Adjustable medical instrument device

Abstract

The invention provides an adjustable medical instrument device, and relates to the technical field of lung volume reduction instruments, the adjustable medical instrument device comprises an elastic implant, an adjusting wire is arranged in the elastic implant, and the adjusting wire extends along with the preset shape of the elastic implant; the first end of the adjusting wire is fixed at the near end of the elastic implant, and the second end, opposite to the first end, of the adjusting wire is fixed at the far end of the elastic implant; wherein the adjusting wire applies a pre-tightening force, so that the elastic implant is close to the near end from the far end, and the compression force of the elastic implant acting on the target emphysema position is adjusted. According to the lung volume reduction instrument provided by the invention, the problems that the residual gas at the target emphysema position is not discharged thoroughly and the volume reduction effect is poor due to the fact that the compression force of the lung volume reduction instrument in the existing market is fixed and limited and the lung volume reduction instrument is not fully recovered to the preset shape are solved.

Description

Technical Field

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

[0002] Emphysema is a common lung disease. Traditional treatments include medication-based medical therapy, surgical resection of diseased lung tissue, and the more recently developed procedure, endoscopic lung volume reduction (ELVR). Compared to medical and surgical treatments, ELVR, as a minimally invasive and emerging treatment, offers advantages such as improved patient quality of life and reduced surgical trauma, making it a hot topic in clinical research and application. In current clinical practice, ELVR primarily includes interventional procedures such as one-way valves, bio-glue, water vapor thermal ablation, and elastic coils.

[0003] A lung volume reduction device widely used in the market, such as Figure 1 and Figure 2 As shown, the lung volume reduction device 600 includes an elastic implant 500 and a delivery device 700. The elastic implant 500 is a tubular structure comprising a hollow tubular elastically deformable portion 51, a flexible guide portion 53 connected to the distal end of the elastically deformable portion 51, and an elastic membrane 55. The elastic implant 500 is open at least at its proximal end. The elastically deformable portion 51 exhibits shape memory properties and includes opposing proximal and distal ends 511 and 513. The elastically deformable portion 51 also includes a plurality of mutually spaced slots 514 that communicate with the lumen of the elastically deformable portion 51. In its natural state (i.e., when not subject to any external force), the elastically deformable portion 51 assumes a predetermined, curled shape. Under external force, it can be constrained into a straight strip or other arbitrary shape and, upon removal of the external force, returns to its predetermined shape through bending and twisting. 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 to a nearly linear delivery state, thereby facilitating delivery of the elastic implant 500 to the lesion site.

[0004] like Figure 3 As shown, when the elastic implant 500 is guided through the working channel 902 of the bronchoscope 901 to the target emphysema location to be treated, the doctor will operate the conveyor 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 be folded and squeezed together with the bronchus and surrounding lung tissues in which it is located, so as to expel the residual gas in the target emphysema location and achieve the effect of volume reduction.

[0005] The advantage of this type of lung volume reduction device is that it can reduce the risk of bronchial wall damage caused by the bending of the implant during the implantation process, thereby improving the safety of lung volume reduction surgery to a certain extent. However, it still has shortcomings in actual clinical applications. Although the elastic implant in the lung volume reduction device will return to the preset shape after implantation, the lung tissue will have an opposite resistance to the elastic implant returning to the preset shape. Since the compression force of the elastic implant itself is fixed and limited, it is often not enough to completely overcome the reaction force of the lung tissue with varying degrees of loss. The restoration to the preset shape is insufficient, resulting in incomplete discharge of residual gas at the target emphysema location, which ultimately leads to poor volume reduction effect and difficulty in achieving the ideal treatment expectations. Summary of the Invention

[0006] In response to the above problems, the present invention provides an adjustable medical device to solve the problem that the compression force of elastic implants on the current market is fixed and limited, and the recovery to the preset shape is insufficient, resulting in incomplete discharge of residual gas at the target emphysema location and poor volume reduction effect.

[0007] The present invention provides an adjustable medical device, which adopts the following technical solution: An adjustable medical device comprises an elastic implant, wherein an adjustment wire is provided in the elastic implant and extends along a preset shape of the elastic implant; and a first end of the adjustment wire is fixed to the proximal end of the elastic implant, and a second end of the adjustment wire opposite to the first end is fixed to the distal end of the elastic implant; wherein a pre-tightening force is applied to the adjustment wire to move the elastic implant closer from the distal end to the proximal end, thereby adjusting the compression force of the elastic implant acting on the target emphysema position.

[0008] As one of the preferred solutions, there are multiple adjustment wires, the first ends of the multiple adjustment wires are fixed to the proximal end of the elastic implant, and the second ends of the multiple adjustment wires are respectively fixed to multiple positions of the elastic implant at different distances from the distal end to the proximal end.

[0009] As one of the preferred solutions, two adjusting wires are provided, and 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.

[0010] As one of the preferred solutions, the adjustment wire is made of at least one of nickel-titanium material, polyester material, stainless steel material and polymer material.

[0011] As one of the preferred solutions, the apparatus further comprises a first fixing device, the first fixing device comprising a first fixing sleeve sleeved on the proximal end of the elastic implant, and the first fixing sleeve is provided with a through hole communicating with the hollow inner cavity of the elastic implant; Wherein, a first fixing hole is opened on the hole wall of the first fixing sleeve, and the first fixing hole passes through the hole wall; The first end of the adjustment wire passes through the hollow inner cavity of the elastic implant and out of the first fixing hole. After applying a pre-tightening force to the adjustment wire, the adjustment wire passing through the first fixing hole is set as a fixing knot, so that the first end of the adjustment wire is fixed to the wall surface of the first fixing sleeve.

[0012] As one of the preferred solutions, the apparatus further comprises a second fixing device, the second fixing device comprising a second fixing sleeve and a pressing block, the second fixing sleeve being sleeved on the proximal end of the elastic implant, the pressing block being sleeved on the proximal end of the second fixing sleeve, and the second fixing sleeve and the pressing block both having through holes communicating with the hollow inner cavity of the elastic implant; A second fixing hole is formed on the hole wall of the second fixing sleeve, and the second fixing hole passes through the hole wall and is located in the contact area between the second fixing sleeve and the pressing block; The first end of the adjustment wire passes through the hollow inner cavity of the elastic implant and out of the second fixing hole. After applying pre-tightening force to the adjustment wire, the pressing block is sleeved into the second fixing sleeve to press the adjustment wire on the contact end surface of the second fixing sleeve and the pressing block.

[0013] As one of the preferred solutions, the second fixing sleeve includes a distal connecting portion and a proximal connecting portion, the distal connecting portion includes an annular insertion section and an annular clamping section, and the proximal 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 to the distal annular surface of the annular connecting section; The second fixing hole includes a fixing hole a and a fixing hole b, wherein 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; Among them, the clamping block is an annular clamping block, which is embedded in the annular connecting section; the inner ring wall of the annular connecting section is provided with an internal thread, and the outer ring wall of the annular clamping block is provided with an external thread, and the annular connecting section is threadedly engaged with the annular clamping block.

[0014] As one of the preferred schemes, 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 pressing 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.

[0015] As one of the preferred solutions, when multiple adjustment wires are provided, the number of the first fixing holes or the number of the second fixing holes and the number of the adjustment wires are in a one-to-one relationship or a one-to-many relationship; Wherein, 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.

[0016] As one of the preferred solutions, a first side of the elastic implant is provided with a plurality of cut grooves, and a second side of the elastic implant facing away from the first side is provided with a plurality of preset grooves.

[0017] Compared with the prior art, this application has the following advantages: An embodiment of the present application provides an adjustable medical device, including an elastic implant, an adjustment wire provided in the elastic implant, and the adjustment wire extending along the preset shape of the elastic implant; and a first end of the adjustment wire is fixed to the proximal end of the elastic implant, and a second end of the adjustment wire opposite to the first end is fixed to the distal end of the elastic implant; wherein a pre-tightening force is applied to the adjustment wire to make the elastic implant move closer from the distal end to the proximal end, thereby adjusting the compression force of the elastic implant acting on the target emphysema position.

[0018] By adopting the technical solution of the embodiment of the present application, since the compression force of the elastic implant is fixed during the design, and it is difficult to fully overcome the resistance of the lung tissue during the actual implantation process. The present application sets an adjustment wire in the elastic implant, and the adjustment wire is extended and arranged along the preset shape of the elastic implant. When adjustment is needed during the operation, the adjustment wire is pulled in the proximal direction, and the adjustment wire can add additional force to the elastic implant, and the distal end of the elastic implant will move closer to its proximal end, thereby changing the compression force applied by the elastic implant to the target area, achieving better compression and folding of the target emphysema tissue, and more fully expelling residual gas. At the same time, the doctor can apply different degrees of pre-tightening force to the adjustment wire as needed. The pre-tightening force of different pre-tightening degrees correspondingly provides compression force of different compression degrees, achieving different degrees of lung compression, ensuring targeted squeezing of different lesions, and being able to better fit the lesion conditions of different patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solution of the present application, the following is a brief introduction to the drawings required for the description of the present application. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0020] Figure 1 It is an elastic implant in the lung volume reduction device currently on the market; Figure 2It is a lung volume reduction device currently on the market; Figure 3 This is a schematic diagram of the working principle of the lung volume reduction device currently on the market when implanted in the target emphysema location; Figure 4 This is a diagram of the overall structure of an adjustable medical device provided in one embodiment of the present application; Figure 5 yes Figure 4 A partial enlarged schematic diagram of point C in the middle; Figure 6 This is a diagram showing the overall structure of an elastic implant provided by an embodiment of the present application when two adjustment wires are provided; Figure 7 1 is a schematic structural diagram of an embodiment of the present application in which an adjustment wire is fixed to the proximal end of an elastic implant through a first fixing device; Figure 8 yes Figure 7 A local enlarged schematic diagram of D in FIG; Figure 9 is a side structural diagram of a first fixing sleeve provided in one embodiment of the present application; Figure 10 This is a schematic structural diagram of a first fixing sleeve provided in one embodiment of the present application; Figure 11 1 is a schematic structural diagram of an embodiment of the present application in which an adjustment wire is fixed to the proximal end of an elastic implant through a second fixing device; Figure 12 yes Figure 11 A local enlarged schematic diagram of point E in FIG; Figure 13 is a structural diagram of a second fixing sleeve provided in one embodiment of the present application; Figure 14 This is a three-dimensional structural diagram of a compression block provided in one embodiment of the present application; Figure 15 This is a schematic diagram of the location of the preset slot provided in one embodiment of the present application; Figure 16 This is a schematic diagram of the structure of the preset slot provided in one embodiment of the present application.

[0021] Description of reference numerals: 201, first adjustment wire; 2011, first distal knot; 202, second adjustment wire; 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 clamping section; 40021, proximal annular surface of the annular clamping section; 4003, annular connecting section; 40031, internal thread; 4004, fixing hole a; 4005, fixing hole b; 500, elastic implant; 5001, preset groove; 600, pressing block; 6001, external thread. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0023] It's important to note that traditional medical treatments for emphysema, including oxygen inhalation, medications to prevent lung infection, and bronchial dilation, have limited efficacy. Surgical treatments for emphysema, often involving thoracotomy and lung volume reduction surgery, have numerous limitations, including numerous complications, unpredictable preoperative outcomes, the inability to compensate for suboptimal outcomes resulting from over- or under-resection, high surgical costs, significant emotional and physical distress, and the inability of some patients to tolerate surgery due to poor lung function. Consequently, postoperative mortality is high, and surgical intervention has been rarely used in recent years.

[0024] To better treat emphysema, improve patients' quality of life, and reduce surgical trauma, international research is underway to utilize ELVR to treat emphysema. Specific technologies include interventional methods such as one-way valves, bio-glue, water vapor thermal ablation, and elastic coils for the treatment of emphysema. Because the effectiveness of one-way valves is affected by collateral ventilation, their indications are relatively narrow, and precise placement in different anatomical locations also presents technical difficulties. Bio-glue completely occludes the emphysematous area, leading to postoperative inflammation, which has not been effectively addressed. Water vapor thermal ablation also destroys the original tissue structure of the emphysematous area, causing postoperative inflammation. Compared to one-way valves, bio-glue, and water vapor thermal ablation, elastic coil implants offer greater treatment flexibility and a lower risk of complications, and are therefore gradually gaining widespread market adoption. However, currently popular lung volume reduction devices using the elastic coil principle suffer from the problems described in the background art, limiting their further large-scale market application.

[0025] In view of this, the present invention aims to provide a medical device implanted in a human cavity (such as the airway or digestive tract), specifically a device implanted in an airway to squeeze out residual air, while also enabling adjustment of the compression function of an elastic implant 500 as needed. Specifically, during surgery, when the compression force of the elastic implant 500 is insufficient or insufficient to fully compress the encased lung tissue, the lung tissue can be fully compressed through adjustment. In one achievable technical solution, the present application provides an adjustable medical device comprising an elastic implant 500, wherein an adjustment wire is disposed within the elastic implant 500, the adjustment wire extending along a predetermined shape of the elastic implant 500; a first end of the adjustment wire being fixed to the proximal end of the elastic implant 500, and a second end of the adjustment wire, opposite the first end, being fixed to the distal end of the elastic implant 500; wherein a preload is applied to the adjustment wire to force the elastic implant 500 toward the proximal end, thereby adjusting the compression force exerted by the elastic implant 500 on the target emphysema site.

[0026] As a specific explanation of this embodiment, the embodiment of the present invention optimizes and improves the existing lung volume reduction device on the market, mainly focusing on how to more fully restore the elastic implant 500 to the preset shape after implantation into the target lung tissue, more effectively and fully fold and compress the lung tissue, and expel residual air. Therefore, the main part of the lung volume reduction device can refer to Figure 1-Figure 3 The embodiments of the present invention will not elaborate on the relevant descriptions in detail.

[0027] The improvement of the embodiment of the present invention is that an adjustment wire is provided in the elastic implant 500. Figure 4 and Figure 5 , Figure 4 A diagram showing the overall structure of an adjustable medical device when an adjustment wire is provided; Figure 5 for Figure 4 A partial enlarged schematic diagram of point C in the middle. Figure 4 F stands for distal end, N stands for proximal end, Figure 6 、 Figure 15 In the figure, F represents the distal end, and N represents the proximal end, which will not be described in detail later. The adjustment wire is arranged to extend along the preset shape of the elastic implant 500, such as a spiral or cage-shaped path, so that the tightening of the adjustment wire will guide the elastic implant 500 to fold along the path to restore its preset shape. Specifically, the initial shape of the adjustment wire is consistent with the preset shape of the elastic implant 500. The adjustment wire is fixed near the distal end of the elastic implant 500, biased towards the inner wall or outer wall of the elastic implant 500 with a smaller curvature, and then extends along the shape of the elastic implant 500 to the proximal end of the elastic implant 500. After applying a pre-tightening force, it is fixed at the proximal end.

[0028] Fixing points are provided at the proximal and distal ends of the implant, respectively, and the opposing ends of the adjustment wire are fixed using a fixing process that matches the fixing points. In some embodiments, the first and second ends of the adjustment wire are fixed using the same or different fixing processes as 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 varying degrees of preload during surgery; the second end is a fixed end, which is directly fixed to the distal end of the elastic implant 500.

[0029] During the specific 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 is passed through the hollow inner cavity of the elastic implant 500 from the distal end to the proximal end. After the elastic implant 500 is implanted at the target emphysema site, the adjustment wire is tightened proximally as needed to apply a pre-tightening force to the adjustment wire, forcing the elastic implant 500 to fold or contract from the distal end to the proximal end in the designed direction (the direction to restore its preset shape), thereby more fully compressing the target emphysema site and effectively expelling residual air.

[0030] Furthermore, the adjustment wire is made of at least one of nickel-titanium, polyester, stainless steel, and polymer materials. The adjustment wire of this embodiment is made of a high-strength and biocompatible material, such as nickel-titanium, stainless steel, polymer materials, polyester, nylon, etc. The diameter of the adjustment wire can be 0.05 mm to 0.5 mm.

[0031] Therefore, since the compression force of the elastic implant 500 is fixed during the design, it is difficult to fully overcome the resistance of the lung tissue during the actual implantation process. In this embodiment, an adjustment wire is set in the elastic implant 500, and the adjustment wire is extended along the preset shape of the elastic implant 500. When adjustment is needed during the operation, the adjustment wire is pulled in the proximal direction, and the adjustment wire can add additional force to the elastic implant 500, and the distal end of the elastic implant 500 will move closer to its proximal end, thereby changing the compression force applied by the elastic implant 500 to the target area, thereby better compressing and folding the target emphysema tissue and more fully expelling residual gas. At the same time, the doctor can apply different degrees of pre-tightening force to the adjustment wire as needed. The pre-tightening force of different pre-tightening degrees correspondingly provides compression force of different compression degrees, achieving different degrees of lung compression, ensuring targeted squeezing of different lesions, and being able to better fit the lesion conditions of different patients.

[0032] In the related art, elastic implant 500 not only suffers from the problem of fixed and insufficient compression force, but also suffers from the unevenness of the lung tissue wrapped by the elastic implant 500. Different parts of the lung tissue have different hardnesses, resulting in uneven compression during the folding process. This means that some parts of the target emphysema area are not fully compressed, and residual air in this area is not completely expelled, resulting in poor volume reduction. To address this issue, the embodiment of the present invention further provides multiple adjustment wires, each of which has a first end fixed to the proximal end of the elastic implant 500, and a second end fixed to multiple locations on the distal end of the elastic implant 500 at varying distances from the proximal end.

[0033] Specifically, multiple adjustment wires can be disposed within the elastic implant 500, with the first ends of each adjustment wire positioned proximally to facilitate fixation after preload is applied. The second ends (fixed ends) are positioned at different locations within the elastic implant 500, with the second ends of each adjustment wire positioned at different distances from the first end. This results in different free lengths of the adjustment wires at different fixed end locations. When preload is applied to the corresponding adjustment wires, the adjustment wires control the elastic implant 500 to move closer from the distal end to the proximal end at different locations, thereby creating different pulling paths and compressive forces. This allows for flexible and precise compression of the desired lung tissue, achieving optimal residual gas expulsion and volume reduction.

[0034] In some embodiments, part of the adjustment wires can be selected to apply pre-tightening force separately as needed.

[0035] Preferably, if Figure 6 As shown, Figure 6 This is a diagram illustrating the overall structure of the elastic implant 500 provided by the present invention when two adjustment wires are provided. Two adjustment wires are provided, and the second end of the first adjustment wire 201 is 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 second adjustment wire 202 is fixed to the distal end of the elastic implant 500 in the same manner as the first adjustment wire 201. However, the second ends of the first and second adjustment wires 201, 202 are located at different positions within the elastic implant 500. This allows the first and second adjustment wires 201, 202 to be pulled as needed to achieve precise and sufficient compression of target emphysematous tissue at different locations.

[0036] As an illustration of this embodiment, the second end of the adjustment wire and the elastic implant 500 can be fixed by knotting, bonding, welding, etc. Figure 4 、 Figure 5 and Figure 6The adjustment wire is secured to the elastic implant 500 by tying 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 adjustment wire is passed from the inner wall of the elastic implant 500 through the knotting hole to the outer wall of the elastic implant 500 and then tied to secure it. Of course, the adjustment wire can also be passed from the outer wall through the knotting hole to the inner wall and then tied to secure it on the inner wall.

[0037] In this embodiment, the second end of the first adjustment wire 201 is disposed at the distal end of the elastic implant 500, and the second end of the second adjustment wire 202 is disposed near the distal end of the elastic implant 500, closer to the proximal end. Therefore, the free length of the first adjustment wire 201 when folded is greater than the free length of the second adjustment wire 202, and the first adjustment wire 201 drives the elastic implant 500 to contract as a whole within the range of its preset shape. The second adjustment wire 202 is tightened more quickly, driving the elastic implant 500 to contract locally within a range smaller than its preset shape. This allows for controllable adjustment of the elastic implant 500 over the entire length range, from local to overall.

[0038] For example, see Figure 6 As shown, a first adjustment wire 201 and a second adjustment wire 202 can be provided on the elastic implant 500. A first knotting hole is provided on the wall surface of the distal end of the elastic implant 500, and a second knotting hole is provided on the wall surface of the elastic implant 500 closer to the proximal end and closer to the distal end. The second end of the first adjustment wire 201 passes from the inner wall of the elastic implant 500 through the first knotting hole to the outer wall of the elastic implant 500, and is then tied into a first distal knot 2011 to secure it. The second end of the second adjustment wire 202 passes from the inner wall of the elastic implant 500 through the second knotting hole to the outer wall of the elastic implant 500, and is then tied into a second distal knot 2021 to secure it.

[0039] If there is a part of the target emphysema location that is not fully compressed, the second adjustment wire 202 can be used to provide directional folding, so that the residual air in this part is completely discharged, achieving a uniform compression effect. If the compression force of the elastic implant 500 is insufficient or insufficient to fully compress the wrapped lung tissue, the first adjustment wire 201 can be used to supplement the compression force to more effectively and fully fold and compress the lung tissue. The arrangement of the first adjustment wire 201 and the second adjustment wire 202 has a simple structure and is easy to operate, forming two controllable paths, local and overall, which are convenient for doctors to choose. At the same time, it solves the problem of uneven compression caused by uneven hardness of lung tissue and the problem of insufficient compression of the elastic implant 500, ensuring a simple structure and operational feasibility.

[0040] As an improvement to this embodiment, the free end of the adjustment wire is fixed to the elastic implant 500 via a first fixing device. Figure 7-10 , Figure 7Schematic diagram of the structure when the adjustment wire is fixed to the proximal end of the elastic implant 500 through the first fixing device; Figure 8 for Figure 7 A local enlarged schematic diagram of D in FIG; Figure 9 is a side structural diagram of the first fixing sleeve 300; Figure 10 The figure 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 that is sleeved on the proximal end of the elastic implant 500. The first fixing sleeve 300 defines a through hole that communicates with the hollow inner cavity of the elastic implant 500. A first fixing hole 3001 is defined in the wall of the hole of the first fixing sleeve 300, and the first fixing hole 3001 extends through the hole wall. The first end of the adjustment wire passes through the hollow inner cavity of the elastic implant 500 and out of the first fixing hole 3001. After applying a preload force to the adjustment wire, the adjustment wire that passes through the first fixing hole 3001 is set as a fixing knot 2012, thereby fixing the first end of the adjustment wire to the wall of the first fixing sleeve 300.

[0041] In this embodiment, please refer to Figure 10 The first fixing sleeve 300 is in a horizontal T-shape, with a through hole extending through the middle of the T-shape. The outer contour of the T-shape serves as the through hole wall. The diameter of the through hole is slightly smaller than the diameter of the hollow inner cavity of the elastic implant 500. The vertical section of the T-shape is an annular insertion section 4001, which is inserted into the proximal interior of the elastic implant 500. The horizontal section of the T-shape is an annular clip section 4002, which clips onto the proximal end face of the elastic implant 500. The through hole is connected to the hollow inner 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 extends through the annular insertion section 4001 and the annular clip 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 adjustment wire. The first end of the adjustment wire extends through the hollow interior of the elastic implant 500, continues straight through the first fixing hole 3001, and is finally tied to the proximal end surface of the annular clamping section 4002 to form a securing knot 2012. Thus, the first fixing sleeve 300 is clamped to the proximal end of the elastic implant 500, and the adjustment wire is tightened and fixed to the wall of the first fixing sleeve 300. In this embodiment, the adjustment wire is passed parallel to the first fixing sleeve 300 and then fixed to the first fixing sleeve 300, making it easier for the doctor to apply a preload and then tie the knot.

[0042] In some embodiments, the first fixing hole 3001 can radially extend through the annular clamping section 4002. The first end of the adjustment wire extends along the hollow inner cavity of the elastic implant 500 to enter the through-hole of the annular insertion section 4001, then passes through the radial side of the annular clamping section 4002 and is tied on the side wall near the proximal end face to form a fixing knot 2012. In this embodiment, the adjustment wire does not need to penetrate the inner wall of the elastic implant 500; it can be simply passed through the lumen and then passed through the annular clamping section 4002.

[0043] The annular insertion section 4001 and the annular clamping section 4002 are integrally formed, formed by a cylindrical through-hole extending through the center of the T-shaped first fixing sleeve 300. The annular insertion section 4001 and the annular clamping section 4002 have the same inner diameter. In some embodiments, the radial width of the annular clamping 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.

[0044] As another improvement of this embodiment, the free end of the adjustment wire is fixed to the elastic implant 500 through a second fixing device. Figure 11-14 , Figure 11 Schematic diagram of the structure when the adjustment wire is fixed to the proximal end of the elastic implant 500 through the second fixing device; Figure 12 for Figure 10 A local enlarged schematic diagram of point E in FIG; Figure 13 is a structural schematic diagram of the second fixing sleeve 400; Figure 14 The figure is a three-dimensional structural diagram of the compression block 600. The device also includes a second fixing device, which includes a second fixing sleeve 400 and a compression block 600. The second fixing sleeve 400 is sleeved on the proximal end of the elastic implant 500, and the compression block 600 is sleeved on the proximal end of the second fixing sleeve 400. Both the second fixing sleeve 400 and the compression block 600 are provided with through holes that communicate with the hollow inner cavity of the elastic implant 500. A second fixing hole is provided on the hole wall of the second fixing sleeve 400, which penetrates the hole wall and is located in the contact area between the second fixing sleeve 400 and the compression block 600. The first end of the adjustment wire passes through the second fixing hole through the hollow inner cavity of the elastic implant 500. After applying a pre-tightening force to the adjustment wire, the compression block 600 is sleeved on the second fixing sleeve 400, and the adjustment wire is compressed on the contact end surface of the second fixing sleeve 400 and the compression block 600.

[0045] As an example of this embodiment, the second fixing sleeve 400 can have the same or partially the same structure as the first fixing sleeve 300. Under the same circumstances, 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 opened on the second fixing sleeve 400 can also axially or radially penetrate the hole wall of the proximal end of the second fixing sleeve 400. In this case, the proximal end of the second fixing sleeve 400 is pressed by the clamping block 600. The position where the adjustment wire passes through corresponds to the compression surface of the clamping block 600. After the clamping block 600 is pushed in, it directly compresses the wire segment of the adjustment wire that passes through. Therefore, there is no need to tie a knot. By pressing the second fixing sleeve 400 with the clamping block 600, the adjustment wire with pre-tightening force applied can be clamped on the second fixing sleeve 400. This embodiment is different from the first fixing sleeve 300 in that the first end of the adjustment wire is fixed by a compression method, which is easier to operate. The compression block 600 is mechanically locked and has 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 achieved, and then push the compression block 600 in to lock it.

[0046] For example, the adjustment wire first passes through the radial wall of the annular clamping section 4002 through the second fixed hole. The doctor tightens the wire and applies a pre-tightening force. The clamping block 600 is a circular clamping nut. The circular clamping nut is sleeved on the annular clamping section 4002, thereby clamping the adjustment wire on the second fixed sleeve 400 to prevent the adjustment wire from loosening.

[0047] In some embodiments, the pressing block 600 can be fixed on the second fixing sleeve 400 by direct insertion, threading, snap-fitting or other methods.

[0048] As a preferred example of this embodiment, the second fixing sleeve 400 has the same structural part as the first fixing sleeve 300, that is, the second fixing sleeve 400 has an innovative design of the proximal connection part compared to the first fixing sleeve 300, and the rest of the structure (annular insertion section 4001 and annular clamping section 4002) is the same. Specifically, the second fixing sleeve 400 includes a distal connection part and a proximal connection part, the distal connection part includes an annular insertion section 4001 and an annular clamping section 4002, and the proximal connection part is an annular connection section 4003; the annular insertion section 4001 is inserted into the elastic implant 500, the distal annular surface of the annular clamping section 4002 is clamped on the proximal end face of the elastic implant 500, and the proximal annular surface 40021 of the annular clamping section is connected to the distal annular surface of the annular connection section 4003; wherein, the second fixing hole includes a fixing hole. Hole a4004 and fixing hole b4005, the fixing hole a4004 axially penetrates the annular insertion section 4001 and the annular clamping section 4002, and the fixing hole b4005 radially penetrates the annular connecting section 4003; wherein, the clamping block 600 is an annular clamping block, embedded in the annular connecting section 4003; the inner ring wall surface of the annular connecting section 4003 is provided with an internal thread 40031, and the outer ring wall surface of the annular clamping block is provided with an external thread 6001, and the annular connecting section 4003 is threadedly engaged with the annular clamping block.

[0049] In this embodiment, the distal annular surface of the annular connecting segment 4003 is connected to the proximal annular surface 40021 of the annular clamping segment. An annular compression block is installed in the inner annular space of the annular connecting segment 4003, with its outer annular surface in close contact with the inner annular surface of the annular connecting segment 4003. The inner annular spaces of the annular compression block, the annular insertion segment 4001, and the annular clamping segment 4002 all function as through-holes in communication with the lumen of the elastic implant 500. In this embodiment, the structure of the fixing hole a4004 is identical to the first fixing hole 3001, which is axially aligned. The fixing hole b4005 radially extends through the annular connecting segment 4003. Therefore, the adjustment wire passes through fixing holes a4004 and b4005 in sequence. The compression block 600 is then screwed into the inner annular space of the annular clamping segment 4002. The external threads 6001 on the compression block 600 engage with the internal threads 40031 on the annular connecting segment 4003, pressing the adjustment wire against the wall of the second fixing sleeve 400.

[0050] In some embodiments, the inner diameter of the annular compression block remains constant from the distal end to the proximal end, and is the same as the inner diameters of the annular insertion section 4001 and the inner diameters of the annular clamping section 4002. Furthermore, the thickness of the annular compression block is equal to the difference between the inner diameters of the annular connecting section 4003 and the inner diameters of the annular clamping section 4002. The outer diameter of the distal portion of the annular compression block gradually increases to the same as the inner diameter of the annular connecting section 4003, while the proximal portion is flush with the annular connecting section 4003. The area of ​​the annular compression block with the gradually increasing outer diameter forms a wedge-shaped space with the annular connecting section 4003, and the distal annular surface of the annular compression block contacts the fixing hole a 4004, with the fixing hole b 4005 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 the adjustment wire extending from the fixing hole a4004 is pressed against the proximal annular surface 40021 of the annular clamping section. After the adjustment wire passes through the fixing hole a4004, it passes through the wedge-shaped space and passes through the fixing hole b4005.

[0051] In this embodiment, the annular insertion section 4001 , the annular clamping section 4002 and the annular connecting section 4003 are integrally formed, and the annular connecting section 4003 can be spirally dug out from the proximal end to the distal end of the longer annular clamping section 4002 .

[0052] Thus, in one fixing method, during surgery, after the adjustment wire passes through the first fixing hole 3001, it is not tied in a knot until adjustment is required. It is only tied and secured after the adjustment is confirmed to be in place. In another fixing method, the adjustment wire passes through fixing hole a4004 and fixing hole b4005 in sequence. After the adjustment wire is adjusted as needed and confirmed to be in place, the pressing block 600 is engaged with the second fixing sleeve 400 to press and secure the adjustment wire to the wall surface of the second fixing sleeve 400. In other fixing methods, the first fixing sleeve 300 and the second fixing sleeve 400 can be fixed to the elastic implant 500 at the proximal end by bonding, interference fit, or other methods.

[0053] It is understood that during surgery, after the adjustment wire is adjusted into place, a knot is tied at the proximal end. This can be achieved by conveying a knotter through the working channel of a bronchoscope or the conveyor of the elastic implant 500. Usually, the knotter has two working heads, one straight and the other curved. Its working principle is as follows: the adjustment wire is first wound around the straight working head, the curved working head hooks the adjustment wire at the distal end and pulls it toward the proximal end, then passes through the loop wound on the straight working head along the distal direction of the straight working head, the curved working head withdraws from the loop toward the proximal end, and the adjustment wire is tightened toward the proximal end. At the same time, the curved working head hooks the adjustment wire that has passed through the loop and pulls it toward the distal end, thus forming a knot. This action can be repeated multiple times so that the knot formed is sufficient to withstand the corresponding preload. Among them, this knotting method is a commonly used method by doctors during surgery. In fact, there are many ways to tie knots, which are not limited in this embodiment.

[0054] It is also understood that during surgery, after the adjustment wire is adjusted into position, it is secured by the compression block 600. This can be achieved by providing a device connected to the compression block 600 on the conveyor of the elastic implant 500, and operating a handle on the conveyor. For example, a commonly used method is to provide a slot on the compression block 600 and a clamping head on the conveyor. When compression is required, the clamping head can be pushed into the slot on the compression block 600. The clamping head is connected to the handle on the conveyor, and the corresponding component on the handle is rotated to engage the compression block 600 with the second fixing sleeve 400, thereby pressing and securing the adjustment wire to the wall surface of the second fixing sleeve 400. Similarly, this compression method is a well-established operating method used by doctors during surgery, and for the sake of clarity and simplicity, it will not be described in detail in this embodiment.

[0055] Of course, multiple adjustment wires can be installed on the elastic implant depending on practical circumstances. Their design and fixation methods are similar to those of the first adjustment wire 201 and the second adjustment wire 202. When multiple adjustment wires are installed, the first and second fixing sleeves 300 and 400 can be provided with multiple holes or a single larger hole to allow for the passage of multiple adjustment wires. During surgery, the elastic implant 500 can be controlled and adjusted at multiple positions as needed to precisely and adequately fold and compress the lung tissue, achieving effective and adjustable compression and fully expelling residual air.

[0056] In another technical solution, a first side of the elastic implant 500 is provided with a plurality of grooves, and a second side of the elastic implant 500 away from the first side is provided with a plurality of preset grooves 5001. Figure 15 and Figure 16 As shown, Figure 15 Schematic diagram of the setting position of the preset slot 5001; Figure 16 Schematic diagram of the structure of the preset groove 5001. The outer wall of the elastic implant 500 with a larger curvature can be Figure 15 The outer wall of one side, shown in center A, is provided with multiple pre-set grooves 5001. These grooves 5001 are spaced apart along the curvature of the elastic implant 500. This facilitates deformation of the elastic implant 500 when the adjustment wire is tightened, thereby enabling the elastic implant 500 to better compress the target lung tissue. The width of the pre-set grooves 5001 ranges from 0.02 mm to 0.2 mm, and their length is 0.05 to 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.

[0057] In summary, the adjustable medical device provided by the present application, after being implanted in the target emphysema location, the elastic implant 500 deforms and returns to a preset shape to fold the lung tissue at the target emphysema location and compress and squeeze the residual air at the target emphysema location. Since the elastic implant 500 wraps around the lung tissue, this can lead to insufficient recovery of the elastic implant 500 and insufficient expulsion of residual air. In addition, uneven lung tissue can also lead to insufficient expulsion of residual air from a portion of the lung tissue wrapped in the elastic implant 500. The present invention provides multiple adjustment wires on the elastic implant 500. By tightening one or more adjustment wires that need to be tightened, the elastic implant 500 can be adjustably tightened so that its distal end approaches the proximal end, thereby fully and effectively compressing and folding the lung tissue at the target emphysema location, expelling residual air, and achieving controllable, sufficient and effective volume reduction.

[0058] It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same and similar parts between the various embodiments can be referenced to each other.

[0059] It should also be noted that, in this article, the directions or positional relationships indicated by the terms "upper", "lower", "left", "right", "inside", "outside", etc. are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, relational terms such as "first" and "second" are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations, nor can they be understood as indicating or implying relative importance. Moreover, the term "comprises" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or terminal device that includes a series of elements includes not only those elements, but also includes other elements that are not explicitly listed, or also includes elements that are inherent to such process, method, article or terminal device.

[0060] The above is a detailed introduction to an adjustable medical device provided by the present application. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is intended only to facilitate understanding of the present application, and the contents of this specification should not be construed as limiting the present application. Furthermore, those skilled in the art will appreciate that various modifications may be made to the specific implementation methods and scope of application according to the present application. It is not necessary and impossible to exhaustively enumerate all implementation methods herein, and any obvious changes or modifications derived therefrom remain within the scope of protection of the present application.

Claims

1. An adjustable medical device comprising an elastic implant, characterized in that: An adjustment wire is provided in the elastic implant, and the adjustment wire extends along the preset shape of the elastic implant; In addition, 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 applies a pre-tightening force to make the elastic implant move closer from the distal end to the proximal end, thereby adjusting the compression force of the elastic implant acting on the target emphysema position.

2. The adjustable medical device according to claim 1, characterized in that: There are multiple adjustment wires, the first ends of the multiple adjustment wires are fixed to the proximal end of the elastic implant, and the second ends of the multiple adjustment wires are respectively fixed to multiple positions of the elastic implant at different distances from the distal end to the proximal end.

3. The adjustable medical device according to claim 2, characterized in that: Two adjusting wires are provided, and 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.

4. The adjustable medical device according to claim 1, characterized in that: The adjustment wire is made of at least one of nickel-titanium material, polyester material, stainless steel material and polymer material.

5. An adjustable medical device according to any one of claims 1 to 4, characterized in that: The apparatus further includes a first fixing device, the first fixing device including a first fixing sleeve sleeved on the proximal end of the elastic implant, and the first fixing sleeve is provided with a through hole communicating with the hollow inner cavity of the elastic implant; Wherein, a first fixing hole is opened on the hole wall of the first fixing sleeve, and the first fixing hole passes through the hole wall; The first end of the adjustment wire passes through the hollow inner cavity of the elastic implant and out of the first fixing hole. After applying a pre-tightening force to the adjustment wire, the adjustment wire passing through the first fixing hole is set as a fixing knot, so that the first end of the adjustment wire is fixed to the wall surface of the first fixing sleeve.

6. An adjustable medical device according to any one of claims 1 to 4, characterized in that: The apparatus further includes a second fixing device, the second fixing device including a second fixing sleeve and a compression block, the second fixing sleeve being sleeved on the proximal end of the elastic implant, the compression block being sleeved on the proximal end of the second fixing sleeve, and the second fixing sleeve and the compression block both having through holes communicating with the hollow inner cavity of the elastic implant; A second fixing hole is formed on the hole wall of the second fixing sleeve, and the second fixing hole passes through the hole wall and is located in the contact area between the second fixing sleeve and the pressing block; The first end of the adjustment wire passes through the hollow inner cavity of the elastic implant and out of the second fixing hole. After applying pre-tightening force to the adjustment wire, the pressing block is sleeved into the second fixing sleeve to press the adjustment wire on the contact end surface of the second fixing sleeve and the pressing block.

7. The adjustable medical device according to claim 6, characterized in that: The second fixing sleeve includes a distal connecting portion and a proximal connecting portion, the distal connecting portion includes an annular insertion section and an annular clamping section, and the proximal 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 to the distal annular surface of the annular connecting section; The second fixing hole includes a fixing hole a and a fixing hole b, wherein 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; Among them, the clamping block is an annular clamping block, which is embedded in the annular connecting section; the inner ring wall of the annular connecting section is provided with an internal thread, and the outer ring wall of the annular clamping block is provided with an external thread, and the annular connecting section is threadedly engaged with the annular clamping block.

8. The adjustable medical device according to claim 7, characterized in that: The inner ring inner diameters of the annular insertion section, the inner ring inner diameters of the annular clamping section and the inner ring inner diameters of the annular pressing 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.

9. The adjustable medical device according to claim 2, characterized in that: In the case where a plurality of adjusting wires are provided, the number of the first fixing holes or the second fixing holes and the number of the adjusting wires are in a one-to-one relationship or a one-to-many relationship; Wherein, 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.

10. The adjustable medical device according to claim 1, characterized in that: A first side of the elastic implant is provided with a plurality of cutting grooves, and a second side of the elastic implant facing away from the first side is provided with a plurality of preset grooves.

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