Asthma is a disease in which (i) bronchoconstriction, (ii) excessive mucus production, and (iii) inflammation and swelling of airways occur, causing widespread but variable airflow obstruction thereby making it difficult for the asthma sufferer to breathe. Asthma is a chronic disorder, primarily characterized by persistent airway inflammation. However, asthma is further characterized by acute episodes of additional airway narrowing via contraction of hyper-responsive airway smooth muscle.
Asthma is managed pharmacologically by: (1) long term control through use of anti-inflammatories and long-acting bronchodilators and (2) short term management of acute exacerbations through use of short-acting bronchodilators. Both of these approaches require repeated and regular use of the prescribed drugs. High doses of corticosteroid anti-inflammatory drugs can have serious side effects that require careful management. In addition, some patients are resistant to steroid treatment. The difficulty involved in patient compliance with pharmacologic management and the difficulty of avoiding stimulus that triggers asthma are common barriers to successful asthma management.
Current management techniques are neither completely successful nor free from side effects. Presently, a new treatment for asthma is showing promise. This treatment comprises the application of energy to the airway smooth muscle tissue. Additional information about this treatment may be found in commonly assigned patents and applications in U.S. Pat. Nos. 6,411,852, 6,634,363 and U.S. published application nos. US-2005-0010270-A1 and US-2002-0091379-A1, the entirety of each of which is incorporated by reference.
The application of energy to airway smooth muscle tissue, when performed via insertion of a treatment device into the bronchial passageways, requires navigation through tortuous anatomy as well as the ability to treat a variety of sizes of bronchial passageways. As discussed in the above referenced patents and applications, use of an RF energy delivery device is one means of treating smooth muscle tissue within the bronchial passageways.
Tortuous anatomy also poses challenges when the treatment device requires mechanical actuation of the treatment portion (e.g., expansion of a treatment element at a remote site). In particular, attempting to actuate a member may be difficult in view of the fact that the force applied at the operator's hand-piece must translate to the distal end of the device. The strain on the operator is further intensified given that the operator must actuate the distal end of the device many times to treat various portions of the anatomy. When a typical device is contorted after being advanced to a remote site in the lungs, the resistance within the device may be amplified given that internal components are forced together.
It is also noted that the friction of polymers is different from that of metals. Most polymers are viscoelastic and deform to a greater degree under load than metals. Accordingly, when energy or force is applied to move two polymers against each other, a significant part of friction between the polymers is the energy loss through inelastic hysteresis. In addition, adhesion between polymers also plays a significant part in the friction between such polymers.
In addition to basic considerations of navigation and site access, there exists the matter of device orientation and tissue contact at the treatment site. Many treatment devices make contact or are placed in close proximity to the target tissue. Yet, variances in the construction of the treatment device may hinder proper alignment or orientation of the device. For example, in the case of a device having a basket-type energy transfer element that is deployed intralumenally, the treatment may benefit from uniform contact of basket elements around the perimeter of the lumen. However, in this case, design or manufacturing variances may tend to produce a device where the angle between basket elements is not uniform. This problem tends to be exacerbated after repeated actuation of the device and/or navigating the device through tortuous anatomy when the imperfections of the device become worsened through plastic deformation of the individual components. Experience demonstrates that once a member becomes predisposed to splaying (i.e., not maintaining the desired angular separation from an adjacent element), or inverting (i.e., buckling inward instead of deploying outward), the problem is unlikely to resolve itself without requiring attention by the operator. As a result, the operator is forced to remove the device from the patient, make adjustments, then restart treatment. This interruption tends to increase the time of the treatment session.
As one example, commonly assigned U.S. Pat. No. 6,411,852, incorporated by reference herein, describes a treatment for asthma using devices having flexible electrode members that can be expanded to better fill a space (e.g., the lumen of an airway.) However, the tortuous nature of the airways was found to cause significant bending and/or flexure of the distal end of the device. As a result, the spacing of electrode members tended not to be even. In some extreme cases, electrode elements could tend to invert, where instead of expanding an electrode leg would invert behind an opposing leg.
For many treatment devices, the distortion of the energy transfer elements might cause variability in the treatment effect. For example, many RF devices heat tissue based on the tissue's resistive properties. Increasing or decreasing the surface contact between the electrode and tissue often increases or decreases the amount of current flowing through the tissue at the point of contact. This directly affects the extent to which the tissue is heated. Similar concerns may also arise with resistive heating elements, devices used to cool the airway wall by removing heat, or any energy transfer device. In any number of cases, variability of the energy transfer/tissue interface causes variability in treatment results. The consequential risks range from an ineffective treatment to the possibility of patient injury.
Furthermore, most medical practitioners recognize the importance of establishing acceptable contact between the transfer element and tissue. Therefore, distortion of the transfer element or elements increases the procedure time when the practitioner spends an inordinate amount of time adjusting a device to compensate for or avoid such distortion. Such action becomes increasingly problematic in those cases where proper patient management limits the time available for the procedure.
For example, if a patient requires an increasing amount of medication (e.g., sedatives or anesthesia) to remain under continued control for performance of the procedure, then a medical practitioner may limit the procedure time rather than risk overmedicating the patient. As a result, rather than treating the patient continuously to complete the procedure, the practitioner may plan to break the procedure in two or more sessions. Subsequently, increasing the number of sessions poses additional consequences on the part of the patient in cost, the residual effects of any medication, adverse effects of the non-therapeutic portion of the procedure, etc.
In view of the above, the present methods and devices described herein provide an improved means for treating tortuous anatomy such as the bronchial passages. It is noted that the improvements of the present device may be beneficial for use in other parts of the anatomy as well as the lungs.
The present invention includes devices configured to treat the airways or other anatomical structures, and may be especially useful in tortuous anatomy. The devices described herein are configured to treat with uniform or predictable contact (or near contact) between an active element and tissue. Typically, the invention allows this result with little or no effort by a physician. Accordingly, aspects of the invention offer increased effectiveness and efficiency in carrying out a medical procedure. The increases in effectiveness and efficiency may be especially apparent in using devices having relatively longer active end members.
In view of the above, a variation of the invention includes a catheter for use with a power supply, the catheter comprising a flexible elongate shaft coupled to at least one energy transfer element that is adapted to apply energy to the body lumen. The shaft will have a flexibility to accommodate navigation through tortuous anatomy. The energy transfer elements are described below and include basket type design, or other expandable designs that permit reduction in size or profile to aid in advancing the device to a particular treatment site and then may be expanded to properly treat the target site. The basket type designs may be combined with expandable balloon or other similar structures.
Variations of the device can include an elongate sheath having a near end, a far end adapted for insertion into the body, and having a flexibility to accommodate navigation through tortuous anatomy, the sheath having a passageway extending therethrough, the passageway having a lubricious layer extending from at least a portion of the near end to the far end of the sheath. Where the shaft is slidably located within the passageway of the sheath.
Variations of devices described herein can include a connector for coupling the energy transfer element to the power supply. The connector may be any type of connector commonly used in such applications. Furthermore, the connector may include a cable that is hard-wired to the catheter and connects to a remote power supply. Alternatively, the connector may be an interface that connects to a cable from the power supply.
As noted below, variations of the device allow for reduce friction between the shaft and sheath to allow relatively low force advancement of a distal end of the shaft out of the far end of the sheath for advancement the energy transfer element.
Additional variations of the invention include devices allowing for repeatable deployment of the expandable energy transfer element while maintaining the orientation and/or profile of the components of the energy transfer element. One such example includes an energy transfer basket comprising a plurality of legs, each leg having a distal end and a proximal end, each leg having a flexure length that is less than a full length of the leg. The legs are coupled to near and far alignment components. The near alignment component includes a plurality of near seats extending along an axis of the alignment component. The near alignment component can be secured to the elongate shaft of the device. The far alignment component may have a plurality of far seats extending along an axis of the alignment component, where the plurality of near seats are in alignment with the plurality of far seats. In these variations of the device, each distal end of each leg is nested within a far seat of the far alignment component and each proximal end of each leg is nested within a near seat of the near alignment component such that an angle between adjacent legs is determined by an angle between adjacent near seats and the flexure length of each length is determined by the distance between near and far alignment components.
One or both of the components may include stops that control flexure length of each leg. Such a design increases the likelihood that the flexure of each leg is uniform.
An additional variation of the device includes a catheter for use in tortuous anatomy to deliver energy from a power supply to a body passageway. Such a catheter includes an expandable energy transfer element having a reduced profile for advancement and an expanded profile to contact a surface of the body passageway and an elongate shaft having a near end, a far end adapted for insertion into the body, the expandable energy transfer element coupled to the far end of the shaft, the shaft having a length sufficient to access remote areas in the anatomy. The design of this shaft includes a column strength sufficient to advance the expandable energy transfer element within the anatomy, and a flexibility that permits self-centering of the energy transfer element when expanded to contact the surface of the body passageway.
Each of the following figures diagrammatically illustrates aspects of the invention. Variation of the invention from the aspects shown in the figures is contemplated.
It is understood that the examples below discuss uses in the airways of the lungs. However, unless specifically noted, the invention is not limited to use in the lung. Instead, the invention may have applicability in various parts of the body. Moreover, the invention may be used in various procedures where the benefits of the device are desired.
As described in U.S. Pat. No. 6,634,363, the entirety of which has been incorporated by reference above, one way of improving airflow is to decrease the resistance to airflow within the lungs. There are several approaches to reducing this resistance, including but not limited to reducing the ability of the airway to contract, increasing the airway diameter, reducing the inflammation of airway tissues, and/or reducing the amount of mucus plugging of the airway. Embodiments described herein include advancing a treatment device into the lung and treating the lung to at least reduce the ability of the lung to produce at least one symptom of reversible obstructive pulmonary disease. The following is a brief discussion of some causes of increased resistance to airflow within the lungs and the treatment described herein. As such, the following discussion is not intended to limit the aspects or objective of the method as the method may cause physiological changes not described below but such changes still contributing to reducing or eliminating at least one of the symptoms of reversible obstructive pulmonary disease.
Reducing the Ability of the Airway to Contract
In embodiments, the inventive treatment reduces the ability of the airways to narrow or to reduce in diameter due to airway smooth muscle contraction. The treatment uses a modality of treatments including, but not limited to the following: chemical, radio frequency, radioactivity, heat, ultrasound, radiant, laser, microwave, or mechanical energy (such as in the form of cutting, punching, abrading, rubbing, or dilating). This treatment reduces the ability of the smooth muscle to contract thereby lessening the severity of an asthma attack. The reduction in the ability of the smooth muscle to contract may be achieved by treating the smooth muscle itself or by treating other tissues which in turn influence smooth muscle contraction or the response of the airway to the smooth muscle contraction. Treatment may also reduce airway responsiveness or the tendency of the airway to narrow or to constrict in response to a stimulus.
The amount of smooth muscle surrounding the airway can be reduced by exposing the smooth muscle to energy which either kills the muscle cells or prevents these cells from replicating. The reduction in smooth muscle reduces the ability of the smooth muscle to contract and to narrow the airway during a spasm. The reduction in smooth muscle and surrounding tissue has the added potential benefit of increasing the caliber or diameter of the airways, this benefit reduces the resistance to airflow through the airways. In addition to the use of debulking smooth muscle tissue to open up the airways, the device used in embodiments of the present invention may also eliminate smooth muscle altogether by damaging or destroying the muscle. The elimination of the smooth muscle prevents the contraction or spasms of hyper-reactive airways of a patient having reversible obstructive pulmonary disease. By doing so, the elimination of the smooth muscle may reduce some symptoms of reversible obstructive pulmonary disease.
The ability of the airway to contract can also be altered by treatment of the smooth muscle in particular patterns. The smooth muscle is arranged around the airways in a generally helical pattern with pitch angles ranging from about −30 to about +30 degrees. Thus, the treatment of the smooth muscle in appropriate patterns interrupts or cuts through the helical pattern of the smooth muscle at a proper pitch and prevents the airway from constricting. This procedure of patterned treatment application eliminates contraction of the airways without completely eradicating smooth muscle and other airway tissue. A pattern for treatment may be chosen from a variety of patterns including longitudinal or axial stripes, circumferential bands, helical stripes, and the like as well as spot patterns having rectangular, elliptical, circular or other shapes. The size, number, and spacing of the treatment bands, stripes, or spots are chosen to provide a desired clinical effect of reduced airway responsiveness while limiting insult to the airway to a clinically acceptable level.
The patterned treatment of the tissues surrounding the airways with energy provides various advantages. The careful selection of the portion of the airway to be treated allows desired results to be achieved while reducing the total healing load. Patterned treatment can also achieve desired results with decreased morbidity, preservation of epithelium, and preservation of a continuous or near continuous ciliated inner surface of the airway for mucociliary clearance. The pattern of treatment may also be chosen to achieve desired results while limiting total treatment area and/or the number of airways treated, thereby improving speed and ease of treatment.
Application of energy to the tissue surrounding the airways may also cause the DNA of the cells to become cross linked. The treated cells with cross linked DNA are incapable of replicating. Accordingly, over time, as the smooth muscle cells die, the total thickness of smooth muscle decreases because of the inability of the cells to replicate. The programmed cell death causing a reduction in the volume of tissue is called apoptosis. This treatment does not cause an immediate effect but causes shrinking of the smooth muscle and opening of the airway over time and substantially prevents re-growth. The application of energy to the walls of the airway may also be used to cause a cross linking of the DNA of the mucus gland cells thereby preventing them from replicating and reducing excess mucus plugging or production over time.
The ability of the airways to contract may also be reduced by altering mechanical properties of the airway wall, such as by increasing stiffness of the wall or by increasing parenchymal tethering of the airway wall. Both of these methods increase the strength of the airway wall and further oppose contraction and narrowing of the airway.
There are several ways to increase the stiffness of the airway wall. One way to increase stiffness is to induce fibrosis or a wound healing response by causing trauma to the airway wall. The trauma can be caused by delivery of therapeutic energy to the tissue in the airway wall, by mechanical insult to the tissue, or by chemically affecting the tissue. The energy is preferably delivered in such a way that it minimizes or limits the intra-luminal thickening that may occur.
Another way to increase the effective stiffness of the airway wall is to alter the submucosal folding of the airway upon narrowing. The mucosal layer includes the epithelium, its basement membrane, and the lamina propria, a subepithelial collagen layer. The submucosal layer may also play a role in airway folding. As an airway narrows, its perimeter remains relatively constant, with the mucosal layer folding upon itself. As the airway narrows further, the mucosal folds mechanically interfere with each other, effectively stiffening the airway. In asthmatic patients, the number of folds is fewer and the size of the folds is larger, and thus, the airway is free to narrow with less mechanical interference of mucosal folds than in a healthy patient. Thus, asthmatic patients have a decrease in airway stiffness and the airways have less resistance to narrowing.
The mucosal folding in asthmatic patients can be improved by treatment of the airway in a manner which encourages folding. Preferably, a treatment will increase the number of folds and/or decrease the size of the folds in the mucosal layer. For example, treatment of the airway wall in a pattern such as longitudinal stripes can encourage greater number of smaller mucosal folds and increase airway stiffness.
The mucosal folding can also be increased by encouraging a greater number of smaller folds by reducing the thickness of the mucosa and/or submucosal layer. The decreased thickness of the mucosa or submucosa may be achieved by application of energy which either reduces the number of cells in the mucosa or submucosal layer or which prevents replication of the cells in the mucosa or submucosal layer. A thinner mucosa or submucosal layer will have an increased tendency to fold and increased mechanical stiffening caused by the folds.
Another way to reduce the ability of the airways to contract is to improve parenchymal tethering. The parenchyma surrounds airways and includes the alveolus and tissue connected to and surrounding the outer portion of the airway wall. The parenchyma includes the alveolus and tissue connected to and surrounding the cartilage that supports the larger airways. In a healthy patient, the parenchyma provides a tissue network which connects to and helps to support the airway. Edema or accumulation of fluid in lung tissue in patients with asthma or COPD is believed to decouple the airway from the parenchyma reducing the restraining force of the parenchyma which opposes airway constriction. Energy can be used to treat the parenchyma to reduce edema and/or improve parenchymal tethering.
In addition, the applied energy may be used to improve connection between the airway smooth muscle and submucosal layer to the surrounding cartilage, and to encourage wound healing, collagen deposition, and/or fibrosis in the tissue surrounding the airway to help support the airway and prevent airway contraction.
Increasing the Airway Diameter
Hypertrophy of smooth muscle, chronic inflammation of airway tissues, and general thickening of all parts of the airway wall can reduce the airway diameter in patients with reversible obstructive pulmonary, disease. Increasing the overall airway diameter using a variety of techniques can improve the passage of air through the airways. Application of energy to the airway smooth muscle of an asthmatic patient can debulk or reduce the volume of smooth muscle. This reduced volume of smooth muscle increases the airway diameter for improved air exchange.
Reducing inflammation and edema of the tissue surrounding the airway can also increase the diameter of an airway. Inflammation and edema (accumulation of fluid) of the airway are chronic features of asthma. The inflammation and edema can be reduced by application of energy to stimulate wound healing and regenerate normal tissue. Healing of the epithelium or sections of the epithelium experiencing ongoing denudation and renewal allows regeneration of healthy epithelium with less associated airway inflammation. The less inflamed airway has an increased airway diameter both at a resting state and in constriction. The wound healing can also deposit collagen which improves parenchymal tethering.
Inflammatory mediators released by tissue in the airway wall may serve as a stimulus for airway smooth muscle contraction. Therapy that reduces the production and release of inflammatory mediator can reduce smooth muscle contraction, inflammation of the airways, and edema. Examples of inflammatory mediators are cytokines, chemokines, and histamine. The tissues which produce and release inflammatory mediators include airway smooth muscle, epithelium, and mast cells. Treatment of these structures with energy can reduce the ability of the airway structures to produce or release inflammatory mediators. The reduction in released inflammatory mediators will reduce chronic inflammation, thereby increasing the airway inner diameter, and may also reduce hyper-responsiveness of the airway smooth muscle.
A further process for increasing the airway diameter is by denervation. A resting tone of smooth muscle is nerve regulated by release of catecholamines. Thus, by damaging or eliminating nerve tissue in the airways the resting tone of the smooth muscle is reduced, and the airway diameter is increased. Resting tone may also be reduced by directly affecting the ability of smooth muscle tissue to contract.
As described in U.S. patent application Ser. No. 09/436,455 (now U.S. Pat. No. 7,425,212), the entirety of which has been incorporated by reference below, the airways which are treated with the device according to embodiments of the present invention are preferably 1 mm in diameter or greater, more preferably 3 mm in diameter. The devices are preferably used to treat airways of the second to eighth generation, more preferably airways of the second to sixth generation.
The particular system 10 depicted in
Referring again to
In many variations of the system, the controller 14 includes a processor 22 that is generally configured to accept information from the system and system components, and process the information according to various algorithms to produce control signals for controlling the energy generator 12. The processor 22 may also accept information from the system 10 and system components, process the information according to various algorithms and produce information signals that may be directed to the visual indicators, digital display or audio tone generator of the user interface in order to inform the user of the system status, component status, procedure status or any other useful information that is being monitored by the system. The processor 22 of the controller 14 may be digital IC processor, analog processor or any other suitable logic or control system that carries out the control algorithms. U.S. Provisional application No. 60/674,106 filed Apr. 21, 2005 entitled CONTROL METHODS AND DEVICES FOR ENERGY DELIVERY the entirety of which is incorporated by reference herein.
As described in U.S. Patent Application Publication No. 2002/0091379, the entirety of which has been incorporated by reference above, the power supply can include circuitry for monitoring parameters of energy transfer: (for example, voltage, current, power, impedance, as well as temperature from the temperature sensing element), and use this information to control the amount of energy delivered. In the case of delivering RF energy, typical frequencies of the RF energy or RF power waveform are from 300 to 1750 kHz with 300 to 500 kHz or 450 to 475 being preferred. The RF power-level generally ranges from about 0-30 W but depends upon a number of factors such as the size and number of the electrodes. The controller may also be configured to independently and selectively apply energy to one or more of the basket leg electrodes.
A power supply may also include control modes for delivering energy safely and effectively. Energy may be delivered in open loop (power held constant) mode for a specific time duration. For example, a power setting of 8 to 30 Watts for up to 10 seconds is suitable and a power setting of 12 to 30 Watts for up to 5 seconds is preferred. For more permanent restructuring of the airways, a power setting of 8 to 15 Watts for 5 to 10 seconds is suitable. For mere temporary relief or enlargement of the airway, a power setting of 10 to 25 Watts for up to 3 seconds is suitable. With higher power settings, correspondingly lower time durations are preferred to limit collateral thermal damage.
Energy may also be delivered in temperature control mode, with output power varied to maintain a certain temperature—for a specific time duration. For example, energy may be delivered for up to 20 seconds at a temperature of 55 to 80 degrees C., and more preferably, energy is delivered up to 10 seconds at a temperature in the range of 60 to 70 degrees C. For more permanent restructuring of the airways, energy is delivered for 5 to 10 seconds at a temperature in the range of 60 to 70 degrees C. For mere temporary relief or enlargement of the airway, energy is delivered for up to 5 seconds at a temperature of 55 to 80 degrees C. Additionally, the power supply may operate in impedance control mode.
As noted above, some variations of the devices described herein have sufficient lengths to reach remote parts of the body (e.g., bronchial passageways around 3 mm in diameter).
Alternatively, or in combination, the lubricious layers 128 may comprise a fluid or liquid (e.g., silicone, petroleum based oils, food based oils, saline, etc.) that is either coated or sprayed on the interface of the shaft 104 and sheath 102. The coating may be applied at the time of manufacture or at time of use. Moreover, the lubricious layers 128 may even include polymers that are treated such that the surface properties of the polymer changes while the bulk properties of the polymer are unaffected (e.g., via a process of plasma surface modification on polymer, fluoropolymer, and other materials). Another feature of the treatment is to treat the surfaces of the devices with substances that provide antibacterial/antimicrobial properties.
In one variation of the invention, the shaft 104 and/or sheath 102 will be selected from a material to provide sufficient column strength to advance the expandable energy transfer element within the anatomy. Furthermore, the materials and or design of the shaft/sheath will permit a flexibility that allows the energy transfer element to essentially self-align or self-center when expanded to contact the surface of the body passageway. For example, when advanced through tortuous anatomy, the flexibility of this variation should be sufficient that when the energy transfer element expands, the shaft and/or sheath deforms to permit self-centering of the energy transfer element. Examples of shaft 104 or sheath 102 materials include nylon, PET, LLDPE, HDPE, Plexar PX, PTFE, teflon and/or any other polymer commonly used in medical devices. As described above, the inner or outer surfaces of the shaft 104 and/or sheath 102 may also comprise lubricant impregnations or coatings, such as silicone fluid, carbon, PTFE, or any of the materials described with reference to lubricous layer 128. It is noted that the other material selection and/or designs described herein shall aid in providing this feature of the invention.
The shaft 104 may also include one or more lumens 132, 134. Typically, one lumen will suffice to provide power to the energy transfer elements (as discussed below). However, in the variation show, the shaft may also benefit from additional lumens (such as lumens 134) to support additional features of the device (e.g., temperature sensing elements, other sensor elements such as pressure or fluid sensors, utilizing different lumens for different sensor leads, and utilizing separate or the same lumen(s) for fluid delivery or suctioning, lumens for blowing gas (e.g., pressurized air, hot air) into the airway to move or desiccate secretions (e.g., mucus) out of the way, etc.). In addition, the lumen(s) may be used to simultaneously or sequentially deliver fluids and/or suction fluid to assist in managing the moisture within the passageway. Such management may optimize the electrical coupling of the electrode to the tissue (by, for example, altering impedance).
Since the device is suited for use in tortuous anatomy, a variation of the shaft 104 may have lumens 134 that are symmetrically formed about an axis of the shaft. As shown, the additional lumens 134 are symmetric about the shaft 104. This construction provides the shaft 104 with a cross sectional symmetry that aid in preventing the shaft 104 from being predisposed to flex or bend in any one particular direction. Further, the shaft 104 may be designed to increase clearance between a center wire 124 that runs through the shaft lumen 132 so as to minimize friction and improve basket 108 deployment in tortuous anatomy. Still further, the shaft 104 may be designed so as to efficiently transmit torque from the handle 106 to the basket array 108 in order to rotate the basket array 108 within the airways so as to enhance device positioning. For example, this may be accomplished by incorporating a braided member (e.g., braided wire) into the shaft 104 extrusion or by joining the shaft 104 coaxially with the braided member.
These oblong, oval, or D-shaped shaft cross sections advantageously allow for a reduced profile while still axially centering the center wire 124 with respect to the expandable basket 108. This reduced size profile not only permits passage of the sheathless catheter of
As described in U.S. Pat. No. 6,634,363, the entirety of which has been incorporated by reference above, embodiments of the invention may also include the additional step of reducing or stabilizing the temperature of lung tissue near to a treatment site. This may be accomplished for example, by injecting a cold fluid into lung parenchyma or into the airway being treated, where the airway is proximal, distal, or circumferentially adjacent to the treatment site. The fluid may be sterile normal saline, or any other bio-compatible fluid. The fluid may be injected into treatment regions within the lung while other regions of the lung normally ventilated by gas. Or, the fluid may be oxygenated to eliminate the need for alternate ventilation of the lung. Upon achieving the desired reduction or stabilization of temperature the fluid may be removed from the lungs. In the case where a gas is used to reduce temperature, the gas may be removed from the lung or allowed to be naturally exhaled. One benefit of reducing or stabilizing the temperature of the lung may be to prevent excessive destruction of the tissue, or to prevent destruction of certain types of tissue such as the epithelium, or to reduce the systemic healing load upon the patient's lung.
The alignment component 150 also includes a stop 154. The stop 154 acts as a reference guide for placement of the arms as discussed below. In this variation, the stop 154 is formed from a surface of an end portion 158. This end portion 158 is typically used to secure the alignment component 150 to (or within) the sheath/shaft of the device. The alignment component 150 may optionally include a through hole or lumen 156.
The alignment components 150 of the present invention may be fabricated from a variety of polymers (e.g., PEEK, ULTEM, PEI, nylon, PET and/or any other polymer commonly used in medical devices), either by machining, molding, or by cutting an extruded profile to length. One feature of this design is electrical isolation between the legs, which may also be obtained using a variation of the invention that employs a ceramic material for the alignment component. However, in one variation of the invention, an alignment component may be fabricated from a conductive material (e.g., stainless steel, polymer loaded with conductive material, or metallized ceramic) so that it provides electrical conductivity between adjacent electrode legs and the conductive wire. In such a case, a power supply may be coupled to the alignment component, which then electrically couples all of the legs placed in contact with that component. The legs may be attached to the conductive alignment component with conductive adhesive, or by soldering or welding the legs to the alignment component. This does not preclude the legs and alignment component form being formed from one piece of metal.
Devices of the present invention may have one or more alignment components. Typically the alignment components are of the same size and/or the angular spacing of the seats is the same. However, variations may require alignment components of different sizes and/or different angular spacing. Another variation of the invention is to have the seats at an angle relative to the axis of the device, so as to form a helically shaped energy delivery element.
Additionally, the alignment components may be designed such that the sleeves 168, 170 may be press or snap fit onto the alignment components, eliminating the need for adhesively bonding the sleeves to the alignment components.
Referring now to
As discussed herein, the seats 152 allow for improved control of the angular spacing of the legs 160. In particular, the seats 152 of the proximal and distal alignment components 144, 146 are aligned, wherein the angle between adjacent legs 160 is determined by the angle between adjacent seat 152. The seats 152 preferably provide for symmetrical deployment of the arms 160, wherein any angle between adjacent legs varies less than 20 degrees. As shown in cross sectional view of
Variations of the wire 124 may include a braided or coiled wire. The wire may be polymer coated or otherwise treated to electrically insulate or increase lubricity for easier movement within the device.
To expand the energy transfer element 108, the wire 124 may be affixed to a handle 106 and actuated with a slide mechanism 114 (as shown in
Referring now to
It will be appreciated that several other pre-shaped variations may be employed to induce buckling in the desired outward direction 165. For example, the pre-bent electrode may comprise a single bend 161 as shown in
Referring now to
In addition or alternatively, inward leg buckling or inversions may also be prevented by disposing basket support(s) inside the expandable basket 108. For example, as shown in the cross sectional view of
By spacing the leads of the thermocouple closely together to minimize temperature gradients in the energy transfer element between the thermocouple leads, thermoelectric voltage generated within the energy transfer element does not compromise the accuracy of the measurement. The leads may be spaced as close together as possible while still maintaining a gap so as to form an intrinsic junction with the energy transfer element. In another variation of the device, the thermocouple leads may be spaced anywhere along the tissue contacting region of the energy transfer element. Alternatively, or in combination, the leads may be spaced along the portion of an electrode that remains substantially straight. The intrinsic junction also provides a more accurate way of measuring surface temperature of the energy transfer element, as it minimizes the conduction error associated with an extrinsic junction adhered to the device.
The thermocouple leads may be attached to an interior of the leg or electrode. Such a configuration protects the thermocouple as the device expands against tissue and protects the tissue from potential trauma. The device may also include both of the thermocouple leads as having the same joint.
The devices of the present invention may use a variety of temperature sensing elements (a thermocouple being just one example, others include, infrared sensors, thermistors, resistance temperature detectors (RTDs), or any other component capable of detecting temperatures or changes in temperature). The temperature detecting elements may be placed on a single leg, on multiple legs or on all of the legs.
The present invention may also incorporate a junction that adjusts for misalignment between the branching airways or other body passages. This junction may be employed in addition to the other features described herein.
The junction 176 helps to eliminate the need for alignment of the axis of the active element 108 with the remainder of the device in order to provide substantially even tissue contact. The junction may be a joint, a flexure or equivalent means. A non-exhaustive listing of examples is provided below.
The legs 160 of the energy transfer element may have various shapes. For example, the shapes may be round, rounded or polygonal in cross section. Additionally, each leg may change cross section along its axis, providing for, for example, electrodes that are smaller or larger in cross section that the distal and proximal portions of each leg. This would provide a variety of energy delivery characteristics and bending profiles, allowing the design to be improved such that longer or wider electrode configurations can be employed. For example, as shown in
As for the action the junction enables, it allows the distal end of the device to self-align with the cavity or passageway to be treated, irrespective of the alignment of the access passageway.
The length of the junction (whether a spring junction or some other structure) may vary. Its length may depend on the overall system diameter. It may also depend on the degree of compliance desired. For example, with a longer effective junction length (made by extending the coil with additional turns), the junction becomes less rigid or more “floppy”.
In any case, it may be desired that the junction has substantially the same diameter of the device structure adjacent the junction. In this way, a more atraumatic system can be provided. In this respect, it may also be desired to encapsulate the junction with a sleeve or covering if they include open or openable structures. Junction 176 shown in
Some of the junctions are inherently protected. Junction 176 shown in
As for junction 176 shown in
Junction 176 in
Yet another junction example is provided in
Another variation of the junctions includes junctions variations where the shaft 104 is “floppy” (i.e., without sufficient column strength for the device to be pushable for navigation). In
To navigate such a device to a treatment site, the energy transfer element 108 and tether 232 may be next to or within the sheath 102. In this manner, the column strength provided by the sheath allows for advancement of the active member within the subject anatomy.
The same action is required to navigate the device shown in
Like the device in
As for other details of the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts a commonly or logically employed. In addition, though the invention has been described in reference to several examples, optionally incorporating various features, the invention is not to be limited to that which is described or indicated as contemplated with respect to each variation of the invention.
Various changes may be made to the invention described and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of the invention. Also, any optional feature of the inventive variations may be set forth and claimed independently, or in combination with any one or more of the features described herein. Accordingly, the invention contemplates combinations of various aspects of the embodiments or of the embodiments themselves, where possible. 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,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise.
This application is a continuation of U.S. patent application Ser. No. 13/860,216, filed Apr. 10, 2013, which is a continuation of U.S. patent application Ser. No. 13/087,161, filed Apr. 14, 2011 (now abandoned), which is a continuation of U.S. patent application Ser. No. 11/618,533, filed Dec. 29, 2006 (now U.S. Pat. No. 7,949,407), the full disclosures of which are incorporated herein by reference. The present application is related to U.S. patent application Ser. No. 11/256,295, filed Oct. 21, 2005 (now U.S. Pat. No. 7,200,445), U.S. patent application Ser. No. 11/420,442, filed May 25, 2006 (now U.S. Pat. No. 7,853,331), PCT Application No. PCT/US2005/040378, filed Nov. 7, 2005, and U.S. Provisional Patent Application Nos. 60/625,256, filed Nov. 5, 2004, and 60/650,368, filed Feb. 4, 2005, the full disclosures of which are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
1155169 | Starkweather | Sep 1915 | A |
1207479 | Bisgaard | Dec 1916 | A |
2072346 | Smith | Mar 1937 | A |
3320957 | Edward | May 1967 | A |
3568659 | Karnegis | Mar 1971 | A |
3667476 | Muller | Jun 1972 | A |
3692029 | Adair | Sep 1972 | A |
4461283 | Doi | Jul 1984 | A |
4503855 | Maslanka | Mar 1985 | A |
4522212 | Gelinas et al. | Jun 1985 | A |
4565200 | Cosman | Jan 1986 | A |
4567882 | Heller | Feb 1986 | A |
4584998 | McGrail | Apr 1986 | A |
4612934 | Borkan | Sep 1986 | A |
4643186 | Rosen et al. | Feb 1987 | A |
4674497 | Ogasawara | Jun 1987 | A |
4706688 | Don Michael et al. | Nov 1987 | A |
4709698 | Johnston et al. | Dec 1987 | A |
4799479 | Spears | Jan 1989 | A |
4802492 | Grunstein | Feb 1989 | A |
4825871 | Cansell | May 1989 | A |
4827935 | Geddes et al. | May 1989 | A |
4862886 | Clarke et al. | Sep 1989 | A |
4920978 | Colvin | May 1990 | A |
4955377 | Lennox et al. | Sep 1990 | A |
4967765 | Turner et al. | Nov 1990 | A |
4976709 | Sand | Dec 1990 | A |
5010892 | Colvin et al. | Apr 1991 | A |
5019075 | Spears et al. | May 1991 | A |
5053033 | Clarke | Oct 1991 | A |
5056519 | Vince | Oct 1991 | A |
5061274 | Kensey | Oct 1991 | A |
5074860 | Gregory et al. | Dec 1991 | A |
5078716 | Doll | Jan 1992 | A |
5084044 | Quint | Jan 1992 | A |
5096916 | Skupin | Mar 1992 | A |
5100388 | Behl et al. | Mar 1992 | A |
5100423 | Fearnot | Mar 1992 | A |
5103804 | Abele et al. | Apr 1992 | A |
5106360 | Ishiwara et al. | Apr 1992 | A |
5109830 | Cho | May 1992 | A |
5116864 | March et al. | May 1992 | A |
5117828 | Metzger et al. | Jun 1992 | A |
5135517 | McCoy | Aug 1992 | A |
5152286 | Sitko et al. | Oct 1992 | A |
5170803 | Hewson et al. | Dec 1992 | A |
5174288 | Bardy et al. | Dec 1992 | A |
5188602 | Nichols | Feb 1993 | A |
5191883 | Lennox et al. | Mar 1993 | A |
5215103 | Desai | Jun 1993 | A |
5254088 | Lundquist et al. | Oct 1993 | A |
5255678 | Deslauriers et al. | Oct 1993 | A |
5255679 | Imran | Oct 1993 | A |
5265604 | Vince | Nov 1993 | A |
5269758 | Taheri | Dec 1993 | A |
5281218 | Imran | Jan 1994 | A |
5292331 | Boneau | Mar 1994 | A |
5293869 | Edwards et al. | Mar 1994 | A |
5309910 | Edwards et al. | May 1994 | A |
5311866 | Kagan et al. | May 1994 | A |
5313943 | Houser et al. | May 1994 | A |
5324284 | Imran | Jun 1994 | A |
5343936 | Beatenbough et al. | Sep 1994 | A |
5345936 | Pomeranz et al. | Sep 1994 | A |
5366443 | Eggers et al. | Nov 1994 | A |
5368591 | Lennox et al. | Nov 1994 | A |
5368592 | Stern et al. | Nov 1994 | A |
5370644 | Langberg | Dec 1994 | A |
5370679 | Atlee, III | Dec 1994 | A |
5374287 | Rubin | Dec 1994 | A |
5383917 | Desai et al. | Jan 1995 | A |
5394880 | Atlee, III | Mar 1995 | A |
5396887 | Imran | Mar 1995 | A |
5400783 | Pomeranz et al. | Mar 1995 | A |
5409469 | Schaerf | Apr 1995 | A |
5411025 | Webster, Jr. | May 1995 | A |
5415166 | Imran | May 1995 | A |
5415656 | Tihon et al. | May 1995 | A |
5417687 | Nardella et al. | May 1995 | A |
5423744 | Gencheff et al. | Jun 1995 | A |
5423811 | Imran et al. | Jun 1995 | A |
5425703 | Feiring | Jun 1995 | A |
5431696 | Atlee, III | Jul 1995 | A |
5433730 | Alt | Jul 1995 | A |
5443470 | Stern et al. | Aug 1995 | A |
5454782 | Perkins | Oct 1995 | A |
5456667 | Ham et al. | Oct 1995 | A |
5458596 | Lax et al. | Oct 1995 | A |
5464404 | Abela et al. | Nov 1995 | A |
5465717 | Imran et al. | Nov 1995 | A |
5471982 | Edwards et al. | Dec 1995 | A |
5474530 | Passafaro et al. | Dec 1995 | A |
5478309 | Sweezer et al. | Dec 1995 | A |
5496271 | Burton et al. | Mar 1996 | A |
5496311 | Abele et al. | Mar 1996 | A |
5500011 | Desai | Mar 1996 | A |
5505728 | Ellman et al. | Apr 1996 | A |
5505730 | Edwards | Apr 1996 | A |
5509411 | Littmann et al. | Apr 1996 | A |
5509419 | Edwards et al. | Apr 1996 | A |
5522862 | Testerman et al. | Jun 1996 | A |
5531779 | Dahl et al. | Jul 1996 | A |
5540681 | Strul et al. | Jul 1996 | A |
5545161 | Imran | Aug 1996 | A |
5545193 | Fleischman et al. | Aug 1996 | A |
5547469 | Rowland et al. | Aug 1996 | A |
5549559 | Eshel | Aug 1996 | A |
5549655 | Erickson | Aug 1996 | A |
5549661 | Kordis et al. | Aug 1996 | A |
RE35330 | Malone et al. | Sep 1996 | E |
5558073 | Pomeranz et al. | Sep 1996 | A |
5562608 | Sekins et al. | Oct 1996 | A |
5562619 | Mirarchi et al. | Oct 1996 | A |
5571088 | Lennox et al. | Nov 1996 | A |
5578067 | Ekwall et al. | Nov 1996 | A |
5582609 | Swanson et al. | Dec 1996 | A |
5588432 | Crowley | Dec 1996 | A |
5595183 | Swanson et al. | Jan 1997 | A |
5598848 | Swanson et al. | Feb 1997 | A |
5599345 | Edwards et al. | Feb 1997 | A |
5601088 | Swanson et al. | Feb 1997 | A |
5605157 | Panescu et al. | Feb 1997 | A |
5607419 | Amplatz et al. | Mar 1997 | A |
5607462 | Imran | Mar 1997 | A |
5620438 | Amplatz et al. | Apr 1997 | A |
5623940 | Daikuzono | Apr 1997 | A |
5624439 | Edwards et al. | Apr 1997 | A |
5626618 | Ward et al. | May 1997 | A |
5628313 | Webster, Jr. | May 1997 | A |
5630425 | Panescu et al. | May 1997 | A |
5630794 | Lax et al. | May 1997 | A |
5634471 | Fairfax et al. | Jun 1997 | A |
5647870 | Kordis et al. | Jul 1997 | A |
5678535 | DiMarco | Oct 1997 | A |
5680860 | Imran | Oct 1997 | A |
5681280 | Rusk et al. | Oct 1997 | A |
5681308 | Edwards et al. | Oct 1997 | A |
5693078 | Desai et al. | Dec 1997 | A |
5699799 | Xu et al. | Dec 1997 | A |
5707352 | Sekins et al. | Jan 1998 | A |
5720775 | Larnard | Feb 1998 | A |
5722401 | Pietroski et al. | Mar 1998 | A |
5722403 | McGee et al. | Mar 1998 | A |
5722416 | Swanson et al. | Mar 1998 | A |
5725525 | Kordis | Mar 1998 | A |
5728094 | Edwards | Mar 1998 | A |
5730128 | Pomeranz et al. | Mar 1998 | A |
5730726 | Klingenstein | Mar 1998 | A |
5730741 | Horzewski et al. | Mar 1998 | A |
5740808 | Panescu et al. | Apr 1998 | A |
5752518 | McGee et al. | May 1998 | A |
5755753 | Knowlton | May 1998 | A |
5759158 | Swanson | Jun 1998 | A |
5769846 | Edwards et al. | Jun 1998 | A |
5772590 | Webster, Jr. | Jun 1998 | A |
5779669 | Haissaguerre et al. | Jul 1998 | A |
5779698 | Clayman et al. | Jul 1998 | A |
5782239 | Webster, Jr. | Jul 1998 | A |
5782795 | Bays | Jul 1998 | A |
5782827 | Gough et al. | Jul 1998 | A |
5782899 | Imran | Jul 1998 | A |
5792064 | Panescu et al. | Aug 1998 | A |
5795303 | Swanson et al. | Aug 1998 | A |
5807306 | Shapland et al. | Sep 1998 | A |
5810807 | Ganz et al. | Sep 1998 | A |
5814029 | Hassett | Sep 1998 | A |
5823189 | Kordis | Oct 1998 | A |
5824359 | Khan et al. | Oct 1998 | A |
5827277 | Edwards | Oct 1998 | A |
5833632 | Jacobsen et al. | Nov 1998 | A |
5836946 | Diaz et al. | Nov 1998 | A |
5836947 | Fleischman et al. | Nov 1998 | A |
5837001 | Mackey | Nov 1998 | A |
5843075 | Taylor | Dec 1998 | A |
5843077 | Edwards | Dec 1998 | A |
5846238 | Jackson et al. | Dec 1998 | A |
5848969 | Panescu et al. | Dec 1998 | A |
5848972 | Triedman et al. | Dec 1998 | A |
5855577 | Murphy-Chutorian et al. | Jan 1999 | A |
5860974 | Abele | Jan 1999 | A |
5863291 | Schaer | Jan 1999 | A |
5865791 | Whayne et al. | Feb 1999 | A |
5868685 | Powell et al. | Feb 1999 | A |
5868740 | Leveen et al. | Feb 1999 | A |
5871443 | Edwards et al. | Feb 1999 | A |
5871523 | Fleischman et al. | Feb 1999 | A |
5873865 | Horzewski et al. | Feb 1999 | A |
5876340 | Tu et al. | Mar 1999 | A |
5876399 | Chia et al. | Mar 1999 | A |
5881727 | Edwards | Mar 1999 | A |
5882346 | Pomeranz et al. | Mar 1999 | A |
5891135 | Jackson et al. | Apr 1999 | A |
5891136 | McGee et al. | Apr 1999 | A |
5891138 | Tu et al. | Apr 1999 | A |
5893847 | Kordis | Apr 1999 | A |
5897554 | Chia et al. | Apr 1999 | A |
5899882 | Waksman et al. | May 1999 | A |
5904651 | Swanson et al. | May 1999 | A |
5904711 | Flom et al. | May 1999 | A |
5906636 | Casscells, III et al. | May 1999 | A |
5908445 | Whayne et al. | Jun 1999 | A |
5908446 | Imran | Jun 1999 | A |
5911218 | DiMarco | Jun 1999 | A |
5916235 | Guglielmi | Jun 1999 | A |
5919147 | Jain | Jul 1999 | A |
5921999 | Dileo | Jul 1999 | A |
5928228 | Kordis et al. | Jul 1999 | A |
5935079 | Swanson et al. | Aug 1999 | A |
5941869 | Patterson et al. | Aug 1999 | A |
5944713 | Schuman | Aug 1999 | A |
5951494 | Wang et al. | Sep 1999 | A |
5954661 | Greenspon et al. | Sep 1999 | A |
5954662 | Swanson et al. | Sep 1999 | A |
5954717 | Behl et al. | Sep 1999 | A |
5957842 | Littmann et al. | Sep 1999 | A |
5957961 | Maguire et al. | Sep 1999 | A |
5964753 | Edwards | Oct 1999 | A |
5964796 | Imran | Oct 1999 | A |
5968087 | Hess et al. | Oct 1999 | A |
5971983 | Lesh | Oct 1999 | A |
5972026 | Laufer et al. | Oct 1999 | A |
5979456 | Magovern | Nov 1999 | A |
5980563 | Tu et al. | Nov 1999 | A |
5991650 | Swanson et al. | Nov 1999 | A |
5992419 | Sterzer et al. | Nov 1999 | A |
5993462 | Pomeranz et al. | Nov 1999 | A |
5997534 | Tu et al. | Dec 1999 | A |
5999855 | DiMarco | Dec 1999 | A |
6003517 | Sheffield et al. | Dec 1999 | A |
6004269 | Crowley et al. | Dec 1999 | A |
6006755 | Edwards | Dec 1999 | A |
6009877 | Edwards | Jan 2000 | A |
6010500 | Sherman et al. | Jan 2000 | A |
6014579 | Pomeranz et al. | Jan 2000 | A |
6016437 | Tu et al. | Jan 2000 | A |
6023638 | Swanson | Feb 2000 | A |
6024740 | Lesh et al. | Feb 2000 | A |
6029091 | De La Rama et al. | Feb 2000 | A |
6033397 | Laufer et al. | Mar 2000 | A |
6036687 | Laufer et al. | Mar 2000 | A |
6036689 | Tu et al. | Mar 2000 | A |
6039731 | Taylor et al. | Mar 2000 | A |
6045549 | Smethers et al. | Apr 2000 | A |
6045550 | Simpson et al. | Apr 2000 | A |
6050992 | Nichols | Apr 2000 | A |
6053172 | Hovda et al. | Apr 2000 | A |
6056744 | Edwards | May 2000 | A |
6056769 | Epstein et al. | May 2000 | A |
6066132 | Chen et al. | May 2000 | A |
6071279 | Whayne et al. | Jun 2000 | A |
6071280 | Edwards et al. | Jun 2000 | A |
6071281 | Burnside et al. | Jun 2000 | A |
6071282 | Fleischman | Jun 2000 | A |
6083255 | Laufer et al. | Jul 2000 | A |
6092528 | Edwards | Jul 2000 | A |
6102886 | Lundquist et al. | Aug 2000 | A |
6119030 | Morency | Sep 2000 | A |
6123703 | Tu et al. | Sep 2000 | A |
H11905 | Hill | Oct 2000 | |
6129751 | Lucchesi et al. | Oct 2000 | A |
6139527 | Laufer et al. | Oct 2000 | A |
6142993 | Whayne et al. | Nov 2000 | A |
6143013 | Samson et al. | Nov 2000 | A |
6149647 | Tu et al. | Nov 2000 | A |
6152899 | Farley et al. | Nov 2000 | A |
6159194 | Eggers et al. | Dec 2000 | A |
6179833 | Taylor | Jan 2001 | B1 |
6183468 | Swanson et al. | Feb 2001 | B1 |
6198970 | Freed et al. | Mar 2001 | B1 |
6200311 | Danek et al. | Mar 2001 | B1 |
6200332 | Del Giglio | Mar 2001 | B1 |
6200333 | Laufer | Mar 2001 | B1 |
6210367 | Carr | Apr 2001 | B1 |
6214002 | Fleischman et al. | Apr 2001 | B1 |
6216043 | Swanson et al. | Apr 2001 | B1 |
6216044 | Kordis | Apr 2001 | B1 |
6216704 | Ingle et al. | Apr 2001 | B1 |
6217576 | Tu et al. | Apr 2001 | B1 |
6235024 | Tu | May 2001 | B1 |
6241727 | Tu et al. | Jun 2001 | B1 |
6251104 | Kesten et al. | Jun 2001 | B1 |
6254598 | Edwards et al. | Jul 2001 | B1 |
6258083 | Daniel et al. | Jul 2001 | B1 |
6258087 | Edwards et al. | Jul 2001 | B1 |
6270476 | Santoianni et al. | Aug 2001 | B1 |
6273907 | Laufer | Aug 2001 | B1 |
6283988 | Laufer et al. | Sep 2001 | B1 |
6283989 | Laufer et al. | Sep 2001 | B1 |
6287290 | Perkins et al. | Sep 2001 | B1 |
6296639 | Truckai et al. | Oct 2001 | B1 |
6299633 | Laufer | Oct 2001 | B1 |
6322559 | Daulton et al. | Nov 2001 | B1 |
6322584 | Ingle et al. | Nov 2001 | B2 |
6338727 | Noda et al. | Jan 2002 | B1 |
6338836 | Kuth et al. | Jan 2002 | B1 |
6379352 | Reynolds et al. | Apr 2002 | B1 |
6409723 | Edwards | Jun 2002 | B1 |
6411852 | Danek et al. | Jun 2002 | B1 |
6416511 | Lesh et al. | Jul 2002 | B1 |
6423105 | Iijima et al. | Jul 2002 | B1 |
6425895 | Swanson et al. | Jul 2002 | B1 |
6440129 | Simpson | Aug 2002 | B1 |
6442435 | King et al. | Aug 2002 | B2 |
6460545 | Kordis | Oct 2002 | B2 |
6463331 | Edwards | Oct 2002 | B1 |
6488673 | Laufer et al. | Dec 2002 | B1 |
6493589 | Medhkour et al. | Dec 2002 | B1 |
6496738 | Carr | Dec 2002 | B2 |
6514246 | Swanson et al. | Feb 2003 | B1 |
6526320 | Mitchell | Feb 2003 | B2 |
6529756 | Phan et al. | Mar 2003 | B1 |
6539265 | Medhkour et al. | Mar 2003 | B2 |
6544226 | Gaiser et al. | Apr 2003 | B1 |
6544262 | Fleischman | Apr 2003 | B2 |
6547788 | Maguire et al. | Apr 2003 | B1 |
6572612 | Stewart et al. | Jun 2003 | B2 |
6575623 | Werneth | Jun 2003 | B2 |
6582427 | Goble et al. | Jun 2003 | B1 |
6582430 | Hall | Jun 2003 | B2 |
6589235 | Wong et al. | Jul 2003 | B2 |
6610054 | Edwards et al. | Aug 2003 | B1 |
6620159 | Hegde | Sep 2003 | B2 |
6626903 | McGuckin, Jr. et al. | Sep 2003 | B2 |
6629951 | Laufer et al. | Oct 2003 | B2 |
6634363 | Danek et al. | Oct 2003 | B1 |
6638273 | Farley et al. | Oct 2003 | B1 |
6640120 | Swanson et al. | Oct 2003 | B1 |
6645199 | Jenkins et al. | Nov 2003 | B1 |
6645200 | Koblish et al. | Nov 2003 | B1 |
6645205 | Ginn | Nov 2003 | B2 |
6652548 | Evans et al. | Nov 2003 | B2 |
6669693 | Friedman | Dec 2003 | B2 |
6673068 | Berube | Jan 2004 | B1 |
6692492 | Simpson et al. | Feb 2004 | B2 |
6692494 | Cooper et al. | Feb 2004 | B1 |
6699243 | West et al. | Mar 2004 | B2 |
6712812 | Roschak et al. | Mar 2004 | B2 |
6714822 | King et al. | Mar 2004 | B2 |
6723091 | Goble et al. | Apr 2004 | B2 |
6740082 | Shadduck | May 2004 | B2 |
6743197 | Edwards | Jun 2004 | B1 |
6749604 | Eggers et al. | Jun 2004 | B1 |
6749606 | Keast et al. | Jun 2004 | B2 |
6749607 | Edwards et al. | Jun 2004 | B2 |
6767347 | Sharkey et al. | Jul 2004 | B2 |
6770070 | Balbierz | Aug 2004 | B1 |
6802843 | Truckai et al. | Oct 2004 | B2 |
6805131 | Kordis | Oct 2004 | B2 |
6837888 | Ciarrocca et al. | Jan 2005 | B2 |
6840243 | Deem et al. | Jan 2005 | B2 |
6849073 | Hoey et al. | Feb 2005 | B2 |
6852091 | Edwards et al. | Feb 2005 | B2 |
6852110 | Roy et al. | Feb 2005 | B2 |
6866662 | Fuimaono et al. | Mar 2005 | B2 |
6869437 | Hausen et al. | Mar 2005 | B1 |
6881213 | Ryan et al. | Apr 2005 | B2 |
6893436 | Woodard et al. | May 2005 | B2 |
6893439 | Fleischman | May 2005 | B2 |
6895267 | Panescu et al. | May 2005 | B2 |
6904303 | Phan et al. | Jun 2005 | B2 |
6917834 | Koblish et al. | Jul 2005 | B2 |
6954977 | Maguire et al. | Oct 2005 | B2 |
6976991 | Hebert et al. | Dec 2005 | B2 |
7027869 | Danek et al. | Apr 2006 | B2 |
7043307 | Zelickson et al. | May 2006 | B1 |
7104987 | Biggs et al. | Sep 2006 | B2 |
7118568 | Hassett et al. | Oct 2006 | B2 |
7122033 | Wood | Oct 2006 | B2 |
7186251 | Malecki et al. | Mar 2007 | B2 |
7198635 | Danek et al. | Apr 2007 | B2 |
7200445 | Dalbec et al. | Apr 2007 | B1 |
7264002 | Danek et al. | Sep 2007 | B2 |
7273055 | Danek et al. | Sep 2007 | B2 |
7371231 | Rioux et al. | May 2008 | B2 |
7387126 | Cox et al. | Jun 2008 | B2 |
7425212 | Danek et al. | Sep 2008 | B1 |
7556624 | Laufer et al. | Jul 2009 | B2 |
7628789 | Soltesz et al. | Dec 2009 | B2 |
7949407 | Kaplan et al. | May 2011 | B2 |
8568403 | Soltesz et al. | Oct 2013 | B2 |
20020072737 | Belden et al. | Jun 2002 | A1 |
20020147391 | Morency | Oct 2002 | A1 |
20020173785 | Spear et al. | Nov 2002 | A1 |
20020198523 | Behl | Dec 2002 | A1 |
20030050631 | Mody et al. | Mar 2003 | A1 |
20030051733 | Kotmel et al. | Mar 2003 | A1 |
20030065371 | Satake | Apr 2003 | A1 |
20040047855 | Ingenito | Mar 2004 | A1 |
20040102804 | Chin | May 2004 | A1 |
20040153056 | Muller et al. | Aug 2004 | A1 |
20040249401 | Rabiner et al. | Dec 2004 | A1 |
20050010270 | Laufer | Jan 2005 | A1 |
20050096644 | Hall et al. | May 2005 | A1 |
20050154386 | West et al. | Jul 2005 | A1 |
20050182393 | Abboud et al. | Aug 2005 | A1 |
20050182431 | Hausen et al. | Aug 2005 | A1 |
20050203503 | Edwards et al. | Sep 2005 | A1 |
20050240176 | Oral et al. | Oct 2005 | A1 |
20060062808 | Laufer et al. | Mar 2006 | A1 |
20060089637 | Werneth et al. | Apr 2006 | A1 |
20060135953 | Kania et al. | Jun 2006 | A1 |
20060247617 | Danek et al. | Nov 2006 | A1 |
20060247618 | Kaplan et al. | Nov 2006 | A1 |
20060247619 | Kaplan et al. | Nov 2006 | A1 |
20060264772 | Aljuri et al. | Nov 2006 | A1 |
20070100390 | Danaek et al. | May 2007 | A1 |
20070106296 | Laufer et al. | May 2007 | A1 |
20070118184 | Danek et al. | May 2007 | A1 |
20070123958 | Laufer | May 2007 | A1 |
20070123961 | Danek et al. | May 2007 | A1 |
20080097424 | Wizeman et al. | Apr 2008 | A1 |
20080255642 | Zarins et al. | Oct 2008 | A1 |
20090018538 | Webster et al. | Jan 2009 | A1 |
20090043301 | Jarrard et al. | Feb 2009 | A1 |
20090069797 | Danek et al. | Mar 2009 | A1 |
20100160906 | Jarrard | Jun 2010 | A1 |
Number | Date | Country |
---|---|---|
189329 | Jun 1987 | EP |
908713 | Apr 1999 | EP |
908150 | May 2003 | EP |
1297795 | Aug 2005 | EP |
2659240 | Jul 1997 | FR |
7289557 | Nov 1995 | JP |
2053814 | Feb 1996 | RU |
2091054 | Sep 1997 | RU |
1989011311 | Nov 1989 | WO |
1993004734 | Mar 1993 | WO |
9502370 | Mar 1995 | WO |
1995010322 | Apr 1995 | WO |
1996004860 | Feb 1996 | WO |
1996010961 | Apr 1996 | WO |
1997032532 | Sep 1997 | WO |
1997033715 | Sep 1997 | WO |
1997037715 | Oct 1997 | WO |
1998044854 | Oct 1998 | WO |
1998052480 | Nov 1998 | WO |
1998056324 | Dec 1998 | WO |
1999003413 | Jan 1999 | WO |
1998058681 | Mar 1999 | WO |
1999013779 | Mar 1999 | WO |
1999034741 | Jul 1999 | WO |
1999044506 | Sep 1999 | WO |
1999045855 | Sep 1999 | WO |
2000051510 | Sep 2000 | WO |
2001003642 | Jan 2001 | WO |
WO 0232334 | Apr 2002 | WO |
2006052940 | May 2006 | WO |
Entry |
---|
Abandoned U.S. Appl. No. 09/095,323, filed Jun. 10, 1998. |
Dierkesmann R., “Indication and Results of Endobronchial Laser Therapy,” Lung, 1990, 168, 1095-1102. |
Hogg J. C., “The Pathology of Asthma,” APMIS, 1997, 105 (10), 735-745. |
Ivanyuta O.M., et al., “Effect of Low-Power Laser Irradiation of Bronchial Mucosa on the State of Systemic and Local Immunity in Patients with Chronic Bronchitis,” Problemy Tuberkuleza, 1991, 6, 26-29. |
Johnson S. R., et al., “Synthetic Functions of Airway Smooth Muscle in Asthma,” Trends Pharmacol. Sci., 1997, 18 (8), 288-292. |
Macklem P. T., “Mechanical Factors Determining Maximum Bronchoconstriction,” European Respiratory Journal, 1989, 6, 516s-519s. |
Netter F.H., “Respiratory System: A Compilation of Paintings Depicting Anatomy and Embryology, Physiology, Pathology, Pathophysiology, and Clinical Features and Treatment of Diseases, In the CIBA Collection of Medical Illustrations M.B. Divertie, ed., Summit: New Jerse,” 1979, 7, 119-135. |
PCT International search report for application No. PCT/US05/40378 dated Aug. 8, 2006, 2 pages. |
PCT International search report for application No. PCT/US05/41244 dated Mar. 20, 2007, 1 page. |
Provotorov V.M., et al., “The Clinical Efficacy of Treating Patients with Nonspecific Lung Diseases Using Low-energy Laser Irradiation and Intrapulmonary Drug Administration,” Terapevticheskii Arkhiv, 1991, 62 (12), 18-23. |
Vorotnev A.I., et al., “The Treatment of Patients with Chronic Obstructive Bronchitis by Using a Low-power Laser at a General Rehabilitation Center,” Terapevticheskii Arkhiv, 1997, 69 (3), 17-19. |
Wiggs B.R., et al., “On the Mechanism of Mucosal Folding in Normal and Asthmatic Airways,” Journal of Applied Physiology, 1997, 83 (6), 1814-1821. |
Notice of Opposition to European Patent No. EP 2 320 821 B1, dated Jul. 23, 2013, 24 pages. |
Reply of Patent Proprietor to Notice of Opposition to European Patent No. EP 2 320 821 B1, dated Mar. 10, 2014, 26 pages. |
Summons to Attend Oral Proceedings Pursuant to Rule 115(1) EPC in Opposition to European Patent No. EP 2 320 821 B1, dated Jul. 14, 2014, 5 pages. |
Number | Date | Country | |
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20140025063 A1 | Jan 2014 | US |
Number | Date | Country | |
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Parent | 13860216 | Apr 2013 | US |
Child | 13949051 | US | |
Parent | 13087161 | Apr 2011 | US |
Child | 13860216 | US | |
Parent | 11618533 | Dec 2006 | US |
Child | 13087161 | US |