![]() stent, retention element and system for immobilizing a nasal passage
专利摘要:
STENT FOR IMMOBILIZATION OF A NASAL PASSAGE. The present invention relates to a stent for immobilizing a nasal passage. The stent (1) consists of a tubular and braided support body (2) which, in the unloaded state, has a diameter of at least 4mm and a length between 25 and 120mm and, in particular, between 25 to 100mm. The stent may have an enlarged section (15) at the proximal end, for immobilizing the nasal alar. Alternatively or in combination, you may have a fixation section (3) at the proximal end of the stent (1), for fixing the dostent (1) in a nasal passage of the user. When fixed, the fixation section protrudes from the user's nostril and can be fixed outside the nose. 公开号:BR112013020115B1 申请号:R112013020115-0 申请日:2012-02-09 公开日:2021-03-02 发明作者:Peter Renner;Klaus Düring;Joachim Georg Pfeffer;Nasib Dlaikan-Campos 申请人:Klaus Düring; IPC主号:
专利说明:
The present invention relates to a stent for immobilizing a nasal passage. Plastic splints under the trade name "Schnarchzapfen" are provided to immobilize the nostrils. Each plastic splice consists of several plastic rings, connected by longitudinal supports. At one end, two of these plastic splints are connected together by a plastic support, so that the two plastic splints can be inserted into the two nostrils. At the ends connected by the plastic support, the diameter of the plastic splint is larger than that of the distal end of the support. Thus, these splints are inserted into the nose with the thinnest end in front. These splints have a length of about 10mm, and ensure that the area of the nose opening remains open. Under the trade name Nasaline®, nasal dilators are provided to expand the nasal wings, thus reducing breathing through the mouth. These nasal dilators are small plastic bushings that are freely interconnected, so that the distance between them is adjustable. Each of these products, the "Schnarchzapfen" and the Nasaline®, are tubular cap-like structures that keep the nasal wings open. Instead of these socket-type structures, there are also wings with which the nasal wings are separated. One of these structures, with two separation wings fixed at a predetermined distance by a rigid nasal support made of titanium, is known under the trade name Nasanita Nasenschmetterling®. Another structure to maintain the clearance of the nasal wings, based on the same mode of action, is sold under the trade name Nozovent®. The devices described above are used to keep the nostrils clear. MBM ScienceBridge GmbH, from Gottingen, Germany, has developed a nasopharyngeal splint. This splint consists of two plastic splints, each of them in a syncline shape, while the syncline splints are interconnected at one end by an elongated support. Each splint can be inserted into a nostril. The splints are shaped so that they can be introduced through the nose, pass through the nasal septum and keep the upper throat open due to its format. The soft palate is prevented from closing the throat. Thus, continued breathing is ensured. In snoring therapy, the splints are adapted once to the patient through endoscopy. This proves necessary in order to ensure that the length of the splint is precisely adjusted. WO 2007/065408 A2 discloses an apnea stent, which serves to immobilize and / or to keep the airway in the throat open. This apnea stent consists of a compressible and self-expanding stent with at least one expanded section. This stent consists of three phases. A distal phase of the stent provides the active part of the apnea stent. This distal phase has a tubular shape and is expandable, so that the airway remains open. The proximal phase of the stent serves to fix the stent in the nasal area. The proximal phase is shaped like a funnel, while this phase extends from the proximal end towards the distal end. The distal and proximal phases are interwoven like a braid, in which the wire strands or fibers or filaments intersect with each other respectively. Each individual metallic wire directed to the distal end of the stent at the distal end of the distal phase, returns to the proximal end of the stent. The folds thus created are referred to below as rounded ends. The function of the stent transition phase is to connect the proximal phase to the distal phase. The transition phase is formed by twisting the wire strands of the stent into twisted wires. As a result, the transition section exhibits high flexibility in a radial direction, so that in a short longitudinal segment there is a strong radial expansion, from the proximal to the distal phase. DE 20 2009 010 3888 UI and PCT / EP 2010/004687, respectively, disclose a fixation device for such an apnea stent in the airway, in which the fixation device contains two fixation elements, among which the proximal end of the airway stent. apnea can be fixed. Furthermore: an introduction tube for the introduction of the apnea stent is described, which is folded at its distal end, in order to simplify the introduction into the airway. The apnea stent contains a connecting and coupling element at the proximal end, so that an introducing rod can be attached to the proximal end of the apnea stent. Through the insertion rod, the stent can be introduced into the introduction tube 6 and compressed by pushing the insertion rod through the introduction tube, so that the apnea stent is pulled by the insertion rod into the introduction tube. US 2009/0010991 Al discloses an expandable nasal stent that is permanently inserted into the nostril of the nasal passage. This stent is made of a polymer or steel mesh and equipped with a filter element positioned at the proximal end of the stent. The stent can be covered by a therapeutic agent. US 2010/0211181 Al and US 5,336,163 reveal more nasal stents, which are constructed as filters in order to filter the inspired air. US 2010/0106255 Al discloses a self-expanding stent, which can be attached with one end to the sinus. The invention is based on the objective of providing a stent for immobilizing a nasal passage, which does not need to be adjusted individually for each nasal passage. It will be easy to insert and comfortable to use, and it will keep the nasal passage completely open, reliably. The purpose is achieved by a stent containing the characteristics of claim 1. Advantageous embodiments are indicated in the sub-claims. According to the present invention, the stent for immobilizing a nasal passage consists of a tubular, braided support body and, optionally, a fixation section. The support body in the unloaded state has a minimum diameter of 4mm and a length of between 25 to 120mm and, in particular, between 25 to 100mm. At the proximal end of the stent a fixation section can be provided, designed to fix the stent to the user's nasal passage, where the fixation section extends out of the user's nostril when being fixed and can be fixed outside the nose. The braided support body is elastically deformable and rests on the inner surface of the nasal passage. The pressure created by the tubular support body against the nasal passage is evenly distributed and, consequently, the support body does not cause pain or discomfort in the sensitive nasal passage. As the support body is braided, it fits well into the different shapes of the nasal passage, and it is not necessary to adapt the stent individually to the nasal passage of an individual user. With some standard stent dimensions, which differ mainly in length and diameter of the support body for almost anyone, a suitable stent can be provided. The support body can be supplied with diameters from 4 to 20mm, while the standard dimensions differ preferentially in diameter and are staggered in segments / steps of 1mm. The length of the support body varies between 25mm and 120mm and, in particular, between 25 and 100mm. Preferably the standard dimensions vary in length and are staggered in 5mm segments / steps. The preferred length of the support body varies between 30mm and 50mm, since this is the normal length of the nasal passage, in the region of the anterior turbinates, in medium-sized bodies. It turns out that, for most users, a support body with a length of about 60mm is positioned with its distal end in an area of the nasal passage and turbinates, which is extremely sensitive. Therefore, it is very useful to provide a support body, either of a shorter length so that it does not come into contact with this sensitive area, or of a greater length so that it extends along this sensitive area. Thus, on the one hand, support bodies with a maximum length of 40 to about 45 or 50 mm, respectively, or support bodies with a length of at least 70 to 80 mm or 100 mm, respectively, are preferred. The function of the fixation section is to prevent the supporting body from moving along the nasal passage towards the throat. Therefore, the securing section is connected to the support body and extends out of the nose. There, the fixing section can be fixed. The fixing section can be designed as a piece, with the support body as a tubular braided section tapering towards the proximal end. The securing section can also be made of any other desired material that is preferably flexible. A coupling element is provided at the proximal end of the fastening section, which can be connected to a coupling element that joins an insertion rod or retaining element. The coupling element is provided at one end of the insertion rod. The stent can be inserted into an introduction tube and compressed with the stent attached to the insertion rod. To do this, the insertion rod is pushed through the insertion tube so that the stent is pulled into the insertion tube by the insertion rod. Preferably, the retaining element is equipped with two coupling elements, for coupling two elements proximal to two stents to the coupling element. In this way, the coupling element provides a detachable support between the two stents that, in a safe way, avoids the movement of the stents too much towards the throat. The coupling element can also be in the form of a clamp, which fixes the fixation section of a stent or two fixation sections of two stents, via locking. The locking can be carried out independently of the coupling element for coupling the stent to an insertion rod or, alternatively, via locking the coupling element to the retaining element. The stent can be braided with metallic thread, fibers and / or filaments that intertwine with each other. Then, only the term metallic thread will be used, since it also includes 5 fibers or filaments, since the term metallic thread is not specified. Each metal wire directed to the distal end of the stent returns to the distal end of the support body, towards the proximal end of the stent. The resulting 10 folds will be referred to below as rounded ends. These have, in the unloaded state of the stent, a diameter that varies between 0.5 and 2mm. Thus, a distal end is provided without any free ends of metallic wire, or in which no free end of metallic wire needs to be connected with another element. The connection of the metallic wire or metallic wires, respectively, of the stent at the proximal end can be made, for example, by crimping or gluing, in order to create a fixation section. Alternatively, the metallic wires can also be connected, for example, with a polymer droplet, a ring or by returning them to the internal lumen of the support body, without creating a fixing section. The extremities caused by the distal end of the stents. The metal wire used for interlacing the support body in particular is made of metal, preferably nitinol or steel wire. Preferably, the distal end of the support body, more preferably only the rounded metallic wires, are provided slightly tapered in relation to the other section of the support body. This prevents the stent from being able to exert pressure with the edge on the tip in the nasal passage, which can be uncomfortable. The support body can be equipped, at its proximal end, with an enlarged section. This extended section is preferably shaped like a ball. The ball will have a diameter of about 10 to 20mm, preferably 12 or 13 to 15 or 17mm, respectively. During use, this enlarged section is positioned in the area directly behind the nostrils, in order to divide the nasal alar to prevent collapse. In addition, the enlarged section fixes the stent to the nose so that, in particular for a stent comprising an enlarged section, the fixation section described above may not be necessary. Such a stent is very useful for the practice of sports during which the nasal passages will be kept open. A protruding nose fixation section is not desirable during sports. It is very useful to provide a removal tool for stents without a fixation section, with which the stent can be removed from the nasal passage. The removal tool can be attached to the stent, for example providing an element to hook the strand of the stent, or an element to hold the strand. For coupling the removal tool, only the braided support body is sufficient. For this purpose, no additional piece is required on the stent. The invention will now be exemplified in more detail, on the basis of the embodiments illustrated in the drawings, in which: Fig. 1 reveals a stent according to a first embodiment of the invention, in a schematic side view, Fig. 2 reveals a stent according to with a second embodiment of the invention, in a schematic side view, Fig. 3 shows a stent according to a third embodiment of the invention, in a schematic side view, Fig. 4 reveals a stent according to a fourth embodiment of the invention, in a schematic side view, Figs. 5a, 5b each show a retaining element seen from above. Fig 6 shows another retaining element seen from above. Figs. 7a, 7b show a retaining element seen from above and from the side, Fig 8 shows a section of an insertion rod seen from the side, 5 Fig. 9 shows a section of an insertion tube in a sectional view Fig. 10 schematically reveals the nasal cavity in a sectional view, Figs. Ila and 11b show, in a schematic way, 10 another retaining element in a grossly simplified side view, Figs. 12a and 12b show, in a schematic way , another retaining element in a grossly simplified side view, 15 Fig. 13a and 13b schematically reveal another retaining element in a grossly simplified side view, Figs 14a to 14c schematically reveal another element of retention in a grossly simplified side view 20, Figs 15a, b, 17a, b each reveal a zone of the proximal end of a stent without a securing section in a front view (Fig. a) and in a side view (Fig. B), and Figs 18a, 18b, 19a, 19b, 19c, 20a, 20b, 20c each reveal a removal tool for removing a stent from the nose under different tightening conditions. According to the invention, a stent 1, for immobilizing a nasal passage, comprises a support body 2 and a fixation section 3. Fig. 1 shows a first incorporation of a stent 1, in which the support body 2 it is tubular and with a constant diameter, and the fixation section 3 tapers from the distal to the proximal end. The support body 2 as well as the securing section 3 are integrally made of a wire braid. Each metal wire directed to the distal end of stent 1, is returned, at the distal end of the support body 2, towards the proximal end of stent 1. The folds thus created are referred to below as rounded ends 4. In the unloaded state of the stent, these folds have a diameter that varies between 0.5 and 2mm. In this way, a distal end is provided without any free wire ends. No free wire ends need to be connected with another element. The rounded ends prevent injury to the airways caused by the distal end of the stents. The stent 1 can be stranded with a single metal wire or with a multitude of metal wires. The ends of the metallic wire or metallic wires, respectively, are connected at the distal end of the stent or at the proximal end of the fixation section 3, respectively, with a pencil or cylinder-shaped body 5. In the present embodiment, the pencil-shaped body 5 is a body 5 embedded around the ends of the metal wires. Thus, it can also be referred to as a crimp body 5. At the distal end of the crimp body 5, there is a thin pin 6. At the end of the pin 6 away from the crimp body 5, there is a bearing clutch 7. With the bearing clutch 7, the stent can be connected to another element that provides the respective for the coupling element. The stent is braided with an elastic metallic thread with a diameter of 0.001mm to 2mm, in particular with a diameter of 0.05mm to 0.5mm, and preferably with a diameter of 0.07mm to 0.2mm. In particular, the wire is metallic, preferably of nitiol or steel. The length L2 of the support body 2 is from 25mm to 120mm, particularly from 25mm to 100mm. Preferably, the L2 length of the support body is between 30mm to 50mm, or 60mm to 120mm or, respectively, from 30mm to 50mm, or from 70mm to 100mm. For larger incorporation, 70mm to 100mm is preferable. The diameter of the support body 2 is from 4mm to 20mm. Preferably, the support body has a diameter of at least 5 mm and, in particular, of a minimum of 6 mm. The fixing section has an L2 length of about 10 to 25mm. With the fixation section, the stent can be attached to the user's body so that the stent cannot move from the user's nasal passage towards the throat. For this, it is necessary that the fixation section extends through the nostrils to the outside, in order to be fixed there with the respective fixation element. Such fastening element, for example, may be plaster, with which fastening section 3 is glued to the area below the user's nose. However, a retention element 8, which extends at least in one direction, is so far that it cannot be introduced through the nostril into the nasal passage. Alternatively, the retaining element 8 can be equipped in such a way that it can be connected to two stents 1, so that it extends as a support between the two stents and avoids pulling the stent too far into the nasal passage. Such a retaining element 8, described in more detail below, is preferably connected to the stent coupling element which - in the present embodiment - it is provided as a bearing clutch 7. However, within the scope of this invention, it is possible to provide the fixing element as a clamp, attached to the fixing section 3 of a stent 1, or to the fixing section 3 of two stents 1. An insertion rod 9, which can be coupled to the coupling element 7, is shown in Fig. 8. The insertion rod 9 is made of plastic. At the distal end of the insertion rod 9, there is a bush or sleeve 10, tubular and made in one piece. The bush has two circular openings 11, diametrically opposite. In the longitudinal direction of the insertion rod 9, in the area of the two circular openings 11, there may be a groove 12. The groove 12 extends to the distal end of the bushing 10. The bushing 10, can be formed integrally at the distal end of the rod insert 9, or exist separately, made of another material, and be forcibly connected to the insertion rod 9, for example with glue. The bearing clutch 7 of the stent 1 can be placed between the two openings 11 of the bushing 10 of the insertion rod 9. In this way, a removable connection of the stent 1 and the insertion rod is provided. The longitudinal groove 12, located in the bushing 10, simplifies the insertion and removal of the bearing clutch 7, in or of the bushing 10, respectively. The relationship between the bearing clutch diameter 7 and the inner diameter of the sleeve 10, and the hardness of the sleeve material 10 and the length of the groove 12, can be used to adjust the connection force or retain the connection between the clutch of bearings 7 and the bushing 10. The bearing clutch 7 can rotate freely in the bushing 10. The insertion rod can take the form of an insertion tube (not shown) in which, at one end, the two circular openings and, optionally, a groove - similar to the bushing 10 - can be integrated. Therefore, the need for separate manufacture of the tubular bush is avoided. The diameter of the insertion rod 9 and the crimp body 5 are dimensioned in such a way that the insertion rod 9, together with stent 1, can be inserted into an insertion tube 13 (Fig. 9). The inlet tube 13 is made of a suitable and sufficiently strong polymer, for example PEBAX, with a Shore hardness of 50 Shore D to 80 Shore D, for example PEBAX 7233 (Shore hardness 69D), PEBAX 6333 (Shore hardness 64D), or PEBAX 55 (Shore 54 D hardness). At the distal end of the introduction tube 13, there may be an introduction tip 14, made of one piece. The insertion tip has the same inside and outside diameter as the introduction tube 13 and is embedded in it. The insertion tip 14 can be made of a flexible and significantly softer material, 5 for example PEBAX with a Shore hardness of 25 Shore D to 45 Shore D. Such an introduction tube can be made of a single material, for example PEBAX 7233, PEBAX 6633 or PEBAX 5533. It is possible to manufacture such an insertion tube made in one piece, through an extrusion process with a 10 degree gradient. continuous material. This insertion tube has a transition section in which the portion of one material decreases and, correspondingly, the portion of the other material increases. The material for such a tube, for example, is PEBAX 7233, in the main body section and PEBAX 3533 in the area of the introduction tip 14, so that the introduction tip is softer than the main body. Regarding the selection of materials, the above description of the two-piece introduction tube applies appropriately. The feed tube may also contain several 20 layers, where the inner layer is preferably harder than the outer layer, in order to provide a more slippery inner surface with low friction (for example PEBAX 7233). Thus, the stent can be inserted into, and collected from, the low resistance introducing tube. Preferably, the outer layer has a Shore hardness of, for example, 6 0A to 95A and is thicker than the inner layer since, in general, the introduction tube has the properties of soft and flexible materials and therefore adapts easily to the course of the nasal passage. Thus, the tube can be easily inserted. Preferably, the outer layer is made of PU 85A, with a thickness of about 0.2 mm, and the inner layer, of PEBAX 7233, with a thickness of about 01. mm. The melting of a short PU 85A tip (about 2 to 10 mm in length), which is preferentially atraumatically rounded, further increases comfort and safety when introducing the tube into the nasal passage. The insertion tube 13 can be straight. It can also have a curvature. The outer diameter of the introduction tube is up to 10mm, preferably up to 5mm, in order to allow the user to insert the tube comfortably, without causing pain. The inside diameter of the introduction tube is up to 4 mm, in order to provide enough lumen for stent uptake 1. The insertion tip has a chamfer 17 on the outer edge. Instead of chamfer 17, the insertion tip 14 can also be equipped with a rounding. Such rounding, for example, can be produced via thermal reformulation or via abrasion, or laser ablation. Such rounding can exist internally and / or externally. The production of such a rounded tip involves more work than a chamfer. However, the rounded tip is even more secure during stenting. Furthermore: the thin-walled end resulting from the striation may harden via the release of the plasticizers from the polymer due to the relatively large surface. The introduction tube may contain a thickening in the shape of an olive or a drop at one or both ends, in order to facilitate the introduction into the nasal passage. The olive or drop at the end of the introduction tube has a length of 2 - 20 mm, preferably 2 - 10 mm and, even more preferably, 2 - 5 mm. The diameter of the olive or the drop is about 3.5 - 6.0 mm, preferably 4.0 - 5.0 mm. These insertion tips 14 are atraumatic tips, in which the shape must be even softer and rounder, the harder the material of which they are made. The incorporation in the shape of an olive or drop has a larger frontal area and, therefore, provides the best distribution of pressure on the nasal tissue. For insertion of stent 1 into the introduction tube 13, stent 1 is first attached via the bearing clutch 7 to the sleeve 10 of the insertion rod 9. Then, the insertion rod is inserted with the proximal end into the insertion tip 14, of the introduction tube 13. The insertion rod 9 is pushed through the introduction tube 13, until the stent 1 is fully inserted in the introduction tube 13. The stent 1 may protrude minimally from the introduction tube. It is essential that stent 1 is compressed by introduction into the introduction tube 13, to a smaller diameter, so that it can be easily inserted into the nasal passage together with the introduction tube and insertion rod. Alternatively, stent 1 is pushed into the delivery tube 13, without the coupling element 7 and without the removable connection with an insertion rod being prepared. Incorporations without coupling elements will be described in more detail below. When the assembly of the stent 1, introduction tube 13 and insertion rod 9 is so advanced, so that the support body is positioned in the nasal passage, first the introduction tube is retracted on the insertion rod 9 and there, the insertion rod is detached from stent 1. The smooth surface of the introduction tube 13 significantly simplifies the introduction of stent 1 into the nasal passage. Figure 2 shows a second incorporation of stent 1, similar to the first incorporation. Therefore, the same parts have the same reference numbers and are not described a second time. According to the second incorporation, stent 1 differs from stent 1 of the first incorporation, only in that the fixation section 3 does not increase conically but is provided by parabolically tapering, in which it tapers more sharply as it approaches the crimp body 5. Fig. 3 shows another stent 1 incorporation in which, again, the same parts of the previous incorporation have the same reference numbers. This stent differs from the above incorporations. The area of the proximal end of the support body 2 has an enlarged section 15. In the present embodiment, the enlarged section 15 is in the form of an enlarged ball. The shape of the enlarged ball section may vary slightly from the ideal ball shape, for example to be oval. It is essential that the enlarged section does not form flaps that exert pressure against the nasal wings but that, due to its rounded shape, support the respective nasal alar from the inside, in a smooth way. The extended ball-shaped section should have a minimum diameter of 10mm, preferably 12mm, and particularly 13mm, in order to obtain an effective enlargement of the nasal wings. However, the diameter should not be too large so that no strong pressure is exerted on the nasal wings. Thus, a maximum diameter of 20mm, particularly 17mm or 15mm respectively, is advantageous. Consequently, the rest of the support body 2 is shorter in the length of this section, when compared to the aforementioned embodiments, so that the total length remains substantially the same. The enlarged ball-shaped section 15 exists in order to be positioned directly behind the nasal entrance, so that the nasal wings can be immobilized to prevent collapse. In particular for embodiments that comprise an enlarged section, it may be advisable not to include a fixation section, as the enlarged ball-shaped section 15, already provides sufficient fixation in the nose, so that a retaining element is not absolutely necessary . Next, some stent incorporations without a fixation section or without a coupling element, respectively, are described based on Figs. 15, 15b, 17a, 17b. According to the embodiment in Figs. 15a, 15b, the extended section 15 exists so that the ends of the metallic wire are connected in a droplet of polymer 93. Preferably, the droplet of polymer is applied to the ends of the metallic wires as a liquid polymer or liquid glue and maintained in its form as long as the polymer is completely hardened. After hardening, the ends of the metal wires are fixed, and neither the braid nor the body tissue in contact with them can be damaged by sharp points. In another embodiment (Figs. 16a, 16b) the ends of metallic wire are connected by a ring 94 of one or two pieces, similar to a rivet. For this, the metallic wires are inserted in a circumferential groove in this ring and, subsequently, this groove is compressed or crimped. According to another embodiment (Figs. 17a, 17b), the metallic wires are connected by interlacing or heat treatment, in which the ends of the metallic wires return to the inner lumen of the enlarged ball-shaped section. For this, the proximal end of the interlaced can be equipped with sprains so that distortion and bending can be avoided. In addition, the ends of the metal wires can be, for example, rolled with a sleeve, and thus secured. In the case of a stent without a coupling element, the insertion tube is retracted on an insertion rod that does not comprise a tubular sleeve, or on an insertion tube without openings or a groove, in which the stent expands and expands. positions itself in the nasal passage. In Fig. 3, the braiding of metallic wires is only shown schematically. Such a shape, for example, can be obtained by braiding a cylindrical stent of metallic nitinol wire, in which the cylindrical stent is positioned on a tool that represents the shape of the support body 2, and exhibits a ball-shaped section and a section cylindrical. Through a special heat treatment, known by experts as annealing, the shape of the body molded in the braid is printed on the braided nitinol wire. After removal of the molded body, the stent remains in this shape. Fig. 4 shows another stent 1 incorporation in which, again, the same parts of the previous incorporation have the same reference numbers. This stent differs from the three other embodiments described above, in that the fixing section 3 is not braided, but the metal wires run either individually and parallel from the support body 2 to the pencil-shaped body or crimp body 5, respectively , or the metallic threads are twisted and the filaments run parallel from the support body 2 to the pencil-shaped body. In this case, each two, three or four metallic wires can be twisted by 5 a twisted filament 16. The advantage of this fixation section 3 lies in its high flexibility and the fact that the stent is highly foldable in the area of the fixation section 3. It is clear that this fixing section 3 can also be combined with the extended section 15, according to the third 10 incorporation. In case the stent is not equipped with a coupling element (for example a bearing clutch), then it will be useful to provide a removal tool to remove stent 1 from the nose. The simplest version is an elongated, thin plastic or metal body, which is uncinate at the distal end (not shown). This curvature is inserted into the metallic wire braid of stent 1, and the stent is extracted from the nose with the removal tool. As an alternative, other embodiments other than removal tools 89 may be applied, as described below, based on Figs. 18a to 20c. A second incorporation of the removal tool 89 (Figs. 18a, 18b), shows elastic tentacles 98 similar to the mandrel of a mechanical pencil with a pencil mine, slidably mounted on a sleeve 91. By pushing the tentacles 90 out of the sleeve 91, the free ends expand due to their spring effect. Tentacles 90 have hooked-in edges. With these hooked edges, the tentacles are positioned on the strand of stent 1. When the tentacles are positioned on the strand, the tentacles 90 are pulled into the sleeve 91, until stent 1 is securely fixed. Then the stent is removed from the nose. In Figs. 19a to 19c, a third embodiment of the removal tool 89 is shown, which, again, is equipped with a sleeve 91. On the sleeve 91, a metal retention tentacle 92 is placed. When it is inside the sleeve, the metal tentacle retention device 92 is stretched, as the inner diameter of the sleeve 91 is only slightly larger than that of the metal retention tentacle 92. The metal retention tentacle 92 is shaped in such a way that it self-coils when released from the sleeve 91, and forms a knot. To attach to the sleeve, the removal tool 89 is positioned at the proximal end of the stent with the metal retaining tentacle 92 pulled into it. Subsequently, the metal retention tentacle 92 is pushed out of the sleeve 91. The metal retention tentacle 92 forms the knot within the stent strand, in which a sufficiently strong tensile force is exerted to pull the stent out of the nose. In this way, stent 1 is removed from the nose. There is a fourth embodiment of the removal tool 89 (Figs. 20a to 20c), similar to that of the third embodiment of the removal tool shown in Figs. 19a to 19c. The fourth embodiment of the removal tool 89 comprises, again, a sleeve 91 in which several metal tentacles of retention 92, each pre-shaped as a loop, are positioned. To grip the stent, the removal tool 89 it is positioned with the hole of the sleeve 91 at the proximal end of the stent. Subsequently, the metal retaining tentacles 92 are pushed out of the sleeve 91. The metal retaining tentacles self-expand within the strand of stent 1 so that the stent can be removed from the nose. Next, some retaining elements are described: Fig. 5 shows a first incorporation of a retaining element 8 which, seen from above, is formed by a rectangular plastic plate. The edges of the plate are rounded. The board has a length of about 3-4 cm and a width of about 0.7-1.5 cm. In the center of this plate-like retaining element 8, there is a circular opening 18, with a diameter slightly larger than the diameter of the bearing clutch 7, of the stent 1. From this opening 18, two grooves 19 are opened, which extend in parallel until to the longitudinal edge 20 of the plate-like retaining element 8. These grooves 19 are positioned in the middle between the opposite longitudinal edges 20. The edges are smaller than the diameter of the bearing clutch 7. Preferably, the grooves are incisions without any distance between the opposite edges of the incision. A bearing clutch 7 can be passed through the opening 18 of the retaining element 8, and the stent can move along one of the two slots 19, where the stent 1 extends with its pin 6 or with the metal wire interlaced through the respective slot 19. A second stent can be inserted with its bearing clutch 7 into opening 18 and be moved to the other slot 19. Stents 1 are mounted on the retaining element 8, once already inserted into the nasal passage, and after the the insertion rod and the insertion rod have been removed. Due to the positioning of the stents 1 on the nose, they are located far from each other, in order to safely avoid the movement of the bearing clutch 7 towards opening 18. Thus, the retaining element is captively connected to both stents 1 In this way, the retaining element 8 thus creates a retainer between the two stents 1, which prevents the movement of the stents too far into the nasal passages and, in particular, to the throat. It is also useful to equip opening 18 with a funnel (not shown) on the retaining element 8, which simplifies the insertion of the bearing clutch 7. During the insertion of the bearing clutch 7 in opening 1, stent 1 is positioned with its support body in the nasal passage. In this way, the bearing clutch 7 is located directly on the nose and at the limit of the user's field of vision. Thus, such a funnel is highly beneficial since, in this way, it is possible to connect the retaining element to stent 1, without the need to see the retaining element and fixation section 3 of stent 1. Fig. 5b shows a second embodiment of a retaining element, similar to that of the first embodiment in Fig. 5a. Thus, some parts have the same reference numbers and are not described a second time. This retaining element is a rectangular plate with two longitudinal edges 20. It also has two grooves 19. The two grooves 19 each end in a separate opening 21, 22, which are slightly apart from the center of the plate. A third embodiment of a retaining element is shown in Fig. 6. This retaining element is similar to the retaining element shown in Fig. 5a. Therefore, some parts have the same reference numbers and are not described a second time. On the front surfaces, each orthogonal to the longitudinal edges, there is a support wing 23. Viewed from above, the support wing is a rectangular plate that extends with its longitudinal edges 24 at an angle to the longitudinal edges 20 of the main body. of the retaining element 8. Each of the two support wings 23 is at an angle to the same side relative to the grooves 19. The support wings can be attached below the nasal wings after fixing the stent 1 with the retaining element 8, in order to keep the nasal wings open. Firstly, this retaining element can be combined with stents, according to the incorporations that do not contain an extended section to keep the nasal wings open, according to Figs. 1, 2 and 3. The longitudinal edges 24 of the support wings 23, with their longitudinal edges 20, form the limits of the main body of the retaining element 8, at an angle between 120 ° and 150 °. Figs. 7a and 7b, show another incorporation of the retention element 8. This retention element is plate type and, seen from above, rectangular with two longitudinal edges 20. This plate comprises a rigid enclosure which, seen from above, is shaped like a bone with two circular sections 26 and a connecting strut 27 between the circular sections 26. This rigid housing 25 is made of, for example, a steel spring. The other section of the plate-like retaining element 8 is made of a material. flexible plastic, in particular an elastomer. In the area of the longitudinal center of the rigid enclosure which, in Fig. 7a, is labeled with the reference number 25, the rigid enclosure is integrally connected with the other plastic material, which is why this zone is referred to below as the connection 28. Flanking connection area 28, the rigid housing 25 is completely eradicated / embossed from the flexible plastic material, as shown in Fig. 7a, with two stamping lines. The flexible plastic material forms two flexible latches 30, which are connected to the rigid housing 25 in the connection zone 28. The flexible latches 30 thus exhibit openings whose shape is complementary to the ends of the rigid housing 25. As shown in the diagram in Fig. 7b, the flexible latches 30 can be removed from the end of the rigid housing 25, so that the openings of the latches 30 can be uncovered. Each fixation section 3 of stent 1 can be passed through an opening. Then, the securing section 3 is secured between the ends of the rigid housing 25 and the flexible latch 30 and thereby secured / connected to the securing element 8. According to Fig. 7a and 7b, this fastening element 8 is of simple construction and inexpensive to produce. However, it securely fixes the securing sections 3 of two stents 1. In the context of the invention, it is clear that it is possible to use other clamping elements, in particular clips with a spring element that connect with two clamps. In addition, the fastening element 8 may contain one or two bushings, designed just like the bush 10 of the insertion rod 9. These bushings also allow the coupling of the stent (s) to the retaining element. According to Figs. 5b, 6, 7a and 7b, the retaining elements may additionally contain an integral funnel in the area of their openings 18, 21, 22 and 29, Fig. 11 shows another fastening element 8, which consists of a hollow, elongated and tubular sleeve or insert 31 and an insert © 32 slidably mounted on the insert 31. The insert 31 has an end closed by a surface front 33 and an open end. The insert 32 is adapted to the shape of the socket 31 in which, preferably, the socket 31 and the insert 32 contain a rectangular, particularly square or circular cross section. The insert 32 can be a solid plastic body with a first recess 34 and a second recess. 35 on a longitudinal edge. The recesses 34 and 35, extend from the longitudinal edge with a pre-established depth B, until the insert 32. In the longitudinal direction, the recesses 34 and 35 extend through a pre-established length L, which, preferably, is significantly greater than than depth B. In the longitudinal direction, each end of the recesses 34 and 35 has the shape of a concave curvature 36. The socket 31 has two longitudinal grooves 37 diametrically opposed, in which each end of a transverse pin 38, positioned with insert 32. The cross pin 38 limits the movement of the insert 32 in the socket 31, in which at a maximum insertion position of the insert 32, the cross pin 38 touches the end of the longitudinal groove 37, towards the front surface 33. In the maximum delivery position of the longitudinal 37 at its end distal to the front surface 33. Thus, the length of the longitudinal groove 37 corresponds to the maximum insertion of the insert 32 in the slot 31. Between the front surface 33 and the insert 32, there is a spring element 39 that pushes the insert 32 to the maximum delivery position (Fig 11a). The socket 31 also displays a first recess 40 and a second recess 41, which are approximately the same shape as the first recess 34 and the second recess 35 of the insert 32, and align at the maximum insertion position of the insert 32, with the recesses 34 and 35. Therefore, the recesses 40, 41 also have concave curvatures 42, which limit the recesses in their longitudinal direction. In the inserted position of the insert 32, in which the first recesses 34, 40 and the second recesses 35, 41 are approximately aligned, thus, in an approximately continuous recess, it follows that each of the fixation sections 3 of a stent 1 can be inserted . When the insert 32 is released, it is moved away from the front surface 33 by the spring element 39. The concave curvatures 36 of the recesses of the insert and the concave curvatures 42 of the socket 31, move towards each other and secure the fastening sections 3 of the stents 1. The insert © 32 is activated in its section that protrudes from the open end of the socket 31 and is pressed against the spring element 39. Fig 11b shows another retaining element 8, which is provided similar to the retaining element 8, according to Fig. 11a, but has only a single indentation 34 in insert 32, and a single indentation 40 in socket 31, which aligns when insert 32 is pushed in. With this retaining element, a single stent can be attached. Two of these fasteners can be connected with a flexible strip, so that with each of the retaining elements 8 a stent 1 can be fixed. The use of two fasteners 8 interconnected with a flexible strip has the advantage of, first, one of the two retention elements can be coupled to one of the stents and, subsequently the other, independent of the other retention element, can be adjusted towards the second stent and coupled to it. Fig 12 shows another retaining element 8, similar to the retaining element shown in Fig. 11a. Thus, the same parts have the same reference numbers and are not described a second time. According to Fig. 12a, the retaining element differs from that shown in Fig. 11a, only by the existence of openings 43, 44 in insert 32, and openings 45, 46 in slot 31, which align when the insert is pushed in. In the present embodiment, openings 43 to 46 have a circular shape. In the context of this invention, it is clear that it is possible to provide longitudinal openings instead of circular openings which are aligned in the longitudinal direction of the socket 31, and of the insert 32, respectively. In Fig. 12b, a retaining element 8 is shown, which is similar to the retaining element according to Fig. 12a, whereas this retaining element (s) each has / has an opening 43, 45 in the insert 32, and the insert 31 which aligns when the insert 31 is pushed inwards. According to Fig. 11b, the retaining element 8 serves to fix a single stent. Two of these retaining elements can be connected by a flexible strip for fixing the two stents. Fig. 13a shows, in a roughly schematic way, another retaining element 8, which has a rectangular frame 47, with two longitudinal supports 48, 49, and two cross supports 50, 51. In this frame 47, there is a plate stamped 52, which is centrally connected with a guide rod arranged orthogonally in relation to the stamped plate 52. On the far side of the guide rod 53, there is a spring element 54 between the stamped plate and the longitudinal support 49. The spring element presses the plate stamped against the longitudinal support 48. The guide rod 53 extends through the respective hole in the longitudinal support 48, so that the stamped plate is conducted parallel to the longitudinal supports 48, 49. In order to connect this retaining element 8 with the two stent clamping sections 3, the guide rod is pushed into the frame 47 against the action of the spring element 52. Then, in this area between the stamped plate 52 and the longitudinal support 48, both fixation sections 3 of stents 1 can be inserted. After the release of the guide rod 53, the stamped plate 52 is pressed against the longitudinal support 48, which is why the fixing sections 3 of the stents 1 are trapped between the stamped plate 52 and the longitudinal supports 48. The advantage of this retaining element 8 lies in the fact that the open area between the stamped plate 52 and the longitudinal supports 48 is quite large, so that it is easy to insert the fastening sections 3. In PCT / EP 2010/004687, it is revealed a fixing device that can also be used here, as a retaining element 8 (Figs. 14a to 14c). Therefore, reference is made to this document. This fastening element 8 comprises a first and a second jaw clamp 55, 56, interconnected by a joint 57. Next, the first jaw clamp 55 is referred to below as the base jaw. The base jaw has a base surface 58. The base surface comprises an upper side 59, a lower side 60 and two side walls 61 that extend from the base surface 58 as its longitudinal sides in an upward direction, in order to that the base surface 58 and the two side walls 61, abut a U-shaped recess. The two opposite ends of the cuboid base 58, are referred to as the joint side 63 and the lock side 64. Two members of annular discs 65 are formed at a distance from each other on the side of the joint 63, on the base surface 58, and are aligned with the outer surfaces of the side walls 61. Each member of the annular disc 65 has a circular opening 66, aligned with each other. The openings 66 are designed to receive a tubular shaft 67 each. The tubular shaft is rotatable in the openings 66 and is aligned with the outer surfaces of the side walls. the first jaw clamp 55 is pivotally connected to the second jaw clamp, 56 through tubular shaft 67. The side walls 61 extend on the side of the lock 64 beyond the front edge of the base surface 58 and, therefore, when viewed from above, define the U-shaped recess of the jaw clamp 55. The side walls are somewhat more high in this zone. The front edge of the base surface 58 on the lower side 60 is referred to below as the locking edge 68. There is a cuboidal fixation block 69 in the U-shaped recess, or in the groove 62, respectively. The cuboid clamping block 69 protrudes approximately 3mm from the upper side 59 of the base surface 58. The cuboid clamping block 69 is made of a plastic material, in particular silicone, and forms a clamping element. The second jaw clamp 56 is shaped like an L and has a cuboidal cross section. The second jaw clamp 56 contains a long arm 70 and a short arm formed from it, at a right angle, this arm being referred to below as the clamping arm 71. The long arm 70 has a base surface 72 and two side walls 73, which define the groove between them. The end of the long arm 70, opposite the clamping arm 71, is referred to as the joint side 74. A tubular joint body 75 is formed on this side of the joint 74. The joint body 75 forms a tube with two front sides and a circular opening, in which the length of the tube corresponds to the interior width of the two ring disk members 65. The tubular shaft 67 is located at the opening of the joint body. The tubular shaft 67 is rotatably supported in the openings 66 of the members of the annular disk 65, and in the opening 75 of the joint body 75. A hole (not shown) is formed in the fixing arm 71, in which said hole is aligned with the groove in the long arm 70. There is a recess in the tubular joint body 75, in which said recess is also aligned with the long arm groove 70. The hole, the long arm groove 70 and the joint body recess 75 accommodate a clamping tube 77. The clamping tube 77 and / or the clamping element is made of plastic material, particularly of silicone. The latch 78 facing the joint body 75 is formed at the free end of the fixing arm 71. The latch 78 is made in such a way as to secure behind the fixing edge 71, when the two arms are compressed. The latch 78 closes behind the fastening edge 71 and retains the retaining element 8 in a closed state. Thus, the latch 78 and the fastening edge form a lock member. When closed, the retaining element, the jaw clamp 55 and the second jaw clamp 56 are arranged approximately parallel to each other, and the clamping block 69 and the clamping tube 77 are pressed against each other. The fixing section 3 of the stent 1 can be placed between the fixing block 55 of the jaw clamp 55, and the fixing tube 77 of the second jaw clamp 56. It is also possible to fix two fixation sections 3 at the same time. two stents, with this retaining element between the fixing block 69 and a fixing tube 77. Therefore, it is advantageous that the fixing block 69 and fixing tube 77 extend, each of them, for a length of at least 3 to 3 cm. In the context of this invention, it may also be advantageous to provide such a retaining element in a miniaturized embodiment, in which the jaw clamps 55, 56 extend only a length of, for example, about Icm. Two retaining elements, thus, are then interconnected by a flexible strip, so that each of the retaining elements can be attached to each of the stents. The retaining elements 8 described above are each designed for fixing two stents 1. In the context of the invention, it is clear that it is also possible to design a fixing element 8 for fixing only one stent. It will be advantageous for the retainer to extend at least in one direction, such that the retainer cannot be pulled into a nostril. According to this invention, Fig. 10 shows a schematic representation of stent 1, according to Fig. 3, inserted in a nasal cavity 79. The nasal cavity 79 extends from the nasal entrance 80 or nostril 80, respectively, in towards the nasopharynx 81. In the nose area, the nasal cavity is confined by the nasal alar 82. In the nasal cavity are two turbinates 83, between the palate 84 and the ethmoid bone plate 8 5 of the nasal cavity 79. Between the palate 84 and the lower turbinate 83, there is the lower nasal passage 86, and between the two turbinates 83, the middle nasal passage, and between the upper turbinate 83 and the ethmoid bone plate 85, the upper nasal passage 88. When the turbinates are swollen, then the nasal passage can be kept patent through the use of the stent, in accordance with the present invention. Stent 1 is mostly used in the lower nasal passage. However, it is also possible to apply the stent in the middle nasal passage 87, or in the upper nasal passage 88, respectively. In particular, the lower nasal passage has a very high sensitivity in the posterior part. In this area, the support body 2 of the stent 1 must not end, as the posterior edge can exert an uncomfortable pressure against the turbinate 83. Therefore, it is advantageous to place the support body so that it only separates the anterior part of the nasal passage, or that extends throughout the nasal passage. It is also advantageous that, according to the invention, the stent is flexible so that it accommodates the shape of the nasal passages. On the one hand, this is achieved by the elasticity of the metallic thread and, on the other hand, by the incorporation as a braid. Fig. 10 merely shows a stent 1, which is secured by a retainer 8. In the context of this invention, it is possible to use only a single stent. However, in general, two stents are applied. Typically, these two stents are the same. However, for special applications, it may be useful to apply two stents of different dimensions (different length and / or diameter and / or construction). According to this invention, it may sometimes make sense to combine a stent to separate a nasal passage, with a stent to separate the airway in the throat, as known from W02007 / 065408 and use at the same time and secure with a retaining element 8. List of reference numbers 1 Endoprosthesis 2 Support body 3 Clamping section 4 Rounded end 5 Crimp body 6 Pin 7 Bearing clutch 8 Retaining element 9 Insertion rod 10 Sleeve / sleeve 11 Opening 12 Groove 13 Introduction tube 14 Tip of introduction 15 Extended section 16 Twisted filament 17 Chamfer 18 Opening 19 Slot 20 Longitudinal edge 21 Opening 22 Opening 23 Support wing 25 Rigid housing 26 Circular section 27 Connecting strand 28 Connecting zone 29 Stamping line 30 Flexible latch 31 Insert 32 Insert 33 Front surface 34 First recess 35 Second recess 36 Concave bend 37 Longitudinal groove 38 Cross pin 39 Spring element 40 First recess 41 Second recess 42 Concave bend 43 Opening 44 Opening 45 Opening 46 Opening 47 Frame 48 Longitudinal support 49 Longitudinal support 51 Cross support 52 Stamped plate 53 Guide rod 54 Spring element 55 First clamp- jaw 56 Second clamp-jaw 57 Gasket 58 Base surface 59 Upper side 60 Lower side 61 Side wall 62 Groove 63 Joint side 64 Lock side 65 Ring disk member 66 Opening 67 Tubular shaft 68 Lock edge 69 Fixing block 70 Arm long 71 Fixation arm 72 Base surface 73 Side wall 74 Joint side 75 Joint body 76 Opening 77 Fixation tube 78 Latch 79 Nasal cavity 80 Nasal / nostril entrance 81 Nasopharynx 82 Nasa 83 turbinate 84 Palate 85 Ethmoid bone plate 86 Lower nasal passage 87 Middle nasal passage 88 Upper nasal passage 89 Removal tool 90 Tentacle 91 Sleeve 92 Tentacle 93 Polymer droplet 94 Ring
权利要求:
Claims (13) [0001] 1. Stent for separation of a nasal passage characterized by the fact that the stent (1) is made of a braided tubular support body (2), in which the support body (2) has a cylindrical shape and has an enlarged section (15) at its proximal end, which is widened in the form of a ball, in which, in an unloaded state, the support body (2) has a diameter of 4 mm to 20 mm and a length of 25 mm to 100 mm . [0002] 2. Stent, according to claim 1, characterized by the fact that the enlarged section (15) has a diameter of at least 10 mm, particularly 12 mm. [0003] 3. Stent according to either of claims 1 or 2, characterized by the fact that the stent (1) has a fixation section (3) positioned at the proximal end of the stent (1), which exists for fixing the stent ( 1) in a user's nasal passage, where the fixation section (3) protrudes from the user's nostril during fixation of the fixation section (3), and can be fixed outside the nose. [0004] 4. Stent according to any one of claims 1 to 3, characterized in that the stent is compressible in an introduction tube (4) and expands with the release of the introduction tube. [0005] Stent according to any one of claims 1 to 4, characterized in that at least the support body (2) is made of braided metal wire. [0006] 6. Stent according to any one of claims 1 to 5, characterized in that the support body (2) is made of an elastic wire with a diameter of 0.001 to 2 mm, in particular a diameter of 0, 05 to 0.5 mm and, preferably, with a diameter of 0.07 to 0.2 mm, in which, in particular, the wire is a metal wire and, preferably, a metallic wire of nitinol or steel wire. [0007] 7. Stent according to any one of claims 1 to 6, characterized by the fact that the stent (1) has a support body (2) which, in the unloaded state, has a maximum diameter of 15 to 20 mm and / or a length of either 30 to 50 mm, or from 70 to 100 mm, or from 70 to 120 mm, respectively. [0008] Stent according to any one of claims 1 to 7, characterized in that the distal end of the support body (2) is tapered. [0009] 9. Stent according to any one of claims 1 to 8, characterized in that the fixing section (3) has a coupling element, in particular a bearing clutch, for fixing the stent (1) to an element retaining bracket (8) and / or an insertion rod (9). [0010] Retention element as described in any one of claims 1 to 9, characterized in that the retention element (8) is designed in such a way that it can be connected, in a captive way, to at least one securing section ( 3) of a stent (2) and, preferably, captively connected to two fixation sections (3) of two stents (1). [0011] Retention element according to claim 10, characterized by the fact that a retention element (8) has at least one and, preferably, two corresponding coupling elements, each of which can be coupled with an coupling (7) of the stent (1). [0012] 12. Immobilization system for a nasal passage characterized by the fact that it comprises a stent (1), as defined in any one of claims 1 to 9, and an insertion rod (9) and an introduction tube (13). [0013] 13. Immobilization system according to claim 12, characterized by the fact that the stent can be detachably connected to the insertion rod (9) and / or the system comprises a removal tool (89) for removal of the stent (1) from the nasal passage, in which the removal tool can be attached to the stent (1).
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同族专利:
公开号 | 公开日 CN103384507A|2013-11-06| US20140018839A1|2014-01-16| CN103384507B|2017-02-08| EP2672938A1|2013-12-18| US20180361129A1|2018-12-20| US11116950B2|2021-09-14| WO2012107229A1|2012-08-16| DE102011010754A1|2012-08-09| EP2672938B1|2018-05-02| BR112013020115A2|2016-10-25|
引用文献:
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法律状态:
2018-02-06| B25C| Requirement related to requested transfer of rights|Owner name: ALAXO GMBH (DE) | 2018-05-22| B25A| Requested transfer of rights approved|Owner name: KLAUS DUERING (DE) | 2018-07-10| B08E| Application fees: payment of additional fee required [chapter 8.5 patent gazette]| 2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-01-15| B08G| Application fees: restoration [chapter 8.7 patent gazette]| 2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-09-24| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]| 2021-01-26| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2021-03-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/02/2012, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
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申请号 | 申请日 | 专利标题 DE102011010754A|DE102011010754A1|2011-02-09|2011-02-09|Stent to the rails of a nasal passage| DE102011010754.1|2011-02-09| PCT/EP2012/000589|WO2012107229A1|2011-02-09|2012-02-09|Stent for splinting a nasal passage| 相关专利
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