US5634901A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of using a catheter sleeve
Assignee: LocalMed Inc
•
Filing: 1994-10-20
•
Granted: 1997-06-03
•
Expires: 2014-10-20
Abstract
Abstract A balloon catheter assembly (2) includes a catheter (8) having a catheter shaft (10) with a balloon (12) at its distal end. A sleeve assembly (16) has a diametrically expanding balloon enlargement sleeve (18) at its distal end sized to be positionable over the balloon when the balloon is deflated. The enlargement sleeve can expand from a relaxed condition, at which it is placed over the deflated balloon, to an expanded condition surrounding the fully inflated balloon. The enlargement sleeve is sufficiently thick when expanded for an enlarged dilatation of the vessel when the balloon is reinflated. The enlargement sleeve can be made of elastic or substantially inelastic material; it can also include a porous matrix material with a drug interspersed therein so the drug is applied topically when the vessel is redilated.
Inventors
- 👤 Paul Alba
- 👤 Enrique J. Klein
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 03:40
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/104; A61B; A61B8/00; A61B8/12; A61B8/44; A61B8/4483; A61B8/4488; A61F; A61F2/00; A61F2/95; A61F2/958; A61F2250/00; A61F2250/0058; A61F2250/0067; A61M25/0021; A61M25/0023; A61M2025/0025; A61M25/0043; A61M2025/0057; A61M2025/0063; A61M25/01; A61M2025/0183; A61M25/09; A61M2025/09175; A61M2025/09183; A61M25/1002; A61M2025/1004; A61M2025/1043; A61M2025/105; A61M2025/1072; A61M2025/1075; A61M2025/1079; A61M2025/1081; A61M2025/1084; A61M2025/1095; A61M25/0054; A61M37/00; A61M37/0092
Claims Analysis
Total Claims: 41
Claim 1
Independent Claim
144 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an expandable balloon enlargement sleeve is disposed over the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; and reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diemertal dimension to further dilate the target site substantially immediately following the positioning step; wherein the enlargement sleeve has a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 2
Independent Claim
144 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an expandable balloon enlargement sleeve is disposed over the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; and reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diemertal dimension to further dilate the target site substantially immediately following the positioning step; wherein the enlargement sleeve has a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 3
Dependent Claim
19 words
The method of claim 1 wherein the inserting step is carried out within the lumen of a blood vessel.
Claim 4
Dependent Claim
10 words
The method of claim 1 wherein the sleeve is elastic.
Claim 5
Dependent Claim
11 words
The method of claim 1 wherein the sleeve is effectively inelastic.
Claim 6
Dependent Claim
29 words
The method of claim 1 wherein the inserting step is carried out by simultaneously inserting both the balloon catheter and the balloon enlargement sleeve therewith into the body lumen.
Claim 7
Dependent Claim
21 words
The method of claim 5 wherein the simultaneously inserting step is carried out with the balloon distal to the enlargement sleeve.
Claim 8
Dependent Claim
21 words
The method of claim 5 wherein the simultaneously inserting step is carried out with the balloon aligned with the enlargement sleeve.
Claim 9
Dependent Claim
22 words
The method of claim 1 wherein the positioning step is carried out by moving the enlargement sleeve relative to the balloon catheter.
Claim 10
Dependent Claim
20 words
The method of claim 1 wherein the sleeve has a wall thickness of about 0.25 to 0.50 mm when expanded.
Claim 11
Dependent Claim
22 words
The method of claim 1 wherein the sleeve has numerous axial openings formed therein to facilitate diametral expansion of the enlargement sleeve.
Claim 12
Dependent Claim
15 words
The method of claim 1 wherein the enlargement sleeve is made of an elastomeric material.
Claim 13
Dependent Claim
18 words
The method of claim 1 wherein the enlargement sleeve is made of a flexible but substantially inelastic material.
Claim 14
Dependent Claim
21 words
The method of claim 1 wherein the enlargement sleeve has a distal portion surrounding the balloon catheter and a proximal portion.
Claim 15
Dependent Claim
25 words
The method of claim 13 wherein the positioning step includes the step of manipulating the distal portion using a push rod as the proximal portion.
Claim 16
Dependent Claim
26 words
The method of claim 1 further comprising the step of predicting the second diametral dimension based upon the first diametral dimension and the enlargement sleeve selected.
Claim 17
Dependent Claim
33 words
The method of claim 1 wherein the enlargement sleeve is sized and constructed to make the second diametral dimension fall within a range of about 110% to 140% of the first diametral dimension.
Claim 18
Independent Claim
125 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting a substantially inelastic expandable balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step including the step of selecting an enlargement sleeve having numerous axial openings formed therein to achieve a desired diametral expansion with the enlargement sleeve.
Claim 19
Independent Claim
125 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting a substantially inelastic expandable balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step including the step of selecting an enlargement sleeve having numerous axial openings formed therein to achieve a desired diametral expansion with the enlargement sleeve.
Claim 20
Independent Claim
125 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an elastomeric, expandable balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step including the step of selecting a balloon enlargement sleeve having numerous axial openings formed therein to achieve a desired diametral expansion with the enlargement sleeve.
Claim 21
Independent Claim
125 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an elastomeric, expandable balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step including the step of selecting a balloon enlargement sleeve having numerous axial openings formed therein to achieve a desired diametral expansion with the enlargement sleeve.
Claim 22
Independent Claim
146 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an elastomeric, expandable balloon enlargement sleeve is disposed on the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; and reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site substantially immediately following the positioning step; wherein the balloon enlargement sleeve has an initial inside diameter and an initial thickness sized to achieve a desired diametral expansion with the enlargement sleeve.
Claim 23
Independent Claim
146 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an elastomeric, expandable balloon enlargement sleeve is disposed on the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; and reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site substantially immediately following the positioning step; wherein the balloon enlargement sleeve has an initial inside diameter and an initial thickness sized to achieve a desired diametral expansion with the enlargement sleeve.
Claim 24
Independent Claim
141 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an elastomeric, expandable balloon enlargement sleeve is disposed on the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site substantially immediately following the positioning step; and predicting the second diametral dimension based upon the first diametral dimension and the wall thickness of the enlargement sleeve selected.
Claim 25
Independent Claim
141 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an elastomeric, expandable balloon enlargement sleeve is disposed on the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site substantially immediately following the positioning step; and predicting the second diametral dimension based upon the first diametral dimension and the wall thickness of the enlargement sleeve selected.
Claim 26
Independent Claim
146 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an expandable balloon enlargement sleeve is disposed on the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; and reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site substantially immediately following the positioning step; wherein the balloon enlargement sleeve is sized and constructed to expand to said second diametral dimension during said reinflating step and further dilate the target site.
Claim 27
Independent Claim
146 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; wherein an expandable balloon enlargement sleeve is disposed on the balloon catheter during at least the inflating and deflating steps; positioning the balloon enlargement sleeve in alignment with the deflated balloon while the balloon remains near the target site; and reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site substantially immediately following the positioning step; wherein the balloon enlargement sleeve is sized and constructed to expand to said second diametral dimension during said reinflating step and further dilate the target site.
Claim 28
Independent Claim
128 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable, elastic balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 29
Independent Claim
128 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable, elastic balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 30
Independent Claim
142 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; moving the deflated balloon from the target site; selecting an expandable balloon enlargement sleeve; aligning the enlargement sleeve and the deflated balloon and then moving said aligned enlargement sleeve and deflated balloon to the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; end the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 31
Independent Claim
142 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; moving the deflated balloon from the target site; selecting an expandable balloon enlargement sleeve; aligning the enlargement sleeve and the deflated balloon and then moving said aligned enlargement sleeve and deflated balloon to the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; end the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 32
Independent Claim
139 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve having a wall thickness of about 0.25 to 0.50 mm when expanded; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 33
Independent Claim
139 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve having a wall thickness of about 0.25 to 0.50 mm when expanded; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 34
Independent Claim
141 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve having numerous axial openings formed therein to facilitate diametral expansion of the enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 35
Independent Claim
141 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve having numerous axial openings formed therein to facilitate diametral expansion of the enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 36
Independent Claim
132 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve made of a lubricious material; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 37
Independent Claim
132 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve made of a lubricious material; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 38
Independent Claim
152 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve; positioning the balloon and the enlargement sleeve relative to one another using radiopaque markers connected to both of the balloon and the balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 39
Independent Claim
152 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an expandable balloon enlargement sleeve; positioning the balloon and the enlargement sleeve relative to one another using radiopaque markers connected to both of the balloon and the balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; and the selecting step comprising the step of selecting an enlargement sleeve having a wall thickness sufficient to make the second diametral dimension at least about 110% of the first diametral dimension.
Claim 40
Independent Claim
155 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an elastomeric, expandable balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; predicting the second diametral dimension based upon the first diametral dimension and the wall thickness of the enlargement sleeve selected; and wherein the predicting step includes the step of determining if the enlargement sleeve is made of an elastomeric materials and, if so, predetermining an expected reduction in the thickness of the elastomeric material when the balloon is reinflated.
Claim 41
Independent Claim
155 words
A method for using a balloon catheter comprising the following steps: inserting a balloon catheter, of the type including a balloon, into a body lumen; aligning the balloon with a target site; inflating the balloon to a first diametral dimension to dilate the target site; deflating the balloon; selecting an elastomeric, expandable balloon enlargement sleeve; positioning the balloon enlargement sleeve in alignment with the deflated balloon at the target site; reinflating the balloon so as to expand the enlargement sleeve therewith at the target site to a second diametral dimension to further dilate the target site; predicting the second diametral dimension based upon the first diametral dimension and the wall thickness of the enlargement sleeve selected; and wherein the predicting step includes the step of determining if the enlargement sleeve is made of an elastomeric materials and, if so, predetermining an expected reduction in the thickness of the elastomeric material when the balloon is reinflated.
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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