MULTI-LAYER FILM WELDED ARTICULATED BALLOON

• US 20100137797A2
• Filed: 09/25/2008
• Published: 06/03/2010
• 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: Strom, Christopher, Shah, Tilak
• Granted Patent: US 7,976,497 B2
• Time in Patent Office: Days
• US Class Current: 604/103.80
• 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 method for the fabrication of an articulated medical balloon device comprising the steps of

(a) providing at least two film layers having opposed edges;

(b) sealing said opposed edges to form a compartment adapted to receive fluid to expand said film layers relative to each other;

(c) providing an opening in said fluid compartment that is adapted to receive a lumen; and

(d) forming a subcompartment between the sealed edges of said compartment of a predetermined shape and dimension by sealing at least one of said layers to another, intermediate said opposed edges.

2. The method of claim 1, wherein said sealing steps are performed by welding one layer to another.

3. The method of claim 1, wherein two layers of film are provided.

4. The method of claim 1, wherein three layers of film are provided.

5. The method of claim 1, wherein each layer of film has a different modulus of elasticity.

6. The method of claim 1, wherein each layer of film has a different thickness.

7. The method of claim 1, including the step of providing at least one opening between said film layers for receiving a lumen.

8. The method of claim 1, wherein said film layers comprise a thermoplastic polymeric film.

9. The method of claim 1, including the step of forming a fluid channel between said subcompartments.

24. A method of treating the prostate, comprising supporting the prostate in spaced relation to other organs with a medical balloon device as claimed in claim 1.

25. The method of claim 24, wherein said treating comprises radiation treatment of the prostate.

26. The method of claim 24, wherein said treating comprises prostate surgery.

10. A medical balloon device, comprising:

at least one film layer having an edge secured to a second film layer to form a fluid compartment therebetween,

and portions of said film layers between said edges being secured intermediate said edges to form a plurality of subcompartments, and

said fluid compartment being provided with an opening to receive a lumen.

11. The medical balloon device of claim 10, wherein each film layer has a different modulus of elasticity.

12. The medical balloon device of claim 10, wherein each film layer has a different thickness.

13. The medical balloon device of claim 10, including three film layers.

14. The medical balloon device of claim 10, wherein said film layers are formed from thermoplastic polymers.

15. The medical balloon device of claim 10, wherein said subcompartments are surrounded by fluid communication channels.

16. The medical balloon device of claim 10, wherein said edges and film layers intermediate said edges are welded to each other.

17. The medical balloon device of claim 10, comprising at least one neck member in a sealing area of the device.

18. The medical balloon device of claim 10, comprising at least one area outside of said secured edges forming an inflation port.

19. A medical balloon device, comprising:

first and second thermoplastic film layers joined to one another at their edges to form an inflatable compartment including proximal and distal portions;

a third thermoplastic film layer joined to the first thermoplastic film layer along a portion of the first thermoplastic film layer, wherein said portion is between side edges of the inflatable compartment, and between proximal and distal portions of the inflatable compartment, arranged so that upon inflation of the inflatable compartment, the distal portion of the inflatable compartment will bulge upwardly; and

a fluid passage for inflating the inflatable compartment.

20. The medical balloon device of claim 19, wherein upon inflation, inflation fluid flows into a subcompartment between the first and third thermoplastic film layers.

21. The medical balloon device of claim 19, wherein the fluid passage extends into the interior of the inflatable compartment.

22. The medical balloon device of claim 21, wherein the inflatable compartment has a neck, and the fluid passage is sealed at the neck of the inflatable compartment.

23. The medical balloon device of claim 19, wherein the first and second thermoplastic film layers have different modulus of elasticity.