Valvuloplasty assisting device
By designing valve forming auxiliary devices, the visual differences and difficulty of valve forming surgery in the prior art are solved, and a higher success rate and lower complication risk are achieved, simplifying the surgical process and reducing costs.
Patent Information
- Application Number
- CN202210597326.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-05-30
- Publication Date
- 2024-12-13
- Estimated Expiration
- 2042-05-30
AI Technical Summary
The prior art has visual differences and difficulty in operation in valve shaping surgery, resulting in poor molding effect, long surgery time, many complications, and difficulty in improving the success rate.
A valve forming auxiliary device is designed, including anterior and posterior valve forming auxiliary device. By measuring the annulus diameter, leaflet height and chondrome length, it guides the selection of the shaping ring model, leaflet folding or resection range, and chondrome indexing location, improve the accuracy and efficiency of the surgery.
It improves the success rate of valvular shaping surgery, shortens the operation time, reduces complications, and has simple structure, convenient operation, low cost, and has good clinical application prospects.
Smart Images
Figure CN114948344B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and more particularly to a valvuloplasty auxiliary device. Background Art
[0002] Valvular heart disease is the most common heart disease, accounting for half of all heart diseases. According to FrostSullivan data, in 2018, approximately 209 million patients worldwide suffered from valvular heart disease, causing approximately 2.6 million deaths each year. The incidence of mitral valve disease is higher. In 2018, the number of patients with mitral regurgitation in the world and China was 95.1 million and 10.3 million, respectively. With the development of valve reconstruction surgery, mitral valvuloplasty has gradually replaced replacement surgery as the main surgical method for treating mitral valve disease. Compared with mitral valve replacement surgery, mitral valvuloplasty has more significant therapeutic advantages. It can restore the function of the valve itself by correcting the valve ring, valve leaflets or subvalvular structure. No lifelong anticoagulation is required after surgery, reducing the occurrence of thromboembolism and endocarditis, especially helping to maintain left ventricular function and improve long-term survival of patients. According to a large number of clinical studies, valvuloplasty is superior to mechanical and biological valve replacement in terms of freedom from valve-related death, surgery-related complications, embolism and reoperation. Data show that currently about 90% of patients with mitral regurgitation in the United States are treated satisfactorily through the implantation of annuloplasty rings, and its long-term efficacy is significantly better than valve replacement. Among patients with senile valvular degenerative disease and tricuspid regurgitation, 80-90% of them can be repaired through annuloplasty without valve replacement. However, the proportion of annuloplasty in the entire valve surgical treatment in China is very low, and most patients who could have been treated with annuloplasty have undergone artificial valve replacement.
[0003] Valve reconstruction surgery is mainly based on three basic principles: retaining or restoring the full range of motion of the valve leaflets, forming a larger valve leaflet coaptation surface, and reshaping and stabilizing the entire valve ring. With the development of shaping concepts, surgical techniques, and artificial materials, a variety of shaping techniques have emerged, including chord transfer, leaflet folding or resection, sliding techniques, edge-to-edge techniques, shaping rings, and artificial chords. Cases of valvuloplasty at home and abroad are mostly concentrated in Carpenter I type leaflet activity (dilatation of the mitral and tricuspid valve annulus, leaflet perforation or tearing, vegetation, etc.) and type II leaflet prolapse, leaflet hyperactivity (rupture of mitral and tricuspid chords, chord extension, papillary muscle rupture, papillary muscle extension, etc.). Among them, valvuloplasty ring implantation is the most important part of mitral valve repair surgery. Implantation of artificial chords without resection of the prolapsed leaflets is used to repair mitral regurgitation caused by ruptured or redundant mitral chords. It has become the mainstream surgical method for mitral valve disease repair, with obvious advantages. Due to the different pathological and physiological changes of various valvular diseases, such as the causes, lesions, and dysfunctions, the surgeon's recognition and judgment of the lesions and the choice and proficiency of reconstruction techniques directly affect the effect of valvuloplasty. This leads to poor valvuloplasty results, long extracorporeal circulation time and operation time, multiple transfers or valve replacement during surgery, and aggravated valve regurgitation after surgery requiring another surgery. Clinically, there is an urgent need for an auxiliary device that can improve the success rate of valvuloplasty.
[0004] Moreover, many valve reconstruction techniques have been reported clinically, but it is difficult to achieve good reshaping results with a single reconstruction technique. Since the anatomical structure of the valve is not fully exposed in open or minimally invasive surgery, the surgeon cannot fully observe the three-dimensional anatomical structure of the valve. There are different degrees of visual differences or subjective judgments during the operation, as well as the difficulty of operating various reshaping techniques, making it difficult to achieve satisfactory reshaping results for the same type of valvular lesions. Summary of the invention
[0005] Based on this, the purpose of the present invention is to provide a valvuloplasty auxiliary device that can improve the success rate of valvuloplasty surgery, significantly shorten the operation time, and reduce surgical complications, thereby improving the patient's quality of life and improving the patient's long-term prognosis.
[0006] The technical solution of the present invention is: a valve shaping auxiliary device, which includes an anterior valve shaping auxiliary device and a posterior valve shaping auxiliary device; it is designed as an anterior valve shaping auxiliary device and a posterior valve shaping auxiliary device according to the different physiological morphologies of the anterior valve and the posterior valve of the mitral valve, respectively.
[0007] The anterior flap shaping auxiliary instrument comprises an anterior flap shaping device body and an anterior flap handle connected to the anterior flap shaping device body; the anterior flap shaping device body comprises an anterior flap body part, an anterior flap front part and an anterior flap rear part respectively arranged on both sides of the anterior flap body part; the anterior flap handle is connected to the anterior flap body part;
[0008] The posterior flap shaping auxiliary instrument includes a posterior flap shaping device body and a posterior flap handle. The posterior flap shaping device body includes a posterior flap front part, a posterior flap rear part, and a posterior flap main body. The posterior flap front part and the posterior flap rear part are respectively arranged on both sides of the posterior flap main body, and the posterior flap handle is connected to the posterior flap main body.
[0009] In the present invention, a valvuloplasty auxiliary device is provided, which can more accurately measure the valve ring diameter, leaflet height and apposition height, the range of leaflet prolapse, and the length of chordae tendineae, and is also capable of guiding the selection of shaping ring models, the shortening or widening range of leaflet height, the range of leaflet folding or resection, the position of chordae transposition or artificial chordae implantation, and other shaping technologies, thereby improving the success rate of valvuloplasty surgery, shortening the operation time, and reducing surgical complications. The valvuloplasty auxiliary device of the present invention has a simple structure, is easy to operate, has a low production cost, is easy to promote technology, and has good clinical application prospects.
[0010] Further preferably, the anterior valve former body as a whole presents the morphological structure of the anatomical anterior leaflet of the mitral valve, the anterior valve main body is fusiform, the center is an arched structure, the midline of the anterior valve main body is the longest, and the width gradually decreases towards both sides; it can anatomically fit the anterior valve leaflet body tissue, measure the height A of the anterior valve leaflet, and the length from the midline of the anterior valve main body to the apposition line H is basically consistent with the normal physiological anterior valve leaflet height, and can be designed to be 14, 16, 18, 20 mm and other lengths, and the design meets the normal anatomical mitral valve anterior leaflet height requirements.
[0011] Further preferably, the anterior flap main body is connected to the anterior flap front part through the coaptation line H, the anterior flap front part outside the coaptation line H is a continuous downward oblique structure, and the anterior flap front part and the anterior flap main body form a certain angle; the width of the anterior flap front part is the longest at the midline, and the width gradually decreases toward both sides. It is conducive to anatomically fitting the leaflet coaptation edge, the midline coaptation height can be designed to be 4-8mm, and the height of the anterior leaflet coaptation edge is measured.
[0012] Further preferably, the front part of the front flap is provided with a measuring scale D, and the front edge of the front part of the front flap is provided with equally divided wire clamping grooves E, and the wire clamping grooves E are consistent with the corresponding measuring scale D. Corresponding to the anatomical contour, the anatomical reference marks help to ensure the placement and alignment of the artificial chordae, facilitate the measurement of the range of leaflet prolapse, and guide the range of leaflet resection and leaflet folding.
[0013] Further preferably, the rear portion of the anterior valve is saddle-shaped, consistent with the anatomical course of the mitral valve ring, and the highest point of the saddle is located at the midline.
[0014] Further preferably, the rear part of the front lobe is provided with several flanges C or continuous flanges. Several flanges C or continuous flanges can be designed at the rear part of the front lobe. When viewed from the side, the flange is located at the upper part and is continuous with the main part of the front lobe, which is conducive to fixation on the valve ring or the forming ring. The flange can preferably have holes and can be sutured on the valve ring or the forming ring to prevent displacement.
[0015] Optionally, the rear part of the front flap is provided with a continuous upward oblique structure F. The rear part of the front flap can also be designed as a continuous upward oblique structure F, which is at a certain angle to the main part of the front flap, so as to facilitate exposure of the anterior leaflet tissue of the mitral valve. The G of the main part of the front flap is the connection point of the front flap handle.
[0016] Optionally, a front flap hollow part is further provided in the front flap main body. The front flap shaping device body is preferably made of transparent material or the front flap main body is hollowed out, and a transparent shaping device is convenient for the operator to observe the valve anatomical structure.
[0017] Furthermore, the main body of the posterior leaflet former is in the morphological structure of the anatomical posterior leaflet of the mitral valve, the main body of the posterior leaflet is in a crescent-shaped structure, the midline of the main body of the posterior leaflet is the longest, and the width gradually decreases towards both sides. The posterior leaflet body tissue can be anatomically fitted, and the height A of the posterior leaflet can be measured. The length from the midline of the main body of the posterior leaflet to the apposition line H is basically consistent with the height of the normal physiological anterior leaflet, and can be designed to be 4, 6, 8, 10 mm, etc., which meets the height requirements of the posterior leaflet of the normal anatomical mitral valve.
[0018] The front part of the posterior leaflet outside the coaptation line H is continuously inclined downward, forming a certain angle with the main part of the posterior leaflet. The width of the front part of the posterior leaflet is longest at the midline, and the width gradually decreases on both sides, which is conducive to anatomical fitting of the leaflet coaptation edge. The midline coaptation height is designed to be 4-8mm, and the height of the posterior leaflet coaptation edge is measured.
[0019] Further preferably, the front part of the posterior leaflet is provided with a measuring scale D, and the front edge of the front part of the posterior leaflet is provided with equally divided wire clamping grooves E, and the wire clamping grooves E are consistent with the corresponding measuring scale D. Corresponding to the anatomical contour, the anatomical reference marks help to ensure the placement and alignment of the artificial chordae tendineae, facilitate the measurement of the range of leaflet prolapse, and guide the range of leaflet resection and leaflet folding.
[0020] The rear part of the posterior leaflet is arc-shaped, consistent with the anatomical course of the posterior leaflet ring of the mitral valve, and the rear part of the posterior leaflet is provided with several flanges C or continuous flanges; viewed from the side, the flanges are located at the upper part and are continuous with the main part of the posterior leaflet, which is conducive to fixation on the leaflet ring or the shaping ring. The flanges may preferably have holes and can be sutured on the leaflet ring or the shaping ring to prevent displacement.
[0021] Optionally, the rear part of the posterior leaflet is provided with a continuous upward oblique structure, which can be designed as a continuous upward oblique structure, which is at a certain angle to the main part of the posterior leaflet, so as to facilitate exposure of the posterior leaflet tissue of the mitral valve. The G of the main part of the posterior leaflet is the connection point of the posterior leaflet handle.
[0022] The size of the shaper is consistent with the sizes of various specifications of valve ring measuring devices currently used in clinical practice. The shaper is preferably made of transparent material or has a hollow body, and a transparent shaper is convenient for the operator to observe the valve anatomical structure.
[0023] Compared with the prior art, the beneficial effects are as follows: the present invention provides a valvuloplasty auxiliary device, which can more accurately measure the valve ring diameter, leaflet height and coaptation height, the range of leaflet prolapse, the length of chordae tendineae, etc., and at the same time guide the selection of shaping ring models, the shortening or widening range of leaflet height, the range of leaflet folding or resection, the position of chordae tendineae transposition or artificial chordae tendineae implantation, etc., thereby improving the success rate of valvuloplasty surgery, shortening the operation time, and reducing surgical complications. Moreover, the valvuloplasty auxiliary device of the present invention has a simple structure, convenient operation, low production cost, and easy technology promotion, and has a good clinical application prospect.
[0024] For better understanding and implementation, the present invention is described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Figure 1 It is a schematic diagram of the overall structure of the anterior valve shaping auxiliary device in Example 1.
[0026] Figure 2 It is a schematic diagram of the side structure of the anterior valve shaping auxiliary device in Example 1.
[0027] Figure 3 It is a schematic diagram of the use status of the anterior valve shaping auxiliary device of Example 1.
[0028] Figure 4 It is a schematic diagram of the overall structure of the anterior valve shaping auxiliary device in Example 2.
[0029] Figure 5 It is a schematic diagram of the side view structure of the anterior valve shaping auxiliary device in Example 2.
[0030] Figure 6 This is a schematic diagram of the use status of the anterior valve shaping auxiliary device in Example 2.
[0031] Figure 7 This is a schematic diagram of the use status of the anterior valve shaping auxiliary device in Example 3.
[0032] Figure 8 It is a schematic diagram of the overall structure of the posterior flap shaping auxiliary device in Example 4.
[0033] Fig. 9 It is a schematic diagram of the side view structure of the posterior flap shaping auxiliary device in Example 4.
[0034] Fig.10 It is a schematic diagram of the use status of the posterior flap shaping auxiliary device of Example 4.
[0035] Fig.11 This is a schematic diagram of a fan-shaped anterior valve shaping auxiliary device in Example 5.
[0036] Fig.12 It is a schematic diagram of a fan-shaped auxiliary device for posterior flap shaping in Example 6.
[0037] Fig.13 Schematic diagram of the handle of the former of Example 7. DETAILED DESCRIPTION
[0038] The directional terms such as up, down, left, right, front, back, front, back, top, bottom, etc. mentioned or may be mentioned in this specification are defined relative to their structure and are relative concepts. Therefore, they may change accordingly according to their different locations and different usage conditions. Therefore, these or other directional terms should not be interpreted as restrictive terms.
[0039] The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present disclosure. Instead, they are merely examples of embodiments consistent with some aspects of the present disclosure.
[0040] The terms used in this disclosure are only for the purpose of describing specific embodiments and are not intended to limit the disclosure. The singular forms of "a", "the" and "the" used in this disclosure are also intended to include plural forms, unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.
[0041] like Figure 1-10 As shown, a valvuloplasty assisting device, which includes a front valvuloplasty assisting device and a back valvuloplasty assisting device;
[0042] The anterior flap shaping auxiliary instrument comprises an anterior flap shaping device body 10 and an anterior flap handle 20 connected to the anterior flap shaping device body 10; the anterior flap shaping device body 10 comprises an anterior flap body portion 11, an anterior flap front portion 12 and an anterior flap rear portion 13 respectively arranged on both sides of the anterior flap body portion 11; the anterior flap handle 20 is connected to the anterior flap body portion 11;
[0043] The posterior flap shaping auxiliary instrument includes a posterior flap shaping device body 100 and a posterior flap handle 200. The posterior flap shaping device body 100 includes a posterior flap front part 101, a posterior flap rear part 102, and a posterior flap main body part 103. The posterior flap front part 101 and the posterior flap rear part 102 are respectively arranged on both sides of the posterior flap main body part 103, and the posterior flap handle 200 is connected to the posterior flap main body part 103.
[0044] Specifically, the anterior leaflet former body 10 is in the shape of the anterior leaflet of the mitral valve anatomy as a whole, the anterior leaflet body 11 is fusiform, and the center is preferably in an arched structure, the midline of the anterior leaflet body 11 is the longest, and the width gradually decreases towards both sides. The anterior leaflet body tissue can be dissected and fitted, and the height A of the anterior leaflet can be measured. The length from the midline of the anterior leaflet body 11 to the apposition line H is basically consistent with the normal physiological anterior leaflet height, and can be preferably designed to be 14, 16, 18, 20 mm, etc., and the design meets the normal anatomical mitral valve anterior leaflet height requirements.
[0045] Specifically, the anterior flap main body 11 is connected to the anterior flap front part 12 through the coaptation line H, and the anterior flap front part 12 outside the coaptation line H is a continuous downward oblique structure, the height of the continuous downward oblique structure is B, and the anterior flap front part 12 and the anterior flap main body 11 form a certain angle; the width of the anterior flap front part 12 is the longest at the midline, and the width gradually decreases toward both sides. It is conducive to anatomically fitting the leaflet coaptation edge, and the midline coaptation height is preferably designed to be 4-8mm, and the height of the anterior flap leaflet coaptation edge is measured.
[0046] Specifically, the front part 12 of the front flap is provided with a measuring scale D, and the front edge of the front part 12 of the front flap is provided with equally divided wire clamping grooves E, and the wire clamping grooves E are consistent with the corresponding measuring scale D. Corresponding to the anatomical contour, the anatomical reference marks help ensure the placement and alignment of the artificial chordae, facilitate the measurement of the range of leaflet prolapse, and guide the range of leaflet resection and leaflet folding.
[0047] Specifically, the rear portion 13 of the anterior valve is saddle-shaped, which is consistent with the anatomical course of the mitral valve ring, and the highest point of the saddle is located at the midline.
[0048] Example 1
[0049] like Figure 1-3 As shown, in this embodiment, the front flap rear part 13 is provided with several flanges C or continuous flanges. The front flap rear part 13 can be designed with several flanges C or continuous flanges. When viewed from the side, the flange C is located at the upper part and is continuous with the front flap main body 11, which is convenient for fixing on the valve ring or shaping ring. The flange can preferably have holes and can be sutured on the valve ring or shaping ring to prevent displacement. The G of the front flap main body 11 is the connection point of the front flap handle 20.
[0050] Example 2
[0051] like Figure 4-6 As shown, the anterior flap rear portion 13 is provided with a continuous upward oblique structure F. The anterior flap rear portion 13 can also be designed as a continuous upward oblique structure F, which is at a certain angle to the anterior flap main portion 11, so as to facilitate exposure of the anterior leaflet tissue of the mitral valve.
[0052] Example 3
[0053] like Figure 7As shown, a front leaflet hollow portion 14 is also provided in the front leaflet main body 11. The front leaflet shaping device body is preferably made of a transparent material or the front leaflet main body is hollowed out, and a transparent shaping device is convenient for the operator to observe the valve anatomical structure.
[0054] Example 4
[0055] like Figure 8-10 As shown, it is a posterior leaflet shaping auxiliary device, the posterior leaflet shaping device body 100 presents the morphological structure of the anatomical posterior leaflet of the mitral valve, the posterior leaflet body part 103 presents a crescent-shaped structure, the midline of the posterior leaflet body part is the longest, and the width gradually decreases towards both sides. The posterior leaflet body tissue can be dissected and fitted, and the height A of the posterior leaflet can be measured. The length from the midline of the posterior leaflet body part 103 to the apposition line H is basically consistent with the height of the normal physiological anterior leaflet, and can be designed to be 4, 6, 8, 10 mm, etc., which meets the height requirements of the normal anatomical mitral valve anterior leaflet.
[0056] The front part 101 of the posterior leaflet outside the coaptation line H is continuously inclined downward and forms a certain angle with the main part 103 of the posterior leaflet. The width of the front part 101 of the posterior leaflet is longest at the midline and gradually decreases towards both sides, which is conducive to anatomical fitting of the coaptation edge of the leaflet. The midline coaptation height is preferably designed to be 4-8mm, and the height of the coaptation edge of the posterior leaflet is measured.
[0057] The front part 101 of the posterior leaflet is provided with a measuring scale D, and the front edge of the front part 101 of the posterior leaflet is provided with equally divided wire-gripping grooves E, which are consistent with the corresponding measuring scale D. The anatomical reference marks corresponding to the anatomical contours help ensure the placement and alignment of the artificial chordae, facilitate the measurement of the range of leaflet prolapse, and guide the range of leaflet resection and leaflet folding.
[0058] The rear portion 102 of the posterior leaflet is an arc-shaped structure, which is consistent with the anatomical course of the posterior leaflet ring of the mitral valve. The rear portion 102 of the posterior leaflet is provided with a plurality of flanges C or a continuous flange. When viewed from the side, the flange C is located at the upper part and is continuous with the main portion 103 of the posterior leaflet, which is conducive to fixation on the leaflet ring or the shaping ring. The flange may preferably have a hole so that it can be sutured on the leaflet ring or the shaping ring to prevent displacement.
[0059] Alternatively, the rear portion 102 of the rear petal is provided with a continuous upward oblique structure, which can be designed as a continuous upward oblique structure ( Figure 8-10 It is at a certain angle to the main body of the posterior leaflet, which is conducive to exposing the posterior leaflet tissue of the mitral valve.
[0060] Example 5
[0061] like Fig.11 As shown, the anterior leaflet former can be designed to be fan-shaped and removed on both sides, which provides better surgical operating space for areas limited to the anterior leaflet A2 area, A1A2 notch or A2A3 notch.
[0062] Example 6
[0063] like Fig.12 As shown, the posterior leaflet former can be designed to be fan-shaped and removed on both sides, which provides better surgical operating space for areas limited to the P2 area, P1P2 notch or P2P3 notch of the posterior leaflet.
[0064] Example 7
[0065] like Fig.13 As shown, the shaper handle includes the front, middle and rear parts of the handle. The front part is cylindrical with threads or buckles, which can be connected to the shaper connection through threads or buckles to fix the shaper; the middle part is cylindrical, preferably made of metal material with adjustable direction, which is conducive to the exposure of surgical field; the rear part is the holding position of the handle, which is larger than the middle part and has an anti-slip layer to increase friction.
[0066] The design of the present invention is not limited to application in valvular diseases such as Carpenter type I normal leaflet activity (mitral valve annular dilatation, leaflet perforation or tear, vegetation, etc.) and type II leaflet prolapse, leaflet hyperactivity (mitral valve chord rupture, chord elongation, papillary muscle rupture, papillary muscle elongation, etc.).
[0067] After successful establishment of extracorporeal circulation during the operation, the mitral valve can be fully exposed through the right atrial-atrial septal incision or the atrial groove incision, and the lesions of the mitral valve ring, leaflet tissue, subvalvular chordae tendineae, and papillary muscles can be explored in turn. For cases with conditions for valvuloplasty, various specifications of shapers are assembled with handles, and the valvuloplasty auxiliary device is used to complete the following shaping techniques.
[0068] First: Use anterior leaflet shaping auxiliary device to complete the selection of shaping ring: The selection of shaping ring is based on the measurement of the base width and height of the anterior leaflet of the mitral valve. First, leave two sutures at the junction of the leaflets as a mark, fully unfold the anterior leaflet, place a shaper with a suitable junction spacing on the entire surface of the entire stretched anterior leaflet, and select a shaping ring of appropriate size according to the distance between the free edge of the anterior leaflet and the shaper. The size setting of the shaper model is consistent with the size of various specifications of valve ring measuring devices currently used in clinical practice. The invention is equipped with shapers of various specifications, and cardiac surgeons can quickly and accurately determine the size of the artificial valve ring to be selected according to the marks on the shaper, thereby improving the success rate of the operation.
[0069] Second: Use anterior leaflet shaping auxiliary device to complete the implantation of artificial chords of the anterior leaflet: First, pre-suture 1 to several CV5 sutures on the corresponding papillary muscle, place the shaper on the surface of the entire stretched anterior leaflet, and the front edge of the shaper is adjacent to the edge of the anterior leaflet of the mitral valve. According to the location of the broken chords or redundant chords found during the operation, refer to the scale and wire groove on the front of the shaper to accurately locate and implant the artificial chords, and it is relatively easy to adjust the height of the artificial chords. For the need to implant multiple artificial chords or use LOOP technology, the advantages are obvious. For the planned chordal transposition, use 5 / 0 sutures to pass through the entire layer of the chords at the corresponding level, and then refer to the front scale and wire groove of the shaper to suture to the edge of the leaflet. The free edge of the prolapsed area can be compared with the free edge of the non-prolapsed area using a nerve hook. The shaper corresponds to the anatomical contour, and the anatomical reference mark helps to ensure the placement and alignment of the artificial chords.
[0070] Third: Use an anterior leaflet shaping auxiliary device to complete the anterior leaflet folding surgery: first, place the shaper on the surface of the entire stretched anterior leaflet, with the leading edge of the shaper adjacent to the anterior leaflet edge of the mitral valve. Use a 2-0 indwelling suture to bypass the unextended chordae tendineae adjacent to the prolapsed area, and gently pull them to the corresponding suture groove. The part protruding into the ventricular surface is the leaflet tissue that needs to be folded, to avoid excessive or insufficient leaflet folding due to differences in surgical vision or subjective judgment. The shaper can achieve more precise leaflet folding, thereby improving the valvuloplasty effect.
[0071] Fourth: Use anterior leaflet shaping auxiliary device to complete the anterior leaflet triangular resection: First, place the shaper on the surface of the entire stretched anterior leaflet, with the front edge of the shaper adjacent to the edge of the anterior leaflet of the mitral valve. Use two nerve hooks to compare the free edge of the prolapsed area with the free edge of the non-prolapsed area, or use a 2-0 indwelling line to bypass the unextended tendon adjacent to the prolapsed area, gently pull it to the corresponding clamping groove, and determine the range of triangular resection based on the measurement scale on the front of the shaper. Avoid the surgeon from removing too many or too few leaflets due to differences in surgical vision or subjective judgment. The shaper can help the surgeon more accurately judge the range of leaflets that need to be removed, thereby improving the effect of valvuloplasty. The resection range of the anterior leaflet should not exceed 10% of the leaflet area.
[0072] Fifth: After the posterior leaflet shaping auxiliary device is used, the leaflet measurement and shaping ring model selection are completed: In most cases, the height of the posterior leaflet is between 10-15mm, and it should be reduced if it exceeds 20mm to avoid the occurrence of SAM. The use of this shaper can systematically measure the height of each segment of the posterior leaflet. Place the shaper of the appropriate size on the entire surface of the stretched posterior leaflet. The cardiac surgeon can quickly and accurately determine the size of the artificial valve ring to be used according to the markings on the shaper. Use 2 nerve hooks or 2 indwelling wires to bypass the unextended tendons adjacent to the prolapse area, and measure the height of each segment of the posterior leaflet according to the scale marks and wire grooves on the shaper.
[0073] Sixth: Implantation of artificial chords after the posterior leaflet is completed using the posterior leaflet shaping auxiliary device: First, pre-suture 1 to several CV5 sutures on the corresponding papillary muscle, place the shaper on the surface of the entire stretched posterior leaflet, and the front edge of the shaper is adjacent to the edge of the posterior leaflet of the mitral valve. According to the location of the broken chords or the redundant chords found during the operation, refer to the scale and the wire groove on the front of the shaper to accurately locate and implant the artificial chords, and it is relatively easy to adjust the height of the artificial chords. For the need to implant multiple artificial chords or apply the LOOP technology, the advantages are obvious. The free edge of the prolapsed area can be compared with the free edge of the non-prolapsed area using a nerve hook. The shaper corresponds to the anatomical contour, and the anatomical reference markers help ensure the placement and alignment of the artificial chords.
[0074] Seventh: Use the posterior leaflet shaping auxiliary device to complete the partial leaflet resection: including triangular resection or rectangular resection of the prolapsed area. First, place the shaper on the surface of the entire stretched posterior leaflet. The front edge of the shaper is adjacent to the edge of the posterior leaflet of the mitral valve. Use two nerve hooks to compare the free edge of the prolapsed area with the free edge of the non-prolapsed area, or use a 2-0 indwelling line to bypass the unextended tendon adjacent to the prolapsed area, gently pull it to the corresponding clamping groove, and determine the range of triangular resection or rectangular resection according to the measurement scale on the front of the shaper. To avoid the surgeon from removing too many or too few leaflets due to differences in surgical vision or subjective judgment, the shaper can help the surgeon more accurately judge the range of leaflets that need to be removed, thereby improving the effect of valvuloplasty.
[0075] Eighth: Use the posterior leaflet shaping auxiliary device to complete the posterior leaflet folding: first, place the shaper on the surface of the entire stretched posterior leaflet, with the leading edge of the shaper adjacent to the edge of the posterior leaflet of the mitral valve. Use a 2-0 indwelling line to bypass the unextended chordae tendineae adjacent to the prolapsed area, and gently pull them to the corresponding wire groove. The part protruding into the ventricular surface is the leaflet tissue that needs to be folded, to avoid excessive or insufficient leaflet folding due to differences in surgical vision or subjective judgment by the surgeon. The shaper can achieve more precise leaflet folding, thereby improving the valvuloplasty effect.
[0076] Ninth: Valvuloplasty effect test: The surgical application is not limited to the above various valvuloplasty techniques. After the valve test, a spherical syringe is filled with saline and injected through the mitral valve orifice to fill the left ventricle to observe the shape of the valve closure line and the valve closure. When the heart is in a static state, it is preliminarily judged that the valvuloplasty effect is satisfactory. The atrial septum and right atrial incision are closed, the ascending aorta is opened after exhausting, and after the heart is successfully restarted, esophageal ultrasound is used to further evaluate the valvuloplasty effect.
[0077] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.
Claims
1. A valvuloplasty assisting device, It is characterized in that It includes anterior valve shaping auxiliary device and posterior valve shaping auxiliary device; The anterior flap shaping auxiliary device comprises an anterior flap shaping device body (10) and an anterior flap handle (20) connected to the anterior flap shaping device body (10); the anterior flap shaping device body (10) comprises an anterior flap body portion (11), an anterior flap front portion (12) and an anterior flap rear portion (13) respectively arranged on both sides of the anterior flap body portion (11); the anterior flap handle (20) is connected to the anterior flap body portion (11); The posterior flap shaping auxiliary instrument comprises a posterior flap shaping device body (100) and a posterior flap handle (200), wherein the posterior flap shaping device body (100) comprises a posterior flap front part (101), a posterior flap rear part (102), and a posterior flap main body part (103), wherein the posterior flap front part (101) and the posterior flap rear part (102) are respectively arranged on both sides of the posterior flap main body part (103), and the posterior flap handle (200) is connected to the posterior flap main body part (103); The anterior leaflet shaping device body (10) as a whole presents the morphological structure of the anterior leaflet of the mitral valve anatomy, the anterior leaflet body (11) is fusiform in top view, the center of the anterior leaflet body (11) is arched in front view, the midline of the anterior leaflet body (11) is the longest, and the width gradually decreases towards both sides; The front flap main body (11) is connected to the front flap front part (12) through the apposition line (H), the front flap front part (12) outside the apposition line (H) is a continuous downward sloping structure, and a certain angle is formed between the front flap front part (12) and the front flap main body (11); the front flap front part (12) is the longest in width at the midline, and the width gradually decreases towards both sides.
2. A valvuloplasty assisting device according to claim 1, Features: The front part (12) of the front flap is provided with a measuring scale (D), and the front edge of the front part (12) of the front flap is provided with equally divided wire clamping grooves (E), and the wire clamping grooves (E) are consistent with the corresponding measuring scale (D).
3. A valvuloplasty assisting device according to claim 2, Features: The anterior flap rear portion (13) is saddle-shaped in frontal view, consistent with the anatomical course of the mitral valve ring, and the highest point of the saddle is located at the midline.
4. A valvuloplasty assisting device according to claim 3, Features: The rear part (13) of the front petal is provided with a plurality of flanges (C) or a continuous flange; or the rear part (13) of the front petal is provided with a continuous upward oblique structure (F).
5. A valvuloplasty assisting device according to claim 1, Features: A front lobe hollow portion (14) is also provided in the front lobe main body portion (11).
6. A valvuloplasty assisting device according to claim 1, Features: The posterior leaflet former body (100) is in the shape of the anatomical posterior leaflet of the mitral valve, and the posterior leaflet body (103) is in a crescent-shaped structure, the midline of the posterior leaflet body is the longest, and the width gradually decreases towards both sides.
7. A valvuloplasty assisting device according to claim 6, Features: The front part (101) of the rear petal is provided with a measuring scale (D), and the front edge of the front part (101) of the rear petal is provided with equally divided wire clamping grooves (E), and the wire clamping grooves (E) are consistent with the corresponding measuring scale (D).
8. A valvuloplasty assisting device according to claim 7, Features: The rear part (102) of the rear petal is provided with a plurality of flanges (C) or a continuous flange; or the rear part (102) of the rear petal is provided with a continuous upward inclined structure.