The present invention relates to medical methods for treating inflammatory lung disease, and more specifically to minimally invasive medical methods for screening for nerves in the lung to ablate which are associated with airway function.
Chronic obstructive pulmonary disease (COPD) and asthma are lung inflammatory diseases and affect many people. Each disease is characterized by limited airflow, and interferes with normal breathing. Although COPD includes a number of diseases including chronic bronchitis and emphysema, it is generally characterized by airflow obstruction. People with airflow obstruction may have a number of symptoms including smooth muscle contraction, chronic cough with excess sputum production, and general thickening of the airway wall, all of which result in obstruction of normal breathing.
Various approaches to treat COPD and asthma include pharmacological treatment and interventional treatments.
Pharmacological treatment is an approach applied to most patients. For example, it is not uncommon for a physician to administer an inhaled bronchodilator (short or long acting) once or twice daily to relax and temporarily open airways. However, the side effects of the pharmacological agents include: nausea and vomiting, diarrhea, palpitations, a rapid heartbeat, an irregular heartbeat, headaches, and problems sleeping (insomnia), all of which are undesirable.
On the other hand, some patients are candidates for interventional treatments. An example of an interventional treatment includes application of radiofrequency energy through the airway wall to the nerve associated with contraction of the wall as described in U.S. Patent Publication No. 2013/0310822. See also, the Nuvaira™ Lung Denervation System (manufactured for clinical trial by Nuvaira, Inc., Minneapolis, Minn., USA, previously named Holaira, Inc.).
A challenge, however, in lung denervation therapy is to accurately identify and treat the nerve that is associated (or controls) the airway wall contraction. Identifying the wrong nerve to ablate can result in a number of non-beneficial or worse, adverse consequences. For example, should the wrong nerve be ablated, the airway obstruction remains unchanged following the procedure. The patient receives no clinical benefit while having had to undergo risk from the initial procedure. Additional procedures may be required, increasing patient risk.
What is more, significant adverse reactions can arise where the wrong nerve is inadvertently ablated. For example, where the targeted pulmonary parasympathetic nerve (PPN) and parasympathetic esophageal nerve (EPN) are intertwined, ablating the PPN can also ablate the EPN, causing inadvertent gastroparesis (paralysis of the esophagus and or stomach). Patients suffering from gastroparesis may require a permanent feeding tube. This is undesirable.
Accordingly, a method for assisting a physician to screen for target nerves to ablate for the treatment of lung inflammatory disease and that overcome the above mentioned challenges is desirable.
The present invention is a method for screening for target nerves to ablate for the treatment lung inflammatory diseases including COPD and asthma.
In embodiments, a method temporarily blocks or paralyzes a candidate nerve for ablation, and monitors the patient's reaction to the temporary block. If the patient does not have an adverse reaction while being observed, the candidate nerve is identified as the target nerve to ablate.
In embodiments, the method further comprises probing or interrogating the candidate nerve for airway responsiveness. Probing is carried out prior to the temporary blocking. If the airway is responsive to the probing of the candidate nerve, the method proceeds to the temporary blocking or paralyzing step.
In embodiments, the temporary blocking or paralyzing step is performed using local anesthetic, cold therapy, or via physical force such as pinching or clamping.
In embodiments, the method further comprises ablating the target nerve after it has been identified. Ablation may be performed using a wide range of techniques including, for example, thermal vapor ablation.
In embodiments, the tool or instrument is advanced through a bronchoscope.
In embodiments, the tool or instrument is a transbronchial needle.
In embodiments the candidate nerve is a pulmonary parasympathetic nerve.
Still other descriptions, objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.
Before the present invention is described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made to the invention described and equivalents may be substituted without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.
Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail).
Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.
Step 510 states to identify a target tissue outside of the airway in a lung for the treatment of lung inflammatory disease. As described herein, examples of target tissue include a nerve and airway smooth muscle. Noninvasive means may be applied to view and identify the target.
Step 520 states to advance a distal section of a vapor delivery catheter to the target tissue. In embodiments, the catheter comprises a working or access lumen and a sharpened tip which is adapted to penetrate the airway wall, creating an opening through the airway wall. The tip is further advanced through the wall, outside of the airway, and towards the target tissue.
Step 530 states to assess the location of the distal section of the catheter. Assessing may be performed by determining whether the distal section is in contact with the target tissue to be ablated using a number of different techniques as described herein. In embodiments, confirmation of the location of the distal section of the vapor delivery catheter is performed by probing the target tissue with the catheter and visually observing movement of the tissue structure commanded by the nerve. However, as described herein, a wide variety of techniques may be employed to assess the location of the vapor delivery catheter.
Step 540 states to temporarily block or screen the candidate nerve prior to the step of ablation to confirm that an adverse reaction shall not result from the ablation. The catheter may be activated to temporarily paralyze the candidate nerve, or another tool or instrument may be advanced through the catheter or sheath, or interchanged therewith to temporarily block the candidate nerve. As described further herein, temporarily blocking or paralyzing the nerve demonstrates whether ablating the candidate nerve has a clinical benefit, or causes an adverse reaction.
Step 550 states to deliver vapor with an amount of energy to ablate the tissue. The vapor follows the boundary of the airway, raising the temperature uniformly across the target tissue as opposed to developing a large temperature gradient. Ablating the target tissue (e.g., the nerve and/or smooth muscles surrounding the airway) serves to alleviate the conditions associated with COPD and asthma as described herein.
In embodiments, the catheter may be moved to additional target locations along the airway, or a different airway and the procedure repeated.
Additionally, in embodiments, the location of the catheter is assessed, and if the catheter is not in proper position, the catheter is further manipulated and the step of assessing is repeated. The process may be repeated until the catheter is ultimately in the desired position.
Now, with reference to
The respiratory system 10 may be characterized by a tree-like structure formed of branched airways including the trachea 68; left and right main stem bronchus 20 and 22 (primary, or first generation) and lobar bronchial branches 24, 26, 28, 32, and 70 (second generation). Segmental and subsegmental branches further bifurcate off the lobar bronchial branches (third and fourth generation). Each bronchial branch and sub-branch communicates with a different portion of a lung lobe, either the entire lung lobe or a portion thereof.
Bronchoscopy Approach
Energy Generator
In embodiments, vapor generator 300 is configured as a self-contained, medical-grade generator unit comprising at least a vaporizing unit 302, a fluid inlet 304, and a vapor outlet 306. The vaporizing unit 302 comprises a fluid chamber for containing a fluid 301, preferably a biocompatible, sterile fluid, in a liquid state. In embodiments, vapor outlet 306 is coupled to one or more pipes or tubes, which in turn are placed in fluid communication with an energy delivery catheter 200. Vapor flow from vapor generator 300 to a catheter (and specifically a vapor lumen of said catheter) is depicted as a vapor flow circuit 314 wherein flow of the vapor is indicated by arrows in
Vaporizer unit 302 is configured to heat and vaporize a liquid contained therein. Other components can be incorporated into the biocompatible liquid 301 or mixed into the vapor. For example, these components can be used to control perioperative and/or post procedural pain, enhance tissue fibrosis, and/or control infection. Other constituents, for the purpose of regulating vapor temperatures and thus control extent and speed of tissue heating, can be incorporated; for example, in one implementation, carbon dioxide, helium, other noble gases can be mixed with the vapor to decrease vapor temperatures.
Vaporizing unit 302 is also shown having a fluid inlet 304 to allow liquid 301 to be added to the fluid chamber as needed. Fluid chamber can be configured to accommodate or vaporize sufficient liquid as needed to apply vapor to one or more target tissues. Liquid in vaporizing unit 302 is heated and vaporized and the vapor flows into vapor outlet 306. A number of hollow tubular shafts or pipes are adapted to fluidly connect vapor outlet 306 to the catheter 200.
In embodiments, a flexible hollow tube or umbilical-like cord extends from the generator 300 and terminates in a handle (not shown). The handle is adapted to operatively couple to a variety of types of energy delivery catheters via a hub assembly (such as hub assembly 214 shown in
In embodiments, a catheter and vapor generator are configured to be directly coupled to one another via mating connectors. Vapor delivery is controlled by the generator, a controller external to the generator, or actuating buttons and mechanisms on the catheter itself. For example, the catheter may comprise a handpiece portion to control vapor doses.
Preferably, there is little or no vapor-to-liquid transition during movement of the vapor through vapor flow circuit 314. Vapor flow through vapor flow circuit 314 is unidirectional (in the direction of arrows), accordingly one or more isolation valves 320 are incorporated in vapor flow circuit 314. Isolation valves 320, which are normally open during use of generator 300, serve to minimize vapor flow in a direction opposite that of the vapor flow circuit 314.
A priming line 330, branching from main vapor flow circuit 314, is provided to minimize or prevent undesirable liquid-state water formation during vapor flow through vapor flow circuit 314. Pressure and temperature changes along vapor flow circuit 314 can affect whether the vapor is sustainable in a vapor state or condensed back into a liquid. Priming line 330 is provided to equalize temperatures and/or pressures along vapor flow circuit 314 in order to minimize or prevent undesirable liquid-state transition of the vapor during its progression through vapor flow circuit 314. In one embodiment, an initial “purge” or “priming” procedure can be performed prior to delivery of a therapeutic vapor dose in order to preheat vapor flow circuit 314 thus maintaining a constant temperature and pressure in the main vapor flow circuit 314 prior to delivery of a vapor to the target lung tissue.
As shown in
A number of sensors, operatively connected to a controller, can be incorporated into vapor generator 300, for example, in the liquid chamber, or along any point in vapor flow circuit 314. Water level sensors, adapted to monitor the water level in the liquid chamber, can be included. These water level sensors are configured as upper and lower security sensors to sense or indicate when a liquid level in the fluid chamber is below or above a set fluid level. For example, if a water level in the fluid chamber falls below the level of a lower water control sensor, the controller can be configured to interrupt the operation of the vapor generator 300.
In yet another embodiment, pressure sensors, or manometers, can be included in vaporizing unit 302, or at various points along the vapor flow circuit 314, to measure the liquid or vapor pressures at various discrete locations and/or to measure vapor pressures within a defined segment along vapor flow circuit 314. One or more control valves 320 can also be installed at various points in the vapor flow circuit 314 to control vapor flow, for instance, to control or increase the vapor flow or vapor flow rates in vapor flow circuit 314.
In yet another embodiment, a safety valve 322 can be incorporated into the liquid chamber of vaporizing unit 302 and coupled to a vapor overflow line 340 if the need for removing or venting vaporizing unit 302 arises during generator 300 operation.
Although the vapor generator is described above having various specific features, the components and configurations of the vapor generator and catheter systems may vary. Additional vapor ablation systems are described in, for example, U.S. Patent Publication No. 2015/0094607 to Barry et al., and U.S. Pat. No. 7,913,698 to Barry et al., and U.S. Pat. No. 8,322,335 to Barry et al., and U.S. Pat. No. 7,993,323 to Barry et al.
In other embodiments, a condensable vapor is created in the handle portion of the catheter system. Consequently, a separate vapor generator unit is not required. Systems including a resistive heater are described in, for example, U.S. Patent Publication No. 2016/0220297 to Kroon et al. and U.S. Patent Publication No. 2014/0276713 to Hoey et al. Indeed, embodiments of the invention include a wide range of mechanisms to create and transport vapor through the working catheter as described herein.
Vapor Ablation Catheter
The distal end section 206 is shown having a pointed tip and a plurality of egress ports 208 for vapor to be directed towards the target tissue. In embodiments, the tip is rigid, sharp, and adapted to penetrate tissue. Examples of suitable materials for the tip of the catheter include stainless steel, Nitinol, and PEEK. At least one egress port 208 is desirable, however, the number of egress ports may range from 1-20, and more preferably 6-12.
The shape of the egress port is shown as a circle. However, the shape and size of the egress ports may vary. In embodiments, the egress port has a circular shape and a diameter in the range of 0.1 to 2 mm.
Additional examples of vapor delivery catheter configurations are described in the literature. Another example of a vapor catheter having components and structures which may be combined with the subject invention is described in U.S. Pat. No. 8,444,636 to Shadduck and Hoey; and U.S. Patent Publication No. 2014/0025057 to Hoey and Shadduck. The catheter and tip configuration may vary widely and the invention is only intended to be limited as recited in the appended claims.
Asthma Treatment
In embodiments, the catheter distal section is advanced through a surgically created opening, passageway, or ancillary appliance, channel or instrument extending through the airway wall to the target tissue. Techniques and instruments for creating passageways and installing working tubes through the airway wall, and for performing procedures through the passageways, are described in, for example, U.S. Pat. Nos. 8,409,167 and 8,709,034.
Vapor 205 is shown delivered from the egress ports 208 towards the nerve 76, and, with reference again to
It should also be appreciated that the embodiment shown in
In embodiments, a method includes dispersing a vapor through a volume of a first tissue (or filling the first tissue structure with the vapor) with a dose sufficient to render the target tissue non-functional, or to destroy the tissue. The amount and type of energy (flow rate, composition, temperature) may be controlled by the system and based on the characteristics of the target tissue including volume, mass, density, location, and type of tissue. Example quantities or amounts of energy range from 10 to 2000 calories, and in embodiments 100 to 1000 calories.
Assessing Catheter Location
In embodiments, as described further herein, methods include assessing the location of the distal end section of the catheter to determine whether the distal section of the catheter is in contact (or otherwise properly located) relative to the target tissue. Nonlimiting examples of target tissue include nerves, smooth muscle, airway tissue, blood vessels as well as tumors, infected or diseased tissues, lymph nodes and tissue growths whether cancerous or benign.
Techniques for confirming or assessing the position of the distal end section may vary. In embodiments, assessing the location of the distal end section may be performed using noninvasive imaging means, and guidance software. Nonlimiting examples of guidance techniques include video or fluoroscopy based tracking and guidance, and electromagnetic based guidance via use of transponders or other sensors or transmitters. Systems may be employed to track the location of the distal end section relative to previously obtained image data of the patient. Examples of tracking and guidance techniques are described in U.S. Pat. No. 7,233,820 to Gilboa; U.S. Pat. No. 7,756,563 to Higgins et al.; U.S. Pat. No. 7,889,905 to Higgins et al.; U.S. Pat. No. 9,265,468 to Rai et al.; and U.S. Patent Publication No. 20160180529 to Rai et al. See, e.g., the Superdimension™ Navigation System, manufactured by Medtronic (Minneapolis, Minn.), and the Archimedes™ System, manufactured by Broncus Medical, Inc., (San Jose, Calif.).
Additionally, in embodiments, the physician can preoperatively plan one or more routes through the airways to the target tissue. An entire pathway or route may be planned from the mouth or nasal passageway, through the airways, and to the target tissue outside of the airway. Then, the pre-planned or pre-determined route may be used during the procedure to guide the physician. One of the above described guidance techniques can be used to assess the location of the catheter as it is advanced into the target position. Examples of a route planning techniques are described in U.S. Pat. No. 9,037,215 and U.S. Patent Publication No. 2009/0156895, both to Higgins et al. See also the LungPoint® Planner, manufactured by Broncus Medical, Inc., (San Jose, Calif.).
Additionally, in embodiments, automatic and semi-automatic compiling and evaluation of lung image data, image reconstruction, and display is performed. See, e.g., U.S. Pat. No. 9,037,215 to Higgins et al., and U.S. Patent Publication Nos. 2009/0156895 and 2010/0310146 both to Higgins et al., and 2014/0275952 to Monroe et al.
Physical assessment of the position of the catheter relative to the target nerve may also be performed, for example, via empirical techniques including observing movement of the nerve/airway and/or measuring nerve activity as the catheter tip is moved into and out of contact with the nerve (e.g., touching, probing, or interrogating).
In embodiments, and with reference to
Additionally, external sensors may interrogate or confirm contact between the distal tip and the nerve or smooth muscle. Such tests record or sense nerve activity or electrical activity in a minimally or noninvasive manner. Nonlimiting examples of external sensors include electromyography (EMG) sensors and systems. In embodiments, a surface-type EMG sensor is affixed to the skin of the patient to monitor nerve activity.
Candidate Nerve Screening Method
Step 610 states to identify the candidate nerve for ablation. An example of a candidate nerve to ablate is the pulmonary parasympathetic nerve (PPN). Endoscopy or noninvasive means such as MRI may be applied to view and identify the target. Further, the physician can locate the PPN radially along the airway (e.g. at 10 o'clock or 2 o'clock as one looks down the airway). The PPN is visible under MRI because the nerve may be 2 to 3 mm in diameter at the point where the physician would desire to ablate.
Optionally, planning software is employed to visualize the candidate nerve in renderings of the patients lungs (e.g., the nerve may be superimposed onto a 3D reconstruction of the airway tree). Examples of route planning techniques are described in U.S. Pat. No. 9,037,215 and U.S. Patent Publication No. 2009/0156895, both to Higgins et al. See also the LungPoint® Planner, manufactured by Broncus Medical, Inc., (San Jose, Calif.).
Step 620 states to advance an instrument or tool to the candidate nerve.
In embodiments, and with reference to step 622, an opening through the airway wall is created. This step may be performed using a needle catheter, or a sharpened tip of the instrument or tool.
Optionally, the hole may be enlarged (step 624) using a dilator or expandable member.
Step 626 states to create the passageway to the candidate nerve. This step may be performed by advancing the instrument through the hole and towards the target tissue outside of the airway. For example, the needle catheter or needle sheath may be advanced through the hole and toward the candidate nerve. Additionally, a tunneling tool can be advanced through the tissue to create a passageway sufficient in size to accommodate the forthcoming procedural steps. A conduit or channel may be installed, serving to provide an open access channel to the nerve. Indeed, a number of techniques and instruments for creating passageways through the airway wall and smooth muscles, and for performing procedures through the passageways, may be used in combination with the invention. Examples are described in U.S. Pat. Nos. 8,409,167 and 8,709,034.
Confirming the location of the tool and instrument is also desired. Techniques for confirming or assessing the position of the distal end section of the tool may be performed using noninvasive imaging means, and guidance software. Nonlimiting examples of guidance techniques include video or fluoroscopy based tracking and guidance, and electromagnetic based guidance including transponders or other sensors or transmitters. Systems may be employed to track the location of the distal end section relative to previously obtained image data of the patient. Examples of tracking and guidance techniques are described in U.S. Pat. No. 7,233,820 to Gilboa; U.S. Pat. No. 7,756,563 to Higgins et al.; U.S. Pat. No. 7,889,905 to Higgins et al.; U.S. Pat. No. 9,265,468 to Rai et al.; and U.S. Patent Publication No. 20160180529 to Rai et al. See, e.g., the Superdimension™ Navigation System, manufactured by Medtronic (Minneapolis, Minn.), and the Archimedes™ System, manufactured by Broncus Medical, Inc., (San Jose, Calif.).
Step 630 states to probe the candidate nerve. As described herein, this step may be carried out using various means. In embodiments, the distal end of the instrument or tool (e.g., a small gauge needle) is urged into the tissue.
Step 640 states to query whether the airway is responsive to the probing step 630. In embodiments, the physician visually monitors the airway for contraction as the nerve is probed.
Additionally, assessment of the candidate nerve may be performed via empirical techniques including observing movement of the nerve/airway and/or measuring nerve activity as the catheter tip is moved into and out of contact with the nerve (namely, hitting or probing). As described above, external sensors may interrogate or confirm contact between the distal tip and the nerve or smooth muscle. Such tests record or sense nerve activity or electrical activity in a minimally or noninvasive manner. Nonlimiting examples of external sensors include electromyography (EMG) sensors and systems. In embodiments, a surface-type EMG sensor is affixed to the skin of the patient to monitor nerve activity. Measuring nerve activity is desirable when direct visualization is impractical due to bleeding in the field of view of the bronchoscope.
Should probing the candidate nerve not generate airway responsiveness, the physician has the option to identify another candidate nerve and repeat the process as indicated in
Step 650 states for the physician to temporarily paralyze the candidate nerve should the airway be responsive to the probing step. Step 650 can be performed using various techniques or tools. For example, temporarily blocking may be performed by injecting local anesthetics such as bupivacaine, levobupivacaine, or ropivacaine.
In embodiments, the nerve is temporarily frozen using cryo.
In embodiments, the nerve is paralyzed by mechanical action (e.g., pinching using a temporary clip or restrictor).
Step 660 states to query for an adverse reaction while the candidate nerve is temporarily paralyzed. Step 660 may be performed by visually monitoring the patient for unintended consequences or collateral damage to nerves and tissues not targeted. If an adverse reaction is observed during the temporarily blocking step, the procedure may be terminated or another candidate nerve may be identified. And the process is repeated returning to step 610.
If, on the other hand, an adverse reaction is not observed, the physician may characterize the candidate nerve as the target nerve to be ablated or otherwise permanently blocked.
Step 670 states to ablate the nerve. If temporarily paralyzing the nerve is observed to be safe and, more preferably, to also provide a clinical benefit to the patient, the physician ablates the nerve at the site where the paralyzing step occurred. In embodiments, the physician follows the previous path used during the paralyzing step, and applies energy directly to the nerve. For reasons described herein, applying energy directly to the nerve is preferred to applying energy indirectly to the nerve (e.g., applying heat to the inner surface of the airway wall, and raising the temperature of the nerve via thermal conduction through the airway wall, through the smooth muscle, and ultimately to the nerve). Precise direct ablation limits the inadvertent ablation of pulmonary vessels and other tissue in the vicinity of the target nerve.
The step of ablation may be carried out using a wide range of techniques. Exemplary modalities of ablation include use of a condensable vapor, RF, microwave, or cryo.
In a preferred embodiment, ablation is carried out using a thermal vapor ablation catheter.
Alternative Embodiments
The invention has been discussed in terms of certain embodiments. One of skill in the art, however, will recognize that various modifications may be made without departing from the scope of the invention. For example, numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Moreover, while certain features may be shown or discussed in relation to a particular embodiment, such individual features may be used on the various other embodiments of the invention.
This application claims the benefit of provisional patent application No. 62/555,118, filed Sep. 7, 2017, entitled “SCREENING METHOD FOR A TARGET NERVE TO ABLATE FOR THE TREATMENT OF INFLAMMATORY LUNG DISEASE”, incorporated by reference herein in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
408899 | Small | Aug 1889 | A |
1719750 | Bridge et al. | Jul 1929 | A |
3507283 | Thomas, Jr. | Apr 1970 | A |
3880168 | Berman | Apr 1975 | A |
4026285 | Jackson | May 1977 | A |
4713060 | Riuli | Dec 1987 | A |
4773410 | Blackmer et al. | Sep 1988 | A |
4793352 | Eichenlaub | Dec 1988 | A |
4915113 | Holman | Apr 1990 | A |
4950266 | Sinofsky | Aug 1990 | A |
5006119 | Acker et al. | Apr 1991 | A |
5011566 | Hoffman | Apr 1991 | A |
5084043 | Hertzmann et al. | Jan 1992 | A |
5112328 | Taboada et al. | May 1992 | A |
5158536 | Michael et al. | Oct 1992 | A |
5263951 | Spears et al. | Nov 1993 | A |
5331947 | Shturman | Jul 1994 | A |
5334190 | Seiler | Aug 1994 | A |
5348551 | Spears et al. | Sep 1994 | A |
5352512 | Hoffman | Oct 1994 | A |
5424620 | Cheon et al. | Jun 1995 | A |
5462521 | Brucker et al. | Oct 1995 | A |
5500012 | Brucker et al. | Mar 1996 | A |
5503638 | Cooper et al. | Apr 1996 | A |
5524620 | Rosenschein | Jun 1996 | A |
5529076 | Schachar | Jun 1996 | A |
5549628 | Cooper et al. | Aug 1996 | A |
5562608 | Michael et al. | Oct 1996 | A |
5575803 | Cooper et al. | Nov 1996 | A |
5591157 | Hennings et al. | Jan 1997 | A |
5620440 | Heckele et al. | Apr 1997 | A |
5695507 | Auth et al. | Dec 1997 | A |
5735811 | Brisken | Apr 1998 | A |
5752965 | Francis et al. | May 1998 | A |
5755753 | Knowlton | May 1998 | A |
5779642 | Nightengale | Jul 1998 | A |
5782914 | Schankereli | Jul 1998 | A |
5800482 | Pomeranz et al. | Sep 1998 | A |
5824703 | Clark, Jr. | Oct 1998 | A |
5827268 | Laufer | Oct 1998 | A |
5913856 | Chia et al. | Jun 1999 | A |
5957919 | Laufer | Sep 1999 | A |
5964752 | Stone | Oct 1999 | A |
5972026 | Laufer et al. | Oct 1999 | A |
5986662 | Argiro et al. | Nov 1999 | A |
5989445 | Wise et al. | Nov 1999 | A |
6032077 | Pomeranz | Feb 2000 | A |
6053909 | Shadduck | Apr 2000 | A |
6059011 | Giolo | May 2000 | A |
6083255 | Laufer et al. | Jul 2000 | A |
6099251 | Lafleur | Aug 2000 | A |
6102037 | Koch | Aug 2000 | A |
6113722 | Hoffman et al. | Sep 2000 | A |
6130671 | Argiro | Oct 2000 | A |
6131570 | Schuster et al. | Oct 2000 | A |
6139571 | Fuller et al. | Oct 2000 | A |
6156036 | Sussman et al. | Dec 2000 | A |
6162232 | Shadduck | Dec 2000 | A |
6179805 | Sussman et al. | Jan 2001 | B1 |
6194066 | Hoffman | Feb 2001 | B1 |
6200333 | Laufer | Mar 2001 | B1 |
6210404 | Shadduck | Apr 2001 | B1 |
6219059 | Argiro | Apr 2001 | B1 |
6273907 | Laufer | Aug 2001 | B1 |
6283988 | Laufer et al. | Sep 2001 | B1 |
6283989 | Laufer et al. | Sep 2001 | B1 |
6299633 | Laufer | Oct 2001 | B1 |
6300150 | Venkatasubramanian | Oct 2001 | B1 |
6312474 | Francis et al. | Nov 2001 | B1 |
6327505 | Medhkour et al. | Dec 2001 | B1 |
6394949 | Crowley et al. | May 2002 | B1 |
6398759 | Sussman et al. | Jun 2002 | B1 |
6398775 | Perkins et al. | Jun 2002 | B1 |
6409723 | Edwards | Jun 2002 | B1 |
6411852 | Danek et al. | Jun 2002 | B1 |
6458231 | Wapner et al. | Oct 2002 | B1 |
6468313 | Claeson et al. | Oct 2002 | B1 |
6488673 | Laufer et al. | Dec 2002 | B1 |
6493589 | Medhkour et al. | Dec 2002 | B1 |
6508816 | Shadduck | Jan 2003 | B2 |
6527761 | Soltesz et al. | Mar 2003 | B1 |
6575929 | Sussman et al. | Jun 2003 | B2 |
6579270 | Sussman et al. | Jun 2003 | B2 |
6585639 | Kotmel et al. | Jul 2003 | B1 |
6588613 | Pechenik et al. | Jul 2003 | B1 |
6589201 | Sussman et al. | Jul 2003 | B1 |
6592594 | Rimbaugh et al. | Jul 2003 | B2 |
6599311 | Biggs et al. | Jul 2003 | B1 |
6610043 | Ingenito | Aug 2003 | B1 |
6629951 | Laufer et al. | Oct 2003 | B2 |
6652594 | Francis et al. | Nov 2003 | B2 |
6653525 | Ingenito et al. | Nov 2003 | B2 |
6669694 | Shadduck | Dec 2003 | B2 |
6676628 | Sussman et al. | Jan 2004 | B2 |
6679264 | Deem et al. | Jan 2004 | B1 |
6682520 | Ingenito | Jan 2004 | B2 |
6692494 | Cooper et al. | Feb 2004 | B1 |
6712812 | Roschak et al. | Mar 2004 | B2 |
6719738 | Mehier | Apr 2004 | B2 |
6755794 | Soukup | Jun 2004 | B2 |
6770070 | Balbierz | Aug 2004 | B1 |
6776765 | Soukup et al. | Aug 2004 | B2 |
6860847 | Alferness et al. | Mar 2005 | B2 |
6885888 | Rezai | Apr 2005 | B2 |
6901927 | Deem et al. | Jun 2005 | B2 |
6904909 | Deem et al. | Jun 2005 | B2 |
6907881 | Suki et al. | Jun 2005 | B2 |
6911028 | Shadduck | Jun 2005 | B2 |
6986769 | Nelson et al. | Jan 2006 | B2 |
6997189 | Biggs et al. | Feb 2006 | B2 |
7022088 | Keast et al. | Apr 2006 | B2 |
7027869 | Danek et al. | Apr 2006 | B2 |
7031504 | Argiro et al. | Apr 2006 | B1 |
7083612 | Littrup et al. | Aug 2006 | B2 |
7128748 | Mooradian et al. | Oct 2006 | B2 |
7136064 | Zuiderveld | Nov 2006 | B2 |
7144402 | Kuester et al. | Dec 2006 | B2 |
7144588 | Nicholas et al. | Dec 2006 | B2 |
7174644 | Critelli et al. | Feb 2007 | B2 |
7175644 | Cooper et al. | Feb 2007 | B2 |
7192400 | Campbell et al. | Mar 2007 | B2 |
7198635 | Danaek et al. | Apr 2007 | B2 |
7233820 | Gilboa | Jun 2007 | B2 |
7235070 | Vanney | Jun 2007 | B2 |
7335195 | Mehier | Feb 2008 | B2 |
7347859 | Garabedian et al. | Mar 2008 | B2 |
7412977 | Fields et al. | Aug 2008 | B2 |
7422563 | Roschak et al. | Sep 2008 | B2 |
7422584 | Loomas et al. | Sep 2008 | B2 |
7425212 | Danek et al. | Sep 2008 | B1 |
7462162 | Phan et al. | Dec 2008 | B2 |
7628789 | Soltesz et al. | Dec 2009 | B2 |
7708712 | Phan et al. | May 2010 | B2 |
7740017 | Danek et al. | Jun 2010 | B2 |
7756563 | Higgins et al. | Jul 2010 | B2 |
7778704 | Rezai et al. | Aug 2010 | B2 |
7815590 | Cooper | Oct 2010 | B2 |
7819908 | Ingenito | Oct 2010 | B2 |
7889905 | Higgins et al. | Feb 2011 | B2 |
7906124 | Laufer et al. | Mar 2011 | B2 |
7913698 | Barry et al. | Mar 2011 | B2 |
7985187 | Wibowo et al. | Jul 2011 | B2 |
7993323 | Barry et al. | Aug 2011 | B2 |
8002740 | Willink et al. | Aug 2011 | B2 |
8088127 | Mayse et al. | Jan 2012 | B2 |
8172827 | Deem et al. | May 2012 | B2 |
8187269 | Shadduck et al. | May 2012 | B2 |
8251070 | Danek et al. | Aug 2012 | B2 |
8292882 | Danek et al. | Oct 2012 | B2 |
8322335 | Barry et al. | Dec 2012 | B2 |
8409167 | Roschak | Apr 2013 | B2 |
8444636 | Shadduck et al. | May 2013 | B2 |
8585645 | Barry et al. | Nov 2013 | B2 |
8608724 | Roschak | Dec 2013 | B2 |
8628495 | Horton et al. | Jan 2014 | B2 |
8709034 | Keast et al. | Apr 2014 | B2 |
8734380 | Barry et al. | May 2014 | B2 |
8784400 | Roschak | Jul 2014 | B2 |
8858549 | Shadduck et al. | Oct 2014 | B2 |
8900223 | Shadduck | Dec 2014 | B2 |
9037215 | Higgins et al. | May 2015 | B2 |
9050076 | Barry et al. | Jun 2015 | B2 |
9133858 | Macchia et al. | Sep 2015 | B2 |
9265468 | Rai et al. | Feb 2016 | B2 |
9913969 | Roschak | Mar 2018 | B2 |
10064697 | Sharma et al. | Sep 2018 | B2 |
20020077516 | Flanigan | Jun 2002 | A1 |
20020111386 | Michael et al. | Aug 2002 | A1 |
20020112723 | Schuster et al. | Aug 2002 | A1 |
20020177846 | Mulier et al. | Nov 2002 | A1 |
20030055331 | Kotmel et al. | Mar 2003 | A1 |
20030099279 | Venkatasubramanian et al. | May 2003 | A1 |
20030181922 | Alferness | Sep 2003 | A1 |
20030233099 | Danaek et al. | Dec 2003 | A1 |
20040031494 | Danek et al. | Feb 2004 | A1 |
20040038868 | Ingenito | Feb 2004 | A1 |
20040047855 | Ingenito | Mar 2004 | A1 |
20040055606 | Hendricksen et al. | Mar 2004 | A1 |
20040068306 | Shadduck | Apr 2004 | A1 |
20040199226 | Shadduck | Oct 2004 | A1 |
20040200484 | Springmeyer | Oct 2004 | A1 |
20040244803 | Tanaka | Dec 2004 | A1 |
20050016530 | Mccutcheon et al. | Jan 2005 | A1 |
20050066974 | Fields et al. | Mar 2005 | A1 |
20050166925 | Wilson et al. | Aug 2005 | A1 |
20050171396 | Pankratov et al. | Aug 2005 | A1 |
20050171582 | Matlock | Aug 2005 | A1 |
20050203483 | Perkins et al. | Sep 2005 | A1 |
20050215991 | Altman et al. | Sep 2005 | A1 |
20050222485 | Shaw et al. | Oct 2005 | A1 |
20060004400 | Mcgurk et al. | Jan 2006 | A1 |
20060047291 | Barry | Mar 2006 | A1 |
20060100619 | Mcclurken et al. | May 2006 | A1 |
20060130830 | Barry | Jun 2006 | A1 |
20060135955 | Shadduck | Jun 2006 | A1 |
20060162731 | Wondka et al. | Jul 2006 | A1 |
20060200076 | Gonzalez et al. | Sep 2006 | A1 |
20060224154 | Shadduck et al. | Oct 2006 | A1 |
20070032785 | Diederich et al. | Feb 2007 | A1 |
20070036417 | Argiro et al. | Feb 2007 | A1 |
20070068530 | Pacey | Mar 2007 | A1 |
20070091087 | Zuiderveld | Apr 2007 | A1 |
20070092864 | Reinhardt et al. | Apr 2007 | A1 |
20070102011 | Danek et al. | May 2007 | A1 |
20070106292 | Kaplan et al. | May 2007 | A1 |
20070109299 | Peterson | May 2007 | A1 |
20070112349 | Danek et al. | May 2007 | A1 |
20070118184 | Danek et al. | May 2007 | A1 |
20070137646 | Weinstein et al. | Jun 2007 | A1 |
20070293853 | Truckai et al. | Dec 2007 | A1 |
20080033493 | Deckman et al. | Feb 2008 | A1 |
20080132826 | Shadduck et al. | Jun 2008 | A1 |
20080249439 | Tracey | Oct 2008 | A1 |
20090018538 | Webster et al. | Jan 2009 | A1 |
20090043301 | Jarrard et al. | Feb 2009 | A1 |
20090118538 | Pizzocaro et al. | May 2009 | A1 |
20090138001 | Barry et al. | May 2009 | A1 |
20090149846 | Hoey et al. | Jun 2009 | A1 |
20090149897 | Dacey, Jr. | Jun 2009 | A1 |
20090156895 | Higgins et al. | Jun 2009 | A1 |
20090192508 | Laufer et al. | Jul 2009 | A1 |
20090216220 | Hoey et al. | Aug 2009 | A1 |
20090301483 | Barry et al. | Dec 2009 | A1 |
20090306640 | Glaze et al. | Dec 2009 | A1 |
20090306644 | Mayse et al. | Dec 2009 | A1 |
20090312753 | Shadduck | Dec 2009 | A1 |
20100094270 | Sharma | Apr 2010 | A1 |
20100204688 | Hoey et al. | Aug 2010 | A1 |
20100256714 | Springmeyer | Oct 2010 | A1 |
20100262133 | Hoey et al. | Oct 2010 | A1 |
20100310146 | Higgins et al. | Dec 2010 | A1 |
20110077628 | Hoey et al. | Mar 2011 | A1 |
20110118725 | Mayse et al. | May 2011 | A1 |
20110160648 | Hoey | Jun 2011 | A1 |
20110172654 | Barry et al. | Jul 2011 | A1 |
20110257644 | Barry | Oct 2011 | A1 |
20110270031 | Frazier et al. | Nov 2011 | A1 |
20110301587 | Deem et al. | Dec 2011 | A1 |
20110319958 | Simon | Dec 2011 | A1 |
20120016363 | Mayse et al. | Jan 2012 | A1 |
20120016364 | Mayse et al. | Jan 2012 | A1 |
20120289776 | Keast et al. | Nov 2012 | A1 |
20130006231 | Sharma et al. | Jan 2013 | A1 |
20130267939 | Barry et al. | Oct 2013 | A1 |
20130324987 | Leung | Dec 2013 | A1 |
20140025057 | Hoey et al. | Jan 2014 | A1 |
20140275952 | Monroe et al. | Sep 2014 | A1 |
20140276713 | Hoey et al. | Sep 2014 | A1 |
20150094607 | Barry et al. | Apr 2015 | A1 |
20150230852 | Barry et al. | Aug 2015 | A1 |
20160180529 | Rai et al. | Jun 2016 | A1 |
20160220297 | Kroon et al. | Aug 2016 | A1 |
20160287307 | Clark | Oct 2016 | A1 |
20160310200 | Wang | Oct 2016 | A1 |
20160374710 | Sinelnikov | Dec 2016 | A1 |
20170172640 | Henne | Jun 2017 | A1 |
20180036084 | Krimsky | Feb 2018 | A1 |
20180318002 | Barry et al. | Nov 2018 | A1 |
20190069948 | Herth et al. | Mar 2019 | A1 |
20190343579 | Tandri | Nov 2019 | A1 |
Number | Date | Country |
---|---|---|
721086 | Jun 2000 | AU |
1003582 | Feb 2003 | EP |
1143864 | Feb 2004 | EP |
1173103 | Oct 2005 | EP |
1326549 | Dec 2005 | EP |
1326548 | Jan 2006 | EP |
1485033 | Aug 2009 | EP |
0011927 | Mar 2000 | WO |
0102042 | Jan 2001 | WO |
02069821 | Sep 2002 | WO |
03070302 | Aug 2003 | WO |
03086498 | Oct 2003 | WO |
2005025635 | Mar 2005 | WO |
2005102175 | Nov 2005 | WO |
2006003665 | Jan 2006 | WO |
2006052940 | May 2006 | WO |
2006053308 | May 2006 | WO |
2006053309 | May 2006 | WO |
2006080015 | Aug 2006 | WO |
2006116198 | Nov 2006 | WO |
2008051706 | May 2008 | WO |
2009009236 | Jan 2009 | WO |
2009009398 | Jan 2009 | WO |
2009015278 | Jan 2009 | WO |
2009137819 | Nov 2009 | WO |
2010042461 | Apr 2010 | WO |
2011056684 | May 2011 | WO |
2011060200 | May 2011 | WO |
2011060201 | May 2011 | WO |
2011127216 | Oct 2011 | WO |
Entry |
---|
Becker, et al.; Lung volumes before and after lung volume reduction surgery; Am J Respir Crit Care Med; vol. 157; pp. 1593-1599; (1998) Oct. 28, 1997. |
Blacker, G. F.; Vaporization of the uterus; J. of Obstetrics and Gynaecology; vol. 33; pp. 488-511; 1902. |
Carpenter III et al.; Comparison of endoscopic cryosurgery and electrocoagulation of bronchi; Trans. Amer. Acad. Opth.; vol. 84; No. 1; pp. ORL-313-ORL-323; Jan. 1977. |
Clinical trials.gov.; Study of the AeriSeal System for HyPerinflation Reduction in Emphysema; 4 pages; Nov. 5, 2014 retrieved from the internet (http://clinicaltrials.gov/show/NCT01449292). |
Coda, et al., “Effects of pulmonary reventilation on gas exchange after cryolytic disobstruction of endobronchial tumors,” Minerva Medical, vol. 72, pp. 1627-1631, Jun. 1981 (w/ Eng. Trans.). |
Cox et al., “Bronchial Thermoplasty for Asthma.” American Journal of Respiratory Critical Care Medicine 173: 965-969 (2006). |
Delaunois; Anatomy and physiology of collateral respiratory pathways; Eur. Respir. J.; 2(9); pp. 893-904; Oct. 1989. |
Eyal et al.; The acute effect of pulmonary burns on lung mechanics and gas exchange in the rabbit; Br. J. Anaesth.; vol. 47; pp. 546-552; (year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date) 1975. |
Ferlay et al.; GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [internet] 16 pages; retrieved from the Internet (http://www.iarc.fr/en/media-centre/iarcnews/2010/GLOBOCAN2008.pdf); Lyon, France: International Agency for Research on Cancer; Jun. 1, 2010. |
Fishman et al., A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema, N Engl J Med, vol. 348, No. 21, pp. 2059-2073, May 22, 2003. |
Goldberg et al.; Radiofrequency tissue ablation in the rabbit lung: Efficacy and complications; Acad. Radiol.; vol. 2; pp. 776-784; Sep. 1995. |
Henne et al.; U.S. Appl. No. 14/957,433 entitled “Vapor treatment of lung nodules and tumors,” filed Dec. 2, 2015. |
Herth et al.; Efficacy predictors of lung volume reduction with zephyr valves in a european cohort; Eur. Respir. J.; 39(6); pp. 1334-1342; Jun. 2012. |
Homasson, et al., “Bronchoscopic cryotherapy for airway strictures caused by tumors,” Chest, vol. 90, No. 2, pp. 159-164, Aug. 1986. |
Kang, Li, “Efficient optimal net surface detection for image segmentation—from theory to practice,” M.Sc. Thesis, The University of Iowa, Dec. 2003. |
Kinsella et al.; Quantitation of emphysema by computed tomography using a “densitymask” program and correlation with pulmonary function tests; Chest; 97(2); pp. 315-321; Feb. 1990. |
Looga, R. U.; Mechanism of changes in the respiratory and cardiovascular reflexes from the lungs associated with intrapulmonary steam burns; Eng. Trans. from Byulleten Eksperimental noi Biologii I Meditsiny; vol. 61; No. 6; pp. 31-33; Jun. 1966. |
Marasso, et al., “Cryosurgery in bronchoscopic treatment of tracheobronchial stenosis,” Chest, vol. 103, No. 2, pp. 472-474, Feb. 1993. |
Marasso, et al., “Radiofrequency resection of bronchial tumours in combination with cryotherapy: evaluation of a new technique,” Thorax, vol. 53, pp. 106-109, (year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date) 1998. |
Mathur et al., Fiberoptic bronchoscopic cryotherapy in the management of tracheobronchial obstruction, Chest, vol. 110, No. 3, pp. 718-723, Sep. 1996. |
Morice et al.; Endobrinchial argon plasma coagulation for treatment of hemotysis and neoplastic airway obstruction, Chest, vol. 119, No. 3, pp. 781-787, Mar. 2001. |
Moritz et al.; The effects of inhaled heat on the air pasage and lungs; American Journal of Pathology; vol. XXI; pp. 311-331; (year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date) 1944. |
Moulding et al.; Preliminary studies for achieving transcervical oviduct occlusion by hot water or low-pressure steam Advances in Planned Parenthood; vol. 12, No. 2; pp. 79-85; (year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date) 1977. |
National Lung Screening Trial Research Team; Reduced lung-cancer mortality with low-dose computed tomographic screening; N. Eng. J. Med.; 365(5); pp. 395-409; Aug. 4, 2011. |
Pieter et al.; U.S. Appl. No. 15/013,748 entitled “Medical vapor generator,” filed Feb. 2, 2016. |
Pracht, Adam, “VIDA takes new approach,” Iowa City Press-Citizen, Sep. 12, 2005. |
Quin, Jacquelyn, “Use of neodymium yttrium aluminum garnet laser in long-term palliation of airway obstruction,” Connecticut Medicine, vol. 59, No. 7, pp. 407-412, Jul. 1995. |
Sciurba et al.; A randomized study of endobronchial valves for advanced emphysema; N. Eng. J. Med.; 363(13); pp. 1233-1244; Sep. 23, 2010. |
Shah et al.; Collateral ventilation and selection of techniques for bronchoscopic lung volume reduction; Thorax; 67(4); pp. 285-286; Apr. 2012. |
Slebos et al.; Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema; Chest; 142(3); pp. 574-582; Sep. 2012. |
Sutedja, et al.; Bronchoscopic treatment of lung tumors; Elsevier, Lung Cancer, 11, pp. 1-17, Jul. 1994. |
Tschirren et al.; Inlialhoracic airway trees: segmentation and airway morphology analysis from low-dose CT scans; IEEE Trans. Med. Imaging; vol. 24, No. 12; pp. 1529-1539; Dec. 2005. |
Tschirren, Juerg; Segmentation, anatomical labeling, branchpoint matching, and quantitative analysis of human airway trees in volumetric CT images; Ph.D. Thesis; The University of Iowa; Aug. 2003. |
Tschirren, Juerg; Segmentation, anatomical labeling, branchpoint matching, and quantitative analysis of human airway trees in volumetric CT images; Slides from Ph.D. defense; The University of Iowa; Jul. 10, 2003. |
Van De Velde; Vapo-cauterization of the uterus; Amer. J. Med. Sci.; vol. CXVIII; (year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date) 1899. |
Vorre et al.; Morphology of tracheal scar after resection with CO2-laser and high-frequency cutting loop; Acta Otolaryngol (Stockh); vol. 107; pp. 307-312; (year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date) 1989. |
Number | Date | Country | |
---|---|---|---|
20190069948 A1 | Mar 2019 | US |
Number | Date | Country | |
---|---|---|---|
62555118 | Sep 2017 | US |