An adjustable medical device

Abstract

The application provides an adjustable medical instrument device, relates to the technical field of lung volume reduction instrument, and comprises an elastic implant body, an adjusting wire is arranged in the elastic implant body, and the adjusting wire extends along a preset shape of the elastic implant body; a first end of the adjusting wire is fixed at a proximal end of the elastic implant body, and a second end opposite to the first end of the adjusting wire is fixed at a distal end of the elastic implant body; wherein, the adjusting wire is provided with a pre-tightening force, so that the elastic implant body is close from the distal end to the proximal end, and the compression force of the elastic implant body acting on a target emphysema position is adjusted. Through the lung volume reduction instrument provided by the application, the problem that the compression force of the lung volume reduction instrument on the market is fixed and limited, the preset shape is insufficient, the residual air of the target emphysema position is not completely discharged, and the volume reduction effect is poor is solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of lung volume reduction devices, in particular to an adjustable medical device. BACKGROUND

[0002] Emphysema is a common lung disease. Traditional treatment methods include drug-based internal medicine treatment, surgical treatment by resecting diseased lung tissue, and endobronchoscopic lung volume reduction (ELVR) gradually developed in recent years. Compared with internal medicine treatment and surgical treatment, ELVR, as a new minimally invasive treatment method, has the characteristics of improving the quality of life of patients and reducing trauma to patients during surgery, and has gradually become a hot spot in clinical research and application in recent years. In current clinical practice, ELVR mainly includes one-way valve, biological glue, water vapor thermal ablation, and elastic coil intervention methods.

[0003] A lung volume reduction device widely used in the existing market, as shown in Figure 1 and Figure 2 , the lung volume reduction device 600 includes an elastic implant 500 and a delivery device 700. The elastic implant 500 is a tubular structure, which includes a hollow tubular elastic deformation part 51, a flexible guide part 53 connected to the distal end of the elastic deformation part 51, and an elastic film 55. The elastic implant 500 is at least open at the proximal end. The elastic deformation part 51 has shape memory characteristics, which includes opposite proximal end 511 and distal end 513. The elastic deformation part 51 also includes a plurality of cut grooves 514 that are spaced apart and connected to the lumen of the elastic deformation part 51. The elastic deformation part 51 is in a curled preset shape in a natural state (i.e. without any external force), and can be constrained into a straight strip shape or other arbitrary shape under the action of external force, and restored to the preset shape by bending and twisting after the external force is removed. The delivery device 700 includes a core wire 71 and a pushing mechanism 73. The core wire 71 is housed in the lumen of the elastic implant 500, and is used to restrict the elastic implant 500 into an approximately straight line delivery state, facilitating the delivery of the elastic implant 500 to the diseased site.

[0004] As shown in Figure 3 , when the elastic implant 500 is guided to reach the target emphysema site to be treated through the working channel 902 of the bronchoscope 901, the doctor will operate the delivery handle 733 to withdraw the core wire 71 from the elastic implant 500, and the elastic implant 500 will restore its preset shape. In the process of restoring the preset shape, the elastic implant 500 will also fold and press the bronchus and surrounding lung tissue where it is located, so as to expel the residual air from the target emphysema site, achieving the effect of volume reduction.

[0005] The lung volume reduction device has the advantages that the risk of bronchial wall injury caused by bending of the implant body during implantation is reduced, and the safety of the lung volume reduction surgery is improved to a certain extent. However, the lung volume reduction device still has some problems in actual clinical application. Although the elastic implant body in the lung volume reduction device can restore to the preset shape after being implanted into the human body, the lung tissue will have an opposite resistance force when the elastic implant body restores to the preset shape. Since the compression force of the elastic implant body is fixed and limited, it is often insufficient to completely overcome the reaction force of the lung tissue with different degrees of loss, and the elastic implant body cannot be fully restored to the preset shape, which causes incomplete residual air discharge at the target emphysema position, and finally the volume reduction effect is poor, and the ideal treatment expectation is difficult to achieve. SUMMARY

[0006] In view of the above problems, the present application provides an adjustable medical device to solve the problems of the existing market that the compression force of the elastic implant body is fixed and limited, the elastic implant body cannot be fully restored to the preset shape, the residual air at the target emphysema position cannot be completely discharged, and the volume reduction effect is poor.

[0007] The present application provides an adjustable medical device, which adopts the technical scheme of:

[0008] The adjustable medical device comprises an elastic implant body, an adjusting wire is arranged in the elastic implant body, the adjusting wire extends along the preset shape of the elastic implant body, a first end of the adjusting wire is fixed to a proximal end of the elastic implant body, and a second end of the adjusting wire opposite to the first end is fixed to a distal end of the elastic implant body; wherein a pre-tightening force is applied to the adjusting wire to make the elastic implant body approach from the distal end to the proximal end, so as to adjust the compression force of the elastic implant body acting on the target emphysema position.

[0009] As one of the preferred schemes, a plurality of adjusting wires are arranged, the first ends of the plurality of adjusting wires are fixed to the proximal end of the elastic implant body, and the second ends of the plurality of adjusting wires are respectively fixed to a plurality of positions at different distances from the proximal end of the distal end of the elastic implant body.

[0010] As one of the preferred schemes, two adjusting wires are arranged, and the second end of the first adjusting wire is farther away from the proximal end of the elastic implant body than the second end of the second adjusting wire.

[0011] As one of the preferred schemes, the adjusting wire is made of at least one of a nickel-titanium material, a polyester material, a stainless steel material, and a high polymer material.

[0012] As one of the preferred schemes, the device further comprises a first fixing device, the first fixing device comprises a first fixing sleeve sleeved on the proximal end of the elastic implant body, and the first fixing sleeve is provided with a through hole in communication with the hollow inner cavity of the elastic implant body.

[0013] The first fixed sleeve is provided with a first fixed hole on the hole wall, and the first fixed hole penetrates the hole wall;

[0014] The first end of the adjusting wire is arranged to pass through the first fixed hole of the elastic implant, and after a pre-tightening force is applied to the adjusting wire, the adjusting wire passing through the first fixed hole is arranged as a fixed knot, so that the first end of the adjusting wire is fixed on the wall surface of the first fixed sleeve.

[0015] As one of the preferred solutions, the device further comprises a second fixing device, the second fixing device comprising a second fixed sleeve and a compression block, the second fixed sleeve being sleeved on the proximal end of the elastic implant, the compression block being sleeved on the proximal end of the second fixed sleeve, and the second fixed sleeve and the compression block are both provided with through holes communicating with the hollow cavity of the elastic implant;

[0016] The second fixed sleeve is provided with a second fixed hole on the hole wall, and the second fixed hole penetrates the hole wall and is located in the contact area between the second fixed sleeve and the compression block;

[0017] The first end of the adjusting wire is arranged to pass through the second fixed hole of the elastic implant, and after a pre-tightening force is applied to the adjusting wire, the compression block is sleeved in the second fixed sleeve, and the adjusting wire is compressed on the contact end surface between the second fixed sleeve and the compression block.

[0018] As one of the preferred solutions, the second fixed sleeve comprises a distal end connecting portion and a proximal end connecting portion, the distal end connecting portion comprises an annular insertion section and an annular clamping section, and the proximal end connecting portion is an annular connecting section; the annular insertion section is inserted into the elastic implant, the distal annular surface of the annular clamping section is clamped on the proximal end surface of the elastic implant, and the proximal annular surface of the annular clamping section is connected with the distal annular surface of the annular connecting section;

[0019] The second fixed hole comprises a fixed hole a and a fixed hole b, the fixed hole a axially penetrates the annular insertion section and the annular clamping section, and the fixed hole b radially penetrates the annular connecting section;

[0020] The compression block is an annular compression block embedded in the annular connecting section; the inner annular wall surface of the annular connecting section is provided with an internal thread, the outer annular wall surface of the annular compression block is provided with an external thread, and the annular connecting section and the annular compression block are threadedly engaged.

[0021] As one of the preferred solutions, the inner ring inner diameter of the annular insertion section, the inner ring inner diameter of the annular clamping section and the inner ring inner diameter of the annular compression block are the same and smaller than the inner ring inner diameter of the annular connecting section; the outer ring inner diameter of the annular clamping section is the same as the outer ring inner diameter of the annular connecting section.

[0022] As one of the preferred solutions, in the case of multiple adjustment wires, the number of first fixing holes or the number of second fixing holes has a one-to-one relationship or a one-to-many relationship with the number of adjustment wires.

[0023] The second end of the adjustment wire is fixed to the distal end of the elastic implant by any one of knotting, bonding and welding.

[0024] As one of the preferred solutions, the first side of the elastic implant is provided with a plurality of cutting grooves, and the second side of the elastic implant away from the first side is provided with a plurality of preset grooves.

[0025] Compared with the prior art, the present application has the following advantages:

[0026] The adjustable medical device provided by the embodiment of the present application comprises an elastic implant, the elastic implant is provided with an adjustment wire, the adjustment wire extends along the preset shape of the elastic implant; the first end of the adjustment wire is fixed to the proximal end of the elastic implant, and the second end of the adjustment wire opposite to the first end is fixed to the distal end of the elastic implant; wherein the adjustment wire is provided with a pre-tightening force to make the elastic implant close from the distal end to the proximal end, so as to adjust the compression force of the elastic implant acting on the target emphysema position.

[0027] By adopting the technical solution of the embodiment of the present application, since the compression force of the elastic implant is fixed in the design and it is difficult to fully overcome the resistance of the lung tissue in the actual implantation process, the adjustment wire is arranged in the elastic implant and extends along the preset shape of the elastic implant. When adjustment is needed during the operation, the adjustment wire is pulled in the proximal direction, the adjustment wire can supplement additional force to the elastic implant, the distal end of the elastic implant will close to the proximal end, so as to change the compression force of the elastic implant applied to the target area, realize better compression and folding of the target emphysema tissue and more fully exhaust residual air. At the same time, the doctor can apply different degrees of pre-tightening force to the adjustment wire according to the need, different pre-tightening degrees of the pre-tightening force correspondingly provide different compression degrees of the compression force, realize different degrees of lung compression, ensure the targeted extrusion of different lesions and better fit the lesion conditions of different patients. BRIEF DESCRIPTION OF DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the present application, the drawings needed to be used in the description of the present application will be briefly introduced as follows. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort on the basis of these drawings.

[0029] Figure 1 is an elastic implant in the lung volume reduction device on the market;

[0030] Figure 2 is a lung volume reduction device on the market;

[0031] Figure 3 is a schematic diagram of the working principle of the lung volume reduction device on the market when implanted in the target emphysema position of the lung;

[0032] Figure 4 is a schematic diagram of the overall structure of the adjustable medical device provided by an embodiment of the present application;

[0033] Figure 5 is Figure 4 is a partial enlarged view of C in

[0034] Figure 6 is a schematic diagram of the overall structure of the elastic implant provided by an embodiment of the present application when two adjustment wires are arranged;

[0035] Figure 7 is a schematic diagram of the structure when the adjustment wire is fixed to the proximal end of the elastic implant through the first fixing device provided by an embodiment of the present application;

[0036] Figure 8 is Figure 7 is a partial enlarged view of D in

[0037] Figure 9 is a side view of the first fixing sleeve provided by an embodiment of the present application;

[0038] Figure 10 is a schematic diagram of the structure of the first fixing sleeve provided by an embodiment of the present application;

[0039] Figure 11 is a schematic diagram of the structure when the adjustment wire is fixed to the proximal end of the elastic implant through the second fixing device provided by an embodiment of the present application;

[0040] Figure 12 is Figure 11 is a partial enlarged view of E in

[0041] Figure 13 is a schematic diagram of the structure of the second fixing sleeve provided by an embodiment of the present application;

[0042] Figure 14 This is a perspective structural diagram of a clamping block provided in an embodiment of this application;

[0043] Figure 15 This is a schematic diagram showing the setting position of the preset slot provided in one embodiment of this application;

[0044] Figure 16 This is a schematic diagram of the structure of a preset groove provided in an embodiment of this application.

[0045] Explanation of reference numerals in the attached figures:

[0046] 201, First adjusting screw; 2011, First distal knot; 202, Second adjusting screw; 2021, Second distal knot; 300, First fixing sleeve; 3001, First fixing hole; 2012, Fixing knot; 400, Second fixing sleeve; 4001, Annular insertion section; 4002, Annular snap-fit ​​section; 40021, Proximal annular surface of the Annular snap-fit ​​section; 4003, Annular connecting section; 40031, Internal thread; 4004, Fixing hole a; 4005, Fixing hole b; 500, Elastic implant; 5001, Preset groove; 600, Clamping block; 6001, External thread. Detailed Implementation

[0047] 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, 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.

[0048] It should be noted that traditional medical treatments for emphysema include oxygen therapy, medication to prevent lung infections, and bronchodilators, but their effectiveness is extremely limited. Surgical treatment for emphysema mainly involves open-chest lung reduction surgery, which has many limitations, such as: numerous complications, unpredictable preoperative efficacy, inability to compensate for unsatisfactory results due to excessive or insufficient resection postoperatively, high surgical costs, significant mental and physical suffering, and the inability of some patients with poor lung function to tolerate the procedure. Therefore, the postoperative mortality rate is high, and surgical treatment has been rarely used in recent years.

[0049] To better treat emphysema, improve patients' quality of life, and reduce surgical trauma, international research has focused on using ELVR (Elastic Endovascular Reduction) for emphysema treatment. Specific techniques include one-way valves, bio-glue, steam ablation, and flexible coils. One-way valves have limited effectiveness due to the influence of collateral ventilation, narrower indications, and technical challenges in precise placement at different anatomical locations. Bio-glue, by completely sealing the emphysema area, has consistently failed to effectively address postoperative inflammation. Steam ablation, by disrupting the original tissue structure of the emphysema area, also leads to postoperative inflammation. Compared to one-way valves, bio-glue, and steam ablation, flexible coil implantation offers greater treatment flexibility and a lower risk of complications, thus gaining wider market adoption. However, current popular lung volume reduction devices utilizing the flexible coil principle suffer from the problems described in the background, limiting their further large-scale market application.

[0050] In view of this, the present invention aims to provide a medical device implanted into human cavities (airway, digestive tract, etc.), particularly for implantation in the airway to compress residual air, while also allowing adjustment of the compression function of the elastic implant 500 as needed. That is, during surgery, when the compression force of the elastic implant 500 is insufficient to fully compress the encapsulated lung tissue, adjustment can be made to allow for sufficient compression of the lung tissue. In one feasible technical solution, this application proposes an adjustable medical device device, including an elastic implant 500, within which an adjustment wire is disposed, extending according to a preset shape of the elastic implant 500; and a first end of the adjustment wire is fixed to the proximal end of the elastic implant 500, and a second end of the adjustment wire opposite to the first end is fixed to the distal end of the elastic implant 500; wherein, a pre-tensioning force is applied to the adjustment wire to move the elastic implant 500 from the distal end to the proximal end, thereby adjusting the compression force of the elastic implant 500 acting on the target emphysema site.

[0051] As a specific explanation of this embodiment, the present invention optimizes and improves existing lung volume reduction devices on the market. The optimization mainly focuses on how the elastic implant 500, after implantation into the target lung tissue, can more fully recover to its preset shape, more effectively fold and compress the lung tissue, and expel residual air. Therefore, the main body of the lung volume reduction device can be referred to... Figures 1-3 The relevant descriptions in the embodiments of the present invention will not be elaborated upon further.

[0052] The improvement of this embodiment of the invention lies in the provision of an adjustment wire within the elastic implant 500, please refer to... Figure 4 and Figure 5 , Figure 4 A diagram showing the overall structure of an adjustable medical device with an adjustable wire. Figure 5 for Figure 4 A magnified view of a portion at point C.Figure 4 In the middle, F represents distal and N represents proximal. Figure 6 , Figure 15 In the diagram, F indicates distal end and N indicates proximal end, which will not be elaborated further. The adjusting wire extends along the preset shape of the elastic implant 500, such as a spiral or cage-like path, so that tightening the adjusting wire guides the elastic implant 500 to fold along a path that restores its preset shape. Specifically, the initial shape of the adjusting wire conforms to the preset shape of the elastic implant 500. Near the distal end of the elastic implant 500, the adjusting wire is biased towards the inner or outer wall of the elastic implant 500 with less curvature, and then extends along the shape of the elastic implant 500 to the proximal end, where a pre-tightening force is applied and it is fixed.

[0053] Fixation points are set at the proximal and distal ends of the implant, and the two ends of the adjustment wire are fixed respectively using a fixation process matching the fixation points. In some embodiments, the first and second ends of the adjustment wire may be the same as or different from the fixation process of the elastic implant 500. In this embodiment, the first end of the adjustment wire is a free end, which is fixed to the proximal end of the elastic implant 500 after applying different degrees of pre-tension force during the operation; the second end is a fixed end, which is directly fixed to the distal end of the elastic implant 500.

[0054] During the fixation process, the second end of the adjustment wire is first fixed to the distal end of the elastic implant 500, and the first end of the adjustment wire extends from the distal end to the proximal end through the hollow cavity of the elastic implant 500. After the elastic implant 500 is implanted at the target emphysema site, the adjustment wire is pulled proximally as needed to apply pre-tension, forcing the elastic implant 500 to fold or contract from the distal end to the proximal end along the designed direction (the direction in which it restores its preset shape), so as to more fully compress the target emphysema site and achieve the effect of fully expelling residual gas.

[0055] Furthermore, the adjusting wire is made of at least one of nickel-titanium, polyester, stainless steel, and polymer materials. In this embodiment, the adjusting wire is made of a high-strength and biocompatible material, such as nickel-titanium, stainless steel, polymer materials, polyester, or nylon. The diameter of the adjusting wire can be 0.05 mm to 0.5 mm.

[0056] Therefore, since the compressive force of the elastic implant 500 is fixed in the design, it is difficult to fully overcome the resistance of lung tissue during actual implantation. In this embodiment, an adjustment wire is placed within the elastic implant 500, extending along the preset shape of the elastic implant 500. When adjustment is needed during surgery, the adjustment wire is pulled proximally, providing additional force to the elastic implant 500. This causes the distal end of the elastic implant 500 to move closer to its proximal end, thereby changing the compressive force applied to the target area. This better compresses and folds the target lung emphysema tissue, allowing for more complete expulsion of residual gas. Simultaneously, the surgeon can apply different levels of pre-tension to the adjustment wire as needed. Different pre-tension levels provide different degrees of compression, achieving varying degrees of lung compression and ensuring targeted compression of different lesions, better fitting the lesion conditions of different patients.

[0057] In related technologies, besides the problem of insufficient and fixed compressive force, the elastic implant 500 also suffers from uneven coverage of lung tissue. The varying hardness of different parts of the lung tissue leads to uneven compression during folding, meaning that some areas of the target lung emphysema are not fully compressed, resulting in incomplete air expulsion and poor volume reduction. To address this, this embodiment of the invention further provides multiple adjustment wires. The first end of each adjustment wire is fixed to the proximal end of the elastic implant 500, and the second end of each adjustment wire is fixed at multiple positions at different distances from the proximal end of the elastic implant 500.

[0058] Specifically, multiple adjustment wires can be installed within the elastic implant 500. The first ends of all adjustment wires are positioned proximally within the elastic implant 500 for easy fixation after applying pre-tension. The second ends (fixed ends) are positioned at different locations within the elastic implant 500, with each adjustment wire's second end at a different distance from its first end, resulting in varying free lengths for the adjustment wires at different fixed end positions. When pre-tension is applied to the corresponding adjustment wire, the wire controls the elastic implant 500 to move from its distal to proximal end at different positions, creating different traction paths and compression forces. This allows for flexible and precise compression of the lung tissue as needed, achieving optimal residual gas expulsion and the best volume reduction effect.

[0059] In some embodiments, preload may be applied to selected sections of the adjusting wires as needed.

[0060] Preferably, such as Figure 6 As shown, Figure 6This diagram illustrates the overall structure of the elastic implant 500 provided by the present invention when two adjustment wires are provided. Two adjustment wires are provided, with the second end of the first adjustment wire 201 being further away from the proximal end of the elastic implant 500 than the second end of the second adjustment wire 202. The relative relationship between the second adjustment wire 202 and the elastic implant 500 is similar to that of the first adjustment wire 201, and the fixation method of the second adjustment wire 202 at the distal end of the elastic implant 500 is also the same as that of the first adjustment wire 201. However, the second ends of the first adjustment wire 201 and the second adjustment wire 202 are located at different positions within the elastic implant 500. This allows the first adjustment wire 201 and the second adjustment wire 202 to be pulled as needed to achieve precise and sufficient compression of target emphysema tissue at different locations.

[0061] As an illustration of this embodiment, the second end of the adjusting wire can be fixed to the elastic implant 500 by knotting, bonding, welding, or other methods. See Figure 4 , Figure 5 and Figure 6 The adjusting wire is secured to the elastic implant 500 by a distal knot. For example, a knotting hole can be provided on the wall of the elastic implant 500, and the second end of the adjusting wire passes through the knotting hole from the inner wall of the elastic implant 500 to the outer wall of the elastic implant 500 and is then knotted for fixation. Of course, the adjusting wire can also pass through the knotting hole from the outer wall to the inner wall and then be knotted for fixation on the inner wall.

[0062] In this embodiment, the second end of the first adjusting wire 201 is located at the distal end of the elastic implant 500, and the second end of the second adjusting wire 202 is located near the distal end of the elastic implant 500, closer to the proximal end. Therefore, the free length of the first adjusting wire 201 when folded is greater than the free length of the second adjusting wire 202. The first adjusting wire 201 drives the elastic implant 500 to contract entirely within its preset shape range. The second adjusting wire 202 will tighten more quickly, driving the elastic implant 500 to contract locally within a range smaller than its preset shape. This achieves controllable adjustment of the elastic implant 500 throughout its entire length range, from local to overall.

[0063] For example, see Figure 6 As shown, a first adjusting wire 201 and a second adjusting wire 202 can be provided on the elastic implant 500. A first knotting hole is provided on the wall surface at the distal end of the elastic implant 500, and a second knotting hole is provided on the wall surface closer to the distal end of the elastic implant 500. The second end of the first adjusting wire 201 passes through the first knotting hole from the inner wall of the elastic implant 500 to the outer wall of the elastic implant 500, and is then tied into a first distal knot 2011 for fixation. The second end of the second adjusting wire 202 passes through the second knotting hole from the inner wall of the elastic implant 500 to the outer wall of the elastic implant 500, and is then tied into a second distal knot 2021 for fixation.

[0064] If a portion of the target lung emphysema area is not fully compressed, the second adjusting wire 202 can provide directional folding, ensuring complete expulsion of residual air and achieving uniform compression. If the elastic implant 500's compression force is insufficient to fully compress the encapsulated lung tissue, the first adjusting wire 201 can supplement the compression force, more effectively and fully folding and compressing the lung tissue. The design of the first adjusting wire 201 and the second adjusting wire 202 results in a simple and easy-to-operate structure, providing two controllable pathways—local and overall—allowing doctors to choose the appropriate approach. This simultaneously addresses the issues of uneven compression due to uneven lung tissue stiffness and insufficient compression of the elastic implant 500, ensuring structural simplicity and operational feasibility.

[0065] As an improvement to this embodiment, the free end of the adjusting wire is fixed to the elastic implant 500 by a first fixing device. See also... Figures 7-10 , Figure 7 A schematic diagram showing the structure when the adjustment wire is fixed to the proximal end of the elastic implant 500 by the first fixing device; Figure 8 for Figure 7 A magnified view of a portion of point D in the diagram; Figure 9 This is a side view of the first fixed sleeve 300. Figure 10 This is a schematic diagram of the structure of the first fixing sleeve 300. The device also includes a first fixing device, which includes a first fixing sleeve 300 sleeved on the proximal end of the elastic implant 500, and the first fixing sleeve 300 has a through hole communicating with the hollow inner cavity of the elastic implant 500; wherein, a first fixing hole 3001 is formed on the hole wall of the first fixing sleeve 300, and the first fixing hole 3001 penetrates the hole wall; the first end of the adjusting wire passes through the hollow inner cavity of the elastic implant 500 and exits through the first fixing hole 3001. After applying a pre-tightening force to the adjusting wire, the adjusting wire that has passed through the first fixing hole 3001 is set as a fixing knot 2012, so that the first end of the adjusting wire is fixed on the wall surface of the first fixing sleeve 300.

[0066] In this embodiment, please refer again. Figure 10The first fixing sleeve 300 is horizontally T-shaped, with a through hole in the middle of the T-shape. The outer contour of the T-shape serves as the wall of the through hole, and the diameter of the through hole is slightly smaller than the diameter of the hollow cavity of the elastic implant 500. The vertical section of the T-shape, the annular insertion section 4001, is inserted into the proximal end of the elastic implant 500, and the horizontal section of the T-shape, the annular snap-fit ​​section 4002, snaps onto the proximal end face of the elastic implant 500. The through hole communicates with the hollow cavity of the elastic implant 500, and their central axes coincide. A first fixing hole 3001 is provided in the annular insertion section 4001. The first fixing hole 3001 axially penetrates the annular insertion section 4001 and the annular snap-fit ​​section 4002 from the distal end to the proximal end. The diameter of the first fixing hole 3001 is slightly larger than the diameter of the adjusting wire. The first end of the adjusting wire extends along the hollow inner cavity of the elastic implant 500, continues straight through the first fixing hole 3001, and finally is knotted at the proximal end face of the annular snap-fit ​​section 4002 to form a fixing knot 2012 for fixation. Therefore, the first fixing sleeve 300 is snapped onto the proximal end of the elastic implant 500, and the adjusting wire is tightened and fixed to the wall surface of the first fixing sleeve 300. In this embodiment, the adjusting wire is inserted parallel to the first fixing sleeve 300 and fixed to it, facilitating the doctor to apply pre-tightening force and then tie a knot.

[0067] In some embodiments, the first fixing hole 3001 can radially penetrate the annular snap-fit ​​section 4002. The first end of the adjusting wire extends along the hollow inner cavity of the elastic implant 500 to the through hole entering the annular insertion section 4001, and then exits from the radial side of the annular snap-fit ​​section 4002, where it is knotted on the side wall near the proximal end face to form a fixing knot 2012. In embodiments, the adjusting wire does not need to penetrate the inner wall of the elastic implant 500; it can simply pass through the lumen and exit from the annular snap-fit ​​section 4002.

[0068] The annular insertion section 4001 and the annular snap-fit ​​section 4002 are integrally formed from a cylindrical through hole penetrating the center of a T-shaped first fixing sleeve 300. The inner diameters of the annular insertion section 4001 and the annular snap-fit ​​section 4002 are the same. In some embodiments, the radial width of the annular snap-fit ​​section 4002, i.e., the difference in inner diameter between the inner and outer rings, can be greater than or equal to the wall thickness of the elastic implant 500.

[0069] As another improvement in this embodiment, the free end of the adjusting wire is fixed to the elastic implant 500 by a second fixing device. Please refer to... Figures 11-14 , Figure 11 A schematic diagram showing the structure when the adjustment wire is fixed to the proximal end of the elastic implant 500 by the second fixation device; Figure 12 for Figure 10 A magnified view of point E in the diagram; Figure 13 This is a structural schematic diagram of the second fixing sleeve 400; Figure 14This is a three-dimensional structural diagram of the clamping block 600. The device also includes a second fixing device, which includes a second fixing sleeve 400 and a clamping block 600. The second fixing sleeve 400 is fitted onto the proximal end of the elastic implant 500, and the clamping block 600 is fitted onto the proximal end of the second fixing sleeve 400. Both the second fixing sleeve 400 and the clamping block 600 have through holes communicating with the hollow inner cavity of the elastic implant 500. The second fixing sleeve 400 has a second fixing hole on its hole wall, which penetrates the hole wall and is located in the contact area between the second fixing sleeve 400 and the clamping block 600. The first end of the adjusting wire passes through the hollow inner cavity of the elastic implant 500 and exits through the second fixing hole. After applying a pre-tightening force to the adjusting wire, the clamping block 600 is fitted into the second fixing sleeve 400, pressing the adjusting wire onto the contact end face between the second fixing sleeve 400 and the clamping block 600.

[0070] As an example of this embodiment, the second fixing sleeve 400 may have the same or partially the same structure as the first fixing sleeve 300. In the same case, the second fixing sleeve 400 is inserted into the proximal end of the elastic implant 500 in the same manner as the first fixing sleeve 300. The second fixing hole on the second fixing sleeve 400 may also penetrate the hole wall at the proximal end of the second fixing sleeve 400 axially or radially. In this case, the clamping block 600 is used to clamp the proximal end of the second fixing sleeve 400, and the position of the adjusting wire passing through corresponds to the pressure surface of the clamping block 600. After the clamping block 600 is pushed in, it directly presses the wire segment of the protruding adjusting wire. Thus, there is no need to tie knots. By clamping the second fixing sleeve 400 with the clamping block 600, the adjusting wire with applied preload can be clamped and held on the second fixing sleeve 400. This embodiment differs from the first fixing sleeve 300 in that it uses a clamping method to fix the first end of the adjusting wire, which makes the operation simpler. The clamping block 600 is mechanically locked, which has a stronger anti-loosening ability. At the same time, the doctor can repeatedly adjust during the pre-tightening process until the optimal pre-tightening force is reached, and then push the clamping block 600 in to lock it.

[0071] For example, the adjusting wire first passes through the second fixing hole and radially out of the radial wall of the annular retaining section 4002. The doctor pulls the wire tight and applies a pre-tightening force. The clamping block 600 is an annular clamping nut. The annular clamping nut is sleeved on the annular retaining section 4002, thereby clamping the adjusting wire on the second fixing sleeve 400 to prevent the adjusting wire from loosening.

[0072] In some embodiments, the clamping block 600 can be clamped and fixed to the second fixing sleeve 400 by means of straight insertion, thread, and snap-fit.

[0073] As a preferred example of this embodiment, the second fixing sleeve 400 has the same structural portion as the first fixing sleeve 300, that is, the second fixing sleeve 400 innovatively designs a proximal connecting portion compared to the first fixing sleeve 300, while the remaining structures (annular insertion section 4001 and annular snap-fit ​​section 4002) are the same. Specifically, the second fixing sleeve 400 includes a distal connecting portion and a proximal connecting portion. The distal connecting portion includes an annular insertion section 4001 and an annular snap-fit ​​section 4002, and the proximal connecting portion is an annular connecting section 4003. The annular insertion section 4001 is inserted into the elastic implant 500, and the distal annular surface of the annular snap-fit ​​section 4002 snaps onto the proximal end face of the elastic implant 500. The proximal annular surface 40021 of the annular snap-fit ​​section is connected to the distal annular surface of the annular connecting section 4003. The second fixing hole includes a fixing... Hole a4004 and fixing hole b4005 are provided. Fixing hole a4004 axially penetrates the annular insertion section 4001 and the annular snap-fit ​​section 4002, and fixing hole b4005 radially penetrates the annular connecting section 4003. Among them, the clamping block 600 is an annular clamping block, which is embedded in the annular connecting section 4003. The inner ring wall of the annular connecting section 4003 is provided with an internal thread 40031, and the outer ring wall of the annular clamping block is provided with an external thread 6001. The annular connecting section 4003 and the annular clamping block are threadedly engaged.

[0074] In this embodiment, the distal annular surface of the annular connecting segment 4003 is connected to the proximal annular surface 40021 of the annular snap-fit ​​segment. An annular clamping block is installed in the inner annular space of the annular connecting segment 4003. The outer annular surface of the clamping block is in close contact with the inner annular surface of the annular connecting segment 4003. The annular clamping block, the annular insertion segment 4001, and the inner annular snap-fit ​​segment 4002 all serve as through holes communicating with the lumen of the elastic implant 500. In this embodiment, the structure of the fixing hole a4004 is the same as that of the first fixing hole 3001 of the axial eye. The fixing hole b4005 radially penetrates the annular connecting segment 4003. Therefore, the adjusting wire passes through the fixing hole a4004 and the fixing hole b4005 in sequence. Then, the clamping block 600 is screwed into the inner annular space of the annular snap-fit ​​segment 4002. The adjusting wire is pressed against the wall of the second fixing sleeve 400 by the engagement of the external thread 6001 on the clamping block 600 and the internal thread 40031 on the annular connecting segment 4003.

[0075] In some embodiments, from the distal end to the proximal end, the inner ring diameter of the annular clamping block remains unchanged and is the same as the inner ring diameter of the annular insertion section 4001 and the annular snap-fit ​​section 4002. The thickness of the annular clamping block is equal to the difference between the inner diameters of the annular connecting section 4003 and the annular snap-fit ​​section 4002. The outer ring diameter of the distal portion of the annular clamping block gradually increases until it is the same as the inner ring diameter of the annular connecting section 4003, while the proximal portion is flush with the annular connecting section 4003. The region of the gradually increasing outer ring diameter of the annular clamping block forms a wedge-shaped space with the annular connecting section 4003, and the distal annular surface of the annular clamping block contacts the fixing hole a4004, with the fixing hole b4005 located within this wedge-shaped space. Therefore, the distal part of the annular clamping block is conical, which can be smoothly aligned and screwed into the annular connecting section 4003, and presses the adjusting wire extending from the fixing hole a4004 onto the proximal annular surface 40021 of the annular snap-fit ​​section. After the adjusting wire passes through the fixing hole a4004, it passes through the wedge-shaped space and exits from the fixing hole b4005.

[0076] In this embodiment, the annular insertion section 4001, the annular snap-fit ​​section 4002, and the annular connecting section 4003 are integrally formed, and the annular connecting section 4003 can be spirally excavated from the proximal end to the distal end of the longer annular snap-fit ​​section 4002.

[0077] Thus, in one fixation method, during surgery, after the adjusting wire passes through the first fixation hole 3001, it is not knotted before adjustment is needed; it is only knotted and fixed after the adjustment is confirmed to be in place. In another fixation method, the adjusting wire passes through fixation holes a4004 and b4005 in sequence. After the adjusting wire has been adjusted as needed and confirmed to be in place, the clamping block 600 engages with the second fixation sleeve 400, pressing and fixing the adjusting wire to the wall surface of the second fixation sleeve 400. In other fixation methods, the first fixation sleeve 300 and the second fixation sleeve 400 can be fixed proximally to the elastic implant 500 by means of bonding, interference fit, or other methods.

[0078] Understandably, during surgery, after the adjusting wire is adjusted to the correct position, a knot is tied proximally. This can be achieved by using a knotter delivered through the working channel of the bronchoscope or the delivery device of the elastic implant 500. Typically, the knotter has two working heads: one straight and one curved. Its working principle is as follows: the adjusting wire first wraps around the straight working head once; the curved working head hooks the distal end of the adjusting wire and pulls it proximally; then, it passes through the loop wrapped on the straight working head along the distal direction. The curved working head then withdraws from the loop proximally, tightening the adjusting wire proximally. Simultaneously, the curved working head hooks the adjusted wire that has passed through the loop and pulls it distally, thus forming a knot. This action can be repeated multiple times to ensure the knot can withstand the corresponding preload. This knotting method is a commonly used technique by surgeons during surgery; in reality, there are many knotting methods, and this embodiment does not limit this one.

[0079] Alternatively, during surgery, after the adjusting wire is adjusted to the correct position, it can be fixed by the clamping block 600. This can be achieved by installing a device connected to the clamping block 600 on the delivery system of the elastic implant 500, and operating a handle on the delivery system. For example, a commonly used method involves a slot on the clamping block 600 and a clamping head on the delivery system. When clamping is required, the clamping head can be pushed into the slot on the clamping block 600. The clamping head connects to the handle on the delivery system, and rotating the corresponding component on the handle engages the clamping block 600 with the second fixing sleeve 400, clamping the adjusting wire to the wall of the second fixing sleeve 400. Similarly, this clamping method is a mature operating technique used by surgeons during surgery, and for clarity and simplicity, it will not be described in detail in this embodiment.

[0080] Of course, multiple adjustment wires can be set on the elastic implant according to the actual situation. Their design and fixation method are similar to the first adjustment wire 201 and the second adjustment wire 202. When multiple adjustment wires are set, the first fixation sleeve 300 and the second fixation sleeve 400 can have multiple holes or a single larger hole to allow the multiple adjustment wires to pass through. During surgery, the elastic implant 500 can be controllably adjusted at multiple positions as needed, precisely and fully folding and compressing the lung tissue to achieve effective adjustable compression and fully expel residual gas.

[0081] In another technical solution, the first side of the elastic implant 500 is provided with multiple grooves, and the second side of the elastic implant 500 opposite to the first side is provided with multiple preset grooves 5001. In this embodiment, see... Figure 15 and Figure 16 As shown, Figure 15 This is a schematic diagram showing the setting position of the preset slot 5001; Figure 16 This is a structural schematic diagram of the pre-set groove 5001. It can be located on the outer wall of the elastic implant 500 with a large curvature, such as... Figure 15 Multiple pre-set grooves 5001 are provided on one side of the outer wall shown in Figure A. These grooves 5001 are spaced apart along the bending direction of the elastic implant 500, facilitating easy deformation of the elastic implant 500 when the adjusting wire is tightened, thus enabling better compression of the target lung tissue. The width of each pre-set groove 5001 is 0.02mm-0.2mm, and its length is 0.05-0.2 times the circumference of the outer wall of the elastic implant 500. The pre-set grooves 5001 may or may not cut through the wall of the elastic implant 500.

[0082] In summary, the adjustable medical device provided in this application, where the elastic implant 500 deforms and returns to a preset shape after implantation at the target emphysema site, folds the lung tissue at the target emphysema site and compresses the residual air. However, because the elastic implant 500 encapsulates the lung tissue, it may not fully recover, resulting in insufficient expulsion of residual air. Furthermore, uneven lung tissue distribution can also lead to insufficient expulsion of residual air from certain portions of the lung tissue encapsulated within the elastic implant 500. This invention addresses this by incorporating multiple adjustment wires on the elastic implant 500. By tightening one or more adjustment wires, the elastic implant 500 can be adjusted to bring its distal end closer to its proximal end, thereby effectively compressing and folding the lung tissue at the target emphysema site, expelling residual air, and achieving controllable and effective volume reduction.

[0083] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0084] It should also be noted that, in this document, the terms "upper," "lower," "left," "right," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor should they be construed as indicating or implying relative importance. Moreover, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements, but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device.

[0085] The above provides a detailed description of an adjustable medical device provided in this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are merely for the purpose of helping to understand this application, and the content of this specification should not be construed as a limitation of this application. Furthermore, those skilled in the art will recognize that various modifications may be made to the specific implementation methods and application scope based on this application. It is neither necessary nor possible to exhaustively list all implementation methods here, but obvious variations or modifications derived therefrom are still within the protection scope of this application.

Claims

1. An adjustable medical device apparatus comprising a resilient implant, characterized in that, The elastic implant is in a preset shape of curling in a natural state, and the elastic implant is provided with an adjusting wire, the adjusting wire extending along the preset shape of the elastic implant; The first end of the adjusting wire is fixed to the proximal end of the elastic implant, and the second end of the adjusting wire opposite to the first end is fixed to the distal end of the elastic implant; wherein the adjusting wire is provided with a pre-tightening force, so that the elastic implant is close from the distal end to the proximal end, thereby adjusting the compression force of the elastic implant acting on the target emphysema position; The first side of the elastic implant is provided with a plurality of cutting grooves, and the second side of the elastic implant away from the first side is provided with a plurality of preset grooves, the preset grooves not cutting through the pipe wall of the elastic implant; The adjusting wire is provided with a plurality of wires, the first end of the plurality of wires is fixed to the proximal end of the elastic implant, and the second end of the plurality of wires is fixed to a plurality of positions at different distances from the proximal end of the distal end of the elastic implant, so that the free lengths of the plurality of wires are different; The device further comprises a first fixing device or a second fixing device; wherein the first end of the adjusting wire is knotted and fixed to the proximal end of the elastic implant through the first fixing device; the first end of the adjusting wire is tightly fixed to the proximal end of the elastic implant through the second fixing device; The first fixing device comprises a first fixing sleeve sleeved on the proximal end of the elastic implant; wherein the first fixing sleeve is provided with a through hole communicating with the hollow inner cavity of the elastic implant, and the hole wall of the first fixing sleeve is provided with a first fixing hole penetrating the hole wall; The second fixing device comprises a second fixing sleeve and an annular compression block; the second fixing sleeve comprises a distal end connecting part and a proximal end connecting part, and the first fixing sleeve and the distal end connecting part are the same in structure; The second fixing sleeve and the annular compression block are both provided with a through hole communicating with the hollow inner cavity of the elastic implant, the hole wall of the second fixing sleeve is provided with a second fixing hole penetrating the hole wall, and the second fixing hole is located in the contact area of the second fixing sleeve and the annular compression block; The distal end connecting part comprises an annular insertion section and an annular clamping section; the second fixing hole comprises a fixing hole a and a fixing hole b, the fixing hole a axially penetrates the annular insertion section and the annular clamping section, and the fixing hole b radially penetrates the annular connecting section; The proximal end connecting part is an annular connecting section, and the annular compression block is embedded in the annular connecting section; the outer ring inner diameter of the distal end part of the annular compression block gradually increases to be the same as the inner ring inner diameter of the annular connecting section, and the gradually increased area of the outer ring inner diameter of the annular compression block and the annular connecting section form a wedge-shaped space, so that the adjusting wire passes through the wedge-shaped space.

2. An adjustable medical device according to claim 1, wherein, The adjusting wire is provided with two wires, the second end of the first adjusting wire is farther away from the proximal end of the elastic implant than the second end of the second adjusting wire.

3. An adjustable medical device apparatus as defined in claim 1, wherein, The adjusting wire is made of at least one of nickel-titanium material, polyester material, stainless steel material and high polymer material.

4. An adjustable medical device according to any one of claims 1-3, wherein the adjustment mechanism comprises a threaded rod. The first end of the adjusting wire passes out of the first fixing hole through the hollow inner cavity of the elastic implant, and after applying a pre-tightening force to the adjusting wire, the adjusting wire passing out of the first fixing hole is set as a fixed knot, so that the first end of the adjusting wire is fixed to the wall surface of the first fixing sleeve.

5. An adjustable medical device according to any one of claims 1-3, wherein the adjustment mechanism comprises a threaded rod. The second fixing sleeve is sleeved on the proximal end of the elastic implant, and the pressing block is sleeved on the proximal end of the second fixing sleeve; the first end of the adjusting wire passes through the hollow inner cavity of the elastic implant and passes out of the second fixing hole, and after a pre-tightening force is applied to the adjusting wire, the pressing block is sleeved in the second fixing sleeve to press the adjusting wire on the contact end face of the second fixing sleeve and the pressing block.

6. An adjustable medical device according to claim 5, wherein, The annular insertion section is inserted into the elastic implant, the distal end annular surface of the annular clamping section is clamped on the proximal end surface of the elastic implant, and the proximal end annular surface of the annular clamping section is connected with the distal end annular surface of the annular connecting section. The inner annular wall surface of the annular connecting section is provided with internal threads, the outer annular wall surface of the annular pressing block is provided with external threads, and the annular connecting section and the annular pressing block are threadedly engaged and connected.

7. An adjustable medical device according to claim 6, wherein, The inner annular inner diameter of the annular insertion section, the inner annular inner diameter of the annular clamping section and the inner annular inner diameter of the annular pressing block are the same and are smaller than the inner annular inner diameter of the annular connecting section; and the outer annular inner diameter of the annular clamping section is the same as the outer annular inner diameter of the annular connecting section.

8. The adjustable medical device of claim 1, wherein, In the case of multiple adjusting wires, the number of first fixing holes or the number of second fixing holes has a one-to-one relationship or a one-to-many relationship with the number of adjusting wires. The second end of the adjusting wire is fixed to the distal end of the elastic implant by any one of knotting, bonding and welding.

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