WO2007016821A1 - Prothèse de stent chirurgical et transporteur pour transporter les prothèses - Google Patents

Prothèse de stent chirurgical et transporteur pour transporter les prothèses Download PDF

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Publication number
WO2007016821A1
WO2007016821A1 PCT/CN2005/001537 CN2005001537W WO2007016821A1 WO 2007016821 A1 WO2007016821 A1 WO 2007016821A1 CN 2005001537 W CN2005001537 W CN 2005001537W WO 2007016821 A1 WO2007016821 A1 WO 2007016821A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
prosthesis
blood vessel
window
self
Prior art date
Application number
PCT/CN2005/001537
Other languages
English (en)
French (fr)
Inventor
Danian Ke
Lizhong Sun
Yi Zhang
Qiyi Luo
Qifeng Mei
Yonggang Xiang
Original Assignee
Microport Medical (Shanghai) Co., Ltd.
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
Application filed by Microport Medical (Shanghai) Co., Ltd. filed Critical Microport Medical (Shanghai) Co., Ltd.
Priority to EP05792175A priority Critical patent/EP1913897A4/en
Publication of WO2007016821A1 publication Critical patent/WO2007016821A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • the present invention pertains to intravascular implants and implant devices for use in vascular surgery, and more particularly to an intraoperative stent prosthesis and a delivery device for delivering such stent prosthesis.
  • the technical problem to be solved by the present invention is to provide an intraoperative stent prosthesis and a conveyor for transporting the stent prosthesis to overcome the above-mentioned drawbacks of the prior art and to complete all procedures at one time.
  • An intraoperative stent prosthesis comprising: a prosthetic vascular prosthesis and a self-elastic vascular stent, the self-elastic stent being fixedly disposed in the artificial vascular prosthesis, the outer wall of the self-elastic stent and the artificial vascular prosthesis The inner wall is in contact with one end of the artificial vascular prosthesis at a distal end than the corresponding end of the self-elastic bracket.
  • the self-elastic stent can be fixed to the artificial vascular prosthesis by suturing or the like.
  • the artificial vascular prosthesis grows out of one end of the stent to facilitate suturing with corresponding portions of other blood vessel or vascular prosthesis.
  • both ends of the artificial vascular prosthesis are made longer than the corresponding end of the self-elastic stent.
  • the stent prosthesis is provided with a window, and the window divides the artificial vascular prosthesis and the self-elastic bracket into independent left and right two sections, and the left and right two self-elastic vascular stents pass through the alloy wire.
  • the wire of the alloy has the same curvature as the artificial blood vessel and is visible through the window at the window.
  • the artificial vascular prosthesis is provided with a window at the coincidence with the self-elastic bracket, and the self-elastic bracket is exposed at the window and visible through the window.
  • the window may be an elliptical window or other shape window, and the artificial vascular prosthesis of the middle segment may be completely eliminated.
  • the window is disposed in a cylindrical shape along the circumferential direction of the artificial blood vessel, and the window divides the artificial blood vessel into two separate left and right sections, and the bracket is barely visible at the corresponding window.
  • the artificial vascular prosthesis has 1 to 3 blood vessel branches.
  • a blood vessel stent can also be provided in each blood vessel branch.
  • the material of the artificial vascular prosthesis is selected from PET or PTFE.
  • the stent is made of a metal material with good elasticity and good biocompatibility, and may be selected from materials such as NiNi shape memory alloy, CoCr alloy or 316L/317L stainless steel.
  • Another object of the present invention is to provide a conveyor for delivering the above-mentioned intraoperative stent prosthesis, comprising a handle, a drawbar and a pull wire, the handle having a tubular port at one end, one end of the pull wire being fixed on the pull rod, and the other end Fixed on the handle, one end of the bracket prosthesis is inserted into the tubular opening and is fastened to the pull rod by a pull wire, the pull rod passes through the tubular mouth of the handle, and is characterized in that it further comprises a core rod with a guide wire hole, the core The head of the stick is provided with a bullet-type introduction head, the handle has a through hole, and the end of the mandrel is fixedly disposed in the handle hole, and the external guide wire can protrude from the introduction head through the guide wire hole.
  • the bullet-type introduction head makes it easier for the intraoperative stent prosthesis to be introduced into the diseased blood vessel, and also protects the blood vessel from damage; when the true lumen of the blood vessel is pressed very small, the lesion can be penetrated through the guide wire, and the core hole is
  • the guide wire is inserted along the outer edge of the guide wire to ensure the convenience and reliability of the operation.
  • the conveyor further includes a pistol-like conveyor body, the end of the handle being fixedly coupled to the muzzle, and the end of the rod is fixedly coupled to the trigger of the pistol.
  • the trigger of the pistol can be pulled during the operation, so that the stent prosthesis can be changed from two-hand operation to one-hand operation during the delivery and release process, and the other hand can be used to fix the floating aortic incision with the surgical tool, thereby conveying And the release operation is easier, more accurate, and improves the operation time and efficiency.
  • the intraoperative stent prosthesis of the present invention can also be delivered by a sheath tube delivery system, the conveyor comprising an outer sheath tube, a push rod, and a mandrel with a guide wire hole, the head of the mandrel being provided with a bullet a type of introduction head, the tail of the mandrel extends into the interior of the push rod and is fixedly connected with the push rod, and the push rod is provided with a through hole through which the external guide wire can pass, and the external guide wire can pass through the guide wire hole
  • the introduction head extends.
  • the bullet-type introduction head makes it easier for the intraoperative stent prosthesis to be introduced into the diseased blood vessel, and also protects the blood vessel from damage; when the true lumen of the blood vessel is pressed very small, the lesion can be penetrated through the guide wire, and the core hole is
  • the guide wire is inserted along the outer edge of the guide wire to ensure the convenience and reliability of the operation.
  • a pistol-like conveyor body is also included, the end of the outer sheath tube being fixedly coupled to the muzzle of the conveyor body, and the push rod is fixedly coupled to the pistol trigger.
  • the stent prosthesis is pre-compressed between the outer sheath tube and the mandrel.
  • the outer sheath tube is inserted into the treated aortic incision, the handle of the push rod is fixed with one hand, and the delivery sheath is withdrawn backward by the other hand, the stent prosthesis It will be released from the outer sheath tube and automatically bounced off, and the arterial incision is cut to be flush with the end of the intraoperative stent, and another artificial blood vessel replacing the aorta is sutured to the overlapping mouth to complete the operation.
  • the invention adopts a blood vessel stent in the artificial blood vessel prosthesis, and changes the operation mode in which the artificial blood vessel prosthesis is replaced by the artificial blood vessel prosthesis in the ascending main segment, and then the suture is sutured with the intraoperative stent, and no suture is required, It saves on operating costs and saves surgery time, making surgery easier. Moreover, it is not necessary to cut the diseased artificial blood vessel during the operation, and it is only necessary to open the incision in the aorta to insert the stent.
  • the central exposed stent prosthesis can align its bare segments Three branches of the bow, or three branches of the three-branch prosthesis are inserted into the three branches of the aortic arch, the anterior segment with the membrane portion corresponding to the ascending main segment, and the posterior segment with the membrane corresponding to the descending aorta, thereby playing the artificial
  • the combined effect of blood vessels and intraoperative stents improves surgical efficiency and saves costs.
  • the windowed intraoperative stent prosthesis connected by the wire can also reduce the stimulation of the vessel wall by eliminating the stent in the window portion.
  • the stent prosthesis of the invention has the advantages of simple structure, convenient use and reliable operation performance, good geometric shape in the blood tube, good mechanical properties and biocompatibility; and various structures can adapt to different lesions. Not only can the operation of the two operations be completed in one operation, but also the time of one operation can be saved.
  • Figure 1 is a schematic view showing the structure of an intraoperative stent of the present invention
  • FIG. 2 is a schematic view showing the structure of an intraoperative stent prosthesis in which all the bare alloy wires are connected in the middle;
  • FIG. 3 is a schematic view showing the structure of the entire bare intraoperative stent prosthesis in the middle portion;
  • Figure 4 is a schematic view showing the structure of the intraoperative stent prosthesis in the middle portion
  • Figure 5 is a schematic view showing the structure of a stent prosthesis with three blood vessel branches
  • Figure 6 is a schematic structural view of a wire-wound conveyor
  • Figure 7 is a schematic structural view of a pistol type wire-wound conveyor
  • Figure 8 is a schematic view showing the structure of a pistol type sheath tube conveyor
  • Figure 9 is a schematic view showing an example of a stent prosthesis of the present invention for descending aorta
  • Figure 10 is a schematic view showing an example of a stent prosthesis of the present invention for use in an abdominal aorta;
  • Figure 11 is a schematic view showing an example of the use of the entire intraoperative stent prosthesis in the middle of the present invention for the bow portion;
  • Figure 12 is a schematic view showing an example of the bare intraoperative stent prosthesis for the bow portion of the present invention;
  • a branch of the intraoperative stent prosthesis is used for a schematic view of the arch.
  • the intraoperative stent prosthesis of the present invention comprises a prosthetic vascular prosthesis 2 and a self-elastic vascular stent 1 fixedly disposed in the artificial vascular prosthesis 2, the outer wall of the self-elastic stent and The inner wall of the artificial vascular prosthesis is in contact with each other, and the length of one end of the artificial vascular prosthesis 2 is longer than the corresponding end of the self-elastic bracket 1 L, L may be about 10 mm. It is also possible that the ends of both ends of the artificial vascular prosthesis 2 are more than the corresponding ends of the self-elastic stent 1.
  • the intraoperative stent prosthesis is provided with a window 204, which divides the artificial vascular prosthesis 2 into two independent left and right segments 201, 202, and the window 204 will be self-elastic.
  • the stent 1 is divided into two independent left and right sections 101, 102.
  • the left and right two sections of the self-elastic vascular stents 101, 102 are connected by an alloy wire 103.
  • the bending angle of the alloy wire 103 is the same as that of the artificial blood vessel 2 and corresponds to the window 204. Bare is visible through window 204.
  • the artificial blood vessel prosthesis 2 is overlapped with the self-elastic bracket 1 at a window 204, which is exposed to the window and visible through the window.
  • the window 204 is an elliptical window.
  • the window is disposed in a cylindrical shape along the circumferential direction of the artificial blood vessel, and the window divides the artificial blood vessel into two independent left and right sections 201 and 202, and the self-elastic bracket 1 corresponds to the columnar shape.
  • the window is barely visible.
  • the artificial vascular prosthesis may have 1 to 3 blood vessel branches 203.
  • a blood vessel stent 104 can also be provided in each blood vessel branch.
  • the self-elastic bracket is a Z-shaped structure or a woven structure, and the bracket may be bent in one direction or curved in a plurality of directions to conform to the curved blood vessel.
  • the material of the artificial blood vessel may be PET, or PTFE, and the surface of the artificial blood vessel may be flat or corrugated.
  • the conveyor for conveying the above-mentioned intraoperative stent prosthesis comprises a handle 3, a pull rod 4 and a pull wire 5, and one end of the handle has a tubular opening 301, and one end of the pull wire 5 is fixed on the pull rod 4, The other end is fixed on the handle 3, and the end of the bracket prosthesis 6 is inserted into the tubular opening 301.
  • the pull rod 4 passes through the handle tubular opening 301, and further comprises a core rod 7 with a core hole and a guide wire 8, the head of the core rod 7 is provided with a bullet type
  • the introduction head 9 has a through hole, and the end of the mandrel 7 is fixedly disposed in the handle hole, and the external guide wire S can protrude from the introduction head 9 through the core hole.
  • the pull rod 4 is a stainless steel wire, and the end of the pull rod has a ring pull handle 401.
  • the conveyor further includes a pistol-like conveyor body 10, and the end of the handle 3 is fixedly connected to the muzzle 11 of the conveyor body, and the end of the rod 4 Fixed connection to the trigger 12 of the pistol. Pull the trigger to release and eject the bracket gradually. The whole process can be completed with one hand.
  • the intraoperative stent prosthesis of the present invention can also be transported by a sheath tube delivery system, the conveyor comprising an outer sheath tube 3, a push rod 4, and a mandrel 7 with a guide wire hole,
  • the head of the mandrel 7 is provided with a bullet-type introduction head 9 .
  • the tail of the mandrel 7 extends into the interior of the push rod 4 and is fixedly connected to the push rod 4 .
  • the push rod 4 is provided with an external guide wire 8 . Through the through hole, the outer guide wire 8 can protrude from the introduction head 9 through the guide wire hole.
  • the patient has a thoracic aortic aneurysm, including the main segment, the bow, and the descendant.
  • Paragraph He underwent a mid-thoracic thoracotomy, replacing the ascending aorta and the arch with a three-branch artificial vascular prosthesis 13; one end of the artificial vascular prosthesis was sutured with the ascending aortic incision; the intraoperative stent prosthesis 14 was inserted Lower the aortic incision and release it to open the suture; suture the intraoperative stent and the descending aortic incision with another port of the artificial blood vessel.
  • the three branches of the artificial blood vessel were sutured with the corresponding branch vessels (ie, the brachiocephalic artery, the common iliac artery, and the left subclavian artery) to complete all the operations.
  • Example 2 Example 2
  • the patient has a thoracic aortic aneurysm, including the ascending aorta, the arch, and the descending aorta.
  • the patient underwent a median thoracotomy, and an incision was made at the ascending aorta.
  • the intraoperative stent prosthesis 14 shown in Figures 2 and 3 is inserted into the descending aorta, so that the bare part of the middle of the stent is facing the three branches of the aortic arch, as shown in Figures 11 and 12,
  • the stent was sutured with the open aortic incision and the incision of the ascending aorta through the heart to complete all operations.
  • the patient is suffering from an aortic aneurysm including the descending aorta and the abdominal aorta, and the lesion affects the left subclavian artery.
  • the patient underwent thoracotomy at the fourth rib of the left rib, replacing the diseased vessel at the descending aorta with a branch of artificial blood vessel, and suturing the corresponding aortic arch incision and the left subclavian artery incision, respectively.
  • the intraoperative incision was inserted into the aortic incision and released as shown in Fig. 10; the intraoperative stent was overlapped with the abdominal aortic incision, and the lower end of the artificial blood vessel was sutured to complete all the operations.
  • the patient has a thoracic aortic aneurysm, including the ascending aorta, the arch, and the descending aorta.
  • the patient underwent a median thoracotomy, and an incision was made at the ascending aorta.
  • the intraoperative stent prosthesis 14 shown in Figure 3 or Figure 4 is inserted into the descending aorta, so that the intraoperative stent is The three branches of the part are inserted into the three branches of the aortic arch.
  • the intraoperative stent is sutured with the open aortic incision and the incision of the ascending aorta through the heart to complete all operations.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Description

术中支架假体以及输送器 技术领域
本发明属于血管外科手术中使用的血管内植入物以及植入器械， 具体 地说， 涉及一种术中支架假体以及用来输送这种支架假体的输送器。 背景技术
在传统的医疗技术中， 用正主开胸手术治疗胸主动脉瘤病变， 包括升 主动脉、 弓部和降主动脉。 在手术中用人造血管假体替代病变的主动脉血 管。 但在正中开胸手术中降主动脉被心脏挡住难以触及， 故对于这段血管 的病变传统的方法是将一般人造血管从降主动脉切口处插入 （俗称象鼻 子）。 这段血管的作用是便于和二次手术 （一般从第四左肋处开胸） 连接。 这样多数病人就须接受二次手术， 在一次手术与二次手术之间， 病人将承 受较大风险。 发明内容
本发明所要解决的技术问题是提供一种术中支架假体以及用来输送这 种支架假体的输送器， 以克服现有技术存在的上述缺陷， 一次完成全部手 术。
本发明解决技术问题的技术方案如下：
一种术中支架假体， 其特征在于， 包括人造血管假体和自弹式血管支 架， 所述自弹式支架固定设置在人造血管假体内， 自弹式支架的外壁与人 造血管假体的内壁相接触， 所述人造血管假体的一端端部比自弹式支架的 相对应端部长。 自弹式支架可以通过缝合等方式与人造血管假体固定。 人 造血管假体长出支架的一端可以便于与其他血管或血管假体的对应部位缝 合。 作为本发明的进一步改进， 所述人造血管假体的两端端部均比自弹式 支架的相对应端部长。
作为本发明的进一步改进， 所述支架假体上设有窗口， 所述窗口将人 造血管假体与自弹式支架分成独立的左右两段， 左右两段自弹式血管支架 之间通过合金丝连接， 所述合金丝的弯曲度与人造血管相同且相应于窗口 处裸露透过窗口可见。
作为本发明的进一步改进， 所述人造血管假体上与自弹式支架重合处 设有窗口， 所述自弹式支架相应于窗口处裸露且透过窗口可见。 所述窗口 可以为椭圆形窗口， 也可以为其他形状窗口， 还可将中间段的人造血管假 体全部取消。
所述窗口沿人造血管环向呈圆柱状设置， 所述窗口使人造血管分成独 立的左右两段， 所述支架于相应窗口处裸露可见。
作为本发明的另一种改进， 所述人造血管假体带有 1〜3 个血管分支。 相应的也可以在每个血管分支内设置血管支架。
所述人造血管假体的材料选自 PET或 PTFE， 所述支架采用弹性好、 生物相容性好的金属材料制成， 可以选自 NiNi形状记忆合金、 CoCr合金 或 316L/317L不锈钢等材料。
本发明的另一个目的是提供一种用于输送上述术中支架假体的输送 器， 包括手柄、 拉杆和拉线， 手柄的一端带有管状口， 所述拉线的一端固 定在拉杆上， 另一端固定在手柄上， 所述支架假体一端插入管状口并通过 拉线绑在拉杆上， 所述拉杆从手柄管状口中穿过， 其特征在于， 还包括带 有导丝孔的芯棒， 所述芯棒的头部设有子弹型导入头， 所述手柄带有通孔， 所述芯棒末端固定设置在手柄孔内， 外来导丝可穿过导丝孔从导入头伸 出。 子弹型导入头使得术中支架假体传入病变血管变得容易， 还能保护血 管不受损伤； 当血管真腔口被压得很小时， 可先借助导丝穿入病变， 在将 芯孔穿在导丝外沿导丝穿入， 从而保证了操作的方便和可靠。 作为对上述输送器的进一步改进， 所述输送器还包括手枪状输送器主 体， 所述手柄末端与枪口处固定连接， 所述拉杆的末端与手枪的扳机固定 连接。 这样可以在手术过程中通过扳动手枪扳机， 即可使支架假体在输送 以及释放过程由双手操作变为单手操作， 另一只手可用手术工具固定浮动 的主动脉血管切口， 从而使输送及释放操作更加容易， 准确， 提高手术时 间和效率。
本发明术中支架假体还可以采用鞘管式输送系统输送， 所述输送器包 括外鞘管、 推送杆， 还包括带有导丝孔的芯棒， 所述芯棒的头部设有子弹 型导入头， 所述芯棒的尾部伸入推送杆内部且与推送杆固定连接， 所述推 送杆内设有可供外来导丝穿过的通孔， 外来导丝可穿过导丝孔从导入头伸 出。 子弹型导入头使得术中支架假体传入病变血管变得容易， 还能保护血 管不受损伤； 当血管真腔口被压得很小时， 可先借助导丝穿入病变， 在将 芯孔穿在导丝外沿导丝穿入， 从而保证了操作的方便和可靠。
作为对上述鞘管式输送器的进一步改进， 还包括手枪状输送器主体， 所述外鞘管末端与输送器主体的枪口处固定连接， 所述推送杆与手枪扳机 固定连接。 支架假体被预先压缩在外鞘管与芯棒之间， 操作时将外鞘管插 入处理的主动脉切口， 用一手固定推送杆的手柄， 另一手将输送鞘管向后 撤出， 支架假体会从外鞘管中释放出来并自动弹开， 剪齐动脉血管切口使 其与术中支架端面平齐并重叠， 将另一段置换主动脉的人造血管与这一重 叠口缝合， 完成手术。
本发明与现有技术相比的有益效果如下：
本发明通过在人造血管假体内设置血管支架， 改变了原有手术时必须 在升主段另外用人造血管假体取代病变血管， 再与术中支架缝合的操作方 式， 且不需缝合， 不仅节省了手术费用， 而且也节省了手术时间， 使手术 变得更加简单。 而且手术时可不用将病变的人造血管剪去， 仅需在主动脉 处开切口将支架插入即可。 此外， 中部裸露式支架假体可以使其裸段对准 弓部三个分支， 或将三分支假体的三个分支插入人体主动脉弓部的三个分 支血管， 其前段带膜部分对应升主段， 后段带膜部分对应降主动脉， 从而 起到了人造血管及术中支架的联合作用， 提高手术效率， 节省费用。 用合 金丝连接的带窗口的术中支架假体由于省去了窗口部的支架， 还可减少支 架对血管壁的刺激。
本发明支架假体具有结构简单、 使用方便操作性能可靠等优点， 在血 管中能保持良好的几何形状， 有良好的机械性能及生物相容性； 而且多种 结构可适应不同的病变。 不仅可一次手术中完成两次手术的操作内容， 而 且可以节省一次手术的时间。 附图说明
图 1是本发明术中支架假体结构示意图；
图 2是中部全部裸露合金丝连接的术中支架假体结构示意图； 图 3是中部全部裸露的术中支架假体结构示意图；
图 4是中部部分裸露的术中支架假体结构示意图；
图 5是带有 3个血管分支的支架假体结构示意图；
图 6是线绑式输送器结构示意图；
图 7是手枪型线绑式输送器结构示意图；
图 8是手枪型鞘管式输送器结构示意图；
图 9是本发明支架假体用于降主动脉实例示意图；
图 10是本发明支架假体用于腹主动脉实例示意图；
图 11是本发明中部全部裸露的术中支架假体用于弓部实例示意图； 图 12是本发明中部部分裸露的术中支架假体用于弓部实例示意图； 图 13是本发明带有 3个分支的术中支架假体用于弓部实例示意图。 具体实施方式 下面结合附图与实施例进一步说明本发明。
参见图 1， 本发明术中支架假体， 包括人造血管假体 2和自弹式血管 支架 1， 所述自弹式支架 1 固定设置在人造血管假体 2 内， 自弹式支架的 外壁与人造血管假体的内壁相接触， 所述人造血管假体 2 的一端端部比自 弹式支架 1 的相对应端部长 L， L的长度可以为 10mm左右。 也可以人造 血管假体 2的两端端部均比自弹式支架 1的相应端部长。
参见图 2， 作为本发明的进一步改进， 所述术中支架假体上设有窗口 204， 所述窗口 204将人造血管假体 2分成独立的左右两段 201、 202, 窗 口 204将自弹式支架 1分成独立的左右两段 101、 102， 左右两段自弹式血 管支架 101、 102之间通过合金丝 103连接， 所述合金丝 103 的弯曲度与 人造血管 2相同且相应于窗口 204处裸露透过窗口 204可见。
参见图 4， 作为本发明的进一步改进， 所述人造血管假体 2 上与自弹 式支架 1 重合处设有窗口 204， 所述自弹式支架相应于窗口处裸露且透过 窗口可见。 所述窗口 204为椭圆形窗口。
参见图 3， 作为本发明的进一步改进， 所述窗口沿人造血管环向呈圆 柱状设置， 所述窗口使人造血管分成独立的左右两段 201 和 202， 所述自 弹式支架 1相应于柱状窗口处裸露可见。
作为进一步改进， 如图 5所示， 所述人造血管假体可以带有 1〜3 个 血管分支 203。 相应的也可以在每个血管分支内设置血管支架 104。
所述自弹式支架为 Z型结构或编织结构， 支架可以向一个方向弯曲也 可以向多个方向弯曲以顺应弯曲的血管。
人造血管的材料可以为 PET、 或 PTFE, 人造血管的表面可以是平整 的也可以是波紋状的。
参见图 6， 本发明用于输送上述术中支架假体的输送器， 包括手柄 3、 拉杆 4和拉线 5， 手柄的一端带有管状口 301， 所述拉线 5 的一端固定在 拉杆 4上， 另一端固定在手柄 3上， 所述支架假体 6—端插入管状口 301 并通过拉线 5绑在拉杆 4上， 所述拉杆 4从手柄管状口 301中穿过， 还包 括带有芯孔的芯棒 7和导丝 8， 所述芯棒 7的头部设有子弹型导入头 9， 所述手柄 3带有通孔， 所述芯棒 7末端固定设置在手柄孔内， 外来导丝 S 可穿过芯孔从导入头 9伸出。 拉杆 4为不锈钢丝， 拉杆的尾端带有圆环拉 手 401。 操作时将术中支架假体 6插入要处理的主动脉切口， 一手固定手 柄， 另一手拉出不锈钢丝拉杆 4， 支架会被释放同时自动弹开， 从手柄管 状口 301中脱出。
如图 7所示， 作为对上述输送器的进一步改进， 所述输送器还包括手 枪状输送器主体 10， 所述手柄 3末端与输送器主体枪口处 11 固定连接， 所述拉杆 4 的末端与手枪的扳机 12 固定连接。 使用时扳动扳机即可将支 架逐步释放并弹出。 整个过程单手操作即可完成。
如图 8所示， 本发明术中支架假体还可以采用鞘管式输送系统输送， 所述输送器包括外鞘管 3、 推送杆 4， 还包括带有导丝孔的芯棒 7， 所述芯 棒 7的头部设有子弹型导入头 9， 所述芯棒 7的尾部伸入推送杆 4内部且 与推送杆 4固定连接， 所述推送杆 4内设有可供外来导丝 8穿过的通孔， 外来导丝 8可穿过导丝孔从导入头 9伸出。 也可以对上述鞘管式输送器进 行改进， 增加一个手枪状输送器主体 10， 将所述外鞘管 3末端与输送器主 体的枪口 11处固定连接， 将所述推送杆 4与手枪扳机 12固定连接。 所述 术中支架假体 6压缩在外鞘管 3与芯棒 7之间， 操作时， 将外管 3插入处 理的主动脉切口， 扳动扳机 12使推送杆 4顶住支架假体 6， 输送器外鞘向 后撤， 支架 6会在外鞘管 3中逐渐释放出来并自动弹开。 剪齐动脉血管切 口使其与术中支架假体端面平齐并重叠， 将另一段置换主动脉的人造血管 与这一重叠口缝合， 完成手术。 实施例 1
参见图 9所示， 病人患有胸主动脉瘤病变， 包括升主段， 弓部和降主 段。 对他进行了正中开胸手术， 将升主动脉段与弓部用带有三分支的人造 血管假体 13 置换； 人造血管假体的一端与升主动脉切口缝合； 将术中支 架假体 14 插入降主动脉切口并使之释放弹开； 将术中支架与降主动脉切 口重叠口与人造血管的另一端口缝合。 将人造血管的三个分支与对应的分 支血管 （即头臂动脉、 胫总动脉及左锁骨下动脉） 分别缝合， 完成全部手 术。 实施例 2
参见图 11、 图 12所示， 病人患有胸主动脉瘤病变， 包括升主动脉、 弓部和降主动脉， 对患者实施了正中开胸手术， 在升主动脉处作切口， 从 切口将图 2和图 3所示的术中支架假体 14插向降主动脉部， 使术中支架 中部裸露的部分正对着主动脉弓部的三个支脉， 如图 11和 12所示， 将术 中支架与开主动脉切口重叠口与升主动脉通心脏边的切口缝合， 完成全部 手术。 实施例 3
参见图 10 所示， 病人所患的是包括降主动脉与腹主动脉的主动脉瘤 病变， 且病变波及左锁骨下动脉。 对病人实施了左肋下第四肋骨处开胸手 术， 用带一个分支的人造血管将降主动脉处的病变血管取代， 并分别与对 应的主动脉弓部切口及左锁骨下动脉切口缝合， 在腹主动脉切口处插入图 1所示的术中支架并将其释放， 如图 10所示； 将术中支架与腹主动脉切口 重叠， 再与人造血管的下端缝合， 完成全部手术。 实施例 4
参见图 13 所示， 病人患有胸主动脉瘤病变， 包括升主动脉、 弓部和 降主动脉， 对患者实施了正中开胸手术， 在升主动脉处作切口， 从切口将 图 2， 图 3或图 4所示的术中支架假体 14插向降主动脉部， 使术中支架中 部的三个分支插入主动脉弓部的三个支脉， 如图 1 1和 12所示， 将术中支 架与开主动脉切口重叠口与升主动脉通心脏边的切口缝合， 完成全部手 术。

Claims

权利要求
1. 一种术中支架假体， 其特征在于， 包括人造血管假体和自弹式血管 支架， 所述自弹式支架固定设置在人造血管假体内， 自弹式支架的外壁与 人造血管假体的内壁相接触， 所述人造血管假体的一端端部比自弹式支架 的相对应端部长。
2. 根据权利要求 1所述的术中支架假体， 其特征在于， 所述人造血管 假体的两端端部均比自弹式支架的相对应端部长。
3. 根据权利要求 1所述的术中支架假体， 其特征在于， 所述支架假体 上设有窗口， 所述窗口将人造血管假体与自弹式支架分成独立的左右两 段， 左右两段自弹式血管支架之间通过合金丝连接， 所述合金丝的弯曲度 与人造血管相同且相应于窗口处裸露透过窗口可见。
4. 根据权利要求 1所述的术中支架假体， 其特征在于， 所述人造血管 假体上与自弹式支架重合处设有窗口， 所述自弹式支架相应于窗口处裸露 且透过窗口可见。
5. 根据权利要求 4所述的术中支架假体， 其特征在于， 所述窗口沿人 造血管环向呈圆柱状设置， 所述窗口使人造血管分成独立的左右两段， 所 述支架相应与柱状窗口处裸露可见。
6. 根据权利要求 1所述的术中支架假体， 其特征在于， 所述人造血管 假体带有 1〜3个血管分支。
7. 根据权利要求 1至 6任一项所述术中支架假体， 其特征在于， 所述 人造血管假体的材料选自 PET或 PTFE， 所述支架的采用弹性金属材料制 成， 选自 NiNi形状记忆合金、 CoCr合金或 316L/317L不锈钢之一。
8.一种用于输送权利要求 1至 7所述的术中支架假体的输送器， 包括 手柄、 拉杆和拉线， 手柄的一端带有管状口， 所述拉线的一端固定在拉杆 上， 另一端固定在手柄上， 所述支架假体一端插入管状口并通过拉线绑在 拉杆上， 所述拉杆从手柄管状口中穿过， 其特征在于， 还包括带有导丝孔 的芯棒， 所述芯棒的头部设有子弹型导入头， 所述手柄带有通孔， 所述芯 棒末端固定设置在手柄孔内。
9. 根据权利要求 8所述的输送器， 其特征在于， 还包括手枪状输送器 主体， 所述手柄末端与枪口处固定连接， 所述拉杆的末端与手枪的扳机固 定连接。
10. 一种用于输送权利要求 1 至 7所述的术中支架假体的输送器， 包 括外鞘管、 推送杆， 其特征在于， 还包括带有导丝孔的芯棒， 所述芯棒的 头部设有子弹型导入头， 所述芯棒的尾部伸入推送杆内部且与推送杆固定 连接， 所述推送杆内设有可供外来导丝穿过的通孔。
11. 根据权利要求 10所述的输送器， 其特征在于， 还包括手枪状输送 器主体， 所述外鞘管末端与输送器主体的枪口处固定连接， 所述推送杆与 手枪扳机固定连接。
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EP2471491A2 (en) 2012-07-04
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CN1911188A (zh) 2007-02-14
CN1911188B (zh) 2010-10-13
EP1913897A4 (en) 2010-10-06

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