Fixation device for vascular anastomosis

Abstract

The present invention provides a fixing device for blood vessel anastomosis, including an expander, a flange presser and a flange turner. The expander is provided with a sac part and a rod part. The sac part is made of a flexible material. When filled with a pressure fluid, it can be converted from a contracted state to an expanded state. In the expanded state, the periphery of the sac part and the anastomotic ring clamp the blood vessel wall together. The flange presser is provided with a first barrel part and a pressing part. The pressing part is annular and matches the anastomotic surface of the anastomotic ring. The flange turner is provided with a second barrel part and a flange part. The flange part is made of a flexible material and forms an arc extending radially outward, so that when the second barrel part is pressed against the anastomotic ring, the flange part is compressed and deformed radially outward, thereby flanging the blood vessel end. According to the present invention, the fixing operation process between the blood vessel end and the anastomotic ring is convenient, fast, and firmly fixed.

Description

Technical Field

[0001] The invention relates to the field of vascular surgery, and in particular to a fixing device for vascular anastomosis. Background Art

[0002] In surgical operations, it is often necessary to use a vascular anastomosis assembly to anastomose two blood vessel ends. In the specific operation, a pair of anastomosis rings must first be fixed to the two blood vessel ends respectively, and then the pair of anastomosis rings must be fixed to each other, thereby completing the anastomosis operation of the two blood vessel ends. Conventional anastomosis rings are provided with a number of needles on the surface, and the blood vessels must first be passed through the central space of the anastomosis ring, and then the blood vessel ends must be turned outward and hung on the needles. The operation space of the entire process is narrow, especially for microvascular operations. The operation is more difficult. The prior art does not yet have a device that can quickly and accurately operate the fixation of the blood vessel ends and anastomosis rings. Summary of the invention

[0003] The invention provides a fixing device for blood vessel anastomosis.

[0004] Specifically, the present invention is achieved through the following technical solutions:

[0005] An embodiment of the present invention provides a fixing device for blood vessel anastomosis, which is used to fix a blood vessel end to an anastomotic ring. The fixing device for blood vessel anastomosis includes:

[0006] The dilator is provided with a sac part and a rod part, both of which are hollow structures. The rod part is connected to the sac part at the distal end and is hollowly connected to each other. The rod part is formed with an opening at the proximal end so that a pressure fluid can be supplied into the sac part through the opening. The sac part is made of a flexible material, so that it can be converted from a contracted state to an expanded state under pressure fluid filling. In the expanded state, the periphery of the sac part and the anastomotic ring clamp the blood vessel wall together.

[0007] The edge press is provided with a first barrel and a pressing part, the first barrel is a hollow structure, the pressing part is annular and matches the anastomotic surface of the anastomotic ring, and the pressing part is formed with holes along the annular circumference, and the holes correspond to the needles of the anastomotic ring;

[0008] The flange device is provided with a second barrel and a flange part, both of which are hollow structures, and the flange part is provided at the distal end of the second barrel, and is made of a flexible material and is formed into an arc extending radially outward, so that when the second barrel is pressed against the anastomotic ring, the flange part is compressed and deformed radially outward, thereby flange the end of the blood vessel;

[0009] Among them, the expander, the flange turner and the flange presser are arranged in sequence from the inside to the outside.

[0010] In some embodiments, the expander is further provided with a core portion, which extends from the opening into the shaft portion to the distal end of the balloon portion and is connected to the center of the balloon portion at the distal end of the balloon portion.

[0011] In some embodiments, the balloon portion extends distally with a tip from its connection with the core portion.

[0012] In some embodiments, the outer peripheral contour of the proximal end of the balloon portion is formed with a first peak, a valley, and a second peak, and the position of the valley corresponds to the anastomotic ring.

[0013] In some embodiments, the outer peripheral contour of the distal end of the balloon portion is formed with a corner portion and a tapered portion, and the tapered portion transitions to the second peak portion through the corner portion.

[0014] In some embodiments, a flared opening is formed near the proximal end of the rod portion, and the shape of the flared opening matches the proximal end of the hollow structure of the second barrel portion.

[0015] In some embodiments, the flange portion is configured as at least a pair of claws, each claw portion is provided with a claw rod and a claw head, the claw rod is connected to the second cylinder portion, and the claw head is provided at the distal end of the claw rod and is in an arc shape extending radially outward.

[0016] In some embodiments, the claw rod extends axially, and a gap is provided between the outer periphery of the claw rod and the first barrel portion, so as to allow the claw rod to expand radially outward at an angle of 3-5 degrees.

[0017] In some embodiments, the expander, flange presser or flange turner is made of a memory alloy core material and an outer layer of silicone material.

[0018] In some embodiments, an arc-shaped inner opening is formed at the distal end of the pressing portion, and the shape of the arc-shaped inner opening matches the arc shape of the flange portion.

[0019] According to an embodiment of the present invention, pressurized fluid is injected into the sac portion through the opening to expand the sac portion so as to cooperate with the anastomotic ring to firmly clamp the blood vessel wall. By pushing the second barrel portion, the flange portion automatically everts the blood vessel end. Then, by pushing the first barrel portion, the pressing portion hangs the everted blood vessel end on the needle of the anastomotic ring and clamps the everted blood vessel end together with the anastomotic ring. The entire operation process is convenient and fast, and the anastomotic ring and the blood vessel end are firmly fixed.

[0020] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0022] Figure 1 is a schematic diagram of a use state of a vascular anastomosis fixing device in one embodiment of the present invention;

[0023] Figure 2is a cross-sectional view of a vascular anastomosis fixing device in one embodiment of the present invention in use;

[0024] Figure 3 is a cross-sectional view of a capsule portion in one embodiment of the present invention;

[0025] Figure 4 is a schematic diagram of a combination of a crimping device and anastomotic ring in one embodiment of the present invention;

[0026] Figure 5 is a schematic diagram of a dilator in one embodiment of the present invention;

[0027] Figure 6 Schematic diagram of an edge turner in one embodiment of the present invention.

[0028] Reference numerals:

[0029] 01: blood vessel; 02: anastomotic ring;

[0030] 10: dilator; 11: capsule; 111: first peak; 112: valley; 113: second peak; 114: corner; 115: cone; 12: stem; 121: opening; 122: flare; 13: core; 14: tip;

[0031] 20: edge press; 21: first barrel; 22: pressing part; 221: hole;

[0032] 30: flanger; 31: second cylinder; 32: claw; 321: claw head; 322: claw rod. DETAILED DESCRIPTION

[0033] The present invention will now be discussed with reference to several embodiments. It should be understood that these embodiments are discussed only to enable those skilled in the art to better understand and thus implement the present invention, rather than implying any limitation on the scope of the present invention.

[0034] As used herein, the term "including" and its variants are to be interpreted as open-ended terms meaning "including but not limited to"; the terms "embodiment" and "one embodiment" are to be interpreted as "at least one embodiment"; the term "another embodiment" is to be interpreted as "at least one other embodiment"; the terms "first", "second", etc. may refer to different or the same objects; the term "setting" is not limited to direct connection or indirect connection, nor is it limited to a specific connection method. Other explicit and implicit definitions may also be included below.

[0035] In the following description, some specific numerical values ​​or numerical ranges may be involved. It should be understood that these numerical values ​​and numerical ranges are merely exemplary, and they may be helpful in putting the idea of ​​the present invention into practice. However, the description of these examples is not intended to limit the scope of the present invention in any way. According to specific application scenarios and requirements, these numerical values ​​or numerical ranges can be set separately.

[0036] As mentioned above, in the prior art, when fixing the end of a blood vessel and an anastomotic ring, the operating space of the entire process is narrow, especially for micro-vessels, the operation is more difficult, and the fixing operation cannot be completed quickly and accurately. The vascular anastomosis fixing device proposed in the embodiment of the present invention at least partially solves the above problem. Figures 1 to 6 To describe the structure and working principle of the vascular anastomosis fixing device according to an exemplary embodiment of the present invention. The vascular anastomosis fixing device of the embodiment of the present invention generally includes a dilator 10, a flange press 20 and a flange turner 30. The dilator 10 is used to dilate from the inside of the blood vessel 01, and clamp the wall of the blood vessel 01 together with the anastomotic ring 02 sleeved on the outside of the blood vessel 01, so as to position the blood vessel 01 and the anastomotic ring 02; the flange turner 30 is used to push the end of the blood vessel 01 to evert to the needle covering the anastomotic ring 02; the flange press 20 is used to press the everted part of the end of the blood vessel 01 to hang on the needle. For the convenience of description, in the embodiment of the present invention, the end of the fixing device close to the blood vessel 01 is set as the "distal end", and the end away from the blood vessel 01 is set as the "proximal end".

[0037] like Figure 1 and Figure 5 As shown, the dilator 10 is composed of a capsule 11, a rod 12 and a core 13. The capsule 11 is located at the distal end of the rod 12. Both the rod 12 and the capsule 11 are hollow structures. The core 13 is arranged inside the rod 12, and the distal end of the core 13 is connected to the center of the capsule 11. An opening 121 is formed at the proximal end of the rod 12. The proximal end of the core 13 can extend from the opening 121 to support the capsule 11 and prevent it from collapsing, so as to facilitate the capsule 11 to extend into the interior of the blood vessel 01. If the capsule 11 is to be expanded and clamp the wall of the blood vessel 01 together with the anastomotic ring 02, a pressure fluid needs to be injected into the capsule 11 through the opening 121. The force of the pressure fluid forcing the capsule to expand can meet the clamping requirement of the wall of the blood vessel 01.

[0038] In one embodiment, the bladder portion is made of a flexible material so that it can be easily deformed by pressure fluid. Although the bladder portion as a whole can shrink and expand, the wall of the bladder portion is prefabricated to have a special shape to meet different usage requirements.

[0039] Figure 3 The sac portion is merely shown in a certain state as a whole, but the wall of the sac portion has a certain shape in any state during the contraction and expansion process. Figure 3As shown, the wall of the capsule 11 is formed with a first peak 111, a valley 112, a second peak 113, a corner 114 and a cone 115 from the proximal end to the distal end. When the capsule 11 and the anastomotic ring 02 clamp the wall of the blood vessel 01 together, the anastomotic ring 02 is located exactly between the first peak 111 and the second peak 113, so that the first peak 111 and the second peak 113 clamp the anastomotic ring 02 from the axial direction (the direction between the proximal end and the distal end), ensuring that the anastomotic ring 02, the blood vessel 01 and the capsule 11 are firmly positioned. The corner 114 is used to transition between the second peak 113 and the cone 115, so that the capsule part proximal to the corner 114 can be basically supported on the inner wall of the blood vessel 01 in the expanded state, further ensuring that the position of the blood vessel 01 remains unchanged during the fixation process. The cone 115 generally presents a gradually expanding shape. In the initial stage when the sac 11 extends into the end of the blood vessel 01 , the cone 115 can be used to guide and gradually wrap the blood vessel 01 around the periphery of the sac 11 .

[0040] In one embodiment, a tip 14 that extends distally from the capsule 11 is formed at the connection between the core 13 and the distal center area of ​​the capsule 11. The tip 14 may be intentionally designed and manufactured, or it may be generated by process factors. In short, the tip 14 is helpful for the operator to observe the positional relationship between the capsule 11 and the end of the blood vessel 01, thereby improving the accuracy of the operation of the capsule extending into the end of the blood vessel 01; at the same time, the tip 14 also serves to guide the capsule 11 into the end of the blood vessel 01. For example, the capsule 11 may deviate from the end of the blood vessel 01 at first. Due to the longer size of the tip 14, it is helpful to utilize the contact between the tip 14 and the end of the blood vessel 01 to guide the capsule 11 to correct the deviated forward direction.

[0041] like Figure 1 and Figure 6 As shown, the flange device 30 is composed of a second barrel portion 31 and a flange portion, and the flange portion is connected to the second barrel portion 31. The second barrel portion 31 and the flange portion are both hollow structures. The hollow structure is not limited to a closed hollow chamber, but it can be any structure as long as it allows the expander 10 to pass from the proximal end to the distal end of the flange device 30. The inner wall of the second barrel portion 31 is configured to match the outer wall profile of the rod portion 12 of the expander 10, and the outer wall is configured to match the inner wall profile of the first barrel portion 21 of the flange pressing device 20, so as to ensure that the three can only move relative to each other in the axial direction. Exemplarily, the second barrel portion 31 is configured to be cylindrical, and correspondingly, the rod portion 12 and the first barrel portion 21 are also configured to be cylindrical.

[0042] The flange portion is generally formed into an arc extending radially outward, and is made of flexible material. When the flange portion contacts the end of the blood vessel 01 and the pressure increases, the flange portion undergoes flexible deformation radially outward, and the end of the blood vessel 01 is driven to evert during the deformation. The everted part of the end of the blood vessel 01 is also called the edge of the blood vessel 01. Under the action of the flange portion, the edge of the blood vessel 01 covers the area of ​​the needle of the anastomosis ring 02, so that the needle can penetrate the edge of the blood vessel 01 by simply pressing the edge of the blood vessel 01 axially.

[0043] In one embodiment, the flange portion may be a circumferentially closed bell-mouth structure, and during the eversion operation, the bell-mouth structure gradually expands and deforms. Figure 6 As shown, the flange portion can also be at least one pair of claws 32, and can be symmetrically two, three or four claws 32, and only each claw 32 is independently deformed radially outward during the flange process. Specifically, each claw 32 is configured to be composed of a claw rod 322 and a claw head 321, the claw rod 322 is connected to the second barrel 31, and the claw head 321 is arranged at the distal end of the claw rod 322 and is in an arc shape extending radially outward. During the deformation process, the end of the claw head 321 presses on the end of the blood vessel 01 and drives the end of the blood vessel 01 to evert.

[0044] In one embodiment, the claw rod 322 extends axially. When the claw head 321 contacts and compresses the end of the blood vessel 01, the axially extending claw rod 322 can remain basically unchanged, thereby ensuring that all deformation occurs on the claw head 321, thereby increasing the deformation amplitude of the claw head 321, and also increasing the eversion effect of the end of the blood vessel 01, so that as large an area of ​​the edge of the blood vessel 01 as possible is covered on the needle.

[0045] In one embodiment, there is a gap between the outer periphery of the claw rod 322 and the first barrel portion 21. When the claw head 321 is deformed radially outward to a certain extent, it will drive the claw rod 322 to expand radially outward. After calculation, the inventor has determined that the reserved gap should allow the claw rod 322 to expand radially outward by a maximum of 3-5 degrees to avoid excessive expansion causing the end of the claw head 321 to become unhooked and slipped from the end of the blood vessel 01.

[0046] like Figure 4 As shown, the edge pressing device 20 is composed of a first barrel 21 and a pressing portion 22. The first barrel 21 is a hollow structure, so that the dilator 10 and the edge turning device 30 can be inserted. The pressing portion 22 is annular as a whole and matches the anastomotic surface of the anastomotic ring 02, so as to ensure that the pressing portion 22 and the anastomotic surface can flatly press the edge of the blood vessel 01. The pressing portion 22 is formed with holes 221 along the annular circumference. The number and position of the holes 221 correspond to the needles of the anastomotic ring 02, so that the needles can pass through the holes 221, so that the pressing portion 22 presses the edge of the blood vessel 01 onto the anastomotic surface of the anastomotic ring 02.

[0047] In one embodiment, an arc-shaped inner opening is formed at the distal end of the pressing portion 22, and the shape of the arc-shaped inner opening matches the arc shape of the flange portion, so that the pressing portion 22 can completely fit the anastomotic surface of the anastomotic ring 02 without being affected by the obstruction of the flange portion in the middle.

[0048] In one embodiment, a flare 122 is formed near the proximal end of the rod 12, and the outer peripheral shape of the flare 122 matches the proximal end of the hollow structure of the second barrel 31, so that the second barrel 31 is limited at the flare 122 and does not fall out from the proximal end of the rod 12. In another embodiment, the large diameter section of the flare 122 is larger than the inner diameter of the first barrel 21, which can also prevent the first barrel 21 from falling out from the proximal end of the rod 12. This arrangement facilitates the overall transportation and storage of the expander 10, the flange turning device 30 and the flange pressing device 20.

[0049] In one embodiment, the expander 10, the edge press 20 or the edge turner 30 is made of a memory alloy core material and an outer layer of silicone material. The outer layer of silicone material ensures that the fixing device will not damage the blood vessel 01. The memory alloy core material makes the fixing device flexible while being able to stably maintain a specific state without rebounding to affect its use.

[0050] When using the blood vessel 01 anastomosis fixing device according to the embodiment of the present invention, Figure 2 As shown, the expander 10, the flange turning device 30 and the edge pressing device 20 are pre-mounted together from the inside to the outside in sequence. During operation, the sac portion 11 is first extended into the end of the blood vessel 01 on which the anastomotic ring 02 has been mounted, and pressure fluid is supplied to the sac portion 11 to expand the sac portion 11 at the corresponding position of the anastomotic ring 02, and the sac portion 11 and the anastomotic ring 02 are used to clamp the wall of the blood vessel 01 together; then the second barrel portion 31 is pushed to make the claw portion 32 expand radially outward after the pressure portion, thereby driving the end of the blood vessel 01 to be everted; then the first barrel portion 21 is pushed to make the pressing portion 22 thread the everted edge of the blood vessel 01 onto the needle, and further press it on the anastomotic surface of the anastomotic ring 02; finally, the pressure fluid in the sac portion 11 is released, the sac portion 11 is pulled out of the blood vessel 01, and at the same time, the flange turning device 30 and the edge pressing device 20 are separated from the anastomotic ring 02, completing the entire fixing operation.

[0051] The description of the embodiments herein and any reference to directions and orientations are only for the convenience of description and are not to be construed as any limitation on the scope of protection of the present invention. The description of the preferred embodiments may involve combinations of features, which may exist independently or in combination, and the present invention is not particularly limited to the preferred embodiments. The scope of the present invention is defined by the claims.

[0052] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A fixing device for blood vessel anastomosis, used for fixing an end of a blood vessel (01) to an anastomotic ring (02), characterized in that: The vascular anastomosis fixing device comprises: The dilator (10) is provided with a sac portion (11) and a rod portion (12), both of which are hollow structures. The rod portion (12) is connected to the sac portion (11) at the distal end and is in hollow communication with the sac portion (11). The rod portion (12) is formed with an opening (121) at the proximal end so that a pressure fluid can be supplied to the sac portion (11) through the opening (121). The sac portion (11) is made of a flexible material so that it can be converted from a contracted state to an expanded state when filled with pressure fluid. In the expanded state, the periphery of the sac portion (11) and the anastomotic ring (02) together clamp the wall of the blood vessel (01); The edge pressing device (20) is provided with a first barrel portion (21) and a pressing portion (22); the first barrel portion (21) is a hollow structure; the pressing portion (22) is annular and matches the anastomotic surface of the anastomotic ring (02); the pressing portion (22) is formed with a hole (221) along the annular circumference; the hole (221) corresponds to the pin of the anastomotic ring (02); The flange device (30) is provided with a second barrel (31) and a flange portion, the second barrel (31) and the flange portion are both hollow structures, the flange portion is provided at the distal end of the second barrel (31), the flange portion is made of a flexible material and is formed into an arc extending radially outward, so that when the second barrel (31) is pressed against the anastomotic ring (02), the flange portion is compressed and deformed radially outward, thereby flangeing the end of the blood vessel (01); The expander (10), the flange turning device (30) and the flange pressing device (20) are arranged in sequence from the inside to the outside.

2. The vascular anastomosis fixing device according to claim 1, characterized in that: The expander (10) is further provided with a core (13), which extends from the opening (121) into the shaft (12) to the distal end of the sac (11), and is connected to the center of the sac (11) at the distal end of the sac (11).

3. The vascular anastomosis fixing device according to claim 2, characterized in that: The sac part (11) extends a tip part (14) distally from the connection with the core part (13).

4. The vascular anastomosis fixing device according to claim 1, characterized in that: The outer peripheral contour of the proximal end of the sac portion (11) is formed with a first peak portion (111), a valley portion (112), and a second peak portion (113), and the position of the valley portion (112) corresponds to the anastomotic ring (02).

5. The vascular anastomosis fixing device according to claim 4, characterized in that: The outer peripheral contour of the distal end of the sac portion (11) is formed with a corner portion (114) and a cone portion (115), and the cone portion (115) transitions to the second peak portion (113) through the corner portion (114).

6. The vascular anastomosis fixing device according to claim 1, characterized in that: A flared opening (122) is formed near the proximal end of the rod portion (12), and the shape of the flared opening (122) matches the proximal end of the hollow structure of the second barrel portion (31).

7. The vascular anastomosis fixing device according to claim 1, characterized in that: The flange portion is provided as at least a pair of claw portions (32), each claw portion (32) being provided with a claw rod (322) and a claw head (321), the claw rod (322) being connected to the second barrel portion (31), and the claw head (321) being provided at the far end of the claw rod (322) and being in the shape of an arc extending radially outwards.

8. The vascular anastomosis fixing device according to claim 7, characterized in that: The claw rod (322) extends axially, and a gap is provided between the outer periphery of the claw rod (322) and the first cylindrical portion (21), so as to allow the claw rod (322) to expand radially outward at an angle of 3-5 degrees.

9. The vascular anastomosis fixing device according to claim 1, characterized in that: The expander (10), the edge presser (20) or the edge turner (30) is made of a memory alloy core material and an outer layer of a silicone material.

10. The vascular anastomosis fixing device according to claim 1, characterized in that: An arc-shaped inner opening is formed at the far end of the pressing portion (22), and the shape of the arc-shaped inner opening matches the arc shape of the flange portion.

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