WO2024021376A1 - 一种经导管微创血管自动吻合装置 - Google Patents

一种经导管微创血管自动吻合装置 Download PDF

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Publication number
WO2024021376A1
WO2024021376A1 PCT/CN2022/132780 CN2022132780W WO2024021376A1 WO 2024021376 A1 WO2024021376 A1 WO 2024021376A1 CN 2022132780 W CN2022132780 W CN 2022132780W WO 2024021376 A1 WO2024021376 A1 WO 2024021376A1
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WIPO (PCT)
Prior art keywords
push rod
transcatheter
minimally invasive
sheath
automatic
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PCT/CN2022/132780
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English (en)
French (fr)
Inventor
张鲁锋
傅元豪
韩会进
董睿涵
陈裕伦
Original Assignee
北京心联路易医疗科技有限公司
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Publication of WO2024021376A1 publication Critical patent/WO2024021376A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on 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
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels

Definitions

  • the present application relates to the technical field of surgical vascular suturing instruments, and in particular to an automatic transcatheter minimally invasive vascular anastomosis device.
  • the general process is to first connect a bridging blood vessel to the epicardial coronary artery, then make a hole in the aorta, and connect and anastomose the bridging blood vessel to the opening in the aorta. , thereby realizing the bypass between the coronary blood vessels and the aorta.
  • the procedure generally involves incising or puncturing the aortic vessel wall at a selected anastomosis location or site, and then suturing a bridging vessel around the puncture to establish fluid (blood) communication between the lumens of the two vessels.
  • This application provides an automatic transcatheter minimally invasive vascular anastomosis device, which solves the problems of surgical vascular anastomosis using a clamp to clamp the host blood vessel to punch holes and suture the transplanted bypass blood vessel, which is difficult and risky, and can reduce the difficulty of the vascular anastomosis surgery. , providing safer surgical conditions.
  • An automatic transcatheter minimally invasive vascular anastomosis device including: a vascular stapler, a loading sheath assembly, a protective sheath assembly and a push rod assembly;
  • the protective sheath assembly is detachably disposed on the channel sheath, and the protective sheath assembly is configured as a protective channel for the entry and exit of surgical instruments and graft vessels;
  • the loading sheath assembly is detachably disposed on the protective sheath assembly, and the surgical instrument provided at the end of the loading sheath is transported to the vascular surgery site through a protective channel formed by the protective sheath assembly. ;
  • the vascular stapler is releasably disposed at the end of the loading sheath assembly and is drivingly connected to the push rod assembly, and the push rod assembly is detachably disposed on the loading sheath assembly, and driving the blood vessel suturing device to operably perform a suturing operation on the host blood vessel wall.
  • it also includes: a suture needle;
  • the vascular stapler is provided with a suture needle.
  • the suture needle punctures the inner wall of the blood vessel at a set angle, and the vascular stapler is operably controlled to pierce the inner wall of the blood vessel at a set angle.
  • the host vessel wall is sutured;
  • the suture needle is connected to a flexible suture, one end of the flexible suture is connected to the end of the suture needle, and the other end of the flexible suture is connected to the bypass blood vessel to be transplanted;
  • the push rod assembly drives the vascular stapler to retract, so that the vascular stapler is stored in the protective sheath assembly.
  • the protective sheath assembly includes: a protective sheath, a first exhaust cap and a first exhaust valve;
  • a first guide through hole is provided in the protective sheath, and one end of the loading sheath is detachably disposed in the protective sheath along the first guide through hole;
  • An end of one end of the protective sheath is adjustably covered with the first exhaust cap to adjust the sealing property of the protective sheath;
  • the first exhaust valve is provided on the first exhaust cap to discharge residual gas from the protective sheath.
  • the loading sheath assembly includes: a loading sheath, a second exhaust cap and a second exhaust valve;
  • a second guide through hole is provided in the loading sheath, and one end of the push rod is detachably located in the loading sheath along the second guide through hole;
  • An end of one end of the loading sheath is adjustably covered with the second exhaust cap to adjust the sealing of the loading sheath;
  • the second exhaust valve is provided on the second exhaust cap to discharge residual gas from the loading sheath.
  • the push rod assembly includes: a push rod and a push handle;
  • One end of the push rod is detachably disposed on the loading sheath, and the other end of the push rod is provided with a push handle.
  • the vascular suturing device includes: a needle holder and a needle groove;
  • the lancet stent includes: a first sliding barrel, a second sliding barrel and an expansion stent; one end of the expansion stent is connected to one end of the first sliding barrel, and the other end of the expansion stent is connected to the second One end of the sliding barrel is connected, the first sliding barrel is sleeved on the end of the push rod, and the second sliding barrel is slidably disposed in the end of the loading sheath;
  • a plurality of needle grooves are arranged around the expansion stent, the needle body of the suture needle is inserted into the needle groove, and the needle tip of the suture needle points to the push handle of the push rod.
  • the first sliding tube is driven away from the second sliding tube to stretch the expansion stent and shrink the expansion stent into a cylindrical structure
  • the expansion stent When the push rod drives the first sliding tube to pull back in the direction of the second sliding tube, the expansion stent is squeezed and opens according to the preset structure, so that the multiple expansion brackets provided on the expansion stent are The suturing needles are evenly distributed in an annular shape around the end of the loading sheath.
  • first symmetrical through holes are provided on both sides of the first sliding tube, and the first sliding tube is connected to the push rod pin through the first symmetrical through hole;
  • a second symmetrical through hole is provided on both sides of the second sliding barrel, and the second sliding barrel is pin-connected to the end of the loading sheath through the second symmetrical through hole.
  • the end of the push rod is provided with a sliding guide groove, and one end of the pin connecting the second slide tube and the end of the loading sheath passes through the sliding guide groove to adjust the push rod shaft. Limit the sliding displacement and radial movement angle.
  • the expansion stent includes: a first wing frame, a second wing frame and a connecting frame;
  • the first wing frame and the second wing frame have the same structure.
  • the connecting frame is provided on the outer edge, and the first wing frame and the second wing frame are symmetrically connected through the connecting frame;
  • the first wing frame is connected to the first sliding tube.
  • the first wing frame contracts along the axial direction of the first sliding tube to form a cylindrical structure;
  • the second wing frame is connected to the second sliding tube, and when the second wing frame is subjected to a tensile force, it shrinks into a cylindrical structure along the axial direction of the second sliding tube;
  • the first wing frame includes: a first connecting part, a second connecting part and a varicose frame;
  • a plurality of first connecting parts are evenly arranged on the circumference of the end of the first sliding tube.
  • One end of the first connecting part is connected to the first sliding tube, and the other end of the first connecting part is connected to the first sliding tube.
  • Two varicose frames are connected, and each varicose frame is connected to the adjacent varicose frame connected to the first connecting portion. When the first wing frame is opened, the two adjacent varicose frames are connected to each other.
  • a connecting part forms a rhombus structure with the varicose skeleton;
  • the second connecting part is connected to the connection point between the two varicose skeletons, and the second connecting part is used to connect the connecting skeleton;
  • the thickness and/or width of the first connecting part and the second connecting part are smaller than that of the varicose skeleton.
  • the first connecting part and the second connecting part are made of memory metal material.
  • the first wing frame and the second wing frame respectively adopt 8 first connecting parts, 8 second connecting parts and 16 varicose frames;
  • first wing frame and the second wing frame When the first wing frame and the second wing frame are unfolded, they form an eight-pointed star structure.
  • the expansion stent is an integrally formed structure.
  • the needle groove has a cylindrical structure, and an axial gap is provided on the side wall of the needle groove, and the axial gap is used for the entry and exit operation channel of the suture needle and the flexible suture thread.
  • the needle groove is axially arranged on the connecting frame.
  • the side walls of the needle groove are symmetrically provided with long notches, and protrusions are provided on both sides of the connecting frame.
  • the protrusions are engaged. in said long notch.
  • it also includes: a cutting component
  • the cutting assembly is detachably disposed on the protective sheath assembly, and is used to perform opening and cutting on the anastomotic portion of the outer wall of the host blood vessel and the bypass blood vessel to be transplanted after the blood vessel stapler enters the host blood vessel.
  • the cutting assembly includes: a cutting catheter, a pipe sleeve and a cutter head;
  • the cutting conduit is a long hollow tube, a pipe sleeve is set on the outer wall of one end of the cutting conduit, the cutter head is arranged on the pipe sleeve, and the tip of the cutter head points toward the cutting conduit. another side.
  • the cutting catheter is provided with an axial opening, and the axial opening is used for the inlet and outlet operation channels of the suture needle and the flexible suture thread.
  • the present application provides an automatic transcatheter minimally invasive vascular anastomosis device, in which a loading sheath is detachably installed on a protective sheath assembly.
  • the end of the loading sheath assembly is provided with a vascular stapler, and the push rod assembly is detachable.
  • the insertion ground is provided on the loading sheath assembly to drive the blood vessel suturing device to attach the bypass blood vessel to be transplanted to the outer wall of the host blood vessel and perform suturing. It solves the problem of high difficulty and high risk in surgical vascular anastomosis, which uses clamps to clamp host blood vessels to drill holes and suture grafted bypass vessels. It can reduce the difficulty of vascular anastomosis surgery and provide safer surgical conditions.
  • Figure 1 is a schematic diagram of a transcatheter minimally invasive automatic vascular anastomosis device provided by this application.
  • Figure 2 is a schematic cross-sectional view of Figure 1 provided by this application.
  • FIG. 3 is an unfolded schematic diagram of an automatic anastomosis device provided by this application.
  • Figure 4 is a schematic diagram of the contraction of an automatic anastomosis device provided by this application.
  • Figure 5 is a schematic structural diagram of a blood vessel suturing device provided by an embodiment of the present application.
  • Figure 6 is a schematic diagram of the installation structure of the vascular suturing device provided by the embodiment of the present application.
  • Figure 7 is a schematic cross-sectional view of Figure 6 provided by an embodiment of the present application.
  • Figure 8 is a schematic structural diagram of a lancet holder provided by an embodiment of the present application.
  • Figure 9 is a schematic structural diagram of an expansion stent provided by an embodiment of the present application.
  • Figure 10 is a schematic diagram of the connection between the expansion stent and the connecting frame provided by the embodiment of the present application.
  • Figure 11 is a schematic front view of the needle slot provided by the embodiment of the present application.
  • Figure 12 is a schematic top view of the needle slot provided by the embodiment of the present application.
  • Figure 13 is a schematic cross-sectional view of the vascular stapler in a contracted state according to an embodiment of the present application.
  • Figure 14 is a partial enlarged view of Figure 13 provided by the embodiment of the present application.
  • Figure 15 is a schematic diagram of the contraction of the lancet stent provided by the embodiment of the present application.
  • Figure 16 is a schematic side view of Figure 15 provided by an embodiment of the present application.
  • Figure 17 is a schematic structural diagram of the cutting assembly provided by this application.
  • Figure 18 is a schematic cross-sectional view of Figure 17 provided by the embodiment of the present application.
  • Figure 19 is a schematic top view of Figure 17 provided by an embodiment of the present application.
  • Figure 20 is a schematic side view of Figure 17 provided by the embodiment of the present application.
  • Figure 21 is a schematic cross-sectional view of the front end of the cutting catheter provided by the embodiment of the present application.
  • vascular anastomosis In view of the current problems of vascular anastomosis in surgical arterial bridge grafting, which uses clamps to clamp the host blood vessel for drilling and suturing to transplant the bypass blood vessel, which is difficult and risky.
  • This application provides a transcatheter minimally invasive automatic vascular anastomosis device to solve the problem of surgical anastomosis.
  • Vascular anastomosis uses a clamp to clamp the host blood vessel for drilling and suturing to transplant the bypass vessel, which has the problem of high difficulty and high risk. However, it can reduce the difficulty of vascular anastomosis and provide safer surgical conditions.
  • an automatic transcatheter minimally invasive vascular anastomosis device includes: a vascular suturing device 100, a loading sheath assembly 300, a protective sheath assembly 400 and a push rod assembly 200.
  • a channel sheath is provided during vascular surgery to construct an access channel through the wall of the host blood vessel.
  • the protective sheath assembly 400 is detachably disposed on the channel sheath, and the protective sheath assembly 400 is configured as a protective channel for the entry and exit of surgical instruments and graft vessels.
  • the loading sheath assembly 300 is detachably disposed on the protective sheath assembly 400, and the surgical instruments provided at the end of the loading sheath are transported to the protective channel through the protective channel formed by the protective sheath assembly 400.
  • Vascular surgery location The vascular stapler 100 is releasably disposed at the end of the loading sheath assembly and is drivingly connected to the push rod assembly 200.
  • the push rod assembly 200 is detachably disposed at the loading sheath assembly. on the assembly 300, and drives the blood vessel suturing device 100 to operably perform a suturing operation on the host blood vessel wall.
  • the host blood vessel is first punctured through the channel sheath, the loading sheath assembly sends the vascular stapler to the surgical position through the protective channel formed by the protective sheath assembly, and the push rod assembly is driven and set on the loading sheath.
  • the vascular stapler on the component passes through the outer wall of the host blood vessel and enters the host blood vessel.
  • the push rod assembly is operable to control the vascular stapler to open, puncture, suture or contract. After suturing, the push rod assembly drives the vascular stapler to contract, so that the vascular stapler follows the loading sheath assembly and is stored in the protective sheath assembly.
  • the blood vessel After the blood vessel is punctured, due to the extensibility and tension of the outer wall of the blood vessel, the blood vessel will bleed very little. At the same time, the outer wall of the blood vessel and the protective sheath assembly will fit together and the blood will not overflow to the outside. Moreover, the vascular stapler is directly sent into the host blood vessel, and the push rod assembly allows the vascular stapler to operate from the inside out, which can solve the operational difficulty and difficulty of using a clamp to clamp the host blood vessel for drilling and suturing the grafted bypass blood vessel during surgical vascular anastomosis. High-risk problems can reduce the difficulty of vascular anastomosis surgery and provide safer surgical conditions.
  • the device also includes: a suture needle 500; the suture needle 500 is provided on the vascular suturing device 100, and when the push rod assembly drives the vascular suturing device to open, the suturing needle It punctures the inner wall of the blood vessel at a set angle, and operatively controls the blood vessel suturing device to perform a suturing operation on the host blood vessel wall.
  • the suture needle 500 is connected to a flexible suture 700. One end of the flexible suture 700 is connected to the end of the suture needle 500, and the other end of the flexible suture 700 is connected to the bypass blood vessel to be transplanted.
  • the push rod assembly drives the vascular stapler to retract, so that the vascular stapler is stored in the protective sheath assembly.
  • the vascular stapler when the vascular stapler is opened, the needle tip of the suture needle is aligned with the inner wall of the host blood vessel. Under the pull of the push rod assembly, the vascular stapler is driven to pull back, so that the suture needle penetrates the blood vessel wall. The operator can pull Remove the suture needle from the vascular stapler and perform the suturing operation. After suturing, the push rod assembly drives the vascular stapler to shrink and pulls back the loading sheath, so that the vascular stapler is stored in the protective sheath assembly and then withdrawn from the protective sheath.
  • This device enables the suture needle to puncture from the inside of the host blood vessel to the outside during blood vessel suturing surgery, which can reduce the difficulty of suturing and reduce the risks of surgical operations.
  • the push rod assembly 200 includes: a push rod 201 and a push handle 202.
  • One end of the push rod 201 is detachably disposed on the loading sheath 301 , and the other end of the push rod 201 is provided with a push handle 202 .
  • the loading sheath assembly 300 includes: a loading sheath 301 , a second exhaust cap 303 and a second exhaust valve 302 .
  • the loading sheath 301 is provided with a second guide through hole, and one end of the push rod 201 is detachably disposed in the loading sheath 301 along the second guide through hole.
  • the second exhaust cap 303 is adjustably mounted on one end of the loading sheath 301 to adjust the air pressure in the loading sheath.
  • the second exhaust valve 302 is provided on the second exhaust cap 303 to perform pressure relief adjustment on the loading sheath.
  • the protective sheath assembly 400 includes: a protective sheath 401 , a first exhaust cap 403 and a first exhaust valve 402 .
  • the protective sheath 401 is provided with a first guide through hole, and one end of the loading sheath 301 is detachably disposed in the protective sheath 401 along the first guide through hole.
  • the first exhaust cap 403 is adjustably mounted on one end of the protective sheath 401 to adjust the air pressure within the protective sheath.
  • the first exhaust valve 402 is provided on the first exhaust cap 403 to perform pressure relief adjustment on the protective sheath.
  • the loading sheath is detachably disposed in the protective sheath
  • the push rod is detachably disposed in the loading sheath.
  • the vascular stapler is releasably disposed at the end of the loading sheath and is drivingly connected to the push rod.
  • the vascular stapler is used to operably connect the graft bypass blood vessel to the host blood vessel for suturing.
  • the vascular stapler is provided with a suture needle. After the vascular stapler passes through the anastomosis hole, the push rod drives the vascular stapler to open so that the suture needle and the inner wall of the blood vessel form a set angle.
  • Puncture and then operatively control the blood vessel suturing device to attach the bypass blood vessel to be transplanted to the outer wall of the host blood vessel and suture it.
  • the push rod drives the vascular stapler to contract, so that the vascular stapler is stored in the loading sheath.
  • the suture needle 500 is connected to a flexible suture thread 700 , and one end of the flexible suture thread 700 passes through the second guide through hole and is connected to the end of the suture needle 500 .
  • the other end of the suture 700 is connected to the bypass vessel to be transplanted.
  • the protective sheath adopts a tubular structure
  • the first guide through hole is a circular through hole
  • the size of the vascular stapler and the loading sheath are smaller than the size of the first guide through hole, and they can be pulled out and inserted back and forth along the first guide through hole.
  • the puncture device punctures the outer wall of the host blood vessel through the first guide through hole in the protective sheath. After forming the puncture hole, the loading sheath and the vascular stapler slide along the first guide and pass through the puncture hole. Enter the host's blood vessels. The push rod pushes the vascular stapler to open so that the suture needle is at a certain angle with the inner wall of the blood vessel.
  • the needle of the suture needle points to the inner wall of the host blood vessel. Then the vascular stapler is pulled to make the suture needle penetrate the inner wall of the host blood vessel. The operator pulls the suture needle. Apply force to the suture and pull the bypass blood vessel to be transplanted to slide along the first guide through hole of the protective sheath, so that the connecting mask of the bypass blood vessel to be transplanted surrounds the puncture hole and fits the host blood vessel, and then passes through A suture needle is used to perform the suturing.
  • the push rod pushes the vascular suture device to contract, so that the vascular anastomosis device is stored in the protective sheath, and then moved out of the body, and then the protective sheath is removed to complete the anastomosis operation.
  • This device can solve the problem of high difficulty and high risk in surgical vascular anastomosis, which uses a clamp to clamp the host blood vessel to punch holes and suture the grafted bypass blood vessel. It can reduce the difficulty of the vascular anastomosis surgery and provide safer surgical conditions.
  • the vascular suturing device 100 includes: a lancet holder 110 and a needle slot 120.
  • the lancet holder 110 includes: a first sliding cylinder 111, a second sliding cylinder 112 and an expansion bracket 113; one end of the expansion bracket 113 is connected to one end of the first sliding cylinder 111, and the expansion bracket 113 has The other end is connected to one end of the second slide tube 112, the first slide tube 111 is sleeved on the end of the push rod 201, and the second slide tube 112 is slidably disposed on the loading within the end of sheath 301.
  • a plurality of needle slots are arranged around the expansion stent 113.
  • the needle body of the suture needle 500 is inserted into the needle slot 120.
  • the needle tip of the suture needle 500 is pointed toward the push rod 201.
  • the first sliding tube 111 is driven away from the second sliding tube 112 to stretch the expansion stent 113 , so that the expansion stent 113 Shrinks into a cylindrical structure.
  • the expansion bracket 113 is squeezed and opened according to the preset structure, so that the expansion bracket 113 is disposed on the expansion bracket 113 .
  • the plurality of suture needles 500 on the bracket 113 are evenly distributed in an annular shape around the end of the loading sheath 301 .
  • first symmetrical through holes 114 are provided on both sides of the first sliding tube 111 , and the first sliding tube 111 is pin-connected to the push rod 201 through the first symmetrical through holes 114 .
  • Second symmetrical through holes 115 are provided on both sides of the second sliding barrel 112 , and the second sliding barrel 112 is pin-connected to the end of the loading sheath 301 through the second symmetrical through holes 115 .
  • the end of the push rod 201 is provided with a sliding guide groove 205, and one end of the pin connected to the end of the second slide tube 112 and the loading sheath 301 passes through the sliding guide groove 205, so as to adjust the sliding guide groove 205.
  • the axial sliding displacement and radial movement angle of the push rod are limited.
  • the first sliding cylinder 111 and the second sliding cylinder 112 at both ends of the lancet holder 110 are respectively provided with a first symmetrical through hole 114 and a second symmetrical through hole.
  • the through hole 115 and the front end of the push rod 201 are provided with a sliding guide groove 205.
  • the length m of the sliding guide groove is greater than the distance required for the puncture needle holder to be retracted.
  • the front end of the lancet holder 110 and the front end of the push rod 201 are fixed (riveted, welded, bonded, etc.) together through the first pin 203 and the sleeve.
  • the inner side of the rear end of the puncture needle holder cooperates with the sliding guide groove 205 of the push rod 201 through the second pin 204, and the outer side is fixed with the front end of the transfer sheath tube.
  • the expansion bracket 113 includes: a first wing frame 1131 , a second wing frame 1132 and a connecting frame 1133 .
  • the first wing frame 1131 and the second wing frame 1132 have the same structure.
  • the connecting frame 1133 is provided on the outer edge of the triangular corresponding frame.
  • the first wing frame 1131 and the second wing frame 1132 are symmetrically connected through the connecting frame 1133 .
  • the first wing frame 1131 is connected to the first sliding tube 111.
  • first wing frame 1131 When the first wing frame 1131 is subjected to a tensile force, it contracts along the axial direction of the first sliding tube 111 to form a cylindrical structure.
  • the second wing frame 1132 is connected to the second sliding tube 112. When the second wing frame 1132 is subjected to a tensile force, it contracts along the axial direction of the second sliding tube 112 to form a cylindrical structure.
  • the push rod 201 drives the first sliding tube 111 to slide, the first wing frame 1131 and the second wing frame 1132 are driven to expand or contract.
  • the first sliding tube 111 and the second sliding tube 112 at both ends are connected to the expansion stent 113 in the middle to form a whole.
  • the two sides of the middle expansion stent 113 are connected by multiple groups of diamond-shaped structures. This structure enables the stent to have stable radial support force.
  • the connecting frame 1133 on the outer periphery of the middle expansion stent 113 is provided with a needle groove 120 .
  • the first wing frame 1131 includes: a first connecting part 11311 , a second connecting part 11312 and a varicose frame 11313 .
  • a plurality of first connecting parts 11311 are evenly arranged on the circumference of the end of the first sliding tube 111.
  • One end of the first connecting parts 11311 is connected to the first sliding tube 111.
  • the first connecting part 11311 is connected to the first sliding tube 111.
  • Two varicose frames 11313 are connected to the other end of the first connecting part 11311.
  • Each varicose frame 11313 is connected to the varicose frame 11313 connected to the adjacent first connecting part 11311.
  • first connecting parts 11311 and the varicose skeleton 11313 form a rhombus structure.
  • the second connecting part 11312 is connected to the connection between the two varicose skeletons 11313, and the second connecting part 11312 is used to connect the connecting skeleton 1133.
  • the first connecting portion 11311 and the second connecting portion 11312 undergo bending deformation.
  • the thickness and/or width of the first connecting part 11311 and the second connecting part 11312 are smaller than the varicose frame 11313 , so that when the first wing frame is subjected to extrusion force, The first connecting part and the second connecting part are first bent and deformed, and then opened according to a preset structure. Correspondingly, when the first wing frame is stretched, the first connecting part and the second connecting part return to their original shapes, so that the first wing frame is stored in a tubular structure.
  • first connection part and the second connection part are made of memory metal material.
  • first wing frame and the second wing frame respectively adopt 8 first connecting parts, 8 second connecting parts and 16 varicose frames.
  • first wing frame and the second wing frame When the first wing frame and the second wing frame are unfolded, they form an eight-pointed star structure.
  • the lancet holder is an integrally formed structure.
  • the lancet holder can be integrally formed using tubular materials and assume a cylindrical structure when contracted and a star-shaped structure when expanded.
  • a soft rubber head 600 can be provided at the end of the vascular suturing device, and the soft rubber head is set at the first
  • the end of the slide tube 111 can be fixed by bonding.
  • the needle groove 120 has a cylindrical structure, and an axial gap 123 is provided on the side wall of the needle groove 120.
  • the axial gap 123 is used for the suture needle and the flexible suture.
  • the needle groove 120 is axially provided on the connecting frame 1133 .
  • long slots 121 are symmetrically provided on the side walls of the needle slot 120, and protrusions are provided on both sides of the connecting frame. When the needle slot 120 is clamped on the connecting frame 1133 , the protrusion is stuck in the long slot 121 .
  • two long slots 121 are provided at the bottom of the needle slot 120 .
  • the protrusions on both sides of the connecting frame 1133 of the expansion stent in the middle cooperate with the long slot, so that the needle slot 120 and the lancet holder 110 are locked and fixed together.
  • other methods of connection such as welding or plugging, can also be used.
  • the upper part of the needle tube is provided with an axial gap 123, and the axial gap 123 can make the needle groove 120 have a certain elasticity.
  • the suture needle 500 and the suture thread 700 can be stably connected in the needle groove 120 through the axial gap 123, and are also easy to remove and insert.
  • An opening groove 122 is provided at the rear of the needle tube. The opening groove 122 makes the rear part of the needle groove 120 elastic, which can facilitate extrusion and deformation and prevent the puncture needle from being displaced or dislodged from the rear part of the needle tube.
  • the device further includes: a cutting component; the cutting component is detachably disposed on the protective sheath component, and is used for cutting the outer wall of the host blood vessel and the bypass to be transplanted after the vascular stapler enters the host blood vessel.
  • the anastomotic part of the blood vessel is cut open.
  • the cutting assembly includes: a cutting catheter 800, a sleeve 810 and a cutter head 900.
  • the cutting catheter 800 is a long hollow tube, and a sleeve 810 is set on the outer wall of one end of the cutting catheter 800.
  • the cutter head 900 is disposed on the sleeve 810, and the cutter head 900 is The tip points to the other end of the cutting catheter.
  • one end of the cutting catheter 800 penetrates the channel sheath and sends the cutter head into the host blood vessel.
  • the cutting catheter 800 is pulled back.
  • the catheter drives the cutter head to pierce the host blood vessel wall from the inside out, and rotates the cutting catheter so that the cutter head cuts a round hole as a host blood vessel bleeding hole in the host blood vessel wall isolated by the bypass vessel to be transplanted, Then, the bypass blood vessel to be transplanted is connected to the bleeding hole on the host blood vessel wall through a flexible suture.
  • the cutting catheter is a long hollow tube, and the graft blood vessel and the flexible suture are passed through the cutting catheter.
  • the cutting catheter, the flexible suture, and the bypass vessel to be transplanted enter the host blood vessel through the channel sheath, and then the channel sheath is withdrawn from the host blood vessel.
  • the cutting catheter is inserted into the host vessel wall while the remaining portion remains outside the host vessel wall. Tightening the flexible suture drives the wall of the vessel to be transplanted to fit into the inner wall of the host vessel to achieve hemostasis and isolation.
  • the cutting catheter is pulled back, and the tip blade of the cutter head at its end pierces the host blood vessel wall from the inside out.
  • the cutting catheter 800 is provided with an axial opening, which is used for the inlet and outlet operation channels of the suture needle and the flexible suture thread.
  • the cutting catheter is composed of a catheter 800, a sleeve 810 and a pin 820.
  • the entire cutting catheter is provided with an axial opening of A°, including both the catheter and the front end sleeve.
  • a boss 811 is provided at the position where the cutting knife is installed on the pipe sleeve, and a slot 901 is provided at the handle of the cutter head 900 . Through the cooperation of the boss 811 and the slot 901, the cutting knife and the pipe sleeve are locked together.
  • the pipe sleeve 810 and the conduit 800 are provided with a through hole, and the pin 820 is fixed at the through hole to fix the positions of the pipe sleeve and the conduit.
  • the cutting knife is equipped with a bidirectional blade, which can achieve bidirectional cutting.
  • the present application provides an automatic transcatheter minimally invasive vascular anastomosis device.
  • a loading sheath is provided in a protective sheath. The end of the loading sheath is provided with a vascular stapler.
  • a push rod is detachably provided on the loading sheath.
  • the vascular suturing device is driven to open or contract, so that the suturing needle provided on the vascular suturing device and the inner wall of the blood vessel are punctured and sutured at a set angle. It solves the problem of high difficulty and high risk in surgical vascular anastomosis, which uses clamps to clamp host blood vessels to drill holes and suture grafted bypass vessels. It can reduce the difficulty of vascular anastomosis surgery and provide safer surgical conditions.

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Abstract

一种经导管微创血管自动吻合装置，包括:血管缝合器(100)、装载鞘管组件(300)、保护鞘管组件(400)和推送杆组件(200)。在血管手术时设置通道鞘管，以构造为穿过宿主血管壁的进出通道。保护鞘管组件(400)可拔插地设置在通道鞘管上，保护鞘管组件(400)被构造为手术器械及移植血管进出的保护通道。装载鞘管组件(300)可拔插地设置在保护鞘管组件(400)上，并通过保护鞘管组件(400)形成的保护通道将设置在装载鞘管端部的手术器械输送至血管手术位置。血管缝合器(100)可开合地设置在装载鞘管组件的端部，并与推送杆组件(200)传动连接，推送杆组件(200)可拔插地设置在装载鞘管组件(300)上，并驱动血管缝合器(100)可操作地对宿主血管壁进行缝合操作。经导管微创血管自动吻合装置能降低血管吻合手术的难度，提供更为安全的外科手术条件。

Description

一种经导管微创血管自动吻合装置 技术领域
本申请涉及外科血管缝合器械的技术领域，尤其涉及一种经导管微创血管自动吻合装置。
背景技术
心肌缺血患者需要进行心脏冠状动脉旁路移植手术，一般过程是先在心外膜的冠状动脉上连接一根桥接血管，然后在主动脉上开孔，将桥接血管与主动脉上的开口连接吻合，从而实现冠状动脉血管与主动脉之间的搭桥。该手术一般涉及在选定的吻合位置或部位处切开或刺穿主动脉血管壁，然后将桥接血管缝合在穿孔周围，以便在两个血管的管腔之间建立流体(血液)连通。由于主动脉内血液压力高、流动速度快，直接在主动脉上开孔将会导致大出血，因此在传统冠状动脉心脏旁路移植手术中，需要首先使用侧壁钳夹住一部分主动脉，隔离出一小部分无血液流动的主动脉组织，然后使用打孔器在该部分主动脉壁上打孔，并完成与移植旁路血管的连接。但是对于微创搭桥手术，患者身体上的开孔很小，操作空间受限，而侧壁钳的体积较大，在微创心脏手术中使用极不方便且危险较高，导致在主动脉上开孔和吻合移植旁路血管成为难题。尽管在外科血管吻合术领域有大量的教导和实践，然而至少鉴于与之相关的上述问题，仍需要开发和实践外科血管吻合手术中使用的新器械和改进的方法。因此，如何开发和实践使用无夹具器械和方法来执行外科血管吻合术，进而改进手术过程，具有重要的研究意义。
发明内容
本申请提供一种经导管微创血管自动吻合装置，解决外科血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，能降低血管吻合手术的难度，提供更为安全的外科手术条件。
为实现以上目的，本申请提供以下技术方案：
一种经导管微创血管自动吻合装置，包括：血管缝合器、装载鞘管组 件、保护鞘管组件和推送杆组件；
在血管手术时设置通道鞘管，以构造为穿过宿主血管壁的进出通道；
所述保护鞘管组件可拔插地设置在所述通道鞘管上，所述保护鞘管组件被构造为手术器械及移植血管进出的保护通道；
所述装载鞘管组件可拔插地设置在所述保护鞘管组件上，并通过所述保护鞘管组件形成的保护通道将设置在所述装载鞘管端部的手术器械输送至血管手术位置；
所述血管缝合器可开合地设置在所述装载鞘管组件的端部，并与所述推送杆组件传动连接，所述推送杆组件可拔插地设置在所述装载鞘管组件上，并驱动所述血管缝合器可操作地对宿主血管壁进行缝合操作。
优选的，还包括：缝合针；
所述血管缝合器上设置有缝合针，在所述推送杆组件驱动所述血管缝合器张开时，使所述缝合针与血管内壁呈设定角度穿刺，并可操作地控制所述血管缝合器对宿主血管壁进行缝合操作；
所述缝合针连接有柔性缝合线，所述柔性缝合线的一端与所述缝合针的端部连接，所述柔性缝合线的另一端与待移植旁路血管连接；
在缝合后，所述推送杆组件驱动所述血管缝合器回缩，以使所述血管缝合器收纳于所述保护鞘管组件内。
优选的，所述保护鞘管组件包括：保护鞘管、第一排气帽和第一排气阀；
所述保护鞘管内设有第一导向通孔，所述装载鞘管的一端沿所述第一导向通孔可拔插地设置在所述保护鞘管内；
所述保护鞘管一端的端部可调节地套设有所述第一排气帽，以调节所述保护鞘管的密封性；
所述第一排气帽上设有所述第一排气阀，以对所述保护鞘管进行残余气体排放。
优选的，所述装载鞘管组件包括：装载鞘管、第二排气帽和第二排气阀；
所述装载鞘管内设有第二导向通孔，所述推送杆的一端沿所述第二导 向通孔可拔插地设在所述装载鞘管内；
所述装载鞘管一端的端部可调节地套设有所述第二排气帽，以调节所述装载鞘管的密封性；
所述第二排气帽上设有所述第二排气阀，以对所述装载鞘管进行残余气体排放。
优选的，所述推送杆组件包括：推送杆和推送手柄；
所述推送杆的一端可拔插地设置在所述装载鞘管上，所述推送杆的另一端设有推送手柄。
优选的，所述血管缝合器包括：刺针支架和针槽；
所述刺针支架包括：第一滑筒、第二滑筒和扩张支架；所述扩张支架的一端与所述第一滑筒的一端部相连接，所述扩张支架的另一端与所述第二滑筒的一端部相连接，所述第一滑筒套设在所述推送杆的端部，所述第二滑筒可滑动地设置在所述装载鞘管的端部内；
多个所述针槽环绕设置在所述扩张支架上，所述缝合针的针体部插接在所述针槽内，所述缝合针的针尖部指向所述推送杆的设置所述推送手柄的一端；
在所述推送杆沿所述装载鞘管向前推送时，带动所述第一滑筒远离所述第二滑筒，以拉伸所述扩张支架，使所述扩张支架收缩呈筒状结构；
在所述推送杆驱动所述第一滑筒向所述第二滑筒方向回拉时，所述扩张支架受挤压力并按预设结构张开，使设置在所述扩张支架上的多个所述缝合针呈环状均布在所述装载鞘管端部的周边。
优选的，所述第一滑筒的两侧设有第一对称通孔，所述第一滑筒通过第一对称通孔与所述推送杆销轴连接；
所述第二滑筒的两侧设有第二对称通孔，所述第二滑筒通过所述第二对称通孔与所述装载鞘管端部销轴连接。
优选的，所述推送杆的端部设有滑行导槽，所述第二滑筒与所述装载鞘管端部连接的销轴的一端贯穿所述滑行导槽，以对所述推送杆轴向滑动位移和径向活动角度进行限定。
优选的，所述扩张支架包括：第一翼架、第二翼架和连接骨架；
所述第一翼架与所述第二翼架为相同结构，所述第一翼架和所述第二翼架受挤压力时曲张呈星形结构，并在每个星三角对应骨架的外缘上设置有所述连接骨架，所述第一翼架与所述第二翼架通过所述连接骨架对称连接；
所述第一翼架与所述第一滑筒相连接，所述第一翼架受拉伸力时沿所述第一滑筒的轴向收缩成筒状结构；
所述第二翼架与所述第二滑筒相连接，所述第二翼架受拉伸力时沿所述第二滑筒的轴向收缩成筒状结构；
在所述推送杆驱动所述第一滑筒滑动时，带动所述第一翼架与所述第二翼架张开或收缩。
优选的，所述第一翼架包括：第一连接部、第二连接部和曲张骨架；
多个所述第一连接部均匀设置在所述第一滑筒端部的圆周上，所述第一连接部的一端与所述第一滑筒相连接，所述第一连接部的另一端连接有两个所述曲张骨架，每个所述曲张骨架与相邻的所述第一连接部连接的所述曲张骨架相连接，在所述第一翼架张开时，相邻两个所述第一连接部与所述曲张骨架形成菱形结构；
在两个所述曲张骨架相连接处连接有所述第二连接部，所述第二连接部用于连接所述连接骨架；
在所述第一翼架受力时，所述第一连接部和所述第二连接部产生弯曲变形。
优选的，所述第一连接部和所述第二连接部的厚度和/或宽度小于所述曲张骨架。
优选的，所述第一连接部和所述第二连接部采用记忆金属材料制备。
优选的，所述第一翼架和所述第二翼架分别采用8根所述第一连接部、8根所述第二连接部和16根所述曲张骨架；
在所述第一翼架和所述第二翼架张开时呈八角星结构。
优选的，所述扩张支架为一体成型结构。
优选的，所述针槽呈圆筒结构，所针槽的侧壁上设有轴向豁口，所述轴向豁口用于所述缝合针和所述柔性缝合线的进出操作通道。
优选的，所述针槽轴向设置在所述连接骨架上。
优选的，所述针槽的侧壁对称设置有长槽口，所述连接骨架的两侧设有凸起，在所述针槽卡接在所述连接骨架上时，所述凸起卡设在所述长槽口内。
优选的，还包括：切割组件；
所述切割组件可拔插地设置在所述保护鞘管组件上，用于在所述血管缝合器进入宿主血管后，对宿主血管外壁与待移植旁路血管的吻合部分进行开孔切割。
优选的，所述切割组件包括：切割导管、管套和刀头；
所述切割导管为中空长管，管套套设在所述切割导管的一端头外侧壁上，所述刀头设置在所述管套上，且所述刀头的刀尖指向所述切割导管的另一端。
优选的，所述切割导管设有轴向开口，所述轴向开口用于所述缝合针和所述柔性缝合线的进出操作通道。
本申请提供一种经导管微创血管自动吻合装置，将装载鞘管可拔插地设置在保护鞘管组件上，所述装载鞘管组件的端部设有血管缝合器，推送杆组件可拔插地设置在所述装载鞘管组件上，以驱动所述血管缝合器将待移植旁路血管贴合在宿主血管外壁上并进行缝合。解决外科血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，能降低血管吻合手术的难度，提供更为安全的外科手术条件。
附图说明
为了更清楚地说明本申请的具体实施例，下面将对实施例中所需要使用的附图作简单地介绍。
图1是本申请提供的一种经导管微创血管自动吻合装置的示意图。
图2是本申请提供的图1的剖面示意图。
图3是本申请实提供的一种自动吻合装置的张开示意图。
图4是本申请提供的一种自动吻合装置的收缩示意图。
图5是本申请实施例提供的一种血管缝合器的结构示意图。
图6是本申请实施例提供的血管缝合器的安装结构示意图。
图7是本申请实施例提供的图6的剖面示意图。
图8是本申请实施例提供的刺针支架的结构示意图。
图9是本申请实施例提供的扩张支架的结构示意图。
图10是本申请实施例提供的扩张支架与连接骨架连接示意图。
图11是本申请实施例提供的针槽正视示意图。
图12是本申请实施例提供的针槽俯视示意图。
图13是本申请实施例提供的血管缝合器收缩状态的剖面示意图。
图14是本申请实施例提供的图13的局部放大图。
图15是本申请实施例提供的刺针支架收缩示意图。
图16是本申请实施例提供的图15的侧视示意图。
图17是本申请提供的切割组件的结构示意图。
图18是本申请实施例提供的图17的剖面示意图。
图19是本申请实施例提供的图17的俯视示意图。
图20本申请实施例提供的图17的侧视示意图。
图21本申请实施例提供的切割导管前端剖面示意图。
具体实施方式
为了使本技术领域的人员更好地理解本申请实施例的方案，下面结合附图和实施方式对本申请实施例作进一步的详细说明。
针对当前外科动脉桥接血管存在血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，本申请提供一种经导管微创血管自动吻合装置，解决外科血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，能降低血管吻合手术的难度，提供更为安全的外科手术条件。
如图1～21所示，一种经导管微创血管自动吻合装置，包括：血管缝合器100、装载鞘管组件300、保护鞘管组件400和推送杆组件200。在血管手术时设置通道鞘管，以构造为穿过宿主血管壁的进出通道。所述保护鞘管组件400可拔插地设置在所述通道鞘管上，所述保护鞘管组件400被构 造为手术器械及移植血管进出的保护通道。所述装载鞘管组件300可拔插地设置在所述保护鞘管组件400上，并通过所述保护鞘管组件400形成的保护通道将设置在所述装载鞘管端部的手术器械输送至血管手术位置。所述血管缝合器100可开合地设置在所述装载鞘管组件的端部，并与所述推送杆组件200传动连接，所述推送杆组件200可拔插地设置在所述装载鞘管组件300上，并驱动所述血管缝合器100可操作地对宿主血管壁进行缝合操作。
具体地，在进行血管移植手术时，首先通过通道鞘管穿刺宿主血管，装载鞘管组件通过保护鞘管组件形成的保护通道将血管缝合器送到手术位置，推送杆组件驱动设置在装载鞘管组件上的血管缝合器穿过宿主血管外壁，并进入宿主血管内。通过推送杆组件可操作地控制血管缝合器进行张开、穿刺、缝合或收缩。在缝合后，推送杆组件驱动血管缝合器收缩，使所述血管缝合器跟随所述装载鞘管组件收纳于所述保护鞘管组件内。由于对血管的穿刺后，由于血管外壁的延伸性和张力，会使血管流血量极少，同时，血管外壁与保护鞘管组件相贴合，不会将血液溢流到外面。而且血管缝合器直接送入宿主血管内，通过推送杆组件使血管缝合器自内向外进行操作，能解决外科血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，能降低血管吻合手术的难度，提供更为安全的外科手术条件。
如图5和图6所示，该装置还包括：缝合针500；所述血管缝合器100上设置有缝合针500，在所述推送杆组件驱动所述血管缝合器张开时，使所述缝合针与血管内壁呈设定角度穿刺，并可操作地控制所述血管缝合器对宿主血管壁进行缝合操作。所述缝合针500连接有柔性缝合线700，所述柔性缝合线700的一端与所述缝合针500的端部连接，所述柔性缝合线700的另一端与待移植旁路血管连接。在缝合后，所述推送杆组件驱动所述血管缝合器回缩，以使所述血管缝合器收纳于所述保护鞘管组件内。
在实际应用中，在血管缝合器张开时，使缝合针的针尖端对准宿主血管内壁，在推送杆组件拉动下，驱动血管缝合器回拉，使缝合针穿透血管壁，操作人员可通过拉动缝合针，使缝合针脱离血管缝合器，并进行缝合 手术。在缝合后，所述推送杆组件驱动所述血管缝合器收缩，并回拉装载鞘管，使所述血管缝合器收纳于所述保护鞘管组件内，进而撤出保护鞘管外。该装置能使血管缝合手术时，缝合针从宿主血管内向外穿刺，能减少缝合难度，减少手术操作风险。
如图1～5所示，所述推送杆组件200包括：推送杆201和推送手柄202。所述推送杆201的一端可拔插地设设置在所述装载鞘管301上，所述推送杆201的另一端设有推送手柄202。
如图1～4所示，所述装载鞘管组件300包括：装载鞘管301、第二排气帽303和第二排气阀302。所述装载鞘管301内设有第二导向通孔，所述推送杆201的一端沿所述第二导向通孔可拔插地设在所述装载鞘管301内。所述装载鞘管301一端的端部可调节地套设有所述第二排气帽303，以调节所述装载鞘管内气压。所述第二排气帽303上设有所述第二排气阀302，以对所述装载鞘管进行泄压调节。
进一步，如图1～4所示，所述保护鞘管组件400包括：保护鞘管401、第一排气帽403和第一排气阀402。所述保护鞘管401内设有第一导向通孔，所述装载鞘管301的一端沿所述第一导向通孔可拔插地设置在所述保护鞘管401内。所述保护鞘管401一端的端部可调节地套设有所述第一排气帽403，以调节所述保护鞘管内气压。所述第一排气帽403上设有所述第一排气阀402，以对所述保护鞘管进行泄压调节。
具体地，所述保护鞘管内可拔插地设有所述装载鞘管，所述装载鞘管内可拔插地设有所述推送杆。所述血管缝合器可开合地设置在所述装载鞘管的端部，并与所述推送杆传动连接，所述血管缝合器用于可操作地连接移植旁路血管至宿主血管的缝合。所述血管缝合器上设置有缝合针，在所述血管缝合器穿过所述吻合孔后，所述推送杆驱动所述血管缝合器张开，使所述缝合针与血管内壁呈设定角度穿刺，进而可操作地控制所述血管缝合器对待移植旁路血管贴合在宿主血管外壁上进行缝合。在缝合后，所述推送杆驱动所述血管缝合器收缩，以使所述血管缝合器收纳于所述装载鞘管内。
进一步，如图5所示，所述缝合针500连接有柔性缝合线700，所述 柔性缝合线700的一端贯穿所述第二导向通孔与所述缝合针500的端部连接，所述柔性缝合线700的另一端与待移植旁路血管连接。
具体地，保护鞘管采用管状结构，第一导向通孔为圆形通孔，血管缝合器和装载鞘管的尺寸比第一导向通孔的尺寸小，可沿第一导向通孔来回拔插。在进行血管移植时，穿刺器件通过保护鞘管内的第一导向通孔对宿主血管的外壁进行穿刺，形成穿刺孔后，装载鞘管和血管缝合器沿所述第一导向通过滑动并通过穿刺孔进入宿主血管内部。推送杆推动血管缝合器张开，使缝合针与血管内壁呈一定角度，其中缝合针的针头指向宿主血管内壁，然后拉动血管缝合器，使缝合针穿透宿主血管内壁，操作者拉动缝合针，使缝合线受力并拉动待移植旁路血管沿保护鞘管的第一导向通孔滑动，使待移植旁路血管的连接口罩围在穿刺孔上，并与宿主血管相贴合后，再通过缝合针进行缝合。在缝合后，所述推送杆推送血管缝合器进行收缩，以使所述血管吻保器收纳于所述保护鞘管内，进而移出体外，进而再移开保护鞘管，完成吻合手术。该装置能解决外科血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，能降低血管吻合手术的难度，提供更为安全的外科手术条件。
在一实施例中，如图5～10所示，所述血管缝合器100包括：刺针支架110和针槽120。所述刺针支架110包括：第一滑筒111、第二滑筒112和扩张支架113；所述扩张支架113的一端与所述第一滑筒111的一端部相连接，所述扩张支架113的另一端与所述第二滑筒112的一端部相连接，所述第一滑筒111套设在所述推送杆201的端部，所述第二滑筒112可滑动地设置在所述装载鞘管301的端部内。
多个所述针槽环绕设置在所述扩张支架113上，所述缝合针500的针体部插接在所述针槽120内，所述缝合针500的针尖部指向所述推送杆201设置所述推送手柄的一端。
在所述推送杆201沿所述装载鞘管301向前推送时，带动所述第一滑筒111远离所述第二滑筒112，以拉伸所述扩张支架113，使所述扩张支架113收缩呈筒状结构。
在所述推送杆201驱动所述第一滑筒111向所述第二滑筒112方向回 拉时，所述扩张支架113受挤压力并按预设结构张开，使设置在所述扩张支架113上的多个所述缝合针500呈环状均布在所述装载鞘管301端部的周边。
进一步，所述第一滑筒111的两侧设有第一对称通孔114，所述第一滑筒111通过第一对称通孔114与所述推送杆201销轴连接。
所述第二滑筒112的两侧设有第二对称通孔115，所述第二滑筒112通过所述第二对称通孔115与所述装载鞘管301端部销轴连接。
进一步，所述推送杆201的端部设有滑行导槽205，所述第二滑筒112与所述装载鞘管301端部连接的销轴的一端贯穿所述滑行导槽205，以对所述推送杆轴向滑动位移和径向活动角度进行限定。
在实际应用中，如图6～8所示，在刺针支架张开状态时，刺针支架110两端的第一滑筒111和第二滑筒112分别设有第一对称通孔114和第二对称通孔115，推送杆201前端设有滑行导槽205，滑行导槽的长度m大于穿刺针支架收放所需的距离。刺针支架110的前端与推送杆201前端通过第一销轴203和轴套固定(铆接，焊接，粘接等)在一起。穿刺针支架后端内侧通过第二销轴204与推送杆201的滑行导槽205配合，外侧与转载鞘管的前端固定在一起。通过移动推送杆201可实现穿刺针支架110的张开与收缩，同时第二销轴204也可防止穿刺针支架101旋转变形。
如图5～9所示，所述扩张支架113包括：第一翼架1131、第二翼架1132和连接骨架1133。所述第一翼架1131与所述第二翼架1132为相同结构，所述第一翼架1131和所述第二翼架1132受挤压力时曲张呈星形结构，并在每个星三角对应骨架的外缘上设置有所述连接骨架1133，所述第一翼架1131与所述第二翼架1132通过所述连接骨架1133对称连接。所述第一翼架1131与所述第一滑筒111相连接，所述第一翼架1131受拉伸力时沿所述第一滑筒111的轴向收缩成筒状结构。所述第二翼架1132与所述第二滑筒112相连接，所述第二翼架1132受拉伸力时沿所述第二滑筒112的轴向收缩成筒状结构。在所述推送杆201驱动所述第一滑筒111滑动时，带动所述第一翼架1131与所述第二翼架1132张开或收缩。
如图7～8所示，在刺针支架扩张状态时，结构为两端的第一滑筒111 和第二滑筒112连接着中部的扩张支架113，形成为一个整体。中部的扩张支架113的两侧面为多组菱形结构连接形成，该结构使支架具有稳定的径向支撑力，中部的扩张支架113外周的连接骨架1133上设有针槽120。
在一实施例中，如图9所示，所述第一翼架1131包括：第一连接部11311、第二连接部11312和曲张骨架11313。多个所述第一连接部11311均匀设置在所述第一滑筒111端部的圆周上，所述第一连接部11311的一端与所述第一滑筒111相连接，所述第一连接部11311的另一端连接有两个所述曲张骨架11313，每个所述曲张骨架11313与相邻的所述第一连接部11311连接的所述曲张骨架11313相连接，在所述第一翼架1131张开时，相邻两个所述第一连接部11311与所述曲张骨架11313形成菱形结构。在两个所述曲张骨架11313相连接处连接有所述第二连接部11312，所述第二连接部11312用于连接所述连接骨架1133。在所述第一翼架1131受力时，所述第一连接部11311和所述第二连接部11312产生弯曲变形。
进一步，如图10所示，所述第一连接部11311和所述第二连接部11312的厚度和/或宽度小于所述曲张骨架11313，以使所述第一翼架受挤压力时，所述第一连接部和所述第二连接部首先弯曲变形，进而按预设结构张开。相应地，在第一翼架受拉伸时，所述第一连接部和所述第二连接部恢复原状，使第一翼架收纳成筒状结构。
进一步，所述第一连接部和所述第二连接部采用记忆金属材料制备。
进一步，所述第一翼架和所述第二翼架分别采用8根所述第一连接部、8根所述第二连接部和16根所述曲张骨架。在所述第一翼架和所述第二翼架张开时呈八角星结构。
进一步，所述刺针支架为一体成型结构。在实际应用中，刺针支架可采用管状材料进行一体成型，在收缩状态时呈筒状结构，在扩张时呈星形结构。
进一步，如图3和图13所示，为了保护血管缝合器在拨插时触碰到血管内壁造成血管损伤，可在血管缝合器的端部设软胶头600，软胶头设置在第一滑筒111的端部，可通过粘接固定。
如图11和12所示，所述针槽120呈圆筒结构，所针槽120的侧壁上 设有轴向豁口123，所述轴向豁口123用于所述缝合针和所述柔性缝合线的进出操作通道。
进一步，所述针槽120轴向设置在所述连接骨架1133上。
在一实施例中，所述针槽120的侧壁对称设置有长槽口121，所述连接骨架的两侧设有凸起，在所述针槽120卡接在所述连接骨架1133上时，所述凸起卡设在所述长槽口121内。
在实际应用中，针槽120下部设有2个长槽口121。中部的扩张支架的连接骨架1133的两侧凸起与该长槽口配合，使针槽120与刺针支架110卡接固定在一起。当然，也可以采用其它方式连接，如焊接或插接。
针管上部设有轴向豁口123，轴向豁口123能够使针槽120具有一定的弹性。缝合针500与缝合线700通过该轴向豁口123，能够稳定的连接在针槽120内，同时也易于拔插。针管后部设有开口槽122，该开口槽122使针槽120后部具有弹性，能够便于挤压变形，防止穿刺针从针管后部移位或脱出。
进一步，该装置还包括：切割组件；所述切割组件可拔插地设置在所述保护鞘管组件上，用于在所述血管缝合器进入宿主血管后，对宿主血管外壁与待移植旁路血管的吻合部分进行开孔切割。
如图17～21所示，所述切割组件包括：切割导管800、管套810和刀头900。所述切割导管800为中空长管，管套810套设在所述切割导管800的一端头外侧壁上，所述刀头900设置在所述管套810上，且所述刀头900的刀尖指向所述切割导管的另一端。
在血管移植手术时，所述切割导管800的一端贯穿所述通道鞘管将所述刀头送入宿主血管内，在待移植旁路血管壁与宿主血管内壁贴合后，回拉所述切割导管，驱动所述刀头自内向外刺破宿主血管壁，旋转所述切割导管，使所述刀头在待移植旁路血管隔离的宿主血管壁上切出一个圆孔作为宿主血管出血孔，进而通过柔性缝合线将待移植旁路血管连接于宿主血管壁上的出血孔上。
具体地，切割导管为中空长管，将移植血管与柔性缝合线通过切割导管穿行。切割导管、柔性缝合线、待移植旁路血管一起自通道鞘管内进入 宿主血管后将通道鞘管退出宿主血管。切割导管将刀头进入宿主血管壁内而其余部分保持于宿主血管壁外。拉紧柔性缝合线驱动待移植血管壁与宿主血管内壁贴合，达到止血与隔离的作用。回拉切割导管，其端部的刀头的头端刀刃自内向外刺破宿主血管壁。旋转切割导管，使刀头在被移植血管隔离的宿主血管壁上切出一个圆孔作为宿主血管出血孔，此时撤除切割组件，并通过打结柔性缝合线将移植血管连接于宿主血管壁上的圆孔。
进一步，所述切割导管800设有轴向开口，所述轴向开口用于所述缝合针和所述柔性缝合线的进出操作通道。
在实际应用中，切割导管由导管800、管套810和销轴820组成。切割导管整体设有A°的轴向开口，包括导管和前端管套均有A°的开口。
管套安装切割刀处设有凸台811，刀头900手柄处设有开槽901。通过凸台811的与开槽901配合，切割刀与管套卡接在一起。
管套810与导管800设有通孔，销轴820固定在该通孔处，使管套与导管位置固定。同时，切割刀设有双向刃，可以实现双向切割。
可见，本申请提供一种经导管微创血管自动吻合装置，在保护鞘管内设置装载鞘管，所述装载鞘管的端部设有血管缝合器，推送杆可拔插地设置在所述装载鞘管内，以驱动所述血管缝合器张开或收缩，使设置在所述血管缝合器上的缝合针与血管内壁呈设定角度穿刺并缝合。解决外科血管吻合术采用夹具夹合宿主血管进行打孔和缝合移植旁路血管存在操作难度大和风险高的问题，能降低血管吻合手术的难度，提供更为安全的外科手术条件。
以上依据图示所示的实施例详细说明了本申请的构造、特征及作用效果，以上所述仅为本申请的较佳实施例，但本申请不以图面所示限定实施范围，凡是依照本申请的构想所作的改变，或修改为等同变化的等效实施例，仍未超出说明书与图示所涵盖的精神时，均应在本申请的保护范围内。

Claims (20)

  1. 一种经导管微创血管自动吻合装置，其特征在于，包括：血管缝合器、装载鞘管组件、保护鞘管组件和推送杆组件；
    在血管手术时设置通道鞘管，以构造为穿过宿主血管壁的进出通道；
    所述保护鞘管组件可拔插地设置在所述通道鞘管上，所述保护鞘管组件被构造为手术器械及移植血管进出的保护通道；
    所述装载鞘管组件可拔插地设置在所述保护鞘管组件上，并通过所述保护鞘管组件形成的保护路径将设置在所述装载鞘管端部的手术器械输送至血管手术位置；
    所述血管缝合器可开合地设置在所述装载鞘管组件的端部，并与所述推送杆组件传动连接，所述推送杆组件可拔插地设置在所述装载鞘管组件上，并驱动所述血管缝合器可操作地对宿主血管壁进行缝合操作。
  2. 根据权利要求1所述的经导管微创血管自动吻合装置，其特征在于，还包括：缝合针；
    所述血管缝合器上设置有缝合针，在所述推送杆组件驱动所述血管缝合器张开时，使所述缝合针与血管内壁呈设定角度穿刺，并可操作地控制所述血管缝合器对宿主血管壁进行缝合操作；
    所述缝合针连接有柔性缝合线，所述柔性缝合线的一端与所述缝合针的端部连接，所述柔性缝合线的另一端与待移植旁路血管连接；
    在缝合后，所述推送杆组件驱动所述血管缝合器回缩，以使所述血管缝合器收纳于所述保护鞘管组件内。
  3. 根据权利要求2所述的经导管微创血管自动吻合装置，其特征在于，所述推送杆组件包括：推送杆和推送手柄；
    所述推送杆的一端可拔插地设置在所述装载鞘管上，所述推送杆的另一端设有推送手柄。
  4. 根据权利要求3所述的经导管微创血管自动吻合装置，其特征在于，所述装载鞘管组件包括：装载鞘管、第二排气帽和第二排气阀；
    所述装载鞘管内设有第二导向通孔，所述推送杆的一端沿所述第二导向通孔可拔插地设在所述装载鞘管内；
    所述装载鞘管一端的端部可调节地套设有所述第二排气帽，以调节所述装载鞘管的密封性；
    所述第二排气帽上设有所述第二排气阀，以对所述装载鞘管进行残余气体排放。
  5. 根据权利要求4所述的经导管微创血管自动吻合装置，其特征在于，所述保护鞘管组件包括：保护鞘管、第一排气帽和第一排气阀；
    所述保护鞘管内设有第一导向通孔，所述装载鞘管的一端沿所述第一导向通孔可拔插地设置在所述保护鞘管内；
    所述保护鞘管一端的端部可调节地套设有所述第一排气帽，以调节所述保护鞘管的密封性；
    所述第一排气帽上设有所述第一排气阀，以对所述保护鞘管进行残余气体排放。
  6. 根据权利要求5所述的经导管微创血管自动吻合装置，其特征在于，所述血管缝合器包括：刺针支架和针槽；
    所述刺针支架包括：第一滑筒、第二滑筒和扩张支架；所述扩张支架的一端与所述第一滑筒的一端部相连接，所述扩张支架的另一端与所述第二滑筒的一端部相连接，所述第一滑筒套设在所述推送杆的端部，所述第二滑筒可滑动地设置在所述装载鞘管的端部内；
    多个所述针槽环绕设置在所述扩张支架上，所述缝合针的针体部插接在所述针槽内，所述缝合针的针尖部指向所述推送杆的设置所述推送手柄的一端；
    在所述推送杆沿所述装载鞘管向前推送时，带动所述第一滑筒远离所述第二滑筒，以拉伸所述扩张支架，使所述扩张支架收缩呈筒状结构；
    在所述推送杆驱动所述第一滑筒向所述第二滑筒方向回拉时，所述扩张支架受挤压力并按预设结构张开，使设置在所述扩张支架上的多个所述缝合针呈环状均布在所述装载鞘管端部的周边。
  7. 根据权利要求6所述的经导管微创血管自动吻合装置，其特征在于，所述第一滑筒的两侧设有第一对称通孔，所述第一滑筒通过第一对称通孔与所述推送杆销轴连接；
    所述第二滑筒的两侧设有第二对称通孔，所述第二滑筒通过所述第二对称通孔与所述装载鞘管端部销轴连接。
  8. 根据权利要求7所述的经导管微创血管自动吻合装置，其特征在于，所述推送杆的端部设有滑行导槽，所述第二滑筒与所述装载鞘管端部连接的销轴的一端贯穿所述滑行导槽，以对所述推送杆轴向滑动位移和径向活动角度进行限定。
  9. 根据权利要求8所述的经导管微创血管自动吻合装置，其特征在于，所述扩张支架包括：第一翼架、第二翼架和连接骨架；
    所述第一翼架与所述第二翼架为相同结构，所述第一翼架和所述第二翼架受挤压力时曲张呈星形结构，并在每个星三角对应骨架的外缘上设置有所述连接骨架，所述第一翼架与所述第二翼架通过所述连接骨架对称连接；
    所述第一翼架与所述第一滑筒相连接，所述第一翼架受拉伸力时沿所述第一滑筒的轴向收缩成筒状结构；
    所述第二翼架与所述第二滑筒相连接，所述第二翼架受拉伸力时沿所述第二滑筒的轴向收缩成筒状结构；
    在所述推送杆驱动所述第一滑筒滑动时，带动所述第一翼架与所述第二翼架张开或收缩。
  10. 根据权利要求9所述的经导管微创血管自动吻合装置，其特征在于，所述第一翼架包括：第一连接部、第二连接部和曲张骨架；
    多个所述第一连接部均匀设置在所述第一滑筒端部的圆周上，所述第一连接部的一端与所述第一滑筒相连接，所述第一连接部的另一端连接有两个所述曲张骨架，每个所述曲张骨架与相邻的所述第一连接部连接的所述曲张骨架相连接，在所述第一翼架张开时，相邻两个所述第一连接部与所述曲张骨架形成菱形结构；
    在两个所述曲张骨架相连接处连接有所述第二连接部，所述第二连接部用于连接所述连接骨架；
    在所述第一翼架受力时，所述第一连接部和所述第二连接部产生弯曲变形。
  11. 根据权利要求10所述的经导管微创血管自动吻合装置，其特征在于，所述第一连接部和所述第二连接部的厚度和/或宽度小于所述曲张骨架。
  12. 根据权利要求11所述的经导管微创血管自动吻合装置，其特征在于，所述第一连接部和所述第二连接部采用记忆金属材料制备。
  13. 根据权利要求12所述的经导管微创血管自动吻合装置，其特征在于，所述第一翼架和所述第二翼架分别采用8根所述第一连接部、8根所述第二连接部和16根所述曲张骨架；
    在所述第一翼架和所述第二翼架张开时呈八角星结构。
  14. 根据权利要求13所述的经导管微创血管自动吻合装置，其特征在于，所述扩张支架为一体成型结构。
  15. 根据权利要求14所述的经导管微创血管自动吻合装置，其特征在于，所述针槽呈圆筒结构，所针槽的侧壁上设有轴向豁口，所述轴向豁口用于所述缝合针和所述柔性缝合线的进出操作通道。
  16. 根据权利要求15所述的经导管微创血管自动吻合装置，其特征在于，所述针槽轴向设置在所述连接骨架上。
  17. 根据权利要求16所述的经导管微创血管自动吻合装置，其特征在于，所述针槽的侧壁对称设置有长槽口，所述连接骨架的两侧设有凸起，在所述针槽卡接在所述连接骨架上时，所述凸起卡设在所述长槽口内。
  18. 根据权利要求2所述的经导管微创血管自动吻合装置，其特征在于，还包括：切割组件；
    所述切割组件可拔插地设置在所述保护鞘管组件上，用于在所述血管缝合器进入宿主血管后，对宿主血管外壁与待移植旁路血管的吻合部分进行开孔切割。
  19. 根据权利要求18所述的经导管微创血管自动吻合装置，其特征在于，所述切割组件包括：切割导管、管套和刀头；
    所述切割导管为中空长管，管套套设在所述切割导管的一端头外侧壁上，所述刀头设置在所述管套上，且所述刀头的刀尖指向所述切割导管的另一端。
  20. 根据权利要求19所述的经导管微创血管自动吻合装置，其特征在 于，所述切割导管设有轴向开口，所述轴向开口用于所述缝合针和所述柔性缝合线的进出操作通道。
PCT/CN2022/132780 2022-07-28 2022-11-18 一种经导管微创血管自动吻合装置 WO2024021376A1 (zh)

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