In the United States alone, approximately 14 million people suffer from some form of Chronic Obstructive Pulmonary Disease (COPD). However, an additional ten million adults have evidence of impaired lung function indicating that COPD may be significantly underdiagnosed. The cost of COPD to the nation in 2002 was estimated to be $32.1 billion. Medicare expenses for COPD beneficiaries were nearly 2.5 times that of the expenditures for all other patients. Direct medical services accounted for $18.0 billion, and indirect cost of morbidity and premature mortality was $14.1 billion. COPD is the fourth leading cause of death in the U.S. and is projected to be the third leading cause of death for both males and females by the year 2020.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease of the airways that is characterized by a gradual loss of lung function. In the United States, the term COPD includes chronic bronchitis, chronic obstructive bronchitis, and emphysema, or combinations of these conditions. In emphysema the alveoli walls of the lung tissue are progressively weakened and lose their elastic recoil. The breakdown of lung tissue causes progressive loss of elastic recoil and the loss of radial support of the airways which traps residual air in the lung. This increases the work of exhaling and leads to hyperinflation of the lung. When the lungs become hyperinflated, forced expiration cannot reduce the residual volume of the lungs because the force exerted to empty the lungs collapses the small airways and blocks air from being exhaled. As the disease progresses, the inspiratory capacity and air exchange surface area of the lungs is reduced until air exchange becomes seriously impaired and the individual can only take short shallow labored breaths (dyspnea).
The symptoms of COPD can range from the chronic cough and sputum production of chronic bronchitis to the severe disabling shortness of breath of emphysema. In some individuals, chronic cough and sputum production are the first signs that they are at risk for developing the airflow obstruction and shortness of breath characteristic of COPD. With continued exposure to cigarettes or noxious particles, the disease progresses and individuals with COPD increasingly lose their ability to breathe. Acute infections or certain weather conditions may temporarily worsen symptoms (exacerbations), occasionally where hospitalization may be required. In others, shortness of breath may be the first indication of the disease. The diagnosis of COPD is confirmed by the presence of airway obstruction on testing with spirometry. Ultimately, severe emphysema may lead to severe dyspnea, severe limitation of daily activities, illness and death.
There is no cure for COPD or pulmonary emphysema, only various treatments, for ameliorating the symptoms. The goal of current treatments is to help people live with the disease more comfortably and to prevent the progression of the disease. The current options include: self-care (e.g., quitting smoking), medications (such as bronchodilators which do not address emphysema physiology), long-term oxygen therapy, and surgery (lung transplantation and lung volume reduction surgery). Lung Volume Reduction Surgery (LVRS) is an invasive procedure primarily for patients who have a localized (heterogeneous) version of emphysema; in which, the most diseased area of the lung is surgically removed to allow the remaining tissue to work more efficiently. Patients with diffuse emphysema cannot be treated with LVRS, and typically only have lung transplantation as an end-stage option. However, many patients are not candidates for such a taxing procedure.
A number of less-invasive surgical methods have been proposed for ameliorating the symptoms of COPD. In one approach new windows are opened inside the lung to allow air to more easily escape from the diseased tissue into the natural airways. These windows are kept open with permanently implanted stents. Other approaches attempt to seal off and shrink portions of the hyperinflated lung using chemical treatments and/or implantable plugs. However, these proposals remain significantly invasive and are still unproven. None of the surgical approaches to treatment of COPD has been widely adopted. Therefore, a large unmet need remains for a medical procedure that can sufficiently alleviate the debilitating effects of COPD and emphysema.
In view of the disadvantages of the state of the art, Applicants have developed a method for treating COPD in which an artificial passageway is made through the chest wall into the lung. An anastomosis is formed between the artificial passageway and the lung by creating a pleurodesis between the visceral and parietal membranes surrounding the passageway as it enters the lung. The pleurodesis prevents air from entering the pleural cavity and causing a pneumothorax (deflation of the lung due to air pressure in the pleural cavity). The pleurodesis is stabilized by a fibrotic healing response between the membranes. The artificial passageway through the chest wall also becomes epithelialized. The result is a stable artificial aperture through the chest wall which communicates with the parenchymal tissue of the lung.
The aperture into the lung through the chest wall is referred to herein as a pneumostoma. A pneumostoma provides an extra pathway that allows air to exit the lung while bypassing the natural airways which have been impaired by COPD and emphysema. By providing this ventilation bypass, the pneumostoma allows the stale air trapped in the lung to escape from the lung thereby shrinking the lung (reducing hyperinflation). By shrinking the lung, the ventilation bypass reduces breathing effort (reducing dyspnea), allows more fresh air to be drawn in through the natural airways and increases the effectiveness of all of the tissues of the lung for gas exchange. Increasing the effectiveness of gas exchange allows for increased absorption of oxygen into the bloodstream and also increased removal of carbon dioxide. Reducing the amount of carbon dioxide retained in the lung reduces hypercapnia which also reduces dyspnea. The pneumostoma thereby achieves the advantages of lung volume reduction surgery without surgically removing a portion of the lung or sealing off a portion of the lung.
Procedures, techniques and tools for creating a pneumostoma are described in Applicants' copending patent application Ser. No. 12/388,453 entitled “Surgical Instruments For Creating A Pneumostoma And Treating Chronic Obstructive Pulmonary Disease” to Tanaka et al. Pneumostoma management devices which can be inserted into a pneumostoma and through which gases may exit a lung of a patient are described in Applicant's copending patent application Ser. No. 12/388,468 entitled “Multi-Layer Pneumostoma Management System And Methods For Treatment Of Chronic Obstructive Pulmonary Disease” to Tanaka et al. These patent applications, and all other patents and patent applications referred to herein, are incorporated by reference in their entirety.
Pneumostoma management devices and auxiliary supplies are supplied to patients on a regular basis for maintaining the pneumostoma. In some cases, pneumostoma management devices are single use disposable items which are replaced daily. It is therefore desirable to provide the pneumostoma management devices to suppliers and patients in a volume efficient manner.
In accordance with one embodiment, the present invention provides sterile trays for delivery of pneumostoma management devices.
In accordance with another embodiment, the present invention provides a pneumostoma management device in a sterile tray.
In accordance with another embodiment, the present invention provides volume-efficient packaging. The packaging is configured for delivery of a plurality of pneumostoma management devices.
In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging for delivery to a patient.
In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging and also includes one or more auxiliary supplies used by a patient during exchange of pneumostoma management devices.
In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging and also includes one or more enhanced-functionality pneumostoma management devices.
In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging for delivery to a patient and also includes features to guide the patient in periodic maintenance and or assessment of the pneumostoma
In accordance with one embodiment, the present invention provides kits having a plurality of pneumostoma management devices secured in volume-efficient packaging for delivery to a patient. The volume-efficient packaging is also useful for controlled disposal of pneumostoma management devices.
Thus, various systems, components and methods are provided for delivery of pneumostoma management devices and managing a pneumostoma and thereby treating COPD. Other objects, features and advantages of the invention will be apparent from drawings and detailed description to follow.
The above and further features, advantages and benefits of the present invention will be apparent upon consideration of the present description taken in conjunction with the accompanying drawings.
The following description is of the best modes presently contemplated for practicing various embodiments of the present invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. It is to be understood that features described in reference to a particular embodiments may be combined with features of other particular embodiments. The scope of the invention should be ascertained with reference to the claims. In the description of the invention that follows, like numerals or reference designators will be used to refer to like parts or elements throughout. In addition, the first digit of a reference number identifies the series of drawings in which the reference number first appears.
In
A pneumostoma is surgically created by forming an artificial channel through the chest wall and joining that channel with an opening through the visceral membrane of the lung into parenchymal tissue of the lung to form an anastomosis. The anastomosis is joined and sealed by sealing the channel from the pleural cavity using adhesives, mechanical sealing and/or pleurodesis. Methods for forming the channel, opening, anastomosis and pleurodesis are disclosed in Applicant's pending and issued patents and applications including U.S. patent application Ser. No. 10/881,408 entitled “Methods and Devices to Accelerate Wound Healing in Thoracic Anastomosis Applications” and U.S. patent application Ser. No. 12/030,006 entitled “Variable Parietal/Visceral Pleural Coupling” which are incorporated herein by reference in their entirety.
An important feature of the pneumostoma is the seal or adhesion surrounding the channel 120 where it enters the lung 130 which may comprise a pleurodesis 124. A pleurodesis 124 is the fusion or adhesion of the parietal membrane 108 and visceral membrane 138. A pleurodesis may be a complete pleurodesis in which the entire pleural cavity 140 is removed by fusion of the visceral membrane 138 with the parietal membrane 108 over the entire surface of the lung 130. However, as shown in
Pleurodesis 124 can be created between the visceral pleura of the lung and the inner wall of the thoracic cavity using chemical methods including introducing into the pleural space irritants such as antibiotics (e.g. Doxycycline or Quinacrine), antibiotics (e.g. iodopovidone or silver nitrate), anticancer drugs (e.g. Bleomycin, Mitoxantrone or Cisplatin), cytokines (e.g. interferon alpha-2β and Transforming growth factor-β); pyrogens (e.g. Corynebacterium parvum, Staphylococcus aureus superantigen or OK432); connective tissue proteins (e.g. fibrin or collagen) and minerals (e.g. talc slurry). A pleurodesis can also be created using surgical methods including pleurectomy. For example, the pleural space may be mechanically abraded during thoracoscopy or thoracotomy. This procedure is called dry abrasion pleurodesis. A pleurodesis may also be created using radiotherapy methods, including radioactive gold or external radiation. These methods cause an inflammatory response and or fibrosis, healing, and fusion of the pleural membranes. Alternatively, a seal can be created in an acute manner between the pleural membranes using biocompatible glues, meshes or mechanical means such as clamps, staples, clips and/or sutures. The adhesive or mechanical seal may develop into pleurodesis over time. A range of biocompatible glues are available that may be used on the lung, including light-activatable glues, fibrin glues, cyanoacrylates and two part polymerizing glues. Applicant's copending U.S. patent application Ser. No. 12/030,006 entitled “VARIABLE PARIETAL/VISCERAL PLEURAL COUPLING” discloses methods such as pleurodesis for coupling a channel through the chest wall to the inner volume of the lung without causing a pneumothorax and is incorporated herein by reference for all purposes.
When formed, pneumostoma 110 provides an extra pathway for exhaled air to exit the lung 130 reducing residual volume and intra-thoracic pressure without the air passing through the major natural airways such as the bronchi 138 and trachea 136. Collateral ventilation is particularly prevalent in an emphysemous lung because of the deterioration of lung tissue caused by COPD. Collateral ventilation is the term given to leakage of air through the connective tissue between the alveoli 134. Collateral ventilation may include leakage of air through pathways that include the interalveolar pores of Kohn, bronchiole-alveolar communications of Lambert, and interbronchiolar pathways of Martin. This air typically becomes trapped in the lung and contributes to hyperinflation. In lungs that have been damaged by COPD and emphysema, the resistance to flow in collateral channels (not shown) of the parenchymal tissue 132 is reduced allowing collateral ventilation to increase. Air from alveoli 134 of parenchymal tissue 132 that passes into collateral pathways of lung 130 is collected in cavity 122 of pneumostoma 110. Pneumostoma 110 thus makes use of collateral ventilation to collect air in cavity 122 and vent the air outside the body via channel 120 reducing residual volume and intra-thoracic pressure and bypassing the natural airways which have been impaired by COPD and emphysema.
By providing this ventilation bypass, the pneumostoma allows stale air trapped in the parenchymal tissue 132 to escape from the lung 130. This reduces the residual volume and intra-thoracic pressure. The lower intra-thoracic pressure reduces the dynamic collapse of airways during exhalation. By allowing the airways to remain patent during exhalation, labored breathing (dyspnea) and residual volume (hyperinflation) are both reduced. Pneumostoma 110 not only provides an extra pathway that allows air to exit the lung 130 but also allows more fresh air to be drawn in through the natural airways. This increases the effectiveness of all of the tissues of the lung 130 and improves gas exchange. Increasing the effectiveness of gas exchange allows for increased absorption of oxygen into the bloodstream and also increased removal of carbon dioxide. Reducing the amount of carbon dioxide retained in the lung reduces hypercapnia which also reduces dyspnea. Pneumostoma 110 thus achieves many of the advantages sought by lung volume reduction surgery without surgically removing a portion of the lung or sealing off a portion of the lung.
Applicants have found that pneumostoma management devices in accordance with embodiments of the present invention are desirable to maintain the patency of the pneumostoma and control flow of materials between the exterior of the patient and the parenchymal tissue of the lung via the pneumostoma. The pneumostoma management devices include a pneumostoma vent to enter the pneumostoma and allow gases to exit the lung and may also include a chest mount, and/or one or more of the tools, packaging, auxiliary device and methods described herein. In general terms a pneumostoma management device (“PMD”) or pneumostoma vent comprises a tube which is inserted into the pneumostoma and an external component which is secured to the skin of the patient to keep the tube in place. Gasses escape from the lung through the tube and are vented external to the patient. The pneumostoma management device may, in some, but not all cases, include a filter which only permits gases to enter or exit the tube. The pneumostoma management device may, in some, but not all cases, include a one-way valve which allows gases to exit the lung but not enter the lung through the tube.
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One aspect of a pneumostoma management system includes protective covers which protect the adhesive portions of the pneumostoma management device prior to use. These protective covers serve the same purpose as the paper covers on an adhesive bandage. However, in preferred embodiments of the present invention, the protective covers are specially designed to facilitate application of the pneumostoma management device. In a preferred embodiment, the protective covers are made from a thin disposable material which can be readily released from the adhesive surfaces. A suitable material is paper waxed on one surface.
After creating and healing of the pneumostoma the patient will be responsible for applying and removing the pneumostoma management device 200. The patient will typically exchange one pneumostoma management device 200 for another and dispose of the used pneumostoma management device 200. Pneumostoma management device 200 will be replaced periodically, such as daily, or when necessary. The patient will be provided with a supply of pneumostoma management devices 200 by a medical practitioner or by prescription. The pneumostoma management devices are preferably provide to the patient in the form of a pneumostoma management system which includes packaging, instructions and/or auxiliary supplies to facilitate delivery, sterility, disposal and/or proper use of the pneumostoma management device 200.
In preferred embodiments of the present invention a pneumostoma management system includes one or more pneumostoma management devices and also one or more of sterile packaging, kit packaging, auxiliary supplies and instructions for use. In preferred embodiments the pneumostoma management system, includes packaging and instructions which assist the patient in utilizing the components of the system in the correct sequence. The packaging may include printed instructions which assist the patient in the appropriate sequence of the steps for using the pneumostoma management device. In addition, the packaging can include auxiliary supplies, for example, cleaning and moisturizing swabs and barrier spray/cream. The packaging of the pneumostoma management system may also be designed to provide the components to the patient in the order required for use and to maintain sterility during use. For example, the package may be designed so that, upon opening the package, items are physically arranged in a tray in the order in which they are to be used by the patient.
In preferred embodiments, the packaging is designed to provide pneumostoma management devices and auxiliary materials sufficient to maintain a pneumostoma for multiple days in a volume-efficient package. For example, in preferred embodiments, the packaging is designed to provide pneumostoma management devices and auxiliary materials sufficient to maintain a pneumostoma for one week, two weeks, four weeks or one month.
As described above, a pneumostoma management system incorporates in some embodiments a sterile tray which holds the pneumostoma management device prior to use.
As shown in
Tray cover 430 is a thin flexible covering which protects the pneumostoma management device and keeps bacteria out of tray 410. Tray cover 430 is adapted to be removably secured top tray 410. Tray cover 430 can be provided with one or more tabs 432 which can be gripped to peel tray cover 430 away from tray 410. The tray cover material is in some embodiments, selected to allow sterilization of the pneumostoma management device 200 inside pneumostoma management system 400 after attachment of cover 430. For example, tray cover is, in some embodiments, selected to be permeable to ethylene oxide such that pneumostoma management system 400 can be sterilized after assembly. In some embodiments tray cover 430 is made of TYVEK® available from DuPont.
During assembly, tube 260 of pneumostoma management device 200 is inserted into tubular extension 416. The external portion of pneumostoma management device 200 is placed in shallow depression 414, and tray cover 430 is secured to raised rim 412. In a preferred embodiment a pressure sensitive and/or contact adhesive is used to secure tray cover 430 to raised rim 412. After assembly pneumostoma management system 400 is exposed to ethylene oxide gas for a preselected period of time. The ethylene oxide penetrates through tray cover 430 and sterilizes the surfaces of tray 410 and also sterilizes the pneumostoma management device 200 and set of covers 300. Thus, the pneumostoma management system provides the pneumostoma management device 200 sterile and ready for use by the patient.
To simplify manufacturing, a single tray configuration is designed to contain a range of different pneumostoma management devices. For example, tubular extension 416 is, in some embodiments, approximately 95 mm deep and 10 mm in inside diameter. Thus, for example, although pneumostoma management devices are made in various sizes having tubes 260 of sizes between 35 mm and 95 mm, a single tray having a tubular extension 95 mm deep can accommodate any of the range of pneumostoma management devices.
The tray configuration of
To facilitate delivery, pneumostoma management system 400 is, in some embodiments, provided as a part of a multi-tray strip. For example, a multi-tray strip can include two, three, four or more pneumostoma management devices in sterile trays which are releasably or permanently attached to one another. In a preferred embodiment a multi-tray strip can include seven pneumostoma management devices in sterile trays. Each tray preferably is provided with an independent tray cover such that one pneumostoma management device can be removed at a time while preserving the sterility of the remaining pneumostoma management devices.
The trays are, in some embodiments, identical but in other embodiments, include different items. For example, one or more of the pneumostoma management devices can include different components and/or attributes suitable for treating or assessing the pneumostoma on a periodic basis. In some embodiments, for example, one pneumostoma management devices per strip of seven includes means for assessing pneumostoma. Thus, a patient will perform a weekly assessment of pneumostoma health and/or functionality, the results of which the patient can report to a physician in order that the physician can make recommendations regarding further diagnosis and/or treatment of the pneumostoma.
External packaging 520 can be provided with an external label 522 indicating the contents batch number and/or information required by the FDA and or a pharmacy. External label 522 is, in some embodiments, provided on the end 524 of external packaging 520, as shown. End-labeling the packages means that the packages can be stacked efficiently on pharmacy shelves while permitting easy location of a package suitable for a particular patient. The end 524 of external packaging 520 is smaller in area than the sides of external packaging 520, thus allowing a greater number of labels to be exposed in a stack of packaging.
A plurality of holes 620 are punched in the side panels 612a, 612b, 612c, 612d. Each hole 620 comprises a central aperture 622 and a plurality of radiating slots 624. The holes 620 are sized slightly smaller than the tubular extension 416 of the sterile pneumostoma management system 400. The slots 624 allow the card surrounding the aperture 622 to bend and conform to the tubular extension 416 of the sterile pneumostoma management system 400.
A plurality of slots 630 are punched in the side panels 612a, 612b, 612c, 612d and end panels 614a, 614b. Each slot 630 defines a tab 632. The tabs 632 are designed to space support 610 from external packaging as illustrated in
During assembly, an adhesive (not shown) is applied to the surface of flap 616a which is then bonded to side panel 612d to create a substantially square-sectioned tube having an interior volume. Flaps 616b, 616c, 616d, 616e are then folded over the ends of the square-sectioned tube. Finally, end panels 614a, 614b are folded over flaps 616b, 616c, 616d, 616e. Ends 615a, 615b are inserted into the interior volume to secure end panels 614a, 614b in place.
Kit 600 provides pneumostoma management supplies sufficient for ten days of at-home pneumostoma care in volume-efficient packaging. With this configuration, for example, ten pneumostoma management devices 400 are supplied in a total package volume of approximately 6 liters or 0.6 liters per unit. This is a considerable savings in packaging volume compared to single trays.
The tubular extension of each tray 400 of pneumostoma management systems 400 is placed through an aperture 720 into the interior volume of the support 710. A total of 16 pneumostoma management systems 400 can be received into the apertures 420 on each side of support 710. The assembly of pneumostoma management devices 400 and support 710 is designed to be placed inside external packaging 780. External packaging 780 is a box made of medical-grade card and only slightly larger in internal dimensions that the maximum external dimensions of the assembly of pneumostoma management devices 400 and support 710. In the configuration of
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In preferred embodiments the pneumostoma management device and tray are formed from biocompatible polymers. In general, preferred materials for manufacturing pneumostoma management devices and trays are biocompatible thermoplastic elastomers that are readily utilized in injection molding and extrusion processing. As will be appreciated, other suitable similarly biocompatible thermoplastic or thermoplastic polymer materials can be used without departing from the scope of the invention.
Biocompatible polymers for manufacturing pneumostoma management devices and trays may be selected from the group consisting of polyethylenes (HDPE), polyvinyl chloride, polyacrylates (polyethyl acrylate and polymethyl acrylate, polymethyl methacrylate, polymethyl-coethyl acrylate, ethylene/ethyl acrylate), polycarbonate urethane (BIONATEG), polysiloxanes (silicones), polytetrafluoroethylene (PTFE, GORE-TEX®, ethylene/chlorotrifluoroethylene copolymer, aliphatic polyesters, ethylene/tetrafluoroethylene copolymer), polyketones (polyaryletheretherketone, polyetheretherketone, polyetherether-ketoneketone, polyetherketoneetherketoneketone polyetherketone), polyether block amides (PEBAX, PEBA), polyamides (polyamideimide, PA-11, PA-12, PA-46, PA-66), polyetherimide, polyether sulfone, poly(iso)butylene, polyvinyl chloride, polyvinyl fluoride, polyvinyl alcohol, polyurethane, polybutylene terephthalate, polyphosphazenes, nylon, polypropylene, polybutester, nylon and polyester, polymer foams (from carbonates, styrene, for example) as well as the copolymers and blends of the classes listed and/or the class of thermoplastics and elastomers/thermoplastic elastomers in general. In one preferred embodiment, the tube is made of Pebax® a block copolymer with suitable mechanical and chemical properties available from Arkema (Colombes, France). Another suitable material is C-FLEX® thermoplastic elastomer available as extruded tube in a variety of dimensions and durometers from Saint-Gobain Performance Plastics in Clearwater, Fla. Reference to appropriate polymers that can be used for manufacturing pneumostoma management devices and trays can be found, for example, in the following documents: PCT Publication WO 02/02158, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO 02/00275, entitled “Bio-Compatible Polymeric Materials;” and, PCT Publication WO 02/00270, entitled “Bio-Compatible Polymeric Materials” all of which are incorporated herein by reference.
The foregoing description of preferred embodiments of the present invention has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many embodiments were chosen and described in order to best explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications that are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.
This application claims priority the following applications: U.S. Provisional Patent Application No. 61/408,852, filed Nov. 1, 2010, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS” (Attorney Docket No. LUNG1-06024US0). The afore-mentioned application is incorporated herein by reference in its entirety. This application is related to all of the following applications, and all the patent applications that claim priority thereto, including: U.S. patent application Ser. No. 12/388,447, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US1); and U.S. patent application Ser. No. 12/388,451, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT METHOD FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US2); and U.S. patent application Ser. No. 12/388,458, filed Feb. 18, 2009, entitled “FLEXIBLE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06004US1); and U.S. patent application Ser. No. 12/684,699, filed Jan. 8, 2010, entitled “PNEUMOSTOMA MANAGEMENT DEVICE WITH INTEGRATED PATENCY SENSOR AND METHOD” (Attorney Docket No. LUNG1-06016US1); and U.S. patent application Ser. No. 12/388,466, filed Feb. 18, 2009, entitled “ONE-PIECE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06017US1); and U.S. patent application Ser. No. 12/388,467, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM WITH SECRETION MANAGEMENT FEATURES FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06019US1); and U.S. patent application Ser. No. 12/388,468, filed Feb. 18, 2009, entitled “MULTI-LAYER PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06022US1); and U.S. patent application Ser. No. 12/388,469, filed Feb. 18, 2009, entitled “VARIABLE LENGTH PNEUMOSTOMA MANAGEMENT SYSTEM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06023US1); and U.S. patent application Ser. No. 13/213,945, filed Aug. 19, 2011, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS”, (Attorney Docket No. LUNG1-06024US1). All of the afore-mentioned applications are incorporated herein by reference in their entireties. This patent application also incorporates by reference in their entireties all patents, applications, and articles discussed and/or cited herein.
Number | Date | Country | |
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61408852 | Nov 2010 | US |