CN221411442U - Annuloplasty ring - Google Patents
Annuloplasty ring Download PDFInfo
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- CN221411442U CN221411442U CN202322395233.3U CN202322395233U CN221411442U CN 221411442 U CN221411442 U CN 221411442U CN 202322395233 U CN202322395233 U CN 202322395233U CN 221411442 U CN221411442 U CN 221411442U
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- 230000008859 change Effects 0.000 claims abstract description 20
- 230000007704 transition Effects 0.000 claims description 37
- 230000013011 mating Effects 0.000 claims description 33
- 230000000149 penetrating effect Effects 0.000 claims description 4
- 229920001296 polysiloxane Polymers 0.000 claims description 4
- 239000010410 layer Substances 0.000 claims 5
- 239000013047 polymeric layer Substances 0.000 claims 4
- 238000000926 separation method Methods 0.000 claims 2
- 210000003709 heart valve Anatomy 0.000 abstract description 20
- 230000033001 locomotion Effects 0.000 abstract description 15
- 238000000034 method Methods 0.000 abstract description 10
- 230000008569 process Effects 0.000 abstract description 10
- 239000002861 polymer material Substances 0.000 description 13
- 210000004115 mitral valve Anatomy 0.000 description 11
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 8
- 239000000741 silica gel Substances 0.000 description 8
- 229910002027 silica gel Inorganic materials 0.000 description 8
- 210000000591 tricuspid valve Anatomy 0.000 description 6
- 239000000463 material Substances 0.000 description 5
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 206010027727 Mitral valve incompetence Diseases 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 230000003205 diastolic effect Effects 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 210000005240 left ventricle Anatomy 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 238000009958 sewing Methods 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- 210000001765 aortic valve Anatomy 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000008602 contraction Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- 210000003102 pulmonary valve Anatomy 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 206010019280 Heart failures Diseases 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 210000005246 left atrium Anatomy 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 208000002815 pulmonary hypertension Diseases 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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Abstract
The utility model discloses an annuloplasty ring, which comprises a main body ring and an outer layer body, wherein the outer layer body is coated on the periphery of the main body ring; the main body ring is a closed ring body formed by matching a front ring section, a rear ring section, a left ring section and a right ring section, the softness of the front ring section and the rear ring section is smaller than that of the left ring section and the right ring section, and the softness of the rear ring section is larger than that of the front ring section; the left ring section and the right ring section all comprise a plurality of connecting pieces which are sequentially arranged, at least two adjacent connecting pieces are movably connected, a movable gap exists at the connecting position, the connecting pieces can be driven to stretch out and draw back along the circumference direction of the main body ring relative to the adjacent connecting pieces so as to change the circumference of the main body ring, and the connecting pieces are driven to rotate relative to the adjacent connecting pieces so as to drive the main body ring to deform along the circumferential direction and the axial direction of the main body ring. The annuloplasty ring can provide proper strength to prevent the expansion of the valve annulus on one hand, and has proper flexibility to adapt to the physiological change curvature of the heart valve in the motion process of systole-diastole-systole on the other hand.
Description
Technical Field
The utility model belongs to the technical field of medical appliances, and particularly relates to an annuloplasty ring.
Background
In the systolic and diastolic cycles of the heart, unidirectional flow of blood is achieved by means of four heart valves, respectively: mitral valve, tricuspid valve, aortic valve and pulmonary valve. When the mitral valve and tricuspid valve are closed, the aortic valve and pulmonary valve are opened, blood in the left ventricle flows into the aorta, and blood in the ventricle is prevented from flowing back to the atrium, so that the mitral valve and tricuspid valve play a role of a one-way valve. Taking the mitral valve as an example, when the mitral valve is diseased, the leaflets fail to close properly and the annulus dilates, which can cause blood to flow back from the left ventricle to the left atrium. Mitral regurgitation may reduce cardiac output and ejection fraction, and thus the end diastole volume and pressure of the left ventricle increase significantly, and patients may develop pulmonary hypertension and heart failure, ultimately leading to death.
A common treatment for mitral regurgitation is valvuloplasty. The surgeon repairs the morphology of the damaged heart valve under extracorporeal circulation, correcting the enlarged annulus, thereby treating mitral regurgitation. To maintain long-term therapeutic effect, after annuloplasty, surgeons often implant a prosthetic annuloplasty ring at the patient's annulus to ensure good shaping of the native annulus, while preventing further enlargement of the annulus to maintain therapeutic effect.
The existing forming rings in clinic mainly relate to soft rings, hard rings and semi-hard rings.
The soft ring is usually made of high polymer materials, is not beneficial to the effective closing of valve leaflets and the shaping of the valve ring, can not effectively recover the physiological structure of the heart valve, and has the problem of re-expansion in long term.
The hard ring is made of metal, has better ring body supporting strength, but the physiological curvature of the valve ring changes along with the opening and closing movement process of the mitral valve leaf, the appearance design of the existing part of products tends to conform to the three-dimensional saddle shape of the physiological curvature, but the hard ring is not easy to bend, and the change of the physiological curvature of the valve ring in the cardiac cycle cannot be realized.
The semi-rigid ring body can be rigidly adjusted, so that certain supporting strength is maintained, and curvature change between the front ring and the rear ring is met to a certain degree. From the design concept perspective, the semi-hard ring compromises the product characteristics of the soft ring and the hard ring, can prevent long-term re-expansion, and can maintain certain physiological curvature. At present, a semi-hard ring mainly adopts a metal ring body structure, and the aim of adjustable hardness is fulfilled by adding or removing materials at certain parts. The design seems to satisfy the 'ring body supporting strength' and the 'good adaptation physiological curvature', and the balance needs to be made among the two characteristics, if the supporting strength is ensured, the ring body cannot be designed to be too soft, and when the mitral valve is contracted, the hardness of the ring body generates certain reverse obstruction, so that the physiological curvature adaptability is sacrificed to a certain extent.
In summary, as a repair device, the annuloplasty ring needs to have two basic properties:
The ring body provides enough strength to prevent the valve ring from expanding;
The ring body is soft enough to adapt to physiological curvature in the systolic period.
Obviously, two opposite purposes are achieved through the characteristics of the material, and the optimal effect is difficult to achieve.
Disclosure of utility model
The object of the present utility model is to provide an annuloplasty ring which on the one hand provides suitable strength against expansion of the annulus and on the other hand has suitable flexibility to adapt to the physiological curvature of the systole.
The technical scheme for achieving the aim comprises the following steps.
An annuloplasty ring comprising a main body ring and an outer layer body, the outer layer body coating the periphery of the main body ring;
The main body ring is a closed ring body formed by matching a front ring section, a rear ring section, a left ring section and a right ring section, the softness of the front ring section and the rear ring section is smaller than that of the left ring section and the right ring section, and the softness of the rear ring section is larger than that of the front ring section; the left ring section and the right ring section all comprise a plurality of connecting pieces which are sequentially arranged, at least two adjacent connecting pieces are movably connected, a movable gap exists at the connecting position, the connecting pieces can stretch out and draw back along the circumference direction of the main body ring correspondingly to the other connecting pieces, so as to change the circumference of the main body ring, and the connecting pieces can rotate correspondingly to the other connecting pieces to drive the main body ring to deform along the circumferential direction and the axial direction of the main body ring correspondingly.
In some embodiments, the left ring section and the right ring section each comprise a main body section and two transition sections, and the two transition sections are arranged at opposite ends of the main body section and are respectively connected with the front ring section and the rear ring section; the body section comprises at least two connecting pieces, the transition section comprises at least one connecting piece, and the whole deformation amplitude of the transition section is smaller than that of the body section.
In some embodiments, the deformation angle range of two adjacent connecting pieces in the transition section is 1-5 degrees, and the integral deformation angle range of the transition section is 0-25 degrees;
The deformation angle range of two adjacent connecting pieces in the main body section is 1-5 degrees, and the integral deformation angle range of the main body section is 0-30 degrees.
In some embodiments, the two opposite ends of the connecting piece are provided with a first matching part and a second matching part, two adjacent connecting pieces are movably connected through the first matching part of the former connecting piece and the second matching part of the latter connecting piece, and the joint has the movable gap.
In some of these embodiments, the spacing distance between adjacent two connectors of the body section is less than the spacing distance between adjacent two connectors of the transition section; the first matching parts and the second matching parts are arranged at intervals along the circumferential direction of the connecting piece, and the number of the first matching parts and the second matching parts of the connecting piece in the main body section is more than that of the first matching parts and the second matching parts of the connecting piece in the transition section.
In some embodiments, the first matching part is an inserting groove which is concave inwards to form a concave arc petal shape, and the width of a notch of the inserting groove is smaller than the width of a groove inside the inserting groove; the second matching part is an arc-shaped plug connector which protrudes outwards to form a fit with the plug groove, and the plug connector is rotationally plugged in the plug groove and has the movable gap.
In some embodiments, the plugging groove is obliquely arranged along the circumferential direction of the connecting piece, and an included angle between the central line of the plugging groove and the central axis of the connecting piece in space ranges from 1 degree to 5 degrees.
In some embodiments, the first matching portion is a circular groove, the second matching portion includes a pushing portion and a clamping piece, the clamping piece includes a connecting pipe with a penetrating structure, two hemispherical elastic clamping portions are arranged at the tail end of the connecting pipe, the two elastic clamping portions can be matched to form a spherical clamping body and extend into or extend out of the first matching portion in a normal state, and the pushing portion can penetrate through the connecting pipe and squeeze into a position between the two elastic clamping portions, so that the two elastic clamping portions are mutually opened and limited in the first matching portion.
In some embodiments, the first matching part is an inward concave polygonal inserting groove, and the width of the notch of the inserting groove is smaller than the width of the groove inside the inserting groove; the second matching part is a polygonal plug connector which protrudes outwards to form a fit with the plug groove, and the plug connector is rotationally plugged in the plug groove and has the movable gap.
In some embodiments, the outer layer body includes a silica gel layer and a polymer material layer, the silica gel layer and the polymer material layer are sequentially coated on the periphery of the main body ring, and the silica gel layer is located between the polymer material layer and the main body ring, and the polymer material layer extends outwards from the main body ring to form a stitching portion.
The technical scheme provided by the utility model has the following advantages and effects:
The annuloplasty ring is coated with an outer layer body through the periphery of the main body ring, and the main body ring can be sutured with the heart through the outer layer body so as to be firmly fixed at the position of the heart valve ring; the front ring section and the rear ring section are respectively movably connected through a plurality of connecting pieces, and the connecting pieces are movably connected with each other at the connecting positions, so that the connecting pieces can be driven to stretch and retract along the circumferential direction of the main body ring relatively to change the circumferential length of the main body ring, and the connecting pieces can be driven to rotate relatively to drive the main body ring to deform along the circumferential direction and the axial direction of the connecting pieces relatively to enable the valve forming ring to have moderate deformation performance, so that on one hand, the valve forming ring can provide proper strength to prevent expansion of the valve ring, and on the other hand, the valve forming ring has proper soft deformation performance and elasticity, and can adapt to the physiological change of a heart valve in the movement process of a systolic phase, a diastolic phase and a systolic phase.
Drawings
FIG. 1 is a schematic view of an annuloplasty ring in accordance with a first embodiment of the utility model;
FIG. 2 is a schematic view in partial cross-section of the annuloplasty ring of FIG. 1;
FIG. 3 is a schematic cross-sectional view of the overall structure of the annuloplasty ring of FIG. 1;
FIG. 4 is a schematic illustration of the connection structure of the connection of the annuloplasty ring of FIG. 1;
FIG. 5 is a schematic view of the angle of motion of the attachment member of the annuloplasty ring of FIG. 1 in rotation;
FIG. 6 is a schematic illustration of the attachment of an annuloplasty ring of the second embodiment of the utility model in an unattached state;
FIG. 7 is a schematic view of the attachment of the annuloplasty ring of FIG. 6 in an attached state;
FIG. 8 is a schematic view in cross-section of the body ring of the annuloplasty ring of FIG. 1;
fig. 9 is a schematic view of a radial cross-section of the annuloplasty ring of fig. 1.
Reference numerals illustrate:
100. An annuloplasty ring;
1. A body ring; 11. a front ring segment; 12. a rear ring segment; 13. a left ring segment; 131. a main body section; 132. a transition section; 14. a right ring segment; 15. a connecting piece; 151. a first mating portion; 152. a second mating portion; 153. a pushing part; 154. a clamping piece; 155. a connecting pipe; 156. an elastic clamping part; 2. an outer layer body; 21. a silica gel layer; 22. a polymer material layer; 23. and a suture part.
Detailed Description
In order that the utility model may be readily understood, a more particular description of specific embodiments thereof will be rendered by reference to specific embodiments that are illustrated in the appended drawings.
The terms "first" and "second" … "as used herein, unless specifically indicated or otherwise defined, are merely used to distinguish between names and do not denote a particular quantity or order.
The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items, unless specifically stated or otherwise defined.
The term "fixed" or "connected" as used herein may be directly fixed or connected to an element, or indirectly fixed or connected to an element.
It should be noted that the annuloplasty ring 100 can be implanted in the patient's annulus to ensure good shaping of the native annulus, to better conform to the movements of the mitral or tricuspid valve, and to prevent further enlargement of the annulus to maintain therapeutic effect.
Example 1
The present utility model provides an annuloplasty ring 100, as shown in fig. 1 to 9, the annuloplasty ring 100 comprises a main body ring 1 and an outer layer body 2, and the outer layer body 2 is wrapped on the periphery of the main body ring 1. Wherein the outer layer 2 protects the structure of the main ring 1 on the one hand and facilitates suturing with the heart on the other hand, wherein the outer layer 2 may be one or more layers, and the material may be specifically selected according to the suturing and coating requirements.
The main body ring 1 is a closed ring body formed by matching a front ring section 11, a rear ring section 12, a left ring section 13 and a right ring section 14, wherein when the main body ring 1 is a closed ring body under the condition that no special description is provided, the closed connection position of the main body ring 1 can be connected in a sewing, bonding, welding, plugging or clamping mode. The softness of the front ring section 11 and the back ring section 12 is smaller than that of the left ring section 13 and the right ring section 14, and the softness of the back ring section 12 is larger than that of the front ring section 11; the left ring section 13 and the right ring section 14 each comprise a plurality of connecting pieces 15 which are sequentially arranged, at least two adjacent connecting pieces 15 are movably connected, a movable gap exists at the joint, the connecting pieces 15 can stretch and retract along the circumferential direction of the main body ring 1 relative to the adjacent connecting pieces 15 so as to change the circumferential length of the main body ring 1, and the connecting pieces 15 can rotate relative to the adjacent connecting pieces 15 so as to drive the main body ring 1 to deform along the circumferential direction and the axial direction of the main body ring; the front link 15 and the rear link 15 described in this embodiment refer to and distinguish two adjacent links 15, but are not limited to the forward and backward positions in the forward rotation direction or the forward and backward positions in the reverse rotation direction.
In particular, in the law of motion of the mitral or tricuspid valve, the valve is in the process of circulatory motion in systole-diastole-systole, while in systole the orifice of the mitral or tricuspid valve contracts, the heart valve annulus takes the shape of a saddle, and the leaflets close. Therefore, in this embodiment, according to the saddle-shaped heart valve annulus state, the front ring segment 11 and the rear ring segment 12 are set to have a softness smaller than that of the left ring segment 13 and the right ring segment 14, and the softness of the rear ring segment 12 is greater than that of the front ring segment 11, the front ring segment 11 and the rear ring segment 12 form a better ring body supporting strength, and according to the fact that the left ring segment 13 and the right ring segment 14 are respectively connected in a matched manner through a plurality of connecting pieces 15, at least two adjacent connecting pieces 15 are movably connected, and a movable gap exists at the connecting position, so that the left ring segment 13 and the right ring segment 14 can form a main deformation area, and can move in a telescopic manner along the circumferential direction of the main body ring 1 relative to the adjacent other connecting piece 15 through the connecting pieces 15, the main body ring 1 can be driven to stretch and retract along the circumferential direction of the main body ring 1 to change the circumferential length of the main body ring 1, so that the circumferential length of the main body ring 1 is in a fixed movable range to prevent the valve from re-expanding, meanwhile, the connecting piece 15 rotates along the connecting piece 15 relative to the adjacent connecting piece 15 to drive the main body ring 1 to deform along the circumferential direction and the axial direction of the main body ring 1, for example, the main body ring 1 can be deformed back and forth between a saddle shape and a plane ring shape according to the shape of a heart valve, and the positions of the main body ring 1 corresponding to the left ring section 13 and the right ring section 14 can be deformed back and forth between an arc shape and a straight line shape to adapt to the physiological curvature of the heart valve in the motion process of the heart valve in the systolic phase, the diastolic phase and the systolic phase. In systole, the mitral valve orifice is contracted, the heart valve ring is saddle-shaped, and the valve leaves are closed, at this time, the main body ring 1 is filled up by the gap, and the heart valve ring can be self-adapted to contraction. The rigid connection of the main body ring 1 ensures the strength of the ring body support and avoids long-term re-expansion.
In summary, the annuloplasty ring 100 is wrapped with the outer layer body 2 through the outer periphery of the main body ring 1, and the main body ring 1 can be sutured with the heart through the outer layer body 2 so as to be firmly fixed at the position of the heart valve ring; the front ring segment 11, the rear ring segment 12, the left ring segment 13 and the right ring segment 14 are matched to form a closed ring body through the main ring 1, softness of the front ring segment 11 and the rear ring segment 12 is smaller than that of the left ring segment 13 and the right ring segment 14, softness of the rear ring segment 12 is larger than that of the front ring segment 11, therefore, the front ring segment 11 and the rear ring segment 12 have better ring body supporting strength in a movement process, the left ring segment 13 and the right ring segment 14 are respectively movably connected through a plurality of connecting pieces 15, movable gaps exist at connecting positions, the connecting pieces 15 can be driven to stretch along the circumferential direction of the main ring 1 relative to the adjacent other connecting pieces 15 to change the circumferential length of the main ring 1, and the connecting pieces 15 are driven to rotate relative to the adjacent other connecting pieces 15 to drive the main ring 1 to deform along the circumferential direction and the axial direction of the main ring 100, so that the valve forming ring 100 has moderate deformation performance, proper strength can be provided, the valve expansion can be prevented, and proper soft deformation performance and proper expansion performance can be provided on the other hand, and the valve expansion can be adapted to the change of the heart valve in a systolic-diastolic movement process.
In some embodiments, as shown in fig. 3 and 8, the left ring section 13 and the right ring section 14 each include a main body section 131 and two transition sections 132, the two transition sections 132 being disposed at opposite ends of the main body section 131 and connected to the front ring section 11 and the rear ring section 12, respectively; the body section 131 comprises at least two connectors 15, the transition section 132 comprises at least one connector 15, and the magnitude of the overall deformation of the transition section 132 is smaller than the magnitude of the overall deformation of the body section 131. As will be appreciated, since the left and right ring segments 13 and 14 are transition regions for connecting the front and rear ring segments 11 and 12, the left and right ring segments 13 and 14 are divided into a main body segment 131 and a transition segment 132 according to the degree of deformation thereof; the transition section 132 is located between the front ring section 11 and the main body section 131 and before the rear ring section 12 and the main body section 131, so that the deformation degree of the transition section 132 is smaller than that of the main body section 131, so that the movement angle of the left ring section 13 and the right ring section 14 is controlled to be in a specific direction and range, specifically, different numbers of connecting pieces 15 are arranged between the transition section 132 and the main body section 131, so that the integral deformation amplitude of the transition section 132 is smaller than that of the main body section 131, and the left ring section 13 or the right ring section 14 formed by matching the transition section 132 and the main body section 131 can be connected with the front ring section 11 and the rear ring section 12 to form a closed ring shape, and the deformation area between the left ring section 13 and the right ring section 14 has a moderate movement range so as to adapt to the physiological change curvature of the heart valve during the movement process of the heart valve in the systolic phase-diastolic phase-systolic phase as much as possible. In addition, the transition section 132 may be connected to the front ring section 11 and the rear ring section 12 by a mating connection, or may be connected by other manners such as stitching, bonding, welding, or clamping.
Specifically, in some embodiments, as shown in fig. 3 and 5, the deformation angle of two adjacent connectors 15 in the transition section 132 ranges from 1 ° to 5 °, and the overall deformation angle of the transition section 132 ranges from 0 ° to 25 °; the deformation angle of two adjacent connectors 15 in the main body section 131 ranges from 1 ° to 5 °, and the integral deformation angle of the main body section 131 ranges from 0 ° to 30 °. The left ring segment 13 and the right ring segment 14 formed by the cooperation of the transition segment 132 and the main body segment 131 in the numerical range can well adapt to the physiological change curvature of the heart valve in the motion process of systole-diastole-systole, and have proper strength to prevent the valve annulus from expanding.
In some embodiments, the two opposite ends of the connecting piece 15 are provided with a first mating portion 151 and a second mating portion 152, and two adjacent connecting pieces 15 are movably connected by the first mating portion 151 of the previous connecting piece 15 and the second mating portion 152 of the next connecting piece 15, and the joint has the movable gap.
In some embodiments, the spacing distance between two adjacent connectors 15 of the body segment 131 is less than the spacing distance between two adjacent connectors 15 of the transition segment 132; the first mating portions 151 and the second mating portions 152 are respectively provided with a plurality of first mating portions 151 and second mating portions 152 along the circumferential direction of the connecting piece 15 at intervals, and the number of the first mating portions 151 and the second mating portions 152 of the connecting piece 15 in the main body section 131 is greater than the number of the first mating portions 151 and the second mating portions 152 of the connecting piece 15 in the transition section 132. It will be appreciated that the spacing between adjacent connectors 15 and the number of first and second mating portions 151, 152 directly affect the magnitude of deformation corresponding to the ring segments. Specifically, the smaller the interval between two adjacent connecting pieces 15, the larger the angle that can deform, therefore, through setting up the interval distance between two adjacent connecting pieces 15 of main body section 131 and being less than the interval distance between two adjacent connecting pieces 15 of changeover portion 132, so that the overall deformation's range in main body section 131 is greater than the overall deformation's range of changeover portion 132, and the number of second cooperation portion 152 and first cooperation portion 151 influences two adjacent connecting pieces 15 rotation direction, be equipped with a plurality of second cooperation portion 152 and first cooperation portion 151 of a plurality of for example at least four and even number through the both ends of connecting piece 15 in main body section 131, so that main body section 131 can rotate in upper and lower direction and left and right direction, can form main body section 131 with great deformation range, so that main body section 131 has flexible deformability and adapts to the physiological change curvature in the heart valve motion process, and changeover portion 132 both ends are equipped with the second cooperation portion 152 and first cooperation portion 151 of less than the cooperation portion number of main body section 131, make changeover portion 132 rotation direction restricted, make changeover portion 132 receive the changeover portion 132 rotation direction limited, can not rotate in the direction but can do not change in the direction but can form the annular ring 11 with changeover portion 11 as the changeover portion 11, on the other hand, can rotate in the direction of the changeover portion 131, can form the main body section 131 with the physiological change in the direction of the flexible deformation, can adapt to the physiological change in the course, and the change in the course of the changeover portion, the changeover portion has the physiological change of the transition ring. In addition, when the connecting piece 15 at the end of the transition section 132 is connected to the connecting piece 15 at the end of the main body section 131, the number of the second mating parts 152 and the first mating parts 151 is adapted to be set so that the two connecting pieces 15 can be smoothly connected and transitionally set.
In this embodiment, the transition section 132 is composed of at least 1 and at most 9 connectors 15, and the length of each connector 15 ranges from 2mm to 10mm; the main body section 131 is composed of 2-10 connectors 15, and the length of the connectors 15 ranges from 2mm to 10mm. Of course, in other embodiments, the number and length of the connecting members 15 of the transition section 132 and the main body section 131 are not limited to the above-described ranges, and other numbers and lengths may be applicable.
In some embodiments, as shown in fig. 3 and fig. 4, the first mating portion 151 is a socket groove that is concave inward to form a concave arc petal shape, and the width of the notch of the socket groove is smaller than the width of the groove inside the socket groove; the second mating portion 152 is an arc-shaped plug connector protruding outwards to form a convex arc shape, and the plug connector is rotatably inserted into the plug slot and has the movable gap. It will be appreciated that the connectors are inserted into the insertion grooves, and the connectors can rotate relative to the insertion grooves so that the rear connector 15 can rotate relative to the front connector 15, and the connectors can be prevented from being separated from the notches of the insertion grooves during the rotation of the two adjacent connectors 15, thereby avoiding affecting the normal working state of the annuloplasty ring 100.
In some embodiments, as shown in fig. 5, the inserting grooves are obliquely arranged along the circumferential direction of the connecting piece 15, and the included angle alpha between the central line of the inserting grooves and the central axis of the connecting piece 15 in space ranges from 1 ° to 5 °, and the shape of the inserting pieces is adapted to the shape of the inserting grooves, so that the rear connecting piece 15 can rotate towards the rear ring section 12 side along the direction of the front connecting piece 15, thereby forming a closed ring shape and having a moderate deformation area.
In some embodiments, as shown in fig. 9, the outer layer 2 includes a silica gel layer 21 and a polymer material layer 22, the silica gel layer 21 and the polymer material layer 22 are sequentially coated on the outer periphery of the main body ring 1, and the silica gel layer 21 is located between the polymer material layer 22 and the main body ring 1, and the polymer material layer 22 extends outwards of the main body ring 1 to form a seam 23. It should be noted that, because the main body ring 1 is a deformable closed ring structure, the outer layer 2 wrapping the main body ring 1 needs to be able to meet the requirement of free contraction and be stably fixed on the heart valve ring, wherein the outer layer 2 is a silica gel layer 21 and a polymer material layer 22 with good extensibility from inside to outside, the polymer material layer 22 is in a hollow structure, the hollow shape can be a circle, a triangle, a hexagon, etc., and the sewing part 23 is a compact hollow structure, so as to be convenient for sewing.
In some embodiments, the thickness of the silicone layer 21 ranges from 0.2mm to 1mm, the thickness of the polymer material layer 22 ranges from 0.1 mm to 0.3mm, and the thickness of the stitching 23 ranges from 0.3mm to 1mm.
In some embodiments, each of the front ring segment 11, the rear ring segment 12, the left ring segment 13, and the right ring segment 14 of the main body ring 1 may be a solid structure or a hollow structure, which is not particularly limited herein. Each of the front ring segment 11, the rear ring segment 12, the left ring segment 13, and the right ring segment 14 of the main body ring 1 may be one material or may be composed of a plurality of materials. In this embodiment, each of the front ring segment 11, the rear ring segment 12, the left ring segment 13 and the right ring segment 14 of the main body ring 1 has an inner hollow tubular structure, the outer diameters of the ring segments are consistent, the diameter ranges from 1mm to 3mm, and the ring segments are made of metal materials with higher strength, such as metal materials commonly used in implantation instruments, for example, stainless steel, nickel-titanium alloy, cobalt-chromium alloy and the like.
Example two
In this embodiment, the annuloplasty ring 100 has a structure similar to that of the first embodiment, and as shown in fig. 6 and 7, the difference from the first embodiment is that:
The first matching portion 151 is a circular groove, the second matching portion 152 comprises a pushing portion 153 and a clamping piece 154, the clamping piece 154 comprises a connecting pipe 155 with a penetrating structure, two hemispherical elastic clamping portions 156 are arranged at the tail end of the connecting pipe 155, the two elastic clamping portions 156 can be matched to form a spherical clamping body in a normal state and can extend into or extend out of the first matching portion 151, the pushing portion 153 can penetrate through the connecting pipe 155 and squeeze into a position between the two elastic clamping portions 156, and accordingly the two elastic clamping portions 156 are mutually opened and limited in the first matching portion 151.
It will be appreciated that, in the unassembled state, the radial length of the spherical structure formed by the engagement of the two elastic clamping portions 156 is smaller than the width of the notch of the first engagement portion 151, so that the elastic clamping portions 156 can smoothly extend into or extend out of the first engagement portion 151, when the respective connecting members 15 are required to be assembled and connected, the elastic clamping portions 156 extend into the first engagement portion 151, the pushing portions 153 are pushed between the two elastic clamping portions 156 to enable the two elastic clamping portions 156 to move outwards, the radial length of the spherical structure formed by the engagement of the two elastic clamping portions 156 is increased, so that the spherical structure of the elastic clamping portions 156 can be accommodated in the first engagement portion 151 and limited to extend out, and the spherical structure of the elastic clamping portions 156 can rotate in the first engagement portion 151, so that the subsequent connecting member 15 can rotate relative to the previous connecting member 15.
Compared with the first embodiment, the annuloplasty ring 100 is matched with the clamping members 154 through the pushing portion 153, so that the connectors 15 can be flexibly assembled, and the assembly can be clinically performed according to specific shaping requirements, so that the flexibility of use is improved.
Example III
In this embodiment, the annuloplasty ring 100 has a structure similar to that of the first embodiment, as shown in fig. 8, which is different from the first embodiment in that:
The first matching part 151 is an inward concave polygonal inserting groove, and the width of the notch of the inserting groove is smaller than the width of the inserting groove; the second mating portion 152 is a plug member that protrudes outward to form a polygon that mates with the socket. The polygonal structure of the inserting groove and the inserting piece is convenient for cutting and processing, has low processing precision, can reduce processing cost, and also has good connection performance.
The above examples are also not an exhaustive list based on the utility model, and there may be a number of other embodiments not listed. Any substitutions and modifications made without departing from the spirit of the utility model are within the scope of the utility model.
Claims (10)
1. An annuloplasty ring, wherein the annuloplasty ring comprises a main body ring and an outer layer body, wherein the outer layer body is coated on the periphery of the main body ring;
The main body ring is a closed ring body formed by matching a front ring section, a rear ring section, a left ring section and a right ring section, the softness of the front ring section and the rear ring section is smaller than that of the left ring section and the right ring section, and the softness of the rear ring section is larger than that of the front ring section; the left ring section and the right ring section all comprise a plurality of connecting pieces which are sequentially arranged, at least two adjacent connecting pieces are movably connected, a movable gap exists at the connecting position, the connecting pieces can stretch out and draw back along the circumference direction of the main body ring correspondingly to the other connecting pieces, so as to change the circumference of the main body ring, and the connecting pieces can rotate correspondingly to the other connecting pieces to drive the main body ring to deform along the circumferential direction and the axial direction of the main body ring correspondingly.
2. The annuloplasty ring of claim 1, wherein the left and right ring segments each comprise a main body segment and two transition segments disposed at opposite ends of the main body segment and connected to the anterior and posterior ring segments, respectively; the body section comprises at least two connecting pieces, the transition section comprises at least one connecting piece, and the whole deformation amplitude of the transition section is smaller than that of the body section.
3. The annuloplasty ring of claim 2, wherein the angle of deformation of adjacent two connectors in the transition section ranges from 1 ° to 5 °, and the angle of overall deformation of the transition section ranges from 0 ° to 25 °;
The deformation angle range of two adjacent connecting pieces in the main body section is 1-5 degrees, and the integral deformation angle range of the main body section is 0-30 degrees.
4. The annuloplasty ring of claim 2, wherein the connectors are provided with first and second mating portions at opposite ends, and adjacent two of the connectors are movably connected by the first mating portion of a preceding connector and the second mating portion of a subsequent connector, and the movable gap exists at the connection.
5. The annuloplasty ring of claim 4, wherein a separation distance between adjacent two of the connectors of the main body section is less than a separation distance between adjacent two of the connectors of the transition section; the first matching parts and the second matching parts are arranged at intervals along the circumferential direction of the connecting piece, and the number of the first matching parts and the second matching parts of the connecting piece in the main body section is more than that of the first matching parts and the second matching parts of the connecting piece in the transition section.
6. The annuloplasty ring of claim 4, wherein the first mating section is an inwardly recessed, concave arcuate shaped mating groove, and a width of a notch of the mating groove is less than a width of a groove of the mating groove; the second matching part is an arc-shaped plug connector which protrudes outwards to form a fit with the plug groove, and the plug connector is rotationally plugged in the plug groove and has the movable gap.
7. The annuloplasty ring of claim 6, wherein the slots are disposed at an incline in a circumferential direction of the connector, and wherein a centerline of the slots is at an angle in space ranging from 1 ° to 5 ° from a central axis of the connector.
8. The annuloplasty ring of claim 4, wherein the first mating portion is a circular slot, the second mating portion includes a pushing portion and a retaining member, the retaining member includes a connecting tube having a penetrating structure, two hemispherical elastic retaining portions are disposed at ends of the connecting tube, the two elastic retaining portions can be mated to form a spherical retaining body and extend into or out of the first mating portion in a normal state, and the pushing portion can be disposed in the connecting tube in a position between the two elastic retaining portions in a penetrating manner so that the two elastic retaining portions are mutually opened and limited in the first mating portion.
9. The annuloplasty ring of claim 4, wherein the first mating section is an inwardly recessed polygonal shaped socket, and a width of a notch of the socket is less than a width of a slot in the socket; the second matching part is a polygonal plug connector which protrudes outwards to form a fit with the plug groove, and the plug connector is rotationally plugged in the plug groove and has the movable gap.
10. The annuloplasty ring of any of claims 1 to 9, wherein the outer body comprises a silicone layer and a polymeric layer, the silicone layer and the polymeric layer sequentially surrounding the outer periphery of the body ring, and the silicone layer is disposed between the polymeric layer and the body ring, the polymeric layer extending outwardly of the body ring to form a suture.
Priority Applications (1)
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CN202322395233.3U CN221411442U (en) | 2023-09-04 | 2023-09-04 | Annuloplasty ring |
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CN202322395233.3U CN221411442U (en) | 2023-09-04 | 2023-09-04 | Annuloplasty ring |
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CN221411442U true CN221411442U (en) | 2024-07-26 |
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CN202322395233.3U Active CN221411442U (en) | 2023-09-04 | 2023-09-04 | Annuloplasty ring |
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