Resorbable hollow devices for implantation and delivery of therapeutic agents

• US 9,662,152 B2
• Filed: 04/15/2009
• Issued: 05/30/2017
• Est. Priority Date: 02/16/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Tai, Joseph, Riley, Susan Lynn, Vaccaro, Alexander R.
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US12/424,140
• Publication Number:
  US 20090259177A1
• Time in Patent Office: 2,967 Days
• Field of Search: 623 1711, 623 1712, 623 1716, 606 92- 94, 606 62, 606 63, 606 67, 606 68
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 restoring bone, comprising:

identifying a cavity within an interior of a vertebra bone;

inserting a first resorbable balloon through an access passageway to the interior of the vertebra bone and into the cavity;

inserting a second resorbable balloon through the access passageway to the interior of the vertebra bone and into the cavity such that the second resorbable balloon is nested within the first resorbable balloon, wherein the inserting of the second resorbable balloon occurs after the inserting of the first resorbable balloon;

injecting a therapeutic agent into at least one of the first and second resorbable balloons;

wherein the first and second resorbable balloons remain in the cavity for an amount of time until the first and second resorbable balloons degrade, thereby allowing the therapeutic agent to be delivered into contact with an interior surface of the cavity.

2. The method of claim 1, wherein the one of the first and second resorbable balloons includes a conduit.

3. The method of claim 1, wherein the therapeutic agent is injected into one of the first and second resorbable balloons through a catheter.

4. The method of claim 1, wherein the therapeutic agent is bone cement.

5. The method of claim 1, wherein the therapeutic agent is bone cement mixed with at least one of antibiotic, analgesic, and growth factor.

6. A method of restoring bone, comprising:

identifying a cavity within an interior of a vertebra bone;

inserting a plurality of resorbable balloons through an access passageway to the interior of the vertebra bone and into the cavity, wherein the plurality of resorbable balloons include a first resorbable balloon and a second resorbable balloon, and further wherein the first resorbable balloon is nested within the second resorbable balloon;

injecting at least one therapeutic agent into at least one of the first and second resorbable balloons, wherein the at least one therapeutic agent includes bone cement mixed with at least one of antibiotic, analgesic, and growth factor;

wherein the first and second resorbable balloons remain in the cavity for an amount of time until the first and second resorbable balloons degrade, thereby allowing the at least one therapeutic agent to be delivered into contact with an interior surface of the cavity, and

wherein the at least one of the first and second resorbable balloons includes a conduit as a continuous part.

7. A method of restoring bone, comprising:

identifying a cavity within an interior of a vertebra bone;

inserting a plurality of resorbable balloons through an access passageway to the interior of the vertebra bone and into the cavity, wherein the plurality of resorbable balloons include a first resorbable balloon and a second resorbable balloon, and further wherein the first resorbable balloon is nested within the second resorbable balloon;

injecting at least one therapeutic agent into at least one of the first and second resorbable balloons, wherein the at least one therapeutic agent includes bone cement mixed with at least one of antibiotic, analgesic, and growth factor;

wherein each of the first and second resorbable balloons degrades at a different time and remains in the cavity until it degrades, thereby allowing the at least one therapeutic agent to be delivered into contact with an interior surface of the cavity.

8. The method of claim 7, wherein the at least one of the first and second resorbable balloons includes a conduit.

9. The method of claim 8, wherein the conduit is attached to an opening in at least one of the first and second resorbable balloons.

10. The method of claim 9, wherein the opening in the at least one of the first and second resorbable balloons is closed after the at least one therapeutic agent is injected into the at least one of the first and second resorbable balloons.

11. The method of claim 8, wherein the conduit is formed as a continuous part of the at least one of the first and second resorbable balloons.

12. The method of claim 8, wherein an opening in the at least one of the first and second resorbable balloons is closed after the at least one therapeutic agent is injected into the balloon with the conduit.

13. The method of claim 7, wherein at least one of the first and second resorbable balloons degrades substantially completely.

14. The method of claim 7, wherein at least one of the first and second resorbable balloons is inserted through an access passageway to the interior of the vertebra bone into the cavity using a catheter.

15. The method of claim 14, wherein the at least one therapeutic agent is injected into at least one of the first and second resorbable balloons through the catheter.

16. The method of claim 7, wherein the at least one therapeutic agent is injected into at least one of the first and second resorbable balloons through a catheter.

17. The method of claim 7, wherein injecting the at least one therapeutic agent into at least one of the first and second resorbable balloons at least partially inflates the at least one resorbable balloon.

18. The method of claim 7, wherein at least one of the first and second resorbable balloons is at least partially deflated before the at least one therapeutic agent is injected into the at least one resorbable balloon.

19. The method of claim 7, wherein at least one of the first and second resorbable balloons includes one of varying thickness or small perforations in an exterior surface adjusted to achieve a desired rate of delivery of the at least one therapeutic agent.