Laser bonding of angioplasty balloon catheters

• US 5,267,959 A
• Filed: 11/29/1991
• Issued: 12/07/1993
• Est. Priority Date: 11/29/1991
• Status: Expired due to Term

• Current Assignee: Schneider Electric SE
• Original Assignee: Schneider Electric SE
• Inventors: Forman, Michael R.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Gutowski, Anthony
• Application Number:
  US07/800,201
• Time in Patent Office: 739 Days
• Field of Search: 604/96, 604/99, 604/101, 604/103, 606/192, 606/194
• US Class Current: 604/103
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: B29C 2035/0822 using IR radiation
• CPC Class Codes: B29C 65/1616 Near infrared radiation [NIR], e.g. by YAG lasers
• CPC Class Codes: B29C 65/1619 Mid infrared radiation [MIR], e.g. by CO or CO2 lasers
• CPC Class Codes: B29C 65/1622 Far infrared radiation [FIR], e.g. by FIR lasers
• CPC Class Codes: B29C 65/1635 at least passing through one of the parts to be joined, i.e. laser transmission welding
• CPC Class Codes: B29C 65/1654 scanning at least one of the parts to be joined
• CPC Class Codes: B29C 65/1661 scanning repeatedly, e.g. quasi-simultaneous laser welding
• CPC Class Codes: B29C 65/1664 making use of several radiators
• CPC Class Codes: B29C 65/1667 at the same time, i.e. simultaneous laser welding
• CPC Class Codes: B29C 65/1683 coated on the article
• CPC Class Codes: B29C 65/1687 making use of light guides
• CPC Class Codes: B29C 65/68 using auxiliary shrinkable elements
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/3452 Making complete joints by combining partial joints
• CPC Class Codes: B29C 66/53241 said articles being tubular and said substantially annular single elements being of finite length relative to the infinite length of said tubular articles making T-shaped pieces by joining tubular articles B29C66/52241
• CPC Class Codes: B29C 66/5344 said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends B29C66/5346 takes precedence
• CPC Class Codes: B29C 66/612 Making circumferential joints
• CPC Class Codes: B29C 66/63 : Internally supporting the article during joining B29C66/49 takes precedence
• CPC Class Codes: B29C 66/65 : with a relative motion between the article and the welding tool B29C65/10, B29C65/12 take precedence
• CPC Class Codes: B29C 66/652 : moving the welding tool around the fixed article
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/80 : General aspects of machine operations or constructions and parts thereof
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2079/08 : PI, i.e. polyimides or derivatives thereof
• CPC Class Codes: B29K 2995/0049 : Heat shrinkable
• CPC Class Codes: B29K 2995/0069 : non-permeable
• CPC Class Codes: B29L 2022/022 : Balloons
• CPC Class Codes: B29L 2031/7542 : Catheters
• CPC Class Codes: B29L 2031/7543 : Balloon catheters

Abstract

A balloon catheter which is assembled by a process of selectively concentrating laser energy along an annular fusion bond site at contiguous surface portions of a length of catheter tubing and a shaft or neck portion of a dilatation balloon. The laser energy wavelength, and the polymeric materials of the balloon and catheter, are matched for high absorption of the laser energy to minimize conductive heat transfer in axial directions away from the bond site. This minimizes crystallization and stiffening in regions near the bond site, permitting fusion bonds to be located close to the proximal and distal cones of the dilatation balloon while preserving the soft, pliant quality of the cones.

Claims

1. A balloon catheter comprising:

an elongate pliable length of catheter tubing formed of a polymeric material and having a proximal end and a distal end;

a polymeric dilatation balloon mounted to the catheter tubing near the distal end and in surrounding relation to the catheter tubing, said balloon including a medial region, proximal and distal neck regions each substantially smaller in diameter than the medial region, and proximal and distal tapered regions between the medial region and the proximal and distal neck regions, respectively, each of the tapered regions diverging in the direction from its associated neck region to the medial region, the distal neck region being contiguous with the catheter tubing to define a distal interface; and

a distal fluid tight fusion bond along the interface of the catheter tubing and the distal neck region, said fusion bond being spaced apart from the distal tapered region by a distance of at most 0.030 inches, and wherein the distal tapered region is substantially free of crystallization.

2. The balloon catheter of claim 1 wherein:

the axial dimension of the distal fusion bond is at most 0.030 inches, and the distal fusion bond is spaced apart from the distal tapered region by less than 0.010 inches.

3. The balloon catheter of claim 1 wherein:

the catheter tubing and the balloon are formed of different polymeric materials.

4. The balloon catheter of claim 3 wherein:

the catheter tubing comprises an extrusion of at least one thermoplastic polymeric material chosen from the group consisting of;

polyesters, polyolefins, polyamides, thermal polyurethanes and their copolymers.

5. The balloon catheter of claim 3 wherein:

the balloon is formed of at least one of the materials from the group consisting of;

polyethylene terephthalate, nylon, polyolefin and their copolymers.

6. The balloon catheter of claim 1 further including:

a fluid tight proximal fusion bond between the catheter tubing and the proximal end region, said proximal fusion bond being axially spaced apart from the proximal tapered region by at most 0.030 inches, and wherein the proximal tapered region is substantially free of crystallization.

7. A balloon catheter comprising:

an elongate pliable length of catheter tubing formed of a polymeric material and having a proximal end and a distal end;

a polymeric dilatation balloon mounted to the catheter tubing near the distal end and in surrounding relation to the catheter tubing, said balloon including a medial region, proximal and distal neck regions each substantially smaller in diameter than the medial region, and proximal and distal tapered regions between the medial region and the proximal and distal neck regions, respectively, each tapered region diverging in the direction from its associated neck region to the medial region; and

proximal and distal fluid tight fusion bonds between the catheter tubing and the proximal and distal neck regions, respectively, wherein each of the proximal and distal fusion bonds is within 0.030 inches of its associated one of the proximal and distal tapered regions, and wherein each of proximal and distal tapered regions is substantially free of crystallization.

8. The balloon catheter of claim 7 wherein:

the inner diameter of the distal neck portion is substantially equal to the outer diameter of the catheter tubing in the region of said distal fusion bond, and the inner diameter of the proximal neck region is substantially equal to the outer diameter of the catheter tubing along the proximal fusion bond.

9. The balloon catheter of claim 8 wherein:

the catheter tubing, neck regions and fusion bonds are annular.

10. The balloon catheter of claim 9 wherein:

the axial dimension of the distal fusion bond is at most 0.030 inches.

11. The balloon catheter of claim 10 wherein:

the axial length of the distal fusion bond is about 0.020 inches.

12. The balloon catheter of claim 11 wherein:

the distal fusion bond is less than 0.010 inches from the distal tapered region.

13. The balloon catheter of claim 7 wherein:

the catheter tubing comprises an extrusion of at least one thermoplastic polymeric material chosen from the group consisting of;

polyesters, polyolefins, polyamides, thermoplastic polyurethanes and their copolymers.

14. The balloon catheter of claim 13 wherein:

the balloon is formed of at least one of the materials from the group consisting of;

polyethylene terephthalate, nylon, polyolefin, and their copolymers.

15. The balloon catheter of claim 7, formed according to a process comprising the steps of:

positioning the polymeric dilatation balloon along and in surrounding relation to the length of catheter tubing, with the dilatation member and the catheter tubing aligned to place a first surface portion of the dilatation balloon and a second surface portion of the catheter tubing in a contiguous and confronting relation;

generating substantially monochromatic energy at a wave length selected to at least approximately match a wave length of maximum spectral absorption of the polymeric materials forming the dilatation balloon and the catheter tubing;

controllably directing the monochromatic energy onto the catheter tubing and the dilatation balloon to concentrate the monochromatic energy in a narrow bond site circumscribing the catheter tubing and running along the interface of the first and second surface portions, thus to melt the polymeric materials only along the bond site and the immediate region thereof; and

allowing the previously melted polymeric materials to cool and solidify to form a fusion bond between the catheter tubing and the dilation balloon.

16. The balloon catheter of claim 15 wherein:

said interface of the first and second surfaces is annular, and the step of directing the monochromatic energy includes focusing the beam to position a focal area of the beam substantially at the interface, and moving the focal area, relative to the catheter tubing and the dilation balloon, in an annular path along the interface to define said bond site.