WO2022022235A1 - 管腔吻合支撑扩张器 - Google Patents

管腔吻合支撑扩张器 Download PDF

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Publication number
WO2022022235A1
WO2022022235A1 PCT/CN2021/104574 CN2021104574W WO2022022235A1 WO 2022022235 A1 WO2022022235 A1 WO 2022022235A1 CN 2021104574 W CN2021104574 W CN 2021104574W WO 2022022235 A1 WO2022022235 A1 WO 2022022235A1
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WO
WIPO (PCT)
Prior art keywords
lumen
support
anastomosis
connecting rod
dilator
Prior art date
Application number
PCT/CN2021/104574
Other languages
English (en)
French (fr)
Inventor
吴炅
罗万川
王强
丁毅
林炜善
陈嘉健
Original Assignee
上海火点医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202021522078.7U external-priority patent/CN213030943U/zh
Priority claimed from CN202010735867.7A external-priority patent/CN111714261A/zh
Application filed by 上海火点医疗器械有限公司 filed Critical 上海火点医疗器械有限公司
Priority to EP21851425.5A priority Critical patent/EP4190284A1/en
Priority to JP2023504501A priority patent/JP2023535574A/ja
Priority to US18/016,781 priority patent/US20230285022A1/en
Publication of WO2022022235A1 publication Critical patent/WO2022022235A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials

Definitions

  • the invention relates to the field of auxiliary instruments for lumen anastomosis in medical and surgical operations, in particular to a lumen anastomosis support expander.
  • Lumen anastomosis is a basic surgical form in clinical, including lumen damage repair, lumen transplantation, lumen overlap, lumen suture and repair, etc. It can be used for blood vessels, lymphatic channels, vas deferens, bile ducts, trachea, bronchi It is an effective treatment method commonly used to reconstruct lumen function. It is widely used in various surgical operations, such as flap transplantation, replantation of severed limbs, accidental vascular injury, organ transplantation, arteriovenous fistula anastomosis, lymphatic anastomosis, vas deferens anastomosis, biliary anastomosis, tracheal anastomosis, etc.
  • the anastomosis of the two opposite ends of the lumen should be accurately aligned, and there should be no torsion, stenosis, valgus or varus. Floor. Such healing scars are minimal and the patency rate is increased. Therefore, it is required that the diameters of the two ends should be as equal as possible, which can be expanded with an equal-diameter dilator or special forceps for expanding the lumen.
  • the paradox is that for some small lumen, atraumatic techniques are attached great importance, and forceps are not allowed to clamp the tube to be anastomosed. Endometrial and muscularis, otherwise the patency rate will be reduced.
  • a flexible or atraumatic inner support is required to achieve apposition of the anastomosis.
  • the blood vessel is a kind of lumen.
  • the blood vessel For vascular anastomosis, the blood vessel needs to be exposed and the blood flow can be controlled to provide a bloodless field of view to complete the operation; according to the size and anatomy of the blood vessel, different types of non-invasive Vascular forceps, soft and elastic colloidal strips, or balloon catheters are used to block blood flow through the lumen of the vessel. After the blood flow is blocked, the blood vessel wall elastically retracts and collapses, and the lumen becomes smaller or even blocked. The operation is difficult, inefficient, and time-consuming, resulting in a long blood flow blocking time and a high risk. Some doctors will make some self-made packing materials to assist suture. Although some problems can be solved, the efficiency is still low, the function is single, and it is not standardized.
  • the technical problem to be solved by the present invention is to provide a lumen anastomosis support dilator in order to overcome the problems in the lumen suture in the prior art.
  • a support body made of an elastic material or a shape memory material for placement at least partially within the lumen to dilate the vessel wall;
  • the connecting rod is connected to the supporting body.
  • the doctor when performing anastomosis, can use instruments (such as micro forceps, needle holders, etc.) to hold the support body, and place the support body in the lumen.
  • instruments such as micro forceps, needle holders, etc.
  • the elastic material or The support body made of shape memory material can rebound and prop up the lumen moderately, which is convenient for doctors to perform subsequent anastomosis operations.
  • the supporting body can be taken out through the unsutured gap by using the connecting rod, and the subsequent suture can be continued. Therefore, the lumen anastomosis support dilator can rapidly expand the lumen, assist in surgical treatment, reduce damage to the tube wall, and improve the efficiency and success rate of lumen anastomosis.
  • the above elastic material can 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, etc.) , methyl vinyl silicone rubber, methyl phenyl silicone rubber, methyl vinyl phenyl silicone rubber, nitrile silicone rubber, fluorosilicone rubber, etc.), polyurea and latex.
  • Shape memory materials may include shape memory alloy materials and shape memory polymer materials.
  • Shape memory alloy materials include but are not limited to nickel-titanium alloys, titanium-nickel-copper, titanium-nickel-iron, titanium-nickel-chromium, copper-nickel alloys, copper-aluminum alloys, copper-zinc alloys, copper-zinc-aluminum alloys, iron-based alloys, iron-silicon alloys Carbon alloys, iron-nickel alloys, iron-manganese alloys, iron-manganese-carbon alloys, iron-manganese-silicon alloys.
  • Shape memory polymer materials include but are not limited to polyvinyl alcohol, polycaprolactone, polylactic acid, polydioxanone, polyisoprene, cross-linked polyethylene, polynorbornene, styrene-butadiene olefin copolymer, polyamide, polyethylene terephthalate, polyacrylic acid, polymethacrylic acid, polyacrylamide, polyN-isopropylacrylamide, epoxy polymer, polydimethylsiloxane, Polyaniline, polyurethane, poly-L-lysine, poly-L-glutamic acid, collagen, alginic acid, hyaluronic acid, chitosan, starch, cellulose and copolymers of the above substances.
  • a plurality of the supporting bodies are provided on the connecting rod.
  • multiple support bodies may be applicable to multiple lumens, and multiple support bodies may have multiple different outer diameters, so one lumen anastomosis support dilator may be applicable to lumens with different diameters.
  • each of the two ends of the connecting rod is provided with the supporting body.
  • the two support bodies can be placed in the two lumens to be anastomosed respectively, so the anastomosis of the two lumens can be achieved by using one lumen anastomosis support dilator, so that the two lumens are relatively fixed during suturing , to facilitate the suture operation, while reducing the number of equipment required in the operation.
  • the supporting body is a rotating body.
  • the supporting body is a rotatable body, which can be better adapted to the lumen, so as to facilitate anastomosis.
  • the support main body includes a main body portion, at least one end of the main body portion is provided with a tapered portion, the outer diameter of the tapered portion decreases outward from the main body portion, and the maximum outer diameter of the main body portion is greater than the maximum outer diameter of the tapered portion;
  • the included angle between the axis lines of the two supporting bodies at both ends of the connecting rod is 0-180°.
  • the main body part has a larger outer diameter and can be used to support the lumen
  • the conical part can be in the shape of a cone, a truncated cone, etc., and the conical part can be easily inserted into the lumen, thereby making the entire supporting body easier into the lumen.
  • the support body may be provided with only one tapered portion, or one tapered portion may be provided at both ends of the body portion, so that the support body can be inserted into the lumen from two directions. That is, the shape of the support body may be such that the middle outer diameter is larger and the outer diameters are smaller at both ends, or the outer diameter at one end is larger and the outer diameter is smaller at the end.
  • the supporting body may be spherical, hemispherical, ellipsoidal, semi-ellipsoidal, conical, truncated, drop-shaped, olive-shaped, gourd-shaped, and the like.
  • the axis lines of the two supporting bodies at both ends of the connecting rod can be set to be collinear, parallel, or at other angles to suit different In cases where lumen anastomosis is required.
  • the maximum outer diameters of the main body portions of each of the supporting bodies are the same or different.
  • the main body parts of the two supporting bodies on the same connecting rod may have the same maximum outer diameter, so as to be suitable for anastomosis between lumens with the same outer diameter.
  • the two support bodies can also have different maximum outer diameters, so as to be suitable for anastomosis between lumens with different diameters.
  • the lumen anastomosis support dilator further comprises an operating rod, and the end of the operating rod is connected to the middle part of the connecting rod.
  • the support body can be pushed and pulled by the operating rod to adjust the position and angle of the support body, and the user can use the operating rod to take out the support body from the lumen.
  • the connecting rod can be bent, so that the relative positions between the different supporting bodies can be adjusted.
  • the connecting rod can be bent, when the support body is taken out, the position and angle of the support body can be automatically adjusted to avoid damage to the lumen.
  • the connecting rod can be bent into any angle, which can be applied to different anastomosis operations.
  • the connecting rod can be a straight rod, or, due to the needs of specific anastomotic procedures, the connecting rod can also be pre-molded into a curved tube.
  • the connecting rod can be made of the same material as the supporting body, and further, the connecting rod can be integrally formed with the supporting body.
  • the connecting rod and the supporting body can also be made of different materials, and those skilled in the art can select materials according to actual conditions. Further, the connecting rod and the supporting body can be integrally formed, but not limited to integral forming.
  • the support body is provided with a hollow cavity, and one end of the support body is provided with a through hole communicating with the hollow cavity; or, both ends of the support body are respectively provided with a hole connected with the hollow cavity. through holes.
  • the support body may 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 molding of the hollow cavity. If both ends of the support body are provided with through holes, the hollow cavity is penetrating. Therefore, during the anastomosis operation, the fluid in the lumen can continue to flow through the hollow cavity, which can solve the problem of the interruption of the tube during the lumen suture process. Collapse of the lumen wall due to fluid flow inside the lumen affects the problem of suturing.
  • the connecting rod is provided with a fluid channel, and the fluid channel communicates with the hollow cavity of the support body.
  • the fluid in the lumen can flow in the hollow cavity, the fluid in the hollow cavity can be drained to a preset position through the fluid channel, and the fluid channel can be set according to the actual situation to facilitate the anastomosis operation.
  • one end of the hollow cavity can be communicated with the fluid channel, so the fluid flowing into the hollow cavity is completely discharged from the fluid channel, or the fluid in the hollow cavity is completely injected from the fluid channel.
  • the hollow cavities of each support body can be communicated through a fluid channel.
  • different support bodies are arranged in different lumen, and the fluid in one lumen It is possible to flow into another lumen through the hollow lumen and fluid channel, thereby enabling communication between the different lumen during suturing.
  • the positive improvement effect of the present invention is that the lumen anastomosis support dilator can be applied to lumen anastomosis operations, such as anastomosis of blood vessels, lymphatic channels, vas deferens, bile ducts, trachea, bronchi and other lumen.
  • the doctor can use instruments (such as micro forceps, needle holders, etc.) to hold the support body and place the support body in the lumen. When the instrument is released, the support body made of elastic material can rebound and moderately prop up
  • the lumen is convenient for doctors to perform subsequent anastomosis operations.
  • the support body Since the support body has a hollow cavity therethrough, during the anastomosis procedure, the fluid in the lumen can continue to flow through the hollow cavity, which can solve the problem of the lumen caused by interrupting the fluid flow inside the lumen during the lumen suturing process. Wall collapse affects the problem of suture.
  • the supporting body When a part of the stitching is completed, the supporting body can be taken out through the unstitched gap by using the connecting rod, and the subsequent stitching can be completed. Therefore, the lumen anastomosis support dilator can rapidly expand the lumen, and maintain the expanded state during the lumen anastomosis, assist the surgical operation, reduce the damage of the tube wall, and improve the efficiency and success rate of anastomosis.
  • FIG. 1 is a schematic structural diagram of a lumen anastomosis support dilator according to Embodiment 1 of the present invention.
  • FIG. 2 is a schematic diagram of the internal structure of the lumen anastomosis support dilator according to Embodiment 1 of the present invention.
  • FIG. 3 is a schematic diagram of the lumen anastomosis support dilator according to Embodiment 1 of the present invention applied to end-to-end anastomosis.
  • FIG. 4 is a schematic diagram of the lumen anastomosis support dilator according to Embodiment 1 of the present invention applied to end-to-side anastomosis.
  • FIG. 5 is a schematic diagram of the lumen anastomosis support dilator according to Embodiment 1 of the present invention applied to side-to-side anastomosis.
  • FIG. 6 is a schematic structural diagram of the lumen anastomosis support dilator according to Embodiment 2 of the present invention.
  • FIG. 7 is a schematic diagram of the lumen anastomosis support dilator according to Embodiment 2 of the present invention applied to end-to-end anastomosis.
  • FIG. 8 is a schematic diagram of a deformed structure of the lumen anastomosis support dilator of FIG. 6 .
  • FIG. 9 is a schematic diagram of a deformed structure of the lumen anastomosis support dilator of FIG. 8 .
  • FIG. 10 is a schematic diagram of another deformation structure of the lumen anastomosis support dilator of FIG. 6 .
  • FIG. 11 is a schematic diagram of the lumen anastomosis support dilator of FIG. 10 applied to end-to-end anastomosis.
  • FIG. 12 is a schematic diagram of the lumen anastomosis support dilator according to Embodiment 3 of the present invention applied to end-to-side anastomosis.
  • FIG. 13 is a schematic diagram of a modified structure of the lumen anastomosis support dilator of FIG. 12 when applied to end-to-side anastomosis.
  • Fig. 14 is a schematic diagram of another modified structure of the lumen anastomosis support dilator of Fig. 13 applied to end-to-side anastomosis.
  • FIG. 15 is a schematic diagram of a deformed structure of the lumen anastomosis support dilator of FIG. 14 .
  • FIG. 16 is a schematic diagram of the lumen anastomosis support dilator of FIG. 15 when applied to end-to-side anastomosis.
  • FIG. 17 is a schematic diagram of the lumen anastomosis support dilator according to Embodiment 4 of the present invention applied to side-to-side anastomosis.
  • FIG. 18 is a schematic diagram of a modified structure of the lumen anastomosis support dilator of FIG. 17 when applied to side-to-side anastomosis.
  • FIG. 19 is a schematic diagram of another modified structure of the lumen anastomosis support dilator of FIG. 17 when applied to side-to-side anastomosis.
  • FIG. 20 is a schematic structural diagram of a deformed structure of the lumen anastomosis support dilator of FIG. 19 .
  • FIG. 21 is a schematic diagram of the lumen anastomosis support dilator of FIG. 20 applied to side-to-side anastomosis.
  • Support body 1 Hollow cavity 11 Tapered part 12 Main body part 13 Through hole 14
  • End-to-side anastomosis is widely used in clinical bypass grafting.
  • a longitudinal straight or oval incision is made in the recipient lumen, and the end face of the donor lumen is trimmed into a bevel, and the length is greater than the diameter of the recipient lumen.
  • the end faces of the two suture lumens 101 should be the same as possible, or they can be trimmed into bevels to expand the area of the anastomosis. Or use internal support to obtain similar suture end faces.
  • the two lumens to be anastomosed are usually approached, and a special lumen clamp is used to clamp the side wall of the anastomosis site to make a corresponding longitudinal incision.
  • the lumen anastomosis support dilator according to Embodiment 1 of the present invention includes a support body 1 and a connecting rod 2 .
  • the support body 1 is made of elastic material or shape memory material, which can be used even if it is deformed. It self-expands to the original shape, that is, it can provide good radial support, the flexible outer surface does not damage the inner surface of the lumen, and it can be easily retracted under the clamping of special instruments.
  • the support body 1 is used to be at least partially placed in the lumen 101 to expand the tube wall 100 , and the support body 1 is provided with a hollow cavity 11 therethrough;
  • the above elastic material can 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, etc.) , methyl vinyl silicone rubber, methyl phenyl silicone rubber, methyl vinyl phenyl silicone rubber, nitrile silicone rubber, fluorosilicone rubber, etc.), polyurea and latex, etc.
  • Shape memory materials may include shape memory alloy materials and shape memory polymer materials.
  • Shape memory alloy materials include but are not limited to nickel-titanium alloys, titanium-nickel-copper, titanium-nickel-iron, titanium-nickel-chromium, copper-nickel alloys, copper-aluminum alloys, copper-zinc alloys, copper-zinc-aluminum alloys, iron-based alloys, iron-silicon alloys Carbon alloys, iron-nickel alloys, iron-manganese alloys, iron-manganese-carbon alloys, iron-manganese-silicon alloys.
  • Shape memory polymer materials include but are not limited to polyvinyl alcohol, polycaprolactone, polylactic acid, polydioxanone, polyisoprene, cross-linked polyethylene, polynorbornene, styrene-butadiene olefin copolymer, polyamide, polyethylene terephthalate, polyacrylic acid, polymethacrylic acid, polyacrylamide, polyN-isopropylacrylamide, epoxy polymer, polydimethylsiloxane, Polyaniline, polyurethane, poly-L-lysine, poly-L-glutamic acid, collagen, alginic acid, hyaluronic acid, chitosan, starch, cellulose and copolymers of the above substances.
  • the doctor can use instruments (such as micro forceps, needle holders, etc.) to hold the support body 1 and place the support body 1 in the lumen 101.
  • instruments such as micro forceps, needle holders, etc.
  • the support body 1 made of material can rebound and provide sufficient radial support force to support the tube wall 100, which is convenient for the doctor to perform subsequent anastomosis operations.
  • the supporting body 1 can be taken out through the unstitched gap by using the connecting rod 2, and the subsequent stitching can be continued. Therefore, the lumen 101 anastomosis support dilator can rapidly expand the lumen 101, assist in surgical treatment, reduce damage to the tube wall 100, and improve the efficiency and success rate of lumen anastomosis.
  • the support body 1 may have a hollow cavity 11 , and one or more through holes 14 communicating with the hollow cavity 11 may be opened at one or both ends of the support body 1 .
  • both ends of the support body 1 are provided with through holes 14 communicating with the hollow cavity 11, so during the anastomosis operation, the fluid in the lumen 101 can continue to flow through the hollow cavity 11, which can solve the problem of The collapse of the wall of the lumen 101 due to interruption of fluid flow inside the lumen 101 during suturing of the lumen 101 affects the problem of suturing.
  • the support body 1 may not be provided with a hollow cavity, that is, the support body 1 is solid, so that the support body 1 has a large supporting force.
  • the support body 1 is preferably a revolving body, so that the support body 1 can be better adapted to the lumen 101 to facilitate anastomosis.
  • the support main body 1 includes a main body portion 13 , 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 decreases outward from the main body portion 13 , and the maximum outer diameter of the main body portion 13 is greater than the maximum outer diameter of the tapered portion 12 . outer diameter.
  • the main body portion 13 has a larger outer diameter and can be used to support the lumen 101.
  • the conical portion 12 can be in the shape of a cone, a truncated cone, etc. The conical portion 12 can be easily inserted into the lumen, thereby making it easier to support the main body 1 as a whole. into the lumen 101.
  • the support body 1 may be provided with only one tapered portion 12 , or may be provided with one tapered portion 12 at both ends of the body portion 13 , so that the support body 1 can be inserted into the lumen from two directions. That is, the shape of the support body 1 may be such that the middle outer diameter is larger and the outer diameters are smaller at both ends, or the outer diameter at one end is larger and the outer diameter is smaller at the end. Specifically, the support body 1 may be spherical, hemispherical, ellipsoidal, semi-ellipsoidal, conical, truncated, water drop, rugby, gourd, and the like.
  • the support body 1 is of a water drop shape, and the sharper end of the support body 1 forms a tapered portion 12 , and the support body 1 can be easily inserted into the lumen 101 by using the tapered portion 12 .
  • end-to-end anastomosis can be performed by using two lumen anastomosis support dilators of the present embodiment, and two lumen anastomosis support dilators are used to separate a support body 1 from the end of a lumen 101 respectively.
  • the opening is inserted into the lumen 101 to support the wall 100, and the two supporting 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 body 1 and to take out the support body 1 .
  • the ends of the two lumens 101 are arranged opposite to each other for suture. After about two-thirds of the suture is completed, the support body 1 is clamped by an instrument and taken out from the lumen 101, and the remaining parts are continued to be sutured until the operation is completed.
  • the end-to-side anastomosis can also be performed by using two lumen anastomosis support dilators of the present embodiment.
  • Two lumen anastomosis support dilators are used, and the support body 1 of one lumen anastomosis support dilator is inserted into The end opening of one lumen 101 supports the tube wall 100 (the lumen anastomosis support dilator is not shown in the figure), and the support body 1 of the other lumen anastomosis support dilator is inserted into the side of the other lumen 101
  • the openings hold up the wall 100 , so that the end opening of one lumen 101 is sutured to the side opening of the other lumen 101 .
  • the fluid in the lumen 101 can continue to flow through the hollow lumen 11 .
  • suturing process reference may be made to the above-mentioned suturing process of end-to-end anastomosis, which will not be repeated here.
  • two lumen anastomosis support dilators of the present embodiment can also be used for side-to-side anastomosis.
  • Two lumen anastomosis support dilators are used to respectively attach a support body to a supporting body. 1. Insert into the lumen 101 from the side opening of one lumen 101 to perform side-to-side anastomosis of the two lumens 101.
  • suturing process reference may be made to the above-mentioned suturing process of end-to-end anastomosis and end-to-side anastomosis, which will not be repeated here.
  • the connecting rod 2 may be provided with a plurality of supporting bodies 1, so that an anastomosis between two lumens 101 can be performed by using one lumen anastomosis support dilator, and the main body parts 13 of the plurality of supporting bodies 1 may have various different Therefore, one lumen anastomosis support dilator can be applied to lumen 101 of different diameters.
  • a support body 1 is provided at each end of the connecting rod 2, and the two support bodies 1 can be respectively placed in the two lumen 101 to be anastomosed.
  • a lumen anastomosis support dilator can be used to realize the The anastomosis of the two lumens 101 makes the two lumens 101 relatively fixed during suture, which facilitates the suture operation and reduces the number of equipment required in the operation.
  • the two supporting 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 with the same diameter.
  • the main body parts 13 of the two supporting bodies 1 may also have different maximum outer diameters, so as to be suitable for anastomosis between lumens 101 with different diameters.
  • one or more supporting bodies 1 may also be provided in the middle of the connecting rod 2 to meet the needs of different lumen anastomosis operations.
  • the included angle between the axis lines of the two supporting bodies 1 at both ends of the connecting rod 2 can be 0-180°, so that the two supports
  • the axis lines of the main body 1 can be set to be collinear, parallel or at other angles, so as to meet the needs of lumen anastomosis in different situations.
  • the connecting rod 2 can be bent, so that the relative positions between different supporting bodies 1 on the connecting rod 2 can be adjusted to prevent damage to the lumen 101 when the supporting body 1 is taken out.
  • the connecting rod 2 can be bent at any angle to be suitable for Different anastomosis procedures. Due to the needs of a specific anastomosis operation, the connecting rod 2 can also be pre-molded into a curved tube. For example, in this embodiment, the included angle between the connecting rod 2 and the axis of a supporting body 1 is 45°.
  • the connecting rod 2 can be made of elastic material or shape memory material.
  • the connecting rod 2 and the supporting body 1 can be integrally formed, and the connecting rod 2 is made of the same material as the supporting body 1, and is in the shape of a strip. Shape or column, different lengths can be set according to requirements.
  • the connecting rod 2 can be deformed compliantly to realize the shape of the lumen 101 , while maintaining a certain angle so as to control the position and angle of the supporting body 1 .
  • the lumen anastomosis support dilator of this embodiment solves the difficult problems in lumen suture through a simple and practical design, can be easily supported and expanded during the operation, more accurately provides an anastomotic end face with the same diameter, and is simple to operate. Easy to recycle. Only simple and special microscopic forceps, needle holders or similar instruments are needed to complete the placement and removal, which greatly improves the efficiency and success rate of suturing, and reduces the risk of adverse outcomes. Moreover, the present invention adopts an integrated molding process, and the cost is relatively low, which is very favorable for the popular use of prefecture-level hospitals with limited cost.
  • the lumen anastomosis support dilator according to the second embodiment of the present invention.
  • This embodiment is basically the same as the first embodiment, the difference is that the two ends of the connecting rod 2 are each provided with an axis supporting the main body 1 The lines are on a straight line, and the axis lines of the two supporting bodies 1 are collinear. Therefore, the lumen anastomosis support dilator in this embodiment may be suitable for end-to-end anastomosis (as shown in FIG. 7 and FIG. 11 ).
  • the supporting body 1 is clamped with instruments (such as micro tweezers, needle holders, etc.), and the sharper ends are placed in the forward direction, respectively, and placed into the ports of the two lumens 101 to be sutured, so as to obtain substantially the same
  • instruments such as micro tweezers, needle holders, etc.
  • the connecting rod 2 is left outside the lumen 101.
  • the connecting rod 2 may also be provided with a fluid channel 21 , and both ends of the fluid channel 21 are communicated with the hollow cavity 11 of the support body 1 .
  • the fluid in the lumen 101 can flow in the hollow lumen 11 , and the fluid in the hollow lumen 11 can be drained into another lumen through the fluid channel 21 .
  • one end of the hollow cavity 11 is connected to the fluid channel 21. Since the end of the hollow cavity 11 is directly connected to the fluid channel 21, the fluid flowing into the hollow cavity 11 is completely discharged from the fluid channel 21, or the hollow cavity 11 is completely discharged from the fluid channel 21. The fluid in the cavity 11 is all injected from the fluid channel 21 .
  • both ends of the fluid channel 21 are respectively communicated with the ends of the hollow cavity 11 of a supporting body 1 , so the hollow cavities 11 of the two supporting bodies 1 are communicated through the fluid channel 21 .
  • Different support bodies 1 are arranged in different lumen 101, and the fluid in one lumen 101 can flow into another lumen 101 through the hollow lumen 11 and the fluid channel 21, so as to realize the different lumen 101 during the suturing operation. Communication between them is possible, and the flow of fluid in the lumen 101 will not be interrupted during the surgical procedure.
  • a plurality of support bodies 1 on a lumen anastomosis support dilator may be of the same size (as shown in FIG. 6 , FIG. 7 , FIG. 9 to FIG. 11 ), or may be of different sizes (as shown in FIG. 8 ).
  • the lumen anastomosis support dilator is provided with two supporting bodies 1, one large and one small, the lumen anastomosis support dilator can be adapted to lumen 101 of various diameters, which improves the application range of the lumen anastomosis support dilator.
  • different sizes of support bodies 1 are used for different diameter lumens 101.
  • the hollow cavity 11 can also be closed at one end, closed at both ends, or a solid structure inside, and the support body of the solid structure has a larger supporting force; With a solid structure, the connecting rod of the solid structure has a larger push-pull force to prevent fluid in the lumen 101 from entering the lumen anastomosis support dilator. This situation is suitable for the situation where the flow of substances in the lumen 101 needs to be interrupted during surgery.
  • the lumen anastomosis support dilator further includes an operating rod 3 , specifically, as shown in FIG. 9 , the end of the operating rod 3 is connected to the middle of the connecting rod 2 .
  • the support body 1 can be pushed and pulled by the operating rod 3 to adjust the position and angle of the support body 1, and the user can use the operating rod 3 to take the support body 1 out of the lumen 101.
  • Figures 12 to 16 show the lumen anastomosis support dilator according to Embodiment 3 of the present invention.
  • This embodiment is basically the same as Embodiment 1, the difference is that each end of the connecting rod 2 is provided with a supporting body 1, The axes of the two supporting bodies 1 are perpendicular to each other. Therefore, when the lumen anastomosis support dilator of this embodiment is applied to end-to-side anastomosis, see FIG. 12 for details.
  • the connecting rod 2 is a curved tube, and the extension directions of the axis lines of the two supporting bodies 1 on the connecting rod 2 are basically perpendicular to each other.
  • one lumen 101 is provided with an opening on the side, one supporting body 1 of the lumen anastomosis supporting dilator is inserted into the lumen 101 from the side opening, and the other supporting body 1 is inserted into the lumen 101. Then it is inserted into the end opening of the other lumen 101.
  • the support body 1 can be clamped with instruments (such as micro forceps, needle holders, etc.) to reduce its volume, and the tapered shape of the support body 1 can be used at the same time.
  • the portion 12 serves as an advancing end to facilitate the entry of the support body 1 into the lumen 101 .
  • the support body 1 can be removed from the unstitched notch, and then the entire stitching is completed.
  • the above-mentioned bending rod can be a bending rod obtained by direct processing and molding, and it can also be understood that the connecting rod 2 in the second embodiment is a bendable material, and the bending rod of this embodiment can be obtained by bending the straight rod in the second embodiment. .
  • a fluid channel 21 may be provided on the connecting rod 2 , and the fluid channel 21 can communicate with the hollow cavities 11 of the two supporting bodies 1 , so that the fluids between the two lumens 101 can communicate with each other.
  • the fluid channel 21 may not be provided ( FIG. 12 and FIG. 13 ), or the flow direction of the fluid channel 21 and the hollow cavity 11 may be changed to meet different surgical needs.
  • the support body 1 on the same lumen anastomosis support dilator can have the same outer diameter (Fig. 12 and Fig. 13), or can have different shapes and sizes (Fig. 14 to Fig. 16) to fit different lumens 101. Those skilled in the art can make adjustments according to the actual situation.
  • the lumen anastomosis support dilator may further include an operating rod 3 , and the end of the operating rod 3 is connected to the middle of the connecting rod 2 , so that the user can push and pull to adjust the position and angle of the supporting body 1 .
  • FIGs 17 to 21 show the lumen anastomosis support dilator according to Embodiment 4 of the present invention.
  • This embodiment is basically the same as Embodiment 1, the difference is that a support body 1 is provided at each end of the connecting rod 2, The axes of the two supporting bodies 1 are parallel to each other. Therefore, the lumen anastomosis support dilator of this embodiment can be applied to side-to-side anastomosis, the connecting rod 2 is V-shaped, and the two supporting bodies 1 on the connecting rod 2 are arranged side by side. At this time, openings are provided on the sides of the two lumen 101 to be anastomosed, and the two supporting bodies 1 are respectively inserted into the two lumen 101 from the side openings.
  • the inserting process can use instruments (such as micro forceps, Needle holder, etc.) to clamp the support body 1 to reduce its volume, and at the same time use the tapered portion 12 of the support body 1 as an advancing end to facilitate the support body 1 entering the lumen 101 .
  • the support body 1 can be removed from the unstitched notch, and then the entire stitching is completed.
  • the hollow cavity 11 of the support body 1 prevents the fluid in the lumen 101 from being blocked, and the connecting rod 2 may also be provided with a fluid channel 21. Both ends of the fluid channel are communicated with the two hollow cavities 11 of the support body 1, respectively. So that the fluid between the two lumens 101 can be communicated.
  • the fluid channel 21 may not be provided, or the flow direction of the fluid channel 21 and the hollow cavity 11 may be changed to meet different surgical needs.
  • the support bodies 1 on the same lumen anastomosis support dilator may have the same outer diameter (Fig. 17 and Fig. 18), and the main body portion 13 of the support body 1 may also have different shapes and sizes (Figs. Adapted to different lumens 101, those skilled in the art can make adjustments according to actual conditions.
  • the lumen anastomosis support dilator may further include an operating rod 3 , and the end of the operating rod 3 is connected to the middle of the connecting rod 2 , so that the user can push and pull to adjust the position and angle of the supporting body 1 .

Abstract

一种管腔吻合支撑扩张器，包括：支撑主体（1），支撑主体（1）由弹性材料或形状记忆材料制成，用于至少部分地置于管腔（101）中以扩张管壁（100）；连接杆（2），连接杆（2）连接于支撑主体（1）。在进行吻合手术时，医生可以用器械夹持支撑主体（1），并将支撑主体（1）放置于管腔（101）中，当器械松开后，弹性材料或形状记忆材料制成的支撑主体（1）可以回弹并适度撑起管腔（101）。因此，该管腔吻合支撑扩张器可快速扩张管腔（101），辅助手术操作，减少管壁（100）损伤，提高管腔（101）吻合效率与成功率。

Description

管腔吻合支撑扩张器
本申请要求申请日为2020年7月28日的中国专利申请2020215220787的优先权、以及申请日为2020年7月28日的中国专利申请2020107358677的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明涉及医疗外科手术管腔吻合辅助器械领域，尤其涉及一种管腔吻合支撑扩张器。
背景技术
管腔吻合术是临床上一种基础手术形式，包括管腔损伤修复、管腔移植、管腔搭接、管腔缝合与修补等，可以用于血管、淋巴道、输精管、胆道、气管、支气管等领域，是常用的重建管腔功能的有效治疗方法。应用十分广泛，常见于各类外科手术中，比如皮瓣移植、断肢再植、血管意外损伤、器官移植、动静脉内瘘吻合、淋巴管吻合、输精管吻合、胆道吻合、气管吻合等等。伴随显微手术器械、显微缝线和手术显微镜的不断发展，手工小(微)管腔吻合技术逐步成熟，可吻合管腔的口径越来越细。然而即便对于经验丰富的外科手术医生来说，要完成一例完美的管腔吻合术也并不是很容易的，尤其是上面提到的小微管腔吻合术。
首先管腔两个断端相对的吻合口要准确地对合，不能有扭转、狭窄、外翻或内翻情况，也就是说要求两断端对合时内膜对内膜，肌层对肌层。这样的愈合瘢痕最少，通畅率亦增高。所以要求两断端的口径尽量相等，可用等直径的扩张器或扩张管腔专用的镊子扩张，然而矛盾的是对于一些小管腔又非常重视无创伤技术，不许用镊子钳夹待吻合的管腔内膜和肌层，否则通畅率会降低。需要柔性或无创伤的内支撑来实现吻合口的对合。
其次，以血管为例，血管作为一种管腔，对于血管吻合术来说，需要血管显露，控制血流才能提供无血视野完成手术操作；根据血管大小及解剖部位，选用不同类型的无损伤血管钳、柔软而有弹性的胶质带，或用球囊导管经血管腔内阻断血流。阻断血流后血管壁的弹性回缩、塌陷，管腔变小甚至闭塞，前后壁常相互贴合不易分开，对缝合操作造成很大障碍，缝合时还容易会刺穿对侧血管壁。操作难度大、效率低、耗时较长，导致血流阻断时间较长，风险大。一些医生会自制一些填塞物来辅助缝合，虽然可以解决部分问题，但效率仍不高、功能单一，且不规范。
发明内容
本发明要解决的技术问题是为了克服现有技术中管腔缝合术中的问题所在，提供一种管腔吻合支撑扩张器。
本发明是通过下述技术方案来解决上述技术问题：
一种管腔吻合支撑扩张器，其特点在于，包括：
支撑主体，所述支撑主体由弹性材料或形状记忆材料制成，用于至少部分地置于管腔中以扩张管壁；
连接杆，所述连接杆连接于所述支撑主体。
在本方案中，在进行吻合手术时，医生可以利用器械(如显微镊、持针器等)夹持支撑主体，并将支撑主体放置于管腔中，当器械松开后，弹性材料或形状记忆材料制成的支撑主体可以回弹并适度撑起管腔，便于医生进行后续的吻合操作。当吻合完成一部分后，可以利用连接杆将支撑主体经未缝合的缺口处取出，并继续后续的缝合。因此，该管腔吻合支撑扩张器可快速扩张管腔，辅助手术治疗，减少管壁损伤，提高管腔吻合效率与成功率。
上述弹性材料可以为橡胶(包括但不限于聚异戊二烯、丁苯橡胶、顺丁橡胶、异戊橡胶、氯丁橡胶、丁基橡胶等)、硅橡胶(包括但不限于甲基硅橡胶,甲基乙烯基硅橡胶、甲基苯基硅橡胶、甲基乙烯基苯基硅橡胶、腈硅橡胶、氟硅橡胶等)、聚脲以及乳胶等。形状记忆材料可以包括形状记忆合金材料和形状记忆高分子材料。形状记忆合金材料包括但不限于镍钛合金、钛镍铜、钛镍铁、钛镍铬、铜镍系合金、铜铝系合金、铜锌系合金、铜锌铝合金、铁系合金、铁硅碳合金、铁镍合金、铁锰合金、铁锰碳合金、铁锰硅合金。形状记忆高分子材料包括但不限于聚乙烯醇、聚己内酯、聚乳酸、聚对二氧环己酮、聚异戊二烯、交联聚乙烯、聚降冰片烯、苯乙烯-丁二烯共聚物、聚酰胺、聚对苯二甲酸乙二酯、聚丙烯酸、聚甲基丙烯酸、聚丙烯酰胺、聚N-异丙基丙烯酰胺、环氧聚合物、聚二甲基硅氧烷、聚苯胺、聚氨酯、聚L-赖氨酸、聚L-谷胺酸、胶原、海藻酸、透明质酸、壳聚糖、淀粉、纤维素以及上述物质的共聚物。
较佳地，所述连接杆上设置有多个所述支撑主体。
在本方案中，多个支撑主体可以适用于多个管腔，而且多个支撑主体可以具有多种不同的外径，因此一个管腔吻合支撑扩张器可以适用于不同直径的管腔。
较佳地，所述连接杆的两端各设置有一所述支撑主体。
在本方案中，两个支撑主体可以分别置于两个待吻合的管腔中，因此利用一个管腔 吻合支撑扩张器就可以实现两个管腔的吻合，使得缝合时两个管腔相对固定，便于缝合操作，同时减少手术中所需器材的数量。
较佳地，所述支撑主体为回转体。
在本方案中，由于管腔的横截面大多基本为圆形，支撑主体为回转体能够较好地适配于管腔，以利于吻合手术。
较佳地，所述支撑主体包括主体部，所述主体部的至少一端部设置有锥形部，所述锥形部的外径自所述主体部向外递减，所述主体部的最大外径大于所述锥形部的最大外径；
和/或，所述连接杆两端的两个所述支撑主体的轴心线之间的夹角为0-180°。
在本方案中，主体部具有较大的外径，可用于支撑管腔，锥形部可以为圆锥、圆锥台等形状，锥形部能够方便地插入管腔中，从而使得整个支撑主体较为容易地进入管腔。支撑主体可以仅设置一个锥形部，也可以在主体部的两端各设置一个锥形部，以使得支撑主体能够从两个方向插入管腔中。即，支撑主体的形状可以为中间外径大两头外径小，或一端外径大一端外径小。具体地，支撑主体可以为球形、半球形、椭球形、半椭球型、圆锥形、圆台形、水滴型、橄榄型、葫芦型等类似形状。
由于两个待缝合管腔的开口之间可能具有不同的相对位置，因此连接杆两端的两个支撑主体的轴心线之间可以设置为共线、平行、或呈其他的角度，以适应不同情况的管腔吻合需要。
较佳地，各个所述支撑主体的主体部的最大外径相同或不同。
在本方案中，同一连接杆上的两个支撑主体的主体部可以具有相同的最大外径，以适用于外径相同的管腔之间的吻合。此外，两个支撑主体也可以具有不同的最大外径，以适用于直径不同的管腔间的吻合。
较佳地，所述管腔吻合支撑扩张器还包括操作杆，所述操作杆的端部连接于所述连接杆的中部。
在本方案中，利用操作杆能够推动、拉引支撑主体，以调整支撑主体的位置和角度，使用者可以利用操作杆将支撑主体从管腔中取出。
较佳地，所述连接杆可弯折，以使得不同所述支撑主体之间的相对位置可调。
在本方案中，由于连接杆可弯折，因此在取出支撑主体时，支撑主体的位置和角度可以自动调整，以避免损伤管腔。而且连接杆可以弯折为任意角度，能够适用于不同的吻合手术。连接杆可以为直杆，另外，由于特定吻合手术的需要，连接杆也可预塑为弯管。连接杆可以采用与支撑主体相同的材料，进一步地，连接杆可以与支撑主体一体成 型。连接杆与支撑主体也可以由不同的材料制成，本领域的技术人员可以根据实际情况选择材料，进一步地，连接杆可以与支撑主体一体成型，但不限于一体成型。
较佳地，所述支撑主体设置有中空腔，所述支撑主体的一端开设有与所述中空腔相连通的通孔；或，所述支撑主体的两端分别开设有与所述中空腔相连通的通孔。
在本方案中，支撑主体可以具有中空腔，以使得支撑主体容易被压缩。支撑主体开设有通孔，以便于中空腔的成型。若支撑主体的两端都开设有通孔，则中空腔为贯穿的，因此在吻合手术的过程中，管腔中的流体可以通过中空腔继续保持流动，可解决管腔缝合过程中由于中断管腔内部的流体流动而导致的管腔壁塌陷影响缝合的问题。支撑主体一端或两端的通孔可以为一个或多个。可以理解的是，支撑主体也可以不设置中空腔，从而使得支撑主体具有较大的支撑力。
较佳地，所述连接杆开设有流体通道，所述流体通道与所述支撑主体的所述中空腔相连通。
在本方案中，管腔中的流体可以在中空腔内流动，中空腔中的流体可以经流体通道被引流至预设的位置，可以根据实际情况设置流体通道，以利于吻合手术的进行。具体地，可以使得中空腔的一端连通于所述流体通道，因此流入中空腔中的流体完全从流体通道中排出，或中空腔中的流体全部从流体通道注入。此外，当连接杆上设置有多个支撑主体时，各支撑主体的中空腔可以通过流体通道相连通，在缝合手术时，不同的支撑主体设置于不同的管腔中，一管腔中的流体可以经中空腔和流体通道流入另一管腔中，从而实现在进行缝合手术时，不同管腔之间能够连通。
本发明的积极进步效果在于：该管腔吻合支撑扩张器可以应用于管腔吻合手术，例如血管、淋巴道、输精管、胆道、气管、支气管等管腔的吻合。医生可以利用器械(如显微镊、持针器等)夹持支撑主体，并将支撑主体放置于管腔中，当器械松开后，弹性材料制成的支撑主体可以回弹并适度撑起管腔，便于医生进行后续的吻合操作。由于支撑主体具有贯穿的中空腔，因此在吻合手术的过程中，管腔中的流体可以通过中空腔继续保持流动，可解决管腔缝合过程中由于中断管腔内部的流体流动而导致的管腔壁塌陷影响缝合的问题。当缝合完成一部分后，可以利用连接杆将支撑主体经未缝合的缺口处取出，并完成后续的缝合。因此，该管腔吻合支撑扩张器可快速扩张管腔，并在管腔吻合过程中保持扩张状态，辅助手术操作，减少管壁损伤，提高吻合效率与成功率。
附图说明
图1为本发明实施例1的管腔吻合支撑扩张器的结构示意图。
图2为本发明实施例1的管腔吻合支撑扩张器的内部结构示意图。
图3为本发明实施例1的管腔吻合支撑扩张器应用于端端吻合术时的示意图。
图4为本发明实施例1的管腔吻合支撑扩张器应用于端侧吻合术时的示意图。
图5为本发明实施例1的管腔吻合支撑扩张器应用于侧侧吻合术时的示意图。
图6为本发明实施例2的管腔吻合支撑扩张器的结构示意图。
图7为本发明实施例2的管腔吻合支撑扩张器应用于端端吻合术时的示意图。
图8为图6的管腔吻合支撑扩张器的一变形结构的示意图。
图9为图8的管腔吻合支撑扩张器的一变形结构的示意图。
图10为图6的管腔吻合支撑扩张器的另一变形结构的示意图。
图11为图10的管腔吻合支撑扩张器应用于端端吻合术时的示意图。
图12为本发明实施例3的管腔吻合支撑扩张器应用于端侧吻合术时的示意图。
图13为图12的管腔吻合支撑扩张器的一变形结构应用于端侧吻合术时的示意图。
图14为图13的管腔吻合支撑扩张器的另一变形结构应用于端侧吻合术时的示意图。
图15为图14的管腔吻合支撑扩张器的一变形结构的示意图。
图16为图15的管腔吻合支撑扩张器应用于端侧吻合术时的示意图。
图17为本发明实施例4的管腔吻合支撑扩张器应用于侧侧吻合术时的示意图。
图18为图17的管腔吻合支撑扩张器的一变形结构应用于侧侧吻合术时的示意图。
图19为图17的管腔吻合支撑扩张器的另一变形结构应用于侧侧吻合术时的示意图。
图20为图19的管腔吻合支撑扩张器的一变形结构的结构示意图。
图21为图20的管腔吻合支撑扩张器的应用于侧侧吻合术时的示意图。
附图标记说明
支撑主体1 中空腔11 锥形部12 主体部13 通孔14
连接杆2 流体通道21 操作杆3 管壁100 管腔101
具体实施方式
下面通过实施例的方式进一步说明本发明，但并不因此将本发明限制在的实施例范围之中。
为更好的理解本发明，下面列出本发明应用的最常用的三种管腔缝合术类型：
1.端侧吻合术
端侧吻合术在临床上作旁路移植时广泛使用，一般受体管腔作纵直线切口或椭圆形切口，供体管腔端面修剪成斜面，长度大于受体管腔直径。
2.端端吻合术
两缝合管腔101端面应尽可能相同，或可修剪成斜面来扩大吻合口面积。或者采用内部支撑方式来获取相近的缝合端面。
3.侧侧吻合术
侧侧吻合，通常将待吻合的两管腔靠近，并用特制的管腔钳夹住吻合部位的侧壁，做对应的纵向切口。
实施例1
如图1至图5所示为本发明实施例1的管腔吻合支撑扩张器，其包括支撑主体1和连接杆2，支撑主体1由弹性材料或形状记忆材料制成，即使发生变形也可以自膨胀为初始的形状，即能提供良好径向支撑作用，柔性外表面又不伤及管腔内表面，在特制器械的夹持下比较容易地回缩。支撑主体1用于至少部分地置于管腔101中以扩张管壁100，支撑主体1开设有贯穿的中空腔11；连接杆2连接于支撑主体1。
上述弹性材料可以为橡胶(包括但不限于聚异戊二烯、丁苯橡胶、顺丁橡胶、异戊橡胶、氯丁橡胶、丁基橡胶等)、硅橡胶(包括但不限于甲基硅橡胶、甲基乙烯基硅橡胶、甲基苯基硅橡胶、甲基乙烯基苯基硅橡胶、腈硅橡胶、氟硅橡胶等)、聚脲以及乳胶等。形状记忆材料可以包括形状记忆合金材料和形状记忆高分子材料。形状记忆合金材料包括但不限于镍钛合金、钛镍铜、钛镍铁、钛镍铬、铜镍系合金、铜铝系合金、铜锌系合金、铜锌铝合金、铁系合金、铁硅碳合金、铁镍合金、铁锰合金、铁锰碳合金、铁锰硅合金。形状记忆高分子材料包括但不限于聚乙烯醇、聚己内酯、聚乳酸、聚对二氧环己酮、聚异戊二烯、交联聚乙烯、聚降冰片烯、苯乙烯-丁二烯共聚物、聚酰胺、聚对苯二甲酸乙二酯、聚丙烯酸、聚甲基丙烯酸、聚丙烯酰胺、聚N-异丙基丙烯酰胺、环氧聚合物、聚二甲基硅氧烷、聚苯胺、聚氨酯、聚L-赖氨酸、聚L-谷胺酸、胶原、海藻酸、透明质酸、壳聚糖、淀粉、纤维素以及上述物质的共聚物。
在进行吻合手术时，医生可以利用器械(如显微镊、持针器等)夹持支撑主体1，并将支撑主体1放置于管腔101中，当器械松开后，弹性材料或形状记忆材料制成的支撑主体1可以回弹并提供足够的径向支撑力撑起管壁100，便于医生进行后续的吻合操作。当缝合完成一部分后，可以利用连接杆2将支撑主体1经未缝合的缺口处取出，并继续后续的缝合。因此，该管腔101吻合支撑扩张器可快速扩张管腔101，辅助手术治疗，减少管壁100损伤，提高管腔吻合效率和成功率。
如图1和图2所示，支撑主体1可以具有中空腔11，支撑主体1的一端或两端可以 开设一个或多个与中空腔11相连通的通孔14。在本实施例中，支撑主体1的两端都开设有中空腔11相连通的通孔14，因此在吻合手术的过程中，管腔101中的流体可以通过中空腔11继续保持流动，可解决管腔101缝合过程中由于中断管腔101内部的流体流动而导致的管腔101壁塌陷影响缝合的问题。
在其他的某些实施例中，支撑主体1也可以不设置中空腔，即支撑主体1为实心的，以使得支撑主体1具有较大的支撑力。
由于管腔的横截面大多基本为圆形，因此支撑主体1优选为回转体，从而使得支撑主体1能够较好地适配于管腔101，以利于吻合手术。
支撑主体1包括主体部13，主体部13的至少一端部设置有锥形部12，锥形部12的外径自主体部13向外递减，主体部13的最大外径大于锥形部12的最大外径。主体部13具有较大的外径，可用于支撑管腔101，锥形部12可以为圆锥、圆锥台等形状，锥形部12能够方便地插入管腔中，从而使得整个支撑主体1较为容易地进入管腔101。支撑主体1可以仅设置一个锥形部12，也可以在主体部13的两端各设置一个锥形部12，以使得支撑主体1能够从两个方向插入管腔中。即，支撑主体1的形状可以为中间外径大两头外径小，或一端外径大一端外径小。具体地，支撑主体1可以为球形、半球形、椭球形、半椭球型、圆锥形、圆台形、水滴型、橄榄型、葫芦型等类似形状。
具体在本实施例中，支撑主体1为水滴型，支撑主体1形状较尖的一端构成锥形部12，利用锥形部12可以较为容易地将支撑主体1塞入管腔101中。
如图3所示，可以使用两个本实施例的管腔吻合支撑扩张器进行端端吻合术，利用两个管腔吻合支撑扩张器，分别将一支撑主体1从一管腔101的端部开口插入管腔101中，以撑起管壁100，两个支撑主体1的最大外径相同。连接杆2则位于管腔101之外，用于调整支撑主体1的位置、以及取出支撑主体1。两个管腔101的端部相对设置以进行缝合，待缝合完成约三分之二左右，通过器械夹持支撑主体1，将其从管腔101中取出，然后继续缝合剩余部分至手术完成。
如图4所示，还可以使用两个本实施例的管腔吻合支撑扩张器进行端侧吻合术，利用两个管腔吻合支撑扩张器，一管腔吻合支撑扩张器的支撑主体1塞入一管腔101的端部开口撑起管壁100(图中未示出该管腔吻合支撑扩张器)，另一管腔吻合支撑扩张器的支撑主体1塞入另一管腔101的侧部开口撑起管壁100，最终使得一管腔101的端部开口与另一管腔101的侧部开口相缝合。在吻合手术的过程中，管腔101中的流体可以通过中空腔11继续保持流动。具体缝合过程可参考上述端端吻合术的缝合过程，在此不再赘述。
此外，如图5所示，还可以使用两个本实施例的管腔吻合支撑扩张器进行侧侧吻合术，具体可参见图5，利用两个管腔吻合支撑扩张器，分别将一支撑主体1从一管腔101的侧部开口插入管腔101中，以进行两个管腔101侧侧吻合。具体缝合过程可参考上述端端吻合术和端侧吻合术的缝合过程，在此不再赘述。
连接杆2上可以设置有多个支撑主体1，因此利用一个管腔吻合支撑扩张器就可以进行两个管腔101间的吻合，而且，多个支撑主体1的主体部13可以具有多种不同的外径，因此一个管腔吻合支撑扩张器可以适用于不同直径的管腔101。在本实施例中，连接杆2的两端各设置有一支撑主体1，两个支撑主体1可以分别置于两个待吻合的管腔101中，因此利用一个管腔吻合支撑扩张器就可以实现两个管腔101的吻合，使得缝合时两个管腔101相对固定，便于缝合操作，同时减少手术中所需器材的数量。
同一连接杆2上的两个支撑主体1可以具有相同的最大外径，以适用于直径相同的管腔101之间的吻合。此外，两个支撑主体1的主体部13也可以具有不同的最大外径，以适用于直径不同的管腔101间的吻合。在某些实施例中，连接杆2的中部也可以设置一个或多个支撑主体1，以满足不同的管腔吻合手术需要。
由于两个待缝合管腔的开口之间可能具有不同的相对位置，因此连接杆2两端的两个支撑主体1的轴心线之间的夹角可以为0-180°，以使得两个支撑主体1的轴心线之间可以设置为共线、平行或呈其他的角度，以适应不同情况的管腔吻合手术的需要。
连接杆2可弯折，以使得连接杆2上不同支撑主体1之间的相对位置可调，防止在取出支撑主体1时损伤管腔101，连接杆2可以弯折为任意角度，以适用于不同的吻合手术。由于特定吻合手术的需要，连接杆2也可预塑为弯管，如在本实施例中，连接杆2与一支撑主体1的轴心线之间的夹角为45°。优选地，连接杆2可以为弹性材料或形状记忆材料制成，进一步地，连接杆2与支撑主体1可以为一体成型结构，连接杆2采用与支撑主体1相同的材料制成，其呈条状或柱状，根据需求可设置不同长度。连接杆2可以顺应性地发生形变，以实现管腔101的形状，同时还可以保持一定角度以便于控制支撑主体1的位置和角度。
本实施例的管腔吻合支撑扩张器通过简单实用的设计，解决管腔缝合中存在的棘手问题，在手术过程中可方便的进行支撑扩张，比较准确地提供口径相同的吻合端面，操作简单，回收方便。只需要简单特制的显微镊、持针器或类似的器械即可完成放置与取出，大大的提高了缝合效率与成功率，降低愈后不良风险。而且本发明采用一体式成型工艺，成本相对较低，非常利于成本有限的地市级医院普及使用。
实施例2
如图6至图11为本发明实施例2的管腔吻合支撑扩张器，本实施例与实施例1基本相同，所不同的是：连接杆2的两端各设置有一支撑主体1的轴心线在一条直线上，两个支撑主体1的轴心线共线。因此本实施例中的管腔吻合支撑扩张器可以适用于端端吻合术(如图7和图11)。在手术时，用器械(如显微镊、持针器等)夹持支撑主体1，较为尖的端部作前进方向，分别放入两待缝合管腔101的端口内，用以获得基本相同的端面尺寸形状，连接杆2留于管腔101的外部。待缝合完成约三分之二左右，通过拉动管腔101外的连接杆2配合器械夹持支撑主体1外表，分别将两管腔101内的支撑主体1取出；然后继续缝合剩余部分至手术完成。
连接杆2还可以设有流体通道21，流体通道21的两端与支撑主体1的中空腔11相连通。管腔101中的流体可以在中空腔11内流动，中空腔11中的流体可以经流体通道21被引流至另一管腔中。
具体在本实施例中，中空腔11的一端连通于流体通道21，由于中空腔11的端部直接连通于流体通道21，因此流入中空腔11中的流体完全从流体通道21中排出，或中空腔11中的流体全部从流体通道21注入。
例如在图7中，流体通道21的两端分别与一支撑主体1的中空腔11的端部连通，因此两个支撑主体1的中空腔11通过流体通道21相连通。不同的支撑主体1设置于不同的管腔101中，一管腔101中的流体可以经中空腔11和流体通道21流入另一管腔101中，从而实现在进行缝合手术时，不同管腔101之间能够连通，手术过程不会中断管腔101内流体的流动。
一个管腔吻合支撑扩张器上的多个支撑主体1可以为相同的尺寸(如图6、图7、图9至图11)，也可以为不同的尺寸(如图8)。当管腔吻合支撑扩张器上设置有一大一小的两个支撑主体1时，管腔吻合支撑扩张器能够适配于多种直径的管腔101，提高管腔吻合支撑扩张器的适用范围，对于不同直径的管腔101，使用不同尺寸的支撑主体1。
所以可以不中断内部物质流动的情况下进行管腔吻合手术。在可替代的实施例中也可以使中空腔11的一端闭合、两端闭合或内部为实心结构，实心结构的支撑主体的支撑力更大；或者在连接杆2上不设置流体通道21或为实心结构，实心结构的连接杆的推拉力更大，以避免管腔101中的流体进入管腔吻合支撑扩张器中，这种情况适用于手术中需要中断管腔101内物质流动的情况。
管腔吻合支撑扩张器还包括操作杆3，具体地，如图9所示，操作杆3的端部连接于连接杆2的中部。利用操作杆3能够推动、拉引支撑主体1，以调整支撑主体1的位置和 角度，使用者可以利用操作杆3将支撑主体1从管腔101中取出。
实施例3
如图12至图16所示为本发明实施例3的管腔吻合支撑扩张器，本实施例与实施例1基本相同，所不同的是：连接杆2的两端各设置有一支撑主体1，两个支撑主体1的轴心线相互垂直。因此本实施例的管腔吻合支撑扩张器应用于端侧吻合术时，具体可参见图12，连接杆2为弯管，连接杆2上的两个支撑主体1的轴心线的延伸方向基本相互垂直。待吻合的两个管腔101中，一管腔101的侧部开设有开口，管腔吻合支撑扩张器的一个支撑主体1从该侧部开口塞入该管腔101中，另一支撑主体1则塞入到另一管腔101的端部开口中，塞入过程可以使用器械(如显微镊、持针器等)夹持支撑主体1以缩小其体积，同时利用支撑主体1的锥形部12作为前进的端部，以利于支撑主体1进入管腔101中。在部分完成缝合后，可以将支撑主体1从未缝合的缺口中取出，随后完成全部的缝合。
上述弯杆可以为直接加工成型而得到的弯杆，也可以理解为实施例2中连接杆2为可弯折的材料，通过弯折实施例2中的直杆能够得到本实施例的弯杆。
如图14所示，在侧部开口的管腔101中，由于支撑主体1具有中空腔11，因此该管腔101内的流体可以正常流动。而且连接杆2上还可以设置流体通道21，流体通道21可以将两个支撑主体1的中空腔11相连通，使得两个管腔101间的流体能够相流通。在可替代的实施例中，也可以不设置流体通道21(图12和图13)，或者改变流体通道21和中空腔11的导流方向，以满足不同的手术需要。
同一管腔吻合支撑扩张器上的支撑主体1可以为相同的外径(图12和图13)，也可以具有不同的形状和尺寸(图14至图16)，以适配于不同的管腔101，本领域的技术人员可以根据实际情况作出调整。
参见图13、15和16所示，管腔吻合支撑扩张器还可以包括操作杆3，操作杆3的端部连接于连接杆2的中部，以便于使用者推拉调整支撑主体1的位置和角度。
实施例4
如图17至图21所示为本发明实施例4的管腔吻合支撑扩张器，本实施例与实施例1基本相同，所不同的是：连接杆2的两端各设置有一支撑主体1，两个支撑主体1的轴心线相互平行。因此本实施例的管腔吻合支撑扩张器能够应用于侧侧吻合术，连接杆2呈V型，连接杆2上的两个支撑主体1并列地设置。此时两个待吻合的管腔101的侧部都 开设有开口，两个支撑主体1分别对应从侧部开口塞入两个管腔101中，塞入过程可以使用器械(如显微镊、持针器等)夹持支撑主体1以缩小其体积，同时利用支撑主体1的锥形部12作为前进的端部，以利于支撑主体1进入管腔101中。在部分完成缝合后，可以将支撑主体1从未缝合的缺口中取出，随后完成全部的缝合。支撑主体1的中空腔11使得管腔101内的流体不被堵塞，且连接杆2上也可以设置有流体通道21，流体通道的两端分别与两个支撑主体1的中空腔11相连通，以使得两个管腔101间的流体能够相连通。在可替代的实施例中，也可以不设置流体通道21，或者改变流体通道21和中空腔11的导流方向，以满足不同的手术需要。
同一管腔吻合支撑扩张器上的支撑主体1可以为相同的外径(图17和图18)，支撑主体1的主体部13也可以具有不同的形状和尺寸(图19至图21)，以适配于不同的管腔101，本领域的技术人员可以根据实际情况做出调整。
参见图18、20和21所示，管腔吻合支撑扩张器还可以包括操作杆3，操作杆3的端部连接于连接杆2的中部，以便于使用者推拉调整支撑主体1的位置和角度。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这仅是举例说明，本发明的保护范围是由所附权利要求书限定的。本领域的技术人员在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改，但这些变更和修改均落入本发明的保护范围。

Claims (10)

  1. 一种管腔吻合支撑扩张器，其特征在于，包括：
    支撑主体，所述支撑主体由弹性材料或形状记忆材料制成，用于至少部分地置于管腔中以扩张管壁；
    连接杆，所述连接杆连接于所述支撑主体。
  2. 如权利要求1所述的管腔吻合支撑扩张器，其特征在于，所述连接杆上设置有多个所述支撑主体。
  3. 如权利要求2所述的管腔吻合支撑扩张器，其特征在于，所述连接杆的两端各设置有一所述支撑主体。
  4. 如权利要求2或3所述的管腔吻合支撑扩张器，其特征在于，所述支撑主体为回转体。
  5. 如权利要求4所述的管腔吻合支撑扩张器，其特征在于，所述支撑主体包括主体部，所述主体部的至少一端部设置有锥形部，所述锥形部的外径自所述主体部向外递减，所述主体部的最大外径大于所述锥形部的最大外径；
    和/或，所述连接杆两端的两个所述支撑主体的轴心线之间的夹角为0-180°。
  6. 如权利要求4或5所述的管腔吻合支撑扩张器，其特征在于，各个所述支撑主体的主体部的最大外径相同或不同。
  7. 如权利要求1至6中至少一项所述的管腔吻合支撑扩张器，其特征在于，所述管腔吻合支撑扩张器还包括操作杆，所述操作杆的端部连接于所述连接杆的中部。
  8. 如权利要求1至7中至少一项所述的管腔吻合支撑扩张器，其特征在于，所述连接杆可弯折，以使得不同所述支撑主体之间的相对位置可调。
  9. 如权利要求1至8中至少一项所述的管腔吻合支撑扩张器，其特征在于，所述支撑主体设置有中空腔，所述支撑主体的一端开设有与所述中空腔相连通的通孔；或，所述支撑主体的两端分别开设有与所述中空腔相连通的通孔。
  10. 如权利要求9所述的管腔吻合支撑扩张器，其特征在于，所述连接杆开设有流体通道，所述流体通道与所述支撑主体的所述中空腔相连通。
PCT/CN2021/104574 2020-07-28 2021-07-05 管腔吻合支撑扩张器 WO2022022235A1 (zh)

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EP21851425.5A EP4190284A1 (en) 2020-07-28 2021-07-05 Lumen anastomosis support dilator
JP2023504501A JP2023535574A (ja) 2020-07-28 2021-07-05 管腔吻合サポート拡張器
US18/016,781 US20230285022A1 (en) 2020-07-28 2021-07-05 Lumen anastomosis supporting dilator

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CN202021522078.7U CN213030943U (zh) 2020-07-28 2020-07-28 管腔吻合支撑扩张器
CN202010735867.7A CN111714261A (zh) 2020-07-28 2020-07-28 管腔吻合支撑扩张器
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5036868A (en) * 1990-01-29 1991-08-06 Unilink Inc. Anastomosis preparation technique
US6030395A (en) * 1997-05-22 2000-02-29 Kensey Nash Corporation Anastomosis connection system
US20080009936A1 (en) * 2006-05-05 2008-01-10 Eidosmed, Llc Stent device for anastomoses of blood vessels and other tubular organs
CN102475559A (zh) * 2010-11-22 2012-05-30 山东超瑞施生物磁学工程技术研究中心 血管和管状器官扩张吻合器械
CN109528258A (zh) * 2018-12-18 2019-03-29 深圳市远为医疗技术有限公司 一种血管吻合支撑扩张器
CN109793580A (zh) * 2019-01-26 2019-05-24 深圳市远为医疗技术有限公司 血管吻合术固定支撑装置及其操作方法
CN111714261A (zh) * 2020-07-28 2020-09-29 上海火点医疗器械有限公司 管腔吻合支撑扩张器
CN213030943U (zh) * 2020-07-28 2021-04-23 上海火点医疗器械有限公司 管腔吻合支撑扩张器

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5036868A (en) * 1990-01-29 1991-08-06 Unilink Inc. Anastomosis preparation technique
US6030395A (en) * 1997-05-22 2000-02-29 Kensey Nash Corporation Anastomosis connection system
US20080009936A1 (en) * 2006-05-05 2008-01-10 Eidosmed, Llc Stent device for anastomoses of blood vessels and other tubular organs
CN102475559A (zh) * 2010-11-22 2012-05-30 山东超瑞施生物磁学工程技术研究中心 血管和管状器官扩张吻合器械
CN109528258A (zh) * 2018-12-18 2019-03-29 深圳市远为医疗技术有限公司 一种血管吻合支撑扩张器
CN109793580A (zh) * 2019-01-26 2019-05-24 深圳市远为医疗技术有限公司 血管吻合术固定支撑装置及其操作方法
CN111714261A (zh) * 2020-07-28 2020-09-29 上海火点医疗器械有限公司 管腔吻合支撑扩张器
CN213030943U (zh) * 2020-07-28 2021-04-23 上海火点医疗器械有限公司 管腔吻合支撑扩张器

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