US20140018839A1 - Stent for splinting a nasal passage - Google Patents
Stent for splinting a nasal passage Download PDFInfo
- Publication number
- US20140018839A1 US20140018839A1 US13/983,028 US201213983028A US2014018839A1 US 20140018839 A1 US20140018839 A1 US 20140018839A1 US 201213983028 A US201213983028 A US 201213983028A US 2014018839 A1 US2014018839 A1 US 2014018839A1
- Authority
- US
- United States
- Prior art keywords
- stent
- fixation
- holding element
- support body
- nasal passage
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
- A61F5/08—Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/56—Devices for preventing snoring
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0071—Three-dimensional shapes spherical
Definitions
- the present invention relates to a stent for splinting a nasal passage.
- plastic splints for splinting of the nostrils are provided.
- the plastic splints each consist of several plastic rings which are connected by longitudinal struts. At one end two of these plastic splints are connected to each other by a plastic holder so that the two plastic splints can be inserted in the two nostrils. At the ends connected by the plastic holder the diameter of the plastic splint is larger than at the end distal from the holder. Thus, these splints are inserted into the nose with the thinner end ahead.
- These splints are about 10 mm long and ensure that the nose in the region of its opening is kept open.
- Nasaline® nasal dilators are provided which expand the nasal alars and thereby shall reduce mouth breathing.
- Such nasal dilators are short plastic bushings which are loosely interconnected so that their distance is adjustable.
- the above described apparatusses serve for maintaining patency of the nostrils.
- nasopharyngeal splint The company MBM ScienceBridge GmbH, Göttingen, Germany has developed a nasopharyngeal splint.
- This splint consists of two plastic splints which each is shaped synclinally whereas the synclinal splints are interconnected at one end by an elongated holder.
- Each splint can be introduced in one nostril.
- the splints are shaped in a way that they can be introduced through the nose, passed along the nasal septum and keep open the upper throat by their shape.
- the soft palate is prevented to close the throat. Thereby, a continuous breathing shall be ensured.
- the splints are onetime adapted for the patient by endoscopy.
- WO 2007/065408 A2 discloses an apnea stent which serves for splinting and/or keeping open the airway in the throat.
- This apnea stent consists of a compressible and self-expanding stent which exhibits 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 expandable in a way so that the airway is kept open.
- a proximal phase of the stent is provided for fixing the stent in the nasal area.
- the proximal phase is funnel-shaped whereas this phase widens from the proximal towards the distal end.
- the distal and the proximal phase are made as a braid in which the wires or fibers or strands, resp. cross each other.
- Each individual wire directed to the distal end of the stent at the distal end of the distal phase is returned to the proximal end of the stent.
- the bends created in this way are referred to below as round ends.
- a transition phase of the stent is intended for the connection of the proximal phase with the distal phase.
- the transition phase is formed by twisting of the wires of the stent into twisted strands. As a result the transition section exhibits a high flexibility in radial direction so that within a short longitudinal stretch a strong radial expansion from the proximal to the distal phase is effected.
- US 2009/0010991 A1 discloses an expandable nasal stent which is permanently inserted into the nostril or the nasal passage.
- This stent is made from a polymer or steel grid and equipped with a filter element which is positioned at the proximal end of the stent.
- the stent can be coated with a therapeutic agent.
- US 2010/0211181 A1 and U.S. Pat. No. 5,336,163 disclose further nasal stents which are constructed as filters for filtering the inhaled air.
- US 2010/0106255 A1 discloses a self-expanding stent which can be anchored with one end in the sinus.
- the invention is based on the object to provide a stent for splinting of a nasal passage which does not need to be individually adjusted for each nasal passage, it shall be easily introduced and comfortable in use, and it shall fully and reliably keep open a nasal passage.
- a stent comprising the features of claim 1 .
- Advantageous embodiments are indicated in the sub-claims.
- the stent for splinting of a nasal passage consists of a braided tubular support body and optionally a fixation section.
- the support body in unloaded state has a diameter of at least 4 mm and a length in the range of 25 to 120 mm and particularly of 25 to 100 mm.
- a fixation section can be provided which is designed for fixation of the stent in the nasal passage of the user wherein the fixation section extends out of the nostril of the user when fixing and can be fixed outside of the nose.
- the braided support body is elastically deformable and nestles to the inner surface of the nasal passage.
- the pressure created by the tubular support body against the nasal passage evenly scatters, and therefore the support body does not cause any pain or unpleasant feeling in the sensitive nasal passage.
- a suitable stent can be provided.
- the support body can be provided with diameters of 4 to 20 mm whereas the standard sizes preferably differ in the diameter and are staggered in 1 mm steps.
- the length of the support body is in the range of 25 mm to 120 mm and particularly 25 to 100 mm.
- Preferably the standard sizes differ in length, staggered in 5 mm steps.
- the preferred length of the support body is in the range of 30 mm to 50 mm as this is the usual length of the nasal passage in the region of the anterior turbinates for average body sizes.
- a support body with a length of about 60 mm is positioned with its distal end in an area of the nasal passage and turbinates which is highly sensitive. Therefore it is useful to provide a support body with either a shorter length so that it is not in contact with this sensitive area, or with a greater length so that it extends along this sensitive are. Therefore, on the one hand support bodies with a length of maximally 40 to about 45 or 50 mm, resp., or support bodies with a length of at least 70 to 80 mm or 100 mm, resp. are preferred.
- the function of the fixation section lies in the prevention that the support body moves along the nasal passage in direction to the throat.
- the fixation section therefore is connected to the support body and extends to the outside of the nose. There, the fixation section can be fixed.
- the fixation section can be designed one-piece with the support body as a braided tubular section tapered towards the proximal end.
- the fixation section can also be made from any desired other material which preferably is flexible.
- a coupling element is provided at the proximal end of the fixation section which can be connected to a mating coupling element of an inserting rod or a holding element.
- the mating coupling element is provided at one end of the inserting rod.
- the stent can be introduced into an introduction tube and compressed with the stent coupled to the inserting rod. For that purpose the inserting rod is pushed through the introduction tube so that the stent is pulled into the introduction tube by the inserting rod.
- the holding element provides two mating coupling elements for coupling of two proximal elements of two stents to the coupling element.
- the coupling element provides a detachable holder between the two stents which securely prevents movement of the stents too far in direction to the throat.
- the coupling element also can be provided as a clamp which fixes the fixation section of a stent or two fixation sections of two stents by clamping.
- the clamping can be executed independent of the coupling element for coupling of the stent to an inserting rod or, alternatively, by clamping of the coupling element in the holding element.
- the stent can be braided from wires, fibers and/or strands which cross each other.
- wire In the following only the term wire is used whereas this includes also fibers or strands as far as the wire is not further specified.
- Each individual wire directed towards the distal end of the stent is returned at the distal end of the support body towards the proximal end of the stent.
- the bends resulting from that are referred to below as round ends.
- These have in unloaded state of the stent a diameter in the range of 0.5 to 2 mm. Thereby a distal end is provided without any individual free wire ends or no free wire ends need to be connected with another element.
- the connection of the wire or the wires, resp., of the stent at the proximal end can be simply realized e.g. by crimping or glueing so that a fixation section is created.
- the wires also can be connected e.g. by a droplet of polymer, a ring, or by returning them into the inner lumen of the support body without creating a fixation section.
- the round ends prevent injury of the airways caused by the distal end of the stents.
- the wire used for braiding of the support body particularly is a metal wire, preferably a nitinol or steel wire.
- the distal end of the support body are provided slightly tapered relative to the other part of the support body. This prevents that the stent may press with its ending border into the nasal passage which may be uncomfortable.
- the support body can be provided at its proximal end with a widened section.
- This widened section preferably has about a ball-shape.
- the ball has a diameter of about 10 to 20 mm, preferably 12 or 13 to 15 or 17 mm, resp.
- This widened section of the support body during use is positioned in the region directly behind the nostrils in order to splint the nasal alar to prevent a collapse. Additionally, the widened section fixes the stent in the nose so that especially for a stent comprising a widened section the above described fixation section may not be necessary. Such a stent is most useful for sports during which the nasal passages shall be kept open. A fixation section protruding from the nose is undesirable during sports.
- the removal tool can be coupled with the stent, e.g. by providing an element for hooking into the braid of the stent or an element for grasping the braid.
- the braided support body is sufficient. For that purpose no additional part needs to be provided at the stent.
- FIG. 1 shows a stent according to a first embodiment of the invention in a schematic side view
- FIG. 2 shows a stent according to 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 shows a stent according to a fourth embodiment of the invention in a schematic side view
- FIGS. 5 a , 5 a show each a holding element in the a top view
- FIG. 6 shows another holding element in a top view
- FIGS. 7 a , 7 b show a holding element in a top view and a side view
- FIG. 8 shows a section of an inserting rod in a side view
- FIG. 9 shows a section of an introduction tube in a section view
- FIG. 10 schematically shows the nasal cavity in a section view
- FIGS. 11 a und 11 b schematically show another holding element in a side view grossly simplified
- FIGS. 12 a und 12 b schematically show another holding element in a side view grossly simplified
- FIGS. 13 a and 13 b schematically show another holding element in a side view grossly simplified
- FIGS. 14 a bis 14 c schematically show another holding element in a side view grossly simplified
- FIGS. 15 a, b bis 17 a, b each show a proximal ending region of a stent without a fixation section in a front view (FIG. a ) and in a side view (FIG. b ), and
- FIG. 18 a , 18 b , 19 a , 19 b , 19 c , 20 a , 20 b , 20 c each show a removal tool for removal of a stent from a nose in different grasping conditions.
- a stent 1 according the invention for splinting of a nasal passage comprises a support body 2 and a fixation section 3 .
- FIG. 1 shows a first embodiment of a stent 1 wherein the support body 2 is provided tubular with a constant diameter and the fixation section 3 conically tapers from the distal to the proximal end.
- the support body 2 as well as the fixation section 3 are integrally made from one wire braid.
- Each individual wire directed towards the distal end of the stent 1 is returned at the distal end of the support body 2 towards the proximal end of the stent 1 .
- the bends resulting from that are referred to below as round ends 4 .
- These have in unloaded state of the stent a diameter in the range of 0.5 to 2 mm. Thereby a distal end is provided without any individual free wire ends. No free wire ends need to be connected with another element.
- the round ends prevent injury of the airways caused by the distal end of the stents.
- the stent 1 can be braided with a single wire or with a multitude of wires.
- the ends of the wire or the wires, resp., are connected at the proximal end of the stent or at the proximal end of the fixation section 3 , resp., with a pencil-shaped or a cylindrical body 5 .
- the pencil-shaped body 5 is a body 5 crimped around the ends of the wires. Therefore it can also be referred to as a crimping body 5 .
- a thin pin 6 is provided at the distal end of the crimping body 5 .
- a ball clutch 7 is provided at the end of the pin 6 distant from the crimping body 5 . With the ball clutch 7 the stent can be connected to another element which provides a respective mating coupling element.
- the stent is braided from an elastic wire with a diameter of 0.001 mm to 2 mm, particularly with a diameter of 0.05 mm to 0.5 mm and preferably with a diameter of 0.07 mm to 0.2 mm.
- the wire particularly is a metal wire and preferably a nitinol or steel wire.
- the length L 2 of the support body 2 is 25 mm to 120 mm and particularly 25 mm to 100 mm.
- the length L 2 of the support body is in the range of 30 mm to 50 mm or 60 mm to 120 mm, or, resp., 30 mm to 50 mm or 70 mm to 100 mm.
- a range of 70 to 100 mm is most preferred.
- the diameter of the support body 2 is in the range or 4 mm to 20 mm.
- the support body has a diameter of at least 5 mm and particularly of at least 6 mm.
- the fixation section 3 has a length L 2 of about 10 to 25 mm.
- the fixation section With the fixation section the stent can be fixed at the body of the user so that the stent cannot move from the nasal passage of the user towards the throat.
- the fixation section extends through the nostril towards the outside in order to be fixed there with the respective fixation element.
- a fixation element e.g. can be a plaster with which the fixation section 3 is taped in the region below the nose of the user.
- a holding element 8 if preferred which extends at least in one direction that far that it cannot be introduced through a nostril into a nasal passage.
- the holding element 8 can be provided in such a way that it can be connected to two stents 1 so that it extends as a holder between the two stens and prevents pulling in too far of the stent into the nasal passage.
- a holding element 8 which is described in more detail in the following preferably is connected to the coupling element of the stent which—in the present embodiment—is provided as a ball clutch 7 .
- the holding element it is also possible to provide the holding element as a clamp which is clamped to the fixation section 3 of a stent 1 or to the fixation sections 3 of two stents 1 .
- FIG. 8 An insertion rod 9 which can be coupled to the coupling element 7 is shown in FIG. 8 .
- the inserting rod 9 is made from plastic.
- a tubular bushing or sleeve 10 is provided at the distal end of the inserting rod 9 as a single-piece.
- the bushing has two diametrically opposite circular openings 11 .
- a slit 12 may be provided in longitudinal direction of the inserting rod 9 in the area of the two circular openings 11 .
- the slit 12 extends to the distal end of the bushing 10 .
- the bushing 10 may be integrally formed at the distal end of the inserting rod 9 or be provided separately, made from another material, and be force-fitted connected to the inserting rod 9 , e.g. by glueing.
- the ball clutch 7 of the stent 1 can be fitted between the two openings 11 of the bushing 10 of the inserting rod 9 . In this way a detachable connection of the stent 1 and the inserting rod 9 is provided.
- the longitudinal slit 12 provided in the bushing 10 simplifies introduction and removal of the ball clutch 7 into or from, resp., the bushing 10 .
- the relation between the diameter of the ball clutch 7 to the inner diameter of the bushing 10 and the hardness of the material of the bushing 10 and the length of the slit 12 can be used for adjustment of the connecting or holding force of the connection between the ball clutch 7 and the bushing 10 .
- the ball clutch 7 is freely rotatable in the bushing 10 .
- the inserting rod also can be provided as an inserting tube (not shown) in which at one end the two circular openings and optionally a slit—similar to the bushing 10 —can be integrated. Thereby the need for separate manufacturing of the tubular bushing is obviated.
- the diameter of the inserting rod 9 and of the crimping body 5 are such dimensioned that the inserting rod 9 together with the stent 1 can be introduced into an insertion tube 13 ( FIG. 9 ).
- the introduction tube 13 is made from a suitable and sufficiently hard polymer, e.g. PEBAX with a shore hardness of 50 Shore D to 80 Shore D, e.g. PEBAX 7233 (Shore hardness 69D), PEBAX 6333 (Shore hardness 64D) or PEBAX 55 (Shore hardness 54D).
- PEBAX 7233 Shore hardness 69D
- PEBAX 6333 Shore hardness 64D
- PEBAX 55 Shore hardness 54D
- an introduction tip 14 may be provided as a single-piece.
- the introduction tip has the same inner as well as outer diameter as the introduction tube 13 and is provided flush-mounted with this.
- the introduction tip 14 can be made from a flexible, significantly smoother material, e.g. PEBAX with a Shore hardness of 25 Shore D to 45 Shore D.
- a single-piece introduction tube can be made from a single material, e.g. PEBAX 7233, PEBAX 6633 or PEBAX 5533. It is possible to manufacture such a single-piece introduction tube in an extrusion process with a continuous material gradient.
- Such an insertion tube has a transition section in which the share of the one material decreases and correspondingly the share of the other material increases.
- Material for such a tube e.g. are PEBAX 7233 in the section of the main body and PEBAX 3533 in the region of the insertion tip 14 so that the insertion tip is smoother than the main body.
- the above description for the two-piece introduction tube apply appropriately.
- the introduction tube also can be provided with multiple layers whereas the inner layer preferably is harder than the outer layer in order to provide a more slippery inner surface with low friction (e.g. PEBAX 7233).
- the stent can be introduced and retracted with low drag into the introduction tube.
- the outer layer preferably has a Shore hardness of e.g. 60A to 95A and is thicker than the inner layer for that the introduction tube generally has smooth and flexible materials properties and therefore easily adapts to the course of the nasal passage. In that way the tube can be easily introduced.
- the outer layer is made from PU 85A with a thickness of about 0.2 mm and the inner layer from PEBAX 7233 with a thickness of about 01. mm.
- the introduction tube 13 may be shape straight. It may also have a curvature.
- the outer diameter of the introduction tube is up to 10 mm, preferably up to 5 mm, in order to enable for the user a comfortable introduction of the tube without pain.
- the inner diameter of the introduction tube is up to 4 mm in order to provide sufficient lumen for uptake of the stent 1 .
- the introduction tip provides a chamfer 17 at the outer edge.
- the introduction tip 14 also can be provided with a rounding.
- a rounding e.g. can be produced by thermal reshaping or by means of abrasion or laser ablation.
- Such a rounding can be provided inside and/or outside.
- Such a rounded tip is more laborious in manufacturing than a chamfer.
- the rounded tip is even more secure during insertion of the stent.
- the thin-walled end resulting form chamfering may harden by release of plasticizers from the polymer due to the relatively large surface.
- the introduction tube may also have an olive or drop shaped thickening at one end or both ends in order to facilitate introduction into the nasal passage.
- the olive of the drop at the end of the introduction tube has a length of 2-20 mm, preferably 2-10 mm and even more preferred 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 shaped introduction tips 14 are atraumatic tips whereas the shape should be even more smooth and round the harder the material of the tip is.
- An olive or drop shaped embodiment has a greater frontal area and therefore exhibits the best pressure distribution towards the nasal tissue.
- the stent 1 For introduction of the stent 1 into the introduction tube 13 the stent 1 first by means of the ball clutch 7 is fixed at the bushing 10 of the inserting rod 9 . The inserting rod then is inserted with its proximal end into the introduction tip 14 of the introduction tube 13 . The insertion rod 9 is pushed through the introduction tube 13 until the stent 1 is completely inserted into the introduction tube 13 .
- the stent 1 may minimally protrude from the introduction tube. It is essential that the stent 1 is compressed by introduction into the introduction tube 13 to a smaller diameter so that it can be easily introduced into the nasal passage together with the introduction tube and the inserting rod. Alternatively the stent 1 is pushed into the introduction tube 13 without a coupling element 7 and no detachable connection with an inserting rod is prepared. Embodiments without coupling elements are described in more detail further below.
- introduction tube 13 and inserting rod 9 When this assembly of stent 1 , introduction tube 13 and inserting rod 9 is advanced that far that the support body is positioned in the nasal passage, first the introduction tube 13 is retracted over the inserting rod 9 and then the inserting rod is detached from stent 1 .
- the smooth surface of the introduction tube 13 significantly simplifies introduction of the stent 1 into the nasal passage.
- FIG. 2 shows a second embodiment of the stent 1 which is provided similar to the first embodiment. Therefore same parts have same reference numbers and are not described a second time.
- the stent 1 according to the second embodiment differs from stent 1 of the first embodiment solely in that the fixation section 3 does not conically increase but is provided about parabolically tapered whereas it tapers more strongly with increasing neighbourhood to the crimping body 5 .
- FIG. 3 shows another embodiment of the stent 1 whereas again same parts as in the previous embodiment have the same reference numbers.
- This stent 1 differs from the above embodiments in that the proximal ending region of the support body 2 has a widened section 15 .
- the widened section 15 in the present embodiment is about ball-shaped widened.
- the shape of the ball-shaped widened section may slightly differ from an ideal ball-shape, e.g. be oval. It is essential that the widened section does not form any edges which press against the nasal alars but that due to its rounded shape it smoothly supports from the inside the respective nasal alar.
- the ball-shaped widened section should have a diameter of at least 10 mm, preferably 12 mm and particularly 13 mm in order to obtain an efficient widening of the nasal alars.
- the diameter should not be too large so that no strong pressure is exerted onto the nasal alars.
- the remaining support body 2 consequently is provided shorter by the length of this section when compared to the above described embodiments so that the overall length remains about the same.
- This ball-shaped widened section 15 is provided in order to be positioned in the region directly behind the nasal entry so that the nasal alars can be splinted to prevent a collapse.
- the widened section 15 is provided in a way so that the wire ends are connected in a polymer drop 93 .
- the polymer drop preferably is applied to the free wire ends as a liquid polymer or liquid glue and maintained in shape as long as the polymer is fully hardened. After hardening the wire ends are fixed and neither the braid nor the body tissue getting into contact therewith can be damaged by sharp-edged tips.
- the wire ends are connected by a single- or two-piece ring 94 similar to a rivet. For that the wire ends are inserted into a circumferential slit at this ring and subsequently this slit is compressed or crimped.
- the wires are connected by braiding or heat treatment whereas the wire ends are returned into the inner lumen of the ball-shaped widened section.
- the proximal end of the braid may be equipped with twists so that distortion and fringing can be excluded.
- the wire ends may be e.g. crimped with a sleeve and thereby fixed.
- the introduction tube is retracted over an inserting rod which does not comprise a tubular bushing or over an inserting tube which does not have openings nor a slit whereby the stent self-expands and positions itself in the nasal passage.
- the wire braid is represented only schematically.
- a shape e.g. can be achieved by braiding of a cylindric stent from a nitinol wire whereby the cylindric stent is positioned on a tool which represents the shape of the support body 2 and provides a ball-shaped section and a cylindric section.
- annealing By a special heat treatment which is known by skilled persons as annealing then the shape of the molded body in the braid is impressed in the nitinol wire braid. After removal of the molded body the stent remains in this shape.
- FIG. 4 shows another embodiment of the stent 1 whereas again same parts as in the previous embodiment have the same reference numbers.
- This stent differs from the three other above described embodiments in that the fixation section 3 is not braided but that the wires run either individually about in parallel from the support body 2 to the pencil-shaped body or crimping body 5 , resp., or the wires are twisted and the twisted strands 16 run about in parallel from the support body 2 to the pencil-shaped body. In that case each two, three or four wires may be twisted into a twisted strand 16 .
- the advantage of this fixation section 3 relies in its very high flexibility and that the stent is highly bendable in the region of the fixation section 3 .
- This fixation section 3 of course may also be combined with the widened section 15 according to the third embodiment.
- the stent 1 is provided without a coupling element (e.g. a ball clutch) then it is useful to provide a removal tool for removal of the stent 1 from the nose.
- a coupling element e.g. a ball clutch
- the most simple version is a thin elongated plastic or metal body which is uncinated at its distal end (not shown). This curvature is inserted into the wire braid of stent 1 and the stent is retracted from the nose with the removal tool.
- FIGS. 18 a , 18 b exhibit elastic tentacles 90 similar to the chuck of a drop-action pencil which are slidably mounted in a sleeve 91 .
- the tentacles 90 have inwardly facing hooked edges. With these hooked edges they are inserted into the braid of stent 1 . Once the tentacles are positioned in the braid the tentacles 90 are pulled into the sleeve 91 to the extent that the stent 1 is securely fixed. Then the stent is pulled out of the nose.
- FIGS. 19 a to 19 c a third embodiment of the removal tool 89 is shown which again provides a sleeve 91 .
- a slidable trap wire 92 is positioned in the sleeve 91 .
- the trap wire 92 is elongated when inside the sleeve because the inner diameter of the sleeve 91 is only slightly larger than the diameter of the trap wire 92 .
- the trap wire 92 is pre-shaped such that it self-coils when released from the sleeve 91 and forms a knot.
- the removal tool 89 is positioned at the proximal end of the stent with the trap wire 92 pulled into it.
- the trap wire 92 is pushed out off the sleeve 91 .
- the trap wire 92 forms the knot inside the braid of the stent 1 whereby a sufficient tensile force is exerted to pull out the stent off the nose. In this way the stent 1 is removed from the nose.
- a fourth embodiment of a removal tool 89 ( FIGS. 20 a to 20 c ) is provided similar to the third embodiment of the removal tool shown in FIGS. 19 a to 19 c .
- the fourth embodiment of the removal tool 89 comprises again a sleeve 91 whereas several trap wires 92 which each are pre-shaped in a loop-like manner are positioned therein.
- the removal tool 89 is positioned with the orifice of the sleeve 91 at the proximal end of the stent.
- the trap wires 92 are pushed out off the sleeve 91 .
- the trap wires self-expand inside of the braid of stent 1 so that the stent can be pulled out off the nose.
- FIG. 5 a shows a first embodiment of a holding element 8 that in the top view is formed by an about rectangular plastic plate.
- the edges of the plate are rounded.
- the plate has a length of about 3-4 cm and a width of about 0.7-1.5 cm.
- a circular opening 18 is provided in the center of this plate-like holding element 8 with its diameter being slightly larger than the diameter of the ball clutch 7 of the stent 1 .
- two slits 19 extend in parallel to the longitudinal edge 20 of the plate-like holding element 8 .
- the slits 19 are positioned in about the middle between the opposite longitudinal edges 20 .
- the slits have a width which is smaller than the diameter of the ball clutch 7 .
- the slits are provided as incisions without any distance between the opposite edges of the incision.
- a ball clutch 7 of a stent 1 can be passed through the opening 18 of the holding element 8 and the stent can be moved along one of the two slits 19 whereby the stent 1 extends with its pin 6 or with the wire braid through the respective slit 19 .
- a second stent can be inserted with its ball clutch 7 into the opening 18 and be moved into the other slit 19 .
- the stents 1 are mounted in the holding element 8 once they are already introduced into the nasal passage and the introduction tube and the inserting rod have been removed. Due to the positioning of the stents 1 in the nose they are located remote from each other so that a movement of the ball clutches 7 towards the openings 18 is securely prevented. Thereby the holding element is captively connected to both stents 1 .
- the holding element 8 thus creates a holder between the two stents 1 which prevents movement of the stents too far down into the nasal passages and especially into the throat.
- Is is also useful to provide the opening 18 with a funnel (not shown) at the holding element 8 which simplifies insertion of the ball clutch 7 .
- a funnel (not shown) at the holding element 8 which simplifies insertion of the ball clutch 7 .
- FIG. 5 b shows a second embodiment of a holding element which is provided similar to the first embodiment in FIG. 5 a . Therefore same parts have same reference numbers and are not described a second time.
- This holding element again is provided as a rectangular plate with two longitudinal edges 20 . It provides again two slits 19 . The two slits 19 each end in a separate opening 21 , 22 which are a little displaced away from the center of the plate.
- FIG. 6 A third embodiment of a holding element 8 is shown in FIG. 6 .
- This holding element is provided similar to the holding element shown in FIG. 5 a . Therefore same parts have same reference numbers and are not described a second time.
- At the front sides orthogonal to the longitudinal edges of the rectangular plate each a support wing 23 is provided.
- the support wing in the top view is a rectangular plate which extends with its longitudinal edges 24 angular to the longitudinal edges 20 of the main body of the holding element 8 .
- the two support wings 23 each are angled to the same side relative to the slits 19 .
- the support wings can be fixed below the nasal alars after fixation of the stent 1 with the holding element 8 so that they keep open the nasal alars.
- This holding element primarily can be combined with the stents according to the embodiments which do not provide a widened section for keeping open the nasal alars according to FIGS. 1 , 2 and 3 .
- the longitudinal edges 24 of the support wings 23 with their longitudinal edges 20 form the boundaries of the main body of the holding element 8 with an angle in the range of 120° to 150°.
- FIGS. 7 a and 7 b show another embodiment of a holding element 8 .
- This holding element again is provided plate-like and in the top view rectangular with two longitudinal edges 20 .
- This plate comprises a stiff enclosure 25 which in the top view is provided about bone-shaped with two circular sections 26 and a connecting strut 27 between the circular sections 26 .
- This stiff enclosure 25 is made e.g. from spring steel.
- the other part of the plate-like holding element 8 is made from a flexible plastic material, particularly an elastomer.
- the stiff enclosure 25 integrally is connected with the other plastic material why this region is referred to below as the connecting region 28 .
- Flanking the connecting region 28 the stiff enclosure 25 is fully stamped out of the flexible plastic material as shown in FIG. 7 a with two stamping lines.
- the flexible plastic material thereby forms two flexible latches 30 which are connected to the stiff enclosure 25 at the connecting region 28 .
- the flexible latches 30 thus exhibit openings whose shape is complementary to the end regions of the stiff enclosure 25 .
- the flexible latches 30 can be lifted from the end region of the stiff enclosure 25 so that the openings present in the latches 30 can be uncovered.
- Each one fixation section 3 of the stent 1 can be passed through an opening.
- the fixation section 3 then is clamped between the end sections of the stiff enclosure 25 and the flexible latch 30 and thereby captively connected to the holding element 8 .
- This holding element 8 according to FIGS. 7 a and 7 b is simply constructed and cheaply producible. Nevertheless it provides for a secure clamping of the fixation sections 3 of two stents 1 .
- the holding element 8 can be provided with one or two bushings which are designed such as the bushing 10 of the inserting rod 9 . These bushings also enable a coupling of the stent(s) to the holding element.
- the holding elements according to FIG. 5 b , FIG. 6 and FIGS. 7 a and 7 b additionally may have an integral funnel in the region of their openings 18, 21, 22, 29.
- FIG. 11 a shows another holding element 8 which consists of a tubular elongated hollow sleeve or housing 31 and an insert 32 which is slidably mounted in the housing 31 .
- the housing 31 has one end closed by a front wall 33 and one open end.
- the insert 32 is adapted to the shape of the housing 31 wherein the housing 31 and the insert 32 preferably have a rectangular, particularly square, or a circular cross section.
- the insert 32 can be a solid plastic body with a first recess 34 and a second recess 35 at one longitudinal edge.
- the recesses 34 , 35 extend from the longitudinal edge with a preset depth B into the insert 32 . In longitudinal direction the recesses 34 , 35 extend in a preset length L which preferably is significantly greater than the depth B.
- Each end of the recesses 34 , 35 in longitudinal direction has a concave curvature shape 36 .
- the housing 31 provides two diametrically opposite longitudinal slits 37 in which each one end of a transverse pin 38 which is connected to the insert 32 is positioned.
- the transverse pin 38 limits the movement of the insert 32 in the housing 31 wherein in a maximally pushed in position of the insert 32 the transverse pin 38 touches the longitudinal slit 37 at its end directing towards the front wall 33 . In a maximally delivered position of the insert 32 the transverse pin 38 touches the longitudinal slit 37 at its end distal to the front wall 33 .
- the length of the longitudinal slit 37 therewith corresponds to the maximal way of the insert 32 in the housing 31 .
- a spring element 39 which pushes the insert 32 into the maximally delivered position ( FIG. 11A ).
- the housing 31 provides also a first recess 40 and a second recess 41 which have about the same shape as the first recess 34 and the second recess 35 of the insert 32 and align in the maximally pushed-in position of the insert 32 with the recesses 34 , 35 .
- the recesses 40 , 41 therefore also have concave curvatures 42 which limit the recesses in their longitudinal direction.
- the insert 32 is activated at its section protruding from the open end of the housing 31 and is pressed against the spring element 39 .
- FIG. 11 b shows another holding element 8 which is provided similar to the holding element 8 according to FIG. 11 a but has only one single recess 34 in the insert 32 and a single recess 40 in the housing 31 which align when the insert 32 is pushed-in.
- a single stent can be fixed.
- Two such holding elements can be connected with a flexible strip so that with each of the holding elements 8 one stent 1 can be fixed.
- the use of two holding elements 8 interconnected with a flexible strip has the advantage that first one of the two holding elements is coupled to one of the stents and subsequently the other one independent of the other holding element can be adjusted towards the second stent and coupled to this.
- FIG. 12 a shows another holding element 8 which is provided similar to the holding element shown in FIG. 11 a . Therefore same parts have same reference numbers and are not described a second time.
- the holding element according to FIG. 12 a differs from that according to FIG. 11 a solely by the provision of openings 43 , 44 in the insert 32 and openings 45 , 46 in the housing 31 which align when the insert is pushed-in.
- the openings 43 to 46 are circularly shaped.
- FIG. 12 b a holding element 8 is shown which is similar to the holding element according to FIG. 12 a whereas this holding element has each an opening 43 , 45 in the insert 32 and the housing 31 which align when the insert 31 is pushed-in.
- the holding element 8 according to FIG. 11 b serves for fixation of a single stent. Two of these holding elements can be connected by a flexible strip for fixation of two stents.
- FIG. 13 a schematically grossly simplified shows a further holding element 8 which provides a rectangular frame 47 with two longitudinal struts 48 , 49 and two transverse struts 50 , 51 .
- a stamp plate 52 is provided which is centrically connected with a guiding rod 53 which is arranged orthogonally to the stamp plate 52 .
- a spring element 54 is provided between the stamp plate and the longitudinal strut 49 . This spring element presses the stamp plate against the longitudinal strut 48 .
- the guiding rod 53 extends through a respective hole in the longitudinal strut 48 so that the stamp plate 52 is guided in parallel to the longitudinal struts 48 , 49 .
- this holding element 8 resides in that the opened area between the stamp plate 52 and the longitudinal struts 48 is quite large so that it is easy to insert the fixation sections 3 .
- This holding element 8 comprises a first and a second clamp jaw 55 , 56 which are interconnected by a joint 57 .
- the first clamp jaw 55 in the following is referred to below as the base jaw.
- the base jaw 55 provides a base wall 58 .
- the base wall comprises a top side 59 , a bottom side 60 and two side walls 61 extend from the base wall 58 an their longitudinal sides upwards so that the base wall 58 and the two side walls 61 confine a U-shaped recess.
- the two opposite ends of the cuboidal base wall 58 are referred to as the joint side 63 and the lock side 64 .
- Two annular disk members 65 are formed at a distance from each other on the joint side 63 of the base wall 58 . They are flush with the outer surfaces of the side walls 61 .
- the annular disk members 65 have a circular opening 66 each which are aligned to each other.
- the openings 66 are designed to receive a tubular shaft 67 each.
- the tubular shaft is rotatably arranged in the openings 66 and aligned with the outer surfaces of the side walls.
- the first clamp jaw 55 is pivotably connected to the second clamp jaw 56 via the tubular shaft 67 .
- the side walls 61 extend at the locking side 64 beyond the front-end edge of the base wall 58 and therefore they define the U-shaped recess in a top view of the base jaw 55 .
- the side walls are somewhat higher in this area.
- the front-end edge of the base wall 58 on the bottom side 60 is referred to below as the locking edge 68 .
- a cuboidal fixing block 69 is arranged in the U-shaped recess or the groove 62 , resp.
- the cuboidal fixing block 69 protrudes approximately 3 mm from the top side 59 of the base wall 58 .
- the cuboidal fixing block 69 is made of a plastic material, particularly silicone, and forms a fixation element.
- the second clamp jaw 56 has an L-shape and a cuboidal cross-section.
- the second clamp jaw 56 comprises a long leg 70 and a short leg formed thereon at right angles, said leg being referred to below as the fixation leg 71 .
- the long leg 70 has a base wall 72 and two side walls 73 which define a groove between them.
- the end of the long leg 70 which is opposite to the fixation leg 71 is referred to as the joint side 74 .
- a tubular joint body 75 is formed on this joint side 74 .
- the joint body 75 forms a tube having two front sides and a circular opening wherein the length of the tube corresponds to the inner width between the two annular disk members 65 .
- the tubular shaft 67 is arranged in the opening of the joint body.
- the tubular shaft 67 is rotatably supported in the openings 66 of the annular disk members 65 and in the opening 75 of the joint body 75 .
- a through hole (not shown) is formed in the fixing leg 71 , said hole being in alignment with the groove of the long leg 70 .
- a recess is provided in the tubular joint body 75 , said recess being also in alignment with the groove of the long leg 70 .
- the through hole, the groove of the long leg 70 and the recess of the joint body 75 accommodate a fixing tube 77 .
- the fixation tube 77 and/or the fixation element is made of plastic material, particularly silicone.
- a latch 78 facing the joint body 75 is formed on the free end of the fixing leg 71 .
- the latch 78 is made so as to grip behind the fixation edge 71 when the two legs are compressed.
- the latch 78 then locks behind the fixing edge 71 and holds the holding element 8 in a closed state.
- the latch 78 and the fixation edge thus form a locking member.
- the base jaw 55 and the second clamp jaw 56 are arranged approximately parallel to each other, the fixation block 69 and the fixation tube 77 being pressed onto each other.
- the fixation section 3 of a stent 1 can be arranged between the fixation block 55 of the clamp jaw 55 and the fixation tube 77 of the second clamp jaw 56 . It is also possible to fix at the same time two fixation sections 3 of two stents with this holding element between the fixation block 69 and a fixation tube 77 . Therefore it is useful that the fixation block 69 and the fixation tube 77 each extend over a length of at least 3 to 3 cm.
- a holding element in a miniaturized embodiment wherein the clamp jaws 55 , 56 extend only over a length of e.g. about 1 cm. Two such holding elements then are interconnected with a flexible strip so that with each of the holding elements each one stent can be fixed.
- the above described holding elements 8 each are designed for fixation of two stents 1 .
- a holding element 8 for fixation of only one single stent. Then it is useful that the holding element extends at least in one direction that long that the holding element cannot be pulled into a nostril.
- FIG. 10 shows in a schematic representation the stent 1 according to this invention according to FIG. 3 inserted into a nasal cavity 79 .
- the nasal cavity 79 extends from the nasal entry 80 or the nostril 80 , resp., towards the nasopharynx 81 .
- the nasal cavity is confined by the nasal alar 82 .
- two turbinates 83 are present which are arranged between the palate 84 and the 85 ethmoid bone plate 85 of the nasal cavity 79 .
- the inferior nasal passage 86 is present, and between the two turbinates 83 a middle nasal passage, and between the upper turbinate 83 and the 85 ethmoid bone plate 85 the upper nasal passage 88 .
- a nasal passage can be kept patent by the use of the stent according to the present invention.
- the stent 1 is mostly used in the inferior nasal passage. Yet, it is also possible to apply the stent into the middle nasal passage 87 or the upper nasal passage 88 , resp. Especially the inferior nasal passage 86 exhibits a high sensitivity in the posterior part. In this region the support body 2 of the stent 1 should not end as the rear edge may uncomfortably press against the turbinate 83 . Therefore, it is useful to arrange the support body in that way that it only splints the anterior part of the nasal passage, or that it extends through the whole nasal passage.
- the stent according to the invention is flexible so that it nestles to the shape of the nasal passages. This is realized on the one hand by the elasticity of the wire and on the other hand by the embodiment as a braid.
- FIG. 10 shows merely a stent 1 which is fixed by a holding element 8 .
- stents 1 In the context of this invention it is possible to use only one single stent. Usually, however, two stents 1 are applied. These two stents normally are the same. For special applications, however, it may be useful to apply two stents of different size (different length and/or diameter and/or construction). Sometimes it may make sense to combine a stent according to this invention for splinting of a nasal passage with a stent for splinting of the airway in the throat as known e.g. from WO 2007/065408 and to use at the same time and to fix with a holding element 8 .
Abstract
The present invention relates to a stent for splinting a nasal passage. The stent (1) consists of a braided tubular support body (2) which, in unloaded state, has a diameter of at least 4 mm and a length in the range of 25 to 120 mm and particularly of 25 to 100 mm. The stent may have a widened section (15) at the proximal end for splinting of the nasal alar. It may alternatively or in combination have a fixation section (3) at the proximal end of the stent (1) for fixation of the stent (1) in a nasal passage of a user. When fixed the fixation section (3) protrudes from the nostril of the user and can be fixed outside of the nose.
Description
- The present invention relates to a stent for splinting a nasal passage. Under the trade name “Schnarchzapfen” plastic splints for splinting of the nostrils are provided. The plastic splints each consist of several plastic rings which are connected by longitudinal struts. At one end two of these plastic splints are connected to each other by a plastic holder so that the two plastic splints can be inserted in the two nostrils. At the ends connected by the plastic holder the diameter of the plastic splint is larger than at the end distal from the holder. Thus, these splints are inserted into the nose with the thinner end ahead. These splints are about 10 mm long and ensure that the nose in the region of its opening is kept open.
- Under the brand name Nasaline® nasal dilators are provided which expand the nasal alars and thereby shall reduce mouth breathing. Such nasal dilators are short plastic bushings which are loosely interconnected so that their distance is adjustable.
- These products “Schnarchzapfen” and Nasaline® are each bushing-type or tubular bodies which shall keep open the nasal alars.
- Instead of such bushing elements also wings exist with which the nasal alars are pushed apart. One such element with two spacer wings which are fixed in a preset distance by a stiff nasal holder made from titanium is known under the brand name Nasanita Nasenschmetterling®. Another element for maintaining patency of the nasal alars relying on the same mode of action is sold under the brand name Nozovent®.
- The above described apparatusses serve for maintaining patency of the nostrils.
- The company MBM ScienceBridge GmbH, Göttingen, Germany has developed a nasopharyngeal splint. This splint consists of two plastic splints which each is shaped synclinally whereas the synclinal splints are interconnected at one end by an elongated holder. Each splint can be introduced in one nostril. The splints are shaped in a way that they can be introduced through the nose, passed along the nasal septum and keep open the upper throat by their shape. The soft palate is prevented to close the throat. Thereby, a continuous breathing shall be ensured. In snoring therapy the splints are onetime adapted for the patient by endoscopy. This is necessary in order to ensure that the length of the splint is exactly adjusted. WO 2007/065408 A2 discloses an apnea stent which serves for splinting and/or keeping open the airway in the throat. This apnea stent consists of a compressible and self-expanding stent which exhibits 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 expandable in a way so that the airway is kept open. A proximal phase of the stent is provided for fixing the stent in the nasal area. The proximal phase is funnel-shaped whereas this phase widens from the proximal towards the distal end. The distal and the proximal phase are made as a braid in which the wires or fibers or strands, resp. cross each other. Each individual wire directed to the distal end of the stent at the distal end of the distal phase is returned to the proximal end of the stent. The bends created in this way are referred to below as round ends. A transition phase of the stent is intended for the connection of the proximal phase with the distal phase. The transition phase is formed by twisting of the wires of the stent into twisted strands. As a result the transition section exhibits a high flexibility in radial direction so that within a short longitudinal stretch a strong radial expansion from the proximal to the distal phase is effected.
- DE 20 2009 010 388 U1 and PCT/EP 2010/004687, respectively, disclose a fixing device for fixation of such an apnea stent in the airway wherein the fixing device exhibits two clamping elements between which the proximal end of the apnea stent can be fixed. Further, an introduction tube for introduction of the apnea stent is described which is bent at its distal end in order to simplify the introduction into the airway. The apnea stent exhibits at its proximal end a connecting and coupling element so that an inserting rod can be fixed at the proximal end of the apnea stent. By means of the inserting rod the stent can be introduced into the introduction tube 6 and be compressed by pushing the inserting rod through the introduction tube so that the apnea stent is pulled by the inserting rod into the introduction tube.
- US 2009/0010991 A1 discloses an expandable nasal stent which is permanently inserted into the nostril or the nasal passage. This stent is made from a polymer or steel grid and equipped with a filter element which is positioned at the proximal end of the stent. The stent can be coated with a therapeutic agent.
- US 2010/0211181 A1 and U.S. Pat. No. 5,336,163 disclose further nasal stents which are constructed as filters for filtering the inhaled air.
- US 2010/0106255 A1 discloses a self-expanding stent which can be anchored with one end in the sinus.
- The invention is based on the object to provide a stent for splinting of a nasal passage which does not need to be individually adjusted for each nasal passage, it shall be easily introduced and comfortable in use, and it shall fully and reliably keep open a nasal passage. This object is achieved by a stent comprising the features of
claim 1. Advantageous embodiments are indicated in the sub-claims. - The stent for splinting of a nasal passage according to the present invention consists of a braided tubular support body and optionally a fixation section. The support body in unloaded state has a diameter of at least 4 mm and a length in the range of 25 to 120 mm and particularly of 25 to 100 mm.
- At the proximal end of the stent a fixation section can be provided which is designed for fixation of the stent in the nasal passage of the user wherein the fixation section extends out of the nostril of the user when fixing and can be fixed outside of the nose.
- The braided support body is elastically deformable and nestles to the inner surface of the nasal passage. The pressure created by the tubular support body against the nasal passage evenly scatters, and therefore the support body does not cause any pain or unpleasant feeling in the sensitive nasal passage. As the support body is braided it nestles well to different shapes of the nasal passage and it is not necessary to individually adapt the stent to the nasal passage of an individual user. With a few standard sizes of the stent which mainly differ in length and diameter of the support body for almost any person a suitable stent can be provided. The support body can be provided with diameters of 4 to 20 mm whereas the standard sizes preferably differ in the diameter and are staggered in 1 mm steps. The length of the support body is in the range of 25 mm to 120 mm and particularly 25 to 100 mm. Preferably the standard sizes differ in length, staggered in 5 mm steps.
- The preferred length of the support body is in the range of 30 mm to 50 mm as this is the usual length of the nasal passage in the region of the anterior turbinates for average body sizes.
- It has turned out that for most users a support body with a length of about 60 mm is positioned with its distal end in an area of the nasal passage and turbinates which is highly sensitive. Therefore it is useful to provide a support body with either a shorter length so that it is not in contact with this sensitive area, or with a greater length so that it extends along this sensitive are. Therefore, on the one hand support bodies with a length of maximally 40 to about 45 or 50 mm, resp., or support bodies with a length of at least 70 to 80 mm or 100 mm, resp. are preferred.
- The function of the fixation section lies in the prevention that the support body moves along the nasal passage in direction to the throat. The fixation section therefore is connected to the support body and extends to the outside of the nose. There, the fixation section can be fixed.
- The fixation section can be designed one-piece with the support body as a braided tubular section tapered towards the proximal end. The fixation section can also be made from any desired other material which preferably is flexible.
- A coupling element is provided at the proximal end of the fixation section which can be connected to a mating coupling element of an inserting rod or a holding element. The mating coupling element is provided at one end of the inserting rod. The stent can be introduced into an introduction tube and compressed with the stent coupled to the inserting rod. For that purpose the inserting rod is pushed through the introduction tube so that the stent is pulled into the introduction tube by the inserting rod.
- Preferably the holding element provides two mating coupling elements for coupling of two proximal elements of two stents to the coupling element. Thereby, the coupling element provides a detachable holder between the two stents which securely prevents movement of the stents too far in direction to the throat.
- The coupling element also can be provided as a clamp which fixes the fixation section of a stent or two fixation sections of two stents by clamping. The clamping can be executed independent of the coupling element for coupling of the stent to an inserting rod or, alternatively, by clamping of the coupling element in the holding element.
- The stent can be braided from wires, fibers and/or strands which cross each other. In the following only the term wire is used whereas this includes also fibers or strands as far as the wire is not further specified.
- Each individual wire directed towards the distal end of the stent is returned at the distal end of the support body towards the proximal end of the stent. The bends resulting from that are referred to below as round ends. These have in unloaded state of the stent a diameter in the range of 0.5 to 2 mm. Thereby a distal end is provided without any individual free wire ends or no free wire ends need to be connected with another element. The connection of the wire or the wires, resp., of the stent at the proximal end can be simply realized e.g. by crimping or glueing so that a fixation section is created. Alternatively, the wires also can be connected e.g. by a droplet of polymer, a ring, or by returning them into the inner lumen of the support body without creating a fixation section. The round ends prevent injury of the airways caused by the distal end of the stents.
- The wire used for braiding of the support body particularly is a metal wire, preferably a nitinol or steel wire.
- Preferably the distal end of the support body, most preferably only the round wires, are provided slightly tapered relative to the other part of the support body. This prevents that the stent may press with its ending border into the nasal passage which may be uncomfortable.
- The support body can be provided at its proximal end with a widened section. This widened section preferably has about a ball-shape. The ball has a diameter of about 10 to 20 mm, preferably 12 or 13 to 15 or 17 mm, resp. This widened section of the support body during use is positioned in the region directly behind the nostrils in order to splint the nasal alar to prevent a collapse. Additionally, the widened section fixes the stent in the nose so that especially for a stent comprising a widened section the above described fixation section may not be necessary. Such a stent is most useful for sports during which the nasal passages shall be kept open. A fixation section protruding from the nose is undesirable during sports.
- It is 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 coupled with the stent, e.g. by providing an element for hooking into the braid of the stent or an element for grasping the braid. For coupling to the removal tool solely the braided support body is sufficient. For that purpose no additional part needs to be provided at 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 shows a stent according to a first embodiment of the invention in a schematic side view, -
FIG. 2 shows a stent according to 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 shows a stent according to a fourth embodiment of the invention in a schematic side view, -
FIGS. 5 a, 5 a show each a holding element in the a top view, -
FIG. 6 shows another holding element in a top view, -
FIGS. 7 a, 7 b show a holding element in a top view and a side view, -
FIG. 8 shows a section of an inserting rod in a side view, -
FIG. 9 shows a section of an introduction tube in a section view, -
FIG. 10 schematically shows the nasal cavity in a section view, -
FIGS. 11 a und 11 b schematically show another holding element in a side view grossly simplified, -
FIGS. 12 a und 12 b schematically show another holding element in a side view grossly simplified, -
FIGS. 13 a and 13 b schematically show another holding element in a side view grossly simplified, -
FIGS. 14 a bis 14 c schematically show another holding element in a side view grossly simplified, -
FIGS. 15 a, b bis 17a, b each show a proximal ending region of a stent without a fixation section in a front view (FIG. a) and in a side view (FIG. b), and -
FIG. 18 a, 18 b, 19 a, 19 b, 19 c, 20 a, 20 b, 20 c each show a removal tool for removal of a stent from a nose in different grasping conditions. - A
stent 1 according the invention for splinting of a nasal passage comprises asupport body 2 and afixation section 3. -
FIG. 1 shows a first embodiment of astent 1 wherein thesupport body 2 is provided tubular with a constant diameter and thefixation section 3 conically tapers from the distal to the proximal end. Thesupport body 2 as well as thefixation section 3 are integrally made from one wire braid. Each individual wire directed towards the distal end of thestent 1 is returned at the distal end of thesupport body 2 towards the proximal end of thestent 1. The bends resulting from that are referred to below as round ends 4. These have in unloaded state of the stent a diameter in the range of 0.5 to 2 mm. Thereby a distal end is provided without any individual free wire ends. No free wire ends need to be connected with another element. The round ends prevent injury of the airways caused by the distal end of the stents. - The
stent 1 can be braided with a single wire or with a multitude of wires. The ends of the wire or the wires, resp., are connected at the proximal end of the stent or at the proximal end of thefixation section 3, resp., with a pencil-shaped or acylindrical body 5. In the present embodiment the pencil-shapedbody 5 is abody 5 crimped around the ends of the wires. Therefore it can also be referred to as a crimpingbody 5. At the distal end of the crimping body 5 a thin pin 6 is provided. At the end of the pin 6 distant from the crimping body 5 aball clutch 7 is provided. With the ball clutch 7 the stent can be connected to another element which provides a respective mating coupling element. - The stent is braided from an elastic wire with a diameter of 0.001 mm to 2 mm, particularly with a diameter of 0.05 mm to 0.5 mm and preferably with a diameter of 0.07 mm to 0.2 mm. The wire particularly is a metal wire and preferably a nitinol or steel wire.
- The length L2 of the
support body 2 is 25 mm to 120 mm and particularly 25 mm to 100 mm. Preferably the length L2 of the support body is in the range of 30 mm to 50 mm or 60 mm to 120 mm, or, resp., 30 mm to 50 mm or 70 mm to 100 mm. For the longer embodiment a range of 70 to 100 mm is most preferred. - The diameter of the
support body 2 is in the range or 4 mm to 20 mm. Preferably the support body has a diameter of at least 5 mm and particularly of at least 6 mm. - The
fixation section 3 has a length L2 of about 10 to 25 mm. With the fixation section the stent can be fixed at the body of the user so that the stent cannot move from the nasal passage of the user towards the throat. For that purpose it is necessary that the fixation section extends through the nostril towards the outside in order to be fixed there with the respective fixation element. Such a fixation element e.g. can be a plaster with which thefixation section 3 is taped in the region below the nose of the user. Yet, a holdingelement 8 if preferred which extends at least in one direction that far that it cannot be introduced through a nostril into a nasal passage. Alternatively, the holdingelement 8 can be provided in such a way that it can be connected to twostents 1 so that it extends as a holder between the two stens and prevents pulling in too far of the stent into the nasal passage. Such a holdingelement 8 which is described in more detail in the following preferably is connected to the coupling element of the stent which—in the present embodiment—is provided as aball clutch 7. Within the scope of this invention, however, it is also possible to provide the holding element as a clamp which is clamped to thefixation section 3 of astent 1 or to thefixation sections 3 of twostents 1. - An
insertion rod 9 which can be coupled to thecoupling element 7 is shown inFIG. 8 . The insertingrod 9 is made from plastic. At the distal end of the insertingrod 9 as a single-piece a tubular bushing orsleeve 10 is provided. The bushing has two diametrically oppositecircular openings 11. In longitudinal direction of the insertingrod 9 in the area of the two circular openings 11 aslit 12 may be provided. Theslit 12 extends to the distal end of thebushing 10. Thebushing 10 may be integrally formed at the distal end of the insertingrod 9 or be provided separately, made from another material, and be force-fitted connected to the insertingrod 9, e.g. by glueing. The ball clutch 7 of thestent 1 can be fitted between the twoopenings 11 of thebushing 10 of the insertingrod 9. In this way a detachable connection of thestent 1 and the insertingrod 9 is provided. Thelongitudinal slit 12 provided in thebushing 10 simplifies introduction and removal of the ball clutch 7 into or from, resp., thebushing 10. The relation between the diameter of the ball clutch 7 to the inner diameter of thebushing 10 and the hardness of the material of thebushing 10 and the length of theslit 12 can be used for adjustment of the connecting or holding force of the connection between theball clutch 7 and thebushing 10. The ball clutch 7 is freely rotatable in thebushing 10. - The inserting rod also can be provided as an inserting tube (not shown) in which at one end the two circular openings and optionally a slit—similar to the
bushing 10—can be integrated. Thereby the need for separate manufacturing of the tubular bushing is obviated. - The diameter of the inserting
rod 9 and of the crimpingbody 5 are such dimensioned that the insertingrod 9 together with thestent 1 can be introduced into an insertion tube 13 (FIG. 9 ). Theintroduction tube 13 is made from a suitable and sufficiently hard polymer, e.g. PEBAX with a shore hardness of 50 Shore D to 80 Shore D, e.g. PEBAX 7233 (Shore hardness 69D), PEBAX 6333 (Shore hardness 64D) or PEBAX 55 (Shore hardness 54D). At the distal end of theinsertion tube 13 anintroduction tip 14 may be provided as a single-piece. The introduction tip has the same inner as well as outer diameter as theintroduction tube 13 and is provided flush-mounted with this. Theintroduction tip 14 can be made from a flexible, significantly smoother material, e.g. PEBAX with a Shore hardness of 25 Shore D to 45 Shore D. Such a single-piece introduction tube can be made from a single material, e.g. PEBAX 7233, PEBAX 6633 or PEBAX 5533. It is possible to manufacture such a single-piece introduction tube in an extrusion process with a continuous material gradient. Such an insertion tube has a transition section in which the share of the one material decreases and correspondingly the share of the other material increases. Material for such a tube e.g. are PEBAX 7233 in the section of the main body and PEBAX 3533 in the region of theinsertion tip 14 so that the insertion tip is smoother than the main body. Regarding the selection of the materials the above description for the two-piece introduction tube apply appropriately. - The introduction tube also can be provided with multiple layers whereas the inner layer preferably is harder than the outer layer in order to provide a more slippery inner surface with low friction (e.g. PEBAX 7233). Thereby, the stent can be introduced and retracted with low drag into the introduction tube. The outer layer preferably has a Shore hardness of e.g. 60A to 95A and is thicker than the inner layer for that the introduction tube generally has smooth and flexible materials properties and therefore easily adapts to the course of the nasal passage. In that way the tube can be easily introduced. Preferably the outer layer is made from PU 85A with a thickness of about 0.2 mm and the inner layer from PEBAX 7233 with a thickness of about 01. mm. Melting of a short tip from PU 85A (about 2 to 10 mm long) which preferably is atraumatically rounded further increases comfort and safety during introduction of the tube through the nasal passage. The
introduction tube 13 may be shape straight. It may also have a curvature. - The outer diameter of the introduction tube is up to 10 mm, preferably up to 5 mm, in order to enable for the user a comfortable introduction of the tube without pain. The inner diameter of the introduction tube is up to 4 mm in order to provide sufficient lumen for uptake of the
stent 1. - The introduction tip provides a
chamfer 17 at the outer edge. Instead of thechamfer 17 theintroduction tip 14 also can be provided with a rounding. Such a rounding e.g. can be produced by thermal reshaping or by means of abrasion or laser ablation. Such a rounding can be provided inside and/or outside. - Such a rounded tip is more laborious in manufacturing than a chamfer. The rounded tip, however, is even more secure during insertion of the stent. Further, the thin-walled end resulting form chamfering may harden by release of plasticizers from the polymer due to the relatively large surface.
- The introduction tube may also have an olive or drop shaped thickening at one end or both ends in order to facilitate introduction into the nasal passage. The olive of the drop at the end of the introduction tube has a length of 2-20 mm, preferably 2-10 mm and even more preferred 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 shaped
introduction tips 14 are atraumatic tips whereas the shape should be even more smooth and round the harder the material of the tip is. An olive or drop shaped embodiment has a greater frontal area and therefore exhibits the best pressure distribution towards the nasal tissue. - For introduction of the
stent 1 into theintroduction tube 13 thestent 1 first by means of theball clutch 7 is fixed at thebushing 10 of the insertingrod 9. The inserting rod then is inserted with its proximal end into theintroduction tip 14 of theintroduction tube 13. Theinsertion rod 9 is pushed through theintroduction tube 13 until thestent 1 is completely inserted into theintroduction tube 13. Thestent 1 may minimally protrude from the introduction tube. It is essential that thestent 1 is compressed by introduction into theintroduction tube 13 to a smaller diameter so that it can be easily introduced into the nasal passage together with the introduction tube and the inserting rod. Alternatively thestent 1 is pushed into theintroduction tube 13 without acoupling element 7 and no detachable connection with an inserting rod is prepared. Embodiments without coupling elements are described in more detail further below. - When this assembly of
stent 1,introduction tube 13 and insertingrod 9 is advanced that far that the support body is positioned in the nasal passage, first theintroduction tube 13 is retracted over the insertingrod 9 and then the inserting rod is detached fromstent 1. The smooth surface of theintroduction tube 13 significantly simplifies introduction of thestent 1 into the nasal passage. -
FIG. 2 shows a second embodiment of thestent 1 which is provided similar to the first embodiment. Therefore same parts have same reference numbers and are not described a second time. Thestent 1 according to the second embodiment differs fromstent 1 of the first embodiment solely in that thefixation section 3 does not conically increase but is provided about parabolically tapered whereas it tapers more strongly with increasing neighbourhood to the crimpingbody 5. -
FIG. 3 shows another embodiment of thestent 1 whereas again same parts as in the previous embodiment have the same reference numbers. Thisstent 1 differs from the above embodiments in that the proximal ending region of thesupport body 2 has a widenedsection 15. The widenedsection 15 in the present embodiment is about ball-shaped widened. The shape of the ball-shaped widened section may slightly differ from an ideal ball-shape, e.g. be oval. It is essential that the widened section does not form any edges which press against the nasal alars but that due to its rounded shape it smoothly supports from the inside the respective nasal alar. The ball-shaped widened section should have a diameter of at least 10 mm, preferably 12 mm and particularly 13 mm in order to obtain an efficient widening of the nasal alars. The diameter, however, should not be too large so that no strong pressure is exerted onto the nasal alars. A maximal diameter of 20 mm, therefore, particularly of 17 mm or 15 mm, resp., is useful. The remainingsupport body 2 consequently is provided shorter by the length of this section when compared to the above described embodiments so that the overall length remains about the same. - This ball-shaped widened
section 15 is provided in order to be positioned in the region directly behind the nasal entry so that the nasal alars can be splinted to prevent a collapse. - Particularly for the embodiments comprising a widened section it may be advisable not to include a fixation section because the ball-shaped widened
section 15 already provides a sufficient fixation in the nose so that a holding element is not absolutely necessary. - In the following some embodiments of the stent without a fixation section or without a coupling element, resp., are described on the basis of
FIGS. 15 , 15 b to 17 a, 17 b. - In the embodiment according to
FIG. 15 a, 15 b the widenedsection 15 is provided in a way so that the wire ends are connected in apolymer drop 93. The polymer drop preferably is applied to the free wire ends as a liquid polymer or liquid glue and maintained in shape as long as the polymer is fully hardened. After hardening the wire ends are fixed and neither the braid nor the body tissue getting into contact therewith can be damaged by sharp-edged tips. - In a further embodiment (
FIGS. 16 a, 16 b) the wire ends are connected by a single- or two-piece ring 94 similar to a rivet. For that the wire ends are inserted into a circumferential slit at this ring and subsequently this slit is compressed or crimped. - According to another embodiment (
FIG. 17 a, 17 b) the wires are connected by braiding or heat treatment whereas the wire ends are returned into the inner lumen of the ball-shaped widened section. For that the proximal end of the braid may be equipped with twists so that distortion and fringing can be excluded. Additionally the wire ends may be e.g. crimped with a sleeve and thereby fixed. - In case of a stent without a coupling element the introduction tube is retracted over an inserting rod which does not comprise a tubular bushing or over an inserting tube which does not have openings nor a slit whereby the stent self-expands and positions itself in the nasal passage.
- In
FIG. 3 the wire braid is represented only schematically. Such a shape e.g. can be achieved by braiding of a cylindric stent from a nitinol wire whereby the cylindric stent is positioned on a tool which represents the shape of thesupport body 2 and provides a ball-shaped section and a cylindric section. By a special heat treatment which is known by skilled persons as annealing then the shape of the molded body in the braid is impressed in the nitinol wire braid. After removal of the molded body the stent remains in this shape. -
FIG. 4 shows another embodiment of thestent 1 whereas again same parts as in the previous embodiment have the same reference numbers. This stent differs from the three other above described embodiments in that thefixation section 3 is not braided but that the wires run either individually about in parallel from thesupport body 2 to the pencil-shaped body or crimpingbody 5, resp., or the wires are twisted and thetwisted strands 16 run about in parallel from thesupport body 2 to the pencil-shaped body. In that case each two, three or four wires may be twisted into atwisted strand 16. The advantage of thisfixation section 3 relies in its very high flexibility and that the stent is highly bendable in the region of thefixation section 3. Thisfixation section 3 of course may also be combined with the widenedsection 15 according to the third embodiment. - In case the
stent 1 is provided without a coupling element (e.g. a ball clutch) then it is useful to provide a removal tool for removal of thestent 1 from the nose. The most simple version is a thin elongated plastic or metal body which is uncinated at its distal end (not shown). This curvature is inserted into the wire braid ofstent 1 and the stent is retracted from the nose with the removal tool. - Alternatively, different other embodiments of
removal tools 89 as described in the following on the basis ofFIGS. 18 a to 20 c can be applied. - A second embodiment of a removal tool 89 (
FIGS. 18 a, 18 b) exhibitelastic tentacles 90 similar to the chuck of a drop-action pencil which are slidably mounted in a sleeve 91. When pushing thetentacles 90 out of the sleeve 91 their free ends expand due to their spring effect. Thetentacles 90 have inwardly facing hooked edges. With these hooked edges they are inserted into the braid ofstent 1. Once the tentacles are positioned in the braid thetentacles 90 are pulled into the sleeve 91 to the extent that thestent 1 is securely fixed. Then the stent is pulled out of the nose. - In
FIGS. 19 a to 19 c a third embodiment of theremoval tool 89 is shown which again provides a sleeve 91. In the sleeve 91 aslidable trap wire 92 is positioned. Thetrap wire 92 is elongated when inside the sleeve because the inner diameter of the sleeve 91 is only slightly larger than the diameter of thetrap wire 92. Thetrap wire 92 is pre-shaped such that it self-coils when released from the sleeve 91 and forms a knot. For fixing at the sleeve theremoval tool 89 is positioned at the proximal end of the stent with thetrap wire 92 pulled into it. Subsequently thetrap wire 92 is pushed out off the sleeve 91. Thetrap wire 92 forms the knot inside the braid of thestent 1 whereby a sufficient tensile force is exerted to pull out the stent off the nose. In this way thestent 1 is removed from the nose. - A fourth embodiment of a removal tool 89 (
FIGS. 20 a to 20 c) is provided similar to the third embodiment of the removal tool shown inFIGS. 19 a to 19 c. The fourth embodiment of theremoval tool 89 comprises again a sleeve 91 whereasseveral trap wires 92 which each are pre-shaped in a loop-like manner are positioned therein. For grasping the stent theremoval tool 89 is positioned with the orifice of the sleeve 91 at the proximal end of the stent. Subsequently thetrap wires 92 are pushed out off the sleeve 91. The trap wires self-expand inside of the braid ofstent 1 so that the stent can be pulled out off the nose. - In the following some holding elements are described:
-
FIG. 5 a shows a first embodiment of a holdingelement 8 that in the top view is formed by an about rectangular plastic plate. The edges of the plate are rounded. The plate 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 holding element 8 acircular opening 18 is provided with its diameter being slightly larger than the diameter of the ball clutch 7 of thestent 1. From thisopening 18 twoslits 19 extend in parallel to thelongitudinal edge 20 of the plate-like holding element 8. Theslits 19 are positioned in about the middle between the opposite longitudinal edges 20. The slits have a width which is smaller than the diameter of theball clutch 7. Preferably the slits are provided as incisions without any distance between the opposite edges of the incision. - A
ball clutch 7 of astent 1 can be passed through theopening 18 of the holdingelement 8 and the stent can be moved along one of the twoslits 19 whereby thestent 1 extends with its pin 6 or with the wire braid through therespective slit 19. A second stent can be inserted with its ball clutch 7 into theopening 18 and be moved into theother slit 19. Thestents 1 are mounted in the holdingelement 8 once they are already introduced into the nasal passage and the introduction tube and the inserting rod have been removed. Due to the positioning of thestents 1 in the nose they are located remote from each other so that a movement of theball clutches 7 towards theopenings 18 is securely prevented. Thereby the holding element is captively connected to bothstents 1. The holdingelement 8 thus creates a holder between the twostents 1 which prevents movement of the stents too far down into the nasal passages and especially into the throat. - Is is also useful to provide the
opening 18 with a funnel (not shown) at the holdingelement 8 which simplifies insertion of theball clutch 7. During insertion of the ball clutch 7 into theopening 1 thestent 1 is positioned with its support body in the nasal passage. Thereby theball clutch 7 is located directly at the nose and at the border of the field of vision of the user. Therefore, such a funnel is highly beneficial as in this way it is possible to connect the holding element to thestent 1 without a need to see the holding element and thefixation section 3 of thestent 1. -
FIG. 5 b shows a second embodiment of a holding element which is provided similar to the first embodiment inFIG. 5 a. Therefore same parts have same reference numbers and are not described a second time. This holding element again is provided as a rectangular plate with twolongitudinal edges 20. It provides again twoslits 19. The twoslits 19 each end in aseparate opening - A third embodiment of a holding
element 8 is shown inFIG. 6 . This holding element is provided similar to the holding element shown inFIG. 5 a. Therefore same parts have same reference numbers and are not described a second time. At the front sides orthogonal to the longitudinal edges of the rectangular plate each asupport wing 23 is provided. The support wing in the top view is a rectangular plate which extends with itslongitudinal edges 24 angular to thelongitudinal edges 20 of the main body of the holdingelement 8. The twosupport wings 23 each are angled to the same side relative to theslits 19. The support wings can be fixed below the nasal alars after fixation of thestent 1 with the holdingelement 8 so that they keep open the nasal alars. This holding element primarily can be combined with the stents according to the embodiments which do not provide a widened section for keeping open the nasal alars according toFIGS. 1 , 2 and 3. - The longitudinal edges 24 of the
support wings 23 with theirlongitudinal edges 20 form the boundaries of the main body of the holdingelement 8 with an angle in the range of 120° to 150°. -
FIGS. 7 a and 7 b show another embodiment of a holdingelement 8. This holding element again is provided plate-like and in the top view rectangular with twolongitudinal edges 20. This plate comprises astiff enclosure 25 which in the top view is provided about bone-shaped with twocircular sections 26 and a connectingstrut 27 between thecircular sections 26. Thisstiff enclosure 25 is made e.g. from spring steel. The other part of the plate-like holding element 8 is made from a flexible plastic material, particularly an elastomer. In the region of the longitudinal center of the stiff enclosure which inFIG. 7 a is labelled with thereference number 28 thestiff enclosure 25 integrally is connected with the other plastic material why this region is referred to below as the connectingregion 28. Flanking the connectingregion 28 thestiff enclosure 25 is fully stamped out of the flexible plastic material as shown inFIG. 7 a with two stamping lines. The flexible plastic material thereby forms twoflexible latches 30 which are connected to thestiff enclosure 25 at the connectingregion 28. The flexible latches 30 thus exhibit openings whose shape is complementary to the end regions of thestiff enclosure 25. - As schematically shown in
FIG. 7 b theflexible latches 30 can be lifted from the end region of thestiff enclosure 25 so that the openings present in thelatches 30 can be uncovered. Each onefixation section 3 of thestent 1 can be passed through an opening. Thefixation section 3 then is clamped between the end sections of thestiff enclosure 25 and theflexible latch 30 and thereby captively connected to the holdingelement 8. - This holding
element 8 according toFIGS. 7 a and 7 b is simply constructed and cheaply producible. Nevertheless it provides for a secure clamping of thefixation sections 3 of twostents 1. In the context of the invention it is of course possible to also use other clamping elements, particularly clips with a spring element which impinge on two clamp jaws. Further, the holdingelement 8 can be provided with one or two bushings which are designed such as thebushing 10 of the insertingrod 9. These bushings also enable a coupling of the stent(s) to the holding element. - The holding elements according to
FIG. 5 b,FIG. 6 andFIGS. 7 a and 7 b additionally may have an integral funnel in the region of theiropenings -
FIG. 11 a shows another holdingelement 8 which consists of a tubular elongated hollow sleeve orhousing 31 and aninsert 32 which is slidably mounted in thehousing 31. Thehousing 31 has one end closed by a front wall 33 and one open end. Theinsert 32 is adapted to the shape of thehousing 31 wherein thehousing 31 and theinsert 32 preferably have a rectangular, particularly square, or a circular cross section. Theinsert 32 can be a solid plastic body with afirst recess 34 and asecond recess 35 at one longitudinal edge. Therecesses insert 32. In longitudinal direction therecesses recesses concave curvature shape 36. - The
housing 31 provides two diametrically oppositelongitudinal slits 37 in which each one end of atransverse pin 38 which is connected to theinsert 32 is positioned. Thetransverse pin 38 limits the movement of theinsert 32 in thehousing 31 wherein in a maximally pushed in position of theinsert 32 thetransverse pin 38 touches thelongitudinal slit 37 at its end directing towards the front wall 33. In a maximally delivered position of theinsert 32 thetransverse pin 38 touches thelongitudinal slit 37 at its end distal to the front wall 33. The length of thelongitudinal slit 37 therewith corresponds to the maximal way of theinsert 32 in thehousing 31. Between the front wall 33 and theinsert 32 is placed aspring element 39 which pushes theinsert 32 into the maximally delivered position (FIG. 11A ). - The
housing 31 provides also afirst recess 40 and asecond recess 41 which have about the same shape as thefirst recess 34 and thesecond recess 35 of theinsert 32 and align in the maximally pushed-in position of theinsert 32 with therecesses recesses concave curvatures 42 which limit the recesses in their longitudinal direction. - In the pushed-in position of the
insert 32 in which thefirst recesses fixation section 3 of astent 1 can be inserted. When theinsert 32 is released it is pushed away from the front wall 33 by thespring element 39. Theconcave curvatures 36 of the recesses of the insert and theconcave curvatures 42 of thehousing 31 move towards each other and clamp thefixation sections 3 of thestents 1. - The
insert 32 is activated at its section protruding from the open end of thehousing 31 and is pressed against thespring element 39. -
FIG. 11 b shows another holdingelement 8 which is provided similar to the holdingelement 8 according toFIG. 11 a but has only onesingle recess 34 in theinsert 32 and asingle recess 40 in thehousing 31 which align when theinsert 32 is pushed-in. With this holding element a single stent can be fixed. Two such holding elements can be connected with a flexible strip so that with each of the holdingelements 8 onestent 1 can be fixed. The use of two holdingelements 8 interconnected with a flexible strip has the advantage that first one of the two holding elements is coupled to one of the stents and subsequently the other one independent of the other holding element can be adjusted towards the second stent and coupled to this. -
FIG. 12 a shows another holdingelement 8 which is provided similar to the holding element shown inFIG. 11 a. Therefore same parts have same reference numbers and are not described a second time. The holding element according toFIG. 12 a differs from that according toFIG. 11 a solely by the provision ofopenings insert 32 andopenings housing 31 which align when the insert is pushed-in. In the present embodiment theopenings 43 to 46 are circularly shaped. In the context of this invention it is of course possible to provide the longitudinal openings instead of the circular openings which are aligned in longitudinal direction of thehousing 31 and theinsert 32, resp. - In
FIG. 12 b a holdingelement 8 is shown which is similar to the holding element according toFIG. 12 a whereas this holding element has each anopening insert 32 and thehousing 31 which align when theinsert 31 is pushed-in. The holdingelement 8 according toFIG. 11 b serves for fixation of a single stent. Two of these holding elements can be connected by a flexible strip for fixation of two stents. -
FIG. 13 a schematically grossly simplified shows a further holdingelement 8 which provides arectangular frame 47 with twolongitudinal struts transverse struts stamp plate 52 is provided which is centrically connected with a guidingrod 53 which is arranged orthogonally to thestamp plate 52. On the side averted from the guiding rod 53 aspring element 54 is provided between the stamp plate and thelongitudinal strut 49. This spring element presses the stamp plate against thelongitudinal strut 48. The guidingrod 53 extends through a respective hole in thelongitudinal strut 48 so that thestamp plate 52 is guided in parallel to thelongitudinal struts - For connection of this holding
element 8 with thefixation sections 3 of twostents 1 the guiding rod is pushed-in against the action of thespring element 52 into theframe 47. In this region between thestamp plate 52 and thelongitudinal strut 48 then bothfixation sections 3 of thestents 1 can be inserted. Upon release of the guidingrod 53 thestamp plate 52 is pressed against thelongitudinal strut 48 why thefixation sections 3 of thestents 1 are clamped between thestamp plate 52 and thelongitudinal struts 48. - The advantage of this holding
element 8 resides in that the opened area between thestamp plate 52 and thelongitudinal struts 48 is quite large so that it is easy to insert thefixation sections 3. - In PCT/EP 2010/004687 a fixation device is disclosed which may be used here, too, as a holding element 8 (
FIGS. 14 a to 14 c). Reference is therefore made to this document. - This holding
element 8 comprises a first and asecond clamp jaw - The
first clamp jaw 55 in the following is referred to below as the base jaw. Thebase jaw 55 provides abase wall 58. The base wall comprises a top side 59, a bottom side 60 and twoside walls 61 extend from thebase wall 58 an their longitudinal sides upwards so that thebase wall 58 and the twoside walls 61 confine a U-shaped recess. The two opposite ends of thecuboidal base wall 58 are referred to as thejoint side 63 and thelock side 64. - Two
annular disk members 65 are formed at a distance from each other on thejoint side 63 of thebase wall 58. They are flush with the outer surfaces of theside walls 61. Theannular disk members 65 have acircular opening 66 each which are aligned to each other. Theopenings 66 are designed to receive atubular shaft 67 each. The tubular shaft is rotatably arranged in theopenings 66 and aligned with the outer surfaces of the side walls. Thefirst clamp jaw 55 is pivotably connected to thesecond clamp jaw 56 via thetubular shaft 67. - The
side walls 61 extend at the lockingside 64 beyond the front-end edge of thebase wall 58 and therefore they define the U-shaped recess in a top view of thebase jaw 55. The side walls are somewhat higher in this area. - The front-end edge of the
base wall 58 on the bottom side 60 is referred to below as the lockingedge 68. - A cuboidal fixing block 69 is arranged in the U-shaped recess or the
groove 62, resp. The cuboidal fixing block 69 protrudes approximately 3 mm from the top side 59 of thebase wall 58. The cuboidal fixing block 69 is made of a plastic material, particularly silicone, and forms a fixation element. - The
second clamp jaw 56 has an L-shape and a cuboidal cross-section. Thesecond clamp jaw 56 comprises along leg 70 and a short leg formed thereon at right angles, said leg being referred to below as thefixation leg 71. Thelong leg 70 has a base wall 72 and twoside walls 73 which define a groove between them. - The end of the
long leg 70 which is opposite to thefixation leg 71 is referred to as thejoint side 74. A tubular joint body 75 is formed on thisjoint side 74. The joint body 75 forms a tube having two front sides and a circular opening wherein the length of the tube corresponds to the inner width between the twoannular disk members 65. Thetubular shaft 67 is arranged in the opening of the joint body. Thetubular shaft 67 is rotatably supported in theopenings 66 of theannular disk members 65 and in the opening 75 of the joint body 75. - A through hole (not shown) is formed in the fixing
leg 71, said hole being in alignment with the groove of thelong leg 70. A recess is provided in the tubular joint body 75, said recess being also in alignment with the groove of thelong leg 70. The through hole, the groove of thelong leg 70 and the recess of the joint body 75 accommodate a fixing tube 77. The fixation tube 77 and/or the fixation element is made of plastic material, particularly silicone. - A
latch 78 facing the joint body 75 is formed on the free end of the fixingleg 71. Thelatch 78 is made so as to grip behind thefixation edge 71 when the two legs are compressed. Thelatch 78 then locks behind the fixingedge 71 and holds the holdingelement 8 in a closed state. Thelatch 78 and the fixation edge thus form a locking member. In the locked state of the holding element, thebase jaw 55 and thesecond clamp jaw 56 are arranged approximately parallel to each other, the fixation block 69 and the fixation tube 77 being pressed onto each other. - The
fixation section 3 of astent 1 can be arranged between thefixation block 55 of theclamp jaw 55 and the fixation tube 77 of thesecond clamp jaw 56. It is also possible to fix at the same time twofixation sections 3 of two stents with this holding element between the fixation block 69 and a fixation tube 77. Therefore it is useful that the fixation block 69 and the fixation tube 77 each extend over a length of at least 3 to 3 cm. - In the context of this invention it may also be useful to provide such a holding element in a miniaturized embodiment wherein the
clamp jaws - The above described holding
elements 8 each are designed for fixation of twostents 1. In the context of the invention it is of course also possible to design a holdingelement 8 for fixation of only one single stent. Then it is useful that the holding element extends at least in one direction that long that the holding element cannot be pulled into a nostril. -
FIG. 10 shows in a schematic representation thestent 1 according to this invention according toFIG. 3 inserted into a nasal cavity 79. The nasal cavity 79 extends from thenasal entry 80 or thenostril 80, resp., towards thenasopharynx 81. In the region of the nose the nasal cavity is confined by thenasal alar 82. In the nasal cavity twoturbinates 83 are present which are arranged between thepalate 84 and the 85ethmoid bone plate 85 of the nasal cavity 79. Between thepalate 84 and theinferior turbinate 83 theinferior nasal passage 86 is present, and between the two turbinates 83 a middle nasal passage, and between theupper turbinate 83 and the 85ethmoid bone plate 85 the uppernasal passage 88. - When the turbinates are swollen then a nasal passage can be kept patent by the use of the stent according to the present invention. The
stent 1 is mostly used in the inferior nasal passage. Yet, it is also possible to apply the stent into themiddle nasal passage 87 or the uppernasal passage 88, resp. Especially theinferior nasal passage 86 exhibits a high sensitivity in the posterior part. In this region thesupport body 2 of thestent 1 should not end as the rear edge may uncomfortably press against the turbinate 83. Therefore, it is useful to arrange the support body in that way that it only splints the anterior part of the nasal passage, or that it extends through the whole nasal passage. - It is also useful that the stent according to the invention is flexible so that it nestles to the shape of the nasal passages. This is realized on the one hand by the elasticity of the wire and on the other hand by the embodiment as a braid.
-
FIG. 10 shows merely astent 1 which is fixed by a holdingelement 8. - In the context of this invention it is possible to use only one single stent. Usually, however, two
stents 1 are applied. These two stents normally are the same. For special applications, however, it may be useful to apply two stents of different size (different length and/or diameter and/or construction). Sometimes it may make sense to combine a stent according to this invention for splinting of a nasal passage with a stent for splinting of the airway in the throat as known e.g. from WO 2007/065408 and to use at the same time and to fix with a holdingelement 8. -
List of reference numbers 1 stent 2 support body 3 fixation section 4 round end 5 crimping body 6 pin 7 ball clutch 8 holding element 9 insertion rod 10 bushing/sleeve 11 opening 12 slit 13 introduction tube 14 introduction tip 15 widened section 16 twisted strand 17 chamfer 18 opening 19 slit 20 longitudinal edge 21 opening 22 opening 23 support wing 24 longitudinal edge 25 stiff enclosure 26 circular section 27 connecting strut 28 connecting region 29 stamping line 30 flexible latch 31 housing 32 insert 33 front wall 34 first recess 35 second recess 36 concave bend 37 longitudinal slit 38 transverse 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 strut 49 longitudinal strut 50 transverse strut 51 transverse strut 52 stamp plate 53 guiding rod 54 spring element 55 first clamp jaw 56 second clamp jaw 57 joint 58 base wall 59 top side 60 bottom side 61 side wall 62 groove 63 joint side 64 lock side 65 annular disk member 66 opening 67 tubular shaft 68 locking edge 69 fixing block 70 long leg 71 fixation leg 72 base wall 73 side wall 74 joint side 75 joint body 76 opening 77 fixation tube 78 latch 79 nasal cavity 80 nasal entry/nostril 81 nasopharynx 82 nasal alar 83 turbinate 84 palate 85 ethmoid bone plate 86 inferior nasal passage 87 middle nasal passage 88 upper nasal passage 89 removal tool 90 tentacle 91 sleeve 92 tentacle 93 polymer drop 94 ring
Claims (15)
1. A stent for splinting of a nasal passage, comprising a braided tubular support body which, in an unloaded state, has a diameter of at least 4 mm and a length in a range of 25 to 120 mm.
2. A stent according to claim 1 , wherein the support body has a widened section at its proximal end.
3. A stent according to claim 2 , wherein the widened section has a diameter of at least 10 mm.
4. A stent according to claim 1 , wherein the stent has a fixation section positioned at the proximal end of the stent which is provided for fixation of the stent in a nasal passage of the user and wherein the fixation section protrudes from the nostril of the user during fixation of the fixation section and can be fixed outside of the nose.
5. A stent according to claim 1 , wherein the stent is compressible in an introduction tube and is self-expanding upon release from the introduction tube.
6. A stent according to claim 1 , wherein at least the support body is made from a wire braid.
7. A stent according to claim 1 , wherein the support body is made from an elastic wire with a diameter of 0.001 to 2 mm, and wherein the wire comprises a metal wire.
8. A stent according to claim 1 , wherein the stent has a support body which, in unloaded state, has at least one of a maximum diameter in a range of 15 to 20 mm and a length in a range of 30 to 50 mm.
9. A stent according to claim 1 , wherein the support body has an essentially cylindric shape.
10. A stent according to claim 1 , wherein the diatal end of the support body is tapered.
11. A stent according to claim 1 , wherein the fixation section comprises a coupling element for fixation of the stent at a holding element and/or a inserting rod.
12. A holding element for a stent according to claim 1 , wherein the holding element is designed such that it can be captively connected in an arrangement selected from the group consisting of (i) arrangements in which the holding element is captively connected to at least one fixation section of a stent, and (ii) arrangements in which the holding element is captively connected to two fixation sections of two stents.
13. A holding element according to claim 12 , wherein the holding element has at least one matching coupling elements that can each be coupled with a coupling element of the stent.
14. A system for splinting of a nasal passage, comprising a stent according to claim 1 and an inserting rod and an introduction tube.
15. A system for splinting of a nasal passage according to claim 14 , wherein the stent can be detachably connected to the inserting rod and/or the system comprises a removal tool for removal of the stent from the nasal passage, wherein the removal tool can be coupled to the stent.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102011010754.1 | 2011-02-09 | ||
DE102011010754A DE102011010754A1 (en) | 2011-02-09 | 2011-02-09 | Stent to the rails of a nasal passage |
PCT/EP2012/000589 WO2012107229A1 (en) | 2011-02-09 | 2012-02-09 | Stent for splinting a nasal passage |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2012/000589 A-371-Of-International WO2012107229A1 (en) | 2011-02-09 | 2012-02-09 | Stent for splinting a nasal passage |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/111,737 Continuation US11116950B2 (en) | 2011-02-09 | 2018-08-24 | Stent for splinting a nasal passage |
Publications (1)
Publication Number | Publication Date |
---|---|
US20140018839A1 true US20140018839A1 (en) | 2014-01-16 |
Family
ID=45774124
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/983,028 Abandoned US20140018839A1 (en) | 2011-02-09 | 2012-02-09 | Stent for splinting a nasal passage |
US16/111,737 Active 2032-12-03 US11116950B2 (en) | 2011-02-09 | 2018-08-24 | Stent for splinting a nasal passage |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/111,737 Active 2032-12-03 US11116950B2 (en) | 2011-02-09 | 2018-08-24 | Stent for splinting a nasal passage |
Country Status (6)
Country | Link |
---|---|
US (2) | US20140018839A1 (en) |
EP (1) | EP2672938B1 (en) |
CN (1) | CN103384507B (en) |
BR (1) | BR112013020115B1 (en) |
DE (1) | DE102011010754A1 (en) |
WO (1) | WO2012107229A1 (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090198179A1 (en) * | 2007-12-18 | 2009-08-06 | Abbate Anthony J | Delivery devices and methods |
US20100211093A1 (en) * | 2009-01-23 | 2010-08-19 | Abbate Anthony J | Devices and methods for dilating tissues |
US20110004192A1 (en) * | 2005-04-04 | 2011-01-06 | Eaton Donald J | Device and methods for treating paranasal sinus conditions |
US20110125091A1 (en) * | 2009-05-15 | 2011-05-26 | Abbate Anthony J | Expandable devices and methods therefor |
US8998986B1 (en) * | 2013-07-05 | 2015-04-07 | Zdzislaw B. Malinowski | Nasal stent |
WO2015150840A1 (en) * | 2014-04-03 | 2015-10-08 | Papageorgiou Evaggelos | Stylet-type stent device with a new multiple activation mechanism |
US20170042634A1 (en) * | 2014-04-23 | 2017-02-16 | Marvis Medical Gmbh | Rod-shaped body and medical instrument |
US9782283B2 (en) | 2008-08-01 | 2017-10-10 | Intersect Ent, Inc. | Methods and devices for crimping self-expanding devices |
US10232152B2 (en) | 2013-03-14 | 2019-03-19 | Intersect Ent, Inc. | Systems, devices, and method for treating a sinus condition |
US10596330B2 (en) | 2015-08-26 | 2020-03-24 | Medtronic Xomed, Inc. | Resorbable, drug-eluting submucosal turbinate implant device and method |
CN113679936A (en) * | 2021-10-27 | 2021-11-23 | 上海微创医疗器械(集团)有限公司 | Degradable drug stent system and intranasal drug stent |
US11291812B2 (en) | 2003-03-14 | 2022-04-05 | Intersect Ent, Inc. | Sinus delivery of sustained release therapeutics |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11039735B2 (en) * | 2013-03-13 | 2021-06-22 | Spiway Llc | Surgical tissue protection sheath |
US10986984B2 (en) | 2013-03-13 | 2021-04-27 | Spiway Llc | Surgical tissue protection sheath |
CN103816002A (en) * | 2014-03-06 | 2014-05-28 | 王震东 | Woven type nickel-titanium alloy nose support frame |
DE102014003654A1 (en) | 2014-03-13 | 2015-09-17 | Nasib Dlaikan-Campos | Compressible self-expandable stent for splinting and / or holding open a cavity, an organ passage and / or a vessel in the human or animal body |
CN106344232B (en) * | 2015-07-14 | 2022-04-01 | 浦易(上海)生物技术股份有限公司 | Sustained-release drug stent for nasal cavity and forming method and application thereof |
CN106510911B (en) * | 2016-12-12 | 2018-05-11 | 郑晓明 | Nasal cavity stent |
FR3069770B1 (en) | 2017-08-03 | 2019-08-30 | Dianosic | IMPLANT FOR MEDICAL USE FOR CLASSIFICATION TO BIOLOGICAL PROTUBERANCE |
CN107753162B (en) * | 2017-09-29 | 2020-05-01 | 依奈德医疗技术(上海)有限公司 | Self-expanding intra-nasal stent assembly |
CN109223265A (en) * | 2018-10-31 | 2019-01-18 | 胡冰 | A kind of opening balloon type biliary tract anti-countercurrent stent |
US11583313B1 (en) | 2018-12-06 | 2023-02-21 | Spiway Llc | Surgical access sheath and methods of use |
WO2023212267A1 (en) * | 2022-04-29 | 2023-11-02 | Board Of Regents, The University Of Texas System | A dilating and stenting oral or nasopharyngeal airway |
Citations (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5246445A (en) * | 1990-04-19 | 1993-09-21 | Instent Inc. | Device for the treatment of constricted ducts in human bodies |
US20030144725A1 (en) * | 2000-02-14 | 2003-07-31 | Sylvie Lombardi | Stent matrix |
US20050197690A1 (en) * | 2004-03-02 | 2005-09-08 | Masoud Molaei | Medical devices including metallic films and methods for making same |
US20070179590A1 (en) * | 2005-12-29 | 2007-08-02 | Wenfeng Lu | Hybrid intraluminal device with varying expansion force |
US20070198075A1 (en) * | 2005-12-23 | 2007-08-23 | Levy Elad I | Bifurcated aneurysm treatment arrangement |
US7294138B2 (en) * | 2004-06-28 | 2007-11-13 | Shippert Ronald D | Nose pack method and apparatus |
US20090266365A1 (en) * | 2008-04-25 | 2009-10-29 | Paul Oberle | Inflatable nasopharyngeal stent |
US20090287294A1 (en) * | 2008-04-21 | 2009-11-19 | Rosqueta Arturo S | Braid-Ball Embolic Devices |
US20100319708A1 (en) * | 2005-12-06 | 2010-12-23 | Richard Mahr | Device for splinting a cavity, organ duct and/or vessel |
US20120143345A1 (en) * | 2009-07-31 | 2012-06-07 | Dr. Klaus Duering | fixing apparatus for fixing an apnea stent in the respiratory duct |
US20130006293A1 (en) * | 2011-06-30 | 2013-01-03 | Smith Oakley | Internally implantable nasal stent |
US8636009B2 (en) * | 2003-08-22 | 2014-01-28 | BiO2 Medical, Inc. | Airway assembly for tracheal intubation |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5336163A (en) | 1993-01-06 | 1994-08-09 | Smith & Nephew Richards, Inc. | Expandable nasal stent |
AU2003231099A1 (en) * | 2002-05-02 | 2003-11-17 | William R. Dubrul | Upper airway device and method |
US20060249161A1 (en) | 2004-12-09 | 2006-11-09 | Kurt Waters | Methods and apparatus for nasal aspiration |
US20090010991A1 (en) | 2007-07-07 | 2009-01-08 | Julian Prabhu | Nasal Passage Stent |
US20100211181A1 (en) | 2008-06-02 | 2010-08-19 | Julian Prabhu | Nasal passage stent |
US20100106255A1 (en) | 2008-10-24 | 2010-04-29 | Dubin Marc G | Self-expanding frontal sinus stent and insertion tool |
-
2011
- 2011-02-09 DE DE102011010754A patent/DE102011010754A1/en not_active Withdrawn
-
2012
- 2012-02-09 WO PCT/EP2012/000589 patent/WO2012107229A1/en active Application Filing
- 2012-02-09 US US13/983,028 patent/US20140018839A1/en not_active Abandoned
- 2012-02-09 EP EP12706453.3A patent/EP2672938B1/en active Active
- 2012-02-09 BR BR112013020115-0A patent/BR112013020115B1/en active IP Right Grant
- 2012-02-09 CN CN201280008471.6A patent/CN103384507B/en active Active
-
2018
- 2018-08-24 US US16/111,737 patent/US11116950B2/en active Active
Patent Citations (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5246445A (en) * | 1990-04-19 | 1993-09-21 | Instent Inc. | Device for the treatment of constricted ducts in human bodies |
US20030144725A1 (en) * | 2000-02-14 | 2003-07-31 | Sylvie Lombardi | Stent matrix |
US8636009B2 (en) * | 2003-08-22 | 2014-01-28 | BiO2 Medical, Inc. | Airway assembly for tracheal intubation |
US20050197690A1 (en) * | 2004-03-02 | 2005-09-08 | Masoud Molaei | Medical devices including metallic films and methods for making same |
US7294138B2 (en) * | 2004-06-28 | 2007-11-13 | Shippert Ronald D | Nose pack method and apparatus |
US20100319708A1 (en) * | 2005-12-06 | 2010-12-23 | Richard Mahr | Device for splinting a cavity, organ duct and/or vessel |
US20070198075A1 (en) * | 2005-12-23 | 2007-08-23 | Levy Elad I | Bifurcated aneurysm treatment arrangement |
US20070179590A1 (en) * | 2005-12-29 | 2007-08-02 | Wenfeng Lu | Hybrid intraluminal device with varying expansion force |
US20090287294A1 (en) * | 2008-04-21 | 2009-11-19 | Rosqueta Arturo S | Braid-Ball Embolic Devices |
US20090266365A1 (en) * | 2008-04-25 | 2009-10-29 | Paul Oberle | Inflatable nasopharyngeal stent |
US8241316B2 (en) * | 2008-04-25 | 2012-08-14 | Paul Oberle | Inflatable nasopharyngeal stent |
US20120143345A1 (en) * | 2009-07-31 | 2012-06-07 | Dr. Klaus Duering | fixing apparatus for fixing an apnea stent in the respiratory duct |
US20130006293A1 (en) * | 2011-06-30 | 2013-01-03 | Smith Oakley | Internally implantable nasal stent |
Cited By (28)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11291812B2 (en) | 2003-03-14 | 2022-04-05 | Intersect Ent, Inc. | Sinus delivery of sustained release therapeutics |
US9585681B2 (en) | 2005-04-04 | 2017-03-07 | Intersect Ent, Inc. | Device and methods for treating paranasal sinus conditions |
US20110004192A1 (en) * | 2005-04-04 | 2011-01-06 | Eaton Donald J | Device and methods for treating paranasal sinus conditions |
US11123091B2 (en) | 2005-04-04 | 2021-09-21 | Intersect Ent, Inc. | Device and methods for treating paranasal sinus conditions |
US11654216B2 (en) | 2007-12-18 | 2023-05-23 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US8986341B2 (en) | 2007-12-18 | 2015-03-24 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US11497835B2 (en) | 2007-12-18 | 2022-11-15 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US11826494B2 (en) | 2007-12-18 | 2023-11-28 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US20090198179A1 (en) * | 2007-12-18 | 2009-08-06 | Abbate Anthony J | Delivery devices and methods |
US10471185B2 (en) | 2007-12-18 | 2019-11-12 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US10010651B2 (en) | 2007-12-18 | 2018-07-03 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US11110210B2 (en) | 2007-12-18 | 2021-09-07 | Intersect Ent, Inc. | Self-expanding devices and methods therefor |
US9782283B2 (en) | 2008-08-01 | 2017-10-10 | Intersect Ent, Inc. | Methods and devices for crimping self-expanding devices |
US9446225B2 (en) | 2009-01-23 | 2016-09-20 | Intersect Ent, Inc. | Devices and methods for dilating tissues |
US20100211093A1 (en) * | 2009-01-23 | 2010-08-19 | Abbate Anthony J | Devices and methods for dilating tissues |
US10357640B2 (en) | 2009-05-15 | 2019-07-23 | Intersect Ent, Inc. | Expandable devices and methods for treating a nasal or sinus condition |
US20110125091A1 (en) * | 2009-05-15 | 2011-05-26 | Abbate Anthony J | Expandable devices and methods therefor |
US11484693B2 (en) | 2009-05-15 | 2022-11-01 | Intersect Ent, Inc. | Expandable devices and methods for treating a nasal or sinus condition |
US10406332B2 (en) | 2013-03-14 | 2019-09-10 | Intersect Ent, Inc. | Systems, devices, and method for treating a sinus condition |
US10232152B2 (en) | 2013-03-14 | 2019-03-19 | Intersect Ent, Inc. | Systems, devices, and method for treating a sinus condition |
US11672960B2 (en) | 2013-03-14 | 2023-06-13 | Intersect Ent, Inc. | Systems, devices, and method for treating a sinus condition |
US8998986B1 (en) * | 2013-07-05 | 2015-04-07 | Zdzislaw B. Malinowski | Nasal stent |
WO2015150840A1 (en) * | 2014-04-03 | 2015-10-08 | Papageorgiou Evaggelos | Stylet-type stent device with a new multiple activation mechanism |
US10758316B2 (en) * | 2014-04-23 | 2020-09-01 | Marvis Interventional Gmbh | Rod-shaped body and medical instrument |
US20170042634A1 (en) * | 2014-04-23 | 2017-02-16 | Marvis Medical Gmbh | Rod-shaped body and medical instrument |
US11654250B2 (en) | 2015-08-26 | 2023-05-23 | Medtronic Xomed, Inc. | Resorbable, drug-eluting submucosal turbinate implant device and method |
US10596330B2 (en) | 2015-08-26 | 2020-03-24 | Medtronic Xomed, Inc. | Resorbable, drug-eluting submucosal turbinate implant device and method |
CN113679936A (en) * | 2021-10-27 | 2021-11-23 | 上海微创医疗器械(集团)有限公司 | Degradable drug stent system and intranasal drug stent |
Also Published As
Publication number | Publication date |
---|---|
US11116950B2 (en) | 2021-09-14 |
WO2012107229A1 (en) | 2012-08-16 |
BR112013020115B1 (en) | 2021-03-02 |
CN103384507B (en) | 2017-02-08 |
CN103384507A (en) | 2013-11-06 |
US20180361129A1 (en) | 2018-12-20 |
BR112013020115A2 (en) | 2016-10-25 |
EP2672938A1 (en) | 2013-12-18 |
DE102011010754A1 (en) | 2012-08-09 |
EP2672938B1 (en) | 2018-05-02 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11116950B2 (en) | Stent for splinting a nasal passage | |
US9370448B2 (en) | Insertion system for deploying a ventilation device | |
JP6242914B2 (en) | Oral device for removing air space in the oral cavity and system for removing air space in the oral cavity | |
US20190167464A1 (en) | Nasal dilator apparatus | |
JP2013538075A5 (en) | ||
US9675494B2 (en) | Elastic tongue-dorsum retraction device, clamping pliers, installation pliers, line guide and implantation method | |
US20170071766A1 (en) | Compressible self-expandable stent for splinting and/or keeping open a cavity, an organ duct, and/or a vessel in the human or animal body | |
US20170049981A1 (en) | Nasopharyngeal device for obstructive sleep apnea syndrome | |
US11166835B2 (en) | Rhinoplasty appliance and method of forming the same | |
US20160121088A1 (en) | Devices and Methods for Dilating a Paranasal Sinus Opening and for Treating Sinusitis | |
US20160367393A1 (en) | Nasal implant for correction | |
US10952737B2 (en) | Tamponade for nasal cavities or sinus cavities | |
US20210077292A1 (en) | Nasal dilation device and method of using | |
KR101637518B1 (en) | Medical suture material equipped with Medical suture material insertion tool | |
US20150201719A1 (en) | Flesh tunnel finding, dangle jewelry and method | |
US20100185137A1 (en) | Device for treatment of watering of the eye | |
US8490625B2 (en) | Intrauterine device string | |
US9486353B2 (en) | Spring-biased nasal molding device | |
JP2017536911A (en) | Tongue advancement system for use in a tongue manipulation system | |
US20140345624A1 (en) | Intrauterine Device Remover | |
KR20180128842A (en) | Apparatus for repositioning a nasobiliary catheter from mouth to nostril | |
US20230240896A1 (en) | System comprising an applicator and a stent for a eustachian tube | |
US9339411B2 (en) | Stabilized handle design | |
WO2018063183A1 (en) | Nasopharyngeal device for obstructive sleep apnea syndrome | |
JP2018519927A (en) | Tube introducer and assembly |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: DUERING, KLAUS, GERMANY Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:RENNER, PETER;PFEFFER, JOACHIM GEORG;DLAIKAN-CAMPOS, NASIB;SIGNING DATES FROM 20130819 TO 20130905;REEL/FRAME:031306/0232 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- AFTER EXAMINER'S ANSWER OR BOARD OF APPEALS DECISION |