Peripheral artery end-side anastomosis device for endovascular access
By using the peripheral artery end-side anastomosis device with transvascular intraluminal approach in peripheral artery bypass surgery, intraluminal vascular blockade and preformed bifurcated artificial vascular stents, the problem of cumbersome and time-consuming anastomosis process in the prior art is solved, and rapid and minimally invasive arterial anastomosis is achieved, and surgical efficiency and safety are improved.
Patent Information
- Application Number
- CN202510201102.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-24
- Publication Date
- 2025-04-18
AI Technical Summary
In the existing peripheral artery bypass surgery, the end-side anastomosis method between the artery and artificial blood vessels is cumbersome, time-consuming, and it is easy to cause anastomosis failure due to operational errors.
The peripheral arterial end-side anastomosis device is adopted with transvascular intraluminal approach. The device includes a branched Y-type artificial vascular stent and a delivery system. Through intraluminal vascular blockade and preformed bifurcated artificial vascular stent, rapid and minimally invasive anastomosis is achieved.
It improves the efficiency of arterial anastomosis, speeds up the speed of peripheral arterial bypass surgery, reduces the overall time of surgery and anesthesia, and reduces the risk of postoperative complications.
Smart Images
Figure CN119837577A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a peripheral artery end-to-side anastomosis device via an intravascular approach, belonging to the technical field of medical supplies. Background Art
[0002] Currently, in peripheral artery bypass surgery, the end-to-side anastomosis method of the graft and the artery is mainly to use vascular sutures (such as Prolene lines) for continuous manual suturing. For example, in the femoral-popliteal artery artificial vascular bypass, it is necessary to expose the proximal end of the common femoral artery (with the superficial circumflex iliac artery as a mark) to the bifurcation of the femoral artery (with the superficial femoral artery and the deep femoral artery as marks). Use a vascular blocking clamp to block the distal blood flow, cut the anterior wall of the artery, and suture the trimmed artificial blood vessel with the incision in a "parachute" manner. The edge of the arterial intima is required to be everted and aligned with the edge of the artificial blood vessel. After exhausting air and blood, suture the last few stitches and tie a knot. This traditional anastomosis method has a long learning curve, requires a long skin incision, is time-consuming, and may cause anastomosis failure due to an inadvertent error in the depth and sequence of needle insertion and withdrawal. Summary of the invention
[0003] The purpose of the present invention is to provide a peripheral artery end-to-side anastomosis device via an intravascular approach, which is used to quickly and minimally invasively perform end-to-side anastomosis between a medium-diameter peripheral artery and an artificial blood vessel (or an autologous venous graft), thereby improving the efficiency of arterial anastomosis, speeding up peripheral artery bypass surgery, and reducing the overall time of surgery and anesthesia.
[0004] The present invention adopts the following technical solutions:
[0005] A peripheral artery end-to-side anastomosis device via intravascular access, comprising a delivery system and an artificial blood vessel stent 5; the artificial blood vessel stent 5 is a Y-shaped structure with branches, the main body is 0.8-1.2 mm larger than the diameter of the anastomotic artery, and the branch part is 0.8-1.2 mm larger than the graft; the main body and the branch part are each provided with two rows of small wire loops along the generatrix direction, after the main body and the branch part are folded respectively, the two rows of small wire loops are overlapped, and the metal wires are sequentially passed through the overlapped wire loops to complete the bundle diameter; the two rows of small wire loops are arranged 180 degrees symmetrically on the cross section; two metal wires extend outside the delivery system; the delivery system comprises a delivery A sheath 3, a delivery rod complex 4, a handle 1 and a rotating wheel 2; the delivery rod complex 4 is located in the delivery sheath 3, and the delivery sheath 3 can accommodate an artificial blood vessel stent 5 after the bundle diameter; the delivery rod complex 4 includes a thin rod 402, a thick rod 401, a balloon 6, and a water injection port 8 connected to the balloon, the thin rod 402 includes a hollow metal rod and a balloon control channel attached to the surface and connected to the balloon 6; the thick rod 401 is a continuation of the thin rod toward the proximal end, and has two long grooves 401a separated by 180° for accommodating the metal wire, and the water injection port 8 is arranged at the proximal end of the thick rod; the rotating wheel 2 is attached to the handle 1, and can be used to withdraw or push the delivery sheath 3 by rotating.
[0006] Preferably, the artificial blood vessel stent 5 is composed of a nickel-titanium memory alloy skeleton and an anti-leakage artificial blood vessel membrane, the length of the main part is 3±0.5 cm, the length of the branch part is 1-1.5 cm, and the angle between the branch part and the main part is 20-30 degrees.
[0007] Preferably, the delivery sheath has a hydrophilic layer and is made of a plastic material with flexibility and anti-bending ability, and the inner diameter is slightly larger than the bundle diameter of the artificial vascular stent in the fully entrapped state.
[0008] Preferably, the overall length of the delivery rod complex 4 is 130-150cm; the thin rod part is a two-layer structure, which includes a hollow metal rod with good flexibility and strong bending resistance, and a balloon control channel attached to the surface and connected to the balloon. The hollow metal rod can accommodate a 0.035in guide wire, and the thin rod part is used to load the stent, which is longer than the artificial blood vessel stent.
[0009] Preferably, the thick rod portion is a plastic material with good flexibility and bending resistance that is wrapped around the outer layer of the thin rod portion, and its diameter is slightly smaller than the inner diameter of the delivery sheath, but not smaller than the bundle diameter of the artificial vascular stent in the fully entrapped state; the end of the thin rod is a compliant balloon, and the filled diameter is slightly larger than the inner diameter of the artery.
[0010] Preferably, a pointed soft head 7 is provided at the distal end of the thin rod portion, which is connected to the thin rod portion and is made of a material that is flexible, resistant to bending, hydrophilic and elastic. The pointed soft head 7 is conical in shape, and its bottom surface is a hemisphere, which can fit the delivery sheath.
[0011] Preferably, the handle 1 is made of hard plastic material, which can accommodate the delivery sheath and the delivery rod complex, and the length of the handle is not less than 10 cm; the rotating wheel is attached to the handle and fits tightly with the delivery sheath, and the delivery sheath can be retracted or pushed by rotating it with fingers.
[0012] Preferably, during the installation combination: the artificial vascular stent is placed on the thin rod, the bundle diameter is adjusted, the metal wire is passed through the long groove of the thick rod, and the installation direction of the artificial vascular stent is determined according to the angle direction of the graft 10 and the artery 9; the artificial vascular stent is gradually tied and the delivery sheath is pushed until the artificial vascular stent is completely wrapped and the end of the delivery sheath is in contact with the tip soft head.
[0013] The beneficial effects of the present invention are:
[0014] 1) Using the transluminal approach, the optimal anastomotic position can be determined in advance by angiography.
[0015] 2) Use intraluminal vascular occlusion instead of extraluminal vascular occlusion to reduce the length of skin incision and artery exposure.
[0016] 3) Using a preformed bifurcated artificial vascular stent as an anastomotic connector can achieve a patency rate comparable to that of manual suturing when the artery diameter is large enough, and the anastomosis speed is faster, reducing the overall operation time.
[0017] 4) After the distal balloon is inflated, heparinized saline can be flushed directly into the anastomosis through the intraluminal vascular sheath without using a venous branch or artificial blood vessel for reverse flushing as a flushing route.
[0018] 5) After the overall bypass surgery is completed, the sheath can be conveniently used for angiography and possible interventional remedial operations. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 The present invention is a perspective view of the entirety of the peripheral artery end-to-side anastomosis device through the intravascular approach.
[0020] Figure 2 It is a schematic diagram of the structure of the artificial vascular stent when it is fully deployed.
[0021] Figure 3 It is a schematic diagram of the bundle diameter of the artificial vascular stent.
[0022] Figure 4 It is a schematic diagram of the use status of an embodiment of the peripheral artery end-to-side anastomosis device for intravascular access of the present invention.
[0023] Figure 5 This is a schematic diagram of an artificial vascular stent in an artery.
[0024] Figure 6It is a schematic diagram of a Y-shaped branch of an artificial vascular stent extending out of the arterial opening and the graft being placed on the branch.
[0025] Figure 7 As Figure 6 A further continuation of this is a schematic diagram of the graft being sutured to the arterial opening.
[0026] Figure 8 It is a partially enlarged schematic diagram of the connection portion between the thick rod and the thin rod of the conveying rod, showing the two long grooves set on the thick rod.
[0027] Fig. 9 It is a schematic diagram of a thin hollow metal rod and a balloon control channel attached to the surface and connected to the balloon.
[0028] Fig.10 This is a schematic diagram of the process of an artificial vascular stent expanding from bundle diameter to full expansion.
[0029] In the figure, 1. handle, 2. rotating wheel, 3. delivery sheath, 4. delivery rod, 5. artificial blood vessel stent, 6. balloon, 7. pointed soft head, 8. water injection port connected to the balloon, 9. artery, 10. graft, 901. arterial opening. DETAILED DESCRIPTION
[0030] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments.
[0031] This embodiment specifically introduces a peripheral artery end-to-side anastomosis device via intravascular access. The device is used via intravascular access to replace some manual anastomosis surgical scenarios of medium-diameter peripheral arteries and grafts, and is mainly used for end-to-side anastomosis of the common femoral artery, common carotid artery, subclavian artery and axillary artery with artificial blood vessels / venous grafts.
[0032] Firstly, the so-called "end-to-side anastomosis" is different from the "end-to-end anastomosis" and refers to the form of anastomosis of the end of the graft with the side wall of the artery. This concept itself is a prior art.
[0033] See also Figure 1-3 Artificial blood vessel stent 5: The artificial blood vessel stent 5 is composed of a nickel-titanium memory alloy skeleton and an anti-leakage artificial blood vessel membrane. The stent is a Y-shaped structure with branches. The length of the main body is generally 3±0.5cm, the length of the branch part is generally 1-1.5cm, and the angle between the branch and the main body is generally 20-30 degrees. The diameter of the main body and the branch is designed according to the needs, and is required to be 1mm larger than the anastomotic artery and the graft. There are several to dozens of small wire rings on the main body and branch artificial blood vessel skeletons, and the small wire rings are symmetrically arranged 180 degrees on the cross section ( Figure 2After the artificial vascular stent body and branches are folded, the symmetrical small wire loops are overlapped, and the metal wires pass through the overlapping wire loops in sequence, which is regarded as the bundle diameter ( Figure 3 ). Two wires extend outside the conveyor system. Fig.10 The process of the artificial vascular stent changing from the narrow diameter state to the fully expanded state is shown. Figure 1 , delivery system: includes a delivery sheath 3, a delivery rod complex 4, a handle 1 and a rotating wheel 2.
[0034] Delivery sheath 3: It is made of a plastic material with a hydrophilic coating and good flexibility and bending resistance. The inner diameter is slightly larger than the bundle diameter of the artificial vascular stent in the fully entrapped state and can accommodate the latter.
[0035] Delivery rod complex 4: It consists of a thin rod part, a thick rod part, a balloon, a water injection port connected to the balloon, and a soft tip. The overall length of the delivery rod is recommended to be more than 130-150cm. The thin rod part is a two-layer structure, which is a hollow metal rod with good flexibility and strong bending resistance, and a balloon control channel attached to the surface and connected to the balloon. The hollow metal rod can accommodate a 0.035in guide wire. The thin rod part is used to load the stent, which is slightly longer than the artificial vascular stent. The thick rod part is a continuation of the thin rod part. The outer layer of the thin rod is wrapped with a plastic material with good flexibility and bending resistance. The diameter is slightly smaller than the inner diameter of the delivery sheath, but not less than the bundle diameter artificial vascular stent in the fully entangled state. Two long grooves are designed in the wrapping layer, which need to accommodate the bundle diameter metal wire to pass through ( Figure 8 The proximal end of the thick rod is connected to a water-injectable interface connected to the balloon control channel. The end of the thin rod is a compliant balloon 6 ( Fig. 9 ), it is recommended that the filling diameter is slightly larger than the inner diameter of the artery. The tip soft head 7 is connected to the thin rod, and is made of a material with good flexibility, strong bending resistance, hydrophilicity and certain elasticity. The soft head is conical, and its bottom surface is a hemisphere, which can fit with the delivery sheath 3.
[0036] Handle 1: Made of hard material, designed to be grasped by hand, it can accommodate the delivery sheath and delivery rod system, and the proximal end of the thick rod with a water injection interface protrudes outside the handle. The handle length is recommended to be no less than 10cm.
[0037] Rotating wheel 2: The rotating wheel is attached to the handle and fits tightly with the delivery sheath. The delivery sheath can be retracted or pushed by rotating it with fingers.
[0038] Installation combination: Place the artificial vascular stent on the thin rod of the delivery system, make the bundle diameter, and pass the bundle diameter wire through the reserved long slot of the thick rod of the delivery system (combined with Figure 2 , 38). The installation direction of the artificial vascular stent needs to be determined according to the specific anastomotic direction (i.e. the angle between the graft and the artery). The stent is gradually tied and the delivery sheath is pushed until the stent is completely wrapped in it and the end of the delivery sheath fits with the tip soft head.
[0039] It should be noted that traditional human tissue anastomosis devices, such as intestinal anastomosis devices and coronary artery anastomosis devices, usually adopt an extraluminal approach and mostly use a "stapler-style" anastomosis method, which is relatively traumatic and complicated to operate. The present invention takes a unique approach and innovatively proposes a new intraluminal anastomosis solution:
[0040] 1) Minimally invasive approach and precise delivery:
[0041] By using a longer delivery sheath, the anastomotic device can be easily delivered into the cavity through the common femoral artery, without the need for thoracotomy or laparotomy, significantly reducing the surgical incision and alleviating the patient's pain.
[0042] 2) Balloon occlusion, precise control:
[0043] By cooperating with the blocking of the proximal common balloon or the sheath with a balloon, and the distal balloon provided on the delivery rod of the present invention, the complete blocking of the artery before anastomosis is achieved, which effectively reduces the intraoperative bleeding, ensures a clear surgical field of view, and improves the accuracy of the operation.
[0044] 3) Bifurcation stents to simplify anastomosis (artificial vascular stents are pre-formed, not bifurcated stents assembled during surgery):
[0045] A unique bifurcated artificial vascular stent is used as a connecting bridge between the artery and the graft. There is no need for traditional cumbersome continuous suturing. A firm connection can be achieved by simply using the static friction between the stent and the blood vessel, which greatly simplifies the anastomosis operation and shortens the operation time.
[0046] 4) Intracavity flushing, safe and efficient:
[0047] After the anastomosis is completed, the balloon occlusion is released and heparin saline and contrast agent can be flushed into the artery through the sheath in the vascular lumen to quickly remove the residues in the blood vessel and effectively reduce the risk of complications such as postoperative thrombosis.
[0048] 5) Further:
[0049] Using the intraluminal approach, the best anastomotic position can be determined in advance through angiography. Using intraluminal vascular occlusion instead of extraluminal vascular occlusion can reduce the length of skin incision and arterial exposure. Using a preformed bifurcated artificial vascular stent as an anastomotic connector can achieve a patency rate similar to that of manual sutures when the artery diameter is large enough, and the anastomosis speed is faster, reducing the overall operation time. After the distal balloon is inflated, heparinized saline can be flushed directly into the anastomosis through the intraluminal vascular sheath without using venous branches or artificial blood vessels as a flushing route. After the overall bypass surgery is completed, the sheath can be conveniently used for angiography and possible interventional repair.
[0050] The following takes the left femoral artery-popliteal artery artificial vascular bypass as an example, with the common femoral artery as the inflow artery. Assuming that the common femoral artery is 5 cm long and 7 mm in diameter, and an ePTFE artificial blood vessel with an inner diameter of 6 mm is selected as the graft, it is necessary to select the bifurcated artificial blood vessel stent in the present invention (specification model: main body length 3 cm, main body diameter 8 mm, branch length 1.5 cm, branch diameter 7 mm) as the anastomosis device, assuming that the outer diameter of the delivery system is 9F. The operation steps are as follows ( Figure 4 ):
[0051] S1. Retrograde puncture of the right common femoral artery, insertion of a 5F short sheath, prefabricated vascular suture, and insertion of an 8F sheath. Use a pigtail catheter to angiography the lower segment of the abdominal aorta to locate the contralateral external iliac-femoral artery.
[0052] S2. Use the super-smooth guidewire with the pigtail catheter to enter the femoral artery on the lesion side, and replace the Amplatz super-hard guidewire. Insert a 9F 45cm long vascular sheath with a balloon, with the tip located in the external iliac artery. Use angiography to locate the best anastomotic area of the femoral artery, which is usually the normal non-stenotic vascular area between the anterior circumflex iliac artery and the deep femoral artery. Reserve 0.5-1cm from the distal end to the deep femoral artery as the balloon blocking area. Use opaque markers (such as vascular clamps) for in vitro positioning.
[0053] S3, above the external marking, cut the skin 3 cm, gradually expose the common femoral artery, and control it with a cuff;
[0054] S4. Introduce the vascular anastomosis device to the marked position, inflate the proximal sheath balloon and the distal blocking balloon of the anastomosis delivery system to completely block the blood flow. Make a longitudinal incision of the anterior wall of the artery about 5 mm.
[0055] S5. Use non-destructive forceps to rotate the branch of the artificial blood vessel stent of the anastomosis device to the incision and pick out the branch. Pull out the bundle diameter metal wire of the main body of the artificial blood vessel stent of the anastomosis device to completely fix it on the inner wall of the artery.
[0056] S6. Trim the graft into a serpentine shape and put it on the artificial blood vessel stent branch of the anastomosis device, as close to the arterial incision as possible. Pull off the bundle diameter metal wire of the artificial blood vessel stent branch of the anastomosis device to make it fit the graft artificial blood vessel completely.
[0057] S7. 5-0 prolene can be used to intermittently reinforce the graft artificial blood vessel and arterial wall.
[0058] S8. Release the proximal blocking balloon and inject heparinized saline to flush the artery, anastomosis device and graft. Release the distal balloon to allow blood flow to continue to perfuse the deep femoral artery. Withdraw the entire delivery system.
[0059] S9. Block the graft artificial blood vessel and continue to manually anastomose the graft artificial blood vessel with the popliteal artery through the submuscular tunnel.
[0060] S10. After the bypass is completed, a 9F sheath is used for angiography to show the inflow artery, the graft vessel, and the outflow artery. After confirmation, the incision and skin are sutured.
[0061] It can be seen that the present invention can be used to quickly and minimally invasively perform end-to-side anastomosis between a medium-diameter peripheral artery and an artificial blood vessel / autologous vein graft, thereby improving the efficiency of arterial anastomosis, accelerating the speed of peripheral artery bypass surgery, and reducing the overall time of surgery and anesthesia.
[0062] The above are preferred embodiments of the present invention. Those skilled in the art may also make respective changes or improvements thereon. Without departing from the general concept of the present invention, these changes or improvements shall fall within the scope of protection claimed by the present invention.
Claims
1. A peripheral artery end-to-side anastomosis device via intravascular access, characterized in that: Including a delivery system and an artificial blood vessel stent (5); The artificial blood vessel stent (5) is in a Y-shaped structure with branches, the main body is 0.8-1.2 mm larger than the diameter of the anastomotic artery, and the branch part is 0.8-1.2 mm larger than the graft in diameter; the main body and the branch part are each provided with two rows of small wire loops along the generatrix direction, and after the main body and the branch part are folded, the two rows of small wire loops overlap, and the metal wires pass through the overlapping wire loops in turn, and after the wires are bundled, the artificial blood vessel stent (5) is folded; the two rows of small wire loops are symmetrically arranged at 180 degrees on the cross section; and the two metal wires extend outside the delivery system; The delivery system comprises a delivery sheath (3), a delivery rod complex (4), a handle (1) and a rotating wheel (2); The delivery rod complex (4) is located in the delivery sheath (3), and the delivery sheath (3) can accommodate the artificial blood vessel stent (5) after the bundle diameter; The delivery rod complex (4) comprises a thin rod (402), a thick rod (401), a balloon (6), and a water injection port (8) connected to the balloon. The thin rod (402) comprises a hollow metal rod and a balloon control channel attached to the surface and connected to the balloon (6). The thick rod (401) is a continuation of the thin rod toward the proximal end, and has two long grooves (401a) spaced 180 degrees apart for accommodating the metal wire. The water injection port (8) is arranged at the proximal end of the thick rod. The rotating wheel (2) is attached to the handle (1) and can be rotated to withdraw or push the delivery sheath (3).
2. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: The artificial blood vessel stent (5) is composed of a nickel-titanium memory alloy skeleton and an anti-leakage artificial blood vessel membrane, the length of the main part is 3±0.5 cm, the length of the branch part is 1-1.5 cm, and the angle between the branch part and the main part is 20-30 degrees.
3. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: The delivery sheath has a hydrophilic layer and is made of a plastic material with flexibility and anti-bending ability, and the inner diameter is slightly larger than the bundle diameter of the artificial vascular stent in a completely entrapped state.
4. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: The overall length of the delivery rod complex (4) is 130-150 cm; the thin rod part is a two-layer structure, which comprises a hollow metal rod with good flexibility and strong bending resistance, and a balloon control channel attached to the surface and connected to the balloon. The hollow metal rod can accommodate a 0.035-inch guide wire, and the thin rod part is used to load the stent, which is longer than the artificial blood vessel stent.
5. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: The thick rod part is made of a flexible and anti-bending plastic material wrapped around the thin rod part. Its diameter is slightly smaller than the inner diameter of the delivery sheath, but not smaller than the bundle diameter of the artificial vascular stent in the fully entrapped state. The end of the thin rod is a compliant balloon, and its filled diameter is slightly larger than the inner diameter of the artery.
6. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: A tip soft head (7) is provided at the distal end of the thin rod portion. The tip soft head (7) is connected to the thin rod portion and is made of a material having good flexibility, strong bending resistance, hydrophilicity and elasticity. The tip soft head (7) is conical in shape, and its bottom surface is a hemisphere, which can fit with the delivery sheath.
7. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: The handle (1) is made of hard plastic material and can accommodate a delivery sheath and a delivery rod complex therein, and the length of the handle is not less than 10 cm; the rotating wheel is attached to the handle and fits tightly with the delivery sheath, and can be rotated by fingers to withdraw or push the delivery sheath.
8. The peripheral artery end-to-side anastomosis device for intravascular access as claimed in claim 1, characterized in that: When installing the assembly: the artificial blood vessel stent is placed on the thin rod, the bundle diameter is adjusted, and the metal wire is passed through the long groove of the thick rod. The installation direction of the artificial blood vessel stent is determined according to the angle direction of the graft (10) and the artery (9); the artificial blood vessel stent is gradually tied and the delivery sheath is pushed until the artificial blood vessel stent is completely wrapped and the end of the delivery sheath is in contact with the tip soft head.