US20100319708A1 - Device for splinting a cavity, organ duct and/or vessel - Google Patents

Device for splinting a cavity, organ duct and/or vessel Download PDF

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Publication number
US20100319708A1
US20100319708A1 US12/096,457 US9645706A US2010319708A1 US 20100319708 A1 US20100319708 A1 US 20100319708A1 US 9645706 A US9645706 A US 9645706A US 2010319708 A1 US2010319708 A1 US 2010319708A1
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Prior art keywords
stent
phase
tube
phases
length
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Abandoned
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US12/096,457
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English (en)
Inventor
Richard Mahr
Joachim-Georg Pfeffer
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DR KLAUS DURING
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Individual
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Priority claimed from DE102005058242A external-priority patent/DE102005058242B3/de
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Assigned to DR. KLAUS DURING reassignment DR. KLAUS DURING ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MAHR, RICHARD
Publication of US20100319708A1 publication Critical patent/US20100319708A1/en
Priority to US13/632,596 priority Critical patent/US10492932B2/en
Assigned to Düring, Klaus, Dr. reassignment Düring, Klaus, Dr. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MAHR, RICHARD, PFEFFER, JOACHIM GEORG
Abandoned legal-status Critical Current

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    • 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
    • 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
    • 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
    • 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
    • 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
    • A61F5/566—Intra-oral devices
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04C—BRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00—Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06—Braid or lace serving particular purposes
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A61F2/186—Nose parts
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/20—Larynxes; Tracheae combined with larynxes or for use therewith
    • A61F2/203—Larynxes; Tracheae combined with larynxes or for use therewith comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis
    • 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
    • A61F2/91—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 made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0048—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/06—Vascular grafts; stents

Definitions

  • the present invention relates to a device for the splinting and/or holding open of a cavity, an organ duct and/or a vessel in the human or animal body with at least one compressible and self-expanding stent which has at least one expanded phase.
  • obstructive sleep apnea is a life-threatening illness resulting from the closure of the rear air passages due to muscle relaxation during sleep. Through repeated and sometimes very frequent interruption of breathing during sleep, the patient is not adequately supplied with oxygen, in extreme cases leading to death.
  • Civilisation-related factors such as e.g. severe obesity or excessive alcohol consumption seriously increase the risk of illness.
  • Snoring is a gentler outcome of the effect than sleep apnea, but results from the same organic cause. Whereas people are aware of snoring, the serious risks to health especially of heavy snoring and of sleep apnea are often not registered, since the patient is not aware of the organic deficiency symptoms.
  • FIG. 1 shows free airways through which normal breathing takes place.
  • the relaxation of the tongue and of the surrounding muscles in the pharyngeal cavity which occurs during sleep leads, due to the inflowing air, to vibrations of the soft palate and the soft parts of the throat, resulting in the noise of snoring.
  • Strong relaxation of the throat tissue and the falling back of the root of the tongue may lead to complete closure of the air passages ( FIG. 2 ).
  • the brain After a certain time (approx. 60-90 seconds) the brain generates a waking reaction.
  • the transition from snoring to apnea is fleeting.
  • the interruption of breathing may last up to 1.5 minutes and be repeated 200-400 times during the night, which does not allow the patient any deep sleep.
  • the current standard therapy for sleep apnea is the active supply to the patient of respiratory air under overpressure by means of an n-CPAP breathing apparatus (nasal continuous positive airway pressure).
  • an n-CPAP breathing apparatus nasal continuous positive airway pressure
  • FIG. 3 The principle of operation is illustrated in FIG. 3 .
  • Significant drawbacks to this standard therapy which is to date the sole treatment option with medical effectiveness, are the discomforts to the patient, created above all by the wearing of an airtight oxygen mask for the whole night, fixed via an adequately strong headband and connected via the supply tube to the breathing apparatus; also through drying out of the mucous membranes and the need for moistening of the respiratory air, plus the operating noise of the breathing apparatus.
  • DE 195 01 363 is a device for insertion through the mouth, characterised by a tube which may be introduced into and fixed in the pharynx. It is meant to prevent the collapse of the soft parts of the pharynx.
  • a drawback cited by the inventor is the need to overcome nausea. Experience shows that the route described here, via the mouth, is impracticable, and does not lead to adequate reduction of symptoms.
  • a similar device to support the soft palate parts in the nose and throat area, but which is intended for introduction through the nose, is proposed in DE 100 28 013. The effect is just as limited as the instrument described above.
  • DE 102 40 725 describes a probe against apnea and snoring, which is expandable at the end by means of a drawing element. It is not described how in practice the expansion by means of the drawing element takes place or how the expanded probe is stabilised in the air passage.
  • the present invention is now based on the problem on the one hand of avoiding the aforementioned drawbacks of the prior art, and on the other hand of making possible a practicable splinting and/or holding open of cavities, organ ducts and/or vessels in the human or animal body.
  • a device according to the invention for the treatment of illnesses such as snoring and apnea, repeated daily use of a device according to the invention is necessary, and therefore special requirements are placed on the durability of any such medical instrument.
  • the principle according to the invention for the device should be effective not only specifically in the air passages for the treatment of snoring and/or sleep apnea, but should also be capable of application for the splinting and/or holding open of other cavities, organ ducts and/or vessels in the human or animal body.
  • the distal end of the at least one stent is expanded.
  • the at least one stent in a further preferred embodiment may be made to have at least three phases, and the different phases of the at least one stent may have different degrees of expansion, wherein the at least one transition phase so connects the at least two functional phases with one another that the latter may assume their configuration unaffected by one another.
  • the at least one transition phase is formed by the twining around of at least two wires, fibres and/or threads (“twist”).
  • a device which, in the compressed state, is inserted in the cavity, organ duct and/or vessel after which, by drawing back an outer tube, the inner at least one stent is released, self-expands and, at least with the phase of greatest expansion, fits up against the wall of the cavity, organ duct and/or vessel.
  • the device By pushing the tube back over the expanded stent, the device may be compressed again and easily removed from the cavity, organ duct and/or vessel.
  • the cavity, organ duct and/or vessel is splinted and/or held open.
  • the tube containing the compressed stent is so dimensioned that it may easily be inserted into the cavity, organ duct and/or vessel, even when the cavity, organ duct and/or vessel is in a collapsed state.
  • the stent is made of a shape memory material. In the operating state, the device is expanded only over a small part in one phase of the stent, again preferably at the distal end, while the other part at the other end of the stent undergoes only a fairly limited expansion on release from the tube.
  • the size and length relationships of the phases of the at least one stent relative to one another may be freely selected.
  • the device may easily follow any curvature of the cavity, organ duct and/or vessel.
  • Optimal adaptation of the stent to the anatomy of the cavity, organ duct and/or vessel is possible with very great ease, due to the scope for varying the elastic expansion of the stent.
  • the stent has a net structure and/or a multiplicity of openings with different angles of opening and/or opening widths in the phases. It is especially preferred for the stent to be made of braiding and/or woven fabric and/or interlaid scrim, in particular from a wire, thread and/or fibre braiding or woven fabric or interlaid scrim. In another embodiment, the at least one stent may be made from a tube slit over at least part of its length, and produced in an especially preferred manner e.g. by laser cutting of a metal or nitinol tube.
  • the stent has preferably smaller angles of opening in its longitudinal direction, and in the at least one distal phase the stent has preferably larger angles of opening in its longitudinal direction, so that the necessary force for expansion, splinting and/or holding open of the cavity, organ duct and/or vessel in this area can be obtained.
  • the angles of opening in the longitudinal direction of the stent may be larger in the at least one proximal phase and smaller in the at least one distal phase.
  • the stent in order to create a transition zone between two functional phases of the stent in the at least one transition phase, is comprised preferably of openings which are larger than those in the functional phases, so that after release from the tube they may adopt their configuration uninfluenced by one another. In an especially preferred version this is obtained by a twisting of at least two wires, fibres and/or threads.
  • these openings may be made by laser cutting in a metal or nitinol tube.
  • the material of the at least one stent may be provided with a coating, in particular with a bio-compatible surface coating, heparin, a carbonisation of nitinol, a nano-technological coating, x-ray-proof particles, a coating releasing an active substance, a preferably microporous bio-technological, or another other coating.
  • a coating in addition to the physical effect, a pharmaceutical effect for example may also be provided.
  • a coating which roughens the surface of the stent fixing of the stent at the point of action is improved. In this connection, though, care is preferably taken to avoid any damage to the respective wall of the cavity, organ duct and/or vessel in the human or animal body in which the stent is used.
  • the at least one stent is/are made of a bio-compatible shape memory material, in particular a metal or a metal alloy, in particular a stainless steel or nitinol or another bio-compatible material, such as in particular a plastic, or monofile and/or multifile and/or composite glass fibres.
  • a bio-compatible shape memory material in particular a metal or a metal alloy, in particular a stainless steel or nitinol or another bio-compatible material, such as in particular a plastic, or monofile and/or multifile and/or composite glass fibres.
  • a shape memory material is advantageously chosen.
  • the stent has at the distal end round ends, i.e. the wire or fibre or thread is guided back into the braiding or woven fabric or interlaid scrim, so that there are no open wire or fibre or thread ends at the distal end of the stent, which could lead to damage to the relevant wall of the cavity, organ duct and/or vessel.
  • the round ends at the distal end are bent slightly inwards.
  • the proximal end of the stent is fixed by at least one end of the wire or fibre or thread, which is open by virtue of its construction, in a closure, e.g. bonded.
  • a closure e.g. bonded.
  • this closure is a threaded closure.
  • the stent may be provided at the proximal end with a fastening, which in a preferred embodiment may be adjusted variably to the anatomical features concerned in each case.
  • the tube may be longer, the same length or shorter than the stent, and where necessary extended by an additional piece needed for handling, downwards from the stent, e.g. beyond the pulling element, and with which it may be adapted flexibly to the particular conditions of use.
  • the device may be pushed forward directly up to the point of use and there released by withdrawing the tube from the stent. This may involve partial or complete withdrawal of the tube.
  • the device may be pushed forward until just before the point of use only, and then the stent pushed out of the tube forward to the point of use, after which the tube is withdrawn wholly or partly or is even not withdrawn at all.
  • the device is preferably so dimensioned that the distal end of the at least one stent just reaches the epiglottis, to avoid irritation of the pharynx and nausea.
  • the distal expanded phase of the stent preferably has a length of 0.5 cm to 20 cm.
  • the whole stent preferably has a length of 2 cm to 50 cm.
  • the length of the tube is preferably between 0.5 cm and 50 cm.
  • the whole stent has a length of 10 cm to 35 cm with a distal expanded phase between 1 cm and 10 cm in length, and with a 10 cm to 35 cm long tube.
  • the air passages may be reliably and reproducibly held open during sleep, and the oxygen saturation in the blood for an apnea patient is able to rise above the critical limit value of 90%. Consequently, replacement of the n-CPAP breathing mask by the device according to the invention for the splinting and/or holding open of a cavity, organ duct and/or vessel is possible easily, efficiently and with very good physical tolerance by the patient.
  • the device according to the invention for the treatment of bronchial stenosis, bile duct constrictions and for the splinting and/or holding open of blood vessels, lymph vessels, urinary ducts, Fallopian tubes and sections of bowel.
  • This list is not intended to be limiting for the range of application of a device according to the invention, but is rather meant to illustrate the breadth of scope for such application.
  • FIG. 1 the free air passage during sleep
  • FIG. 2 the blocked air passage during sleep as the cause of snoring and obstructive sleep apnea
  • FIG. 3 the opening of the air passages by n-CPAP therapy.
  • FIG. 4 shows a view of the components of a first embodiment of a device according to the invention for the splinting and/or holding open of a cavity, organ duct and/or vessel with a three-phase stent.
  • FIG. 5 shows a view of a three-phase stent of a first embodiment of a device according to the invention.
  • FIG. 6 shows a braiding pattern with round ends at the distal end of the braiding and/or woven fabric and/or interlaid scrim of a stent of a second embodiment of a device according to the invention, in which only one wire or fibre or thread is always guided back separately and directly.
  • FIG. 7 shows a braiding pattern with round ends at the distal end of the braiding and/or woven fabric and/or interlaid scrim of a stent of a third embodiment of a device according to the invention, in which two wires or fibres or threads always cross at the return point.
  • FIG. 8 shows a braiding pattern with round ends at the distal end of the braiding and/or woven fabric and/or interlaid scrim of a stent of a third embodiment of a device according to the invention, in which at least two wires or fibres or threads are guided back at least partly parallel.
  • FIG. 1 shows the nasal chamber ( 1 ), the hard palate ( 2 ), the trachea ( 3 ), the soft palate ( 4 ), the oral cavity ( 5 ), the free airways ( 6 ) and the tongue ( 7 ). Illustrated is the free airway during sleep of a healthy person.
  • FIG. 2 shows the closed airway ( 8 ) in the pharynx, as occurs in obstructive sleep apnea.
  • FIG. 3 shows the use of the n-CPAP breathing apparatus with the breathing mask ( 9 ) in place, and the air passages opened by the overpressure.
  • FIG. 4 shows a view of the components of a first embodiment of a device according to the invention for the splinting and/or holding open of a cavity, organ duct and/or vessel in a human or animal body.
  • the device comprises a three-phase stent ( 10 ), connected at its proximal end ( 21 ) via a connecting element ( 11 ) to the connecting element ( 12 ) of a pulling element ( 13 ).
  • the stent is inserted into the tube ( 14 ) and compressed.
  • the stent ( 10 ) is firmly fixed in a connecting element ( 11 ).
  • the connecting element ( 11 ) which may contain e.g. a screw thread
  • the connection to the connecting element ( 12 ) of the pulling element ( 13 ) which may similarly contain a screw thread.
  • the tube ( 14 ) may be made preferably of a plastic polymer, for example a PTFE, PVC, PE, PU, silicon or Teflon tube, or be a catheter.
  • the puling element ( 13 ) may be made preferably of a plastic, a metal or a metal alloy, or glass fibre materials.
  • the two connecting elements ( 11 ) and ( 12 ) may be produced as a single solid element, so that the stent ( 10 ) is permanently connected to the pulling element ( 13 ).
  • the device is inserted, compressed in the tube ( 14 ), into one of the two nostrils and preferably pushed forward as far as possible towards the epiglottis, and positioned at its point of use.
  • the stent ( 10 ) is released, and self-expands to its pre-impressed size. This prevents the collapse of the pharynx and the closing of the air passages. A free airflow and normal breathing are thereby made possible.
  • a fastening ( 15 ) may be fixed at the proximal end ( 21 ) of the stent ( 10 ).
  • a mounting plate ( 16 ) may also be provided to prevent the stent from accidentally slipping into the air passage and the pharynx. After insertion of the device and release of the stent ( 10 ) by withdrawing the tube ( 14 ), the pulling element ( 13 ) is separated and removed from the stent ( 10 ) by releasing the connecting element ( 12 ) from the connecting element ( 11 ). In this phase and fixed by the fastening ( 15 ) and if applicable the mounting plate ( 16 ), the stent is worn during sleep.
  • an additional fastening of the stent to the head may be provided as security against it slipping out of the air passage. This may be provided for example by a soft headband, which may be fastened to the mounting plate.
  • FIG. 5 shows a view of a three-phase stent ( 10 ) in a first embodiment of a device according to the invention for the splinting and/or holding open of a cavity, organ duct and/or vessel in a human or animal body for the treatment of snoring and/or sleep apnea.
  • the distal functional phase ( 17 ) of the stent is in this first embodiment the therapeutically active part of the medical device, which is expanded sufficiently to hold open the air passages.
  • the proximal functional phase ( 19 ) of the stent may be used in particular for locating the stent in the nasal area and is accordingly expanded only slightly.
  • the distal phase ( 17 ) therefore has a greater expansion diameter than the proximal phase ( 19 ).
  • the distal phase ( 17 ) and the proximal phase ( 19 ) are connected to one another by a transition phase ( 18 ), preferably twisted together and which, through the stability of the twisted wires, fibre or threads allows the distal phases to assume their configuration, uninfluenced by one another, after release from the tube.
  • the design of the stent ( 10 ), in this form of at least three phases, composed of at least two functional phases and at least one transition phase is an important element of an embodiment of a device according to the invention and thus distinguishes the stent ( 10 ) significantly from the nowadays generally common stents for the hang or holding open of e.g. blood vessels.
  • the phase with the greatest diameter in the expanded state of the at least three phases of the at least one stent ( 10 ) may be chosen freely.
  • a transition phase ( 18 ) may have either the same or a greater or even a smaller diameter than the functional phases.
  • the transition phase ( 18 ) is preferably created by the twisting of at least two wires or fibres or threads, while the other phases are preferably constructed through the crossing of at least one thread.
  • a braiding and/or woven fabric and/or interlaid scrim with smaller angles of opening in the longitudinal direction of the stent is chosen.
  • a braiding and/or woven fabric and/or interlaid scrim with larger angles of opening in the longitudinal direction of the stent is chosen.
  • the stent has a net structure. This may be formed e.g. by a wire, thread and/or fibre braiding and/or woven fabric and/or interlaid scrim. Alternatively a cut tube may be provided with such a structure, with openings of different sizes, especially preferably prepared by laser cutting of a metal or nitinol tube. The important factor here is a number of openings sufficient to allow an unimpeded air flow.
  • the stent may therefore have a very fine network or a coarser network.
  • the stent is made from a shape memory material. This may be for example nitinol, stainless steel, plastic or monofile, multifile and/or composite glass fibre material.
  • the stent is made by manual or machine braiding in predefined patterns to produce the different phases.
  • a particular problem with repeated insertion and removal of a device according to the invention on the one hand, and possible use in open cavities on the other hand lies in the fact that open ends of a material from which the braiding and/or woven fabric and/or interlaid scrim of the stent ( 10 ) is made may lead to irritation of the wall of the cavity, organ duct and/or vessel.
  • the stent ( 10 ) may be made preferably of only one wire or one fibre or one thread, to give only closed ends at the distal end ( 20 ) of the stent ( 10 ), and two open wire or fibre or thread ends at the proximal end ( 21 ) of the stent ( 10 ).
  • the number of wires or fibres or threads used to produce the stent ( 10 ) matches the number of closed ends required. This may be for example 12, 18 or 24 wires or fibres or threads for 12, 18 or 24 closed ends at the distal end ( 20 ) of the stent ( 10 ).
  • the material properties should be balanced with the mechanical properties of the braiding and/or woven fabric and/or interlaid scrim.
  • the stent ( 10 ) is made of nitinol wire with a diameter of 0.001 mm to 2 mm, even more preferably with a diameter of 0.05 mm to 0.5 mm, and most preferably with a diameter of 0.1 mm to 0.2 mm.
  • the diameter of the nitinol wire, and the density and angle of opening of the braiding determine the forces involved in the expansion and holding open of the cavity, organ duct and/or vessel in the more strongly expanded phase of the stent ( 10 ). In certain forms of treatment such as that for snoring and sleep apnea, these forces contribute significantly to the well-being of the patient.
  • FIG. 6 shows a braiding pattern with round ends at the distal end ( 20 ) of the stent ( 10 ) in a preferred embodiment of a device according to the invention, in which in each case only one wire or fibre or thread is guided back separately into the braiding.
  • the incoming wire or fibre or thread is guided back round directly into the braiding.
  • FIG. 7 the incoming wire or fibre or thread is so guided back that two wires or fibres or threads always cross at the return point.
  • FIG. 8 shows a braiding pattern with round ends at the distal end ( 20 ) of the stent ( 10 ) in a preferred embodiment of a device according to the invention, in which at least two wires or fibres or threads are guided back at least partly parallel.
  • the incoming wire or fibre or thread is guided back round into the second position within the braiding pattern.
  • the incoming wire or fibre or thread is guided back round into the third or subsequent position within the braiding pattern.
  • the shape of the stent may be matched to the shape of the cavity or organ duct or vessel. In some cases shorter stents with a larger opening diameter are more suitable, while at other points of use narrower, longer stents may be advantageous.
  • numerous further embodiments may similarly be created. In each of these embodiments, at least one functional phase of the stent is connected to at least one other functional phase by a transition phase which facilitates the free development of the two different configurations of the functional phases.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nursing (AREA)
  • Manufacturing & Machinery (AREA)
  • Textile Engineering (AREA)
  • Prostheses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
US12/096,457 2005-12-06 2006-12-01 Device for splinting a cavity, organ duct and/or vessel Abandoned US20100319708A1 (en)

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DE102005058242.7 2005-12-06
DE102005058242A DE102005058242B3 (de) 2005-12-06 2005-12-06 Vorrichtung zur Verhinderung des Schnarchens und der Atemstillstände während des Schlafs (Apnoe)
DE102006040301A DE102006040301A1 (de) 2005-12-06 2006-08-29 Vorrichtung zur Schienung eines Hohlraums, Organwegs und/oder Gefäßes
DE102006040301.0 2006-08-29
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CA2632420C (en) 2017-10-03
WO2007065408A8 (de) 2008-06-19
US10492932B2 (en) 2019-12-03
EP1959882A2 (de) 2008-08-27
JP2009518082A (ja) 2009-05-07
CA2632420A1 (en) 2007-06-14
WO2007065408A2 (de) 2007-06-14
EP1959882B1 (de) 2014-02-12
DE102006040301A1 (de) 2008-03-06
WO2007065408A3 (de) 2007-11-01
US20130090720A1 (en) 2013-04-11

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