Lung volume reduction elastic implant and lung volume reduction instrument

Abstract

The invention discloses a lung volume reduction elastic implant and a lung volume reduction instrument. The lung volume reduction elastic implant comprises a coiled elastic deformation section, a flexible guide section located at the far end of the implant, a flexible connection section located at the near end of the implant, a far-end straight section and a near-end straight section; the far-end straight section is arranged between the flexible guide section and the elastic deformation section, and the far-end straight section straightly extends along the tail end of the elastic deformation section connected with the far-end straight section; the near-end straight section is arranged between the flexible connecting section and the elastic deformation section, and the near-end straight section straightly extends along the tail end of the elastic deformation section connected with the near-end straight section; wherein the deflection force required by the flexible guide section to deflect relative to the far-end straight section is smaller than the deflection force required by the far-end straight section to deflect relative to the elastic deformation section; and the deflection force required by the flexible connecting section to deflect relative to the near-end straight section is smaller than that required by the near-end straight section to deflect relative to the elastic deformation section. The invention aims to solve the technical problem that the existing implant is easy to shift after being implanted.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, and in particular to a lung volume reduction elastic implant and lung volume reduction device. Background Technology

[0002] Emphysema is a common chronic obstructive pulmonary disease, with a particularly high incidence among the elderly. Statistics show that the 5-year survival rate for patients with end-stage emphysema is less than 50%. Traditional treatments include oxygen therapy, prevention of lung infections, and bronchodilators, but their effectiveness is limited. Surgical treatment for emphysema faces challenges such as strict surgical indications, numerous complications, and high costs. Furthermore, some patients cannot tolerate surgery due to poor lung function, leading to a high postoperative mortality rate.

[0003] Currently, lung volume reduction implants, as a percutaneous interventional treatment, are inserted into the lungs through the working channel of a bronchoscope. After the loading system is removed, the implant returns to its natural shape, compressing emphysematous areas, expelling gas, and reducing lung tissue volume, thereby improving lung function. Although existing lung volume reduction implants have shown some efficacy in clinical applications, design deficiencies have been observed in practical use, particularly the tendency for displacement after implantation. This displacement not only affects the treatment outcome but may also pose additional risks of complications for patients, limiting the safety and effectiveness of its clinical application. Summary of the Invention

[0004] This invention provides an improved elastic lung volume reduction implant and lung volume reduction device, aiming to solve the technical problem that existing implants are prone to displacement after implantation.

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

[0006] This invention provides a lung volume reduction elastic implant with shape memory properties. In its natural state, the implant is at least partially coiled. Under a preset external force, the implant can be constrained into an elongated shape and return to its natural state after the force is removed. The implant includes a coiled elastic deformation segment, a flexible guiding segment at the distal end of the implant, and a flexible connecting segment at the proximal end of the implant. The implant further includes a distal straight segment and a proximal straight segment.

[0007] The distal straight section is disposed between the flexible guide section and the elastic deformation section. The distal end of the distal straight section is connected to the proximal end of the flexible guide section, and the proximal end of the distal straight section is connected to the distal end of the elastic deformation section. The distal straight section extends straight along the end of the elastic deformation section to which it is connected.

[0008] The proximal straight segment is disposed between the flexible connecting segment and the elastically deformable segment. The proximal end of the proximal straight segment is connected to the distal end of the flexible connecting segment, and the distal end of the proximal straight segment is connected to the proximal end of the elastically deformable segment. The proximal straight segment extends straight along the distal end of the elastically deformable segment to which it is connected; wherein,

[0009] The deflection force required for the flexible guide segment to deflect relative to the distal straight segment is less than the deflection force required for the distal straight segment to deflect relative to the elastically deformable segment.

[0010] The deflection force required for the flexible connecting segment to deflect relative to the proximal straight segment is less than the deflection force required for the proximal straight segment to deflect relative to the elastically deformable segment.

[0011] In one embodiment, the elastically deformable segment accounts for 35% to 80% of the total length of the implant, and the distal straight segment and the proximal straight segment each account for 3% to 20% of the total length of the implant.

[0012] In one embodiment, the coiled elastic deformable segment includes a plurality of generally C-shaped curved segments connected in sequence. The connected curved segments are spirally coiled at intervals between the distal straight segment and the proximal straight segment. The free ends of the curved segments at both ends are respectively connected to the distal straight segment and the proximal straight segment. After coiling, the free end of the curved segment at one end faces the curved segment at the other end, such that the distal straight segment and the proximal straight segment connected to the curved segments at both ends tend to move closer to the elastic deformable segment.

[0013] In one embodiment, there are an even number of curved segments. After the even number of curved segments are connected, the distal straight segment and the proximal straight segment are located on both sides of the elastic deformation segment. The elastic deformation segment is compressed along the interval direction of the even number of curved segments, and the angle between the projections of the extension direction of the distal straight segment and the extension direction of the proximal straight segment perpendicular to the compression direction is not greater than 180°.

[0014] In one embodiment, the elastic deformation segment includes at least a first bending segment and a second bending segment, wherein the distal end of the first bending segment is connected to the proximal end of the distal straight segment, and the proximal end of the second bending segment is connected to the distal end of the proximal straight segment; wherein the distal straight segment and the first bending segment connected thereto are substantially coplanar to form a first plane, and the proximal straight segment and the second bending segment connected thereto are substantially coplanar to form a second plane, and the included angle between the first plane and the second plane is between 40° and 90°.

[0015] In one embodiment, the bending resistance of the elastically deformable segment is greater than that of the flexible guide segment, and the bending resistance of the distal straight segment is greater than or equal to that of the elastically deformable segment; and / or,

[0016] The bending resistance of the elastically deformable segment is greater than that of the flexible connecting segment, and the bending resistance of the proximal straight segment is greater than or equal to that of the elastically deformable segment.

[0017] In one embodiment, the minimum bending radius of the elastic deformation segment is less than or equal to 12 mm.

[0018] In one embodiment, the implant further includes an anchoring element disposed at least on the distal straight section of the implant, the anchoring element being used to contact the tissue to prevent displacement of the implant relative to the tissue.

[0019] In one embodiment, the anchoring element includes an anchor spike; wherein,

[0020] The root of the anchor is connected to the distal straight section, the free end of the anchor extends toward the proximal side of the implant, and the distance between the anchor and the distal straight section gradually increases from far to near; or;

[0021] The root of the anchor bar is connected to the distal straight section, the free end of the anchor bar extends laterally toward the distal end, and the distance between the anchor bar and the distal straight section gradually increases from near to far; or,

[0022] The root of the anchor is connected to the straight section at the distal end, and the free end of the anchor extends a predetermined distance toward the distal side before turning back to extend toward the proximal side.

[0023] In one embodiment, the implant includes a hollow tubular matrix and an elastic membrane at least partially attached to the surface of the tubular matrix; a groove is provided on the distal straight section of the tubular matrix, and an anchor is provided at the corresponding groove position, with the free end of the anchor protruding through the elastic membrane.

[0024] In one embodiment, the anchor bar is self-deployable and deformable under external force; the elastic film has a perforation corresponding to the groove position, the free end of the anchor bar can extend through the perforation and can be placed in the groove through the perforation under external force.

[0025] In one embodiment, the groove is disposed on the inner side of the distal straight section of the tubular substrate facing the elastically deformable section.

[0026] In one embodiment, the implant includes a hollow tubular matrix and an elastic film at least partially attached to the surface of the tubular matrix; the anchor includes an anchoring structure formed on the elastic film in the distal straight section, the anchoring structure including one or more of a spiral structure, a protruding structure, and a recessed structure.

[0027] In one embodiment, the elastic film on the distal straight section includes at least a non-contact section separated from the tubular substrate, and the anchoring structure is disposed on the film of the non-contact section.

[0028] The present invention also provides a lung volume reduction device, comprising the above-described implant and a delivery device compatible with the implant. The delivery device includes a core wire and a hollow pusher. The implant is detachably connected to the distal end of the pusher via the proximal end of the implant. The core wire is movably inserted into the lumen of the implant and the lumen of the pusher.

[0029] The lung volume reduction elastic implant and lung volume reduction device of the present invention have a coiled elastic deformation segment with strong restoring torque, which ensures the ability to twist and grasp tissue. At both ends, a bending blocking and limiting position that is not easy to deflect is formed between the distal straight segment and the elastic deformation segment, and between the proximal straight segment and the elastic deformation segment, thereby forming an effective blocking constraint and limiting. This prevents the implant from moving and shifting due to tissue rebound during and after the release of the implant, ensuring a close fit between the implant and the lesion area. The implant can better compress the lesion area, maximize the volume reduction effect, and improve the patient's respiratory function. Attached Figure Description

[0030] To more clearly illustrate the solutions in this invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention or corresponding prior art. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Wherein:

[0031] Figure 1 This is a schematic diagram of the structure of an exemplary implant of the present invention from one perspective;

[0032] Figure 2 This is a schematic diagram of the elongated structure of an exemplary implant of the present invention;

[0033] Figure 3 This is a schematic diagram of the structure of an exemplary implant of the present invention from another perspective;

[0034] Figure 4 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective;

[0035] Figure 5 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective;

[0036] Figure 6 This is a schematic diagram of the structure of an exemplary implant of the present invention after it has been compressed along its coiling direction from one perspective.

[0037] Figure 7 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective;

[0038] Figure 8 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective;

[0039] Figure 9 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective;

[0040] Figure 10 This is a schematic diagram of the structure of an exemplary implant of the present invention, including a tubular matrix and an elastic membrane;

[0041] Figure 11 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective;

[0042] Figure 12 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective; wherein, the implant of this embodiment is provided with anchor pins;

[0043] Figure 13 yes Figure 12 A schematic diagram of the tubular matrix from one perspective;

[0044] Figure 14 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective; wherein, the anchor of the implant in this embodiment is constricted;

[0045] Figure 15 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective; wherein, the implant of this embodiment is provided with anchors, and the anchors are flipped.

[0046] Figure 16 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective; wherein, the elastic film of the implant in this embodiment is provided with an anchoring structure;

[0047] Figure 17 This is a structural schematic diagram of an exemplary implant of the present invention from another perspective; wherein, the elastic film of the implant in this embodiment is provided with a protruding structure. Detailed Implementation

[0048] The technical solutions in the embodiments of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0049] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for 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. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. When an element is referred to as being "fixed to" or "set on" another element, the element may be directly connected to the other element or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or connected to the other element through one or more connecting elements.

[0050] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction refers to the direction along the wire diameter or radius. It is important to note that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end point," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, endpoint, or end face, but also includes a portion extending axially and / or radially from the tip, endpoint, or end face on the element to which the tip, endpoint, or end face belongs. The above definitions are for convenience only and should not be construed as limiting the invention.

[0051] Please see Figure 1 and Figure 2 This invention provides a lung volume-reducing elastic implant 100, wherein the implant 100 has shape memory properties, and the implant 100 with shape memory properties is at least partially coiled in its natural state. The implant 100 in its natural state (e.g.) Figure 1 It can be constrained into a long strip shape under the action of a preset external force (such as...). Figure 2 And after the external force is removed, it returns to its natural state through bending and torsion (such as...). Figure 1The natural state described in this invention refers to the state when it is not subjected to any external force. The natural state of the implant 100 can be obtained through a pre-formation method. It is understood that the implant 100 with shape memory characteristics in its natural state can also take on other shapes under the action of external force, such as a ring with its two ends facing each other. It is understood that the closer the implant 100, which is constrained into a long strip shape, is to a straight strip, the easier it is to deliver. Of course, the required constraint force will also increase accordingly, and excessive constraint force will lead to increased difficulty in release. Therefore, the implant 100 may still have a slightly curved shape in some areas after being constrained.

[0052] Exemplary methods of constraining the implant 100 include, but are not limited to: the implant 100, which is at least partially coiled in its natural state, can be placed inside the constraining outer tube of the delivery device to make it elongated; or the implant 100 can be configured to be at least partially hollow, with the constraining core wire of the delivery device inserted into the hollow cavity to straighten the implant 100 and make it elongated. It should be noted that the above-described constraining methods are merely illustrative and are not limited thereto.

[0053] The implant 100 with shape memory properties of the present invention can be made of a superelastic material commonly used in the industry (such as nickel-titanium alloy). The present invention does not limit the specific material, as long as it is suitable for the human body and has superelasticity.

[0054] See also Figure 1 and Figure 2 Specifically, the implant 100 includes a coiled elastic deformable segment 11, a flexible guiding segment 12 located at the distal end of the implant 100, and a flexible connecting segment 13 located at the proximal end of the implant 100. Furthermore, the implant 100 of the present invention differs from the applicant's prior art in that the present invention further includes a distal straight segment 14 and a proximal straight segment 15. The distal straight segment 14 is disposed between the flexible guiding segment 12 and the elastic deformable segment 11, and the distal end of the distal straight segment 14 is connected to the proximal end of the flexible guiding segment 12. The proximal straight segment 15 is disposed between the flexible connecting segment 13 and the elastic deformable segment 11, and the proximal end of the proximal straight segment 15 is connected to the distal end of the flexible connecting segment 13. The distal end of the proximal straight segment 15 is connected to the proximal end of the elastic deformable segment 11. The implant 100 of the present invention includes a flexible connecting segment 13, a proximal straight segment 15, an elastically deformable segment 11, a distal straight segment 14, and a flexible guiding segment 12, connected sequentially from proximal to distal. For example, Figure 1 and Figure 2 As shown, the implant 100 of the present invention has a tubular structure, and the flexible connecting segment 13, the proximal straight segment 15, the elastic deformation segment 11, the distal straight segment 14, and the flexible guiding segment 12 are coaxially arranged and connected in sequence from proximal to distal.

[0055] The distal straight segment 14 of the present invention extends straight along the end of the elastically deformable segment 11 connected thereto. Preferably, the distal straight segment 14 extends straight along the tangent at the end of the elastically deformable segment 11 connected thereto. Figure 1 The tangent at the distal end of the elastically deformable segment 11 is Fa, and the extension direction of the distal straight segment 14 is F14, which is substantially parallel to Fa. The proximal straight segment 15 extends straight along the end of the elastically deformable segment 11 connected to it; preferably, the proximal straight segment 15 extends straight along the tangent at the end of the elastically deformable segment 11 connected to it. Figure 1 The tangent at the proximal end of the elastically deformable segment 11 is Fb, and the extension direction of the proximal straight segment 15 is F15, which is substantially parallel to Fb. After the proximal straight segment 15 and the distal straight segment 14 of this invention extend, the deflection force required for the flexible guiding segment 12 to deflect relative to the distal straight segment 14 is less than the deflection force required for the distal straight segment 14 to deflect relative to the elastically deformable segment 11; the deflection force required for the flexible connecting segment 13 to deflect relative to the proximal straight segment 15 is less than the deflection force required for the proximal straight segment 15 to deflect relative to the elastically deformable segment 11. The deflection force required for deflection as described in this invention refers to the force required to achieve the same deflection angle. Specifically, the deflection force of the present invention can be measured using a testing tool. For example, the distal straight section 14 is fixed, and the distal end of the flexible guide section 12 is pulled to one side (here, "one side" refers to one of the left or right sides of the distal straight section 14) to rotate, causing it to deflect relative to the distal straight section 14 by a predetermined angle A° (e.g., 5°), and the deflection force X is recorded. Similarly, the elastic deformation section 11 is fixed (at this time, both the flexible guide section 12 and the distal straight section 14 are in a free state), and the distal end of the distal straight section 14 is pulled to one side (here, "one side" refers to one of the left or right sides of the distal end of the elastic deformation section 11) to rotate, causing it to deflect relative to the elastic deformation section 11 by a predetermined angle A° (e.g., 5°), and the deflection force Y is recorded. If X < Y, then the deflection force required for the flexible guide section 12 to deflect relative to the distal straight section 14 is less than the deflection force required for the distal straight section 14 to deflect relative to the elastic deformation section 11. Similarly, the above measurement method can be used to measure the deflection force between the flexible connecting section 13, the near-end straight section 15, and the elastic deformation section 11.

[0056] Through the above-described method of the present invention, the coiled elastic deformation segment 11 has a strong restoring torque, ensuring the ability to torsionally grasp tissue. Furthermore, at both ends, a bending blocking and limiting position that is not prone to deflection is formed between the distal straight segment 14 and the elastic deformation segment 11, and between the proximal straight segment 15 and the elastic deformation segment 11, respectively. This forms an effective blocking and restraining constraint, preventing the implant 100 from shifting due to tissue rebound after release. In addition, with the same length, the arrangement of the two straight segments at the front and rear also reduces the torsional stress of the implant 100, facilitating the reduction of restraint force during transport to keep the implant 100 in a long strip shape. Furthermore, the flexible guide segment 12 located at the distal end of the distal straight segment 14 is flexible to avoid damaging the distal tissue. After the end of the flexible guide segment 12 comes into contact with the tissue, it will form a certain deflection bend. This deflection bend will form a bending angle with the distal straight segment 14, which further enhances the ability of the distal straight segment 14 to restrain tissue rebound and improves the anchoring effect of the implant 100.

[0057] In this invention, to ensure that the distal straight segment 14 and the proximal straight segment 15 form an effective constraint, the angle between the extending direction of the distal straight segment 14 and the tangent of the connected curved segment at its furthest point is less than or equal to 90°. Similarly, the angle between the extending direction of the proximal straight segment 15 and the tangent of the connected curved segment at its furthest point is less than or equal to 90°. Figure 1 The distal straight segment 14 extends in the direction of F14, and the tangent of the curved segment connected to it at its furthest point is Fc. The angle α1 between F14 and fc is less than or equal to 90°. The proximal straight segment 15 extends in the direction of F15, and the tangent of the curved segment connected to it at its furthest point is Fd. The angle α2 between F15 and fd is less than or equal to 90°.

[0058] In other embodiments, such as Figure 2As shown, the length L1 of the elastically deformable segment 11 of the implant 100 of the present invention accounts for 35% to 80% of the total length of the implant 100, the length L4 of the distal straight segment 14 accounts for 3% to 20% of the total length of the implant 100, and the length L5 of the proximal straight segment 15 accounts for 3% to 20% of the total length of the implant 100. For the present invention, when the total length of the implant 100 is limited, the proportion of the elastically deformable segment 11 and the two straight segments at the front and rear ends is particularly important. It cannot be too large or too small. If the proportion of the elastically deformable segment 11 is too small, its ability to grasp tissue is reduced, and the volume reduction effect cannot be achieved. If the proportion is too large, the winding increases and the recovery torque is large, making it more difficult to constrain it into a long strip shape, and also increasing the difficulty of release, which will bring difficulties to the doctor's operation. At the same time, if the proportion of the straight segment is too large, it will inevitably lead to the reduction of the elastically deformable segment 11 when the total length is limited, affecting the volume reduction effect. Moreover, the excessively long straight segment makes the end away from the elastically deformable segment 11 prone to deflection, reducing the effective blocking effect. Therefore, the above-mentioned proportions of the present invention are based on the comprehensive effect of volume reduction, delivery, release and other multiple dimensions.

[0059] Exemplary, the coiled elastic deformable segment 11 of the present invention includes a plurality of generally C-shaped curved segments connected in sequence. The connected curved segments are spirally coiled at intervals between the distal straight segment 14 and the proximal straight segment 15. The free ends of the curved segments at both ends are connected to the distal straight segment 14 and the proximal straight segment 15, respectively. After coiling, the free end of the curved segment at one end faces the curved segment at the other end, such that the distal straight segment 14 and the proximal straight segment 15, which are connected to the curved segments at both ends, tend to move closer to the elastic deformable segment 11. Figure 1 , Figure 3 , Figure 4 and Figure 5 The exemplary coiled elastic deformation segment 11 of the present invention includes two generally C-shaped curved segments, namely a first curved segment 111 and a second curved segment 112. The first curved segment 111 and the second curved segment 112 are connected. The first curved segment 111 and the second curved segment 112 are spirally coiled at intervals between the distal straight segment 14 and the proximal straight segment 15, with a maximum interval of h. The free end a of the first curved segment 111 is connected to the distal straight segment 14, and the free end b of the second curved segment 112 is connected to the proximal straight segment 15. After coiling, the free end b of the second curved segment 112 faces the first curved segment 111; or the first curved segment 111, after coiling, faces the second curved segment 112 from its free end a. Based on the above coiling, referring to... Figure 5 This causes the distal straight section 14 connected to the first curved section 111 and the proximal straight section 15 connected to the second complete section 112 to tend to converge relative to the elastically deformable section 11. For example... Figure 5As shown, AA is the central axis passing through the connection between the first curved segment 111 and the second curved segment 112, and the distal straight segment 14 and the proximal straight segment 15 tend to gradually converge relative to the central axis AA along their respective extension directions.

[0060] The exemplary implant 100 of the present invention has a coiled elastic deformation segment 11 that is spirally coiled between a distal straight segment 14 and a proximal straight segment 15. When the implant 100 is released, it forms a circumferentially progressive and orderly grasping structure, which facilitates the discharge of tissue gas. The distal straight segment 14 and the proximal straight segment 15, which are respectively connected to the curved segments at both ends, tend to move closer to the elastic deformation segment 11, so that the two ends of the implant can form a centrally clamping and abutting structure. After the implant 100 captures and coils the tissue, it can obtain a better grasping and clamping effect.

[0061] In other embodiments, see Figure 3 and Figure 6 As shown, the generally C-shaped curved segments constituting the elastic deformation segment 11 of the present invention have an even number. After the even number of curved segments are connected, the distal straight segment 14 and the proximal straight segment 15 are located on both sides of the elastic deformation segment 11, such that the distal straight segment 14 and the proximal straight segment 15 at both ends extend toward the side where the elastic deformation segment 11 exists, i.e. Figure 6 As shown, the elastic deformation segment 11 is compressed along the even-number intervals of the curved segments (i.e., perpendicular to the paper plane). The angle β1 between the projections of the extension directions of the distal straight segment 14 and the proximal straight segment 15 at both ends onto the compression direction (i.e., parallel to the paper plane) is no greater than 180°. Here, the angle β1 is defined as the angle at which the projection of the proximal straight segment 15 reaches the projection of the distal straight segment 14 in a counterclockwise direction. This arrangement positions the coiled elastic deformation segment 11 between the distal straight segment 14 and the proximal straight segment 15, creating a good clamping effect. Furthermore, the distal straight segment 14 and the proximal straight segment 15 are located on the same side, preventing the distal straight segment 14 from extending to the distal end after coiling and affecting the coiling effect. In other embodiments, such as... Figure 6 As shown, the elastic deformation segment 11 is compressed along the intervals of multiple C-shaped curved segments. After compression, the multiple C-shaped curved segments in the elastic deformation segment 11 will stack, forming an approximately circular ring. In this state, the angle between the projections of the extension direction of the distal straight segment 14 and the extension direction of the proximal straight segment 15 perpendicular to the compression direction is less than or equal to 90°, i.e., as shown... Figure 6 As shown, the included angle β1 is less than or equal to 90°, thus ensuring excellent capture and gripping effects.

[0062] In one embodiment, see Figures 7-9As mentioned above, the elastically deformable segment 11 includes at least a first curved segment 111 and a second curved segment 112. The distal end of the first curved segment 111 is connected to the proximal end of the distal straight segment 14, and the proximal end of the second curved segment 112 is connected to the distal end of the proximal straight segment 15. The distal straight segment 14 and the connected first curved segment 111 are substantially coplanar, forming a first plane I-I. The first plane I-I may be a plane passing through the central axis of the distal straight segment 14 and the central axis of the first curved segment 111. The proximal straight segment 15 and the connected second curved segment 112 are substantially coplanar, forming a second plane II-II. The second plane II-II may be a plane passing through the proximal straight segment 111. The plane formed by the central axis of the straight segment 15 and the central axis of the second curved segment 112, with the included angle γ1 between the first plane I-I and the second plane II-II between 40° and 90°, at which point the projection of the connection between the roughly C-shaped first curved segment 111 and the roughly C-shaped second curved segment 112 falls simultaneously within the first plane I-I and the second plane II-II. This structural design ensures that the implant 100 fits tightly to the lesion area within a limited size range and under the condition that the recovery torque cannot be too large. The implant can better compress the lesion area, maximize the volume reduction effect, and improve the patient's respiratory function.

[0063] In other embodiments, see Figure 6 As shown, the minimum bending radius r of the elastic deformation segment 11 of the present invention is less than or equal to 12 mm. This avoids the implant 100 from breaking during the insertion of the bronchoscope, thus preventing unnecessary harm to the patient or even surgical failure. In addition, it also allows the elastic deformation segment 11 to have good recovery torque.

[0064] In this invention, the bending resistance of the elastically deformable segment 11 of the implant 100 is greater than that of the flexible guiding segment 12, and the bending resistance of the distal straight segment 14 is greater than or equal to that of the elastically deformable segment 11. The bending resistance of the elastically deformable segment 11 is greater than that of the flexible connecting segment 13, and the bending resistance of the proximal straight segment 15 is greater than or equal to that of the elastically deformable segment 11. In other embodiments, in its natural state, the distal end of the flexible guiding segment 12 may be bent relative to the distal straight segment 14 toward the side where the elastically deformable segment 11 is located.

[0065] For example, refer to Figure 1 The flexible guiding segment 12 includes a first flexible segment 121 and a second flexible segment 122 connecting the first flexible segment 121 and the distal straight segment 14. The distal end of the first flexible segment 121 serves as the distal end of the implant 100. A radiopaque element (not shown) is disposed within the first flexible segment 121.

[0066] The first flexible segment 121 includes an insertion segment and a distal segment. The portion of the first flexible segment 121 near the proximal end of the implant 100 is the insertion segment, and the portion near the distal end of the implant 100 is the distal segment. The insertion segment of the first flexible segment 121 is inserted into the second flexible segment 122. When the insertion segment of the first flexible segment 121 is inserted into the second flexible segment 122, the proximal end of the imaging element extends into the second flexible segment 122. Specifically, the material of the first flexible segment 121 is a polymeric elastic material, such as silicone, polytetrafluoroethylene, PEBAX, etc. Because polymeric elastic materials are more flexible than metal materials and have lower bending resistance (the minimum force required to bend them), during implantation, the distal end of the first flexible segment 121, which is the distal end of the implant 100, is the end that directly contacts the tissues inside the body to prevent damage to the tissues. Preferably, the distal end face of the first flexible segment 121 is designed as a partially spherical surface. During implantation, when the distal end of the implant touches tissues such as the bronchi or lungs in the human body, the first flexible segment 121 is softer and has lower bending resistance, making it easier to bend and thus preventing damage to the tissues in the human body.

[0067] See Figure 10 The tubular implant 100 of the present invention includes a hollow tubular substrate 20 and an elastic film 30 at least partially attached to the surface of the tubular substrate 20. In this embodiment, the tubular substrate 20 may be made of a superelastic material (e.g., nickel-titanium alloy), and the elastic film 30 may be made of a polymeric elastic material, such as silicone, polytetrafluoroethylene, PEBAX, or other polymeric elastic materials.

[0068] For example, refer to Figure 10 The tubular substrate 20 of the second flexible segment 122 has multiple grooves, and the bending resistance of the second flexible segment 122 can be changed with the change of the spacing between adjacent grooves. For example, the tubular substrate 20 of the second flexible segment 122 includes continuous spiral grooves. On the unfolded plane of the second flexible segment 122 cut along its generatrix, the spacing between two adjacent grooves gradually increases from the distal end to the proximal end of the second flexible segment 122, so as to achieve the purpose of gradually increasing the bending resistance of the second flexible segment 122 from the distal end to the proximal end. The first flexible segment 121 can be formed by hot-melting an elastic film 30.

[0069] The elastically deformable segment 11 is hyperelastic and includes opposing proximal and distal ends. The distal end is connected to the distal straight segment 14, and the proximal end is connected to the proximal straight portion 15. For example, as... Figure 10As shown, the tubular base 20 of the elastic deformable segment 11 also includes a plurality of spaced-apart grooves that communicate with the lumen of the tubular base 20. These grooves facilitate the bending of the elastic deformable segment 11 of the elastic implant 100 into a predetermined shape in its natural state, for example... Figure 1 The shape. Similarly, the tubular base 20 of the distal straight section 14 and the proximal straight section 15 also includes a plurality of mutually spaced grooves that communicate with the lumen of the tubular base 20, thereby achieving the pre-forming of the distal straight section 14 and the proximal straight section 15 by setting the grooves. When the bending resistance of the distal straight section 14 is greater than the bending resistance of the elastic deformation section 11, refer to Figure 11 This can be achieved by providing fewer grooves 20a on the tubular base 20 of the straight section 14 at the distal end, and more grooves 20a on the tubular base 20 of the elastically deformable section 11.

[0070] Based on any of the above-described implants, the implant 100 of the present invention further includes an anchoring element, which is at least disposed on the distal straight segment 14 of the implant 100. The anchoring element is used to contact the tissue to further prevent the implant 100 from shifting relative to the tissue. Understandably, without affecting delivery and release, in order to improve the anchoring effect, an anchoring element may also be disposed on the proximal straight segment 15 or on other segments.

[0071] Reference Figure 12 The anchoring element includes an anchor 41; wherein the root of the anchor 41 is connected to the distal straight section 14, and the free end of the anchor 41 extends towards the proximal side of the implant 100, and the distance between the anchor 41 and the distal straight section 14 gradually increases from far to near. That is, the root of the anchor 41 is located on the distal side, the free end is located on the proximal side, and the free end gradually deviates from the root of the anchor 41. The anchor 41 can self-deploy and can be elastically deformed and retracted under external force. In this configuration, the anchor 41 can be completely contained within the delivery sheath. When released, the anchor 41 self-deploys and abuts against the tissue when the implant 100 captures tissue until it anchors into the tissue, thereby enhancing the anchoring performance.

[0072] In another embodiment, the root of the anchor is connected to the distal straight section 14, and the free end of the anchor extends distally, with the distance between the anchor and the distal straight section 14 gradually increasing from near to far (not shown). Unlike the previous embodiment, the anchor's orientation is different; in this embodiment, the root of the anchor is located proximally, and the free end is located distally, with the free end gradually deviating from the root. Similarly, the anchor can self-deploy and elastically deform under external force to be retracted. With this configuration, the anchor can be completely contained within the delivery sheath. Upon release, the anchor self-deploys and abuts against the tissue when the implant 100 captures tissue until it anchors into the tissue, thereby enhancing anchoring stability.

[0073] Reference Figure 15In other embodiments, the root of the anchor 41 is connected to the distal straight section 14. The free end of the anchor 41 extends a predetermined distance toward the distal side and then flips to extend toward the proximal side. That is, the root of the anchor 41 is located on the proximal side, and the free end is also located on the proximal side, giving the anchor 41 a hook shape. The anchor 41 can self-deploy and can undergo elastic deformation and be retracted under external force. With this configuration, the anchor 41 can not only be completely contained within the delivery sheath, but also self-deploy after release and abut against the tissue when the implant 100 captures the tissue until it anchors into the tissue, thereby enhancing anchoring stability. Moreover, the anchor configuration in this embodiment provides good anchoring effect and allows for multiple retrieval and re-release.

[0074] As one implementation method of the aforementioned anchor barb setup, combined with Figures 12-15 A groove 14a is provided on the distal straight section 14 of the tubular substrate 20, and an anchor 41 is provided at the corresponding position of the groove 14a. The free end of the anchor 41 protrudes through the elastic membrane 30. Preferably, in order to facilitate the convergence of the elastic anchor 41, a perforation 14b is provided on the elastic membrane 30 at the corresponding position of the groove. The free end of the anchor 41 can protrude through the perforation 14b and can be accommodated in the perforation 14b or placed in the groove 14a through the perforation 14b under the action of external force. In this embodiment, the anchor 41 can be formed by cutting the tubular substrate 20 (the groove 14a can be elongated). On the one hand, the groove 14a can be formed by cutting, which facilitates the shaping of the distal straight section 14. On the other hand, the material formed by the groove is used to form the anchor 41, and then the anchor 41 is deflected and pre-shaped. This method of integral cutting and pre-shaping is simple in process, has high structural strength, and good reliability.

[0075] Better, such as Figures 12-15 As shown, the groove 14a and the anchor 41 are disposed on the inner side of the distal straight section 14 of the tubular base 20 facing the elastic deformation section 11. During the release of the implant 100, the inner side of the elastic deformation section 11 contacts the tissue and continuously spirals around it. Therefore, by only setting the anchor on the inner side, not only is the reliability of the inner anchoring guaranteed, but also the circumferential ring is avoided from affecting the strength and constraint of the distal straight section 14.

[0076] In other embodiments, the anchor may also be disposed on the elastic film 30. Exemplarily, the anchor includes an anchoring structure formed on the elastic film 30 of the distal straight section 14, the anchoring structure including a helical structure (such as...). Figure 16 As shown), protruding structure (such as) Figure 17 (as shown), one or more of the recessed structures.

[0077] In this embodiment, the tubular substrate 20 is made of a superelastic material (e.g., nickel-titanium alloy), and the elastic film 30 is made of a polymeric elastic material, such as silicone, polytetrafluoroethylene, or PEBAX. The elastic film 30 is attached to the surface of the tubular substrate 20 by heat fusion. During the heat fusion process, the anchoring structure described above is formed by extrusion or other methods. Thus, when the distal straight segment 14 of the implant 100 contacts the tissue after release, the anchoring structure contacts the tissue, enhancing the anchoring performance. This method is simple to manufacture and can greatly reduce production costs.

[0078] Further, see Figure 16 The elastic film 30 on the distal straight segment 14 includes at least a non-contact segment that is separated from the tubular substrate 20, i.e. Figure 16 In segment L41, the elastic membrane 30 is not fixed relative to the tubular 20, meaning the two are in a separated state. The anchoring structure mentioned above is located on the membrane 30 of the non-contact segment, that is, the anchoring structure is located on the elastic membrane 30 of segment L41. When the distal straight segment 14 contacts the tissue during the release of the implant 100, not only does the anchoring structure contact the tissue, enhancing the anchoring, but also, because the elastic membrane 30 has a certain elasticity, it will accumulate and compress as it moves, forming a certain stack, thereby further reducing the risk of displacement.

[0079] In addition to any of the aforementioned lung volume reduction elastic implants, the present invention also provides a lung volume reduction device, the device comprising an implant 100 and a delivery device compatible with the implant 100. The delivery device includes a core wire and a hollow pusher. The implant 100 is detachably connected to the distal end of the pusher via the proximal end of the implant 100. The core wire is movably inserted into the lumen of the implant 100 and the lumen of the pusher. During adaptation with the delivery device, the implant 100 is configured to be at least partially hollow.

[0080] The lung volume reduction elastic implant and lung volume reduction device of the present invention have a coiled elastic deformation segment with strong restoring torque, which ensures the ability to twist and grasp tissue. At both ends, a bending blocking and limiting position that is not easy to deflect is formed between the distal straight segment and the elastic deformation segment, and between the proximal straight segment and the elastic deformation segment, thereby forming an effective blocking constraint and limiting. This prevents the implant from moving and shifting due to tissue rebound during and after the release of the implant, ensuring a close fit between the implant and the lesion area. The implant can better compress the lesion area, maximize the volume reduction effect, and improve the patient's respiratory function.

[0081] The fixed connection method or relatively fixed method of the present invention can be adopted by means mastered by those skilled in the art, including but not limited to welding, gluing, crimping, metal wire sewing, etc.

[0082] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of the claims of the present invention.

Claims

1. A lung volume-reducing elastic implant, the implant having shape memory characteristics, wherein the implant is at least partially coiled in its natural state, and the implant in its natural state can be constrained into an elongated shape under a preset external force and return to the natural state after the external force is removed; the implant includes a coiled elastic deformation segment, a flexible guiding segment located at the distal end of the implant, and a flexible connecting segment located at the proximal end of the implant, characterized in that, The implant also includes a distal straight segment and a proximal straight segment; The distal straight section is disposed between the flexible guide section and the elastic deformation section. The distal end of the distal straight section is connected to the proximal end of the flexible guide section, and the proximal end of the distal straight section is connected to the distal end of the elastic deformation section. The distal straight section extends straight along the end of the elastic deformation section to which it is connected. The proximal straight segment is disposed between the flexible connecting segment and the elastically deformable segment. The proximal end of the proximal straight segment is connected to the distal end of the flexible connecting segment, and the distal end of the proximal straight segment is connected to the proximal end of the elastically deformable segment. The proximal straight segment extends straight along the distal end of the elastically deformable segment to which it is connected; wherein, The deflection force required for the flexible guide segment to deflect relative to the distal straight segment is less than the deflection force required for the distal straight segment to deflect relative to the elastically deformable segment. The deflection force required for the flexible connecting segment to deflect relative to the proximal straight segment is less than the deflection force required for the proximal straight segment to deflect relative to the elastically deformable segment.

2. The lung volume reduction elastic implant according to claim 1, characterized in that, The elastically deformable segment accounts for 35% to 80% of the total length of the implant, and the distal straight segment and the proximal straight segment each account for 3% to 20% of the total length of the implant.

3. The lung volume reduction elastic implant according to claim 1, characterized in that, The coiled elastic deformation segment includes multiple generally C-shaped curved segments connected in sequence. The connected curved segments are spirally coiled at intervals between the distal straight segment and the proximal straight segment. The free ends of the curved segments at both ends are connected to the distal straight segment and the proximal straight segment, respectively. After coiling, the free end of the curved segment at one end faces the curved segment at the other end, so that the distal straight segment and the proximal straight segment connected to the curved segments at both ends tend to move closer to the elastic deformation segment.

4. The lung volume reduction elastic implant according to claim 3, characterized in that, The number of curved segments is even. After the even number of curved segments are connected, the distal straight segment and the proximal straight segment are located on both sides of the elastic deformation segment. The elastic deformation segment is compressed along the interval direction of the even number of curved segments, and the angle between the projections of the extension direction of the distal straight segment and the extension direction of the proximal straight segment perpendicular to the compression direction is not greater than 180°.

5. The lung volume reduction elastic implant according to claim 4, characterized in that, The elastic deformation segment includes at least a first bending segment and a second bending segment. The distal end of the first bending segment is connected to the proximal end of the distal straight segment, and the proximal end of the second bending segment is connected to the distal end of the proximal straight segment. The distal straight segment and the first bending segment connected thereto are substantially coplanar to form a first plane, and the proximal straight segment and the second bending segment connected thereto are substantially coplanar to form a second plane. The included angle between the first plane and the second plane is between 40° and 90°.

6. The lung volume reduction elastic implant according to claim 1, characterized in that, The bending resistance of the elastic deformation section is greater than that of the flexible guide section, and the bending resistance of the distal straight section is greater than or equal to that of the elastic deformation section. And / or, The bending resistance of the elastically deformable segment is greater than that of the flexible connecting segment, and the bending resistance of the proximal straight segment is greater than or equal to that of the elastically deformable segment.

7. The lung volume reduction elastic implant according to claim 1, characterized in that, The minimum bending radius of the elastic deformation section is less than or equal to 12 mm.

8. The lung volume reduction elastic implant according to any one of claims 1 to 7, characterized in that, The implant also includes an anchor, which is provided at least on the distal straight section of the implant and is used to contact the tissue to prevent the implant from shifting relative to the tissue.

9. The lung volume reduction elastic implant according to claim 8, characterized in that, The anchoring element includes an anchor bolt; wherein... The root of the anchor is connected to the distal straight section, the free end of the anchor extends toward the proximal side of the implant, and the distance between the anchor and the distal straight section gradually increases from far to near; or; The root of the anchor bar is connected to the distal straight section, the free end of the anchor bar extends laterally toward the distal end, and the distance between the anchor bar and the distal straight section gradually increases from near to far; or, The root of the anchor is connected to the straight section at the distal end, and the free end of the anchor extends a predetermined distance toward the distal side before turning back to extend toward the proximal side.

10. The lung volume reduction elastic implant according to claim 9, characterized in that, The implant includes a hollow tubular matrix and an elastic membrane at least partially attached to the surface of the tubular matrix; a groove is provided on the straight section at the distal end of the tubular matrix, and an anchor is provided at the corresponding groove position, with the free end of the anchor protruding through the elastic membrane.

11. The lung volume reduction elastic implant according to claim 10, characterized in that, The anchor barb is self-deployable and can deform under external force; the elastic film has a perforation corresponding to the groove position, the free end of the anchor barb can extend through the perforation, and can be placed in the groove through the perforation under external force.

12. The lung volume reduction elastic implant according to claim 9, characterized in that, The groove is provided on the inner side of the distal straight section of the tubular substrate facing the elastically deformable section.

13. The lung volume reduction elastic implant according to claim 8, characterized in that, The implant includes a hollow tubular matrix and an elastic membrane at least partially attached to the surface of the tubular matrix; the anchor includes an anchoring structure formed on the elastic membrane in the distal straight section, the anchoring structure including one or more of a spiral structure, a protruding structure, and a recessed structure.

14. The lung volume reduction elastic implant according to claim 13, characterized in that, The elastic film on the distal straight section includes at least a non-contact section that is separated from the tubular substrate, and the anchoring structure is disposed on the film of the non-contact section.

15. A lung volume reduction device, characterized in that, The device includes an implant as described in any one of claims 1 to 14 and a delivery device associated with the implant, the delivery device comprising a core wire and a hollow pusher, the implant being detachably connected to the distal end of the pusher via the proximal end of the implant, the core wire being movably inserted into the lumen of the implant and the lumen of the pusher.

Images