Pressure compensation device for tissue ligation, tissue ligation component and ligation device

Abstract

The invention relates to a pressure compensation device for tissue ligation, a tissue ligation component and a ligation device. The pressure compensation device for tissue ligation comprises a pressure compensation main body, the pressure compensation main body comprises a radial direction perpendicular to the surface direction of a to-be-ligated tissue and an axial direction tangent to the surface direction of the to-be-ligated tissue; the pressure compensation body comprises a flexible inner layer, a flexible middle layer and a flexible outer layer in the radial direction away from the surface of the to-be-ligated tissue. The pressure compensation body comprises a first adjusting portion enabling the pressure compensation body to contract in the radial direction and a second adjusting portion adjusting the width of the pressure compensation body in the axial direction. The pressure compensation device for tissue ligation can be conveyed along with a tissue ligation component through the catheter, surgical wounds are reduced, the effect of fixed-point tissue ligation is achieved, the pressure compensation device can adapt to the forms of various to-be-ligated tissues, and damage to ligation parts in the tissue ligation process can be effectively avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and relates to an implantable medical device, in particular to a pressure compensation device for tissue ligation, a tissue ligation component and a ligation device. Background Art

[0002] For most neoplasms or redundant soft tissues in the human body, surgical resection is generally used, and usually good therapeutic effects can be achieved. However, for some neoplasms or soft tissues, such as hemangiomas, left atrial appendages, etc., which are not suitable for resection, ligation or occlusion means are often used for treatment.

[0003] Taking the left atrial appendage as an example, the left atrial appendage is a long and narrow, curved blind-end structure extending forward and downward along the anterior lateral wall of the left atrium, and has the functions of active contraction and relaxation. The left atrial appendage has two relatively prominent characteristics. One is the large individual differences in its shape and size. For example, the internal volume is at least 0.77 mL and at most 19.2 mL; the length range can be from 16 mm to 51 mm; the internal opening diameter is at least 5 mm and at most 40 mm, and the main axes of 70% of the left atrial appendages are significantly curved or spiral. Different from the mature left atrium, the left atrial appendage has rich pectinate muscles and trabeculae. The diameters of 97% of the pectinate muscles are greater than 1 mm. The ear edge has serrated notches and is lobulated, and 80% has multiple lobes. The other is that the tissue at the root of the left atrial appendage is very fragile, especially in elderly patients. Therefore, when using a device or instrument to clamp or ligate the left atrial appendage from the outside, it not only needs to be adaptable to left atrial appendages of various shapes and sizes to easily locate and capture the left atrial appendage, but also needs to avoid tearing the tissue at the root of the left atrial appendage.

[0004] At present, representatives of such products on the market include the AtriClip series of clamping devices of Atricure company and the LARIAT series of ligation devices of SentreHeart company, both of which have been applied in clinical operations. To be applicable to left atrial appendages of different sizes and shapes, the AtriClip series of clamping devices provides a variety of size specifications, including ACH135 (35 mm), ACH140 (40 mm), ACH145 (45 mm), ACH150 (50 mm), ACH160 (60 mm) and ACH170 (70 mm). The LARIAT series of ligation devices provides two specifications, LARIAT45 (45 mm) and LARIAT50 (50 mm). However, due to the complex anatomical structure of the left atrial appendage, all requirements still cannot be met.

[0005] In terms of the principle of action, the AtriClip series of clamping devices control the clamping force through a nitinol spring, and the LARIAT series of ligation devices control the tightening force through a ligation wire tightener to clamp or ligate the root of the left atrial appendage. In addition, the AtriClip series of devices are surgical instruments with a large surgical trauma surface, a long recovery period, and are prone to complications. The LARIAT series of devices are transcatheter surgical instruments that can avoid such problems and can also avoid tearing the left atrial appendage by controlling the ligation force. However, the ligation wire does not have any device for releasing stress, and the magnitude of the ligation force is subjectively controlled by the user. Applying a large ligation force to a smaller left atrial appendage is likely to be cut by the ligation wire, while applying a small ligation force to a larger left atrial appendage is likely to result in an incomplete ligation and a residual cavity. Therefore, a structure or device for releasing stress needs to be added during the clamping and ligation of the left atrial appendage to avoid the above problems. Summary of the Invention

[0006] Aiming at the deficiencies of the existing technology, the purpose of the present invention is to provide a pressure compensation device for tissue ligation, a tissue ligation component, and a ligation device. The pressure compensation device for tissue ligation can effectively avoid damage to the ligation site during tissue ligation, especially avoid damage to the root of the left atrial appendage during the ligation of the left atrial appendage, and can also be transported through a catheter together with the tissue ligation component, reducing surgical trauma and achieving the effect of targeted tissue ligation.

[0007] To achieve the purpose of this invention, the following technical solutions are adopted:

[0008] In the first aspect, the present invention provides a pressure compensation device for tissue ligation, and the pressure compensation device for tissue ligation includes a pressure compensation main body;

[0009] The pressure compensation main body includes a radial direction perpendicular to the surface of the tissue to be ligated and an axial direction tangent to the surface of the tissue to be ligated;

[0010] Along the radial direction away from the surface of the tissue to be ligated, the pressure compensation main body includes a flexible inner layer, a flexible intermediate layer, and a flexible outer layer.

[0011] The pressure compensation main body includes a first adjustment part for contracting the pressure compensation main body in the radial direction and a second adjustment part for adjusting the width of the pressure compensation main body in the axial direction.

[0012] The structures of the first adjustment part and the second adjustment part are each independently at least one of a laminated folding adjustment part, a mechanical adjustment part, an elastic spring adjustment part, a memory material adjustment part, or an inflation adjustment part; the memory material adjustment part uses a memory material for shape adjustment; optionally, the memory material of the present invention includes a memory material that deforms with temperature.

[0013] The pressure compensation device for tissue ligation provided by the present invention has a simple structure and can be transported together with the tissue ligation component through a catheter. Moreover, the pressure compensation device for tissue ligation can effectively avoid damage to the ligation site during the tissue ligation process, especially avoid damage to the root of the left atrial appendage during the left atrial appendage ligation process. The size can also be flexibly set according to the shape of the left atrial appendage, so as to adapt to the shapes of various tissues to be ligated.

[0014] Preferably, the first adjusting portion is arranged on the flexible inner layer.

[0015] Preferably, the first adjustment portion is a laminated folding adjustment portion, including a flexible folding portion and a first adjustment rope passing through the flexible folding portion; the first adjustment rope is used to adjust the folding amplitude of the flexible folding portion, thereby adjusting the contraction amplitude of the pressure compensation body in the radial direction.

[0016] Preferably, the pressure compensation body includes a first surface and a second surface in an axial direction.

[0017] The second adjustment portion includes a second adjustment rope that reciprocates and pierces the first surface and the second surface respectively; the second adjustment rope is used to adjust the width of the pressure compensation body in the axial direction.

[0018] Preferably, the flexible intermediate layer is filled with a sustained-release substance.

[0019] Preferably, the sustained-release material comprises a sustained-release drug; the sustained-release drug has a degradable outer coating and can slowly release the drug when used.

[0020] Preferably, a bionic structure is provided on the surface of one side of the flexible inner layer close to the auricle;

[0021] The bionic structure comprises curved grooves distributed along the circumference of the pressure compensation body.

[0022] Preferably, a bionic structure is provided on a surface of the flexible outer layer away from the auricle;

[0023] The bionic structure comprises curved grooves distributed along the circumference of the pressure compensation body.

[0024] In a second aspect, the present invention provides a tissue ligating component, comprising a support ring, a tightening portion connected to the support ring, and the pressure compensation device for tissue ligation described in the first aspect arranged on a side of the tightening portion close to the surface of the tissue to be ligated.

[0025] Preferably, the tightening portion comprises a net bag and a ligature for tightening an open end of the net bag;

[0026] The connection method between the ligature rope and the pressure compensation device for tissue ligation includes:

[0027] A plurality of the pressure compensation devices for tissue ligation are discontinuously distributed on the tightening side of the tightening part;

[0028] Or, the ligation rope reciprocally penetrates through the pressure compensation device for tissue ligation;

[0029] Or, the pressure compensation device for tissue ligation spirally winds around the tightening part.

[0030] In a third aspect, the present invention provides a ligation device, which includes the pressure compensation device for tissue ligation described in the first aspect or the tissue ligation component described in the second aspect.

[0031] The numerical ranges described in the present invention not only include the point values exemplified above, but also include any point values between the above numerical ranges not exemplified. Due to space limitations and for the sake of brevity, the present invention does not exhaustively list the specific point values included in the ranges.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The pressure compensation device for tissue ligation provided by the present invention has a simple structure, can be transported together with the tissue ligation component through a catheter, and the pressure compensation device for tissue ligation can effectively avoid damage to the ligation site during tissue ligation, especially avoid damage to the root of the left atrial appendage during left atrial appendage ligation, and can also be flexibly sized according to the morphology of the tissue to be ligated, so as to be able to adapt to the morphology of various tissues to be ligated. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 Schematic structural diagram of the pressure compensation device when the first adjustment part is a laminated folding adjustment part;

[0035] Figure 2 Schematic structural diagram of the pressure compensation device when the first adjustment part is a mechanical adjustment part;

[0036] Figure 3 Schematic structural diagram of the pressure compensation device when the first adjustment part is an elastic spring adjustment part;

[0037] Figure 4 and Figure 5 Schematic structural diagram of the pressure compensation device when the first adjustment part is an inflation adjustment part;

[0038] Figure 6 Schematic structural diagram of the bionic structure;

[0039] Figure 7 Schematic structural diagram of the pressure compensation device for tissue ligation discontinuously distributed on the tightening side of the ligation rope;

[0040] Figure 8 Schematic diagram of the structure where the ligation rope reciprocally penetrates through the flexible inner layer and the flexible outer layer of the pressure compensation device for tissue ligation;

[0041] Figure 9 Schematic diagram of the structure of the pressure compensation device for tissue ligation with the ligation rope spirally wound.

[0042] Wherein: 1, pressure compensation device for tissue ligation; 101, outer surface; 102, inner surface; 103, first surface; 104, second surface; 105, bionic structure; 201, flexible folding part; 202, first adjustment pull rope; 203, corrugated cloth; 204, rotary fastener; 205, spring; 206, air inlet; 207, air outlet; 301, second adjustment pull rope; 4, ligation rope. Specific embodiments

[0043] The technical solution of the present invention will be further described below through specific embodiments. Those skilled in the art should understand that the embodiments are only for helping to understand the present invention and should not be regarded as specific limitations to the present invention.

[0044] An embodiment of the present invention provides a pressure compensation device 1 for tissue ligation, and the pressure compensation device 1 for tissue ligation includes a pressure compensation main body;

[0045] The pressure compensation main body includes a radial direction perpendicular to the surface direction of the tissue to be ligated and an axial direction tangent to the surface direction of the tissue to be ligated;

[0046] Along the radial direction away from the surface of the tissue to be ligated, the pressure compensation main body includes a flexible inner layer, a flexible intermediate layer and a flexible outer layer.

[0047] The pressure compensation device 1 for tissue ligation provided by the present invention has a simple structure, can be transported together with the tissue ligation component through a catheter, and the pressure compensation device 1 for tissue ligation can effectively avoid damage to the ligation site during tissue ligation, especially avoid damage to the root of the left atrial appendage during left atrial appendage ligation, and can also be transported together with the tissue ligation component through a conventional catheter in the art, reducing surgical trauma and achieving the effect of fixed-point tissue ligation.

[0048] Exemplarily, the pressure compensation main body of the pressure compensation device 1 for tissue ligation provided by the present invention includes a flexible inner layer, a flexible intermediate layer and a flexible outer layer, and it can be connected to a net bag with a ligation rope 4; the net bag with the ligation rope 4 is connected to a support ring, and the overall structure can be received into the catheter and released.

[0049] In the present invention, the flexible inner layer, the flexible intermediate layer and the flexible outer layer are separated by sewing cloth. Exemplarily, along the radial direction away from the surface of the tissue to be ligated, the pressure compensation body at least includes an inner layer surface 102, a first sewing cloth, a second sewing cloth and an outer layer surface 101. The inner layer surface 102 and the first sewing cloth form the flexible inner layer, the first sewing cloth and the second sewing cloth form the flexible intermediate layer, and the second sewing cloth and the outer layer surface 101 form the flexible outer layer.

[0050] The inner layer surface 102 herein refers to the contact surface of the pressure compensation body with the tissue to be ligated; the outer layer surface 101 herein refers to the surface of the pressure compensation body on the side away from the tissue to be ligated.

[0051] In some embodiments, the pressure compensation body includes a first adjusting portion for contracting the pressure compensation body in the radial direction, and a second adjusting portion for adjusting the width of the pressure compensation body in the axial direction.

[0052] The structures of the first adjusting portion and the second adjusting portion are each independently at least one of a laminated folding adjusting portion, a mechanical adjusting portion, an elastic spring adjusting portion, a memory material adjusting portion or an inflatable adjusting portion; the memory material adjusting portion uses a memory material for shape adjustment; optionally, the memory material in the present invention includes a memory material that deforms with temperature.

[0053] The tissue ligation pressure compensation device 1 provided by the present invention has a simple structure, can be transported together with the tissue ligation component through a catheter, and the tissue ligation pressure compensation device 1 can effectively avoid damage to the ligation site during tissue ligation, especially avoid damage to the root of the left atrial appendage during left atrial appendage ligation, and can also flexibly set the size according to the shape of the left atrial appendage, so as to adapt to the shapes of various tissues to be ligated.

[0054] When the first adjusting portion is a laminated folding adjusting portion, its structural schematic diagram is as Figure 1 shown. When the laminated folding adjusting portion is tightened, the tissue ligation pressure compensation device 1 contracts in the radial direction, and when the laminated folding adjusting portion is restored, the tissue ligation pressure compensation device 1 is released in the radial direction.

[0055] In some embodiments, the sewing cloth used for the laminated folding adjusting portion has a porosity of 30%-50%, a thickness of 0.07 mm-1.5 mm, a water seepage coefficient of 150 mL / (min / cm 2 )-300 mL / (min / cm 2 ), a bursting strength ≥50 N, a transverse tensile strength of 1.5 N / mm-6 N / mm, and a longitudinal tensile strength of 1.5 N / mm-6 N / mm.

[0056] When the first adjustment part is a mechanical adjustment type adjustment part, its structural schematic diagram is as shown in Figure 2 shown. As a preferred technical solution, its mechanical adjustment structure includes a corrugated sewing cloth 203; one end of the corrugated sewing cloth 203 is fixed, and the other end is connected to a rotating fastener 204; the rotating fastener 204 is fixed on the outer surface of the pressure compensation device and can rotate relatively to adjust the tightness of the corrugated sewing cloth 203; when the corrugated sewing cloth 203 is tightened, the corrugated sewing cloth 203 is flattened, and the pressure compensation device 1 for tissue ligation moves away from the ligated tissue in the radial direction; when the corrugated sewing cloth 203 is not tightened, the sewing cloth returns to the corrugated shape during sewing, and the pressure compensation device 1 for tissue ligation contracts in the radial direction.

[0057] In some embodiments, the porosity of the corrugated sewing cloth 203 used in the mechanical adjustment type adjustment part is 30%-50%, the thickness is 0.07 mm-1.5 mm, the water permeability coefficient is 150 mL / (min / cm 2 )-300 mL / (min / cm 2 ), the bursting strength is ≥50 N, the transverse tensile strength is 1.5 N / mm-6 N / mm, and the longitudinal tensile strength is 1.5 N / mm-6 N / mm.

[0058] When the first adjustment part is an elastic spring type adjustment part, its structural schematic diagram is as shown in Figure 3 shown. As a preferred technical solution, its elastic spring type adjustment structure includes a spring 205 arranged on an elastic guide rail. Pull wires are arranged at both ends of the spring 205. When the pull wires at both ends are pulled simultaneously, the spring 205 is pulled out along with the pull wires, and the spring 205 deforms to adjust the contraction and release state of the pressure compensation device 1 for tissue ligation.

[0059] In some embodiments, the pitch of the spring 205 of the elastic spring type adjustment part is 0.5 mm-1.5 mm, the pitch is 1 mm-1.5 mm; the diameter of the elastic guide rail is 0.1 mm-0.45 mm.

[0060] When the first adjustment part is an inflatable adjustment part, its structural schematic diagram is as shown in Figure 4 shown. As a preferred technical solution, the inflatable adjustment structure of the inflatable adjustment part has a sealing component, an air inlet 206 and an air outlet 207 connected to the sealing component (see Figure 5 ); by adjusting the pressure in the sealing component, the inflation and deflation of the sealing component are realized, so as to realize the adjustment of the contraction and release state of the pressure compensation device 1 for tissue ligation.

[0061] In some embodiments, the first adjustment part is arranged on the flexible inner layer.

[0062] In some embodiments, when the first adjusting part is a laminated folding adjusting part, it includes a flexible folding part 201 and a first adjusting drawstring 202 passed through the flexible folding part 201; the first adjusting drawstring 202 is used to adjust the folding amplitude of the flexible folding part 201, so as to adjust the contraction amplitude of the pressure compensation body in the radial direction (see Figure 1 );

[0063] Exemplarily, when the first adjusting drawstring 202 is tightened, the flexible folding part 201 is tightened under the drive of the first adjusting drawstring 202, so that the flexible inner layer is tightened accordingly, realizing the adjustment of the diameter of the pressure compensation device 1 for tissue ligation, enabling it to better cooperate with the tightening part of the tissue ligation component, and reducing the risk of the tightening part cutting the tissue to be ligated.

[0064] In some embodiments, the axial direction of the pressure compensation body includes a first surface 103 and a second surface 104;

[0065] The second adjusting part includes a second adjusting drawstring 301 that reciprocally penetrates the first surface 103 and the second surface 104 respectively; the second adjusting drawstring 301 is used to adjust the width of the pressure compensation body in the axial direction.

[0066] The first surface 103 or the second surface 104 of the present invention is independently at least two layers respectively, for example, it can be at least two layers formed by folding a sewing cloth; the second adjusting drawstring 301 reciprocally penetrates the first surface 103 and the second surface 104 respectively. When the second adjusting drawstring 301 is tightened, the width of the pressure compensation device 1 for tissue ligation in the axial direction reaches the minimum value; when the second adjusting drawstring 301 is released, the width of the pressure compensation device 1 for tissue ligation in the axial direction increases.

[0067] In some embodiments, a sustained-release substance is filled in the flexible intermediate layer.

[0068] In some embodiments, the sustained-release substance includes a sustained-release drug; the sustained-release drug has a degradable outer coat and can slowly release the drug during use.

[0069] In some embodiments, the drug includes heparin and / or CD34 antibody, which can increase the endothelial coverage speed at the ligation site by 200%, reduce the risk of postoperative complications, and improve the safety of treatment.

[0070] In some embodiments, a bionic structure 105 is provided on the surface of the flexible inner layer close to the auricle;

[0071] The bionic structure 105 includes curved grooves distributed circumferentially along the pressure compensation body (see Figure 6 ).

[0072] In some embodiments, a bionic structure 105 is provided on the surface of the flexible outer layer away from the auricle;

[0073] The bionic structure 105 includes curved grooves distributed circumferentially along the pressure compensation body (see Figure 6 ).

[0074] The present invention uses curved grooves distributed circumferentially along the pressure compensation body as the bionic structure 105, simulating the arrangement law of collagen fibers of muscle texture, and can induce the directional extension of endothelial cells along the curved grooves.

[0075] The preparation method of the curved grooves of the present invention can adopt conventional methods in the art. In some embodiments, the curved grooves are obtained by laser etching.

[0076] In some embodiments, the material of the tissue ligation pressure compensation device 1 includes any one or a combination of at least two of biocompatible polyester fabric, PTFE (polytetrafluoroethylene) or ePTFE (expanded polytetrafluoroethylene), so that the tissue ligation pressure compensation device 1 has excellent anti-fatigue performance; it can also include biocompatible elastic materials, such as any one or a combination of at least two of silica gel, rubber or biological tissue, so that the tissue ligation pressure compensation device 1 has excellent shock absorption and buffering effects; it can also include biocompatible absorbable materials, including at least one of polymers of glycolide, ring-opening polymers of lactide cyclic diester-lactide, lactide-glycolide copolymers, polyglycolic acid esters or polydioxanone; it can also include natural polymer absorbable materials, including at least one of polyoxanic acid esters, collagen, chitin or alginic acid.

[0077] An embodiment of the present invention provides a tissue ligation component, which includes a support ring, a tightening part connected to the support ring, and the tissue ligation pressure compensation device 1 described in the first aspect provided on the side of the tightening part close to the surface of the tissue to be ligated.

[0078] During the process of using the tissue ligation component provided by the present invention, when the tightening part shrinks and becomes smaller, the tissue ligation pressure compensation device 1 separates the tightening part from the surface of the tissue to be ligated, avoiding the tissue to be ligated from being cut or torn by the tightening part.

[0079] In some embodiments, the tightening part includes a mesh bag and a ligation rope 4 for tightening the open end of the mesh bag.

[0080] Exemplarily, the tissue ligation component includes the mesh sleeve device for tissue ligation in CN118680620A. This mesh sleeve device includes a support module, a mesh pocket, and a connection module. The support module includes a support ring, a skirt, and at least one guide rod. The skirt covers the support ring. The proximal end and the distal end of the guide rod are respectively provided with a first bending portion and a second bending portion. The first bending portion and the second bending portion bend towards the same side of the guide rod. The first bending portion is connected to the support ring. At least one end of the mesh pocket is provided with an opening. The opening end of the mesh pocket is detachably connected to the support ring along the circumference through the connection module. A tightening rope is arranged on the mesh pocket. The mesh pocket is a three-dimensional braided body with a hollow grid. The ligation tightening rope is cross-threaded between the hollow grids along the circumference of the mesh pocket opening. The pressure compensation device 1 for tissue ligation in the present invention is arranged on one side of the tightening rope close to the surface of the auricle, avoiding damage to the root of the left auricle during the ligation of the left auricle, and can also be transported together with the tissue ligation component through a conventional catheter in the art, reducing surgical trauma and achieving the effect of fixed-point tissue ligation.

[0081] Exemplarily, the tissue ligation component includes the tissue ligation system in CN117357188A. This tissue ligation system includes a mesh pocket and a root sleeve. The root sleeve is circumferentially connected to the opening at one end of the mesh pocket. The ligation device includes a connecting rod and a ligation mechanism. One end of the connecting rod is connected to the ligation mechanism, and the other end is connected to the mesh sleeve structure through a rope inside the rod. When in use, the mesh pocket completely covers the tumor or soft tissue, and the position of the root sleeve is basically flush with its root. Then, the root sleeve is tightened to gradually contract and reduce the root diameter of the tumor or soft tissue. The pressure compensation device 1 for tissue ligation in the present invention is arranged on the inner layer of the root sleeve, avoiding damage to biological tissue by the root sleeve.

[0082] Exemplarily, the tissue ligation component includes the balloon-expandable ligation ring preformed left auricle ligation system in CN115252032A, including a left auricle ligation loop, a separable component, a balloon, and a delivery rod. Among them, the left auricle ligation loop is fixed on the delivery rod through the separable component. The balloon is arranged on the delivery rod and is located at both ends of the separable component. When the balloon is inflated, the balloon lifts the left auricle ligation loop and makes the left auricle ligation loop open into an elliptical shape. After deflation, the left auricle ligation loop naturally rebounds and closes. The pressure compensation device 1 for tissue ligation in the present invention is arranged inside the left auricle ligation loop, avoiding damage to biological tissue by the left auricle ligation loop.

[0083] Exemplarily, the tissue ligation component includes the tissue ligation device disclosed in CN105307581A, including an elongated body and a snare loop assembly. This snare loop assembly includes a snare and a suture loop releasably attached to the snare. The pressure compensation device 1 for tissue ligation in the present invention is arranged inside the suture loop, avoiding damage to biological tissue by the suture loop.

[0084] Exemplarily, the tissue ligation component includes the tissue ligation device disclosed in CN102448383A, which includes a snare loop assembly and a handle for controlling the snare loop assembly. Among them, the snare loop assembly includes a snare and a suture loop. The pressure compensation device 1 for tissue ligation in the present invention is arranged inside the suture loop to avoid damage to biological tissue by the suture loop.

[0085] Exemplarily, the tissue ligation component includes the device for closing tissue disclosed in CN106974682A, which includes a closing device and a tensioning device. The closing device includes a snare loop and a suture loop releasably coupled to the snare loop; the tensioning device includes a spring, an extension member, a suture connection mechanism, and a housing including a handle. Among them, the first section of the spring is attached to the extension member, the second end of the spring is attached to the housing, and the suture connection mechanism is coupled to the extension member. The pressure compensation device 1 for tissue ligation in the present invention is arranged inside the suture loop to avoid damage to biological tissue by the suture loop.

[0086] Exemplarily, the tissue ligation component includes the device for closing the left atrial appendage disclosed in CN107530070A, which includes an elongated body, a closing element, and a suture loop. The elongated body includes a reinforced proximal portion, a flexible intermediate portion, and a distal portion. The reinforced distal portion includes a cylindrical cross-section respectively, and the distal portion includes a D-shaped cross-section having a height. The flexible intermediate portion includes a groove configured to receive a guide wire. The diameter of the reinforced proximal portion is greater than the height of the flexible intermediate portion, and the height of the flexible intermediate portion is greater than the height of the distal portion. The pressure compensation device 1 for tissue ligation in the present invention is arranged inside the suture loop to avoid damage to biological tissue by the suture loop.

[0087] In some embodiments, the connection manner between the mesh bag and the pressure compensation device 1 for tissue ligation includes ultrasonic welding, hot melting, suturing, or bonding, etc.

[0088] In some embodiments, the connection manner between the ligation rope 4 and the pressure compensation device 1 for tissue ligation includes: a plurality of the pressure compensation devices 1 for tissue ligation are discontinuously distributed on the tightening side of the tightening portion (see Figure 7 );

[0089] Or, the ligation rope 4 reciprocally penetrates through the pressure compensation device 1 for tissue ligation (see Figure 8 );

[0090] Or, the pressure compensation device 1 for tissue ligation spirally winds around the tightening portion (see Figure 9 ).

[0091] For connection method 1, the discontinuous distribution can reduce the overall volume of the pressure compensation device and the surface area of the long-term implant in the human body, thereby reducing the risk of accidents; for connection method 2, the reciprocating threading is beneficial to the integration of the ligation rope and the pressure compensation device, preventing the displacement of the pressure compensation device during the ligation process of the tightening part; for connection method 3, the spiral winding combines the advantages of discontinuous distribution and reciprocating threading.

[0092] An embodiment of the present invention provides a ligation device, which includes the pressure compensation device for tissue ligation described in any one of the embodiments, or the tissue ligation component described in any one of the embodiments.

[0093] Among the ligation devices in the art, there is a delivery catheter for delivering the tissue ligation component. The pressure compensation device for tissue ligation provided by the present invention can be delivered through the delivery catheter together with the tissue ligation component.

[0094] In summary, the pressure compensation device for tissue ligation provided by the present invention has a simple structure, can be delivered through the catheter together with the tissue ligation component, and the pressure compensation device for tissue ligation can effectively avoid damage to the ligation site during the tissue ligation process, especially avoid damage to the root of the left atrial appendage during the ligation of the left atrial appendage. It can also be delivered through a conventional catheter in the art together with the tissue ligation component, reducing surgical trauma and achieving the effect of fixed-point tissue ligation; moreover, the pressure compensation device for tissue ligation provided by the present invention can flexibly set the size according to the shape of the left atrial appendage, so as to adapt to the shapes of various tissues to be ligated.

[0095] The applicant declares that the above is only the specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by any person skilled in the art within the technical scope disclosed by the present invention fall within the protection scope and the disclosure scope of the present invention.

Claims

1. A pressure compensation device for tissue ligation, characterized in that: The pressure compensation device for tissue ligation comprises a pressure compensation body; The pressure compensation body includes a radial direction perpendicular to the surface direction of the tissue to be ligated, and an axial direction tangent to the surface direction of the tissue to be ligated; Along the radial direction away from the surface of the tissue to be ligated, the pressure compensation body comprises a flexible inner layer, a flexible middle layer and a flexible outer layer; The pressure compensation body comprises a first adjustment portion for causing the pressure compensation body to contract in a radial direction, and a second adjustment portion for adjusting an axial width of the pressure compensation body; The structures of the first adjustment part and the second adjustment part are independently at least one of a laminated folding adjustment part, a mechanical adjustment adjustment part, an elastic spring adjustment part, a memory material adjustment part or an inflatable adjustment part.

2. The pressure compensation device for tissue ligation according to claim 1, characterized in that: The first adjusting portion is arranged on the flexible inner layer.

3. The pressure compensation device for tissue ligation according to claim 2, characterized in that: The first adjustment part is a laminated folding adjustment part, including a flexible folding part and a first adjustment rope passing through the flexible folding part; the first adjustment rope is used to adjust the folding amplitude of the flexible folding part, thereby adjusting the contraction amplitude of the pressure compensation body in the radial direction.

4. The pressure compensation device for tissue ligation according to any one of claims 1 to 3, characterized in that: The pressure compensation body includes a first surface and a second surface in an axial direction; The second adjustment portion includes a second adjustment rope that reciprocates and pierces the first surface and the second surface; the second adjustment rope is used to adjust the width of the pressure compensation body in the axial direction.

5. The pressure compensation device for tissue ligation according to claim 1, characterized in that: The flexible middle layer is filled with a sustained-release substance.

6. The pressure compensation device for tissue ligation according to claim 1, characterized in that: A bionic structure is provided on a surface of the flexible inner layer close to the auricle; The bionic structure comprises curved grooves distributed along the circumference of the pressure compensation body.

7. The pressure compensation device for tissue ligation according to claim 1, characterized in that: A bionic structure is provided on a surface of the flexible outer layer on one side away from the auricle; The bionic structure comprises curved grooves distributed along the circumference of the pressure compensation body.

8. A tissue ligation component, characterized in that: The tissue ligation component comprises a support ring, a tightening portion connected to the support ring, and a pressure compensation device for tissue ligation according to any one of claims 1 to 7 arranged on a side of the tightening portion close to a surface of a tissue to be ligated.

9. The tissue ligating component according to claim 8, characterized in that: The tightening part includes a net bag and a ligature rope for tightening the open end of the net bag; The connection method between the ligature rope and the pressure compensation device for tissue ligation includes: A plurality of the tissue ligation pressure compensation devices are intermittently distributed on the tightening side of the tightening portion; Or, the ligature rope is reciprocatedly inserted into the pressure compensation device for tissue ligation; Alternatively, the tissue ligation pressure compensation device is spirally wound around the tightening portion.

10. A ligation device, characterized in that: The ligation device comprises the pressure compensation device for tissue ligation according to any one of claims 1 to 7, or the tissue ligation component according to claim 8 or 9.

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