CN115708732A - Artificial chordae tendineae tensioning device and operator - Google Patents
Artificial chordae tendineae tensioning device and operator Download PDFInfo
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- CN115708732A CN115708732A CN202211229328.1A CN202211229328A CN115708732A CN 115708732 A CN115708732 A CN 115708732A CN 202211229328 A CN202211229328 A CN 202211229328A CN 115708732 A CN115708732 A CN 115708732A
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Abstract
The invention relates to an artificial chordae tensioning device and an operator, the artificial chordae tensioning device comprising: the seat body is arranged outside the heart and comprises a body part and a clamping structure arranged on the body part; the clamping assembly comprises a clamping piece and a first elastic piece, the clamping piece is slidably arranged on the clamping structure, the first elastic piece is respectively connected with the clamping structure and the clamping piece, and under the action of elastic force of the first elastic piece, the clamping piece is matched with the clamping structure to clamp one end of the artificial chordae tendineae extending out of the heart; the adjusting component is arranged between the seat body and the heart and can push the seat body to be far away from the heart so as to tension the artificial chordae tendineae. According to the artificial chordae tendineae tensioning device provided by the invention, the seat body is pushed by the adjusting assembly to move towards the direction far away from the heart so as to tension the artificial chordae tendineae, a secondary implantation operation is not required, and secondary operation injury to a patient is avoided. The artificial chordae tendineae tensioning device is arranged outside the heart, and can not cause damage to the internal tissues of the heart after long-term use.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to an artificial chordae tendineae tensioning device and an operator.
Background
This section provides background information related to the present disclosure only and is not necessarily prior art.
Mitral Regurgitation (MR) is one of the most common heart valve diseases today, and the main causes are rheumatic heart disease, mitral valve myxoid degeneration, ischemic heart disease, cardiomyopathy and the like, which cause lesions of annulus, leaflets, chordae tendineae and papillary muscles in the mitral valve structure, resulting in incomplete closure of the leaflets of the mitral valve.
The main interventional procedure for mitral regurgitation is the implantation of artificial chordae tendineae, which are fixed at one end to the mitral valve and extend out of the heart at the other end and are sutured to the myocardium by sutures. Some enlargement of the left ventricular volume may occur due to prolonged or severe mitral regurgitation in patients. After implantation of the prosthetic chordae, regurgitation of the mitral valve is reduced or eliminated and blood flow to the mitral valve returns to normal. In the post-operative recovery period, the heart of the patient is working normally, and the volume of the left ventricle is correspondingly reduced to a normal level, so that the artificial chordae tendineae can be loosened, and mitral regurgitation can recur.
Among the prior art scheme, after implanting artificial chordae tendineae, treat that artificial chordae tendineae relaxs the back, carry out surgery operation again or carry out the implant of a regulation and control artificial chordae tendineae of wicresoft again, such operation easily causes secondary damage to the patient. Also, the implant is placed over the artificial chordae, which is suspended in the left ventricle and is prone to damage to cardiac tissue and long-term wear on the artificial chordae.
Disclosure of Invention
The invention aims to at least solve the problem that the placement of an implant through a secondary operation after the artificial chordae tendineae are loosened causes secondary injury to a patient. The purpose is realized by the following technical scheme:
according to a first aspect of the present invention, there is provided an artificial chordae tensioning device for tensioning artificial chordae implanted in a heart, the artificial chordae tensioning device comprising: the seat body is arranged outside the heart and comprises a body part and a clamping structure arranged on the body part; the clamping assembly comprises a clamping piece and a first elastic piece, the clamping piece is slidably arranged on the clamping structure, the first elastic piece is respectively connected with the clamping structure and the clamping piece, and under the action of elastic force of the first elastic piece, the clamping piece is matched with the clamping structure to clamp one end of the artificial chordae tendineae extending out of the heart; the adjusting component is arranged between the base body and the heart and can push the base body to be far away from the heart so as to tension the artificial chordae tendineae.
According to the artificial chordae tensioning device provided by the invention, the clamping assembly and the clamping structure clamp and fix one end of the artificial chordae extending out of the heart, and when the volume of the left ventricle is reduced and the artificial chordae is loosened, the seat body is pushed by the adjusting assembly to move towards the direction far away from the heart so as to tension the artificial chordae, a secondary implantation operation is not needed, and secondary operation injury to a patient is avoided. It should also be noted that the seat body, the clamping component and the adjusting component are all arranged outside the heart, and the internal tissues of the heart cannot be injured after long-term use. Because the artificial chordae tendineae tensioning device and the artificial chordae tendineae extending out of the heart are kept relatively fixed, the abrasion of the artificial chordae tendineae tensioning device on the artificial chordae tendineae in the long-term use process is reduced.
In addition, the artificial chordae tensioning device according to the invention may also have the following additional technical features:
in some embodiments of the invention, the adjustment assembly comprises: the sliding seat comprises a shell, a sliding channel is defined in the shell, two ends of the sliding channel form openings in the shell, and a seat body is slidably arranged in the sliding channel and can slide along the length direction of the sliding channel; a limiting member connected with the far end of the shell and abutted against the heart; one end of the third elastic part is connected with the limiting part, and the other end of the third elastic part is connected with the seat body; wherein the third elastic element applies an elastic force to the seat body in a direction away from the heart.
In some embodiments of the present invention, one of the inner wall of the sliding channel and the seat body is provided with a sliding groove, and the other of the inner wall of the sliding channel and the seat body is provided with a sliding rail in sliding fit with the sliding groove; wherein, the spout and the slide rail extend along the length direction of slide passage.
In some embodiments of the present invention, the housing further forms a limiting portion, the limiting portion is convexly disposed at the proximal end of the sliding channel, and the limiting portion is matched with the stop of the seat body.
In some embodiments of the present invention, a side of the body portion facing the position-limiting member forms a position-limiting pillar; a limiting groove is formed in one side, facing the body part, of the limiting piece, and the limiting groove is arranged corresponding to the limiting column; the third elastic piece is a pressure spring, one end of the pressure spring is sleeved on the limiting column, and the other end of the pressure spring is inserted into the limiting groove.
In some embodiments of the invention, the adjustment assembly comprises: the supporting plate is arranged between the clamping structure and the heart and is abutted against the heart; one end of the second elastic piece is connected with the supporting plate, and the other end of the second elastic piece is connected with the seat body; wherein the second elastic element applies an elastic force to the seat body in a direction away from the heart.
In some embodiments of the invention, the housing further comprises: the sliding matching part is arranged on one side of the body part facing the heart; the support plate is slidably disposed on the sliding fit portion.
In some embodiments of the invention, the sliding fit portion is annular, and the side wall of the support plate slidably abuts against an inner wall of the sliding fit portion.
In some embodiments of the invention, the adjustment assembly comprises: the balloon is fixedly connected with the seat body and is positioned between the seat body and the heart; the far end of the guide tube is communicated with the saccule, and the near end of the guide tube is arranged outside the human body; and the connecting valve is arranged at the near end of the flow guide pipe.
In some embodiments of the invention, the balloon is formed with a tendon channel through the balloon through which the artificial tendon passes.
In some embodiments of the invention, the clamping structure comprises: the supporting part is connected with the body part, and a supporting plane is formed on one side of the supporting part, which is far away from the body part; the clamping part is arranged on the supporting plane, and a clamping space is defined between the clamping part and the supporting plane; a connecting part arranged on the body part, wherein the connecting part and the clamping space are arranged at intervals; the clamping piece is slidably arranged in the clamping space; the first elastic piece is respectively connected with the connecting part and the clamping piece, and applies elastic force towards the clamping part to the clamping piece.
In some embodiments of the invention, the clamping portion comprises: a first side wall connected to the support part; a second side wall connected to the supporting part and disposed in parallel to and spaced apart from the first side wall; the top wall is respectively connected with the first side wall and the second side wall, the top wall, the first side wall, the second side wall and the supporting plane jointly define the clamping space, and a first clamping surface is formed on one side, facing the clamping space, of the top wall; the clamping piece comprises a sliding plane in sliding fit with the supporting plane and a second clamping surface matched with the first clamping surface, and the second clamping surface is abutted to the first clamping surface under the action of elastic force of the first elastic piece.
In some embodiments of the invention, the first clamping surface and/or the second clamping surface is configured as a roughened surface.
In some embodiments of the invention, a first wire passing hole is formed at the proximal end of the clamping portion, a second wire passing hole is formed at the distal end of the clamping portion, and the first wire passing hole and the second wire passing hole are both communicated with the clamping space.
In some embodiments of the invention, the first side wall and the second side wall are each provided with an elongated hole communicating with the clamping space; the clamping piece is provided with a through connecting hole; the number of the connecting parts is two, one of the two connecting parts is positioned on one side of the first side wall, and the other connecting part is positioned on one side of the second side wall; the first elastic piece penetrates through the long hole and the connecting hole, and two ends of the first elastic piece are connected with the two connecting parts respectively.
According to a second aspect of the present invention, there is provided an applicator for implanting the artificial chordae tensioning device of any of the first aspect, the applicator comprising: a handle; the proximal end of the sheath is connected with the handle; the tension claw is connected with the distal end of the sheath tube and is provided with a hook part which can be hooked to a first elastic piece in the artificial chordae tendineae tensioning device; the push rod is slidably arranged in the sheath tube, and the distal end of the push rod can be abutted against a support part of a seat body in the artificial chordae tendineae tensioning device; the adjusting button is arranged on the handle and connected with the near end of the push rod, and the adjusting button can push the push rod to move relative to the sheath along the length direction of the sheath.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated with like reference numerals throughout the drawings. In the drawings:
fig. 1 schematically shows a structural schematic diagram of a seat and a clamping assembly according to an embodiment of the invention;
fig. 2 is a schematic structural view of a base and a clamping assembly from a bottom view according to an embodiment of the invention;
FIG. 3 schematically illustrates a structural view of a clamp according to an embodiment of the present invention;
FIG. 4 schematically illustrates a structural view of a clamp from a left perspective according to an embodiment of the present invention;
fig. 5 is a schematic structural diagram of a base and a clamping assembly from a top view according to an embodiment of the invention;
fig. 6 schematically shows a structural view of an operator according to an embodiment of the present invention;
fig. 7 schematically shows a structural view of injecting saline into a balloon according to an embodiment of the present invention;
fig. 8 schematically shows a state diagram of the balloon before the balloon is injected with saline according to an embodiment of the present invention;
fig. 9 schematically illustrates a cross-sectional view of a balloon before saline is injected therein, according to an embodiment of the present invention;
fig. 10 schematically illustrates a cross-sectional view of the balloon after injection of saline into the balloon, in accordance with an embodiment of the present invention;
figure 11 schematically illustrates an enlarged schematic view of an artificial tendon tensioning device according to an embodiment of the present invention;
figure 12 schematically illustrates an enlarged schematic view of an artificial chordae tensioning device according to an embodiment of the present invention;
figure 13 schematically shows a structural schematic of an artificial tendon tensioning device according to an embodiment of the present invention;
figure 14 schematically illustrates an exploded view of a part of an artificial chordae tensioning device in accordance with an embodiment of the present invention;
figure 15 schematically illustrates an enlarged schematic view of an artificial chordae tensioning device according to an embodiment of the present invention;
figure 16 schematically illustrates a schematic structural view of an artificial chordae tensioning device according to an embodiment of the present invention;
figure 17 schematically illustrates a schematic view of an implantation procedure of an artificial chordae tensioning device according to an embodiment of the invention;
fig. 18 schematically shows a partially enlarged schematic view of a portion a in fig. 17.
The reference numbers are as follows:
100-artificial chordae tendineae tensioning device;
10-seat body, 11-body part, 111-sliding fit part, 112-sliding groove, 113-limiting column, 12-clamping structure, 121-supporting part, 1211-supporting plane, 122-clamping part, 1221-first side wall, 1222-second side wall, 1223-top wall, 1224-first wire passing hole, 1225-second wire passing hole, 1226-long hole, 123-connecting part and 124-clamping space;
20-clamping component, 21-clamping piece, 211-sliding plane, 212-second clamping surface, 213-connecting hole and 22-first elastic piece;
30-adjusting component, 31-balloon, 311-tendon channel, 32-guide tube, 33-connecting valve, 34-supporting plate, 35-second elastic component, 36-shell, 361-sliding channel, 3611-sliding rail, 362-limiting part, 37-limiting component, 371-limiting groove and 38-third elastic component;
200-an operator;
201-handle, 202-sheath tube, 203-pulling force claw, 204-push rod, 205-adjusting button;
300-artificial chordae tendineae.
Detailed Description
Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both an up and down orientation. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
It should be noted that "distal" and "proximal" are used as terms of orientation that are commonly used in the field of interventional medical devices, wherein "distal" refers to the end that is distal from the operator during the procedure, and "proximal" refers to the end that is proximal to the operator during the procedure. Axial, meaning a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; radial, means a direction perpendicular to the above-mentioned axial direction.
As shown in fig. 1 and 7, according to an embodiment of the present invention, an artificial chordae tensioning device is provided.
The artificial chordae tensioning device is used to tension the artificial chordae 300 implanted in the heart to prevent the mitral valve regurgitation from recurring as a result of the artificial chordae 300 relaxing.
Specifically, the artificial chordae tensioner includes a housing 10, a clamping assembly 20 and an adjustment assembly 30. The seat body 10 is disposed outside the heart, specifically, placed at the apex of the heart, and the seat body 10 includes a body 11 and a holding structure 12 disposed on the body 11. The clamping assembly 20 is disposed on the clamping structure 12, and the clamping assembly 20 cooperates with the clamping structure 12 to clamp an end of the artificial chordae tendineae 300 extending out of the heart, so as to fix the end of the artificial chordae tendineae 300 extending out of the heart at the apical part outside the heart. The adjusting component 30 is disposed between the seat body 10 and the heart, and the adjusting component 30 can push the seat body 10 away from the heart to tension the artificial chordae tendineae 300. Therefore, when the volume of the left ventricle is reduced and the artificial chordae tendineae 300 can be loosened, the adjusting assembly 30 pushes the seat body 10 to move towards the direction away from the heart so as to tension the artificial chordae tendineae 300, so that a secondary implantation operation is not needed, and secondary operation injury to the patient is avoided.
It should be noted that, in the surgical procedure of implanting the artificial chordae tendineae 300 through the apex of the heart, an artificial chordae tendineae tensioning device is added, and the artificial chordae tendineae tensioning device has two functions of fixing the artificial chordae tendineae 300 and tensioning and adjusting the artificial chordae tendineae 300. After the operation, the artificial chordae tendineae 300 are loosened due to the change of the heart volume or the stretching and extension of the artificial chordae tendineae 300, and the artificial chordae tendineae 300 in the patient can be manually or automatically regulated by the artificial chordae tendineae tensioning device without invasive operation, so as to maintain the effect of the artificial chordae tendineae 300 on the treatment of mitral regurgitation.
It should be noted that, the seat body 10, the clamping assembly 20 and the adjusting assembly 30 are all disposed outside the heart, and the artificial chordae tendineae tensioning device does not need to contact with flowing blood and internal tissues of the heart, and does not cause damage to the internal tissues of the heart after long-term use. Because the artificial chordae tensioner remains relatively fixed to the artificial chordae 300 extending out of the heart, wear of the artificial chordae tensioner 100 on the artificial chordae 300 during long term use is reduced.
In some embodiments of the present invention, as shown in fig. 1-5, the clamping structure 12 comprises: a support portion 121, a clamping portion 122, and a connecting portion 123. Specifically, the main body 11 and the supporting portion 121 are both plate-shaped, the supporting portion 121 is disposed on a plane of a proximal side of the main body 11, the supporting portion 121 is disposed obliquely with respect to the main body 11, an included angle is formed between the supporting portion 121 and the main body 11, a supporting plane 1211 is formed on a side of the supporting portion 121 facing away from the main body 11, and the supporting plane 1211 is disposed obliquely with respect to the plane of the proximal side of the main body 11. The clamping portion 122 is disposed on the support plane 1211 and defines a clamping space 124 between the clamping portion 122 and the support plane 1211. The clamping portion 122 includes a first sidewall 1221, a second sidewall 1222, and a top wall 1223, the first sidewall 1221 and the second sidewall 1222 are connected to the supporting portion 121, and the first sidewall 1221 and the second sidewall 1222 are arranged in parallel and spaced apart. The top wall 1223 is connected on both sides to the first side wall 1221 and the second side wall 1222, respectively, and the top wall 1223, the first side wall 1221, the second side wall 1222 and the support plane 1211 together define the clamping space 124. The connecting portion 123 is disposed on a side plane of the main body 11 facing the proximal end, in this embodiment, the connecting portion 123 is a cylindrical protrusion protruding from the main body 11, the cylindrical protrusion is provided with a through hole, and the connecting portion 123 is spaced from the clamping space 124.
The clamping assembly 20 includes: a clamping member 21 and a first elastic member 22, wherein the clamping member 21 is slidably disposed in the clamping space 124, the clamping member 21 includes a sliding plane 211 slidably engaged with the supporting plane 1211, and the clamping member 21 is limited by the first side wall 1221 and the second side wall 1222, and the clamping member 21 can slide on the supporting plane 1211 in the clamping space 124 to move closer to or farther away from the top wall 1223. The side of the top wall 1223 facing the clamping space 124 forms a first clamping surface (not shown), and the clamping member 21 further includes a second clamping surface 212 cooperating with the first clamping surface, so that the clamping member 21 can make the first clamping surface abut against or separate from the second clamping surface 212 when the clamping space 124 slides. The first elastic member 22 is connected to the connecting portion 123 and the clamping member 21, and the first elastic member 22 applies an elastic force to the clamping member 21 toward the clamping portion 122 to make the first clamping surface abut against the second clamping surface 212, so as to clamp the artificial chordae tendineae 300 between the first clamping surface and the second clamping surface 212.
It should be noted that, in order to increase the locking force on the artificial chordae tendineae 300, the first clamping surface or the second clamping surface 212 is configured as a rough surface, or both the first clamping surface and the second clamping surface 212 are configured as rough surfaces, so as to lock the artificial chordae tendineae 300.
It is emphasized that during the implantation procedure of the artificial chordae tensioner 100, the procedure is performed through the chest opening. Because the artificial chordae tensioning device 100 abuts against the apex of the heart, generally, the apex of the heart faces in the proximal direction, and the operator has an inclination angle with the apex of the heart, when the artificial chordae tensioning device 100 abuts against the apex of the heart, in the implantation process, on one hand, a pulling force needs to be applied to the first elastic member 22, so that the first elastic member 22 drives the clamping member 21 to be separated from the first clamping surface, and meanwhile, one end of the artificial chordae 300 extending out of the heart needs to be captured and pass between the clamping member 21 and the first clamping surface. Therefore, by arranging the support plane 1211 obliquely relative to the body portion 11, operable spaces open towards the proximal end are formed between the proximal end of the support plane 1211 and the body portion 11 and between the support plane 1211 and the first clamping surface, which is beneficial to capturing the artificial chordae tendineae more smoothly and making the artificial chordae tendineae run through the clamping spaces, reducing the operation difficulty of the artificial chordae tendineae tensioning device 100 during implantation, improving the implantation efficiency of the artificial chordae tendineae tensioning device 100, and shortening the operation time.
In an exemplary embodiment, as shown in FIG. 4, the second clamping surface 212 is serrated. In other embodiments, the second clamping surface 212 is provided with a knurled pattern or a densely-covered bump structure to increase the roughness of the second clamping surface 212.
In this embodiment, as shown in fig. 2 and 5, the proximal end of the clamping portion 122 is provided with a first wire through hole 1224, the distal end of the clamping portion 122 is provided with a second wire through hole 1225, and both the first wire through hole 1224 and the second wire through hole 1225 are communicated with the clamping space 124, so that the end of the artificial tendon 300 extending out of the heart enters the clamping space 124 through the second wire through hole 1225, is clamped between the first clamping surface and the second clamping surface 212, and extends out through the first wire through hole 1224, so as to adjust the tension of the artificial tendon 300 during the operation of implanting the artificial tendon 300.
In the present embodiment, as shown in fig. 3 and 13, each of the first side wall 1221 and the second side wall 1222 is provided with an elongated hole 1226 communicating with the nip space 124, and a length direction of the elongated hole 1226 is parallel to the support plane 1211. The holder 21 is provided with a through coupling hole 213, and both ends of the coupling hole 213 are opposed to the elongated holes 1226 of the first side wall 1221 and the second side wall 1222, respectively. The number of the connecting portions 123 is two, and one of the two connecting portions 123 is located on one side of the first side wall 1221 and the other is located on one side of the second side wall 1222. The first elastic member 22 is a linear elastic member, which may be made of one or more elastic wires. Both ends of the first elastic member 22 are connected to the two connection portions 123, respectively, and the first elastic member 22 passes through the elongated hole 1226 and the connection hole 213 in sequence. Under the condition of no external force, the first elastic element 22 is in a tensioned state, and the clamping element 21 is pressed against the top wall 1223, so that the first clamping surface and the second clamping surface 212 are tightly attached.
In some embodiments of the present invention, as shown in fig. 7, the adjustment assembly 30 includes: a balloon 31, a delivery tube 32 and a connecting valve 33.
Specifically, as shown in fig. 8, the balloon 31 is located between the seat 10 and the heart, one side of the balloon 31 abuts against the heart (specifically, the balloon 31 abuts against the apex of the heart), and the other side is fixedly connected to the seat 10. The balloon 31 may be connected to the housing 10 by bonding, integral molding, mechanical connection, or the like. The distal end of the delivery tube 32 is communicated with the balloon 31, the proximal end of the delivery tube 32 is led out of the operation wound, the connecting valve 33 is arranged at the proximal end of the delivery tube 32, and the connecting valve 33 is used for connecting the injector and preventing the balloon 31 from leaking.
As shown in fig. 7, when the artificial chordae tendineae 300 is loose, the catheter 32 is connected to an injector in vitro, saline is injected into the catheter 32 to fill the balloon 31, the balloon 31 pushes the seat body 10 away from the heart, and the artificial chordae tendineae 300 can be straightened, so as to complete the length control of the artificial chordae tendineae 300. And the ultrasonic instrument is combined to carry out in-vitro examination on the patient, judge the heart reflux condition and regulate and control the liquid injection amount so as to control the length regulation and control amount of the artificial chordae tendineae 300.
In the present embodiment, as shown in fig. 9 and 10, the balloon 31 is formed with a tendon channel 311 penetrating through the balloon 31, so that the overall appearance of the balloon 31 is an annular structure, and two ends of the tendon channel 311 are transited with the outer wall of the balloon 31 by an arc curved surface, so that on one hand, the balloon 31 is more attached to the apex of the heart, and the balloon 31 is ensured to be closely attached to the surface of the heart after being filled, and has no suspended part; on the other hand, the artificial chordae 300 can pass through the chordae channel 311 into the clamping space 124, and the balloon 31 is prevented from contacting and rubbing the artificial chordae 300 to cause injury.
In some embodiments of the present invention, as shown in fig. 11 and 12, the adjustment assembly 30 includes: a supporting plate 34 and a second elastic member 35.
Specifically, the second elastic member 35 may be a spring, a superelastic part, or the like. The supporting plate 34 is arranged between the clamping structure 12 and the heart and is abutted against the heart; one end of the second elastic member 35 is connected to the supporting plate 34, and the other end of the second elastic member 35 is connected to the seat body 10. After the artificial chordae tendineae 300 is clamped and fixed to the artificial chordae tendineae tensioning device, the second elastic element 35 is compressed, and the second elastic element 35 applies an elastic force to the seat body 10 in a direction away from the heart, and the value of the elastic force is F, and under the elastic force of the second elastic element 35, the clamping element 21 and the clamping structure 12 provide a traction force F to the artificial chordae tendineae 300. The pulling force of the leaflet beating on the artificial chordae tendineae 300 is F '(approximately 0.75-1.0N), F = F', according to known clinical literature data. Understandably, when the artificial chorda tendineae 300 become loose, the first elasticity can keep applying the elastic force F to the artificial chorda tendineae 300 through the seat body 10, the seat body 10 is away from the heart, and makes part of the artificial chorda tendineae 300 in the heart extend out of the heart, so that the artificial chorda tendineae 300 are tensioned, and the second elastic element 35 can always keep the artificial chorda tendineae 300 having a reaction force against the mitral valve leaflets, which do not prolapse, so as to solve the problem of mitral regurgitation.
In this embodiment, the seat body 10 further includes: the sliding fitting portion 111 is annular, the sliding fitting portion 111 is disposed on a side of the main body 11 facing the heart, and a side wall of the supporting plate 34 slidably abuts against an inner wall of the sliding fitting portion 111, so that the sliding fitting portion 111 limits a moving direction of the supporting plate 34, and the supporting plate 34 moves more stably.
In some embodiments of the present invention, as shown in fig. 13 and 14, the adjustment assembly 30 includes: a housing 36, a retaining member 37 and a third elastic member 38.
The housing 36 is hollow and cylindrical, a sliding channel 361 is defined in the housing 36, both ends of the sliding channel 361 in the length direction form openings on the housing 36, and the seat body 10 is slidably disposed in the sliding channel 361 and can slide along the length direction of the sliding channel 361. The limiting member 37 is connected to the distal end of the casing 36 and abuts against the heart, one end of the third elastic member 38 is connected to the limiting member 37, and the other end of the third elastic member 38 is connected to the seat body 10. The third elastic member 38 is a spring, specifically, a compression spring, and is used for applying an elastic force to the holder body 10 in a direction away from the heart.
As shown in fig. 15, after the artificial chordae 300 is clamped and fixed to the artificial chordae tensioning device, the third elastic element 38 is in a compressed state, the third elastic element 38 applies an elastic force to the seat body 10 in a direction away from the heart based on the limiting element 37, and the value of the elastic force is F2, and under the elastic force of the third elastic element 38, the clamping element 21 and the clamping structure 12 provide a traction force to the artificial chordae 300, which is also F2. As known from clinical literature data, the pulling force of leaflet beating on the artificial chordae tendineae 300 is F '(approximately 0.75-1.0N), F2= F'. Understandably, when the artificial chorda tendineae 300 become loose, the second elasticity can keep applying the elastic force F2 to the artificial chorda tendineae 300 through the seat body 10, so that the seat body 10 is far away from the heart, and part of the artificial chorda tendineae 300 in the heart is extended out of the heart, and the artificial chorda tendineae 300 are tightened by compensating the elastic force. The third elastic element 38 can always keep the artificial chordae tendineae 300 reacting to the mitral valve leaflets, and the leaflets will not prolapse, so as to solve the problem of mitral regurgitation.
In the present embodiment, the connection manner of the limiting member 37 and the housing 36 includes, but is not limited to, welding, bonding, and snap connection.
Further, as shown in fig. 14, the other one is provided with a sliding rail 3611 slidably engaged with the sliding groove 112, the sliding groove 112 and the sliding rail 3611 extend along the length direction of the sliding channel 361, and the sliding groove 112 and the sliding rail 3611 are in clearance fit, so as to improve the stability and smoothness of the sliding of the seat body 10 in the sliding channel 361 through the engagement of the sliding groove 112 and the sliding rail 3611.
In one embodiment, the inner wall of the sliding channel 361 is provided with a sliding slot 112, and the edge of the seat body 10 is provided with a sliding rail 3611. In other embodiments, the inner wall of the sliding channel 361 is provided with a sliding rail 3611, and the edge of the seat body 10 is provided with a sliding groove 112.
Further, as shown in fig. 13, the housing 36 further forms a limiting portion 362, the limiting portion 362 is convexly disposed at the proximal end of the sliding channel 361, and the limiting portion 362 is in stop fit with the seat body 10 to prevent the seat body 10 from being pulled out from the proximal end of the sliding channel 361.
Further, as shown in fig. 14, a limit post 113 is formed on one side of the main body 11 facing the limit piece 37, a limit groove 371 is formed on one side of the limit piece 37 facing the main body 11, the limit groove 371 is disposed corresponding to the limit post 113, the third elastic element 38 is a compression spring, one end of the compression spring is sleeved on the limit post 113, and the other end of the compression spring is inserted into the limit groove 371, so as to improve the stability of the third elastic element 38.
As shown in fig. 15, when the artificial chordae 300 and the artificial chordae tensioning device are implanted immediately, the third elastic element 38 of the artificial chordae tensioning device is in a compressed state, and the distance between the implant base 10 and the stop element 37 is L1, at this time, the artificial chordae 300, the valve leaflet, and the artificial chordae tensioning device are always kept relatively tensioned, i.e. the elastic force F2. When the shape of the heart of the patient changes and the artificial chordae tendineae 300 are relaxed, the elastic force of the third elastic element 38 of the artificial chordae tendineae tensioning device can compensate for a part of the relaxed length of the artificial chordae tendineae 300, and the third elastic element 38 pushes the seat body 10 to spring away by a distance due to the existing elastic force, where the distance between the seat body 10 and the limiting element 37 is L2, as shown in fig. 16. The compensation length is L2-L1, and the larger the designed compensation length is, the larger the adjustment range is.
The material of each component in the artificial tendon tensioning device proposed in the present invention is preferably a metal or a polymer material meeting the biocompatibility requirement, such as stainless steel SUS316L, a cobalt-based alloy, PEEK (polyetheretherketone), and the like.
According to an embodiment of the present invention, as shown in fig. 6, 17 and 18, a manipulator 200 is further provided, the manipulator 200 is used for implanting the artificial chordae tensioning device, and the operator performs the actions of delivering, implanting, locking, releasing and the like of the artificial chordae tensioning device through the use of the manipulator 200.
The manipulator 200 includes: handle 201, sheath 202, pulling claw 203, push rod 204 and adjusting button 205.
Specifically, the proximal end of the sheath 202 is connected to the handle 201; a pulling pawl 203 is attached to the distal end of the sheath 202, the pulling pawl 203 having a hook portion that is capable of hooking to the first resilient element 22 in the artificial chordae tensioning device. The push rod 204 is slidably disposed in the sheath 202, and a distal end of the push rod 204 can abut against the support portion 121 of the seat body 10 in the artificial chordae tensioning device. The adjusting button 205 is disposed on the handle 201 and connected to the proximal end of the push rod 204, and the adjusting button 205 can push the push rod 204 to move along the length direction of the sheath 202 relative to the sheath 202.
The process of implanting the artificial chordae tensioning device is as follows:
(1) The first elastic element 22 is hooked and pulled by the pulling claw 203, the push rod 204 is pushed by the adjusting button 205, so that the sheath drives the pulling claw 203 to move towards the proximal end relative to the push rod 204, the clamping element 21 is pulled open, a channel is opened between the first clamping surface and the second clamping surface 212, and the channel width is D, wherein D is greater than or equal to the diameter of the artificial chordae tendineae 300. After opening the channel, the artificial chordae 300 are threaded through the channel.
(2) The length of the artificial chordae tendineae 300 can be freely adjusted by keeping the state of pressing the adjusting button 205, the length which needs to be implanted finally is determined, the pressing state is cancelled, the clamping piece 21 moves towards the top wall 1223 under the action of the elastic force of the first elastic piece 22, and the first clamping surface and the second clamping surface 212 are abutted to clamp and fix the artificial chordae tendineae 300 and lock the length.
(3) After the length is determined again, the adjusting button 205 is pushed, so that the pulling claw 203 is separated from the first elastic piece 22, and the artificial chordae tensioning device is released, thus completing the operation. The artificial chordae tensioning device can apply a locking force F to the artificial chordae 300 to lock and fix the artificial chordae 300 to the apex of the heart.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (16)
1. An artificial chordae tensioning device for tensioning artificial chordae implanted in the heart, the artificial chordae tensioning device comprising:
the seat body is arranged outside the heart and comprises a body part and a clamping structure arranged on the body part;
the clamping assembly comprises a clamping piece and a first elastic piece, the clamping piece is slidably arranged on the clamping structure, the first elastic piece is respectively connected with the clamping structure and the clamping piece, and the clamping piece is matched with the clamping structure under the action of elastic force of the first elastic piece so as to clamp one end of the artificial chordae tendineae extending out of the heart;
the adjusting component is arranged between the base body and the heart and can push the base body to be far away from the heart so as to tension the artificial chordae tendineae.
2. The artificial chordae tensioning device of claim 1, wherein the adjustment assembly comprises:
the sliding seat comprises a shell, a sliding channel is defined in the shell, two ends of the sliding channel form openings in the shell, and a seat body is slidably arranged in the sliding channel and can slide along the length direction of the sliding channel;
a limiting member connected to the distal end of the housing and abutting against the heart;
one end of the third elastic piece is connected with the limiting piece, and the other end of the third elastic piece is connected with the seat body;
wherein the third elastic element applies an elastic force to the seat body in a direction away from the heart.
3. The artificial chordae tensioning device of claim 2, wherein,
one of the inner wall of the sliding channel and the seat body is provided with a sliding chute, and the other of the inner wall of the sliding channel and the seat body is provided with a sliding rail in sliding fit with the sliding chute;
wherein, the spout and the slide rail extend along the length direction of slide passage.
4. The artificial chordae tensioning device of claim 2, wherein,
the shell further forms a limiting part, the limiting part is convexly arranged at the near end of the sliding channel, and the limiting part is matched with the stop of the seat body.
5. The artificial chordae tensioning device of claim 2, wherein,
one side of the body part facing the limiting part forms a limiting column;
a limiting groove is formed in one side, facing the body part, of the limiting piece, and the limiting groove is arranged corresponding to the limiting column;
the third elastic piece is a pressure spring, one end of the pressure spring is sleeved on the limiting column, and the other end of the pressure spring is inserted into the limiting groove.
6. The artificial chordae tensioning device of claim 1, wherein the adjustment assembly comprises:
the supporting plate is arranged between the clamping structure and the heart and is abutted against the heart;
one end of the second elastic piece is connected with the supporting plate, and the other end of the second elastic piece is connected with the seat body;
wherein the second elastic member applies an elastic force to the seat body in a direction away from the heart.
7. The artificial chordae tensioning device of claim 6, wherein the seat further comprises:
the sliding matching part is arranged on one side of the body part facing the heart;
the support plate is slidably disposed on the sliding fit portion.
8. The artificial chordae tensioning device of claim 7, wherein,
the sliding fit part is annular, and the side wall of the supporting plate can be slidably abutted against the inner wall of the sliding fit part.
9. The artificial chordae tensioning device of claim 1, wherein the adjustment assembly comprises:
the balloon is fixedly connected with the seat body and is positioned between the seat body and the heart;
the far end of the guide tube is communicated with the saccule, and the near end of the guide tube is arranged outside the human body;
and the connecting valve is arranged at the near end of the flow guide pipe.
10. The artificial chordae tensioning device of claim 9, wherein,
the balloon is formed with a tendon channel that runs through the balloon and through which the artificial tendon runs.
11. The artificial chordae tensioning device of any one of claims 1-10, wherein,
the clamping structure includes:
the supporting part is connected with the body part, and a supporting plane is formed on one side of the supporting part, which is far away from the body part;
the clamping part is arranged on the supporting plane, and a clamping space is defined between the clamping part and the supporting plane;
the connecting part is arranged on the body part, and the connecting part and the clamping space are arranged at intervals;
the clamping piece is slidably arranged in the clamping space;
the first elastic piece is respectively connected with the connecting part and the clamping piece, and applies elastic force towards the clamping part to the clamping piece.
12. The artificial chordae tensioning device of claim 11, wherein,
the clamping portion includes:
a first side wall connected to the support part;
a second side wall connected to the supporting part and disposed in parallel to and spaced apart from the first side wall;
the top wall is respectively connected with the first side wall and the second side wall, the top wall, the first side wall, the second side wall and the supporting plane jointly define the clamping space, and a first clamping surface is formed on one side, facing the clamping space, of the top wall;
the clamping piece comprises a sliding plane in sliding fit with the supporting plane and a second clamping surface matched with the first clamping surface, and the second clamping surface is abutted to the first clamping surface under the action of elastic force of the first elastic piece.
13. The artificial chordae tensioning device of claim 12, wherein,
the first clamping surface and/or the second clamping surface are configured as rough surfaces.
14. The artificial chordae tensioning device of claim 12, wherein,
the near end of the clamping part is provided with a first wire passing hole, the far end of the clamping part is provided with a second wire passing hole, and the first wire passing hole and the second wire passing hole are communicated with the clamping space.
15. The artificial chordae tensioning device of claim 12, wherein,
the first side wall and the second side wall are both provided with long holes communicated with the clamping space;
the clamping piece is provided with a through connecting hole;
the number of the connecting parts is two, one of the two connecting parts is positioned on one side of the first side wall, and the other connecting part is positioned on one side of the second side wall;
the first elastic piece penetrates through the long hole and the connecting hole, and two ends of the first elastic piece are connected with the two connecting parts respectively.
16. An operator for implanting the artificial chordae tensioning device as claimed in any one of claims 1-15, the operator comprising:
a handle;
the proximal end of the sheath is connected with the handle;
the tension claw is connected with the distal end of the sheath tube and is provided with a hook part which can be hooked to a first elastic piece in the artificial chordae tendineae tensioning device;
the push rod is slidably arranged in the sheath, and the distal end of the push rod can be abutted against a seat body in the artificial chordae tendineae tensioning device;
the adjusting button is arranged on the handle and connected with the near end of the push rod, and the adjusting button can push the push rod to move relative to the sheath along the length direction of the sheath.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202211229328.1A CN115708732B (en) | 2022-10-08 | 2022-10-08 | Artificial tendon tensioning device and manipulator |
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| CN202211229328.1A CN115708732B (en) | 2022-10-08 | 2022-10-08 | Artificial tendon tensioning device and manipulator |
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| CN115708732B CN115708732B (en) | 2023-07-25 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2024074089A1 (en) * | 2022-10-08 | 2024-04-11 | 瀚芯医疗科技(深圳)有限公司 | Artificial chordae tendineae clamping device and operator |
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