US6517533B1 — Balloon catheter for controlling tissue remodelin…

Claim 1

Independent Claim 211 words

A catheter for controlling tissue remodeling or proliferation at a tissue site comprising: an outer balloon located on a distal end of the catheter; a first lumen in fluid communication with the outer balloon at a distal end and fluidly connected to a source of liquid at a proximal end for expanding the outer balloon with liquid to contact the tissue site; a second lumen fluidly connected to a source of coolant fluid at a proximal end for transporting the coolant fluid to a distal end of the second lumen to cool the liquid in the outer balloon and thereby the tissue site to a cryo-therapeutic temperature; and an inner balloon in fluid communication with the distal end of the second lumen in close proximity to the outer balloon; a third lumen surrounding at least a portion of the second lumen and in fluid communication with the inner balloon for removing the coolant fluid from the inner balloon; wherein the second lumen includes an orifice configured and dimensioned to allow the coolant fluid to expand as it passes therethrough to reduce coolant fluid temperature; and the fluid communication between the second lumen and the inner balloon is through the orifice to allow the coolant fluid to expand into the inner balloon.

Claim 2

Dependent Claim 211 words

A catheter for controlling tissue remodeling or proliferation at a tissue site comprising: an outer balloon located on a distal end of the catheter; a first lumen in fluid communication with the outer balloon at a distal end and fluidly connected to a source of liquid at a proximal end for expanding the outer balloon with liquid to contact the tissue site; a second lumen fluidly connected to a source of coolant fluid at a proximal end for transporting the coolant fluid to a distal end of the second lumen to cool the liquid in the outer balloon and thereby the tissue site to a cryo-therapeutic temperature; and an inner balloon in fluid communication with the distal end of the second lumen in close proximity to the outer balloon; a third lumen surrounding at least a portion of the second lumen and in fluid communication with the inner balloon for removing the coolant fluid from the inner balloon; wherein the second lumen includes an orifice configured and dimensioned to allow the coolant fluid to expand as it passes therethrough to reduce coolant fluid temperature; and the fluid communication between the second lumen and the inner balloon is through the orifice to allow the coolant fluid to expand into the inner balloon.

Claim 3

Dependent Claim 26 words

The catheter of claim 1 further comprising a fourth lumen configured and dimensioned to receive a guide wire for directing the catheter to the tissue site.

Claim 4

Dependent Claim 26 words

The catheter of claim 2 wherein the third lumen is fluidly connected to a vacuum to assist in removing the coolant fluid from the inner balloon.

Claim 5

Dependent Claim 21 words

The catheter of claim 1 wherein the outer balloon has a temperature sensor for monitoring the temperature of the tissue site.

Claim 6

Dependent Claim 29 words

The catheter of claim 1 further comprising a valve between the fluid coolant source and the second lumen for controlling introduction of the coolant gas into the second lumen.

Claim 7

Dependent Claim 21 words

The catheter of claim 1 wherein the coolant fluid temperature is sufficient to freeze the liquid after expansion through the orifice.

Claim 8

Dependent Claim 193 words

A catheter for controlling tissue remolding or proliferation at a tissue site comprising: a first lumen configured and dimensioned to receive a guide wire for directing the catheter to the tissue site; an outer balloon located on a distal end of the catheter; a second lumen in fluid communication with the outer balloon at a distal end and fluidly connected to receive a media at a proximal end for expanding the outer balloon with the media so that the outer balloon is in contact with the tissue site, the media normally in an inactive state in which the media has no effect on tissue remodeling or proliferation and the media transformable upon addition of energy to an active state in which the media effects tissue remodeling or proliferation; an inner balloon located on the distal end of the catheter and in close proximity to the outer balloon; and a third lumen in fluid communication with the inner balloon at a distal end for receiving an activation factor at a proximal end and transporting the activation factor to the inner balloon to provide the energy needed to transform the media to the active state.

Claim 9

Dependent Claim 193 words

A catheter for controlling tissue remolding or proliferation at a tissue site comprising: a first lumen configured and dimensioned to receive a guide wire for directing the catheter to the tissue site; an outer balloon located on a distal end of the catheter; a second lumen in fluid communication with the outer balloon at a distal end and fluidly connected to receive a media at a proximal end for expanding the outer balloon with the media so that the outer balloon is in contact with the tissue site, the media normally in an inactive state in which the media has no effect on tissue remodeling or proliferation and the media transformable upon addition of energy to an active state in which the media effects tissue remodeling or proliferation; an inner balloon located on the distal end of the catheter and in close proximity to the outer balloon; and a third lumen in fluid communication with the inner balloon at a distal end for receiving an activation factor at a proximal end and transporting the activation factor to the inner balloon to provide the energy needed to transform the media to the active state.

Claim 10

Dependent Claim 13 words

The catheter of claim 7 wherein the activation factor is light or heat.

Claim 11

Dependent Claim 10 words

The catheter of claim 7 wherein the media includes saline.

Claim 12

Dependent Claim 18 words

The catheter of claim 7 wherein the media includes a substance that is radioactive in the active state.

Claim 13

Independent Claim 112 words

A method for controlling tissue remodeling or proliferation at a tissue site including the steps of: fluidly connecting a quantity of cryo-medium to a catheter having at least two lumens; inserting said catheter into a patient and conveying said catheter to said tissue site; dispensing the cryo-medium through a lumen within said catheter, the lumen having a plurality of holes at a distal end to deliver the cryo-medium to the tissue site; providing an inflatable balloon for securing the catheter to the site, the balloon having an outer impervious wall and an inner wall with holes therein; and conveying the cryo-medium between the outer and inner walls and in through the holes.

Claim 14

Independent Claim 112 words

A method for controlling tissue remodeling or proliferation at a tissue site including the steps of: fluidly connecting a quantity of cryo-medium to a catheter having at least two lumens; inserting said catheter into a patient and conveying said catheter to said tissue site; dispensing the cryo-medium through a lumen within said catheter, the lumen having a plurality of holes at a distal end to deliver the cryo-medium to the tissue site; providing an inflatable balloon for securing the catheter to the site, the balloon having an outer impervious wall and an inner wall with holes therein; and conveying the cryo-medium between the outer and inner walls and in through the holes.

Claim 15

Dependent Claim 22 words

The method of claim 11 wherein said providing step includes the step of maintaining said cryo-medium at a temperature below 14° C.

Claim 16

Dependent Claim 27 words

The method of claim 11 wherein said fluidly connecting step includes the step of passing the cryo-medium through an orifice to reduce the temperature of the cryo-medium.

Claim 17

Dependent Claim 20 words

The method of claim 11 wherein said catheter has two spaced balloons, inflatable upstream and downstream of said tissue site.

Claim 18

Dependent Claim 36 words

The method of claim 11 wherein said catheter has an inner passageway with a closed distal end and a peripheral wall with holes therein, said method including the step of dispensing the cryo-medium through said holes.

Claim 19

Dependent Claim 195 words

A catheter for controlling tissue remodeling or proliferation at a tissue site comprising: a first lumen configured and dimensioned to receive a guide wire for directing the catheter to the tissue site; an outer balloon located on a distal end of the catheter and having a coating of a media, the media normally in an inactive state in which the media has no effect on tissue remodeling or proliferation and the media transformable upon addition of energy to an active state in which the media effects tissue remodeling or proliferation; a second lumen in fluid communication with the outer balloon at a distal end and fluidly connected to a source of fluid at a proximal end for expanding the outer balloon with the media so that the outer balloon is in contact with the tissue site; an inner balloon located on the distal end of the catheter and in close proximity to the outer balloon; and a third lumen fluid communication with the inner balloon at a distal end and configured and dimensioned to receive an activation factor at a proximal end for providing the energy needed to transform the media to the active state.

Claim 20

Dependent Claim 195 words

A catheter for controlling tissue remodeling or proliferation at a tissue site comprising: a first lumen configured and dimensioned to receive a guide wire for directing the catheter to the tissue site; an outer balloon located on a distal end of the catheter and having a coating of a media, the media normally in an inactive state in which the media has no effect on tissue remodeling or proliferation and the media transformable upon addition of energy to an active state in which the media effects tissue remodeling or proliferation; a second lumen in fluid communication with the outer balloon at a distal end and fluidly connected to a source of fluid at a proximal end for expanding the outer balloon with the media so that the outer balloon is in contact with the tissue site; an inner balloon located on the distal end of the catheter and in close proximity to the outer balloon; and a third lumen fluid communication with the inner balloon at a distal end and configured and dimensioned to receive an activation factor at a proximal end for providing the energy needed to transform the media to the active state.

Claim 21

Dependent Claim 17 words

The catheter of claim 16 wherein the coating is on an outer surface of the outside balloon.

Claim 22

Dependent Claim 12 words

The catheter of claim 17 wherein the coating includes bromide or iodide.

Claim 23

Dependent Claim 12 words

The catheter of claim 17 wherein the coating includes a radioactive material.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2006-02-10	2006-08-12	2007-02-11	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2010-02-10	2010-08-12	2011-02-11	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2014-02-10	2014-08-12	2015-02-11	$7700.00	Window Closed / Lapsed

Balloon catheter for controlling tissue remodeling and/or tissue proliferation

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