WO2021129298A1 - 管腔支架 - Google Patents

管腔支架 Download PDF

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Publication number
WO2021129298A1
WO2021129298A1 PCT/CN2020/131664 CN2020131664W WO2021129298A1 WO 2021129298 A1 WO2021129298 A1 WO 2021129298A1 CN 2020131664 W CN2020131664 W CN 2020131664W WO 2021129298 A1 WO2021129298 A1 WO 2021129298A1
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WO
WIPO (PCT)
Prior art keywords
branch
tubular body
oblique opening
oblique
catheter
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PCT/CN2020/131664
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English (en)
French (fr)
Inventor
肖本好
吴轩
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深圳市先健畅通医疗有限公司
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Publication of WO2021129298A1 publication Critical patent/WO2021129298A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a lumen stent.
  • Aneurysm is a common clinical vascular disease, which mostly occurs in the elderly. This disease can easily lead to aortic aneurysm rupture, posing a great threat to the life of the patient.
  • This treatment method is to compress the stent graft into the delivery device and guide it into the human body along the pre-implanted guide wire track.
  • the stent graft After reaching the diseased location, the stent graft is released to isolate the blood flow and the diseased location, and at the same time rebuild the blood flow
  • aneurysm and dissection lose blood supply, the remaining blood in the tumor cavity gradually forms a thrombus and muscles into vascular tissue.
  • the expanded tumor wall shrinks due to compression and gradually returns to the original state, thereby achieving the treatment of aneurysm and dissection the goal of.
  • a stent graft that can reconstruct the branch artery is required.
  • a straight tube type stent graft is connected inside the straight tube stent, which is usually called an internal branch, and the two are connected to each other through a hole on the external stent graft. Together, the two are in fluid communication through holes.
  • the hole of the external stent graft is correspondingly placed at the opening of the branch artery, and a straight tube stent is implanted to connect the internal branch and the branch artery to achieve the purpose of rebuilding the branch artery.
  • the stent system will prepare a preset guide wire in the inner branch.
  • the preset guide wire It is often very thin, usually 0.014" or 0.018" diameter guide wire is used as the preset guide wire.
  • the catheter is first transported into the inner branch along the channel established by the preset guide wire, and then the 0.035" hard guide wire is exchanged , The branch stent completes the implantation of the stent through the channel established by the hard guide wire.
  • the luminal aperture of the catheter is compatible with the hard guide wire, and the preset guide wire is thinner than the hard guide wire, so the lumen aperture of the catheter is relative to the preset guide wire It is too large.
  • the difference in the radial size of the preset guide wire and the catheter will form a step, so that the end of the catheter will be easy when the catheter enters the inner branch along the preset guide wire. Carded at the end of the inner branch.
  • the present invention provides a lumen stent to solve the technical problem that the catheter is prone to jams when entering the internal branch.
  • a luminal stent comprising a tubular body, and at least one inner branch located inside the tubular body and communicating with the tubular body, the inner branch is hollow and both ends are open, and the inner branch includes a branch
  • the main body and the flaring section connected with the proximal end of the branch body, the proximal end of the flaring section is provided with an oblique opening, and the oblique opening is inclined toward the inside of the tubular body and inclined to the distal end, and the oblique
  • a ring with a smooth surface is provided at the position where the mouth is located.
  • the present invention provides a luminal stent.
  • the luminal stent includes a tubular body and an inner branch arranged in the tubular body and communicating with the tubular body.
  • the proximal end of the inner branch is provided with a flaring section to make it easier for the catheter to align with the inner branch.
  • Proximal end; the proximal end of the flaring section is provided with an oblique opening, and the oblique opening is inclined from the inner wall of the tubular body to the distal end of the branch body, so that the oblique opening of the flaring section enables the catheter to follow the oblique opening
  • the oblique mouth slides down and enters the inner branch, reducing the chance of stuck.
  • Fig. 1 is a schematic structural diagram of a lumen stent according to an embodiment
  • Fig. 2 is a schematic diagram of an embodiment when the luminal stent is delivered to an aneurysm via a conveyor;
  • Fig. 3 is a schematic diagram of the release state of the lumen stent from the conveyor in an embodiment
  • Fig. 4 is a schematic diagram of the state before the catheter enters the lumen stent along the preset guide wire after the luminal stent in an embodiment is released to the aneurysm;
  • Fig. 5 is a schematic diagram showing the state of the internal branch of the catheter into the lumen stent along the preset guide wire after the luminal stent is released to the aneurysm in an embodiment
  • Fig. 6 is a schematic diagram of the state where the end of the catheter is in conflict with the end of the inner branch when the catheter enters the inner branch;
  • Fig. 7 is a schematic diagram of a state where the end of the catheter abuts against the end of the inner branch, and the inner branch is squeezed by the catheter to produce a collapsed state;
  • Figure 8 (a) is a partial structural diagram of the luminal stent of Example 1;
  • Figure 8 (b) is a partial structural diagram of the luminal stent shown in Figure 8 (a), the normal line of the oblique opening and the tubular body The schematic diagram of the intersection of the central axes;
  • Figure 8(c) is a schematic diagram of the lumen stent of an embodiment, and the catheter is guided by a preset guide wire when it is against the oblique port of the inner branch;
  • Figure 8(d) is an embodiment of Lumen stent, the schematic diagram when the end of the catheter slides along the oblique opening to the bottom position adjacent to the oblique opening;
  • FIG. 9 is a schematic diagram of the oblique opening of the inner branch of the luminal stent of embodiment 1 being inclined to the central axis of the tubular body;
  • Fig. 10 is a partial structural diagram of an inner branch of a lumen stent according to an embodiment
  • Fig. 11 is a partial structural diagram of an inner branch of a lumen stent according to another embodiment
  • FIG. 12 is an axial top view schematic diagram of the lumen stent when the lumen stent of embodiment 2 has two inner branches, and the figure shows the gap formed between the two inner branches and the inner wall of the tubular body;
  • FIG. 13 is a schematic diagram of the luminal stent of Embodiment 2 in which part of the edges of the two inner branch flaring sections are connected to block the gap;
  • Fig. 14 is a schematic structural diagram of the lumen stent shown in Fig. 13;
  • Fig. 15 is a schematic plan view of a luminal stent according to another embodiment in an axial direction. The figure shows that the two oblique openings of the inner branches in the tubular body are both fan-shaped;
  • Fig. 16 is a schematic structural diagram of the lumen stent shown in Fig. 15;
  • FIG. 17 is a partial structural diagram of an inner branch with a support member of the luminal stent of Embodiment 3; FIG.
  • FIG. 18 is a schematic structural diagram of an integral structure of the support member and the ring member of the lumen stent according to another embodiment
  • 19 is a partial structural diagram of an inner branch with another support structure of a lumen stent according to another embodiment
  • 20 is a partial structural diagram of an inner branch with another support structure of a lumen stent according to another embodiment
  • Fig. 21 is a schematic structural diagram of a support member of a lumen stent according to an embodiment
  • Fig. 22 is a schematic structural diagram of a support member of a lumen stent according to another embodiment
  • Figure 23 is a schematic structural diagram of a lumen stent provided with a bare stent according to an embodiment
  • FIG. 24 is a schematic structural diagram of the luminal stent shown in FIG. 23 when the catheter passes through the bare stent when the luminal stent is in an anchored state;
  • FIG. 25 is a schematic structural diagram of a lumen stent provided with a bare stent according to Embodiment 4.
  • Fig. 26 is a schematic structural diagram of the luminal stent shown in Fig. 25 when the catheter passes through the bare stent when the luminal stent is in an anchored state.
  • the end of the stent implanted in the human or animal body that is closer to the heart is generally called the "proximal end”, and the end farther from the heart is called the “distal”, and the stent is defined according to this principle
  • the "proximal end” and “distal” of any part of the device; the end of other medical devices implanted in the human or animal body closer to the operator is called the “proximal end”, and the end farther from the operator It is called the “distal” and defines the “proximal” and “distal” of any component of other medical devices based on this principle.
  • Axial generally refers to the length direction of the medical device when it is transported, and “radial” generally refers to the direction perpendicular to the “axial” of the medical device, and the "axis” of any part of the medical device is defined according to this principle. Toward” and “Radial”.
  • the inner branch 12 in the luminal stent of the present invention can be used on the chest and abdomen main stent, lunge stent, iliac bifurcation stent, suprarenal aneurysm stent and other luminal stents.
  • the inner branch 12 is applied to the thoracic and abdomen main stent below Taking an example for detailed description, the application of the inner branch 12 to other luminal stents is the same or similar to this, and will not be repeated here.
  • Embodiment 1 provides a luminal stent 10.
  • the luminal stent 10 includes a tubular body 11 and at least one inner branch 12 located inside the tubular body 11 and communicating with the tubular body 11.
  • FIG. 1 shows that the luminal stent 10 has two internal branches 12 in the tubular body 11.
  • the lumen stent 10 may be provided with one or more than two inner branches 12.
  • the tubular body 11 includes a tapered section 11a, a proximal section 11b, and a distal section 11c.
  • the proximal section 11b is connected to the proximal end of the tapered section 11a
  • the distal section 11c is connected to the distal end of the tapered section 11a.
  • the tapered section 11a is located in the middle section of the tubular body 11, and the size of the distal end of the tapered section 11a is smaller than the size of the proximal end of the tapered section 11a.
  • an inner branch window 12a connected to the inner branch 12 is provided on the tapered section 11a.
  • a corresponding number of inner branch windows 12a are also provided on the tapered section 11a.
  • the distal end of one inner branch 12 is connected to one inner branch window 12a, and the proximal end of the inner branch 12 is connected to the inner branch window 12a.
  • the tubular body 11 may not be provided with a tapered section 11a, and only a proximal section 11b and a distal section 11c may be provided.
  • the outer diameter of the proximal section 11b and the outer diameter of the distal section 11c may be equal or unequal.
  • One or more inner branch windows are provided on the proximal section 11b or the distal section 11c, and the inner branch windows are used to connect with the distal end of the inner branch 12 to make the inner branch window communicate with the cavity of the inner branch 12 .
  • the interior of the inner branch 12 is hollow and both ends are open, so that the inner branch 12 will communicate with the tubular body 11 through an opening at its proximal end, and the catheter that enters the tubular body 11 can also enter the inner branch 12 through manipulation. .
  • the luminal stent 10 includes at least one outer branch 101, which is located on the outside of the tubular body 11 and communicates with the inside of the tubular body 11 through its proximal end.
  • the proximal end of the outer branch 101 is connected to the tapered section 11a, and communicates with the interior of the tubular body 11 through the outer branch window 101a provided on the tapered section 11a.
  • the structure of the lumen stent 10 and its mechanism of action will be further described below with reference to FIGS. 2 to 5, taking the operation process of the lumen stent 10 acting on the thoracic-abdominal aortic aneurysm as an example.
  • FIG. 2 schematically shows the distribution of the thoracic-abdominal aortic aneurysm 100 a and the branch blood vessels 100 b in which it is located.
  • the luminal stent 10 is entered from the femoral artery through the transporter 1 and transported to the location of the tumor. As shown in Figure 3, the luminal stent 10 is released at the position of the tumor, and the preset guide wire 2 passing through the inner branch 12 in advance is grasped by the catcher 3, wherein the catcher 3 can be from the carotid artery or The subclavian artery is transported to the vicinity of the inner branch 12.
  • the two inner branches 12 are respectively provided with preset guide wires 2 in advance, so as to use the corresponding preset guide wires 2
  • the catheter 4 is guided to the corresponding inner branch 12 respectively.
  • the two catheters 4 respectively enter the corresponding inner branch 12 under the guidance of the respective preset guide wire 2, thereby establishing a channel for the inner branch 12.
  • the relative position of the catheter 4 and the luminal stent 10 unchanged, withdraw the preset guide wire 2 and exchange other thicker guide wires for subsequent operations.
  • the inventor found that because the preset guide wire 2 is too thin, when the catheter 4 enters the inner branch 12 along the preset guide wire 2, the end 4a of the catheter 4 is often staggered
  • the cavity of the inner branch 12 conflicts with the end 12b of the inner branch 12, as shown in FIG. 6.
  • the end 4a of the catheter 4 and the end 12b of the inner branch 12 conflict, which will cause the catheter 4 to get stuck when entering the inner branch 12, and thus cannot enter the inner branch 12 smoothly. Referring to Fig.
  • the proximal end of the inner branch 12 is located in the tubular body 11 and enters the inner part as a catheter 4
  • the inlet end of the branch 12 in one embodiment, is provided with a flaring structure at the proximal end of the inner branch 12, so that the catheter 4 enters the inner branch 12 and reduces the chance of the stuck phenomenon.
  • the inner branch 12 includes a branch body 121 and a flaring section 122 connected to the proximal end 121 a of the branch body 121.
  • the flaring section 122 has a bell mouth shape.
  • the opening area at the proximal end of the flaring section 122 is larger than the opening area at the distal end of the flaring section 122. Since the flaring section 122 is connected to the proximal end 121a of the branch body 121, the flaring section 122 serves as a pipe section for guiding the catheter 4 into the branch body 121.
  • the catheter 4 When the catheter 4 enters the inner branch 12, first start from the proximal end of the flaring section 122. Enter the flaring section 122, and then guide the branch body 121 from the flaring section 122, so that the proximal opening area of the flaring section 122 is larger than the distal opening area of the flaring section 122, which enables the catheter 4 to have a greater probability of aligning to the inside.
  • the inner diameter of the flaring section 122 is larger than the inner diameter of the branch main body 121, wherein the inner diameter of the flaring section 122 includes the inner diameter of the flaring section 122 along its length in any cross section.
  • the branch body 121 is roughly cylindrical, and the distal end of the flaring section 122 is connected to the proximal end 121a of the branch body 121, and then the size of the distal opening of the flaring section 122 is equal to the inner diameter of the branch body 121 .
  • the catheter 4 can enter the branch main body 121 along the flaring section 122 to reduce the jam caused by the conflict between the two ends 4a and 12b when the catheter 4 enters the inner branch 12, thereby improving the ability of the catheter 4 to enter the inner branch 12. Smoothness.
  • the proximal end of the flaring section 122 is provided with an oblique opening 122a
  • the oblique opening 122a faces the inside of the tubular body 11 and is inclined to the distal end
  • the position where the oblique opening 122a is located is provided with a smooth surface ring member (not shown in the figure). show).
  • the oblique opening 122a is arranged obliquely from the proximal end to the distal end, when the end 4a of the catheter 4 abuts on the oblique opening 122a, the pressure of the catheter 4 against the oblique opening 122a is decomposed into perpendicular to the oblique opening.
  • the upper edge of the oblique opening 122a is connected to the inner wall 11b of the tubular body 11.
  • the inner wall 11b of the tubular main body 11 can face the oblique opening.
  • 122a provides a better supporting effect and weakens the force F2 along the surface where the inclined opening 122a is located. Therefore, the possibility of the duct 4 deforming the end 12b of the inner branch 12 is greatly reduced, so that the oblique opening 122a can be maintained with a larger opening area, so that the duct 4 enters the flaring section 122 from the oblique opening 122a, and then enters smoothly.
  • the inside of the branch body 121 The inside of the branch body 121.
  • the supporting force of the ring member is greater than the supporting force of the proximal end 121a of the branch body 121.
  • the supporting force of the ring member in the axial direction is greater than the supporting force of the proximal end 121a of the branch body 121 in the axial direction.
  • the supporting force of the shaped member in the radial direction is greater than the supporting force of the proximal end 121a of the branch body 121 in the radial direction, so that when the end 4a of the catheter 4 abuts against the ring member, the support of the ring member is opposite.
  • the proximal end 121a of the branch body 121 is relatively high, so that the flaring section 122 supported by the ring member is not easy to collapse, so that the flaring section 122 at the oblique opening 122a can maintain a large opening area to facilitate the end of the catheter 4
  • the portion 4a has a greater probability of entering the flaring section 122.
  • the end 4a of the duct 4 can resist and slide along the ring to enter the flaring section 122 with sufficient support provided by the ring.
  • the oblique opening 122a is inclined from the inner wall 11b of the tubular body 11 toward the central axis z of the tubular body 11, so that when the catheter 4 enters the interior of the tubular body 11, it is easier to face the opening at the proximal end of the inner branch 12 , And then can enter the inner branch 12 more smoothly.
  • the portion of the oblique opening 122a closest to the proximal end of the tubular body 11 is called "top 1221", correspondingly Ground, the portion of the oblique opening 122a closest to the distal end of the tubular body 11 is referred to as the "bottom 1222". Since the oblique opening 122a is inclined toward the inside of the tubular body 11 and inclined to the distal end, the bottom 1222 of the oblique opening 122a is also the part of the oblique opening 122a closest to the distal end of the branch main body 121.
  • the oblique opening 122a is inclined from the inner wall 11b of the tubular body 11 toward the central axis z of the tubular main body 11 and inclined to the distal end, which can be understood as the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a.
  • the line m where the line is located intersects the central axis z of the tubular body 11 and is not perpendicular.
  • the normal line f of the plane where the oblique opening 122a is located intersects the line connecting the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a
  • the normal f of ⁇ also intersects the central axis z of the tubular body 11.
  • the line m connecting the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a lies on the straight line m, the central axis z of the tubular body 11, the normal line of the plane where the oblique opening 122a is located, and the bottom 1222 of the oblique opening 122a and the oblique opening 122a.
  • the normal f where the line of the top 1221 of the mouth 122a intersects is coplanar.
  • the oblique opening 122a can not only better receive the catheter 4 entering the tubular body 11, but also facilitate the manipulation of the catheter 4 along the preset guide wire 2 from the oblique opening 122a into the inner branch 12, and it can also be used in the oblique
  • the tubular main body 11 is kept from deforming, so as to ensure that the part of the tubular main body 11 connected to the oblique opening 122a can fit the blood vessel wall well.
  • FIG. 8(c) and FIG. 8(d) for the schematic diagram of the process of the catheter 4 gradually entering the inner branch 12 under the guidance of the preset guide wire 2.
  • the catheter 4 moves toward the proximal end of the inner branch 12 under the guidance of the preset guide wire 2 until the end 4a of the catheter 4 abuts on the oblique opening 122a of the inner branch 12.
  • the abutment position is located in the middle position of the side edge between the bottom 1222 and the top 1221 of the oblique opening 122a.
  • the end 4a of the catheter 4 slides down along the ring member on the oblique opening 122a.
  • Figure 8(d) Please refer to the process shown in Figure 8(d).
  • the line m between the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a is located, and the minimum included angle a 1 between the vertical line from the top 1221 of the oblique opening 122a toward the distal end is The value range of is 45 degrees to 60 degrees.
  • the line m connecting the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a lies with the central axis z of the tubular body 11
  • the minimum included angle a 1 between is also in the range of 45 degrees to 60 degrees.
  • the included angle is also the line m between the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a, and the minimum included angle a 1 between the inner wall 11b of the tubular body 11 and the straight line m.
  • the oblique opening 122a will be able to better decompose the force applied by the catheter 4, so as to prevent the flaring section 122 from being deformed, so as to maintain the flaring section 122 with a larger opening.
  • the catheter 4 can enter the inner branch 12 smoothly.
  • the oblique opening 122a may also be inclined from the inner wall 11b of the tubular body 11 and not toward the central axis z of the tubular body 11, as long as the oblique opening 122a is from the inner wall 11b of the tubular body 11 toward the inside of the tubular body 11 and deviates farther.
  • the end is inclined, that is, the top 1221 of the oblique opening 122a can be as close as possible to the inner wall 11b of the tubular body 11, so that the top 1221 of the oblique opening 122a or the part adjacent to the top 1221 can be sewn to the tubular main body 11.
  • the anti-extrusion collapse performance of the oblique opening 122a can be improved.
  • the top 1221 of the oblique opening 122a may be adjacent to the top 1221
  • the near part is sutured to the tubular body 11, so that when the end 4a of the catheter 4 continues to be pushed into the inward branch 12, the end 4a of the catheter 4 will slide down along the edge of the oblique opening 122a without causing the oblique opening 122a
  • the oblique opening 122a can still maintain a larger opening, so that the end 4a of the catheter 4 can smoothly enter the flaring section 122, and then enter the branch body 121 along the flaring section 122.
  • the line m connecting the bottom 1222 of the oblique opening 122a and the top 1221 of the oblique opening 122a is located, and the minimum included angle a 1 between the vertical line of the top 1221 of the oblique opening 122a towards the distal end is 45. Degrees to 60 degrees.
  • the angle between the plane where the oblique opening 122a is located and the central axis z of the tubular body 11 ranges from 45 degrees to 60 degrees, so as to transmit the force of the catheter 4 against the oblique opening 122a to the inner wall 11b of the tubular body 11.
  • the oblique opening 122a is prevented from being squeezed and collapsed, so as to maintain a large enough opening for the catheter 4 to enter the inner branch 12.
  • the shape of the oblique opening 122a is an ellipse. It should be noted that the shape of the oblique opening 122a may be a regular ellipse or an irregular ellipse, that is, the shape of the oblique opening 122a is roughly elliptical, so that the contour of the oblique opening 122a is rounded, which is beneficial to the catheter 4. Enter the flaring section 122.
  • the shape of the oblique opening 122a can also be fan-shaped, "U"-shaped, and other shapes, so that the contour of the oblique opening 122a includes an arc section, so that the arc section is more stable with the inner wall of the tubular body 11. 11b is connected, thereby improving the support of the inner wall 11b of the tubular body 11 to the oblique opening 122a, so that the oblique opening 122a is not easily deformed when the catheter 4 enters the inner branch 12.
  • the ring member is made of a metal coil 13a, so that the ring member has enhanced compression resistance, so as to improve strong support at the oblique opening 122a and prevent the catheter 4 from entering
  • the oblique opening 122a is squeezed and deformed.
  • the ring member can also be made by densely stitching the film on the proximal edge of the flaring section 122 with the suture 13b, and the suture 13b can be made of metal thread to improve the suture film. The stability.
  • the shortest line from the bottom 1222 of the oblique opening 122a to the proximal end 121a of the branch body 121 and the central axis z of the tubular body 11 has a minimum angle a 2 ranging from 30 degrees to 70 degrees. degree. Since the extension direction of the branch main body 121 of the inner branch 12 in the tubular main body 11 is approximately parallel to the central axis Z of the tubular main body 11, the shortest distance between the bottom 1222 of the oblique opening 122a and the proximal end 121a of the branch main body 121 under this configuration is The minimum included angle between the connecting line and the central axis of the branch main body 121 ranges from 30 degrees to 70 degrees.
  • the end 4a of the catheter 4 is not easily stuck at the lower edge of the oblique opening 122a, and it is easy to enter the branch body 121 along the flaring section 122.
  • the luminal stent 10 of embodiment 2 includes two inner branches 12, and the structure of the two inner branches 12 is similar to that of the inner branch 12 of Embodiment 1, that is, the inner branch 12 includes a branch body 121 and a branch body 121 adjacent to each other.
  • the flaring section 122 connected to the end 121a is provided with an oblique opening 122a at the proximal end of the flaring section 122, and the oblique opening 122a is inclined from the inner wall 11b of the tubular body 11 toward the inside of the tubular body 11 and inclined to the distal end.
  • the structure of the inner branch 12 will not be repeated here.
  • the two inner branches 12 When the two inner branches 12 are connected to the inner wall 11b of the tubular body 11 adjacent to each other, the two inner branches 12 and the inner wall 11b of the tubular body 11 are enclosed to form a gap 10a. If the blood flow in the gap 10a is not smooth, it is easy to form a thrombus in the gap 10a. When the formed thrombus is washed out by the blood flow, it will flow into the blood vessel along the blood flow and cause the blood vessel to be blocked. For this reason, the inventor proposes to use the combined structure of the flaring sections 122 of the two inner branches 12 to reduce the gap 10a, so as to improve the problem of clogging of blood vessels caused by thrombus at the gap 10a. Specifically, as shown in FIG. 13 and FIG.
  • a part of the edges of the respective flaring sections 122 of the two inner branches 12 and the inner wall 11b of the tubular body 11 cooperate with each other to at least partially block the two inner branches 12 and the tubular The gap 10a between the inner walls 11b of the main body 11.
  • the two inner branches 12 are both arranged in the tubular main body 11, and the respective flared sections 122 are fixed to the inner wall 11b of the tubular main body 11, for example, a connection method such as stitching or glue bonding is adopted to connect the corresponding The flaring section 122 of the inner branch 12 is connected to the inner wall of the tubular body 11.
  • a connection method such as stitching or glue bonding is adopted to connect the corresponding
  • the flaring section 122 of the inner branch 12 is connected to the inner wall of the tubular body 11.
  • the gap 10a can be partially blocked, so that the gap 10a can be as far as possible.
  • the ground is reduced to reduce the chance of thrombosis in the gap 10a.
  • top 1221 of the oblique opening 122a of one of the inner branches 12 is fixed together with the top 1221 of the oblique opening 122a of the other inner branch 12, such as stitching or bonding together, and other fixing methods can also be used.
  • This structure that connects the tops 1221 of the oblique openings 122a of the two inner branches 12 to each other, on the one hand, can improve the connection between the two inner branches 12 and the inner wall 11b of the tubular body 11 by enhancing the stability of the connection between the two inner branches 12
  • the tops 1221 of the oblique openings 122a of the two inner branches 12 are connected, so that the tops 1221 can be as close to the inner wall 11b of the tubular body 11 as possible, so as to better
  • the gap 10a between the two inner branches 12 and the inner wall 11b of the tubular body 11 is sealed, thereby reducing the chance of thrombus.
  • the respective oblique openings 122a of the two inner branches 12 each include a first edge 1201 and a second edge 1202, and the first edge 1201 and the second edge 1202 are respectively adjacent to On opposite sides of the top 1221 of the respective oblique openings 122a, the first edge 1201 of the oblique opening 122a of one inner branch 12 is fixed on the inner wall 11b of the tubular body 11, and the second edge 1202 is connected to the oblique opening 122a of the other inner branch 12 The first edge 1201 of the inner branch 12 is connected, and the second edge 1202 of the oblique opening 122a of the other inner branch 12 is fixed on the inner wall 11b of the tubular body 11.
  • the gap 10a between the two inner branches 12 and the inner wall 11b of the tubular body 11 will be effectively reduced under the sealing of the corresponding side wall of the flaring section 122, thereby reducing the occurrence of thrombus here. Probability.
  • the tops 1221 of the respective oblique openings 122a of the two inner branches 12 are fixed to the inner wall 11b of the tubular body 11.
  • the first edge 1201 of the oblique opening 122a of one of the inner branches 12 is completely fixed on the inner wall 11b of the tubular body 11, that is, the first edge 1201 of the oblique opening 122a of the inner branch 12 Any part of the edge 1201 is fixedly connected to the inner wall 11 b of the tubular body 11.
  • the second edge 1202 of the oblique opening 122a of the other inner branch 12 is completely fixed on the inner wall 11b of the tubular body 11, that is, any part of the second edge 1202 of the oblique opening 122a of the inner branch 12 is connected to the tubular body 11
  • the inner wall 11b of 11 is fixedly connected.
  • the tops 1221 of the oblique openings 122a of the two inner branches 12 are arc-shaped, and the arc-shaped tops 1221 can be more tightly fixed to the inner wall of the tubular body 11 11b, to better seal the gap 10a.
  • the tops 1221 of the oblique openings 122a of the two inner branches 12 are both fixed to the inner wall 11b of the tubular body 11.
  • top 1221 of the oblique opening 122a is arc-shaped, when the top 1221 of the oblique opening 122a of the two inner branches 12 are fixed to each other, the top 1221 of the oblique opening 122a of the two inner branches 12 can be completely attached to the tube.
  • the inner wall 11b of the main body 11 is such that there is no gap between the inner wall 11b of the tubular main body 11 and the tops 1221 of the oblique openings 122a of the two inner branches 12.
  • the sides 1221a, 1221b of the oblique openings 122a of the two inner branches 12 adjacent to each other and close to the top 1221 of the oblique opening 122a are connected to each other, so that the two inner branches 12 can be completely blocked.
  • the gap 10a between the inner wall 11b of the tubular body 11 and the inner wall 11b can effectively prevent the formation of thrombus.
  • the shape of the oblique opening 122a can be improved so that the orthographic projection of the oblique opening 122a on the cross section of the tubular body 11 is substantially It is fan-shaped so that when the oblique openings 122a of the two inner branches 12 are connected, the oblique openings 122a of this structure can be tightly connected together to enhance the sealing effect, and at the same time improve the two inner branches 12 and the tubular body 11 The stability of the connection to obtain better support and prevent the catheter 4 from being prone to jamming when it enters the inner branch 12.
  • the same or similarities between the lumen stent 10 of Example 3 and the lumen stent 10 of Example 1 or Example 2 will not be repeated here.
  • the main difference is that the lumen stent 10 of Example 3 has a flaring
  • the side wall of the section 122 is provided with a support member, the support member is connected with the ring member, so that the ring member is stably supported on the inner wall 11b of the tubular body 11 by the support member, thereby further strengthening the ring member at the oblique opening 122a.
  • the supporting effect prevents the flared section 122 from collapsing after being squeezed at the inclined opening 122a.
  • a support member is provided at a position of the flaring section 122 close to the inner wall of the tubular body 11, so as to stably support the ring member, thereby strengthening the support force of the ring member to the inclined opening 122a.
  • the support member and the ring member at the inclined opening 122a may be an integral structure. For example, as shown in FIG.
  • a support rod 13d for connecting the inner wall of the tubular body 11 and/or connecting to the branch body 121 is led out, so that the support can be used
  • the rod 13d serves as a support member to provide a better support effect for the ring member, thereby enabling the ring member to strengthen the compression resistance at the inclined opening 122a, that is, when the catheter 4 enters the inner branch 12, the opening is flared.
  • the section 122 is not easily squeezed and collapsed under the support of the ring member and the support rod 13d, so that the oblique opening 122a has a larger opening, thereby facilitating the duct 4 to enter the flaring section 122 from the oblique opening 122a and along the flaring section. 122 enters the branch main body 121.
  • the ring member 13 and the support member 14 are integrally formed by cutting a tube.
  • the ring member 13 and the support member 14 do not need to be connected by other connection methods, the structure is simple, and the connection between the two is stable, so as to provide a stable support effect.
  • the support may be a ring-shaped metal corrugated ring.
  • the supporting member 14 is a zigzag wave ring adapted to the shape of the flaring section 122, and has a wave crest 14a and a wave trough 14b. Among them, at least one wave crest 14a is connected to the bottom 1222 of the oblique opening 122a to provide better Supportive.
  • two troughs 14b of the support member 14 are adjacently arranged.
  • two adjacent troughs 14b corresponding to the bottom 1222 of the inclined opening 122a Close to each other to better support the bottom 1222 of the inclined opening 122a.
  • the two adjacent troughs 14b is provided, between the two peaks 14a of the troughs 14b form a 3 near the corner 108 °, i.e., a case where the allowable error exists, constituting the two band
  • the two poles 141 are approximately parallel.
  • the two poles 141 near the bottom 1222 of the inclined opening 122a can better support the inclined opening 122a.
  • the two wave crests 14a are adjacently arranged at the bottom 1222 of the oblique opening 122a, which can also obtain better support.
  • the two wave rods 141 corresponding to the two wave crests 14a may not be connected through the wave trough 14b.
  • the two wave rods 141 supported at the bottom 1222 of the oblique opening 122a are connected by a steel sleeve 142, so that the support 14 can still form a complete wave ring to obtain a better radial
  • the anti-extrusion performance while using the support 14 to provide better support in the flaring section 122, it can also improve the radial anti-extrusion property of the flaring section 122, which in turn causes the inclined opening 122a to be squeezed by the duct 4 When compressed, the flaring section 122 is not prone to collapse and affects the patency of the catheter 4 when it enters.
  • the supporting member 14 may also be a wave ring in the shape of an M-shaped wave, a V-shaped wave, a sine wave, or the like.
  • the structure of the bare stent 111 at the proximal end of the luminal stent 10 is improved, so that the bare stent 111 can pre-guide the catheter 4 so that the catheter 4 can enter the interior more smoothly.
  • Branch 12 reduce the chance of lag.
  • a bare stent 111 is provided at the proximal end of the tubular body 11, and the bare stent 111, that is, the proximal end of the tubular body 11 and the fixed anchor 111a are anchored.
  • the bare stent 111 is an expandable and contractible structure with a number of wave rods 1111 connected end to end and in a natural state of a wave loop shape, which has opposite wave crests 1101 and wave troughs 1102.
  • the wave crest 1101 of the bare stent 111 is locked on the fixed anchor 111a.
  • the wave rod 1111 of the bare stent 111 is converged inward by the radial anchoring force of the fixed anchor 111a.
  • the part of the bare stent 111 corresponding to the inner branch 12 in the tubular body 11 is symmetrically provided with two arc-shaped poles 1111, and adjacent poles 1111
  • the arc-shaped sections of the stent form a large gap 1112 between each other.
  • the rod 1111 can radially confine the catheter 4 in the gap 1112, and the catheter 4 is in the gap 1112.
  • the activity space is larger than other linear poles.
  • the gap 1112 formed between the two adjacent poles 1111 with an arc-shaped section is less than the gap formed between the two adjacent poles 111 at the same trough 1101.
  • the space area is larger, so that the catheter 4 can enter the gap 1112 with a greater probability, and fall into the inner branch 12 with a greater probability under the guidance of the gap 1112, so as to avoid the end 4a of the catheter 4 from the inner branch 12 It is stuck at the proximal end and cannot enter the inner branch 12.
  • the inner branch 12 here may be the inner branch 12 with a flaring section 122 in any one of Embodiments 1 to 3.
  • the gap 1112 is close to the inner wall 11b of the tubular body 11, the pole 1111 of the bare stent 111 above the inner branch 12 may be S-shaped, and the S-shaped pole 1111 includes an arc-shaped section 1111a and is connected to the arc-shaped section 1111a
  • the reverse arc section 1111b it is understandable that the reverse arc section 1111b refers to the part that has the opposite bending direction to the arc section 1111a.
  • the gap 1112 formed by the two arc segments 1111a arranged in mirror symmetry is close to the inner wall 11b of the tubular body 11 and corresponds to the wave trough 1102; correspondingly, the two reverse arc segments 1111b arranged in mirror symmetry are close to the wave peak 1101.

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Abstract

一种管腔支架(10),包括管状主体(11),以及位于管状主体(11)内部且分别与管状主体(11)连通的至少一个内分支(12),内分支(12)的内部中空且两端均开口,内分支(12)包括分支主体(121)和与分支主体(121)的近端(121a)连接的扩口段(122),扩口段(122)的近端设有斜口(122a),斜口(122a)自管状主体(11)的内壁朝向分支主体(121)的远端倾斜,且斜口(122a)所在的位置处设有表面光滑的环状件(13)。该管腔支架(10)利用扩口段(122)的斜口(122a)使得导管(4)能够容易进入内分支(12)而减少卡顿机率,此外,通过在斜口(122a)所在位置处设置表面光滑的环状件(13)进一步提高导管(4)进入内分支(12)的通畅性,以有效避免导管(4)进入内分支(12)时端部容易出现卡顿而产生不良影响。

Description

管腔支架 技术领域
本发明涉及介入医疗器械技术领域,特别是涉及一种管腔支架。
背景技术
动脉瘤是临床上常见的血管疾病,多发生在老年人身上,这种疾病容易导致主动脉瘤破裂,对患者的生命造成极大的威胁。随着现在医学技术的不断发展,利用微创手术将覆膜支架植入体内,治疗主动脉瘤及夹层动脉瘤的治疗手术被使用,因其创伤小,恢复快,得到了广泛应用。此治疗方式是将覆膜支架压缩入输送装置中,沿着事先植入的导丝轨道引导进入人体,到达病变位置后,将覆膜支架释放出来以隔绝血流和病变位置,同时重建血流通道,动脉瘤和夹层在丧失血流供应后,瘤腔内残存血液逐渐形成血栓并肌化成血管组织,扩张状态的瘤壁因受压而收缩,逐渐恢复原始状态,从而达到治疗动脉瘤和夹层的目的。
然而,人体的血管结构复杂,当病变发生在分支部位的话,就需要采用能重建分支动脉的覆膜支架。目前针对此类病变的覆膜支架有一种是内置覆膜支架,即直管支架内部再连接一个直管型覆膜支架,通常称为内分支,两者通过外部覆膜支架上的孔连接在一起,两者通过孔实现流体连通。实际使用时,将外部覆膜支架的孔对应放置在分支动脉开口的位置,再植入一个直管支架从而连通内分支和分支动脉,达到重建分支动脉的目的。覆膜支架重建分支动脉时,都需要建立从覆膜支架上的孔到分支动脉的导丝轨道。
但是手术过程中内分支的导丝通道很难建立,为了简化手术的操作,支架系统会在内分支里准备好预置导丝,为了减小对支架的装配和释放的影响,预置导丝往往很细,常用的是0.014"或者0.018"直径的导丝作为预置导丝,实际使用时,先将导管沿着预置导丝建立的通道输送进入内分支,然后交换0.035"硬导丝,分支支架通过硬导丝建立的通道完成支架的植入。
由于导管的管腔要能通过0.035"的硬导丝,导管的管腔孔径与硬导丝相适应,而预置导丝比硬导丝细,因此导管的管腔孔径相对于预置导丝就偏大,预置导丝引导导管操作过程中,预置导丝与导管径向尺寸差异将会形成台阶,这样便会在导管沿预置导丝进入内分支时,导管的端部容易卡在内分支的端部。
发明内容
基于此,本发明提供一种管腔支架,解决导管进入内分支时容易出现卡顿的技术问题。
一种管腔支架,包括管状主体,以及位于所述管状主体内部且分别与所述管状主体连通的至少一个内分支,所述内分支的内部中空且两端均开口,所述内分支包括分支主体和与所述分支主体的近端连接的扩口段,所述扩口段的近端设有斜口,所述斜口朝向所述管状主体的内部并偏向远端倾斜,且所述斜口所在的位置处设有表面光滑的环状件。
本发明提供了管腔支架,该管腔支架包括管状主体以及设置于管状主体内并与管状主体连通的内分支, 内分支的近端设置扩口段,以使导管更容易对准内分支的近端;扩口段的近端设有斜口,斜口自管状主体的内壁朝分支主体的远端倾斜,以利用扩口段的斜口使得导管在抵接在斜口上时,能够顺着斜口下滑而进入内分支,减少卡顿机率。此外,通过在斜口所在位置处设置表面光滑的环状件,使导管抵接在斜口上时更容易下滑,进一步提高导管进入内分支的通畅性,以有效避免导管进入内分支时端部容易出现卡顿而产生不良影响。
附图说明
图1为一实施例的管腔支架的结构示意图;
图2为一实施例的管腔支架经输送器输送至动脉瘤时示意图;
图3为一实施例中的管腔支架从输送器释放状态示意图;
图4为一实施例中的管腔支架释放至动脉瘤后,导管沿预置导丝进入管腔支架前状态示意图;
图5为一实施例中的管腔支架释放至动脉瘤后,导管沿预置导丝进入管腔支架内的内分支状态示意图;
图6为导管进入内分支时,导管的端部与内分支的端部相抵状态示意图;
图7为导管的端部与内分支的端部相抵,导管挤压内分支产生塌陷状态示意图;
图8(a)为实施例1的管腔支架的部分结构示意图;图8(b)为图8(a)示出的管腔支架的部分结构图中,斜口的法线与管状主体的中心轴相交的示意图;图8(c)为一实施例的管腔支架,导管在预置导丝的引导下与内分支的斜口相抵时的示意图;图8(d)为一实施例的管腔支架,导管的端部沿斜口下滑至邻近斜口的底部位置时的示意图;
图9为实施例1的管腔支架的内分支的斜口朝向管状主体的中心轴倾斜设置的示意图;
图10为一实施例的管腔支架的内分支的部分结构示意图;
图11为另一实施例的管腔支架的内分支的部分结构示意图;
图12为实施例2的管腔支架具有两个内分支时,管腔支架的轴向俯视示意图,图中示出了两个内分支与管状主体的内壁之间形成的空隙;
图13为实施例2的管腔支架中,两个内分支的扩口段的部分边缘相连接封堵空隙的示意图;
图14为图13示出的管腔支架的结构示意图;
图15为另一实施例的管腔支架的轴向俯视示意图,图中示出了管状主体内的两个内分支的斜口均呈扇形;
图16为图15示出的管腔支架的结构示意图;
图17为实施例3的管腔支架的具有支撑件的内分支的部分结构示意图;
图18为另一实施例的管腔支架的支撑件与环状件一体的结构示意图;
图19为另一实施例的管腔支架的具有另一支撑件结构的内分支的部分结构示意图;
图20为再一实施例的管腔支架的具有另一支撑件结构的内分支的部分结构示意图;
图21为一实施例的管腔支架的支撑件的结构示意图;
图22为另一实施例的管腔支架的支撑件的结构示意图;
图23为一实施例的设有裸支架的管腔支架的结构示意图;
图24为图23示出的管腔支架处于锚定状态下,导管穿过裸支架时的结构示意图;
图25为实施例4的设有裸支架的管腔支架的结构示意图;
图26为图25示出的管腔支架处于锚定状态下,导管穿过裸支架时的结构示意图。
具体实施方式
为了便于理解本发明,下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施方式。但是,本发明可以以许多不同的形式来实现,并不限于本文所描述的实施方式。相反地,提供这些实施方式的目的是使对本发明的公开内容理解的更加透彻全面。
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
在介入医疗器械领域,一般将植入人体或动物体内的支架的距离心脏较近的一端称为“近端”,将距离心脏较远的一端称为“远端”,并依据此原理定义支架的任一部件的“近端”和“远端”;并将植入人体或动物体内的其他医疗器械的距离操作者较近的一端称为“近端”,将距离操作者较远的一端称为“远端”,并依据此原理定义其他医疗器械的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向,“径向”一般是指医疗器械的与其“轴向”垂直的方向,并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
本发明的管腔支架中的内分支12可用于胸腹主支架、弓步支架、髂分叉支架、肾上动脉瘤支架等管腔支架上,以下将以内分支12应用于胸腹主支架上为例进行详细说明,内分支12在其他管腔支架上的应用与此相同或相似,在此不再一一赘述。
实施例1
请参考图1,实施例1提供一种管腔支架10,管腔支架10包括管状主体11,以及位于管状主体11内部且分别与管状主体11连通的至少一个内分支12。例如,图1中示出了管腔支架10在管状主体11内设置了 2个内分支12。在其他实施例中,管腔支架10可以设置一个或2个以上的内分支12。
管状主体11包括锥度段11a、近端段11b以及远端段11c。近端段11b连接于锥度段11a的近端,远端段11c连接于锥度段11a的远端。该锥度段11a位于管状主体11的中间段,且锥度段11a的远端尺寸小于锥度段11a的近端尺寸。
具体地,锥度段11a上设置供与内分支12相连的内分支窗口12a。对于管状主体11内部设有多个内分支12时,锥度段11a上也设置相应数量的内分支窗口12a,一个内分支12的远端与一个内分支窗口12a连接,内分支12的近端将位于管状主体11内。在其他一些实施方式中,管状主体11上可不设置锥度段11a,而仅设有近端段11b和远端段11c。近端段11b的外径与远端段11c的外径相等或不相等均可。在近端段11b或远端段11c上设有一个或多个内分支窗口,该内分支窗口用于与内分支12的远端连接后,使该内分支窗口与内分支12的腔体连通。
需要说明的是,内分支12的内部中空且两端均开口,这样内分支12将通过位于其近端的开口与管状主体11连通,进而进入管状主体11的导管经操控也可以进入内分支12。
在一些实施例中,管腔支架10包括至少一个外分支101,外分支101位于管状主体11的外部,且通过其近端末端与管状主体11的内部相连通。例如,外分支101的近端末端与锥度段11a相连接,并通过设置在锥度段11a上的外分支窗口101a与管状主体11的内部相连通。
为了便于理解,下面将结合图2至图5所示,以管腔支架10在作用至胸腹主动脉瘤的操作过程为例对管腔支架10的结构及其作用机制作进一步说明。
参阅图2所示,图2中示意性示出了胸腹主动脉瘤100a以及其所位于的分支血管100b分布。管腔支架10是通过输送器1从股动脉进入并输送到达瘤体位置。结合图3所示,在瘤体位置释放出管腔支架10,并将预先穿过内分支12的预置导丝2通过抓捕器3抓出,其中,抓捕器3可以从颈动脉或锁骨下动脉输送到内分支12附近。结合图4和图5所示,以管状主体11内设有2个内分支12为例,2个内分支12内分别预先穿设有预置导丝2,以利用相应的预置导丝2分别将导管4导向相应的内分支12。具体地,在抓捕器3将预置导丝2抓出后,2个导管4分别在各自的预置导丝2的导向作用下进入对应的内分支12,从而建立内分支12的通道。此时,保持导管4和管腔支架10的相对位置不变,将预置导丝2抽出,并交换其他较粗的导丝,进行后续操作。
对于近端为平齐开口的内分支12结构,发明人发现,由于预置导丝2偏细,导管4在沿预置导丝2进入内分支12时,导管4的端部4a往往会错开内分支12的腔体而与内分支12的端部12b相抵,如图6所示。导管4的端部4a和内分支12的端部12b相抵,会导致导管4进入内分支12时出现卡顿,进而无法顺利的进入内分支12。参阅图7所示,在导管4的端部4a与内分支12的端部12b相抵时,若强行推送导管4会导致内分支12的端部12b塌陷,会加剧卡顿,导致导管4更加无法穿入内分支12,影响后续操作。对此,发明人通过对管腔支架10的结构进行改进,以减少导管4进入内分支12时的卡顿机率,提高导管4进入内分 支12的顺畅性。
结合图8(a)所示,由于内分支12的远端与位于管状主体11的锥度段11a的内分支窗口12a相连,内分支12的近端位于管状主体11内,并作为导管4进入内分支12的进口端,从而在一实施例中,通过在内分支12的近端进行设置扩口的结构,以便于导管4进入内分支12而减少卡顿现象出现机率。
具体地,内分支12包括分支主体121和与分支主体121的近端121a连接的扩口段122。从而便于导管4由扩口段122进入分支主体121。可以理解的,扩口段122呈喇叭口状。总之,扩口段122的近端开口面积大于扩口段122的远端开口面积。由于扩口段122是连接于分支主体121的近端121a,因此,扩口段122作为引导导管4进入分支主体121的管段,导管4进入内分支12时,首先从扩口段122的近端进入扩口段122,再由扩口段122导向分支主体121,从而扩口段122的近端开口面积大于扩口段122的远端开口面积,就能够使得导管4具有更大概率对准内分支12的腔体。扩口段122的内径大于分支主体121的内径,其中,扩口段122的内径包含扩口段122沿其长度方向,在其任意横截面上所呈轮廓的内径。
内分支12中,分支主体121大致呈圆柱状管体,扩口段122的远端与分支主体121的近端121a相连,继而扩口段122的远端开口的大小与分支主体121的内径相等。此时,导管4将可以顺着扩口段122进入分支主体121,以减少导管4进入内分支12时两者端部4a、12b相抵而引起的卡顿,从而提高导管4进入内分支12的顺畅性。
进一步地,扩口段122的近端设有斜口122a,斜口122a朝向管状主体11的内部并偏向远端倾斜,且斜口122a所在的位置处设有表面光滑的环状件(图未示出)。这样,在导管4进入内分支12时,即使导管4的端部4a与内分支12的端部12b相抵,在斜口122a以及环状件的引导下,导管4的端部4a将沿着斜口122a下滑,并落入扩口段122的内部,进而进入分支主体121内。
具体地,由于斜口122a自近端至远端呈倾斜设置,从而在导管4的端部4a抵在斜口122a上时,导管4对斜口122a的抵压力被分解成了垂直于斜口122a所在面的力F1和沿斜口122a所在面的力F2。斜口122a的上缘连接在管状主体11的内壁11b上,由于沿斜口122a所在面的力F2传递到内分支12的斜口122a的上缘,从而管状主体11的内壁11b能够对斜口122a提供较好的支撑效果,消弱沿斜口122a所在面的力F2。因此,导管4将内分支12的端部12b顶变形的可能性大大降低,从而能够维持斜口122a具有较大的开口面积,以利于导管4从斜口122a进入扩口段122,进而顺利进入分支主体121的内部。
环状件的支撑力大于分支主体121的近端121a的支撑力,具体地,环状件在轴向方向上的支撑力大于分支主体121的近端121a在轴向方向上的支撑力,环状件在径向方向上的支撑力大于分支主体121的近端121a在径向方向上的支撑力,从而在导管4的端部4a与环状件相抵时,由于环状件的支撑性相对分支主体121的近端121a较高,从而在环状件支撑下的扩口段122不容易塌陷,使得斜口122a处的扩口段122能够维持较大的开口面积,以方便导管4的端部4a具有更大概率进入扩口段122。且由于环状件的表面光滑,从而在环状件提供足够的支撑下,导管4的端部4a能够抵持并沿环状件下滑进入扩口段122。
在一些实施例中,斜口122a自管状主体11的内壁11b朝向管状主体11的中心轴z倾斜,以使导管4在进入管状主体11的内部时,更容易对着内分支12近端的开口,进而能够更为顺利地进入内分支12。
为了便于理解,结合图8(a)所示,在沿管状主体11的中心轴z的延伸方向上,将斜口122a的最靠近管状主体11的近端的部分称为“顶部1221”,相应地,将斜口122a的最靠近管状主体11的远端的部分称为“底部1222”。由于斜口122a朝向管状主体11的内部并偏向远端倾斜,从而斜口122a的底部1222也是斜口122a的最靠近分支主体121的远端的部位。
结合图8(b)所示,斜口122a自管状主体11的内壁11b朝向管状主体11的中心轴z并偏向远端倾斜,可以理解为斜口122a的底部1222与斜口122a的顶部1221的连线所在直线m,与管状主体11的中心轴z相交且不垂直,同时,斜口122a所在平面的法线f中,与斜口122a的底部1222和斜口122a的顶部1221的连线相交的法线f也与管状主体11的中心轴z相交。确切的说,斜口122a的底部1222与斜口122a的顶部1221的连线所在直线m、管状主体11的中心轴z、斜口122a所在平面的法线中与斜口122a的底部1222和斜口122a的顶部1221的连线相交的法线f三者共面。在这种结构设置下,斜口122a不仅能够更好的接收进入管状主体11内的导管4,继而有利于操控导管4沿预置导丝2从斜口122a进入内分支12,还能够在斜口122a固定在管状主体11的内壁上后,保持管状主体11不变形,从而保证管状主体11的与斜口122a连接的部分,能够很好地贴合血管壁。
请参考图8(c)和图8(d)所示出的导管4在预置导丝2的引导下逐步进入内分支12内部的过程示意图。在图8(c)所示过程中,导管4在预置导丝2的引导下朝向内分支12的近端移动,直至导管4的端部4a抵接在内分支12的斜口122a上,且抵接的位置位于斜口122a的底部1222和顶部1221之间的侧边缘的中间位置。之后,导管4的端部4a沿着斜口122a上环状件下滑。请参考图8(d)所示过程,当导管4的端部4a下滑至将要临近底部1222的位置时,由于穿设在内分支12内的预置导丝2受到内分支12的内壁限制,预置导丝2朝向中心轴z靠近的最远位置,只能是抵靠在分支主体121近端121a的最靠近中心轴z的位置处,而斜口122a的底部1222较该位置更加靠近中心轴z,因而,导管4会在预置导丝2的作用下受到一个使其无法继续靠近中心轴z的牵拉力,由此便可以使导管4的端部4a跳跃进入扩口段122的内部,并在预置导丝2的引导下顺利进入分支主体121的内部,且在这些过程中导管4几乎没有出现卡顿的情况。
进一步地,结合图9所示,斜口122a的底部1222与斜口122a的顶部1221的连线所在直线m,与斜口122a的顶部1221朝向远端的垂线之间的最小夹角a 1的取值范围为45度至60度,对于呈圆柱体的管状主体11而言,斜口122a的底部1222与斜口122a的顶部1221的连线所在直线m,与管状主体11的中心轴z之间的最小夹角a 1的取值范围也为45度至60度。该夹角也是斜口122a的底部1222与斜口122a的顶部1221的连线所在直线m,与管状主体11的内壁11b之间的最小夹角a 1。在该角度范围内,斜口122a将能够更好的对导管4所施加的力起到分解的效果,以防止扩口段122被顶变形,从而能够维持扩口段122具有较大开口,以便导管4能够顺利进入内分支12。
在其他实施例中,斜口122a也可以自管状主体11的内壁11b而未朝向管状主体11的中心轴z倾斜,只要斜口122a自管状主体11的内壁11b朝向管状主体11的内部并偏向远端倾斜,也即斜口122a的顶部1221能够尽可能靠近管状主体11的内壁11b,便于将斜口122a的顶部1221或者与顶部1221相邻近的部分缝合到管状主体11上即可,这样便可以提高斜口122a的抗挤压坍塌性能,也即,导管4在进入内分支12时,即使导管4的端部4a与斜口122a相抵,由于斜口122a的顶部1221或者与顶部1221相邻近的部分被缝合到管状主体11上,从而导管4的端部4a继续向内分支12内推送时,导管4的端部4a将会沿着斜口122a的边缘下滑而不会造成斜口122a坍塌,进而斜口122a仍然能够维持较大的开口,以便导管4的端部4a能够顺利进入扩口段122,进而顺着扩口段122进入分支主体121。此时,斜口122a的底部1222与斜口122a的顶部1221的连线所在直线m,与斜口122a的顶部1221朝向远端的垂线之间的最小夹角a 1的取值范围为45度至60度。
斜口122a所在的平面与管状主体11的中心轴z之间的夹角的取值范围为45度至60度,以便将导管4抵压斜口122a的力传递到管状主体11的内壁11b,避免斜口122a受挤压而坍塌,从而维持足够大的开口以供导管4进入内分支12。
斜口122a的形状为椭圆形。需要说明的是,斜口122a的形状可以为规则的椭圆形,也可以为非规则的椭圆形,即斜口122a的形状大致呈椭圆形,以使得斜口122a的轮廓圆润,有利于导管4进入扩口段122。
在其他实施例中,斜口122a的形状还可以为扇形、“U”形等其他形状,以使得斜口122a的轮廓包含弧形段,从而利用弧形段更稳定地与管状主体11的内壁11b相连接,进而提高管状主体11的内壁11b对斜口122a的支撑性,使得导管4进入内分支12时斜口122a不容易被挤压变形。
结合图10所示,在一些实施例中,环状件由金属线圈13a制得,以使得环状件具有加强的抗压缩性,以在斜口122a处提高较强支撑性,防止导管4进入内分支12时斜口122a被挤压变形。在其他实施例中,结合图11所示,环状件也可以由缝线13b密集地缝合扩口段122近端边缘的覆膜制得,缝线13b可以采用金属线,以提高缝合覆膜的稳定性。
结合图9所示,斜口122a的底部1222到分支主体121的近端121a的最短连线,与管状主体11的中心轴z之间的最小夹角a 2的取值范围为30度至70度。由于内分支12的分支主体121在管状主体11内的延伸方向大致与管状主体11的中心轴Z平行,从而这种结构设置下,斜口122a的底部1222到分支主体121的近端121a的最短连线,与分支主体121的中轴线的最小夹角取值范围为30度至70度。该角度范围下,导管4的端部4a不容易卡顿在斜口122a的下缘,且容易沿扩口段122进入分支主体121。有效避免了该夹角a 2过小时,扩口段122的与斜口122a的底部1222相应处的侧壁过于竖直而起不到导向效果,导管4的端部4a容易抵在斜口122a的下缘而出现卡顿现象。同时,也避免了该夹角a 2过大时,扩口段122的与斜口122a的底部1222相应处的侧壁过于水平,导管4的端部4a不容易沿着扩口段122进入分支主体121。
实施例2
实施例2的管腔支架10与实施例1的管腔支架10的相同或相似之处在此不再赘述,两者的主要区别在于,实施例2的管腔支架10中,请结合图12所示,管腔支架10包括两个内分支12,该两个内分支12的结构与实施例1的内分支12结构相似,也即,内分支12包括分支主体121和与分支主体121的近端121a连接的扩口段122,扩口段122的近端设有斜口122a,斜口122a自管状主体11的内壁11b朝向管状主体11的内部并偏向远端倾斜。对于内分支12的结构,在此不做赘述。
两个内分支12相互邻接地分别连接在管状主体11的内壁11b上时,两个内分支12和管状主体11的内壁11b围合形成空隙10a。如果空隙10a处的血流流通不通畅,很容易在空隙10a处形成血栓。当形成的血栓被血流冲出,会顺着血流流进血管而造成血管堵塞。为此,发明人提出利用两个内分支12的扩口段122的结合结构,来减小空隙10a,以改善空隙10a处容易产生血栓而造成血管堵塞的问题。具体地,结合图13和图14所示,两个内分支12各自的扩口段122的一部分边缘以及管状主体11的内壁11b相互配合,以至少部分地封堵位于两个内分支12和管状主体11的内壁11b之间的空隙10a。
该实施例中,由于两个内分支12均设置在管状主体11内,且各自的扩口段122均与管状主体11的内壁11b固定,例如,采取缝合或胶水粘接等连接方式,将相应的内分支12的扩口段122与管状主体11的内壁相连接。将两个内分支12的扩口段122的一部分边缘以相互配合的形式来封堵内分支12和管状主体11的内壁11b之间的空隙10a时,便可以减小空隙10a,甚至是完全封堵空隙10a,从而避免空隙10a处产生血栓。
对于利用扩口段122的一部分边缘相互配合来封堵空隙10a的结构,具有多种可能。例如,结合图13和图14所示,两个内分支12的扩口段122中,靠近斜口122a的顶部1221且相邻接的地方相互连接。具体地,在其中一种实现方式中,在两个内分支12的扩口段122分别与管状主体11的内壁11b固定后,两个内分支12的扩口段122彼此相挤压,继而使得扩口段122的斜口122a的边缘更靠近管状主体11的内壁11b,此时,将扩口段122彼此挤压的地方连接起来,便可以对空隙10a进行部分封堵,使得空隙10a尽可能地减小,以降低空隙10a处产生血栓的机率。
进一步地,其中一个内分支12的斜口122a的顶部1221,与另一个内分支12的斜口122a的顶部1221固定在一起,例如缝合或粘结在一起,也可以采用其他固定方式。这种将两个内分支12的斜口122a的顶部1221彼此相连的结构,一方面可以通过增强两个内分支12之间的连接稳定性来提高彼此之间与管状主体11的内壁11b的结合稳定性,从而整体上能够获得较好的支撑性;另一方面两个内分支12的斜口122a的顶部1221相连可以尽可能多的将顶部1221靠近管状主体11的内壁11b,从而更好地封堵两个内分支12和管状主体11的内壁11b之间的空隙10a,以此减少产生血栓的机率。
继续参阅图13和图14所示,在一些实施例中,两个内分支12各自的斜口122a均包括第一边缘1201和第二边缘1202,第一边缘1201和第二边缘1202分别邻接于各自斜口122a的顶部1221的相对两侧,其中一个内分支12的斜口122a的第一边缘1201固定在管状主体11的内壁11b上,第二边缘1202与另一个内 分支12的斜口122a的第一边缘1201相连接,另一个内分支12的斜口122a的第二边缘1202固定在管状主体11的内壁11b上。这种结构下,两个内分支12和管状主体11的内壁11b之间的空隙10a,将在扩口段122的相应侧壁的封堵下,得到有效的减小,进而减少此处产生血栓机率。
进一步地,两个内分支12各自的斜口122a的顶部1221均固定在管状主体11的内壁11b。由此,两个内分支12中,其中一个内分支12的斜口122a的第一边缘1201完全被固定在管状主体11的内壁11b上,也即,该内分支12的斜口122a的第一边缘1201的任意一处均与管状主体11的内壁11b固定连接。另一个内分支12的斜口122a的第二边缘1202完全被固定在管状主体11的内壁11b上,也即,该内分支12的斜口122a的第二边缘1202的任意一处均与管状主体11的内壁11b固定连接。这种结构设置下,两个内分支12的斜口122a与管状内壁11的内壁11b的连接,将完全封堵两个内分支12和管状主体11的内壁11b之间的空隙10a,从而有效避免产生血栓。
结合图15和图16所示,在一些实施例中,两个内分支12的斜口122a的顶部1221均呈弧形,呈弧形的顶部1221可以更为紧密地固定至管状主体11的内壁11b,以更好的封堵空隙10a。具体地,两个内分支12的斜口122a的顶部1221均固定于管状主体11的内壁11b。由于斜口122a的顶部1221呈弧形,从而在两个内分支12的斜口122a的顶部1221彼此固定在一起时,两个内分支12的斜口122a的顶部1221能够完全的贴合于管状主体11的内壁11b,从而使得管状主体11的内壁11b与两个内分支12的斜口122a的顶部1221之间不存在缝隙。在此基础上,两个内分支12的斜口122a的彼此相邻近的一侧、且靠近斜口122a的顶部1221的边缘1221a、1221b彼此相连,便可以完全地封堵两个内分支12与管状主体11的内壁11b之间的空隙10a,从而有效防止血栓的形成。
进一步地,两个内分支12的斜口122a的顶部1221均呈弧形的实施例中,可以对斜口122a的形状进行改进,使得斜口122a在管状主体11的横截面上的正投影基本呈扇形,以便两个内分支12的斜口122a之间进行连接时,这种结构的斜口122a能够紧密的连接在一起,以增强封堵效果,同时提高两个内分支12与管状主体11的连接稳定性,以获得较好的支撑性,防止导管4进入内分支12时容易出现卡顿现象。
实施例3
实施例3的管腔支架10与实施例1或实施例2的管腔支架10的相同或相似之处在此不再赘述,其主要区别在于,实施例3的管腔支架10中,扩口段122的侧壁上设有支撑件,支撑件与环状件相连接,以利用支撑件将环状件稳定支撑于管状主体11的内壁11b,从而进一步加强环状件在斜口122a处的支撑效果,防止扩口段122在斜口122a处受挤压后发生塌陷。
在一些实施例中,扩口段122的靠近管状主体11内壁的位置处设有支撑件,从而稳定地支撑环状件,进而加强环状件对斜口122a的支撑力。支撑件与斜口122a处的环状件可以为一体结构。例如,结合图17所示,环状件通过金属丝13c绕制呈环状后,引出一用于连接管状主体11内壁和/或连接至分支主体121的支撑杆13d,这样便可以利用该支撑杆13d作为支撑件,以对环状件起到较好的支撑效果,进而使得环状件 能够加强在斜口122a处的抗挤压性,也即,导管4进入内分支12时,扩口段122在环状件和支撑杆13d的支撑下不容易受挤压而塌陷,以使得斜口122a具有较大的开口,从而便于导管4从斜口122a进入扩口段122并沿扩口段122进入分支主体121。
在另一些实施例中,结合图18所示,环状件13和支撑件14是利用管件切割一体成型。这种结构下,环状件13和支撑件14之间无需在通过其他连接方式进行连接,结构简单,且两者之间连接稳定,以提供稳定地支撑效果。
在一些实施例中,支撑件可以是环形的金属波圈。例如,如图19所示,支撑件14为适应扩口段122形状的Z字形波圈,具有波峰14a和波谷14b,其中,至少一个波峰14a和斜口122a的底部1222连接,以提供较好的支撑性。
结合图20和图21所示,与斜口122a的底部1222对应处,支撑件14的两个波谷14b邻近设置,通俗来说,与斜口122a的底部1222对应处的两个相邻波谷14b紧挨在一起,以更好的对斜口122a的底部1222进行支撑。例如,在一些实施例中,两个波谷14b邻接设置后,该两个波谷14b之间的波峰14a所呈拐角a 3接近108°,也即,允许误差存在的情况下,构成该波段的两个波杆141大致平行。这种结构设置下,靠近斜口122a的底部1222的两条波杆141能够更好的支撑斜口122a。结合图22所示,在一些实施例中,两个波峰14a邻接设置于斜口122a的底部1222位置,同样能够获得较好的支撑性。
需要说明的是,该实施例中,与该两个波峰14a相对应的两条波杆141之间可以不通过波谷14b的形式相连。例如,结合图22所示,支撑于斜口122a的底部1222的两条波杆141之间通过钢套142连接,这样仍然能够使得支撑件14构成完整的波圈,以获得径向上较佳的抗挤压性能,继而在利用该支撑件14在扩口段122提供较佳支撑性的同时,也能够提高扩口段122径向的抗挤压性,继而使得斜口122a受到导管4的挤压时,扩口段122不容易出现塌陷而影响导管4进入时的通畅性。在其他实施例中,支撑件14也可以是呈M形波、V形波、正弦型波等形状的波圈。
实施例4
在前述实施例1至实施例3的基础上,对管腔支架10近端的裸支架111的结构加以改进,使得裸支架111对导管4起到预导向作用,以便导管4更舒畅地进入内分支12,减少卡顿的机率。
具体地,结合图5和图23所示,管腔支架10中,管状主体11的近端处对应设置裸支架111,该裸支架111也即管状主体11的近端与固定锚111a进行锚定的部分,裸支架111为若干波杆1111首尾相连且自然状态呈波圈状的可膨胀收缩结构,其具有相对的波峰1101和波谷1102。在处于锚定状态时,裸支架111的波峰1101被锁定在固定锚111a上,此时,裸支架111的波杆1111便受固定锚111a的径向锚定力而向内会聚。
结合图24所示,导管4在进入内分支12前,需要穿过相邻两个波杆1111之间的间隙1112进入管状主体11。发明人发现,在导管4穿过相邻两个波杆1111之间的间隙1112进入管状主体11后,在没有导向的情况下,导管4的端部4a位置难以控制,使得导管4在进入内分支12时,容易产生卡顿。对此,在本实施 例中,提出对裸支架111的部分波杆1111进行改进,以此,使得裸支架111在锚定状态下,能够对导管4起到预导向效果,以便导管4更准确进入内分支12,减小卡顿机率。具体地,结合图25和图26所示,裸支架111中与管状主体11内的内分支12相对应的部分,对称地设置两个具有弧形段的波杆1111,且相邻波杆1111的弧形段彼此之间形成一较大的间隙1112,,在裸支架111处于锚定状态下,波杆1111能够将导管4径向限位于该间隙1112,且导管4在该间隙1112内的活动空间较其他呈直线型的波杆更大。
进一步地,与裸支架111的位于同一个波谷1101处的其他相邻两个波杆111之间形成的间隙相比,具有弧形段的相邻两个波杆1111之间形成的间隙1112的空间面积更大,从而使得导管4能够较大概率地进入该间隙1112,并在该间隙1112的导向下较大概率地落入内分支12内,以避免导管4的端部4a在内分支12的近端处卡顿而无法进入内分支12内。继而利用波杆1111的弧形段所形成的间隙1112对导管4的导向效果,提高导管4进入内分支12的顺畅性,以减少卡顿机率。可以理解,这里的内分支12可以为实施例1至实施例3中任一实施例中的具有扩口段122的内分支12。
进一步地,该间隙1112靠近管状主体11的内壁11b,内分支12上方的裸支架111的波杆1111可以是S形,该S形的波杆1111包括弧形段1111a以及与弧形段1111a相连的反向弧段1111b,可理解的,反向弧段1111b指的是与弧形段1111a具有相反弯曲方向的部分。呈镜像对称设置的两个弧形段1111a所形成的间隙1112,靠近管状主体11的内壁11b,对应波谷1102;相应地,呈镜像对称设置的两个反向弧段1111b靠近波峰1101。
在此结构下,裸支架111处于被锚定状态下时,S形的波杆1111中,临近波峰1101部分的反向弧段1111b将被挤压,使得形成间隙1112的两个弧形段1111a朝相反方向张开,从而在波谷1102对应处形成更大间隙1112,进而穿过该间隙1112的导管4更容易以接近竖直的方式贴近管状主体11的内壁11b进入内分支12,使得进入内分支12时被卡顿的风险更小。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种管腔支架,包括管状主体,以及位于所述管状主体内部且分别与所述管状主体连通的至少一个内分支,所述内分支的内部中空且两端均开口,其特征在于,所述内分支包括分支主体和与所述分支主体的近端连接的扩口段,所述扩口段的近端设有斜口,所述斜口朝向所述管状主体的内部并偏向远端倾斜,且所述斜口所在的位置处设有表面光滑的环状件。
  2. 根据权利要求1所述的管腔支架,其特征在于,所述斜口自所述管状主体的内壁朝向所述管状主体的中心轴并偏向远端倾斜。
  3. 根据权利要求1所述的管腔支架,其特征在于,在相同的外力作用下,所述环状件的支撑力大于所述分支主体的近端的支撑力。
  4. 根据权利要求1所述的管腔支架,其特征在于,在所述扩口段的侧壁上设有支撑件,所述支撑件与所述环状件相连接。
  5. 根据权利要求1所述的管腔支架,其特征在于,所述管腔支架包括两个所述内分支,所述两个所述内分支各自的扩口段的一部分边缘以及所述管状主体的内壁相互配合,以至少部分地封堵位于两个所述内分支和所述管状主体的内壁之间的空隙。
  6. 根据权利要求5所述的管腔支架,其特征在于,其中一个所述内分支的斜口的顶部,与另一个所述内分支的斜口的顶部固定在一起。
  7. 根据权利要求5或6所述的管腔支架,其特征在于,所述两个内分支各自的斜口均包括第一边缘和第二边缘,所述第一边缘和所述第二边缘分别邻接于各自斜口的顶部的相对两侧,其中一个所述内分支的斜口的第一边缘固定在所述管状主体的内壁上,第二边缘与另一个所述内分支的斜口的第一边缘相连接,另一个所述内分支的斜口的第二边缘固定在所述管状主体的内壁上。
  8. 根据权利要求6所述的管腔支架,其特征在于,所述两个所述内分支的斜口均呈扇形,所述两个所述内分支的斜口的顶部均分别固定于所述管状主体的内壁;所述两个所述内分支的斜口的彼此相邻近的一侧,其靠近所述斜口的顶部的部分边缘彼此相连。
  9. 根据权利要求1所述的管腔支架,其特征在于,所述管状主体的近端设有裸支架,所述裸支架包括对称设置且具有弧形段的相邻两个波杆,所述两个波杆与所述管状主体内的所述内分支对应设置。
  10. 根据权利要求9所述的管腔支架,其特征在于,所述两个波杆呈S形且镜像对称设置。
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