US6830577B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
System and method of use for treating occluded vessels and diseased tissue
Assignee: DSM Biomedical Inc
•
Filing: 2002-01-28
•
Granted: 2004-12-14
•
Expires: 2022-01-28
Abstract
Abstract A system and method for treating diseased target tissue of a living being. The system comprises a working head, e.g., a rotary impacting impeller, a stent delivery catheter, a flush catheter, or liquid jets, a debris extraction sub-system, and may have barrier means in certain embodiments. The working head is arranged to treat diseased tissue, e.g., at least partially occluded with atherosclerotic plaque, or surrounding tissue being compromised by a disease such as cancer, in vessels or lumens, whereupon some debris may be produced. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head and withdraws that liquid and some blood at a second and higher flow rate, to create a differential flow adjacent the working head. The introduction of the infusate liquid may also be used to deliver drugs and other therapies systemically or locally, between the working head and the distal protection barrier.
Inventors
- 👤 John E. Nash
- 👤 Douglas G. Evans
- 👤 David M. Hoganson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 23:43
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/32; A61B17/3203; A61B17/32037; A61B17/3205; A61B17/3207; A61B17/320758; A61B17/22; A61B17/221; A61B2017/22001; A61B2017/22038; A61B2017/22047; A61B2017/22048; A61B2017/22051; A61B2017/22065; A61B2017/22067; A61B2017/22068; A61B2217/00; A61B2217/002; A61B2217/005; A61B2217/007; A61F; A61F2/00; A61F2/95; A61M; A61M1/00; A61M1/71; A61M1/77; A61M1/84; A61M1/85; A61M25/00; A61M25/10; A61M2025/1043; A61M2025/1095; A61M2205/00; A61M2205/05; A61M5/00; A61M5/14; A61M5/142; A61M5/14212; A61M5/14232
Claims Analysis
Total Claims: 80
Claim 1
Independent Claim
227 words
A system for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head, a pump means, and barrier means, said working head being arranged to treat the occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, whereupon some debris may be produced from occlusive material by said treatment, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head engages said occlusive material or said interior surface during said treatment, said barrier means being arranged for location downstream of said working head and activatable to restrict the flow of the debris downstream of said barrier means, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of target tissue.
Claim 2
Independent Claim
227 words
A system for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head, a pump means, and barrier means, said working head being arranged to treat the occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, whereupon some debris may be produced from occlusive material by said treatment, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head engages said occlusive material or said interior surface during said treatment, said barrier means being arranged for location downstream of said working head and activatable to restrict the flow of the debris downstream of said barrier means, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of target tissue.
Claim 3
Dependent Claim
47 words
The system of claim 1 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging device, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.
Claim 4
Dependent Claim
22 words
The system of claim 1 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.
Claim 5
Dependent Claim
19 words
The system of claim 3 wherein said liquid jets cause penetration of said infusate into said diseased target tissue.
Claim 6
Dependent Claim
25 words
The system of claim 4 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.
Claim 7
Dependent Claim
14 words
The system of claim 5 wherein said biologically active material comprises a growth factor.
Claim 8
Dependent Claim
20 words
The system of claim 5 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.
Claim 9
Dependent Claim
29 words
The system of claim 1 wherein said barrier means is offset relative to said working head, with said offset causing said working head to engage said vessel or lumen.
Claim 10
Dependent Claim
17 words
The system of claim 1 wherein said barrier means comprises a balloon, filter, or other expandable member.
Claim 11
Dependent Claim
28 words
The system of claim 1 wherein said working head and said barrier means are arranged to be inserted or retracted through a deployed stent or other intraluminal prosthesis.
Claim 12
Dependent Claim
13 words
The system of claim 1 wherein said system additionally comprises a separate catheter.
Claim 13
Dependent Claim
15 words
The system of claim 11 wherein said separate catheter is arranged to deliver a stent.
Claim 14
Dependent Claim
18 words
The system of claim 11 wherein said separate catheter is arranged to deliver said infusate or irrigation liquid.
Claim 15
Dependent Claim
37 words
The system of claim 1 wherein said diseased target tissue is located near a branched portion of said vessel or lumen, said system further comprising a second barrier means arranged to be disposed in said branched portion.
Claim 16
Independent Claim
230 words
A system for treating diseased target tissue in a living being, wherein the diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head, a pump means, and barrier means, said working head being arranged to treat occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, whereupon some debris may be produced from the occlusive material by said treatment, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head does not engage said occlusive material or said interior surface during said treatment, said barrier means being arranged for location downstream of said working head and activatable to restrict the flow of the debris downstream of said barrier means, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of the target tissue.
Claim 17
Independent Claim
230 words
A system for treating diseased target tissue in a living being, wherein the diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head, a pump means, and barrier means, said working head being arranged to treat occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, whereupon some debris may be produced from the occlusive material by said treatment, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head does not engage said occlusive material or said interior surface during said treatment, said barrier means being arranged for location downstream of said working head and activatable to restrict the flow of the debris downstream of said barrier means, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of the target tissue.
Claim 18
Dependent Claim
22 words
The system of claim 15 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.
Claim 19
Dependent Claim
14 words
The system of claim 16 wherein said jets are arranged to cause turbulent flow.
Claim 20
Dependent Claim
19 words
The system of claim 17 wherein said turbulent flow facilitates diffusion of said infusate into said diseased target tissue.
Claim 21
Dependent Claim
22 words
The system of claim 18 wherein said introduction of infusate liquid is separated from withdrawing of said liquid by a dwell time.
Claim 22
Dependent Claim
22 words
The system of claim 19 wherein said dwell time facilitates the diffusion or penetration of said infusate into said diseased target tissue.
Claim 23
Dependent Claim
47 words
The system of claim 15 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging device, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.
Claim 24
Dependent Claim
22 words
The system of claim 15 wherein said introduction of infusate liquid is separated from withdrawing of said liquid by a dwell time.
Claim 25
Dependent Claim
11 words
The system of claim 22 wherein said dwell time is predetermined.
Claim 26
Dependent Claim
36 words
The system of claim 20 wherein said dwell time comprises a through-flow stage, wherein said through-flow stage comprises introduction of a second infusate at a third rate and withdrawing said second infusate at said third rate.
Claim 27
Dependent Claim
13 words
The system of claim 15 wherein said barrier means comprises an expandable member.
Claim 28
Dependent Claim
12 words
The system of claim 25 wherein said expandable member comprises a balloon.
Claim 29
Dependent Claim
25 words
The system of claim 15 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.
Claim 30
Dependent Claim
14 words
The system of claim 27 wherein said biologically active material comprises a growth factor.
Claim 31
Dependent Claim
20 words
The system of claim 27 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.
Claim 32
Dependent Claim
47 words
The system of claim 15 wherein said system additionally comprises a flexible instrument and wherein said working head comprises a portion of said instrument, said instrument being arranged to be passed through the being's body so that said working head is located adjacent the diseased target tissue.
Claim 33
Dependent Claim
28 words
The system of claim 15 wherein said working head and said barrier means are arranged to be inserted or retracted through a deployed stent or other intraluminal prosthesis.
Claim 34
Dependent Claim
13 words
The system of claim 15 wherein said system additionally comprises a separate catheter.
Claim 35
Dependent Claim
15 words
The system of claim 32 wherein said separate catheter is arranged to deliver a stent.
Claim 36
Dependent Claim
18 words
The system of claim 32 wherein said separate catheter is arranged to deliver said infusate or irrigation liquid.
Claim 37
Dependent Claim
31 words
The system of claim 15 wherein said system comprises a working head locater member, wherein said working head locater member serves to position said working head in said vessel or lumen.
Claim 38
Dependent Claim
15 words
The system of claim 35 wherein said working head locator member comprises said barrier means.
Claim 39
Dependent Claim
18 words
The system of claim 35 wherein said position is approximately on the center-line of said vessel or lumen.
Claim 40
Dependent Claim
37 words
The system of claim 15 wherein said diseased target tissue is located near a branched portion of said vessel or lumen, said system further comprising a second barrier means arranged to be disposed in said branched portion.
Claim 41
Independent Claim
193 words
A system for treating diseased target tissue in a living being, wherein the diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head and pump means, said working head being arranged to treat the occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head does not engage said occlusive material or said interior surface during said treatment, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon at least a portion of any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of target tissue.
Claim 42
Independent Claim
193 words
A system for treating diseased target tissue in a living being, wherein the diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head and pump means, said working head being arranged to treat the occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head does not engage said occlusive material or said interior surface during said treatment, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon at least a portion of any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of target tissue.
Claim 43
Dependent Claim
47 words
The system of claim 39 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging device, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.
Claim 44
Dependent Claim
22 words
The system of claim 39 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.
Claim 45
Dependent Claim
14 words
The system of claim 41 wherein said jets are arranged to cause turbulent flow.
Claim 46
Dependent Claim
19 words
The system of claim 42 wherein said turbulent flow facilitates diffusion of said infusate into said diseased target tissue.
Claim 47
Dependent Claim
25 words
The system of claim 39 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.
Claim 48
Dependent Claim
14 words
The system of claim 44 wherein said biologically active material comprises a growth factor.
Claim 49
Dependent Claim
20 words
The system of claim 44 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.
Claim 50
Dependent Claim
47 words
The system of claim 39 wherein said system additionally comprises a flexible instrument and wherein said working head comprises a portion of said instrument, said instrument being arranged to be passed through the being's body so that said working head is located adjacent the diseased target tissue.
Claim 51
Dependent Claim
24 words
The system of claim 39 wherein said working head is arranged to be inserted or retracted through a deployed stent or other intraluminal prosthesis.
Claim 52
Dependent Claim
13 words
The system of claim 39 wherein said system additionally comprises a separate catheter.
Claim 53
Dependent Claim
15 words
The system of claim 49 wherein said separate catheter is arranged to deliver a stent.
Claim 54
Dependent Claim
18 words
The system of claim 49 wherein said separate catheter is arranged to deliver said infusate or irrigation liquid.
Claim 55
Dependent Claim
31 words
The system of claim 39 wherein said system comprises a working head locater member, wherein said working head locater member serves to position said working head in said vessel or lumen.
Claim 56
Dependent Claim
15 words
The system of claim 52 wherein said working head locator member comprises a barrier means.
Claim 57
Dependent Claim
18 words
The system of claim 52 wherein said position is approximately on the center-line of said vessel or lumen.
Claim 58
Dependent Claim
37 words
The system of claim 53 wherein said diseased target tissue is located near a branched portion of said vessel or lumen, said system further comprising a second barrier means arranged to be disposed in said branched portion.
Claim 59
Independent Claim
233 words
A method for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said diseased target tissue being located within a portion of a patent vessel or lumen portion, said method comprising, in no certain order: (a) extending a guiding catheter into said patent vessel or lumen portion into a position proximal to said diseased target tissue; (b) extending a flexible member having a working head through said guiding catheter so that said working head is located in the vessel or lumen proximate with said diseased target tissue; (c) providing a barrier means to be arranged distally of said working head, and positioning said barrier means distally of said diseased target tissue to block the flow of infusate, blood, and/or any debris created; and (d) operating said working head to treat said vessel or lumen comprising said diseased target tissue, wherein said operation comprises introducing an infusate at a first flow rate at said working head and withdrawing said infusate at a second and higher flow rate to create a differential flow at said working head, whereupon at least a portion of any debris produced is withdrawn with said infusate, wherein said infusate comprises at least one material.
Claim 60
Independent Claim
233 words
A method for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said diseased target tissue being located within a portion of a patent vessel or lumen portion, said method comprising, in no certain order: (a) extending a guiding catheter into said patent vessel or lumen portion into a position proximal to said diseased target tissue; (b) extending a flexible member having a working head through said guiding catheter so that said working head is located in the vessel or lumen proximate with said diseased target tissue; (c) providing a barrier means to be arranged distally of said working head, and positioning said barrier means distally of said diseased target tissue to block the flow of infusate, blood, and/or any debris created; and (d) operating said working head to treat said vessel or lumen comprising said diseased target tissue, wherein said operation comprises introducing an infusate at a first flow rate at said working head and withdrawing said infusate at a second and higher flow rate to create a differential flow at said working head, whereupon at least a portion of any debris produced is withdrawn with said infusate, wherein said infusate comprises at least one material.
Claim 61
Dependent Claim
25 words
The method of claim 56 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.
Claim 62
Dependent Claim
14 words
The method of claim 57 wherein said biologically active material comprises a growth factor.
Claim 63
Dependent Claim
20 words
The method of claim 57 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.
Claim 64
Dependent Claim
47 words
The method of claim 56 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging catheter, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.
Claim 65
Dependent Claim
22 words
The method of claim 56 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.
Claim 66
Dependent Claim
19 words
The method of claim 61 wherein said liquid jets cause penetration of said infusate into said diseased target tissue.
Claim 67
Dependent Claim
13 words
The method of claim 56 wherein said guiding catheter comprises an insertion sheath.
Claim 68
Dependent Claim
29 words
The method of claim 56 wherein said barrier means is offset relative to said working head, with said offset causing said working head to engage said vessel or lumen.
Claim 69
Dependent Claim
42 words
The method of claim 56 wherein said method additionally comprises: (e) supplying a separate catheter, wherein said separate catheter is located in the vessel or lumen proximate with said diseased target tissue and said separate catheter being arranged to deliver a stent.
Claim 70
Dependent Claim
65 words
The method of claim 56 wherein said method additionally comprises: (e) supplying a separate catheter, wherein said separate catheter is located in said vessel or lumen proximate with said diseased target tissue with said separate catheter being arranged to deliver a stent; (f) said working head being arranged to be inserted through a delivered stent; and (g) employing said second catheter to deliver said stent.
Claim 71
Dependent Claim
13 words
The method of claim 66 wherein said working head comprises an irrigation catheter.
Claim 72
Dependent Claim
18 words
The method of claim 67 wherein said stent is delivered prior to the operation of said working head.
Claim 73
Dependent Claim
29 words
The method of claim 68 wherein said method further comprises: (h) moving said working head such that it traverses at least the length of said stent during its operation.
Claim 74
Dependent Claim
79 words
The method of claim 56 wherein said diseased target is located near a branched portion of said vessel or lumen, said method further comprising: (e) supplying a second barrier means arranged to be disposed in said branched portion; (f) expanding said second barrier means in said branched portion prior to the operation of said working head, thereby blocking the flow of infusate, blood, and/or any debris created by the operation of said working head downstream through said branched portion.
Claim 75
Independent Claim
187 words
A method for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said diseased target tissue being located distally of a patent vessel or lumen portion, said method comprising: (a) extending a guiding catheter into said patent vessel or lumen portion into a position proximal to said diseased target tissue; (b) extending a flexible member having a working head through said guiding catheter so that said working head is located in the vessel or lumen proximate with said diseased target tissue; and (c) operating said working head to treat said vessel or lumen comprising said diseased target tissue, wherein said operation comprises introducing an infusate at a first flow rate at said working head and withdrawing said infusate at a second and higher flow rate to create a differential flow at said working head, whereupon any debris produced is withdrawn with said infusate, wherein said infusate comprises at least one material.
Claim 76
Independent Claim
187 words
A method for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said diseased target tissue being located distally of a patent vessel or lumen portion, said method comprising: (a) extending a guiding catheter into said patent vessel or lumen portion into a position proximal to said diseased target tissue; (b) extending a flexible member having a working head through said guiding catheter so that said working head is located in the vessel or lumen proximate with said diseased target tissue; and (c) operating said working head to treat said vessel or lumen comprising said diseased target tissue, wherein said operation comprises introducing an infusate at a first flow rate at said working head and withdrawing said infusate at a second and higher flow rate to create a differential flow at said working head, whereupon any debris produced is withdrawn with said infusate, wherein said infusate comprises at least one material.
Claim 77
Dependent Claim
13 words
The method of claim 71 wherein said guiding catheter comprises an insertion sheath.
Claim 78
Dependent Claim
25 words
The method of claim 71 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.
Claim 79
Dependent Claim
14 words
The method of claim 73 wherein said biologically active material comprises a growth factor.
Claim 80
Dependent Claim
20 words
The method of claim 73 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 2007-12-14 | 2008-06-14 | 2008-12-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2011-12-14 | 2012-06-14 | 2012-12-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2015-12-14 | 2016-06-14 | 2016-12-14 | $7700.00 | Window Closed / Lapsed |