Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-21
2002-06-04
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S035000, C604S107000, C604S164030, C604S164130
Reexamination Certificate
active
06398775
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical apparatus, systems, methods, and kits. More particularly, the present invention relates to methods and apparatus for isolating sub-bronchial regions of the lung and delivering or retrieving substances from such isolated regions.
Lung access and isolation is of interest in numerous therapeutic and diagnostic medical procedures. In particular, access to the lungs is useful for both local and systemic drug delivery, lung lavage, visual assessment and diagnosis of lung function, and the like.
For drug delivery, access is most simply achieved by introducing an aerosol to the lungs through the mouth or nose, and a variety of inhalers, nebulizers, metered dose inhalers (MDIs), nasal sprayers, and the like, have been developed over the years. While very effective for many drugs, delivery through the mouth or nose can be very inefficient, often with less than 20% of the drug reaching circulation or a targeted local treatment region. Moreover, inhalation through the mouth or nose is not able to target drug delivery to a particular region of the lungs. While this may not be a problem for systemic delivery, it can be a significant drawback in the treatment of localized disease where a highly controlled delivery profile would be preferred.
In an effort to overcome at least some of these shortcomings, a variety of endotracheal drug delivery and lung lavage systems have been developed. Most simply, an endotracheal or tracheostomy tube having an inflatable cuff at its distal end may be placed in a patient's trachea and used to deliver a drug aerosol to the whole of the lungs. While this can improve the efficiency of drug delivery (reducing the amount of drug deposited in the nasal passages or throat), it helps little in targeting treatment within any particular region of the lungs. Thus, it has been further proposed to use a secondary catheter placed through an endotracheal or tracheostomy tube for selectively isolating the left or right bronchus. For example, the secondary catheter can have an inflatable cuff which is positioned immediately beyond the main branching between the left and right bronchi. One of the bronchi can then be accessed through the secondary catheter while the other is accessed through the tracheal tube. Such systems are described, for example, in U.S. Pat. Nos. 5,285,778 and 5,660,175. While such systems offer significant benefits over the use of an endotracheal tube by itself, they still do not permit isolation of sub-bronchial regions of the lung for drug delivery, lavage, or any other purpose.
A system for bronchoalveolar lavage which can isolate a sub-bronchial region of the lung is described in published Application No. WO 92/10971. A co-axial catheter system is placed through an endotracheal tube, with the inner most catheter having an isolation wedge or balloon which can be positioned in a remote bronchiole to effect isolation of a distal region of the lung. The outer catheter has no capability for isolating the lung and is used, for example, for ventilating the lung proximal to the isolation cuff. While potentially an improvement over prior systems, the apparatus of WO 92/10971 will be very difficult to position, making targeting of particular sub-bronchial regions very difficult. Moreover, the inability to isolate a bronchus upstream from the distal isolation cuff limits the ability to selectively treat different regions of the bronchus in different ways. That is, while the particular sub-bronchial region which is isolated by the distal isolation cuff may be treated in one way, the remainder of that bronchus as well as the entire other lung must be ventilated and treated in a common manner through either the endotracheal tube or the outer catheter of the co-axial catheter pair.
For these reasons, it would be desirable to provide improved apparatus, systems, methods, and kits for the treatment and diagnosis of selected regions of a patient's lungs, particularly a lobar or targeted sub-lobar regions of the patient's lungs. The present invention should provide for the efficient delivery of pharmaceutical and other substances to the targeted sub-lobar regions of the lung. Moreover, in some embodiments, the present invention should be able to provide at least a second level of isolation within a particular bronchus and/or the ability to instill the pharmaceuticals or other substances at a point significantly distal to a point of isolation within the bronchus. The systems and apparatus of the present invention should be capable of being positioned precisely to a targeted bronchi within the bronchus, preferably providing on-board visualization while components of the system are positioned over a guidewire. Additionally, the apparatus, systems, methods, and kits of the present invention should be suitable for a wide variety of purposes, including pharmaceutical drug delivery, lung lavage (optionally in combination with drug delivery), diagnosis (optionally in combination with lung lavage), and the like. In particular, the present invention should be useful for localized drug delivery where a particular drug or other therapeutic agent can be delivered to a well-defined, isolated sub-bronchial region of the lung (as defined hereinafter) with little or no delivery to other regions of the lung. At least some of these objectives will be met by the inventions described hereinafter.
2. Description of the Background Art
WO 92/10971 describes a bronchoalveolar lavage catheter system having an outer catheter and an inner catheter with an enlarged (optionally inflatable) tip which is advanced until the tip wedges in a bronchiole of the patient. A region of the lungs distal to the enlarged tip may then be lavaged to retrieve sample. U.S. Pat. Nos. 5,660,175; 5,653,231; 4,716,896; and 4,453,545, describe single and co-axial catheter systems for accessing a patient's lungs. U.S. Pat. No. 5,285,778, describes a co-axial endoscopic lung access system. U.S. Pat. Nos. 5,309,903 and 5,207,220 describe systems for administering liquid pharmaceutical formulations to an isolated lung.
SUMMARY OF THE INVENTION
The present invention provides improved apparatus, systems, methods, and kits for isolating lobar and sub-lobar regions of a patient's lungs. The isolated region will be a portion (not the whole) of the right or left lung, and isolation will be accomplished by occluding a bronchial passage at at least one location in the lobar, segmental, and subsegmental bronchus. Thus, a primary occlusion will be formed after both the main bifurcation of the trachea and a further bifurcation into the lobar bronchus. Optionally, the lobar and/or sub-lobar region can be further isolated at at least one secondary location distal to the primary point of isolation and usually after further branching of the bronchial passages. Isolation at the primary location and optional additional locations within the bronchial passages will usually be effected by expansion of an occlusion member, such as an inflatable cuff, inflatable balloon, or the like.
Once the lobar or sub-lobar region has been isolated, a variety of therapeutic and diagnostic procedures can be performed within the isolated region. For example, pharmaceutical formulations including small molecule drugs, biological macromolecular drugs, and the like, can be specifically delivered to the isolated region with minimal or no cross-delivery to other regions of the lungs. Similarly, lavage may be performed within the isolated region with minimal impact on adjacent regions of the lungs. Isolation of the lobar or sub-lobar region permits such drug delivery and lavage procedures to be further controlled by control of the volumes, rates, pressures, temperatures, repetitions, retention times, and other method and system parameters. For example, the pressure within the isolated region can be controlled separately from the pressure or pressures maintained outside of the isolated region. In this way, a variety of delivery parameters
Kotmel Robert
Perkins Rodney A.
Soltesz Peter P.
Casler Brian L.
Pulmonx
Thissell Jeremy
Townsend and Townsend / and Crew LLP
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