Expandable fluoropolymer device for delivery of therapeutic agents and method of making

• US 20050154416A1
• Filed: 02/28/2005
• Published: 07/14/2005
• Est. Priority Date: 01/25/1999
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Martakos, Paul, Karwoski, Theodore, Herweck, Steve A., Gingras, Peter H.
• Granted Patent: US 7,740,793 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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: B29C 2049/465 being incompressible
• CPC Class Codes: B29C 48/00 Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor extrusion blow-moulding B29C49/04
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• 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 2305/026 Porous
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A method of making a radially expandable fluid delivery device includes providing a tube of biocompatible fluoropolymer material with a predetermined porosity based on an extrusion and expansion forming process, applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension, and removing the radial expansion force. The tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device.

Claims

1. A method of manufacturing a radially expandable fluid delivery device, comprising:

providing a tube of biocompatible fluoropolymer material having a microstructure of nodes interconnected by fibrils, wherein the microstructure has a predetermined porosity based on an extrusion and expansion forming process;

applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension; and

removing the radial expansion force;

wherein the tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension.

2. The method of claim 1, wherein the step of providing a tube of biocompatible fluoropolymer material comprises the steps of:

creating a billet by blending a mixture of a fluoropolymer and a lubricant and compressing the mixture;

extruding the billet to form an extruded article having a longitudinal axis;

removing the lubricant from the extruded article;

expanding the extruded article to form the tube of biocompatible fluoropolymer material having a microporous structure; and

heat setting the tube.

3. The method of claim 2, further comprising varying at least one process parameter to achieve a porosity of the tube of biocompatible fluoropolymer material sufficient for a pressurized fluid to permeate through the wall.

4. The method of claim 1, wherein the step of applying a radial expansion force comprises:

inserting a balloon into the tube; and

inflating the balloon to apply the radial expansion force to the tube.

5. The method of claim 4, wherein the balloon is expanded by inflation caused by the introduction of a pressurized fluid into the balloon.

6. The method of claim 1, further comprising:

providing a mold having an internal cavity of predefined size and shape;

positioning the tube within the internal cavity; and

applying the radial expansion force to the tube with a balloon disposed within the tube, while the tube remains positioned in the internal cavity of the mold.

7. The method of claim 1, wherein an outer surface of the radially expandable fluid delivery device is hydrophilic.

8. The method of claim 1, wherein an outer surface of the radially expandable fluid delivery device is hydrophobic.

9. The method of claim 1, wherein an outer surface of the radially expandable fluid delivery device is at least partially hydrophilic and at least partially hydrophobic.

10. The method of claim 1, wherein the radially expandable fluid delivery device is formed of multiple layers.

11. The method of claim 1, wherein the radially expandable fluid delivery device has a hydraulic conductivity less than 1000 (cm⁴/(dyne*s)*10¹²).

12. The method of claim 1, wherein the predetermined porosity is sufficient to allow fluid to pass through at a flow rate of approximately 0.01 ml/min to 100 ml/min.

13. The method of claim 1, wherein the radially expandable fluid delivery device has a unitary construction of generally homogenous material.

14. The method of claim 1, wherein the radially expandable fluid delivery device is configured to receive the inflation force being generated by a fluid including a medicinal agent.

15. The method of claim 14, wherein the medicinal agent is selected from the group consisting of thrombolytics, antibiotics, antisense oligonucleotides, chemotherapeutics, surfactants, diagnostic agents, steroids, vasodilators, vasoconstrictors, and embolic agents.

16. The method of claim 1, wherein the radially expandable fluid delivery device comprises a microporous wall portion bordering a second wall portion generally impermeable to pressurized fluid providing the inflation force.

17. The method of claim 1, wherein the radially expandable fluid delivery device comprises a generally impermeable wall portion interposed between a first microporous wall portion and a second microporous wall portion.

18. The method of claim 1, wherein the radially expandable fluid delivery device comprises a microporous wall portion of the predetermined porosity bordering a second wall portion modified to have a different porosity.

19. The method of claim 1, wherein the radially expandable fluid delivery device comprises a medical treatment device for treating a body vessel, the radially expandable fluid delivery device having a microporous portion with a hydraulic conductivity less than a hydraulic conductivity of the body vessel.

20. A method of manufacturing a radially expandable fluid delivery device, comprising:

providing a tube of biocompatible fluoropolymer material having a microstructure of nodes interconnected by fibrils, wherein the microstructure has a predetermined porosity based on an extrusion and expansion forming process;

applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension; and

removing the radial expansion force;

wherein the tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension; and

wherein the microstructure includes at least one microporous portion of micro-channels and the predetermined porosity is sufficient for a fluid to inflate the fluid delivery device and permeate through the at least one microporous portion of micro-channels at a controlled rate of permeation.