Multi-layer film welded articulated balloon

• US 9,737,694 B1
• Filed: 10/27/2016
• Issued: 08/22/2017
• 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): Aftergut, Jeff
• Application Number:
  US15/336,122
• Time in Patent Office: 299 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 method for the fabrication of an articulable medical balloon device configured for use in an in vivo medical procedure, said method comprising the steps of (a) providing at least two elongate film layers having opposed peripheral edges;

(b) sealing said opposed peripheral edges to form an elongate compartment adapted to receive fluid to expand said film layers relative to each other, said elongate compartment having a closed distal end and a proximal neck portion;

(c) providing an opening at said proximal neck portion of said elongate fluid compartment that is adapted to receive a lumen so that the lumen is aligned with an elongate direction of the elongate compartment; and

(d) sealing at least one of said layers to a third layer, intermediate said opposed peripheral edges, to form a subcompartment in fluid communication with said compartment that is configured to enable the device to articulate to a predetermined shape and dimension for said in vivo medical procedure, said predetermined shape comprising an upwardly bulging distal portion of the elongate compartment, wherein said two elongate film layers are sealed to one another at peripheral edges thereof.

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

3. The method of claim 2, wherein said welding comprises radio frequency (RF) welding.

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

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

6. The method of claim 1, wherein each of said at least two elongate film layers comprises thermoplastic film.

7. The method of claim 1, further comprising sealing said lumen to said neck portion of the medical balloon device.

8. The method of claim 1, wherein said subcompartments are configured to enable the device to articulate to a predetermined shape and dimension to support a prostate in spaced relation to other organs in prostate surgery.

9. The method of claim 1, wherein said lumen has a lumen axis, and wherein the medical balloon device is constructed and arranged so that inflation of the elongate compartment causes sides of the medical balloon device to be drawn inwardly relative to said lumen axis.

10. The method of claim 7, further comprising disposing a valve in said lumen.

11. The method of claim 10, wherein said valve comprises an anti-reflux valve.

12. The method of claim 1, wherein the at least two elongate film layers comprises at least two layers having different properties from one another.

13. The method of claim 12, wherein said different properties comprise different thickness.

14. The method of claim 12, wherein said different properties comprise different modulus of elasticity.

15. The method of claim 12, wherein said different properties comprise different thickness and different modulus of elasticity.

16. The method of claim 1, wherein the medical balloon device is a low-pressure medical balloon device.

17. The method of claim 1, wherein the elongate compartment and subcompartments are constructed and arranged so that the medical balloon device articulates to said predetermined shape at pressure of said fluid in a range of from 1 to 10 pounds per square inch (psi).

18. The method of claim 1, wherein the elongate compartment and subcompartments are constructed and arranged so that the medical balloon device articulates to said predetermined shape at pressure of said fluid in a range of from 1 to 3 pounds per square inch (psi).

19. A method of fabricating an articulable prostate surgery balloon device, said method comprising:

sealing opposed peripheral edges of at least two elongate film layers to form an elongate compartment adapted to receive fluid to expand said film layers relative to each other, said elongate compartment having a closed distal end and a proximal neck portion;

providing an opening at said proximal neck portion of said elongate fluid compartment that is adapted to receive a fluid inflation lumen so that said lumen is aligned with an elongate direction of the elongate compartment;

sealing said lumen to said neck portion of the prostate surgery balloon device so that said lumen is aligned with the elongate direction of the elongate compartment, wherein said lumen has a lumen axis aligned with a longitudinal axis of the elongate compartment; and

sealing at least one of said layers to a third layer, intermediate said opposed peripheral edges, to form a subcompartment in fluid communication with said compartment that is ere configured to enable the prostate surgery balloon device to articulate to a predetermined shape and dimension for prostate surgery upon fluid inflation of the device, said predetermined shape comprising an upwardly bulging distal portion of the elongate compartment.

20. The method of claim 19, wherein said sealing of opposed peripheral edges of at least two elongate film layers comprises at least one selected from the group consisting of radio frequency (RF) welding, heat impulse welding, solvent welding, and adhesive bonding.

21. The method of claim 19, wherein said sealing of opposed peripheral edges of at least two elongate film layers comprises RF welding.

22. The method of claim 19, wherein said sealing of at least one of said layers to another, intermediate said opposed peripheral edges, to form subcompartments comprises at least one selected from the group consisting of radio frequency (RF) welding, heat impulse welding, solvent welding, and adhesive bonding.

23. The method of claim 19, wherein said sealing of at least one of said layers to another, intermediate said opposed peripheral edges, to form subcompartments comprises RF welding.

24. The method of claim 19, wherein said sealing of opposed peripheral edges of at least two elongate film layers, and said sealing of at least one of said layers to another, intermediate said opposed peripheral edges, to form subcompartments, each comprise RF welding.

25. The method of claim 19, performed with two elongate film layers.

26. The method of claim 19, performed with three elongate film layers.

27. The method of claim 19, wherein the prostate surgery balloon device is constructed and arranged so that said fluid inflation causes sides of the prostate surgery balloon device to be drawn inwardly relative to said lumen axis.

28. The method of claim 19, further comprising disposing a valve in said inflation lumen.

29. The method of claim 19, wherein the at least two elongate film layers comprise at least two layers having different properties from one another, wherein said different properties comprise at least one of different thickness and different modulus of elasticity.

30. The method of claim 19, wherein the elongate compartment and subcompartments are constructed and arranged so that the prostate surgery balloon device articulates to said predetermined shape at pressure of said fluid in a range of from 1 to 10 pounds per square inch (psi).