WO2014131341A1 - 可调式人工瓣膜环 - Google Patents

可调式人工瓣膜环 Download PDF

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Publication number
WO2014131341A1
WO2014131341A1 PCT/CN2014/072391 CN2014072391W WO2014131341A1 WO 2014131341 A1 WO2014131341 A1 WO 2014131341A1 CN 2014072391 W CN2014072391 W CN 2014072391W WO 2014131341 A1 WO2014131341 A1 WO 2014131341A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
segment
ring segment
adjustable prosthetic
adjusting
Prior art date
Application number
PCT/CN2014/072391
Other languages
English (en)
French (fr)
Inventor
孟旭
钟生平
Original Assignee
金仕生物科技（常熟）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201310062236.3A external-priority patent/CN104000671B/zh
Priority claimed from CN201310062050.8A external-priority patent/CN104000670B/zh
Application filed by 金仕生物科技（常熟）有限公司 filed Critical 金仕生物科技（常熟）有限公司
Publication of WO2014131341A1 publication Critical patent/WO2014131341A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings

Definitions

  • the present invention relates to medical device technology, and more particularly to an adjustable prosthetic valve annulus. Background technique
  • the basis of the mitral and tricuspid occlusion function of the heart is that there is sufficient mutual depth (sufficient area of fit) adjacent to the leaflet margin, so the final treatment effect of the mitral and tricuspid valvuloplasty is investigated.
  • the criteria are: whether the restoration of the effective leaflet area and the long-term maintenance of the effective matching area thus completed are completed.
  • the recovery of ventricular enlargement due to preoperative ventricular overload is often not achieved during the perioperative period.
  • the ventricular enlargement and the subvalvular structure (such as papillary muscle ectopic) abnormalities during surgery and shortly after surgery remain presence.
  • the area of the valve leaflet that is restored by the existing mitral and tricuspid valvuloplasty is the area of the valve leaflet that is still in the circumstance of the ventricular enlargement and the subvalvular structure is not fully restored; Continuation, the loss of ventricular overload causes the enlarged ventricle to gradually shrink, and the ectopic structure of the under-valve structure (mainly the papillary muscle) is gradually reduced and eliminated. This result can lead to the leaflet combination formed at the time of surgical repair and formation.
  • the area of the papillary muscles is reduced due to the relative prolongation of the chordae tendine compared with that at the time of surgery. That is to say, the valve area of the valve repair and the formation of the valve should be larger than the area of the normal physiological valve.
  • the reduction of the area of the collaterals is beneficial to the protection of the long-term valve. This is the concept of the "reservoir" of the valve area of the clinical cardiac surgery valve repair surgery.
  • the depth and area of the valve leaflet combined during the mitral and tricuspid valvuloplasty of the heart are easy to be due to the reduction of the ventricle and the abnormality of the subvalvular structure after 3-6 months of surgery.
  • the imbalance of direct ventricular pressure distribution in the valve leaflets, especially the margin of the valve, after the mitral and tricuspid valvuloplasty is significantly increased, and the mitral annulus and tricuspid annulus function are reduced and the petals are weakened.
  • the effective depth of the leaf is affected by the depth of the valve repair surgery Effectiveness.
  • the object of the present invention is to provide an adjustable prosthetic valve ring for ensuring the effective leaflet pair in view of the fact that the prior artificial valve annulus cannot adjust the area of the valve leaf and the lack of long-term maintenance of the area of the valve leaf. Long-term maintenance of the combined area and effective matching area.
  • An adjustable artificial valve ring comprising a ring body, and the ring body is provided with an adjusting line for adjusting the spacing of the ring segments.
  • the ring body is a mitral annuloplasty ring or a tricuspid annuloplasty ring.
  • the ring body is a mitral valve forming ring, and the ring body is provided with an adjusting line for adjusting the distance between the front ring segment and the rear ring segment.
  • the ring body is a closed ring body integrally formed by a front ring segment, a rear ring segment, a left ring segment and a right ring segment.
  • the mitral valve forming ring is a saddle forming ring.
  • the mitral valve forming ring is a saddle forming ring, and the saddle forming two arcuate protrusions of the ring shape, the higher arcuate protrusion is a front ring segment, and the lower arcuate protrusion is a rear ring a segment; the two recessed segments of the saddle forming ring are a left ring segment and a right ring segment, respectively.
  • the artificial valve ring is a mitral valve forming ring
  • the adjusting line is one
  • the front ring segment is symmetrically disposed with two threading holes
  • the highest point of the rear ring segment is provided with a threading
  • the adjusting wire is disposed in the two threading holes of the front ring, and the two ends of the adjusting wire pass through the threading hole of the rear ring segment.
  • the distance between the two threading holes on the front ring segment from the highest point of the front ring segment is l-3 mm.
  • the artificial valve ring is a mitral valve forming ring
  • the adjusting line is two
  • the highest point of the rear ring segment is provided with a threading hole
  • one ends of the two adjusting wires are symmetrically fixed at each
  • the two points of the adjustment line fixed to the front ring segment are fixed points
  • one end of the two adjustment wires away from the front ring segment passes through the threading hole of the rear ring segment.
  • the distance between the fixed point and the highest point of the front ring segment is l-3 mm.
  • the ring body is a tricuspid valve forming ring
  • the tricuspid valve forming ring is an annular ring body integrally formed by a front ring segment, a rear ring segment and a spacer ring segment, and the rear ring segment is disposed at Between the front ring and the spacer ring, the ring body is provided with an adjusting line for adjusting the distance between the front ring segment and the spacer ring segment.
  • the artificial valve ring is a tricuspid valve forming ring
  • the adjusting line is one
  • the front ring segment is provided with two threading holes
  • the spacer ring segment is provided with a threading hole
  • the adjusting wire is disposed in the two threading holes of the front ring, and the two ends of the adjusting wire pass through the threading holes of the ring segment.
  • the two threading holes on the front ring segment are located at 1/3 of the front ring segment in the direction of the rear ring segment, and the distance between the two threading holes on the front ring segment is 3-8 mm.
  • the threading hole on the spacer segment is located in the middle of the spacer segment.
  • the artificial valve ring is a tricuspid annuloplasty ring
  • the adjustment line is two.
  • the spacer ring segment is provided with a threading hole, and one ends of the two adjusting wires are respectively fixed on the front ring segment.
  • the two points of the adjustment line fixed to the front ring segment are fixed points, and the two ends of the adjustment line are far from the threading holes of the spacer ring segment away from the end of the front ring segment.
  • the two fixed points on the front ring segment are located at 1/3 of the front ring segment in the direction of the rear ring segment, and the distance between the two fixed points on the front ring segment is 3-8 mm.
  • the threading hole on the spacer segment is located in the middle of the spacer segment.
  • the adjustment line is a Gore-Tex line.
  • the ring body is provided with a plurality of soft segments and hard segments at intervals in the circumferential direction.
  • the hard segment is located in a front ring segment and a rear ring segment of the ring body.
  • the higher arcuate protrusion is a front ring segment
  • the lower arcuate protrusion is a rear ring segment
  • the saddle forms two recessed segments of the ring
  • the left ring segment and the right ring segment are respectively a hard segment, and the left ring segment and the right ring segment are soft segments.
  • the mitral valve forming ring is a saddle forming ring, and the saddle forming two arcuate protrusions of the ring shape, the higher arcuate protrusion is a front ring segment, and the lower arcuate protrusion is a rear ring
  • the two recessed sections of the saddle forming ring are respectively a left ring segment and a right ring segment, and a connecting segment is respectively disposed between the front ring segment, the left ring segment, the rear ring segment and the right ring segment;
  • the front ring segment, the left ring segment, the rear ring segment and the right ring segment are hard segments, and the connecting segment is a soft segment.
  • the soft segment and the hard segment are made of a memory alloy having different woven sparsity; or the soft segment is a medical silicon strip or a medical polyester woven fabric, and the hard segment is a titanium alloy.
  • each of the soft segment and the hard segment is two, or each of the soft segment and the hard segment is four.
  • the ring is coated with a medical polyester fiber fabric.
  • the adjustable prosthetic valve ring structure of the invention is simple, reasonable and compact, and has the following advantages compared with the prior art: a.
  • the tightening adjustment of the adjustment line reduces the distance between the front ring segment of the adjustable prosthetic valve ring and the corresponding rear ring segment Therefore, the depth of the edge of the joint can be made into a reasonable range (the valve-to-edge depth reaches 8 to 10 mm), and the "reservoir" of the edge-to-edge depth is realized for the ventricular enlargement;
  • the adjustment line is located at the higher point of the three-dimensional artificial ring on the saddle forming ring, and the distance of the corresponding ring segment is fixed after the knotting, and the artificial ring saddle shape is constantly maintained. State; also enables the saddle-shaped state to be maintained during ventricular diastolic and systolic cardiac cycle motion, and the saddle-shaped state is maintained to buffer the impact of ventricular pressure on the valve and the long-term effective area of the valve edge. Maintenance; The application of the adjustment line in the non-saddle ring is also because the adjustment line fixes the distance between the segments to facilitate the long-term maintenance of the valve leaf height or the matching area.
  • Figure 1 is a perspective view of a saddle forming a ring
  • FIG. 2 is a schematic structural view of the adjustable prosthetic annulus according to Embodiment 1;
  • Figure 3 is a perspective view of the adjustable prosthetic annulus of Embodiment 2;
  • Figure 4 is a plan view of Figure 3;
  • Figure 5 is a schematic view showing the structure of the adjustable prosthetic annulus before adjustment
  • Figure 6 is a schematic view of the adjustable artificial valve annulus after adjustment
  • FIG. 7 is a schematic view showing the structure of a mitral annuloplasty ring of the adjustable artificial valve annulus according to Embodiment 4. Detailed ways
  • the invention discloses an adjustable prosthetic valve ring which can reshape a diseased heart valve ring into a normal physiological shape and contour, and is used for surgical treatment of clinical heart annulus insufficiency
  • the adjustable artificial valve ring comprises a ring body, the ring
  • An adjustment line for adjusting the pitch of the ring segments is provided on the body.
  • the adjustable prosthetic annulus is a mitral annuloplasty ring or a tricuspid annuloplasty ring.
  • the spacing of the ring segments is the spacing between the front ring segment and the rear ring segment, and is preferably adjusted to 2 to 5 mm;
  • the adjustable prosthetic valve is a tricuspid annuloplasty ring.
  • the spacing of the ring segments is the spacing between the front ring segment and the spacer ring segment, and is preferably adjusted to 2 to 5 mm.
  • the mitral annuloplasty ring can be formed by a conventional planar forming ring or a saddle forming ring having a three-dimensional structure.
  • the mitral annuloplasty ring includes a ring body that is a closed ring body integrally formed of a front ring segment, a rear ring segment, a left ring segment, and a right ring segment.
  • the ring shape of the saddle forming ring can be referred to, for example, in the forming ring disclosed in Publication No.
  • the adjustable prosthetic annulus of the present invention is a mitral annuloplasty ring
  • the adjustment line is used to adjust the spacing of the anterior segment and the posterior segment.
  • the adjustment line can be set as follows: the adjustment line is one, and the front ring segment is symmetrically disposed with two threading holes, that is, the front ring The two threading holes on the segment are at the same distance from the highest point of the front ring segment, and the highest point of the rear ring segment is provided with a threading hole, and the adjusting wire is movably disposed in the two threading holes of the front ring, the adjustment The two ends of the wire pass through the threading holes of the rear ring segment.
  • the distance between the two threaded holes on the front ring segment from the highest point of the front ring segment is l-3mm.
  • the highest point of the rear ring segment is provided with a threading hole, and one ends of the two adjusting wires are respectively symmetrically fixed on the front ring segment, that is, the fixed point is from the highest point of the front ring segment
  • the distances of the two adjustment lines fixed at the front ring segment are fixed points, and the two ends of the adjustment line are far from the threading holes of the rear ring segment.
  • the distance between the fixed point and the highest point of the front ring segment is l-3mm.
  • the tricuspid annuloplasty ring is an annular ring body integrally formed by the front ring segment, the rear ring segment and the spacer ring segment, and the rear ring segment is disposed between the front segment ring and the segment ring, and the front ring segment corresponds to the front
  • the leaflet, the posterior ring segment corresponds to the posterior leaflet
  • the septum ring corresponds to the septum leaf.
  • the adjustment line is used to adjust the spacing of the anterior segment ring and the segment ring.
  • the adjustment line can be set as follows: the adjustment line is one, and the front ring segment is provided with two threading holes, and the spacer ring segment is disposed on the spacer ring segment. There is a threading hole, and the adjusting wire is movably disposed in the two threading holes of the front ring, and the two ends of the adjusting wire pass through the threading hole of the ring segment.
  • the two threading holes on the front ring segment are located at 1/3 of the front ring segment in the direction of the rear ring segment, and the distance between the two threading holes on the front ring segment is 3-8 mm.
  • the threading hole on the spacer segment is located in the middle of the spacer segment.
  • the ring segment is provided with a threading hole, and one end of the two adjusting wires is respectively fixed on the front ring segment, and the two fixing wires are fixed at the point of the front ring segment as a fixed point.
  • the two ends of the adjusting wire are far away from the threading hole of the ring segment away from the end of the front ring segment.
  • the two fixed points on the front ring segment are located at 1/3 of the front ring segment in the direction of the rear ring segment, and the distance between the two fixed points on the front ring segment is 3-8 mm.
  • the threading hole on the spacer segment is located in the middle of the spacer segment.
  • the conditioning wire of the present invention is, but not limited to, a Gore-Tex wire, and the main component is polytetrafluoroethylene polytetrafluoroethylene (abbreviated as PTFE).
  • PTFE polytetrafluoroethylene polytetrafluoroethylene
  • the role of the adjustment line (taking the saddle-shaped mitral annuloplasty ring as an example): a.
  • the tightening adjustment of the adjustment line reduces the distance between the anterior ring segment of the mitral annuloplasty ring and the corresponding posterior ring segment, thereby enabling the alignment
  • the depth of the rim reaches a reasonable range (the depth of the rim is 8 ⁇ 10mm), and the concept of "reservoir” for achieving the depth of the valvular ablation is obvious.
  • b. Even after the mitral annuloplasty is implanted, the leaflets The matching area has reached a satisfactory state, and the existence of the adjustment line still makes sense:
  • the adjustment line is applied in the form of the saddle forming ring.
  • the adjustment line starts from the higher point of the three-dimensional artificial ring, the distance of the corresponding ring segment is fixed after the knotting. , the artificial saddle-shaped state is maintained constantly, and the saddle-shaped state is also maintained during the ventricular diastolic and systolic cardiac cycle motions, and the saddle-shaped state is maintained to buffer the impact of the ventricular pressure on the valve body and The long edge of the effective area of the valve edge is maintained.
  • the application of the adjustment wire in the non-saddle ring is also due to the fact that the adjustment wire fixes the distance between the segments to facilitate the long-term maintenance of the valve leaf height or the matching area.
  • the ring body is further provided with a plurality of soft segments and hard segments along the circumferential direction.
  • the soft segment and the hard segment are two or four each.
  • the hard segment is located in the front ring segment and the rear ring segment of the ring body.
  • the mitral annuloplasty ring has a saddle-shaped profile, and a four-segment design can be adopted: the saddle forms two annular protrusions of the shape ring, and the higher arcuate protrusion is the front ring segment. a lower arcuate protrusion is a rear ring segment; the two recessed segments of the saddle forming ring are respectively a left ring segment and a right ring segment; the front ring segment and the rear ring segment are hard segments, the left The ring segment and the right ring segment are soft segments.
  • the mitral annuloplasty ring has a saddle-shaped profile, and an eight-segment design can also be adopted: the saddle-forming ring has two arcuate protrusions, and the higher arcuate protrusion is a front ring.
  • a lower arcuate projection is a rear ring segment;
  • the two recessed segments of the saddle forming ring are a left ring segment and a right ring segment, respectively, the front ring segment, the left ring segment, the rear ring segment and the right ring segment
  • a connecting section is disposed between adjacent ring segments of the segment, wherein the connecting segment has a length of 5-8 mm; the front ring segment, the left ring segment, the rear ring segment and the right ring segment are hard segments, and the connecting segment is It is a soft segment.
  • the ring body of the mitral annuloplasty ring is formed by the interval between the soft segment and the hard segment.
  • the "soft" and “hard” of the mass are relative, that is, the hardness of the soft segment is less than the hardness of the hard segment.
  • the mitral annuloplasty ring of the present invention can be made by selecting two materials having differences in hardness from any of the materials currently making the mitral annuloplasty ring.
  • the soft segment and the hard segment can be respectively prepared by using different hardness materials, such as the medical segment using medical silicon strip or medical polyester woven fabric, the hard segment adopting titanium alloy; soft segment and hard segment
  • the segment can also be made of a memory alloy with different weaving sparsity. The weaving of the sparse memory alloy is less rigid, and the denser memory alloy is harder.
  • the outer ring may be coated with a medical polyester fiber fabric.
  • FIG. 1 is a perspective view of a saddle forming ring in one embodiment of the present invention, in which the two arcuate projections of the saddle forming ring have a higher arcuate projection as a front ring segment and a lower arcuate projection as a rear ring.
  • the distance between the highest point A of the front ring segment and the highest point P of the rear ring segment is the short axis of the mitral annuloplasty ring, and the two concave segments of the saddle forming ring are the left ring segment and the right ring segment respectively, and the left ring segment is concave.
  • the lowest point of the curvature is the lowest point of the L and the right ring segment curvature is R; the left ring segment indicates the identification point C1 of the anterior border of the mitral valve and the marker point C2 of the right ring segment indicating the posterior junction of the mitral valve
  • the distance is the long axis of the mitral annuloplasty ring, the ratio of the minor axis to the major axis is 3:4; and the highest point A of the anterior ring segment of the mitral annuloplasty ring, the lowest point L of the left ring segment and the right ring
  • the plane formed by the lowest point R of the segment has an angle (140 to 150 degrees) from the plane formed by the highest point P of the rear ring segment, the lowest point L of the left ring segment, and the lowest point R of the right ring segment.
  • the mitral annuloplasty ring is provided with a plurality of soft segments and hard segments spaced along the circumferential direction, and the mitral annuloplasty ring motion is divided into four motion units: front, rear, left and right, and the motion coefficients of the front and rear motion units are symmetric.
  • the motion of the left and right motion units is symmetric, but the total trajectory of the motion elements of the front and rear motion units is different from the total motion of the left and right motion units (the anterior and posterior ring segments of the systolic period are displaced downwards, the left ring segment And the right ring segment is displaced upwards and inward; the anterior ring segment and the posterior ring segment of the diastolic phase are displaced upward and outward, and the left and right ring segments are displaced upward and outward).
  • the mitral annulus can be coordinated with each cardiac cycle of the heart beat.
  • the forming ring of the "four-segment" ring segment or the "eight-segment” ring segment structure realizes that the mitral valve forming ring forms four main ring segments in the front, the back, the left and the right respectively due to the difference in material hardness.
  • the respective active spaces, the soft or hard segments of the mitral annuloplasty ring are mainly used to maintain the curvature of the mitral annuloplasty to simulate the physiological mitral annulus structure, while the soft segment and the hard segment Responding to the formation of the mitral annuloplasty ring tends to physiological mitral annulus movement and the required movement pattern, which is applied to the mitral valve reconstruction surgery.
  • the mitral annuloplasty ring can coordinate with each cardiac cycle of the heart beat. motion.
  • the adjustable prosthetic valve ring of the invention can improve the matching depth of the leaflets by setting an adjustment line capable of adjusting the spacing of the ring segments, and is beneficial for restoring the normal valve leaf abutment area, and the reasonable matching area is an adjustable artificial valve ring.
  • the hallmark of the physiological function of the normal annulus is also an important basis for maintaining long-term stable surgical outcomes.
  • the adjustable person of the present invention When the valve ring is a mitral valve forming ring, a plurality of soft segments and hard segments are arranged at a circumferential direction of the ring body, and the mitral annuloplasty ring motion is divided into a plurality of motion units, and is applied to the mitral valve. In a prosthetic procedure, the mitral annuloplasty ring can coordinate with the cardiac cycle.
  • FIG. 2 is a schematic structural view of the adjustable prosthetic annulus according to Embodiment 1.
  • the mitral annuloplasty ring in which the lesion mitral annulus is a normal physiological shape and contour.
  • the mitral annuloplasty ring includes a ring body, and the ring body is a front body.
  • the higher arcuate projection is the front ring segment 1
  • the lower arcuate projection is the rear ring segment 2
  • the two concave segments of the saddle forming ring are respectively the left ring segment 3 and the right ring segment 4
  • the front ring segment 1, the left ring segment 3, the rear ring segment 2 and the adjacent ring segment of the right ring segment 4 are respectively provided with a connecting segment 5, the connecting segment length is 6 mm
  • the left ring segment 3, the rear ring segment 2 and the right ring segment 4 are hard segments
  • the connecting segment 5 is a soft segment.
  • the front ring segment 1 and the rear ring segment 2 of the mitral annuloplasty ring of the present embodiment are provided with an adjustment line 6 capable of adjusting the distance between the front ring segment 1 and the rear ring segment 2, and the adjustment wire 6 is a Gore-Tex line.
  • Two threading holes are symmetrically arranged on the front ring segment 1, and the distance between the two threading holes on the front ring segment 1 is 2 mm from the highest point of the front ring segment 1, and the highest point of the rear ring segment 2 is provided with a threading hole.
  • the line 6 is moved through the two threading holes of the front ring 1, and the two ends of the adjusting wire 6 are passed out from the threading holes of the rear ring section 2.
  • the use method of the mitral valve forming ring adjusting line 6 of the present embodiment After the mitral valve forming ring is completed by the conventional surgical method, the adjusting wire 6 which is taken out from the threading hole of the rear ring segment is pulled, and the tensioning (shortening) adjustment is performed. Line 6 adjusts the distance between the mitral valve forming ring segments, so that the valve leaf depth and the matching area are satisfactory, and the ring segment of the adjusting line 6 is knotted and fixed, and the adjusting wire 6 is left in the body.
  • the front ring segment 1 and the rear ring segment 2 are pulled by the adjusting wire 6, and the distance between the front ring segment 1 and the rear ring segment 2 is adjusted, and the height of the anterior and posterior lobes of the mitral valve is adjusted to reach the anterior and posterior mitral lobes.
  • a reasonable area of the joint is a sign that the mitral valve plays a physiological role in the normal mitral valve, and is also an important basis for maintaining long-term stable surgical outcome.
  • the mitral annuloplasty ring with the adjustment wire 6 is applied to a clinical operation, and the detection indicates that the adjustment of the anterior ring segment 1 and the posterior ring segment 2 of the mitral annuloplasty ring by the adjustment wire 6 is 2 ⁇ 3 mm, and the partial leaflet can be realized.
  • the height of the joint is increased by 1.5 to 2 mm.
  • the mitral annuloplasty ring is surrounded by a hollow tube type material in the whole memory alloy. According to the hard and softness requirements of each ring segment, the difference in the motion amplitude of each ring segment is realized by adjusting the processing hollow density, and the larger memory alloy is hollowed out. The hardness is small, and the memory alloy with a small hollow is harder.
  • the outer ring of the embodiment is also coated with a medical polyester fiber fabric.
  • the distance between the highest point A of the front ring segment 1 and the highest point P of the rear ring segment 2 is the short axis
  • the left ring segment indicates that the distance from the marker point of the anterior border of the mitral valve to the marker point of the right ring segment indicating the junction of the posterior mitral valve is long.
  • the ratio of the short axis to the long axis is 3:4.
  • the plane formed by the point L and the lowest point R of the right ring segment 4 has an angle (140 degrees).
  • the mitral annuloplasty ring is provided with four soft segments and four hard segments spaced along the circumferential direction, which can coordinate movement with each cardiac cycle of the heart beat: the anterior ring segment 1 and the posterior ring segment 2 are downwardly systolic The internal displacement, the left ring segment 3 and the right ring segment 4 are displaced upward and upward; the diastolic anterior ring segment 1 and the rear ring segment 2 are displaced upward and outward, and the left ring segment 3 and the right ring segment 4 are displaced upward and outward.
  • the mitral annuloplasty ring is circumferentially arranged with a plurality of soft segments and hard segments, and the mitral valve artificial ring is divided into a front ring segment 1, a rear ring segment 2, a left ring segment 3 and a right ring segment 4 Multiple motion units, the arcuate curvature of the artificial front ring and the microbow curvature of the middle section of the rear ring and the angle between the front ring plane and the rear ring plane shape, designed to achieve a physiological "saddle" shape of the artificial ring, with an artificial ring Short-axis 3: 4 physiological ratio and a number of functional characteristics that can realize the coordinated movement of the artificial mitral annuloplasty ring with the cardiac cycle, reflecting the advantage of the most physiological mitral annulus trend of the mitral valve artificial ring, suitable for application Clinical mitral valve repair surgery.
  • Example 2
  • FIG. 3 is a perspective view of the adjustable prosthetic valve ring of FIG. 2;
  • FIG. 4 is a plan view of FIG. 3;
  • FIG. 5 is a schematic view of the adjustable prosthetic valve ring before adjustment; FIG. .
  • This embodiment discloses a tricuspid annuloplasty ring in which the resectable tricuspid annulus is a normal physiological shape and contour.
  • the tricuspid annuloplasty ring is composed of the front ring segment 1 and the posterior ring segment.
  • the ring segment 2 and the spacer segment 7 are formed with a ring body having an opening, and the front ring segment 1 and the spacer ring segment 7 are provided with adjustment wires 6 for adjusting the spacing of the front segment ring 1 and the spacer ring 7.
  • the adjusting wire 6 is a Gore-Tex line
  • the front ring segment 1 is provided with two threading holes
  • the spacer ring segment 7 is provided with a threading hole
  • the adjusting wire 6 is movable through the two threading holes of the front ring 1
  • the two ends of the adjusting wire 6 are pierced from the threading holes of the spacer ring segment 7.
  • the two threading holes on the front ring segment 1 are located at 1/3 of the front ring segment 1 in the direction of the near ring segment, and the distance between the two threading holes on the front ring segment 1 is 5 mm, and the threading hole on the spacer ring segment 7 Located in the middle of the spacer section 7.
  • the posterior ring segment 2 is disposed between the anterior segment ring 1 and the segment ring 7, and the front ring segment 1 corresponds to the front The leaflet, the posterior ring segment 2 corresponds to the posterior leaflet, and the segment ring 7 corresponds to the septum leaf.
  • the mitral annuloplasty ring disclosed in this embodiment is basically the same as that of Embodiment 1, except that the mitral valve forming ring disclosed in the present embodiment has the same ring hardness and is integrally formed from a titanium alloy.
  • the mitral annuloplasty ring disclosed in this embodiment can pull the front ring segment and the rear ring segment through the adjusting line, adjust the distance between the front ring segment and the rear ring segment, and adjust the height of the anterior and posterior lobes of the mitral valve, and further Restore the normal area of the anterior and posterior mitral lobes.
  • the present invention is not limited to the adjustable prosthetic annulus described in the above embodiments, and the arrangement position and material change of the adjustment line are all within the scope of the present invention.
  • Example 4
  • FIG. 7 is a schematic view showing the structure of a mitral annuloplasty ring of the adjustable artificial valve annulus according to Embodiment 4.
  • the mitral annuloplasty ring in which the lesion mitral annulus is a normal physiological shape and contour.
  • the mitral annuloplasty ring includes a ring body, and the ring body is a front body.
  • the mitral valve forming ring of the present embodiment adopts a four-stage design: among the two arcuate protrusions in which the saddle forms a ring, the higher arcuate protrusion is the front ring segment 1, and the lower arcuate protrusion is the rear ring segment. 2; the two concave sections of the saddle forming ring are the left ring segment 3 and the right ring segment 4; the front ring segment 1 and the rear ring segment 2 are hard segments, and the left ring segment 3 and the right ring segment 4 are soft segments. .
  • the soft section of the mitral annuloplasty ring is made of medical silicon strips, and the hard section is made of titanium alloy.
  • the outer ring is coated with a medical polyester fiber fabric.
  • the front ring segment 1 and the rear ring segment 2 of the mitral annuloplasty ring of the present embodiment are provided with an adjustment line (not shown) capable of adjusting the distance between the front ring segment 1 and the rear ring segment 2, and the adjustment line is a On the Gore-Tex line, two threading holes are symmetrically arranged on the front ring section 1, and a threading hole is arranged at the highest point of the rear ring section 2, and the adjusting line is moved through the two threading holes of the front ring 1, the adjusting line The two ends are pierced from the threading holes of the rear ring section 2.
  • the distance between the highest point A of the front ring segment 1 and the highest point P of the rear ring segment 2 is the short axis
  • the left ring segment indicates the distance from the marker point C1 of the anterior mitral valve boundary to the marker point C2 of the right ring segment indicating the border of the mitral valve.
  • the ratio of the short axis to the long axis is 3:4.
  • the plane formed by the point L and the lowest point R of the right ring segment 4 has an angle (150 degrees).
  • the mitral annuloplasty ring can coordinate movement with each cardiac cycle of the heart beat: such as the anterior ring segment and the posterior ring segment of the systolic phase, the left and right segments are displaced upward and inward; the diastolic phase The front ring segment and the rear ring segment are displaced upward and outward, and the left ring segment and the right ring segment are displaced upward and outward.

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Abstract

一种可调式人工瓣膜环，包括环体，该环体上设置有用于调节环间距的调节线（6）。该可调式人工瓣膜环结构简单、合理、紧凑，可以在植入可调式人工瓣膜环后通过调节环段间距实现瓣膜修复手术中瓣叶对合程度调节和保持，有益于远期维持良好的治疗效果。

Description

可调式人工瓣膜环
技术领域
本发明涉及医疗器械技术， 尤其涉及一种可调式人工瓣膜环。 背景技术
心脏二尖瓣和三尖瓣闭合功能的基础是相互邻近瓣叶瓣缘有足够的相互对合深度 (足够的对合面积），所以考察心脏二尖瓣和三尖瓣成形手术的最终治疗效果的标准是： 是否完成有效瓣叶对合面积的恢复和对由此完成的有效对合面积的远期保持。
心脏二尖瓣和三尖瓣关闭不全的病理发展过程中， 均出现因关闭不全产生血液返流 到左心房或右心房引起左心室或右心室的过负荷状态， 继而表现为左心室或右心室的扩 大， 心室的扩大必然伴随着瓣叶瓣下结构异常如乳头肌的异位等， 这是多数患者在手术 前均必然呈现的心脏重构表现。 现有心脏二尖瓣和三尖瓣成形手术可以在手术时矫正病 变瓣叶关闭不全恢复正常瓣叶对合功能， 但应该正视的事实是， 成形手术恢复的瓣叶对 合面积是即刻的结果， 因术前心室过负荷产生的心室扩大的恢复往往是在手术围术期时 不能实现的， 手术时和手术后短期内心室的扩大和瓣下结构 （如乳头肌异位） 异常的情 况仍存在。 现有心脏二尖瓣和三尖瓣成形手术恢复的瓣叶对合面积是在仍有心室扩大和 瓣叶瓣下结构没完全恢复生理状态下的瓣叶对合面积； 随着手术后时间的延续， 心室过 负荷消失使得扩大的心室逐渐縮小， 进而瓣叶瓣下结构 （主要是乳头肌） 异位逐渐的减 轻和消除,这样的结果则可以导致在手术修复成形当时形成的瓣叶对合面积由于乳头肌回 位使腱索出现较手术当时相比的相对延长现象而表现下降， 也就是说在瓣膜修复和成形 手术时的瓣膜对合面积应该要求比正常生理瓣膜对合面积要大一些， 以应对手术后出现 腱索相对延长现象导致的对合面积下降有益于远期瓣膜对合功能的保障； 这就是临床心 脏外科瓣膜修复成形手术的瓣膜对合面积"储备"理念。
因此， 在心脏二尖瓣和三尖瓣成形手术时完成的瓣叶对合深度和面积易由于手术后 3-6 月心室的縮小和瓣叶瓣下结构异常程度的好转， 出现瓣叶对合深度和对合面积的下 降和人工瓣膜环 （马鞍形） 的趋平面化转变。 其结果使心脏二尖瓣和三尖瓣成形手术后 瓣叶尤其是瓣缘局部承受的直接心室压力分布不均衡明显增加， 二尖瓣膜环和三尖瓣膜 环塑型功能下降而且减弱了对瓣叶有效对合深度的保障， 影响了瓣膜修复成形手术的远 期疗效。
设计和研发更加合理的人工瓣膜环， 在保证病变瓣环通过人工瓣环手术塑型矫正的 同时， 维持人工瓣膜环生理构型趋向和二尖瓣或三尖瓣手术时瓣叶的有效对合面积， 以 保障良好的远期手术治疗效果， 成为一亟待解决的问题。 发明内容
本发明的目的在于， 针对上述现有人工瓣膜环无法调整瓣叶对合面积和缺乏远期维 持瓣叶对合面积保障的问题， 提出一种可调式人工瓣膜环， 以实现保证有效瓣叶对合面 积和有效对合面积的远期保持。
为实现上述目的， 本发明采用的技术方案是： 一种可调式人工瓣膜环， 包括环体， 该环体上设置有用于调节环段间距的调节线。所述环体为二尖瓣成形环或三尖瓣成形环。
进一步地， 所述环体为二尖瓣成形环， 该环体上设置有用于调节前环段和后环段间 距的调节线。
进一步地， 所述环体为由前环段、 后环段、 左环段和右环段一体形成的封闭环体。 进一步地， 所述二尖瓣成形环为马鞍形成形环。
进一步地， 所述二尖瓣成形环为马鞍形成形环， 所述马鞍形成形环的两个弓形凸起 中， 较高的弓形凸起为前环段， 较低的弓形凸起为后环段； 所述马鞍形成形环的两个凹 陷段分别为左环段和右环段。
进一步地， 所述人工瓣膜环为二尖瓣成形环， 所述调节线为一根， 所述前环段上对 称地设置有两个穿线孔， 所述后环段的最高点设置有一个穿线孔， 所述调节线活动穿设 在前段环的两个穿线孔中， 所述调节线的两个端部自后环段的穿线孔穿出。 优选的， 所 述前环段上两个穿线孔距前环段最高点的距离为 l-3mm。
进一步地， 所述人工瓣膜环为二尖瓣成形环， 所述调节线为两根， 所述后环段的最 高点设置有一个穿线孔， 两根所述调节线的一端分别对称地固定在前环段上， 两根所述 调节线固定在前环段的点为固定点， 两根所述调节线远离前环段的一端自后环段的穿线 孔穿出。 优选的， 所述固定点距前环段最高点的距离为 l-3mm。
进一步地， 所述环体为三尖瓣成形环， 所述三尖瓣成形环为由前环段、 后环段和隔 环段一体形成的具有开口的环体， 所述后环段设置在前段环与隔段环之间， 该环体上设 置有用于调节前环段和隔环段间距的调节线。 进一步地， 所述人工瓣膜环为三尖瓣成形环， 所述调节线为一根， 所述前环段上设 置有两个穿线孔， 所述隔环段上设置有一个穿线孔， 所述调节线活动穿设在前段环的两 个穿线孔中， 所述调节线的两个端部自隔环段的穿线孔穿出。 优选的所述前环段上两个 穿线孔位于前环段近后环段方向的 1/3部， 所述前环段上两个穿线孔的距离为 3-8mm。 所述隔环段上的穿线孔位于隔环段的中部。进一步地，所述人工瓣膜环为三尖瓣成形环， 所述调节线为两根， 所述隔环段上设置有一个穿线孔， 两根所述调节线的一端分别 固定在前环段上， 两根所述调节线固定在前环段的点为固定点， 两根所述调节线远离前 环段的一端自隔环段的穿线孔穿出。 优选的所述前环段上两个固定点位于前环段近后环 段方向的 1/3部， 所述前环段上两个固定点的距离为 3-8mm。 所述隔环段上的穿线孔位 于隔环段的中部。
进一步地， 所述调节线为 Gore-Tex线。
进一步地， 该环体沿周缘方向间隔设置有多个软质段和硬质段。
进一步地， 所述硬质段位于环体的前环段和后环段。
进一步地， 所述马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段， 较低 的弓形凸起为后环段； 所述马鞍形成形环的两个凹陷段分别为左环段和右环段； 所述前 环段和后环段为硬质段， 所述左环段和右环段为软质段。
进一步地， 所述二尖瓣成形环为马鞍形成形环， 所述马鞍形成形环的两个弓形凸起 中， 较高的弓形凸起为前环段， 较低的弓形凸起为后环段； 所述马鞍形成形环的两个凹 陷段分别为左环段和右环段， 所述前环段、 左环段、 后环段和右环段之间分别设置有连 接段； 所述前环段、 左环段、 后环段和右环段为硬质段， 所述连接段为软质段。
进一步地， 所述软质段和硬质段采用编织稀疏度不同的记忆合金制成； 或所述软质 段为医用硅条或医用涤纶织布， 所述硬质段为钛合金。
进一步地， 所述软质段和硬质段各为两个， 或所述软质段和硬质段各为四个。 进一步地， 所述环体外包覆有医用聚酯纤维织物。
本发明可调式人工瓣膜环结构简单、合理、紧凑，与现有技术相比较具有以下优点： a. 调节线的抽紧调整使可调式人工瓣膜环前环段与相对应后环段距离减小， 从而可 使对合的瓣缘深度达到合理的范围 （瓣膜对合缘深度达到 8〜10mm)， 对于心室扩大明 显者实现瓣缘对合深度的"储备"；
b. 既使可调式人工瓣膜环植入后， 瓣叶对合面积已经达到满意状态， 调节线的存在 仍有意义:以马鞍形成形环为例，调节线在马鞍形成形环上均位于三维人工环的较高点， 打结后就固定了相应环段的距离， 则恒定维持了人工环马鞍形状态； 还使马鞍形状态在 心室舒张期和收縮期的心动周期运动中也可得到保持， 马鞍形状态的保持有利于缓冲心 室压力对瓣体的冲击和使瓣缘有效对合面积的远期维持； 调节线在非马鞍形环的应用也 因为调节线固定了环段间距离从而有利于瓣叶对合高度或对合面积的远期维持。 附图说明
图 1为马鞍形成形环的立体图；
图 2为实施例 1所述的可调式人工瓣膜环的结构示意图；
图 3为实施例 2所述的可调式人工瓣膜环的立体图；
图 4为图 3的俯视图；
图 5为可调式人工瓣膜环调节前结构示意图；
图 6为可调式人工瓣膜环调节后结构示意图；
图 7为实施例 4所述的可调式人工瓣膜环的二尖瓣成形环的结构示意图。 具体实施方式
本发明公开了一种可重塑病变心脏瓣环为正常生理形状和轮廓的可调式人工瓣膜环， 用于临床心脏瓣环关闭不全的外科治疗， 该可调式人工瓣膜环包括环体， 该环体上设置 有用于调节环段间距的调节线。
本发明的具体方案中， 可调式人工瓣膜环为二尖瓣成形环或三尖瓣成形环。 当可调 式人工瓣膜环为二尖瓣成形环时，所述环段间距为前环段和后环段的间距，调节至 2~5mm 为宜；所述可调式人工瓣膜为三尖瓣成形环时，所述环段间距为前环段和隔环段的间距， 调节至 2~5mm为宜。
二尖瓣成形环可选用常规平面成形环或具有三维结构的马鞍形成形环。 二尖瓣成形 环包括环体， 所述环体为由前环段、 后环段、 左环段和右环段一体形成的封闭环体。 所 述马鞍形成形环的环体形状例如可以参照公开号 CN101374478A、 发明名称为用于二尖 瓣脱垂的瓣膜成形环中公开的成形环。 该马鞍形成形环的两个弓形凸起中， 较高的弓形 凸起为前环段， 较低的弓形凸起为后环段， 马鞍形成形环的两个凹陷段分别为左环段和 右环段。 常规平面成形环的轮廓与马鞍形成形环投影到平面的轮廓相同， 前环段、 后环 段、左环段和右环段的对应位置也相同。当本发明可调式人工瓣膜环为二尖瓣成形环时， 所述调节线用于调节前段环和后段环的间距。
当可调式人工瓣膜环为二尖瓣成形环时， 调节线可采用如下方法设置： 所述调节线 为一根， 所述前环段上对称地设置有两个穿线孔， 即所述前环段上两个穿线孔距前环段 最高点的距离相等， 所述后环段的最高点设置有一个穿线孔， 所述调节线活动穿设在前 段环的两个穿线孔中， 所述调节线的两个端部自后环段的穿线孔穿出。 前环段上两个穿 线孔距前环段最高点的距离为 l-3mm。 或采用两根调节线， 所述后环段的最高点设置有 一个穿线孔， 两根所述调节线的一端分别对称地固定在前环段上， 即所述固定点距前环 段最高点的距离相等， 两根所述调节线固定在前环段的点为固定点， 两根所述调节线远 离前环段的一端自后环段的穿线孔穿出。 固定点距前环段最高点的距离为 l-3mm。
调节线的使用方法： 在可调式人工环常规手术方法植入完成后， 抽拉自后环段穿线 孔穿出的调节线， 牵拉 （縮短） 调节线调整二尖瓣成形环前环段和后环段之间的距离， 使瓣叶对合深度和对合面积达到满意程度后在调节线穿出部位的环段打结固定， 调节线 留于体内。 三尖瓣成形环为由前环段、 后环段和隔环段一体形成的具有开口的环体， 所述后环 段设置在前段环与隔段环之间， 所述前环段对应前瓣叶， 所述后环段对应后瓣叶， 所述 隔段环对应隔膜叶。 当本发明可调式人工瓣膜环为三尖瓣成形环时， 所述调节线用于调 节前段环和隔段环的间距。
当可调式人工瓣膜环为三尖瓣成形环时， 调节线可采用如下方法设置： 所述调节线 为一根， 所述前环段上设置有两个穿线孔， 所述隔环段上设置有一个穿线孔， 所述调节 线活动穿设在前段环的两个穿线孔中， 所述调节线的两个端部自隔环段的穿线孔穿出。 优选的所述前环段上两个穿线孔位于前环段近后环段方向的 1/3 部， 所述前环段上两个 穿线孔的距离为 3-8mm。 所述隔环段上的穿线孔位于隔环段的中部。
或采用两根调节线所述隔环段上设置有一个穿线孔， 两根所述调节线的一端分别固 定在前环段上， 两根所述调节线固定在前环段的点为固定点， 两根所述调节线远离前环 段的一端自隔环段的穿线孔穿出。 优选的所述前环段上两个固定点位于前环段近后环段 方向的 1/3部， 所述前环段上两个固定点的距离为 3-8mm。 所述隔环段上的穿线孔位于 隔环段的中部。 调节线的使用方法： 在可调式人工环常规手术方法植入完成后， 抽拉自后环段穿线 孔穿出的调节线， 牵拉 （縮短） 调节线调整三尖瓣成形环前环段和隔环段之间的距离， 使瓣叶对合深度和对合面积达到满意程度后在调节线穿出部位的环段打结固定， 调节线 留于体内。
本发明所述调节线采用但不限于 Gore-Tex 线， 主要成分为聚四氟乙烯 polytetraflouroethylene , 缩写 PTFE。
调节线的作用（以马鞍形二尖瓣成形环为例）： a. 调节线的抽紧调整使二尖瓣成形环 前环段与相对应后环段距离减小， 从而可使对合的瓣缘深度达到合理的范围 （对合缘深 度达到 8〜10mm)， 对于心室扩大明显者实现瓣缘对合深度的"储备"理念； b. 既使二尖 瓣成形环植入后， 瓣叶对合面积已经达到满意状态， 调节线的存在仍有意义： 调节线在 马鞍形成形环应用则由于调节线均起于三维人工环的较高点， 打结后就固定了相应环段 的距离， 则恒定维持了人工环鞍形状态， 还使马鞍形状态在心室舒张期和收縮期的心动 周期运动中也可得到保持， 马鞍形状态的保持有利于缓冲心室压力对瓣体的冲击和使瓣 缘有效对合面积的远期维持。 此外， 调节线在非鞍形环的应用也因为调节线固定了环段 间距离从而有利于瓣叶对合高度或对合面积的远期维持。 本发明的具体方案中， 当可调式人工瓣膜环为二尖瓣成形环时， 该环体沿周缘方向 还间隔设置有多个软质段和硬质段。 考虑到二尖瓣成形环的运动规律， 所述软质段和硬 质段各为两个或各为四个为宜。 所述硬质段位于环体的前环段和后环段。
本发明的实施方案中， 所述二尖瓣成形环具有马鞍形轮廓， 可采用四段式设计： 所 述马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段， 较低的弓形凸起为后环 段； 所述马鞍形成形环的两个凹陷段分别为左环段和右环段； 所述前环段和后环段为硬 质段， 所述左环段和右环段为软质段。
本发明的实施方案中， 所述二尖瓣成形环具有马鞍形轮廓， 也可采用八段式设计： 所述马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段， 较低的弓形凸起为后 环段； 所述马鞍形成形环的两个凹陷段分别为左环段和右环段， 所述前环段、 左环段、 后环段和右环段的相邻环段之间分别设置有连接段， 所述连接段长度为 5-8mm; 所述前 环段、 左环段、 后环段和右环段为硬质段， 所述连接段为软质段。
二尖瓣成形环的环体由软质段与硬质段间隔设置而成， 应该理解， 所述软质段和硬 质段的 "软"与"硬"是相对的， 即， 软质段的硬度小于硬质段的硬度。 可以从目前制造二 尖瓣成形环的任何材料中选择二种硬度存在差异的材料来制成本发明的二尖瓣成形环。 软质段和硬质段可分别采用不同软硬度的材料进行制备， 如所述软质段采用医用硅条或 医用涤纶织布， 所述硬质段采用钛合金； 软质段和硬质段也可采用编织稀疏度不同的记 忆合金制成， 编织较稀疏的记忆合金硬度较小， 编织较密实的记忆合金硬度较大。
本发明的实施方案中， 所述环体外可以包覆医用聚酯纤维织物。
图 1为本发明的一个实施例中马鞍形成形环的立体图， 该马鞍形成形环的两个弓形 凸起中， 较高的弓形凸起为前环段， 较低的弓形凸起为后环段， 前环段最高点 A和后环 段最高点 P的距离为二尖瓣成形环的短轴， 马鞍形成形环的两个凹陷段分别为左环段和 右环段， 左环段凹陷曲度的最低点为 L和右环段凹陷曲度的最低点为 R; 左环段指示二 尖瓣前交界的标识点 C1与右环段指示二尖瓣后交界的标识点 C2之间的距离为二尖瓣成 形环的长轴， 所述短轴与长轴的比为 3:4; 而二尖瓣成形环的前环段的最高点 A、 左环段 的最低点 L和右环段的最低点 R形成的平面与后环段最高点 P、 左环段的最低点 L和右 环段的最低点 R形成的平面之间有夹角 （140〜150度）。
上述二尖瓣成形环沿周缘方向间隔设置有多个软质段和硬质段， 将二尖瓣成形环运 动分为前、 后、 左、 右四个运动单元， 前、 后运动单元运动对称一致， 左、 右运动单元 运动对称一致， 但前、 后运动单元运动总轨迹与左、 右运动单元运动总轨迹不同 （心脏 收縮期前环段和后环段向下向内位移， 左环段和右环段向上向内位移； 心脏舒张期前环 段和后环段向上向外位移， 左环段和右环段向上向外位移）。所述四个运动单元结构符合 或模拟了生理状态时二尖瓣环能随心脏搏动的每个心动周期协调运动的特点。
本发明中， "四段 "环段或"八段"环段结构的成形环， 实现了二尖瓣成形环在前、 后 和左、 右分别因材料硬度的不同而形成四个主要环段的各自活动空间， 二尖瓣成形环的 软质段或硬质段主要作用是维持二尖瓣成形环模拟生理性二尖瓣环鞍形结构的曲度， 而 软质段则与硬质段呼应形成二尖瓣成形环趋于生理性二尖瓣环运动方式和要求的运动模 式， 将其应用于二尖瓣成形修复手术中， 二尖瓣成形环可随心脏搏动的每个心动周期协 调运动。
本发明可调式人工瓣膜环通过设置能调节环段间距的调节线， 有利于维持瓣叶对合 深度， 有利于恢复正常的瓣叶对合面积， 合理的对合面积是可调式人工瓣膜环发挥正常 瓣环生理功能的标志， 也是维持长期稳定的手术疗效的重要基础。 此外本发明可调式人 工瓣膜环为二尖瓣成形环时， 环体的周缘方向间隔设置有多个软质段和硬质段， 将二尖 瓣成形环运动分为多个运动单元， 将其应用于二尖瓣成形修复手术中， 二尖瓣成形环能 随心动周期协调运动。 实施例 1
图 2为实施例 1所述可调式人工瓣膜环的结构示意图。
本实施例公开了一种可重塑病变二尖瓣环为正常生理形状和轮廓的二尖瓣成形环， 如图 2所示， 该二尖瓣成形环包括环体， 该环体为由前环段 1、 后环段 2、 左环段 3和右 环段 4一体形成的封闭环体， 具体地， 该环体为封闭的具有三维结构的马鞍形成形环， 该环体沿周缘方向间隔设置有四个软质段和四个硬质段。 马鞍形成形环的两个弓形凸起 中， 较高的弓形凸起为前环段 1， 较低的弓形凸起为后环段 2; 马鞍形成形环的两个凹陷 段分别为左环段 3和右环段 4， 前环段 1、 左环段 3、 后环段 2和右环段 4中的相邻环段 间分别设置有连接段 5， 连接段长度为 6mm; 前环段 1、 左环段 3、 后环段 2和右环段 4 为硬质段， 连接段 5为软质段。
本实施例二尖瓣成形环的前环段 1和后环段 2上设置有能调节前环段 1和后环段 2 间距的调节线 6，该调节线 6为一根 Gore-Tex线，前环段 1上对称地设置有两个穿线孔， 前环段 1上两个穿线孔距前环段 1最高点的距离均为 2mm， 后环段 2的最高点设置有一 个穿线孔， 调节线 6活动穿设在前段环 1的两个穿线孔中， 调节线 6的两个端部自后环 段 2的穿线孔穿出。
本实施例二尖瓣成形环调节线 6的使用方法： 在完成二尖瓣成形环常规手术方法植 入后， 抽拉自后环段穿线孔穿出的调节线 6， 牵拉（縮短）调节线 6调整二尖瓣成形环段 之间的距离， 使瓣叶对合深度和对合面积达到满意程度后在调节线 6穿出部位的环段打 结固定， 调节线 6留于体内。
通过该调节线 6牵拉前环段 1和后环段 2，调整前环段 1和后环段 2间距离，调整二 尖瓣前后叶瓣缘对合的高度， 进而达到二尖瓣前后叶对合面积的手术要求， 合理的对合 面积是二尖瓣发挥正常二尖瓣生理功能的标志， 也是维持长期稳定的手术疗效的重要基 础。 将具有调节线 6的二尖瓣成形环应用于临床手术中， 检测表明利用调节线 6縮短二 尖瓣成形环的前环段 1 和后环段 2 间距离 2~3mm， 可以实现局部瓣叶对合高度增加 1.5〜2mm。 该二尖瓣成形环由整根记忆合金中镂空管型材料围成， 依各环段的硬软度要求， 通 过调整加工镂空密度不同实现各环段运动幅度的差别， 镂空较大的记忆合金硬度较小， 镂空较小的记忆合金硬度较大。 本实施例环体外还包覆有医用聚酯纤维织物。
前环段 1最高点 A和后环段 2最高点 P的距离为短轴， 左环段指示二尖瓣前交界的 标识点至右环段指示二尖瓣后交界的标识点的距离为长轴， 短轴与长轴的比为 3:4。二尖 瓣成形环的前环段 1的最高点 A、 左环段 3的最低点 L和右环段 4的最低点 R形成的平 面与后环段 2最高点 P、 左环段 3的最低点 L和右环段 4的最低点 R形成的平面有夹角 ( 140度）。
二尖瓣成形环沿周缘方向间隔设置有四个软质段和四个硬质段， 能随心脏搏动的每 个心动周期协调运动： 心脏收縮期前环段 1和后环段 2向下向内位移， 左环段 3和右环 段 4向上向内位移；心脏舒张期前环段 1和后环段 2向上向外位移，左环段 3和右环段 4 向上向外位移。
本实施例二尖瓣成形环的周缘方向间隔设置有多个软质段和硬质段， 将二尖瓣人工 环分成前环段 1、 后环段 2、 左环段 3和右环段 4多个运动单元， 人工前环的弓形曲度和 后环中段的微弓形曲度以及前环平面与后环平面形的夹角， 设计实现了人工环维持生理 "马鞍 "形状态， 具备人工环短长轴 3: 4生理比例和可以实现人工二尖瓣成形环随心动周 期协调运动的多项功能特质， 体现了本二尖瓣人工环最具生理性二尖瓣环趋向的优势， 适合应用于临床二尖瓣成形修复手术。 实施例 2
图 3为实施例 2所述的可调式人工瓣膜环的立体图； 图 4为图 3的俯视图； 图 5为 可调式人工瓣膜环调节前结构示意图； 图 6为可调式人工瓣膜环调节后结构示意图。
本实施例公开了一种可重塑病变三尖瓣环为正常生理形状和轮廓的三尖瓣成形环， 如图 3和图 4所示，三尖瓣成形环为由前环段 1、后环段 2和隔环段 7—体形成的具有开 口的环体，前环段 1和隔环段 7上设置有调节线 6用于调节前段环 1和隔段环 7的间距。
该调节线 6为一根 Gore-Tex线， 前环段 1上设置有两个穿线孔， 隔环段 7上设置有 一个穿线孔， 调节线 6活动穿设在前段环 1的两个穿线孔中， 调节线 6的两个端部自隔 环段 7的穿线孔穿出。具体地， 前环段 1上两个穿线孔位于前环段 1近后环段方向的 1/3 部， 前环段 1上两个穿线孔的距离为 5mm， 隔环段 7上的穿线孔位于隔环段 7的中间。 调节线 6的使用方法： 在三尖瓣成形环常规手术方法植入完成后， 如图 4所示， 后 环段 2设置在前段环 1与隔段环 7之间， 前环段 1对应前瓣叶， 后环段 2对应后瓣叶， 隔段环 7对应隔膜叶。抽拉自隔环段 7穿线孔穿出的调节线 6， 牵拉（縮短）调节线调整 三尖瓣成形环前环段 1和隔环段 7之间的距离， 使瓣叶对合深度和对合面积达到满意程 度后在调节线 6穿出部位的环段打结固定， 调节线 6留于体内， 如图 5所示。 实施例 3
本实施例公开的二尖瓣成形环与实施例 1基本相同， 不同的是本实施例公开的二尖 瓣成形环的环体硬度相同， 由钛合金一体成型制备而成。
本实施例公开的二尖瓣成形环能通过该调节线牵拉前环段和后环段， 调整前环段和 后环段间距离， 调整二尖瓣前后叶瓣缘对合的高度， 进而恢复正常的二尖瓣前后叶的对 合面积。
本发明不局限于上述实施例所描述的可调式人工瓣膜环， 调节线的设置位置和材质 的改变均在本发明的保护范围之内。 实施例 4
图 7为实施例 4所述的可调式人工瓣膜环的二尖瓣成形环的结构示意图。
本实施例公开了一种可重塑病变二尖瓣环为正常生理形状和轮廓的二尖瓣成形环， 如图 7所示， 该二尖瓣成形环包括环体， 该环体为由前环段 1、 后环段 2、 左环段 3和右 环段 4一体形成的封闭环体， 具体地， 该环体为封闭的具有三维结构的马鞍形成形环， 该环体沿周缘间隔设置有两个软质段和两个硬质段。 即本实施例二尖瓣成形环采用了四 段式设计： 马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段 1， 较低的弓形凸 起为后环段 2; 马鞍形成形环的两个凹陷段分别为左环段 3和右环段 4; 前环段 1和后环 段 2为硬质段， 左环段 3和右环段 4为软质段。 该二尖瓣成形环软质段采用医用硅条， 硬质段采用钛合金。 环体外包覆有医用聚酯纤维织物。
本实施例二尖瓣成形环的前环段 1和后环段 2上设置有能调节前环段 1和后环段 2 间距的调节线 （图中未示出）， 该调节线为一根 Gore-Tex线， 前环段 1上对称地设置有 两个穿线孔， 后环段 2的最高点设置有一个穿线孔， 调节线活动穿设在前段环 1的两个 穿线孔中， 调节线的两个端部自后环段 2的穿线孔穿出。 前环段 1最高点 A和后环段 2最高点 P的距离为短轴， 左环段指示二尖瓣前交界的 标识点 C1至右环段指示二尖瓣后交界的标识点 C2的距离为长轴，短轴与长轴的比为 3:4。 二尖瓣成形环的前环段 1的最高点 A、 左环段 3的最低点 L和右环段 4的最低点 R形成 的平面与后环段 2最高点 P、 左环段 3的最低点 L和右环段 4的最低点 R形成的平面有 夹角 （150度）。
该二尖瓣成形环能随心脏搏动的每个心动周期协调运动： 如心脏收縮期前环段和后 环段向下向内位移， 左环段和右环段向上向内位移； 心脏舒张期前环段和后环段向上向 外位移， 左环段和右环段向上向外位移。 最后应说明的是： 以上各实施例仅用以说明本发明的技术方案， 而非对其限制； 尽 管参照前述各实施例对本发明进行了详细的说明， 本领域的普通技术人员应当理解： 其 依然可以对前述各实施例所记载的技术方案进行修改， 或者对其中部分或者全部技术特 征进行等同替换； 而这些修改或者替换， 并不使相应技术方案的本质脱离本发明各实施 例技术方案的范围。

Claims

权 利 要 求
1. 一种可调式人工瓣膜环， 包括环体， 其特征在于， 该环体上设置有用于调节环段 间距的调节线。
2. 根据权利要求 1所述可调式人工瓣膜环，其特征在于，所述环体为二尖瓣成形环， 该环体上设置有用于调节前环段和后环段间距的调节线。
3. 根据权利要求 2所述可调式人工瓣膜环， 其特征在于， 所述环体为由前环段、 后 环段、 左环段和右环段一体形成的封闭环体。
4. 根据权利要求 2或 3所述可调式人工瓣膜环， 其特征在于， 所述二尖瓣成形环为 马鞍形成形环。
5. 根据权利要求 2所述可调式人工瓣膜环， 其特征在于， 所述二尖瓣成形环为马鞍 形成形环， 所述马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段， 较低的弓 形凸起为后环段； 所述马鞍形成形环的两个凹陷段分别为左环段和右环段。
6. 根据权利要求 5所述可调式人工瓣膜环， 其特征在于， 所述调节线为一根， 所述 前环段上对称地设置有两个穿线孔， 所述后环段的最高点设置有一个穿线孔， 所述调节 线活动穿设在前段环的两个穿线孔中， 所述调节线的两个端部自后环段的穿线孔穿出。
7. 根据权利要求 6所述可调式人工瓣膜环， 其特征在于， 所述前环段上两个穿线孔 距前环段最高点的距离为 l-3mm。
8. 根据权利要求 5所述可调式人工瓣膜环， 其特征在于， 所述调节线为两根， 所述 后环段的最高点设置有一个穿线孔，两根所述调节线的一端分别对称地固定在前环段上， 两根所述调节线固定在前环段的点为固定点， 两根所述调节线远离前环段的一端自后环 段的穿线孔穿出。
9. 根据权利要求 8所述可调式人工瓣膜环， 其特征在于， 所述固定点距前环段最高 点的距离为 l-3mm。
10. 根据权利要求 1所述可调式人工瓣膜环，其特征在于，所述环体为三尖瓣成形环， 所述三尖瓣成形环为由前环段、 后环段和隔环段一体形成的具有开口的环体， 所述后环 段设置在前段环与隔段环之间，该环体上设置有用于调节前环段和隔环段间距的调节线。
11. 根据权利要求 10所述可调式人工瓣膜环， 其特征在于， 所述调节线为一根， 所 述前环段上设置有两个穿线孔， 所述隔环段上设置有一个穿线孔， 所述调节线活动穿设 在前段环的两个穿线孔中， 所述调节线的两个端部自隔环段的穿线孔穿出。
12. 根据权利要求 10所述可调式人工瓣膜环， 其特征在于， 所述调节线为两根， 所 述隔环段上设置有一个穿线孔， 两根所述调节线的一端分别固定在前环段上， 两根所述 调节线固定在前环段的点为固定点， 两根所述调节线远离前环段的一端自隔环段的穿线 孔穿出。
13. 根据权利要求 1-12任意一项所述可调式人工瓣膜环， 其特征在于， 所述调节线 为 Gore-Tex线。
14. 根据权利要求 2-9任意一项所述可调式人工瓣膜环， 其特征在于， 该环体沿周缘 方向间隔设置有多个软质段和硬质段。
15. 根据权利要求 14所述可调式人工瓣膜环， 其特征在于， 所述硬质段位于环体的 前环段和后环段。
16. 根据权利要求 14所述可调式人工瓣膜环， 其特征在于， 所述二尖瓣成形环为马 鞍形成形环， 所述马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段， 较低的 弓形凸起为后环段； 所述马鞍形成形环的两个凹陷段分别为左环段和右环段； 所述前环 段和后环段为硬质段， 所述左环段和右环段为软质段。
17. 根据权利要求 14所述可调式人工瓣膜环， 其特征在于， 所述二尖瓣成形环为马 鞍形成形环， 所述马鞍形成形环的两个弓形凸起中， 较高的弓形凸起为前环段， 较低的 弓形凸起为后环段； 所述马鞍形成形环的两个凹陷段分别为左环段和右环段， 所述前环 段、 左环段、 后环段和右环段之间分别设置有连接段； 所述前环段、 左环段、 后环段和 右环段为硬质段， 所述连接段为软质段。
18. 根据权利要求 14-17任意一项所述可调式人工瓣膜环， 其特征在于， 所述软质段 和硬质段采用编织稀疏度不同的记忆合金制成； 或所述软质段为医用硅条或医用涤纶织 布， 所述硬质段为钛合金。
19. 根据权利要求 14所述可调式人工瓣膜环， 其特征在于， 所述软质段和硬质段各 为两个， 或所述软质段和硬质段各为四个。
20. 根据权利要求 14-17任意一项所述二尖瓣成形环， 其特征在于， 所述环体外包覆 有医用聚酯纤维织物。
PCT/CN2014/072391 2013-02-27 2014-02-21 可调式人工瓣膜环 WO2014131341A1 (zh)

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