Medical balloon having strengthening rods

• US 7,354,419 B2
• Filed: 10/15/2004
• Issued: 04/08/2008
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Futuremed Interventional, Inc. (Biomerics LLC)
• Inventors: Davies, William F. Jr., Pepper, Lanny R., Hayes, Kelli
• Primary Examiner(s): DESANTO, MATTHEW F
• Application Number:
  US10/967,038
• Publication Number:
  US 20060085023A1
• Time in Patent Office: 1,271 Days
• Field of Search: 604/95.04, 604/508, 604/96.01, 604/509, 60410306-10309, 604/103.13, 604/103.12, 606192-194
• US Class Current: 604/103.06
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B05D 1/36 Successively applying liquids or other fluent materials, e.g. without intermediate treatment
• CPC Class Codes: B05D 5/00 Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures

Abstract

A non-compliant medical balloon includes a balloon layer having an outer surface and a strengthening rod connected to the outer surface of the balloon layer. The strengthening rod may be connected longitudinally on the outer surface of the balloon layer. Typically, the balloon is formed of a polymer like polyethylene terephthalate.

Claims

1. A non-compliant medical balloon, where the balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon, comprising:

a balloon layer having an outer surface, the balloon layer including a base layer, an adhesive layer, a first reinforcing layer, a second reinforcing layer and an outer coating layer;

the base layer being formed of a polymer material in the shape of the inflated balloon;

the adhesive layer being applied directly to the surface of the base layer;

the first reinforcing layer being affixed to the adhesive layer, the first reinforcing layer being one of either

a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and having a length substantially equal to the length of the long axis of the balloon and

a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric;

the second reinforcing layer being applied at least partially over the first reinforcing layer, the second reinforcing layer being one of either

at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon such that the circumferential inelastic fibers are evenly distributed along the length of the long axis of the balloon and

a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric;

at least one of the first and second reinforcing layers being one of the first and second layer of textile fabric material;

the outer coating layer being applied over the second reinforcing layer and affixing the second reinforcing layer to the first reinforcing layer; and

a strengthening rod connected to the outer surface of the balloon layer;

wherein, when the balloon is in the deflated state, the outer surface of the balloon layer has a folded configuration of relatively small diameter, when the balloon is in a fully inflated state, the outer surface of the balloon layer has an unfolded configuration with a relatively large diameter, and when the balloon is fully inflated, it has a length and diameter that do not substantially change as the internal pressure increases.

2. The balloon of claim 1, further comprising a plurality of strengthening rods connected to the outer surface of the balloon layer.

3. The balloon of claim 2, wherein said plurality of strengthening rods are arranged circumferentially.

4. The balloon of claim 2, wherein said plurality of strengthening rods are arranged equidistantly.

5. The balloon of claim 2, wherein said plurality of strengthening rods are arranged such that a long axis of the strengthening rods are substantially parallel.

6. The balloon of claim 1, wherein the base layer of the balloon layer is formed of a blow-molded polymer.

7. The balloon of claim 6, wherein said polymer is polyethylene terephthalate.

8. The balloon of claim 1, wherein the outer coating layer on the outer surface of the balloon layer secures the strengthening rod to the balloon layer.

9. The balloon of claim 8, wherein said outer coating layer is a polymer.

10. The balloon of claim 1, wherein said strengthening rod is disposed longitudinally on the outer surface of the balloon layer.

11. The balloon of claim 1, wherein the base layer of the balloon layer is formed of a liquid polymer that has been cured on a mandrel in the shape of an inflated balloon.

12. The balloon of claim 1, wherein a length of said strengthening rod is substantially equal to a length of the balloon layer.

13. The balloon of claim 1, wherein said strengthening rod is formed of polyetheretherketone.

14. The balloon of claim 1, wherein a cross-section of said strengthening rod has the shape of a circle.

15. The balloon of claim 1, wherein a cross-section of strengthening rod has the shape of a square.

16. The balloon of claim 1, wherein a cross-section of said strengthening rod has the shape of a triangle.

17. A non-compliant medical balloon catheter, where the balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon, comprising:

a catheter tube;

a balloon layer having an outer surface, wherein said balloon layer is connected to said catheter tube, the balloon layer including a base layer, an adhesive layer, a first reinforcing layer, a second reinforcing layer and an outer coating layer;

the base layer being formed of a polymer material in the shape of the inflated balloon;

the adhesive layer being applied directly to the surface of the base layer;

the first reinforcing layer being affixed to the adhesive layer, the first reinforcing layer being one of either

a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and having a length substantially equal to the length of the long axis of the balloon and

a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric;

the second reinforcing layer being applied at least partially over the first reinforcing layer, the second reinforcing layer being one of either

at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon such that the circumferential inelastic fibers are evenly distributed along the length of the long axis of the balloon and

a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric;

at least one of the first and second reinforcing layers being one of the first and second layer of textile fabric material;

the outer coating layer being applied over the second reinforcing layer and affixing the second reinforcing layer to the first reinforcing layer; and

a strengthening rod connected to the outer surface of the balloon layer;

wherein, when the balloon is in the deflated state, the outer surface of the balloon layer has a folded configuration of relatively small diameter, when the balloon is in a fully inflated state, the outer surface of the balloon layer has an unfolded configuration with a relatively large diameter, and when the balloon is fully inflated, it has a length and diameter that do not substantially change as the internal pressure increases.

18. The balloon catheter of claim 17, further comprising a plurality of strengthening rods connected to the outer surface of the balloon layer.

19. The balloon catheter of claim 18, wherein said plurality of strengthening rods are arranged circumferentially.

20. The balloon catheter of claim 18, wherein said plurality of strengthening rods are arranged equidistantly.

21. The balloon catheter of claim 18, wherein said plurality of strengthening rods are arranged such that a long axis of the strengthening rods are substantially parallel.

22. The balloon catheter of claim 17, wherein the base layer of the balloon layer is formed of a blow-molded polymer.

23. The balloon catheter of claim 22, wherein said polymer is polyethylene terephthalate.

24. The balloon catheter of claim 17, wherein the outer coating layer on the outer surface of the balloon layer secures the strengthening rod to the balloon layer.

25. The balloon catheter of claim 24, wherein said outer coating layer is a polymer.

26. The balloon catheter of claim 17, wherein said strengthening rod is disposed longitudinally on the outer surface of the balloon layer.

27. The balloon catheter of claim 17, wherein the base layer of the balloon layer is formed of a liquid polymer that has been cured on a mandrel in the shape of an inflated balloon.

28. The balloon catheter of claim 17, wherein a length of said strengthening rod is substantially equal to a length of the balloon layer.

29. The balloon catheter of claim 17, wherein said strengthening rod is formed of polyetheretherketone.

30. The balloon catheter of claim 17, wherein a cross-section of said strengthening rod has the shape of a circle.

31. The balloon catheter of claim 17, wherein a cross-section of said strengthening rod has the shape of a square.

32. The balloon catheter of claim 17, wherein a cross-section of said strengthening rod has the shape of a triangle.

33. A non-compliant medical balloon that may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon, the balloon comprising:

a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer, and a second reinforcing layer;

the base layer being formed of a polymer material in the shape of the inflated balloon;

the first reinforcing layer overlying the base layer;

the second reinforcing layer at least partially overlying the first reinforcing layer;

one of the first and second reinforcing layers being a textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric comprising a plurality of fibers oriented at angles to one another;

the other of the first and second reinforcing layers being formed of inelastic fibers aligned in one of either a first direction and a second direction, the first direction being substantially parallel to the long axis of the balloon and the second direction being around the circumference of the balloon substantially transverse to the long axis of the balloon; and

a strengthening rod connected to the outer surface of the balloon layer;

wherein, when the balloon is in the deflated state, the outer surface of the balloon layer has a folded configuration of relatively small diameter, when the balloon is in a fully inflated state, the outer surface of the balloon layer has an unfolded configuration with a relatively large diameter, and when the balloon is fully inflated, it has a length and diameter that do not substantially change as the internal pressure increases.

34. The medical balloon of claim 33, wherein the angles between the plurality of fibers in the textile fabric remain substantially unchanged as the outer surface of the balloon layer changes from the folded configuration to the unfolded configuration.

35. The medical balloon of claim 34, wherein the textile fabric is a woven fabric and the plurality of fibers includes warp threads and wefi threads.

36. The medical balloon of claim 35, wherein the warp threads and the weft threads are interlaced within a single layer of fabric.