RESORBABLE HOLLOW DEVICES FOR IMPLANTATION AND DELIVERY OF THERAPEUTIC AGENTS

• US 20100065989A1
• Filed: 11/23/2009
• Published: 03/18/2010
• Est. Priority Date: 02/16/2005
• Status: Abandoned Application

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Alexander R. Vaccaro
• Inventors: VACCARO, ALEXANDER R., RILEY, SUSAN LYNN, TAI, JOSEPH
• Application Number:
  US12/624,217
• Publication Number:
  US 20100065989A1
• Time in Patent Office: Days
• US Class Current: 264/535
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/8813 Discharging means for excessively introduced fluid fillers, e.g. discharging excess cement
• CPC Class Codes: A61B 2017/883 Means for indicating hardening of bone cement
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• 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 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: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A method of manufacturing a resorbable balloon designed to contain bone cement for vertebroplasty or kyphoplasty applications is described. The resorbable balloon can be inserted into a vertebral body following vertebral cavitation and filled with bone cement. The balloon remains in place in the vertebral body and resorbs over time. Methods and apparatus are also described for delivering therapeutic agents using collapsible, resorbable balloons. The balloons may be nested and filled with various therapeutic agents that are released over time at rates dependent upon structures and degradation rates of the balloons. Furthermore, the function of the hollow devices can encompass both encapsulation and therapeutic substance delivery roles simultaneously.

Claims

1. A method of forming a resorbable balloon, comprising:

placing a resorbable tube in a mold, the tube having two side parts and a region therebetween with a lumen and a lumen axis, and having a wall thickness of about 0.1 mm to about 3 mm;

performing one or more of heating and cooling of the region and pulling the tube along the axis, thereby thinning the wall of the tube at the region, wherein the performing comprises cooling;

forcing a gas or liquid through the lumen while heating the region, thereby causing the region to expand and form a balloon with the wall thickness being reduced to about 0.005 mm to about 0.1 mm;

sealing one of the side parts in proximity to the balloon so that the lumen is obstructed only at the side part; and

inserting a nonporous resorbable hollow device through the lumen near the other side part and into the balloon, the device being catheterless, expandable, and having a cavity extending from a first portion that is sealed to a second portion that is coaxial with the other side part.

2. The method as set forth in claim 1, wherein the performing is preceded by:

extruding resorbable tubing; and

cutting the extruded tubing to desired lengths, thereby forming the tube.

3. The method as set forth in claim 1, wherein the one side part is sealed before forcing a gas or liquid through the lumen of the tube.

4. The method as set forth in claim 3, wherein:

the sealing comprises at least one of thermally welding or heat sealing the tube; and

the sealing is followed by removing excess tubing beyond the sealed point.

5. The method as set forth in claim 1, wherein the performing comprises providing heat from an element in different, non-zero amounts along a direction of the element that is about parallel to the longitudinal axis of the tube.

6. The method as set forth in claim 1, wherein the liquid or gas is heated air.

7. A method of forming a resorbable balloon, comprising:

providing a resorbable tube;

supplying with an element one or more of heating and cooling emissions to a region of the resorbable tube, the region being disposed along a longitudinal axis of the resorbable tube and corresponding to a supplying portion of the element, the one or more of heating and cooling emissions being supplied from the supplying portion in different amounts along a dimension that is about parallel to the longitudinal axis and impinging on the region in different amounts along the longitudinal axis, wherein the supplying comprises cooling;

forcing a gas or liquid through a lumen of the resorbable tube while supplying the one or more of heating and cooling emissions to the region of the resorbable tube, thereby causing a portion of the resorbable tube to expand and form a balloon; and

disposing a nonporous resorbable hollow device in the lumen and the balloon, the device being catheterless, expandable, and having a cavity that extends without obstruction along the longitudinal axis from a sealed end to an opposing end and that is coaxial with the lumen whereby the cavity is obstructed only at the sealed end.

8. The method as set forth in claim 7, wherein the supplying comprises heating the region of the resorbable tube, the heating emissions contacting the region in different amounts along the longitudinal axis of the resorbable tube.

9. The method as set forth in claim 7, wherein:

the providing comprises proving the resorbable tube with a wall thickness ranging from about 0.1 mm to about 3 mm; and

the forcing comprises forming a balloon with the wall thickness being reduced from the range of 0.1 mm to about 3 mm to a range from about 0.005 mm to about 0.1 mm.

10. The method as set forth in claim 9, wherein the supplying and the forcing are performed in a single mold.

11. The method as set forth in claim 9, wherein the supplying is performed by cooling the region of the resorbable tube, the cooling emissions contacting the region in different amounts along the longitudinal axis of the resorbable tube.

12. The method as set forth in claim 7, wherein the supplying comprises heating the region of the resorbable tube, the heating emissions contacting the region in different amounts along the longitudinal axis of the resorbable tube.

13. The method as set forth in claim 12, wherein the supplying and the forcing are performed in the same mold.

14. The method as set forth in claim 7, wherein the supplying comprises heating.

15. The method as set forth in claim 7, wherein the supplying comprises heating, which is preceded by:

extruding resorbable tubing;

cutting tubing to desired lengths, thereby forming the plurality of resorbable tubes; and

the element is a heating coil with different resistances along the supplying portion thereof for causing the one or more heating and cooling emissions to be supplied from the supplying portion in different amounts along the dimension.

16. The method as set forth in claim 7, wherein the supplying is performed by cooling the region of the resorbable tube, the cooling emissions being provided in different amounts along the longitudinal axis of the resorbable tube.

17. A method of forming a resorbable balloon, comprising:

providing a resorbable tube;

generating one or more of heating and cooling emissions along a first dimension of an element, the element having a longitudinal axis that is about parallel with the first dimension, and the one or more of heating and cooling emissions being received by the resorbable tube along a second dimension of the resorbable tube that is about parallel to a longitudinal axis of the resorbable tube, the one or more of heating and cooling emissions being generated in different amounts along the first dimension of the element, wherein an orientation of the longitudinal axis of the element is about the same as an orientation of the longitudinal axis of the resorbable tube, wherein the generating comprises cooling;

forcing a gas or liquid through a lumen of the resorbable tube while generating the one or more of heating and cooling emissions, thereby causing a portion of the resorbable tube to expand and form a balloon; and

inserting a nonporous resorbable device through the lumen and into the balloon, the device being catheterless and expandable, and having two opposing ends and an unobstructed hollow interior extending therebetween along the longitudinal axis and coaxially with the lumen.

18. The method as set forth in claim 17, wherein:

the providing comprises proving the resorbable tube with a wall thickness ranging from about 0.1 mm to about 3 mm; and

the forcing comprises forming a balloon with the wall thickness being reduced from the range of 0.1 mm to about 3 mm to a range from about 0.005 mm to about 0.1 mm.

19. The method as set forth in claim 17, wherein the generating and the forcing are performed in a single mold.

20. The method as set forth in claim 17, wherein the element is a coil with different resistances along the first dimension thereof for causing the one or more heating and cooling emissions to be generated in different amounts along the first dimension.