Patent Application
20220273489
Examples described herein are related to systems and methods for diffuse endoluminal thermal treatment of diseased anatomy.
Minimally invasive medical techniques may generally be intended to reduce the amount of tissue that is damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques may be performed through natural orifices in a patient anatomy or through one or more surgical incisions. Through these natural orifices or incisions an operator may insert minimally invasive medical instruments such as therapeutic instruments, diagnostic instruments, imaging instruments, and surgical instruments. In some examples, a minimally invasive medical instrument may be a thermal energy treatment instrument for use within an endoluminal passageway of a patient anatomy.
The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.
In some embodiments, a system may comprise a liquid source from which a liquid is delivered, and a catheter coupled to the liquid source. The catheter may include a distal portion from which the liquid is released into an anatomic lumen. The system may also include an occlusion device coupled to the catheter and configured to prevent flow of the liquid in the anatomic lumen proximally of the occlusion device. The system may also include a heating device near the distal portion of the catheter. The heating device may be configured to heat the liquid to a temperature of less than a vaporization temperature for the liquid.
It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.
Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures, wherein showings therein are for purposes of illustrating embodiments of the present disclosure and not for purposes of limiting the same.
The technology described herein provides techniques and treatment systems for endoluminal thermal treatment of diseased tissue. Although the examples provided herein may refer to treatment of lung tissue and pulmonary disease, it is understood that the described technology may be used in treating artificially created lumens or any endoluminal passageway or cavity, including in a patient trachea, colon, intestines, stomach, liver, kidneys and kidney calices, brain, heart, circulatory system including vasculature, fistulas, and/or the like. In some examples, treatment described herein may be referred to as endobronchial thermal liquid treatment and may be used in procedures to treat lung tumors and/or chronic obstructive pulmonary disease (COPD).
Lung tumors may include ground glass opacity tumors, semi-solid tumors, or spiculated tumors. Often, they may occur in the peripheral, outer third of the lung volume. Some lung tumor treatment methods and systems may be particularly suited for the low-density, peripheral areas of the lung. Tumors may be cancerous, and effective treatment of lung cancer may include the destruction of the tumor core, peripheral tumors, and cancerous or non-cancerous areas at the margin of the tumors. Conventional ablation treatment may directly heat the tumor core without treating the tissue at the margin. Some endoluminal thermal liquid treatments may cause infarction of a segment of the lung, thus destroying tumors and the tissue around the tumor within the infarcted region.
Chronic obstructive pulmonary disease may include one or more of a plurality of disease conditions or states including chronic bronchitis, emphysema, and bronchiectasis. Chronic bronchitis is the inflammation of bronchial tubes and may be characterized by increased mucous secretions and goblet cell hyperplasia. Emphysema is a condition in which the parenchyma including the alveoli at the distal ends of the bronchial tubes are damaged, thereby causing hyperinflation and reduced lung function. Bronchiectasis is a condition in which the bronchial tubes become widened and thickened by scarring. Pockets form in the bronchial tube walls filled with bacterial biofilm, creating a nidus for bronchiectasis exacerbations.
At an optional process 202, a treatment device is positioned in an anatomic lumen at a first location. For example, and with reference to
At an optional process 204, factors may be assessed related to the procedure to be performed with the medical instrument 100. For example, either before (e.g., pre-operatively) or after (e.g., intra-operatively) the instrument 100 is positioned in the lumen 122, anatomic images of the lung 104, including the region 113 may be obtained. The images may be obtained by imaging systems using technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, or nanotube X-ray imaging. The images may provide information about the type, location, volume and density of the diseased tissue (e.g. a lung tumor, emphysema, chronic bronchitis, brochiectasis), lumen size, lumen volume and may be used to determine a suitable treatment type and a location for delivering the treatment.
At an optional process 206, the anatomic lumen may be prepared for delivery of an endoluminal thermal treatment. In some examples, a lavage treatment may be delivered to the anatomic lumen 122 to remove mucous and expose biofilm. In some examples, a suctioning treatment may be applied to the anatomic lumen to remove mucous and liquid. In some examples, a medicinal treatment may be delivered to the lumen 122.
At a process 208, the occlusion device 156 may be deployed. In some examples, the occlusion device 156 may be an expandable device such as an inflatable balloon, an expandable membrane, or an expandable hood that extends circumferentially around the catheter shaft 160. The occlusion device 156 may have a collapsed configuration as shown in
At a process 210, a non-compressible fluid is heated in or near the distal portion of the catheter. For example, the heating device 158 within the inner catheter 152 may heat a non-compressible fluid such as liquid 162 to a temperature of less than 100 degrees Celsius. The heating device 158 may, for example, heat the liquid 162 using a radiofrequency (RF) heating element, a resistive heating element, a microwave heating element, an ultrasonic heating element, a magnetic heating element, or a light/laser-based heating element. The liquid 162 may be delivered to the catheter from a liquid source 161 such as a fluid reservoir or another coupled liquid source coupled to a proximal portion of the inner catheter 152. In some embodiments, the catheter may be considered the liquid source. The liquid 162 may be, for example, water (including sterile or de-ionized water), saline, gel, solution, glycerin, or oil that maintains a liquid state at temperatures approaching 100 degrees Celsius. Generally the liquid may be held at a temperature lower than the liquid's vaporization or boiling point. Depending on the components of the liquid, it may be heated to a temperature greater than 100 degrees Celsius while maintaining a liquid state. In some examples, the liquid may be heated to a temperature between approximately 50 and 200 degrees Celsius. In some examples, the liquid may be a gel having a viscosity of between approximately 0.5 and 10,000 centipoise. In some examples, the liquid may be a pure solvent such as water, propylene glycol, diglyme, tetrahydrofurfuryl alcohol, N-methyl-2-pyrrolidone, or solketal. In some examples, the liquid may be comprised of inert or generally inert substances and may comprise a variety of solvents and solutes such as antimicrobial, antibiotic, antifungal, and or aseptic additives to facilitate healing, injury, or other responses. The liquid may further include radiopaque additives such as calcium carbonate, gold flakes, iodine, barium-sulphate, gadolinium or other radiopaque materials that facilitate delivery and monitoring of the delivered liquid. The liquid may include additives that adjust the heat capacity, heat transfer properties, viscosity, and/or osmolarity of the liquid, including starches, polyethylene, or fiber. In some embodiments, the liquid may be bioabsorbable over a period of time such as approximately one to six weeks. In some embodiments, the heating device 158 may also include a pressurization system for pressurizing the liquid 162. The heating device 158 may pressurize the liquid using, for example, a linear actuator, a screw pump, a piston pump, a rotary pump, a diaphragm pump, or a peristaltic pump. In some embodiments, the liquid may be heated by a heating and pressurization device at a proximal portion of the medical instrument or in a reservoir coupled to the medical instrument. The heated liquid may be pressurized and delivered into the proximal portion of the inner catheter and may flow through the inner catheter to the distal portion of the inner catheter before being released from the distal opening. In some embodiments, the liquid may be heated by a heating device coupled to and located externally of the distal opening. In some embodiments, the liquid may serve as a resistor in a resistive circuit. In some embodiments, the liquid may be heated with an exothermic reaction, such as a reaction of zeolite with water.
At an optional process 212, parameters associated with the liquid may be adjusted based on the intended outcome of the treatment. For example, parameters 220 such as the temperature of the liquid 222, the rate of liquid release 224, the volume of released liquid 226, the duration of the liquid release 228, and/or the pressure at which the liquid is released 230 may be adjusted based on the type of disease to be treated, the size of the lumens, the proximity of other passageways, or other environmental factors.
At a process 214, the heated liquid is released from the distal portion of the catheter into the anatomic lumen. For example, the heated liquid 162 may be released from the distal opening 164 into the lumen 122 distally as shown in
At an optional process 216, the catheter may be moved as the heated liquid is released from the distal portion of the catheter. For example, the inner catheter 152 may be retracted as the liquid 162 is released from the opening 164. If the occlusion device is mounted to the inner catheter as shown in
At an optional process 218, the liquid may be removed from the anatomic lumen. For example, suction may be applied through the catheter 152 or through another suctioning instrument to remove at least some of the liquid 162 from the lumen 122.
In some embodiments the method 200 may be used for the treatment of emphysema to induce airway occlusion and lung volume reduction of lung regions distal of the tertiary bronchi 112, such as sixth to tenth generation airways. Emphysema may result in heterogeneously distributed hyperinflation of the alveoli. These hyperinflated segments of the lung may have poor gas exchange and may encroach upon healthier regions of alveoli. Reducing these poorly functioning hyperinflated segments of lung may improve lung function and quality of life. Heating the bronchial passageways, and in some treatments the adjacent arteries, with the heated liquid may induce cell injury and subsequent tissue proliferation and thereby airway and vasculature occlusion. The heat may ablate the bronchial wall, resulting in collagen shrinkage and neo-intima hyperplasia. This may lead to occlusion of the bronchial passageway and subsequent lung volume reduction of that hyperinflated segment. A reduction of air and blood flow to emphysematous tertiary and more distal segments of the lung may redirect air and blood flow from poorly functioning distal segments to better functioning segments. This may improve pulmonary function and quality of life for emphysema patients.
Because of the smaller size of bronchi and the close proximity and small size of the adjacent vasculature, delivery of the heated liquid at the tertiary or sub-tertiary bronchi provides sufficient heat capacity, heat transfer and heat dissipation that primarily results in bronchial wall ablation and, in some cases, airway occlusion and secondarily results in occlusion of the vasculature structures as the healing process proceeds. Additionally, ablating at the tertiary bronchi level may maintain the mucociliary transport, which begins proximal to the tertiary bronchi. Other thermal methods ablate at the bronchus level thereby thermally ablating critical mucociliary transport that can negatively affect the healing process. In some embodiments, a viscous liquid, such a gel, may enable the heat energy to remain in place regardless of gravitational forces during heat transfer from the airways to the surrounding tissue structures including the parenchyma and vasculature. In some embodiments, surface tension in the narrow bronchi may be sufficient to hold a non-viscous liquid, such as a saline solution, in place regardless of the gravitational forces.
For emphysema an ablation through the artery wall to the adventitia but not ablating the bronchial artery may be effective. Treatment parameters including liquid temperature, liquid volume, liquid delivery speed and distance to static position of the heated liquid may be determined and controlled in order to achieve ablation at the effective depth. The treatment parameters, including temperature and depth of ablation of the passageway may be selected based on bronchial wall thickness. The bronchial wall depth may vary in thickness from approximately 0.3 mm to 1.0 mm and may be determined from imaging data, such as intra-operative or pre-operative CT data. Once the wall thickness is determined, the parameters for ablation through the bronchial wall but not through the bronchial arteries may be determined. Using the described endoluminal thermal liquid treatment methods, multiple airways may be simultaneously ablated due to the liquid's ability to traverse into a multitude of airways down to the terminal bronchioles. These treatment methods may be faster as compared to techniques that reduce lung volume with multiple focal treatments. Using the described endoluminal thermal liquid treatment methods, multiple airways may be subsequently ablated from distal to proximal in order to maximize the temperature of each airway treated.
The use of the described systems and methods for treatment of emphysema may be effective in, for example, the third to fifth generation bronchi and may be used in approximately 3 to 6 segments during a procedure. For treatment of emphysema, a temperature of the heated liquid (with a boiling point of about 100 degrees Celsius, such as water, for example) may be just below 100 degrees Celsius or approximately 85 to 99 degrees Celsius at release. For treatment of some disease states, which may include emphysema, liquids at temperatures greater than 100 degrees Celsius (while maintaining a liquid state) may be suitable. Generally, the depth of ablation may extend only through to the adventitia. Therefore, in some embodiments, no thermal damage or subsequent permanent occlusion may occur to the arteries.
In some embodiments, the method 200 may be used for the treatment of chronic bronchitis. Chronic bronchitis may result in hypersecretion of goblet cells which reside within the airway epithelium resulting in excess mucus, frequent infective exacerbations, and chronic productive cough. Ablating these hypersecreting goblet cells while preserving the intercellular matrix may cause regeneration of more normally secreting goblet cells and consequentially, a reduction of mucus production, infective exacerbations and cough. When treating chronic bronchitis, the depth and uniformity of epithelium ablation may be significant factors. If the thermal energy delivery is too shallow, the goblet cells may be insufficiently ablated. If the thermal energy delivery is too deep, the lamina propria, smooth muscle cells, and submucosa may be ablated, causing neomucosal hyperplasia and potentially resulting in unwanted airway obstruction. Depth of ablation may be controlled by the temperature and heat capacity of the liquid to target goblet cells at a depth of 0.05 mm to 0.15 mm within the airway epithelium that lines the bronchial lumen. Goblet cells reside in the epithelium until the terminal bronchi, and the heated liquid delivery allows for ablation of the airway to the terminal bronchi for complete goblet cell ablation. Ablating the cilia and hypersecreting goblet cells while preserving the cellular matrix may allow for the regrowth of healthier goblet cells and cilia without airway obstruction. The healthy regrowth may reduce mucus production, improve lung function, and improve quality of life.
Chronic bronchitis airways may form pleats. Using any of the endoluminal thermal liquid treatments described herein, the heated liquid may fill the pleats to ablate otherwise inaccessible goblet cells and cilia. This treatment may improve efficiency compared to devices with focal treatments that may be repeated multiple times to achieve the same treatment results. (see heated balloon application for clinical details). For chronic bronchitis an ablation depth of 0.05 mm to 0.15 mm may be effective. Treatment parameters including liquid temperature, liquid volume, liquid delivery speed and distance to static position of the heated liquid may be determined and controlled in order to achieve ablation at the effective depth. The use of the disclosed systems and methods for treatment of chronic bronchitis may be effective in, for example, the third to fifth generation bronchi and may be used in any or all of the lobes of the lung. For treatment of chronic bronchitis, a temperature of the heated liquid (with a boiling point of about 100 degrees Celsius, such as water, for example) may be approximately 70 to 95 degrees Celsius at release. For treatment of some disease states, liquids at temperatures greater than 100 degrees Celsius (while maintaining a liquid state) may be suitable.
The lumen may be generally tapered and somewhat cylindrical, with ridges, bumps and other imperfections. The heated liquid provides for a controlled ablation depth. For example, the temperature of the liquid may be adjusted to provide a low rate of ablation that allows for highly controlled ablation depth. As compared to rigid ablation devices that may force the lumen to comply with the ablation device creating areas of higher-pressure contact and compression of the epithelium which can result in uneven depth of ablation, the use of a heated liquid for ablation may provide for complete ablation of the irregular surface of the bronchial lumen as the liquid conforms to the shape of the lumen. Applying the heated liquid to the airway may also provide for safe and consistent overlap of ablation zones since it relies simply on heat transfer through a tissue. Other energy devices that rely on the electrical properties of the tissue for ablation can result in varying ablation depths based on whether the tissue has been previously ablated. Applying heated liquid to the airway also allows for ablation of bifurcated bronchial passageways at bronchial carinas by delivering a volume of liquid that is slightly greater than the targeted airway lumen being filled. This slight overfilling results in a truncated Y-shaped ablation pattern.
In some embodiments, the method 200 may be used for the treatment of bronchiectasis. Bronchiectasis is an abnormal, chronic enlargement of the bronchi that may occur due to infection or noninfectious factors. Bronchiectasis may result in enlarged bronchial pockets and damaged cilia. A decreased ability to clear secretions due to damage of the cilia may accompany the enlargement of the bronchi. Failure to clear secretions allows microbes to collect in them along with the formation of biofilms, which leads to more secretions and inflammation that further damage the airways, causing still further dilation. Bronchiectasis maybe localized, occurring in a single portion of the lung or may be diffuse, occurring throughout the lungs. It is the major lung abnormality of cystic fibrosis, causing infective exacerbations and pneumonia. Applying heated liquid to the airway may improve bronchiectasis in one or more ways. For example, applying the heated liquid to the airway may kill biofilm, bacteria, fungus and other microbes. Ablating the damaged cilia with heated liquid may result in a regrowth of more normal cilia. Cilia reside in the epithelium until the terminal bronchi.
Ablating the submucosa in the enlarged portions of the airway may result in neomucosal hyperplasia which reduces the size of the pockets and facilitates mucus clearance and reduced nidus for infection. Reducing the biofilm, bacteria, fungus and other microbes and improving the mucociliary transport, along with reducing the pockets, results in fewer infective exacerbations may improve the quality of life for the patient and may reduce hospitalizations and associated costs. The suitable temperature of the liquid and the duration for which it is applied to the cilia and submucosa may be determined, monitored and controlled. In some embodiments, the liquid, such as a viscous gel, may conform to the shape of the lumen to provide complete ablation of the pocket as well as irregular surface of the lumen. Applying the heated liquid to the airway may also provide for safe and consistent overlap of ablation zones since it relies simply on heat transfer through a tissue. Other energy devices that rely on the electrical properties of the tissue for ablation can result in varying ablation depths based on whether the tissue has been previously ablated.
For bronchiectasis an ablation through the artery wall to the adventitia but not ablating the bronchial artery may be effective. Treatment parameters including liquid temperature, liquid volume, liquid delivery speed and distance to static position of the heated liquid may be determined and controlled in order to achieve ablation at the effective depth. The parameters, including temperature and depth of ablation may be selected based on bronchial wall thickness. The bronchial wall depth may vary in thickness from approximately 0.3 mm to 1.0 mm and may be determined from imaging data, such as intra-operative or pre-operative CT data. Once the wall thickness is determined, the time to ablate through the bronchial wall but not through the bronchial arteries may be determined. The use of the disclosed systems and methods for treatment of bronchiectasis may be effective in, for example, the third to fifth generation bronchi and may be used in any of three lobes of the lung during a procedure. For treatment of bronchiectasis, a temperature of the heated liquid (with a boiling point of about 100 degrees Celsius, such as water, for example) may be just below 100 degrees Celsius or approximately 85 to 99 degrees Celsius during treatment. For treatment of some disease states, which may include bronchiectasis, liquids at temperatures greater than 100 degrees Celsius (while maintaining a liquid state) may be suitable.
When treating bronchiectasis using the method 200, a vigorous lavage or scouring may be used at process 206 to remove mucus and expose biofilm. For the process 202, the catheter may be positioned such that the distal opening is at the midway point of the pocket. As shown in
In some embodiments, the method 200 may be used for the treatment of a lung tumor. In some embodiments, the lung tumor may have a diameter of approximately 2 cm or less. Delivery of heated liquid to the distal bronchi may provide conduction and migration of thermal energy to the entire sub-segmental microvasculature and parenchyma resulting in the ablation of the tumor and tumor margin via cellular death and ischemia. Subsequent to ablation, naturally occurring macrophage removal of the ablated segmental tissue may result in removal of the ablated tissue because it is not thermally fixed or altered. Ablated tissue that is not thermally fixed may be subsequently removed by the body. When the ablation follows the anatomical boundaries, the result may be complete or substantially complete removal of the entire anatomical structure that includes the tumor, with results similar to a pulmonary segmentectomy. The ablation of a margin of a tumor may result in a lower local recurrence rate. This method of treatment may also promote an immunostimulation effect. In traditional ablation methods that directly provide thermal ablation via radiofrequency, high intensity focused ultrasound, microwave, or radiotherapy, tumor antigens and epitopes are significantly denatured and destroyed, reducing the ability for the immune system to identify the diseased cells. Using a heated liquid, as in method 200, may kill the tumor cells while preserving the cellular proteins and antigens, allowing the immune system to recognize the diseased cell type which enables the immune system to attack tumor cells elsewhere in the body. This is demonstrated by the abscopal effect, which can occur following certain tumor ablations.
With the method 200, heat can be projected from the catheter via the flow of the liquid. The liquid may flow from the catheter placed proximally to the tumor and may follow the natural airways in the lung. This allows for a simpler catheter placement because there is no need to place the catheter within the tumor or to create new channels in the lung. Additionally, because the liquid may flow to and around the tumor, via the airway lumens, there is minimal risk of pneumothorax from a catheter placed too closely to the lung surface. Thus, tumors at the lung surface may be evenly heated.
In some embodiments the liquid 532 may include an additive, such as a dye, to increase the light absorption capacity of the liquid. In some embodiments, the optical transmission member 530 may include lenses, mirrors, or other optical components at the ends of optical fibers to enhance dispersal of the optical energy within the liquid. In some embodiments, the light source 528 may include a pulsed laser. In some embodiments, a temperature sensor may extend into or otherwise contact the liquid 532. Temperature data for the liquid obtained from the temperature sensor may be used to modulate power to the light source 528 to control heating of the liquid to a specific temperature. In some embodiments, an opacity differential within the released liquid may improve the transmission of the thermal energy. With the liquid disposed in a cylindrical airway, the liquid 532 at the exterior (e.g., closest to the bronchial wall) may be relatively opaque to the light 533 and the liquid 532 at the interior (e.g., near the center of the lumen 521) may be relatively translucent to the light 533. The translucent interior may thus for a liquid tube through which the light 533 may be conducted, effectively allowing the liquid tube to serve as a continuation of the optical transmission member 530. The opacity of the liquid may be achieved using various additives, such as electrically charged particles that migrate to the edges of the liquid to create opacity.
In an alternative embodiment, the liquid may be conductive or comprise conductive particles, such as iron oxide. When the conductive liquid is exposed to the oscillating magnetic field 615, eddy currents may be induced in the liquid which causes the liquid to heat by induction heating. In some embodiments, a conductive object, such as a wire or coil may extend from the catheter into the liquid. The conductive object, when exposed to the oscillating magnetic field 615 may induce eddy currents and heat the conductive object through induction. The heat from the conductive object may be conducted to the liquid. In some embodiments, a temperature sensor may extend into or otherwise contact the liquid. Temperature data for the liquid obtained from the temperature sensor may be used to modulate power or frequency of the magnetic field generator to control the inductive heating of the liquid or the conductive object to a specific temperature.
An occlusion device 708 (e.g. the occlusion device 156) is coupled to the catheter 702. The occlusion device 708 may be an inflatable device such as a silicone balloon. The occlusion device 708 may be in fluid communication with an inflation device 709 via the catheter 702. In some embodiments the inflation device 709 may be a syringe including a fluid reservoir for containing a predetermined amount of inflation medium that may be injected into the occlusion device 708 to inflate the occlusion device. In some embodiments, for example, a 1 cm balloon occlusion device may be inflated with 1 cc of air from the syringe inflation device. The inflation device 709 may be coupled to a proximal portion of the catheter 702 via a valve 710, such as a stopcock.
A proximal portion of the catheter 702 may also be coupled via the valve 710 to a liquid source such as a fluid reservoir 712 which contains a non-compressible fluid 714, such as a liquid. The liquid 714 in the reservoir 712 may be heated by a heating device 716. The liquid 714 may be, for example, water, saline, gel, glycerin, solution, or oil that maintains a liquid state at temperatures approaching 100 degrees Celsius. Depending on the components of the liquid, it may be heated to a temperature greater than 100 degrees Celsius while maintaining a liquid state. Glycerin and oil-based liquids may, for example, have boiling points greater than 100 degrees Celsius and thus may be used in endoluminal thermal liquid treatment at temperatures higher than 100 degrees Celsius. In some examples, the liquid may be heated to a temperature between approximately 50 and 200 degrees Celsius. The liquid 714 may include any of the liquid materials or additives described in other embodiments. In one embodiment, the reservoir 712 may be a syringe and may contain 3 cc of liquid that may be heated to approximately 98 degrees Celsius by the heating device 716.
The proximal portion of the catheter 702 may also be coupled via the valve 710 to a flush reservoir 718 which contains a flushing medium such as air or another fluid that may be used to flush the catheter 702. In some embodiments, the flush reservoir 718 may be a syringe that contains 1 cc of air for flushing the catheter 702.
The instrument 700 may minimize heat loss through the catheter because the heated liquid will be in contact with the insulating silicone inner tube 706. The air flush after the injection of the liquid 714 may minimize the temperature of the catheter 702 so that adjacent instrumentation, such as a robotically controlled endoscope is not damaged by transferred heat.
If length of the catheter 702 is too long or if the catheter is not sufficiently insulated, the temperature of the heated liquid 714 may be become sufficiently lowered during delivery down the length of the catheter that the liquid may not perform the ablation as intended. In an alternative embodiment, all or a portion of the catheter may be heated along its length to maintain the temperature of the heated liquid.
At a process 804, a medical instrument may be positioned at a location in the target bronchial passageway. For example, as shown in
At a process 806, the expandable device 826 may be inflated and may compress a bronchial artery 842 extending along the bronchial passageway 820. Compressing the bronchial artery 842 may restrict blood flow through the bronchial artery. By eliminating the heat dissipating blood flow, the following ablation processes may be more effective and efficient. At a process 808, a heated liquid within the expandable device 826 may heat the expandable device. In some embodiments, the liquid is heated within the expandable device 826 by the heating system 830. Additionally or alternatively, the liquid may be heated proximally of the expandable device 826 and may be introduced to expandable device already heated. At a process 810, the heat from the liquid and the expandable device may heat the bronchial passageway 820 and the compressed bronchial artery 842. At a process 812, the heat may cause occlusion of the bronchial passageway and the bronchial artery. For example, the heat may be sufficiently high to cause neointimal hyperplasia of the bronchial artery 842 and occlusion of the bronchial passageway 820. The occlusion may thus result in volume reduction of emphysematous parenchyma distal of the treatment location. Ablating the bronchial artery in addition to the bronchial wall may reduce blood supply to the injured airway wall during the neointimal hyperplasia process, resulting in increased hyperplasia and occlusion.
In some embodiments, the emphysematous parenchyma may be reduced by only ablating the bronchial wall, without ablating and occluding the bronchial artery. The neointimal hyperplasia resulting from the ablation occludes a plurality of airways from the subsegmental level to the terminal bronchioles. This occlusion of airways may result in volume reduction of emphysematous parenchyma. By occluding the airways, and not the bronchial artery, blood supply to the injured airway wall may be maintained during the neointimal hyperplasia process. In some embodiments the method 800 may be used in combination with (e.g., following) a diffuse heated liquid ablation as described in method 200.
In some embodiments, reliable lung tumor removal may be achieved by occlusion of the bronchial lumen, the pulmonary artery and the bronchial artery. In some embodiments, a heated balloon or diffuse heated liquid treatment (e.g. method 200) may occlude the bronchial lumen, the pulmonary artery, and the bronchial artery. Sometimes, however, these treatments alone may not be sufficient for full occlusion of all structures. For example, the elastic limit of the bronchial wall may be reached before a heated dilated balloon may cause collapse of the pulmonary artery. An incomplete pulmonary artery collapse may permit continued blood flow and heat dissipation associated with the blood flow. This continued blood flow and heat dissipation may limit the extent of arterial ablation and the subsequent neointimal hyperplasia and may result in a partial infarction or no infarction at all.
In some embodiments, a total acute collapse of the pulmonary artery, via the heated dilated balloon, may not be required to achieve total permanent occlusion of the pulmonary artery. This is because heat to the inner diameter of the artery closest to the heated dilated balloon will cause platelet activation and aggregation which may be sufficient to create acute occlusion. Acute occlusion may create hemostasis which eliminates heat dissipating blood flow through the pulmonary artery, allowing for heat conduction through the static blood and resulting in ablation of the entire circumference of the pulmonary artery. A complete circumferential ablation of the pulmonary artery may maximize the potential for complete permanent neo-intimal hyperplasia occlusion, resulting in a maximum propensity for parenchymal infarction. If, however, platelet activation and aggregation of a partially occluded pulmonary artery from the heated balloon device does not create acute hemostasis, there may be blood flow in the pulmonary artery which could act as a heat dissipater potentially prohibiting ablation of the entire circumference of the pulmonary artery. Failure to ablate the entire circumference of the pulmonary artery may reduce possibility of permanent pulmonary occlusion via neo-intimal hyperplasia.
In some embodiments, the flow of air through a bronchial passageway may be blocked in addition to or as an alternative to blocking blood flow through the pulmonary artery. Ablation of the airway may induce neointimal hyperplasia and occlusion during the healing process. However, this process may take several days and may be too slow. In some embodiments, a physical airway occlusion device may be inserted after an airway heating procedure. The airway occlusion device may include a plug (e.g. a silicone or plastic plug), a one-way valve device, a glue and/or a foam. The plug may be temporarily placed and may be removed after intended necrosis is complete. Alternatively, it may be absorbed by the body or may be left permanently.
Any of the methods, techniques, or systems described in this disclosure may be used in combination or series with each other or with the methods, techniques, or systems described in the incorporated by reference PCT Application (Docket No. P02302-WO) filed Jul. 7, 2020, titled “Systems and Method for Localized Endoluminal Thermal Liquid Treatment.” Use of both the localized expandable device treatment and the diffuse liquid treatment may be useful, for example, in emphysema treatment when partial infarction is desirable. If insufficient heat energy can be delivered to ablate the bronchial arteries with the diffuse liquid method, the dilated heated balloon method may be used to create bronchial artery ablation after or prior to the diffuse method. Thus, a maximum number of airways may be occluded and partial infarction for additional lung volume reduction may be achieved. Similarly, combination treatments may be used for lung tumor ablation. Ablating the microvasculature of the segment in which the tumor resides via the diffuse method either before or after the balloon treatment method may ensure complete infarction of the segment.
In some embodiments, the systems and methods disclosed herein may be used in a medical procedure performed with a robot-assisted medical system as described in further detail below. As shown in
Robot-assisted medical system 1000 also includes a display system 1010 for displaying an image or representation of the surgical site and medical instrument 1004 generated by a sensor system 1008 which may include an endoscopic imaging system. Display system 1010 and master assembly 1006 may be oriented so an operator O can control medical instrument 1004 and master assembly 1006 with the perception of telepresence.
The sensor system 1008 may include a position/location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and/or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and/or shape of the medical instrument 1004. The sensor system 1008 may also include temperature sensors.
Robot-assisted medical system 1000 may also include control system 1012. Control system 1012 includes at least one memory 1016 and at least one computer processor 1014 for effecting control between medical instrument 1004, master assembly 1006, sensor system 1008, and display system 1010. Control system 1012 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a plurality of operating modes of the robot-assisted medical system including a navigation planning mode, a navigation mode, and/or a procedure mode. Control system 1012 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement some or all of the processes described in accordance with aspects disclosed herein, including, for example, expanding an expandable device, regulating the temperature of a heating system, controlling insertion and retraction of a treatment instrument, controlling actuation of a distal end of the treatment instrument, receiving sensor information, selecting a treatment location, deploying an occlusion device and/or determining a size of an anatomic lumen.
Control system 1012 may optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument 1004 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based upon reference to an acquired pre-operative or intra-operative dataset of anatomic passageways. The virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like.
In the description, specific details have been set forth describing some embodiments. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure.
Elements described in detail with reference to one embodiment, implementation, or application optionally may be included, whenever practical, in other embodiments, implementations, or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Thus, to avoid unnecessary repetition in the following description, one or more elements shown and described in association with one embodiment, implementation, or application may be incorporated into other embodiments, implementations, or aspects unless specifically described otherwise, unless the one or more elements would make an embodiment or implementation non-functional, or unless two or more of the elements provide conflicting functions. Not all the illustrated processes may be performed in all embodiments of the disclosed methods. Additionally, one or more processes that are not expressly illustrated in may be included before, after, in between, or as part of the illustrated processes. In some embodiments, one or more of the processes may be performed by a control system or may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors may cause the one or more processors to perform one or more of the processes.
Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In addition, dimensions provided herein are for specific examples and it is contemplated that different sizes, dimensions, and/or ratios may be utilized to implement the concepts of the present disclosure. To avoid needless descriptive repetition, one or more components or actions described in accordance with one illustrative embodiment can be used or omitted as applicable from other illustrative embodiments. For the sake of brevity, the numerous iterations of these combinations will not be described separately. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.
The systems and methods described herein may be suited for imaging, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the lung, colon, the intestines, the stomach, the liver, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and/or the like. While some embodiments are provided herein with respect to medical procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. For example, the instruments, systems, and methods described herein may be used for non-medical purposes including industrial uses, general robotic uses, and sensing or manipulating non-tissue work pieces. Other example applications involve cosmetic improvements, imaging of human or animal anatomy, gathering data from human or animal anatomy, and training medical or non-medical personnel. Additional example applications include use for procedures on tissue removed from human or animal anatomies (without return to a human or animal anatomy) and performing procedures on human or animal cadavers. Further, these techniques can also be used for surgical and nonsurgical medical treatment or diagnosis procedures.
One or more elements in embodiments of this disclosure may be implemented in software to execute on a processor of a computer system such as control processing system. When implemented in software, the elements of the embodiments of this disclosure may be code segments to perform various tasks. The program or code segments can be stored in a processor readable storage medium or device that may have been downloaded by way of a computer data signal embodied in a carrier wave over a transmission medium or a communication link. The processor readable storage device may include any medium that can store information including an optical medium, semiconductor medium, and/or magnetic medium. Processor readable storage device examples include an electronic circuit; a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device. The code segments may be downloaded via computer networks such as the Internet, Intranet, etc. Any of a wide variety of centralized or distributed data processing architectures may be employed. Programmed instructions may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein. In some examples, the control system may support wireless communication protocols such as Bluetooth, Infrared Data Association (IrDA), HomeRF, IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), ultra-wideband (UWB), ZigBee, and Wireless Telemetry.
Note that the processes presented might not inherently be related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the operations described. The required structure for a variety of these systems will appear as elements in the claims. In addition, the embodiments of the invention are not described with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein.
This disclosure describes various instruments, portions of instruments, and anatomic structures in terms of their state in three-dimensional space. As used herein, the term position refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term orientation refers to the rotational placement of an object or a portion of an object (e.g., in one or more degrees of rotational freedom such as roll, pitch, and/or yaw). As used herein, the term pose refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom). As used herein, the term shape refers to a set of poses, positions, or orientations measured along an object.
While certain illustrative embodiments of the invention have been described and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative of and not restrictive on the broad invention, and that the embodiments of the invention not be limited to the specific constructions and arrangements shown and described, since various other modifications may occur to those ordinarily skilled in the art.
Various aspects of the subject matter described herein are set forth in the following numbered examples.
Example 1: A method comprises positioning a catheter in an anatomic lumen, the catheter including a distal portion; deploying an occlusion device from the catheter; heating a liquid in the distal portion of the catheter to a temperature of less than 100 degrees Celsius with a heating device at the distal portion of the catheter; and releasing the heated liquid from the distal portion of the catheter into the anatomic lumen, wherein the occlusion device restricts flow of the heated liquid proximally of the occlusion device. The temperature may be less than the temperature at which the liquid becomes vapor. For fluids other than water at sea level pressure, a vaporization or boiling temperature may be greater than 100 degrees Celsius. For example, oil-based liquids may have a boiling point greater than 100 degrees Celsius.
Example 2: The method of Example 1, wherein the anatomic lumen is an airway in a lung.
Example 3: The method of Example 1 wherein the liquid is contained in a heated liquid reservoir coupled to the proximal portion of the catheter.
Example 4: A system comprising: a catheter sized to extend within a first endoluminal passageway, the catheter including a distal opening; and an occlusion device configured to extend through the catheter, through the distal opening, through a wall of the first endoluminal passageway and into a second endoluminal passageway adjacent to the first endoluminal passageway to generate an occlusion in the second endoluminal passageway.
Example 5: The system of Example 4, wherein the occlusion device includes an RF wire.
Example 6: The system of Example 5, wherein the occlusion device includes a hollow needle configured to deliver an occlusive material into the second endoluminal passageway.
Example 7: The system of Example 5, wherein the occlusion device includes a resistive coil.
Example 8: The system of Example 5, wherein the occlusion device includes a balloon catheter and a balloon coupled to a distal end of the balloon catheter.
Example 9: A system comprising a catheter sized to extend within a first endoluminal passageway, the catheter including a distal opening; and an occlusion device configured to extend from the distal opening, the occlusion device including a rod and an occlusion bar pivotally coupled to the rod, wherein in a first configuration the occlusion bar extends generally parallel to a longitudinal axis of the catheter and wherein in a second configuration the occlusion bar extends generally transverse to the longitudinal axis of the catheter and compresses a second endoluminal passageway adjacent to the first endoluminal passageway.
Example 10: The system of Example 9, wherein the rod in configured to transmit radiofrequency energy to the occlusion bar to heat the second endoluminal passageway.
Example 11: The system of Example 9, further comprising a pullwire coupled to the occlusion bar to transition the occlusion bar from the first configuration to the second configuration.
This application claims the benefit of U.S. Provisional Application 62/871,569 filed Jul. 8, 2019; U.S. Provisional Application 62/871,677 filed Jul. 8, 2019; U.S. Provisional Application 62/871,678 filed Jul. 8, 2019; 62/938,614 filed Nov. 21, 2019; and U.S. Provisional Application 62/988,299 filed Mar. 11, 2020, all of which are incorporated by reference herein in their entirety. This application incorporates by reference in its entirety PCT Application (Docket No. P02302-WO) filed Jul. 7, 2020, titled “Systems and Method for Localized Endoluminal Thermal Liquid Treatment.”
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/041071 | 7/7/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62871569 | Jul 2019 | US | |
| 62871677 | Jul 2019 | US | |
| 62871678 | Jul 2019 | US | |
| 62938614 | Nov 2019 | US | |
| 62988299 | Mar 2020 | US |
