A vascular anastomosis support dilator

Abstract

The embodiment of the present invention discloses a vascular anastomosis support dilator, which includes a support body, the support body is used to be at least partially placed in a blood vessel to dilate the blood vessel; one end of the support body is connected to a tail structure, the tail structure is used to push, pull or adjust the size of the support body; the support body has a minimum diameter and a maximum diameter, and the maximum diameter of the support body is the rated diameter or the diameter supported by the support. In solving the problem of vascular wall adhesion caused by ischemia during vascular suturing, an equal-caliber anastomosis condition is provided, which is more conducive to the suturing effect.

Description

Technical Field

[0001] The invention relates to the field of medical surgical vascular anastomosis auxiliary instruments, and in particular to a vascular anastomosis support dilator. Background Art

[0002] Vascular anastomosis is a basic form of clinical surgery, including vascular injury repair, vascular transplantation, vascular lap joint, vascular suturing and repair, etc. It is a commonly used and effective treatment method for reconstructing blood flow. It is widely used and commonly seen in various types of surgical operations, such as replantation of severed limbs, accidental vascular injury, organ transplantation, arteriovenous fistula anastomosis, etc. With the continuous development of microsurgical instruments, microsutures and surgical microscopes, manual small (micro) vascular anastomosis technology has gradually matured, and the caliber of blood vessels that can be anastomosed has become thinner and thinner. However, even for experienced surgeons, it is not easy to complete a perfect vascular anastomosis, especially the small and micro vascular anastomosis mentioned above.

[0003] First of all, the two ends of the blood vessel must be accurately aligned with the anastomosis, without twisting, stenosis, eversion or inversion. In other words, the two ends must be aligned with the intima against the intima and the muscular layer against the muscular layer. This will minimize the healing scar and increase the patency rate. Therefore, the caliber of the two ends should be as equal as possible, and they can be expanded with dilators of equal diameter or forceps for dilating blood vessels. However, the contradiction is that for some small blood vessels, non-invasive technology is very important, and forceps are not allowed to clamp the intima and muscular layer of the blood vessels to be anastomosed, otherwise the patency rate will be reduced. Flexible or non-invasive internal support is required to achieve the alignment of the anastomosis. There are also reports that the use of vascular staplers for anastomosis has good results when anastomosing the aorta, but its accuracy is still lacking when anastomosing blood vessels with smaller calibers, and there is a higher stenosis rate. Of course, the high cost of equipment is also one of the reasons that hinder its popularization.

[0004] Another necessary step in vascular surgery is to expose the blood vessels and control the blood flow to provide a bloodless field of view to complete the operation; according to the size of the blood vessels and the anatomical site, different types of non-destructive vascular clamps, soft and elastic colloid bands, or balloon catheters are used to block the blood flow through the vascular cavity. After blocking the blood flow, the elasticity of the blood vessel wall shrinks and collapses, the lumen becomes smaller or even occluded, and the front and back walls often fit together and are difficult to separate, which poses a great obstacle to the suturing operation. It is also easy to pierce the lower blood vessel wall during suturing. The operation is difficult and inefficient, and it takes a long time, resulting in a long blood flow blockage time and high risk. Some doctors will make some homemade packings to assist in suturing. Although this can solve some problems, the efficiency is still low, the function is single, and it is not standardized.

[0005] Vascular suture as a method of anastomosis is more dependent on the surgeon's experience and skills. Although some new vascular anastomosis methods have been developed in recent years, such as anastomosis clip method, stapler method, cannula method, bonding method, etc., they all have various shortcomings. Manual suturing method as the most common means is still the "gold standard" for microvascular anastomosis.

[0006] How to shorten the suturing time, reduce the suturing risk, and improve the patency rate of blood vessels after surgery is the research focus of the present invention. Summary of the invention

[0007] In view of the above-mentioned problems in vascular suturing, the present invention provides a vascular anastomosis support dilator, which aims to solve the problem of vascular wall adhesion caused by ischemia affecting suturing during vascular suturing, and at the same time provides an equal-caliber anastomosis condition, which is more conducive to the suturing effect.

[0008] The present invention provides a blood vessel anastomosis support dilator, comprising a support body, wherein the support body is a flexible and foldable structure, has a certain circumferential support force, and is used to be at least partially placed in a blood vessel to dilate the blood vessel;

[0009] One end of the support body is connected to a tail structure, and the tail structure is used to push or pull the support body or adjust the support size of the support body;

[0010] The support body has a minimum diameter and a maximum diameter, and the maximum diameter of the support body is a rated diameter or a diameter supported by a support.

[0011] Optionally, the maximum diameter of the support body is the rated diameter, the support body comprises a small end and a large end, the outer diameter of the large end is the maximum diameter of the support body; the support body is made of a flexible material and has sufficient radial support strength, and hollow cavities are provided inside the small end and the large end;

[0012] Wherein, one end of the hollow cavity is closed, and the tail structure is connected to the closed end of the support body, or

[0013] The hollow cavity passes through the supporting body, and the tail structure is connected to the supporting body at an offset angle.

[0014] Optionally, the support body is in a teardrop shape, an olive shape, a gourd shape or a spherical shape, and the outer wall of the large end is also provided with a groove for an instrument to clamp the support body.

[0015] Optionally, the support body is in a teardrop shape or an olive shape, and a side wall of the support body is provided with a semi-opening portion, and an opening angle of the semi-opening portion is 90°-125°.

[0016] Optionally, the support body includes a fixed ring and a sliding ring, a guide wire and a support portion are provided between the sliding ring and the fixed ring, and the support portion is arranged around the guide wire; the tail structure includes a portion of the guide wire extending out of the sliding ring, and a hose sleeved on the portion, and pushing the hose can drive the sliding ring to squeeze the support portion, so that the outer diameter of the support portion changes, and its value can be adjusted according to actual needs, and the maximum value is the maximum value set by the support body.

[0017] Optionally, the vascular anastomosis support dilator also includes a first hand-held part, which includes a limiting rod connected to the guide wire, a pushing head connected to the hose, and an operating handle cooperating with the limiting rod; by rotating the operating handle, the operating handle can move on the limiting rod and drive the pushing head forward.

[0018] Optionally, the hand-held part also includes a hand-held handle, the limit rod is fixed to the hand-held handle, the operating knob is fixed to the pushing head, and a limit distance is left between the hand-held handle and the operating knob; the limit rod and the hand-held handle can limit the support body so that its diameter does not exceed a set maximum setting value.

[0019] Optionally, the tail structure includes a microcatheter with one end closed, the microcatheter is provided with a filling hole, the supporting body is a balloon fixed on the microcatheter, and the filling hole is located in the balloon; liquid or gas is injected into the microcatheter, and the liquid or gas can enter the balloon through the filling hole to expand the balloon.

[0020] Optionally, the vascular anastomosis support dilator also includes a second hand-held part, which includes a filling chamber connected to the microcatheter, a sealing piston placed in the filling chamber, and an inflation knob rotatably connected to the filling chamber; rotating the inflation knob can push the sealing piston to move forward or backward within the chamber in the filling chamber, thereby adjusting the expansion size of the balloon, and the maximum size does not exceed the set maximum size.

[0021] Optionally, the tail structure further includes a hollow cavity, which is arranged in upper and lower layers with the microcatheter, the microcatheter includes a ventilation cavity connected to the filling hole, and a hollow cavity with openings at both ends is provided in the hollow cavity.

[0022] The vascular anastomosis support dilator provided in the embodiment of the present invention can solve the problem of vascular wall adhesion caused by ischemia affecting suturing during vascular suturing, can quickly dilate blood vessels, assist surgical treatment, and improve treatment efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1It is a schematic diagram of a water drop type support body in one embodiment of the present invention.

[0024] Figure 2 for Figure 1 Schematic diagram of the special form of the water drop support body.

[0025] Figure 3 for Figure 1 Cross-sectional view of .

[0026] Figure 4 for Figure 1 Schematic diagram of the support body being placed in a blood vessel.

[0027] Figure 5 for Figure 1 Schematic diagram of two support bodies placed in a blood vessel.

[0028] Figure 6 It is a schematic diagram of an olive-shaped supporting body in one embodiment of the present invention.

[0029] Figure 7 for Figure 6 Cross-sectional view of .

[0030] Figure 8 for Figure 6 Schematic diagram of a support body placed in a blood vessel.

[0031] Fig. 9 Schematic diagram of a support body with an opening in one embodiment of the present invention.

[0032] Fig.10 10b is Fig.10 10a is a cross-sectional view of Fig.10 Side view of b.

[0033] Fig.11 It is a three-dimensional diagram of a metal bracket type supporting body in one embodiment of the present invention.

[0034] Fig.12 for Fig.11 Side view of the central support body.

[0035] Fig.13 For Fig.11 A three-dimensional view of a first hand-held portion used in conjunction with the middle support body.

[0036] Fig.14 For Fig.13 Cross-sectional view of the first hand-held part.

[0037] Fig.15 for Fig.11 Schematic diagram of a support body placed in a blood vessel.

[0038] Fig.16It is a cross-sectional view of a double-balloon support body in one embodiment of the present invention.

[0039] Fig.17 It is a cross-sectional view of a double-balloon support body in use in one embodiment of the present invention.

[0040] Fig.18 For Fig.16 A three-dimensional view of a second hand-held portion used in conjunction with the middle support body.

[0041] Fig.19 For Fig.18 A cross-sectional view of the second handheld portion.

[0042] Fig. 20 for Fig.16 Schematic diagram of a support body placed in a blood vessel.

[0043] Fig.21 for Figure 1 21a is a three-dimensional schematic diagram, and 21b is a cross-sectional view of 21a.

[0044] Fig. 22 for Figure 6 22a is a three-dimensional schematic diagram, and 22b is a cross-sectional view of 22a.

[0045] Fig.23 for Fig.16 The deformed structure. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0047] For a better understanding of the present invention, the three most commonly used types of vascular sutures used in the present invention are listed below:

[0048] 1. End-to-side anastomosis

[0049] End-to-side anastomosis is widely used in clinical bypass transplantation. Generally, a longitudinal straight line incision or an elliptical incision is made on the recipient vessel, and the end face of the donor vessel is trimmed into an inclined surface with a length greater than the diameter of the recipient vessel.

[0050] 2. End-to-end anastomosis

[0051] The two sutured blood vessel ends should be as similar as possible, or they can be trimmed into a bevel to expand the anastomotic area. Alternatively, internal support can be used to obtain similar suture end surfaces.

[0052] 3. Side-to-side anastomosis

[0053] Common clinical applications of side-to-side anastomosis include arteriovenous fistula, aortopulmonary artery shunt, etc. Usually, the two blood vessels to be anastomosed are brought close together, and the side walls of the anastomotic site are clamped with a special vascular clamp to make a corresponding longitudinal incision.

[0054] The vascular anastomosis support dilator provided by the present invention includes a main support part and an extravascular connection operation part, which is divided into three types according to the different structures and materials of the main support part: an elastic plug-type support body, a metal stent-type support body, and a double-balloon support body. Specifically, the vascular anastomosis support dilator includes a support body, which is used to be at least partially placed in a blood vessel to dilate the blood vessel. A tail structure is connected to one end of the support body, and the tail structure is used to push or pull the support body or adjust the size of the support body. The support body and the tail structure constitute the main support part; the extravascular connection operation part is composed of a handheld part. Among them, the support body has a minimum diameter and a maximum diameter, and the maximum diameter of the support body is the rated diameter or the diameter supported by the support. The present invention is further illustrated by the following embodiments:

[0055] The maximum diameter of the support body is the rated diameter, and the support body is drop-shaped or olive-shaped. The support body includes a small end and a large end, the small end is the end that is placed in the blood vessel, and the large end is used to support the blood vessel. The outer diameter of the large end is the maximum diameter of the support body; the support body is made of a flexible material, and a hollow cavity with one end closed is provided inside the small end and the large end. The outer wall of the large end is also provided with a groove for an instrument to clamp the support body.

[0056] 1. Elastic plug type support.

[0057] like Figure 1 As shown, one of its preferred shapes is a teardrop shape, with one end having a large diameter and connected to the tail structure 110, and the other end having a small diameter. The support body 100 is internally designed with a hollow cavity 101 closed at one end, and the hollow cavity 101 is formed at the large end 103 and the small end 102. The hollow cavity 101 has a uniform wall thickness, and its size is 25%-30% of the maximum outer diameter D. It has good elasticity and provides sufficient radial support performance. A groove position 104 is provided on the outer surface of the large end 103 to facilitate operations such as clamping of the instrument. The center of the R fillet is gourd-shaped outward, such as Figure 2As shown, it can be regarded as a special form of a teardrop-shaped elastic plug; it can also be spherical. The material of the support body 100 and the tail structure 110 can be made of special medical silica gel, which can provide good radial support, and the flexible outer surface does not hurt the inner surface of the blood vessel, and is relatively easy to retract under the clamping of a special instrument.

[0058] like Figure 3 As shown in the cross-sectional view, the maximum outer diameter is equivalent to the blood vessel supported by the expansion, and the large end 103 can be divided into six specifications: 1.0mm, 1.5mm, 2.0mm, 3.0mm, 5.0mm, and 6.0mm; the size of the small end 102 is about 50% of the maximum diameter, and the length size is as follows Figure 2 As shown in L, there are three specifications: 2.5mm, 3.5mm, and 5mm.

[0059] The teardrop-shaped support dilator with a rated outer diameter provided in this embodiment can be used in three types of surgeries: end-to-end, end-to-side, and side-to-side, or can be used in conjunction with other types of support bodies.

[0060] Figure 4 The invention discloses an application of a teardrop-shaped elastic plug support in end-to-side anastomosis.

[0061] The blood flow is blocked at both ends of the recipient blood vessel, and an incision of about 3mm in length is cut at the predetermined suture position (this length is determined according to the end face size of the donor blood vessel, and in this case, the donor blood vessel has a diameter of about 1mm). At this time, since there is no blood flow, the blood vessel wall elastically shrinks and fits together. The teardrop-shaped elastic plug (dilator) in the first embodiment of the present invention is clamped by an instrument at the groove 104 of the supporting body 100, and the small end 102 is placed inward from the incision into the fitted blood vessel, and the large end 103 is outward to support the blood vessel to the shape required for suture; the tail structure 110 is left outside the blood vessel. When about two-thirds of the suture is completed, the diameter of the unsutured gap is about 80% of the maximum diameter of the supporting body 100, and the supporting body 100 part 100 is taken out by pulling the tail structure 110 to cooperate with the instrument to clamp the outer groove of the main body part, and then continue to suture the remaining part until the operation is completed. In this case, one dilator can be used, or two dilators can be used to support the two ends of the recipient blood vessel respectively.

[0062] Figure 5 The invention relates to an application of a teardrop-shaped elastic plug support in end-to-end anastomosis.

[0063] After the two blood vessels are sutured to block the blood flow, Figure 4The same specification of the teardrop-shaped dilator is clamped with an instrument, and its support body 100 is placed in the two ports of the blood vessels to be sutured, so as to obtain the same end surface size and shape as much as possible, and the tail structure 110 is left outside the blood vessels. When about two-thirds of the suture is completed, the diameter of the unsutured gap is about 80% of the maximum diameter of the support body 100. By pulling the tail structure 110 and cooperating with the groove 104 on the outer surface of the support body 100 clamped by the instrument, the support body 100 parts in the two blood vessels are taken out respectively; then continue to suture the remaining parts until the operation is completed.

[0064] Figure 6 The dilator is an olive-shaped device, wherein the middle portion is a large end portion 203 with a maximum diameter, and the other two ends are small ends 202 / 204 with a small diameter. One end 204 is connected to the tail structure 110, and the other end 202 is open inside. The maximum outer diameter should be equivalent to the blood vessel to be dilated and supported, such as Figure 7 As shown in the cross-sectional view, the large end 203 has six specifications: 1.0mm, 1.5mm, 2.0mm, 3.0mm, 5.0mm, and 6.0mm. The small end size is about 50% of the maximum diameter; the length should be slightly larger than the side suture incision length, such as Figure 7 As shown in the cross-sectional diagram, the size L has four specifications: 1.2mm, 2.5mm, 3.5mm, and 5.0mm. The spherical dilator with a length of 1.2mm can be regarded as a special form of the olive type. Similar to the teardrop-shaped dilator, its internal design has a closed hollow cavity 201 and a groove 205 at one end, with a uniform wall thickness and a size of 25%-35% of the maximum outer diameter, ensuring good elasticity and providing sufficient radial support performance, while being relatively easy to retract under the clamping of special instruments. The material is a special medical silicone, which can provide good radial support, and the flexible outer surface does not hurt the inner surface of the blood vessel.

[0065] Figure 8 The invention discloses an olive-shaped elastic plug support for use in side-to-side anastomosis.

[0066] The two blood vessels to be anastomosed are brought close together, the blood flow is blocked at both ends of the blood vessels, and the side walls of the anastomosis site are clamped with a vascular clamp to make a corresponding longitudinal incision. At this time, since there is no blood flow, the blood vessel wall elastically shrinks and fits together. The support body 200 is clamped with an instrument, and the open end 202 of the small end is placed into the fitted blood vessel from the two blood vessel incisions in the forward direction. The maximum diameter part of the support body 200 is roughly located in the middle of the incision, and the blood vessel is supported to the shape required for suturing. The tail structure 210 is left outside the blood vessel; when about three-quarters of the suturing is completed, the diameter of the unsutured gap is about 80% of the maximum diameter of the support body 200, and the support body 200 is taken out by pulling the tail structure 210 to cooperate with the groove 205 on the outer surface of the support body 200 clamped by the instrument; then the remaining part is sutured until the operation is completed. In this case, two olive-shaped elastic plugs can be used, or two semi-open elastic plugs can be used.

[0067] The present invention is based on Figure 6 The olive-shaped dilator shown also provides a semi-open dilator (see Fig. 9 ), the side wall of the support body 200 is provided with a semi-opening portion 301, and the opening angle of the semi-opening portion 301 is 90°-125°. There is no hollow cavity 201 inside and no groove-shaped position 205 outside. In other embodiments, the semi-opening expander can also be a teardrop shape.

[0068] Fig. 9 The olive-shaped dilator is preferably a semi-open type, and the shape is a shorter olive shape, including a tail structure 310 and a support body 300, and one side of the support body 300 is opened to form an opening 301 (such as Fig.10 a, 10a is a side view of 10b). The middle is the largest diameter, and the other two ends are smaller diameters. Its opening is on the side, not at one end. The maximum outer diameter should be comparable to the blood vessel supported by the expansion, such as Fig.10 of Fig.10 As shown in the D size in b, there are six specifications: 1.0mm, 1.5mm, 2.0mm, 3.0mm, 5.0mm, and 6.0mm; the small end size is about 50% of the maximum diameter, and the length is Fig.10 The L size shown in b has three specifications: 2.5mm, 3.5mm, and 5mm. The inner opening angle is 90°-125°. Its material is a special medical silicone, which can provide good radial support, and the flexible outer surface does not hurt the inner surface of the blood vessel. It is particularly suitable for end-to-side surgery to avoid excessive contact between the suture needle and the support body, which reduces the efficiency of the operation. It is also more conducive to the clamping of the instrument during removal; it can also be used in side-to-side surgery.

[0069] In the above embodiment, the tail structure and the support body are an integrally formed structure. The tail structure is made of the same material as the support body and is in a strip shape, and different lengths can be set according to needs.

[0070] The present invention solves two thorny problems in vascular suturing through a simple and practical design. It can be easily supported and expanded during surgery, and relatively accurately provide anastomotic end faces with similar calibers. It is simple to operate and easy to recycle. Only simple special fine-mouthed clamps or similar instruments are needed to complete placement and removal, which greatly improves suturing efficiency and reduces the risk of poor prognosis. In addition, the present invention adopts an integrated molding process, which is relatively low in cost and is very conducive to the popularization and use of prefecture-level hospitals with limited costs.

[0071] 2. Metal bracket type support body.

[0072] like Fig.11 As shown, the expander includes a metal stent-type support body and a first hand-held part. The support body 500 includes a fixed ring 501 and a sliding ring 502, and a guide wire 522 and a support part 503 are arranged between the sliding ring 502 and the fixed ring 501, and the support part 503 is arranged around the guide wire 522; the tail structure 510 includes a portion of the guide wire 522 extending out of the sliding ring 502, and a hose 510 sleeved on the portion, and pushing the hose 510 can drive the sliding ring 502 to squeeze the support part 503, and the outer diameter of the support part 503 after deformation is the maximum diameter of the support body 500.

[0073] Specifically, the support body 500 is olive-shaped, and the support portion 503 composed of three or four metal guide wires is bent along the axial direction, and adjacent support portions 503 are distributed at 90 degrees on the outer circumference of the guide wire 522. Fig.11 FIG. 5 shows a support body 500 having three support portions 503. Fig.12 A cross-sectional view of the support portion 503 is shown, which includes three support portions 503. For end-side suturing, preferably no guide wire should be provided within a range of about 150°-180° to avoid mis-suturing by the suture needle.

[0074] The size of the guide wire 522 is different according to the diameter of the blood vessel to be supported, and there are three specifications: 0.1mm, 0.2mm, and 0.5mm. The maximum outer diameter should be equivalent to the blood vessel to be supported by expansion, and there are six specifications: 1.0mm, 1.5mm, 2.0mm, 3.0mm, 5.0mm, and 6.0mm; the length is different according to the length of the incision, and there are three specifications: 3mm, 4mm, and 5mm.

[0075] The tail structure 510 passes through the support body 500. The center of the support body 500 is a guide wire 522. The wire diameter has two specifications of 0.2mm and 0.5mm according to the diameter of the blood vessel to be dilated. The proximal end is fixed to the handheld operation control part.

[0076] The support body 500 is laser cut from nickel-titanium tubing, with a complete tube ring (fixed ring 501 and sliding ring 502) left at each end; the fixed ring 501 is fixed to the central guide wire 522, preferably by laser welding. The sliding ring 502 can slide freely on the guide wire 522. A polymer hose 510 is sleeved on the guide wire 522, and one end of the hose 510 is in contact or connected with the sliding ring 502, which plays a role in controlling the partial support and contraction of the support body 500 and adjusting the expansion diameter. The distal end of the hose 510 is connected to the first handheld part.

[0077] like Fig.13 , Fig.14 As shown, the first hand-held part includes a limit rod 523 connected to the guide wire 522, a push head 521 connected to the hose 510, and an operating handle 524 matched with the limit rod 523. By rotating the operating handle 524, the operating handle 524 can drive the limit rod 523 to move upward and drive the push head 521 to move forward. The hand-held part also includes a hand-held handle 525, the limit rod 523 is fixed to the hand-held handle 525, the operating handle is fixed to the push head 521, and a limit distance is left between the hand-held handle 525 and the operating handle 524; the limit rod 523 and the hand-held handle 525 can limit the operating handle.

[0078] The first hand-held part is composed of an operating handle 524, a push head 521 and a limit rod 523, and is connected to the support body 500 through a guide wire 522. Fig.14 As shown, a certain limit distance can be set between the rotating handle and the hand-held handle. This distance is determined according to the maximum diameter of the support body 500 that needs to be expanded. For example, when the expanded diameter is 1.1mm, the limit advancement distance is 0.15mm. (Note: the above dimensions are calculated when the rated diameter of the support part is 1.0mm, and other expanded diameters are slightly different.) Under such a small advancement distance, the direct push method is difficult to control. Therefore, the design changes the direct push method to a rotation method. The half-circle rotation provides more room for control, and the limit rod 523 effectively prevents excessive advancement or pulling back, resulting in excessive support and damage to the inner wall of the blood vessel.

[0079] The guide wire 522 is welded and fixed to the limit rod 523, and bonded and fixed to the handheld handle 525. The rotary handle 524 is bonded and fixed to the push head 521 to form a whole, and moves axially along the limit rod 523. By rotating the rotary handle, the polymer hose 510 is pushed or pulled to push or pull the proximal sliding ring 502 of the main body, thereby controlling the expansion or contraction of the main body.

[0080] Preferably, the support body 500 is in a supporting state with the largest outer diameter in a natural state, that is, when the proximal ring is not subjected to the push or pull of the hose 510, and the support body 500 is contracted to the smallest diameter by pulling the hose 510 at the handheld end, so as to facilitate recovery from the blood vessel. In a natural state, that is, when the proximal ring is not subjected to the push or pull of the hose 510, the support body 500 is in a contracted state with the smallest outer diameter, and the handheld end pushes the hose 510 to expand the main body to the largest diameter, thereby playing a role in supporting the blood vessel, and the external force at the operating end is removed and the support body 500 is returned to the smallest contracted state, so as to facilitate recovery.

[0081] The metal stent-type support body 500 is particularly suitable for end-to-side anastomosis surgery due to its controllable contraction and expansion, and can be used in both end-to-end and side-to-side suturing.

[0082] Fig.15 It is the application of metal stent-type support in end-to-side anastomosis.

[0083] The blood flow is blocked at both ends of the recipient blood vessel, and an incision of about 3 mm in length is cut at the predetermined suture position (this length is determined according to the end face size of the donor blood vessel, in this example, the donor blood vessel is about 1 mm in diameter). At this time, since there is no blood flow, the blood vessel wall elastically shrinks and fits together, and the metal stent-type support body 500 of the present invention is placed into the recipient blood vessel incision with the distal end as the advancing direction. At this time, the support body 500 is in a contracted state. The handheld operating section handle 525 is rotated about 180° in the direction of the arrow, driving the connected polymer hose 510 to move about 0.15 mm toward the distal end along the guide wire 522, while the position of the guide wire 522 remains unchanged. Since the distal ring of the support body 500 is fixed on the guide wire 522, its position remains unchanged. The sliding ring 502 of the support body 500 is pushed forward by the hose 510, compressing the support part 503 to slowly release it into an olive shape, supporting the blood vessel. Adjust the position and angle of the support body 500 in the incision so that the support body 500 is located in the middle of the incision, and the area of ​​about 150° on one side of the support body 500 where the support part 503 is not provided is as close to the donor blood vessel as possible to reduce the accidental contact between the suture needle and the support guide wire during suturing. After starting to sew, wait until about a quarter of the suturing is completed, and the diameter of the unsutured gap is about 65% of the maximum diameter of the support body 500. Prepare to remove the support body 500. First, rotate it 180° in the opposite direction of the knob arrow. Similarly, the guide wire of the support body 500 changes from the olive shape in the released state to the contracted state under the action of the connected hose 510. Slowly pull the hose 510 to remove the compressed support body; then continue to sew the remaining part until the operation is completed.

[0084] 3. Double balloon support body.

[0085] like Fig.16 , Fig.17As shown, the tail structure 610 is a microcatheter with one end closed, a filling hole 602 is provided on the microcatheter, and the supporting body 600 is a balloon 601 fixed on the microcatheter, and the filling hole 602 is located in the balloon 601; liquid or gas is injected into the microcatheter, and the liquid or gas can enter the balloon 601 through the filling hole 602 to expand the balloon 601.

[0086] The dilator further includes a second handheld part, which includes a filling cavity 624 connected to the microcatheter, a sealing piston 622 placed in the filling cavity 624, and an inflation knob 623 rotatably connected to the filling cavity 624; rotating the inflation knob 623 can push the sealing piston 622 to move forward or backward in a chamber 625 in the filling cavity 624. The filling cavity 624 includes a sealing switch 621, and rotating the sealing switch 621 can make the liquid or gas in the balloon in a sealed state, so that the liquid or gas in the chamber remains in a filled state.

[0087] In this embodiment, the support body 600 is composed of two balloons 601 of the same size. The distance between the two balloons 601 is 3mm, 4mm, and 6mm according to the length of the incision. The maximum expanded outer diameter of the balloon 601 is divided into six specifications of 1.0mm, 1.5mm, 2.0mm, 3.0mm, 5.0, and 6.0mm according to the diameter of the blood vessel to be supported; the length of a single balloon 601 is divided into four specifications of 1.0, 2.0, 3.0, and 5.0.

[0088] The main body of the double-balloon 601 support body is centered on a microcatheter, and the diameter of the wire is 0.4mm, 0.6mm, and 1.0mm according to the diameter of the blood vessel to be dilated. The distal end is fixedly connected to the support balloon 601 and is provided with a filling hole 602; the proximal end is fixed to the handheld operation control part.

[0089] like Fig.18 As shown, the dilator further includes a second handheld part, which includes a filling cavity 624 connected to the microcatheter, a sealing piston 622 placed in the filling cavity 624, and an inflation knob 623 rotatably connected to the filling cavity 624; rotating the inflation knob 623 can push the sealing piston 622 to move forward or backward in a chamber 625 in the filling cavity 624. The filling cavity 624 includes a sealing switch 621, and rotating the sealing switch 621 can change the size of the chamber 625 in the filling cavity 624, so that the chamber 625 is filled with liquid or gas.

[0090] The balloon 601 is connected to the support body through a microcatheter. The balloon 601 is expanded or contracted by rotating the inflation knob 623 to compress the internal liquid or gas, thereby avoiding the use of a syringe for direct-push filling, where the force is difficult to control. The knob can be limited to prevent the balloon 601 from rupturing due to excessive liquid or gas being pushed. Fig.19 It is a side profile view of the double balloon 601 type.

[0091] Preferred solution 1 is to use liquid to fill and expand the balloon 601, thereby playing a supporting and expanding role; preferred solution 2 is to use gas compression to fill and expand the balloon 601, thereby playing a supporting and expanding role.

[0092] The double balloon 601 support is suitable for supporting blood vessels during suturing when one end is not clamped and the length of the blood vessel to be operated needs to be greater than 9 mm, because it uses two balloons 601 of the same size to provide the best support effect and is more conducive to suturing.

[0093] Fig. 20 The invention discloses an application of a double-balloon 601-type support in end-to-side anastomosis.

[0094] The blood flow is blocked at one end of the recipient blood vessel, and the other end is open or semi-clamped, and an incision of about 3 mm in length is cut at the predetermined suture site (this length is determined by the end face size of the donor blood vessel, and in this example, the donor blood vessel is about 1 mm in diameter). At this time, since there is no blood flow, the blood vessel wall elastically shrinks and fits together, and the double-balloon 601 stent-type support body 600 in Example 4 of the present invention is placed into the recipient blood vessel incision from the open end with the distal end as the forward direction. At this time, the support body 600 is in an unexpanded state; the handheld operating section handle 106 is rotated about 180°-360° in the direction of the arrow, that is, half a circle to one circle. This example adopts the preferred solution 1 with liquid as the filling material, and the internal liquid enters the balloon 601 under the compression of the sealing piston 622, so that the balloon 601 slowly expands to the maximum diameter size shape to support the blood vessel.

[0095] The operating end rotary handle has a limit position structure to avoid the risk of balloon 601 rupture or over-support due to over-filling; after the balloon 601 is filled, turn the sealing switch 621 to seal the gas or liquid inside the balloon 601 to maintain the filled state; adjust the position of the support body 600 in the incision so that the support body 600 is located in the middle of the incision and start suturing; after all the suturing is completed, prepare to remove the support body, first rotate the knob 180°-360° in the opposite direction of the arrow, and the liquid in the balloon 601 will slowly flow back into the cavity of the handheld operating section along the microcatheter under the action of negative pressure, and the balloon 601 will be in a compressed state, and slowly pull the microcatheter to remove the support body 600; then continue with other parts of the operation.

[0096] Furthermore, the present invention also provides several deformation structures of the above technical solution; the deformation structures can ensure that the use of the expander will not block blood circulation.

[0097] like Fig.21 In Fig.21 a. Fig.21 As shown in b, Figure 1 The large end 103 and the small end 102 of the support body are penetrated by a hollow cavity 101c, and the tail structure 110 is offset and arranged on the support body at a certain angle d° with the support body. Figure 4 and Figure 5 As shown, the expander in this embodiment is placed in a blood vessel, and blood can flow through the hollow cavity 101c without blocking the blood vessel. Figure 1 The embodiments shown are identical.

[0098] Similarly, if Fig. 22 In Fig. 22 a. Fig. 22 As shown in b, Figure 6 The deformed structure of the expander shown. Fig.21 The embodiment shown is the same, wherein the cavity 201c runs through the large end 203 and the small end 202 / 204, and blood can flow through the hollow cavity 201c without blocking the blood vessels.

[0099] Fig.23 for Fig.16 The deformed structure of the expander can also allow blood to flow through the hollow cavity 605. Fig.16 In the embodiment shown, the tail structure is a microcatheter, and in this embodiment, the microcatheter is a part of the tail structure, and the tail structure also includes a hollow cavity 606, and the hollow cavity 606 is arranged in the upper and lower layers with the microcatheter 604. The microcatheter 604 includes a ventilation cavity 603 connected to the filling hole 602, and a hollow cavity 605 with two ends opened is provided in the hollow cavity 606. In this embodiment, Fig.23 The structure shown can be a separate structure or an integrated structure. It should be understood that the structure includes a hollow cavity 605 that can be used for blood circulation.

[0100] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A vascular anastomosis support dilator, characterized in that: The supporting body comprises a flexible and foldable structure, has a certain circumferential supporting force, and is used to be at least partially placed in a blood vessel to dilate the blood vessel; One end of the support body is connected to a tail structure, and the tail structure is used to push and pull the support body; The support body has a minimum diameter and a maximum diameter, and the maximum diameter of the support body is the rated diameter; The support body is an elastic plug-type support body; The support body comprises a small end and a large end, the outer diameter of the large end is the maximum diameter of the support body; the support body is made of a flexible material and has sufficient radial support strength, and a hollow cavity is provided inside the small end and the large end, wherein one end of the hollow cavity is closed, and the tail structure is connected to the closed end of the support body, or the hollow cavity runs through the support body, and the tail structure is connected to the support body at a certain angle; The support body is in a teardrop shape, olive shape, gourd shape or ball shape, and the outer wall of the large end is also provided with a groove for a device to clamp the support body; The side wall of the support body is provided with a semi-opening portion, and the opening angle of the semi-opening portion is 90°-125°.

2. A vascular anastomosis support dilator, characterized in that: The supporting body comprises a flexible and foldable structure, has a certain circumferential supporting force, and is used to be at least partially placed in a blood vessel to dilate the blood vessel; One end of the support body is connected to a tail structure, and the tail structure is used to push or pull the support body or adjust the support size of the support body; The support body has a minimum diameter and a maximum diameter, and the maximum diameter of the support body is the diameter supported by the support; The supporting body is a metal bracket type supporting body; The support body includes a fixed ring and a sliding ring, a guide wire and a support portion are arranged between the sliding ring and the fixed ring, and the support portion is arranged around the guide wire; the tail structure includes a portion of the guide wire extending out of the sliding ring, and a hose sleeved on the portion, and pushing the hose can drive the sliding ring to squeeze the support portion, and the outer diameter of the support portion changes, and its value can be adjusted according to actual needs, and the maximum value is the maximum value set by the support body; The vascular anastomosis support dilator further comprises a first hand-held part, which comprises a limit rod connected to the guide wire, a push head connected to the hose, and an operating handle matched with the limit rod; by rotating the operating handle, the operating handle can move on the limit rod and drive the push head to move forward; The hand-held part also includes a hand-held handle, the limit rod is fixed to the hand-held handle, the operating knob is fixed to the pushing head, and a limit distance is left between the hand-held handle and the operating knob; the limit rod and the hand-held handle can limit the support body so that its diameter does not exceed a set maximum setting value.

3. A vascular anastomosis support dilator, characterized in that: The supporting body comprises a flexible and foldable structure, has a certain circumferential supporting force, and is used to be at least partially placed in a blood vessel to dilate the blood vessel; One end of the support body is connected to a tail structure, and the tail structure is used to push or pull the support body or adjust the support size of the support body; The support body has a minimum diameter and a maximum diameter, and the maximum diameter of the support body is the diameter supported by the support; The support body is a double-balloon support body; The tail structure comprises a microcatheter with one end closed, a filling hole is provided on the microcatheter, the supporting body is a balloon fixed on the microcatheter, and the filling hole is located in the balloon; liquid or gas is injected into the microcatheter, and the liquid or gas can enter the balloon through the filling hole to expand the balloon; The vascular anastomosis support dilator also includes a second handheld part, which includes a filling cavity connected to the microcatheter, a sealing piston placed in the filling cavity, and an inflation knob rotatably connected to the filling cavity; rotating the inflation knob can push the sealing piston to move forward or backward in the cavity of the filling cavity, thereby playing a role in adjusting the expansion size of the balloon, and the maximum size does not exceed the set maximum size; The tail structure also includes a hollow cavity, which is arranged in upper and lower layers with the microcatheter. The microcatheter includes a ventilation cavity connected to the filling hole, and a hollow cavity with openings at both ends is arranged in the hollow cavity.

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