opening of the waste membrane storage cavity 331. The support pad 321 is an elastic protrusion structure made of medical-grade silicone material. To avoid spatial conflicts, the outer diameter of the support pad 321 is strictly limited to be smaller than the inner diameter of the annular blade 330, and also smaller than the inner diameter of the metal ring 350.

[0035] When the recycling mechanism operates, in the first stroke phase, the annular blade 330 advances downward. Just before cutting through the support film, the film is tightly pressed against the support pad 321. As the annular blade 330 cuts the film to form a circular waste film, the descending blade 330 presses the support pad 321 downward as well, causing it to elastically deform and store energy. When the annular blade 330 retracts due to the unlocking of the stroke latch structure 180, the pressure on the surface of the support pad 321 decreases sharply, releasing an upward elastic restoring force. This elastic force propels the cut waste film upward and into the waste film collection cavity 331 inside the retracted annular blade 330. Once inside the cavity, the edges of the waste film are hooked and locked by densely packed one-way barbs 332, preventing it from falling again. Meanwhile, since the outer diameter of the support pad 321 is smaller than the inner diameter of the metal ring 350, the subsequently falling suture pusher tube 340 and rigid suture staple 360 ​​can pass through the annular gap around the support pad 321, and the two do not interfere with each other in spatial projection. Through the design of this forced recovery mechanism, closed-loop capture of surgical waste is achieved, eliminating embolic complications caused by foreign body residue.

[0036] In summary, this invention integrates the manual suturing process into three highly synchronized mechanical actions: punching, automatic retraction, and ring and staple placement, through a cam and latch-based hierarchical linkage reset mechanism configured within the handle. This structure utilizes the instantaneous springback mechanism of the central cutter to avoid physical interference issues associated with coaxial nested parts. Combined with forced waste membrane recycling and a universal joint adjustment structure, it enhances the quality and strength of the suture node, ensuring operational safety and adaptability. This is a preoperative processing aid with significant clinical application value.

[0037] It should be noted that the various specific parameters, component shapes, and transmission connection methods mentioned in this specification are only for illustrating preferred embodiments of the present invention, and the scope of protection of this application is not limited thereto. Those skilled in the art, after understanding the core timing control and anti-interference logic of the present invention, who employ similar gear and rack systems, pneumatic micro-pistons, or other equivalent mechanical transmission alternatives to achieve the same two-stage working logic, should all fall within the scope of protection of this application.

Claims

1. Arterial stent fenestration suture device, including a handle, a slender delivery rod, and a composite anastomosis device; The two ends of the slender delivery rod are respectively connected to the handle and the composite anastomosis device; The composite stapler has a U-shaped operating groove; The two opposite walls of the U-shaped operating groove are respectively provided with a matching head and a nail seat; The handle is equipped with an operating trigger and a graded linkage reset mechanism connected to the operating trigger. Its features are, The anastomosis head is coaxially nested with an annular blade and a pusher tube along the central axis inside. The front end of the push pin tube is provided with a metal ring for installing rigid sew pins; The graded linkage reset mechanism is configured to execute two-stage timing control logic in response to the pulling displacement of the operating trigger; In the first stroke phase, the graded linkage reset mechanism drives the annular blade to move forward and cut through the support film; And when the cutting stroke ends, the stroke latching structure is triggered, and the annular blade retracts to the initial position under the action of the return spring and releases the central axial space; In the second stroke phase, the graded linkage reset mechanism releases the stroke lock on the pusher tube and drives the pusher tube to advance; The push pin tube presses against the metal ring, causing the rigid pin to penetrate the support membrane and undergo plastic deformation within the forming bending groove of the pin seat.

2. The arterial stent fenestration suture device as described in claim 1, characterized in that, The graded linkage reset mechanism includes a timing cam plate, a first push rod, and a second push rod; The timing cam plate is mechanically connected to the operating trigger, and the timing cam plate is displaced in a straight line as the operating trigger is pulled; The first push rod is connected to the annular blade, and a first driven pin is provided on the first push rod; The second push rod is connected to the push pin tube, and a second driven pin is provided on the second push rod; The timing cam plate is provided with a first guide groove for the first driven pin to slide and engage, and a second guide groove for the second driven pin to slide and engage.

3. The arterial stent fenestration suture device as described in claim 2, characterized in that, The shapes of the first guide groove and the second guide groove determine the timing of the first stroke stage and the second stroke stage; The first guide groove includes a driving inclined groove section and a rapid rebound section that are sequentially and continuously distributed along the straight direction; The second guide groove includes a delayed flat groove section and a nail-driving section that are sequentially and continuously distributed along the straight direction; The starting position of the rapid rebound section and the ending position of the delayed flat groove section are aligned in the straight line direction.

4. The arterial stent fenestration suture device as described in claim 3, characterized in that, The rapid rebound section is a straight groove structure parallel to the straight line direction; The stroke latching structure is provided at the junction of the drive inclined groove section and the rapid rebound section of the first guide groove; The travel buckle structure is a one-way flip-plate structure; When the first driven pin slides to its farthest end in the drive sloping groove section, it passes over the one-way flap structure and falls into the rapid rebound section. The return spring releases energy and drives the first driven pin to slide backward within the rapid rebound section.

5. The arterial stent fenestration suture device as described in claim 1, characterized in that, The anastomosis head and the staple seat are respectively provided with a waste membrane forced recycling mechanism; The waste film forced recycling mechanism includes a waste film collection chamber and a support pad; The waste film collection cavity is arranged coaxially inside the annular blade. The supporting pad is disposed in the central area of ​​the nail seat; The supporting pad is directly opposite the opening of the waste film collection cavity.

6. The arterial stent fenestration suture device as described in claim 5, characterized in that, The inner wall of the waste film collection cavity is provided with multiple one-way barbs; The tip of the unidirectional barb points towards the interior of the waste membrane collection cavity; The supporting pad is an elastic protrusion structure, and the outer diameter of the supporting pad is smaller than the inner diameter of the annular blade. During the first stroke phase, the annular blade cuts through the support film to form waste film, while the supporting pad is compressed and undergoes elastic deformation. When the annular blade retracts, the supporting pad releases its elastic restoring force, pushing the waste film into the waste film storage cavity, where it is locked by the one-way barbs.

7. The arterial stent fenestration suture device as described in claim 1, characterized in that, The composite stapler is connected to the front end of the slender delivery rod via a universal joint; The stitcher also includes an angle adjustment knob on the handle and a flexible traction wire that passes through the elongated delivery rod and connects to the universal joint; The angle adjustment knob is configured to change the orientation angle of the U-shaped operating groove by retracting or extending the traction wire; The adjustment range of the orientation angle is: ,in The initial parallel angle, This represents the maximum deflection angle.

8. The arterial stent fenestration suture device as described in claim 1, characterized in that, The forming bending groove on the nail seat has a symmetrical double groove structure; The bottom of the forming bending groove is surface hardened and is provided with a guide slope; When the push pin tube presses against the metal ring, causing the tip of the rigid pin to contact the guide slope, the rigid pin curls inward and closes along the guide slope.

9. The arterial stent fenestration suture device as described in claim 1, characterized in that, The cutting edge at the front end of the annular blade has a wavy toothed edge structure; The wavy edge structure includes alternating peak teeth and trough teeth; The tip of the wave crest tooth has a chamfered and polished structure.

10. The arterial stent fenestration suture device as described in claim 1, characterized in that, The inner wall of the front end of the push pin tube is provided with an annular groove; The outer wall of the metal ring is provided with an elastic snap-fit ​​protrusion that matches the annular slot.

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