Valved devices, treatments and methods to restore tissue elastic recoil
In some instances, it is desired to restrict or block airflow to a region of the lung such as to replicate the effects of lung volume reduction surgery. This may be achieved with the use of a pulmonary treatment valve that is implanted minimally invasively without the need for surgery. In some instances, such a valve allows air to flow out of the lobe through the valve when the patient exhales but blocks air from entering the lobe during inhalation. This facilitates emptying the lobe of air over time. This has been shown to be beneficial in the treatment of a population of patients suffering from emphysema. In other instances, the airflow is reduced or restricted rather than blocked. And in still other instances, the airflow is restricted upon exhalation and blocked upon inhalation.
1 . A pulmonary treatment valve for treating a lung by placement within a lung passageway of the lung, the pulmonary treatment valve comprising:
a securing element configured to secure itself to luminal walls of the lung passageway in a manner so as to maintain airflow through the lung passageway;
a sealing element configured to create a seal with the luminal walls of the lung passageway; and
a valve element configured to restrict airflow through the lung passageway to at least 8.1 ml/see at 1 psi in at least one direction.
2 . A pulmonary treatment valve as in claim 1 , wherein the valve element is configured to restrict airflow through the lung passageway to less than 5 ml/see at 1 psi in the at least one direction.
3 . A pulmonary treatment valve as in claim 2 , wherein the valve element is configured to restrict airflow through the lung passageway to less than 2 ml/see at 1 psi in the at least one direction.
4 . A pulmonary treatment valve as in claim 1 , wherein the securing element and the sealing element are formed by a continuous shaft comprising shape memory material, and wherein the continuous shaft has a straightened configuration when constrained and the securing element and the sealing element form from curvatures in the continuous shaft as the continuous shaft transitions toward an unconstrained configuration.
5 . A pulmonary treatment valve as in claim 4 , wherein the sealing element is comprised of a loop and the valve element is disposed within the loop.
6 . A pulmonary treatment valve claim 4 , further comprising a non-extendible midsection that connects the securing element with the sealing element.
7 . A pulmonary treatment valve as in claim 1 , wherein the sealing element is configured to contact a wall of the lung passageway for a width of up to 10 mm along the wall of the lung passageway.
8 . A pulmonary treatment valve as in claim 1 , wherein the valve element comprises a one-way valve.
9 . A pulmonary treatment valve as in claim 8 , wherein the lung passageway leads to a first lobe and wherein the one-way valve allows airflow out of the first lobe and obstructs airflow into the first lobe.
10 . A pulmonary treatment valve as in claim 8 , wherein the one-way valve comprises a duck-bill valve.
11 . A pulmonary treatment valve as in claim 1 , wherein the valve element comprises at least one hole along a blocking element, wherein the blocking element includes at least one surrounding structure that controls expansion of the at least one hole while air is passing therethrough.
12 . A pulmonary treatment valve as in claim 11 , wherein the at least one hole has a diameter of up to 4 mm.
13 . A pulmonary treatment valve as in claim 12 , wherein the at least one hole comprises a plurality of holes.
14 . A pulmonary treatment valve as in claim 1 , wherein the valve element is disposed within the sealing element.
15 . A pulmonary treatment valve for treating a lung by placement within a lung passageway of the lung, the pulmonary treatment valve comprising:
a continuous shaft comprising a shape memory material, wherein the shaft has a straightened shape when in a constrained configuration and a plurality of curves in an unconstrained configuration, wherein the plurality of curves form
a) a securing element configured to secure itself to luminal walls of the lung passageway in a manner so as to maintain airflow through the lung passageway, and
b) a sealing element configured to create a seal with the luminal walls of the lung passageway; and
a valve element configured to restrict airflow through the lung passageway to at least 8.1 ml/see at 1 psi in at least one direction.
16 . A pulmonary treatment valve as in claim 15 , wherein the continuous shaft comprises a first end and second end, and wherein the sealing element is disposed between the first end and the second end.
17 . A pulmonary treatment valve as in claim 16 , wherein the first end and the second end are arranged so as to be simultaneously deployable from a lumen of a delivery device prior to deployment of the sealing element.
18 . A pulmonary treatment system for treating a lung comprising:
a securing element configured to secure itself to luminal walls of the lung passageway;
a sealing element configured to create a seal with the luminal walls of the lung passageway; and
a valve element configured to restrict airflow through the lung passageway to at least 8.1 ml/see at 1 psi in at least one direction, wherein the valve element is comprised of a material that has undergone a treatment to prevent or reduce bacterial adhesion.
19 . A pulmonary treatment system as in claim 18 , wherein the valve element is comprised of silicone.
20 . A pulmonary treatment system as in claim 18 , wherein the treatment includes a preliminary activation/oxidation step is utilized to change the surface polarity of the material by providing polar groups onto the surface as hydroxyl or hydroperoxide groups and/or wherein the treatment includes a replacement of at least one methyl silicone group (Si—CH3) of a PDMS siloxane backbone by reactive at least one silanol group (Si—OH).
21 . A pulmonary treatment system as in claim 18 , wherein the treatment includes exposing the material to an energy source that delivers highly reactive molecules and/or wherein the treatment includes plasma treatment, corona discharge, UV irradiation, or the combination of UV and ozone.