Patent Description:
Percutaneous interventional techniques of implants for treating pulmonary emphysema have been reported in the literatures. That is, an elastic implant is delivered into a lung through a working channel of a bronchoscope in a form of a straight piece under the restriction of a delivery system. After the implant is delivered into a bronchus of a pulmonary emphysema area, the restriction of the delivery system on the implant is withdrawn, and the implant recovers and deforms to a natural shape (namely a shape in the absence of an external force). In the mean time, the pulmonary emphysema area is squeezed under the pulling action of the implant, and gas in the bronchus is exhausted, and the volume of a lung tissue in the pulmonary emphysema area is reduced, thereby allowing relatively healthy peripheral lung tissues to better exert its physiological functions.

<CIT> discloses an endovascular implant for treating an abdominal aortic aneurysm comprising a Y-shaped body having an expandable frame coupled to a graft member. At least one adjustable element made of a shape memory material is attached to the body, which has at least two configurations. Switching form one configuration to another occurs in response to an energy source external to the patient's body. <CIT> discloses a lung volume-reducing elastic implant that comprises a proximal implant end, an elastic deformation part and a distal implant end; the elastic deformation part has shape memory property.

When treating pulmonary emphysema, an implant includes a metal substrate, and an elastic outer layer which is made of a macromolecular material and arranged on the surface of the metal substrate covering the metal substrate. When the implant is pushed into the bronchus of the pulmonary emphysema area through a delivery system, or when the implant is withdrawn back into the delivery system because of a poor half-release position, a limited binding force between the metal substrate and the elastic outer layer of the implant may possibly cause the elastic outer layer at the proximal end of the implant to separate from the metal substrate, which might damage the implant. A slotted hole is formed in the metal substrate, which allows the elastic outer layer to be embedded into the slotted hole of the metal substrate. Although this may increase the binding force between the metal substrate and the elastic outer layer, but because the wall of the metal substrate is relatively thin, so the opening of the slotted hole is formed to be relatively shallow, which limits the increase of the binding force between the elastic outer layer and the metal substrate. In addition, the hole may not be formed when a relatively small-sized implant is used, and the formation of the hole in the metal substrate may affect the rigidity of the metal substrate, and affect the overall safety of the implant.

An object of the present invention is to provide an implant having a more reliable connection between an elastic outer layer and the implant body. When the implant is implanted into a human body, it should be more difficult to separate the elastic outer layer from the implant body, and thus the implant is safer and more reliable during surgery.

According to the present invention, a lung volume reduction implant is provided as defined in claim <NUM>.

The implant includes an elastic deformation portion made of shape memory material and a connection portion connected with a proximal end of the elastic deformation portion. The elastic deformation portion is covered by an elastic outer layer. A proximal end of the connection portion is provided with a tightening ring that forms an outer jacket surrounding the proximal end. A proximal end of the elastic outer layer is covered by the tightening ring.

A first end of the tightening ring is provided with a connection plug, and a second end opposite to the first end is provided with an insertion slot corresponding with the connection plug, and used for inserting the connection plug.

Furthermore, the tightening ring is provided with a thin slot connected with the insertion slot, and the thin slot is located on one side of the insertion slot away from the connection plug.

The tightening ring is further provided with a through hole communicating with the insertion slot, and the through hole and the insertion slot are respectively located at two opposite ends of the thin slot.

In one embodiment of the technical solution, the connection plug has a T-shaped connection, and the plug includes a head portion and a neck portion connected with the head portion. The axial width of the neck portion is less than that of a connection part which connects the head portion with the neck portion.

In one embodiment of the technical solution, the axial width of the head portion of the connection plug is gradually increased along a direction close to the neck portion.

In one embodiment of the technical solution, an included angle of the inner edge of the head portion of the connection plug along the axial line of the tightening ring is <NUM> to <NUM> degrees.

In one embodiment of the technical solution, the center of the through hole is located on an extension line of the center line of the thin slot of the tightening ring.

In one embodiment of the technical solution, the ratio of the diameter of the through hole to the width of the tightening ring ranges between <NUM>:<NUM> and <NUM>:<NUM>.

In one embodiment, under the application of the same external force, a flexible guide portion deforms more easily than the elastic deformation portion. The proximal end of a connection member is further provided with a boss. The outer diameter of the boss is greater than that of a portion of the elastic implant that is close to the boss when in a delivery state.

In one embodiment of the technical solution, under the application of the same external force, the flexible guide portion deforms more, and more easily, from the proximal end to the distal end.

In one embodiment of the technical solution, under the application of the same external force, the connection portion deforms more easily than the elastic deformation portion.

In one embodiment of the technical solution, the connection portion is provided with a plurality of cutting slots in a spaced-apart manner along a lengthwise direction of the connection portion, and all the cutting slots of the connection portion are communicated with a lumen of the connection portion.

In one embodiment of the technical solution, the connection portion includes multiple hollow sub-components connected end to end. The proximal end of each hollow sub-component includes multiple proximal end protrusions distributed along a circumferential direction of the hollow sub-component. The circumferential length of each proximal end protrusion from the proximal end to the distal end is gradually decreased, and a proximal end groove is formed between two adjacent proximal end protrusions. The distal end of each hollow sub-component includes multiple distal end protrusions distributed along the circumferential direction of the hollow sub-component. The circumferential length of each distal end protrusion from the proximal end to the distal end is gradually increased, and a distal end groove is formed between two adjacent distal end protrusions.

In one embodiment of the technical solution, part of the distal-end face of the boss is sunken towards the proximal end of the boss to form an annular groove surrounding the longitudinal center axis of the boss.

In one embodiment of the technical solution, part of the side surface of the boss is sunken into the inside of the boss to form an annular groove surrounding the longitudinal center line of the boss.

In one embodiment of the technical solution, the boss includes multiple small protrusions distributed in a spaced-apart manner along the circumferential direction of the boss.

According to the implant of the present disclosure, the proximal end of the connection portion is provided with the tightening ring that forms an outer jacket surrounding the proximal end, and the tightening ring may provide a relatively uniform compression force from the circumferential direction to the macromolecular elastic outer layer at the proximal end of the connection portion, so the elastic outer layer is fixed to the outer surface of the connection portion more closely and firmly, so as to prevent the elastic outer layer from rolling over, and also improving the safety of lung volume reduction surgery.

During installation of the tightening ring on the implant of the present disclosure, only the connection plug is required to be aligned with the insertion slot, and an external force is applied to insert the connection plug into the insertion slot, and after the external force is withdrawn, the connection plug may be clamped in the insertion slot, so that the operation is more convenient. The implant is of a relatively small size, so that it is convenient to set the tightening ring, and the installation process of the tightening ring may be greatly simplified.

The present invention will be further described below in conjunction with the accompanying drawings which show embodiments. In the drawings:.

Here specific embodiments of the present invention are described in detail in combination with the accompanying drawings. In the interventional field, generally, the end relatively close to an operator is defined as a proximal end, and the end relatively far from the operator is defined as a distal end.

Unless otherwise defined, all technical and scientific terms used herein are the same as the meanings according to the general understandings of those skilled in the present art. The terms "and/or" used herein include any and all combinations of one or more related listed items.

Referring to <FIG> together, an implant <NUM> provided by one embodiment of the present disclosure is of a tubular structure, and includes an elastic deformation portion <NUM>, a flexible guide portion <NUM> connected with the distal end of the elastic deformation portion <NUM>, a connection portion <NUM> connected with the proximal end of the elastic deformation portion <NUM>, a connection member <NUM> connected with the proximal end of the connection portion <NUM>, and an elastic outer layer <NUM>. A portion of the proximal end of the connection portion <NUM> adjacent to the connection member <NUM> is provided with a tightening ring <NUM> that forms an outer jacket surrounding the proximal end of the connection portion. The elastic outer layer <NUM> covers the outer wall of the implant <NUM>. Specifically, the proximal end of the elastic outer layer <NUM> is flush with the proximal end of the connection portion <NUM> and is covered by the tightening ring <NUM>. The distal end portion of the elastic outer layer <NUM> is flush with the distal end portion of the implant <NUM> so as to cover the outer wall of the implant <NUM>. It can be understood that the proximal end portion of the elastic outer layer <NUM> is flush with the proximal-end face of the tightening ring <NUM>. The elastic deformation portion <NUM> and the flexible guide portion <NUM> may be made in one piece, or also may be fixedly connected. The distal end of the flexible guide portion <NUM> is the distal end of the elastic implant <NUM>. Under the application of the same external force, the flexible guide portion <NUM> deforms more easily than the elastic deformation portion <NUM> (that is, under the application of the same external force, the anti-bending performance of the flexible guide portion <NUM> is lower than that of the elastic deformation portion <NUM>), so that the flexible guide portion <NUM> can move more effectively in a bronchus without injuring surrounding tissues. The elastic outer layer <NUM> may reduce bronchitis and injury to the bronchus due to friction of the implant and the inner wall of the bronchus in a respiratory process to lower the risk of pneumonia and infections of the small airway, and may effectively reduce the release of metal elements. In addition, as it is arranged at the proximal end of the connection portion <NUM> in a covering manner, the tightening ring <NUM> may provide a circumferentially relatively uniform compression force to compress the elastic outer layer <NUM> covering the outer surface of the implant <NUM> after the head and tail ends of the tightening ring <NUM> are connected to form a ring-like object, so as to allow the elastic outer layer <NUM> to cover the outer surface of the connection portion <NUM> more closely and firmly, which increases a binding force between the elastic outer layer <NUM> and a metal substrate of the connection portion <NUM>, thereby preventing the elastic outer layer <NUM> from being separated from the implant <NUM>, and avoiding damage to the integrity of the implant, and thereby improving the safety of lung volume reduction surgery.

As shown in <FIG>, in the present disclosure, the head and tail ends of the tightening ring <NUM> are connected to form a circular ring shape. Referring to <FIG> together, the tightening ring <NUM> may be formed by bending a rectangular sheet, and has a certain elasticity. The head end of the rectangular sheet is a first end of the tightening ring <NUM>, and the tail end of the rectangular sheet is a second end of the tightening ring <NUM>. After the rectangular sheet is bent into a ring shape, its head end faces its tail end, namely the first end faces the second end. The first end is provided with a connection plug <NUM> which may be directly cut from the first end of the tightening ring <NUM>. It can be understood that the connection plug <NUM> also may be connected with a main body of the tightening ring <NUM> by welding, or may be connected in other ways, and there is no limitation here as to the manner of connection. In the present embodiment, the specific shape of the connection plug <NUM> approximates a dumbbell shape. The overall T-shaped connection plug <NUM> includes a head portion <NUM> and a neck portion <NUM> connected with the head portion <NUM>. The neck portion <NUM> connects the head portion <NUM> of the tightening ring <NUM> with the main body section. The axial width of the neck portion <NUM> of the connection plug <NUM> is less than that of a portion which is located at a connection portion of the head portion <NUM> of the connection plug and the neck portion <NUM>, and the axial direction here is along an axial direction of the tightening ring. It can be understood that the outer surface of the head portion <NUM> in the present embodiment is an arcuate surface, and the outer surface of the head portion <NUM> in other embodiments also may be planar. The width of the head portion <NUM> gradually increases as it gets closer to the neck portion <NUM>. The axial width of the neck portion <NUM> is less than that of the portion which is located at a connection portion of the head portion <NUM> and the neck portion <NUM>, so a clamping slot-shaped recess may be formed in the position of a joint of the head portion <NUM> and the neck portion <NUM>, and the direction of the recess is towards the axial line of the neck portion <NUM>. The outer surface that is opposite to the insertion slot of the head portion of the connection plug <NUM> is designed as a smooth arcuate surface to ensure that it is easier to provide a first protruding edge <NUM> and a second protruding edge <NUM> which are opposite to each other in a slotted hole of the insertion slot <NUM> when the connection plug <NUM> is inserted into the insertion slot <NUM>, so as to allow the connection plug <NUM> to be inserted more smoothly into the insertion slot <NUM>. As the axial width of the connection plug <NUM> in the direction close to the neck portion <NUM> is gradually increased, it can be understood that the entire head portion <NUM> of the connection plug <NUM> approximates the shape of an arrow. The connection plug may also be of other shapes, such as a cone or a column, and there is no specific limitation here.

Referring to <FIG> and <FIG> together, the second end of the tightening ring <NUM> is provided with the insertion slot <NUM> having a U-shaped open structure. The first protruding edge <NUM> and the second protruding edge <NUM>, which are opposite to each other, are respectively arranged at the opening. A space for insertion is formed between the first protruding edge <NUM> and the second protruding edge <NUM>. The first protruding edge <NUM> and the second protruding edge <NUM> have the same shape and are opposite to each other. Each protruding edge is of an L shape on a whole. The portions of the inner surfaces of the first protruding edge and the second protruding edge that are close to the innermost side of the insertion slot <NUM> are both arcuate surfaces, and their radians correspond to the radian of the outer surface of the head portion of the connection plug <NUM>. When the connection plug <NUM> is inserted into the insertion slot <NUM>, the outer surface of the head portion of the connection plug <NUM> may be completely fitted to the inner surfaces of the first protruding edge <NUM> and the second protruding edge <NUM>, and the space encircled by the first protruding edge <NUM> and the second protruding edge <NUM> is filled with the connection plug <NUM>. Furthermore, the inner and outer surfaces of the connection plug <NUM> will not protrude from the inner and outer surfaces of the first protruding edge <NUM> and the inner and outer surfaces of the second protruding edge <NUM>, thereby ensuring that after the tightening ring <NUM> is tightened, the surfaces of the inserted portions are in snug fit, and the starting part of the elastic outer layer covered below will not be exposed.

Referring to <FIG>, <FIG>, <FIG> together, the tightening ring <NUM> is provided with a thin slot <NUM> that communicates with the insertion slot <NUM> and is located on a side of the insertion slot <NUM> away from the connection plug <NUM>. The tightening ring <NUM> is further provided with a through hole <NUM> which communicates with the insertion slot <NUM> through the thin slot <NUM>. The through hole <NUM> and the insertion slot <NUM> are respectively located at two opposite ends of the thin slot <NUM>. During tightening of the tightening ring <NUM>, when a radial force F is applied to the tightening ring <NUM>, the first end and the second end of the tightening ring <NUM> move closer to each other, and the connection plug <NUM> contacts the first protruding edge <NUM> and the second protruding edge <NUM> of the insertion slot <NUM>. When the connection plug <NUM> contacts the first protruding edge <NUM> and the second protruding edge <NUM> of the insertion slot <NUM>, the radial force F is continuously applied, and the first protruding edge <NUM> and the second protruding edge <NUM> separate from each other under the pushing of the connection plug <NUM>, that is, the opening of the insertion slot <NUM> is enlarged. When the first protruding edge <NUM> and the second protruding edge <NUM> contact the connection plug <NUM>, the insertion slot <NUM> may experience elastic deformation, and the thin slot <NUM> may experience the elastic deformation to become a trapezoidal slot from a rectangular slot, and the opening of a portion that is close to the insertion slot <NUM> of the thin slot <NUM> is enlarged. The arrangement of the through hole <NUM> and the thin slot <NUM> disperses the stress in this area to prevent plastic deformation of the insertion slot <NUM>, so as to ensure that an elastic force for shape recovery may be generated after the opening of the insertion slot <NUM> is enlarged. The provision of the through hole <NUM> may ensure that the slot opening of the insertion slot <NUM> may still recover its initial shape after being expanded. After the opening of the insertion slot <NUM> is enlarged, the connection plug <NUM> may be inserted into the insertion slot <NUM>, and the first protruding edge <NUM> and the second protruding edge <NUM> of the insertion slot <NUM> are reset to their initial positions under the application of the elastic force. The first protruding edge <NUM> and the second protruding edge <NUM> may simply contact the neck portion <NUM> of the connection plug <NUM> so as to be hooked with the head portion <NUM> of the connection plug <NUM> to ensure that the connection plug <NUM> will not disengage from the insertion slot <NUM>, and thus the tightening of the implant is completed. Referring to <FIG> and <FIG> together, before the tightening ring is tightened, its diameter D1 is slightly greater than the outer diameter of the connection portion of the implant to ensure that the tightening ring may be arranged on the implant in a covering manner. The circumferential force F is applied to the tightening ring to insert the connection plug into the insertion slot. After the connection plug is inserted into the insertion slot, the diameter of the tightening ring is decreased to D2, and thus the tightening of the implant is completed. The range of D1 to D2 varies between <NUM> percent and <NUM> percent, and an operator can determine the specific variation depending on the clinical situation. This tightening mode may provide a circumferentially relative uniform compression to compress the elastic outer layer of the implant to allow the elastic outer layer to be fixed on the outer surface of the connection portion more closely and firmly, which increases the binding force between the elastic outer force and the connection portion. During implantation of the implant, under the tightening action of the tightening ring, the connection between the elastic outer layer and the connection portion is closer and firmer, so the operation in the implantation of the implant is safer.

Further, referring to <FIG>, in the present embodiment, the distance between the first protruding edge <NUM> and the second protruding edge <NUM> is greater than or equal to the axial width of the neck portion <NUM> of the connection plug <NUM>. The distance between the first protruding edge <NUM> and the second protruding edge <NUM> herein refers to a distance between the first protruding edge <NUM> and the second protruding edge <NUM> in its natural state. The distance between the first protruding edge <NUM> and the second protruding edge <NUM> is greater than or equal to the axial width of the neck portion <NUM> of the connection plug <NUM> to ensure that after the connection plug <NUM> is inserted into the insertion slot <NUM>, the first protruding edge <NUM> and the second protruding edge <NUM> may contact the two sides of the neck portion <NUM> of the connection plug <NUM>. If the distance between the first protruding edge <NUM> and the second protruding edge <NUM> is too short, the first protruding edge <NUM> and the second protruding edge <NUM> are still in a stressed state after the connection plug is inserted into the insertion slot, and extend beyond the axial line of the tightening ring <NUM>, which gives rise to protruding corners on the outer circumference of the tightening ring <NUM> and thus affects the implantation of the implant.

Further, referring to <FIG>, after the tightening ring spreads into a straight line, an included angle a between the inner edge of the head portion of the connection plug <NUM> and the axial line of the tightening ring is <NUM> to <NUM> degrees to ensure that the connection plug <NUM> will not disengage after being inserted into the insertion slot. If the included angle a is more than <NUM> degrees, the degree to which the protruding edges of the insertion slot and the connection plug <NUM> mesh is relatively low after the connection plug <NUM> is inserted into the insertion slot; and under the application of the elastic force, the connection plug <NUM> can be easily separated from the protruding edges of the insertion slot, which may result in the connection plug <NUM> disengaging from the insertion slot. When the included angle a is less than <NUM> degrees, the length of the connection plug <NUM> is increased under the same axial width, which gives rise to an extremely large feed amount of the tightening ring during tightening, and thus leads to an extremely small diameter of the tightening ring after the connection plug <NUM> is inserted into the insertion slot, and the extremely small diameter may generate a relatively high compression pressure acting on the elastic outer layer covered by the tightening ring, and thereby damaging the elastic outer layer. Therefore, the included angle a here is preferably <NUM> to <NUM> degrees, which would guarantee the tightening stability of the tightening ring and also guarantee no damage to the elastic outer layer of the implant.

Further, as shown in <FIG>, in the present embodiment, the center of the through hole <NUM> is located on an extension line of the center line of the thin slot of the tightening ring. The main objective of arranging the center of the through hole <NUM> on the horizontal axial line of the tightening ring is to maintain the second end of the entire tightening ring in axial symmetry, so that after the connection plug <NUM> is inserted into the insertion slot <NUM>, the first protruding edge and the second protruding edge experience relatively uniform stress, and have approximately the same elastic deformations. Meanwhile, the through hole may disperse the stress of this area more effectively to prolong the service life of the tightening ring. The ratio of the diameter of the through hole to the width of the tightening ring is between <NUM>:<NUM> and <NUM>:<NUM>. If the diameter of the through hole is too large, this would affect the strength of the whole tightening ring. If the diameter of the through hole is too small, the stress dispersion effect of the through hole is relatively poor, and thus the insertion slot <NUM> produces plastic deformation easily. As a result, the springback effect is lowered after the slot opening is expanded, and it is difficult to separate the first protruding edge and the second protruding edge of the tightening ring, which affects the simplicity and the convenience of the operation of the tightening ring. The ratio of the diameter of the through hole to the width of the tightening ring is set between <NUM>:<NUM> and <NUM>:<NUM> to guarantee a relatively good stress dispersion effect, and to improve the hardness of the tightening ring to the maximum extent.

In the embodiment of the present disclosure, the through hole <NUM> is a circular hole. In other embodiments, the through hole <NUM> may also be a square hole, an elliptical hole or holes of other shapes.

Referring to <FIG>, <FIG>, the elastic deformation portion <NUM> has a shape memory characteristic, and includes a proximal end <NUM> and a distal end <NUM> which are opposite to each other. The distal end <NUM> is connected with the flexible guide portion <NUM>. The elastic deformation portion <NUM> further includes multiple mutually isolated cutting slots <NUM> communicating with the lumen of the elastic deformation portion <NUM>. The multiple cutting slots <NUM> allow the elastic deformation portion <NUM> of the elastic implant <NUM> to bend into a predetermined shape in the natural state, such as a shape as shown in <FIG>.

The elastic deformation portion <NUM> has a predetermined curled shape in the natural state (in the absence of external force), may be restrained into a straight piece shape or any other shapes under the action of an external force, and recovers to the predetermined shape through bending and torsion after the external force is withdrawn. The elastic deformation portion <NUM> may be made of a material commonly used in the industry and having a shape memory function. In the present disclosure, there is no limitation to specific materials as long as this material is applicable to the human body and has the shape memory function. In the present embodiment, the elastic deformation portion <NUM> is made of a nickel-titanium alloy and has a diameter of about <NUM>-<NUM> and a wall thickness of <NUM>-<NUM>.

Referring to <FIG> together, in the present embodiment, to allow the elastic deformation portion <NUM> to extend into a thinner bronchus and achieve a better compression effect on corresponding tissues, preferably, a conical nickel-titanium tube having a consistent inner diameter and a gradually varying wall thickness is adopted, such as a conical nickel-titanium tube having an inner diameter of <NUM>-<NUM> and a wall thickness varying from <NUM> at the distal end to <NUM> at the proximal end. Multiple dumbbell-shaped cutting slots <NUM> are formed in the nickel-titanium tube. The extension direction (namely the incision direction) <NUM> of these cutting slots <NUM> and the axial line <NUM> of the elastic deformation portion <NUM> form a certain angle A. Preferably, the angle A is <NUM>-<NUM> degrees. A gap <NUM> of about <NUM>-<NUM> is provided between two adjacent cutting slots <NUM>. It can be understood that as the elastic deformation portion <NUM> has the multiple cutting slots <NUM>, the anti-bending performance of the elastic deformation portion <NUM> may vary with changes of the lengths <NUM> of the cutting slots <NUM> in the extension direction <NUM>. Those skilled in the art can set the lengths <NUM> of the cutting slots <NUM> of the elastic deformation portion <NUM> in the extension direction <NUM> based on clinical requirements so to make the anti-bending performance of the flexible guide portion <NUM> lower than that of the elastic deformation portion <NUM>.

Referring to <FIG> together, the flexible guide portion <NUM> is located at the distal end of the elastic deformation portion <NUM> and used for guiding the elastic deformation portion <NUM>, and deforms more, and more easily, from the proximal end to the distal end under the application of the same external force. The axial line <NUM> of the distal end of the flexible guide portion <NUM> and the axial line <NUM> of the distal end <NUM> of the elastic deformation portion <NUM> form an included angle B of <NUM>-<NUM> degrees. In the present embodiment, the flexible guide portion <NUM> includes a main body section <NUM>, a flexible guide portion head end <NUM> arranged at the distal end of the main body section <NUM> and a spring <NUM> arranged on the outer wall of the main body section <NUM>.

The main body section <NUM> supports the spring <NUM> and may be made of a relatively high elasticity metal such as a nickel-titanium alloy or a cobalt-chromium alloy, and the outer diameter of the main body section <NUM> is gradually increased from the distal end of the main body section <NUM> to the proximal end of the main body section <NUM>. The proximal end of the main body section <NUM> is connected with the distal end <NUM> of the elastic deformation portion <NUM> using techniques of covering a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering, and the like. In the present embodiment, the main body section <NUM> is a solid nickel-titanium rod. It can be understood that the main body section <NUM> also may be a hollow nickel-titanium tube. When the main body section <NUM> is a hollow nickel-titanium tube, the outer diameter of the main body section <NUM> is gradually increased from the distal end to the proximal end if the inner diameter of the main body section <NUM> is unchanged from the proximal end to the distal end, and the inner diameter of the main body section <NUM> is gradually decreased from the distal end to the proximal end if the outer diameter of the main body section <NUM> is unchanged from the proximal end to the distal end.

In the present embodiment, the distal end of the spring <NUM> and the distal end of the main body section <NUM> are fused together to form the flexible guide portion head end <NUM>. The flexible guide portion head end <NUM> is coaxial with the distal end of the main body section <NUM> and closes the distal end of the main body section <NUM>. The flexible guide portion head end <NUM> may be further provided with a developing mark (not shown in the figures).

The spring <NUM> is wound by a metal wire (preferably a tungsten metal wire, a tantalum metal wire and other metal wires having relatively high X-ray developing performance) having a wire diameter of <NUM>-<NUM>. It can be understood that the flexible guide portion head end <NUM>, the spring <NUM> and the main body section <NUM> also may be molded respectively and are connected together by a conventional process. During separate molding, the flexible guide portion head end <NUM> is preferably made of a metal such as tungsten or tantalum having relatively high X-ray developing performance. It can be further understood that the flexible guide portion head end <NUM> may be omitted as required.

It can be further understood that when the flexible guide portion head end <NUM> is omitted and the main body section <NUM> is a hollow nickel-titanium tube, on one hand, a closing member made of the same or similar material as the guide head <NUM> may be arranged in the proximal end of the main body section <NUM> to fully or partially close the distal end of the elastic deformation portion <NUM>; and on the other hand, the proximal end of the main body section <NUM> may also communicate with the elastic deformation portion <NUM>, and at the moment, the proximal end and the distal end of the implant <NUM> are both opened. Any arrangement is possible as long as the core wire (specifically described below) does not pass through the distal end of the flexible guide portion <NUM>. That is, when the distal end of the implant <NUM> is opened, the core wire enters the implant <NUM> and the outer diameter of the core wire is greater than the diameter of an inscribed circle of the opening in the distal end of the implant <NUM> (when the opening is a non-circular opening such as a triangular opening or a square opening) or the diameter of the opening in the distal end (when the opening is a circular opening).

Referring to <FIG>, <FIG> and <FIG> together, the connection portion <NUM> is connected between the connection member <NUM> and the elastic deformation portion <NUM>. Under the application of the same external force, the anti-bending performance of the connection portion <NUM> is lower than that of the elastic deformation portion <NUM> (namely under the application of the same external force, the connection portion <NUM> deforms more easily than the elastic deformation portion <NUM>). In the present embodiment, the connection portion <NUM> is provided with multiple cutting slot groups <NUM>. After the connection portion <NUM> is cut along the axial direction and spread out, it can be seen that each cutting slot group <NUM> includes three cutting slots 1702a, 1702b and 1702c arrayed along the circumferential direction of the connection portion <NUM> and parallel to one another. Two ends of the three cutting slots are aligned with each other in the circumferential direction. A certain gap <NUM> is provided between two adjacent cutting slots in each cutting slot group <NUM>, and a gap <NUM> is provided between two adjacent cutting slot groups <NUM>. Each cutting slot has a slim profile, and the extension direction AC of the multiple cutting slots and the axial line <NUM> of the connection portion <NUM> form a certain included angle C. By adjusting the number of the cutting slots in each cutting slot group <NUM>, the size of each gap <NUM>, the size of the included angle C between the extending direction AC of the cutting slots and the axial line <NUM> of the elastic deformation portion <NUM> and the size of the gap <NUM> between two adjacent cutting slot groups <NUM>, the anti-bending performance of the whole connection portion <NUM> may be adjusted to be lower than that of the elastic deformation portion <NUM>. In other embodiments, each cutting slot group <NUM> may include <NUM>-<NUM> cutting slots, the gap <NUM> between two adjacent cutting slots in each cutting slot group <NUM> is <NUM>-<NUM>, the included angle C is <NUM>-<NUM> degrees, and the gap <NUM> between two groups is <NUM>-<NUM>. The elastic deformation portion <NUM> has an outer diameter of about <NUM>-<NUM> and a wall thickness of <NUM>-<NUM>. The connection between the connection portion <NUM> and the elastic deformation portion <NUM> may be accomplished by techniques such as covering of a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering, and the like. On the basis of the prior art, integrated cutting is preferred, and the elastic deformation portion <NUM> and the connection portion <NUM>, which have different textural features, are cut from different areas on the same tube.

Referring to <FIG> together, the connection member <NUM> is located at the proximal end of the connection portion <NUM> and includes a boss <NUM> and a connection section <NUM>. The outer diameter D of the boss <NUM> is greater than the outer diameter of the portion close to the boss <NUM> of the elastic implant <NUM> when in a delivery state. In the present implementation mode, the outer diameter of the portion close to the boss <NUM> of the elastic implant <NUM> in the delivery state is the outer diameter of the proximal end of the connection portion <NUM>. An internal thread <NUM> is arranged inside the boss <NUM>. The connection section <NUM> is located between the boss <NUM> and the connection portion <NUM>, and is provided with a cavity <NUM> extending through the proximal-end face and the distal-end face of the connection section <NUM>. In the present embodiment, the cross section that is parallel to the longitudinal center axis of the boss <NUM> includes two opposite semicircles. The outer diameter D may not exceed <NUM> and is preferably <NUM>-<NUM>. The boss <NUM> effectively enlarges a contact area of the proximal end of the elastic implant <NUM> and the bronchus to reduce injury to the lung tissues after the elastic implant <NUM> is implanted. It can be understood that part of the distal-end face of the boss <NUM> may also be sunken towards the proximal end of the boss <NUM> to form an annular groove <NUM> (see <FIG>) surrounding the longitudinal center line of the boss <NUM> to provide a fastening position for a biopsy forceps, so that the biopsy forceps clamp a connection apparatus more effectively to withdraw the elastic implant <NUM>.

Referring to <FIG> and <FIG> together, the elastic outer layer <NUM> completely covers the outer surface of the elastic implant <NUM> except the boss <NUM> and fills each cutting slot <NUM> without blocking the lumen of the elastic implant <NUM>, thereby ensuring that the elastic outer layer <NUM> firmly covers the elastic implant <NUM> and guaranteeing no blockage in the lumen of the elastic implant <NUM>. The elastic outer layer <NUM> may be <NUM>-<NUM> in thickness. The elastic outer layer <NUM> may be made of a macromolecular solution having the following features: good chemical stability, water resistant and weather resistant, good lower compressibility, good biocompatibility, high mechanical strength, nontoxicity, odorless, and the like. For example, these macromolecular solutions may be silicone rubber or polyurethane solutions. Because of the basic bonding characteristics of the elastic outer layer <NUM> and the metal substrate, it is easy for the proximal end portion of the elastic outer layer <NUM> to roll over or fall off under the application of an external force, and since the outer diameter of the boss <NUM> is greater than that of the portion close to the boss <NUM> of the elastic implant <NUM> in the delivery state, so the boss <NUM> can protect the proximal end portion of the elastic outer layer <NUM> from being in contact with a vascular wall during the delivery or withdrawal processes, and thereby protect the elastic outer layer <NUM> from rolling over or falling off during the delivery and withdrawal processes.

Referring to <FIG> and <FIG> together, a lung volume reduction device <NUM> includes an elastic implant <NUM> and a delivery apparatus <NUM>. The delivery apparatus <NUM> includes a core wire <NUM> and a pushing mechanism <NUM>.

The core wire <NUM> is accommodated in the lumen of the elastic implant <NUM> to restrain the elastic implant <NUM> into an approximately linear delivery state to conveniently deliver the implant <NUM> to a lesion locus, so a delivery sheath for restraining the implant <NUM> is no longer needed, which avoids any injury caused by the delivery sheath to a trachea during the delivery process, and further reduces the incidence rate of pneumothorax. The core wire <NUM> may be made of a section of metal wire having a diameter of <NUM>-<NUM>. Compared with the prior art, the implant <NUM> does not need a delivery sheath, and may be implanted into a lung bypass or the tail ends of certain tracheas having small diameters to achieve a better therapeutic effect.

Referring to <FIG> together, to promote a safe and convenient operation, a flexible core wire guide head <NUM> coaxial with the core wire <NUM> and provided with a developing mark is arranged at the distal end of the core wire <NUM>. The outer diameter of the core wire guide head <NUM> is consistent with that of the core wire <NUM>. The core wire guide head <NUM> includes a guide column <NUM> and a spring <NUM> surrounding and fixedly arranged outside the guide column <NUM>. The guide column <NUM> and the core wire <NUM> can be made in one piece, or the guide column <NUM> is fixedly connected to the distal end of the core wire <NUM>. The spring <NUM> is provided with a developing mark.

The core wire guide head <NUM> is used for guiding the core wire <NUM> to enter the lumen of the elastic implant <NUM>. The flexible core wire guide head <NUM> may be implemented using a soft spring, that is, the spring <NUM> is arranged on the guide column <NUM> which is made in one piece with the core wire <NUM> or fixedly connected to and surrounding the distal end of the core wire <NUM>. A specific manufacturing method is as follows: the head end of the core wire <NUM> is thinned to prepare the guide column <NUM>, and then one section of spring <NUM> having a length of <NUM>-<NUM> is fixed outside the guide column <NUM>. The spring <NUM> may be fixed on the core wire <NUM> by the covering of a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering, and the like. Under the guidance of the flexible core wire guide head <NUM>, the core wire <NUM> may enter the lumen of the implant <NUM> successfully from the proximal end of the implant <NUM> and may restrain the implant <NUM> from the shape as shown in <FIG> into the approximately linear shape (as shown in <FIG>).

In the present embodiment, due to the existence of the flexible guide portion <NUM>, the implant <NUM> with the core wire <NUM> also has an effect of exploring a pathway in the bronchus to the lesion region. To guide and monitor the operation condition of the core wire <NUM> entering the lung, a developing mark is required to be arranged on the core wire guide head <NUM>. The developing mark may display the implant through a fluorescent inspection system, an ultrasonic imaging system, an MRI (Magnetic Resonance Imaging) system, a computed tomography (CT) system or other remote imaging systems. There is no limitation to specific structures. The core wire <NUM> is displayed and guided through these systems. In the present embodiment, the spring wound by one or more metal wires, such as tungsten metal wire or tantalum metal wire, having relatively high X-ray developing performance and a wire diameter of <NUM>-<NUM>, is used as the developing mark. In the present embodiment, the developing mark and the core wire guide head <NUM> are combined into one component to achieve two functions. In addition to this mode, an extra developing mark may also be arranged on the core wire guide head <NUM>. Of course, when the surface of the implant of the present disclosure is not covered by an elastic film and the implant itself is made of a developing material such as nickel-titanium alloy, the developing mark may be omitted.

The pushing mechanism <NUM> includes a hollow pushing member <NUM> and an operation handle <NUM> connected with the hollow pushing member <NUM>. The hollow pushing member <NUM> and the implant <NUM> are arranged on the core wire <NUM> in a surrounding manner in sequence from outside to inside, and the distal end of the hollow pushing member <NUM> is detachably connected with the proximal end <NUM> of the implant <NUM>. In the present embodiment, the hollow pushing member <NUM> is a pushing steel cable, and its distal end is provided with a connection matching part <NUM> having an external thread matched with the internal thread of the connection member <NUM>. During assembly, the internal thread of the connection member <NUM> may be threadably connected with the connection matching part <NUM> via the external thread of the pushing mechanism <NUM>, and the implant <NUM> may be reliably fixed at the distal end of the hollow pushing member <NUM>. After the implant <NUM> is pushed to a corresponding position of the bronchus, the connection member <NUM> of the implant <NUM> and the connection matching part <NUM> of the hollow pushing member <NUM> are unscrewed and separated by turning around the operation handle <NUM> of the hollow pushing member <NUM>. The connection member <NUM> and the connection matching part <NUM> may also be embodied as other detachable fixed connection components, such as a magnetic connection apparatus, an elastic buckle and a noose, which are respectively arranged on the implant <NUM> and the hollow pushing member <NUM> to achieve a detachable connection.

The elastic implant <NUM>, the core wire <NUM> and the hollow pushing member <NUM> are assembled as follows: first, the elastic implant <NUM> is threadably connected with the connection matching part <NUM> at the distal end of the hollow pushing member <NUM> to allow the hollow pushing member <NUM> to be communicated with an internal channel of the elastic implant <NUM>; and then the core wire <NUM> is pushed into the elastic implant <NUM> along the channel of the hollow pushing member <NUM> to restrain the curled elastic implant <NUM> in the natural state into a tube in an approximately linear delivery state.

Referring to <FIG>, a delivery catheter <NUM> is pushed to the distal end of the working channel along a working channel <NUM> of a bronchoscope <NUM>; a measurement guide wire <NUM> enters the delivery catheter <NUM>, and extends out of the delivery catheter <NUM> to enter into the bronchus; the delivery catheter <NUM> is pushed along the measurement guide wire <NUM> until the distal end of the delivery catheter <NUM> is overlapped with the distal end of the measurement guide wire <NUM>; while maintaining the position of the delivery catheter <NUM> unchanged, the measurement guide wire <NUM> is withdrawn until it is completely withdrawn out of the delivery catheter <NUM>; the elastic implant <NUM> installed with the hollow pushing member <NUM> is pushed along an inner cavity of the delivery catheter <NUM> until it can be seen under X-ray that the distal end of the elastic implant <NUM> is overlapped with the distal end of the delivery catheter <NUM>; the operation handle <NUM> is operated to withdraw the core wire <NUM> from the elastic implant; along with the withdrawal of the core wire <NUM>, the elastic implant <NUM> automatically recovers its natural shape from the linear delivery state restrained by the core wire <NUM>, and may compress and pull the emphysema region in this recovery process, and also allow relatively healthy peripheral lung tissues to better exert their respiratory physiological functions to achieve a lung volume reduction effect; and the elastic implant <NUM> is released by operating the operation handle <NUM>.

Referring to <FIG>, an elastic implant 500a provided by another embodiment of the present disclosure includes a hollow tubular elastic deformation portion 51a, a flexible guide portion 53a connected with the distal end of the elastic deformation portion 51a, a connection portion 52a connected with the proximal end of the elastic deformation portion 51a, and a connection member 57a connected with the proximal end of the connection portion 54a. The implant 500a is at least provided with an opening in the proximal end. The elastic deformation portion 51a and the flexible guide portion 53a may be made in one piece, or fixedly connected with each other. The distal end of the flexible guide portion 53a is the distal end of the elastic implant 500a. Under the application of the same external force, the flexible guide portion 53a deforms more easily than the elastic deformation portion 51a (that is, under the application of the same external force, the anti-bending performance of the flexible guide portion 53a is lower than that of the elastic deformation portion 51a), so that the flexible guide portion 53a can experience better movement in a bronchus without injuring surrounding tissues.

Referring to <FIG> together, the elastic deformation portion 51a includes multiple cutting slot clusters <NUM> arrayed in a spaced-apart manner along an axial direction of the elastic deformation portion 51a. Each cutting slot cluster <NUM> has five side-by-side elliptical cutting slot groups <NUM> arrayed in a steplike manner. In the present embodiment, each cutting slot group <NUM> has two parallel cutting slots. A certain distance <NUM> is provided between the two cutting slots in each cutting slot group <NUM>. The long axis of each cutting slot is perpendicular to the axial line of the elastic deformation portion 51a. An extension direction <NUM> of the arrangement between one group and another group in each cutting slot cluster <NUM> and the axial line 501a of the elastic deformation portion 51a form a certain included angle E which may be <NUM>-<NUM> degrees. A distance 508a of about <NUM>-<NUM> is provided between two adjacent cutting slot groups <NUM> in each cutting slot cluster <NUM>. The steplike arrayed cutting slot groups <NUM> are favorable for bending the elastic deformation portion 51a into a specific shape. A portion, having a length of about <NUM>-<NUM>, of the proximal end 511a of the elastic deformation portion 51a is cut into a threaded groove that is used as a connection member 57a. The cut nickel-titanium tube is bent into a shape as shown in <FIG> with a mold and then is thermally set into the elastic deformation portion 51a of the elastic implant 500a.

Under the application of the same external force, the anti-bending performance of the connection portion 52a is lower than that of the elastic deformation portion 51a so as to better reduce injury caused by the connection portion 52a to the wall of the bronchus. Referring to <FIG>, in the present embodiment, the connection portion 52a is a tubular body formed by connecting multiple hollow sub-components <NUM> end to end, and having multiple circumferentially continuous wave-shaped cutting slots <NUM>. Each cutting slot <NUM> has a certain width <NUM>. Preferably, the width of each cutting slot may be <NUM>-<NUM>. The start point and the end point of two adjacent wave-shaped cutting slots <NUM> are overlapped in the circumferential direction of the connection portion 52a. Preferably, in the present embodiment, the proximal end of each sub-component <NUM> includes multiple proximal end protrusions <NUM> distributed in an equal spaced-apart manner along the circumferential direction of the hollow sub-component <NUM>. The circumferential length of each proximal end protrusion <NUM> from the proximal end to the distal end is gradually decreased, so that a dovetail-shaped proximal end groove <NUM> having an opening facing the proximal end is formed between two adjacent proximal end protrusions <NUM>. The distal end of each hollow sub-component <NUM> includes multiple distal end protrusions <NUM> distributed in an equal spaced-apart manner along the circumferential direction of the hollow sub-component <NUM>. The circumferential length of each distal end protrusion <NUM> from the proximal end to the distal end is gradually increased, so that a dovetail-shaped distal end groove <NUM> having an opening facing the distal end is formed between two adjacent distal end protrusions <NUM>. The number of the proximal end protrusions <NUM> of each hollow sub-component <NUM> is equal to that of the distal end protrusions <NUM> of the same hollow sub-component <NUM>, and one distal end groove <NUM> on each hollow sub-component <NUM> is aligned with one proximal end protrusion <NUM> on the same hollow sub-component <NUM>. In this way, in two hollow sub-components <NUM>, the multiple dovetail-shaped proximal end protrusions <NUM> on one hollow sub-component <NUM> mesh with the multiple distal end grooves <NUM> of the other hollow sub-component <NUM>, so that the two mutually separated hollow sub-components <NUM> form an interlocked structure, and the multiple hollow sub-components <NUM> are spliced and combined into the connection portion 52a. As all the mutually separated hollow sub-components <NUM> are connected through meshing structures of the dovetail-shaped protrusions and the dovetail grooves, the connection portion 52a of this structure has extremely high flexibility and extremely high connection strength and may transmit a torsion to the elastic deformation portion 51a in a ratio of <NUM>:<NUM> during twisting of the connection member <NUM>. On the basis of the prior art, the sub-components <NUM> may also be made using by other techniques such as machining, casting and powder metallurgy. It can be understood that the connection portion 52a is extremely flexible and extremely low in anti-bending performance, so it is very easy to make the anti-bending performance of the connection portion 52a lower than that of the elastic deformation portion 51a by adjusting the anti-bending performance of the elastic deformation portion 51a. It can be understood that the multiple proximal end protrusions <NUM> also may be distributed at the proximal ends of the sub-components <NUM> in non-equal spacings as long as the multiple sub-components <NUM> may be spliced.

Under the application of the same external force, the anti-bending performance of the flexible guide portion 53a is lower than that of the elastic deformation portion 51a so as to better guide the elastic deformation portion 51a to move in the bronchus and to reduce the chance of injury to the wall of the bronchus. Under the application of the same external force, the anti-bending performance of the flexible guide portion 53a from the distal end to the proximal end is gradually improved. Referring to <FIG> together, in the present embodiment, the flexible guide portion 53a is a tubular body cut from a nickel-titanium tube through laser and having cutting slots, and under the application of the same external force, the anti-bending performance of the flexible guide portion 53a from the distal end to the proximal end is gradually improved (that is, under the application of the same external force, the deformation performance of the flexible guide portion 53a from the distal end to the proximal end is gradually lowered, namely the flexible guide portion 53a becomes progressively harder from the distal end to the proximal end) so as to better guide the elastic implant <NUM>. It can be understood that as the flexible guide portion 53a is the tubular body having the multiple cutting slots, the anti-bending performance of the flexible guide portion 53a may vary with changes in the distances between adjacent cutting slots. Those skilled in the art can set the distances between adjacent cutting slots according to clinical requirements to make the anti-bending performance of the flexible guide portion 53a lower than that of the elastic deformation portion 51a.

The flexible guide portion 53a includes multiple slender cutting slot groups <NUM>-<NUM>. Each cutting slot group (such as <NUM>) is composed of two or more parallel cutting slots 1601a and 1601b, and each parallel cutting slot has a certain width <NUM>. The extension direction of these cutting slot groups <NUM>-<NUM> and the axial line 513a of the flexible guide portion 53a form a certain angle F. A gap <NUM> is provided between two adjacent cutting slot groups. By adjusting the number and the width <NUM> of the cutting slots in each cutting slot group, the size of the angle F and the size of each gap <NUM>, the anti-bending performance of the flexible guide portion 53a may be adjusted. Preferably, there may be <NUM>-<NUM> parallel cutting slots <NUM>, the width <NUM> may be <NUM>-<NUM>, the angle F is preferably <NUM>-<NUM> degrees, and the gap <NUM> is preferably <NUM>-<NUM>. The parallel cutting slot groups (<NUM>-<NUM>) having different widths <NUM> are combined into the same nickel-titanium tube to fulfill the objective of gradually improving the anti-bending performance of the flexible guide portion 53a from the distal end to the proximal end under the application of the same external force. The flexible guide portion 53a having the gradually changing anti-bending performance may be more effective in guiding the elastic implant 500a.

The connection between the flexible guide portion 53a and the elastic deformation portion 51a may be implemented by techniques such as covering a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering, and the like. On the basis of the prior art, integrated cutting is preferred, and the flexible guide portion 53a and the elastic deformation portion 51a which have different textural features are cut from different areas on the same tube. To achieve the gradually changing anti-bending performance of the flexible guide portion 53a, one feasible mode is to maintain the angle F in two adjacent cutting slot groups unchanged, and to gradually decrease the width <NUM> of each cutting slot from the distal end to the proximal end, and another feasible mode is to maintain the width <NUM> of each cutting slot in two adjacent cutting slot groups unchanged, and to gradually increase the angle F from the distal end to the proximal end. It can be understood that simultaneously changing the angle F and the width <NUM> of each cutting slot in two adjacent cutting slot groups may also achieve the effect of gradually improving the anti-bending performance of the flexible guide portion 53a from the distal end to the proximal end.

Referring to <FIG> and <FIG>, the connection member 57a is approximately the same as the connection member <NUM>, but a difference lies in the fact that the boss 571a of the connection member 57a has multiple small protrusions <NUM> distributed in an equal spacing along its circumferential direction and connected with one another. Referring to <FIG>, the multiple small protrusions <NUM> taken together define a virtual circumference <NUM> (namely a circumscribed circle of the multiple small protrusions <NUM> is <NUM>). The diameter of the circumference <NUM> is the outer diameter of the boss 571a. Due to the existence of the small protrusions <NUM>, a fastening position is provided for biopsy forceps, so that the biopsy forceps can clamp a connection apparatus more effectively to withdraw the elastic implant 500a. The connection between the connection member 57a and the connection portion 52a may be implemented by techniques such as covering of a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering and the like.

Referring to <FIG>, an elastic implant 500b provided by another embodiment of the present disclosure includes a hollow tubular elastic deformation portion 51b, a flexible guide portion 53b connected with the distal end of the elastic deformation portion 51b, a connection portion 52b connected with the proximal end of the elastic deformation portion 51b, and a connection member 57b connected with the proximal end of the connection portion 54b. The implant 500b is at least provided with an opening in the proximal end. The elastic deformation portion 51b and the flexible guide portion 53b may be made in one piece or fixedly connected. The distal end of the flexible guide portion 53b is the distal end of the elastic implant 500b. Under the application of the same external force, the flexible guide portion 53b deforms more easily than the elastic deformation portion 51b, so that the flexible guide portion 53b can move more effectively in a bronchus without injuring surrounding tissues.

The arrangement mode of the cutting slots of the elastic deformation portion 51b is approximately the same as that of the cutting slots of the connection portion <NUM> in the one Embodiment above, and no more details will be described here.

Referring to <FIG> together, the flexible guide portion 53b is a tubular body cut from a nickel-titanium tube by laser and having continuously spiral cutting slots, and under the application of the same external force, the anti-bending performance of the flexible guide portion 53b from the distal end to the proximal end is gradually improved (that is, under the application of the same external force, the deformation performance of the flexible guide portion 53a from the distal end to the proximal end is gradually lowered) so as to better guide the elastic implant 500b. It can be understood that as the flexible guide portion 53b is the tubular body having the continuously spiral cutting slots, the anti-bending performance of the flexible guide portion 53b may vary with changes in the distances between adjacent cutting slots. Those skilled in the art can set the distances between adjacent cutting slots according to clinical requirements to make the anti-bending performance of the flexible guide portion 53b lower than that of the elastic deformation portion 51b.

The flexible guide portion 53b includes the continuously spiral cutting slots <NUM>. In a planar view showing the flexible guide portion 53b cut away along its axial direction, the distance between two adjacent cutting slots <NUM> is also gradually increased from the distal end to the proximal end of the flexible guide portion 53b to gradually improve the anti-bending performance of the flexible guide portion 53b from the distal end to the proximal end.

It can be understood that, on the planar view showing the flexible guide portion 53b cut away along its axial direction, from the distal end to the proximal end of the flexible guide portion 53b, when an included angle G between the extension direction <NUM> of the cutting slots <NUM> of the flexible guide portion 53b and the axial direction <NUM> of the flexible guide portion 53b is unchanged and the width of each cutting slot of the flexible guide portion 53b along the axial direction <NUM> of the flexible guide portion 53b is gradually decreased, the distance between two adjacent cutting slots <NUM> is gradually increased as well so as to gradually improve the anti-bending performance of the flexible guide portion 53b from the distal end to the proximal end.

It can be understood that, on the planar view showing the flexible guide portion 53b cut away along its axial direction, from the distal end to the proximal end of the flexible guide portion 53b, when the width of each cutting slot of the flexible guide portion 53b along the axial direction <NUM> of the flexible guide portion 53b is unchanged and the included acute angle between the extending direction <NUM> of the cutting slots of the flexible guide portion 53b and the axial direction <NUM> of the flexible guide portion 53b is gradually increased, the distance between two adjacent cutting slots <NUM> is gradually increased as well so as to gradually improve the anti-bending performance of the flexible guide portion 53b from the distal end to the proximal end.

The structure of the connection portion 52b is approximately the same as that of the connection portion 52a, and no more details will be described here.

Preferably, an integrated molding mode is adopted. The features of the elastic deformation portion 51b, the flexible guide portion 53b and the connection portion 52b which are cut from the same nickel-titanium tube by laser are as shown in <FIG>, and the problems of low connection strength and the like caused by the connection mode may be avoided.

Claim 1:
A lung volume reduction implant comprising:
an elastic deformation portion (<NUM>) having a shape memory characteristic and a proximal end (<NUM>), wherein the elastic deformation portion (<NUM>) has a predetermined curled shape in a natural state without external force and may be expanded into an approximately linear delivery shape under the pushing action of a core wire of a delivery device;
a connection portion (<NUM>) connected with the proximal end of the elastic deformation portion (<NUM>), the connection portion (<NUM>) having a proximal end;
an elastic outer layer (<NUM>) covering the elastic deformation portion (<NUM>), the elastic outer layer (<NUM>) having a proximal end;
a tightening ring (<NUM>) provided on the proximal end of the connection portion (<NUM>) and forming an outer jacket covering the proximal end of the connection portion (<NUM>) and also covering the proximal end of the elastic outer layer (<NUM>);
wherein the tightening ring (<NUM>) has a first end provided with a connection plug (<NUM>) and a second end opposite the first end provided with an insertion slot (<NUM>), the connection plug (<NUM>) being insertable into the insertion slot (<NUM>),
wherein the tightening ring (<NUM>) is provided with a through hole (<NUM>) which communicates with the insertion slot (<NUM>) along a thin slot (<NUM>), the through hole (<NUM>) and the insertion slot (<NUM>) being respectively located at two opposite ends of the thin slot (<NUM>).