CN111110400B - Heart valve tether and have its heart valve subassembly - Google Patents

Heart valve tether and have its heart valve subassembly Download PDF

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Publication number
CN111110400B
CN111110400B CN201911253704.9A CN201911253704A CN111110400B CN 111110400 B CN111110400 B CN 111110400B CN 201911253704 A CN201911253704 A CN 201911253704A CN 111110400 B CN111110400 B CN 111110400B
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heart valve
tether
heart
valve tether
coils
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CN111110400A (en
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姚斌
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Shenzhen Jianxin Medical Technology Co ltd
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Lifetech Scientific Shenzhen Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

A heart valve tether and a heart valve assembly with the same are provided, wherein one end of the heart valve tether is connected with a heart valve implanted in the heart, the other end of the heart valve tether is fixed outside the heart, and at least part of the heart valve tether is elastic, so that the length of the heart valve tether can be adjusted along with the stress value of the heart valve tether. The heart valve tether can be in elastic connection required by self-adaption heart beating, can apply fixed tension to the heart valve according to the change of the length of the tether, prevents the heart valve from falling into an atrium, can adapt to the tension with different sizes in the heart beating process, and prevents the damage to the heart caused by overlarge tension.

Description

Heart valve tether and have its heart valve subassembly
Technical Field
The invention relates to the field of medical equipment, in particular to a heart valve tether and a heart valve assembly with the same.
Background
Some known prosthetic heart valves (e.g., prosthetic mitral valves) include one or more tethers that extend from the valve to the exterior of the heart and are secured to the outer ventricular wall of the heart with an epicardial anchor device. By the restraining force of the tether, the valve is not squeezed into the atrium during systole, thereby reducing the risk of regurgitation of blood from the mitral valve into the atrium.
The tether is in a tensioning state in the heart, and is fixed at the apex cordis fixing device after the tensioning degree of the tether is measured by an adjustable force measuring mechanism. In order to ensure that the tension between the prosthetic heart valve and the apex cordis fixing device is maintained at a stable value, the tension of the tether is measured by using a force measuring handle in the existing prosthetic heart valve implantation operation, but the prosthetic heart valve implantation operation still has many problems:
1. the tension degree of the tether is measured through the force measuring handle, so that the implantation operation process of the prosthetic heart valve is complex, the operation time is long, and the organs of a patient are damaged due to long-time anesthesia;
2. the force measuring handle measures the tension of the tether in the process of heart beating, interference factors are more, and the tether is difficult to maintain at a stable value;
3. the patient of moderate and severe regurgitation pathological change often can be accompanied by ventricle and enlarge, heart scheduling problem, and after implanting prosthetic heart valve, the palirrhea disappears, and the heart does not need the blood of the original volume of pump this moment, and the space of ventricle can reduce gradually and resume normal size, and at this moment, the original length of tether and original pulling force value all will no longer be suitable for the ventricle after reducing, and what more can influence the heart and resume.
Disclosure of Invention
Based on this, there is a need to provide a heart valve tether.
A heart valve tether, one end of the tether is connected with a heart valve implanted in the heart, the other end of the tether is fixed outside the heart, and at least part of the tether is elastic, so that the tether can be adjusted in length along with the stress value of the tether.
A heart valve assembly comprising a heart valve and a heart valve tether as described above.
The heart valve tether can be in elastic connection required by self-adaption heart beating, can apply fixed tension to the heart valve according to the change of the length of the tether, prevents the heart valve from falling into an atrium, can adapt to the tension with different sizes in the heart beating process, and prevents the damage to the heart caused by overlarge tension.
When the two ends of the heart valve tether have tension due to the contraction of the heart, the heart valve tether is in a stretched state and restores to an original state when the heart is in diastole, so that the heart valve tether can adapt to the tension with different sizes in the process of beating the heart.
The heart valve tether can reduce the dependence on the force measuring handle in the heart valve implantation operation, thereby reducing the complexity of the heart valve implantation operation and reducing the time of the heart valve implantation operation.
Drawings
FIG. 1 is a schematic view of a first embodiment of a heart valve tether of the present invention deployed within the heart;
FIG. 2 is a partial schematic structural view of the tether of the heart valve of FIG. 1 in a normal state;
FIG. 3 is a partial schematic structural view of the heart valve tether of FIG. 1 in a stretched state;
FIG. 4 is a schematic partial view of a heart valve tether according to another embodiment of the present invention;
FIG. 5 is a schematic view of a heart valve tether of another embodiment of the present invention deployed within the heart;
FIG. 6 is a partial schematic structural view of the heart valve tether of FIG. 5 in a normal state;
FIG. 7 is a partial schematic structural view of the heart valve tether of FIG. 5 in a stretched condition;
FIG. 8 is a schematic view of a second embodiment of a heart valve tether of the present invention deployed within the heart;
FIG. 9 is a partial schematic structural view of the heart valve tether of FIG. 8 in a normal state;
FIG. 10 is a partial schematic structural view of the heart valve tether of FIG. 8 in a stretched condition;
fig. 11 is a partial schematic structural view of a heart valve tether according to a third embodiment of the present invention.
Detailed Description
To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "outer", "inner", "end", "portion", "axial", "upper", "side", "proximal", "distal", and the like are used herein for illustrative purposes only.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
In order to make the technical solutions in the present application better understood by those skilled in the art, the technical solutions are clearly and completely described below in connection with examples of different types of stent end structures, and further, the examples are only a part of the examples in the present application, but not all examples. In the field of interventional medicine, it is generally defined that the end of the instrument proximal to the operator is the proximal end, the end distal to the operator is the distal end, and in the present invention, the position near the apex of the heart is the proximal end, and the position near the heart valve is the distal end. Specific embodiments of heart valve tethers are as follows:
example one
As shown in fig. 1, one end of a heart valve tether 30 is connected to a heart valve 20 implanted in a heart 10, and the other end of the heart valve tether 30 is fixed to an apex pad 40 outside the heart 10, and at least a portion of the heart valve tether has elasticity to enable the length adjustment of the heart valve tether 30 according to a force value of the heart valve tether 30. In the illustrated embodiment, the heart valve tether 30 is provided with a spiral segment 31 extending along the axial direction of the heart valve tether 30, the spiral segment 31 has a shape memory function, fig. 2 shows a partial structural view of the heart valve tether 30 in a normal state, fig. 3 shows a partial structural view of the heart valve tether 30 in a stretched state, when tension is applied to both ends of the heart valve tether 30, the length of the spiral segment 31 is increased, and as shown in fig. 2, when the tension is released, the spiral segment 31 returns to an original state.
The spiral section 31 may be formed of a spiral metal wire, which may be made of a biocompatible material such as stainless steel, nickel titanium, etc., the surface of which is coated with a coating layer to prevent endothelial growth on the spiral metal wire, and a core rope made of a metal having a shape memory or a nonmetal and a braided rope wound on the core rope.
Specifically, the two ends of the heart valve tether 30 are straight segments, the middle segment of the heart valve tether 30 is composed of a plurality of spiral coils spaced 1-5 times, and a plurality of diameters of the plurality of spiral coils increase along the axial direction of the heart valve tether 30, and a first spiral coil 311 with the largest diameter of the plurality of spiral coils is located near the apex of the heart, and a second spiral coil 312 with the smallest diameter of the plurality of spiral coils is located near the heart valve 20, so that the plurality of spiral coils are arranged such that, when the heart valve tether 30 is stretched, the second spiral coil 312 with the smallest diameter is firstly deformed (because the contraction force of the heart 10 is firstly transmitted to the end of the heart valve tether 30 near the heart valve 20), and the first spiral coil 311 with the largest diameter is farther from the heart valve 20, the contraction force of the heart 10 is generally borne by the second spiral coil 312 and the spiral coils near the second spiral coil 312, the first helical coil 311 generally does not deform or deforms by a small amount during contraction of the heart 10, such that deformation of the largest diameter first helical coil 311 does not affect the inner tissue of the heart 10 during contraction or relaxation of the heart 10.
Further, the first coil 311 with the largest diameter among the multiple coils is attached to the inner wall of the heart 10, so that the first coil 311 with the largest diameter also has the function of fixing the heart valve tether 30, so that the first coil 311 is attached to the inner wall of the heart 10 without moving, and only bears the contraction force and the relaxation force of the heart 10 in a deformation manner, thereby reducing the phenomenon that all the multiple coils of the heart valve tether 30 integrally move when bearing the contraction force of the heart 10.
It should be noted that, the first coil 311 with the largest diameter is disposed at the proximal end of the heart valve tether 30, and the second coil 312 with the smallest diameter is disposed at the distal end of the heart valve tether 30, which is only a preferred embodiment, and is not a limitation on the relative distribution positions of the first coil 311 and the second coil 312, as shown in fig. 4, according to another embodiment, the first coil 311 with the largest diameter may be disposed at the distal end of the heart valve tether 30, and the second coil 312 with the smallest diameter may be disposed at the proximal end of the heart valve tether 30, which also achieves the purpose of adapting the heart valve tether 30 to the beating of the heart 10, and this adjustment belongs to the protection scope of the heart valve tether 30.
According to another embodiment, as shown in fig. 5, a plurality of spiral coils with the same diameter may be disposed on the heart valve tether 30, the plurality of spiral coils with the same diameter are distributed at intervals along the axial direction of the heart valve tether 30, and the plurality of spiral coils with the same diameter are preferably distributed on the heart valve tether 30 at equal intervals. Fig. 6 is a partial structural diagram of the heart valve tether shown in fig. 5 in a normal state, and fig. 7 is a partial structural diagram of the heart valve tether shown in fig. 5 in a stretched state, where, as shown in fig. 7, when tension is applied to both ends of the heart valve tether 30, a coil close to the heart valve 20 among a plurality of coils with the same diameter is stretched first, and the remaining coils are stretched sequentially according to the distance from the heart valve 20 until the elastic force of the plurality of coils with the same diameter is balanced with the contraction force of the heart 10, as shown in fig. 6, after the tension is released, a coil far from the heart valve 20 among the plurality of coils with the same diameter is restored to an original state first, and the remaining coils are restored to an original state sequentially according to the distance from the heart valve 20.
The heart valve tether 30 can be elastically connected in a self-adaptive manner as required by the beating of the heart 10, the heart valve tether 30 can apply fixed tension to the heart valve 20 according to the change of the length of the heart valve tether 30, so that the heart valve 20 is prevented from falling into the atrium LA from the ventricle LV, and meanwhile, the heart valve tether can adapt to different tension forces in the beating process of the heart 10, so that the damage to the heart 10 caused by the overlarge tension force is prevented.
When the heart valve tether 30 has tension at both ends due to contraction of the heart 10, the spiral section 31 on the heart valve tether 30 is in a stretched state, and when the heart 10 is in diastole, the spiral section 31 returns to an original state, so that the heart valve tether 30 can adapt to tension of different sizes during the beating of the heart 10.
The heart valve tether 30 can reduce the dependence on the force measuring handle in the heart valve implantation operation, or the tension degree of the heart valve tether 30 does not need to be measured by using the force measuring handle, so that the complexity of the heart valve implantation operation is reduced, and the time of the heart valve implantation operation is shortened.
Example two
As shown in fig. 8, the heart valve tether 30 is provided with two ends staggered with each other to form a bending ring 32, the heart valve tether 30 may be provided with one bending ring 32 or a plurality of bending rings 32, a bending plane formed by the bending ring 32 is parallel to or coincides with an axis of the heart valve tether 30, that is, a winding direction of the bending ring 32 faces towards the apex of the heart valve 20 and the apex of the ventricle LV respectively, a plane of the bending ring 32 is perpendicular to the apex gasket 40 at the apex position, such that the heart valve tether 30 enables the bending rings to bear a pulling force borne by the two ends of the heart valve tether 30, and the bending rings uniformly bear a contraction force of the heart 10 so as to reduce an overall deformation amount of the heart valve tether 30.
Fig. 9 is a partial structural diagram of the heart valve tether 30 in a normal state, and fig. 10 is a partial structural diagram of the heart valve tether 30 in a stretched state, as shown in fig. 10, when tension is applied to two ends of the heart valve tether 30, an end portion of the bending loop 32 close to the heart valve 20 is stretched in a direction toward the heart valve 20, an area of the bending loop 32 is gradually reduced, as shown in fig. 9, and after the tension is released, the bending loop 32 returns to an original state.
It should be noted that, the bending plane formed by the bending ring 32 is parallel to or coincident with the axis of the heart valve tether 30 only in the preferred embodiment, and the bending direction of the bending ring 32 is not limited, for example, according to another embodiment of the present invention, the bending plane formed by the bending ring 32 may also be perpendicular or inclined with respect to the axis of the heart valve tether 30, and such an adjustment belongs to the protection scope of the bending ring 32.
According to another embodiment, when the heart valve tether 30 may have a plurality of bending loops 32, the plurality of bending loops 32 are spaced along the axial direction of the heart valve tether 30, and the plurality of bending loops are preferably equally spaced on the heart valve tether 30. When the two ends of the tether 30 have tension, the bending loops close to the heart valve 20 among the bending loops 32 are firstly stretched, and the rest bending loops 32 are sequentially stretched according to the distance from the heart valve 20 until the elastic force of the bending loops is balanced with the contraction force of the heart 10, and after the tension is released, the bending loops far away from the heart valve 20 among the bending loops 32 are firstly restored to the original shape, and the rest bending loops 32 are sequentially restored to the original shape according to the distance from the heart valve 20.
EXAMPLE III
The heart valve tether 30 is made of stainless steel, nitinol, or a biocompatible metallic material, or a non-metallic material with a high elastic modulus, or an absorbable material.
As shown in fig. 11, the heart valve tether 30 is a spring-like structure itself or a segment of the spring-like structure is disposed on the heart valve tether 30, the wire diameter of the spring-like structure ranges from 0.1mm to 1mm, the outer diameter of the spring-like structure ranges from 0.3mm to 5mm, when the heart 10 contracts, the heart valve 20 moves distally relative to the fixed end of the apex of the heart, so that each portion of the heart valve tether 30 is in a stretched state; when the heart 10 relaxes, constrained by the structural properties of the spring-like structure, the heart valve tether 30 returns to the as-implanted state.
The present embodiment is different from the first embodiment in that each adjacent two of the plurality of coils in the first embodiment have a larger distance therebetween and a larger diameter, while the plurality of coils in the first embodiment have a smaller distance therebetween and even abut against each other, and the plurality of coils in the present embodiment have a smaller diameter, so that the heart valve tether 30 has better stability.
Example four
The heart valve tether 30 has a low modulus of elasticity and is stretchable.
The heart valve tether 30 is itself an elastic cord or has a length of elastic cord structure, such that when the heart 10 contracts, the heart valve 20 moves distally relative to the apex of the heart, thereby placing each portion of the heart valve tether 30 in tension, or placing a portion of the heart valve tether 30 in tension; when the heart 10 relaxes, the heart valve tether 30 may return to its original state as a whole when implanted.
It should be noted that the difference between the present embodiment and the above embodiments is that the heart valve tether 30 itself or a segment of the heart valve tether 30 has a low elastic modulus, so that at least a segment of the heart valve tether 30 can be in a stretched state under the force of heart contraction, thereby bearing the force of heart 10 contraction.
Based on the heart valve tether 30 of the above embodiment, as shown in fig. 1, the embodiment of the present invention further provides a heart valve assembly, which includes a heart valve 20 and the heart valve tether 30 of the above embodiment, the heart valve assembly further includes an apex pad 40 located outside the heart 10, one end of the heart valve tether 30 is connected to the heart valve 20, and the other end of the heart valve tether 30 extends out of the heart 10 and is fixed on the apex pad 40 at the apex.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (8)

1. A heart valve tether, one end of the tether is connected with a heart valve implanted in a heart, the other end of the tether is fixed outside the heart, the tether is elastic at least in part to enable the tether to be adjusted in length along with the force value of the tether, the tether is at least partially provided with a spiral section extending along the axial direction of the tether, the spiral section comprises a plurality of spiral coils distributed at intervals, and the diameters of the spiral coils are gradually increased from the proximal end to the distal end along the axial direction of the tether.
2. The heart valve tether of claim 1, wherein a first coil of the plurality of coils having a largest diameter is located proximate to an apex of the heart and a second coil of the plurality of coils having a smallest diameter is located proximate to the heart valve.
3. The heart valve tether of claim 1, wherein a first coil of the plurality of coils having a largest diameter is configured to conform to an inner wall of the heart.
4. The heart valve tether of claim 1, wherein the heart valve tether is at least partially provided with a loop formed by staggering two ends of the loop.
5. The heart valve tether of claim 4, wherein the bending plane formed by the bending loop is parallel to or coincident with an axis of the heart valve tether.
6. A heart valve tether as claimed in claim 1, wherein the heart valve tether is at least partially provided with a spring-like structure.
7. The heart valve tether of any one of claims 1-6, wherein the heart valve tether comprises a core and a braided rope wound around the core, the core being made of a metal or non-metal having shape memory.
8. A heart valve assembly comprising a heart valve and a heart valve tether of any one of claims 1-7.
CN201911253704.9A 2019-12-09 2019-12-09 Heart valve tether and have its heart valve subassembly Active CN111110400B (en)

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