AIRWAY IMPLANTS AND METHODS AND DEVICES FOR INSERTION AND RETRIEVAL

• US 20080066769A1
• Filed: 08/08/2007
• Published: 03/20/2008
• Est. Priority Date: 02/08/2005
• Status: Active Grant

• Current Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Original Assignee: Aspire Medical Incorporated
• Inventors: Frazier, Andrew, Jackson, Jasper, Dineen, Michael, Roue, Chad, van der Burg, Erik, Hirotsuka, Mark, Shulock, Damien
• Granted Patent: US 8,096,303 B2
• Time in Patent Office: Days
• US Class Current: 128/897
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00814 Surgery of the tongue, e.g. glossoplasty
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0433 the anchor or the separate member comprising threads, e.g. a set screw or a worm gear for moving spreading members
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• CPC Class Codes: A61B 2017/044 : with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0451 : Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0618 : elastic, e.g. stretchable
• CPC Class Codes: A61B 2017/248 : Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61F 5/56 : Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 5/566 : Intra-oral devices

Abstract

Embodiments of the present invention relate to methods and devices for the treatment of airway obstruction, such as obstructive sleep apnea, and devices and methods that facilitate insertion and retrieval of the same. In one embodiment, disclosed is a tissue tensioner that includes an elongate flexible tether having a first end and a second end, a bone anchor configured to be connected to a patient'"'"'s mandible, a tissue ingrowth implant configured to be implanted in a patient'"'"'s tongue and connected to the second end of the tether, and an adjustment mechanism configured to be held by the bone anchor adjacent the patient'"'"'s mandible and configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient'"'"'s mandible and tongue. Various anchors, tethers, securement mechanisms, and adjustment mechanisms that can be used with glossal and palatal remodeling systems are also disclosed.

Claims

1. A tissue tensioner for treating a condition of a patient'"'"'s airway, said tissue tensioner comprising:

an elongate flexible tether having a first end and a second end;

a bone anchor configured to be connected to a patient'"'"'s mandible;

a tissue ingrowth implant, configured to be implanted in a patient'"'"'s tongue, the tissue ingrowth implant being connected to the second end of the tether; and

an adjustment mechanism configured to be held by the bone anchor adjacent the patient'"'"'s mandible, the adjustment mechanism configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient'"'"'s mandible and the patient'"'"'s tongue.

2. The tensioner of claim 1, wherein the tether is an active variable length tether.

3. The tensioner of claim 1, wherein the tether has a coating tending to cause tissue ingrowth.

4. The tensioner of claim 1, wherein the adjustment mechanism comprises a rotational spool assembly.

5. A tissue tensioner for treating a condition of a patient'"'"'s airway, said tissue tensioner comprising:

an elongate flexible tension member;

a first portion of the tension member configured to be secured relative to a body tissue and a second portion of the tension member comprising a tissue ingrowth material configured to be secured to a portion of a tongue; and

an adjustment mechanism configured to adjust tension in the tension member between the body tissue and said portion of a tongue.

6. The tensioner of claim 5, wherein the first portion of the tension member is connected to a bone anchor.

7. The tensioner of claim 5, wherein the first portion of the tension member is connected to a tissue anchor.

8. The tensioner of claim 5, wherein the tissue ingrowth material is a woven material comprising a single strand.

9. The tensioner of claim 5, further comprising a cap element covering at least a portion of the tissue ingrowth material.

10. The tensioner of claim 9, wherein the cap element comprises a radioopaque portion.

11. A method for treating airway obstruction comprising:

placing a tissue tensioner within a patient'"'"'s tongue, the tensioner comprising;

a flexible elongate tension member having a first portion configured to be secured relative to a body tissue and a second portion that is connected to a tissue ingrowth material;

an adjustment mechanism configured to adjust tension in the tension member between the body tissue and the tissue ingrowth material;

securing the first portion relative to a body tissue and implanting the tissue ingrowth material within a portion of the tongue; and

adjusting the tension of the tension member by manipulating the adjustment mechanism.

12. The method of claim 11, wherein the first portion is secured relative to a patient'"'"'s mandible using a bone anchor.

13. The method of claim 11, wherein the first portion is secured to tongue tissue using a tissue anchor.

14. The method of claim 11, wherein the tissue ingrowth implant comprises a woven material comprising a single strand.

15. A tissue tensioner for treating a condition of a patient'"'"'s airway comprising:

an elongate flexible tension member comprising a first portion and a second portion, wherein the first portion of the tension member is securable relative to a body tissue and wherein the second portion being connected to a tissue ingrowth material; and

means for adjusting the tension between the tissue ingrowth material and the body tissue.

16. The tensioner of claim 15, wherein the first portion of the tension member is configured to be connected to a bone anchor.

17. The tensioner of claim 15, wherein the first portion of the tension member is configured to be connected to a tissue anchor.

18. A tissue tensioner for treating a condition of a patient'"'"'s airway comprising:

a flexible elongate tension member having a first portion and a second portion, the first portion being securable relative to a body tissue; and

the second portion being connected to a woven implant comprising a single strand configured to be implanted in a patient'"'"'s tongue.

19. The tensioner of claim 18, further comprising a cap element covering at least a portion of the woven implant.

20. A method for treating airway obstruction comprising:

deploying a tissue tensioner into a patient'"'"'s tongue, the tissue tensioner comprising a flexible elongate tension member having a first portion secured relative to a body tissue and a second portion comprising a woven implant comprising a single strand implanted in the patient'"'"'s tongue.

21. The method of claim 20, further comprising removing the tissue tensioner from the patient by pulling on the single strand with sufficient force such that the woven implant unravels.

22. The method of claim 20, wherein the first portion is secured relative to the patient'"'"'s mandible.

23. The method of claim 20, wherein the first portion is secured within the patient'"'"'s tongue.

24. A tissue tensioner for treating a condition of a patient'"'"'s airway comprising:

a flexible, elongate elastic member having a first portion and a second portion, wherein the first portion is configured to be secured relative to a body tissue and the second portion is connected to a tissue ingrowth material; and

a locking bar releasably attached to the first portion and the second portion, the locking bar configured to prevent migration of the first portion relative to the second portion.

25. A method for treating a condition of a patient'"'"'s airway, the method comprising:

positioning a tissue tensioner within a patient, the tissue tensioner comprising a flexible, elongate elastic member having a first portion secured relative to a body tissue and a second portion comprising a tissue ingrowth material implanted in a portion of the tongue, wherein a locking bar is releasably attached to the first portion and the second portion to prevent migration of the first portion with respect to the second portion; and

manually pulling out the locking bar to allow migration of the first portion with respect to the second portion.

26. A method for removing a tissue tensioner, the method comprising:

providing a tissue tensioner, the tissue tensioner comprising a batten implant connected to a flexible tether;

threading the flexible tether through a dilator;

advancing the dilator over the flexible tether through tissue to the batten implant;

advancing a cannula over dilator and over the implant; and

removing the batten implant, the cannula, and the dilator.

27. The method of claim 26, wherein at least a portion of the tissue ingrowth material is covered by a cap element.

28. A method for treating a condition of a patient'"'"'s airway, the method comprising:

passing a first tension member through a patient'"'"'s genioglossus muscle exiting the dorsum lateral to a midline of the patient'"'"'s tongue creating a first exit hole;

passing a second tension member through the patient'"'"'s genioglossus muscle exiting the dorsum lateral to the midline of the patient'"'"'s tongue creating a second exit hole;

passing a sling element under the tongue surface though the first exit hole and the second exit hole;

attaching the first tension member to a first portion of the sling;

attaching the second tension member to a second portion of the sling; and

securing first and second tension members relative to body tissue.

29. The method of claim 28, comprising securing the first and second tension members to a bone anchor.

30. A method for treating airway obstruction comprising:

placing a tissue tensioner within a patient'"'"'s oral cavity, the tensioner comprising;

a flexible elongate tension member having a first portion configured to be secured relative to a body tissue and a second portion that is connected to a tissue ingrowth material;

an adjustment mechanism configured to adjust tension in the tension member between the body tissue and the tissue ingrowth material;

securing the first portion relative to a body tissue and implanting the tissue ingrowth material within a portion of the patient'"'"'s soft palate; and

adjusting the tension of the tension member by manipulating the adjustment mechanism.

31. The method of claim 30, wherein the first portion is secured relative to a patient'"'"'s hard palate.

32. A tissue tensioner for treating a condition of an airway, said tissue tensioner comprising:

an elongate flexible tension member, a first portion of the tension member connected to a first tissue ingrowth material and a second portion of the tension member connected to a second tissue ingrowth material; and

an adjustment mechanism configured to adjust tension in the tension member between the first tissue ingrowth material and the second tissue ingrowth material.

33. The tensioner of claim 32, wherein the first tissue ingrowth material is implanted in a first body tissue and the second tissue ingrowth material is implanted in a second body tissue.

34. A method for treating airway obstruction comprising:

placing a tissue tensioner within the tongue, the tensioner comprising a flexible elongate tension member having a first portion connected to a first tissue ingrowth material and a second portion connected to a second tissue ingrowth material;

implanting the first tissue ingrowth material in a first portion of the tongue and implanting the second tissue ingrowth material in a second portion of the tongue; and

adjusting the tension or length of the tension member by manipulating an adjustment mechanism configured to adjust tension in the tension member between the first tissue ingrowth material and the second tissue ingrowth material.

35. A tissue tensioner for treating a condition of a patient'"'"'s airway, said tissue tensioner comprising:

an elongate flexible tension member, a first portion of the tension member comprising a tissue anchor configured to be secured to a first portion of a patient'"'"'s tongue and a second portion of the tension member comprising a tissue ingrowth material configured to be secured to a second portion of the patient'"'"'s tongue.

36. The tensioner of claim 35, wherein the tissue anchor is a fishbone anchor comprising a plurality of barbs extending radially from the tension member.

37. A method for treating airway obstruction comprising:

placing a tissue implant within a patient'"'"'s tongue or palate, the tissue implant comprising a multiple-pronged stiffening element; and

expanding the stiffening element within the tongue or palate to stretch tissue laterally.