Stent delivery catheter with enhanced balloon shape

• US 6,221,043 B1
• Filed: 08/13/1999
• Issued: 04/24/2001
• Est. Priority Date: 08/13/1999
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/373,552
• Time in Patent Office: 620 Days
• Field of Search: 604/96.01, 604/103.05, 604/103.06, 604/103.07, 604/103.08, 604/915, 604/916, 606/108, 606/192, 606/198, 606/194, 623/1.11
• US Class Current: 604/103.07
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Disclosed is a balloon on a distal portion of a balloon angioplasty catheter. The section of the balloon onto which a stent can be mounted has a central segment that is substantially cylindrical in shape that is centered between two segments each having the shape of a sector of a prolate spheroid. This shape for a balloon for a stent delivery catheter provides a more cylindrical shape for the stent after it is implanted in an artery that has a typical distribution of plaque in an arterial stenosis, which distribution of plaque is greatest for some limited length at a central region of the stenosis and then decreases somewhat uniformly as one approaches the edges of the stenosis. Another embodiment of the invention utilizes two segments that are frustums of a cone instead of sectors of a prolate spheroid, which conical segments surround the central cylindrical segment. Also disclosed is a balloon whose compliance decreases continuously as a function of the distance away from either end of the central segment. Any of these embodiments can employ dual conical end segments at each end of the balloon which consist of two adjacent frustums of a cone making different half-angles with the longitudinal axis of the balloon.

Claims

1. An inflated balloon situated at a distal portion of a balloon angioplasty catheter, the balloon having an elongated proximal spheroid segment that has a proximal end, a distal end and a length L3, the balloon also having an elongated distal spheroid segment that has a proximal end, a distal end and a length L4, the proximal spheroid segment and the distal spheroid segment each having substantially the shape of a sector of a prolate spheroid, the balloon also having a central segment that has a proximal end, a distal end and a length L1, the central segment having a substantially cylindrical shape, the distal end of the proximal spheroid segment being joined to the proximal end of the central segment and the proximal end of the distal spheroid segment being joined to the distal end of the central segment, the balloon being characterized by having the length of the central segment being less than the sum of the lengths of the proximal spheroid segment and the distal segment which can be written as L1<

L3+L4, the balloon being further characterized by having a proximal end segment and a distal end segment each having a proximal end and a distal end and each having the general shape of a frustrum of a cone, the distal end of the proximal end segment being joined to the proximal end of the proximal spheroid segment and the proximal end of the distal end segment being joined to the distal end of the distal spheroid segment.

2. The balloon of claim 1 wherein the proximal end segment is a proximal dual conical end segment having a proximal end and a distal end and the distal end segment is a distal dual conical end segment having a proximal end and a distal end, the distal end of the proximal dual conical end segment being joined to the proximal end of the balloon'"'"'s proximal spheroid segment and the proximal end of distal dual conical end segment being joined to the distal end of balloon'"'"'s distal spheroid segment, each dual conical end segment being characterized by having the shape of a first frustum of a cone that makes an angle “

C”

with the balloon'"'"'s longitudinal axis, and a second frustum of a cone that makes an angle “

B”

with the balloon'"'"'s longitudinal axis, the angle “

C”

being greater than the angle “

B”

.

3. The balloon of claim 2 wherein the angle “

B”

is between 10 and 25 degrees.

4. The balloon of claim 2 wherein the angle “

C”

is between 40 and 70 degrees.

5. The balloon of claim 1 wherein the length L3 is approximately equal to the length L4.

6. An inflated balloon onto which a metal stent is coaxially placed, the balloon and the stent both being situated at a distal portion of a balloon angioplasty catheter, the balloon having an elongated proximal spheroid segment that has a proximal end, a distal end and a length L3, the balloon also having an elongated distal spheroid segment that has a proximal end, a distal end and a length L4, the proximal spheroid segment and the distal spheroid segment each having substantially the shape of a sector of a prolate spheroid, the balloon also having a central segment that has a proximal end, a distal end and a length L1, the central segment having a substantially cylindrical shape, the distal end of the proximal spheroid segment being joined to the proximal end of the central segment and the proximal end of the distal spheroid segment being joined to the distal end of the central segment, the balloon being characterized by having the length of the central segment being less than the sum of the lengths of the proximal spheroid segment and the distal segment which can be written as L1<

L3+L4, the balloon being further characterized by having a proximal end segment and a distal end segment each having a proximal end and a distal end and each having the general shape of a frustrum of a cone, the distal end of the proximal end segment being joined to the proximal end of the proximal spheroid segment and the proximal end of the distal end segment being joined to the distal end of the distal spheroid segment.

7. The balloon and stent of claim 6 wherein the proximal end segment of the balloon is a proximal dual conical end segment having a proximal end and a distal end and the distal end segment is a distal dual conical end segment having a proximal end and a distal end, the distal end of the proximal dual conical end segment being joined to the proximal end of the balloon'"'"'s proximal spheroid segment and the proximal end of distal dual conical end segment being joined to the distal end of balloon'"'"'s distal spheroid segment, each dual conical end segment being characterized by having the shape of a first frustum of a cone that makes an angle “

C”

with the balloon'"'"'s longitudinal axis, and a second frustum of a cone that makes an angle “

B”

with the balloon'"'"'s longitudinal axis, the angle “

C”

being greater than the angle “

B”

.

8. The balloon and stent of claim 6 wherein the stent is mounted on that portion of the balloon that includes the proximal spheroid segment, the central segment and the distal spheroid segment, the stent having a proximal end that is placed within 1.0 mm from the proximal end of the proximal spheroid segment and the stent having a distal end that is placed within 1.0 mm from the distal end of the distal spheroid segment.