US6432130B1 — Fully sheathed balloon expandable stent delivery …

Claim 1

Independent Claim 191 words

A stent delivery system comprising: a stent delivery catheter, the stent delivery catheter having a stent mounting region, the stent mounting region including a stent inflation balloon; a stent disposed about the stent mounting region, the stent having an unexpanded state and being pressure expandable to a fully expanded state; a retaining sleeve, the retaining sleeve includes proximal and distal end sections and a center section, at least a portion of the proximal and distal end sections being fixedly engaged to the catheter, at least a portion of the central section having a pleated configuration, the retaining sleeve retaining and immobilizing the stent in the unexpanded state on the stent delivery catheter, the central section having a central proximal section and a central distal section joined together by a structurally weakened section of the retaining sleeve, such that when the balloon is expanded the structurally weakened section ruptures separating the central proximal section form the central distal section, the central proximal section and the central distal section respectively collapsing toward the fixedly engaged proximal end section and the distal end section as the stent is expanded to the fully expanded state.

Claim 2

Dependent Claim 191 words

A stent delivery system comprising: a stent delivery catheter, the stent delivery catheter having a stent mounting region, the stent mounting region including a stent inflation balloon; a stent disposed about the stent mounting region, the stent having an unexpanded state and being pressure expandable to a fully expanded state; a retaining sleeve, the retaining sleeve includes proximal and distal end sections and a center section, at least a portion of the proximal and distal end sections being fixedly engaged to the catheter, at least a portion of the central section having a pleated configuration, the retaining sleeve retaining and immobilizing the stent in the unexpanded state on the stent delivery catheter, the central section having a central proximal section and a central distal section joined together by a structurally weakened section of the retaining sleeve, such that when the balloon is expanded the structurally weakened section ruptures separating the central proximal section form the central distal section, the central proximal section and the central distal section respectively collapsing toward the fixedly engaged proximal end section and the distal end section as the stent is expanded to the fully expanded state.

Claim 3

Dependent Claim 17 words

The stent delivery system of claim 1 wherein the pair of end portions have a pleated configuration.

Claim 4

Dependent Claim 24 words

The stent delivery system of claim 1 wherein the pair of end portions provide retraction tension on the proximal section and the distal section.

Claim 5

Dependent Claim 26 words

The stent delivery system of claim 1 wherein the weakened section is defined by a plurality of perforations between the proximal section and the distal section.

Claim 6

Dependent Claim 21 words

The stent delivery system of claim 1 wherein the stent mounting region is defined by one or more radiopaque marker bands.

Claim 7

Dependent Claim 13 words

The stent delivery system of claim 1 wherein the stent is not crimped.

Claim 8

Dependent Claim 32 words

The stent delivery device of claim 1 wherein the sleeve is constructed from at least one member of the group essentially consisting of polyurethane, elastic polymers, non-elastic polymers and any combinations thereof.

Claim 9

Dependent Claim 78 words

A method of manufacturing the sleeve of claim 7 comprising the steps of: (a) extruding a tube of elastic material; (b) swelling the extruded tube; (c) shrinking the extruded tube over a mandrel, the mandrel having an outside surface characterized as being pleated, the outside surface providing the extruded tube with the pleated configuration; (d) heat setting the tube while it is in place on the mandrel; and (e) swelling the heat set tube off of the mandrel.

Claim 10

Dependent Claim 16 words

The method of claim 8 further comprising the step of: weakening a portion of the tube.

Claim 11

Dependent Claim 19 words

The method of claim 9 wherein the weakening is created by forming perforations in the portion of the tube.

Claim 12

Dependent Claim 19 words

The method of claim 10 wherein the perforations are formed as a result of surface features of the mandrel.

Claim 13

Dependent Claim 31 words

The method of claim 8 wherein the elastic material is selected from at least one member of the group essentially consisting of polyurethane, elastic polymers, non-elastic polymers and any combinations thereof.

Claim 14

Dependent Claim 147 words

A sleeve having sufficient radial compression to retain a stent in an unexpanded state on a stent delivery catheter and further having columnar strength characteristics sufficient to provide the sleeve with the ability to be readily withdrawn from the stent comprising: a proximal end and a distal end, the ends constructed and arranged to engage a stent delivery catheter; a central portion, at least the central portion having a pleated configuration, the central portion constructed and arranged to be disposed about the stent in the unexpanded state, the central portion constructed and arranged to separate into a proximal section and a distal section when a predetermined pressure is applied to the central portion, the proximal section constructed and arranged to be drawn off of the stent toward the proximal end, the distal section constructed and arranged to be drawn off of the stent toward the distal end.

Claim 15

Dependent Claim 147 words

A sleeve having sufficient radial compression to retain a stent in an unexpanded state on a stent delivery catheter and further having columnar strength characteristics sufficient to provide the sleeve with the ability to be readily withdrawn from the stent comprising: a proximal end and a distal end, the ends constructed and arranged to engage a stent delivery catheter; a central portion, at least the central portion having a pleated configuration, the central portion constructed and arranged to be disposed about the stent in the unexpanded state, the central portion constructed and arranged to separate into a proximal section and a distal section when a predetermined pressure is applied to the central portion, the proximal section constructed and arranged to be drawn off of the stent toward the proximal end, the distal section constructed and arranged to be drawn off of the stent toward the distal end.

Claim 16

Dependent Claim 13 words

The sleeve of claim 13 wherein the predetermined pressure is approximately 6 atmospheres.

Claim 17

Dependent Claim 20 words

The sleeve of claim 13 wherein the predetermined pressure is characterized as a uniform radial pressure from within the sleeve.

Claim 18

Dependent Claim 21 words

The sleeve of claim 13 wherein the ends are further constructed and arranged to engage the catheter by an interference fit.

Claim 19

Dependent Claim 11 words

The sleeve of claim 13 wherein the stent is not crimped.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2005-08-12	2006-02-11	2006-08-13	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2009-08-12	2010-02-11	2010-08-13	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2013-08-12	2014-02-11	2014-08-13	$7700.00	Window Closed / Lapsed

Fully sheathed balloon expandable stent delivery system

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