A mitral valve annulus contraction device

Abstract

The present invention relates to the technical field of medical devices, and in particular to a mitral valve annulus contraction device, comprising a tightening device, a tightening line, a slender body, and an anchoring piece; the two ends of the slender body are respectively an anchoring hole and a tightening hole, the anchoring hole is connected to the anchoring piece, and the tightening hole is connected to the tightening line; the tightening device comprises a protective sleeve, a ratchet knob, and a cable drum, the ratchet knob is fixedly connected to the cable drum, and the protective sleeve is sleeved outside the cable drum; the ratchet knob has a rotating shaft penetrated into the cable drum, the rotating shaft has a threading hole on the circumference, and the interior of the rotating shaft is hollowed out from the threading hole and passes through to the bottom of the ratchet knob, and the cable drum has a threading hole on the circumference corresponding to the threading hole of the rotating shaft; the tightening line passes through the protective sleeve, the threading hole, and the threading hole in sequence to the outside of the bottom of the ratchet knob; the end of the tightening line has an anti-slip structure, and the bottom end of the protective sleeve has an annular limiting protrusion.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a mitral valve annulus contraction device. Background Art

[0002] The mitral valve of the human heart has a very different structure from other valves in the heart. The mitral valve includes a ring-shaped valve ring, a pair of leaflets, chordae tendineae, papillary muscles and other parts. The leaflets extend downward from the valve ring into the left ventricle, and the leaflets are connected to the papillary muscles by chordae tendineae. There are anterior leaflets and posterior leaflets in the leaflet structure, and the side with the valve ring is called the posterior leaflet. The normal anterior leaflet and posterior leaflet of the valve act together as a one-way valve, so that blood can only flow from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrium contracts and the left ventricle expands, the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrium relaxes and the left ventricular muscle contracts, the increased blood pressure in the left ventricle pushes the two leaflets together, thereby closing the one-way mitral valve. The blood cannot flow back to the left atrium but is discharged from the left ventricle through the aortic valve. In order to prevent the two leaflets from prolapsing under pressure and folding back to the left atrium through the mitral valve ring, the chordae tendineae fix the leaflets to the papillary muscles.

[0003] Heart valve disease is a common heart disease. With the development of economy and society and the aging of population, the incidence of mitral regurgitation (MR) has shown a clear upward trend. Normally, the anterior and posterior leaflets of the mitral valve have a large coaptation area, and the anterior leaflet has a large potential compensatory capacity. If the valve ring expands, the coaptation area between the two leaflets will decrease; when the valve ring expands extremely, the two leaflets cannot completely coapt, and a gap will appear between them, which will cause MR.

[0004] In addition, the muscles at the junction of the left atrium and left ventricle support the posterior leaflet of the mitral valve. The endocardium on the surface of the posterior leaflet of the mitral valve is continuous with the endocardium of the posterior wall of the left atrium, so when the left atrium expands, it can pull the posterior leaflet and reduce the effective area of ​​the posterior leaflet, which can also cause MR.

[0005] Surgical valve replacement or repair is still the first choice for patients with mitral regurgitation. However, for patients who are elderly, have a history of open-chest surgery, have poor heart function, and have multiple organ dysfunction, surgery is traumatic, difficult to heal, has many complications, and has high risks, and some patients may not be able to tolerate it.

[0006] In view of the above problems, the present invention develops a device to solve the problem without damaging the heart tissue to the greatest extent. Summary of the invention

[0007] The purpose of the present invention is to provide a protective device for mitral valve replacement surgery in view of the defects of the prior art.

[0008] In order to achieve the above purpose, the present invention adopts the following technical solutions:

[0009] A mitral valve annulus contraction device comprises a tightening device, a tightening wire, a slender body, and an anchoring piece; two ends of the slender body are respectively an anchoring hole and a tightening hole, the anchoring hole is connected to the anchoring piece, and the tightening hole is connected to the tightening wire; the tightening device comprises a protective sleeve, a ratchet knob, and a cable drum, the ratchet knob is fixedly connected to the cable drum, and the protective sleeve is sleeved outside the cable drum; the ratchet knob has a rotating shaft penetrated into the cable drum, the rotating shaft has a threading hole on the circumference, and the interior of the rotating shaft is hollowed out from the threading hole and passes through to the bottom of the ratchet knob, and the cable drum has a threading hole on the circumference corresponding to the threading hole of the rotating shaft; the tightening wire passes through the protective sleeve, the threading hole, and the threading hole in sequence to the outside of the bottom of the ratchet knob; the end of the tightening wire has an anti-slip structure, and the bottom end of the protective sleeve has an annular limiting protrusion.

[0010] Furthermore, it also includes an adjustable ring, which is a spiral metal coil and is arranged on the outside of the slender body and the protective cover.

[0011] Furthermore, the outer side of the adjustable ring is wrapped with a coating, and the material of the coating includes one or more of PET and PTFE.

[0012] Furthermore, a first slot which is sleeved with a push rod of a conveying device is provided on a side surface of the ratchet knob, so that the ratchet knob rotates along with the rotation of the push rod.

[0013] Furthermore, the protective sleeve includes a tube core and a sheath covering the outside of the tube core; the tube core is a hollow cylindrical structure for allowing the tightening wire to pass through; and the sheath is a water-soluble biomedical material.

[0014] Furthermore, the material of the tightening line is one or more of a polymer material and a metal material with high biocompatibility.

[0015] Furthermore, the material of the slender body is memory metal; a developing ring is provided in the middle section of the slender body, and the developing ring is used to adjust the position of the slender body.

[0016] Furthermore, the anchoring member includes a connecting portion and an anchoring portion fixedly connected to the connecting portion, and a second slot for plugging into a pushing rod of a conveying device is provided at the top of the connecting portion so that the pushing rod and the connecting portion can be plugged in; the anchoring portion is a spiral structure, and the end of the spiral structure is needle-shaped.

[0017] Furthermore, the outer diameter of the anchoring portion of the anchoring member is smaller than the aperture of the anchoring hole of the slender body; and the diameter of the connecting portion of the anchoring member is larger than the aperture of the anchoring hole of the slender body.

[0018] Furthermore, the diameter of the adjustable ring is larger than the diameters of the slender body and the protective sleeve; the diameter of the adjustable ring is smaller than the diameters of the annular limiting protrusion and the anchoring hole of the slender body.

[0019] Compared with the prior art, the ring contraction device of the present invention retains the leaflets and subvalvular structure of the mitral valve, retains the left ventricular structure to the greatest extent, slows down heart recession, and improves the therapeutic effect of mitral regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic diagram of the cardiac anatomical structure of Embodiment 1 of the present invention;

[0021] Figure 2 This is a structural diagram of a mitral valve annulation device according to Embodiment 1 of the present invention;

[0022] Figure 3 It is a structural schematic diagram of a tightening device according to Embodiment 1 of the present invention;

[0023] Figure 4 It is a schematic structural diagram of a ratchet knob and a cable spool according to the first embodiment of the present invention;

[0024] Figure 5 It is a schematic structural diagram of the slender body of the first embodiment of the present invention;

[0025] Figure 6 This is a schematic structural diagram of an anchor member according to Embodiment 1 of the present invention;

[0026] Figure 7 This is a schematic diagram of the adjustable ring after implantation according to the first embodiment of the present invention;

[0027] Figure 8 It is a schematic diagram of the initial state of the adjustable ring according to the first embodiment of the present invention;

[0028] Fig. 9 This is a cardiac anatomical diagram after implantation of the device according to Embodiment 1 of the present invention;

[0029] Fig.10 This is a top-down anatomical diagram of the heart after the device of Example 1 of the present invention is implanted;

[0030] Among them: 1. Superior vena cava; 2. Right atrium; 3. Entrance of coronary sinus; 4. Coronary sinus; 5. Mitral valve ring; 6. Left atrium; 7. Mitral valve; 8. Posterior leaflet of mitral valve; 9. Papillary muscle; 10. Left ventricle; 11. Right ventricle; 12. Tricuspid valve; 13. Inferior vena cava; 14. Heart septum; 15. Aortic valve; 20. Tightening device; 21. Protective sleeve; 22. Annular limiting protrusion; 23. Tube core; 24. Mantle; 25. Ratchet knob; 251. Knob part; 2511. Small hole; 252. Rotating shaft; 253. First bundle Wire hole; 254. Second wire hole; 255. Check pawl; 256. Ratchet; 257. First threading hole; 258. Second threading hole; 259. First slot; 26. Wire barrel; 30. Take-up wire; 31. Knot point; 40. Slender body; 41. Take-up hole; 42. Developing ring; 43. Anchor hole; 50. Anchor member; 51. Connecting part; 511. Second slot; 52. Anchor part; 60. Adjustable ring; 60a, 60c, 60f. Hard section of adjustable ring; 60b, 60d. Soft section of adjustable ring; 70 Coating. DETAILED DESCRIPTION

[0031] The following describes the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0032] The purpose of the present invention is to provide a mitral valve annulus contraction device in view of the defects of the prior art.

[0033] Embodiment 1:

[0034] like Figure 1-10As shown, a mitral valve annulus contraction device of the present embodiment comprises a tightening device 20, a tightening line 30, a slender body 40, an anchor 50, an adjustable ring 60, and a covering 70; the two ends of the slender body 40 are respectively an anchor hole 43 and a tightening hole 41, the anchor hole 43 is connected to the anchor 50, and the tightening hole 41 is connected to the tightening line 30; the tightening device 20 comprises a protective cover 21, a ratchet knob 25, and a cable drum 26, the ratchet knob 25 is fixedly connected to the cable drum 26, and the protective cover 21 is sleeved outside the cable drum 26; the knob portion 251 of the ratchet knob is provided with a small hole 25 11. The ratchet knob 25 has a rotating shaft 252 that passes through the cable drum, and the rotating shaft 252 has a first threading hole 257 and a second threading hole 258 on its circumference. The interior of the rotating shaft 252 is hollowed out from the first threading hole 257 and the second threading hole 258 and passes through to the bottom of the ratchet knob 25. The cable drum 26 has a first cable hole 253 and a second cable hole 254 corresponding to the first threading hole 257 and the second threading hole 258 of the rotating shaft 252 on its circumference. The end of the tightening wire 30 has an anti-slip structure, and the bottom end of the protective cover 21 has an annular limiting protrusion 22.

[0035] like Figure 1 It is a schematic diagram of the anatomical structure of the heart, including superior vena cava 1, right atrium 2, coronary sinus entrance 3, coronary sinus 4, mitral valve ring 5, left atrium 6, mitral valve 7, posterior leaflet of mitral valve 8, papillary muscle 9, left ventricle 10, right ventricle 11, tricuspid valve 12, inferior vena cava 13, cardiac septum 14, and aortic valve 15. Some of the heart tissues are related to the present embodiment.

[0036] like Figure 2 The figure shows a device for mitral valve ring contraction, including a tightening device 20, a tightening wire 30, an elongated body 40, an anchor 50, an adjustable ring 60, and a coating 70. The figure shows that the tightening wire 30 passes through the tightening hole 41 of the elongated body 40. After the tightening wire 30 passes through the tightening hole 41 of the elongated body 40, one end of the tightening wire 30 passes through the protective cover 21, the first bundle hole 253, and the first threading hole 257 in sequence to the outside of the small hole 2511 of the ratchet knob; the other end of the tightening wire 30 passes through the protective cover 21, the second bundle hole 254, and the second threading hole 258 in sequence to the outside of the small hole 2511 of the ratchet knob; after the two ends of the tightening wire 30 are placed outside the small hole 2511 of the ratchet knob, the two strands of wire are knotted to obtain a closed knot point 31, so that when the ratchet knob 25 is turned, the tightening wire can be contracted to reduce the area of ​​the mitral valve orifice and reduce regurgitation.

[0037] The material of the tightening line 30 is made of a polymer material with high biocompatibility and a relatively soft metal material, which can ensure strength while allowing better endothelialization. It is preferred to use a unique nano-complex filament. The medical suture prepared by the composite spinning technology has a wide range of uses. First, the most widely used is biomedical functional materials. Since the valve suture of the composite spinning technology has good structural compatibility and biocompatibility, it has been widely used in biomembranes, medical stents, sustained-release drugs, etc., which can ensure strength while allowing better endothelialization. Secondly, the valve suture of the composite spinning technology has a large specific surface area, so it is an ideal endothelialization material. In addition, since the valve suture of the composite spinning technology has stronger physical properties than ordinary sutures, it will have important applications in the process of preparing heart valves. Sutures prepared by the composite spinning method of sutures are also used in sensors, electronic materials, new special fibers, clothing, etc. The polymer is woven onto the line using the composite spinning method to form a dense nanofiber membrane on the surface of the line. This line with a nanofiber membrane on the surface can be used in many occasions, the most common of which is used in medical treatment.

[0038] like Figure 3 The figure shows a schematic diagram of the structure of the tightening device 20, which includes a protective cover 21, a ratchet knob 25, and a cable drum 26. The ratchet knob 25 is fixedly connected to the cable drum 26, and the protective cover 21 is sleeved outside the cable drum 26; the bottom end of the protective cover 21 has an annular limiting protrusion 22. The protective cover 21 is used to protect the coronary sinus and surrounding heart tissue to prevent the tightening line from causing embedded damage to the tissue in the area, and is also used to fix the tightening device and the tightening line; the annular limiting protrusion 22 is used to prevent the tightening knob 20 from further entering the coronary sinus and causing damage to the heart tissue; the ratchet knob 25 is used to tighten the tightening line 30.

[0039] The protective cover 21 of the tightening device 20 is a hollow cylindrical structure for passing the tightening wire. The protective cover 21 is composed of a tube core 23 and a mantle 24 coated on the outside of the tube core 23. In this embodiment, the material of the tube core 23 is preferably a catheter made of silicone rubber, thermoplastic polyurethane elastomer (TPU) or thermoplastic polyolefin elastomer (TPE) that meets the medical implant standards. The purpose is to ensure the mechanical strength and support capacity of the tube body so that it will not collapse due to the material being too soft or bend due to insufficient strength under the tension of the tightening wire 30, thereby avoiding treatment failure due to material mechanical problems. The outer anti-adhesion layer of the mantle 24 is made of a water-soluble biomedical material to prevent tearing damage caused by adhesion.

[0040] like Figure 4The figure shows a schematic diagram of the structure of a ratchet knob and a cable spool. The knob portion 251 of the ratchet knob 25 is provided with a small hole 2511 for passing the tightening wire 30. The side of the ratchet knob 25 is provided with a first slot 259 which is sleeved with the push rod of the conveying device so that the ratchet knob 25 rotates with the rotation of the push rod.

[0041] The ratchet knob 25 has an internal ratchet mechanism, including a non-return pawl 255 and a ratchet 256. When the ratchet knob 25 is rotated, the non-return pawl 255 slides on the back of the teeth of the ratchet 256. If the ratchet knob is rotated in the reverse direction, the non-return pawl 255 is inserted into the tooth groove of the ratchet 256 to prevent the ratchet 256 from rotating in the reverse direction. Therefore, the ratchet knob 25 can only rotate in one direction to prevent the tightening line from loosening due to the rotation, and the tension of the mitral valve cannot be maintained. It should be noted that the ratchet mechanism is similar to the principle in the prior art, and no further description is given here.

[0042] The cable drum 26 is a hollow cylinder, and has a first cable hole 253 and a second cable hole 254 on its circumference. The first cable hole 253 and the second cable hole 254 are used for the tightening wire 30 to pass through.

[0043] The ratchet knob 25 also has a rotating shaft 252 that passes through the cable barrel 26. The rotating shaft 252 is a hollow cylindrical structure. The rotating shaft 252 has a first threading hole 257 and a second threading hole 258 corresponding to the first threading hole 253 and the second threading hole 254 of the cable barrel 26 on its circumferential side. The interior of the rotating shaft 252 is hollowed out from the first threading hole 257 and the second threading hole 258 and passes through to the bottom of the ratchet knob 25.

[0044] like Figure 5 The figure shows a schematic diagram of the structure of the slender body. A tightening hole 41 is provided at one end of the slender body 40 for connecting the tightening wire 30; a developing ring 42 is provided at the middle part of the slender body 40, which is suitable for digital silhouette angiography (DSA) analysis and is used to adjust the position of the slender body 40; an anchoring hole 43 is provided at the other end of the slender body 40 for implanting an anchoring member 50 therein to fix the anchoring hole 43.

[0045] In this embodiment, the elongated body 40 is made of memory metal, preferably memory alloy, wherein the memory alloy is preferably nickel-titanium alloy, which is a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature. The memory alloy has recovery, and the effective part of the elongated body 40 in the original state is roughly straight, and will bend to a certain extent under the tension of the tightening wire 30, but the final curvature is still smaller than the posterior leaflet ring body of the mitral valve, so as to ensure that it can continuously exert constraints on the mitral valve ring body.

[0046] The slender body 40 will be inserted into the coronary sinus near the posterior leaflet of the mitral valve. The curvature of the slender body 40 is smaller than the curvature of this section of the coronary sinus so that the curvature of the coronary sinus will not increase further when tightened, and the posterior leaflet will move toward the anterior leaflet, thereby improving the coaptation of the anterior leaflet and the posterior leaflet.

[0047] The slender body 40 is roughly straight (with a small curvature) in its initial state without external force. When the tightening wire 30 is in the tightened state, it is deformed by the tension and has a certain degree of curvature. When the curvature reaches the maximum curvature, it is still smaller than the curvature of the coronary sinus at the implantation site. At this time, the middle section of the slender body will exert a forward force to move the adjacent posterior leaflet forward, thereby further improving the leaflet coaptation and reducing backflow.

[0048] like Figure 6 The structure diagram of the anchor 50 is shown. The anchor 50 includes a connecting portion 51 and an anchoring portion 52 fixedly connected to the connecting portion. The anchor 50 is used to fix the anchor hole 43 of the slender body 40. The top of the connecting portion 51 is provided with a second slot 511 plugged with the push rod of the conveying device so that the push rod and the connecting portion are plugged; the anchor 52 is a spiral structure, and the end of the spiral structure is in the shape of a needle tip. The anchor 52 passes through the anchor hole 43 at the distal end of the slender body 40, and can be implanted into the ventricular septum by rotating it with external force, and the connecting portion 51 remains outside to play a fixing role. 511 is an anchor slot, which can be connected with the push rod sleeve of the conveyor. The push rod can be rotated to control its rotation, and the anchor can be inserted into the heart tissue by rotating the push rod.

[0049] The anchoring member 50 needs to fix the anchoring hole 43 of the slender body 40 , so the outer diameter of the helical structure of the anchoring portion 52 must be smaller than the aperture of the anchoring hole 43 of the slender body 40 , and the maximum diameter of the connecting portion 51 must be larger than the aperture of the anchoring hole 43 of the slender body 40 .

[0050] like Figure 7 The figure shows a schematic diagram of an adjustable ring after implantation, wherein the adjustable ring 60 is arranged outside the slender body 40 and the protective sleeve 21; the adjustable ring 60 is a spiral metal coil, and the material is preferably a nickel-titanium alloy with good elasticity. The adjustable ring 60 can be divided into hard segments 60a, 60c and 60f and soft segments 60b and 60d according to the density and rigidity. The hard segments 60a, 60c and 60f have denser coils and better rigidity, which are convenient for shaping; the soft segments 60b and 60d have sparser coils and weaker rigidity, which are convenient for bending and compression. That is, when adjusting the tightening line 30, the soft segments 60b and 60d are compressed first. Figure 8 It is a schematic diagram of the initial state of the adjustable ring 60.

[0051] The diameter of the adjustable ring 60 is larger than the diameter of the slender body 40 and the protective cover 21 ; the diameter of the adjustable ring 60 is smaller than the diameter of the annular limiting protrusion 22 and the slender body anchoring hole 43 , one end of the adjustable ring abuts against one side of the annular limiting protrusion 22 , and the other end of the adjustable ring abuts against one side of the anchoring hole 43 .

[0052] The adjustable ring 60 is wrapped with a coating 70 to protect the coronary sinus and increase the speed of endothelialization of the ring contraction device. The material of the coating 70 is PET or PTFE, and the preparation process is preferably composite spinning technology. The conventional ordinary coating requires 8-16 months or even longer to complete the endothelialization process, while the coating in this embodiment can complete the endothelialization in 2-3 months, thanks to the composite spinning technology.

[0053] Figure 9-10 The anatomical diagram of the heart from a top view after implantation of the device is shown, in order to more clearly and intuitively demonstrate the implantation status of the ring contraction device. Fig.10 The adjustable ring and the covering are hidden in the slender body 40. The coronary sinus usually has a portion of about 8 cm extending roughly to the vicinity of the posterior leaflet ring of the mitral valve. By implanting the slender body 40, the inherent curvature of this section of the coronary sinus can be modified, and the curvature of the posterior leaflet of the mitral valve can be modified accordingly. Moreover, after the slender body 40 is configured at this position, the change of the curvature of the posterior leaflet of the mitral valve can be effectively constrained during the tightening process, so that the rear ring body moves forward, which is convenient for improving the coaptation of the leaflets, thereby reducing mitral valve regurgitation.

[0054] The annular contraction device of this embodiment retains the leaflets and subvalvular structure of the mitral valve, retains the left ventricular structure to the greatest extent, slows down heart recession, and improves the therapeutic effect of mitral regurgitation.

[0055] The specific embodiments described herein are merely examples of the spirit of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in similar ways, but they will not deviate from the spirit of the present invention or exceed the scope defined by the appended claims.

Claims

1. A mitral valve annulus device, characterized in that: It comprises a tightening device, a tightening line, a slender body and an anchoring piece; the two ends of the slender body are respectively an anchoring hole and a tightening hole, the anchoring hole is connected to the anchoring piece, and the tightening hole is connected to the tightening line; the tightening device comprises a protective cover, a ratchet knob and a cable drum, the ratchet knob is fixedly connected to the cable drum, and the protective cover is sleeved outside the cable drum; the ratchet knob has a rotating shaft penetrated into the cable drum, the peripheral side of the rotating shaft has a threading hole, and the interior of the rotating shaft is hollowed out from the threading hole and passes through to the bottom of the ratchet knob, and the peripheral side of the cable drum has a cable hole corresponding to the threading hole of the rotating shaft; the tightening line passes through the protective cover, the cable hole and the threading hole in sequence to the outside of the bottom of the ratchet knob; the end of the tightening line has an anti-slip structure, and the bottom end of the protective cover has an annular limiting protrusion; It also includes an adjustable ring, which is a spiral metal coil, and is arranged on the outside of the slender body and the protective sleeve, and the outside of the adjustable ring is wrapped with a coating, and the material of the coating includes one or more of PET and PTFE; The protective cover comprises a tube core and a mantle film covering the outside of the tube core; The tube core is a hollow cylindrical structure for passing the tightening wire; The outer shell is a water-soluble biomedical material; The material of the slender body is memory metal; a developing ring is provided in the middle section of the slender body, and the developing ring is used to adjust the position of the slender body; The anchoring member includes a connecting portion and an anchoring portion fixedly connected to the connecting portion. A second slot for plugging into a pushing rod of a conveying device is provided at the top of the connecting portion so that the pushing rod is plugged into the connecting portion. The anchoring portion is a spiral structure, and the end of the spiral structure is in the shape of a needle tip.

2. A mitral valve annulation device according to claim 1, characterized in that: A first slot which is sleeved with a push rod of a conveying device is provided on the side of the ratchet knob so that the ratchet knob rotates along with the rotation of the push rod.

3. A mitral valve annulation device according to claim 1, characterized in that: The outer diameter of the anchoring portion of the anchoring member is smaller than the aperture of the anchoring hole of the slender body; and the diameter of the connecting portion of the anchoring member is larger than the aperture of the anchoring hole of the slender body.

4. A mitral valve annulation device according to claim 1, characterized in that: The diameter of the adjustable ring is larger than the diameters of the slender body and the protective sleeve; the diameter of the adjustable ring is smaller than the diameters of the annular limiting protrusion and the anchoring hole of the slender body.

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