WO2018049828A1 - 穿刺导管及组织紧缩系统 - Google Patents

穿刺导管及组织紧缩系统 Download PDF

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Publication number
WO2018049828A1
WO2018049828A1 PCT/CN2017/083724 CN2017083724W WO2018049828A1 WO 2018049828 A1 WO2018049828 A1 WO 2018049828A1 CN 2017083724 W CN2017083724 W CN 2017083724W WO 2018049828 A1 WO2018049828 A1 WO 2018049828A1
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WO
WIPO (PCT)
Prior art keywords
puncture
catheter
segment
tubular body
section
Prior art date
Application number
PCT/CN2017/083724
Other languages
English (en)
French (fr)
Inventor
王刚
麦锐成
江巍
Original Assignee
先健科技(深圳)有限公司
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Publication of WO2018049828A1 publication Critical patent/WO2018049828A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac

Definitions

  • the present invention relates to the field of medical devices, and in particular to a puncture catheter and a tissue contracting system having the same.
  • transcatheter valve implantation/repair has become more mature and widely used, especially transcatheter aortic valve placement and transcatheter mitral valvuloplasty. It is recommended for the treatment of heart and valve diseases in Europe and the United States.
  • Transcatheter minimally invasive interventional treatment of mitral regurgitation (MR) has attracted more and more attention.
  • the lesions of any structure of the mitral valve (valve, papillary muscle, chordae, annulus) can cause MR.
  • the technical concept of transcatheter mitral valve repair is similar to surgery, such as "edge-to-edge" mitral valve repair and annuloplasty.
  • the prior mitral annulus compression system includes a delivery catheter 200 , a puncture catheter 300 , two tissue anchors 400 , a folding lock 600 , and a connecting wire 700 .
  • the mitral annuloplasty method includes the following steps: First, the delivery catheter 200 is positioned in the left ventricle, and the delivery catheter 200 is adjusted such that the distal end of the delivery catheter 200 contacts the mitral annulus on the left ventricular side; second, in delivery The catheter 200 is pushed in the catheter 200 to form a first puncture point on the mitral annulus, and a tissue anchor 400 is secured to the first puncture site by the puncture catheter 300; then, the delivery catheter 200 is re-adjusted to a second puncture At a predetermined position of the point, the puncture catheter 300 is pushed to form a second puncture point, and another tissue anchor 400 is fixed to the second puncture point by the puncture catheter 300; finally, the folding lock 600 is transported to adjust between the two tissue anchors
  • the puncture catheter 300 is to be pushed through the delivery catheter 200 that has been turned, the resistance is large, the puncture is difficult, the surgical procedure is complicated, and the safety of the operation is low.
  • the invention provides a puncture catheter comprising a hollow tubular body and a traction wire.
  • the tubular body includes an elastic puncture segment.
  • the traction wire is connected to the puncture segment.
  • the piercing section is bent into a predetermined shape under the pulling of the pulling wire.
  • the distal end of the puncture segment has a needle tip shape.
  • the piercing section is provided with a plurality of slits along the longitudinal direction of the tubular body, and the plurality of slits are located on the same side of the piercing section.
  • the slit After the puncture segment is not cut along the longitudinal direction of the puncture segment and the puncture segment is deployed, the slit includes a rhombic body portion, and the pair of the rhombic body portion The length of the corner line is different, and the diagonal of the length of the rhombic body portion is parallel to the longitudinal direction of the puncture segment.
  • the puncture segment is provided with two through holes, and the two through holes are closer to the distal end of the puncture segment than the plurality of the slots.
  • the line connecting the centers of the two through holes is collinear with the shorter diagonal of the rhombic body portion.
  • one end of the pulling wire enters the inside of the puncture segment through one of the two through holes, and then passes through the other through hole of the two through holes.
  • the interior of the puncture segment exits the puncture segment and is coupled to a portion of the traction wire that is outside of the puncture segment.
  • each of the slits further includes two stress-dispersing ends, and the two stress-distributing ends are respectively located at opposite ends of the longer diagonal of the corresponding rhombic body portion And each of the stress dispersion ends is in communication with a corresponding rhombic body portion on a circumferential surface of the puncture segment.
  • the contour of the stress-dispersing end is a smooth curve.
  • the puncture catheter further includes an outer covering structure, and the outer covering structure and the tubular body have a longitudinal receiving hole extending along the longitudinal direction of the tubular body, and is received in The traction wire in the longitudinal receiving hole can move in the receiving hole under the action of an external force.
  • the outer cladding structure is tubular and overlies the tubular body.
  • the covering structure is in the form of a sheet that covers a portion of the circumferential surface of the tubular body.
  • the puncture catheter has an outer diameter of no more than 3 mm.
  • the plurality of slits are aligned in an array.
  • the difference between the arc length of the large curved side of the puncture segment and the arc length of the small curved side is equal to a plurality of the slots Number and the rhombic body The product of the length of the shorter diagonal.
  • the present invention also provides a tissue tightening system for tightening tissue comprising the puncture catheter and tissue compacting assembly of any of the above, the tissue compacting assembly being deflated by a path established by the cannulated catheter.
  • the puncture segment of the puncture catheter of the present invention can be bent by itself under the action of the traction wire, so that the guiding sheath does not need to be adjusted during the whole puncture process, so that the pushing resistance of the puncture catheter is relatively small.
  • the pushing process is relatively easy, the puncture process is relatively simple, the surgical procedure is relatively simple, and the safety of the operation is high.
  • FIG. 1 is a schematic view of a delivery catheter and a puncture catheter of a conventional mitral annulus compression system
  • FIG. 2 is a schematic view showing a tissue anchor, a folding lock, and a connecting line of a conventional mitral annulus contraction system placed on a tissue to be contracted;
  • FIG. 3 is a schematic view of the prior art mitral annulus contraction system after tightening the tissue
  • FIG. 4 is a schematic diagram of a tissue tightening system according to an embodiment of the present invention.
  • Figure 5 is a partial cross-sectional view of the tissue contracting system of Figure 4.
  • Figure 6 is a cross-sectional view of the tip end of the puncture catheter of the tissue compression system of Figure 5;
  • Figure 7 is an enlarged view of a portion M of Figure 6;
  • Figure 8 is a schematic view showing the structure of the tubular body of the puncture catheter of the tissue compacting system of Figure 5;
  • Figure 9 is a schematic view of the distal end portion of the tubular body of Figure 8 after being bent into a U-shaped structure;
  • Figure 10 is a schematic view of the side of the tubular body of Figure 8 cut and expanded along its length;
  • Figure 11 is a partial cross-sectional view of the puncture catheter of the tissue compacting system of Figure 5 without an outer covering structure;
  • Figure 12 is an enlarged view of a portion L in Figure 11;
  • Figure 13 is a schematic view showing the connection relationship between the pulling wire and the tubular body in another embodiment
  • Figure 14 is a schematic view showing the connection relationship between the pulling wire and the tubular body in still another embodiment
  • Figure 15 is a schematic view showing the connection relationship between the pulling wire and the tubular body in still another embodiment
  • Figure 16 is a schematic view showing the structure of the handle of the tissue tightening system of Figure 4.
  • Figure 17 is an exploded perspective view of the handle of Figure 16;
  • Figure 18 is an exploded perspective view showing another angle of the handle of Figure 16;
  • Figure 19 is a partial cross-sectional view of the handle of Figure 16.
  • FIG 20 is a schematic illustration of the tissue compacting assembly of the tissue compression system of Figure 4.
  • Figure 21 is a schematic view of the structure of the heart
  • Figure 22 is a schematic view of the puncture catheter in the tissue tightening system of Figure 4 after being newly introduced into the left ventricle under the guidance of the guiding sheath;
  • Figure 23 is a schematic view of the tip of the puncture catheter of Figure 22 after entering the left atrium through the annulus of the mitral valve;
  • Figure 24 is a schematic view of the distal end of the guiding sheath of Figure 23 after the tip of the puncture catheter is guided through the mitral annulus into the left atrium;
  • Figure 25 is a schematic view of the tip of the puncture catheter of Figure 24 after being turned;
  • Figure 26 is a schematic view of the tip of the puncture catheter of Figure 25 after entering the left atrium through the mitral annulus;
  • Figure 27 is a schematic illustration of the anterior fixation anchor of the tissue locking assembly being delivered to the left ventricular side of the mitral annulus via the puncturing catheter;
  • Figure 28 is a schematic illustration of the tip of the puncture catheter of Figure 27 being pushed to the left atrial side of the mitral annulus;
  • Figure 29 is a schematic view of the posterior fixation anchor and the locking member of the tissue locking assembly being delivered to the left atrium side of the mitral annulus via the puncture catheter;
  • Figure 30 is a schematic illustration of the tissue locking assembly after the tissue has been compressed and the connecting line has been severed.
  • an element when referred to as being “fixed” to another element, it can be directly on the other element or the element can be present.
  • a component When a component is considered to be “connected” to another element Piece, it can be directly connected to another component or possibly a centered component.
  • the end near the operator is usually referred to as the proximal end, and the end far from the operator is referred to as the distal end.
  • the present invention introduces the use of the tissue tightening system by taking the mitral annulus repair as an example, and the concept of the tissue compacting system of the present invention can also be used for tricuspid annulus repair, cardiac defect sealing, etc. In the surgical method.
  • the tissue tightening system 100 of the present invention includes a puncture catheter 10 and a tissue compacting assembly 30.
  • the tissue tightening assembly 30 tightens the tissue through the orbit established by the puncture catheter 10.
  • the puncture catheter 10 includes a hollow tubular body 11, a pulling wire 12, a handle 13, and an outer covering structure 15 disposed on the tubular body 11 and the pulling wire 12.
  • the outer covering structure 15 covers the pulling wire 12 on the tubular body 11, and the outer covering structure 15 and the tubular body 11 have a longitudinal receiving hole 151 extending along the longitudinal direction of the tubular body 11, so that the pulling wire 12 is at the handle
  • the outer wall of the tubular body 11 can be moved along the longitudinal direction of the tubular body 11 under the operation of 13.
  • the material of the outer covering structure 15 is polytetrafluoroethylene
  • the outer covering structure 15 is a tubular structure covering the tubular body 11 on the pulling wire 12.
  • the material of the outer covering structure may also be a polymer material such as polyperfluoroethylene propylene (FEP) or ethylene-vinyl acetate copolymer (EVA), or may be a metal material such as stainless steel or nickel titanium alloy;
  • FEP polyperfluoroethylene propylene
  • EVA ethylene-vinyl acetate copolymer
  • the tubular outer covering structure can also be divided into a plurality of sections, and the sections are coated on the tubular body 11 and the pulling wire 12 spaced apart from each other, that is, the pulling wire 12 can be tubularly wrapped from the adjacent two sections. Exposed between.
  • the outer covering structure can also be a unitary sheet-like structure, or the sheet-shaped outer covering structure can also be divided into a plurality of sheet-like structures, each of which is covered with a part of the circumference of the tubular body 11
  • the face and the pulling wire 12, that is, the pulling wire 12 can be exposed between the adjacent two sheet-like outer covering structures.
  • the tubular body 11 has a resilient piercing section 111 and a proximal portion 115 that is stiffer than the piercing section 111.
  • the proximal end of the proximal section 115 is coupled to the handle 13.
  • the tubular body 11 also includes at least one delivery lumen 112 to deliver the tissue compression assembly 30 to a predetermined position.
  • the tip end of the puncture section 111 (i.e., the distal end of the tubular body 11) has a needle-like design, and the puncture section 111 is provided with a plurality of slits 113 along the longitudinal direction of the tubular body 11.
  • a plurality of slits 113 are located on the same side of the puncture segment 111.
  • the slit 113 includes a rhombic body portion 1131 extending through the side wall of the puncture section 111, so that when the puncture section 111 is bent into a U-shaped structure, the adjacent sides of the rhombic body portion 1131 of each of the slits 113 are in surface contact, thereby improving
  • the stability of the U-shaped structure further increases the puncture stiffness of the puncture catheter 10.
  • the lengths of the two diagonal lines of the rhombic body portion 1131 are not equal, and the diagonal length of the rhombic body portion 1131 is longer than the longitudinal direction of the puncture segment 111, and the diagonal length of the rhombic body portion 1131 is shorter.
  • the plurality of slots 113 are aligned in an array to prevent the piercing segment 111 from breaking during the puncture.
  • the alignment into an array means that the longer diagonal lines of the plurality of slots 113 are parallel to each other, and one ends of the plurality of longer diagonal lines are aligned, and the other ends of the plurality of longer diagonal lines are also Align.
  • the side of the puncture section 111 on which the plurality of slits 113 are provided is simply referred to as a "small curved side"; the side of the puncture section 111 opposite to the small curved side is not provided with the slit 113, and the puncture section 111 is not provided with the slit.
  • the side of 113 is referred to as "large curved side”. It can be understood that in other embodiments, the plurality of slots 113 can be arranged in a staggered manner.
  • the distal end of the puncture section 111 is provided with at least two through holes 1111, 1112.
  • the through holes are all circular, the number of the through holes is two, and the line connecting the center of the through hole 1111 and the through hole 1112 and the diagonal of the length of the rhombic body portion 1131 are shorter. Collinear to reduce the traction required for cornering. It can be understood that in other embodiments, the line connecting the centers of the two through holes may intersect or be parallel to the diagonal of the length of the rhombic body portion 1131, which may be determined according to actual needs. It can also be understood that in other embodiments, the number of through holes may be three, four or more, as long as the pulling wire 12 can be connected to the puncture segment 111 through the through hole.
  • each slot 113 further includes two circular hollow stress dispersion ends 1133 to reduce the bending stress of the piercing section 111 when being bent into a U-shaped structure.
  • the possibility of focusing on the slit 113 further reduces the possibility that the puncture catheter 10 is broken after being repeatedly bent into a U-shaped structure (i.e., after the puncture catheter 10 is used multiple times), thereby improving the service life of the puncture catheter 10.
  • one stress-dispersing end portion 1133 of each of the slits 113 is located at one end of a longer diagonal line of the corresponding rhombic body portion 1131, and the other stress-dispersing end portion 1133 is located at a corresponding rhombus shape.
  • the other end of the diagonal portion of the main body portion 1131 having a long length, and the two stress dispersion end portions 1133 are in communication with the corresponding rhombic body portion 1131 on the circumferential surface of the puncture section 111.
  • the shape of the stress dispersion end portion 113 may also be an elliptical shape, a quincunx shape or other outer contour lines having a smooth curved shape as long as the stress dispersion end portion can disperse the bending stress.
  • the pulling wire 12 is used to pull the end 1111 of the puncture section 111, thereby driving the puncture section 111 of the tubular body 11 to be bent into a predetermined shape.
  • the pulling wire 12 may be composed of at least one strand of wire (nickel titanium wire, stainless steel wire, etc.) or other polymer wires (polytetrafluoroethylene wire, nylon wire, etc.).
  • the pulling wire 12 is a strand of nickel-titanium wire; one end of the pulling wire 12 enters the inside of the tubular body 11 from the through hole 1111 which is relatively far from the slit 113, and is then relatively close from the slit 113.
  • the through hole 1112 passes through the tubular body 11 and is attached to the handle 13 together with the other end of the pulling wire 12.
  • the pulling wire 12 pulls the puncture section 111 to drive the puncture section 1111 to be bent into a predetermined shape.
  • the pulling wire 12 can also be fixed at one end directly or through the anchoring ring 18 to the head end of the puncture section 111, and is located on the small curved side, and the other end is connected to the handle 13 (as shown in FIGS. 12 and 13).
  • a large bending side and a small curved side of the puncture section 111 can also be respectively provided with a pulling wire 12 (as shown in FIG.
  • the end of the pulling wire 12 passing through the inside of the tubular body 11 can also be connected to the portion of the pulling wire 12 located outside the tubular body 11, in which case only the pulling wire 12 is far away.
  • the end of the through hole 1111 may be connected to the handle 13.
  • the handle 13 includes a Y-joint 131, a slider 133, a spinner 135, an end cap 137, and a T-joint 139.
  • the Y-joint 131 has a main branch 1311 and a side branch 1313 which is connected to the main branch 1311 and intersects the axis of the tubular body 11.
  • the main branch pipe 1311 is connected to the tubular body 11 and the lumen of the main branch pipe 1311 communicates with the inner cavity 112 of the tubular body 11.
  • the side branch pipe 1313 extends from one side of the main branch pipe 93 and communicates with the main branch pipe 93.
  • a predetermined positioning member 1317 is also provided in the side branch pipe 1313 for preventing the distal end of the tubular body 11 from being further bent when the head end of the piercing section 111 of the tubular body 11 is adjusted to a predetermined angle.
  • the positioning member 1317 is a positioning pin, one end of which is fixed to the end of the side branch pipe 1313 away from the tubular body 11, and the end face of the other end faces the slider 133; the predetermined angle is 180 degrees. It can be understood that the predetermined angle can be set as needed, and the length of the positioning member 1317 can also be set as needed. It can also be understood that the positioning member 1317 can also omit unnecessary.
  • the slider 133 is placed in the side branch 1313, which is closer to the tubular body 11 than the positioning member 1317 and is translatable along the longitudinal axis of the guide groove 1315.
  • one end of the slider 133 is connected to both ends of the pulling wire 12, so that the moving slider 133 and the pulling wire 12 can drive the tip end of the puncture section 111 of the tubular body 11 to a predetermined angle.
  • the slider 133 has a rectangular parallelepiped structure, and a pair of parallel side faces are respectively in contact with the inner wall opposite to the side branch pipe 1313, and the other pair of parallel side faces are respectively provided with teeth 1331, and the teeth 1331 protrude from the guide groove 1315.
  • the slider 133 can be made of a metal such as stainless steel or a polymer material. The color of the slider 133 is different from the color of the side branch pipe 24.
  • the side branch 1313 can be made of a light color (such as white or light blue) material; the slider 133 is made of a darker color (such as red, black or dark blue), such as a plastic with a higher hardness (POM, PA) , ABS, etc.), formed by machining or injection molding.
  • a limiting plate 1319 may be disposed at a root portion of the side branch pipe 1313 adjacent to the main branch pipe 1311.
  • the inner diameter of the rotating drum 135 is smaller than the maximum diameter of the limiting plate 1319. When the rotating drum 135 is rotated, the limiting plate 1319 holds the rotating drum. 135 to resist the pulling force of the pulling wire to ensure the smooth and free rotation of the rotating drum 135.
  • the drum 135 is a cylinder that is slightly longer or equal in length than the guide groove 1315, and can be freely rotated over the side branch pipe 1313 and closes the guide groove 1315.
  • a spiral tooth groove 1351 matching the teeth 1331 of the slider 133 is provided on the inner wall of the drum 135.
  • the slider 133 is driven by the rotating drum 135 to linearly reciprocate, and the pulling wire 4 connected to the slider 133 is pulled to change the bending angle of the distal end of the tubular body 11.
  • the rotating drum 135 can be made of a transparent material, such as transparent plastic such as PC, PS, PET, etc., and the side branch pipe 1313 can be seen through the rotating drum 135, and the rotating drum can be seen through the rotating drum 135 from different directions. Slider 133 in 135.
  • the end cap 137 is fixedly coupled to the end of the side branch pipe 1313 away from the main branch pipe 1311 for preventing the spinner 135 from coming off the side branch pipe 1313.
  • the end cap 137 is circular and the outer diameter of the end cap 137 is larger than the inner diameter of the spinner 135. It can be understood that the end cap 137 can also be square, triangular or pentagonal as long as the diameter of the circumscribed circle is larger than the inner diameter of the drum 135.
  • the T-joint 139 can be connected to a three-way valve (not shown) through a hose, and a ring cover 11 is disposed at the proximal end of the T-joint 139, and the three-way valve can be connected to the tubular body through a syringe or other instruments. Injecting liquid or extracting body fluid into the delivery lumen of 11.
  • the operator only needs to rotate the rotating drum 135.
  • the tooth groove 1351 is engaged with the teeth 1331 of the slider 133, and the slider 133 moves only in the axial direction of the rotating drum 135 under the restriction of the guiding groove 1315.
  • the slot 1351 rotates with the drum 135 but cannot translate in the axial direction of the drum 135.
  • the slider 133 moves from the limit plate 27 toward the end cover 137, and the pulling force in the pulling wire 4 is increased, forcing the corner of the distal end of the tubular body 11 to increase, and the slider 133 is to be moved.
  • the slider 133 When in contact with the positioning member 1317, the slider 133 can no longer rotate clockwise, that is, the operator is prompted to adjust the distal end of the sheath tube 10 to a predetermined angle.
  • the drum 135 When the drum 135 is rotated counterclockwise, the slider 133 returns to the limit plate 27, the pulling force in the pulling wire 4 is reduced, and the corner of the distal end of the tubular body 11 is reduced.
  • the puncture segment 111 automatically returns to the initial natural state.
  • the tissue tightening assembly 30 includes a connector 31 and a locking member 33.
  • the connecting member 31 includes a front fixing anchor 311, a rear fixing anchor 313, and a connecting line 315.
  • One end of the connecting wire 315 is connected to the front fixing anchor 311, the other end passes through the rear fixing anchor 313, and the rear fixing anchor 313 is freely movable on the connecting wire 315.
  • the fixed anchor 313 has a lantern-like structure under the action of no external force, and when the external force is pulled, the deformation is contracted into a substantially disc-like structure.
  • the locking member 33 can be fixed when the distance between the front fixing anchor 311 and the rear fixing anchor 313 reaches a desired distance (that is, when the structure between the front fixing anchor 311 and the rear fixing anchor 313 is contracted to an intended size).
  • the anchor 313 is locked to prevent the rear anchor 313 from moving on the connecting line 315, that is, to prevent the distance between the front anchor 311 and the rear anchor 313 from changing.
  • the locking member 33 is a commonly used structure in the industry and will not be described herein.
  • the annulus 200 has opposing ventricular side 21 and atrial side 23.
  • the tissue tightening system 100 can also include a guiding sheath 50 for receiving the puncture catheter 10 during tissue contraction.
  • the guiding sheath 50 is also a commonly used structure in the industry, except that the distal end thereof has a needle tip design, and the inner cavity is precisely slidingly fitted with the outer diameter of the puncture catheter 10.
  • the position of the guiding sheath 50 is adjusted, and the puncture catheter 10 is pushed, so that the tissue at the distal puncture annulus 200 of the puncture catheter 10 reaches the atrial side 23 to form a first puncture point.
  • the guiding sheath 50 is pushed so that the distal end of the guiding sheath 50 reaches the atrial side 23 via the first puncture point A.
  • the puncture segment 111 of the puncture catheter 10 is completely pushed out from the guiding sheath 50, and the handle 13 is operated to make the puncture segment 111 into a U-bend state and achieve the required rigidity.
  • the puncture catheter 10 is rotated about the axis of the tubular body 11 of the puncture catheter 10 to align the puncture site, and a second puncture is prepared.
  • the puncture catheter 10 is pulled toward the distal end of the guiding sheath 50, so that the puncture catheter 10 moves relative to the guiding sheath 50, and the distal end of the puncture catheter 10 penetrates the tissue at the annulus 200.
  • the ventricle side 21 is reached to form a second puncture point B.
  • the front anchor 311 in the contracted state is delivered to the ventricular side 21 of the annulus 200 through the delivery lumen 112 of the puncture catheter 10, and the front anchor 311 is released at A.
  • the handle 13 is moved so that the U-shaped puncture section 111 of the puncture catheter 10 moves toward the atrial side 23.
  • the anchor 313 is released and locked. Specifically, first, the handle 13 is operated such that the puncture segment 111 is converted from a U-shaped shape to a substantially linear shape. Secondly, the substantially linear puncture segment 111 is completely returned into the guiding sheath 10, and the sheath 10 is guided.
  • the distal end is withdrawn from the atrial side 23 to the ventricular side 21; then, the posterior anchor 313 is pushed out from the distal end of the puncture catheter 10 and the anchor 9 is fixed after the first puncture point A is released; then, by moving the connecting line 315 Adjusting the distance between the front anchor anchor 31 and the rear anchor bolt 33 (ie, the distance between the first puncture point A and the second puncture point B), The tissue of the annulus is tightened, thereby reducing the size of the annulus; finally, the locking member 33 is passed through the connecting line 315, and the locking member 33 is transported along the delivery lumen 112 of the puncture catheter 10 to the posterior anchor 313 and tightly The anchor 313 is fixed after attachment to lock the distance between the front anchor 311 and the rear anchor 313.
  • the connecting wire 315 outside the locking member 33 is cut off by a cutting tool (not shown), and the guiding sheath 50 containing the puncture catheter 10 is withdrawn from the human body, and the apex and the chest cavity are removed. Incision suture, that is, complete mitral annulus reduction surgery.
  • the guiding sheath 50 Since the puncture segment 111 of the puncture catheter 10 of the present invention can be bent by itself, the guiding sheath 50 does not need to be turned over during the entire puncture process, so that the pushing resistance of the puncture catheter 10 is relatively small, the pushing process is relatively easy, and the puncture process is also easy. It is relatively simple, the surgical procedure is relatively simple, and the safety of the operation is high. In addition, since the guiding sheath tube 50 of the present invention does not need to be adjusted during the entire tissue contraction process, the moving distance is short and the path is relatively straight, and the puncture catheter 10 housed in the guiding sheath tube 50 is in the guiding sheath tube.
  • the precision of the puncture segment 111 of the puncture catheter 10 in the human body can be directly controlled without the need of a curved path, and the puncture point positioning is also relatively easy.
  • the puncture segment of the puncture catheter protrudes to guide the distal end of the sheath before bending, that is, the distal segment of the guiding sheath does not bend with the puncture of the puncture catheter.
  • Folding, that is, the tissue tightening system has only one catheter (ie, the puncture catheter) in the process of bending, and the puncture segment of the catheter is bent, thereby reducing the required pulling force of the bending tissue compacting system and facilitating the operation of the surgery.

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Abstract

一种穿刺导管(10),包括中空的管状体(11)及牵引丝(12)。管状体(11)包括弹性穿刺段(111)。牵引丝(12)与穿刺段(111)相连。穿刺段(111)在牵引丝(12)的牵拉下弯曲成预定形状。穿刺段(111)的远端呈针尖状。穿刺段(111)沿管状体(11)的长度方向设有多个切槽(113),多个切槽(113)位于穿刺段(111)的同一侧。在穿刺段(111)未设切槽(113)的一侧沿穿刺段(111)的长度方向剖开且展开穿刺段(111)后，切槽(113)包括菱形主体部(1131)，菱形主体部(1131)的两条对角线的长度不同，菱形主体部(1131)的长度较短的对角线平行于穿刺段(111)的长度方向。由于穿刺导管(10)的穿刺段(111)在牵引丝(12)的作用下本身可以弯折，在整个穿刺过程中，引导鞘管(50)无须调弯，从而使得穿刺导管(10)的推送阻力相对较小，穿刺过程也比较简单。

Description

穿刺导管及组织紧缩系统 技术领域
本发明涉及医疗器械领域，尤其涉及一种穿刺导管及具有该穿刺导管的组织紧缩系统。
背景技术
近年来，经导管瓣膜置入/修复术逐渐成熟并广泛应用，尤其是经导管主动脉瓣置入和经导管二尖瓣夹合术得到了欧洲和美国心脏瓣膜疾病治疗指南的推荐，是心脏瓣膜疾病介入治疗领域里程碑式的进展。经导管微创介入治疗二尖瓣反流(MR)越来越引起人们的关注，二尖瓣任一结构(瓣叶、乳头肌、腱索、瓣环)的病变均会导致MR。经导管二尖瓣修复术采用的技术理念类似于外科手术，如“缘对缘”二尖瓣修复术和瓣环成形术等。
请一并参阅图1、图2及图3，现有的二尖瓣瓣环紧缩系统包括输送导管200、穿刺导管300、两个组织锚400、折叠锁600及连接线700。二尖瓣瓣环紧缩方法包括如下步骤：首先，将输送导管200定位在左心室中，并调弯输送导管200使输送导管200的远端接触左心室内侧的二尖瓣环；其次，在输送导管200中推送穿刺导管300以在二尖瓣瓣环上形成第一穿刺点，并通过穿刺导管300将一个组织锚400固定在第一穿刺点上；然后，重新调整输送导管200至第二穿刺点的预定位置上，推送穿刺导管300形成第二穿刺点，并通过穿刺导管300将另一个组织锚400固定在第二穿刺点上；最后，输送折叠锁600以调整两个组织锚400之间的连接线长度，并锁死，形成二尖瓣环的局部皱褶，达到紧缩二尖瓣瓣环以消除返流的效果。
然而，穿刺导管300要通过已经调弯的输送导管200进行推送，阻力会很大，导致穿刺困难，手术过程比较复杂，手术的安全性较低。
发明内容
基于此，有必要提供一种穿刺容易的穿刺导管及具有该穿刺导管的组织紧缩系统，以简化手术过程，提高手术的安全性。
本发明提供一种穿刺导管,包括中空的管状体及牵引丝。所述管状体包括弹性穿刺段。所述牵引丝与穿刺段相连。所述穿刺段在牵引丝的牵拉下弯曲成预定形状。所述穿刺段的远端呈针尖状。所述穿刺段沿管状体的长度方向设有多个切槽,多个所述切槽位于所述穿刺段的同一侧。在所述穿刺段未设所述切槽的一侧沿所述穿刺段的长度方向剖开且展开所述穿刺段后，所述切槽包括菱形主体部，所述菱形主体部的两条对角线的长度不同，所述菱形主体部的长度较短的对角线平行于所述穿刺段的长度方向。
在其中一个实施例中，所述穿刺段上设有两个通孔，两个所述通孔较多个所述切槽靠近所述穿刺段的远端。
在其中一个实施例中，两个所述通孔的中心的连线与所述菱形主体部的长度较短的对角线共线。
在其中一个实施例中，所述牵引丝的一端经两个所述通孔中的一个通孔进入所述穿刺段的内部，再经两个所述通孔中的另一个通孔从所述穿刺段的内部穿出所述穿刺段，并连接于所述牵引丝的位于所述穿刺段外的部分。
在其中一个实施例中，每个所述切槽还包括两个应力分散端部，两个所述应力分散端部分别位于相应的所述菱形主体部的长度较长的对角线的两端，且每个所述应力分散端部在所述穿刺段的周面上均与相应的菱形主体部相连通。
在其中一个实施例中，所述应力分散端部的轮廓线为光滑的曲线。
在其中一个实施例中，所述穿刺导管还包括一个外包覆结构，所述外包覆结构与所述管状体之间具有一个沿所述管状体的长度方向延伸的纵向收容孔，收容于所述纵向收容孔中的牵引丝在外力的作用下可以在所述收容孔中移动。
在其中一个实施例中，所外包覆结构呈管状，其套于所述管状体上。
在其中一个实施例中，所述包覆结构呈片状，其包覆于所述管状体的部分圆周面上。
在其中一个实施例中，所述穿刺导管的外径不大于3毫米。
在其中一个实施例中，多个所述切槽对齐成一阵列。
在其中一个实施例中，所述穿刺段的远端弯曲至180度时，所述穿刺段的大弯侧的弧长与小弯侧的弧长之差，等于多个所述切槽的个数与所述菱形主体部 的长度较短的对角线的长度之积。
本发明还提供一种组织紧缩系统，用于紧缩组织，其包括上述任一所述的穿刺导管及组织紧缩组件，所述组织紧缩组件经所述管刺导管建立的路径紧缩组织。
与现有技术比较，由于本发明的穿刺导管的穿刺段在牵引丝的作用下本身可以弯折，在整个穿刺过程中，引导鞘管无须调弯，从而使得穿刺导管的推送阻力相对较小，推送过程比较容易，穿刺过程也比较简单，手术过程比较简单，手术的安全性较高。
附图说明
图1为现有的二尖瓣瓣环紧缩系统的输送导管及穿刺导管的示意图；
图2为现有二尖瓣瓣环紧缩系统的组织锚、折叠锁及连接线置于待紧缩组织上的示意图；
图3为现有的二尖瓣瓣环紧缩系统紧缩组织后的示意图；
图4为本发明实施例提供的组织紧缩系统的示意图；
图5为图4中的组织紧缩系统的部分剖视图；
图6为图5中的组织紧缩系统的穿刺导管的尖端的剖视图；
图7为图6的M部分的放大图；
图8为图5中的组织紧缩系统的穿刺导管的管状体的结构示意图；
图9为图8中的管状体的远端部弯成U型结构后的示意图；
图10为图8中的管状体的侧面沿其长度方向剪开并展开后的示意图；
图11为图5中的组织紧缩系统的未设置外包覆结构的穿刺导管的部分剖视图；
图12为图11中的L部分的放大图；
图13为另一实施例中牵引丝与管状体之间的连接关系示意图；
图14为再一实施例中牵引丝与管状体之间的连接关系示意图；
图15为又一实施例中牵引丝与管状体之间的连接关系示意图；
图16为图4中的组织紧缩系统的手柄的结构示意图；
图17为图16中的手柄的分解示意图；
图18为图16中的手柄的另一个角度的分解示意图；
图19为为图16中的手柄的部分剖视图；
图20为图4中的组织紧缩系统的组织紧缩组件的示意图；
图21为心脏结构的示意图；
图22为图4中的组织紧缩系统中的穿刺导管在导引鞘管的引导下经新建进入左心室后的示意图；
图23为图22中的穿刺导管的尖端经二尖瓣的瓣环进入左心房后的示意图；
图24为图23中的导引鞘管的远端在穿刺导管的尖端的引导下经二尖瓣的瓣环进入左心房后的示意图；
图25为图24中的穿刺导管的尖端被调弯后的示意图；
图26为图25中的穿刺导管的尖端经二尖瓣瓣环进入左心房后的示意图；
图27为组织锁定组件的前固定锚经穿刺导管被送至二尖瓣瓣环的左心室侧后的示意图；
图28为图27中的穿刺导管的尖端被推至二尖瓣瓣环的左心房侧后的示意图；
图29为组织锁定组件的后固定锚及锁定件经穿刺导管被送至二尖瓣瓣环的左心房侧后的示意图；
图30为组织锁定组件紧缩组织后且连接线被剪断后的示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”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。在介入领域，通常将相对操作者近的一端称为近端，相对操作者远的一端称为远端。
需要说明的是,本发明以二尖瓣瓣环修复为例来介绍组织紧缩系统的使用方法，而本发明的组织紧缩系统的构思还可以用在三尖瓣瓣环修复、心脏缺损封堵等手术方法中。
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例的目的，不是旨在于限制本发明。本文所使用的术语“及/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。
请参阅图4及图5，本发明提供的组织紧缩系统100包括穿刺导管10及组织紧缩组件30。组织紧缩组件30经穿刺导管10建立的轨道紧缩组织。
请一并参阅图4至图7，穿刺导管10包括中空的管状体11、牵引丝12、手柄13、及设于管状体11及牵引丝12上的外包覆结构15。外包覆结构15将牵引丝12包覆于管状体11上，且外包覆结构15与管状体11之间具有沿管状体11的长度方向延伸的纵向收容孔151，使得牵引丝12在手柄13的操作下可以贴着管状体11的外壁沿管状体11的长度方向移动。本实施例中，外包覆结构15的材料为聚四氟乙烯，且外包覆结构15为包覆在管状体11在牵引丝12上的管状结构。其他实施例中，外包覆结构的材料也可以为聚全氟乙丙烯(FEP)、乙烯-醋酸乙烯酯共聚物(EVA)等高分子材料，也可以为不锈钢、镍钛合金等金属材料；管状的外包覆结构也可以分成多段，各段相互隔开地包覆在管状体11和牵引丝12上，也就是说，牵引丝12可以从相邻的两段呈管状的外包覆结构之间露出。还可以理解的是，外包覆结构还可以为整体的片状结构，或者片状的外包覆结构也可以分成多个片状结构，各片隔开地包覆在管状体11的部分圆周面和牵引丝12上，也就是说，牵引丝12可以从相邻的两个片状的外包覆结构之间露出。
请一并参阅图8和图12，管状体11具有一个具有弹性的穿刺段111及较穿刺段111硬的近端段115。近端段115的近端与手柄13相连。管状体11还包含至少一个输送内腔112，以输送组织紧缩组件30至预定位置。
穿刺段111的头端(即管状体11的远端)为针尖状设计，且穿刺段111沿管状体11的长度方向设有多个切槽113。多个切槽113位于穿刺段111的同一侧。切槽113包括一个贯穿穿刺段111的侧壁的菱形主体部1131，使得穿刺段111被弯成U型结构时，每个切槽113的菱形主体部1131的邻边相贴呈面接触，提高了U型结构的稳定性，进而提高了穿刺导管10的穿刺刚度。菱形主体部1131的两条对角线的长度并不相等，菱形主体部1131的长度较长的对角线垂直于穿刺段111的长度方向，菱形主体部1131的长度较短的对角线平行于穿刺段111的长度方向。优选地，本实施例中，多个切槽113对齐成一阵列，以防止穿刺段111在穿刺过程中断裂。所述对齐成一阵列是指，多个切槽113的较长的对角线相互平行，且多个长度较长的对角线的一端对齐，多个长度较长的对角线的另一端也对齐。下文中，穿刺段111上设有多个切槽113的一侧简称“小弯侧”；穿刺段111的与小弯侧相对的一侧未设切槽113，穿刺段111的未设切槽113的一侧简称“大弯侧”。可以理解的是，其他实施例中，多个切槽113可以错落排布。
从在大弯侧沿穿刺段111的轴向剖开且展开的图10中可以看出，穿刺段111的远端设有至少两个通孔1111、1112。优选地，本实施例中，通孔均为圆形，通孔的个数为两个，且通孔1111及通孔1112的中心的连线与菱形主体部1131的长度较短的对角线共线，以降低调弯所需要的牵引力。可以理解的是，其他实施例中，两个通孔的中心的连线可以与菱形主体部1131的长度较短的对角线相交或者平行，可以根据实际需要来确定。还可以理解的事，其他实施例中，通孔的个数也可以为三个、四个或者更多个，只要牵引丝12可以经通孔与穿刺段111相连即可。
切槽113设计的计算过程如下：假设穿刺导管外径为r，穿刺段111弯曲成U型后小弯侧的半径为R，U型弯为180°(即穿刺段111的远端弯曲至180度)，r不大于3毫米，R不大于15毫米，则，穿刺段111弯曲成U型后，小弯侧弧长为L1＝πR，大弯侧弧长为L2＝π(R+r)，而两段弧长之差L3就等于n个切槽的个数n与切槽的菱形主体部的长度较短的对角线长度L之积L*n，即L3＝L1-L2＝L*n。在L3为定值的情况下，若n的数值越大，则L越短，穿刺导管 10越柔软，反之亦然，可以根据实际需要来设定。
请一并参阅图8，优选地，本实施例中，每个切槽113还包括两个圆形的中空的应力分散端部1133，以降低穿刺段111在被弯成U型结构时弯曲应力集中于切槽113上的可能，进而降低了穿刺导管10被反复弯成U型结构后(即穿刺导管10多次使用后)断裂的可能，提高了穿刺导管10的使用寿命。每个切槽113的两个应力分散端部1133中，一个应力分散端部1133位于相应的菱形主体部1131的长度较长的对角线的一端，另一个应力分散端部1133位于相应的菱形主体部1131的长度较长的对角线的另一端，且两个应力分散端部1133在穿刺段111的周面上均与相应的菱形主体部1131连通。
可以理解的是，应力分散端部113的形状也可以为椭圆形、梅花形或者其他外部轮廓线为光滑曲线的形状，只要应力分散端部可以分散弯曲应力即可。
请参阅图10及图11，牵引丝12用于牵引穿刺段111的端头1111，进而带动管状体11的穿刺段111弯曲成预定形状。牵引丝12可以由至少一股的金属丝(镍钛丝、不锈钢丝等)或其他高分子丝(聚四氟乙烯丝、尼龙丝等)组成。本实施例中，牵引丝12为一股的镍钛丝；牵引丝12的一端从距切槽113相对较远的通孔1111进入管状体11的内部，而后从距离切槽113相对较近的通孔1112穿出管状体11，并与牵引丝12的另一端一起连于手柄13上。当牵引丝12的两端在手柄13的操作下向移动时，牵引丝12牵拉穿刺段111来带动穿刺段1111弯曲成预定形状。可以理解的是，牵引丝12也可以一端可以直接或者通过锚定环18固定于穿刺段111的头端上，且位于小弯侧，另一端连接于手柄13上(如图12及13所示)。还可以理解的是，穿刺段111的大弯侧及小弯侧也可以分别设置一根牵引丝12(如图14所示)，在此情况下，当一根牵引丝处于拉伸状态时，另一根牵引丝处于松弛状态。可以理解的是，其他实施例中，牵引丝12从管状体11内部穿出的端部也可以连接于牵引丝12位于管状体11外的部分上，此种情况下，仅牵引丝12的远离通孔1111的端部与手柄13相连即可。
请参阅图15至图18，手柄13包括Y型接头131、滑块133、旋筒135、端盖137和T型接头139。Y型接头131具有一个主支管1311，及一个与主支管1311相连且与管状体11的轴线相交的侧支管1313。
主支管1311与管状体11相连且主支管1311的管腔与管状体11的内腔112相连通。侧支管1313从主支管93的一侧延伸出，且与主支管93相连通。侧支管1313内还设有一个预设的定位件1317，用于待管状体11的穿刺段111的头端调整至预定角度时，防止管状体11的远端进一步弯曲。本实施例中，定位件1317为定位销，其一端固定于侧支管1313远离管状体11的端部，另一端的端面朝向滑块133；所述预定角度为180度。可以理解的是，所述预定角度可以根据需要来设定，而定位件1317的长度也可以根据需要来设定。还可以理解的是，定位件1317也可以省略不要。
滑块133置于侧支管1313，较定位件1317靠近管状体11，且可沿导槽1315的纵向轴线平移。
本实施例中，滑块133的一端与牵引丝12的两个端部相连，以使得移动的滑块133及牵引丝12即可带动管状体11的穿刺段111的头端调整至预定角度。本实施例中，滑块133为长方体结构，其一对平行的侧面分别与侧支管1313相对的内壁接触，其另一对平行的侧面分别设置齿牙1331，且齿牙1331突出导槽1315。滑块133可以用金属(如不锈钢)或高分子材料制作。滑块133的颜色异于侧支管24的颜色。侧支管1313可用浅色(如白色或浅蓝色)材料制作；滑块133使用颜色较深(如红色、黑色或深蓝色)的材料制作而成，例如硬度较高的塑料(POM，PA，ABS等)，采用机械加工或者注塑加工方式成型。此外，在侧支管1313的靠近主支管1311的根部可以设置一个限位盘1319，旋筒135的内径小于限位盘1319的最大直径，转动旋筒135时，限位盘1319托住旋筒135以抵抗牵引丝的拉力，保证旋筒135的平稳自由旋转。
旋筒135是一个比导槽1315略长或等长的圆筒，其可以套在侧支管1313上自由转动并且将导槽1315封闭。旋筒135的内壁上设有与滑块133的齿牙1331匹配的螺旋形的齿槽1351。滑块133由转动的旋筒135驱动做直线往复运动，拉动与滑块133连接的牵引丝4，使管状体11的远端的弯曲角度改变。旋筒135可采用透明材料制成，比如PC、PS、PET等透明的塑料，可以透过旋筒135看到侧支管1313，并保证从不同方向都可以透过旋筒135看到旋筒135内的滑块133。
端盖137固定连接于侧支管1313远离主支管1311的末端，用于防止旋筒135脱离侧支管1313。本实施例中，端盖137为圆形且端盖137的外径大于旋筒135的内径。可以理解的是，端盖137也可以呈方形、三角形或五边形，只要其外接圆的直径大于旋筒135的内径即可。
可选地，T型接头139可以通过软管与三通阀(图未示)相连，在T型接头139的近端设置一个环盖11，可以通过注射器或者其他器械连接三通阀向管状体11的输送内腔中注入液体或者抽取体液。
操作者仅需旋转旋筒135，此时齿槽1351与滑块133的齿牙1331保持咬合，滑块133在导槽1315的限制下只沿旋筒135的轴向移动，旋筒135两端分别被限位盘27和端盖137限制，齿槽1351随着旋筒135转动但无法沿旋筒135的轴向平移。当旋筒135做顺时针转动时，滑块133从限位盘27移向端盖137，牵引丝4中的拉力增大，迫使管状体11的远端的弯角增大，待滑块133与定位件1317接触时，滑块133无法再顺时针转动，即提示操作者可调弯鞘管10的远端已调至预定角度。当旋筒135做逆时针方向转动时，滑块133向限位盘27返回，牵引丝4中的拉力减小，管状体11的远端的弯角减小。滑块133回到限位盘27，则穿刺段111自动恢复初始的自然状态。
请参阅图20，组织紧缩组件30包括连接件31及锁定件33。连接件31包括前固定锚311、后固定锚313及连接线315。连接线315的一端与前固定锚311相连，另一端穿过后固定锚313，且后固定锚313可以在连接线315上自由活动。
固定锚313在无外力作用下呈灯笼状结构，在外力拉动时，其变形紧缩为一个大致的盘状结构。
锁定件33可以待前固定锚311和后固定锚313之间的距离达到预期距离时(也就是说，前固定锚311和后固定锚313之间的组织紧缩到预期尺寸时)，将后固定锚313锁定，防止后固定锚313在连接线315上移动，也就是说，防止前固定锚311和后固定锚313之间的距离发生改变。锁定件33为业界常用的结构，在此不再赘述。
请一并参阅图21，采用组织紧缩系统100对二尖瓣瓣环进行紧缩的手术方法如下所述。瓣环200具有相对的心室侧21及心房侧23。
请参阅图22，第一步，在胸腔开一个小切口，并将收容有穿刺导管10的导引鞘管50经心尖80介入至左心室90。也就是说，组织紧缩系统100还可以包括导引鞘管50，导引鞘管50用于在组织紧缩过程中收容穿刺导管10。导引鞘管50也为业界常用结构，不同之处在于，其远端呈针尖设计，其内腔与穿刺导管10的外径精密滑动配合。
请一并参阅图23，第二步，调整导引鞘管50的位置，并推送穿刺导管10，使得穿刺导管10的远端穿刺瓣环200处的组织到达心房侧23，形成第一穿刺点A。
请一并参阅图24，第三步，推送导引鞘管50使导引鞘管50的远端经第一穿刺点A到达心房侧23。
请一并参阅图25，第四步，将穿刺导管10的穿刺段111从导引鞘管50内完全推送出来，操作手柄13使穿刺段111成为U型弯折的状态并达到所需的刚度，并绕穿刺导管10的管状体11的轴线旋转穿刺导管10以找准穿刺位置，准备第二次穿刺。
请一并参阅图26，第五步，向导引鞘管50的远端拉动穿刺导管10，使得穿刺导管10相对导引鞘管50移动，穿刺导管10的远端穿刺瓣环200处的组织到达心室侧21，形成第二穿刺点B。
请一并参阅图27，第六步，释放前固定锚311。具体地，将紧缩状态下的前固定锚311通过穿刺导管10的输送内腔112送至瓣环200的心室侧21，并将前固定锚311释放于A处。
请一并参阅图28，第七步，移动手柄13，使得穿刺导管10的呈U型状的穿刺段111向心房侧23移动。
请一并参阅图29，第八步，释放并锁定后固定锚313。具体地，首先，操作手柄13，使得穿刺段111从U型状转变为大致的直线状；其次，将大致呈直线状的穿刺段111完全回收入引导鞘管10内，并将引导鞘管10的远端从心房侧23撤至心室侧21；然后，将后固定锚313从穿刺导管10的远端推出，并在第一穿刺点A释放后固定锚9；接着，通过移动连接线315来调整前固定锚31和后固定锚33之间的距离(即第一穿刺点A和第二穿刺点B之间的距离)，使 得瓣环的组织紧缩，进而缩小瓣环的尺寸；最后，将锁定件33穿过连接线315，并沿着穿刺导管10的输送内腔112将锁定件33输送至后固定锚313处并紧贴后固定锚313，以将前固定锚311和后固定锚313之间的距离锁定。
第九步，请一并参阅图30，使用切断工具(图未示)切除锁定件33外的连接线315，将收容有穿刺导管10的引导鞘管50撤出人体，并将心尖及胸腔的介入口缝合，即完成二尖瓣瓣环缩小手术。
由于本发明的穿刺导管10的穿刺段111本身可以弯折，在整个穿刺过程中，引导鞘管50无须调弯，从而使得穿刺导管10的推送阻力相对较小，推送过程比较容易，穿刺过程也比较简单，手术过程比较简单，手术的安全性较高。另外，由于本发明的导引鞘管50在整个组织紧缩过程中，无须调弯，其移动距离较短，路径也较直，收容于导引鞘管50中的穿刺导管10在导引鞘管50建立的较直的轨道的引导下，无须通过弯曲的路径，直接使得穿刺导管10的穿刺段111在人体内调弯的精度较易控制，穿刺点定位也较容易。再者,组织紧缩过程中,穿刺导管的穿刺段突出引导鞘管的远端之后才进行弯折,也就是说,引导鞘管的远段段并未随着穿刺导管的穿刺段的弯折而弯折,即组织紧缩系统在弯折的过程中仅有一个导管(即穿刺导管)的穿刺段在弯折,从而减小了弯折组织紧缩系统的所需要的拉力,方便手术的操作。
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 (13)

  1. 一种穿刺导管,包括中空的管状体及牵引丝,所述管状体包括弹性穿刺段,所述牵引丝与穿刺段相连,所述穿刺段在牵引丝的牵拉下弯曲成预定形状,所述穿刺段的远端呈针尖状,所述穿刺段沿管状体的长度方向设有多个切槽,多个所述切槽位于所述穿刺段的同一侧；在所述穿刺段未设所述切槽的一侧沿所述穿刺段的长度方向剖开且展开所述穿刺段后，所述切槽包括菱形主体部，所述菱形主体部的两条对角线的长度不同，所述菱形主体部的长度较短的对角线平行于所述穿刺段的长度方向。
  2. 根据权利要求1所述的穿刺导管，其特征在于，所述穿刺段上设有两个通孔，两个所述通孔较多个所述切槽靠近所述穿刺段的远端。
  3. 根据权利要求2所述的穿刺导管，其特征在于，两个所述通孔的中心的连线与所述菱形主体部的长度较短的对角线共线。
  4. 根据权利要求2所述的穿刺导管，其特征在于，所述牵引丝的一端经两个所述通孔中的一个通孔进入所述穿刺段的内部，再经两个所述通孔中的另一个通孔从所述穿刺段的内部穿出所述穿刺段，并连接于所述牵引丝的位于所述穿刺段外的部分。
  5. 根据权利要求1所述的穿刺导管，其特征在于，每个所述切槽还包括两个应力分散端部，两个所述应力分散端部分别位于相应的所述菱形主体部的长度较长的对角线的两端，且每个所述应力分散端部在所述穿刺段的周面上均与相应的菱形主体部相连通。
  6. 根据权利要求5所述的穿刺导管，其特征在于，所述应力分散端部的轮廓线为光滑的曲线。
  7. 根据权利要求1所述的穿刺导管，其特征在于，所述穿刺导管还包括一个外包覆结构，所述外包覆结构与所述管状体之间具有一个沿所述管状体的长度方向延伸的纵向收容孔，收容于所述纵向收容孔中的牵引丝在外力的作用下可以在所述收容孔中移动。
  8. 根据权利要求7所述的穿刺导管，其特征在于，所外包覆结构呈管状，其套于所述管状体上。
  9. 根据权利要求7所述的穿刺导管，其特征在于，所述包覆结构呈片状， 其包覆于所述管状体的部分圆周面上。
  10. 根据权利要求1所述的穿刺导管，其特征在于，所述穿刺导管的外径不大于3毫米。
  11. 根据权利要求1所述的穿刺导管，其特征在于，多个所述切槽对齐成一阵列。
  12. 根据权利要求1所述的穿刺导管，其特征在于，所述穿刺段的远端弯曲至180度时，所述穿刺段的大弯侧的弧长与小弯侧的弧长之差，等于多个所述切槽的个数与所述菱形主体部的长度较短的对角线的长度之积。
  13. 一种组织紧缩系统，用于紧缩组织，其包括权利要求1至12任一所述的穿刺导管及组织紧缩组件，所述组织紧缩组件经所述管刺导管建立的路径紧缩组织。
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CN104306053A (zh) * 2014-10-22 2015-01-28 广州新诚生物科技有限公司 可控向穿刺鞘

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CN108904102A (zh) * 2018-07-19 2018-11-30 上海诺强医疗科技有限公司 经导管二尖瓣环缩系统及其使用方法
CN108904102B (zh) * 2018-07-19 2023-12-12 上海诺强医疗科技有限公司 经导管二尖瓣环缩系统及其使用方法
CN112244961A (zh) * 2020-11-09 2021-01-22 北京华脉泰科医疗器械有限公司 鞘管调节机构及可调弯鞘管
CN112244961B (zh) * 2020-11-09 2024-06-07 北京华脉泰科医疗器械股份有限公司 鞘管调节机构及可调弯鞘管
WO2022251389A1 (en) * 2021-05-26 2022-12-01 Foldé Inc. Flexible catheters and related methods
US11672950B2 (en) 2021-05-26 2023-06-13 Foldé Inc. Flexible catheters and related methods

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