Limacon geometry balloon angioplasty catheter systems and method of making same

• US 4,958,634 A
• Filed: 05/06/1987
• Issued: 09/25/1990
• Est. Priority Date: 05/06/1987
• Status: Expired due to Fees

• Current Assignee: Jang G. David
• Original Assignee: Jang G. David
• Inventors: Jang, G. David
• Primary Examiner(s): Truluck, Dalton L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/047,049
• Time in Patent Office: 1,238 Days
• Field of Search: 128/344, 128/348.1 D, 128/10, 128/207.15, 128/303.1, 128/303.11, 604/96-103, 604/21, 264/573
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed in an angioplasty catheter comprising a catheter shaft having a distal end and at least one, and preferably two, angioplasty balloons on the distal end of the catheter shaft, wherein the distal end of the catheter and the balloons are formed from a single monolithic piece of polymer material. The distal end of the catheter may also include additional balloons formed from the same piece of polymer material. Each of the balloons is separately inflatable and deflatable by virtue of a separate lumen running through the catheter shaft to the balloon. Also disclosed is a method for making angioplasty balloons as described above, comprising the steps of forming from a single piece of polymer material the length of catheter shaft material having at least a first lumen therein, wherein each lumen has an outer wall and, if there are more than one lumen, each lumen has a common wall where the outer walls of at least two lumens converge, sealing the distal end of the first lumen to form a first sealed lumen, applying pressure to the proximal end of the first sealed lumen and heating the outer wall thereof to expand the outer wall of the first sealed lumen inside of first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of the die. Additional balloons may be formed on the catheter in the same manner.

Claims

1. An angioplasty catheter, comprising:

a catheter shaft having a proximal end and a distal end;

first and second independently inflatable and independently deflatable angioplasty balloons at the distal end of said catheter, each said balloon having a balloon wall and having a length and a maximum inflated diameter, wherein said balloons and said distal end of said catheter shaft comprise a single, integral, monolithic piece of polymer material and wherein said balloons are eccentrically positioned with respect to each other, wherein said first balloon has a maximum inflated diameter less than that of said second balloon and is at least partially inside said second balloon.

2. The catheter of claim 1, wherein at least 15% but less than 85% of the length of said first balloon is inside said second balloon.

3. An angioplasty catheter, comprising:

a catheter shaft having a proximal end and a distal end;

at least two independently inflatable and independently deflatable angioplasty balloons at the distal end of said catheter, each said balloon having a balloon wall and having a length and a maximum inflated diameter, wherein said balloons and said distal end of said catheter shaft comprise a single, monolithic piece of polymer material and wherein said balloons are eccentrically positioned in a radial direction with respect to each other, said catheter shaft includes at least a first lumen and a second lumen extending through said catheter shaft, and said balloons comprise a first balloon and a second balloon, wherein said first lumen terminates inside said first balloon and said second lumen terminates inside said second balloon; and

an axial torque guidewire extending through said first lumen and out of the distal end of said first balloon and said catheter, wherein the distal end of said first balloon is sealed to said guidewire, wherein the walls of said first balloon have been formed by expanding the walls of said first lumen and wherein said first balloon is substantially coaxial with said first lumen.

4. The catheter of claim 3, wherein the walls of said second balloon have been formed by expanding the walls of said second lumen and wherein said second balloon is eccentric with respect to said second lumen.

5. The catheter of claim 3 or 4, wherein said balloons further comprise a third balloon and wherein said catheter shaft has a third lumen in communication with and terminating inside said third balloon, wherein said third balloon is eccentric with respect to said third lumen.

6. An angioplasty catheter, comprising:

a catheter shaft having a proximal end, a distal end, and a longitudinal axis extending from said proximal end to said distal end;

at least two independently inflatable and independently deflatable inelastic angioplasty balloons at the distal end of said catheter, each said balloon having a longitudinal axis and a balloon wall and having a length and a different predetermined maximum inflated working diameter, wherein said balloons and said distal end of said catheter shaft comprise a single, integral monolithic piece of polymer material and wherein said axes of said balloons are eccentrically positioned with respect to each other;

wherein each balloon has a proximal end and a distal end, and wherein the distal end of one of said balloons is joined to the wall of another of said balloons.

7. A method for making angioplasty balloons, comprising the steps of:

forming from a single piece of polymer material a length of catheter shaft material having at least a first lumen and a second lumen therein, each lumen having an outer wall, each lumen having a proximal end and a distal end, and each lumen having a common wall where the outer walls of at least two lumens converge;

closing one end of said first lumen to form a first closed lumen;

applying pressure to the interior of said first closed lumen and heating the outer wall thereof to expand the outer wall of said first sealed lumen inside a first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of said die, wherein said common wall of said first lumen comprises one side of said first balloon and wherein said first balloon is joined to said common wall along substantially its entire length.

8. The method of claim 7, further comprising the steps of:

closing one end of said second lumen to form a second closed lumen;

applying pressure to the interior of said second closed lumen and heating the outer wall thereof to expand the second closed lumen inside a second die to form a second balloon therefrom having dimensions determined by the dimensions of the interior of said second die, wherein said first balloon and said second balloon each have a longitudinal axis, which axes are eccentric with respect to each other.

10. The method of claim 8, wherein the outer wall of said first lumen is located inside the outer wall of said second lumen.

12. The method of claim 8, wherein said forming step and said closing step are molding steps.

13. The method of claim 8, wherein said forming step is an extrusion step.

17. The method of any one of claims 8-14, wherein said catheter shaft material further has a third lumen therein, further comprising the steps of:

sealing the distal end of said third lumen to form a third sealed lumen;

applying pressure to the proximal end of said third sealed lumen and heating the outer wall thereof to expand the outer wall of said third sealed lumen inside a die to form a third balloon therefrom having dimensions determined by the dimensions of the interior of said die.

23. The method of claim 8, wherein said second balloon is located distally of said first balloon, wherein said catheter includes an axial torque guidewire extending through said second lumen and said step of closing said second lumen comprising sealing the distal end thereof to said guidewire.

25. A method for performing balloon angioplasty, comprising the steps of:

positioning the first balloon of the angioplasty catheter of claim 8, 17, or 22 in a first stenosis in a vessel, wherein the maximum inflated diameter of said first balloon is approximately equal to the negative diameter of said vessel at the location of said first stenosis;

inflating said first balloon to dilate said first stenosis;

positioning the second balloon of said catheter in a second stenosis in a vessel, wherein the maximum inflated diameter of said second balloon is approximately equal to the native diameter of said vessel at the location of said second stenosis; and

inflating said second balloon to dilate said second stenosis.

9. A method for making angioplasty balloons, comprising the steps of:

forming from a single piece of polymer material a length of catheter shaft material having at least a first lumen and a second lumen therein, each lumen having an outer wall, each lumen having a proximal end and a distal end, and each lumen having a common wall where the outer walls of at least two lumens converge;

sealing shut the distal end of said first lumen to form a first closed lumen;

applying pressure to the interior of said first closed lumen and heating the outer wall thereof to expand the outer wall of said first closed lumen inside a first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of said die;

sealing shut the distal end of said second lumen to form a second closed lumen;

applying pressure to the interior of said second closed lumen and heating the outer wall thereof to expand the second closed lumen inside a second die to form a second balloon therefrom having dimensions determined by the dimensions of the interior of said second die, wherein said first balloon and said second balloon are eccentric with respect to each other, wherein the sealed end of said first lumen is located distally of the sealed end of said second lumen so that the distal end of said first balloon is located distally of the distal end of said second balloon.

11. A method for making angioplasty balloons, comprising the steps of:

forming from a single piece of polymer material a length of catheter shaft material having at least a first lumen and a second lumen therein, each lumen having an outer wall, each lumen having a proximal end and a distal end, and each lumen having a common wall where the outer walls of at least two lumens converge;

closing one end of said first lumen to form a first closed lumen;

applying pressure to interior of said first closed lumen and heating the outer wall thereof to expand the outer wall of said first closed lumen inside a first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of said die;

closing one end of said second lumen to form a second closed lumen;

applying pressure to interior of said second closed lumen and heating the outer wall thereof to expand the second closed lumen inside a second die to form a second balloon therefrom having dimensions determined by the dimensions of the interior of said second die, wherein said first balloon and said second balloon are eccentric with respect to each other, wherein said first balloon and said second balloon are located on opposite sides of said catheter.

14. A method for making angioplasty balloons, comprising the steps of:

forming from a single piece of polymer material a length of catheter shaft material having at least a first lumen and a second lumen therein, each lumen having an outer wall, each lumen having a proximal end and a distal end, and each lumen having a common wall where the outer walls of at least two lumens converge;

sealing the distal end of said first lumen to form a first sealed lumen;

applying pressure to the interior of said first sealed lumen and heating the outer wall thereof to expand the outer wall of said first sealed lumen inside a first die to form a first balloon therefrom having dimensions determined by the dimensions of the interior of said die;

sealing the distal end of said second lumen to form a second sealed lumen;

applying pressure to the interior of said second sealed lumen and heating the outer wall thereof to expand the second sealed lumen inside a second die to form a second balloon therefrom having dimensions determined by the dimensions of the interior of said second die, wherein said first balloon and said second balloon are eccentric with respect to each other, wherein said forming step is an extrusion step; and

shortening said second lumen prior to sealing the distal end thereof by removing a length of the outer wall of said second lumen at the distalmost end of said second lumen so that the distal end of said second lumen is located proximally of the distal end of said first lumen.

15. The method of claim 14, wherein said sealing step for said second lumen comprises bonding the outer wall of said second lumen at the distal end thereof to the outer wall of said first lumen.

16. The method of claim 14, wherein said sealing step for said second lumen comprises bonding the outer wall of said second lumen at the distal end thereof to said catheter shaft.

24. The method of claim 15 or 16, wherein said bonding of said outer wall of said second lumen is carried out along a semicircular line.

18. An angioplasty catheter, comprising:

a catheter shaft having a proximal end, a distal end, and a longitudinal axis extending from said proximal end to said distal end;

at least two independently inflatable and independently deflatable inelastic angioplasty balloons at the distal end of said catheter, each said balloon having a longitudinal axis and a balloon wall and having a length and a different predetermined maximum inflated working diameter, wherein said balloons and said distal end of said catheter shaft comprise a single, integral monolithic piece of polymer material and wherein said axes of said balloons are eccentrically positioned with respect to each other;

wherein the distal end of one of said balloons is bonded to the wall of another of said balloons.

19. An angioplasty catheter, comprising:

a catheter shaft having an axis, a distal end, and a proximal end;

a first independently inflatable angioplasty balloon on a first side of the distal end of said shaft;

a second independently inflatable angioplasty balloon on a second side of the distal end of said shaft, wherein said first balloon and said second balloon are only in part axially coextensive on said catheter shaft;

wherein the distal end of said catheter has a first predetermined diameter when said first balloon is inflated, a different second predetermined diameter when said second balloon is inflated, and a different third predetermined diameter when said first and second balloons are both inflated.

20. An angioplasty catheter, comprising:

a catheter shaft having an axis, a distal end, and a proximal end;

a first independently inflatable angioplasty balloon on a first side of the distal end of said shaft;

a second independently inflatable angioplasty balloon on a second side of the distal end of said shaft, wherein said first balloon and said second balloon are only in part axially coextensive on said catheter shaft;

wherein a first portion of said first balloon is opposite said second balloon on said catheter shaft and a second portion of said first balloon is not, and wherein said first portion has a first predetermined maximum inflated diameter and said second portion has a second, different predetermined maximum inflated diameter.

21. The catheter of claim 20, wherein said second portion of said first balloon is located distally of said first portion.

22. An angioplasty catheter, comprising:

a catheter shaft having an axis, a distal end, and a proximal end;

a first independently inflatable angioplasty balloon coaxially disposed on the distal end of said shaft;

a second independently inflatable angioplasty balloon extending from one side of said first balloon along at least a part of the length of said first balloon so that said first and second balloons are at least in part axially coextensive.