Resorbable hollow devices for implantation and delivery of therapeutic agents

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 60 / 653,778, filed Feb. 16, 2005 and entitled RESORBABLE BALLOON FOR BIOMEDICAL IMPLANTATION, and U.S. Provisional Application No. 60 / 672,839, filed Apr. 18, 2005 and entitled RESORBABLE HOLLOW DEVICES FOR DELIVERY OF THERAPEUTIC AGENTS, the entire contents of both which are hereby incorporated by reference. This application also relates to U.S. application Ser. No. 10 / 129,214 (Docket MA9263P), filed Oct. 21, 2002 and entitled TIME-RELEASED SUBSTANCE DELIVERY DEVICE, the entire contents of which are hereby incorporated by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to implants and, more particularly, to biomedical balloons and applications employing such balloons. [0004] 2. Description of Related Art [0005] Balloon catheters have been employed in angioplasty applications for many years. A cathe...

AI Technical Summary

Benefits of technology

[0013] The present invention further provides apparatus and methods that may avoid problems associated with prior art methods of delivering therapeutic agents. Delivery methods and devices of various embodiments of the present invention may provide delivery of therapeutic agents while avoiding or attenuating problems associated with one or more of: combinations of the therapeutic agent with a delivery material or vehicle, diffusion through a material of the delivery device, implantation of multitudes of small delivery devices, and open surgical procedures. The invention herein disclosed thus can employ resorbable hollow devices which can be introduced into a desired anatomical location with, in many instances, a minimum of trauma. As an example, an implementation of a method according to the present invention can comprise a first collapsible resorbable hollow device, such as a resorbable balloon. A surgical procedure, which may be a laparoscopic procedure, may be performed to generate a cavity in a desired anatomical location of a body of a patient. The resorbable hollow device may be deflated, and subsequently inserted into the cavity. At least one therapeutic agent may be injected into the first collapsible resorbable hollow device. According to another implementation of the method, a second collapsible resorbable hollow device may be provided, and the second device may be inserted into the first collapsible resorbable hollow device. At least one therapeutic agent then may be injected into the second collapsible resorbable hollow device. Various therapeutic agents may be injected according to typical implementations of the present invention. For example, a therapeutic agent may comprise one or more of a natural organic substance, a synthetic organic substance, an inorganic substance, and combinations thereof.

Problems solved by technology

Inflating the balloon may cause pieces of the fracture to return to a positions or orientations approximating those existing before for example a traumatic event that caused the fracture.

Unfortunately, cement extravasation can be a problem in these kyphoplasty and vertebroplasty situations.

For instance, cement inserted into bone may extrude into surrounding tissues and nerves, causing pain and other complications.

Such a solution may not always be viable due for example to confounding factors such as situations wherein the presence of the balloon may prevent bonding between the bone cement and the bone tissue of interest.

Consequently, gaps may form between an outer surface of the balloon and surrounding bone, introducing for example attendant risks of infection, bone loss, and pain.

Systemically delivered medicinal substances can be inefficient when only a small amount of the administered dose reaches the site sought for therapeutic action.

Moreover, with systemic delivery a medicinal substance can enter parts of the body where it can actually do harm or produce a noxious side effect.

In some cases the therapeutic agent is destroyed, denatured, or looses its activity when combined with the delivery vehicle or material.

In other cases, controlled delivery devices rely on diffusion of the therapeutic agent from the delivery material or vehicle, but the therapeutic agent may be too large to diffuse through a delivery material matrix of the controlled delivery device at a reasonable rate.

The microspheres, however, may be difficult to retrieve if there is a complication.

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