US6537195B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Combination x-ray radiation and drug delivery devices and methods for inhibiting hyperplasia
Assignee: Nucletron Operations BV
•
Filing: 2001-05-07
•
Granted: 2003-03-25
•
Expires: 2021-05-07
Abstract
Abstract The present invention provides improved devices, methods, and kits for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides controlled drug delivery in combination with x-ray radiation delivery to selected locations within a patient's vasculature to reduce and/or inhibit restenosis and hyperplasia rates with increased efficacy. In one embodiment, the combination radiation and agent delivery catheter for inhibiting hyperplasia comprises a catheter body having a proximal end and distal end, an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen, and a porous material, matrix, membrane, barrier, coating, infusion lumen, stent, graft, or reservoir for releasing an agent to the body lumen.
Inventors
- 👤 Michael R. Forman
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:19
CPC Classifications
A; A61; A61N; A61N5/00; A61N5/10; A61N5/1001; A61K; A61K51/00; A61K51/12; A61K51/1282; A61M; A61M25/00; A61M25/10; A61M2025/1043; A61M2025/105; A61M2025/1052; A61M25/1011; A61N5/1002; A61N2005/1003; A61N2005/1004
Claims Analysis
Total Claims: 48
Claim 1
Independent Claim
87 words
A combined radiation and agent delivery catheter for inhibiting hyperplasia, comprising: a catheter body having a proximal end and a distal end; an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen; a balloon on the catheter body; and a matrix formed over at least a portion of the balloon for releasing an agent to the body lumen, wherein the agent is in or beneath the matrix, wherein the combined x-ray tube and matrix for releasing the agent inhibit hyperplasia.
Claim 2
Dependent Claim
87 words
A combined radiation and agent delivery catheter for inhibiting hyperplasia, comprising: a catheter body having a proximal end and a distal end; an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen; a balloon on the catheter body; and a matrix formed over at least a portion of the balloon for releasing an agent to the body lumen, wherein the agent is in or beneath the matrix, wherein the combined x-ray tube and matrix for releasing the agent inhibit hyperplasia.
Claim 3
Dependent Claim
68 words
A combined radiation and agent delivery catheter for inhibiting hyperplasia, comprising: a catheter body having a proximal end and a distal end; an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen; a microporous balloon on the catheter body for releasing an agent to the body lumen, wherein the combined x-ray tube and microporous balloon for releasing the agent inhibit hyperplasia.
Claim 4
Dependent Claim
68 words
A combined radiation and agent delivery catheter for inhibiting hyperplasia, comprising: a catheter body having a proximal end and a distal end; an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen; a microporous balloon on the catheter body for releasing an agent to the body lumen, wherein the combined x-ray tube and microporous balloon for releasing the agent inhibit hyperplasia.
Claim 5
Dependent Claim
31 words
A delivery catheter as in claim 1 or 2 , wherein the agent is selected from the group consisting of radiosensitizer, immunomodulator, cytotoxic agent, cytostatic agent, anti-restenotic agent, and anti-inflammatory agent.
Claim 6
Dependent Claim
32 words
A delivery catheter as in claim 1 or 2 , wherein the agent is a radiosensitizer selected from the group consisting of taxol, misonidazole, metronidazole, etanidazole, 5-fluorouracil, texaphyrin, C225, and cyclooxygenase-2 inhibitor.
Claim 7
Dependent Claim
32 words
A delivery catheter as in claim 1 or 2 , wherein the agent is an immunomodulator selected from the group consisting of rapamycin, beta interferon, alpha interferon, methotraxate, cyclosporine, six-mercaptopurine, and cimetidine.
Claim 8
Dependent Claim
26 words
A delivery catheter as in claim 1 or 2 , wherein the agent comprises taxol incorporated in a solution with polyoxyethylated castor oil and dehydrated alcohol.
Claim 9
Dependent Claim
23 words
A delivery catheter as in claim 1 or 2 , wherein the agent is attached or encapsulated in a lipid or surfactant carrier.
Claim 10
Dependent Claim
35 words
A delivery catheter as in claim 1 , wherein the matrix comprises a rate controlling material, wherein the rate controlling material controls the rate at which the agent is released from or through the matrix.
Claim 11
Dependent Claim
21 words
A delivery catheter as in claim 8 , wherein the agent is released from the matrix by diffusion through the matrix.
Claim 12
Dependent Claim
21 words
A delivery catheter as in claim 8 , wherein the agent is released from the matrix by degradation of the matrix.
Claim 13
Dependent Claim
27 words
A delivery catheter as in claim 8 , wherein the rate controlling material is porous and the agent is released from the material by elution from pores.
Claim 14
Dependent Claim
16 words
A delivery catheter as in claim 1 , wherein the agent is disposed on the balloon.
Claim 15
Dependent Claim
19 words
A delivery catheter as in claim 1 or 2 , wherein the x-ray tube is positionable within the balloon.
Claim 16
Dependent Claim
26 words
A delivery catheter as in claim 1 or 2 , wherein the x-ray tube is translatable along an axial direction through a center of the balloon.
Claim 17
Dependent Claim
21 words
A delivery catheter as in claim 1 or 2 , further comprising perfusion threading on an outer surface of the balloon.
Claim 18
Dependent Claim
18 words
A delivery catheter as in claim 15 , wherein the threading has a spiral, helical, or angled pattern.
Claim 19
Dependent Claim
18 words
A delivery catheter as in claim 1 or 2 , wherein the catheter body has a perfusion lumen.
Claim 20
Dependent Claim
28 words
A delivery catheter as in claim 2 , wherein the microporous balloon contains the agent and the agent is released from the microporous balloon by elution from pores.
Claim 21
Dependent Claim
17 words
A delivery catheter as in claim 18 , wherein the microporous balloon is inflatable with the agent.
Claim 22
Dependent Claim
84 words
A combined radiation and agent delivery catheter for inhibiting hyperplasia, comprising: a catheter body having a proximal end, a distal end, and an infusion lumen for releasing an agent; a pair of axially spaced apart radiation shielding balloons on the catheter body so as to aid in uniform radiation dosimetry; and an x-ray tube coupleable to the catheter body for applying a radiation dose between the axially spaced apart balloons, wherein the combined x-ray tube and infusion lumen for releasing the agent inhibit hyperplasia.
Claim 23
Dependent Claim
84 words
A combined radiation and agent delivery catheter for inhibiting hyperplasia, comprising: a catheter body having a proximal end, a distal end, and an infusion lumen for releasing an agent; a pair of axially spaced apart radiation shielding balloons on the catheter body so as to aid in uniform radiation dosimetry; and an x-ray tube coupleable to the catheter body for applying a radiation dose between the axially spaced apart balloons, wherein the combined x-ray tube and infusion lumen for releasing the agent inhibit hyperplasia.
Claim 24
Dependent Claim
39 words
A delivery catheter as in claim 20 , further comprising a source for releasing at least one agent selected from the group consisting of radiosensitizer, immunomodulator, cytotoxic agent, cytostatic agent, anti-restenotic agent, and anti-inflammatory agent through the infusion lumen.
Claim 25
Dependent Claim
38 words
A delivery catheter as in claim 20 , further comprising a source for releasing at least one radiosensitizer selected from the group consisting of taxol, misonidazole, metronidazole, etanidazole, 5-fluorouracil, texaphyrin, C225, and cyclooxygenase-2 inhibitor through the infusion lumen.
Claim 26
Dependent Claim
38 words
A delivery catheter as in claim 20 , further comprising a source for releasing at least one immunomodulator selected from the group consisting of rapamycin, beta interferon, alpha interferon, methotraxate, cyclosporine, six-mercaptopurine, and cimetidine through the infusion lumen.
Claim 27
Dependent Claim
97 words
A combined radiation and agent delivery device for inhibiting hyperplasia, comprising: a catheter body having a proximal end and a distal end; an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen; a stent releasable from the catheter body, wherein the x-ray tube may be positioned within the catheter body to deliver radiation to a vascular region where the stent has been released; and a source of an agent on the stent, wherein the agent is released from the stent after the stent has been implanted in the body lumen.
Claim 28
Dependent Claim
97 words
A combined radiation and agent delivery device for inhibiting hyperplasia, comprising: a catheter body having a proximal end and a distal end; an x-ray tube coupleable to the catheter body for applying a radiation dose to a body lumen; a stent releasable from the catheter body, wherein the x-ray tube may be positioned within the catheter body to deliver radiation to a vascular region where the stent has been released; and a source of an agent on the stent, wherein the agent is released from the stent after the stent has been implanted in the body lumen.
Claim 29
Independent Claim
43 words
A method for inhibiting hyperplasia in a body lumen, said method comprising: releasing an anti-hyperplasia agent at a target region within the body lumen; and directing x-ray radiation at the target region, wherein the agent and the x-ray radiation combine to inhibit hyperplasia.
Claim 30
Independent Claim
43 words
A method for inhibiting hyperplasia in a body lumen, said method comprising: releasing an anti-hyperplasia agent at a target region within the body lumen; and directing x-ray radiation at the target region, wherein the agent and the x-ray radiation combine to inhibit hyperplasia.
Claim 31
Dependent Claim
24 words
A method as in claim 25 , further comprising inflating a balloon at the target region, wherein the agent is released from the balloon.
Claim 32
Dependent Claim
28 words
A method as in claim 26 , wherein the balloon is inflated with the agent and the agent is released from an interior of the balloon through pores.
Claim 33
Dependent Claim
18 words
A method as in claim 26 , wherein the agent is released from a surface of the balloon.
Claim 34
Dependent Claim
17 words
A method as in claim 28 , wherein the agent is released through a rate controlling matrix.
Claim 35
Dependent Claim
18 words
A method as in claim 26 , wherein the directing comprises positioning an x-ray tube within the balloon.
Claim 36
Dependent Claim
22 words
A method as in claim 25 , further comprising isolating the target region, wherein the agent is released into the isolated region.
Claim 37
Dependent Claim
18 words
A method as in claim 31 , wherein isolating comprises inflating a pair of axially spaced apart balloons.
Claim 38
Dependent Claim
19 words
A method as in claim 31 , wherein isolating comprises expanding a pair of axially spaced apart mechanical barriers.
Claim 39
Dependent Claim
19 words
A method as in claim 31 , wherein directing comprises positioning an x-ray tube within the isolated target region.
Claim 40
Dependent Claim
26 words
A method as in claim 30 or 34 , wherein positioning comprises energizing the x-ray tube and translating the x-ray tube to traverse the target region.
Claim 41
Dependent Claim
26 words
A method as in claim 25 , wherein the body lumen is a blood vessel and the target region is a region at risk of hyperplasia.
Claim 42
Dependent Claim
26 words
A method as in claim 25 , wherein the directing comprises applying a total radiation dose in a range from about 4 Gy to 24 Gy.
Claim 43
Dependent Claim
22 words
A method as in claim 25 , wherein the releasing the agent and directing an x-ray radiation dose are carried out simultaneously.
Claim 44
Dependent Claim
22 words
A method as in claim 25 , wherein the releasing the agent and directing an x-ray radiation dose are carried out sequentially.
Claim 45
Independent Claim
55 words
A method for inhibiting hyperplasia in a body lumen, said method comprising: positioning an x-ray tube at a target region in the body lumen; positioning a stent at the target region in the body lumen; applying an x-ray radiation dose to the target region; and releasing an agent from the stent to the target region.
Claim 46
Independent Claim
55 words
A method for inhibiting hyperplasia in a body lumen, said method comprising: positioning an x-ray tube at a target region in the body lumen; positioning a stent at the target region in the body lumen; applying an x-ray radiation dose to the target region; and releasing an agent from the stent to the target region.
Claim 47
Dependent Claim
35 words
A kit comprising: a catheter capable of applying a radiation dose and releasing an agent in a body lumen; and instructions to use the catheter according to any one of claims 25 - 40 .
Claim 48
Dependent Claim
13 words
A kit as in claim 41 , further comprising a source of agent.
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