Rotary debulking atherectomy device with a crossing balloon
An atherectomy system that utilizes an anchoring balloon with a rotary debulker and a crossing balloon to remove or debulk lesions formed on the interior wall surface of a body vessel. The system may include a first balloon coupled to a first tubular member, a rotary debulker coupled to a second tubular member, a second balloon coupled to both the third tubular member and the axially moveable fourth tubular member such that the second balloon is disposed inside the third tubular member. Methods for operating this device are also provided.
1 . An atherectomy device that includes a handle coupled to a working tip via a plurality of axially disposed tubular members, the handle including:
a housing that extends from a first housing end to a second housing end along a housing longitudinal axis, the second housing end being coupled to a first tubular member, the first tubular member surrounding at least a portion of a second tubular member, the second tubular member being coupled to a rotary member proximate the housing and disposed around a portion of a third tubular member, the third tubular member disposed around a portion of an axially moveable fourth tubular member; and
the working tip spaced from the handle and extending along a working tip longitudinal axis, the working tip including:
a first balloon coupled to the first tubular member,
a rotary debulker coupled to the second tubular member, and
a second balloon coupled to both the third tubular member and the axially moveable fourth tubular member such that the second balloon is disposed inside the third tubular member and wherein a distal end of the axially movable fourth tubular member is configured to be extendable beyond a distal end of the third tubular member.
2 . The device of claim 1 , further comprising an outer sheath coupled to the housing, the outer sheath surrounding a portion of the first tubular member.
3 . The device of claim 2 , wherein the outer sheath comprises a polymeric tubular member having a proximal end mounted to the handle and configured for axial movement along the housing longitudinal axis so that when the outer sheath is moved axially in a proximal direction, a distal end of the outer sheath is moved axially in the proximal direction to uncover the first tubular member.
4 . The device of claim 3 , wherein the outer sheath further comprises a locking mechanism to prevent axial movement of the outer sheath.
5 . The device of claim 3 , wherein the third tubular member comprises a second polymeric member defining a second fluid passage in which the fourth tubular member is disposed in the second fluid passage.
6 . The device of claim 5 , wherein the fourth tubular member is supported for axial movement along the working tip longitudinal axis.
7 . The device of claim 6 , wherein the fourth tubular member is connected at a first terminal end of the second balloon and the third tubular member is connected to a second terminal end of the second balloon.
8 . The device of claim 5 , wherein the fourth tubular member defines a guidewire passage for deployment of a guidewire.
9 . The device of claim 3 , wherein the first balloon comprises a first outer diameter greater than a second outer diameter of the second balloon.
10 . The device of claim 9 , wherein a maximum outer diameter of the rotary debulker is less than the first outer diameter of the first balloon.
11 . The device of claim 1 , wherein the first tubular member comprises a first polymeric member defining a first fluid passage that extends from a first fluid port disposed proximate the handle to an inner volume of the first balloon.
12 . The device of claim 1 , wherein the second tubular member is supported for rotation relative to the first tubular member.
13 . The device of claim 12 , wherein the second tubular member is supported for rotation relative to the third tubular member.
14 . An atherectomy tip for use with a handle, the atherectomy tip comprising:
an outer sheath extending along a longitudinal axis, the outer sheath surrounding a portion of a first tubular member, the first tubular member surrounding at least a portion of a second tubular member, the second tubular member disposed around a portion of a third tubular member, the third tubular member disposed around a portion of an axially moveable fourth tubular member;
a first balloon coupled to the first tubular member;
a rotary debulker being coupled to the second tubular member so that the rotary debulker is rotatable about the longitudinal axis by rotational motion of the second tubular member about the longitudinal axis; and
a second balloon coupled to both the third tubular member and the axially moveable fourth tubular member such that the second balloon is disposed partly inside the third tubular member and wherein a distal end of the axially movable fourth tubular member is configured to be extendable beyond a distal end of the third tubular member.
15 . The device of claim 14 , wherein the outer sheath comprises a polymeric tubular member having a proximal end mounted to the handle and configured for axial movement along a longitudinal axis of the handle so that when the outer sheath is moved axially in a proximal direction, a distal end of the outer sheath is moved axially in the proximal direction to uncover the first tubular member, the first tubular member including a polymeric member defining a first fluid passage that extends from a first fluid port disposed proximate the handle to an inner volume of the first balloon.
16 . The device of claim 14 , wherein the outer sheath further comprises a locking mechanism to prevent axial movement of the outer sheath.
17 . The device of claim 14 , wherein the second tubular member is supported for rotation relative to the first tubular member and the second tubular member is supported for rotation relative to the third tubular member.
18 . The device of claim 17 , wherein the third tubular member comprises a polymeric member defining a second fluid passage in which the fourth tubular member is disposed in the second fluid passage, the fourth tubular member is supported for axial movement along a longitudinal axis of the working tip, and the fourth tubular member is connected at a first terminal end of the second balloon and the third tubular member is connected to a second terminal end of the second balloon.
19 . The device of claim 18 , wherein the fourth tubular member defines a guidewire passage for deployment of a guidewire.
20 . The device of claim 14 , wherein the first balloon comprises a first outer diameter greater than a second outer diameter of the second balloon and a maximum outer diameter of the rotary debulker is less than the first outer diameter of the first balloon.
21 . An atherectomy device that includes a handle coupled to a working tip via a plurality of axially disposed tubular members, the handle including:
a housing that extends from a first housing end to a second housing end along a housing longitudinal axis, the second housing end being coupled to a first tubular member, the first tubular member surrounding at least a portion of a second tubular member, the second tubular member being coupled to a rotary member proximate the housing and disposed around a portion of a third tubular member, the third tubular member disposed around a portion of an axially moveable fourth tubular member; and
the working tip spaced from the handle and extending along a working tip longitudinal axis, the working tip including:
a first balloon coupled to the first tubular member,
a rotary debulker coupled to the second tubular member, and
a second balloon having a first end coupled to the axially movable fourth tubular member and a second end coupled to the third tubular member;
wherein the fourth tubular member is supported for axial movement along the working tip longitudinal axis.
22 . The atherectomy device of claim 21 , wherein the first end of the second balloon is proximal of the second end of the second balloon with the second balloon is deflated.
23 . The atherectomy device of claim 21 , wherein the first end of the second balloon is distal of the second end of the second balloon when the second balloon is inflated.
24 . The atherectomy device of claim 21 , wherein inflation of the second balloon is configured to pull the axially movable fourth tubular member in a distal direction along the working tip longitudinal axis.
25 . The atherectomy device of claim 21 , wherein the second balloon is disposed inside the third tubular member.
26 . The atherectomy device of claim 21 , wherein a distal end of the axially movable fourth tubular member is configured to be extendable beyond a distal end of the third tubular member.