WO2014150603A1 - Systems and methods for treatment using magnetic fields - Google Patents

Systems and methods for treatment using magnetic fields Download PDF

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Publication number
WO2014150603A1
WO2014150603A1 PCT/US2014/023765 US2014023765W WO2014150603A1 WO 2014150603 A1 WO2014150603 A1 WO 2014150603A1 US 2014023765 W US2014023765 W US 2014023765W WO 2014150603 A1 WO2014150603 A1 WO 2014150603A1
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WO
WIPO (PCT)
Prior art keywords
magnetic field
magnetic
lung
control unit
implantable
Prior art date
Application number
PCT/US2014/023765
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French (fr)
Inventor
Sri Radhakrishnan
Ryan Olivera
Hoang Nguyen
Original Assignee
Sri Radhakrishnan
Ryan Olivera
Hoang Nguyen
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Filing date
Publication date
Application filed by Sri Radhakrishnan, Ryan Olivera, Hoang Nguyen filed Critical Sri Radhakrishnan
Publication of WO2014150603A1 publication Critical patent/WO2014150603A1/en

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    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
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    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0404Special features for tracheal tubes not otherwise provided for with means for selective or partial lung respiration
    • A61M16/0406Special features for tracheal tubes not otherwise provided for with means for selective or partial lung respiration implanted flow modifiers
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    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00411Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like actuated by application of energy from an energy source outside the body
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    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/009Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
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    • A61F2220/0008Fixation appliances for connecting prostheses to the body
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    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
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Definitions

  • This invention relates generally to medical devices and more specifically to devices, systems and methods for treating tissue using implants and magnetic fields.
  • Chronic obstructive pulmonary disease is a significant medical problem affecting 16 million people or about 6% of the U.S. population. Specific diseases in this group include chronic bronchitis, asthmatic bronchitis, and emphysema. While a number of therapeutic interventions are used and have been proposed, none are completely effective, and chronic obstructive pulmonary disease remains the fourth most common cause of death in the United States. Thus, improved and alternative treatments and therapies would be of significant benefit.
  • lung function in patients suffering from some forms of chronic obstructive pulmonary disease can be improved by reducing the effective lung volume, typically by resecting diseased portions of the lung.
  • Resection of diseased portions of the lungs both promotes expansion of the non-diseased regions of the lung and decreases the portion of inhaled air which goes into the lungs but is unable to transfer oxygen to the blood.
  • Lung volume reduction is conventionally performed in open chest or thoracoscopic procedures where the lung is resected, typically using stapling devices having integral cutting blades.
  • LVRS lung volume reduction surgery
  • endobronchial lung volume reduction uses endobronchial ⁇ introduced devices which plug or otherwise isolate a diseased compartment from healthier regions of the lung in order to achieve volume reduction of the diseased compartment.
  • Isolation devices may be implanted in the main airways feeding the diseased region of the lung, and volume reduction takes place via absorption atelectasis after implantation or via collapse by actively suctioning of the target compartment prior to implantation.
  • implanted isolation devices can be, for example, self-expanding occlusive stents that prevent air flow in both directions or one-way valves that allow flow in the exhalation direction only.
  • ELVR can have a limited therapeutic benefit when the treated region in the lung is exposed to collateral ventilation from adjacent regions.
  • the lungs comprise a plurality of compartments, referred to as lung compartments or lobes, which are separated from one another by a double layer of enfolded reflections of visceral pleura, referred to as fissures. While the fissures which separate the compartments are typically impermeable, in patients suffering from COPD, the fissures are frequently incomplete, leaving a pathway for collateral airflow or inter-lobular collateral ventilation. Such collateral airflow can result in the intrusion of air into the isolated lung compartments treated by ELVR, thus reducing or eliminating the desired volume reduction.
  • One method for treating a lung region comprises implanting a pulmonary device comprising a material configured to be affected by a magnetic field in the lung region and applying a magnetic device external to the patient's body.
  • the magnetic field of the magnetic device influences the position of the implanted pulmonary device thereby influencing the position of the lung region.
  • the implanted pulmonary device and the magnetic field of the magnetic device are oriented to repel the lung region preventing hyperinflation of the lung region.
  • the implanted pulmonary device and the magnetic field of the magnetic device are oriented to attract the lung region causing collapse of the lung region.
  • a lung region is first identified to involve an air leak before implanting the pulmonary device.
  • the implanted pulmonary device and the magnetic field of the magnetic device are oriented to attract the lung region towards the chest cavity allowing the visceral and parietal pleura to come in contact.
  • FIG. 1A illustrates an anterior view of a pair of human lungs and a bronchial tree.
  • FIG. IB illustrates a lateral view of the right lung.
  • FIG. 1C illustrates a lateral view of the left lung.
  • FIG. ID illustrates an anterior view of the trachea and a portion of the bronchial tree.
  • FIG. 2 shows an anterior view of a pair of human lungs and a bronchial tree with multiple pulmonary devices implanted in a lung region.
  • FIG. 3 shows an exemplary embodiment of a magnetic device.
  • FIG. 4 shows an exemplary embodiment of an implantable magnetic device.
  • lung region refers to a defined division or portion of a lung.
  • lung regions are described herein with reference to human lungs, wherein some exemplary lung regions include lung lobes and lung segments.
  • lung region can refer, for example, to a lung lobe or a lung segment.
  • Such nomenclature conforms to nomenclature for portions of the lungs that are known to those skilled in the art.
  • lung region does not necessarily refer to a lung lobe or a lung segment, but can refer to some other defined division or portion of a human or non-human lung.
  • FIG. 1A shows an anterior view of a pair of human lungs 110, 115 and a bronchial tree 120 that provides a fluid pathway into and out of the lungs 110, 115 from a trachea 125, as will be known to those skilled in the art.
  • the term "fluid” can refer to a gas, a liquid, or a combination of gas(es) and liquid(s).
  • FIG. 1 A shows only a portion of the bronchial tree 120, which is described in more detail below with reference to FIG. ID.
  • FIG. 1 A shows a path 102 that travels through the trachea 125 and through a bronchial passageway into a location in the right lung 110.
  • proximal direction refers to the direction along such a path 102 that points toward the patient's mouth or nose and away from the patient's lungs. In other words, the proximal direction is generally the same as the expiration direction when the patient breathes.
  • the arrow 104 in FIG. 1 A points in the proximal or expiratory direction.
  • distal direction refers to the direction along such a path 102 that points toward the patient's lung and away from the mouth or nose.
  • the distal direction is generally the same as the inhalation or inspiratory direction when the patient breathes.
  • the arrow 106 in FIG. 1 A points in the distal or inhalation direction.
  • the lungs include a right lung 110 and a left lung 115.
  • the right lung 110 includes lung regions comprised of three lobes, including a right upper lobe 130, a right middle lobe 135, and a right lower lobe 140.
  • the lobes 130, 135, 140 are separated by two interlobar fissures, including a right oblique fissure 126 and a right transverse fissure 128.
  • the right oblique fissure 126 separates the right lower lobe 140 from the right upper lobe 130 and from the right middle lobe 135.
  • the right transverse fissure 128 separates the right upper lobe 130 from the right middle lobe 135.
  • the left lung 115 includes lung regions comprised of two lobes, including the left upper lobe 150 and the left lower lobe 155.
  • An interlobar fissure comprised of a left oblique fissure 145 of the left lung 115 separates the left upper lobe 150 from the left lower lobe 155.
  • the lobes 130, 135, 140, 150, 155 are directly supplied, air via respective lobar bronchi, as described in detail below.
  • FIG. IB is a lateral view of the right lung 110.
  • the right lung 110 is subdivided into lung regions comprised of a plurality of bronchopulmonary segments.
  • the bronchopulmonary segment is directly supplied air by a corresponding segmental tertiary bronchus, as described below.
  • the bronchopulmonary segments of the right lung 110 include a right apical segment 210, a right posterior segment 220, and a right anterior segment 330, all of which are disposed in the right upper lobe 130.
  • the right lung bronchopulmonary segments further include a right lateral segment 240 and a right medial segment 250, which are disposed in the right middle lobe 135.
  • the right lower lobe 140 includes
  • bronchopulmonary segments comprised of a right superior segment 260, a right medial basal segment (which cannot be seen from the lateral view and is not shown in FIG. IB), a right anterior basal segment 280, a right lateral basal segment 290, and a right posterior basal segment 295.
  • FIG. 1C shows a lateral view of the left lung 115, which is subdivided into lung regions comprised of a plurality of bronchopulmonary segments.
  • the bronchopulmonary segments include a left apical segment 310, a left posterior segment 320, a left anterior segment 330, a left superior segment 340, and a left inferior segment 350, which are disposed in the left lung upper lobe 150.
  • the lower lobe 155 of the left lung 115 includes
  • bronchopulmonary segments comprised of a left superior segment 360, a left medial basal segment (which cannot be seen from the lateral view and is not shown in FIG. 1C), a left anterior basal segment 380, a left lateral basal segment 390, and a left posterior basal segment 395.
  • FIG. ID shows an anterior view of the trachea 125 and a portion of the bronchial tree 120, which includes a network of bronchial passageways, as described below.
  • the trachea 125 divides at a lower end into two bronchial passageways comprised of primary bronchi, including a right primary bronchus 410 that provides direct air flow to the right lung 110, and a left primary bronchus 415 that provides direct air flow to the left lung 115.
  • Each primary bronchus 410, 415 divides into a next generation of bronchial passageways comprised of a plurality of lobar bronchi.
  • the right primary bronchus 410 divides into a right upper lobar bronchus 417, a right middle lobar bronchus 420, and a right lower lobar bronchus 322.
  • the left primary bronchus 415 divides into a left upper lobar bronchus 425 and a left lower lobar bronchus 430.
  • Each lobar bronchus 417, 420, 422, 425, 430 directly feeds fluid to a respective lung lobe, as indicated by the respective names of the lobar bronchi.
  • the lobar bronchi each divide into yet another generation of bronchial passageways comprised of segmental bronchi, which provide air flow to the bronchopulmonary segments discussed above.
  • a bronchial passageway defines an internal lumen through which fluid can flow to and from a lung or lung region.
  • the diameter of the internal lumen for a specific bronchial passageway can vary based on the bronchial passageway's location in the bronchial tree (such as whether the bronchial passageway is a lobar bronchus or a segmental bronchus) and can also vary from patient to patient.
  • the internal diameter of a bronchial passageway is generally in the range of 3 millimeters (mm) to 10 mm, although the internal diameter of a bronchial passageway can be outside of this range.
  • a bronchial passageway can have an internal diameter of well below 1 mm at locations deep within the lung.
  • the internal diameter can also vary from inhalation to exhalation as the diameter increases during inhalation as the lungs expand, and decreases during exhalation as the lungs contract.
  • the present disclosure describes methods, kits, systems, and devices for treating a patient using magnetic fields.
  • An implantable device 500 configured to be used in conjunction with a magnetic device 600 is implanted at a treatment location in a patient.
  • the magnetic device 600 produces a magnetic field that influences the position of the implantable device 500 thereby influencing the position of the tissue at the treatment location.
  • FIG. 2 shows an anterior view of a pair of human lungs and a bronchial tree with multiple implantable devices 500 implanted in a lung region. It should be noted that although the embodiment as seen in FIG. 2 is exemplarily shown as comprising multiple implantable devices 500, it is contemplated that a single implantable device 500 may be used as well.
  • Implantable devices 500 are configured to be secured in the lung so as to remain in place during breathing.
  • the exterior of an implantable device 500 may be configured along all or part of its exterior to aid in fixing the device in place.
  • the fixation structure may comprise adhesives, tissue growth-inducing substances, struts, fasteners, staples, prongs, clips, sutures, stents, balloons, sleeves, sintered, etched, roughened, barbed or alternatively treated surfaces, etc.
  • Implantable devices 500 comprise a material configured to be influenced by a magnetic field.
  • Implantable devices 500 may comprise ferromagnetic material such as iron, nickel, cobalt, rare earth metals, etc.
  • the implantable devices 500 comprise a ferromagnetic alloy such as steel or cobalt-chromium.
  • the implantable 500 device may comprise a permanent magnet or an electromagnet.
  • the implantable devices 500 are configured to be affected by a specific magnetic field while unaffected or minimally affected by other magnetic fields.
  • the implanted device 500 is configured to be influenced by the magnetic field of the magnetic device 600 but will not be influenced or be minimally influenced by other magnetic fields that may be present.
  • the implantable devices 500 may be configured to allow a patient with the implantable devices 500 to use magnetic resonance imaging safely.
  • the implantable devices 500 as exemplarily shown in FIG. 2 comprise a tubular stent having struts to enhance fixation of the implantable devices 500 in a hollow body structure such as a bronchial passageway. Additionally or alternatively, the implantable devices 500 may comprise coils, rings, barbs, staples, prongs, valves, sleeves, or any other configuration allowing placement in a hollow body structure. In one embodiment the implantable device 500 is movable between collapsed and expanded orientations to enable easy delivery and deployment. That is, an implantable device 500 may be collapsed and held in a sheath for delivery through a relatively small space, for example, the working channel of a bronchoscope.
  • the implantable device 500 is configured to be used in conjunction with one or more magnetic devices.
  • the magnetic device 600 may be implantable or external. In an embodiment where the magnetic device 600 is external as seen in FIG. 3, the magnetic device 600 is configured to be worn, attached, strapped, or applied external to the patient.
  • the magnetic device 600 may be attached to or comprise clothing.
  • the magnetic device 600 may also be attached to or comprise a band wearable by the patient.
  • the magnetic device 600 is a patch device.
  • the magnetic device 600 is configured to be applied at a location such that its magnetic field influences the implantable device 500 at the treatment location.
  • the magnetic device 600 is a vest configured to influence implanted pulmonary devices 500.
  • the magnetic device 600 could be attached or attachable to clothing or bands wearable by a patient.
  • the magnetic device 600 comprises a magnetic unit 601, control unit 602, sensor 603, and networking unit 604.
  • the magnetic unit 601 produces the magnetic field.
  • the magnetic unit 601 is configured to be positioned in close proximity to the implant site.
  • the magnetic unit 601 can be moved to various locations on the magnetic device in order to optimize the influence of the magnetic field on the implantable device 500.
  • the magnetic device comprises multiple magnetic units 601 wherein one or more of the magnetic units 601 are selected to be active based on their distance and/or orientation in relation to the implantable device 500.
  • the magnetic device 600 may be configured to produce magnetic fields of various shapes or orientations.
  • the magnetic field generated by the magnetic device 600 can be two- dimensional or three-dimensional. Additionally, the magnetic device 600 may be configured to have multiple magnetic fields active at the same time. The multiple magnetic fields may have multiple orientations and/or strengths.
  • Control unit 602 is configured to control one or more treatment parameters associated with the produced magnetic field including but not limited to treatment time, magnetic field shapes, orientations, strength, and magnitude.
  • the control unit 602 is configured to spatially adjust the produced magnetic field of specific depth and 3D orientation. Control unit 602 can also adjust the strength of the magnetic field.
  • the control unit 602 can control each magnetic field independently.
  • multiple control units 602 may be present wherein multiple magnetic fields are controlled by separate control units 602.
  • control unit 602 can control which magnetic units 601 are active.
  • the control unit 602 is further configured to adjust orientation or strength of the produced magnetic field can be adjusted to have varying orientations and strengths.
  • Control unit 602 may time the treatment period. Additionally, control unit 602 may vary characteristics of the magnetic fields based on time periods. In an embodiment the control unit 602 produces cyclic variations in the magnetic field.
  • the control unit 602 comprises at least one processing unit (CPU) that is in communication with a memory unit via a bus.
  • the memory unit may comprise an EEPROM, EPROM, RAM, ROM, and/or other storage means.
  • the memory unit of the control unit 602 may be configured to store one or more treatment parameters or schedules. For example, a treatment parameter comprising with a pre-determined treatment time, magnetic field shapes, orientations, and/or magnitude to achieve the desired degree of lung volume reduction to achieve a specific degree of lung volume reduction may be stored in the memory unit of the control unit. Thereupon user selection or activation, the control unit 602 is configured to execute the treatment parameters to achieve the desired treatment result.
  • Control unit 602 is configured to adjust the magnetic field based on the sensor 603 data.
  • the control unit 602 can adjust the magnetic field based on sensed changes in the treatment area to provide a feedback mechanism.
  • the magnetic device 600 may comprise user controls that allow a user to adjust aspects of the magnetic field such as strength, orientation, or timing.
  • the control unit 602 can be adjusted using a separate device such as a server, desktop computer, laptop computer, tablet computer, personal digital assistant (PDA), smart phone, mobile phone, medical device, or the like.
  • PDA personal digital assistant
  • the networking unit 604 may directly or indirectly communicate with a wireless network such as through a base station, a router, switch, or other computing devices.
  • the networking unit 604 may be configured to utilize various communication protocols such as Global System for Mobile Communications (GSM), General Packet Radio Services (GPRS), Enhanced Data GSM Environment (EDGE), Code Division Multiple Access (CDMA), Wideband Code Division Multiple Access (WCDMA), Bluetooth, ZigBee, High Speed Packet Access (HSPA), Long Term Evolution (LTE), and Worldwide Interoperability for Microwave Access (WiMAX).
  • GSM Global System for Mobile Communications
  • GPRS General Packet Radio Services
  • EDGE Enhanced Data GSM Environment
  • CDMA Code Division Multiple Access
  • WCDMA Wideband Code Division Multiple Access
  • Bluetooth ZigBee
  • HSPA High Speed Packet Access
  • LTE Long Term Evolution
  • WiMAX Worldwide Interoperability for Microwave Access
  • the networking unit 604 may be further configured to utilize user datagram protocol (UDP), transport control protocol (TCP), Wi-Fi, satellite links and various other communication protocols, technologies, or methods. Additionally, the networking unit 604 may be connected to an electronic network without communicating through a wireless network. The networking unit 604 may be configured to utilize analog telephone lines (dial-up connection), digital lines (Tl, T2, T3, T4, or the like), Digital Subscriber lines (DSL), ethernet, or the like. It is further contemplated that the networking unit 604 may be connected directly to a computing device through a USB port, Bluetooth, ZigBee, infrared (IR), firewire port, thunderbolt port, ad-hoc wireless connection, or the like.
  • UDP user datagram protocol
  • TCP transport control protocol
  • Wi-Fi Wireless Fidelity
  • satellite links and various other communication protocols, technologies, or methods. Additionally, the networking unit 604 may be connected to an electronic network without communicating through a wireless network.
  • the networking unit 604 may be configured to utilize analog telephone
  • the magnetic device 700 may be implanted.
  • Implantable magnetic devices 700 may comprise a magnetic unit, and optionally, a control unit, sensor, networking unit, or any other component found in an external magnetic device. Additionally, implantable magnetic devices 700 may be configured to perform any of the functions of an external magnetic device.
  • the magnetic device 700 may be placed in the lung, an intercostal space, subdermally, or any other location near the implantable device 500.
  • FIG. 4 shows an implantable magnetic device 700 in a bronchial passageway leading to the location of the implantable devices 500.
  • the implantable magnetic device 700 is configured to attract the implantable devices 500, thereby causing the target lung region to move toward the magnetic device 700 and volume reduction or collapse of the lung region.
  • an external or implantable magnetic device 600 may be used in conjunction with an external or implantable control device configured to control the magnetic field of the magnetic device 600.
  • the control device may comprise a control unit, sensor, or networking unit.
  • the magnetic treatment system can be used for lung volume reduction.
  • Implantable devices 500 are implanted in a target lung region selected for lung volume reduction.
  • the implantable devices 500 and the magnetic field of the magnetic device 600 can be oriented to repel the target lung region from the magnetic device 600 thereby preventing hyperinflation of the target lung region or collapsing the lung region.
  • the implantable devices 500 and the magnetic field of the magnetic device 600 can alternatively be oriented to gradually attract the lung region toward the magnetic device 600 causing volume reduction or collapse of the lung region.
  • Embodiments of the magnetic treatment system may also be used for treating air- leaks.
  • the implanted devices 500 could be placed in discrete lung regions identified to be involved in the leak. Air-leaks to diseased lung compartments can be detected, for example using the methods described in co-pending, commonly-owned U.S. patent application Ser. No. 11/296,591, filed on Dec. 7, 2005 (US 2006/0264772A1) and Ser. No. 11/550,660, filed on Oct. 18, 2006 (US 2007/0142742A1). The foregoing references are incorporated by reference in their entirety.
  • the implantable devices 500 and the magnetic field of the magnetic device 600 could be oriented to attract the lung region towards the chest cavity allowing the visceral and parietal pleura to come in contact and enable healing.
  • the treatment system can be used to assist in patient ventilation.
  • the implanted devices 500 could be placed in the lung tissue or in the diaphragm.
  • the control unit 602 could alternate the produced magnetic field to cause expansion and contraction of the lung or the diaphragm. This could also include feedback mechanisms to act like a pacemaker based on the patients respiratory rate, sleep patterns, and exercise.
  • the magnetic device 600 and implantable devices 500 can also be used as a closure system for wound care.
  • the magnetic field of the magnetic device 600 can interact with implanted devices 500 to apply tension or compression to the wound area to prevent bleeding, assist in healing, and reduce scarring.
  • the system can also be used for treating obesity.
  • the implantable devices 500 could be placed in the stomach or outside the stomach.
  • the magnetic field of the magnetic device 600 could be adjusted to create of a sense of satiety. This can be adjusted over time to slowly reduce the intake of food.
  • the system can be used to treat urinary incontinence.
  • the implanted devices 500 could be placed around the bladder.
  • the control unit 602 could adjust the produced magnetic field to squeeze the bladder sphincter to prevent incontinence.
  • kits for use in practicing the one or more methods described herein, where the kits typically include one or more of implantable devices. Kits may also include one or more delivery catheters, loading devices, connectors, or the like. In one embodiment, one or more magnetic devices could also be included in the kit.
  • the subject kits typically further include instructions for using the components of the kit to practice the subject methods. The instructions for practicing the subject methods are generally recorded on a suitable recording medium. For example, the instructions may be printed on a substrate, such as paper or plastic, etc.
  • the instructions may be present in the kits as a package insert, in the labeling of the container of the kit or components thereof (i.e., associated with the packaging or sub- packaging) etc.
  • the instructions are present as an electronic storage data file present on a suitable computer readable storage medium, e.g., CD-ROM, diskette, etc.
  • the actual instructions are not present in the kit, but means for obtaining the instructions from a remote source, e.g. via the internet, are provided.
  • An example of this embodiment is a kit that includes a web address where the instructions can be viewed and/or from which the instructions can be downloaded. As with the instructions, this means for obtaining the instructions is recorded on a suitable substrate.

Abstract

Devices, systems, and methods are disclosed for treating tissue using magnetic fields. The system includes an implantable device configured to be affected by a magnetic field and a magnetic device configured to influence the position of the implantable device in order to influence the position of the tissue at the implant location.

Description

SYSTEMS AND METHODS FOR TREATMENT USING MAGNETIC FIELDS
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional Application No.
61/793,816 (Attorney Docket No. 20920-770.101), filed Mar. 15, 2013, the full disclosure of which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to medical devices and more specifically to devices, systems and methods for treating tissue using implants and magnetic fields.
BACKGROUND
[0003] Chronic obstructive pulmonary disease is a significant medical problem affecting 16 million people or about 6% of the U.S. population. Specific diseases in this group include chronic bronchitis, asthmatic bronchitis, and emphysema. While a number of therapeutic interventions are used and have been proposed, none are completely effective, and chronic obstructive pulmonary disease remains the fourth most common cause of death in the United States. Thus, improved and alternative treatments and therapies would be of significant benefit.
[0004] Of particular interest to the present invention, lung function in patients suffering from some forms of chronic obstructive pulmonary disease can be improved by reducing the effective lung volume, typically by resecting diseased portions of the lung. Resection of diseased portions of the lungs both promotes expansion of the non-diseased regions of the lung and decreases the portion of inhaled air which goes into the lungs but is unable to transfer oxygen to the blood. Lung volume reduction is conventionally performed in open chest or thoracoscopic procedures where the lung is resected, typically using stapling devices having integral cutting blades.
[0005] While effective in many cases, conventional lung volume reduction surgery (LVRS) is significantly traumatic to the patient, even when thoracoscopic procedures are employed. Such procedures often result in the unintentional removal of healthy lung tissue, and frequently leave perforations or other discontinuities in the lung which result in air leakage from the remaining lung. Even technically successful procedures can cause respiratory failure, pneumonia, and death. In addition, many older or compromised patients are not able to be candidates for these procedures.
[0006] As an alternative to LVRS, endobronchial lung volume reduction (ELVR) uses endobronchial^ introduced devices which plug or otherwise isolate a diseased compartment from healthier regions of the lung in order to achieve volume reduction of the diseased compartment. Isolation devices may be implanted in the main airways feeding the diseased region of the lung, and volume reduction takes place via absorption atelectasis after implantation or via collapse by actively suctioning of the target compartment prior to implantation. These implanted isolation devices can be, for example, self-expanding occlusive stents that prevent air flow in both directions or one-way valves that allow flow in the exhalation direction only.
[0007] While a significant improvement over LVRS, ELVR can have a limited therapeutic benefit when the treated region in the lung is exposed to collateral ventilation from adjacent regions. The lungs comprise a plurality of compartments, referred to as lung compartments or lobes, which are separated from one another by a double layer of enfolded reflections of visceral pleura, referred to as fissures. While the fissures which separate the compartments are typically impermeable, in patients suffering from COPD, the fissures are frequently incomplete, leaving a pathway for collateral airflow or inter-lobular collateral ventilation. Such collateral airflow can result in the intrusion of air into the isolated lung compartments treated by ELVR, thus reducing or eliminating the desired volume reduction.
[0008] For these reasons, it would be desirable to provide alternative and improved methods and apparatus for lung volume reduction. At least some of these objectives will be met by the inventions described herein below.
SUMMARY OF THE INVENTION
[0009] In one aspect, the present application discloses devices, systems and methods for treating tissue using one or more implants and magnetic fields where the implant is configured to be influenced by magnetic fields. In one aspect, the implant may be a pulmonary implant capable of being implanted in a lung region. In another aspect, an external magnetic device such as a device wearable by the patient produces a magnetic field. The produced magnetic field influences the position of the implant thereby influencing the position of the tissue at the implant location. In one aspect, the magnetic field of the magnetic device may be three-dimensional. In another aspect, the magnetic device may be configured to have multiple magnetic fields active at the same time. [0010] In one aspect, the magnetic device comprises a control unit configured to control the produced magnetic field. The control unit may adjust the magnetic field spatially. The control unit may be configured to adjust the strength of the produced magnetic field. The control unit may adjust the orientation of the produced magnetic field. The control unit may be configured to adjust the produced magnetic field to assist in ventilation.
[0011] Other aspects of the invention include methods corresponding to the devices and systems described above. One method for treating a lung region comprises implanting a pulmonary device comprising a material configured to be affected by a magnetic field in the lung region and applying a magnetic device external to the patient's body. The magnetic field of the magnetic device influences the position of the implanted pulmonary device thereby influencing the position of the lung region.
[0012] In one aspect, the implanted pulmonary device and the magnetic field of the magnetic device are oriented to repel the lung region preventing hyperinflation of the lung region.
[0013] In another aspect, the implanted pulmonary device and the magnetic field of the magnetic device are oriented to attract the lung region causing collapse of the lung region.
[0014] In yet another aspect, a lung region is first identified to involve an air leak before implanting the pulmonary device. The implanted pulmonary device and the magnetic field of the magnetic device are oriented to attract the lung region towards the chest cavity allowing the visceral and parietal pleura to come in contact.
[0015] This and other aspects of the present disclosure are described herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Present embodiments have other advantages and features which will be more readily apparent from the following detailed description and the appended claims, when taken in conjunction with the accompanying drawings, in which:
[0017] FIG. 1A illustrates an anterior view of a pair of human lungs and a bronchial tree.
[0018] FIG. IB illustrates a lateral view of the right lung.
[0019] FIG. 1C illustrates a lateral view of the left lung.
[0020] FIG. ID illustrates an anterior view of the trachea and a portion of the bronchial tree.
[0021] FIG. 2 shows an anterior view of a pair of human lungs and a bronchial tree with multiple pulmonary devices implanted in a lung region.
[0022] FIG. 3 shows an exemplary embodiment of a magnetic device. [0023] FIG. 4 shows an exemplary embodiment of an implantable magnetic device.
DETAILED DESCRIPTION OF THE INVENTION
[0024] Although the detailed description contains many specifics, these should not be construed as limiting the scope of the disclosure but merely as illustrating different examples and aspects of the disclosure. It should be appreciated that the scope of the disclosure includes other embodiments not discussed herein. Various other modifications, changes and variations which will be apparent to those skilled in the art may be made in the arrangement, operation and details of the method, device, and system of the present embodiments disclosed herein without departing from the spirit and scope of the disclosure as described here.
[0025] Throughout the specification and claims, the following terms take the meanings explicitly associated herein unless the context clearly dictates otherwise. The meaning of "a", "an", and "the" include plural references. The meaning of "in" includes "in" and "on." Referring to the drawings, like numbers indicate like parts throughout the views.
Additionally, a reference to the singular includes a reference to the plural unless otherwise stated or inconsistent with the disclosure herein.
[0026] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as advantageous over other implementations.
[0027] Exemplary Lung Regions
[0028] Throughout this disclosure, reference is made to the term "lung region". As used herein, the term "lung region" refers to a defined division or portion of a lung. For purposes of example, lung regions are described herein with reference to human lungs, wherein some exemplary lung regions include lung lobes and lung segments. Thus, the term "lung region" as used herein can refer, for example, to a lung lobe or a lung segment. Such nomenclature conforms to nomenclature for portions of the lungs that are known to those skilled in the art. However, it should be appreciated that the term "lung region" does not necessarily refer to a lung lobe or a lung segment, but can refer to some other defined division or portion of a human or non-human lung.
[0029] FIG. 1A shows an anterior view of a pair of human lungs 110, 115 and a bronchial tree 120 that provides a fluid pathway into and out of the lungs 110, 115 from a trachea 125, as will be known to those skilled in the art. As used herein, the term "fluid" can refer to a gas, a liquid, or a combination of gas(es) and liquid(s). For clarity of illustration, FIG. 1 A shows only a portion of the bronchial tree 120, which is described in more detail below with reference to FIG. ID.
[0030] Throughout this description, certain terms are used that refer to relative directions or locations along a path defined from an entryway into the patient's body (e.g., the mouth or nose) to the patient's lungs. The path of airflow into the lungs generally begins at the patient's mouth or nose, travels through the trachea into one or more bronchial passageways, and terminates at some point in the patient's lungs.
[0031] For example, FIG. 1 A shows a path 102 that travels through the trachea 125 and through a bronchial passageway into a location in the right lung 110. The term "proximal direction" refers to the direction along such a path 102 that points toward the patient's mouth or nose and away from the patient's lungs. In other words, the proximal direction is generally the same as the expiration direction when the patient breathes. The arrow 104 in FIG. 1 A points in the proximal or expiratory direction. The term "distal direction" refers to the direction along such a path 102 that points toward the patient's lung and away from the mouth or nose. The distal direction is generally the same as the inhalation or inspiratory direction when the patient breathes. The arrow 106 in FIG. 1 A points in the distal or inhalation direction.
[0032] The lungs include a right lung 110 and a left lung 115. The right lung 110 includes lung regions comprised of three lobes, including a right upper lobe 130, a right middle lobe 135, and a right lower lobe 140. The lobes 130, 135, 140 are separated by two interlobar fissures, including a right oblique fissure 126 and a right transverse fissure 128. The right oblique fissure 126 separates the right lower lobe 140 from the right upper lobe 130 and from the right middle lobe 135. The right transverse fissure 128 separates the right upper lobe 130 from the right middle lobe 135.
[0033] As shown in FIG. 1A, the left lung 115 includes lung regions comprised of two lobes, including the left upper lobe 150 and the left lower lobe 155. An interlobar fissure comprised of a left oblique fissure 145 of the left lung 115 separates the left upper lobe 150 from the left lower lobe 155. The lobes 130, 135, 140, 150, 155 are directly supplied, air via respective lobar bronchi, as described in detail below.
[0034] FIG. IB is a lateral view of the right lung 110. The right lung 110 is subdivided into lung regions comprised of a plurality of bronchopulmonary segments. Each
bronchopulmonary segment is directly supplied air by a corresponding segmental tertiary bronchus, as described below. The bronchopulmonary segments of the right lung 110 include a right apical segment 210, a right posterior segment 220, and a right anterior segment 330, all of which are disposed in the right upper lobe 130. The right lung bronchopulmonary segments further include a right lateral segment 240 and a right medial segment 250, which are disposed in the right middle lobe 135. The right lower lobe 140 includes
bronchopulmonary segments comprised of a right superior segment 260, a right medial basal segment (which cannot be seen from the lateral view and is not shown in FIG. IB), a right anterior basal segment 280, a right lateral basal segment 290, and a right posterior basal segment 295.
[0035] FIG. 1C shows a lateral view of the left lung 115, which is subdivided into lung regions comprised of a plurality of bronchopulmonary segments. The bronchopulmonary segments include a left apical segment 310, a left posterior segment 320, a left anterior segment 330, a left superior segment 340, and a left inferior segment 350, which are disposed in the left lung upper lobe 150. The lower lobe 155 of the left lung 115 includes
bronchopulmonary segments comprised of a left superior segment 360, a left medial basal segment (which cannot be seen from the lateral view and is not shown in FIG. 1C), a left anterior basal segment 380, a left lateral basal segment 390, and a left posterior basal segment 395.
[0036] FIG. ID shows an anterior view of the trachea 125 and a portion of the bronchial tree 120, which includes a network of bronchial passageways, as described below. The trachea 125 divides at a lower end into two bronchial passageways comprised of primary bronchi, including a right primary bronchus 410 that provides direct air flow to the right lung 110, and a left primary bronchus 415 that provides direct air flow to the left lung 115. Each primary bronchus 410, 415 divides into a next generation of bronchial passageways comprised of a plurality of lobar bronchi. The right primary bronchus 410 divides into a right upper lobar bronchus 417, a right middle lobar bronchus 420, and a right lower lobar bronchus 322. The left primary bronchus 415 divides into a left upper lobar bronchus 425 and a left lower lobar bronchus 430.
[0037] Each lobar bronchus 417, 420, 422, 425, 430 directly feeds fluid to a respective lung lobe, as indicated by the respective names of the lobar bronchi. The lobar bronchi each divide into yet another generation of bronchial passageways comprised of segmental bronchi, which provide air flow to the bronchopulmonary segments discussed above.
[0038] As is known to those skilled in the art, a bronchial passageway defines an internal lumen through which fluid can flow to and from a lung or lung region. The diameter of the internal lumen for a specific bronchial passageway can vary based on the bronchial passageway's location in the bronchial tree (such as whether the bronchial passageway is a lobar bronchus or a segmental bronchus) and can also vary from patient to patient. However, the internal diameter of a bronchial passageway is generally in the range of 3 millimeters (mm) to 10 mm, although the internal diameter of a bronchial passageway can be outside of this range. For example, a bronchial passageway can have an internal diameter of well below 1 mm at locations deep within the lung. The internal diameter can also vary from inhalation to exhalation as the diameter increases during inhalation as the lungs expand, and decreases during exhalation as the lungs contract.
[0039] Exemplary Magnetic Treatment Systems and Methods
[0040] The present disclosure describes methods, kits, systems, and devices for treating a patient using magnetic fields. An implantable device 500 configured to be used in conjunction with a magnetic device 600 is implanted at a treatment location in a patient. The magnetic device 600 produces a magnetic field that influences the position of the implantable device 500 thereby influencing the position of the tissue at the treatment location.
[0041] FIG. 2 shows an anterior view of a pair of human lungs and a bronchial tree with multiple implantable devices 500 implanted in a lung region. It should be noted that although the embodiment as seen in FIG. 2 is exemplarily shown as comprising multiple implantable devices 500, it is contemplated that a single implantable device 500 may be used as well.
[0042] Implantable devices 500 are configured to be secured in the lung so as to remain in place during breathing. The exterior of an implantable device 500 may be configured along all or part of its exterior to aid in fixing the device in place. The fixation structure may comprise adhesives, tissue growth-inducing substances, struts, fasteners, staples, prongs, clips, sutures, stents, balloons, sleeves, sintered, etched, roughened, barbed or alternatively treated surfaces, etc.
[0043] Implantable devices 500 comprise a material configured to be influenced by a magnetic field. Implantable devices 500 may comprise ferromagnetic material such as iron, nickel, cobalt, rare earth metals, etc. In one embodiment the implantable devices 500 comprise a ferromagnetic alloy such as steel or cobalt-chromium. In one embodiment, the implantable 500 device may comprise a permanent magnet or an electromagnet.
[0044] In one embodiment, the implantable devices 500 are configured to be affected by a specific magnetic field while unaffected or minimally affected by other magnetic fields. In such an embodiment the implanted device 500 is configured to be influenced by the magnetic field of the magnetic device 600 but will not be influenced or be minimally influenced by other magnetic fields that may be present. For instance, the implantable devices 500 may be configured to allow a patient with the implantable devices 500 to use magnetic resonance imaging safely.
[0045] The implantable devices 500 as exemplarily shown in FIG. 2 comprise a tubular stent having struts to enhance fixation of the implantable devices 500 in a hollow body structure such as a bronchial passageway. Additionally or alternatively, the implantable devices 500 may comprise coils, rings, barbs, staples, prongs, valves, sleeves, or any other configuration allowing placement in a hollow body structure. In one embodiment the implantable device 500 is movable between collapsed and expanded orientations to enable easy delivery and deployment. That is, an implantable device 500 may be collapsed and held in a sheath for delivery through a relatively small space, for example, the working channel of a bronchoscope. (A typical bronchoscope has a diameter of about 6 or 7 mm, while the working channel has a diameter of about 2 or 3 mm.) All or part of the implantable device 500 may be formed of a self-expanding material with shape memory properties, e.g., nitinol. In this case the implantable device 500 immediately expands and engages the tissue upon retraction of sheath. Alternatively, the implantable device 500 could rely on a mechanism such as a balloon or heat activation to expand in use.
[0046] Implantable device 500 may comprise a flow control device such as a one-way valve configured to allow flow in the exhalation direction only. Additionally or alternatively, implantable device 500 may be used with a separate flow control device to aid in lung volume reduction.
[0047] The implantable device 500 is configured to be used in conjunction with one or more magnetic devices. The magnetic device 600 may be implantable or external. In an embodiment where the magnetic device 600 is external as seen in FIG. 3, the magnetic device 600 is configured to be worn, attached, strapped, or applied external to the patient. The magnetic device 600 may be attached to or comprise clothing. The magnetic device 600 may also be attached to or comprise a band wearable by the patient. In another embodiment the magnetic device 600 is a patch device. The magnetic device 600 is configured to be applied at a location such that its magnetic field influences the implantable device 500 at the treatment location.
[0048] As seen in the exemplary magnetic device shown in FIG. 3, the magnetic device 600 is a vest configured to influence implanted pulmonary devices 500. Alternatively, the magnetic device 600 could be attached or attachable to clothing or bands wearable by a patient. The magnetic device 600 comprises a magnetic unit 601, control unit 602, sensor 603, and networking unit 604. The magnetic unit 601 produces the magnetic field. In one embodiment, the magnetic unit 601 is configured to be positioned in close proximity to the implant site. In one embodiment the magnetic unit 601 can be moved to various locations on the magnetic device in order to optimize the influence of the magnetic field on the implantable device 500. In another embodiment the magnetic device comprises multiple magnetic units 601 wherein one or more of the magnetic units 601 are selected to be active based on their distance and/or orientation in relation to the implantable device 500.
[0049] The magnetic device 600 may be configured to produce magnetic fields of various shapes or orientations. The magnetic field generated by the magnetic device 600 can be two- dimensional or three-dimensional. Additionally, the magnetic device 600 may be configured to have multiple magnetic fields active at the same time. The multiple magnetic fields may have multiple orientations and/or strengths.
[0050] Control unit 602 is configured to control one or more treatment parameters associated with the produced magnetic field including but not limited to treatment time, magnetic field shapes, orientations, strength, and magnitude. In embodiment, the control unit 602 is configured to spatially adjust the produced magnetic field of specific depth and 3D orientation. Control unit 602 can also adjust the strength of the magnetic field. In one embodiment where multiple magnetic fields are produced, the control unit 602 can control each magnetic field independently. Alternatively or additionally, multiple control units 602 may be present wherein multiple magnetic fields are controlled by separate control units 602. In another embodiment where multiple magnetic units 601 are present, control unit 602 can control which magnetic units 601 are active. The control unit 602 is further configured to adjust orientation or strength of the produced magnetic field can be adjusted to have varying orientations and strengths. Control unit 602 may time the treatment period. Additionally, control unit 602 may vary characteristics of the magnetic fields based on time periods. In an embodiment the control unit 602 produces cyclic variations in the magnetic field.
[0051] In one embodiment, the control unit 602 comprises at least one processing unit (CPU) that is in communication with a memory unit via a bus. The memory unit may comprise an EEPROM, EPROM, RAM, ROM, and/or other storage means. The memory unit of the control unit 602 may be configured to store one or more treatment parameters or schedules. For example, a treatment parameter comprising with a pre-determined treatment time, magnetic field shapes, orientations, and/or magnitude to achieve the desired degree of lung volume reduction to achieve a specific degree of lung volume reduction may be stored in the memory unit of the control unit. Thereupon user selection or activation, the control unit 602 is configured to execute the treatment parameters to achieve the desired treatment result.
[0052] In one embodiment, the magnetic device 600 may comprise various sensors 603 configured to sense the implantable device 500, tissue function, and/or lung function.
Control unit 602 is configured to adjust the magnetic field based on the sensor 603 data. In an example, the control unit 602 can adjust the magnetic field based on sensed changes in the treatment area to provide a feedback mechanism.
[0053] Additionally or alternatively, the magnetic device 600 may comprise user controls that allow a user to adjust aspects of the magnetic field such as strength, orientation, or timing. Alternatively or additionally, the control unit 602 can be adjusted using a separate device such as a server, desktop computer, laptop computer, tablet computer, personal digital assistant (PDA), smart phone, mobile phone, medical device, or the like.
[0054] Magnetic device 600 may comprise a networking unit 604 configured to
communicate directly or indirectly with a computing device such as a server, desktop computer, laptop computer, tablet computer, personal digital assistant (PDA), smart phone, mobile phone, medical device, or the like. The networking unit 604 may directly or indirectly communicate with a wireless network such as through a base station, a router, switch, or other computing devices. In one embodiment, the networking unit 604 may be configured to utilize various communication protocols such as Global System for Mobile Communications (GSM), General Packet Radio Services (GPRS), Enhanced Data GSM Environment (EDGE), Code Division Multiple Access (CDMA), Wideband Code Division Multiple Access (WCDMA), Bluetooth, ZigBee, High Speed Packet Access (HSPA), Long Term Evolution (LTE), and Worldwide Interoperability for Microwave Access (WiMAX). The networking unit 604 may be further configured to utilize user datagram protocol (UDP), transport control protocol (TCP), Wi-Fi, satellite links and various other communication protocols, technologies, or methods. Additionally, the networking unit 604 may be connected to an electronic network without communicating through a wireless network. The networking unit 604 may be configured to utilize analog telephone lines (dial-up connection), digital lines (Tl, T2, T3, T4, or the like), Digital Subscriber lines (DSL), ethernet, or the like. It is further contemplated that the networking unit 604 may be connected directly to a computing device through a USB port, Bluetooth, ZigBee, infrared (IR), firewire port, thunderbolt port, ad-hoc wireless connection, or the like.
[0055] In an embodiment shown in FIG. 4, the magnetic device 700 may be implanted. Implantable magnetic devices 700 may comprise a magnetic unit, and optionally, a control unit, sensor, networking unit, or any other component found in an external magnetic device. Additionally, implantable magnetic devices 700 may be configured to perform any of the functions of an external magnetic device. The magnetic device 700 may be placed in the lung, an intercostal space, subdermally, or any other location near the implantable device 500. FIG. 4 shows an implantable magnetic device 700 in a bronchial passageway leading to the location of the implantable devices 500. In this embodiment, the implantable magnetic device 700 is configured to attract the implantable devices 500, thereby causing the target lung region to move toward the magnetic device 700 and volume reduction or collapse of the lung region.
[0056] In another embodiment, an external or implantable magnetic device 600 may be used in conjunction with an external or implantable control device configured to control the magnetic field of the magnetic device 600. The control device may comprise a control unit, sensor, or networking unit.
[0057] The magnetic treatment system can be used for lung volume reduction. Implantable devices 500 are implanted in a target lung region selected for lung volume reduction. The implantable devices 500 and the magnetic field of the magnetic device 600 can be oriented to repel the target lung region from the magnetic device 600 thereby preventing hyperinflation of the target lung region or collapsing the lung region. The implantable devices 500 and the magnetic field of the magnetic device 600 can alternatively be oriented to gradually attract the lung region toward the magnetic device 600 causing volume reduction or collapse of the lung region.
[0058] Embodiments of the magnetic treatment system may also be used for treating air- leaks. The implanted devices 500 could be placed in discrete lung regions identified to be involved in the leak. Air-leaks to diseased lung compartments can be detected, for example using the methods described in co-pending, commonly-owned U.S. patent application Ser. No. 11/296,591, filed on Dec. 7, 2005 (US 2006/0264772A1) and Ser. No. 11/550,660, filed on Oct. 18, 2006 (US 2007/0142742A1). The foregoing references are incorporated by reference in their entirety. The implantable devices 500 and the magnetic field of the magnetic device 600 could be oriented to attract the lung region towards the chest cavity allowing the visceral and parietal pleura to come in contact and enable healing.
[0059] Additionally, the treatment system can be used to assist in patient ventilation. The implanted devices 500 could be placed in the lung tissue or in the diaphragm. The control unit 602 could alternate the produced magnetic field to cause expansion and contraction of the lung or the diaphragm. This could also include feedback mechanisms to act like a pacemaker based on the patients respiratory rate, sleep patterns, and exercise.
[0060] While some of the above described embodiments involve the lung, the system may be used at other body locations. The magnetic device 600 and implantable devices 500 can also be used as a closure system for wound care. The magnetic field of the magnetic device 600 can interact with implanted devices 500 to apply tension or compression to the wound area to prevent bleeding, assist in healing, and reduce scarring.
[0061] The system can also be used for treating obesity. The implantable devices 500 could be placed in the stomach or outside the stomach. The magnetic field of the magnetic device 600 could be adjusted to create of a sense of satiety. This can be adjusted over time to slowly reduce the intake of food.
[0062] Additionally, the system can be used to treat urinary incontinence. The implanted devices 500 could be placed around the bladder. The control unit 602 could adjust the produced magnetic field to squeeze the bladder sphincter to prevent incontinence.
[0063] Present disclosure also provides one or more kits for use in practicing the one or more methods described herein, where the kits typically include one or more of implantable devices. Kits may also include one or more delivery catheters, loading devices, connectors, or the like. In one embodiment, one or more magnetic devices could also be included in the kit. In addition to above-mentioned components, the subject kits typically further include instructions for using the components of the kit to practice the subject methods. The instructions for practicing the subject methods are generally recorded on a suitable recording medium. For example, the instructions may be printed on a substrate, such as paper or plastic, etc. As such, the instructions may be present in the kits as a package insert, in the labeling of the container of the kit or components thereof (i.e., associated with the packaging or sub- packaging) etc. In other embodiments, the instructions are present as an electronic storage data file present on a suitable computer readable storage medium, e.g., CD-ROM, diskette, etc. In yet other embodiments, the actual instructions are not present in the kit, but means for obtaining the instructions from a remote source, e.g. via the internet, are provided. An example of this embodiment is a kit that includes a web address where the instructions can be viewed and/or from which the instructions can be downloaded. As with the instructions, this means for obtaining the instructions is recorded on a suitable substrate.
[0064] While the above is a complete description of various embodiments, any of a number of alternatives, modifications, and equivalents may be used in alternative embodiments. Therefore, the above description should not be taken as limiting the scope of the invention as it is defined by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A system for treating a lung of a patient comprising:
a magnetic device configured to produce a magnetic field; and an implantable pulmonary device comprising a material configured to be affected by the magnetic field, wherein the implantable pulmonary device is configured to be implantable in a lung region;
wherein the magnetic field of the magnetic device is configured to influence the position of the implantable pulmonary device in order to influence the position of the lung region.
2. The system of claim 1, wherein the magnetic device is configured to be wearable external to the patient's body.
3. The system of claim 1, wherein the magnetic device is configured to be implanted in the patient's body.
4. The system of claim 1, wherein the magnetic field of the magnetic device is three-dimensional.
5. The system of claim 1, wherein the magnetic device is configured to have multiple magnetic fields active at the same time.
6. The system of claim 1, wherein the magnetic device comprises a control unit configured to control the produced magnetic field.
7. The system of claim 6, wherein the control unit is configured to spatially adjust the produced magnetic field.
8. The system of claim 6, wherein the control unit is configured to adjust the strength of the produced magnetic field.
9. The system of claim 6, wherein the control unit is configured to adjust the orientation of the produced magnetic field.
10. The system of claim 6, wherein the control unit is configured to adjust the produced magnetic field to assist in ventilation.
11. A treatment system, comprising:
a magnetic device configured to be wearable external to a patient's body and produce a magnetic field, wherein the magnetic device comprises a control unit configured to control the produced magnetic field; and
an implantable device comprising a material configured to be affected by the magnetic field;
wherein the magnetic field of the magnetic device is configured to influence the position of the implantable device in order to influence the position of the tissue region.
12. The system of claim 11, wherein the magnetic device is configured to have multiple magnetic fields active at the same time.
13. The system of claim 11, wherein the control unit is configured to spatially adjust the produced magnetic field.
14. The system of claim 11 , wherein the control unit is configured to adjust the strength of the produced magnetic field.
15. The system of claim 11, wherein the control unit is configured to adjust the orientation of the produced magnetic field.
16. A method for treating a lung of a patient comprising:
implanting a pulmonary device in a lung region, wherein the implanted pulmonary device comprises a material configured to be affected by a magnetic field; and applying a magnetic device external to the patient's body, wherein the magnetic device is configured to produce the magnetic field;
wherein the produced magnetic field influences the position of the implanted pulmonary device thereby influencing the position of the lung region.
17. The method of claim 16, wherein the implanted pulmonary device and the magnetic field of the magnetic device are oriented to repel the lung region preventing hyperinflation of the lung region.
18. The method of claim 16, wherein the implanted pulmonary device and the magnetic field of the magnetic device are oriented to attract the lung region causing collapse of the lung region.
19. The method of claim 16, further comprising identifying the lung region as involving an air leak before implanting the pulmonary device;
wherein the implanted pulmonary device and the magnetic field of the magnetic device are oriented to attract the lung region towards the chest cavity allowing the visceral and parietal pleura to come in contact.
20. The method of claim 16, wherein the magnetic field of the magnetic device is configured to adjust to assist in ventilation.
PCT/US2014/023765 2013-03-15 2014-03-11 Systems and methods for treatment using magnetic fields WO2014150603A1 (en)

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