US20020045892A1
Expired / Lapsed
US
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Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation employing microporous balloon
Assignee: Zoll Circulation Inc
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Filing: 2001-08-17
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Granted: —
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Expires: 2021-08-17
Abstract
Abstract An enhanced method and device are provided to inhibit or reduce restenosis following angioplasty or stent placement. A porous balloon-tipped catheter is disposed in the area treated or opened through balloon angioplasty immediately following angioplasty. The balloon, which can have a dual balloon structure, may be delivered through a guiding catheter and over a guidewire already in place. A fluid such as a perfluorocarbon flows into the balloon to freeze the tissue adjacent the balloon, this cooling being associated with reduction of restenosis. A similar catheter may be used to reduce atrial fibrillation by inserting and inflating the porous balloon such that an exterior surface of the balloon, as well as a portion of the cold working fluid, from the microporosity contacts at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.
Inventors
- 👤 Hans Kramer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 06:29
CPC Classifications
A; A61; A61F; A61F7/00; A61F7/12; A61B; A61B18/00; A61B18/02; A61B18/04; A61B18/08; A61B17/00; A61B17/22; A61B2017/22001; A61B2017/22002; A61B2017/22051; A61B2017/22054; A61B2018/00005; A61B2018/00011; A61B2018/00023; A61B2018/00041; A61B2018/00053; A61B2018/00214; A61B2018/0022; A61B2018/0212; A61B2018/0231; A61B2018/0262; A61F2007/126
Claims Analysis
Total Claims: 57
Claim 1
Independent Claim
109 words
1 . A device to treat tissue, comprising: an outer tube; an inner tube disposed at least partially within the outer tube; and a dual balloon including an inner balloon and an outer balloon, the inner balloon coupled to the inner tube at a proximal end and at a distal end, the outer balloon having at least one pore therein and coupled to the inner tube at a distal end and to the outer tube at a proximal end, a first interior volume defined between the outer balloon and the inner balloon in fluid communication with an inlet in the volume between the outer tube and the inner tube.
Claim 2
Dependent Claim
109 words
1 . A device to treat tissue, comprising: an outer tube; an inner tube disposed at least partially within the outer tube; and a dual balloon including an inner balloon and an outer balloon, the inner balloon coupled to the inner tube at a proximal end and at a distal end, the outer balloon having at least one pore therein and coupled to the inner tube at a distal end and to the outer tube at a proximal end, a first interior volume defined between the outer balloon and the inner balloon in fluid communication with an inlet in the volume between the outer tube and the inner tube.
Claim 3
Dependent Claim
24 words
2 . The device of claim 1 , wherein the inner tube further defines: a guidewire lumen; a supply lumen; and a return lumen.
Claim 4
Dependent Claim
67 words
3 . The device of claim 2 , wherein the supply lumen defines a hole such that a fluid flowing in the supply lumen may be caused to flow into a volume defined by the inner balloon, and wherein the return lumen defines a hole such that a fluid flowing in a volume defined by the inner balloon may be caused to flow into the return lumen.
Claim 5
Dependent Claim
29 words
4 . The device of claim 2 , wherein the guidewire lumen extends from a proximal end of the inner tube to a distal end of the inner tube.
Claim 6
Dependent Claim
34 words
5 . The device of claim 1 , further comprising at least two radially extending tabs disposed around a circumference of the inner tube to substantially center the inner tube within the dual balloon.
Claim 7
Dependent Claim
32 words
6 . The device of claim 1 , further comprising at least one marker band disposed on the inner tube to locate a working region of the device at a desired location.
Claim 8
Dependent Claim
46 words
7 . The device of claim 1 , further comprising a source of chilled fluid having a supply tube and a return tube, the supply tube coupled in fluid communication to the supply lumen and the return tube coupled in fluid communication to the return lumen.
Claim 9
Dependent Claim
33 words
8 . The device of claim 1 , further comprising a source of fluid, the source of fluid coupled in fluid communication to the volume between the inner balloon and the outer balloon.
Claim 10
Dependent Claim
15 words
9 . The device of claim 7 , wherein the chilled fluid is a perfluorocarbon.
Claim 11
Dependent Claim
14 words
10 . The device of claim 9 , wherein the fluid is Galden® fluid.
Claim 12
Dependent Claim
29 words
11 . The device of claim 1 , wherein the outer balloon is a porous or microporous balloon having pores with a size on the order of a micron.
Claim 13
Dependent Claim
29 words
12 . The device of claim 11 , wherein the pores are shaped in a configuration selected from the group consisting of: a band, a ring, a single pore.
Claim 14
Dependent Claim
17 words
13 . The device of claim 7 , wherein the source of fluid includes a gear pump.
Claim 15
Dependent Claim
31 words
14 . The device of claim 13 , wherein the gear pump is one selected from the group consisting of a radial spur gear pump and a helical tooth gear pump.
Claim 16
Dependent Claim
82 words
15 . A method of reducing restenosis after angioplasty in a blood vessel, comprising: inserting a catheter into a blood vessel, the catheter having a balloon, the balloon having at least one pore formed therein; inflating the balloon with a perfluorocarbon such that an exterior surface of the balloon, and the leaked perfluorocarbon, is in contact with at least a partial inner perimeter of the blood vessel, the perfluorocarbon having a temperature in the range of about −10° C. to −50° C.
Claim 17
Dependent Claim
82 words
15 . A method of reducing restenosis after angioplasty in a blood vessel, comprising: inserting a catheter into a blood vessel, the catheter having a balloon, the balloon having at least one pore formed therein; inflating the balloon with a perfluorocarbon such that an exterior surface of the balloon, and the leaked perfluorocarbon, is in contact with at least a partial inner perimeter of the blood vessel, the perfluorocarbon having a temperature in the range of about −10° C. to −50° C.
Claim 18
Dependent Claim
26 words
16 . The method of claim 15 , further comprising the step of disposing the catheter at a desired location using at least one marker band.
Claim 19
Dependent Claim
31 words
17 . The method of claim 15 , further comprising flowing the perfluorocarbon into the balloon using a supply lumen and exhausting the perfluorocarbon from the balloon using a return lumen.
Claim 20
Dependent Claim
30 words
18 . The method of claim 15 , wherein the balloon is a dual balloon, and further comprising providing a heat transfer fluid in the volume between the dual balloons.
Claim 21
Dependent Claim
17 words
19 . The method of claim 17 , wherein the perfluorocarbon is circulated by a gear pump.
Claim 22
Dependent Claim
27 words
20 . The method of claim 15 , further comprising disposing the catheter such that at least a portion of the balloon is in a coronary artery.
Claim 23
Dependent Claim
27 words
21 . The method of claim 15 , further comprising disposing the catheter such that at least a portion of the balloon is in a carotid artery.
Claim 24
Dependent Claim
116 words
22 . A method of reducing atrial fibrillation, comprising: inserting a catheter at least partially into the heart, the catheter having a cold balloon having at least one pore formed therein, a portion of the balloon located in the left atrium and a portion of the balloon located in a pulmonary vein; inflating the cold balloon with a perfluorocarbon such that an exterior surface of the cold balloon, and the portion of the perfluorocarbon emergent from the at least one pore, is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −10° C. to −50° C.
Claim 25
Dependent Claim
116 words
22 . A method of reducing atrial fibrillation, comprising: inserting a catheter at least partially into the heart, the catheter having a cold balloon having at least one pore formed therein, a portion of the balloon located in the left atrium and a portion of the balloon located in a pulmonary vein; inflating the cold balloon with a perfluorocarbon such that an exterior surface of the cold balloon, and the portion of the perfluorocarbon emergent from the at least one pore, is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −10° C. to −50° C.
Claim 26
Dependent Claim
27 words
23 . The method of claim 22 , wherein the cold balloon has a working region having a length of between about 5 mm and 10 mm.
Claim 27
Dependent Claim
17 words
24 . The method of claim 22 , wherein the perfluorocarbon is circulated by a gear pump.
Claim 28
Dependent Claim
92 words
25 . The method of claim 22 , further comprising: inserting a wire capable of rupturing the atrial septum from the femoral vein into the right atrium; forming a hole using the wire in the interatrial septum between the right atrium and the left atrium; inserting a guide catheter into the right atrium; inserting a guide wire through the guide catheter into the right atrium and further into a pulmonary vein; disposing the catheter over the guidewire into a volume defined by the joint of the right atrium and the pulmonary vein.
Claim 29
Dependent Claim
20 words
26 . The method of claim 22 , further comprising disposing a warm fluid balloon distal of the cold balloon.
Claim 30
Dependent Claim
91 words
27 . A catheter system to treat restenosis or atrial fibrillation, comprising: a catheter shaft; a warm balloon disposed on the catheter shaft, said warm balloon fluidically coupled to at least one lumen for inflating and deflating the warm balloon; and a cold balloon disposed on the catheter shaft, said cold balloon having at least one pore formed therein, and fluidically coupled to two lumens for circulating a cold working fluid to and from the cold balloon, such that said cold balloon is located adjacent but proximal to said warm balloon.
Claim 31
Dependent Claim
91 words
27 . A catheter system to treat restenosis or atrial fibrillation, comprising: a catheter shaft; a warm balloon disposed on the catheter shaft, said warm balloon fluidically coupled to at least one lumen for inflating and deflating the warm balloon; and a cold balloon disposed on the catheter shaft, said cold balloon having at least one pore formed therein, and fluidically coupled to two lumens for circulating a cold working fluid to and from the cold balloon, such that said cold balloon is located adjacent but proximal to said warm balloon.
Claim 32
Dependent Claim
17 words
28 . The system of claim 27 , wherein said warm balloon is made of silicone tubing.
Claim 33
Dependent Claim
18 words
29 . The system of claim 28 , wherein said warm balloon is secured by heat shrink tubing.
Claim 34
Dependent Claim
17 words
30 . The system of claim 28 , wherein said warm balloon is secured by an adhesive.
Claim 35
Dependent Claim
16 words
31 . The system of claim 28 , wherein said warm balloon is secured by bands.
Claim 36
Dependent Claim
13 words
32 . The system of claim 31 , wherein said bands are metal.
Claim 37
Dependent Claim
15 words
33 . The system of claim 27 , wherein said working fluid is a perfluorocarbon.
Claim 38
Dependent Claim
15 words
34 . The system of claim 33 , wherein said working fluid is Galden fluid.
Claim 39
Dependent Claim
22 words
35 . The system of claim 27 , wherein said warm balloon is structured and configured to anchor in a pulmonary vein.
Claim 40
Dependent Claim
30 words
36 . The system of claim 35 , wherein said cold balloon is structured and configured to be disposed partially in a pulmonary vein and partially in the left atrium.
Claim 41
Dependent Claim
32 words
37 . The system of claim 36 , wherein said cold balloon has a length of between about 1 to 2½ cm and a diameter of between about 1 to 2½ cm.
Claim 42
Dependent Claim
28 words
38 . The system of claim 27 , further comprising at least one marker band disposed within one or both of the cold balloon and the warm balloon.
Claim 43
Dependent Claim
21 words
39 . The system of claim 27 , further comprising a set of mapping electrodes disposed distal of the warm balloon.
Claim 44
Dependent Claim
18 words
40 . The system of claim 27 , further comprising an insulation sleeve disposed around the catheter shaft.
Claim 45
Dependent Claim
18 words
41 . The system of claim 40 , wherein the insulation sleeve is formed of a foamed extrusion.
Claim 46
Dependent Claim
38 words
42 . The system of claim 27 , further comprising a silicone sleeve disposed circumferentially about the catheter shaft adjacent a point at which at least one of the cold or warm balloons attaches to the catheter shaft.
Claim 47
Dependent Claim
25 words
43 . The system of claim 27 , further comprising a gear pump, and wherein the cold working fluid is circulated by said gear pump.
Claim 48
Dependent Claim
165 words
44 . A method of reducing atrial fibrillation, comprising: inserting a catheter at least partially into the heart, the catheter having a warm balloon and a cold balloon proximal of the warm balloon, at least a portion of the cold balloon located in the left atrium and at least a portion of the warm balloon located in a pulmonary vein; inflating the warm balloon with a biocompatible fluid; inflating the cold balloon with a perfluorocarbon such that an exterior surface of the cold balloon is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −10° C. to −70° C.; wherein the cold balloon has at least one pore formed therein; and further comprising leaking a portion of the perfluorocarbon into the space defined between the cold balloon and the at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.
Claim 49
Dependent Claim
165 words
44 . A method of reducing atrial fibrillation, comprising: inserting a catheter at least partially into the heart, the catheter having a warm balloon and a cold balloon proximal of the warm balloon, at least a portion of the cold balloon located in the left atrium and at least a portion of the warm balloon located in a pulmonary vein; inflating the warm balloon with a biocompatible fluid; inflating the cold balloon with a perfluorocarbon such that an exterior surface of the cold balloon is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −10° C. to −70° C.; wherein the cold balloon has at least one pore formed therein; and further comprising leaking a portion of the perfluorocarbon into the space defined between the cold balloon and the at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.
Claim 50
Dependent Claim
28 words
45 . The method of claim 44 , wherein inflating the warm balloon includes pressurizing the warm balloon to a pressure of between about 1 to 2 atmospheres.
Claim 51
Dependent Claim
28 words
46 . The method of claim 44 , wherein inflating the cold balloon includes pressurizing the cold balloon to a pressure of between about 1 to 2 atmospheres.
Claim 52
Dependent Claim
18 words
47 . The method of claim 44 , further comprising circulating said cold perfluorocarbon with a gear pump.
Claim 53
Dependent Claim
128 words
48 . A device to reduce atrial fibrillation, comprising: a catheter, the catheter having a warm balloon and a cold balloon proximal of the warm balloon, at least a portion of the cold balloon locatable in the left atrium and at least a portion of the warm balloon locatable in a pulmonary vein; a source of warm biocompatible fluid to inflate the warm balloon; a source of cold perfluorocarbon to inflate the cold balloon, such that an exterior surface of the cold balloon is contactable with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −10° C. to −70° C.; wherein the cold balloon has at least one pore formed therein.
Claim 54
Dependent Claim
128 words
48 . A device to reduce atrial fibrillation, comprising: a catheter, the catheter having a warm balloon and a cold balloon proximal of the warm balloon, at least a portion of the cold balloon locatable in the left atrium and at least a portion of the warm balloon locatable in a pulmonary vein; a source of warm biocompatible fluid to inflate the warm balloon; a source of cold perfluorocarbon to inflate the cold balloon, such that an exterior surface of the cold balloon is contactable with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −10° C. to −70° C.; wherein the cold balloon has at least one pore formed therein.
Claim 55
Dependent Claim
24 words
49 . The device of claim 48 , further comprising a gear pump, and wherein the cold perfluorocarbon is circulated by said gear pump.
Claim 56
Dependent Claim
92 words
50 . A catheter system to treat restenosis or atrial fibrillation, comprising: a catheter shaft; a warm balloon disposed on the catheter shaft, said warm balloon fluidically coupled to at least one lumen for inflating and deflating the warm balloon; a cold balloon disposed on the catheter shaft, said cold balloon fluidically coupled to two lumens for circulating a cold working fluid to and from the cold balloon, such that said cold balloon is located adjacent but proximal to said warm balloon; and a gear pump for circulating the cold working fluid.
Claim 57
Dependent Claim
92 words
50 . A catheter system to treat restenosis or atrial fibrillation, comprising: a catheter shaft; a warm balloon disposed on the catheter shaft, said warm balloon fluidically coupled to at least one lumen for inflating and deflating the warm balloon; a cold balloon disposed on the catheter shaft, said cold balloon fluidically coupled to two lumens for circulating a cold working fluid to and from the cold balloon, such that said cold balloon is located adjacent but proximal to said warm balloon; and a gear pump for circulating the cold working fluid.
References Cited (Backward Citations)
US6527798B2
Cited
US6602276B2
Cited
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