WO2015188705A1 - 肺减容弹性植入体及器械 - Google Patents

肺减容弹性植入体及器械 Download PDF

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Publication number
WO2015188705A1
WO2015188705A1 PCT/CN2015/080373 CN2015080373W WO2015188705A1 WO 2015188705 A1 WO2015188705 A1 WO 2015188705A1 CN 2015080373 W CN2015080373 W CN 2015080373W WO 2015188705 A1 WO2015188705 A1 WO 2015188705A1
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WIPO (PCT)
Prior art keywords
implant
elastic
lung volume
guide wire
elastic deformation
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PCT/CN2015/080373
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English (en)
French (fr)
Inventor
林伟林
李思漪
李安宁
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先健科技(深圳)有限公司
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Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to KR1020187033333A priority Critical patent/KR101939039B1/ko
Priority to KR1020177000646A priority patent/KR20170016953A/ko
Priority to JP2016572440A priority patent/JP6732663B2/ja
Publication of WO2015188705A1 publication Critical patent/WO2015188705A1/zh

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Definitions

  • the invention belongs to the technical field of interventional treatment, and relates to an implant and an instrument for interventional treatment, in particular to a lung volume reduction elastic implant and a device.
  • emphysema is a common lung disease, especially in the elderly. According to statistics, patients with end-stage emphysema are sick 5 The annual survival rate is less than 50% .
  • Traditional emphysema medical treatment includes oxygen inhalation, prevention of pulmonary infection, bronchial spasm, etc., but the curative effect is extremely limited; while the surgical treatment of emphysema is mostly based on lung volume reduction surgery, and there are many limitations.
  • figure 1 It is a schematic diagram of a lung volume reduction elastic coil of the prior art.
  • the product is made of a nickel-titanium memory alloy wire and can be elastically deformed under external force. 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 procedure for using the elastic coil includes three procedures of inserting a bronchoscope, establishing a channel, and implanting a product.
  • the schematic diagram of inserting the bronchoscope is shown in Figure 2. As shown, the bronchoscope 201 is inserted orally or nasally, and the bronchoscope 201 displays an image detected by the bronchoscope distal end 203 on the monitor 204 to guide the bronchoscope 201. Arrived in the bronchial 205 of the human lung.
  • FIG. 2 A schematic diagram of establishing a channel is shown in Fig. 2.
  • the outer diameter of the guide wire 206 is about 5Fr to about 7Fr, and the diameter of the delivery sheath can be about Between 5Fr and 9Fr.
  • the guidewire 206 is advanced through the lumen of the dilator 207, which travels through the lumen of the delivery sheath 208, the guidewire 206, the dilator 207 Once assembled with the delivery sheath 208, it enters the bronchoscope 201 from the working channel 202 of the bronchoscope 201 and enters the bronchus 205 through the distal end 203 of the bronchoscope 201.
  • the guidewire 206 is advanced through the lumen of the dilator 207, which travels through the lumen of the delivery sheath 208, the guidewire 206, the dilator 207
  • the bronchoscope 201 Once assembled with the delivery sheath 208, it enters the bronchoscope
  • the distal end 209 of the guidewire 206 is provided with a length indicia 210 indicating the distance from the distal end 209 along the guidewire 206.
  • the distal end of the delivery sheath 208 211 The logo 210 may be in the form of a plurality of corresponding high contrast metal strips including gold, platinum, rhodium, ruthenium, tungsten, and/or the like.
  • remote imaging capture device 212 A fluoroscopy system, an ultrasound imaging system, an MRI system, a computed tomography (CT) system, or some other remote imaging implant can guide the guidewire 206.
  • CT computed tomography
  • the remote imaging capture device 212 can display the detected image on the monitor 213, and the guidewire 206 track or imaging mark 210 is identified by the remote imaging capture device 212. To establish a channel.
  • the dilator 207 and the guidewire 206 are withdrawn proximally from the delivery sheath 208 so that the sheath 208 can be delivered.
  • the open cavity is loaded with a lung volume reduction elastic coil 301.
  • a schematic diagram of the implanted coil 301 is shown in Fig. 3, and the loading system 302 carrying the coil 301 is connected through the locking hub 303. Coupled to the proximal end of the delivery sheath 208.
  • the coil 301 is introduced into the delivery sheath, as shown in Figure 4, and the product is pushed out of the delivery sheath 208 by the cable 305 of the actuator 304.
  • the distal end thus enters the bronchi 205, the delivery sheath 208 is withdrawn, and the coil 301 is released by the gripper 306 of the actuator 304. Coil 301 When the initial shape is restored, the bronchi 205 is also pulled into a curl, thereby achieving a therapeutic effect of emphysema volume reduction.
  • the existing elastic coil made of nickel-titanium wire needs to be released through the delivery sheath, and the process of pushing the sheath into the bronchus may cause damage to the inner wall of the bronchus, leading to adverse events such as pneumothorax.
  • the existing surgical procedure for implanting the elastic coil requires three independent operations of inserting the bronchoscope, establishing the passage, and implanting the product, and the operation time is long, and the operation is performed while the patient is awake, if the operation time Too long, easy to cause patient discomfort and The occurrence of adverse events such as acute exacerbation of COPD.
  • the technical problem to be solved by the present invention is that, in view of the above-mentioned drawbacks in the prior art, an implant that does not employ a delivery sheath and is directly delivered by a guide wire is provided.
  • the use of the implant can prevent the sheath from causing damage to the inner wall of the bronchus and reduce the incidence of pneumothorax.
  • the technical problem to be further solved by the present invention is to provide an implantation operation process and a surgical operation for implanting an implant into a lung bypass or some small-diameter tracheal end according to actual requirements, combining a channel process and an implant.
  • a lung volume reduction device that is more convenient, reduces the operation time of the operation, and achieves a better therapeutic effect.
  • a lung volume reduction elastic implant the implant being tubular and including a proximal end of the implant, an elastic deformation portion and a distal end of the implant, the elastic deformation portion being located at the proximal end of the implant and the implant Between the distal ends and at least the elastic deformation portion
  • the shape has a shape memory property, and the implant body is open at least at the proximal end of the implant body, and the elastic deformation portion is spaced apart along the longitudinal direction thereof with a plurality of slits, and each of the slits communicates with the lumen of the elastic deformation portion.
  • the lung volume reduction elastic implant has an axially cut plane, and the angle between the slit direction of each slot and the length direction of the elastic deformation portion is 10- 90° And the shape and arrangement of the slots satisfy the elastic deformation portion for multi-directional bending and torsion, and meet the bending stress requirements of the implant.
  • the implant further includes an elastic film coated on an outer wall of the elastic deformation portion.
  • the elastic film may also cover the entire implant surface and fill into the slit.
  • the outer diameter of the implant is increased from the distal end to the proximal end.
  • the proximal end of the implant is integrally formed with the proximal end of the elastic deformation portion.
  • the distal end of the implant body extends outwardly and is connected with a flexible implant guiding head, and the implant guiding head is coaxial with the distal end of the implant and closes the implant.
  • the implant guide head is provided with a development mark.
  • the proximal end of the implant is provided with a detachable connecting member.
  • a technical solution adopted by the present invention further provides a lung volume reduction device, comprising any of the above implants and a conveying device matched with the implant, the conveying device comprising a guide wire and a hollow pushing member,
  • An implant is detachably coupled to a distal end of the pusher by a proximal end of the implant, the guide wire movably threading into a lumen of the implant and a lumen of the pusher .
  • the distal end of the guide wire is provided with a soft guide wire guiding head coaxial with the guide wire, and the outer diameter of the guide wire guide head is consistent with the outer diameter of the guide wire.
  • the soft guide wire guiding head may be provided with a development mark.
  • the guide wire guiding head includes a guiding column and a spring fixed to the guiding column, and the guiding column and the guide wire integral structure or the guiding column are fixed to the distal end of the guide wire; With a development mark.
  • the implant of the invention has a tubular shape and at least the proximal end of the implant is open, and the guide wire can be directly inserted into the lumen of the implant to bind the implant into a straight strip for transport. Therefore, the delivery sheath which is larger than the outer diameter of the implant is no longer needed to restrain the implant, and the damage of the delivery sheath to the trachea during transportation is avoided, and the incidence of pneumothorax is further reduced.
  • the implant can be open at both the proximal end of the implant and the distal end of the implant, or it can be the proximal end of the implant only.
  • the guide wire can be used to directly guide and establish a passage in the trachea.
  • the implant may include a flexible guide head disposed at the distal end of the implant and closing the distal end of the implant, in which case the guide wire may be directly passed
  • the flexible guide head is used to guide and establish a passage in the trachea by inserting into the lumen of the implant and binding the flexible guide.
  • the implant of the invention has a hollow lumen structure, which facilitates the passage of the guide wire through the lumen of the implant before the operation, so that the implant is loaded on the guide wire, and the two are pushed together to the lung through the bronchoscope.
  • the guide wire or the implant itself is used to establish a channel, and after the implant is pushed to the appropriate target area, the guide wire is released to release the implant, that is, the established channel of the prior art.
  • the process and the implantation of the implant are completed simultaneously, which can effectively reduce the operation time of the operation and thus avoid Adverse events such as acute exacerbations of COPD.
  • the implant is covered with an elastic film on the elastic deformation portion or the entire implant, which can avoid direct contact between the metal surface of the implant and the inner wall of the bronchus, and reduce the release of metal elements, thereby effectively reducing pneumonia. Or a small airway infection.
  • the device of the present invention uses the guide wire to load the implant while guiding the establishing channel and conveying the implant and releasing it; or the soft end of the implant body is provided at the distal end of the implant body, and the implant guiding head can Guide and establish the function of the channel, the implant can be released immediately after the channel is established; using this solution to combine the process of establishing the channel and the implantation process of the implant, the operation is more convenient and the operation time can be reduced.
  • the delivery device adopts a guide wire to penetrate into the implant having the lumen structure, and is pushed by the push mechanism to complete the delivery of the implant.
  • the guide wire is constrained to make the implant pass the natural state (ie, heat treatment).
  • the predetermined state of the obtained curl is converted into a delivery state (ie, a straight strip shape in accordance with the shape of the guide wire), and after the guide wire is withdrawn from the lumen of the implant, the constraint of the guide wire is released, and the plant can be made
  • the infusion body is transformed from a delivery state to a natural state, thereby achieving the effect of squeezing the target area of emphysema.
  • the delivery device has a smaller diameter, which enables the implant to enter a smaller emphysema target area and achieve a better therapeutic effect.
  • the invention adopts the technical scheme of establishing a channel and releasing the implant, which can shorten the whole operation time and can be more accurately positioned in the target area of the emphysema.
  • the device of the invention is also coated on the surface of the implant with an elastic membrane, and the elastic membrane is made of a polymer material with better biocompatibility, so that the elastic membrane of the polymer material is in contact with the inner wall of the bronchus, and the prior art
  • the nickel-titanium wire in the direct contact with the inner wall of the bronchus can reduce bronchial inflammation and damage caused by friction between the implant and the inner wall of the bronchus during breathing, thereby reducing the risk of pneumonia and small airway infection.
  • the metal surface of the implant is coated with an elastic film of a polymer material, which can effectively reduce the release of metal elements.
  • FIG. 1 is a schematic structural view of a prior art elastic coil
  • FIG. 2 is a schematic view showing the operation of establishing a passage for implanting a bronchoscope and a guide wire in the prior art
  • Figure 3 is a schematic view of a prior art conveying elastic coil
  • Figure 4 is a schematic view of a prior art release elastic coil
  • FIG. 5 is a schematic structural view of an implant according to an embodiment of the present invention.
  • Figure 6 is a cross-sectional view of the implant shown in Figure 5;
  • FIG. 7 is a schematic view showing a slit of the implant according to an embodiment of the present invention, which is cut along the longitudinal direction thereof and expanded;
  • FIG. 8 is a schematic view showing a structure of a slit after the elastic deformation portion of the implant is restrained into a straight strip according to another embodiment of the present invention.
  • Figure 9 is a partial cross-sectional view of the implant shown in Figure 8.
  • FIG. 10 is a development view of an embodiment of a slit of an implant according to still another embodiment of the present invention.
  • Figure 11 is a partial schematic view showing the elastic deformation portion of the implant shown in Figure 10;
  • FIG. 12 is a development view of another embodiment of a slit of an implant according to still another embodiment of the present invention.
  • Figure 13 is a partial schematic view showing the elastic deformation portion of the implant shown in Figure 12;
  • FIG. 14 is a schematic structural view of an implant with a connector and a skeleton guiding head according to an embodiment of the present invention
  • FIG. 15 is a schematic structural view of an implant retaining a partial elastic film according to an embodiment of the present invention.
  • FIG. 16 is a schematic view of a lung volume reduction device according to an embodiment of the present invention.
  • Figure 17 is an enlarged view of I of Figure 16;
  • FIG. 18 is a schematic diagram of a working channel for establishing a lung volume reduction device according to an embodiment of the present invention.
  • Figure 19 is an enlarged view of A of Figure 18;
  • 20 is a schematic view of an implant implanted in an embodiment of the present invention.
  • Figure 21 is an enlarged view of B of Figure 20.
  • a lung volume reduction elastic implant is tubular and includes a proximal end of the implant. 201, an elastic deformation portion 205 and an implant distal end 202, the elastic deformation portion 205 being located between the implant proximal end 201 and the implant distal end 202 and at least the elastic deformation portion 205 Having shape memory characteristics, the implant 2 is at least open at the proximal end 201 of the implant (the proximal end is near the end of the operator), the implant 2
  • the three components can be a one-piece structure, or the three parts can be realized by a fixed connection.
  • the elastic deformation portion 205 includes a lumen 207.
  • the elastic deformation portion 205 is provided with a plurality of slots along its axial direction, that is, in the longitudinal direction. 204, the slot 204 is in communication with the lumen 207.
  • the elastic deformation portion 205 is an implant 2
  • the main structure is a predetermined shape that is curled in a natural state (ie, when it is not subjected to any external force), and 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.
  • Implant 2 It can be made of a material having a shape memory function 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 a human body and has a shape memory function.
  • the implant 2 Made of nickel-titanium alloy, specifically hollow nickel-titanium tube. Specifically, the hollow nickel-titanium tube raw material is laser-engraved to a certain slit 204, and then bent into a predetermined shape, and then heat-treated and shaped to obtain the implant 2 .
  • Implant 2 The outer and inner diameters are determined by their own characteristics and the outer diameter of the guidewire, ie, as far as possible, to maintain a sufficient elasticity to pull the lung tissue, as far as possible to implant the lung bypass or the end of some small diameter trachea To achieve better therapeutic results.
  • the implant The inner diameter of 2 needs to be larger than the outer diameter of the guide wire.
  • the implant 2 has an outer diameter of 0.5 to 2.5 mm and a wall thickness of 0.01 to 0.5 mm.
  • Implant 2 It is possible to use an equal diameter pipe having the same outer diameter and inner diameter from one end to the other end, and a non-equal diameter pipe having a change in outer diameter and inner diameter.
  • the implant 2 is a conical tube whose lumen 207 has a diameter which is gradually thickened from the distal end to the proximal end, that is, the outer diameter of the implant 2 is increased from the distal end toward the proximal end.
  • the wall thickness of the conical tube varies from 0.01 mm at the distal end 202 of the implant to 0.2 mm at the proximal end 201 of the implant.
  • the presence of the slit 204 enables the elastic deformation portion 205 to perform a curvature with a large curvature, and can also realize the elastic deformation portion 205. Torsing at various angles to form a complex predetermined shape.
  • the arrangement of the slots 204 is not limited, and the slots 204 are generally arranged in parallel, spiral, etc., from the elastic deformation portion.
  • the slits 204 may be partially arranged or may be arranged in the circumferential direction of the elastic deformation portion 205.
  • the grooving 204 has a variety of shapes, for example, grooving 204 It is generally a long and narrow structure.
  • the angle between the slit 204 and the axis of the elastic deformation portion 205 is 10-90°; that is, the slit 204
  • the angle between the opening direction and the axis of the elastic deformation portion 205 is 10-90°, and the arrangement of the slit 204 is for better bending and torsion, the groove 204 and the elastic deformation portion.
  • the axis of the 205 is not parallel to facilitate the bending of the elastic deformation portion 205, and in the case where the angle ⁇ is 90°, the bending of the elastic deformation portion 205 in the same plane is facilitated, and the angle is less than 90°.
  • the elastic deformation portion 205 can be formed in a range of 360°.
  • the angle ⁇ between the slot 204 and the axis of the elastic deformation portion 205 is preferably 45-90°.
  • the shape and number of the slits 204, the density of the arrangement, and the position of the slit 204 should satisfy the elastic deformation portion 205 for multi-directional bending and twisting, and the slit 204
  • the position, number and shape, and the arrangement density are required to meet the bending stress requirements applied to the extruded lung tissue after the implant 2 is implanted into the lung tissue, that is, the implant 2 Do not pierce the bronchi when pulling the tissue in the emphysema area during the process of restoring deformation.
  • the grooving 204 can be specifically set according to actual calculations, so that the implant 2 When implanted into the lungs, it will not cause piercing of the bronchus due to excessive local stress, and also avoid damage to the human body caused by damage and breakage of the implant 2 due to excessive stress.
  • a single slit 204 is a dumbbell shape, and the elastic deformation portion 205 shown in Fig. 7 is shown.
  • the slit 204 forms an angle ⁇ with the axis of the elastic deformation portion 205 of 90°.
  • Multiple slots 204 are equally spaced, all slots 204 Parallel to each other.
  • the dumbbell-shaped slit 204 satisfies the bending and twisting of the elastic deformation portion 205.
  • Elastic deformation The 205 has an outer diameter of 0.5-1.5 mm and a wall thickness of 0.01-0.2 mm.
  • each set of slits 204 includes three slits 204a, slits 204b, and slits 204c which are circumferentially arranged along the elastic deformation portion. And both ends of the three slits are aligned with each other in the circumferential direction.
  • the grooving 204a, the grooving 204b, and the grooving 204c have a certain interval 209, and there is a gap between the two adjacent grooving grooves 204. 208.
  • the slits 204 are elongated structures, and the extending directions of the slits 204 form an angle ⁇ with the axis of the elastic deformation portion 205.
  • the entire elastic deformation portion 205 can be adjusted.
  • the bending stress makes it meet the implant requirements.
  • the number of slots in each set of slots 204 may be 2-6, and the spacing between adjacent slots 204 may be 0.05-1.
  • Mm the angle ⁇ can be 10-85°
  • the interval 208 between each group is 0.1-1.0 mm.
  • the outer diameter of the elastic deformation portion 205 is about 1.0-2.0 mm, and the wall thickness is 0.05-0.3 mm.
  • each group of slots 204 is composed of two or more side by side elliptical slots 204.
  • each group of slots 204 is composed of two parallel slots 204a and slots 204b, and slots are formed.
  • the slot 204b is iteratively arranged, the slot 204a, the slot 204b has a certain spacing 209, and the angle ⁇ between the slot 204 and the axis of the elastic deformation portion 205 is At 90°, the extending direction of the arrangement between the groups forms a certain angle ⁇ with the axis of the elastic deformation portion 205.
  • the angle ⁇ can be 60-90°, and there is about 0.3-5 between each group of slots 204.
  • the pitch of mm is 208, and the groovings 204 of each group are arranged in a stepwise periodic manner. For example, 5-20 sets of grooving 204 may be a cycle, and the stepped periodic grooving 204 is beneficial to the elastic deformation part.
  • the elastic deformation portion 205 of 205 is bent into a specific shape.
  • the proximal end of the elastic deformation portion 205 has a proximal end 201 of about 1.5-10 mm length and a distal end 202 of the implant, proximal end of the implant 201 has a length of about 0.5-5 mm cut into a threaded groove as the connecting member 210.
  • the mold use the mold to bend the cut implant 2 into a figure 14
  • the shape shown is heat treated and shaped into the implant 2 described.
  • the implant 2 has an outer diameter of 1.2-2.5 mm and a wall thickness of 0.1-0.4 mm.
  • the two ends of the elastic deformation portion 205 are the proximal end 201 of the implant and the distal end of the implant 202, respectively.
  • the implant proximal end 201 is used to set the connector 210 and the distal end 202 of the implant is used to advance into the trachea.
  • Implant proximal 201 A connecting member 210 for detachably connecting with a pushing mechanism (such as a hollow push cable) is connected.
  • the detachable connecting method in the present invention means that the connecting member 210 before pushing and during pushing. Fixed with the push mechanism, the connector 210 is disengaged from the push mechanism when pushed into position.
  • the connector 210 has a variety of structures and connections for detachable connections, such as shown in Figure 5, with a threaded connection to the proximal end of the implant. 201 Welded with a female threaded connection 210. When assembled, it can be screwed with the external thread provided by the pushing mechanism; after the push reaches the corresponding position, the connecting member 210 is passed through the torsion pushing mechanism. Can be separated from the push mechanism.
  • the connector 210 can also be other components that can be detached from the fixed connection, such as magnetic connecting devices, elastic snaps, lassos, etc., respectively disposed at the proximal end of the implant of the implant 2.
  • the detachable fixed connection is achieved.
  • the connecting member 210 disposed at the proximal end 201 of the implant is a spiral connecting hook, and the same pushing mechanism is also provided with a spiral connecting hook, and the two are rotated and hooked together to insert the implant 2 It can be detachably fixedly attached to the distal end of the push mechanism.
  • the implant distal end 202 is not open when the distal end of the implant 2 is not open.
  • the implant guide head 211 Extendingly coupled to a flexible implant guide head 211, the implant guide head 211 is coaxial with the implant distal end 202 and encloses the implant distal end 202, the implant guide head 211 A development mark is provided.
  • the implant guide head 211 has a function of guiding and establishing a passage, and may be integrally formed with the distal end 202 of the implant, or may be additionally fixed to the distal end 202 of the implant.
  • Implant head The 211 has relative flexibility to avoid scratching the tracheal wall after entering the trachea.
  • the purpose of the development mark setting is to facilitate monitoring during the push process.
  • the development mark can pass the fluoroscopy system, the ultrasound imaging system, and the MRI.
  • CT computed tomography
  • the identification of the implant by the system, computed tomography (CT) system or other remote imaging, the specific structure is not limited.
  • the implant 2 is displayed and guided by these systems, in this embodiment A wire with a diameter of 0.1-0.5 mm and a relatively strong X-ray developable tungsten, tantalum or the like is wound with a length of about 1-10 mm as a developing mark.
  • This embodiment will develop the identification mark and the implant guide head 211 merge into one part to achieve two functions.
  • a development mark such as a developing ring may be additionally provided on the implant guiding head 211, and the developing ring is sleeved on the implant guiding head 211. On.
  • the elastic deformation portion 205 may be covered with an elastic film 206.
  • the elastic membrane 206 completely covers the elastic deformation portion 205, the proximal end 201 of the implant, and the distal end 202 of the implant, facilitating the overall implant 2
  • the trachea is not damaged during implantation.
  • the elastic film 206 can also be filled into the slit 204 to ensure that the surface of the implant 2 is smooth as a whole, and the elastic film 206 is filled in the slit 204 to also make the elastic film 206 can be more firmly coated on the surface of the implant 2.
  • the inner wall and the elastic deformation portion formed by the elastic film 206 in the slit 204 are formed.
  • the inner wall of the lumen 207 is flush.
  • the elastic film 206 may have a thickness of 0.01 to 0.3 mm.
  • the elastic film 206 It can be made of polymer materials with excellent chemical stability, water resistance, weathering resistance, good low compressibility, good biocompatibility, high mechanical strength, non-toxicity and odorless properties. For example, these polymer materials may be silicone rubber or polyurethane materials.
  • Figure 15 is a cross-sectional view of an implant 2 with a retained partial elastic membrane 206, an elastic deformation portion 205, in accordance with an embodiment of the present invention.
  • the deformation portion includes a plurality of sets of slots 204.
  • the elastic deformation portion 205, the proximal end 201 of the implant, the distal end 202 of the implant, and the surface of the implant guiding head 211 are covered with an elastic membrane 206. .
  • the lung volume reduction elastic body 2 of one embodiment of the present invention is open at both ends, that is, the proximal end of the implant 201 and the distal end of the implant 202.
  • the ends are open and may not include the implant guide head 211.
  • An embodiment of the present invention further provides a lung volume reduction device, as shown in FIG. 1-21, comprising an implant 2 and a delivery device 1 , the implant 2
  • the tubular structure having shape memory characteristics has a main body which is an elastic deformation portion 205, and the elastic deformation portion 205 has a lumen 207; the two ends of the implant 2 are the proximal end of the implant 201 And the distal end 202 of the implant, the wall of the elastic deformation portion 205 is provided with a plurality of slits 204, and the slit 204 penetrates into the lumen 207 of the elastic deformation portion 205;
  • 1 includes a guide wire 101 and a push mechanism 110 (the push mechanism 110 generally includes a hollow pusher member, i.e., a hollow steel cable 103 and a steering handle connected to the push cable 103)
  • the implant 2 is detachably coupled to the distal end of the push mechanism 110 by a connector 210, and the implant 2 and the push cable 103 are respectively fitted
  • the guide wire 101 is used to carry the implant 2, guide and establish a channel, and the implant 2 is integrally placed on the guide wire 101. Further, the implant 2 is constrained by the guide wire 101 into a straight strip shape, that is, the implant 2 is stretched by the guide wire 101 into a straight conveying state in conformity with the guide wire 101 to facilitate entry into the trachea.
  • a guide wire 101 can be inserted from the proximal end 201 of the implant 2, and the guide wire 101 can be used with a diameter of Made of 0.1-1.1 mm wire.
  • the purpose of the guide wire 101 is to establish a channel and implant the implant 2
  • the delivery to the lesion site eliminates the need to transport the sheath to bind the implant, thereby avoiding damage to the trachea during delivery, further reducing the incidence of pneumothorax.
  • the wire has a certain rigidity and toughness, can be properly bent, conforms to the shape of the trachea, and can be gradually advanced along the trachea. Compared to the prior art, the implant is no longer needed, and the implant is no longer needed. 2 Implantable lung bypass or the end of some small diameter trachea for better therapeutic results.
  • the guide wire guide head 102 includes a guide post 102a and a guide post 102a.
  • the outer sleeve fixed spring 102b, the guide post 102a and the guide wire 101 are integrally formed or the guide post 102a is fixed to the distal end of the guide wire 101; the spring 102b With a development logo.
  • the guide wire guiding head 102 is the distal end of the guide wire 101
  • the soft treatment can effectively avoid damage to the tracheal wall when the trachea is implanted.
  • the flexible guidewire guide 102 can be realized by a spring having a soft feature, i.e., integral with the guidewire 101 or attached to the guidewire 101.
  • the distal guide post 102a is fitted with a spring 102b.
  • the specific manufacturing may be: the tip end of the guide wire 101 is refined to form a guide post 102a, and the length of the guide post 102a is fixed to a length of 5-150 mm spring 102b.
  • the fixing method may be a polymer heat shrinkable tube or a film coating, a glue bonding, a laser welding, a soldering or the like.
  • Guidewire 101 is guided from the proximal end of implant 2 of implant 2 under the guidance of a flexible guidewire guide 102 It can smoothly enter the lumen of the elastic deformation portion 205, and the implant 2 can be restrained from the shape shown in Figs. 5 and 6 into a straight conveying state, as shown in Fig. 16. Obviously, based on the prior art, the implant is loaded
  • the guide wire 101 of 2 also has the function of guiding and establishing a passage in the bronchus.
  • the development mark can pass the fluoroscopy system, ultrasound imaging system, MRI system, computed tomography (CT)
  • CT computed tomography
  • the identification of the display by the system or other remote imaging, the specific structure is not limited.
  • the guide wire 101 is displayed and guided by these systems, and in this embodiment, a wire diameter of 0.01-0.3 mm is used.
  • a spring wound with a wire such as tungsten or tantalum with strong X-ray developability is used as a development mark.
  • This embodiment will develop the identification mark and the guide wire guiding head 102. Merge into one component to achieve two functions. In addition to this, it is also possible to guide the head 102.
  • a development mark is additionally set on the upper side.
  • 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.
  • a guide wire handle 105 is provided at the proximal end of the guide wire 101 for conveying the guide wire 101. , or after the implant 2 is delivered into place, the guide wire 101 is withdrawn.
  • the push mechanism 110 includes a hollow push cable 103, and a steering handle 106 coupled to the push cable 103.
  • the push cable 103 and the implant 2 are both set on the guide wire 101, and the distal end of the push cable 103 is connected to the proximal end of the implant 2 210 Connected.
  • the connection is detachably connected by a coupling fitting 109 provided at the distal end of the connector 210 of the implant 2 and the push cable 103, respectively.
  • Connector 210 and connection fitting 109 There are a variety of configurations and connections, such as a threaded connection, a connector 210 with internal threads welded to the proximal end 201 of the implant 2, or directly at the proximal end of the implant 201 Directly drive the internal thread as a connector 210.
  • An externally threaded connecting fitting 109 is provided at the distal end of the push cable 103, and the internal thread of the connecting member 210 and the pushing mechanism 110 can be assembled during assembly.
  • the implant 2 With the externally threaded connection, the implant 2 is securely attached to the distal end of the push cable 103; after the implant 2 is pushed to the corresponding position, the steering handle of the cable 103 is pushed by twisting 106 Then, the connecting member 210 of the implant 2 and the connecting fitting 109 of the push cable 103 are spun out.
  • Connector 210 and connection fitting 109 Other detachable fixed connecting members, such as magnetic connecting devices, elastic snaps, lassos, etc., are respectively disposed on the implant proximal end 201 of the implant 2 and the push cable 103 for detachable connection. .
  • the connecting member 210 disposed at the proximal end 201 of the implant is a spiral connecting hook
  • the distal end of the push cable 103 is also provided with a spiral connecting hook, and the two are rotated and hooked together to be implanted.
  • Body 2 The detachable fixed connection is at the distal end of the pushing mechanism 110, and after the implant 2 is pushed into position, the steering handle 106 of the push-pull cable 103 is reversely rotated, and the two helical connecting hooks are separated from each other.
  • the assembly of the implant 2 with the guide wire 101 can be accomplished by means of a loader during production assembly.
  • the implant 2 By inserting into the loader, the implant body 2 which is curled in a natural state can be restrained into a tube in a straight strip conveying state by the limitation of the loader space, and the guide wire 101 assembled with the pushing mechanism 110 can be implanted.
  • the implant proximal end 201 is inserted and passed through the implant distal end 202 of the implant 2 until the guidewire guide 102 of the guidewire 101 is threaded out of the distal end of the implant 2 of the implant 2 Stopping, or with the implant distal end 202 closed by the implant guide head 211, the guidewire 101 is inserted through the implant proximal end 201 of the implant 2 and inserted into the implant 2 implant distally end 202 stops, at which point the loader can be unloaded, the implant 2 has been loaded into a straight delivery state under the constraint of the guide wire 101, and the connection fitting of the distal end of the push cable 103 in the push mechanism 110 will be 109 is connected to the connector 210 of the implant 2.
  • the guide wire 101 of the implant 2 is sheathed through the working channel 902 of the bronchoscope 901.
  • the implant 2 is used along the guide wire 101 by the push cable 103.
  • Pushing to the guide wire guiding head 102 the guide wire 101 is withdrawn, and the guide wire 101 is withdrawn, and the implant 2 is guided by the guide wire 101 as shown in Figs.
  • the straight-line conveying state that is restrained automatically returns to the natural shape shown in Figs. 20 and 21, and the recovery process can squeeze and pull the emphysema area.
  • the peripherally relatively healthy lung tissue can better exert its respiratory physiological function, thereby achieving the effect of lung volume reduction.
  • the push cable can then be released by rotating the steering handle 106 of the cable 103.
  • the distal connecting fitting is threadedly coupled to the connector 210 of the implant 2 to release the implant 2.

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Abstract

一种肺减容弹性植入体（2）及肺减容器械，肺减容弹性植入体（2）呈管状且包括植入体近端（201）、弹性变形部（205）和植入体远端（202），弹性变形部（205）位于植入体近端（201）和植入体远端（202）之间且至少弹性变形部（205）具有形状记忆特性，肺减容弹性植入体（2）至少在植入体近端（201）开口，弹性变形部（205）沿其长度方向间隔设有若干切槽（204），各切槽（204）与弹性变形部（205）的管腔相通；肺减容器械包括肺减容弹性植入体（2）和与其配套的输送装置（1），输送装置（1）包括导丝（101）和中空推送件（110），肺减容弹性植入体（2）通过植入体近端（201）可拆卸地连接在中空推送件（110）的远端，导丝（101）可移动地贯穿肺减容弹性植入体（2）的管腔和中空推送件（110）的管腔。肺减容器械使得手术操作更方便、时间更短，避免对支气管内壁的损伤，减少气胸发生率。

Description

肺减容弹性植入体及器械 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器械。
背景技术
在临床治疗中，肺气肿是一种常见肺部疾病，尤其老年人的发病率较高。据统计，终末期肺气肿患者患病 5 年的生存率不足 50% 。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，临床指标不佳，已遭美国 FDA 的拒绝，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。
使用所述弹性线圈的术式包括插入支气管镜、建立通道和植入产品三个操作过程。插入支气管镜的示意图如图 2 所示，经口或鼻插入支气管镜 201 ，支气管镜 201 可将支气管镜远端 203 探测到的图像显示在监测器 204 上，从而引导支气管镜 201 到达人类肺部的支气管 205 中。
建立通道的示意图如图 2 所示，导丝 206 外径约为 5Fr 到约 7Fr ，而输送鞘管管径可以在约 5Fr 和 9Fr 之间。将导丝 206 行进通过扩张器 207 的内腔，扩张器 207 行进通过输送鞘管 208 的内腔，导丝 206 、扩张器 207 和输送鞘管 208 装配好后一起从支气管镜 201 的工作通道 202 进入支气管镜 201 内，通过支气管镜 201 的远端 203 进入支气管 205 内。导丝 206 的远端 209 设有长度标记 210 ，该标记 210 指示从远端 209 开始沿导丝 206 的距离。输送鞘管 208 的远端 211 可具有多个相对应的高对比金属带（包括金、铂、钽、铱、钨和 / 或类似金属）形式的标识 210 。使用具有远程成像捕捉装置 212 的荧光检查系统、超声成像系统、 MRI 系统、计算 X 线断层摄像术（ CT ）系统或一些其它的远程成像植入体能对导丝 206 进行引导。如图 2 中，远程成像捕捉装置 212 能将探测到的图像显示在监测器 213 上，通过远程成像捕捉装置 212 识别出导丝 206 轨迹或成像标记 210 ，从而建立通道。
建立通道后，从输送鞘管 208 中朝近端抽出扩张器 207 和导丝 206 ，从而可在输送鞘管 208 的打开空腔中装载肺减容弹性线圈 301 。植入线圈 301 的示意图见图 3 ，将装载好线圈 301 的装载系统 302 通过锁定毂连接 303 联接于输送鞘管 208 的近端。将线圈 301 导入输送鞘管内，如图 4 所示，通过致动装置 304 的钢缆 305 将产品推出输送鞘管 208 的远端从而进入支气管 205 内，后撤输送鞘管 208 ，通过致动装置 304 的抓持器 306 释放线圈 301 。线圈 301 恢复初始形状的同时也牵拉着支气管 205 成为卷曲状，从而实现肺气肿减容的治疗效果。
上述植入体及其植入方式具有以下缺陷：
1 、现有的镍钛丝制成的弹性线圈需要通过输送鞘管进行释放，输送鞘管在支气管内推送的过程可能会对支气管内壁造成损伤，导致气胸等不良事件的发生。
2 、由于输送鞘管外径较大，约在 5Fr 至 9Fr ，因此，通过输送鞘管很难将弹性线圈植入到肺部旁路或某些小直径气管的末端，通过弹性线圈得到挤压和牵拉的肺气肿区范围有限，影响减容效果。
3 、现有植入弹性线圈的术式需要有插入支气管镜、建立通道、植入产品三个独立的操作过程，操作时间较长，而且该手术是在病人清醒状态下进行操作的，若操作时间过长，易引起病人的不适以及 COPD 急性恶化等不良事件的发生。
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，提供一种不采用输送鞘管、直接采用导丝输送的植入体。采用该植入体能避免输送鞘管对支气管内壁造成损伤，减少气胸的发生率。
本发明进一步要解决的技术问题，是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、合并建立通道过程和植入体的植入操作过程、手术操作更加方便、减少手术操作时间、达到更好治疗效果的肺减容器械。
本发明解决其技术问题所采用的一种技术方案是：
一种肺减容弹性植入体，所述植入体呈管状且包括植入体近端、弹性变形部和植入体远端，所述弹性变形部位于植入体近端和植入体远端之间且至少所述弹性变形部 具有形状记忆特性，所述植入体中至少在植入体近端开口，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。
在本技术方案一实施例中，所述的肺减容弹性植入体沿轴向剖开的展开平面上，各切槽的切口方向与所述弹性变形部的长度方向夹角 α 为 10-90° ；且切槽形状和排布满足弹性变形部进行多方向弯曲和扭转，并符合植入体的弯曲应力要求。
在本技术方案一实施例中，所述植入体还包括包覆于所述弹性变形部外壁的弹性膜。
在本技术方案一实施例中，所述弹性膜还可以包覆整个植入体表面并填充至所述切槽中。
在本技术方案一实施例中，所述植入体外径从远端往近端方向递增。
在本技术方案一实施例中，所述植入体近端与所述弹性变形部的近端成一体结构。
在本技术方案一实施例中，所述植入体远端向外延伸连接有柔性的植入体导向头，所述植入体导向头与植入体远端同轴且封闭所述植入体的远端，所述植入体导向头设有显影标识。
在本技术方案一实施例中，所述的肺减容弹性植入体中，所述植入体近端设有可拆卸连接件。
本发明采用的一种技术方案还提供一种肺减容器械，包括上述任一种植入体和与所述植入体配套的输送装置，所述输送装置包括导丝和中空推送件，所述植入体通过所述植入体近端可拆卸地连接在所述推送件的远端，所述导丝可移动地穿至所述植入体的管腔和所述推送件的管腔中。
在本技术方案一实施例中，所述导丝的远端设有与导丝同轴的软性导丝引导头，所述导丝引导头外径与导丝外径一致。
在本技术方案一实施例中，所述软性导丝引导头上可设有显影标识。
在本技术方案一实施例中，所述导丝引导头包括导向柱、导向柱外套装固定的弹簧，所述导向柱与导丝一体结构或者导向柱固接在导丝远端；所述弹簧具有显影标识。
相比现有技术，本发明的植入体呈管状且至少植入体近端开口，可以直接将导丝穿入到植入体的管腔中来将植入体束缚成直条形进行输送，从而不再需要比植入体外径大的输送鞘管来束缚植入体，避免了输送过程中输送鞘管对气管的伤害，进一步减少气胸的发生率。另一方面，所述植入体可以是在植入体近端和植入体远端都开口，也可以是仅植入体近端开口。当植入体近端和植入体远端都开口时，可以利用导丝直接在气管中导向并建立通道。当植入体仅植入体近端开口时，所述植入体可包括设于所述植入体远端且封闭该植入体远端的柔性导向头，此时可直接通过将导丝插入所述植入体的管腔内并束缚所述柔性导向头的方式来利用所述柔性导向头在气管中导向并建立通道。通过导丝进行装载和释放，可以植入到肺部旁路或某些小直径气管的末端，对肺气肿区域进行挤压，以达到肺部介入治疗的效果。
本发明的植入体具有空心管腔的结构，方便手术时预先将导丝穿过植入体的管腔，使植入体装载在导丝上，通过支气管镜将该两者一起推送至肺气肿区的支气管内，如前所述，利用导丝或植入体本身建立通道，将植入体推送到合适靶区后，后撤导丝释放植入体，即将现有技术的建立通道过程和植入体的植入两个操作过程同步完成，可以有效减少手术操作的时间，从而避免 COPD 急性加重等不良事件的发生。
再者，植入体在弹性变形部或者整个植入体都采用弹性膜包覆在表面，能够避免植入体的金属表面与支气管内壁的直接接触，减少了金属元素的释放，从而有效减少肺炎或者小气道感染。
本发明的器械利用导丝装载植入体，同时导向建立通道以及输送植入体并进行释放；或者植入体远端设有软性的植入体导向头，植入体导向头可起到导向和建立通道的作用，在建立通道后可立即释放植入体；利用这个方案合并建立通道过程和植入体的植入操作过程，手术操作更加方便，还能减少手术操作的时间。
本发明器械中，输送装置是采用导丝穿进具有管腔结构的植入体中，并通过推送机构推送来完成植入体的输送，导丝的约束使得植入体经由自然状态（即热处理后得到的卷曲的预定状态）转变为输送状态（即配合导丝形状的直条状），将导丝从植入体的管腔内撤出后，便解除了导丝的约束，可使得植入体由输送状态转变为自然状态，从而达到挤压肺气肿靶区域的效果。与现有技术采用输送鞘管相比，输送装置直径更小，能使得植入体进入更小的肺气肿靶区域，达到更好的治疗效果。本发明采用建立通道与释放植入体相结合的技术方案，可以缩短整个手术时间，并能够更精确地定位于肺气肿靶区域内。
本发明的器械还采用弹性膜包覆在植入体表面，弹性膜选择生物相容性更好的高分子材料制成，使得与支气管内壁接触的是高分子材料的弹性膜，与现有技术中的镍钛丝直接与支气管内壁接触的方案相比，能减少在呼吸过程中因植入体与支气管内壁的摩擦导致的支气管发炎及损伤，从而减少肺炎以及小气道感染的风险。另外，将植入体的金属表面包覆上高分子材料的弹性膜，能有效减少金属元素的释放。
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 是现有技术中植入支气管镜和导丝建立通道的操作示意图；
图 3 是现有技术中输送弹性线圈的示意图；
图 4 是现有技术中释放弹性线圈的示意图；
图 5 是本发明一实施例提供的植入体的结构示意图；
图 6 是图 5 所示植入体的剖示图；
图 7 是将本发明一实施例提供的植入体沿其长度方向剖开并展开后的切槽示意图；
图 8 是本发明另一实施例提供的植入体的弹性变形部约束成直条后的切槽结构示意图；
图 9 是图 8 所示植入体的局部剖视图；
图 10 是本发明又一实施例提供的植入体的切槽一种实施方式的展开图；
图 11 是图 10 所示植入体的弹性变形部的局部示意图；
图 12 是本发明再一实施例提供的植入体的切槽另一实施方式的展开图；
图 13 是图 12 所示植入体的弹性变形部的局部示意图；
图 14 是本发明一实施例提供的带有连接件和骨架导向头的植入体的结构示意图；
图 15 是本发明一实施例提供的保留局部弹性膜的植入体的结构示意图；
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 的 I 处放大图；
图 18 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 19 是图 18 的 A 处放大图；
图 20 是植入本发明一实施例提供的植入体的示意图；
图 21 是图 20 的 B 处放大图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
如图 5 、 6 所示，本发明一实施例提供的肺减容弹性植入体，所述植入体 2 呈管状且包括植入体近端 201 、弹性变形部 205 和植入体远端 202 ，所述弹性变形部 205 位于植入体近端 201 和植入体远端 202 之间且至少所述弹性变形部 205 具有形状记忆特性，所述植入体 2 中至少在植入体近端 201 开口（近端指靠近手术操作者的一端） ，植入体 2 的三个组成部分可以为一体结构，也可以这三部分通过固定连接实现。
所述弹性变形部 205 包括管腔 207 。所述弹性变形部 205 沿其轴向即长度方向上间隔设有若干切槽 204 ，切槽 204 与管腔 207 连通。 弹性变形部 205 为植入体 2 的主要结构，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。植入体 2 可由本行业内常使用的具有形状记忆功能的材料制成， 本发明中不对具体材料进行限定，只要适用于人体且具有形状记忆功能的材料即可。本实施例中 植入体 2 采用镍钛合金制成，具体为空心镍钛管。具体地，将空心 镍钛管原材料经激光雕刻出一定的切槽 204 后，弯曲成预定形状，再进行热处理定型即得到植入体 2 。
植入体 2 的外径和内径根据其本身特性和导丝外径来决定，即在保持其有足够的弹力来牵拉肺部组织的前提下，尽可能植入肺部旁路或某些小直径气管的末端，达到更好的治疗效果。另外，植入体 2 的内径需大于导丝外径。作为一种实施方式，植入体 2 的外径为 0.5-2.5 mm 、壁厚可为 0.01-0.5mm 。
植入体 2 可以选用从一端到另一端的外径和内径保持同一大小的等径管，也可以选用外径和内径变化的非等径管。为使植入体 2 能伸进较细的支气管，在本发明其他实施例中， 所述 植入体 2 为管腔 207 直径不变管壁从远端至近端方向逐步增厚的锥形管，即所述 植入体 2 外径从远端往近端方向递增。 例如选择内径为 0.8-1.0 mm 锥形管，锥形管的壁厚从植入体远端 202 的 0.01 mm 变化到植入体近端 201 的 0.2 mm 。
切槽 204 的存在能实现弹性变形部 205 进行曲率较大的弯曲，并且还能实现弹性变形部 205 各种不同角度的扭转，从而形成复杂的预定形状。本发明中， 切槽 204 的排布方式不作限定，各切槽 204 之间一般为平行、螺旋等多种方式排布，从弹性变形部 205 周向上看，切槽 204 可以局部排布，也可在弹性变形部 205 周向上全部排布。 切槽 204 形状有多种结构，例如， 切槽 204 一般为狭长结构。在弹性变形部 205 沿轴向剖开的展开平面上，所述切槽 204 与弹性变形部 205 的轴线夹角 α 为 10-90° ； 即切槽 204 的开口方向与 弹性变形部 205 的轴线夹角 α 为 10-90° ，切槽 204 的这种设置方式是为了能更好进行弯曲和扭转，切槽 204 与弹性变形部 205 的轴线不平行是方便弹性变形部 205 的弯曲，其中夹角 α 为 90° 情况下，方便弹性变形部 205 在同一平面内的弯曲，小于 90° 的夹角 α 同时能实现弯曲和扭转使得弹性变形部 205 能在 360° 范围内实现成型。在本发明其他实施例中，切槽 204 与弹性变形部 205 的轴线夹角 α 优选为 45-90° 。切槽 204 的形状和数量、排布的密度以及切槽 204 的位置应满足弹性变形部 205 进行多方向弯曲和扭转，切槽 204 设置位置、数量和形状、排布密度需符合植入体 2 植入肺组织后为挤压肺组织施加的弯曲应力要求，即植入体 2 在恢复形变的过程中牵拉肺气肿区组织时不得刺破支气管。切槽 204 具体可以根据实际测算进行设置，这样在植入体 2 植入到肺部时，不会带来由于局部应力过大刺穿支气管，也避免植入体 2 由于应力过大出现损伤、断裂而对人体造成的伤害。
本实施例中，如图 7 、 8 所示，单个切槽 204 为哑铃形，在图 7 所示的弹性变形部 205 沿轴向剖开的平面展开图中可以看出，切槽 204 与弹性变形部 205 的轴线形成夹角 α 为 90° 。多个切槽 204 连续等间距设置，所有切槽 204 相互平行。哑铃形的切槽 204 能满足弹性变形部 205 的弯曲和扭转。各个切槽 204 之间有约 0.05-0.5 mm 的间距 208 。弹性变形部 205 的外径在 0.5-1.5 mm ，壁厚为 0.01-0.2 mm 。
在本发明又一实施方式中，如图 10 、 11 所示，弹性变形部 205 设有多组切槽 204 。将所述弹性变形部沿轴向剖开并平展后可见，每组切槽 204 包括三个沿弹性变形部周向排列的切槽 204a 、切槽 204b 、切槽 204c ，且该三个切槽的两端在所述周向上相互对齐。切槽 204a 、切槽 204b 、切槽 204c 具有一定的间隔 209 ，相邻两组切槽 204 之间留有间隔 208 。切槽 204 为细长结构，这些切槽 204 的延伸方向与弹性变形部 205 的轴线形成一定的夹角 α 。通过调整各组平行的切槽 204 的个数和间隔 209 、切槽 204 与弹性变形部 205 轴线的夹角 α 的角度以及各组切槽 204 之间的间距 208 ，可以调整整个弹性变形部 205 的弯曲应力，使其符合植入要求。在其他实施例中，每组切槽 204 中的切槽个数可以为 2-6 个，相邻切槽 204 之间的间距 209 可以为 0.05-1 mm ，夹角 α 可为 10-85° ，每组之间的间隔 208 为 0.1-1.0 mm 。弹性变形部 205 的外径约 1.0-2.0 mm ，壁厚为 0.05-0.3 mm 。
在本发明再一实施例中，如图 12 、 13 所示，将弹性变形部 205 的中间段分割成多组长椭圆状的切槽 204 ，每组切槽 204 由两个以上的并排椭圆切槽 204 组成，本实施例中每组切槽 204 由两个并列的切槽 204a 、切槽 204b 组成，切槽 204a 、切槽 204b 迭代排布，切槽 204a 、切槽 204b 间具有一定的间距 209 ，切槽 204 与弹性变形部 205 轴线的夹角 α 为 90° ，组与组之间排列的延伸方向与弹性变形部 205 的轴线形成一定的夹角 β 。夹角 β 可为 60-90° ，各组切槽 204 之间有约 0.3-5 mm 的间距 208 ，各组切槽 204 呈阶梯状周期性排布，举例而言，可以 5-20 组切槽 204 为一周期，阶梯周期性的切槽 204 有利于弹性变形部 205 的弹性变形部 205 弯曲成特定的形状。弹性变形部 205 的两端有约 1.5-10 mm 长的植入体近端 201 和植入体远端 202 ，植入体近端 201 有约 0.5-5 mm 的长度被切割成螺纹状沟槽作为 连接件 210 。再用模具将切割后的植入体 2 弯曲成图 14 所示形状，热处理定型成为所述的植入体 2 。本实施方式中植入体 2 外径为 1.2-2.5 mm ，壁厚为 0.1-0.4 mm 。
如图 5 、 14 所示，弹性变形部 205 的两端分别为植入体近端 201 和植入体远端 202 ，其中植入体近端 201 用于设置连接件 210 ，植入体远端 202 用于先期进入气管。植入体近端 201 连接有用于与推送机构（如中空推送钢缆）可拆卸连接的连接件 210 ， 本发明中可拆卸连接方式是指：在推送前及推送过程中，连接件 210 与推送机构固定在一起，当推送到位后连接件 210 脱离推送机构。连接件 210 与可拆卸连接的结构和连接方式有多种，例如图 5 所示，采用螺纹连接，植入体近端 201 焊接上带有内螺纹的连接件 210 。装配时，可与推送机构带有的外螺纹螺纹连接；推送到达相应位置后，通过扭转推送机构，该连接件 210 能与推送机构分离。显然，基于现有技术，连接件 210 也可以是其它可脱离固定连接的部件，如磁性连接装置、弹性卡扣、套索等等，分别设置在植入体 2 的植入体近端 201 和推送机构上，实现可脱离固定连接。或者直接在植入体近端 201 直接车出内螺纹（即所述植入体近端 201 是所述弹性变形部 205 的一部分），如图 14 所示，设置在植入体近端 201 的连接件 210 为螺旋状连接钩，同样推送机构上也设置螺旋状连接钩，二者之间相互旋转钩挂在一起便将植入体 2 可脱离地固定连接在推送机构远端。
如图 14 所示，为了使得植入体 2 能顺畅进入气管，在植入体 2 远端不开口时，所述植入体远端 202 向外延伸连接有柔性的植入体导向头 211 ，所述植入体导向头 211 与植入体远端 202 同轴且封闭所述植入体远端 202 ，所述植入体导向头 211 设有显影标识。植入体导向头 211 具有导向和建立通道的作用， 可以与植入体远端 202 一体结构，也可以是另外固定在植入体远端 202 上。植入体导向头 211 具有相对的柔性，避免在进入气管后对气管壁的划伤 。 显影标识设置的目的是便于在推送过程中监控，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。通过这些系统对植入体 2 进行显示和引导，本实施例中 采用丝径为 0.1-0.5 mm 的 X 射线显影性较强的钨、钽等金属丝绕成的长度约为 1-10 mm 弹簧作为 显影标识。本实施例将显影标识与植入体导向头 211 合并成一个部件，实现两个功能。除了这种方式外，还可以在植入体导向头 211 上另外设置显影标识，例如显影环，显影环套设在植入体导向头 211 上。
如图 6 、 9 所示，上述各种实施方式中，所述弹性变形部 205 外还可以包覆有弹性膜 206 。作为一种实施方式，弹性膜 206 将弹性变形部 205 、植入体近端 201 和植入体远端 202 全部包覆，利于整体植入体 2 在植入过程中不损伤气管。所述弹性膜 206 还可以填充至切槽 204 中，从整体上保证植入体 2 表面光滑，且切槽 204 中填充弹性膜 206 也使得弹性膜 206 能更牢固地包覆在植入体 2 表面。 同时为保证弹性变形部 205 管腔 207 内的畅通，弹性膜 206 在切槽 204 中形成的内壁与弹性变形部 205 管腔 207 内壁齐平。弹性膜 206 的厚度可为 0.01-0.3 mm 。所述弹性膜 206 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材料制成。例如：这些高分子材料可以是硅橡胶或聚氨酯材料。在具有植入体导向头 211 时，弹性膜 206 同时 包裹所述弹性变形部 205 及其植入体导向头 211 ，形成一个整体结构的弹性膜 206 。
图 15 为本发明一实施例提供的带有保留局部弹性膜 206 的植入体 2 的剖视图，弹性变形部 205 的变形部包含多组切槽 204 。弹性变形部 205 、植入体近端 201 、植入体远端 202 、植入体导向头 211 的表面覆有一层弹性膜 206 。
值得一提的是，本发明一实施例的肺减容弹性体 2 的两端均开口，即 植入体近端 201 、植入体远端 202 两端开口，且可以不包括植入体导向头 211 。
本发明一实施例还提供一种肺减容器械，如图 1-21 所示，包括植入体 2 和输送装置 1 ，所述植入体 2 为 具有形状记忆特性的管状结构，其主体为弹性变形部 205 ，所述弹性变形部 205 带有管腔 207 ；所述植入体 2 两端为植入体近端 201 和植入体远端 202 ，所述弹性变形部 205 的壁面上开设有若干切槽 204 ，所述切槽 204 贯通至弹性变形部 205 的管腔 207 ；所述输送装置 1 包括导丝 101 和推送机构 110 ，（推送机构 110 通常包括中空推送件即中空钢缆 103 和与推送钢缆 103 相连的操控手柄 106 ），所述植入体 2 通过连接件 210 可拆卸地连接在所述推送机构 110 的远端，所述植入体 2 和推送钢缆 103 分别套装在所述导丝 101 外，即所述导丝 101 装载在所述植入体 2 和所述推送钢缆 103 中，所述植入体 2 可沿导丝 101 移动。
输送装置 1 中，导丝 101 用于承载植入体 2 、导向并建立通道，植入体 2 整体套装在导丝 101 外，植入体 2 由所述导丝 101 约束成直条状，即植入体 2 被导丝 101 拉伸成跟导丝 101 形状配合的直形输送状态，便于进入到气管中。
参见图 16 ，从植入体 2 的植入体近端 201 可插入导丝 101 ，导丝 101 可用一段直径为 0.1-1.1 mm 的金属丝制得。导丝 101 的作用是建立通道，并将植入体 2 输送到病变部位，从而不再需要输送鞘管来束缚植入体，也就避免了输送过程中输送鞘管对气管的伤害，进一步减少气胸的发生率。金属丝具有一定的刚度和韧性，能适当弯曲，符合气管形状，并且能沿气管逐步前进。相比现有技术，由于不再需要输送鞘管，植入体 2 可植入肺部旁路或某些小直径气管的末端，达到更好的治疗效果。
为了操作的安全方便，需要在导丝 101 的远端设有与导丝 101 同轴的且带有显影标识的软性导丝引导头 102 ，所述导丝引导头 102 外径与导丝 101 外径一致。如图 17 所示，所述导丝引导头 102 包括导向柱 102a 、导向柱 102a 外套装固定的弹簧 102b ，所述导向柱 102a 与导丝 101 一体结构或者导向柱 102a 固接在导丝 101 远端；所述弹簧 102b 带有显影标识。
导丝引导头 102 是将导丝 101 远端 柔软处理，能在植入气管时有效避免对气管壁的损伤。柔性的导丝引导头 102 可通过具有柔软特征的弹簧实现，即在 与导丝 101 一体结构或者固接在导丝 101 远端的导向柱 102a 上套装弹簧 102b 。具体制造可以为：将 导丝 101 的头端经细化后制成导向柱 102a ，在导向柱 102a 外固定一段长度为 5-150 mm 的弹簧 102b 。弹簧 102b 与导丝 101 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。在柔软的导丝引导头 102 的导向下，导丝 101 从植入体 2 的植入体近端 201 可顺利进入弹性变形部 205 的管腔内，可将 植入体 2 从图 5 、 6 所示形状束缚成直形输送状态，如图 16 所示。显然，基于现有技术，装载了 植入体 2 的导丝 101 还具备在支气管内起导向和建立通道的作用。由于需要对导丝 101 进入肺部的操作状况进行引导和监控，则在导丝引导头 102 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。通过这些系统对导丝 101 进行显示和引导，本实施例中 采用丝径为 0.01-0.3 mm 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导丝引导头 102 合并成一个部件，实现两个功能。除了这种方式外，还可以在导丝引导头 102 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。
为了导丝 101 输送方便，在导丝 101 的近端设置有导丝手柄 105 ，用于向前输送导丝 101 ，或在植入体 2 输送到位后，撤离导丝 101 。
具体地，推送机构 110 包括中空推送钢缆 103 、与推送钢缆 103 连接的操控手柄 106 ，推送钢缆 103 和植入体 2 都套装在导丝 101 上，推送钢缆 103 的远端与植入体 2 近端设置的连接件 210 相连接。连接的方式是采用分别设置在植入体 2 的连接件 210 和推送钢缆 103 远端的连接配合件 109 可拆卸连接。连接件 210 与连接配合件 109 结构和连接方式有多种，例如采用螺纹连接，在植入体 2 的植入体近端 201 焊接上带有内螺纹的连接件 210 ，或者直接在植入体近端 201 直接车出内螺纹作为连接件 210 。在推送钢缆 103 远端设有外螺纹的连接配合件 109 ，装配时，可将连接件 210 的内螺纹与推送机构 110 带有的外螺纹螺纹连接，则植入体 2 便可靠固定在推送钢缆 103 远端；在植入体 2 推送到达相应位置后，通过扭转推送钢缆 103 的操控手柄 106 ，则植入体 2 的连接件 210 与推送钢缆 103 的连接配合件 109 旋出分离。连接件 210 和连接配合件 109 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 2 的植入体近端 201 和推送钢缆 103 上，实现可脱离连接。如图 16 所示，设置在植入体近端 201 的连接件 210 为螺旋状连接钩，同样推送钢缆 103 远端也设置螺旋状连接钩，二者之间相互旋转钩挂在一起便将植入体 2 可拆卸固定连接在推送机构 110 远端，植入体 2 推送到位后，反向旋转推送钢缆 103 的操控手柄 106 ，则两个螺旋状连接钩相互脱离。
在生产组装时，植入体 2 与导丝 101 的装配可借助装载器来完成。首先，将植入体 2 穿入装载器中，利用装载器空间的限制，可将自然状态下呈卷曲状的植入体 2 约束成直条形输送状态的管子，将与推送机构 110 装配好的导丝 101 通过植入体 2 的植入体近端 201 插入并从植入体 2 的植入体远端 202 穿出，直至将导丝 101 的导丝引导头 102 穿出植入体 2 的植入体远端 202 停止，或者在植入体远端 202 被植入体导向头 211 封闭 的情况下，导丝 101 通过植入体 2 的植入体近端 201 插入并插装到植入体 2 植入体远端 202 停止，此时可卸载装载器，植入体 2 在导丝 101 的约束下已被装载成直形的输送状态，将推送机构 110 中的推送钢缆 103 远端的连接配合件 109 与植入体 2 的连接件 210 连接好。
参见图 18-21 ，通过支气管镜 901 的工作通道 902 将套穿有植入体 2 的导丝 101 送入肺部 903 的支气管 904 内，在 X 射线的辅助下，通过导丝 101 建立通道后，利用推送钢缆 103 沿着导丝 101 将植入体 2 推送至导丝引导头 102 处，后撤导丝 101 ，导丝 101 后撤的同时，植入体 2 从如图 18 、 19 的被导丝 101 束缚成的直条形输送状态自动回复成如图 20 、 21 所示的自然形状，在这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。然后通过旋转推送钢缆 103 的操控手柄 106 ，可解脱推送钢缆 103 远端的连接配合件与植入体 2 的连接件 210 的螺纹连接，从而释放植入体 2 。

Claims (10)

  1. 一种肺减容弹性植入体，其特征在于：所述植入体呈管状且包括植入体近端、弹性变形部和植入体远端，所述弹性变形部位于植入体近端和植入体远端之间且至少所述弹性变形部 具有形状记忆特性，所述植入体中至少在植入体近端开口，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。
  2. 根据权利要求 1 所述的肺减容弹性植入体，其特征在于，在植入体沿轴向剖开的展开平面上，各切槽的切口方向与所述弹性变形部的长度方向夹角 α 为 10-90° ；且切槽形状和排布满足弹性变形部进行多方向弯曲和扭转，并符合植入体的弯曲应力要求。
  3. 根据权利要求 2 所述的肺减容弹性植入体，其特征在于，所述植入体还包括至少包覆于所述弹性变形部外壁的弹性膜。
  4. 根据权利要求 3 所述的肺减容弹性植入体，其特征在于，所述弹性膜还填充所述切槽。
  5. 根据权利要求 1 所述的肺减容弹性植入体，其特征在于，所述植入体外径从远端往近端方向递增。
  6. 根据权利要求 1 所述的肺减容弹性植入体，其特征在于，所述植入体远端向外延伸连接有柔性的植入体导向头，所述植入体导向头与植入体远端同轴且封闭所述植入体远端，所述植入体导向头设有显影标识。
  7. 根据权利要求 1 所述的肺减容弹性植入体，其特征在于，所述植入体近端设有可拆卸连接件。
  8. 一种肺减容器械，其特征在于，包括如权利要求 1-7 任一项所述植入体和与所述植入体配套的输送装置，所述输送装置包括导丝和中空推送件，所述植入体通过植入体近端可拆卸地连接在所述推送件的远端，所述导丝可移动地穿至所述植入体的管腔和所述推送件的管腔中。
  9. 根据权利要求 8 所述的肺减容器械，其特征在于，所述导丝的远端设有与导丝同轴的软性导丝引导头，所述导丝引导头外径与导丝外径一致。
  10. 根据权利要求 9 所述的肺减容器械，其特征在于，所述导丝引导头包括导向柱、导向柱外套装固定的弹簧，所述导向柱与导丝一体结构或者导向柱固接在导丝远端；所述弹簧具有显影标识。
PCT/CN2015/080373 2014-06-11 2015-05-29 肺减容弹性植入体及器械 WO2015188705A1 (zh)

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