A heart fenestration assembly

Abstract

This application discloses a cardiac opening assembly, including: a ventricular connector having an inner ring with multiple first positioning parts, a step forming between the first positioning parts and the surface of the inner ring, the first positioning parts being evenly spaced around the center of the inner ring, and a clearance groove forming between adjacent first positioning parts; and an apical opening knife having a main body with multiple locking protrusions on the outer periphery of the main body, the locking protrusions corresponding one-to-one with the first positioning parts, the locking protrusions being screwed into the clearance grooves and having a clearance fit with the first positioning parts at the step, thereby fixing the apical opening knife and the ventricular connector relatively. The ventricular connector and the apical opening knife of this application can be locked axially, allowing the doctor to hold the apical opening knife with one hand to maintain the ventricular connector and the ventricle in contact, while pressing the blade of the opening knife into the ventricular tissue with the other hand. The doctor's two hands can coordinate their force, ensuring the stability of the surgical process and avoiding injury to human tissue.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a cardiac opening assembly. Background Technology

[0002] Many medical devices require implantation through openings in the body's tissues to create an implantation space or a blood circulation channel. For example, during the implantation of an implantable left ventricular assist device (LVAD, or artificial heart), an opening needs to be made in the left ventricle to connect the LVAD's blood inlet tube to the left ventricle. The LVAD is then installed in the left ventricle via a ventricular connector. The opening in the ventricle must be centered on the connector and its diameter must match the outer diameter of the LVAD inlet tube to minimize leakage at the connection point. During the LVAD implantation procedure, it's crucial to ensure that any removed tissue is removed to prevent vascular blockage. If the opening is misaligned—not centered on the connector—significant bleeding will occur between the LVAD inlet tube and the ventricle. If removed tissue falls into the ventricle, extensive cleaning is required, and this process also involves significant bleeding. Therefore, the tools used for creating openings in the heart must be precise in location and size, and able to easily remove any removed tissue.

[0003] The existing ventricular connector and apical perforator are not axially locked together. They are mostly achieved by the doctor and his assistant holding the tool together, which requires a lot of experience from the doctor and is prone to causing the perforation to be outward, resulting in poor adhesion between the subsequently implanted LVAD inlet tube and the ventricular tissue. In addition, during the operation, the doctor always holds the tool with one hand and applies a certain amount of force to push it against the surface of the ventricular connector, while the other hand overcomes the elasticity of the spring in the apical perforator to press the blade into the human tissue. The doctor applies force with both hands at the same time, and the force is not consistent, which can easily cause instability and tissue injury during the operation. Utility Model Content

[0004] This application aims to solve one of the technical problems in the prior art.

[0005] This application provides a cardiac apical opening assembly. The ventricular connector and apical apical opening knife of this application can be locked in the axial direction. The doctor can hold the apical apical opening knife with one hand to maintain the fit between the ventricular connector and the ventricle, and press the cutting head of the opening knife into the ventricular tissue with the other hand. The doctor's two hands can coordinate the force to ensure the stability of the operation and avoid injury to human tissue.

[0006] This application provides a cardiac opening assembly, including:

[0007] A ventricular connector has an inner ring with a plurality of first positioning portions. The surfaces of the first positioning portions and the inner ring are stepped. The first positioning portions are evenly spaced around the center of the inner ring, and a clearance groove is formed between two adjacent first positioning portions.

[0008] The apical perforator has a main body with multiple locking protrusions on its outer periphery. Each locking protrusion corresponds to a first positioning part. The locking protrusions are screwed into the relief groove and are in clearance fit with the first positioning part at the step, thereby fixing the apical perforator and the ventricular connector relative to each other.

[0009] In some embodiments, the number of the first positioning parts is 2-5.

[0010] In some embodiments, the locking protrusion has an end face and auxiliary arc surfaces disposed on opposite sides of the end face. The auxiliary arc surfaces have a first arc surface segment and a second arc surface segment arranged in the circumferential direction of the body. The second arc surface segment connects to the outer periphery of the body. The second arc surface segment is recessed inward toward the locking protrusion. The first arc surface segment protrudes outward in a direction away from the locking protrusion. The arc surface length of the second arc surface segment in the circumferential direction of the body is greater than the arc surface length of the first arc surface segment in the circumferential direction of the body.

[0011] In some embodiments, the slope of the second arcuate segment gradually becomes steeper from its position near the outer periphery of the body to its position where it connects to the first arcuate segment.

[0012] In some embodiments, the locking protrusion further has a thrust surface, and the end face of the first positioning portion and the thrust surface of the locking protrusion abut against each other.

[0013] In some embodiments, the inner ring is further provided with a plurality of blocking portions, each of which corresponds to the first positioning portion. The blocking portions protrude from the side edge of the first positioning portion and can restrict the main body.

[0014] In some embodiments, a positioning outer circle is formed on the body, and a groove is defined between the positioning outer circle and the locking protrusion, wherein the first positioning portion is connected to the groove.

[0015] In some embodiments, the apical perforator further comprises a cutting head, a rotating handle, and a handle linkage;

[0016] The rotating handle is movably located at the rear end of the main body;

[0017] The cutting head is connected to the front end of the main body, and the cutting head and the rotating handle are connected by the handle linkage.

[0018] An elastic element connects the interior of the main body and the rotating handle.

[0019] In some embodiments, the ventricular connector further has an outer ring having a second positioning portion configured to match and fix with a clamping tool.

[0020] In some embodiments, the ventricular connector includes a first frame, a second frame, a crimping member, and a skirt member;

[0021] The first frame, the second frame, the pressing member, and the skirt component are all annular;

[0022] The inner ring is defined inside the first frame.

[0023] The skirt component is connected to the end of the first frame;

[0024] The pressing component is sleeved on the outer periphery of the first frame and is used to press the skirt component tightly;

[0025] The second frame is fastened to the outer periphery of the first frame to press the crimping member.

[0026] As can be seen from the above technical solutions, the embodiments of this application have the following advantages:

[0027] The ventricular connector has an inner ring with multiple first positioning parts. These first positioning parts are evenly spaced around the center of the inner ring, and a clearance groove is formed between adjacent first positioning parts. The apical perforation knife has a main body with multiple locking protrusions on its outer periphery. Each locking protrusion corresponds to one of the first positioning parts. The locking protrusions are screwed into the clearance grooves and fit with the first positioning parts at the step position, thus fixing the apical perforation knife and the ventricular connector relatively. In this way, the ventricular connector and the apical perforation knife can be locked axially. The doctor can hold the apical perforation knife with one hand to maintain the fit between the ventricular connector and the ventricle, and use the other hand to press the tip of the perforation knife into the ventricular tissue to make an opening in the ventricle. The doctor's two hands can coordinate their force to ensure the stability of the operation and avoid injury to human tissue. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings.

[0029] Figure 1 This is a schematic diagram of the structure of a cardiac opening assembly disclosed in an embodiment of this application;

[0030] Figure 2 for Figure 1 The diagram shown illustrates the disassembly of the ventricular connector and apical perforator.

[0031] Figure 3 for Figure 1 A schematic diagram showing the cutting head perspective of the cardiac opening assembly;

[0032] Figure 4 for Figure 3 The view shown is a cross-sectional view at the locking protrusion position;

[0033] Figure 5 for Figure 1 A partial enlarged view of the cardiac opening assembly shown;

[0034] Figure 6 for Figure 2 A partial enlarged view of the apex drilling tool shown;

[0035] Figure 7 for Figure 1 A schematic diagram of the locking protrusion of the apex drilling tool shown in the figure;

[0036] Figure 8 for Figure 1 An exploded view of the components of the ventricular connector shown;

[0037] Figure 9 for Figure 6 A schematic diagram of the structure of the first frame shown;

[0038] Figure 10 for Figure 9 A partial enlarged view of the first frame shown.

[0039] The meanings of the reference numerals in the attached figures are as follows:

[0040] 1. Ventricular connector; 11. Inner ring; 111. Step; 12. First positioning part; 121. Internal tooth; 122. Relief groove; 123. Blocking part; 124. Positioning inner circle; 13. Outer ring; 14. Second positioning part; 16. First frame; 161. Flanged edge; 162. Protrusion; 17. Second frame; 171. Spike; 18. Press-fit part; 19. Skirt component; 2. Apical hole cutter; 21. Main body; 211. Positioning outer circle; 22. Locking protrusion; 221. End face; 222. Auxiliary arc surface; 222a. First arc surface segment; 222b. Second arc surface segment; 223. Thrust surface; 23. Cutting head; 24. Rotating handle; 25. Locking handle; 26. Groove. Detailed Implementation

[0041] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0042] The blood pump has an inlet end and an outlet end. When implanted in the human body, the outlet end is connected to the aorta through an artificial blood vessel, and the inlet end is inserted into the ventricle through an opening at the apex of the heart. In order to fix it relatively to the heart, the blood pump is usually connected to the heart through a ventricular connector.

[0043] In related technologies, the ventricular connector includes a skirt and a retaining ring. The retaining ring includes a first half-ring, a second half-ring, and a threaded connector. The first half-ring and the second half-ring can form a channel for the inlet end of a blood pump to be inserted. One end of the first half-ring and the second half-ring are connected, and the other end is connected by the threaded connector. The threaded connector can rotate around its own axis, so that the other ends of the first half-ring and the second half-ring are closer to or further away from each other. This adjusts the radial dimension of the channel, thereby adjusting the clamping or releasing of the inlet end of the blood pump.

[0044] Implanting a blood pump requires creating a hole in the ventricular tissue of the heart.

[0045] In this regard, such as Figures 1-7 As shown in the figure, this application embodiment provides a cardiac opening assembly, including a ventricular connector 1 and an apical opening knife 2; the ventricular connector 1 has an inner ring 11, the inner ring 11 is provided with a plurality of first positioning parts 12, the surface of the first positioning parts 12 and the inner ring 11 is formed with a step, the first positioning parts 12 are arranged around the center of the inner ring 11 and are evenly spaced, and a clearance groove 122 is formed between two adjacent first positioning parts 12; the apical opening knife 2 has a main body 21, the outer periphery of the main body 21 is provided with a plurality of locking protrusions 22, the locking protrusions 22 and the first positioning parts 12 are one-to-one corresponding, the locking protrusions 22 are screwed into the clearance groove 122, and the locking protrusions 22 and the first positioning parts 12 are gap-fitted at the step 111 to realize the relative fixation of the apical opening knife 2 and the ventricular connector 1.

[0046] Based on the above technical solution, the ventricular connector 1 and the apical perforator 2 can be locked in the axial direction. The doctor can hold the apical perforator 2 with one hand to maintain the fit between the ventricular connector 1 and the ventricle, and press the blade 23 of the perforator into the ventricular tissue with the other hand to make an opening in the ventricle. The doctor's two hands can coordinate their efforts to ensure the stability of the operation and avoid injury to human tissue.

[0047] The main body 21 of the apical perforator 2 is inserted into the ventricular connector 1 and aligned with the ventricular connector 1 to ensure accurate perforation position and avoid misalignment of the perforation, which could lead to massive bleeding between the LVAD inlet tube and the ventricle. The apical perforator 2 can also remove the excised tissue from the ventricle.

[0048] The first positioning part 12 is arranged around the center of the inner ring 11 and at even intervals. The locking protrusion 22 cooperates with the first positioning part 12 to ensure that the apical drilling knife 2 and the ventricular connector 1 are aligned. When drilling the ventricle, the apical drilling knife 2 is prevented from shifting, which would cause the drilling to become skewed and result in massive bleeding.

[0049] In some embodiments, the number of first positioning parts 12 is 2-5. If there are two, two clearance grooves 122 can be formed between the two first positioning parts 12, and the line connecting the two clearance grooves 122 is perpendicular to the line connecting the center positions of the two first positioning parts 12. If there are three, three clearance grooves 122 can be formed between the three first positioning parts 12, and the central angle formed by the line connecting any two clearance grooves 122 and the center of the inner ring 11 is 120°. If there are four, four clearance grooves 122 can be formed between the four first positioning parts 12, and the central angle formed by the line connecting any two clearance grooves 122 and the center of the inner ring 11 is 90°. If there are five, five clearance grooves 122 can be formed between the five first positioning parts 12, and the central angle formed by the line connecting any two clearance grooves 122 and the center of the inner ring 11 is 72°.

[0050] When inserting the apical perforator 2 into the ventricular connector 1, the doctor can use one hand to hold and fix the outer ring 13 of the ventricular connector 1 with a tool, and use the other hand to align the locking protrusion 22 on the main body 21 of the apical perforator 2 with the relief groove 122 of the inner ring 11 of the ventricular connector 1 and insert it, and rotate the main body 21 relative to the ventricular connector 1 so that the locking protrusion 22 and the first positioning part 12 abut against each other.

[0051] The locking protrusion 22 has an end face 221 and auxiliary arc surfaces 222 disposed on opposite sides of the end face 221. The surface of the inner ring 11 forms a slope (not shown in the figure) starting from the position of the relief groove 122. The auxiliary arc surface 222 and the slope abut against each other, thereby restricting the rotation of the main body 21 in the circumferential direction. For example, when rotating the handle of the apical perforator 2 to make an incision in the ventricle, the main body 21 is restricted from moving by friction, so as to avoid affecting the doctor's operation. Here, the slope formed on the surface of the inner ring 11 can be achieved by using existing known methods.

[0052] Specifically, the auxiliary arc surface 222 has a first arc surface segment 222a and a second arc surface segment 222b arranged in the circumferential direction of the main body 21. The second arc surface segment 222b is connected to the outer periphery of the main body 21. The second arc surface segment 222b is recessed inward toward the locking protrusion 22. The first arc surface segment 222a protrudes outward away from the locking protrusion 22. The arc length of the second arc surface segment 222b in the circumferential direction of the main body 21 is greater than the arc length of the first arc surface segment 222a in the circumferential direction of the main body 21. The slope of the second arc surface segment 222b gradually becomes steeper from its position near the outer periphery of the main body 21 to its position connecting to the first arc surface segment 222a. In this way, the doctor can precisely control the force and easily rotate the main body 21 of the apical perforator 2 so that the locking protrusion 22 and the first positioning part 12 abut against each other, without causing the ventricular connector 1 to shift position.

[0053] In some embodiments, a plurality of internal teeth 121 are formed on the first positioning part 12, and the internal teeth 121 are configured to mesh with the inlet end of the blood pump; the locking protrusion 22 also has a thrust surface 223, and the end face of the first positioning part 12 and the thrust surface 223 cooperate to abut against each other to ensure that the apical perforation knife 2 and the ventricular connector 1 will not have relative axial movement. After the end face of the first positioning part 12 and the thrust surface 223 of the locking protrusion 22 cooperate to abut against each other, the gap between the two is small; in addition, a positioning outer circle 211 is formed on the main body 21, and a groove 26 is defined between the positioning outer circle 211 and the locking protrusion 22. The first positioning part 12 is connected in the groove 26. The positioning inner circle 124 of the ventricular connector 1 and the positioning outer circle 211 of the apical perforation knife 2 are also in close fit with a small gap. While the apical perforation knife 2 can be smoothly screwed in, it can be ensured that there will be no large skew or positional displacement between the apical perforation knife 2 and the ventricular connector 1. During this process, the contact friction generated is not very large and will not cause any obstruction when rotating the main body 21. The doctor can easily rotate the main body 21 and easily remove and install the apical endocardial knife 2 from the ventricular connector 1.

[0054] When the main body 21 is screwed into the inner ring 11 of the ventricular connector 1, the main body 21 needs to be driven to spiral outward relative to the ventricular connector 1 to avoid affecting the ventricle. However, in order to prevent the locking protrusion 22 from leaving the first positioning part 12, a plurality of blocking parts 123 are also provided on the inner ring 11. The blocking parts 123 correspond one-to-one with the first positioning part 12. The blocking parts 123 protrude from the side edge of the first positioning part 12 and can restrict the main body 21.

[0055] The apex drilling cutter 2 also has a cutting head 23, a rotating handle 24 and a handle connecting rod. The rotating handle 24 is movably located at the rear end of the main body 21, and the cutting head 23 is connected to the front end of the main body 21. The cutting head 23 and the rotating handle 24 are connected by a handle connecting rod. An elastic element is connected between the interior of the main body 21 and the rotating handle 24.

[0056] Before use, make a cross-shaped incision at the apex of the heart with a scalpel, then insert the blade 23 into the apex of the heart to complete the incision. Press the palm against the rotating handle 24 to compress the elastic element and drive the blade 23 to rotate to remove the tissue. When the rotating handle 24 is driven to rotate the blade 23, the slope on the outer periphery of the main body 21 and the end face 221 of the locking protrusion 22 generate friction. The friction will limit the rotation of the main body 21, thereby preventing the main body 21 from rotating with the rotating handle 24, making the doctor's operation smoother.

[0057] As a preferred option, the elastic element can be a spring, which is directly sleeved on the outer periphery of the handle connecting rod, with the two ends of the spring abutting against the inner side of the main body 21 and the rotating handle 24, respectively.

[0058] Furthermore, a pair of locking handles 25 are transversely provided on the main body 21, which are used to lock the handle connecting rod in the axial direction of the main body 21 when the cutter head 23 is extended, so as to prevent the cutter head 23 from moving in the axial direction of the main body 21 during drilling, which would affect the drilling action and drilling accuracy.

[0059] The ventricular connector 1 also has an outer ring 13, on which a second positioning portion 14 is formed. The second positioning portion 14 has a plurality of continuous external teeth and is configured to match and fix with a clamping tool.

[0060] Specifically, the ventricular connector 1 includes a first frame 16, a second frame 17, a crimping member 18, and a skirt member 19. The first frame 16, the second frame 17, the crimping member 18, and the skirt member 19 are all annular. The first frame 16 has an inner ring 11 defined inside. The skirt member 19 is connected to the end of the first frame 16. The crimping member 18 is sleeved on the outer periphery of the first frame 16 to press the skirt member 19. The second frame 17 is fastened to the outer periphery of the first frame 16 to press the crimping member 18.

[0061] The second frame 17 is provided with a plurality of circumferentially spaced protrusions 171. The crimping member 18 has through holes corresponding to the positions of each protrusion 171, and each protrusion 171 passes through the corresponding through hole and inserts into the skirt member 19.

[0062] The end of the first frame 16 is provided with a flange 161, and the skirt member 19 is clamped between the flange 161 and the pressing member 18.

[0063] Furthermore, a protrusion 162 is provided on the outer peripheral surface of the first frame 16, and a groove is provided on the inner peripheral side of the crimping member 18 and the second frame 17 to avoid the protrusion 162, so that the crimping member 18 and the second frame 17 can be fitted onto the outer periphery of the first frame 16. A snap-fit ​​groove is also constructed on the inner side of the second frame 17, and the protrusion 162 is snapped into the snap-fit ​​groove. The snap-fit ​​groove can support the protrusion 162 in the axial direction and prevent the first frame 16 from axially falling off relative to the second frame 17.

[0064] A first countersunk hole is provided on the end face 221 of the second frame 17, and a second countersunk hole is provided on the end face 221 of the protrusion 162. When the protrusion 162 is engaged in the engagement groove, the first countersunk hole and the second countersunk hole are combined to form a complete countersunk hole. The fastener can be threaded into this complete countersunk hole to prevent the second frame 17 and the protrusion 162 from rotating relative to each other, that is, to prevent the second frame 17 and the first frame 16 from rotating relative to each other in the circumferential direction.

[0065] In the description of this utility model, "several" means one or more, "multiple" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0066] In the description of this utility model, unless otherwise explicitly defined, terms such as "setting," "installation," and "connection" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this utility model in conjunction with the specific content of the technical solution.

[0067] In the description of this utility model, the terms "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of this utility model. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0068] The technical means disclosed in this utility model are not limited to those disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of this utility model, and these improvements and modifications are also considered within the scope of protection of this utility model.

Claims

1. A heart fenestration assembly, comprising: include: A ventricular connector has an inner ring with a plurality of first positioning portions. The surfaces of the first positioning portions and the inner ring are stepped. The first positioning portions are evenly spaced around the center of the inner ring, and a clearance groove is formed between two adjacent first positioning portions. The apical perforator has a main body with multiple locking protrusions on its outer periphery. Each locking protrusion corresponds to a first positioning part. The locking protrusions are screwed into the relief groove and are in clearance fit with the first positioning part at the step, thereby fixing the apical perforator and the ventricular connector relative to each other.

2. The cardiac opening assembly according to claim 1, characterized in that, The number of the first positioning parts is 2-5.

3. The cardiac opening assembly according to claim 1, characterized in that, The locking protrusion has an end face and auxiliary arc surfaces disposed on opposite sides of the end face. The auxiliary arc surfaces have a first arc surface segment and a second arc surface segment arranged along the circumferential direction of the main body. The second arc surface segment connects to the outer periphery of the main body. The second arc surface segment is recessed towards the inside of the locking protrusion. The first arc surface segment protrudes outward in a direction away from the locking protrusion. The arc surface length of the second arc surface segment in the circumferential direction of the main body is greater than the arc surface length of the first arc surface segment in the circumferential direction of the main body.

4. The cardiac opening assembly according to claim 3, characterized in that, The slope of the second arc segment gradually becomes steeper from its position near the outer periphery of the main body to its position where it connects to the first arc segment.

5. The cardiac opening assembly according to claim 3, characterized in that, The locking protrusion also has a thrust surface, and the end face of the first positioning part and the thrust surface of the locking protrusion abut against each other.

6. The cardiac opening assembly according to claim 1, characterized in that, The inner ring is also provided with a plurality of blocking parts, each of which corresponds to the first positioning part. The blocking parts protrude from the side edge of the first positioning part and can restrict the main body.

7. The cardiac opening assembly according to claim 1, characterized in that, A positioning outer circle is formed on the main body, and a groove is defined between the positioning outer circle and the locking protrusion, and the first positioning part is connected in the groove.

8. The cardiac opening assembly according to claim 1, characterized in that, The apical drilling tool also has a cutting head, a rotating handle, and a handle connecting rod; The rotating handle is movably located at the rear end of the main body; The cutting head is connected to the front end of the main body, and the cutting head and the rotating handle are connected by the handle linkage. An elastic element connects the interior of the main body and the rotating handle.

9. The cardiac opening assembly according to claim 1, characterized in that, The ventricular connector also has an outer ring, on which a second positioning portion is formed, the second positioning portion being configured to match and fix with a clamping tool.

10. The cardiac opening assembly according to claim 1, characterized in that, The ventricular connector includes a first frame, a second frame, a crimping member, and a skirt component; The first frame, the second frame, the pressing member, and the skirt component are all annular; The inner ring is defined inside the first frame. The skirt component is connected to the end of the first frame; The pressing component is sleeved on the outer periphery of the first frame and is used to press the skirt component tightly; The second frame is fastened to the outer periphery of the first frame to press the crimping member.

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