A valve chordae tendineae-assisted reconstruction device and method

Abstract

This invention discloses a device and method for chordae tendineae-assisted mitral valve reconstruction, belonging to the field of minimally invasive cardiac surgical instruments. It includes a gripping component, a pressure bar sheath, a pressure bar, and a fixation frame. The innovative aspects of this invention are as follows: Innovative procedures: The traditional steps are simplified to "temporary fixation → assessment → final fixation," significantly shortening the operation time and improving the success rate; Precise control: The locking component can lock or release the pressure bar in real time at the gripping end, achieving stepless adjustment of the chordae tendineae height and preventing suture slippage; Repeatable adjustment: The tension of the chordae tendineae can be repeatedly fine-tuned during the operation, and the closure of the valve leaflets can be verified immediately, eliminating the need for repeated loosening and threading of sutures; Economical and safe: The overall structure is simple, resistant to high-temperature and high-pressure sterilization, and reusable, without increasing disposable consumables or patient costs; Minimally invasive compatibility: Particularly suitable for small-incision mitral valve repair techniques; This invention has outstanding advantages in simplifying the operation process, improving fixation accuracy, and reducing medical costs, and can be widely applied to various mitral valve chordae tendineae reconstruction surgeries.

Description

Technical Field

[0001] This invention relates to the field of minimally invasive cardiac surgical instruments, and more particularly to a valve chordae tendineae-assisted reconstruction device and method. Background Technology

[0002] Determining the height of the chordae tendineae at the leaflet margins is a crucial step in mitral and tricuspid valve chordae tendineae reconstruction. This can be achieved primarily through several methods: 1. fixed length, 2. anatomical length, and 3. adjustable length. Among these, the "adjustable length" method is widely used clinically due to its versatility and ease of adjustment.

[0003] However, with traditional "adjustable length" methods, whether "continuous suture" or "loop suture," surgeons typically need to use forceps or other tools to first fix the height of the chordae tendineae before tying them. Factors such as the diversity of mitral valves, differences in surgeon technique, and operational errors can all cause displacement of the chordae tendineae fixation point, resulting in an actual fixation height deviating from the target height. This can lead to incomplete closure during the hydropneumatic test. In such cases, it is necessary to readjust the fixation position by untying the knots. This "fixation-testing-untying-refixation" process is cumbersome and time-consuming, and the risk of incomplete closure remains uncontrollable. Summary of the Invention

[0004] The purpose of this invention is to provide a valve chordae tendineae-assisted reconstruction device and method to solve the problem that the fixed height may shift during knotting in the traditional "chordae tendineae-leaflet fixation steps," which may result in repeated "fixation-detection-loosening of knots-refixation-redetection."

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0006] This invention discloses a valve chordae tendineae-assisted reconstruction device, comprising a gripping assembly. The gripping assembly includes a fixed grip and a movable grip. A pressure bar sheath is provided on one side of the fixed grip, and a pressure bar is provided inside the pressure bar sheath. The movable grip drives the pressure bar to move. A fixing frame is provided at the bottom of the pressure bar sheath away from the fixed grip, and a partition is provided on the fixing frame. A locking assembly for locking the position of the pressure bar is provided between the fixed grip and the movable grip.

[0007] Furthermore, the fixing frame is inclinedly disposed at the end of the pressure bar sheath.

[0008] Furthermore, the pressure bar includes a first rod body and a second rod body, with a transition slope provided between the first rod body and the second rod body.

[0009] Furthermore, the end of the second rod away from the first rod is configured as an arc-shaped end.

[0010] Furthermore, the bent portion of the first rod is connected to the movable handle.

[0011] Furthermore, the locking assembly includes a first lock and a second lock, which are respectively disposed on the fixed handle and the movable handle, and the opposing surfaces of the first lock and the second lock are configured with mutually matching teeth.

[0012] A method for reconstructing chordae tendineae, using the auxiliary reconstruction device described above to fix and knot the chordae tendineae, includes the following steps:

[0013] Step 1: Pass the artificial tendon chord fixed to the papillary muscle through the edge of the mitral valve leaflet to be fixed, with a spacing of 3-5 mm; insert the two free ends of the artificial tendon chord into the fixation frame from the lower end of the pressure bar sheath, so that the two free ends are located on both sides of the septum.

[0014] Step 2: Hold the device and adjust the relative height of the bottom of the device. After the height is determined, use the movable handle to push the pressure bar down along the pressure bar sheath to lock the artificial tendon cable into the bottom edge of the device and fix it with the locking assembly.

[0015] Step 3: Conduct a water injection test to check the valve closure and adjust the fixed height in real time according to the test results;

[0016] Step 4: When the results of the water-spraying experiment in Step 3 meet expectations, tie a knot at the free end of the artificial tendon chord to fix the knot at the bottom of the device, with the knot located on the outside of the partition.

[0017] Step 5: Loosen the pressure bar, move the device so that the knot is above the separator, and retract the knot into the pressure bar sheath;

[0018] Step six: Remove the extraction device.

[0019] Compared with the prior art, the beneficial technical effects of the present invention are as follows:

[0020] The device of the present invention comprises a grip assembly, a pressure bar sheath, a pressure bar, and a fixing frame: the grip assembly includes a fixed grip and a movable grip, with a one-button lock between them; the pressure bar sheath is fixed to the front end of the fixed grip and slidably accommodates the pressure bar inside; a fixing frame is provided at the bottom of the distal end of the pressure bar sheath for temporarily anchoring the tendon chord. This invention addresses potential uncertainties in the "chordae tendineae-leaflet fixation procedure" by proposing an instrument that allows for flexible adjustment of the chordae tendineae fixation height. It simplifies the traditional "chordae tendineae-leaflet fixation procedure" of "fixing the knot → assessing leaflet closure → loosening the knot → re-fixing" to "temporary fixation → assessment → final fixation," improving the issue of displacement during knot tying in traditional artificial chordae tendineae fixation. The "locking assembly" at the gripping end controls the flexible adjustment of the pressure rod, fixing the artificial chordae tendineae height and performing a water injection test. After the water injection test determines the height, the position where the pressure rod fixes the artificial chordae tendineae is its knotting position, effectively ensuring consistency between the chordae tendineae fixation height and the knot position. Surgeons can use this device to repeatedly adjust and test the chordae tendineae fixation height, thereby effectively reducing the risk of repeated "knot loosening and re-fixation," improving surgical efficiency and success rate. Attached Figure Description

[0021] The present invention will be further described below with reference to the accompanying drawings.

[0022] Figure 1 This is a front view of the valve chordae tendineae-assisted reconstruction device of the present invention;

[0023] Figure 2 This is a cross-sectional view of the valve chordae tendineae-assisted reconstruction device of the present invention;

[0024] Figure 3 This is a partial structural schematic diagram from the main view of the artificial tendon chord insertion state of the present invention;

[0025] Figure 4 This is a partial structural schematic diagram of the artificial tendon chord inserted in the present invention, viewed from below.

[0026] Figure 5 This is a partial structural schematic diagram of the artificial tendon cord compression state from a frontal view angle.

[0027] Figure 6 This is a partial structural schematic diagram of the artificial tendon cord compression state of the present invention, viewed from below.

[0028] Figure 7 This is a partial structural schematic diagram of the artificial tendon cord knot state from the main view angle of the present invention;

[0029] Figure 8 for Figure 7 Enlarged view of A in the middle;

[0030] Figure 9 This is a partial structural schematic diagram of the artificial tendon chords of the present invention from a bottom-view angle, showing the compressed and knotted state of the tendon chords.

[0031] Figure 10 This is a partial structural diagram of the reconstruction device of the present invention, showing the partition moving downwards and away from the artificial tendon chords, viewed from an upward angle.

[0032] Figure 11 This is a partial structural schematic diagram of the reconstruction device of the present invention in a state of separation from the artificial tendineae, viewed from below.

[0033] Figure 12 This is a schematic diagram of the locking assembly of the present invention.

[0034] Explanation of reference numerals in the attached drawings: 1. Fixed grip; 2. Movable grip; 3. Pressure bar sheath; 4. Pressure bar; 401. First bar body; 402. Second bar body; 403. Transition slope; 5. Locking assembly; 501. First lock; 502. Second lock; 6. Fixed frame; 601. Divider; 7. Artificial tendon chord. Detailed Implementation

[0035] like Figure 1-12 As shown, a valve chordae tendineae-assisted reconstruction device includes a grip assembly comprising a fixed grip 1 and a movable grip 2. A pressure bar sheath 3 is connected to one side of the fixed grip 1, and a pressure bar 4 is disposed inside the pressure bar sheath 3. The movable grip 2 drives the pressure bar 4 to move. A fixing frame 6 is connected to the bottom of the pressure bar sheath 3 away from the fixed grip 1, and a partition 601 is connected to the fixing frame 6. A locking assembly 5 for locking the position of the pressure bar 4 is provided between the fixed grip 1 and the movable grip 2. Specifically, the width of the partition 601 in this device is 3 mm.

[0036] The fixing frame 6 is installed at an angle at the end of the pressure bar sheath 3; the ramp design increases the fit between the device and the leaflet edge when the mitral valve is closed.

[0037] The pressure rod 4 includes a first rod body 401 and a second rod body 402, with a transition slope 403 connecting the first rod body 401 and the second rod body 402. The end of the second rod body 402 away from the first rod body 401 is configured as an arc-shaped end.

[0038] The fixed grip 1 and the movable grip 2 are hinged together by a connecting shaft; the bent part of the first rod 401 is connected to the movable grip 2.

[0039] like Figure 11As shown, the locking assembly 5 includes a first locking buckle 501 and a second locking buckle 502. The first locking buckle 501 and the second locking buckle 502 are respectively connected to the fixed handle 1 and the movable handle 2. The opposing surfaces of the first locking buckle 501 and the second locking buckle 502 are provided with matching teeth. The control lever of the "locking assembly" at the holding end of the device is flexibly adjusted to fix the height of the artificial tendon chord and to conduct water spraying test.

[0040] A method for reconstructing chordae tendineae, using the auxiliary reconstruction device described above to fix and knot the chordae tendineae, includes the following steps:

[0041] Step 1: Pass the artificial tendineae 7, fixed to the papillary muscle, through the edge of the mitral valve leaflet to be fixed, at intervals of 3-5 mm; insert the two free ends of the artificial tendineae 7 into the fixation frame 6 from the lower end of the pressure bar sheath 3, so that the two free ends are located on both sides of the partition 601; (e.g. Figure 3-4 (As shown)

[0042] Step two: Hold the device and adjust the relative height of its bottom. Once the height is determined, use the movable handle 2 to push the pressure rod 4 down along the pressure rod sheath 3, securing the artificial tendon chord 7 to the bottom edge of the device. Secure it using the locking assembly 5. (e.g.) Figure 5-6 (As shown)

[0043] Step 3: Conduct a water injection test to check the valve closure and adjust the fixed height in real time according to the test results;

[0044] Step four: If the water-spraying experiment results in step three meet expectations, tie a knot at the free end of the artificial tendon chord 7, fixing the knot to the bottom of the device, with the knot positioned outside the partition 601; (e.g.) Figure 7-9 (As shown)

[0045] Step 5: Loosen the pressure rod 4, move the device so that the knot is above the separator 601, and the knot retracts into the pressure rod sheath 3; (e.g.) Figure 10 (As shown)

[0046] Step six, remove the extraction device. (e.g.) Figure 11 (As shown)

[0047] After determining the height through a water-spraying experiment, the position of the artificial tendon cord fixed by the pressure rod is the knot position (with an error of less than 1mm), effectively ensuring the consistency between the tendon cord fixing height and the knot position.

[0048] The innovations of this invention are as follows: (1) Step innovation: The traditional cycle of "fixing the knot → assessing the leaflet closure → loosening the knot → re-fixing" is simplified to "temporary fixation → assessment → final fixation", which significantly shortens the operation time and improves the success rate. (2) Precise control: The locking component can lock or release the pressure rod at the grip end in real time, realizing stepless adjustment of the chordae tendineae height; the current position of the pressure rod is the final knot position, completely avoiding the slippage of the knot. (3) Repeatable adjustment: The tension of the chordae tendineae can be repeatedly finely adjusted during the operation and the leaflet closure can be verified in real time without repeated loosening and threading. (4) Economical and safe: The overall structure is simple, resistant to high temperature and high pressure sterilization, and can be reused without increasing disposable consumables and patient costs. (5) Minimally invasive compatibility: It is particularly suitable for small incision mitral valve repair technology, providing reliable support for fine operation in limited space. In summary, this invention has outstanding advantages in simplifying the operation process, improving fixation accuracy and reducing medical costs, and can be widely used in various mitral valve chordae tendineae reconstruction surgeries.

[0049] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A valve chordae-assist reconstruction device, characterized by: The device comprises a holding assembly, which comprises a fixed handle (1) and a movable handle (2), one side of the fixed handle (1) is provided with a pressure rod sheath (3), the inside of the pressure rod sheath (3) is provided with a pressure rod (4), the movable handle (2) drives the pressure rod (4) to move, the bottom of the end of the pressure rod sheath (3) away from the fixed handle (1) is provided with a fixed frame (6), the fixed frame (6) is provided with a separation part (601), two free ends of an artificial tendon chord (7) are passed into the fixed frame (6) from the lower end of the pressure rod sheath (3), so that the two free ends are located on the two sides of the separation part (601) respectively; the fixed frame (6) is obliquely arranged at the end of the pressure rod sheath (3), through the slope design, the fitting degree of the device and the edge of the valve leaflet when the mitral valve is closed is increased; a lock buckle assembly (5) for locking the position of the pressure rod (4) is arranged between the fixed handle (1) and the movable handle (2), the lock buckle assembly (5) comprises a first lock buckle (501) and a second lock buckle (502), the first lock buckle (501) and the second lock buckle (502) are arranged on the fixed handle (1) and the movable handle (2) respectively, the opposite surfaces of the first lock buckle (501) and the second lock buckle (502) are provided with the clamping teeth matched with each other; the lock buckle assembly (5) can lock or release the pressure rod at the holding end in real time, so that the stepless adjustment of the height of the tendon chord is realized; through the control of the lock buckle assembly (5) of the holding end of the device, the pressure rod is flexibly adjusted, the height of the artificial tendon chord (7) is fixed, and the water test detection is carried out.

2. The valve chordae-assist reconstruction device according to claim 1, characterized in that: The pressure rod (4) comprises a first rod body (401) and a second rod body (402), and a transition inclined surface (403) is arranged between the first rod body (401) and the second rod body (402).

3. The valve chordae-assist reconstruction device of claim 2, wherein: The end of the second rod body (402) away from the first rod body (401) is provided with an arc-shaped end head.

4. The valve chordae-assist reconstruction device according to claim 2, characterized in that: The bent part of the first rod body (401) is connected with the movable handle (2). The bent part of the first rod body (401) is connected with the movable handle (2).

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