Source: http://www.docstoc.com/docs/82146380/Device-And-Method-For-Intra-bronchial-Provision-Of-A-Therapeutic-Agent---Patent-7942931
Timestamp: 2015-03-05 01:35:57
Document Index: 613539721

Matched Legal Cases: ['Application No. 03', 'Application No. 2003219927', 'Application No. 2', 'Application No. 2', 'Application No. 2', 'Application No. 200780019455', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 03', 'Application No. 2003', 'Application No. 10', 'Application No. 2', 'Application No. 03', 'Application No. 2', 'Application No. 09739872', 'Application No. 11', 'art\n1']

Device And Method For Intra-bronchial Provision Of A Therapeutic Agent - Patent 7942931
82146380
There is a continuing need for improved minimally invasive delivery of therapeutic agents to all portions of the respiratory system, particularly the lungs, bronchi and bronchioli, blood vessels, and lymphatic system. There is also a continuingneed for improved minimally invasive access to lung tissue and structures. The airways in the lungs anatomically constitute an extensive network of conduits that reach all lung areas and lung tissues. The airways have extensive branching that distally communicates with the parenchyma alveoli where gas exchange occurs,and proximally with the trachea and atmosphere (air). Because of the physiological characteristics of the airways, a therapeutic agent placed in bronchi and bronchioli may be delivered focally, localized, or systemically depending on the agent and themanner in which it is placed. Historically, there has been a limited use of airways for delivery of therapeutic agents, diagnostic procedures, and instrumentation for invasive procedures. The airways have successfully been used for delivery of certain small particletherapeutic agents, such as inhalers for asthma, administration of gas anesthesia, and for introduction of certain visual diagnostic tools in conjunction with a bronchoscope. Through the bronchoscope, a limited number of invasive procedures are nowbeing performed, including biopsies and removal of foreign objects. Treatment of certain lung diseases and conditions would benefit from targeted intra-bronchial delivery of therapeutic agents into the involved regions, particularly those associated with the lungs such as pneumonia and lung cancer. Treatmentwould be further benefited if the therapeutic agent is generally confined to the involved regions. For example, treatment of a disease such as pneumonia will benefit by being able to deliver an antibiotic to the specific lung region involved. Furthermore, treatment of lung cancer may benefit from non-invasive brachytherapy. However, the full potential
United States Patent: 7942931
7,942,931
method for providing a therapeutic agent to a patient. A device includes
a flow control member for placement in an air passageway communicating
with a lung portion, and when deployed in the air passageway inhibits a
therapeutic agent distal of the control member from moving proximal of
the control member, and includes the therapeutic agent associated with
the flow control member. The control member may inhibit movement of the
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10/317,667 (now U.S. Pat. No. 6,929,637), filed on Dec. 11, 2002, which
is a continuation-in-part of and claims priority based on United States
applications entitled INTRA-BRONCHIAL AIRFLOW CONTROL DEVICE THAT
CONTROLS BIOLOGICAL INTERACTION WITH THE PATIENT filed Feb. 21, 2002,
application Ser. No. 10/081,712 now abandoned; and INTRA-BRONCHIAL
AIRFLOW CONTROL DEVICE THAT CONTROLS BIOLOGICAL INTERACTION WITH THE
PATIENT filed Jun. 21, 2002, application Ser. No. 10/178,073 now
abandoned. The entire contents of each of the above-noted prior patent
applications are hereby incorporated by reference herein and made a part
1.  An intra-bronchial device for maintaining a therapeutic agent within an air passageway, the device comprising: a flow control member arranged for placement in an air
passageway and inhibiting the therapeutic agent from moving proximal of the flow control member;  at least one anchor associated with the flow control member, the at least one anchor having a linear elongate portion with a first end and second end, the
first end of the linear elongate portion coupled to the flow control member, the second end of the linear elongate portion extending away from the flow control member, the linear elongate portion comprising more than one bend configured to allow the at
least one anchor to be collapsed for positioning within a delivery catheter;  and the therapeutic agent associated with the flow control member.
2.  The intra-bronchial device of claim 1 further comprising an introducer that introduces the therapeutic agent in a lung portion distal of the flow control member.
3.  The intra-bronchial device of claim 1, wherein the flow control member inhibits movement of the therapeutic agent by limiting flow from the air passageway.
4.  The intra-bronchial device of claim 1, wherein the flow control member inhibits the movement of the therapeutic agent by limiting mucociliary transport from the air passageway.
5.  The intra-bronchial device of claim 1, wherein the flow control member includes a one-way valve.
6.  The intra-bronchial device of claim 5, wherein the at least one anchor is positioned proximally relative to the one-way valve, and the one-way valve is positioned to permit inhalation of air into the air passageway, and the intra-bronchial
device to prevent exhalation of air from the air passageway.
7.  The intra-bronchial device of claim 5, wherein the at least one anchor is positioned distally relative to the one-way valve, and the one-way valve is positioned to permit exhalation of air from the air passageway.
8.  The intra-bronchial device of claim 1, wherein the flow control member includes a flexible membrane impervious to air flow.
9.  The intra-bronchial device of claim 8, wherein the flexible membrane is arranged in cooperation with a wall of the air passageway to form a one-way valve permitting airflow from the air passageway.
10.  The intra-bronchial device of claim 8, wherein the flexible membrane is arranged in cooperation with a wall of the air passageway to form a one-way valve permitting airflow into the air passageway.
11.  The intra-bronchial device of claim 1, wherein the flow control member includes a separator arranged to inhibit the movement of the therapeutic agent while allowing movement of air.
12.  The intra-bronchial device of claim 11, wherein molecules of the therapeutic agent are associated with molecules larger than air molecules, and the separator is arranged to inhibit movement of the associated molecules while allowing
movement of air molecules.
13.  The intra-bronchial device of claim 1, wherein the flow control member includes a semi-permeable membrane arranged to retain the therapeutic agent distal of the control member while permitting air and water molecules to be exhaled.
14.  The intra-bronchial device of claim 1, wherein the flow control member allows airflow from the air passageway sufficiently to prevent over-inflation of a lung portion.
15.  The intra-bronchial device of claim 1, wherein the flow control member is further arranged to automatically terminate the inhibiting of movement by the therapeutic agent.
16.  The intra-bronchial device of claim 1, wherein the flow control member is further arranged to permit mucociliary transport from the air passageway.
17.  The device of claim 1, wherein the therapeutic agent is one of antimicrobial agents such as adrenergic agents, antibiotic agents or antibacterial agents, antiviral agents, anthelmintic agents, anti-inflammatory agents, antineoplastic
agents, antioxidant agents, biological reaction inhibitors, botulinum toxin agents, chemotherapy agents, diagnostic agents, gene therapy agents, hormonal agents, mucolytic agents, radioprotective agents, radioactive agents including brachytherapy
materials, tissue growth inhibitors, tissue growth enhancers, and vasoactive agents.
18.  The intra-bronchial device of claim 1, wherein the linear elongate portion comprises a first portion and a second portion, the second portion forming a substantially perpendicular angle relative to a central axis extending between distal
and proximal ends of the device.
19.  The intra-bronchial device of claim 1, wherein the flow control member further comprises at least one support member having a curved end for allowing removal of the device.
20.  The intra-bronchial device of claim 1 further comprises a central support structure to carry the flow control member, the central support structure configured to extend proximally to allow a removal device to engage and remove the device.
21.  The intra-bronchial device of claim 1, wherein the therapeutic agent is carried by the flow control member.
22.  The intra-bronchial device of claim 1, wherein the therapeutic agent is absorbed into a portion of the flow control member.
23.  The intra-bronchial device of claim 1, wherein the flow control member is configured to prevent exhalation airflow from a lung portion.
24.  The intra-bronchial device of claim 1, wherein the flow control member further comprises at least one lip configured to open when air pressure in the lung portion exceeds a threshold level to allow exhalation airflow from the lung
The invention also provides an assembly including a therapeutic agent arranged for intra-bronchial delivery into an air passageway of a patient, and a flow control member arranged for placement in the air passageway and inhibiting the
therapeutic agent from moving proximal of the control member.  The flow control member may be arranged to allow the therapeutic agent to be associated with the flow control member after the flow control member is placed in the air passageway.  The flow
control member may be arranged to allow the therapeutic agent to be placed into the air passageway distal of the flow control member after the flow control member is placed in the air passageway.
The invention also provides an intra-bronchial device for providing a therapeutic agent to a patient.  The device including means for delivering a therapeutic agent into an air passageway of the patient, and means for intra-bronchially
inhibiting movement of the therapeutic agent from the air passageway.  The movement may be inhibited by limiting exhalation from the air passageway, by limiting inhalation into the air passageway, and/or by limiting movement of mucus from the air
In the following detailed description of exemplary embodiments of the invention, reference is made to the accompanying drawings that form a part hereof.  The detailed description and the drawings illustrate specific exemplary embodiments by
A characteristic of a healthy respiratory system is the arched or inwardly arcuate diaphragm 26.  As the individual inhales, the diaphragm 26 straightens to increase the volume of the thorax 22.  This causes a negative pressure within the
thorax.  The negative pressure within the thorax in turn causes the lung lobes to fill with air.  When the individual exhales, the diaphragm returns to its original arched condition to decrease the volume of the thorax.  The decreased volume of the
thorax causes a positive pressure within the thorax, which in turn causes exhalation of the lung lobes.
Therapeutic agent 105 may be associated with all or any portion of the control member 90 in any manner known to those skilled in the art, and as required by the therapeutic action desired and the limitations of the selected therapeutic agent
105.  Association methods include overlayment, absorption, and imbedding, which may be by any method known to those in the art, including spraying, dipping, ion implantation, and painting.  Alternative embodiments of the invention may include associating
FIG. 9 is a longitudinal sectional view illustrating an intra-bronchial device placed in an air passageway 50 for providing a therapeutic agent 105 to a patient, the control member 90 of the intra-bronchial device having a cavity 110 for
carrying the therapeutic agent 105, in accordance with the invention.  Control member 90 includes a cavity 110 that carries therapeutic agent 105.  While the cavity 110 is illustrated in FIG. 9 as cylindrical in configuration, it may be of any shape.
Radioactive seeds may be carried in cavity 110.  A plurality of intra-bronchial devices may be placed in a lung portion, thus allowing providers to group or cluster the radioactive seeds in a manner similar to that used to treat tumors in other portions
of the body, such as prostate, breast, and brain tumors.
FIG. 13 is a longitudinal sectional view illustrating the intra-bronchial device placed in the air passageway 50.  The intra-bronchial device may be placed in the air passageway 50 using any method known to those skilled in the art, including
the method described in conjunction with FIGS. 3-6.  The one-way valve structure opens to permit inspiration airflow 128 (in the direction indicated by the arrow), but limits exhalation airflow.  This orientation permits air to be inhaled into the distal
bronchioli once smaller devices are developed.  Such miniature intra-bronchial devices 300 may be guided by very small diameter bronchoscopes, or other types of high resolution imaging techniques that may include using ancillary catheters and possibly a
Intra-bronchial device 300 may be any member that does not significantly obstruct flow of air.  For example, the intra-bronchial device carrying therapeutic agent 105 may be a tubular member coated with therapeutic agent 105, which may be
balloon expandable as is known in the art, or may be self-expanding.
"Device And Method For Intra-bronchial Provision Of A Therapeutic Agent - Patent 7942931"
Bronchial Hygiene Techniques(1)