The instant patent of invention relates to artificial bronchi for the treatment of pulmonary emphysema, and may be associated with a one-way valve.
Pulmonary emphysema is a type of chronic obstructive pulmonary disease (COPD), which is characterized by the permanent enlargement of the gas exchange units (acini) associated with the destruction of alveolar walls, without fibrosis.
The destruction of these alveolar walls shows distinct patterns in each person, with different distribution and intensity. This gradual and irreversible rupture of lung tissue leads to the loss of the elastic capacity of lung recoil, namely, the loss of the ability to expel inspired air. As a result, there is a structural derangement of the rib cage, increase of the thorax diameters and diaphragm rectification (air entrapment and hyperinflation).
Areas affected by the disease fill the thoracic cavity, leaving less volume available for the healthy areas of lung tissue perform hematosis. The loss of respiratory capacity leads to a progressive functional disability of individuals with the disease.
Although there is no cure for pulmonary emphysema, there are some forms of treatment, including medicines, muscle training and oxygen therapy. For some more severe cases, a lung volume reduction surgery or lung transplantation may be indicated. While the medicines and muscle training have limited results, the lung volume reduction surgery and lung transplantation are very traumatic, and a very limited number of patients can be submitted to these treatments.
Since the year 2000, several less traumatic alternatives have been proposed to alleviate the suffering of patients with pulmonary emphysema.
a) Methods based on forced scarring of the sick tissue using chemicals or steam to produce mechanical retraction. These techniques are still being assessed and have the risk of producing or accelerating the damage caused by the disease itself after an initial improvement.
b) The European patent EP1524942 describes a self-expanding nitinol endobronchial valve covered by a silicone membrane, which has a structure that allows unidirectional air flow. This valve is implanted in areas close to the affected regions, causing the air accumulated therein to be expelled. Due to its unidirectional characteristic, it does not allow the reentry of air into the affected areas. The problem of this technique is the collateral communication between the entrapped air in the treated area and the remaining parts of the same lung. Another problem is that the working tissue should be excluded, for there to be a beneficial effect.
c) An alternative approach was the creation of ancillary air passages in the bronchi wall, to allow lung emptying. Although this alternative presents a more efficient solution over the affected lung, the existing state of the art results demonstrated the premature closure of these passages.
d) There is also treatment with mechanical retraction of the airways, where nitinol spirals (nickel-titanium alloy) are implanted using a straightened bronchoscope and, after the implant, the covers that keep the spiral straightened are removed, causing it to return to its original conformation, thus performing the retraction of the pulmonary parenchyma. This method is limited due to its irreversibility, inability of using an anticoagulant medication (for circulatory illnesses), a very high risk in patients with high pulmonary arterial pressure and lack of effect on patients affected with an advanced form of the disease, when there is not almost lung parenchyma.
Thus, there is the need for an alternative, a procedure that is not aggressive to the lung and that promotes lung disinsufflation without excluding its healthy areas.
In order to meet the need for an effective form of treatment, which is not an aggressive or an invasive procedure for the body, an implantable artificial bronchus (IAB) was developed.
The IAB, according to the present invention, consists of a tapered cylindrical body, where the upper nozzle is greater than the lower opening, comprising openings along its length and side wings.
In this invention, openings are any kind of side perforation or leakage from a network assembly.
The IAB (1) can be built in two alternative forms, with a silicone body (SB) or a nitinol web body (NWB), wherein both comprise in the body (2) a nozzle (3) and side wings (4), with side openings (5), upper (6) and lower (7) which enable the peripheral range for promoting lung deflation, which may have various longitudinal lengths.
In the SB assembly, the side wings are used for fixing the same in the air way/lung parenchyma, and in the NWB assembly, they enable a better handling, in case of IAB withdrawal.
The NWB embodiment further has silicone or fluoropolymer like polytetrafluoroethylene rings (8) and longitudinal rods (9), of silicone or fluoropolymer like polytetrafluoroethylene, and these structures prevent the incorporation of the nitinol web by the lung wall, and also preserves the possibility of IAB withdrawal in case of rejection or need to reimplant.
Another embodiment of this invention is the association of IAB with a one-way valve, as described in EP1524942—of H. Michael to Emphasys Medical Inc., published on Apr. 27, 2005, incorporated herein by reference. This association prevents lung parenchyma against injuries caused by dry air and moisture reduction, thus avoiding tissue reaction and closure by healing of those openings.
The IAB (1) features a (proximal) upper opening (6) which allows the association with the one-way valve, and also its maintenance, since it allows the removal of the valve, device cleaning with bronchoscope and valve reimplantation. In some embodiments, a length of the implantable artificial bronchus is greater than 5 times a size of a largest diameter of the implantable artificial bronchus. In some embodiments, the diameter of the proximal upper opening is greater than twice the diameter of the distal lower opening. In some embodiments, the body is configured to curve in a first radial direction along a first length of the body and in a second radial direction opposite the first radial direction along a second length of the body.
The use of this device is made by bronchoscopy. Initially, it is necessary to identify the locations where it is desired to carry out the application, through an image study obtained by computed tomography of the thorax, associated or not to a three-dimensional reconstruction program.
After identifying the positions, the application can be performed in two ways, one for IAB with SB, which begins with the passage of the needle for piercing the bronchial wall and introducing the guide wire in the lung parenchyma, and optionally, the balloon dilator can be passed.
The implanting of IAB with NWB does not require perforations into the lung wall. The implant path is initially identified with a malleable metal guide. A subsequent catheter passage can be done to guide the compressed IAB or the compressed IAB can be introduced directly by guidewire. After withdrawing the catheter, the IAB naturally expands and remain on the airway, promoting the enlargement of this path and providing causing lung deflation.
The present invention avoids the state of the art problems, since its cylindrical body allows the implantation without the need for extensive cuts or openings that trigger healing processes, or along the airways. Moreover, in the second embodiment according to the present invention, there is no need for any perforation except eventually for very distal airway. Additionally, its conformation with decreasing radius along the body, with side openings, promotes swirling of the air which enters the IAB. Thus, there is no sudden entry and the air is dispersed more evenly, thus ensuring an efficient and safe distribution, without causing tissue healing.
The use of IAB provides more safety and effectiveness in the treatment of lung emphysema, since it allows the air exit, does not trigger the healing mechanisms and does not destroy or annul the normal lung tissue.
It shall be understood that the embodiments described above are merely illustrative and any modification to them may occur for a person skilled in the art. Therefore, the present invention should not be considered as being limited to the embodiments described in this document.
The person skilled in the art will be able to readily evaluate, by means of the teachings contained in the text and in the presented examples, advantages of the invention, and to propose modifications and equivalent alternatives to the embodiments, without departing from the scope of the invention, as defined in the attached claims.
Number | Date | Country | Kind |
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10 2015 0113765 | May 2015 | BR | national |
This application is a continuation of U.S. patent application Ser. No. 15/156,841, filed on May 17, 2016 entitled “Implantable Artificial Bronchus and Use of an Implantable Artificial Bronchus” which claims priority to Brazilian Patent Application No. 10 2015 011376 5 filed May 18, 2015, each of which is incorporated by reference herein in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
5269802 | Garber | Dec 1993 | A |
D380831 | Kavteladze et al. | Jul 1997 | S |
5667486 | Mikulich et al. | Sep 1997 | A |
5938697 | Killion et al. | Aug 1999 | A |
6168617 | Blaeser et al. | Jan 2001 | B1 |
6409750 | Hyodoh et al. | Jun 2002 | B1 |
D484979 | Fontaine | Jan 2004 | S |
6770101 | Desmond, III et al. | Aug 2004 | B2 |
6792979 | Konya et al. | Sep 2004 | B2 |
7011094 | Rapacki et al. | Mar 2006 | B2 |
D553746 | Fliedner | Oct 2007 | S |
7402169 | Killion et al. | Jul 2008 | B2 |
D612499 | Ondracek et al. | Mar 2010 | S |
7780719 | Killion et al. | Aug 2010 | B2 |
7857844 | Norton et al. | Dec 2010 | B2 |
7896887 | Rimbaugh et al. | Mar 2011 | B2 |
D660967 | Braido et al. | May 2012 | S |
8323351 | Kubena et al. | Dec 2012 | B2 |
8414635 | Hyodoh et al. | Apr 2013 | B2 |
8474460 | Barrett et al. | Jul 2013 | B2 |
8568488 | Stack et al. | Oct 2013 | B2 |
8585628 | Harris et al. | Nov 2013 | B2 |
8623067 | Berez et al. | Jan 2014 | B2 |
8709080 | Marten et al. | Apr 2014 | B2 |
8808360 | Laguna | Aug 2014 | B2 |
D723166 | Igaki et al. | Feb 2015 | S |
8974516 | Hyodoh et al. | Mar 2015 | B2 |
D732666 | Nguyen et al. | Jun 2015 | S |
9173736 | Bertini | Nov 2015 | B2 |
9265634 | Brady et al. | Feb 2016 | B2 |
9265635 | Walak | Feb 2016 | B2 |
9387099 | McHugo | Jul 2016 | B2 |
9388517 | Lilburn et al. | Jul 2016 | B2 |
9539083 | Krimsky et al. | Jan 2017 | B2 |
9539126 | Walsh et al. | Jan 2017 | B2 |
9687367 | Gill et al. | Jun 2017 | B2 |
9895242 | Sheldon et al. | Feb 2018 | B2 |
D834193 | Erzberger | Nov 2018 | S |
10149776 | Brady et al. | Dec 2018 | B2 |
10369030 | Treacy et al. | Aug 2019 | B2 |
D867595 | Armer et al. | Nov 2019 | S |
D883485 | Carpenter et al. | May 2020 | S |
D887003 | Garza et al. | Jun 2020 | S |
20020042564 | Cooper et al. | Apr 2002 | A1 |
20030040804 | Stack et al. | Feb 2003 | A1 |
20030069647 | Desmond, III et al. | Apr 2003 | A1 |
20030083734 | Friedrich et al. | May 2003 | A1 |
20030164168 | Shaw | Sep 2003 | A1 |
20040117031 | Stack et al. | Jun 2004 | A1 |
20040148032 | Rutter et al. | Jul 2004 | A1 |
20040215310 | Amirana | Oct 2004 | A1 |
20050033310 | Alferness | Feb 2005 | A1 |
20050096733 | Kovneristy et al. | May 2005 | A1 |
20050145253 | Wilson et al. | Jul 2005 | A1 |
20050273160 | Lashinski et al. | Dec 2005 | A1 |
20060130830 | Barry | Jun 2006 | A1 |
20070055358 | Krolik et al. | Mar 2007 | A1 |
20080072914 | Hendricksen et al. | Mar 2008 | A1 |
20080221670 | Clerc et al. | Sep 2008 | A1 |
20090157158 | Ondracek et al. | Jun 2009 | A1 |
20090264991 | Paul, Jr. et al. | Oct 2009 | A1 |
20090287299 | Tabor et al. | Nov 2009 | A1 |
20100168839 | Braido et al. | Jul 2010 | A1 |
20100234937 | Wang | Sep 2010 | A1 |
20110017207 | Hendricksen et al. | Jan 2011 | A1 |
20110071613 | Wood et al. | Mar 2011 | A1 |
20110079315 | Norton et al. | Apr 2011 | A1 |
20110146673 | Keast | Jun 2011 | A1 |
20120046728 | Huser et al. | Feb 2012 | A1 |
20120095483 | Babkes et al. | Apr 2012 | A1 |
20120253471 | Tully et al. | Oct 2012 | A1 |
20120259407 | Clerc et al. | Oct 2012 | A1 |
20120296414 | Hartley | Nov 2012 | A1 |
20130066415 | Hocking | Mar 2013 | A1 |
20130103163 | Krimsky et al. | Apr 2013 | A1 |
20130116775 | Roeder et al. | May 2013 | A1 |
20130144372 | Wood et al. | Jun 2013 | A1 |
20140058433 | Barrett et al. | Feb 2014 | A1 |
20140074220 | Clerc et al. | Mar 2014 | A1 |
20140082924 | Lundkvist et al. | Mar 2014 | A1 |
20140180393 | Roeder | Jun 2014 | A1 |
20140288588 | Lam et al. | Sep 2014 | A1 |
20150051709 | Vasquez et al. | Feb 2015 | A1 |
20150209136 | Braido et al. | Jul 2015 | A1 |
20150265438 | Hossainy et al. | Sep 2015 | A1 |
20160081787 | Parodi et al. | Mar 2016 | A1 |
20160158037 | Shin et al. | Jun 2016 | A1 |
20160338822 | Rocha | Nov 2016 | A1 |
20170135835 | Matsunami et al. | May 2017 | A1 |
20170172771 | Bruckheimer et al. | Jun 2017 | A1 |
20170304093 | During et al. | Oct 2017 | A1 |
20170333230 | Folan et al. | Nov 2017 | A1 |
20180021154 | Leanne et al. | Jan 2018 | A1 |
20180055631 | Morin et al. | Mar 2018 | A1 |
20180092731 | Radhakrishnan et al. | Apr 2018 | A1 |
20180104043 | Schlick et al. | Apr 2018 | A1 |
20180125630 | Hynes et al. | May 2018 | A1 |
20180153676 | Gong et al. | Jun 2018 | A1 |
20180214141 | Mendez | Aug 2018 | A1 |
20180289486 | Moll et al. | Oct 2018 | A1 |
20190175374 | Park et al. | Jun 2019 | A1 |
20190254817 | Centola et al. | Aug 2019 | A1 |
Number | Date | Country |
---|---|---|
1524942 | Jul 2005 | EP |
0187170 | Nov 2001 | WO |
03020338 | Mar 2003 | WO |
2004010845 | Feb 2004 | WO |
WO-2005013835 | Feb 2005 | WO |
WO-2012042287 | Apr 2012 | WO |
2016200103 | Dec 2016 | WO |
2018027145 | Feb 2018 | WO |
Entry |
---|
International Search Report and Written Opinion for International Patent Application No. PCT/US2019/062132 dated Feb. 5, 2020, 11 pages. |
European Patent Office Communication Pursuant to Article 94(3) EPC for European Patent Application No. 16169972.3 dated Oct. 29, 2019, 6 pages. |
Hagl et al. “External Stabilization of Long-Segment Tracheobronchomalacia Guided by Intraoperative Bronchoscopy.” The Annals of Thoracic Surgery, vol. 64, No. 5, 1997, pp. 1412-1421. |
Xavier et al. “Development of a Modified Dumon Stent for Tracheal Applications: an Experimental Study in Dogs.” J. Bras. Pneumol. 2008; 34(1 ): 21-26. |
Number | Date | Country | |
---|---|---|---|
20180344445 A1 | Dec 2018 | US |
Number | Date | Country | |
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Parent | 15156841 | May 2016 | US |
Child | 16055686 | US |