Valve clamp capable of adjusting clamping positionTechnical Field
The present invention relates to a valve clamp, and more particularly to a valve clamp for treating regurgitation of a heart valve.
Background
The mitral valve is a two-piece valve attached to the periphery of the left atrioventricular orifice (as shown in fig. 1), and chordally attached to the papillary muscles, has the effect of preventing blood from flowing back into the left atrium.
Mitral Regurgitation (MR) is a series of pathophysiological changes caused by poor anterior and posterior She Wenge of the mitral valve due to organic or functional changes in the mitral valve leaflets and their associated structures, and the regurgitation of blood flow from the left ventricle to the left atrium. Severe MR causes left ventricular enlargement, eventually leading to left heart contractile failure dysfunction and heart failure, while left atrial pressure also increases due to regurgitation, easily leading to left atrial enlargement, atrial fibrillation, and pulmonary hypertension. MR prognosis is poor, the annual mortality rate of symptomatic and non-operating persons is around 5%, and the 5-year mortality rate of severe heart failure patients reaches 60%. Meanwhile, MR is also one of the most common heart diseases. The incidence of people over the ages of 65 and 75 was counted as 6.4% and 9.3%, respectively. With the development of the economic society and the aging of the population, the incidence of mitral regurgitation is in a markedly rising state.
Clinical trials have shown that drug treatment can only improve patient symptoms, but cannot prolong patient survival or surgical opportunities. Surgical valve repair or replacement is considered a standard treatment for this disease and has been demonstrated to alleviate symptoms and extend the life of patients. However, surgery has the disadvantages of large trauma, obvious postoperative pain, slow recovery, high risk, and the like, and in addition, some patients who are old, have history of chest opening, have poor cardiac function, and incorporate multiple organ insufficiency are often rejected from the surgery because of the large risk of the surgery. Therefore, there is a great social and market need to develop minimally invasive, low risk, interventional therapeutic devices for the treatment of MR. In recent years, with the breakthrough development of valve interventional therapy technology, an MR interventional instrument has become one of the important directions for developing domestic and foreign cardiovascular instruments.
Among them, the valve clamping mechanism developed according to the surgical valve edge-to-edge suturing technology principle is most affirmed at present because of high safety, simple technology principle and high feasibility. The surgical valve edge-to-edge sewing technique principle is shown in fig. 2: when the mitral valve is in regurgitation, the edges of two valve leaflets cannot be closed in a closing way in the systole, so that gaps exist, and blood flow of the left ventricle returns to the left atrium from the gaps; surgical edge-to-edge suturing sutures the middle points of the edges of the two leaflets of the mitral valve such that the inter-leaflet space changes from one large orifice to two small orifices during systole, thereby reducing mitral regurgitation (fig. 2 a), while the flow into the left ventricle is unaffected when the mitral valve is open during diastole (fig. 2 b). The only minimally invasive interventional instrument commercially available from International for therapeutic MR is MITRACLIP from Evalve, which is a valve clamping device. However, the device comprises a complex control system, and the manufacturing and production costs are high; the device needs to pass through vein, right atrium, interatrial septum and left atrium to finally reach left ventricle during operation, and the access way is long and is bent at a plurality of places, so that the operation is very complicated, doctors need to repeatedly fine-adjust the bending degree, the direction, the horizontal position and the vertical depth of the conveying system, and the doctors can clamp the valve after reaching the ideal position, so that the doctors often take a long time to complete an operation, and the defect is serious.
Patent CN106175986a, which is exclusively developed by the institute of advanced university, affiliated to the middle mountain hospital and is exclusively owned by the medical science and technology limited company, discloses a valve clamp device which adopts upper and lower clamps to clamp two sides of a valve respectively, but because of extremely high precision degree of operation, one clamp can not be ensured to clamp the valve at an ideal clamping position in the actual operation process, and a plurality of adjustments are needed. In the clamp device disclosed in the patent, the upper clamp and the lower clamp adopt square insertion holes, and when in actual use and in processing, the insert rods of the upper clamp and the lower clamp can not smoothly pass through the insertion holes and the upper clamp arms and the lower clamp arms are misplaced due to the transposition of connecting threads, so that the operation is influenced; in addition, the insert rod section of the second clamping component is made of nickel-titanium alloy, and in actual machining, it is found that a threaded hole is difficult to be machined in the insert rod to realize threaded connection with the connecting piece at the far end.
Accordingly, those skilled in the art have focused on developing a valve clamp with an adjustable clamping position that can be tried multiple times during the procedure to ultimately secure the valve in the desired clamping position.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, an object of the present invention is to provide a valve clip with a function of adjusting the clipping position.
The valve clamp comprises a first clamping component, a second clamping component and a connecting part, wherein the first clamping component is provided with at least two first clamping arms, the second clamping component is provided with a corresponding number of second clamping arms, each first clamping arm and the corresponding second clamping arms can be combined into a group of clamps, the connecting part is provided with a first end and a second end, the first end is suitable for being connected with the first clamping component, the second clamping component and the second end are respectively provided with a inserted rod section and a jack which are suitable for being mutually connected in an inserting way, the inserted rod section and the jack are provided with sections with non-equidistant edge distances from the center of mass, and the length of the inserted rod section is 15-45mm.
Preferably, the cross section is square, regular triangle, rectangle, ellipse, diamond, racetrack or irregular pattern; more preferably racetrack-shaped or oval.
Further, the connecting portion comprises an adapter sleeve and an extension piece, one end of the adapter sleeve is the first end of the connecting portion, and the other end of the adapter sleeve is suitable for being detachably connected with the extension piece.
Still further, the extension member and at least a portion of the adapter sleeve are both included within the rod segment.
Preferably, the distal end of the adapter sleeve and the first clamping member are physically or welded together.
Preferably, the proximal end of the adapter sleeve is threadably connected to the elongate member, and when the threaded connection is tightened, the adapter sleeve is aligned with each plane of the elongate member.
Still further, the first clamping component and the second clamping component are made of nickel-titanium alloy, and the adapter sleeve is made of one or more of stainless steel, aluminum, copper, titanium, aluminum alloy, magnesium alloy, titanium alloy, cobalt-chromium alloy and tetrafluoroethylene or a combination thereof.
The invention also provides a valve clamp system comprising a valve clamp and a pushing device, wherein the valve clamp comprises a first clamping component, a second clamping component, a connecting part and a closed ring, the first clamping component is provided with at least two first clamping arms, the second clamping component is provided with a corresponding number of second clamping arms, each first clamping arm and the corresponding second clamping arm can be combined into a group of clamps, the connecting part is provided with a first end and a second end, the first end is suitable for being connected with the first clamping component, the second clamping component and the second end are respectively provided with a inserted rod section and a jack which are suitable for being mutually connected in an inserting way, the inserted rod section and the jack are provided with sections with non-equidistant edges from the mass center, the length of the inserted rod section is 15-45mm, the distal end of the closed ring and the proximal end of the second clamping component are respectively provided with internal threads and external threads which are mutually matched, the second clamping arm is provided with a through hole which is matched with the fixed teeth, and the pushing device is provided with a through hole which can be connected with the fixed teeth.
Preferably, the cross section is square, regular triangle, rectangle, ellipse, diamond, racetrack or irregular pattern; more preferably racetrack-shaped or oval.
Further, the connecting portion comprises an adapter sleeve and an extension piece, one end of the adapter sleeve is the first end of the connecting portion, and the other end of the adapter sleeve is suitable for being detachably connected with the extension piece.
Still further, the extension member and at least a portion of the adapter sleeve are both included within the rod segment.
Preferably, the distal end of the adapter sleeve and the first clamping member are physically or welded together.
Preferably, the proximal end of the adapter sleeve is threadably connected to the elongate member, and when the threaded connection is tightened, the adapter sleeve is aligned with each plane of the elongate member.
Still further, the first clamping component and the second clamping component are made of nickel-titanium alloy, and the adapter sleeve is made of one or more of stainless steel, aluminum, copper, titanium, aluminum alloy, magnesium alloy, titanium alloy, cobalt-chromium alloy and tetrafluoroethylene or a combination thereof.
In the expression of the invention that the inserted bar section and the jack have the cross section with the edge not equidistant from the centroid, the centroids of the inserted bar section and the jack refer to centroids when the mass of the cross section is uniformly distributed, and for the regular graph, the geometric centers of the regular graph, such as the center of a circle, the intersection point of the diagonal lines of a diamond, and the like.
In the present invention, the terms "proximal" and "distal" refer to the relative positions of the valve and the operator during the valve operation. Wherein the proximal end refers to an end proximal to the operator and the distal end refers to an end distal from the operator.
Technical effects
1. The valve clamp provided by the invention adopts the connecting part with a certain length to connect the upper clamp and the lower clamp, and the lower clamp can slide on the connecting part, so that an operator can freely adjust the clamping positions of the upper clamp and the lower clamp before fixing the upper clamp and the lower clamp in the use process, and the problem that the traditional clamp cannot be repaired once the clamping error is caused by unadjustable operation is avoided.
2. The inserted link section adopts non-circular cross section with the jack for the relative angle when inserted link section inserts the jack is fixed, and then utilizes this fixed angle to press from both sides about with on the coplanar, has prevented the inseparable problem of clamp because upper and lower clamp dislocation causes.
3. When the runway-shaped or oval-shaped cross section design is adopted, even if slight dislocation is generated between the upper clamp and the connecting part in the fixing process, the running-to-shape design can be automatically corrected, so that the smooth use of the clamp is ensured.
4. The number of the clamping arms is matched with the cross section, so that the positions of the upper clamp and the lower clamp are mutually corresponding once the inserted rod section of the connecting part can be inserted into the jack in the using process of the clamp.
5. By means of the precisely arranged threaded connection, when threads between the adapter sleeve and the extension piece are screwed up, the extension piece and the adapter sleeve can be aligned exactly, the tight installation of the device is guaranteed, and meanwhile the sliding smoothness of the second clamping component at the connecting portion is improved.
6. The clamping component is fixed by the closed ring, and the internal thread on the ring can be used for fixing the lower clamp and tightening the upper clamp and the lower clamp.
7. The adapter sleeve can improve the processing feasibility of the inserted link. Since the clamp is typically made of nitinol, the metal is hard and brittle, and it is difficult to make fine threaded holes in it. The adapter sleeve can be made of stainless steel or other relatively soft materials, and can be provided with a tiny threaded hole, so that the adapter sleeve can be in threaded connection with the extension piece.
The conception, specific structure, and technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, features, and effects of the present invention.
Drawings
FIG. 1 is a schematic representation of the anatomy of a heart; in the figure, 1 is an upper vena cava, 2 is a lower vena cava, 3 is a right atrium, 4 is a tricuspid valve, 5 is a right ventricle, 6 is a pulmonary valve, 7 is a pulmonary artery, 8 is a pulmonary vein, 9 is a left atrium, 10 is a mitral valve, 11 is a left ventricle, 12 is an aortic valve, 13 is an aorta, 14 is a descending aorta, 15 is an oxygenated blood flow direction, and 16 is an anoxic blood flow direction;
FIG. 2 is a schematic diagram of a surgical mitral valve edge-to-edge suturing technique, wherein 2a is mitral valve closure and 2b is mitral valve patency;
FIG. 3 is a schematic view of the upper clip of the valve clip provided in a preferred embodiment of the present invention;
FIG. 4 is a schematic view of the lower clip of the valve clip of the embodiment of FIG. 3;
FIG. 5 is a schematic view of the aperture structure of the lower clip of the embodiment of FIG. 3, and an alternative to the other preferred embodiments;
FIG. 6 is a schematic view of the structure of the connecting portion and its connection manner with the upper clip in the embodiment of FIG. 3;
FIG. 7 is a schematic view of the embodiment of FIG. 3 using a pushing device to transport the binder;
fig. 8 is a schematic view of a closed loop in accordance with other preferred embodiments of the present invention.
Reference numerals:
30-first clamping part, 301-first clamping arm, 302-first clamping tooth, 303-adapter;
40-second clamping part, 401-second clamping arm, 403-second clamping tooth, 403-external thread, 404-receptacle;
50-connecting parts, 501-adapter sleeves; 502-an extension; 60-pushing device;
70-closed ring, 701-internal threads, 702-push interface;
Detailed Description
Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative and intended to explain the present invention and should not be construed as limiting the invention.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, as well as the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is less level than the second feature.
The present embodiment provides a middle upper and lower clip structure valve clip and a valve surgical clip system comprising the same, wherein the valve clip comprises an upper clip, a lower clip and a connecting part 50. Wherein the upper clip, i.e., the first clip part 30, adopts the structure shown in fig. 3; the lower clip, i.e., the second clip part 40, adopts the structure shown in fig. 4; the structure of the connecting part and the connecting mode are shown in fig. 6, and the structure and the using method of the pushing device in the clamping system with the valve clamp are shown in fig. 7.
From fig. 3 and 4, the first clamping member 30 and the second clamping member 40 have mutually matched clamping arm structures, the clamping arms of the first clamping member 30 are called as first clamping arms 301, the clamping arms of the second clamping member 40 are called as second clamping arms 401, the clamping arms on the two members are the same in number and opposite in position, the clamping teeth on the first clamping arms 301 are corresponding in arrangement positions of clamping teeth, and the clamping teeth on the second clamping arms 401 are second clamping teeth 402. When the valve is captured between the clips, the clips are brought closer together by an external force, which gradually squeezes the valve therebetween and secures it by the clip teeth.
The bottom of the first clamping member 30 is further provided with an adapter 303 for detachable fixed connection with the adapter sleeve 501.
The bottom of the second clamping member 40 is further provided with a slider for sliding fit with the connecting portion, and the slider is provided with a through hole, i.e. an insertion hole 404, along the axial direction of the second clamping member 40. In this embodiment, the receptacle 404 has a racetrack cross-section, the cross-sectional shape of which is shown in FIG. 5 a. Correspondingly, as shown in fig. 6, the connecting portion 50 is provided with a rod segment with the same cross-sectional shape, and the length L of the rod segment is 45mm, and the rod segment comprises an upper adapter sleeve 501 and a lower extension piece 502, that is, the adapter sleeve 501 and the extension piece 502 are all rod-shaped members with the same outline shape as the jack 402.
This design allows the second clamping member 40 to slide up and down anywhere over almost the entire length of the connecting portion 50, and allows the upper and lower clamps to be separated at any time by a distance of about 45mm to release the valve re-clamp when there is a problem of a deviation in the clamping position or failure in the surgical procedure. Meanwhile, due to the non-circular design of the outline, the second clamping component 40 and the connecting part 50 cannot slide relatively, when the installation angle of the first clamping component 30 and the connecting part 50 is preset, the first clamping component 30 and the second clamping component 40 can always keep the state that the clamping arms are mutually corresponding and have no dislocation in the conveying and clamping processes, and the reduction of the clamping compactness due to the dislocation of the clamping arms is prevented, so that the operation effect is affected.
In addition, since the racetrack-shaped cross section is used, when the insert bar section is inserted into the insertion hole 404 at a certain angle, the insert bar section is pulled out and rotated 180 degrees around the axis and also inserted into the insertion hole 404, and at this time, the second pinching arm 401 is also rotated 180 degrees around the axis. Since the two sets of the first clamping arms 301 and the second clamping arms 401 are arranged along a straight line in the bottom view direction, that is, the clamping arms are still unchanged in orientation after rotating 180 degrees, the two methods can ensure that the clamping positions of the first clamping arms 301 and the second clamping arms 401 correspond to each other, so that the positions of the upper and lower clamps correspond to each other as long as the inserting rod section of the connecting portion 50 can be inserted into the inserting hole 404.
The purpose of designing the adapter sleeve is to improve the processing feasibility of the inserted link. Since the entire clamp member is made of nickel-titanium alloy, the metal is hard and brittle, and it is difficult to make a fine screw hole thereon. The adapter sleeve is made of stainless steel or other relatively soft materials, and can be provided with a tiny threaded hole, so that threaded connection between the adapter sleeve and the extension piece is realized.
Experiments show that in the use process, a certain dislocation phenomenon may exist between the adapter sleeve 501 and the extension piece 502, if square, rectangular or diamond-shaped jacks 404 are adopted, once slight dislocation occurs, the adapter sleeve 501 cannot pass through the lower clamping jacks 404. The cross section of the racetrack hole or the oval hole allows a certain fault tolerance rate when the connector is fixed, and the adapter sleeve 501 can automatically adjust the stress in the process of pulling down by force and enter the jack 404 on the second clamping component 40.
In other preferred embodiments of the present invention, the receptacles 404 may be shaped as shown in FIGS. 5b-5f, and may be configured as ovals, diamonds, irregular patterns, rectangles, squares, etc.
As shown in fig. 6, in the valve clamp provided in this embodiment, the adapter sleeve 501 and the extension piece 502 are connected by threads, and when the threaded connection is screwed, the planes of the adapter sleeve and the extension piece are aligned, and this design ensures the tight installation of the adapter sleeve 501 and the extension piece 502, and at the same time, the second clamping component 40 can freely pass through the connection between the two, so as to improve the smoothness of the sliding of the second clamping component at the connection part.
As shown in fig. 7, when the valve clamp provided in this embodiment is used, the valve clamp needs to be pushed to a valve by using an additional pushing device 60, and the pushing device 60 is thicker than the hole size of the second clamping member 40, so as to ensure that the second clamping member 40 does not slide along the pushing device 60 continuously during the conveying process. The pushing device 60 and the connecting portion 50 are limited in relative rotation, so that when the upper and lower clips complete the clamping step, the pushing device 60 can be controlled to unscrew the connecting portion 50 and take the same out of the body.
In another preferred embodiment of the present invention, the upper and lower clamps may be fixed by a closed loop 70 as shown in fig. 8, in which the outer side of the second clamping arm 401 of the second clamping member 40 is provided with a fixed tooth, the bottom of which is provided with an external thread 403 matching with the internal thread 701 of the top of the closed loop, and the bottom of the closed loop is further provided with a push interface 702 for connection with the push device 60. The internal thread 701 on the closed ring 70 may be rotationally fixed with the external thread 403, and continued rotation may enable the external thread 403 to pass through the internal thread 701 and into the closed ring 70, which may further slide relatively along the inner wall of the closed ring 70. When slid until the internal thread 701 coincides with the fixation teeth of the second clamping member 40, the first clamping member 30 and the second clamping member 40 will be fixed by the tightening force of the closure ring, while the second clamping member 40 and the closure ring 70 will be fixed by the cooperation of the fixation teeth with the internal thread 701, finally completing the fixation of the valve clamp.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.