Methods and devices for the treatment of airway obstruction, sleep apnea and snoring

• US 5,988,171 A
• Filed: 06/26/1997
• Issued: 11/23/1999
• Est. Priority Date: 06/26/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Influence Medical Technologies Ltd.
• Inventors: DeRowe, Ari, Sohn, Ze'ev
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/883,220
• Time in Patent Office: 880 Days
• Field of Search: 128/846, 128/848, 606/232
• US Class Current: 128/848
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 17/8891 at its periphery
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00814 Surgery of the tongue, e.g. glossoplasty
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/0619 thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it suture cutters A61B17/0467; ultrasonic cutters A61B17/320068; electrically heated instruments A61B18/08
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61B 2090/035 preventing further rotation
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

Methods and devices for the treatment of airway obstruction, sleep apnea and snoring, by tongue suspension for treatment of airway obstruction in a human subject, including the steps of inserting a bone anchor into the mandible of the subject, and fastening at least one suture to the bone anchor to suspend the tongue to the mandible. Preferably, the bone anchors used are surgical screws. The sutures are fastened to at least one surgical screw, and are preferably inserted in positions adjacent to the mandible'"'"'s midline. Alternatively, suspension of the hyoid bone is accomplished.

Claims

1. A method for treatment of airway obstruction, comprising:

providing a self tapping bone anchor which is sized for insertion into the mandible of a human patient, said bone anchor having attached suture;

inserting said bone anchor into a bone in the mouth of a patient using an anchor insertion device, said anchor insertion device having a distal portion for holding said anchor, said anchor insertion device being of a non-linear configuration such that said distal portion of said device can be inserted into the mouth of the patient for insertion of the bone anchor into the mandible of the patient, said anchor insertion device further having an activating trigger located outside of the patient'"'"'s mouth; and

,

suspending the tongue of the patient using said suture, to prevent the tongue from obstructing the patient'"'"'s airway.

2. A method as claimed in claim 1, further comprising the step of passing said suture through the tongue of the patient.

3. A method as claimed in claim 2, wherein said suture is passed through the tongue of the patient using a suture passer.

4. A method for treatment of airway obstruction, comprising:

providing a bone anchor, said bone anchor having suture attached thereto;

inserting said bone anchor into a bone in the mouth of a patient; and

,

suspending the tongue of the patient using said suture to prevent the tongue from obstructing the patient'"'"'s airway.

5. A method as claimed in claim 4, wherein said bone anchor is inserted using a bone anchor inserter.

6. A method as claimed in claim 5, wherein said bone anchor inserter further comprises shut-off indicating means associated with said bone anchor inserter to detect a change in torque during insertion of said bone anchor into bone.

7. A method as claimed in claim 5, wherein said bone anchor inserter further comprises suture protective means to protect said suture as said bone anchor is driven into bone.

8. A method as claimed in claim 5, wherein said bone screw anchor inserter comprises torque sensing means for detecting the decrease in torque acting on a bone anchor as it is inserted into bone.

9. A method as claimed in claim 8, wherein said torque sensing means is connected to a visual light which illuminates upon the decrease of said torque acting by said bone anchor inserter on a bone anchor as it is inserted into bone.

10. A method as claimed in claim 8, wherein said torque sensing means provides the user of said bone anchor inserter with an indication that said torque acting on said bone anchor by said bone anchor inserter has decreased.

11. A method as claimed in claim 10, wherein said indication is tactile.

12. A method as claimed in claim 10, wherein said indication is audible.

13. A method as claimed in claim 10, wherein said indication is visual.

14. A method as claimed in claim 10, wherein said indication is accomplished by the combination of a spiral ramp located at the driving end of the bone anchor inserter which causes a washer with a mating head and imbedding spikes to ride thereover such that the spikes embed into the surface of the bone upon maximum desired insertion of said bone anchor into bone, and the torque of said imbedding causes said washer to glide over and then slip back onto said ramp.

15. A method as claimed in claim 5, wherein said bone anchor inserter comprises a driving end, and wherein said driving end is provided with a retractable pin element which contacts and is forced backwardly as said bone anchor is inserted into bone until said pin element causes an electrical shut-off of said bone anchor inserter.

16. A method as claimed in claim 4, wherein said bone anchor is a self tapping bone screw anchor comprising a distal bone-piercing tip portion and a proximal portion of smaller diameter than said tip portion, said proximal portion comprising an external spiral thread, said proximal portion further comprising a rearwardly directed suture holding hole for receiving and securing said suture thereto.

17. A method as claimed in claim 4, wherein said bone anchor is a self tapping bone screw anchor comprising a distal bone-piercing tip portion and a proximal portion of smaller diameter than said tip portion, said proximal portion comprising an external spiral thread, and wherein said proximal portion is crimped onto said suture to simnultaneously secure said suture and form said proximal portion into a driving shape.

18. A method as claimed in claim 17, wherein said driving shape is non-circular.

19. A method as claimed in claim 17, wherein said proximal portion is crimped to form a hexagonal shape.

20. A method as claimed in claim 4, wherein said bone anchor comprises a bone-boring tip and a rearwardly-located proximal body portion, said body portion being provided with screw threads for facilitating insertion of said bone anchor into bone;

said body portion having a rear-end portion of a non-circular shape;

and wherein said bone anchor is inserted using a bone anchor inserter, said bone anchor inserter comprising a rotatable driving socket of a shape corresponding to said non-circular shape of said rear-end portion of said body portion;

the diameter of said driving socket being less than the maximum diameter of said screw threads of said bone anchor.

21. A method as claimed in claim 20, wherein said bone anchor inserter further comprises shut-off indicating means associated with said bone anchor inserter to detect a change in torque during insertion of said bone anchor into bone.

22. A method as claimed in claim 20, further comprising bone contact means associated with said bone anchor inserter and said driving socket, said bone contact means being of a greater diameter than the maximum diameter of said screw threads of said bone anchor.

23. A method as claimed in claim 20, wherein said bone anchor inserter further comprises suture protective means to protect said suture as said bone anchor is driven into bone.

24. A method as claimed in claim 4, wherein said suture is threaded through the patient'"'"'s tongue using a suture passer, said suture passer comprising:

a) a body defining a bore passing therethrough, said body having an inner wall; and

,

b) a rod portion, said rod portion located in said hollow body, said body being provided with an opening for threading of a suture into said body, said rod axially movable within said body to slide within said body past said opening to secure a suture into said body by wedging the suture between said rod and said inner wall.

25. A method as claimed in claim 24, wherein said suture passer further comprises a piercing tip.

26. A method as claimed in claim 24, wherein said rod of said suture passer is provided with a resilient forward end which when extended from said hollow body splits outwardly to provided a longitudinal forward facing opening, said opening closing when said forward end is retracted into said rod.

27. A method as claimed in claim 26, wherein said forward end of said rod splits into sections forming, when retracted into said rod, said piercing tip.

28. A method as claimed in claim 4, wherein said suture is attached to an implantable electrode for implantation within a patient and capable of activating a nerve for controlling the position of the tongue;

and further comprising the step of implanting an induction coil in the patient in electrical connection with said electrode.

29. A method as claimed in claim 28, further comprising the step of providing an externally positionable driving coil for location outside the patient, and drivable with appropriate current to create a magnetic field and induced current in said induction coil for delivering energy to said induction coil such that said induction coil can deliver energy to said implantable electrode to activate a patient'"'"'s nerve.

30. A method as claimed in claim 29, further comprising the step of providing an electric current controller for creating and controlling said magnetic field in said driving coil.

31. A method as claimed in claim 30, further comprising an external sensor in electrical connection with said controller, said sensor being capable of detecting a characteristic of airway obstruction, and when so detecting, providing an electrical signal to said controller to activate said driving coil.

32. A method as claimed in claim 31, wherein said sensor comprises a microphone.

33. A method as claimed in claim 31, wherein said sensor is a chest motion sensor.

34. A method as claimed in claim 31, wherein said sensor is an airflow sensor.

35. A method as claimed in claim 30, further comprising a sensor in electrical connection with said controller, said sensor being capable of detecting the position of the tongue as a function of muscle tone of the same and providing an electrical signal to said controller to activate said driving coil.

36. A method as claimed in claim 35 wherein said sensor is a piezoelectric element.

37. A method, comprising:

suspending the base of a patient'"'"'s tongue, said suspension being conducted by attaching said base of the tongue to a bone using sutures.

38. A method as claimed in claim 37, wherein said suture is threaded through the patient'"'"'s tongue using a suture passer, said suture passer comprising:

a) a body defining a bore passing therethrough, said body having an inner wall; and

,

b) a rod portion, said rod portion located in said hollow body, said body being provided with an opening for threading of a suture into said body, said rod axially movable within said body to slide within said body past said opening to secure a suture into said body by wedging the suture between said rod and said inner wall.

39. A method as claimed in claim 38, wherein said suture passer further comprises a piercing tip.

40. A method as claimed in claim 37, wherein said suture is attached to an implantable electrode for implantation within a patient and capable of activating a nerve for controlling the position of the tongue;

and further comprising the step of implanting an induction coil in the patient in electrical connection with said electrode.

41. A method as claimed in claim 40, further comprising the step of providing an externally positionable driving coil for location outside the patient, and drivable with appropriate current to create a magnetic field and induced current in said induction coil, for delivering energy to said induction coil such that said induction coil can deliver energy to said implantable electrode to activate a patient'"'"'s nerve.

42. A method as claimed in claim 41, further comprising the step of providing an electric current controller for creating and controlling said magnetic field in said driving coil.

43. A method as claimed in claim 42, further comprising an external sensor in electrical connection with said controller, said sensor being capable of detecting a characteristic of airway obstruction, and when so detecting, providing an electrical signal to said controller to activate said driving coil.

44. A method as claimed in claim 43, wherein said sensor comprises a microphone.

45. A method as claimed in claim 43, wherein said sensor is a chest motion sensor.

46. A method as claimed in claim 43, wherein said sensor is an airflow sensor.

47. A method as claimed in claim 42, further comprising a sensor in electrical connection with said controller, said sensor being capable of detecting the position of the tongue as a function of muscle tone of the same and providing an electrical signal to said controller to activate said driving coil.

48. A method as claimed in claim 47, wherein said sensor is a piezoelectric element.

49. A method as claimed in claim 37, wherein said suture is threaded through the patient'"'"'s tongue using a suture passer, said suture passer comprising a pair of rods each having a handle end and an arc-shaped piercing tip facing one another, each tip having a suture gasping segment which, when the tips are in an adjacent position to one another, allows suture to be transferred from one piercing tip to the other, said rods and said piercing tips being rotatable about one another by squeezing together or release of said handles, such that said piercing tips penetrate a tissue from both sides and suture is passed through the hole formed by said piercing tips.

50. A method as claimed in claim 49, wherein said handles are spring-biased such that said piercing tips are in said adjacent position.

51. A method as claimed in claim 49, wherein one of said rods is provided with a rotation bearing for the other of said rods.

52. A method as claimed in claim 49, wherein suture holding and release means are provided to at least one of said piercing tips.

53. A method as claimed in claim 49, wherein said piercing tips are provided with opposed and mating slots to facilitate the selective transfer of suture from one of said piercing tips to the other.

54. A method as claimed in claim 53, wherein said slots are angled with respect to the longitudinal axis of said piercing tips.

55. A method as claimed in claim 37, wherein said suture is inserted using a suture passer, said suture passer comprising a straight tube defining a lumen, and comprising a rod reciprocable within said lumen, said rod being formed from an elastic material such that when retracted into said tube it is substantially straight and such that when projected forwardly from said tube the portion of said rod projecting from tube bends to form a circular configuration, said rod having suture holding and release means.

56. A method as claimed in claim 55, wherein said rod is formed with a second lumen and a tissue drilling needle passing through said second lumen.

57. A method as claimed in claim 56, wherein said suture holding and release means cooperates with said tissue drilling needle.