Luminal anastomosis support dilator

Abstract

The luminal anastomosis support dilator includes a support body (1) made of an elastic or shape-memory material for being at least partially disposed within a lumen (101) to expand a luminal wall (100), and a connecting rod (2) connected to the support body (1). During an anastomosis operation, a surgeon uses an instrument to clamp and support the support body (1), disposes the support body (1) within the lumen (101), and after releasing the instrument, the support body (1) made of an elastic or shape-memory material rebounds to properly support the lumen (101). Therefore, the luminal anastomosis support dilator can rapidly expand the lumen (101), assist surgical operations, reduce damage to the luminal wall (100), and improve the efficiency and success rate of anastomosis of the lumen (101).

Description

[Technical field]

[0001] This application claims priority to Chinese patent application CN2020215220787, filed on July 28, 2020, and Chinese patent application CN2020107358677, filed on July 28, 2020. This application cites the above-mentioned Chinese patent application in full.

[0002] The present invention relates to the field of auxiliary devices for luminal anastomosis in medical surgery, and in particular to luminal anastomosis support dilators. [Background technology]

[0003] Luminal anastomosis is a basic surgical form in clinical practice, including luminal injury repair, luminal transplantation, luminal overlap, luminal suture and repair, etc., and can be used in the fields of blood vessels, lymphatic vessels, vas deferens, bile duct, trachea, bronchi, etc., and is an effective treatment method that is often used to reconstruct luminal function. It is widely used in various surgical procedures, such as skin flap transplantation, replantation of amputated limbs, accidental vascular injury, organ transplantation, arteriovenous fistula anastomosis, lymphatic anastomosis, vas deferens anastomosis, bile duct anastomosis, and tracheal anastomosis. With the continuous development of microsurgical instruments, microsutures, and operating microscopes, manual small (micro)luminal anastomosis techniques are gradually maturing, but the caliber of the luminal cavity that can be anastomosed is becoming thinner and thinner. However, even for experienced surgeons, it is not easy to complete a perfect luminal anastomosis, especially the above-mentioned microluminal anastomosis.

[0004] First, it is necessary that the anastomosis of the two opposing luminal stumps be accurately aligned, without any twisting, stenosis, eversion or inversion, i.e., when the two stumps are joined, the intima and intima, and the muscular layer and the muscular layer must match. This minimizes the scars of healing and improves the patency rate. Therefore, the calibers of the two stumps must be as equal as possible, and can be expanded with a dilator of the same diameter or a special forceps for expanding the lumen, but paradoxically, for some small lumens, non-invasive techniques are very important, and clamping the luminal intima and muscular layer to be anastomosed with forceps is not allowed, otherwise the patency rate will decrease. To achieve the alignment of the anastomosis, a flexible or non-invasive internal support is required.

[0005] Secondly, take blood vessels as an example. As a kind of lumen, blood vessels need to be exposed and blood flow controlled in order to provide a bloodless view to vascular anastomosis and complete the surgical operation. According to the size and anatomical structure of the blood vessel, various kinds of non-invasive vascular clamps, soft and elastic colloidal tape, or balloon catheters are selected to block the blood flow through the vascular lumen. After blocking the blood flow, the vascular wall will elastically contract and collapse, the lumen will become smaller and even blocked, and the anterior and posterior walls will stick together and be difficult to separate, which will be a major obstacle to suturing and will easily pierce the opposite vascular wall during suturing. The operation is difficult, inefficient and time-consuming, which will increase the time to block the blood flow and increase the risk. Some doctors make their own stuffing to assist in suturing, which can solve some problems, but it is still inefficient, has a single function and is not standardized. Summary of the Invention [Problem to be solved by the invention]

[0006] The technical problem to be solved by the present invention is to provide a luminal anastomosis support dilator to overcome the problems of luminal suturing in the prior art. [Means for solving the problem]

[0007] The present invention solves the above technical problems through the following technical solutions: A luminal anastomosis support expander, comprising: a support body made of an elastic material or a shape memory material for being placed at least partially within a lumen to expand a luminal wall; and a connecting rod connected to the support body.

[0008] In this method, when performing anastomosis, the doctor uses an instrument (such as microforceps, needle holder, etc.) to clamp the support body, place the support body in the lumen, and release the instrument. After that, the support body made of elastic material or shape memory material rebounds and can support the lumen moderately, which is convenient for the doctor to perform the subsequent anastomosis operation. When a part of the anastomosis is completed, the connecting rod can be used to take out the support body from the unsewn gap, and the subsequent suturing can be continued. Therefore, the luminal anastomosis support expander can rapidly expand the lumen, assist the surgical treatment, reduce the damage to the luminal wall, and improve the efficiency and success rate of luminal anastomosis.

[0009] The elastic material may be rubber (including, but not limited to, polyisoprene, styrene butadiene rubber, butadiene rubber, isoprene rubber, neoprene, butyl rubber, etc.), silicone rubber (including, but not limited to, methyl silicone rubber, methyl vinyl silicone rubber, methyl phenyl silicone rubber, methyl vinyl phenyl silicone rubber, nitrile silicone rubber, fluorosilicone rubber, etc.), polyurea, latex, etc. The shape memory material may include a shape memory alloy material and a shape memory polymer material. The shape memory alloy material includes, but is not limited to, nickel-titanium alloy, titanium-nickel-copper, titanium-nickel-iron, titanium-nickel-chromium, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, copper-zinc-aluminum alloy, iron alloy, iron-silicon-carbon alloy, iron-nickel alloy, iron-manganese alloy, iron-manganese-carbon alloy, and iron-manganese-silicon alloy. Shape memory polymeric materials include, but are not limited to, polyvinyl alcohol, polycaprolactone, polylactic acid, polydioxanone, polyisoprene, cross-linked polyethylene, polynorbornene, styrene-butadiene copolymers, polyamides, polyethylene glycol terephthalate, polyacrylic acid, polymethacrylic acid, polyacrylamide, poly N-isopropylacrylamide, epoxy polymers, polydimethylsiloxane, polyaniline, polyurethane, poly-L-lysine amino acid, poly-L-glutamic acid, collagen, alginic acid, hyaluronic acid, chitosan, starch, cellulose, and copolymers of the above materials.

[0010] Preferably, the connecting rod is provided with a plurality of the support bodies.

[0011] In this solution, multiple support bodies can be applied to multiple lumens, and the multiple support bodies may have multiple different outer diameters, so that one luminal anastomosis support dilator can be applied to lumens with different diameters.

[0012] Preferably, one support body is provided at each end of the connecting rod.

[0013] In this method, two support bodies may be disposed in the two lumens to be anastomosed, respectively, so that one luminal anastomosis support expander can be used to achieve anastomosis of the two lumens, and the two lumens can be fixed relative to each other during suturing, facilitating the suturing operation and reducing the number of instruments required for surgery.

[0014] Preferably, the supporting body is a rotating body.

[0015] In this solution, since most of the cross section of the lumen is basically circular, the support body being a rotating body can better fit the lumen and facilitate the anastomosis operation.

[0016] Preferably, the support main body includes a main body portion having a tapered portion at least at one end thereof, the outer diameter of the tapered portion decreasing outwardly from the main body portion, and the maximum outer diameter of the main body portion being greater than the maximum outer diameter of the tapered portion.

[0017] And / or, the angle between the axes of the two support bodies at both ends of the connecting rod is 0 to 180°.

[0018] In this solution, the main body has a large outer diameter and can be used to support the lumen, and the tapered part can be in the shape of a cone, a truncated cone, etc., and the tapered part can be easily inserted into the lumen, making it easy for the entire support main body to enter the lumen. The support main body may have only one tapered part, or one tapered part may be provided at each end of the main body so that the support main body can be inserted into the lumen from two directions. That is, the support main body may have a shape with a large outer diameter at the center and small outer diameters at both ends, or a shape with a large outer diameter at one end and small outer diameter at the other end. Specifically, the support main body may have a similar shape such as a sphere, a hemisphere, an ellipsoid, a semi-ellipsoid, a cone, a truncated cone, a teardrop, an olive, or a gourd.

[0019] Since the relative positions of the openings of the two lumens to be sutured may be different, the axes of the two support bodies at both ends of the connecting rod may be set to be collinear, parallel or at other angles to meet the requirements of luminal anastomosis in different situations.

[0020] Preferably, the maximum outer diameters of the main body portions of the support bodies are the same or different.

[0021] In this solution, the main body portions of the two support bodies on the same connecting rod may have the same maximum outer diameter to suit an anastomosis between lumens with the same outer diameter, or the main body portions of the two support bodies may have different maximum outer diameters to suit anastomosis between lumens with different diameters.

[0022] Preferably, the luminal anastomosis support dilator further includes an operating rod, the end of which is connected to the middle part of the connecting rod.

[0023] In this solution, the operating rod can be used to push or pull the supporting body to adjust the position and angle of the supporting body, and the user can use the operating rod to remove the supporting body from the lumen.

[0024] Preferably, the connecting rod can be bent so that the relative positions between different supporting bodies can be adjusted.

[0025] In this solution, the connecting rod can be bent, so that when the supporting body is taken out, the position and angle of the supporting body can be automatically adjusted to avoid damaging the lumen. Furthermore, the connecting rod can be bent at any angle, which can be applied to different anastomosis operations. The connecting rod can be a straight rod, and the connecting rod can be preformed into a curved tube according to the requirements of a specific anastomosis operation. The connecting rod can use the same material as the supporting body, and furthermore, the connecting rod can be integrally molded with the supporting body. The connecting rod and the supporting body can be made of different materials, and those skilled in the art can select the materials according to the actual situation, and furthermore, the connecting rod can be integrally molded with the supporting body, and is not limited to integrally molded.

[0026] Preferably, the support main body has a hollow cavity, and one end of the support main body has a through hole communicating with the hollow cavity, or both ends of the support main body have through holes communicating with the hollow cavity.

[0027] In this solution, the support body can have a hollow cavity so that the support body can be easily compressed. The support body is provided with a through hole to facilitate the formation of the hollow cavity. When the support body has through holes at both ends, the hollow cavity is penetrated, so that the fluid in the lumen can continue to flow through the hollow cavity during the anastomosis operation, and the problem of the collapse of the lumen wall due to the obstruction of the flow of the fluid in the lumen during the suturing of the lumen can be solved. There may be one or more through holes at one or both ends of the support body. It can be understood that the support body does not need to have a hollow cavity so that the support body has a larger supporting force.

[0028] Preferably, the connecting rod is provided with a fluid passage, the fluid passage communicating with the hollow cavity of the support body.

[0029] In this solution, the fluid in the lumen can flow in the hollow cavity, and the fluid in the hollow cavity can flow to a preset position through the fluid passage, so that the fluid passage can be set according to the actual situation, which facilitates the anastomosis operation. Specifically, one end of the hollow cavity can be connected to the fluid passage, so that the fluid flowing into the hollow cavity can be completely discharged from the fluid passage, or the fluid in the hollow cavity can be completely injected through the fluid passage. In addition, when the connecting rod is provided with multiple support bodies, the hollow cavities of each support body can be connected through the fluid passage, so that different support bodies are placed in different lumens during the suturing operation, and the fluid in one lumen can flow into the other lumen through the hollow cavity and the fluid passage, so that different lumens can be connected during the suturing operation.

[0030] The positive and progressive effects of the present invention are: the luminal anastomosis support expander can be applied to luminal anastomosis surgery, such as anastomosis of luminal blood vessels, lymphatic vessels, vas deferens, bile duct, trachea, bronchus, etc. The doctor uses an instrument (micro forceps, needle holder, etc.) to clamp the support body, place the support body in the lumen, and after releasing the instrument, the support body made of elastic material rebounds and can properly support the lumen, which is convenient for the doctor to perform the subsequent anastomosis operation. Since the support body has a hollow cavity penetrating it, the fluid in the lumen can continue to flow through the hollow cavity during the anastomosis surgery, which can solve the problem of the collapse of the lumen wall due to the obstruction of the flow of fluid in the lumen affecting the suture during the luminal suture. When a part of the suture is completed, the support body can be taken out from the unsewn gap using a connecting rod, and the subsequent suture can be completed. Therefore, the luminal anastomosis support dilator can rapidly expand the lumen, maintain the expanded state during luminal anastomosis, assist surgical operations, reduce damage to the luminal wall, and improve the efficiency and success rate of anastomosis. [Brief description of the drawings]

[0031] [Figure 1] FIG. 2 is a schematic diagram of the structure of the luminal anastomosis support expander of the first embodiment of the present invention. [Diagram 2]FIG. 2 is a schematic diagram of the internal structure of the luminal anastomosis support expander according to the first embodiment of the present invention. [Diagram 3] FIG. 2 is a schematic diagram showing the luminal anastomosis support expander of the first embodiment of the present invention when used in end-to-end anastomosis. [Figure 4] FIG. 2 is a schematic diagram showing the luminal anastomosis support dilator of the first embodiment of the present invention being used in end-to-side anastomosis. [Diagram 5] FIG. 2 is a schematic diagram showing the luminal anastomosis support expander of the first embodiment of the present invention being used in side-to-side anastomosis. [Figure 6] FIG. 2 is a schematic diagram of the structure of a luminal anastomosis support expander according to a second embodiment of the present invention. [Figure 7] FIG. 2 is a schematic diagram showing the luminal anastomosis support expander of the second embodiment of the present invention when used in end-to-end anastomosis. [Figure 8] FIG. 7 is a schematic diagram of one modified structure of the luminal anastomosis support dilator of FIG. 6. [Figure 9] FIG. 9 is a schematic diagram of one modified structure of the luminal anastomosis support dilator of FIG. 8. [Figure 10] 7 is a schematic diagram of another modified structure of the luminal anastomosis support dilator of FIG. 6. FIG. [Figure 11] FIG. 11 is a schematic diagram of the luminal anastomosis support dilator of FIG. 10 when used in an end-to-end anastomosis procedure. [Figure 12] FIG. 13 is a schematic diagram showing the luminal anastomosis support dilator of Example 3 of the present invention being used in end-to-side anastomosis. [Figure 13] FIG. 13 is a schematic diagram of one modified structure of the luminal anastomosis support dilator of FIG. 12 when used in end-to-side anastomosis. [Figure 14] FIG. 14 is a schematic diagram of another modified structure of the luminal anastomosis support dilator of FIG. 13 when used in end-to-side anastomosis. [Figure 15] FIG. 15 is a schematic diagram of one variation of the luminal anastomosis support dilator of FIG. 14. [Figure 16] FIG. 16 is a schematic diagram of the luminal anastomosis support dilator of FIG. 15 when used in end-to-side anastomosis. [Figure 17] FIG. 13 is a schematic diagram showing the luminal anastomosis support expander of Example 4 of the present invention when used in side-to-side anastomosis. [Figure 18] FIG. 18 is a schematic diagram of one modified structure of the luminal anastomosis support dilator of FIG. 17 when used in a side-to-side anastomosis procedure. [Figure 19] FIG. 18 is a schematic diagram of another modified structure of the luminal anastomosis support dilator of FIG. 17 when used in a side-to-side anastomosis procedure. [Figure 20] FIG. 20 is a schematic diagram of one variation of the luminal anastomosis support dilator of FIG. 19. [Figure 21] FIG. 21 is a schematic diagram of the luminal anastomosis support dilator of FIG. 20 when used in a side-to-side anastomosis procedure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] The present invention will be further described below with reference to examples, but the present invention is not limited to the scope of the examples.

[0033] To better understand the present invention, the three most common types of luminal suturing procedures to which the present invention is applicable are listed below.

[0034] 1. End-to-side anastomosis End-to-side anastomosis is widely used in clinical bypass grafting, and generally, the recipient lumen is created with a longitudinal straight or elliptical incision, and the end faces of the donor lumen are trimmed into bevels such that the length is greater than the diameter of the recipient lumen.

[0035] 2. End-to-end anastomosis The end faces of the two suture lumens 101 should be as similar as possible, or can be trimmed to a bevel to increase the area of ​​the anastomotic opening, or an internal support method can be used to obtain similar suture end faces.

[0036] 3. Lateral anastomosis In a side-to-side anastomosis, the two lumens to be anastomosed are typically approximated, specially designed luminal forceps are used to clamp the side walls of the anastomosis site, and a corresponding longitudinal incision is made. EXAMPLES

[0037] Example 1 As shown in Fig. 1 to Fig. 5, the luminal anastomosis support expander of the first embodiment of the present invention includes a support body 1 and a connecting rod 2, the support body 1 is made of an elastic material or a shape memory material, can self-expand to its original shape even after deformation, i.e., can provide good radial support, has a soft outer surface that does not damage the inner surface of the lumen, and can rebound relatively easily under the clamp of a special instrument. The support body 1 is used to be at least partially disposed in the lumen 101 to expand the luminal wall 100, and the support body 1 is provided with a hollow cavity 11 passing therethrough. The connecting rod 2 is connected to the support body 1.

[0038] The elastic material may be rubber (including, but not limited to, polyisoprene, styrene butadiene rubber, butadiene rubber, isoprene rubber, neoprene, butyl rubber, etc.), silicone rubber (including, but not limited to, methyl silicone rubber, methyl vinyl silicone rubber, methyl phenyl silicone rubber, methyl vinyl phenyl silicone rubber, nitrile silicone rubber, fluorosilicone rubber, etc.), polyurea, latex, etc. The shape memory material may include a shape memory alloy material and a shape memory polymer material. The shape memory alloy material includes, but is not limited to, nickel-titanium alloy, titanium-nickel-copper, titanium-nickel-iron, titanium-nickel-chromium, copper-nickel alloy, copper-aluminum alloy, copper-zinc alloy, copper-zinc-aluminum alloy, iron alloy, iron-silicon-carbon alloy, iron-nickel alloy, iron-manganese alloy, iron-manganese-carbon alloy, and iron-manganese-silicon alloy. Shape memory polymeric materials include, but are not limited to, polyvinyl alcohol, polycaprolactone, polylactic acid, polydioxanone, polyisoprene, cross-linked polyethylene, polynorbornene, styrene-butadiene copolymers, polyamides, polyethylene glycol terephthalate, polyacrylic acid, polymethacrylic acid, polyacrylamide, poly N-isopropylacrylamide, epoxy polymers, polydimethylsiloxane, polyaniline, polyurethane, poly-L-lysine amino acid, poly-L-glutamic acid, collagen, alginic acid, hyaluronic acid, chitosan, starch, cellulose, and copolymers of the above materials.

[0039] When performing an anastomosis operation, the doctor can use an instrument (such as microforceps, needle holder, etc.) to pinch the support body 1 and place the support body 1 in the lumen 101. After releasing the instrument, the support body 1 made of elastic material or shape memory material can rebound and provide sufficient radial support to support the vascular wall 100, which is convenient for the doctor to perform the subsequent anastomosis operation. After a part of the suturing is completed, the connecting rod 2 can be used to take out the support body 1 from the unsuturing gap and continue the subsequent suturing. Therefore, the lumen 101 anastomosis support expander can rapidly expand the lumen 101, assist the surgical operation, reduce the damage to the vascular wall 100, and improve the efficiency and success rate of luminal anastomosis.

[0040] 1 and 2, the supporting body 1 may have a hollow cavity 11, and one or both ends of the supporting body 1 may be provided with one or more through holes 14 communicating with the hollow cavities 11. In this embodiment, both ends of the supporting body 1 are provided with through holes 14 communicating with the hollow cavities 11. Therefore, in the process of anastomosis surgery, the fluid in the lumen 101 can continue to flow through the hollow cavity 11, and the problem of the collapse of the wall of the lumen 101 due to the interruption of the flow of fluid in the lumen 101 during the suturing process of the lumen 101 affecting the suturing can be solved.

[0041] In some other embodiments, the support body 1 may not have a hollow cavity, ie, the support body 1 is solid, so that the support body 1 has a large supporting capacity.

[0042] Since the cross section of the lumen is approximately circular, the supporting body 1 is preferably a body of revolution, so that the supporting body 1 can better fit the lumen 101 to facilitate the anastomosis procedure.

[0043] The support main body 1 includes a main body portion 13, and at least one end of the main body portion 13 is provided with a tapered portion 12, the outer diameter of the tapered portion 12 decreasing from the main body portion 13 toward the outside, and the maximum outer diameter of the main body portion 13 is larger than the maximum outer diameter of the tapered portion 12. The main body portion 13 has a large outer diameter and can be used to support the lumen 101, and the tapered portion 12 may be in the shape of a cone, a truncated cone, or the like, and the tapered portion 12 can be easily inserted into the lumen, making it easy for the entire support main body 1 to enter the lumen 101. The support main body 1 may be provided with only one tapered portion 12, or one tapered portion 12 may be provided at each end of the main body portion 13 so that the support main body 1 can be inserted into the lumen from two directions. That is, the support main body 1 may have a shape in which the outer diameter is large at the center and small at both ends, or may have a shape in which the outer diameter is large at one end and small at the other end. Specifically, the support main body 1 may be a similar shape such as a sphere, a hemisphere, an ellipsoid, a semi-ellipsoid, a cone, a truncated cone, a water drop, an olive, or a gourd.

[0044] Specifically, in this embodiment, the support body 1 is teardrop-shaped, and the pointed end of the support body 1 forms a tapered portion 12, which can be used to insert the support body 1 into the lumen 101 relatively easily.

[0045] As shown in Fig. 3, two luminal anastomosis support expanders of this embodiment can be used to perform end-to-end anastomosis, and two luminal anastomosis support expanders are used to insert one support main body 1 into one lumen 101 from the end opening of the lumen 101 to support the tubular wall 100, and the two support main bodies 1 have the same maximum outer diameter. The connecting rod 2 is located outside the lumen 101 and is used to adjust the position of the support main body 1 or remove the support main body 1. The ends of the two lumens 101 are placed on opposite sides to each other for suturing, and when about 2 / 3 of the suturing is completed, the support main body 1 is clamped with an instrument and removed from the lumen 101, and the remaining part is continued to be suturing until the operation is completed.

[0046] As shown in FIG. 4, two luminal anastomosis support expanders of this embodiment may be used to perform end-to-side anastomosis, and two luminal anastomosis support expanders are used to insert the support body 1 of one luminal anastomosis support expander into the end opening of one lumen 101 to support the luminal wall 100 (the luminal anastomosis support expander is not shown), and the support body 1 of the other luminal anastomosis support expander is inserted into the side opening of the other lumen 101 to support the luminal wall 100, and finally, the end opening of one lumen 101 is sutured with the side opening of the other lumen 101. During the anastomosis operation process, the fluid in the lumen 101 can continue to flow through the hollow cavity 11. For the specific suturing process, the suturing process of the end-to-end anastomosis described above can be referred to, and will not be repeated here.

[0047] In addition, as shown in Fig. 5, two luminal anastomosis support expanders of this embodiment may be used to perform side-to-side anastomosis, and details may refer to Fig. 5. Using the two luminal anastomosis support expanders, one support body 1 is inserted into one lumen 101 from the side opening of the lumen 101, respectively, to perform side-to-side anastomosis of the two lumens 101. For the specific suturing process, reference may be made to the suturing process of the end-to-end anastomosis and end-to-side anastomosis described above, and the process will not be repeated here.

[0048] A connecting rod 2 may be provided with a plurality of support bodies 1, so that one luminal anastomosis support expander can be used to perform anastomosis between two lumens 101, and the main body parts 13 of the plurality of support bodies 1 may have a plurality of different outer diameters, so that one luminal anastomosis support expander can be applied to lumens 101 of different diameters. In this embodiment, one support body 1 is provided at each end of the connecting rod 2, and the two support bodies 1 may be disposed in the two lumens 101 to be anastomosed, so that one luminal anastomosis support expander can be used to achieve anastomosis of the two lumens 101, and the two lumens 101 are fixed relative to each other during suturing, which facilitates the suturing operation and reduces the number of instruments required for surgery.

[0049] Two support bodies 1 on the same connecting rod 2 may have the same maximum outer diameter, so as to be suitable for anastomosis between lumens 101 of the same diameter. In addition, the main body portions 13 of the two support bodies 1 may have different maximum outer diameters, so as to be suitable for anastomosis between lumens 101 of different diameters. In some embodiments, one or more support bodies 1 may be provided in the middle of the connecting rod 2 to meet the requirements of different lumen anastomosis operations.

[0050] Since the openings of the two lumens to be sutured may have different relative positions, the included angle between the axes of the two supporting bodies 1 at both ends of the connecting rod 2 may be 0-180°, and the axes of the two supporting bodies 1 may be set to be collinear, parallel, or at other angles to meet the requirements of different luminal anastomosis operations.

[0051] The connecting rod 2 can be bent so as to adjust the relative position between different supporting bodies 1 on the connecting rod 2, and the connecting rod 2 can be bent at any angle so as to avoid damaging the lumen 101 when the supporting body 1 is taken out, and to be applicable to different anastomosis operations. For the requirements of a specific anastomosis operation, the connecting rod 2 can be preformed into a curved tube, for example, in this embodiment, the included angle between the axis of the connecting rod 2 and the supporting body 1 is 45°. Preferably, the connecting rod 2 can be made of elastic material or shape memory material, and even the connecting rod 2 can be integrally molded with the supporting body 1, and the connecting rod 2 can be made of the same material as the supporting body 1, and has the shape of a strip or column, and can have various lengths according to requirements. The connecting rod 2 can be adaptively deformed to realize the shape of the lumen 101, and at the same time, can maintain a certain angle for the convenience of controlling the position and angle of the supporting body 1.

[0052] The luminal anastomosis support dilator of this embodiment solves the difficult problems existing in luminal suture by a simple and practical design, and can conveniently support and dilate in the operation process, provide anastomosis end surface of the same caliber more accurately, and the operation is simple and easy to retrieve. The placement and removal can be done by simple and special micro forceps, needle holder or similar instruments, which greatly improves the suturing efficiency and success rate and reduces the risk of poor prognosis. Moreover, the present invention adopts a one-piece molding process, which is relatively low cost and is very advantageous for general use in county-level hospitals with limited costs.

[0053] Example 2 6 to 11 show a luminal anastomosis support expander of the second embodiment of the present invention, which is basically the same as the first embodiment, but differs as follows. A support main body 1 is provided at each end of the connecting rod 2, and the axes of the two support main bodies 1 are on the same line. Therefore, the luminal anastomosis support expander of this embodiment can be suitable for end-to-end anastomosis (as shown in Figs. 7 and 11). During surgery, the support main body 1 is pinched using an instrument (microforceps, needle holder, etc.), and the pointed end is advanced, and inserted into the end openings of the two lumens 101 to be sutured, so that the size and shape of the end faces are almost the same, and the connecting rod 2 is left outside the lumen 101. When about 2 / 3 of the suture is completed, the connecting rod 2 outside the lumen 101 is pulled to pinch the outer surface of the support main body 1 in cooperation with the instrument, and the support main body 1 in the two lumens 101 is taken out. After that, the remaining parts are continued to be sutured until the surgery is completed.

[0054] The connecting rod 2 may also be provided with a fluid passage 21, and both ends of the fluid passage 21 communicate with the hollow cavity 11 of the support main body 1. The fluid in the lumen 101 can flow within the hollow cavity 11, and the fluid in the hollow cavity 11 can flow into another lumen through the fluid passage 21.

[0055] Specifically, in this embodiment, one end of the hollow cavity 11 is connected to the fluid passage 21, and the end of the hollow cavity 11 is directly connected to the fluid passage 21, so that the fluid that flows into the hollow cavity 11 is completely discharged from the fluid passage 21, or all of the fluid in the hollow cavity 11 is injected from the fluid passage 21.

[0056] 7, for example, both ends of the fluid passage 21 are connected to the ends of the hollow lumen 11 of one of the support main bodies 1, so that the hollow lumen 11 of the two support main bodies 1 are connected through the fluid passage 21. Different support main bodies 1 are disposed in different lumens 101, and the fluid in one lumen 101 can flow into the other lumen 101 through the hollow lumen 11 and the fluid passage 21. Therefore, when performing a suturing operation, the different lumens 101 can communicate with each other, and the flow of the fluid in the lumen 101 is not interrupted during the operation.

[0057] The multiple support main bodies 1 on one luminal anastomosis support dilator may be the same size (as shown in Figs. 6, 7, 9 to 11) or different sizes (as shown in Fig. 8). When the luminal anastomosis support dilator has two support main bodies 1, one large and one small, the luminal anastomosis support dilator can accommodate lumens 101 of various diameters, expanding the range of application of the luminal anastomosis support dilator, and support main bodies 1 of different sizes are used for lumens 101 of different diameters.

[0058] Therefore, an anastomosis operation can be performed without interrupting the flow of the internal material. In an alternative embodiment, one end of the hollow cavity 11 can be closed, both ends can be closed, or the inside can be a solid structure, and the support body of the solid structure has a larger support force. Alternatively, the connecting rod 2 does not have a fluid passage 21 or has a solid structure, and the connecting rod of the solid structure has a larger pushing and pulling force, so that the fluid in the lumen 101 is prevented from entering the luminal anastomosis support expander, which is suitable for the situation where the flow of the material in the lumen 101 needs to be interrupted during the operation.

[0059] The luminal anastomosis support expander further includes a manipulation rod 3, specifically, as shown in Fig. 9, an end of the manipulation rod 3 is connected to the middle part of the connecting rod 2. The manipulation rod 3 can be used to push or pull the supporting main body 1 to adjust the position and angle of the supporting main body 1, and the user can use the manipulation rod 3 to remove the supporting main body 1 from the lumen 101.

[0060] Example 3 12 to 16 show a luminal anastomosis support expander of Example 3 of the present invention, which is basically the same as Example 1, but differs as follows: A support main body 1 is provided on each end of a connecting rod 2, and the axes of the two support main bodies 1 are perpendicular to each other. Therefore, when the luminal anastomosis support expander of this example is applied to end-to-side anastomosis, refer to FIG. 12 for details, the connecting rod 2 is a curved tube, and the extending directions of the axes of the two support main bodies 1 on the connecting rod 2 are approximately perpendicular to each other. Of the two lumens 101 to be anastomosed, one of the lumens 101 has an opening on its side, the support body 1 of the luminal anastomosis support expander is inserted into the lumen 101 from the side opening, and the other support body 1 is inserted into the end opening of the other lumen 101. During the insertion process, an instrument (such as a microforceps, a needle holder, etc.) can be used to pinch the support body 1 to reduce its volume, and at the same time, the tapered portion 12 of the support body 1 can be used as the forward end to make it convenient for the support body 1 to enter the lumen 101. After the suturing is partially completed, the support body 1 can be taken out from the unsutted gap, and then all the suturing is completed.

[0061] The above curved rod may be a curved rod obtained by direct processing, and the connecting rod 2 in Example 2 is a bendable material, and the curved rod of this example can be obtained by bending the straight rod in Example 2.

[0062] As shown in Fig. 14, in the lumen 101 with a side opening, the supporting main body 1 has a hollow cavity 11, so that the fluid in the lumen 101 can flow normally. In addition, the connecting rod 2 is also provided with a fluid passage 21, which can connect the hollow cavities 11 of the two supporting main bodies 1, and can connect the fluid between the two lumens 101. In alternative embodiments, the fluid passage 21 may not be provided (Figs. 12 and 13), or the flow guide directions of the fluid passage 21 and the hollow cavity 11 can be changed to meet different surgical requirements.

[0063] The support body 1 on the same luminal anastomosis support expander may have the same outer diameter (FIGS. 12 and 13), or may have different shapes and sizes to fit different lumens 101 (FIGS. 14 to 16), and those skilled in the art can make adjustments according to the actual situation.

[0064] 13, 15 and 16, in order to facilitate the user to adjust the position and angle of the support body 1 by pushing or pulling it, the luminal anastomosis support expander further includes an operating rod 3, the end of which may be connected to the middle of the connecting rod 2.

[0065] Example 4 17 to 21 show a luminal anastomosis support expander of the fourth embodiment of the present invention, which is basically the same as the first embodiment, but differs as follows. A support main body 1 is provided at each end of the connecting rod 2, and the axes of the two support main bodies 1 are parallel to each other. Therefore, the luminal anastomosis support expander of this embodiment can be applied to side-to-side anastomosis, the connecting rod 2 is V-shaped, and the two support main bodies 1 on the connecting rod 2 are arranged side by side. At this time, openings are provided on the sides of the two lumens 101 to be anastomosed, and the two support main bodies 1 are inserted into the two lumens 101 respectively from the side openings. In the insertion process, the support main body 1 can be pinched using an instrument (such as a microforceps, a needle holder, etc.) to reduce its volume, and at the same time, the tapered portion 12 of the support main body 1 can be used as the forward end to make it convenient for the support main body 1 to enter the lumen 101. After the suturing is partially completed, the support main body 1 can be taken out from the unsuturing gap, and then all the suturing is completed. The hollow cavity 11 of the supporting body 1 prevents the fluid in the lumen 101 from being blocked, and the connecting rod 2 may be provided with a fluid passage 21, both ends of which communicate with the hollow cavities 11 of the two supporting bodies 1 respectively, so that the fluid between the two lumens 101 can communicate with each other. In alternative embodiments, the fluid passage 21 may not be provided, or the flow guiding direction of the fluid passage 21 and the hollow cavity 11 may be changed to meet the requirements of different operations.

[0066] The supporting main body 1 on the same luminal anastomosis supporting dilator may have the same outer diameter (Figures 17 and 18), and the main body portion 13 of the supporting main body 1 may also have different shapes and sizes to fit different lumens 101 (Figures 19 to 21), and those skilled in the art can make adjustments according to the actual situation.

[0067] 18, 20 and 21, in order to facilitate the user to adjust the position and angle of the support body 1 by pushing or pulling it, the luminal anastomosis support expander further includes an operating rod 3, the end of which may be connected to the middle of the connecting rod 2.

[0068] Although specific embodiments of the present invention have been described above, those skilled in the art should understand that these are merely examples, and the scope of protection of the present invention is limited by the scope of the accompanying claims. Those skilled in the art should understand that various changes or modifications can be made to these embodiments without departing from the principles and essence of the present invention, and all such changes or modifications are within the scope of protection of the present invention.

Claims

1. A support body made of an elastic or shape-memory material for being disposed at least partially within a lumen to expand a vascular wall, and a connecting rod connected to the support body, The connecting rod is provided with a plurality of the support bodies, The connecting rod is provided at each end with one of the support bodies, The support body at one end of the connecting rod is larger than the support body at the other end of the connecting rod; The connecting rod is bendable so as to adjust the relative positions of the different support bodies.

2. The luminal anastomosis support expander according to claim 1 , wherein the support body is a rotating body.

3. the support main body includes a main body portion, at least one end of the main body portion is provided with a tapered portion, an outer diameter of the tapered portion decreases from one end of the tapered portion connected to the main body portion toward the other end of the tapered portion not connected to the main body portion, and a maximum outer diameter of the main body portion is larger than a maximum outer diameter of the tapered portion; And / or, the included angle between the axes of the two support bodies at both ends of the connecting rod is 0-180°.

4. The luminal anastomosis support expander according to claim 3 , wherein the maximum outer diameters of the main body portions of the support main bodies are different.

5. The luminal anastomosis support expander according to any one of claims 1 to 4, characterized in that the luminal anastomosis support expander further includes an operating rod, the end of which is connected to the middle part of the connecting rod.

6. The luminal anastomosis support expander according to claim 1, characterized in that the support main body has a hollow cavity, and one end of the support main body has a through hole communicating with the hollow cavity, or both ends of the support main body have through holes communicating with the hollow cavity.

7. The luminal anastomosis support expander according to claim 6, wherein the connecting rod is provided with a fluid passage, the fluid passage communicating with the hollow cavity of the support body.

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