Cryogenic kyphoplasty instrument and methods of use

Patent metadata

Field	Value
Publication number	US-2018199977-A1
Application number	US-201815921049-A
Country	US
Kind code	A1
Filing date	Mar 14, 2018
Priority date	May 28, 2014
Publication date	Jul 19, 2018
Grant date	—

Abstract

A surgical instrument includes an outer shaft defining a passageway. An inner shaft is disposed within the passageway and defines a lumen. An expandable structure has a first end coupled to a second end of the outer shaft and a second end coupled to a second end of the inner shaft. The expandable member defines a chamber. A delivery shaft includes a first end positioned within the passageway and a second end positioned within the chamber. The delivery shaft defines a channel configured to deliver a coolant out of an opening in the second end of the delivery shaft and into the chamber to move the expandable structure from an unexpanded configuration to an expanded configuration. A variable exhaust valve is in communication with the passageway and is configured to regulate pressure within the chamber. Systems and methods are disclosed.

First claim

1 . A surgical instrument, comprising:
an outer shaft extending along a longitudinal axis between a first end and an opposite second end, the outer shaft comprising an inner surface defining a passageway; an inner shaft disposed within the passageway, the inner shaft extending between a first end and an opposite second end, the inner shaft comprising an inner surface defining a lumen; an expandable structure having a first end coupled to the second end of the outer shaft and an opposite second end coupled to the second end of the inner shaft, the expandable member comprising an inner surface defining a chamber; a delivery shaft comprising a first end positioned within the passageway and a second end positioned within the chamber, the delivery shaft comprising an inner surface defining a channel configured to deliver a coolant out of an opening in the second end of the delivery shaft and into the chamber to move the expandable structure from an unexpanded configuration to an expanded configuration; and a variable exhaust valve in communication with the passageway configured to regulate pressure within the chamber.

2 - 14 . (canceled)

15 . A surgical method comprising:
providing the surgical instrument of claim 1 ; creating an incision; creating a surgical pathway from the incision to cancellous bone; positioning the expandable structure within the cancellous bone; delivering the coolant into the chamber to move the expandable structure from the unexpanded configuration to the expanded configuration to create a cavity within the cancellous bone; and decreasing pressure within the chamber to create cold energy that denervates the cancellous bone, wherein the material is nitrous oxide.

16 . A method as recited in claim 15 , wherein:
delivering the coolant into the chamber comprises increasing pressure within the chamber to a first pressure to create the cavity; decreasing pressure within the chamber comprises adjusting pressure within the chamber from the first pressure to a second pressure that is less than the first pressure to create the cold energy; and the first pressure is greater than about 50 psi and the second pressure is about 10 psi.

17 . A method as recited in claim 16 , wherein the coolant is maintained within the chamber as pressure within the chamber is decreased.

18 . A method as recited in claim 15 , wherein decreasing pressure within the chamber comprises adjusting the variable exhaust valve.

19 . A method as recited in claim 15 , further comprising: moving the expandable structure from the expanded configuration to the unexpanded configuration; removing the surgical instrument from the cavity; and filling the cavity with bone cement.

20 . (canceled)

21 . A surgical method comprising:
positioning a balloon within a bone; delivering a material into the balloon to expand the balloon such that the balloon creates a cavity within the bone; reducing pressure within the balloon such that the material transitions from a liquid to a gas, wherein reducing pressure within the balloon creates cold energy that denervates the bone.

22 . A method as recited in claim 21 , wherein the material is nitrous oxide.

23 . A method as recited in claim 21 , further comprising positioning a second balloon within the bone and delivering a material into the second balloon to expand the second balloon such that the second balloon creates a portion of the cavity.

24 . A method as recited in claim 21 , wherein the balloon is part of an instrument that includes a handle and reducing pressure within the balloon comprises moving the material from the balloon to the handle, where the material is stored.

25 . A method as recited in claim 21 , wherein:
the balloon is part of an instrument that includes an outer shaft, a delivery shaft disposed within the outer shaft, and an inner shaft disposed within the delivery shaft, a proximal end of the balloon being coupled to the outer shaft and a distal end of the balloon being coupled to the inner shaft; and delivering the material into the balloon moving the material through a lumen defined by an outer surface of the inner shaft and an inner surface of the delivery shaft.

26 . A method as recited in claim 21 , wherein:
the balloon is part of an instrument that includes an outer shaft, a delivery shaft disposed within the outer shaft, and an inner shaft disposed within the delivery shaft, a proximal end of the balloon being coupled to the outer shaft and a distal end of the balloon being coupled to the inner shaft; and the method further comprises:
inserting a guide wire through the inner shaft such that the guide wire engages the bone; and
sliding the instrument along the guide wire.

27 . A method as recited in claim 21 , wherein:
the balloon is part of an instrument that includes an outer shaft, a delivery shaft disposed within the outer shaft, and an inner shaft slidably disposed within the delivery shaft, a proximal end of the balloon being coupled to the outer shaft and a distal end of the balloon being coupled to the inner shaft; and the method further comprises moving the inner shaft axially relative to the outer shaft to move a portion of the balloon within the outer shaft.

28 . A method as recited in claim 21 , wherein:
delivering the material into the balloon comprises increasing pressure within the balloon to a first pressure to create the cavity; and reducing pressure within the balloon comprises adjusting pressure within the balloon from the first pressure to a second pressure that is less than the first pressure to create the cold energy.

29 . A method as recited in claim 28 , wherein the first pressure is greater than about 50 psi and the second pressure is about 10 psi.

30 . A surgical method comprising:
positioning a first balloon within a bone; delivering an inflation material into the first balloon to expand the first balloon such that the first balloon creates a cavity within the bone; removing the first balloon from the cavity; positioning a second balloon within the cavity; delivering coolant into the second balloon such that the material transitions from a liquid to a gas to create cold energy that denervates the bone.

31 . A method as recited in claim 30 , wherein the coolant is nitrous oxide.

32 . A method as recited in claim 30 , further comprising positioning a third balloon within the bone and delivering an inflation material into the third balloon to expand the third balloon such that the third balloon creates a portion of the cavity.

33 . A method as recited in claim 30 , wherein delivering coolant into the second balloon comprises adjusting pressure within the second balloon from the first pressure to a second pressure that is less than the first pressure to transition the coolant from the liquid to the gas.

34 . A method as recited in claim 33 , wherein the second balloon is part of an instrument that includes a handle and adjusting pressure within the second balloon comprises moving the coolant from the second balloon to the handle, where the coolant is stored.

Assignees

• Kyphon Sarl

Inventors

• Nash Stephen

Classifications

• A61B2018/00339

  Spine, e.g. intervertebral disc · CPC title

• A61B2018/00577

  Ablation · CPC title

• A61B18/02 Primary

  by cooling, e.g. cryogenic techniques · CPC title

• A61B2018/0022

  Balloons · CPC title

• A61B2018/00041

  Heating, e.g. defrosting · CPC title