Patent Description:
Pulmonary emphysema is a common pulmonary disease. Traditional internal therapies for pulmonary emphysema include oxygen inhalation, pulmonary infection prevention, bronchus spasm relaxation and the like, but the curative effect is extremely limited. Surgical therapies for pulmonary emphysema mostly adopt lung volume reduction surgery, and there are also many limitations, for example: strict surgical indications, risks of many complications, anesthesia and anesthesia-related complications, difficulty in curative effect prediction before the surgery, and an irreparable non-ideal curative effect caused by over-cutting or sub-cutting after the surgery, excessively high surgery cost and great mental and physical sufferings. In addition, some patients always cannot tolerate the surgery due to their poor lung functions, and lead to a higher postoperative mortality rate, which limits the application of surgical operation.

<CIT> discloses a contraceptive fallopian tube occlusion device having proximal and distal end anchoring members. A lumen-traversing region extends between the anchor members and has a helical outer surface. The lumen-traversing region is preferably made of copper and has a ribbon wound over its outer surface.

<CIT> discloses a lung volume reduction system including an implantable device configured to impart a compressive force on lung tissue, the device being expandable and collapsible. In the expanded configuration, the implant has at least two helical sections with a transition section located between the two helical sections.

<CIT> discloses relevant prior art according to Article <NUM>(<NUM>) EPC.

In order to treat pulmonary emphysema better, improve living quality of a patient and reduce traumas to the patient during surgery, internationally, it has been researched to use a bronchoscope to implement interventional modes such as one-way valve, biogel, steam thermal ablation and elastic coil for treating pulmonary emphysema. However, the one-way valve has been rejected by the FDA (Food and Drug Administration) in USA due to its low clinical indicators that residual gas and sputum in a target region cannot be effectively and actively excreted, and technical difficulties in collateral ventilation and precise placement of the one-way valve at different anatomical structure positions also limit the curative effectiveness of the one-way valve. The problem that the biogel completely blocks an emphysema region and leads to postoperative inflammation is still unsolved. The steam thermal ablation would lead to the postoperative inflammation due to a defect of destroying an original tissue structure of the emphysema region.

At the present, an updated therapy method is adopted for pulmonary emphysema, meaning that an elastic coil serving as an implant is implanted into a lesion portion of the lung of a human body. <FIG> is a schematic diagram of a lung volume reduction elastic coil in the prior art. This product is designed and made of a nickel-titanium memory alloy metal wire, and may elastically deform under the action of an external force. Under the restriction of a loading system, this product may be implanted into a lung through a working channel of a bronchoscope in a straight line form. After being delivered into a bronchus of a pulmonary emphysema region, the coil is released from the restriction of the loading system and then recovers to a natural shape (which is a shape without the external force) as shown in <FIG>, and at the same time, the emphysema region is squeezed under the pulling action of the nickel-titanium alloy wire, thereby discharging gas in the bronchus and reducing the volume of a lung tissue in the pulmonary emphysema region; and therefore, a relatively healthy lung tissue therearound may exert a physiological function better.

A surgical method using the elastic coil includes three operation processes of inserting a bronchoscope, building a channel and implanting a product. Insertion of the bronchoscope is as shown in <FIG>: a bronchoscope <NUM> is inserted through a mouth or a nose, and may display an image detected by the distal end <NUM> of the bronchoscope <NUM> on a monitor <NUM>, thereby guiding the bronchoscope <NUM> to reach the bronchus <NUM> of a human lung.

Building of the channel is as shown in <FIG>. The outer diameter of a guide wire <NUM> is about <NUM> Fr to <NUM> Fr, and the diameter of a delivery sheath may be about <NUM> Fr to <NUM> Fr. The guide wire <NUM> is moved to pass through an inner cavity of an expander <NUM>, and the expander <NUM> is moved to pass through an inner cavity of the delivery sheath <NUM>; after being assembled, the guide wire <NUM>, the expander <NUM> and the delivery sheath <NUM> enter the bronchoscope <NUM> together from a working channel <NUM> of the bronchoscope <NUM>, and then pass through the distal end <NUM> of the bronchoscope <NUM> and enter the bronchus <NUM>. A length label <NUM> is disposed at the distal end <NUM> of the guide wire <NUM>, and indicates a distance along the guide wire <NUM> from the distal end <NUM>. The distal end <NUM> of the delivery sheath <NUM> may have multiple corresponding labels <NUM> in a form of high-contrast metal straps (including gold, platinum, tantalum, iridium, tungsten and/or metalloids). A fluorescence inspection system, an ultrasonic imaging system, an MRI (Magnetic Resonance Imaging) system, an X-ray CT (Computerized Tomography) system, which are provided with a remote imaging and capturing device <NUM>, or some other remote imaging implants are configured to guide the guide wire <NUM>. As shown in <FIG>, the remote imaging and capturing device <NUM> may display a detected image on a monitor <NUM>, and identify a track of the guide wire <NUM> or an imaging label <NUM>, thereby building the channel.

After the channel is built, the expander <NUM> and the guide wire <NUM> are pulled out towards the proximal end from the delivery sheath <NUM>, so that a lung volume reduction elastic coil <NUM> may be loaded in an open cavity of the delivery sheath <NUM>. Implantation of the coil <NUM> is shown in <FIG>, and the loading system <NUM> with the coil <NUM> is connected to the proximal end of the delivery sheath <NUM> through a locking hub connector <NUM>. The coil <NUM> is introduced into the delivery sheath, as shown in <FIG>, and a steel cable <NUM> of an actuation device <NUM> pushes the product out of the distal end of the delivery sheath <NUM> and enables the product to enter the bronchus <NUM>. And then the delivery sheath <NUM> is withdrawn, and a gripper <NUM> of the actuation device <NUM> is configured to release the coil <NUM>. When recovering to an initial shape, the coil <NUM> also pulls the bronchus <NUM> to be in curled shape, thereby achieving a pulmonary emphysema volume reduction treatment effect.

The above-mentioned implant and its implantation method have defects as follows:.

In order to solve the technical problems, in view of the above-mentioned defects in the prior art, the object of the present invention is to provide an implant, which is directly delivered through a core wire instead of a delivery sheath. The implant should prevent the delivery sheath from injuring the inner wall of a bronchus and reduce incidence of pneumothorax.

In particular, the implant should integrate a channel building process with an implant implantation operation process, make surgical operation more convenient, shorten the surgical operation time and achieve a better treatment effect.

According to the present invention, a lung volume reduction elastic implant is provided as defined in claim <NUM>. The implant is tubular and at least opens at the proximal end. The implant includes a hollow tubular elastic deformation section, a flexible guide section connected with the distal end of the elastic deformation section, and a protuberance connected with the proximal end of the elastic deformation section. The elastic deformation section has a shape memory characteristic and has a plurality of cutout grooves formed in a spacing manner along its lengthwise direction. Each groove is communicated with a lumen of the elastic deformation section. Under the action of a same external force, the flexible guide section deforms more easily than the elastic deformation section, and the outer diameter of the protuberance is larger than that of a portion of the elastic implant, which is close to the protuberance in a delivery state.

Under action of a same external force, the flexible guide section deforms easily in an increasing manner from the proximal end to the distal end. The elastic implant further includes a connection section located between the elastic deformation section and the protuberance. Under action of a same extermanl force, the connection section deforms more easily than the elastic deformation section.

In one embodiment of the technical scheme, an included angle between the incision direction of each groove and the lengthwise direction of the elastic deformation section ranges from <NUM> to <NUM> degrees.

In one embodiment of the technical scheme, the implant further includes an elastic film at least wrapping the outer walls of the elastic deformation section and the flexible guide section.

In one embodiment of the technical scheme, the grooves are further filled with the elastic film.

In one embodiment of the technical scheme, the elastic deformation section is made of a conical nickel-titanium tube having an outer diameter gradually increased from the distal end to the proximal end, and a gap of <NUM> to <NUM> is reserved between every two adjacent grooves of the elastic deformation section.

In one embodiment of the technical scheme, the flexible guide section includes a main body portion having a spring on the outer wall; the proximal end of the main body portion is connected with the elastic deformation section; and the outer diameter of the main body portion is gradually increased from its distal end to proximal end.

In one embodiment of the technical scheme, the flexible guide section includes a tubular body which is cut from the nickel-titanium tube and has continuous spiral grooves.

In one embodiment of the technical scheme, a gap between every two adjacent grooves of the flexible guide section along the axial direction of the flexible guide section is gradually increased from the distal end to the proximal end of the flexible guide section.

In one embodiment of the technical scheme, the connection section has a plurality of grooves formed in a spacing manner along its lengthwise direction, and each groove of the connection section is communicated with the lumen of the connection section.

In one embodiment of the technical scheme, the connection section includes multiple hollow subcomponents connected with one another in an end-to-end manner. The proximal end of each hollow subcomponent includes multiple proximal end bulges distributed in a circumferential direction of the hollow subcomponent; the circumferential length of each proximal end bulge from the proximal end to the distal end is gradually decreased; a proximal end recess is formed between every two adjacent proximal end bulges; the distal end of each hollow subcomponent includes multiple distal end bulges distributed in the circumferential direction of the hollow subcomponent; the circumferential length of each distal end bulge from the proximal end to the distal end is gradually increased; and a distal end recess is formed between every two adjacent distal end bulges.

In one embodiment of the technical scheme, the end surface of part of the distal end of the protuberance is sunken towards the proximal end of the protuberance, thereby forming an annular recess surrounding the longitudinal central line of the protuberance.

In one embodiment of the technical scheme, part of the side surface of the protuberance is sunken towards the inside of the protuberance, thereby forming an annular recess surrounding the longitudinal central line of the protuberance.

In one embodiment of the technical scheme, the protuberance includes multiple small bulges distributed in the circumferential direction of the protuberance in a spacing manner.

A further description for the present disclosure in combination with drawings and embodiments is as follows. In the drawings:.

A detailed description for specific embodiments of the present invention with drawings is as follows.

In the field of intervention, generally, an end relatively close to an operator is called a proximal end, and an end relatively far away from the operator is called a distal end.

Unless otherwise defined, all technical and scientific terms used herein have the same meanings of general understandings of persons skilled in the art of the present disclosure. Terms used in the description of the present disclosure herein are only intended to describe the specific embodiments, but not to limit the present disclosure. Terms "and/or" used herein include any and all combinations of one or multiple relevant listed items.

With reference to <FIG>, an elastic implant <NUM> provided by one embodiment of the present disclosure is of a tubular structure, which includes a hollow tubular elastic deformation section <NUM>, a flexible guide section <NUM> connected with the distal end of the elastic deformation section <NUM>, a connection section <NUM> connected with the proximal end of the elastic deformation section <NUM>, a connection member <NUM> connected with the proximal end of the connection section <NUM>, and an elastic film <NUM>. The implant <NUM> at least opens at the proximal end; the elastic deformation section <NUM> and the flexible guide section <NUM> may be of an integrated structure, or are fixedly connected with each other. The distal end of the flexible guide section <NUM> is the distal end of the elastic implant <NUM>. Under the action of a same external force, the flexible guide section <NUM> deforms more easily than the elastic deformation section <NUM> (that is to say, under the action of a same external force, the bending resistance of the flexible guide section <NUM> is lower than that of the elastic deformation section <NUM>), so that it may move in a bronchus better without injuring a surrounding tissue.

The elastic deformation section <NUM> has a shape memory characteristic, and includes a proximal end <NUM> and a distal end <NUM> which are opposite; and the distal end <NUM> is connected with the flexible guide section <NUM>. The elastic deformation section <NUM> further includes multiple grooves <NUM> which are isolated from one another and are communicated with a lumen of the elastic deformation section <NUM>. The multiple grooves <NUM> enable the elastic deformation section <NUM> of the elastic implant <NUM> to be bent into a preset shape in a natural state, for example, a shape as shown in <FIG>.

In the natural state (namely without any external force), the elastic deformation section <NUM> is of a preset curled shape, but under the action of an external force, it may be restricted into a straight line form or any other shapes, and would be recovered into the preset shape through bending and twisting if the external force is withdrawn. The elastic deformation section <NUM> may be made of any material which is commonly used in this industry and has a shape memory function. The present disclosure does not limit specific materials, and materials which are applicable to human body and have shape memory function are acceptable. In this embodiment, the elastic deformation section <NUM> is made of a nickel-titanium alloy. To be more specific, a machining method of an elastic deformation section <NUM> includes: firstly, cutting a section of hollow nickel-titanium tube having a diameter of about <NUM> to <NUM> and a wall thickness of <NUM> to <NUM> with laser; then bending the cut nickel-titanium tube with a die into a shape of an elastic deformation section <NUM> as shown in <FIG>; and finally, performing thermal treatment for modeling, thus obtaining the elastic deformation section <NUM>.

With reference to <FIG> and <FIG> together, in this embodiment, for the purpose that the elastic deformation section <NUM> may extend into a thinner bronchus to achieve a better squeezing effect on a corresponding tissue, preferably, the elastic deformation section <NUM> is made of a conical nickel-titanium tube having a consistent inner diameter and a gradually varying wall thickness, for example, a conical nickel-titanium tube having an inner diameter of <NUM> to <NUM> and a wall thickness varying from <NUM> at the distal end to <NUM> at the proximal end; multiple dumbbell-shaped grooves <NUM> are formed in the nickel-titanium tube, and an extending direction <NUM> (namely an incision direction) of these grooves <NUM> and the axial line <NUM> of the elastic deformation section <NUM> form a certain angle A which is preferably <NUM> to <NUM> degrees. A gap <NUM> of about <NUM> to <NUM> is reserved between every two adjacent grooves <NUM>. It should be understood that as the elastic deformation section <NUM> has the multiple grooves <NUM>, its bending resistance may vary with changes of the lengths <NUM> of the grooves <NUM> along their extending direction <NUM>. A person skilled in the art could set the lengths <NUM> of the grooves <NUM> of the elastic deformation section <NUM> in their extending direction <NUM> according to an actual requirement to achieve an aim that the bending resistance of the flexible guide section <NUM> is lower than that of the elastic deformation section <NUM>.

With reference to <FIG> together, the flexible guide section <NUM> is disposed at the distal end of the elastic deformation section <NUM>, and is configured to play a guide role for the elastic deformation section <NUM>, and under the action of the same external force, the flexible guide section <NUM> deforms easily in an increasing manner from the proximal end to the distal end. The axial line <NUM> at the distal end of the flexible guide section <NUM> and the axial line <NUM> at the distal end <NUM> of the elastic deformation section <NUM> form an included angle B which may be <NUM> to <NUM> degrees. In this embodiment, the flexible guide section <NUM> includes a main body portion <NUM>, a flexible guide section head end <NUM> disposed at the distal end of the main body portion <NUM> and a spring <NUM> disposed on the outer wall of the main body portion <NUM>.

The main body portion <NUM> may support the spring <NUM>, and may be made of a metal with relatively high elasticity, such as a nickel-titanium alloy and a cobalt-chromium alloy, and the outer diameter of the main body portion <NUM> is gradually increased from the distal end of the main body portion <NUM> to the proximal end of the main body portion <NUM>. The proximal end of the main body portion <NUM> is connected with the distal end <NUM> of the elastic deformation section <NUM> in ways of macromolecular heat-shrink tube or film wrapping, glue adhesion, laser welding, soldering and the like. In this embodiment, the main body portion <NUM> is a solid nickel-titanium rod. It should be understood that the main body portion <NUM> also may be a hollow nickel-titanium tube. As a hollow nickel-titanium tube, if the inner diameter of the main body portion <NUM> does not change from the proximal end to the distal end, its outer diameter is gradually increased from the distal end to the proximal end, and if the outer diameter of the main body portion <NUM> does not change from the proximal end to the distal end, its inner diameter is gradually decreased from the distal end to the proximal end.

In this embodiment, the distal end of the spring <NUM> and the distal end of the main body portion <NUM> are fused together at high temperature, thus forming the flexible guide section head end <NUM>. The flexible guide section head end <NUM> is coaxial with the distal end of the main body portion <NUM> and closes the distal end of the main body portion <NUM>. The flexible guide section head end <NUM> may further have an imaging label (not shown in the figures).

The spring <NUM> is formed by winding a metal wire with a diameter of <NUM> to <NUM> (preferably, a tungsten metal wire, a tantalum metal wire and the like with relatively high X-ray developing property). It should be understood that the flexible guide section head end <NUM>, the spring <NUM> and the main body portion <NUM> may be formed separately as well, and then the flexible guide section head end <NUM>, and the distal end of the spring <NUM> are connected together with the distal end of the main body portion <NUM> in ways of macromolecular heat-shrink tube or film wrapping, glue adhesion, laser welding and the like; in case of separate forming, preferably, the flexible guide section head end <NUM> is made of a metal with relatively high X-ray developing property, such as tungsten and tantalum. It further should be understood that the flexible guide section head end <NUM> may be removed as required.

It further should be understood that if there is no flexible guide section head end <NUM>, and the main body portion <NUM> is a hollow nickel-titanium tube, on one hand, a closing member made of the same material or a similar material as the guide head <NUM> may be disposed in the proximal end of the main body portion <NUM> to fully close or half close the distal end of the elastic deformation section <NUM>; on the other hand, the proximal end of the main body portion <NUM> may be also communicated with the elastic deformation section <NUM>; and at this moment, the implant <NUM> opens at both the proximal end and the distal end. In any case, it only needs to ensure that a core wire (specifically described below) does not penetrate through the distal end of the flexible guide section <NUM>, that is to say, when the implant <NUM> opens at the distal end, it needs to ensure that the core wire may enter the implant <NUM> and the outer diameter of the core wire would be larger than that of an incircle of the opening in the distal end of the implant <NUM> (when the opening is a non-circular opening, such as a triangular opening and a square opening) or larger than that of the opening in the distal end (when the opening is a circular opening).

With reference to <FIG> together, the connection section <NUM> is connected between the connection member <NUM> and the elastic deformation section <NUM>, and under the action of a same external force, the bending resistance of the connection section <NUM> is lower than that of the elastic deformation section <NUM> (namely under the action of a same external force, the connection section <NUM> deforms more easily than the elastic deformation section <NUM>). In this embodiment, multiple groove groups <NUM> are disposed on the connection section <NUM>. After the connection section <NUM> is split along an axial direction and then flattened, it can be seen that each groove group <NUM> includes three grooves 1702a, 1702b and 1702c which are arrayed in a circumferential direction of the connection section <NUM> and are parallel to one another, and two ends of the three grooves are aligned with each other in the circumferential direction. And a certain gap <NUM> is reserved between every two adjacent grooves in each groove group <NUM>, and a gap <NUM> is reserved between every two adjacent groove groups <NUM>. Each groove is of a slender structure, and the extending direction AC of the multiple grooves and the axial line <NUM> of the connection section <NUM> form a certain included angle C. The bending resistance of the whole connection section <NUM> may be adjusted by adjusting the number of the grooves in each groove group <NUM>, the sizes of the gaps <NUM>, the degree size of the included angle C between the extending direction AC of the grooves and the axial line <NUM> of the elastic deformation section <NUM> and the size of the gap <NUM> between every two adjacent groove groups <NUM>, so that the bending resistance of the connection section <NUM> is lower than that of the elastic deformation section <NUM>. In other embodiments, there may be <NUM> to <NUM> grooves in each groove group <NUM>, the gap <NUM> between every two adjacent grooves in each groove group <NUM> may be <NUM> to <NUM>, the included angle C may be <NUM> to <NUM> degrees, and the gap <NUM> between every two adjacent groups may be <NUM> to <NUM>. The outer diameter of the elastic deformation section <NUM> is about <NUM> to <NUM>, and the wall thickness is <NUM> to <NUM>. Connection between the connection section <NUM> and the elastic deformation section <NUM> may be realized in ways of macromolecular heat-shrink tube or film wrapping, glue adhesion, laser welding, soldering and the like. Based on prior arts, an integrated cutting way is preferred that is the elastic deformation section <NUM> and the connection section <NUM> which have different texture features are cut from different regions on the same tube material.

With reference to <FIG> and <FIG> together, the connection member <NUM> is disposed at the proximal end of the connection section <NUM>, and includes a protuberance <NUM> and a connection portion <NUM>. The outer diameter D of the protuberance <NUM> is larger than that of a portion, which is close to the protuberance <NUM>, on the elastic implant <NUM> in a delivery state. In this implementation mode, the outer diameter of the portion, which is close to the protuberance <NUM>, on the elastic implant <NUM> is the outer diameter of the proximal end of the connection section <NUM>. An internal thread <NUM> is in the protuberance <NUM>. The connection portion <NUM> is disposed between the protuberance <NUM> and the connection section <NUM>, and has a cavity <NUM> which penetrates through the end surfaces of the proximal end and the distal end of the connection portion <NUM>. In this embodiment, the cross section, which is parallel to a longitudinal central axis of the protuberance <NUM>, of the protuberance <NUM> includes two opposite semicircles, and the outer diameter D would not exceed <NUM>, preferably <NUM> to <NUM>. The protuberance <NUM> effectively enlarges a contact area of the proximal end of the elastic implant <NUM> and reduce the injury to a lung tissue due to the implantation of the elastic implant <NUM>. It should be understood that the end surface of part of the distal end of the protuberance <NUM> is sunken towards the proximal end of the protuberance <NUM>, thereby forming an annular recess <NUM> (see <FIG>) surrounding the longitudinal central line of the protuberance <NUM> to provide a grasping position for biopsy forceps which may clamp a connection device more effectively to recycle the elastic implant <NUM>.

With reference to <FIG> together, the elastic implant film <NUM> completely wraps the outer surface of the elastic implant <NUM> except for the protuberance <NUM>, and each groove <NUM> is filled with the film, but the film does not block the lumen of the elastic implant <NUM>, thereby ensuring that the elastic implant film <NUM> firmly wraps the elastic implant <NUM> and also ensuring that the lumen of the elastic implant <NUM> is unblocked. The elastic implant film <NUM> may have a thickness of <NUM> to <NUM>, and may be prepared from macromolecular solutions featuring high chemical stability, water resistance and weather aging resistance, good low compressibility, good biocompatibility, high mechanical strength, non-toxicity, odorlessness and the like. For example, these macromolecular solutions may be silicone rubber or polyurethane solutions. As the elastic implant film <NUM> is combined with a metal matrix, the end portion of its proximal end would turn up and fall off most easily under an external force; the outer diameter of the protuberance <NUM> is larger than that of the portion, which is close to the protuberance <NUM>, on the elastic implant <NUM> in the delivery state, so that the protuberance <NUM> may protect the end portion of the proximal end of the elastic implant film <NUM> from being in contact with a tube wall in delivery and withdrawal processes, thereby protecting the elastic implant film <NUM> from turning up and falling off in the delivery and withdrawal processes.

With reference to <FIG> together, a comparative lung volume reduction device <NUM> (not part of the invention) includes an elastic implant <NUM> and a delivery device <NUM>. The delivery device <NUM> includes a core wire <NUM> and a pushing mechanism <NUM>.

The core wire <NUM> is accommodated in a lumen of the elastic implant <NUM>, and is configured to limit the elastic implant <NUM> in an approximately straight line type delivery state to facilitate delivery of the implant <NUM> to a lesion portion, thus no delivery sheath is needed to restrict the implant <NUM>, which prevents the delivery sheath from injuring a trachea in a delivery process and further reduces incidence of pneumothorax. The core wire <NUM> may be made of a section of metal wire having a diameter of <NUM> to <NUM>. Compared with the prior art, the present disclosure does not need the delivery sheath, so that the implant <NUM> may be implanted into a lung bypass or the ends of some small-diameter tracheas to achieve a better treatment effect.

With reference to <FIG> together, for the purpose of safety and convenience in operation, it needs to dispose a flexible core wire guide head <NUM>, which is coaxial with the core wire <NUM> and has an imaging label, 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 post <NUM> and a spring <NUM> fixed outside the guide post <NUM> in a sleeving manner. The guide post <NUM> and the core wire <NUM> are of an integrated structure or the guide post <NUM> is fixedly connected to the distal end of the core wire <NUM>; and the spring <NUM> has an imaging label.

The core wire guide head <NUM> is configured to guide the core wire <NUM> to successfully enter the lumen of the elastic implant <NUM>. The flexible core wire guide head <NUM> may be implemented through a flexible spring, and namely the spring <NUM> is disposed in a sleeving manner on the guide post <NUM> which is of an integrated structure with the core wire <NUM> or is fixedly connected to the distal end of the core wire <NUM>. A specific manufacturing method may include: firstly thinning the head end of the core wire <NUM> to manufacture the guide post <NUM>, and then fixing a section of the spring <NUM> having a length of <NUM> to <NUM> outside the guide post <NUM>. The spring <NUM> and the core wire <NUM> may be fixed in ways of macromolecular heat-shrink tube or film wrapping, glue adhesion, laser welding, soldering and the like. Under the guide of the flexible core wire guide head <NUM>, the core wire <NUM> may successfully enter the lumen of the implant <NUM> from the proximal end of the implant <NUM> to restrict the implant <NUM> into an approximate straight line form (as shown in <FIG>) from the shape as shown in <FIG> and <FIG>.

With the flexible guide section <NUM>, the implant <NUM> equipped with a core wire <NUM> further has a function of exploring a path in the bronchus to reach the lesion region. It needs to dispose the imaging label on the core wire guide head <NUM> to guide and monitor an operation condition of the core wire <NUM> in the lung. The imaging label can display the implant through a fluorescence inspection system, an ultrasonic imaging system, an MRI (Magnetic Resonance Imaging) system, an X-ray CT (Computerized Tomography) system or other remote imaging systems, and there is no limitation to a specific structure. The core wire <NUM> is developed and guided through these systems. In this embodiment, the spring formed by winding a metal wire with the wire diameter of <NUM> to <NUM> and relatively high X-ray developing property, such as a tungsten metal wire and a tantalum metal wire, is used as an imaging label. In this embodiment, the imaging label and the core wire guide head <NUM> are combined into one component to realize two functions. Besides such a mode, an extra developing label may be disposed on the core wire guide head <NUM>. Of course, when the surface of the implant of the present disclosure is not wrapped by an elastic film, and the implant is made of a material capable of realizing imaging by itself, such as the nickel-titanium alloy, no imaging label is disposed.

The pushing mechanism <NUM> includes a hollow pushing member <NUM> and a control handle <NUM> connected with the hollow pushing member <NUM>. The hollow pushing member <NUM> and the implant <NUM> are disposed on the core wire <NUM> in a sleeving 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 this embodiment, the hollow pushing member <NUM> is a pushing steel cable, and a connection matching member <NUM> having an external thread matched with the internal thread of the connection member <NUM> is disposed at its distal end. During assembling, the internal thread of the connection member <NUM> is in threaded connection with the connection matching member <NUM> with 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 an implant <NUM> is pushed to a corresponding position of the bronchus, the connection member <NUM> of the implant <NUM> is screwed out of and separated from the connection matching member <NUM> of the hollow pushing member <NUM> by twisting the control handle <NUM> of the hollow pushing member <NUM>. The connection member <NUM> and the connection matching member <NUM> may be other detachably fixed connection components, such as magnetic connection devices, elastic buckles and ropes, which are disposed on the implant <NUM> and the hollow pushing member <NUM> respectively to realize detachable connection.

Assembling steps of the elastic implant <NUM> and the core wire <NUM> as well as the hollow pushing member <NUM> are as follows: firstly, connecting the elastic implant <NUM> with the connection matching member <NUM> at the distal end of the hollow pushing member <NUM> through the threads to communicate the hollow pushing member <NUM> with an inner channel of the elastic implant <NUM>; and then pushing the core wire <NUM> into the elastic implant <NUM> along a channel of the hollow pushing member <NUM> to restrict the elastic implant <NUM>, which is curled in a natural state, into a tube in an approximately straight line type delivery state.

With reference to figures from <FIG>, an implant <NUM> equipped with the core wire <NUM> and the hollow pushing member <NUM> is delivered into the bronchus <NUM> of a lung <NUM> through a working channel <NUM> of a bronchoscope <NUM>. With the assistance of X-rays, the implant <NUM> is pushed to an expected position by using the hollow pushing member <NUM>, and then the core wire <NUM> is withdrawn. During withdrawal of the core wire <NUM>, the implant <NUM> is automatically recovered to the natural shape as shown in <FIG> from the straight line type delivery state restricted by the core wire <NUM>; and in this recovery process, the pulmonary emphysema region may be squeezed and pulled, and a relatively healthy lung tissue therearound may better exert a respiration physiological function, thereby achieving a lung volume reduction effect. The threaded connection between the connection matching member <NUM> at the distal end of the hollow pushing member <NUM> and the connection member <NUM> of the elastic implant <NUM> is relieved by rotating the handle <NUM>, thereby releasing the implant <NUM>.

With reference to <FIG>, an elastic implant 500a provided by another embodiment of the present disclosure includes a hollow tubular elastic deformation section 51a, a flexible guide section 53a connected with the distal end of the elastic deformation section 51a, a connection section 52a connected with the proximal end of the elastic deformation section 51a, and a connection member 57a connected with the proximal end of the connection section 54a. The implant 500a at least opens at the proximal end, and the elastic deformation section 51a and the flexible guide section 53a may be of an integrated structure, or are fixedly connected with each other. The distal end of the flexible guide section 53a is the distal end of the elastic implant 500a. Under the action of a same external force, the flexible guide section 53a deforms more easily than the elastic deformation section 51a (that is to say, under the action of the same external force, the bending resistance of the flexible guide section 53a is lower than that of the elastic deformation section 51a), so that it may move in a bronchus better without injuring a surrounding tissue.

With reference to <FIG> together, the elastic deformation section 51a includes multiple groove clusters <NUM> which are arrayed in an axial direction of the elastic deformation section 51a in a spacing manner. Each groove cluster <NUM> consists of five elliptical groove groups <NUM> which are disposed side by side and are arrayed in a stair-stepping manner. Each groove group <NUM> in this embodiment consists of two side-by-side grooves; a certain gap <NUM> is reserved between the two grooves in each groove group <NUM>; and the long axis of each groove is perpendicular to the axial line of the elastic deformation section 51a. The extending direction <NUM> of arrangement of every two groups in each groove cluster <NUM> and the axial line 501a of the elastic deformation section 51a form a certain included angle E which may be <NUM> to <NUM> degrees. A gap 508a of about <NUM> to <NUM> is reserved between every two adjacent groove groups <NUM> in each groove cluster <NUM>. The groove groups <NUM> arrayed in the stair-stepping manner contribute to bending the elastic deformation section 51a into a specific shape. A portion having a length of about <NUM> to <NUM> at the proximal end 511a of the elastic deformation section 51a is cut into a threaded trench serving as a connection member 57a. A cut nickel-titanium tube is bent with a die into a shape as shown in <FIG>, and then is subjected to thermal treatment modeling, thereby forming the elastic deformation section 51a of an elastic implant 500a.

Under the action of the same external force, the bending resistance of the connection section 52a is lower than that of the elastic deformation section 51a to reduce injury of the connection section 52a to a bronchus wall better. With reference to Figures from <FIG>, in this embodiment, the connection section 52a is a tubular body which is formed by connecting multiple hollow subcomponents <NUM> in an end-to-end manner and has multiple circumferentially continuous wavy grooves <NUM>. The grooves <NUM> have certain widths <NUM> which may be preferably <NUM> to <NUM>. Starting points and ending points of every two adjacent wavy grooves <NUM> are overlapped in the circumferential direction of the connection section 52a. Preferably, in this embodiment, the proximal end of each subcomponent <NUM> includes multiple proximal end bulges <NUM> distributed in the circumferential direction of the hollow subcomponent <NUM> in an equal spacing manner; and the circumferential length of each proximal end bulge <NUM> is gradually decreased from the proximal end to the distal end, thus a dovetail-shaped opening towards a proximal end recess <NUM> at the proximal end is formed between every two adjacent proximal end bulges <NUM>; the distal end of each hollow subcomponent <NUM> includes multiple distal end bulges <NUM> distributed in the circumferential direction of the hollow subcomponent <NUM> in an equal spacing manner; and the circumferential length of each distal end bulge <NUM> is gradually increased from the proximal end to the distal end, thus a dovetail-shaped opening towards a distal end recess <NUM> at the distal end is formed between every two adjacent distal end bulges <NUM>; the quantity of the proximal end bulges <NUM> of each hollow subcomponent <NUM> is equal to that of the distal end bulges <NUM> of the same hollow subcomponent <NUM>; and one distal end recess <NUM> on each hollow subcomponent <NUM> is aligned with one proximal end bulge <NUM> on the same hollow subcomponent <NUM>. Therefore, in two hollow subcomponents <NUM>, the multiple dovetail-shaped proximal end bulges <NUM> on one hollow subcomponent <NUM> mesh with the multiple distal end recesses <NUM> of the other hollow subcomponent <NUM>, so that the two separated hollow subcomponents <NUM> form an interlocked structure, and the multiple hollow subcomponents <NUM> are spliced and combined to form the connection section 52a. As all the separated subcomponents <NUM> are connected through meshing structures of the dovetail-shaped bulges and the dovetail recesses, the connection section 52a with such structure has extremely high flexibility and connection strength, and may transmit a torque to the elastic deformation section 51a at a ratio of <NUM> to <NUM> during twisting of the connection member <NUM>. Based on prior arts, the subcomponents <NUM> may be also machined in other ways, such as machining, casting and powder metallurgy. It should be understood that the connection section 52a has extremely high flexibility and extremely low bending resistance, so that the aim that the bending resistance of the connection section 52a is lower than that of the elastic deformation section 51a may be achieved easily by adjusting the bending resistance of the elastic deformation section 51a. It should be understood that the multiple proximal end bulges <NUM> may be also distributed at the proximal ends of the subcomponents <NUM> in a non-equal spacing manner to achieve the aim that the multiple subcomponents <NUM> may be spliced together.

Under the action of the same external force, the bending resistance of the flexible guide section 53a is lower than that of the elastic deformation section 51a, so as to guide the elastic deformation section 51a better to move in the bronchus and reduce injury to the bronchus wall. Under the action of the same external force, the bending resistance of the flexible guide section 53a is gradually enhanced from the distal end to the proximal end. With reference to <FIG> and <FIG> together, in this embodiment, the flexible guide section 53a is a tubular body, which is cut from a nickel-titanium tube through laser and has grooves, and under the action of the same external force, its bending resistance is gradually enhanced from the distal end to the proximal end (that is to say, under the action of the same external force, its deformability is gradually lowered from the distal end to the proximal end, and namely it becomes harder and harder from the distal end to the proximal end), so as to achieve a better guide effect on the elastic implant 500a. It should be understood that as the flexible guide section 53a is the tubular body having the multiple grooves, its bending resistance may change with the change of a gap between every two adjacent grooves. A person skilled in the art could set the gap between every two adjacent grooves according to an actual requirement to achieve an aim that the bending resistance of the flexible guide section 53a is lower than that of the elastic deformation section 51a.

The flexible guide section 53a includes multiple slender groove groups from <NUM> to <NUM>. Each groove group (for example <NUM>) consists of two or more parallel grooves 1601a and 1601b, and each parallel groove has a certain width <NUM>. The extending direction of these groove groups from <NUM> to <NUM> and the axial line 513a of the flexible guide section 53a form a certain angle F. A gap <NUM> is reserved between every two adjacent groove groups. The bending resistance of the flexible guide section 53a may be adjusted by adjusting the number and the widths <NUM> of the grooves in each groove group, the degree size of the angle F and the sizes of the gaps <NUM>. Preferably, there are <NUM> to <NUM> parallel grooves <NUM>, the gaps <NUM> are <NUM> to <NUM>, the angle F is <NUM> to <NUM> degrees, and the gaps <NUM> is <NUM> to <NUM>. The parallel groove groups (from <NUM> to <NUM>) with different widths <NUM> are combined into a same nickel-titanium tube, thereby achieving the aim that under the action of the same external force, the bending resistance of the flexible guide section 53a is gradually enhanced from the distal end to the proximal end; and the flexible guide section 53a with a bending resistance gradual change effect may achieve a better guide effect on the elastic implant 500a.

The flexible guide section 53a and the elastic deformation section 51a may be connected in ways of macromolecular heat-shrink tube or film wrapping, glue adhesion, laser welding, soldering and the like. Based on the prior art, an integrated cutting way is preferred: cutting the flexible guide section 53a and the elastic deformation section 51a which have different texture features from different regions on the same tube material. For the purpose of achieving a bending resistance gradual change effect on the flexible guide section 53a, one feasible mode is to keep the angle F between every two adjacent groove groups unchanged and gradually decrease the widths <NUM> of the grooves from the distal end to the proximal end, and another feasible mode is to keep the widths <NUM> of the grooves in every two adjacent groove groups unchanged and gradually enlarge the angle F. It should be understood that the effect of gradually enhancing the bending resistance of the flexible guide section 53a from the distal end to the proximal end also may be achieved by simultaneously changing the angle F and the widths <NUM> of the grooves in every two adjacent groove groups.

With reference to <FIG>, the connection member 57a is substantially the same as the connection body <NUM>, but what is different is that a protuberance 571a of the connection member 57a has multiple small bulges <NUM> which are distributed in the circumferential direction of the protuberance 571a in an equal spacing manner and are connected with one another. With reference to <FIG>, the multiple small bulges <NUM> form a virtual circumference <NUM> together (namely an circumcircle of the multiple small bulges <NUM> is <NUM>). The diameter of the circumference <NUM> is the outer diameter of the protuberance 571a. The multiple small bulges <NUM> provide a buckling position for biopsy forceps, so that the biopsy forceps may effectively clamp the connection device to recycle the elastic implant 500a. The connection member 57a and the connection section 52a may be connected in ways of macromolecular heat-shrink tube or film wrapping, glue adhesion, laser welding, soldering and the like.

With reference to <FIG>, an elastic implant 500b provided by another embodiment of the present disclosure includes a hollow tubular elastic deformation section 51b, a flexible guide section 53b connected with the distal end of the elastic deformation section 51b, a connection section 52b connected with the proximal end of the elastic deformation section 51b, and a connection member 57b connected with the proximal end of the connection section 52b. The implant 500b at least opens at the proximal end; the elastic deformation section 51b and the flexible guide section 53b may be of an integrated structure, or are fixedly connected with each other. The distal end of the flexible guide section 53b is the distal end of the elastic implant 500b. Under the action of a same external force, the flexible guide section 53b deforms more easily than the elastic deformation section 51b, so that it may move in a bronchus better without injuring a surrounding tissue.

The arrangement mode of grooves of the elastic deformation section 51b is substantially the same as that of the grooves of the connection section <NUM> of the embodiment I, and no repeated descriptions will be given here.

With reference to <FIG> and <FIG>, the flexible guide section 53b is a tubular body which is cut from a nickel-titanium tube through laser and has continuous spiral grooves, and under the action of the same external force, its bending resistance is gradually enhanced from the distal end to the proximal end (that is to say, under the action of the same external force, its deformability is gradually lowered from the distal end to the proximal end) to achieve a better guide effect on the elastic implant 500b. It should be understood that as the flexible guide section 53b is a tubular body having continuous spiral grooves, its bending resistance may change with the change of a gap between every two adjacent grooves. A person skilled in the art could set the gap between every two adjacent grooves according to an actual requirement to achieve an aim that the bending resistance of the flexible guide section 53b is lower than that of the elastic deformation section 51b.

The flexible guide section 53b includes the continuous spiral grooves <NUM>. On an unfolded plane formed by splitting the flexible guide section 53b along its axial direction, from the distal end to the proximal end of the flexible guide section 53b, the gap between every two adjacent grooves <NUM> is gradually increased as well to achieve the aim of gradually enhancing the bending resistance of the flexible guide section 53b from the distal end to the proximal end.

It should be understood that on the unfolded plane formed by splitting the flexible guide section 53b along its axial direction, from the distal end to the proximal end of the flexible guide section 53b, when an included angle G between the extending direction <NUM> of the grooves <NUM> of the flexible guide section 53b and the axial direction <NUM> of the flexible guide section 53b is unchanged, and the widths of the grooves of the flexible guide section 53b along the axial direction <NUM> of the flexible guide section 53b are gradually decreased, the gap between every two adjacent grooves <NUM> is gradually increased as well, and the aim of gradually enhancing the bending resistance of the flexible guide section 53b from the distal end to the proximal end may be also achieved.

It should be understood that on the unfolded plane formed by splitting the flexible guide section 53b along its axial direction, from the distal end to the proximal end of the flexible guide section 53b, when the widths of the grooves of the flexible guide section 53b along the axial direction <NUM> of the flexible guide section 53b are unchanged, and the included acute angle between the extending direction <NUM> of the grooves of the flexible guide section 53b and the axial direction <NUM> of the flexible guide section 53b is gradually enlarged, the gap between every two adjacent grooves <NUM> is gradually increased as well, and the aim of gradually enhancing the bending resistance of the flexible guide section 53b from the distal end to the proximal end may be also achieved.

The structure of the connection section 52b is substantially the same as that of the connection section 52a, and no repeated descriptions will be given here.

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

Claim 1:
A lung volume reduction elastic implant, wherein the implant is tubular, at least opens at its proximal end, and comprises a hollow tubular elastic deformation section (<NUM>), a flexible guide section (<NUM>) connected with the distal end of the elastic deformation section (<NUM>) and a protuberance (<NUM>) connected with the proximal end of the elastic deformation section (<NUM>), and the elastic deformation section (<NUM>) has a shape memory characteristic and has a plurality of grooves (<NUM>) formed in a spacing manner along a lengthwise direction of the elastic deformation section (<NUM>) and each groove is communicated with a lumen of the elastic deformation section (<NUM>) and wherein, under the action of a same external force, the flexible guide section (<NUM>) deforms more easily than the elastic deformation section (<NUM>)
whereby under the action of the same external force, the flexible guide section (<NUM>) deforms more easily in an increasing manner from the proximal end to the distal end,
a connection section (<NUM>) is located between the elastic deformation section (<NUM>) and the protuberance (<NUM>), and wherein under action of a same external force, the connection section (<NUM>) deforms more easily than the elastic deformation section (<NUM>), and
wherein the outer diameter of the protuberance (<NUM>) is larger than that of a portion of the elastic implant, which is close to the protuberance in a delivery state.