Multi-layer film welded articulated balloon

• US 9,713,476 B2
• Filed: 11/26/2012
• Issued: 07/25/2017
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: 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): Bouchelle, Laura
• Assistant Examiner(s): BUI, ANH T
• Application Number:
  US13/685,448
• Publication Number:
  US 20130085324A1
• Time in Patent Office: 1,702 Days
• 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 multi-layer film heat welded medical balloon device comprising a multiplicity of layers of thermoplastic film including at least two thermoplastic film layers heat welded at peripheral edges to form a compartment adapted to receive fluid to expand said film layers relative to each other, and heat welded at one or more locations inside an area enclosed by the heat welded peripheral edges so as to enable the balloon device to articulate to a desired shape upon inflation, with a third thermoplastic film layer of said multiplicity of layers arranged so that a distal portion of the balloon device will bulge upwardly to form said desired shape upon inflation, and at least one of the layers heat welded to another of said layers, intermediate said peripheral edges, to form subcompartments in fluid communication with one another in said compartment that are configured to enable the device to articulate to said desired shape, wherein all layers are heat welded to one another at peripheral edges thereof, wherein all heat welded locations of said medical balloon device comprise heat weld regions on the thermoplastic film layers joining the thermoplastic film layers at said locations to one another.

2. The medical balloon device of claim 1, comprising a fluid passage member sealed at a proximal neck of the balloon device for inflation of the balloon device.

3. The medical balloon device of claim 1, wherein said desired shape is effective to support a prostate in spaced relation to other organs during prostate surgery.

4. The medical balloon device of claim 1, wherein said multiplicity of layers comprises layer(s) of different thickness.

5. The medical balloon device claim 1, wherein said multiplicity of layers comprises layer(s) of different modulus of elasticity.

6. A multi-layer film heat welded medical balloon device, comprising a multiplicity of layers of thermoplastic film including first and second thermoplastic film layers heat welded to one another to form a first inflatable compartment, and a third thermoplastic film layer heat welded to the second thermoplastic film layer to form a second inflatable compartment, wherein the first and second inflatable compartments are in fluid communication with one another in an inflatable interior volume sealed by heat welded thermoplastic film edges, and arranged so that upon inflation of the medical balloon device, a distal portion of the balloon device will bulge upwardly, wherein all layers are heat welded to one another at peripheral edges thereof, and wherein at least one of the layers is heat welded to another of said layers, intermediate said peripheral edges, to enable the distal portion of the balloon device to bulge upwardly, wherein all heat welded locations of said medical balloon device comprise heat weld regions on the thermoplastic film layers joining the thermoplastic film layers at said locations to one another.

7. The medical balloon device of claim 6, comprising a fluid passage member communicating with said interior volume and sealed at a proximal neck of the balloon device.

8. The medical balloon device of claim 6, wherein the balloon device upon inflation and upward bulging of the distal portion thereof is effective to support a prostate in spaced relation to other organs during prostate surgery.

9. The medical balloon device of claim 6, wherein said multiplicity of layers comprises layer(s) of different thickness.

10. The medical balloon device claim 6, wherein said multiplicity of layers comprises layer(s) of different modulus of elasticity.