Multi-layer film welded articulated balloon

• US 8,740,845 B2
• Filed: 06/06/2011
• Issued: 06/03/2014
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc., Polyzen Incorporated (Compagnie Generale DES Etablissements Michelin SCA)
• Original Assignee: Polyzen Incorporated (Compagnie Generale DES Etablissements Michelin SCA)
• Inventors: Shah, Tilak M., Strom, Christopher D.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): PATEL, PRITESH ASHOK
• Application Number:
  US13/154,229
• Publication Number:
  US 20110295202A1
• Time in Patent Office: 1,093 Days
• Field of Search: 604/103.06, 604/96.01, 604/194, 604/101.02, 604/103, 60410301-10308, 60410311-10314
• US Class Current: 604/103.06
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2210/166 Prostate
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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 25/104 used for angioplasty
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/02 : by heating, with or without pressure
• CPC Class Codes: B29C 65/04 : Dielectric heating, e.g. high-frequency welding , i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
• CPC Class Codes: B29C 65/38 : Impulse heating
• CPC Class Codes: B29C 65/48 : using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4895 : Solvent bonding, i.e. the surfaces of the parts to be joined being treated with solvents, swelling or softening agents, without adhesives
• 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 66/21 : said joint lines being formed by a single dot or dash or by several dots or dashes, i.e. spot joining or spot welding
• CPC Class Codes: B29C 66/43 : Joining a relatively small portion of the surface of said articles B29C66/45 takes precedence
• CPC Class Codes: B29C 66/4312 : for making flat seams in tubular or hollow articles, e.g. transversal seams
• CPC Class Codes: B29C 66/4742 : said single elements being spouts
• CPC Class Codes: B29C 66/73521 : of different thickness, i.e. the thickness of one of the parts to be joined being different from the thickness of the other part
• CPC Class Codes: B29K 2101/12 : Thermoplastic materials
• CPC Class Codes: B29K 2995/0046 : Elastic
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2022/02 : Inflatable articles balls B29L2031/54 ; inner tyres B29L2023/245
• CPC Class Codes: B29L 2022/022 : Balloons
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/182 : one or more of the layers being plastic
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor

Abstract

A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

Claims

1. A medical balloon device, comprising a multiplicity of layers of thermoplastic film including layers sealed at peripheral edges thereof to form an inflatable interior volume enclosed by the sealed edges, and layers sealed at one or more locations in the interior volume to enable the device to articulate to a predetermined shape upon inflation of the interior volume with an inflation fluid, to accommodate a predetermined medical application, wherein the inflatable interior volume is adapted to receive an inflation fluid.

2. The medical balloon device of claim 1, wherein the layers sealed at one or more locations in the interior volume to enable the device to articulate to a predetermined shape upon inflation of the interior volume with an inflation fluid, have a different modulus of elasticity.

3. The medical balloon device of claim 1, wherein the layers sealed at one or more locations in the interior volume to enable the device to articulate to a predetermined shape upon inflation of the interior volume with an inflation fluid, have a different thickness.

4. The medical balloon device of claim 1, comprising two layers of thermoplastic film.

5. The medical balloon device of claim 1, comprising three layers of thermoplastic film.

6. The medical balloon device of claim 1, comprising a layer forming a compartment that is exterior to said interior volume.

7. The medical balloon device according to claim 1, wherein said predetermined shape accommodates a predetermined medical application selected from the group consisting of gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications.

8. The medical balloon device according to claim 1, wherein said predetermined shape accommodates a prostatic medical application.

9. The medical balloon device according to claim 1, wherein one of said layers is an intermediate layer in said interior volume configured to form compartments, one of which is an inflation compartment adapted for coupling with a luminal element to enable inflation of the interior volume and another one of which bulges outwardly upon inflation so that the device articulates to said predetermined shape.

10. A medical balloon device, comprising:

a first thermoplastic film layer including a first edge;

a second thermoplastic film layer including a second edge joined to the first edge to form a bottom inflatable compartment between the first and second layer;

a third thermoplastic film layer including a third edge joined to the second edge to form a top inflatable compartment between the second and third layer, in fluid communication with the bottom inflatable compartment; and

said bottom inflatable compartment being adapted to receive an inflation fluid and said top inflatable compartment being adapted to articulate to a predetermined shape to accommodate a predetermined medical application.

11. The medical balloon device of claim 10, wherein the second and third layers are secured intermediate said second and third edges so that the distal portion of the third layer bulges upwardly upon inflation.

12. The medical balloon device of claim 10, wherein the top inflatable compartment is adapted to distend to form a bulged conformation of the distal portion of the third layer relative to the proximal portion upon inflation.

13. The medical balloon device of claim 10, wherein the top inflatable compartment is further secured between the second and third layers intermediate said second and third edges to form an arcuate shape in the distal portion of the third layer upon inflation.

14. The medical balloon device of claim 10, wherein the second and third layers are secured at an intermediate portion so that said third layer upon inflation bulges upwardly between the intermediate portion and the third edge at the distal portion of the third layer.

15. A medical balloon device, comprising a balloon body including at least two layers of thermoplastic film sealed at peripheral edges thereof and sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, wherein an additional layer of thermoplastic film of said balloon body is disposed in relation to said at least two layers of thermoplastic film to form compartments in an interior volume of said balloon body including a first compartment adapted to receive an inflation fluid, and a second compartment communicating with said first compartment and configured to enable the balloon body to articulate to a predetermined shape upon inflation with said inflation fluid to accommodate a predetermined medical application.

16. The medical balloon device according to claim 15, wherein said predetermined shape accommodates a predetermined medical application selected from the group consisting of gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications.

17. The medical balloon device according to claim 15, wherein said predetermined shape accommodates a prostatic medical application.

18. The medical balloon device according to claim 15, wherein said at least two layers and said additional layer of thermoplastic film comprise polyurethane thermoplastic film.

19. The medical balloon device according to claim 15, wherein said at least two layers and said additional layer of thermoplastic film comprise at least two layers of differing modulus of elasticity to enable such layers to distend at different rates during said inflation with said inflation fluid, to form a predetermined arcuate or curved shape.

20. The medical balloon device according to claim 15, further comprising a luminal element coupled to said first compartment to enable inflation of the balloon body with said inflation fluid.

21. The medical balloon device according to claim 20, further comprising a source of inflation gas coupled to a proximal end of said luminal element, with a distal end of said luminal element coupled to said first compartment.