WO2018121346A1 - 肺减容弹性植入体及肺减容器械 - Google Patents

肺减容弹性植入体及肺减容器械 Download PDF

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Publication number
WO2018121346A1
WO2018121346A1 PCT/CN2017/117181 CN2017117181W WO2018121346A1 WO 2018121346 A1 WO2018121346 A1 WO 2018121346A1 CN 2017117181 W CN2017117181 W CN 2017117181W WO 2018121346 A1 WO2018121346 A1 WO 2018121346A1
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Prior art keywords
flexible
lung volume
distal end
implant
elastic
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PCT/CN2017/117181
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English (en)
French (fr)
Inventor
李安宁
李思漪
Original Assignee
先健科技(深圳)有限公司
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Priority to US16/474,728 priority Critical patent/US11266415B2/en
Priority to EP17887300.6A priority patent/EP3563801A4/en
Publication of WO2018121346A1 publication Critical patent/WO2018121346A1/zh

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Definitions

  • the invention belongs to the technical field of interventional therapy, and relates to an implant and an instrument for interventional treatment, in particular to a lung volume reduction elastic implant and a lung volume reduction device.
  • Emphysema is a common lung disease.
  • Traditional emphysema treatment includes oxygen inhalation, prevention of pulmonary infection, bronchial spasm, etc., but the curative effect is extremely limited.
  • the surgical treatment of emphysema is mostly with lung volume reduction.
  • Surgery-based there are many limitations, such as: strict surgical indications, there are more complications, anesthesia and anesthesia-related complications, preoperative efficacy is difficult to predict, postoperative can not make up for excessive resection or Too few results in unsatisfactory results, high surgical costs and greater mental and physical pain, and because some patients have poor lung function and often cannot tolerate surgery, so postoperative mortality is higher, which limits The application of surgery.
  • FIG. 1 is a schematic view of a prior art lung volume reduction elastic coil which is designed from a nickel-titanium memory alloy wire and which is elastically deformed by an external force.
  • the product Under the constraint of the loading system, the product can be implanted into the lungs through the bronchoscope working channel in a straight strip.
  • the coil When the coil is delivered into the bronchi of the emphysema area, the coil loses the constraint of the loading system and restores the deformation to the figure.
  • the peripherally relatively healthy lung tissue can better exert physiological functions.
  • the above implant has the following defects: in order to pursue a better extrusion and volume reduction effect, the implant usually adopts a metal elastic coil with better elasticity, which has higher hardness and poor flexibility, and is implanted in the bronchus. It is easy to cause damage to the bronchus.
  • the technical problem to be solved by the present invention is to provide an implant capable of having a good softness in view of the above-mentioned drawbacks in the prior art.
  • the technical problem to be further solved by the present invention is to provide a method for implanting an implant into a lung bypass or some small-diameter tracheal end according to actual requirements, so as to make the operation safer and better. Therapeutic effect of lung volume reduction devices.
  • a lung volume reduction elastic implant includes an elastic deformation portion and a flexible guide portion coupled to a distal end of the elastic deformation portion, the flexible guide portion being provided with a first flexible segment, the first flexible segment including an insertion segment And a distal segment, the insertion segment is connected to a distal end of the elastic deformation portion, and a distal end of the distal segment of the first flexible segment is a distal end of the lung volume reduction elastic implant, the first A developing member is disposed in the flexible section.
  • the flexible guiding portion further includes a hollow second flexible segment connected between the elastic deformation portion and the first flexible segment, and the insertion section of the first flexible segment is inserted To the second flexible section, the proximal end of the developing member is inserted into the second flexible section with the insertion section of the first flexible section.
  • the insertion section of the first flexible segment has a radial length smaller than a radial length of the distal segment, and the connection between the insertion segment and the distal segment is stepped.
  • the proximal end of the developing member is closer to the distal end of the distal end segment than the proximal end of the insertion portion, and the proximal end of the developing member and the proximal end of the first flexible segment are The vertical distance between the two is 0.5 mm to 20 mm.
  • the developing member includes a developing wire disposed in the first flexible section.
  • the developing member further includes a developing ring, and the developing ring is coupled to a distal end of the developing wire.
  • the second flexible segment is more and more deformable from the proximal end to the distal end under the same external force.
  • the second flexible segment comprises a tubular body having a continuous spiral slit cut by a nickel-titanium tube.
  • the spacing between two adjacent slots of the second flexible segment gradually increases along the axial direction of the second flexible segment.
  • the lung volume reduction elastic implant is at least proximally open and further includes a boss connected to a proximal end of the elastic deformation portion, the elastic deformation portion having superelasticity, the elasticity
  • the deformation portion is spaced apart along the longitudinal direction thereof, and a plurality of slots are formed. Each of the slots is in communication with the lumen of the elastic deformation portion, and the flexible guiding portion is more easily deformed than the elastic deformation portion by the same external force.
  • the outer diameter of the boss is larger than the outer diameter of the elastic implant near the boss in the transport state.
  • the elastic implant further includes a connecting portion between the elastic deformation portion and the boss, and the connecting portion is more elastic than the elastic portion under the same external force More easily deformed.
  • the connecting portion is provided with a plurality of slots along the length direction thereof.
  • the connecting portion includes a plurality of hollow sub-members that are spliced end to end, and each of the proximal ends of the hollow sub-members includes a plurality of near-longitudinal distributions along a circumferential direction of the hollow sub-members.
  • each proximal projection gradually decreases from the proximal end to the distal end, and a proximal end groove is formed between the adjacent two proximal projections;
  • the distal end of each of the hollow sub-members Each includes a plurality of distal projections distributed along the circumferential direction of the hollow sub-member, each circumferential projection gradually increasing in length from the proximal end to the distal end, between adjacent distal projections A distal groove is formed.
  • the distal end of the boss portion is recessed toward the proximal end of the boss to form a longitudinal center line surrounding the boss The annular groove.
  • a portion of the side surface of the boss is recessed toward the interior of the boss to form an annular groove surrounding a longitudinal centerline of the boss.
  • the boss includes a plurality of small protrusions distributed along the circumferential direction of the boss.
  • the present invention also provides a lung volume reduction device comprising any of the implants described above and a delivery device associated with the implant, the delivery device comprising a core wire and a conveyor, the plant body being near The end is detachably coupled to the distal end of the conveyor, the core wire being movably threaded into the lumen of the implant and the lumen of the conveyor.
  • the distal end of the core wire is provided with a core wire guiding head coaxial with the core wire, and the outer diameter of the core wire guiding head is consistent with the outer diameter of the core wire.
  • the core guide head includes a guide post and a spring sleeved on the guide post, and the guide post and the core wire integral structure or the guide post are fixed to the distal end of the core wire.
  • the spring has a development mark.
  • the proximal end of the implant is detachably connected to the distal end of the conveyor.
  • the implant of the present invention comprises an elastic deformation portion and a flexible guiding portion connected to the distal end of the elastic deformation portion, the flexible guiding portion is provided with a first flexible segment, and the first flexible segment has better softness when the implant is implanted
  • the present invention compares the distal end of the distal segment of the first flexible segment as a lung volume reduction elastic implant compared to the prior art.
  • the distal end of the body, when the first flexible segment is stressed, because it has better softness, is easy to bend and the surface is relatively soft, thereby greatly reducing the damage of the lung volume-reducing elastic implant to the lung tissue. .
  • FIG. 1 is a schematic structural view of a prior art elastic coil
  • FIG. 2 is a schematic view of an implant of a torn partial film according to an embodiment of the present invention
  • Figure 3 is a schematic view showing the structure of the first flexible section of the implant shown in Figure 2;
  • Figure 4 is a partial cross-sectional view of the flexible guide of the implant of Figure 2;
  • Figure 5 is a schematic view showing the structure of the second flexible section of the implant of Figure 2;
  • Figure 6 is a schematic view of the second flexible section of Figure 5 taken along its length and expanded;
  • Figure 7 is a partial cross-sectional view of the implant of Figure 2;
  • Figure 8 is a cross-sectional view of the elastic deformation portion of the implant shown in Figure 2;
  • Figure 9 is a schematic view showing the slit of the elastic deformation portion of the implant of Figure 2 taken along its length and expanded;
  • Figure 10 is a schematic view of the connecting portion of the implant of Figure 2;
  • Figure 11 is a schematic view of the connecting portion of Figure 10 taken along its length and expanded;
  • Figure 12 is a schematic illustration of the connector of the implant of Figure 2;
  • Figure 13 is a cross-sectional view of the connector of Figure 12;
  • Figure 14 is a schematic view showing the deformation of the connector of Figure 12;
  • Figure 15 is a cross-sectional view of the connector of Figure 14;
  • FIG. 16 is a schematic view of a lung volume reduction device according to an embodiment of the present invention.
  • Figure 17 is an exploded perspective view of the lung volume reduction device of Figure 16;
  • Figure 18 is a schematic illustration of the core wire of the lung volume reduction device of Figure 16.
  • Figure 19 is an enlarged view of M at Figure 18;
  • FIG. 20 is a schematic diagram of a working channel for establishing a lung volume reduction device according to an embodiment of the present invention.
  • Figure 21 is an enlarged view of A of Figure 20;
  • Figure 22 is a schematic view of the implant after release
  • Figure 23 is an enlarged view of B of Figure 22;
  • FIG. 24 is a schematic view of an implant according to another embodiment of the present invention.
  • Figure 25 is a schematic illustration of the elastic deformation portion of the implant of Figure 24;
  • Figure 26 is a schematic view of the elastic deformation portion of Figure 24 taken along its length and expanded;
  • Figure 27 is a schematic view of the connecting portion of the implant of Figure 24;
  • Figure 28 is a schematic view of the connecting portion of Figure 27 taken along its length and expanded;
  • Figure 29 is a schematic illustration of the connecting sub-assembly of the connecting portion of Figure 27;
  • Figure 30 is a schematic illustration of the flexible guide of the implant of Figure 24;
  • Figure 31 is a partial plan view showing the flexible guide portion of Figure 30 taken along its length and expanded;
  • Figure 32 is a schematic illustration of the connector of the implant of Figure 24;
  • Figure 33 is a cross-sectional view of the connector of Figure 32;
  • Figure 34 is a plan view of the proximal side of the connector of Figure 32;
  • elastic deformation portion 51 flexible guiding portion 53, connecting portion 52, connecting member 57, elastic film 55, first flexible segment 531, second flexible segment 532, elastic implant 500, developing member 56, elastic The deformed portion proximal end 511, the elastic deformation portion distal end 513, the developing member 56, the developing wire 561, and the developing ring 562.
  • the end near the operator is usually referred to as the proximal end, and the end far from the operator is referred to as the distal end.
  • an elastic implant 500 is a tubular structure including a hollow tubular elastic deformation portion 51, a flexible guiding portion 53 connected to the distal end of the elastic deformation portion 51, and an elastic deformation portion.
  • the flexible guiding portion 53 includes a first flexible segment 531 and a second flexible segment 532 connected between the first flexible segment 531 and the elastic deformation portion 51.
  • the distal end of the first flexible section 531 serves as the distal end of the elastic implant 500.
  • a developing member 56 is disposed in the first flexible section 531.
  • the first flexible section 531 includes an insertion section 5312 and a distal section 5311.
  • the portion of the first flexible segment 531 near the proximal end of the implant 500 is the insertion segment 5312, and the portion of the first flexible segment 531 near the distal end of the implant 500 is the distal segment 5311.
  • the insertion section 5312 of the first flexible section 531 is inserted into the second flexible section 532.
  • the proximal end of the developing member 56 projects into the second flexible section 532.
  • the material of the first flexible segment 531 herein is a polymer elastic material, for example, a polymer elastic material such as silica gel, polytetrafluoroethylene or PEBAX material. Since the polymer elastic material has a softer property than the metal material, and the bending resistance of the polymer elastic material (the minimum force required to bend it) is lower, the implant is implanted as an implant.
  • the distal end of the first flexible segment 531 of the distal end of the 500 is the end that is in direct contact with the tissue in the human body to prevent it from damaging the tissue in the human body.
  • the distal end surface of the first flexible segment 531 is designed as a partial spherical surface.
  • the first flexible segment 531 has a softer and less bending resistance, and is more easily bent, so that Contusion to the organization of the human body.
  • the insertion section 5312 and the distal section 5311 can be integrally formed, for example, directly by a mold or by cutting, or the insertion section and the distal section can be separately formed, and then glued or otherwise adhered thereto. Solid connection, here is not specifically limited.
  • the insertion section 5312 of the first flexible section 531 has a radial length that is smaller than the radial length of the distal section 5311, such that the junction of the insertion section 5312 and the distal section 5311 is stepped.
  • the insertion portion 5312 of the first flexible segment 531 and the body portion of the distal segment 5311 are each preferably cylindrical, and the insertion segment 5312 is on the same horizontal line as the axis of the distal segment 5311.
  • the insertion section 5312 has a radial length that matches the lumen diameter of the second flexible section 532, and when the first flexible section 531 is coupled to the second flexible section 532, the insertion section 5312 can be inserted into the lumen of the second flexible section 532. Since the polymer material has a certain elasticity, when the insertion portion 5312 is inserted into the lumen of the second flexible segment 532, the insertion portion 5312 can be appropriately compressed, and the elasticity of the material can ensure that it is surrounded by the lumen of the second flexible segment 532. The fastening is fastened, thereby effectively avoiding the problem of poor connection reliability caused by other connection methods.
  • the radial length of the insertion section 5312 matches the lumen diameter of the second flexible section 532, meaning that the radial length of the insertion section 5312 may be slightly larger, equal to, or smaller than the lumen inner diameter of the second flexible section 532; slightly larger than when inserted
  • the segment 5312 can be squeezed into the lumen of the second flexible segment 532 by compression deformation, and can still be integrated with the second flexible segment 532 without the aid of foreign objects; when inserted or equal to, the insertion segment 5312 can be easily Inserted into the lumen of the second flexible section 532, at this time, the insertion section 5312 and the second flexible section 532 need to be integrally joined by a polymeric elastic material wrapped around the periphery of the second flexible section 532.
  • the distal length of the distal section 5311 of the first flexible section 531 is the same as the outer diameter of the second flexible section 532.
  • the step width at the junction of the insertion section 5312 and the distal section 5311 can be the same as the thickness of the tube wall of the second flexible section 532, thereby It can be ensured that after the first flexible segment 531 is connected with the second flexible segment 532, the outer surface of the joint is a smooth surface, thereby ensuring smoothness of the external surface of the implant, and avoiding damage to tissues and organs in the human body due to the convex surface. It can also reduce the difficulty of subsequent processing.
  • the second flexible section 532 is a slitted tubular body formed by laser cutting of a nickel-titanium tube, and its bending resistance from the distal end to the proximal end is gradually enhanced under the same external force (that is, under the same external force) Its deformability from the distal end to the proximal end is gradually weakened, that is, it is hardened from the distal end to the proximal end, so as to be able to better guide the elastic implant 500.
  • the bending resistance of the second flexible segment 532 is less than the bending resistance of the elastic deformation portion 51, and is greater than the bending resistance of the first flexible segment 531 to facilitate the flexible guiding portion 53 to better move within the bronchus without damaging the surrounding organization.
  • the second flexible segment 532 is a tubular body having a plurality of slots
  • the bending resistance of the second flexible segment 532 can be changed as the spacing of adjacent slots changes, and those skilled in the art can It is necessary to set the adjacent grooving pitch to achieve the purpose that the bending resistance of the second flexible section 532 is smaller than the bending resistance of the elastic deformation portion 51.
  • the second flexible section 532 includes a continuous helically shaped slot 2502. In the unfolding plane of the second flexible section 532 along its axial direction, the distance between the adjacent two slots 2502 is gradually increased from the distal end to the proximal end of the second flexible section 532 to achieve the second flexibility. The resistance of the segment 532 from the distal end to the proximal end is gradually enhanced.
  • the second flexible section 532 extends along the axially-expanded plane thereof, from the distal end to the proximal end of the second flexible section 532, when the slit 2502 of the second flexible section 532 extends
  • the angle G between the direction 2505 and the axial direction 2504 of the second flexible section 532 is constant, and the slit of the second flexible section 532 is gradually smaller along the width of the axial direction 2504 of the second flexible section 532.
  • the spacing between the adjacent two slits 2502 is also gradually increased, and the bending resistance of the second flexible section 532 from the distal end to the proximal end can be gradually enhanced.
  • the second flexible segment 532 is along its axially-expanded plane, from the distal end to the proximal end of the second flexible segment 532, and the slot of the second flexible segment 532 is along the axis of the second flexible segment 532.
  • the width of the 2504 is constant, the acute angle between the extending direction 2505 of the slit of the second flexible section 532 and the axial direction 2504 of the second flexible section 532 is gradually increased, the spacing between the adjacent two slits 2502 It also gradually becomes larger, and the purpose of gradually increasing the bending resistance of the second flexible segment 532 from the distal end to the proximal end can also be achieved.
  • the second flexible segment 532 is also omitted.
  • the insertion segment of the first flexible segment 531 can be inserted into the elastic deformation portion 51 as long as the first flexible segment of the obtained implant is obtained.
  • the distal segment of 531 is soft and does not easily damage the tissue.
  • the developing member 56 is disposed in the first flexible section 531 and has elasticity.
  • the first flexible segment 531 is made of a polymer material, and the developing member 56 can be embedded in the first flexible segment 531.
  • the developing member 56 can be disposed in the first flexible segment 531 by other methods, which is not specifically limited herein.
  • the implant 500 When the implant 500 is implanted, it can be developed by the developing member 56 in the first flexible section 531. In addition, since the proximal end of the developing member 56 projects into the lumen of the second flexible segment 532, the developing member 56 can not only exhibit the bending variation of the first flexible segment 531 during the implantation process, but also The bending change of the second flexible segment 532 is developed to ensure the accuracy and safety of the operation.
  • the bending resistance of the first flexible segment 531 is less than the bending resistance of the second flexible segment 532, and when the implant twists the organ or tissue, the first A sharp deformation difference between the flexible segment 531 and the second flexible segment 532 is highly prone to occur, resulting in a large stress concentration in a region where the deformation difference is large, thereby causing a break between the first flexible segment 531 and the second flexible segment 532.
  • the developing member 56 in the embodiment has a certain elasticity, and can provide a certain stress support to the first flexible segment 531 and the second flexible segment 532, which is equivalent to reducing the first flexible segment 531 and the second flexible segment 532.
  • the gap between the bending resistance forces so that the flexible guiding section has a gradual bending resistance from the distal end to the proximal end, that is, the bending resistance gradually decreases from the distal end to the proximal end, so that the first flexible segment 531 can be avoided.
  • a sharp deformation difference occurs between the second flexible segments 532, thereby preventing breakage between the first flexible segment 531 and the second flexible segment 532.
  • the proximal end of the developing member 56 is closer to the distal end of the implant 500 than the proximal end of the first flexible segment 531, and its vertical distance A from the proximal end of the first flexible segment 531 ranges from 0.5 mm to 20 mm. .
  • the core wire needs to be inserted into the lumen of the implant to restrict the elastic implant to an approximately linear conveying state, and the distal end of the core wire is in contact with the first flexible segment.
  • the distance between the proximal end of the developing member 56 and the proximal end of the first flexible segment 531 is 0.5 mm to 20 mm to ensure that the core wire does not touch the developing member 56, and further, the developing member 56 is ensured
  • the position of the first flexible segment 531 is fixed such that it does not separate from the first flexible segment 531 due to the push-in of the core wire.
  • the vertical between the proximal end of the developing member 56 and the proximal end of the first flexible segment 531 The distance is set in the range of 0.5 mm to 20 mm, so that the skilled person can adjust the depth of the developing member 56 into the second flexible section 532 according to the actual situation, so that the flexible guiding section has a gradual bending resistance from the distal end to the proximal end. Breaking between the first flexible section 531 and the second flexible section 532 is avoided. If the vertical distance between the proximal end of the developing member 56 and the proximal end of the first flexible segment 531 is less than 0.5 mm, the core wire is more likely to touch the developing member 56 during the implantation process, changing the shape of the developing member 56, thereby affecting Development effect.
  • the developing member 56 includes a developing wire 561 disposed in the longitudinal central axis direction of the first flexible segment 531 and a developing ring 562 disposed on the distal end of the developing wire 561.
  • the developing wire 561 has a certain length and can be made of a heavy metal such as gold, platinum or tungsten which has a better developing effect under X-ray. At the same time, the developing wire 561 has a better developing effect when the first flexible segment 531 and the second flexible segment 532 are bent, and the bending change of the developing wire 561 itself can display the first flexible segment 531 and the second flexible segment 532 outside thereof.
  • the developing wire 561 is disposed in the longitudinal central axis direction of the first flexible segment 531 to maximize the length of the developing wire 561 to ensure that it remains in the first flexible segment, thereby enabling A better development effect can provide better elasticity while providing greater stress support, preventing breakage between the first flexible section 531 and the second flexible section 532.
  • the developing wire 561 is disposed in the first flexible segment 531, and the proximal end extends into the second flexible segment 532, which ensures that during implantation of the implant, Developing the degree of bending of the first flexible segment 531 and the second flexible segment 532, when the first flexible segment 531 is displayed to be bent to a certain extent, the operator can determine whether the end of the implant has reached the predetermined position according to the development result, thereby being able to Improve the safety of lung volume reduction surgery.
  • the developing ring 562 is adjacent to the distal end of the first flexible segment 531, preferably disposed at the distal end of the first flexible segment 531. Since the developing wire 561 is thin, the developing ring 562 is disposed at the end of the first flexible segment 531.
  • the position information of the distal end of the implant can be better developed, which is more convenient for the operator to judge the position of the distal end of the implant, thereby improving the safety and accuracy of the operation.
  • the developing wire of the developing member 56 may include a mandrel and a developing material disposed on the mandrel, and the developing material is preferably a heavy metal material such as gold, platinum, or tungsten which has a better developing effect under X-rays.
  • the mandrel may preferably be a nickel-titanium alloy or a cobalt-chromium alloy having a good elasticity. This design also ensures that the developing member 56 has good elasticity. It can also be understood that in other embodiments, the developing ring 562 in the developing member 56 can be omitted according to actual needs.
  • the elastic deformation portion 51 has superelasticity including an opposite proximal end 511 and a distal end 513.
  • the distal end 513 is coupled to the flexible guide portion 53.
  • the elastic deformation portion 51 further includes a plurality of slits 514 spaced apart from each other and communicating with the lumen of the elastic deformation portion 51.
  • the plurality of slits 514 facilitate the elastic deformation portion 51 of the elastic implant 500 to be bent into a predetermined shape in a natural state, such as the shape of FIG.
  • the elastic deformation portion 51 is in a predetermined shape which is curled in a natural state (that is, when it is not subjected to any external force), can be restrained into a straight strip shape or any other shape under the action of an external force, and is restored to a predetermined state by bending and twisting after the external force is removed. shape.
  • the elastic deformation portion 51 can be made of a material having superelasticity which is commonly used in the industry, and the specific material is not limited in the present invention as long as it is suitable for the human body and has a superelastic material. In the present embodiment, the elastic deformation portion 51 is made of a nickel titanium alloy.
  • the processing method of the elastic deformation portion 51 includes: first, cutting a hollow nickel-titanium tube having a diameter of about 0.5 to 2.0 mm and a wall thickness of 0.01 to 0.4 mm by laser; then, bending the cut nickel-titanium tube with a mold The shape shown in the elastic deformation portion 51 in Fig. 2 is formed; finally, the heat treatment is fixed into the elastic deformation portion 51.
  • the pressing effect on the corresponding tissue is better.
  • the inner diameter is uniform and the wall thickness is gradually increased.
  • a tapered conical nickel-titanium tube is fabricated, for example, a tapered nickel-titanium tube having an inner diameter of 0.8 to 1.0 mm, a wall thickness varying from 0.01 mm at the distal end to a proximal end of 0.4 mm; and a plurality of dumbbells formed on the nickel-titanium tube
  • the slits 514, the extending direction of the slits 514 (i.e., the slit direction) 518 form an angle A with the axis 501 of the elastic deformation portion 51, and preferably the angle A may be 10 to 90 degrees.
  • the elastic deformation portion 51 has a plurality of slits 514, the bending resistance of the elastic deformation portion 51 can be changed as the length 510 of the slit 514 in the extending direction 518 is changed, and those skilled in the art can It is actually necessary to set the length 510 of the slit 514 of the elastic deformation portion 51 in the extending direction 518 to achieve the purpose that the bending resistance of the flexible guiding portion 53 is smaller than the bending resistance of the elastic deformation portion 51.
  • the connecting portion 52 is connected between the connecting member 57 and the elastic deformation portion 51, and under the same external force, the bending resistance of the connecting portion 52 is smaller than the bending resistance of the elastic deformation portion 51 (ie, The connecting portion 52 is more deformable than the elastic deformation portion 51 by the same external force.
  • the connecting portion 52 is provided with a plurality of slot sets 1702.
  • the connecting portion 52 is axially cut and flattened, and each of the grooving groups 1702 includes three slits 1702a, a slit 1702b, and a slit 1702c which are circumferentially arranged along the connecting portion 52 and are parallel to each other.
  • Both ends of the slots are aligned with each other in the circumferential direction. There is a certain interval 1703 between adjacent two slots in each slot group 1702, and a gap 1704 is left between two adjacent slot groups 1702.
  • Each of the slots is an elongated structure, and the extending direction AC of the plurality of slots forms a certain angle C with the axis 513 of the connecting portion 52.
  • the size of the interval 1704 between 1702 can adjust the bending resistance of the entire connecting portion 52, so that the bending resistance of the connecting portion 52 is smaller than the bending resistance of the elastic deformation portion 51.
  • the number of slots in each slot group 1702 may be 2-6, and the spacing 1703 between adjacent slots in each slot group 1702 may be 0.05-1 mm.
  • the angle C can be 10-85° and the spacing 208 between each group is 0.1-1.0 mm.
  • the elastic deformation portion 51 has an outer diameter of about 1.0 to 2.0 mm and a wall thickness of 0.05 to 0.3 mm.
  • the connecting portion 52 and the elastic deformation portion 51 may be connected by a polymer heat shrinkable tube or a film coating, a glue bonding, a laser welding, a soldering or the like. According to the prior art, a preferred method is to adopt an integrated cutting method. Different regions on the same tube cut the elastic deformation portion 51 and the connecting portion 52 having different texture features.
  • the slot and the lumen may not be connected as long as the elasticity of the elastic deformation portion can be enhanced. It can also be understood that, in other embodiments, the elastic deformation portion can be more resistant to bending from the distal end to the proximal end by other means, for example, from the distal end to the proximal end wall thickness. The thicker the tube.
  • the connecting member 57 is located at the proximal end of the connecting portion 52, and includes a boss 571 and a connecting portion 573.
  • the outer diameter D of the boss 571 is larger than the outer diameter of the elastic implant 500 near the boss 571 in the transport state.
  • the outer diameter of the elastic implant 500 in the transport state near the boss 571 is the outer diameter of the proximal end of the connecting portion 52.
  • An internal thread 574 is provided in the boss 571.
  • the connecting portion 573 is located between the boss 571 and the connecting portion 52, and is provided with a cavity 575 extending through the proximal end surface and the distal end surface of the connecting portion 573.
  • the cross section of the boss 571 parallel to the longitudinal central axis thereof includes two opposite semicircles, the outer diameter D cannot exceed 2.8 mm, and the preferred D may be 2.0 mm to 2.3 mm.
  • the boss 571 effectively increases the contact area between the proximal end of the elastic implant 500 and the bronchus, and reduces lung injury to the lung tissue after the elastic implant 500 is implanted.
  • a portion of the distal end surface of the boss 571 can also be recessed toward the proximal end of the boss 571 to form an annular groove 576 (see FIGS. 14 and 15) surrounding the longitudinal centerline of the boss 571 to provide the biopsy forceps.
  • the snap position allows the biopsy forceps to more effectively clamp the attachment and thereby recover the elastic implant 50.
  • the elastic implant film 55 completely encloses the outer surface of the elastic implant 500 except for the boss 571, and is filled in each of the slots 514, but does not block the elastic implant 500.
  • the lumen ensures that the elastic implant film 55 securely covers the elastic implant 500 while ensuring smooth flow in the lumen of the elastic implant 500.
  • the elastic implant film 55 may have a thickness of 0.01 to 0.8 mm.
  • the elastic implant film 55 can be made of a polymer solution having excellent chemical stability, water resistance, weather resistance, good low compressibility, good biocompatibility, high mechanical strength, non-toxicity, and odorless properties. to make.
  • these polymer solutions may be silicone rubber or polyurethane solutions.
  • the first flexible section 531 is also made of a polymer material, and the insertion section of the first flexible section 531 is inserted into the lumen of the second flexible section 532, when the elastic implant film 55 wraps the surface of the elastic implant, The circumference of the second flexible segment 532 is completely covered by the polymer material, so that the second flexible segment 532 is more firmly bonded to the first flexible segment 531, and the connection between the elastic implant film 55 and the implant is further stabilized. . Due to the bonding characteristics of the elastic implant film 55 and the metal substrate, the proximal end of the elastic implant film 55 is most likely to be cuffed and detached under the action of an external force, and the outer diameter of the boss 571 is greater than the elasticity under the conveying state.
  • the implant body 500 is close to the outer diameter of the boss 571. Therefore, the boss 571 can protect the proximal end of the elastic implant film 55 from contacting the pipe wall during transportation and retraction, thereby protecting the elastic implant.
  • the body membrane layer 55 does not tumbling or falling off during transport and withdrawal.
  • a lung volume reduction device 600 includes an elastic implant 500 and a delivery device 700.
  • the delivery device 700 includes a core wire 71 and a conveyor 73.
  • the core wire 71 is received in the lumen of the elastic implant 500 for restricting the elastic implant 500 to an approximately linear conveying state, and is convenient for transporting the implant 500 to the lesion.
  • the core wire 71 can be used with a diameter of 0.1- Made of 1.1mm wire.
  • the core wire guiding head 75 includes a guiding post 751 and a spring 753 fixedly fixed to the guiding post 751.
  • the guiding post 751 is integral with the core wire 71 or the guiding post 751 is fixed to the distal end of the core wire 71; the spring 753 is provided with a developing mark.
  • the core wire guiding head 75 is used to guide the guiding core wire 71 into the lumen of the elastic implant 500 smoothly.
  • the flexible core guide 75 can be realized by a soft spring, i.e., a spring 753 is fitted over a guide post 751 that is integral with the core wire 71 or that is attached to the distal end of the core wire 71.
  • the manufacturing method may be as follows: firstly, the tip end of the core wire 71 is refined to form a guiding post 751; then a spring 753 having a length of 5-150 mm is fixed outside the guiding post 751.
  • the fixing manner of the spring 753 and the core wire 71 may be a polymer heat shrinkable tube or a film coating, a glue bonding, a laser welding, a soldering or the like.
  • the core wire 71 Under the guidance of the flexible core guide 75, the core wire 71 can smoothly enter the lumen of the implant 500 from the proximal end of the implant 500, and the implant 500 can be bound from the shape shown in Fig. 2 to approximate Straight (as shown in Figure 16).
  • the implant 500 loaded with the core wire 71 also has a function of exploring a path in the bronchus to reach the lesion area. Since it is necessary to guide and monitor the operating condition of the core wire 71 into the lungs, it is necessary to provide a development mark on the core wire guiding head 75.
  • the development mark is an identifier that can be displayed on the implant by a fluoroscopy system, an ultrasound imaging system, an MRI system, a computed tomography (CT) system, or other remote imaging, and the specific structure is not limited.
  • CT computed tomography
  • a spring wound with a wire having a diameter of 0.01 to 0.3 mm and having a strong X-ray developability such as tungsten or tantalum is used as a development mark.
  • This embodiment combines the development mark with the core wire guiding head 75 into one component to realize two functions.
  • a development mark can be additionally provided on the core guide head 75.
  • the surface of the implant of the present invention is not coated with an elastic film and is made of a material that can be developed by itself, such as a nickel titanium alloy, the development mark may not be included.
  • the push mechanism 73 includes a conveyor 731 and an operating handle 733 coupled to the conveyor 731.
  • the conveyor 731 and the implant 500 are fitted over the core wire 71, and the distal end of the conveyor 731 is detachably coupled to the proximal end 511 of the implant 500.
  • the conveyor 731 is a push cable, and the distal end thereof is provided with a coupling fitting 735 having an external thread for use with the internal thread of the connecting member 57.
  • the internal thread of the connecting member 57 can be screwed with the external threaded connecting fitting 735 of the pushing mechanism 73, and the implant 500 is securely fixed at the distal end of the conveyor 73; the implant 500 is pushed and reached.
  • the connecting member 57 and the connecting fitting 735 may also be other detachable fixed connecting members, such as magnetic connecting devices, elastic snaps, lassos, etc., respectively disposed on the implant 500 and the conveyor 103 for detachable connection. .
  • the assembly of the elastic implant 500 with the core wire 71 and the conveyor 731 is as follows: First, the elastic implant 500 and the distal end connection fitting 735 of the conveyor 731 are screwed so that the conveyor 731 and the elastic implant The internal passage of the 500 is communicated; then, the core wire 71 is pushed into the interior of the elastic implant 500 along the channel of the conveyor 731, so that the elastic implant 500 which is curled in a natural state is restrained into a tube which is approximately linearly conveyed.
  • the delivery catheter 400 is advanced through the working channel 902 of the bronchoscope 901 along the working channel 902 to the distal end of the working channel; the measuring guidewire 300 is advanced along the delivery catheter 400 and extends out of the delivery catheter 400 into the bronchial tube for delivery.
  • the catheter 400 is pushed along the measurement guidewire 300 until the distal end of the delivery catheter 400 coincides with the distal end of the measurement guidewire 300; the position of the delivery catheter 400 is maintained unchanged, the measurement guidewire 300 is withdrawn until the delivery catheter 400 is completely withdrawn, and the delivery device
  • the 731 assembled elastic implant 500 is pushed along the lumen of the delivery catheter 400 until the distal end of the elastic implant 500 can be seen to coincide with the distal end of the delivery catheter 400 under X-rays, the conveyor handle 733 is operated, and the core wire is 71 is withdrawn from the elastic implant, and as the core wire 71 is withdrawn, the elastic implant 500 automatically returns to a natural shape from a straight strip-shaped transport state previously bound by the core wire 71, and the elastic implant 500 is
  • the recovery process can squeeze and pull the emphysema area, and also make the peripheral relatively healthy lung tissue better play its respiratory physiological function, thereby achieving the effect of lung volume reduction; then by operating the conveyor handle 733 The elastic implant 500 is released.
  • an elastic implant 500a is a tubular structure including an elastic deformation portion 51a and a flexible guiding portion 53a connected to the distal end of the elastic deformation portion 51a, and is adjacent to the elastic deformation portion 51a.
  • the flexible guiding portion 53a includes a first flexible segment 531a and a second flexible segment 532a connected between the first flexible segment 531a and the elastic deformation portion 51a.
  • the distal end of the first flexible section 531a serves as the distal end of the elastic implant 500a.
  • a developing member 56a is disposed in the first flexible section 531a.
  • the first flexible segment 531a is substantially the same as the first flexible segment 531.
  • the developing member 56a and the developing member 56 are substantially identical in structure, and are not described herein again.
  • the elastic deformation portion 51a includes a plurality of slit groups 1802 which are arranged at intervals in the axial direction of the elastic deformation portion 51a.
  • Each of the slot groups 1802 is composed of five side-by-side elliptical slot groups 1803 arranged in a stepped manner.
  • each slot group 1803 is composed of two parallel slots, each slot group. There is a certain distance 1801 between the two slots in 1803, and the long axis of each slot is perpendicular to the axis of the elastic deformation portion 51a.
  • the extending direction 1805 arranged between the groups in each of the grooving groups 1802 forms a certain angle E with the axis 501a of the elastic deformation portion 51a.
  • the angle E can be 60-90°.
  • the stepped group of slits 1803 facilitates bending of the elastic deformation portion 51a into a specific shape.
  • the proximal end 511a of the elastic deformation portion 51a is cut into a thread-like groove as a connecting member 57a with a length of about 0.5 to 5 mm.
  • the cut nickel-titanium tube was bent into a shape as shown in Fig. 24 by a mold, and heat-treated to form the elastic deformation portion 51a of the elastic implant 500a.
  • the connecting portion 52a is a tubular body having a plurality of circumferentially continuous wavy slits 2001 formed by splicing the plurality of hollow sub-members 2004.
  • the slit 2001 has a certain width 2005, and the preferred slit has a width of 0.01 mm to 0.3 mm.
  • the start and end points of the wavy slits 2001 of the adjacent two slits 2001 coincide in the circumferential direction of the connecting portion 52a.
  • each sub-assembly 2004 includes a plurality of proximal protrusions 2002 equally spaced along the circumferential direction of the hollow sub-member 2004, each proximal protrusion 2002 from the proximal end to the proximal end The circumferential length of the distal end is gradually reduced such that a dovetail-shaped opening is formed between the adjacent two proximal projections 2002 toward the proximal proximal groove 2006; the distal end of each hollow sub-assembly 2004 is included A plurality of distal protrusions 2007 of the hollow member 2004 are equally spaced in the circumferential direction, and the circumferential length of each of the distal protrusions 2007 gradually increases from the proximal end to the distal end, so that the adjacent two distal protrusions 2007 Forming a dovetail-shaped opening toward the distal distal groove 2008; the number of proximal projections 2002 of the hollow sub-assembly
  • a plurality of dovetail-type proximal bosses 2002 on one central sub-assembly 2004 are engaged with a plurality of distal-groove grooves 2008 of the other hollow sub-assembly 2004 such that the two are separated from each other.
  • the hollow sub-members 2004 form an interlocking structure, and the plurality of hollow sub-members 2004 are joined together to form a connecting portion 52a. Since the mutually separated sub-members 2004 are connected by the meshing structure of the dovetail-type boss and the dovetail groove, the connecting portion 52a of the structure has great flexibility while having a high joint strength while being capable of twisting the connecting member 57.
  • the torque is transmitted to the elastic deformation portion 51a at 1:1.
  • Other processing methods such as machining, casting, powder metallurgy, etc., may also be employed based on prior art sub-components 2004.
  • the connecting portion 52a has great flexibility and its bending resistance is small. Therefore, by adjusting the bending resistance of the elastic deformation portion 51a, it is easy to realize that the bending resistance of the connecting portion 52a is smaller than that of the elastic deformation portion 51a. The purpose of bending resistance.
  • the plurality of proximal protrusions 2002 can also be distributed at non-equal intervals on the proximal end of the sub-assembly 2004 as long as the purpose of splicing between the plurality of sub-components 2004 can be achieved.
  • the bending resistance of the flexible guiding portion 53a is smaller than that of the elastic deformation portion 51a, so as to better guide the elastic deformation portion 51a to move in the bronchus, and the damage to the bronchial wall can be reduced.
  • the bending resistance of the second flexible segment 53a from the distal end to the proximal end is gradually enhanced.
  • the second flexible segment 532a is a slotted tubular body formed by laser cutting of a nickel-titanium tube, and its resistance from the distal end to the proximal end under the same external force.
  • the bending ability is gradually enhanced (that is, under the same external force, its deformability from the distal end to the proximal end is gradually weakened, that is, hardening from the distal end to the proximal end), so as to be able to act on the elastic implant 500a.
  • the second flexible segment 532a is a tubular body having a plurality of slots
  • the bending resistance of the second flexible segment 532a can be changed as the spacing of adjacent slots changes, and those skilled in the art can It is necessary to set the adjacent grooving pitch to achieve the purpose that the bending resistance of the second flexible section 532a is smaller than the bending resistance of the elastic deformation portion 51a.
  • the second flexible section 532a includes a plurality of sets of elongated slotted groups 1601 - 1608.
  • Each set of slots (e.g., 1601) is comprised of two or more parallel slots 1601a and 1601b, each having a width 1609.
  • the extending direction of the grooving groups 1601 to 1608 forms a certain angle F with the axis 513a of the flexible guiding portion 53a.
  • the bending resistance of the second flexible segment 532a can be adjusted by adjusting the number of slots and the width 1609, the size of the angle F, and the size of the spacing 1610 in each set of slots.
  • the number of parallel slits 1601 may be 2 to 6, the distance 1609 may be 0.05 to 1 mm, the angle F is preferably 5 to 85 degrees, and the interval 1610 is preferably 0.1 to 1.0 mm.
  • Combining the parallel grooving groups (1601 ⁇ 1608) of different widths 1609 onto the same nickel-titanium tube can realize the purpose of gradually increasing the bending resistance of the second flexible segment 532a from the distal end to the proximal end under the same external force.
  • the flexible guiding section 53a which is resistant to the bending ability of the bending ability can provide a better guiding effect on the elastic implant 500a.
  • the second flexible segment 532a and the elastic deformation portion 51a may be connected by a polymer heat shrinkable tube or a film coating, a glue bonding, a laser welding, a soldering or the like. According to the prior art, the preferred method is to adopt an integrated cutting method. The second flexible segment 532a and the elastic deformation portion 51a having different texture features are cut in different regions on the same pipe.
  • a feasible way is that from the distal end to the proximal end, the angle F of the adjacent two grooving groups does not change, and the width 1609 of the grooving becomes smaller;
  • a feasible way is that from the distal end to the proximal end, the width 1609 of the slots in the adjacent two slot groups is unchanged, and the angle F is gradually increased. It can be understood that the effect of gradually increasing the bending resistance of the flexible guiding section 53a from the distal end to the proximal end can also be achieved by simultaneously changing the angle F of the adjacent two slitting groups and the width 1609 of the slit.
  • the connecting member 57a is substantially the same as the connecting body 57 except that the boss 571a of the connecting member 57a has a plurality of small projections 578 which are equally spaced apart in the circumferential direction and are connected to each other.
  • a plurality of small bosses 578 collectively form a virtual circumference 579 (i.e., the circumscribed circle of the plurality of small projections 578 is 579).
  • the diameter of the circumference 579 is the outer diameter of the boss 571a.
  • the connecting member 57a and the connecting portion 52a may be connected by a polymer heat shrinkable tube or a film coating, a glue bonding, a laser welding, a soldering or the like.
  • the second flexible segment since the material of the second flexible segment is the same as the material of the elastic deformation portion, the second flexible segment may be omitted, and the first flexible segment is directly connected to the elastic deformation portion. Let me repeat.

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Abstract

一种肺减容弹性植入体（500）及肺减容器械，肺减容弹性植入体（500）包括弹性变形部（51）以及与弹性变形部（51）远端相连接的柔性引导部（53，53a），柔性引导部（53，53a）设置有第一柔性段（531），第一柔性段（531）包括插入段（5312）及远端段（5311），插入段（5312）与弹性变形部（51）的远端相连，第一柔性段（531）的远端段（5311）的远端为肺减容弹性植入体（500）远端，第一柔性段（531）内设置有显影件（56）。该肺减容弹性植入体（500）及肺减容器械中，植入体（500）提供有效的弯曲力的同时能够具有较好的柔软度，当植入体（500）植入支气管后，能够减少植入体（500）弯曲过程中挫伤支气管的风险，提高肺减容手术的安全性。

Description

肺减容弹性植入体及肺减容器械 技术领域
本发明属于介入治疗技术领域，涉及一种介入治疗用植入体和器械，尤其涉及一种肺减容弹性植入体及肺减容器械。
背景技术
肺气肿是一种常见肺部疾病，传统的肺气肿内科治疗包括吸氧、预防肺部感染、支气管解痉等，但疗效极为有限；而肺气肿的外科治疗则多以肺减容手术为主，也存在较多的局限性，如：严格的手术适应症，存在较多并发症，麻醉及与麻醉相关的并发症，术前疗效难以预测、术后无法弥补因切除过多或过少所造成疗效不理想的结果，高昂的手术费用和较大的精神、肉体痛苦，另外由于部分患者本身肺功能较差而往往不能耐受手术，因此术后死亡率较高，这限制了外科手术的应用。
为了更好地治疗肺气肿，提高患者的生活质量，减少手术过程中对患者的创伤，国际上研究利用经支气管镜实施单向活瓣、生物胶、水蒸气热消融、弹性线圈等介入方式对肺气肿进行治疗。单向活瓣由于靶区残余气体和痰液未能有效主动地排出，临床效果不佳，另外单向活瓣治疗的有效性还受到侧支通气和精确放置到不同解剖结构位置的技术难度限制。生物胶因完全封堵了气肿区，导致术后发炎的问题一直也未能很好地解决。而水蒸气热消融，也因破坏了气肿区原有的组织结构，导致术后发炎。
目前对肺气肿采用一种更新的治疗方式，即将弹性线圈作为植入体植入人 体肺部病变位置。图1是现有技术的一种肺减容弹性线圈的示意图，该产品是由镍钛记忆合金金属丝设计制成，在外力作用下可发生弹性形变。该产品在装载系统的约束下，可呈直条形式通过支气管镜工作通道植入肺部，当线圈被输送到肺气肿区的支气管内后，线圈失去装载系统的约束，恢复形变至如图1所示的自然形状(即不受外力时的形状)，同时气肿区在镍钛合金丝的牵拉作用下被挤压，支气管内的气体排出，肺气肿区的肺组织体积减小，从而使周边相对健康的肺组织更好地发挥生理功能。
上述植入体具有以下缺陷：植入体为了追求较好的挤压减容效果，通常采用弹性较好的金属制弹性线圈，其硬度较高，柔韧性较差，在植入支气管的过程中，容易对支气管造成损伤。
发明内容
本发明要解决的技术问题在于，针对现有技术中上述缺陷，提供一种能够具有较好的柔软度的植入体。当本发明植入体植入支气管后，能够减少植入体弯曲过程中挫伤支气管的风险，提高肺减容手术的安全性。
本发明进一步要解决的技术问题，针对现有技术中上述缺陷，提供一种能根据实际要求将植入体植入肺部旁路或某些小直径气管末端，使手术操作更加安全、达到更好治疗效果的肺减容器械。
本发明所采用的一种技术方案是：
一种肺减容弹性植入体包括弹性变形部以及与所述弹性变形部远端相连接的柔性引导部，所述柔性引导部设置有第一柔性段，所述第一柔性段包括插入段及远端段，所述插入段与所述弹性变形部的远端相连，所述第一柔性段的远端段的远端为所述肺减容弹性植入体远端，所述第一柔性段内设置有显影件。
在本技术方案一实施例中，所述柔性引导部还包括连接于所述弹性变形部与所述第一柔性段之间的中空的第二柔性段，所述第一柔性段的插入段插入至所述第二柔性段，所述显影件近端随所述第一柔性段的插入段插入至所述第二柔性段。在本技术方案一实施例中，所述第一柔性段的插入段径向长度小于所述远端段的径向长度，所述插入段与所述远端段的连接处呈台阶状。
在本技术方案一实施例中，所述显影件近端较所述插入段的近端靠近所述远端段的远端，且所述显影件近端与所述第一柔性段近端之间的垂直距离为0.5毫米至20毫米。
在本技术方案一实施例中，所述显影件包括设置在所述第一柔性段内的显影丝。
在本技术方案一实施例中，所述显影件还包括显影环，所述显影环连接于所述显影丝的远端。
在本技术方案一实施例中，在相同外力作用下，所述第二柔性段从近端至远端越来越易变形。
在本技术方案一实施例中，所述第二柔性段包括由镍钛管切割而成的具有连续的螺旋状切槽的管状体。
在本技术方案一实施例中，从所述第二柔性段的远端至近端，所述第二柔性段的相邻两个切槽沿所述第二柔性段轴向的间距逐渐变大。
在本技术方案一实施例中，所述肺减容弹性植入体至少近端开口且还包括与所述弹性变形部近端相连的凸台，所述弹性变形部具有超弹性，所述弹性变形部沿其长度方向间隔设有若干切槽，各切槽与所述弹性变形部的管腔相通，在相同外力作用下，所述柔性引导部比所述弹性变形部更容易变形，所述凸台的外径大于输送状态下的所述弹性植入体靠近所述凸台处的外径。
在本技术方案一实施例中，所述弹性植入体还包括位于所述弹性变形部及所述凸台之间的连接部，在相同外力作用下，所述连接部比所述弹性变形部更容易变形。
在本技术方案一实施例中，所述连接部沿其长度方向间隔设有若干切槽。
在本技术方案一实施例中，所述连接部包括多个首尾相拼接的中空子部件，每个所述中空子部件的近端均包括沿所述中空子部件的圆周方向分布的多个近端凸起，每个近端凸起从近端至远端的周向长度逐渐缩小，相邻两个近端凸起之间形成一个近端凹槽；每个所述中空子部件的远端均包括沿所述中空子部件的圆周方向分布的多个远端凸起，每个远端凸起从近端至远端的周向长度逐渐增大，相邻两个远端凸起之间形成一个远端凹槽。
在本技术方案一实施例中，从所述柔性引导部的远端至近端，所述凸台部分远端端面向所述凸台的近端凹陷形成一个围绕所述凸台的纵向中心线的环形凹槽。
在本技术方案一实施例中，所述凸台的部分侧表面向所述凸台内部凹陷形成一个围绕所述凸台的纵向中心线的环形凹槽。
在本技术方案一实施例中，所述凸台包括多个沿所述凸台周向间隔分布的小凸起。
本发明还提供一种肺减容器械，其包括上述任一所述植入体和与所述植入体配套的输送装置，所述输送装置包括芯丝和输送器，所述植物体的近端可拆卸的连接在所述输送器的远端，所述芯丝可移动地穿至所述植入体的管腔和所述输送器的管腔中。
在本技术方案一实施例中，所述芯丝的远端设有与芯丝同轴的芯丝引导头，所述芯丝引导头外径与芯丝外径一致。
在本技术方案一实施例中，所述芯丝引导头包括导向柱及套设于所述导向柱上的的弹簧，所述导向柱与芯丝一体结构或者导向柱固接在芯丝远端；所述弹簧具有显影标识。
在本技术方案一实施例中，所述植入体近端与所述输送器的远端可拆卸相连。
本发明植入体包括弹性变形部以及与弹性变形部远端相连接的柔性引导部，柔性引导部设置有第一柔性段，第一柔性段具有较好的柔软度，当植入体植入至支气管后，由于第一柔性段具有比金属更加柔软的特性，且具有良好的弹性，相比于现有技术，本发明将第一柔性段的远端段远端作为肺减容弹性植入体的远端，当第一柔性段受力时，由于其自身具有更好的柔软度，易于弯折且表面相对柔软，从而能够极大的减少肺减容弹性植入体对肺脏组织的伤害。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是现有技术弹性线圈的结构示意图；
图2是本发明一实施例提供的被撕开部分薄膜的植入体的示意图；
图3是图2所示植入体的第一柔性段的结构示意图；
图4是图2所示植入体的柔性引导部的局部剖视图；
图5是图2所述植入体的第二柔性段的结构示意图；
图6是图5中的第二柔性段沿其长度方向剖开且展开后的示意图；
图7是图2中的植入体的局部剖视图；
图8是图2所示植入体的弹性变形部的剖示图；
图9是将图2中的植入体的弹性变形部沿其长度方向剖开并展开后的切槽 示意图；
图10是图2中的植入体的连接部的示意图；
图11是图10中的连接部沿其长度方向剖开且展开后的示意图；
图12是图2中的植入体的连接件的示意图；
图13是图12中的连接件的剖视图；
图14是图12中的连接件的变形示意图；
图15是图14中的连接件的剖视图；
图16是本发明一实施例提供的肺减容器械的示意图；
图17是图16中的肺减容器械的分解示意图；
图18是图16中的肺减容器械的芯丝的示意图；
图19是图18的M处的放大图；
图20是本发明一实施例提供的肺减容器械建立工作通道的示意图；
图21是图20的A处放大图；
图22是释放植入体后的示意图；
图23是图22的B处的放大图；
图24是本发明另一实施例提供的植入体的示意图；
图25是图24中的植入体的弹性变形部的示意图；
图26是图24中的弹性变形部沿其长度方向剖开且展开后的示意图；
图27是图24中的植入体的连接部的示意图；
图28是图27中的连接部沿其长度方向剖开且展开后的示意图；
图29是图27中的连接部的连接子部件的示意图；
图30是图24中的植入体的柔性导引部的示意图；
图31是图30中的柔性导引部沿其长度方向剖开且展开后的部分示意图；
图32是图24中的植入体的连接件的示意图；
图33是图32中的连接件的剖视图；
图34是图32中的连接件近端侧的俯视图；
附图标记：弹性变形部51，柔性导引部53，连接部52，连接件57，弹性薄膜55，第一柔性段531，第二柔性段532，弹性植入体500，显影件56，弹性变形部近端511，弹性变形部远端513，显影件56，显影丝561，显影环562。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
在介入领域，通常将相对操作者近的一端称为近端，相对操作者远的一端称为远端。
除非另有定义，本文所使用的所有技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
请参阅图2，本发明一实施例提供的弹性植入体500为管状结构，其包括空心管状的弹性变形部51、与弹性变形部51远端相连的柔性导引部53，与弹性变形部51近端相连的连接部52、与连接部52近端相连的连接件57、以及弹性薄膜55。
柔性引导部53包括第一柔性段531及连接于第一柔性段531及弹性变形部51之间的第二柔性段532。第一柔性段531的远端作为弹性植入体500的远端。第一柔性段531内设置有显影件56。
请一并参阅图3，第一柔性段531包括插入段5312以及远端段5311。第一柔性段531靠近植入体500近端的部分为插入段5312，第一柔性段531靠近植入体500远端的部分为远端段5311。第一柔性段531的插入段5312插入至第二柔性段532中。当第一柔性段531的插入段5312插入至第二柔性段532中时，显影件56的近端伸入至第二柔性段532中。具体的，这里的第一柔性段531的材料为高分子弹性材料，例如：硅胶、聚四氟乙烯、PEBAX材料等高分子弹性材料。由于高分子弹性材料具有比金属材料更加柔软的特性，且高分子弹性材料的抗弯曲力(使其弯曲所需的最小力)更低，在植入体植入的过程中，作为植入体500的远端的第一柔性段531的远端为与人体内组织直接接触的一端，以防止其挫伤人体内组织，优选地，第一柔性段531的远端端面设计成部分球面。在植入体植入的过程中，当其远端触碰人体内支气管或肺脏等组织时，因第一柔性段531具有更柔软、抗弯曲力低的特性，更容易弯折，从而不会对人体内组织造成挫伤。
这里的插入段5312与远端段5311可以一体成型，例如，通过模具直接制作或者采用切削的方式进行制作，也可以分别制作插入段与远端段，再通过胶水粘结或其他方式将其紧固连接，这里不做具体限定。第一柔性段531的插入段5312径向长度小于远端段5311的径向长度，如此，插入段5312与远端段5311的连接处呈台阶状。本实施例中，第一柔性段531的插入段5312及远端段5311的主体部分均优选为圆柱形，并且插入段5312与远端段5311的轴线在同一水平线上。其中插入段5312径向长度与第二柔性段532的管腔内径相 匹配，当第一柔性段531与第二柔性段532连接时，插入段5312能够插入至第二柔性段532的管腔内，由于高分子材料具有一定的弹性，当插入段5312插入至第二柔性段532的管腔内，插入段5312能够适当被压缩，其材质的弹性能够保证其被第二柔性段532的管腔紧固套牢，从而有效避免了其他连接方式导致的连接可靠性差的问题。插入段5312径向长度与第二柔性段532的管腔内径相匹配，是指插入段5312的径向长度可以略大于、等于或者小于第二柔性段532的管腔内径；略大于时，插入段5312被压缩变形可以挤入第二柔性段532的管腔中，且在不借助外物的作用下仍然可以与第二柔性段532连为一体；等于或者小于时，插入段5312可以容易地插入第二柔性段532的管腔中，此时，需要借助包裹在第二柔性段532外围的高分子弹性材料将插入段5312与第二柔性段532连为一体。
优选的，第一柔性段531的远端段5311的径向长度与第二柔性段532的外径相同。当第一柔性段531的插入段5312插入至第二柔性段532的管腔内时，插入段5312与远端段5311连接处的台阶宽度能够与第二柔性段532的管壁厚度相同，从而能够保证第一柔性段531与第二柔性段532连接后，其连接处的外表面为光滑面，进而保证植入体外表面光滑，避免因表面有凸起而对人体内组织器官造成损伤，同时也能够降低后续加工难度。第二柔性段532为由镍钛管经激光切割而成的具有切槽的管状体，且在相同外力作用下其从远端至近端的抗弯曲能力逐渐增强(也就是说,在相同外力作用下,其从远端至近端的变形能力逐渐减弱，亦即从远端至近端越来越硬)，以能够对弹性植入体500起到更好的导引作用。此外，第二柔性段532的抗弯曲能力小于弹性变形部51的抗弯曲能力，且大于第一柔性段531的抗弯曲能力，以利于柔性引导部53更好地在支气管内移动而不损伤周围组织。
可以理解的是，由于第二柔性段532为具有多个切槽的管状体，第二柔性段532的抗弯曲能力可以随着相邻切槽间距的改变而改变，本领域技术人员可以根据实际需要来设定相邻切槽间距以实现第二柔性段532的抗弯曲能力小于弹性变形部51的抗弯曲能力这一目的。
第二柔性段532包括连续的呈螺旋状的切槽2502。在第二柔性段532沿其轴向剖开的展开平面上，从第二柔性段532的远端至近端，相邻两切槽2502之间的间距也逐渐变大，以达到第二柔性段532从远端至近端的抗弯曲能力逐渐增强的目的。
可以理解的是，第二柔性段532沿其轴向剖开的展开平面上，从所述第二柔性段532的远端至近端，当所述第二柔性段532的切槽2502的延伸方向2505与所述第二柔性段532的轴向2504之间的夹角G不变，所述第二柔性段532的切槽沿所述第二柔性段532的轴向2504的宽度逐渐小时，相邻两切槽2502之间的间距也逐渐变大,也可以达到第二柔性段532从远端至近端的抗弯曲能力逐渐增强的目的。
可以理解的是，第二柔性段532沿其轴向剖开的展开平面上，从第二柔性段532的远端至近端，第二柔性段532的切槽沿第二柔性段532的轴向2504的宽度不变，第二柔性段532的切槽的延伸方向2505与第二柔性段532的轴向2504之间的所夹锐角逐渐变大时，相邻两切槽2502之间的间距也逐渐变大,也可以达到第二柔性段532从远端至近端的抗弯曲能力逐渐增强的目的。可以理解的是，其他实施例中，第二柔性段532也省略不要，此时，第一柔性段531的插入段可以插入弹性变形部51内，只要所获得的植入体的第一柔性段531的远端段较柔软，不易损伤组织即可。请再次参阅图4，显影件56设置于第一柔性段531内，且具有弹性。由于第一柔性段531为高分子材料制成，显 影件56可嵌入至第一柔性段531内，也可以采取其他方法将显影件56设置于第一柔性段531内，这里不作具体限定。当第一柔性段531的插入段插入至第二柔性段532的管腔中时，显影件56的近端伸入至第二柔性段532的管腔中。当植入体500在植入过程中，可通过第一柔性段531内的显影件56进行显影。另外，由于显影件56的近端伸入至第二柔性段532的管腔中，当植入体在植入过程中，显影件56不仅能够显示出第一柔性段531的弯曲变化，还能够对第二柔性段532的弯曲变化进行显影，进而保证操作的准确性与安全性。再者由于第一柔性段531与第二柔性段532材质不同，第一柔性段531的抗弯曲力小于第二柔性段532的抗弯曲力，当植入体扭曲脏器或组织时，第一柔性段531与第二柔性段532之间极易发生剧烈的形变差异，导致在形变差异较大的区域产生较大应力集中，进而导致第一柔性段531与第二柔性段532之间发生断裂，而本实施例中的显影件56本身具有一定弹性，能够对第一柔性段531及第二柔性段532提供一定的应力支撑，相当于能够减小第一柔性段531与第二柔性段532之间的抗弯曲力的差距，从而使柔性引导段从远端到近端具有渐变的抗弯曲力，即抗弯曲力从远端到近端逐渐变小，从而能够避免第一柔性段531与第二柔性段532之间发生剧烈的形变差异，进而能够避免第一柔性段531与第二柔性段532之间发生断裂。优选地，显影件56近端较第一柔性段531的近端靠近植入体500的远端，且其与第一柔性段531近端之间的垂直距离A的范围为0.5毫米至20毫米。本实施例中，植入过程中，植入体的管腔内需要插入芯丝，将弹性植入体限制成近似直线的输送状态，此时芯丝的远端端部抵触在第一柔性段531的近端外壁上，显影件56近端与第一柔性段531近端的距离为0.5毫米至20毫米可以保证芯丝不会触碰到显影件56，进一步的，保证了显影件56在第一柔性段531内位置的固定性，使其不会因为芯丝 的推入，而与第一柔性段531产生分离此外，显影件56近端与第一柔性段531近端之间的垂直距离设置在0.5毫米至20毫米范围内，可以使相关技术人员根据实际情况调整显影件56进入第二柔性段532的深度，从而使柔性引导段从远端到近端具有渐变的抗弯曲力，避免第一柔性段531与第二柔性段532之间发生断裂。若显影件56近端与第一柔性段531近端之间的垂直距离设置小于0.5毫米，则植入过程中，芯丝较易碰触到显影件56，改变显影件56的形状，进而影响显影效果。若显影件56近端与第一柔性段531近端之间的垂直距离设置大于20毫米，则柔性引导段从远端到近端渐变的抗弯曲力就会受到较大影响，进而使得第一柔性段531与第二柔性段532之间容易出现剧烈的形变差异，增加了第一柔性段531与第二柔性段532之间发生断裂的可能。请一参阅图2与图4，显影件56包括设置在所述第一柔性段531纵向中心轴方向上的显影丝561及设于显影丝561远端上的显影环562。显影丝561具有一定长度，可以采用X射线下显影效果较好的黄金、铂金、钨等重金属材质制成。同时显影丝561在随着第一柔性段531及第二柔性段532弯曲时，其显影效果较好，显影丝561自身的弯曲变化能够显示其外的第一柔性段531及第二柔性段532的弯曲变化，优选的，将显影丝561设置于第一柔性段531的纵向中心轴方向上能够最大限度利用显影丝561的长度，保证其在第一柔性段内保持延展状态，从而能够带来更好的显影效果的同时能够提供更好的弹性，从而能够提供更大应力支撑，防止第一柔性段531与第二柔性段532之间发生断裂。同时，由于本器械需要在X射线辅助下进行操作，将显影丝561设置在第一柔性段531内，并且近端伸入至第二柔性段532，能够保证在植入体植入过程中，显影出第一柔性段531与第二柔性段532的弯曲程度，当显示第一柔性段531弯曲至一定程度时，操作人员能够根据显影结果判断植入体端部是否已经 到达预定位置，从而能够提高肺减容术的安全性。
显影环562靠近第一柔性段531远端，优选的设置在第一柔性段531的远端端部，由于显影丝561较细，在第一柔性段531的端部设置显影环562，在植入体进行植入时能够较好的显影出植入体远端的位置信息，更加有利于操作人员判断植入体远端端部的位置，从而提高操作的安全性与准确性。
可以理解的是，其他实施例中，显影件56的显影丝可以包括芯轴以及设于芯轴的显影材料，显影材料优选为X射线下显影效果较好的黄金、铂金、钨等重金属材质，芯轴可优先选用弹性较好的镍钛合金、钴铬合金等，这种设计方式也能够保证显影件56具有良好的弹性。还可以理解的是，其他实施例中，可以根据实际需要，将显影件56中的显影环562省略不要。
弹性变形部51具有超弹性，其包括相对的近端511和远端513。远端513与柔性引导部53相连。弹性变形部51还包含多个相互隔开的且与所述弹性变形部51的管腔相连通的切槽514。多个切槽514有利于弹性植入体500的弹性变形部51在自然状态下能弯曲成预定的形状，例如图2的形状。
弹性变形部51在自然状态下(即不受任何外力时)呈卷曲的预定形状，在外力作用下可被约束成直条形或其他任意形状，并在外力撤销后通过弯曲和扭转恢复至预定形状。弹性变形部51可由本行业内常使用的具有超弹性的材料制成，本发明中不对具体材料进行限定，只要适用于人体且具有超弹性的材料即可。本实施例中，弹性变形部51采用镍钛合金制成。具体地，弹性变形部51的加工方法包括：首先，用激光切割一段直径约0.5～2.0mm，壁厚为0.01～0.4mm的空心镍钛管；然后，用模具将切割后的镍钛管弯曲成图2中弹性变形部51所示形状；最后热处理定型成为所述的弹性变形部51。
请一并参阅图8及图9，本实施例中，为了使得弹性变形部51能伸进更 细的支气管，对相应的组织的挤压效果会更好，优选地，采用内径一致，壁厚逐渐变化的锥形镍钛管进行制作，例如内径为0.8～1.0mm，壁厚从远端的0.01mm变化到近端的0.4mm的锥形镍钛管；在镍钛管上形成多个哑铃状的切槽514，这些切槽514的延伸方向(即切口方向)518与弹性变形部51的轴线501形成一定的角度A，优选地角度A可为10～90度。相邻两个切槽514之间有约0.05～0.5mm的间隔508。可以理解的是，由于弹性变形部51具有多个切槽514，弹性变形部51的抗弯曲能力可以随着切槽514在延伸方向518上的长度510的改变而改变，本领域技术人员可以根据实际需要来设定弹性变形部51的切槽514在延伸方向518上的长度510以实现柔性引导部53的抗弯曲能力小于弹性变形部51的抗弯曲能力这一目的。
请一并参阅图10及11，连接部52连接在连接件57与弹性变形部51之间，且在相同外力作用下，连接部52的抗弯曲能力小于弹性变形部51的抗弯曲能力(即在相同外力作用下，连接部52较弹性变形部51更易变形)。本实施例中，连接部52设有多个切槽组1702。将连接部52沿轴向剖开并平展后可见，每个切槽组1702均包括三个沿连接部52周向排列且相互平行的切槽1702a、切槽1702b、切槽1702c，且该三个切槽的两端在所述周向上相互对齐。每个切槽组1702中的相邻两个切槽之间具有一定的间隔1703，相邻两个切槽组1702之间留有间隔1704。每个切槽均为细长结构，多个切槽的延伸方向AC与连接部52的轴线513形成一定的夹角C。通过调整每个切槽组1702中的切槽的个数和间隔1703的大小、切槽的延伸方向AC与弹性变形部51轴线501的夹角C的角度的大小以及相邻两个切槽组1702之间的间隔1704的大小，可以调整整个连接部52的抗弯曲能力，使连接部52的抗弯曲能力小于弹性变形部51的抗弯曲能力。在其他实施例中，每个切槽组1702中的切槽个数可以 为2-6个，每个切槽组1702中相邻两个切槽之间的间距1703可以为0.05-1mm，夹角C可为10-85°，每组之间的间隔208为0.1-1.0mm。弹性变形部51的外径约1.0-2.0mm，壁厚为0.05-0.3mm。连接部52与弹性变形部51的连接方式可以是高分子热缩管或薄膜包覆、胶水粘接、激光焊接、锡焊等方式，基于现有技术，优选的方式是采用一体切割方式，在同一根管材上的不同区域切割出具有不同的纹理特征的弹性变形部51及连接部52。
可以理解的是，在其他实施例中，切槽与管腔也可以不连通，只要能够加强弹性变形部的弹性即可。还可以理解的是，在其他实施例中，也可以通过其他方式来实现弹性变形部从远端到近端抗弯曲能力越来越强的特性，例如采用从远端到近端壁厚越来越厚的管体。
请一并参阅图2、图12及图13，连接件57位于连接部52的近端，其包含凸台571及连接段573。凸台571的外径D大于输送状态下的弹性植入体500靠近所述凸台571处的外径。本实施方式中，输送状态下的弹性植入体500靠近所述凸台571处的外径即为连接部52近端的外径。凸台571内设有内螺纹574。连接段573位于凸台571及连接部52之间，其设有贯穿连接段573的近端端面及远端端面的腔体575。本实施例中，凸台571平行于其纵向中心轴的截面包括相对的两个半圆，外径D不能超过2.8mm，优选的D可以为2.0mm～2.3mm。凸台571有效增加弹性植入体500近端与支气管的接触面积，减少弹性植入体500植入后对肺脏组织肺伤害。
可以理解的是，凸台571的部分远端端面还可以向凸台571的近端凹陷形成一个围绕凸台571的纵向中心线的环形凹槽576(见图14及15)，以为活检钳提供了卡扣位置，使得活检钳更有效的夹紧连接装置进而回收弹性植入体50。
一并参见图2和图7，弹性植入体薄膜55完全包裹除凸台571外的弹性植入体500的外表面，且填充在每一个切槽514中，但不阻塞弹性植入体500的管腔，从而保证了弹性植入体薄膜55牢固地包覆住弹性植入体500，同时又保证弹性植入体500管腔内的畅通。弹性植入体薄膜55的厚度可为0.01～0.8mm。所述弹性植入体薄膜55可以采用具有优良的化学稳定性、耐水、耐气候老化、良好的低压缩性、生物相容性好、机械强度高、无毒、无味等特性的高分子溶液制成。举例而言，这些高分子溶液可是硅橡胶或聚氨酯溶液。由于第一柔性段531也采用高分子材料制得，且第一柔性段531的插入段插入至第二柔性段532的管腔中，当弹性植入体薄膜55包裹弹性植入体表面时，第二柔性段532的周围完全被高分子材料覆盖，从而使得第二柔性段532与第一柔性段531更加牢固的结合，也使弹性植入体薄膜55与植入体之间的连接更加稳固。由于弹性植入体薄膜55与金属基体的结合特性，弹性植入体薄膜55近端端部是最容易在外力作用下出现翻边、脱落，而凸台571的外径大于输送状态下的弹性植入体500靠近凸台571处的外径，故，该凸台571能够保护弹性植入体薄膜55近端端部在输送、回撤过程中不会接触到管道壁，进而保护弹性植入体膜层55在输送和回撤过程中不会翻遍、脱落。
请一并参阅图16及17，本发明一实施例提供的肺减容器械600包括弹性植入体500和输送装置700。所述输送装置700包括芯丝71和输送器73。
芯丝71收容于弹性植入体500的管腔内，用于将弹性植入体500限制成近似直线状输送状态，便于输送植入体500至病变部位，芯丝71可用一段直径为0.1-1.1mm的金属丝制得。
请一并参阅图18及19，为了操作的安全方便，需要在芯丝71的远端设置与芯丝71同轴的且带有显影标识的柔性芯丝引导头75。芯丝引导头75外 径与芯丝71外径一致。芯丝引导头75包括导向柱751、导向柱751外套装固定的弹簧753。导向柱751与芯丝71为一体结构或者导向柱751固接在芯丝71远端；弹簧753带有显影标识。
芯丝引导头75用于引导导引芯丝71顺利进入弹性植入体500管腔内。柔性的芯丝引导头75可通过柔软的弹簧实现，即在与芯丝71一体结构或者固接在芯丝71远端的导向柱751上套装弹簧753。具体制作方法可以为：先将芯丝71的头端经细化后制成导向柱751；然后在导向柱751外固定一段长度为5-150mm的弹簧753。弹簧753与芯丝71的固定方式可以是高分子热缩管或薄膜包覆、胶水粘接、激光焊接、锡焊等方式。在柔软的芯丝引导头75的导向下，芯丝71从植入体500的近端可顺利进入植入体500的管腔内，可将植入体500从图2所示形状束缚成近似直线状(如图16所示)。
本实施例中，正是由于柔性导引部53的存在，装载了芯丝71的植入体500还具备在支气管内探索路径以到达病灶区域的作用。由于需要对芯丝71进入肺部的操作状况进行引导和监控，则需在芯丝引导头75上设置显影标识。显影标识是能通过荧光检查系统、超声成像系统、MRI系统、计算X线断层摄像术(CT)系统或其它远程成像对植入体进行显示的标识，具体结构不作限定。通过这些系统对芯丝101进行显示和引导，本实施例中采用丝径为0.01-0.3mm的X射线显影性较强的钨、钽等金属丝绕成的弹簧作为显影标识。本实施例将显影标识与芯丝引导头75合并成一个部件，实现两个功能。除了这种方式外，还可以在芯丝引导头75上另外设置显影标识。当然，当本发明的植入体表面未包覆弹性膜且采用本身可显影的材料如镍钛合金制成时，可不包括所述显影标识。
请再次参阅图17，推送机构73包括输送器731、与输送器731连接的操 控手柄733。输送器731和植入体500套装在芯丝71上，输送器731的远端与植入体500近端511可拆卸地连接。本实施例中，输送器731为推送钢缆，且其远端设有一个具有与连接件57的内螺纹相配合使用的外螺纹的连接配合件735。装配时，可将连接件57的内螺纹与推送机构73带有的外螺纹的连接配合件735螺纹连接，则植入体500便可靠固定在输送器73远端；在植入体500推送到达支气管的相应位置后，通过扭转输送器73的操控手柄733，则植入体500的连接件57与输送器73的连接配合件735旋出分离。连接件57和连接配合件735也可以是其它的可拆卸固定连接部件，如磁性连接装置、弹性卡扣、套索等等，分别设置在植入体500和输送器103上，实现可拆卸连接。
弹性植入体500与芯丝71、输送器731的装配如下所述：首先，将弹性植入体500与输送器731远端连接配合件735经螺纹连接，使得输送器731与弹性植入体500的内部通道连通；然后，将芯丝71沿输送器731通道推送进入弹性植入体500内部，使得自然状态下呈卷曲状的弹性植入体500被约束成近似直线状输送状态的管子。
参见图20-23，通过支气管镜901的工作通道902将输送导管400沿工作通道902推送至工作通道远端；测量导丝300沿输送导管400进入，并伸出输送导管400进入支气管，将输送导管400沿测量导丝300推送，直至输送导管400远端与测量导丝300远端重合；保持输送导管400位置不变，回撤测量导丝300直至完全撤出输送导管400，将与输送器731装配好的弹性植入体500沿输送导管400的内腔推送，直至在X射线下能够看到弹性植入体500远端与输送导管400远端重合，操作输送器手柄733，将芯丝71从弹性植入体中撤出，随着芯丝71的回撤，弹性植入体500从先前被芯丝71束缚成的直条形输送状态自动回复成自然形状，弹性植入体500在恢复的过程可对气肿区进行 挤压和牵拉，同时也使周边相对健康的肺组织更好地发挥其呼吸生理功能，从而达到肺减容的效果；然后通过操作输送器手柄733可释放弹性植入体500。
请参阅图24，本发明另一实施例提供的弹性植入体500a为管状结构，其包括弹性变形部51a、与弹性变形部51a远端相连的柔性导引部53a，与弹性变形部51a近端相连的连接部52a、与连接部52a近端相连的连接件57a、以及弹性薄膜55a。柔性引导部53a包括第一柔性段531a及连接于第一柔性段531a与弹性变形部51a之间的第二柔性段532a。第一柔性段531a的远端作为弹性植入体500a的远端。第一柔性段531a内设置有显影件56a。
其中，第一柔性段531a与第一柔性段531结构大体上相同，显影件56a与显影件56结构上大致相同，在此不再赘述。
请一并参阅图25及图26，弹性变形部51a包含多个沿弹性变形部51a的轴向上间隔排列的切槽群1802。每个切槽群1802均由五个并排的且呈阶梯状排列的椭圆切槽组1803组成，本实施例中每个切槽组1803均由两个并列的切槽组成，每个切槽组1803中的两个切槽之间具有一定的间距1801，每个切槽的长轴垂直于弹性变形部51a轴线。每个切槽群1802中组与组之间排列的延伸方向1805与弹性变形部51a的轴线501a形成一定的夹角E。夹角E可为60-90°。每个切槽群1802中的相邻两个切槽组1803之间有约0.3-5mm的间距508a。阶梯状排列的切槽组1803有利于弹性变形部51a弯曲成特定的形状。弹性变形部51a的近端511a有约0.5-5mm的长度被切割成螺纹状沟槽作为连接件57a。再用模具将切割后的镍钛管弯曲成图24所示形状，热处理定型成为所述的弹性植入体500a的弹性变形部51a。
在相同外力作用下，连接部52a的抗弯曲能力小于弹性变形部51a的抗弯曲能力，以便于更好地减少连接部52a对支气管壁的伤害。请参阅图27-29， 本实施例中，连接部52a为由多个中空子部件2004首尾拼接形成的具有多个周向连续的波浪状切槽2001的管状体。切槽2001具有一定的宽度2005，优选的切槽的宽度可以是0.01mm～0.3mm。相邻两个切槽2001波浪状切槽2001的起点和终点在连接部52a的圆周方向上重合。优选地，本实施例中，每个子部件2004的近端均包括沿所述中空子部件2004的圆周方向等间隔分布的多个近端凸起2002，每个近端凸起2002从近端至远端的周向长度逐渐缩小，从而相邻两个近端凸起2002之间形成一个燕尾状的开口朝向近端的近端凹槽2006；每个中空子部件2004的远端均包括沿中空子部件2004的圆周方向等间隔分布的多个远端凸起2007，每个远端凸起2007从近端至远端的周向长度逐渐增大，从而相邻两个远端凸起2007之间形成一个燕尾状的开口朝向远端的远端凹槽2008；中空子部件2004近端凸起2002的数量等于同一中空子部件2004的远端凸起2008的数量，且中空子部件2004上的一个远端凹槽2008与同一中空子部件2004上的一个近端凸起2002对齐。如此，两个中空子部件2004中，一个中部子部件2004上多个燕尾型的近端凸台2002与另一个中空子部件2004的多个远端凹槽2008啮合，使得相互分离的两个中空子部件2004形成一种互锁的结构，多个中空子部件2004拼接组合形成连接部52a。由于各个相互分离的子部件2004由燕尾型凸台和燕尾槽的啮合结构而相连，使得该种结构的连接部52a具有极大柔性的同时具有很高的连接强度，同时能够在扭转连接件57时1:1地传递扭矩至弹性变形部51a。基于现有技术子部件2004亦可以采用其他加工方式，如机械加工、铸造、粉末冶金等。可以理解的是，连接部52a具有极大柔性，其抗弯曲能力很小，故，通过调整弹性变形部51a的抗弯曲能力，可以很容易实现连接部52a的抗弯曲能力小于弹性变形部51a的抗弯曲能力的目的。可以理解的是，多个近端凸起2002也可以非等间隔地分 布于子部件2004的近端，只要可以实现多个子部件2004之间可以拼接的目的即可。
在相同外力作用下，柔性引导部53a的抗弯曲能力小于弹性变形部51a的抗弯曲能力，以便于更好地引导弹性变形部51a在支气管内移动，且可以减少对支气管壁的伤害。在相同外力作用下，第二柔性段53a从远端至近端的抗弯曲能力逐渐增强。
请一并参阅图30及31，本实施例中，第二柔性段532a为由镍钛管经激光切割而成的具有切槽的管状体，且在相同外力作用下其从远端至近端的抗弯曲能力逐渐增强(也就是说,在相同外力作用下,其从远端至近端的变形能力逐渐减弱，亦即从远端至近端越来越硬)，以能够对弹性植入体500a起到更好的导引作用。可以理解的是，由于第二柔性段532a为具有多个切槽的管状体，第二柔性段532a的抗弯曲能力可以随着相邻切槽间距的改变而改变，本领域技术人员可以根据实际需要来设定相邻切槽间距以实现第二柔性段532a的抗弯曲能力小于弹性变形部51a的抗弯曲能力这一目的。
第二柔性段532a包括多组细长状的切槽组1601～1608。每组切槽(如1601)由两个以上的平行切槽1601a及1601b组成，各个平行切槽具有一定的宽度1609。这些切槽组1601～1608的延伸方向与柔性导引部53a的轴线513a形成一定的角度F。相邻两切槽组之间具有间隔1610。通过调整各组切槽组中切槽的个数和宽度1609大小、角度F的大小以及间隔1610的大小，可以调整第二柔性段532a的抗弯曲能力。优选地，平行切槽1601的个数可以为2～6个，距离1609可以为0.05～1mm，角度F优选为5～85度，间隔1610优选为0.1～1.0mm。将不同宽度1609的平行切槽组(1601～1608)组合到同一镍钛管上，能够实现在相同外力作用下，第二柔性段532a从远端至近端的抗弯曲能力逐 渐增强的目的，而具有抗弯曲能力渐变效果的柔性导引段53a能够对弹性植入体500a起到更好的导引作用。
第二柔性段532a与弹性变形部51a的连接方式可以是高分子热缩管或薄膜包覆、胶水粘接、激光焊接、锡焊等方式，基于现有技术，优选的方式是采用一体切割方式，在同一根管材上的不同区域切割出具有不同的纹理特征的第二柔性段532a及弹性变形部51a。为了达到柔性导引段53a抗弯曲能力渐变效果，一种可行的方式是，从远端至近端，相邻两个切槽组中角度F不变，切槽的宽度1609逐渐变小；另一种可行的方式是，从远端至近端，相邻两个切槽组中切槽的宽度1609不变，角度F逐渐增大。可以理解的是，同时改变相邻两个切槽组中的角度F和切槽的宽度1609，亦可以达到柔性导引段53a从远端至近端抗弯曲能力逐渐增大的效果。
请参阅图32及图33，连接件57a大体上与连接体57相同，不同之处在于，连接件57a的凸台571a具有多个沿其周向等间隔分布且相互连接的小凸起578。参见图34，多个小凸台578共同组成一个虚拟的圆周579(即多个小凸起578的外接圆为579)。圆周579的直径即为凸台571a的外径。由于多个小凸起578的存在，为活检钳提供了卡扣位置，使得活检钳更有效的夹紧连接装置进而回收弹性植入体500a。连接件57a与连接部52a的连接方式可以是高分子热缩管或薄膜包覆、胶水粘接、激光焊接、锡焊等。
可以理解的是，本发明其他实施例中，由于第二柔性段材质与弹性变形部材质相同，也可以将第二柔性段省略，将第一柔性段直接与弹性变形部相连接，在此不再赘述。
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本 领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，这些均属于本发明的保护之内。

Claims (20)

  1. 一种肺减容弹性植入体，其特征在于：所述肺减容弹性植入体包括弹性变形部以及与所述弹性变形部远端相连接的柔性引导部，所述柔性引导部设置有第一柔性段，所述第一柔性段包括插入段及远端段，所述插入段与所述弹性变形部的远端相连，所述第一柔性段的远端段的远端为所述肺减容弹性植入体远端，所述第一柔性段内设置有显影件。
  2. 根据权利要求1所述的肺减容弹性植入体，其特征在于：所述柔性引导部还包括连接于所述弹性变形部与所述第一柔性段之间的中空的第二柔性段，所述第一柔性段的插入段插入至所述第二柔性段，所述显影件近端随所述第一柔性段的插入段插入至所述第二柔性段。
  3. 根据权利要求2所述的肺减容弹性植入体，其特征在于：所述第一柔性段的插入段径向长度小于所述远端段的径向长度，所述插入段与所述远端段的连接处呈台阶状。
  4. 根据权利要求3所述的肺减容弹性植入体，其特征在于：所述显影件近端较所述插入段的近端靠近所述远端段的远端，且所述显影件近端与所述第一柔性段近端之间的垂直距离为0.5毫米至20毫米。
  5. 根据权利要求1所述的肺减容弹性植入体，其特征在于：所述显影件包括设置在所述第一柔性段内的显影丝。
  6. 根据权利要求5所述的肺减容弹性植入体，其特征在于：所述显影件还包括显影环，所述显影环连接于所述显影丝的远端。
  7. 根据权利要求2所述的肺减容弹性植入体，其特征在于，在相同外力作用下，所述第二柔性段从近端至远端越来越易变形。
  8. 根据权利要求7所述的肺减容弹性植入体，其特征在于，所述第二柔 性段包括由镍钛管切割而成的具有连续的螺旋状切槽的管状体。
  9. 根据权利要求8所述的肺减容弹性植入体，其特征在于，从所述第二柔性段的远端至近端，所述第二柔性段的相邻两个切槽沿所述第二柔性段轴向的间距逐渐变大。
  10. 根据权利要求2所述的肺减容弹性植入体，其特征在于：所述肺减容弹性植入体至少近端开口且还包括与所述弹性变形部近端相连的凸台，所述弹性变形部具有超弹性，所述弹性变形部沿其长度方向间隔设有若干切槽，在相同外力作用下，所述柔性引导部比所述弹性变形部更容易变形，所述凸台的外径大于输送状态下的所述弹性植入体靠近所述凸台处的外径。
  11. 根据权利要求10所述的肺减容弹性植入体，其特征在于，所述弹性植入体还包括位于所述弹性变形部及所述凸台之间的连接部，在相同外力作用下，所述连接部比所述弹性变形部更容易变形。
  12. 根据权利要求11所述的肺减容弹性植入体，其特征在于，所述连接部沿其长度方向间隔设有若干切槽。
  13. 根据权利要求12所述的肺减容弹性植入体，其特征在于，所述连接部包括多个首尾相拼接的中空子部件，每个所述中空子部件的近端均包括沿所述中空子部件的圆周方向分布的多个近端凸起，每个近端凸起从近端至远端的周向长度逐渐缩小，相邻两个近端凸起之间形成一个近端凹槽；每个所述中空子部件的远端均包括沿所述中空子部件的圆周方向分布的多个远端凸起，每个远端凸起从近端至远端的周向长度逐渐增大，相邻两个远端凸起之间形成一个远端凹槽。
  14. 根据权利要求7所述的肺减容弹性植入体，其特征在于，所述凸台部分远端端面向所述凸台的近端凹陷形成一个围绕所述凸台的纵向中心线的环 形凹槽。
  15. 根据权利要求7所述的肺减容弹性植入体，其特征在于，所述凸台的部分侧表面向所述凸台内部凹陷形成一个围绕所述凸台的纵向中心线的环形凹槽。
  16. 根据权利要求7所述的肺减容弹性植入体，其特征在于，所述凸台包括多个沿所述凸台周向间隔分布的小凸起。
  17. 一种肺减容器械，其特征在于，包括如权利要求1至16任一所述植入体和与所述植入体配套的输送装置，所述输送装置包括芯丝和输送器，所述植入体的近端可拆卸的连接在所述输送器的远端，所述芯丝可移动地穿至所述植入体的管腔和所述输送器的管腔中。
  18. 根据权利要求17所述的肺减容器械，其特征在于，所述芯丝的远端设有与所述芯丝同轴的芯丝引导头，所述芯丝引导头外径与芯丝外径一致。
  19. 根据权利要求18所述的肺减容器械，其特征在于，所述芯丝引导头包括导向柱及套设于所述导向柱上的的弹簧，所述导向柱与芯丝一体结构或者导向柱固接在芯丝远端；所述弹簧具有显影标识。
  20. 根据权利要求19所述的肺减容器械，其特征在于，所述植入体近端与所述输送器的远端可拆卸相连。
PCT/CN2017/117181 2016-12-30 2017-12-19 肺减容弹性植入体及肺减容器械 WO2018121346A1 (zh)

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