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 produce extremely limited therapeutic effect. Surgical therapies for pulmonary emphysema mostly adopt lung volume reduction surgery, and also have limitations, for example: strict surgical indications, risks of many complications, anesthesia and anesthesia-related complications, difficulty in predicting therapeutic effect before the surgery, and a possibly irreparable undesired therapeutic effect caused by over-cutting or sub-cutting after the surgery, high surgical costs, and mental and physical sufferings. In addition, some patients will not be able to tolerate the surgery due to their poor lung functions, thereby leading to a higher postoperative mortality rate, which limits the use of surgical therapies.

To better treat pulmonary emphysema, improve the quality of life for a patient, and reduce trauma to the patient during surgery, interventional modes for treating pulmonary emphysema, such as the modes of applying a one-way valve, biogel, steam thermal ablation, or an elastic coil with the help of a bronchoscope, have been researched and utilized internationally. However, the one-way valve interventional mode produces poor clinical effect because of the failure in effectively and actively expelling residual gas and sputum in a target region, and its therapeutic effect is restricted by technical difficulties in collateral ventilation and the requirement for precise placement of the one-way valve at different anatomical structure positions. The problem of postoperative inflammation caused by biogel interventional mode due to a fully blocked emphysema region has not been properly solved. Steam thermal ablation would result in postoperative inflammation due to the destruction of original tissue structure of the emphysema region.

<CIT> discloses a lung volume-reducing elastic implant having a proximal end, an elastic deformation part and a distal end. The elastic deformation part has a shape memory characteristic and is provided with a plurality of grooves at intervals along the longitudinal direction thereof. Each groove communicates with the inner lumen of the elastic deformation part.

At the present time, an updated therapeutic method for pulmonary emphysema is a method of implanting an elastic coil, serving as an implant, into a lesion locus of a human lung. <FIG> is a schematic diagram of a lung volume reduction elastic coil in the prior art. This product is 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 delivery system, this product may be implanted in a straight line form into the lung through a working channel of the bronchoscope. After being delivered into a bronchus of a pulmonary emphysema region, the coil is released from the restriction of the delivery system and then recovers its natural shape (a shape in the absence of 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 to exhaust gas in the bronchus and reduce the volume of the lung tissue in the pulmonary emphysema region. Therefore, a relatively healthy lung tissue therearound may better exert a physiological function.

The above-mentioned implant has the following defects: to achieve a relatively good squeezing volume reduction effect, the implant is generally made of a metal elastic coil with relatively high elasticity, and has a high degree of hardness and has a low degree of flexibility, so it easily causes injury to the bronchus when implanted into the bronchus.

The object of the present invention is to provide an implant that has a relatively high degree of flexibility so as to solve the above technical problems. After the implant is implanted into a bronchus, the risk of bruising the bronchus during bending of the implant should be reduced, and the safety of lung volume reduction surgery should be improved.

A lung volume reduction instrument should also be provided which can deliver the implant into a lung bypass, or the ends of some small-diameter tracheas, according to specific clinical requirements so as to ensure safer surgical operation and to achieve a better therapeutic effect.

According to the present invention, a lung volume reduction elastic implant is provided as defined in claim <NUM>. The implant includes an elastic deformation part and a flexible guide part connected with a distal end of the elastic deformation part. The flexible guide part is provided with a first flexible section. The first flexible section includes an insert section and a distal section. The insert section is connected with the distal end of the elastic deformation part. A distal end of the distal section of the first flexible section is a distal end of the lung volume reduction elastic implant. A radiograph component is arranged in the first flexible section.

The flexible guide part further includes a hollow second flexible section connected between the elastic deformation part and the first flexible section. The insert section of the first flexible section is inserted into the second flexible section, and a proximal end of the radiograph component is inserted into the second flexible section along with the insert section of the first flexible section.

In one embodiment of the present invention, the radial height of the insert section of the first flexible section is less than that of the distal section, and a joint of the insert section and the distal section has a stepped shape.

In another embodiment, the proximal end of the radiograph component is closer to a distal end of the distal section than a proximal end of the insert section, and a perpendicular distance between the proximal end of the radiograph component and a proximal end of the first flexible section is <NUM> to <NUM>.

In another embodiment, the radiograph component includes a radiograph wire arranged in the first flexible section.

In another embodiment, the radiograph component further includes a radiograph ring connected to a distal end of the radiograph wire.

In another embodiment, under the action of the same external force, the second flexible section deforms more easily from a proximal end to a distal end.

In another embodiment, the second flexible section includes a tubular body cut from a nickel-titanium tube and having continuous spiral cutting slots.

In another embodiment, the distance between two adjacent cutting slots of the second flexible section along the axial direction of the second flexible section is gradually increased from the distal end to the proximal end of the second flexible section.

In another embodiment, the lung volume reduction elastic implant has an opening in a proximal end and further includes a boss connected with a proximal end of the elastic deformation part. The superelastic elastic deformation part is provided with a plurality of cutting slots in a spaced-apart manner along the longitudinal direction of the elastic deformation part. Each cutting slot communicates with a lumen of the elastic deformation part. Under the action of the same external force, the flexible guide part deforms more easily than the elastic deformation part. An outer diameter of the boss is greater than that of a part of the elastic implant that is close to the boss in a delivery state.

In another embodiment, the elastic implant further includes a connection part located between the elastic deformation part and the boss. Under the action of the same external force, the connection part deforms more easily than the elastic deformation part.

In another embodiment, the connection part is provided with a plurality of cutting slots in a spaced-apart manner along the longitudinal direction of the connection part.

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

In another embodiment, from the distal end to the proximal end of the flexible guide part, part of a distal-end face of the boss is sunken towards a proximal end of the boss to form an annular groove surrounding the longitudinal center line of the boss.

In another embodiment, part of a side surface of the boss is sunken into the inner of the boss to form an annular groove surrounding the longitudinal center line of the boss.

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

The present invention also provides a lung volume reduction instrument as defined in claim <NUM>. The instrument includes any one of the above-mentioned implants, and a delivery apparatus matched with the implant. The delivery apparatus includes a core wire and a delivery mechanism. A proximal end of the implant is detachably connected to a distal end of the delivery mechanism. The core wire may be movably arranged in and extends through a lumen of the implant and a lumen of the delivery mechanism.

In another embodiment of the instrument, a core wire guide head coaxial with the core wire is arranged at a distal end of the core wire, and an outer diameter of the core wire guide head is consistent with that of the core wire.

In another embodiment, the core wire guide head includes a guide column and a spring arranged on and surrounding the guide column. The guide column and the core wire are made from one piece, or the guide column is fixedly connected to the distal end of the core wire. The spring is provided with a radiopaque marker.

In another embodiment, the proximal end of the implant is detachably connected with the distal end of the delivery mechanism.

The present implant includes the elastic deformation part and the flexible guide part connected with the distal end of the elastic deformation part. The flexible guide part is provided with a first flexible section having relatively high flexibility. The distal end of the distal section of the first flexible section serves as the distal end of the lung volume reduction elastic implant. The present invention offers the following advantages. As the first flexible section is more flexible than a metal and has high elasticity, when the first flexible section is stressed, it will bend more easily because of its higher flexibility and has a relatively soft surface, so injury caused by the lung volume reduction elastic implant to a lung tissue can be greatly reduced.

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

Numerals in the drawings: <NUM>: elastic deformation part; <NUM>: flexible guide part; <NUM>: connection part; <NUM>: connection member; <NUM>: elastic thin film; <NUM>: first flexible section; <NUM>: second flexible section; <NUM>: elastic implant; <NUM>: radiograph component; <NUM>: proximal end of the elastic deformation part; <NUM>: distal end of the elastic deformation part; <NUM>: radiograph component; <NUM>: radiograph wire; and <NUM>: radiograph ring.

For the purpose of making objectives and advantages of the present invention clearer and more understandable, embodiments are described in detail below in combination with the accompanying drawings.

In the field of interventional therapy, generally, the end relatively close to an operator is called a proximal end, and the 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.

Referring to <FIG>, an elastic implant <NUM> provided by one embodiment is of a tubular structure, including a hollow tubular elastic deformation part <NUM>, a flexible guide part <NUM> connected to the distal end of the elastic deformation part <NUM>, a connection part <NUM> connected to the proximal end of the elastic deformation part <NUM>, a connection member <NUM> connected to the proximal end of the connection part <NUM>, and an elastic thin film <NUM>.

The flexible guide part <NUM> includes a first flexible section <NUM> and a second flexible section <NUM> connected between the first flexible section <NUM> and the elastic deformation part <NUM>. The distal end of the first flexible section <NUM> serves as the distal end of the elastic implant <NUM>. A radiograph component <NUM> is arranged in the first flexible section <NUM>.

Referring also to <FIG>, the first flexible section <NUM> includes an insert section <NUM> and a distal section <NUM>. The part that is close to the proximal end of the implant <NUM> of the first flexible section <NUM> is the insert section <NUM>, and the part that is close to the distal end of the implant <NUM> of the first flexible section <NUM> is the distal section <NUM>. The insert section <NUM> of the first flexible section <NUM> is inserted into the second flexible section <NUM>. When the insert section <NUM> of the first flexible section <NUM> is inserted into the second flexible section <NUM>, the proximal end of the radiograph component <NUM> extends into the second flexible section <NUM>. Specifically, the first flexible section <NUM> is made of a macromolecular elastic material, such as silica gel, polytetrafluoroethylene or a PEBAX material. The macromolecular elastic material is more flexible than a metal material and has a lower anti-bending force (the minimum force for bending the material), so that during implantation of the implant, the distal end that serves as the distal end of the implant <NUM> of the first flexible section <NUM> is the end in direct contact with tissue in a human body, so as to prevent the implant from bruising the tissue in the human body. Preferably, the distal-end face of the first flexible section <NUM> is designed to be a partial spherical face. During the implantation of the implant, when its distal end is in contact with the tissue, such as a bronchus or a lung, in the human body, the first flexible section <NUM> is easier to bend because of its characteristics of greater flexibility and lower anti-bending force, and therefore will not bruise the tissue in the human body.

The insert section <NUM> and the distal section <NUM> here may be formed in one piece. For example, they are directly manufactured through a mold or by a cutting method. The insert section and the distal section also may be separately manufactured and then fastened and connected through glue or other techniques, and there is no specific limitation here. The radial height of the insert section <NUM> of the first flexible section <NUM> is less than that of the distal section <NUM>. In this manner, a joint of the insert section <NUM> and the distal section <NUM> can have a stepped shape. In the present embodiment, main body parts of the insert section <NUM> and the distal section <NUM> of the first flexible section <NUM> are preferably cylindrical, and the axial lines of the insert section <NUM> and the distal section <NUM> are located on the same horizontal line. The radial height of the insert section <NUM> is matched with the inner diameter of the lumen of the second flexible section <NUM>. When the first flexible section <NUM> is connected with the second flexible section <NUM>, the insert section <NUM> may be inserted into the lumen of the second flexible section <NUM>. As the macromolecular material has a certain elasticity, the insert section <NUM> may be properly compressed when inserted into the lumen of the second flexible section <NUM>, and the elasticity of the material of the insert section <NUM> may ensure that the insert section <NUM> may be firmly fastened through the lumen of the second flexible section <NUM>, thereby effectively avoiding the problem of ineffective connection reliability caused by other connection techniques. The radial height of the insert section <NUM> being matched with the inner diameter of the lumen of the second flexible section <NUM> means that the radial height of the insert section <NUM> may be slightly greater than, equal to, or less than the inner diameter of the lumen of the second flexible section <NUM>. When the radial height is slightly greater than the inner diameter, the insert section <NUM> is compressed to deform to squeeze into the lumen of the second flexible section <NUM>, and may still be integrated with the second flexible section <NUM> without the help of a foreign object. When the radial height is equal to or less than the inner diameter, the insert section <NUM> may be easily inserted into the lumen of the second flexible section <NUM>, and at that moment, the insert section <NUM> and the second flexible section <NUM> are connected into an unitary object with the help of the macromolecular elastic material covering the periphery of the second flexible section <NUM>.

Preferably, the radial height of the distal section <NUM> of the first flexible section <NUM> is equal to the outer diameter of the second flexible section <NUM>. When the insert section <NUM> of the first flexible section <NUM> is inserted into the lumen of the second flexible section <NUM>, the width of the step of the joint of the insert section <NUM> and the distal section <NUM> may be equal to the thickness of the lumen wall of the second flexible section <NUM>, so as to ensure that the outer surface of the joint of the first flexible section <NUM> and the second flexible section <NUM> is flush after the first flexible section <NUM> and the second flexible section <NUM> are connected, and then to guarantee the smooth outer surface of the implant to avoid injury to tissue organs in the human body caused by protrusions on the surface and also lower the subsequent processing difficulty. The second flexible section <NUM> is a tubular body cut from a nickel-titanium tube through laser and having cutting slots, and under the action of the same external force, its anti-bending performance from the distal end to the proximal end is gradually improved (that is, under the action of the same external force, the deformation performance from the distal end to the proximal end is gradually lowered, namely the second flexible section becomes harder from the distal end to the proximal end), so as to better guide the elastic implant <NUM>. In addition, the anti-bending performance of the second flexible section <NUM> is lower than that of the elastic deformation part <NUM> and is higher than that of the first flexible section <NUM>, so as to allow the flexible guide section <NUM> to move more effectively in the bronchus without injuring surrounding tissues.

It can be understood that, as the second flexible section <NUM> is the tubular body having the multiple cutting slots, the anti-bending performance of the second flexible section <NUM> may vary with the changes of the distances between adjacent cutting slots. Those skilled in the art can set the distances between adjacent cutting slots according to different clinical requirements to allow the anti-bending performance of the second flexible section <NUM> to be lower than that of the elastic deformation part <NUM>.

The second flexible section <NUM> includes the continuously spiral cutting slots <NUM>. On a spread plane cut along the axial direction of the second flexible section <NUM>, the distance between two adjacent cutting slots <NUM> is also gradually increased from the distal end to the proximal end of the second flexible section <NUM> to gradually improve the anti-bending performance of the second flexible section <NUM> from the distal end to the proximal end.

It can be understood that, on the spread plane cut along the axial direction of the second flexible section <NUM>, from the distal end to the proximal end of the second flexible section <NUM>, when an included angle G between the extending direction <NUM> of the cutting slots <NUM> of the second flexible section <NUM> and the axial direction <NUM> of the second flexible section <NUM> is unchanged, and the width of each cutting slot of the second flexible section <NUM> along the axial direction <NUM> of the second flexible section <NUM> 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 second flexible section <NUM> from the distal end to the proximal end.

It can be understood that, on the spread plane cut along the axial direction of the second flexible section <NUM>, from the distal end to the proximal end of the second flexible section <NUM>, when the width of each cutting slot of the second flexible section <NUM> along the axial direction <NUM> of the second flexible section <NUM> is unchanged, and the included acute angle between the extending direction <NUM> of the cutting slots of the second flexible section <NUM> and the axial direction <NUM> of the second flexible section <NUM> 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 second flexible section <NUM> from the distal end to the proximal end. It can be understood that, in other embodiments, the second flexible section <NUM> also may be omitted. At the moment, the insert section of the first flexible section <NUM> may be inserted into the elastic deformation part <NUM> as long as the distal section of the first flexible section <NUM> of the obtained implant is relatively flexible and does not injure the tissue easily.

Referring to <FIG> again, the elastic radiograph component <NUM> is arranged in the first flexible section <NUM>. As the first flexible section <NUM> is made of the macromolecular material, the radiograph component <NUM> may be embedded into the first flexible section <NUM>, or may be arranged in the first flexible section <NUM> by other methods, and there is no specific limitation here. When the insert section of the first flexible section <NUM> is inserted into the lumen of the second flexible section <NUM>, the proximal end of the radiograph component <NUM> extends into the lumen of the second flexible section <NUM>. During the implantation of the implant <NUM>, the implant <NUM> may be displayed through the radiograph component <NUM> in the first flexible section <NUM>. In addition, as the proximal end of the radiograph component <NUM> extends into the lumen of the second flexible section <NUM>, the radiograph component <NUM> may display a bending change of the first flexible section <NUM> and also may display a bending change of the second flexible section <NUM> during the implantation of the implant, so as to guarantee the accuracy and the safety of the operation.

Furthermore, as the first flexible section <NUM> and the second flexible section <NUM> are made of different materials, the anti-bending force of the first flexible section <NUM> is lower than that of the second flexible section <NUM>. When the implant twists a visceral organ or tissue, it is extremely easy to produce a dramatic deformation difference between the first flexible section <NUM> and the second flexible section <NUM>, leading to relatively high stress concentration in a region having a relatively large deformation difference, and thus resulting in breakage between the first flexible section <NUM> and the second flexible section <NUM>. However, the radiograph component <NUM> in the present embodiment may provide a certain stress support for the first flexible section <NUM> and the second flexible section <NUM> by virtue of its certain elasticity; that is, the anti-bending force difference between the first flexible section <NUM> and the second flexible section <NUM> may be reduced, so the flexible guide section is allowed to have a gradually changing anti-bending force, namely the anti-bending force is gradually lowered from the distal end to the proximal end to avoid the dramatic deformation difference between the flexible section <NUM> and the second flexible section <NUM> and thus avoid breakage between the first flexible section <NUM> and the second flexible section <NUM>.

Preferably, the proximal end of the radiograph component <NUM> is closer to the distal end of the implant <NUM> than the proximal end of the first flexible section <NUM>, and a perpendicular distance A between the proximal end of the radiograph component <NUM> and the proximal end of the first flexible section <NUM> ranges between <NUM> and <NUM>.

In the present embodiment, during the implantation, a core wire is required to be inserted into the lumen of the implant to restrain the elastic implant in an approximately linear delivery state, and the distal end portion of the core wire abuts with the outer wall of the proximal end of the first flexible section <NUM>. The distance between the proximal end of the radiograph component <NUM> and the proximal end of the first flexible section <NUM> is <NUM> to <NUM> to ensure that the core wire does not touch the radiograph component <NUM> and further guarantee the firmness of the position of the radiograph component <NUM> in the first flexible section <NUM> so as to prevent the radiograph component <NUM> from being separated from the first flexible section <NUM> along with the pushing of the core wire. In addition, the perpendicular distance between the proximal end of the radiograph component <NUM> and the proximal end of the first flexible section <NUM> ranges between <NUM> and <NUM> to allow the clinical technician to adjust the entry depth of the radiograph component <NUM> in the second flexible section <NUM> based on the actual clinical situation, so as to allow the flexible guide section to have the gradually changing anti-bending force from the distal end to the proximal end, and avoid the breakage between the first flexible section <NUM> and the second flexible section <NUM>. If the perpendicular distance between the proximal end of the radiograph component <NUM> and the proximal end of the first flexible section <NUM> is set to be less than <NUM>, the core wire can easily contact the radiograph component <NUM> during the implantation process, changing the shape of the radiograph component <NUM>, thereby affecting the radiograph effect.

If the perpendicular distance between the proximal end of the radiograph component <NUM> and the proximal end of the first flexible section <NUM> is set to be more than <NUM>, the gradually changing anti-bending force of the flexible guide section from the distal end to the proximal end would be greatly affected, and then the dramatic deformation difference between the first flexible section <NUM> and the second flexible section <NUM> would easily occur, so the possibility of breakage between the first flexible section <NUM> and the second flexible section <NUM> is increased.

Referring to <FIG> and <FIG> together, the radiograph component <NUM> includes a radiograph wire <NUM> arranged in the longitudinal center axis direction of the first flexible section <NUM> and a radiograph ring <NUM> arranged at the distal end of the radiograph wire <NUM>. The radiograph wire <NUM> has a certain length and may be made of a heavy metal material, such as gold, platinum and tungsten, which presents a relatively good radiographic effect under X-ray. Meanwhile, the radiograph wire <NUM> presents relatively good radiographic effect when bending along with the first flexible section <NUM> and the second flexible section <NUM>, and the bending change of the radiograph wire <NUM> may reflect bending changes of the first flexible section <NUM> and the second flexible section <NUM> outside the radiograph wire <NUM>. Preferably, the arrangement of the radiograph wire <NUM> in the longitudinal center axis direction of the first flexible section <NUM> will help to use the length of the radiograph wire <NUM> to the maximum extent, to ensure that it is maintained in an extending state in the first flexible section, and thereby achieve a better radiographic effect and provide a higher elasticity and a higher stress support to prevent the breakage between the first flexible section <NUM> and the second flexible section <NUM>. In addition, as the instrument is required to be operated under the help of X-ray, the radiograph wire <NUM> is arranged in the first flexible section <NUM>, and the proximal end extends into the second flexible section <NUM>, to ensure that the bending degrees of the first flexible section <NUM> and the second flexible section <NUM> may be displayed during the implantation of the implant. When it is displayed that the first flexible section <NUM> bends to a certain extent, an operator can judge whether the end portion of the implant arrives at a predetermined position according to the displayed result, so as to improve the safety of the lung volume reduction surgery.

The radiograph ring <NUM> is close to the distal end of the first flexible section <NUM>, and is preferably arranged at the distal end portion of the first flexible section <NUM>. As the radiograph wire <NUM> is relatively thin, and the end portion of the first flexible section <NUM> is provided with the radiograph ring <NUM>, the position information of the distal end of the implant may be effectively displayed during the implantation of the implant, so it is more favorable for the operator to judge the position of the distal end portion of the implant to improve the safety and the accuracy of the operation.

It can be understood that, in other embodiments, the radiograph wire of the radiograph component <NUM> may include a core shaft and a radiographic material arranged on the core shaft. The radiographic material is preferably a heavy metal material, such as gold, platinum and tungsten, which provides relatively good radiograph effect under X-ray. The core shaft is preferably made of a nickel-titanium alloy, a cobalt-chromium alloy and the like which is relatively high in elasticity. This design mode also ensures that the radiograph component <NUM> has high elasticity. It can be further understood that, in other embodiments, the radiograph ring <NUM> in the radiograph component <NUM> may be omitted depending on actual clinical requirements.

The elastic deformation part <NUM> with super-elasticity 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 part <NUM>. The elastic deformation part <NUM> further includes multiple mutually isolated cutting slots <NUM> communicating with the lumen of the elastic deformation part <NUM>. The multiple cutting slots <NUM> allow the elastic deformation part <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 part <NUM> is of a predetermined curled shape in its natural state (in the absence of an external force), and may be restrained into a straight bar 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 part <NUM> may be made of a material commonly used in the industry and having superelasticity. In the present disclosure, there is no limitation to specific materials as long as this material is can be used in the human body and has superelasticity. In the present embodiment, the elastic deformation part <NUM> is made of a nickel-titanium alloy. Specifically, a processing method of the elastic deformation part <NUM> includes: first, a section of hollow nickel-titanium tube having a diameter of about <NUM> to <NUM> and a wall thickness of <NUM> to <NUM> is cut by laser; second, the cut nickel-titanium tube is bent into a shape as shown by the elastic deformation part <NUM> in <FIG> through a mold; and finally, the tube is thermally set to form the elastic deformation part <NUM>.

Referring together to <FIG>, in the present embodiment, to allow the elastic deformation part <NUM> to extend into a thinner bronchus and to achieve a better squeezing effect on corresponding tissues, preferably, a conical nickel-titanium tube having a consistent inner diameter and a gradually changing wall thickness is adopted, such as a conical nickel-titanium tube having an inner diameter of <NUM> to <NUM> and the 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 extending direction (namely the direction of the incision) <NUM> of these cutting slots <NUM> and the axial line <NUM> of the elastic deformation part <NUM> form a certain angle A. Preferably, the angle A is <NUM> to <NUM> degrees. A gap <NUM> of about <NUM> to <NUM> is provided between two adjacent cutting slots <NUM>. It can be understood that, as the elastic deformation part <NUM> has the multiple cutting slots <NUM>, the anti-bending performance of the elastic deformation part <NUM> may vary with the changes of the lengths <NUM> of the cutting slots <NUM> in the extending direction <NUM>. Those skilled in the art can set the lengths <NUM> of the cutting slots <NUM> of the elastic deformation part <NUM> in the extending direction <NUM> according to an actual clinical requirement to allow the anti-bending performance of the flexible guide part <NUM> to be lower than that of the elastic deformation part <NUM>.

Referring together to <FIG>, the connection part <NUM> is connected between the connection member <NUM> and the elastic deformation part <NUM>. Under the action of the same external force, the anti-bending performance of the connection part <NUM> is lower than that of the elastic deformation part <NUM> (namely, under the action of the same external force, the connection part <NUM> deforms more easily than the elastic deformation part <NUM>). In the present embodiment, the connection part <NUM> is provided with multiple cutting slot groups <NUM>. After the connection part <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 part <NUM> and parallel to one another. The 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 structure, and the extending direction AC of the multiple cutting slots and the axial line <NUM> of the connection part <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 part <NUM>, and the size of the gap <NUM> between two adjacent cutting slot groups <NUM>, the anti-bending performance of the entire connection part <NUM> can be adjusted to be lower than that of the elastic deformation part <NUM>. In other embodiments, each cutting slot group <NUM> may include <NUM> to <NUM> cutting slots, the gap <NUM> between two adjacent cutting slots in each cutting slot group <NUM> is <NUM> to <NUM>, the included angle C is <NUM> to <NUM> degrees, and the gap <NUM> between two groups is <NUM> to <NUM>. The elastic deformation part <NUM> has an outer diameter of about <NUM> to <NUM> and a wall thickness of <NUM> to <NUM>. The connection between the connection part <NUM> and the elastic deformation part <NUM> may be implemented by techniques such as covering of a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering and the like. Based on the prior art, integrated cutting is preferred, and the elastic deformation part <NUM> and the connection part <NUM> which have different textural features are cut from different areas on the same tube.

It can be understood that, in other embodiments, the cutting slots and the lumen may also not be connected as long as the elasticity of the elastic deformation part is improved. It can be further understood that, in other embodiments, the characteristic of the gradually improving anti-bending performance of the elastic deformation part from the distal end to the proximal end may also be accomplished in other ways. For example, a tube body, the wall thickness of which is gradually increased from the distal end to the proximal end, can be adopted.

Referring together to <FIG>, <FIG> and <FIG>, the connection member <NUM> is located at the proximal end of the connection part <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 part of the elastic implant <NUM> that is close to the boss <NUM> in a delivery state. In the present implementation mode, the outer diameter of the part of the elastic implant <NUM> that is close to the boss <NUM> in the delivery state is the outer diameter of the proximal end of the connection part <NUM>. An internal thread <NUM> is arranged inside the boss <NUM>. The connection section <NUM> is located between the boss <NUM> and the connection part <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 semi-circles. The outer diameter D may not exceed <NUM> and is preferably <NUM> to <NUM>. The boss <NUM> effectively enlarges a contact area of the proximal end of the elastic implant <NUM> with the bronchus to reduce the injury to the lung tissues after the elastic implant <NUM> has been 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>, so as to provide a fastening position for biopsy forceps, so that the biopsy forceps can clamp a connection apparatus more effectively to withdraw the elastic implant <NUM>.

Referring together to <FIG> and <FIG>, the elastic implant thin film <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 implant thin film <NUM> firmly covers the elastic implant <NUM> and guarantees no blockage in the lumen of the elastic implant <NUM>. The elastic implant thin film <NUM> may have a thickness of <NUM> to <NUM>. The elastic implant thin film <NUM> may be made of a macromolecular solution featured by good chemical stability, water resistance and weathering resistance, low compressibility, good biocompatibility, high mechanical strength, nontoxicity, being odorless, and the like. For example, these macromolecular solutions may be silicone rubber or polyurethane solutions. As the first flexible section <NUM> is also made of the macromolecular material, and the insert section of the first flexible section <NUM> is inserted into the lumen of the second flexible section <NUM>, when the elastic implant thin film <NUM> covers the surface of the elastic implant, the periphery of the second flexible section <NUM> is completely covered by the macromolecular material, which allows the second flexible section <NUM> and the first flexible section <NUM> to be combined more securely and allows the connection between the elastic implant thin film <NUM> and the implant to be more stable. It is easiest for the proximal end portion of the elastic implant thin film <NUM> to roll over and fall off under the action of an external force due to the combination characteristic of the elastic implant thin film <NUM> and a metal matrix, but the outer diameter of the boss <NUM> is greater than that of the part of the elastic implant <NUM> that is close to the boss <NUM> in the delivery state, so the boss <NUM> can protect the proximal end portion of the elastic implant thin film <NUM> from being in contact with a vascular wall during the delivery and withdrawal processes, and thereby protect the elastic implant thin film <NUM> from rolling over and falling off during the delivery and withdrawal processes.

Referring together to <FIG>, a lung volume reduction instrument <NUM> provided by one embodiment of the present disclosure 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. The core wire <NUM> may be made of a section of metal wire having a diameter of <NUM> to <NUM>.

Referring together to <FIG> and <FIG>, for the purpose of safe and convenient operation, a flexible core wire guide head <NUM> coaxial with the core wire <NUM> and provided with a radiopaque marker is required to be 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> fixedly arranged outside ad surrounding the guide column <NUM>. The guide column <NUM> and the core wire <NUM> can be provided 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 radiopaque marker.

The core wire guide head <NUM> is used for guiding the core wire <NUM> to successfully 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 provided 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: first, 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> to <NUM> is fixed outside the guide column <NUM>. The spring <NUM> may be fixed on the core wire <NUM> using techniques such as 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 successfully enter the lumen of the implant <NUM> 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 part <NUM>, the implant <NUM> loaded with the core wire <NUM> also has the 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, the radiopaque marker is required to be arranged on the core wire guide head <NUM>. The radiopaque marker can 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 systems. The core wire <NUM> is displayed and guided through these systems. In the present embodiment, the spring wound by a metal wire, such as a tungsten metal wire or a tantalum metal wire, having relatively high X-ray radiograph performance and a wire diameter of <NUM> to <NUM>, serves as the radiopaque marker. In the present embodiment, the radiopaque marker and the core wire guide head <NUM> are combined into one component to realize two functions. In addition to this mode, an additional radiopaque marker can 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 radiographic material such as a nickel-titanium alloy, the radiopaque marker may be omitted.

Referring again to <FIG>, the pushing mechanism <NUM> includes a delivery mechanism <NUM> and an operation handle <NUM> connected with the delivery mechanism <NUM>. The delivery mechanism <NUM> and the implant <NUM> surround the core wire <NUM>, and the distal end of the delivery mechanism <NUM> is detachably connected with the proximal end <NUM> of the implant <NUM>. In the present embodiment, the delivery mechanism <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 in threaded connection with the connection matching part <NUM> through the external thread of the pushing mechanism <NUM>, and the implant <NUM> can be reliably fixed at the distal end of the delivery mechanism <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 delivery mechanism <NUM> are unscrewed and separated by turning around the operation handle <NUM> of the pushing mechanism <NUM>. The connection member <NUM> and the connection matching part <NUM> can also be other detachable fixed connection components, such as a magnetic connection apparatus, an elastic buckle or a noose, which are respectively arranged on the implant <NUM> and the delivery mechanism <NUM> to accomplish a detachable connection.

The elastic implant <NUM>, the core wire <NUM> and the delivery mechanism <NUM> are assembled as follows: first, the elastic implant <NUM> is in threaded connection with the connection matching part <NUM> at the distal end of the delivery mechanism <NUM> to allow the delivery mechanism <NUM> to communicate 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 delivery mechanism <NUM> to restrain the curled elastic implant <NUM> in its natural state into a tube that is in an approximately linear delivery state.

Referring to <FIG>, a delivery catheter <NUM> is pushed to the distal end of a working channel <NUM> along the 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 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 delivery mechanism <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 straight bar-shaped delivery state restrained by the core wire <NUM>, and can squeeze 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 has a tubular structure and includes an elastic deformation part 51a, a flexible guide part 53a connected with the distal end of the elastic deformation part 51a, a connection part 52a connected with the proximal end of the elastic deformation part 51a, a connection member 57a connected with the proximal end of the connection part 52a, and an elastic thin film 55a. The flexible guide part 53a includes a first flexible section 531a and a second flexible section 532a connected between the first flexible section 531a and the elastic deformation part 51a. The distal end of the first flexible section 531a serves as the distal end of the elastic implant 500a. A radiograph component 56a is arranged in the first flexible section 531a.

The structures of the first flexible section 531a and the first flexible section <NUM> are substantially the same, and the structures of the radiograph component 56a and the radiograph component <NUM> are approximately the same, so no more details will be described here.

Referring together to <FIG> and <FIG>, the elastic deformation part 51a includes multiple cutting slot clusters <NUM> arrayed in a spaced-apart manner along an axial direction of the elastic deformation part 51a. Each cutting slot cluster <NUM> is composed of five side-by-side elliptical cutting slot groups <NUM> arrayed in a step-like manner. In the present embodiment, each cutting slot group <NUM> is composed of two paratactic 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 part 51a. An extending 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 part 51a form a certain included angle E which may be <NUM> to <NUM> degrees. A distance 508a of about <NUM> to <NUM> is provided between two adjacent cutting slot groups <NUM> in each cutting slot cluster <NUM>. The step-like arrayed cutting slot groups <NUM> are favorable for bending the elastic deformation part 51a into a specific shape. A part, having a length of about <NUM> to <NUM>, of the proximal end 511a of the elastic deformation part 51a is cut into a threaded trench serving 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 part 51a of the elastic implant 500a.

Under the action of the same external force, the anti-bending performance of the connection part 52a is lower than that of the elastic deformation part 51a so as to better reduce the injury of the connection part 52a to the wall of the bronchus. Referring to <FIG>, in the present embodiment, the connection part 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> to <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 part 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 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 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 part 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 part 52a of this structure has extremely high flexibility and extremely high connection strength, and can transmit a torsion to the elastic deformation part 51a in a ratio of <NUM>:<NUM> during twisting of the connection member 57a. Based on the prior art, the sub components <NUM> can also be made by other techniques such as machining, casting and powder metallurgy. It can be understood that the connection part 52a is extremely high in flexibility and extremely low in anti-bending performance, so it is very easy to make the anti-bending performance of the connection part 52a lower than that of the elastic deformation part 51a by adjusting the anti-bending performance of the elastic deformation part 51a. It can be understood that the multiple proximal end protrusions <NUM> can also be distributed at the proximal end of the sub component <NUM> in a non-equal spaced-apart manner as long as the multiple sub components <NUM> can be spliced.

Under the action of the same external force, the anti-bending performance of the flexible guide part 53a is lower than that of the elastic deformation part 51a so as to better guide the elastic deformation part 51a to move in the bronchus and reduce the injury to the wall of the bronchus. Under the action of the same external force, the anti-bending performance of the second flexible section 532a from the distal end to the proximal end is gradually improved.

Referring together to <FIG>, in the present embodiment, the second flexible section 532a is a tubular body laser cut from a nickel-titanium tube and has cutting slots, and under the action of the same external force, the anti-bending performance of the second flexible section 532a from the distal end to the proximal end is gradually improved (that is, under the action of the same external force, the deformation performance of the second flexible section 532a from the distal end to the proximal end is gradually lowered; namely, the second flexible section 532a becomes gradually 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 second flexible section 532a is the tubular body having the multiple cutting slots, the anti-bending performance of the second flexible section 532a 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 an actual clinical requirement to allow the anti-bending performance of the second flexible section 532a to be lower than that of the elastic deformation part 51a.

The second flexible section 532a 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 extending direction of these cutting slot groups <NUM>-<NUM> and the axial line 513a of the flexible guide part 53a form a certain angle F. A gap <NUM> is provided between two adjacent cutting slot groups. By adjusting the number and the widths <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 second flexible section 532a can be adjusted. Preferably, there may be <NUM> to <NUM> parallel cutting slots (1601a, 1601b), the width <NUM> may be <NUM> to <NUM>, the angle F is preferably <NUM> to <NUM> degrees, and the gap <NUM> is preferably <NUM> to <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 second flexible section 532a from the distal end to the proximal end under the action of the same external force. The flexible guide section 53a having the gradually changing anti-bending performance can better guide the elastic implant 500a.

The connection between the second flexible section 532a and the elastic deformation part 51a may be implemented through techniques such as covering of a macromolecular thermal shrinkage tube or thin film, gluing, laser welding, soldering and the like. Based on the prior art, integrated cutting is preferred, and the second flexible section 532a and the elastic deformation part 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 section 53a, one feasible mode is to keep the angle F in two adjacent cutting slot groups unchanged and gradually decrease the width <NUM> of each cutting slot from the distal end to the proximal end, and another feasible mode is to keep the width <NUM> of each cutting slot in two adjacent cutting slot groups unchanged and 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 can also achieve the effect of gradually improving the anti-bending performance of the flexible guide section 53a from the distal end to the proximal end.

Claim 1:
A lung volume reduction elastic implant, comprising an elastic deformation part (<NUM>) and a flexible guide part (<NUM>) connected with a distal end of the elastic deformation part (<NUM>), wherein the flexible guide part (<NUM>) is provided with a first flexible section (<NUM>); the first flexible section (<NUM>) comprises an insert section (<NUM>) and a distal section (<NUM>); the insert section (<NUM>) is connected with the distal end of the elastic deformation part (<NUM>); a distal end of the distal section (<NUM>) of the first flexible section (<NUM>) is a distal end of the lung volume reduction elastic implant; and a radiograph component (<NUM>) is arranged in the first flexible section (<NUM>),
characterized in that
the flexible guide part (<NUM>) further comprises a hollow second flexible section (<NUM>) connected between the elastic deformation part (<NUM>) and the first flexible section (<NUM>); and the insert section (<NUM>) of the first flexible section (<NUM>) is inserted into the second flexible section (<NUM>), and a proximal end of the radiograph component (<NUM>) is inserted into the second flexible section (<NUM>) along with the insert section (<NUM>) of the first flexible section (<NUM>).