MEDICAL BALLOON HAVING STRENGTHENING RODS

• US 20080188805A1
• Filed: 04/07/2008
• Published: 08/07/2008
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: FutureMatrix Interventional, Inc. (Biomerics LLC)
• Inventors: Pepper, Lanny R., Hayes, Kelli, Davies, William F.
• Granted Patent: US 8,353,868 B2
• Time in Patent Office: Days
• 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 may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises 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 is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to 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 is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to 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 is a layer of textile fabric material. At least one strengthening rod is connected to the outer surface of the balloon layer.

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, and when the balloon is fully inflated, it has a length and diameter that do not substantially change as the internal pressure further increases, 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;

the first reinforcing layer disposed over the base 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

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 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; and

at least one strengthening rod connected to the outer surface of the balloon layer.

2. A balloon in accordance with claim 1, wherein the base layer of the balloon layer comprises a base layer balloon.

3. A balloon in accordance with claim 2, wherein the base layer balloon is formed from a polymeric material that is, by itself, substantially non-compliant.

4. A balloon in accordance with claim 2, wherein the base layer balloon is formed from a polymeric material that is, by itself, substantially compliant.

5. A balloon in accordance with claim 1, wherein the base layer of the balloon layer is formed of a polymer that is applied in liquid form on a mandrel in the shape of an inflated balloon and cured into a solid form, the material of the cured solid form being, by itself, substantially non-compliant.

6. A balloon in accordance with claim 1, wherein the base layer of the balloon layer is formed of a polymer that is applied in liquid form on a mandrel in the shape of an inflated balloon and cured into a solid form, the material of the cured solid form being, by itself, substantially compliant.

7. A balloon in accordance with claim 1, wherein a plurality of strengthening rods are disposed substantially symmetrically around the periphery of the outer surface of the balloon.

8. A balloon in accordance with claim 1, wherein the strengthening rods are disposed asymmetrically on the outer surface of the balloon.

9. A balloon in accordance with claim 8, wherein the strengthening rods form an outward blade surface concentrating the force generated by the pressure of the inflated balloon in a particular direction.

10. A balloon in accordance with claim 1, wherein when the balloon is fully inflated, the balloon layer includes a first cone region formed at one end having a first cone angle and a second cone region formed at a second end having a second cone angle.

11. A balloon in accordance with claim 10, wherein when the balloon is fully inflated, the first cone angle and the second cone angle are substantially identical to one another.

12. A balloon in accordance with claim 10, wherein when the balloon is fully inflated, the first cone angle and the second cone angle are substantially different from one another.

13. 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, and when the balloon is fully inflated, it has a length and diameter that do not substantially change as the internal pressure further increases, the balloon catheter comprising:

a catheter tube;

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;

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

at least one strengthening rod connected to the outer surface of the balloon layer.

14. A balloon catheter in accordance with claim 13, wherein the base layer of the balloon layer is formed from a polymeric material that is, by itself, substantially non-compliant.

15. A balloon catheter in accordance with claim 13, wherein the base layer of the balloon layer is formed from a polymeric material that is, by itself, substantially compliant.

16. A method of forming 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 method comprising the following steps:

forming a base layer from a polymer material in the shape of the inflated balloon having a long axis and a circumference;

applying a first reinforcing layer over the base 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

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

applying a second reinforcing layer 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 and

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

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

affixing at least one strengthening rod to the outer surface of the balloon layer formed by the previous steps.

17. A method in accordance with claim 16, wherein the base layer is formed of a substantially non-compliant material that is internally pressurized to maintain its shape during the application of the first and second reinforcing layers.

18. A method in accordance with claim 16, wherein the step of forming a base layer further comprises:

applying a polymer in liquid form over a mandrel having the shape desired for the inflated balloon; and

curing the polymer into a solid form having the shape of the mandrel.

19. A method in accordance with claim 18, wherein the cured polymer in solid form is, by itself, substantially non-compliant.

20. A method in accordance with claim 18, wherein the cured polymer in solid form is, by itself, substantially compliant.