Devices and methods for treating a lung
11103678 · 2021-08-31
Assignee
Inventors
- Paul Smith (Smithfield, RI, US)
- Robert B. DEVRIES (Northborough, MA, US)
- Jason Weiner (Grafton, MA, US)
- Man Minh Nguyen (Harvard, MA, US)
- Gary J. Leanna (Holden, MA, US)
- Kevin John WILCOX (Brighton, MA, US)
- Javier Palomar-Moreno (Galway, IE)
- Fergal Horgan (County Mayo, IE)
- MARTYN G. FOLAN (Loughrea, IE)
- Patricia Kelly (Galway, IE)
- Michael G. Hayes (Galway, IE)
- Sean P. Fleury (Minneapolis, MN, US)
Cpc classification
A61K31/56
HUMAN NECESSITIES
A61M25/007
HUMAN NECESSITIES
International classification
A61K31/56
HUMAN NECESSITIES
A61B17/12
HUMAN NECESSITIES
Abstract
Methods and devices for treating a lung are disclosed. The method may include deploying a catheter into an airway of the lung, and discharging a media into the airway through the catheter. The media may be configured to increase elasticity of lung tissue in the vicinity of the airway or occlude the airway.
Claims
1. A method of treating a lung, comprising: deploying a catheter into an airway of the lung; and discharging a media into the airway through the catheter, the media being configured to expand in the airway and occlude the airway after being discharged from the catheter, wherein the media includes a thermoplastic shell enclosing an expandable material; wherein the shell remains substantially intact after expansion of the media; wherein the shell increases in temperature and softens when discharged into the airway; wherein the shell expands via a force applied by the expandable material after softening; wherein the expandable material is a liquid hydrocarbon, and after discharge of the media into the airway, the liquid hydrocarbon within each shell increases a pressure within the shell.
2. The method of claim 1, wherein the media includes a drug, and the method further includes releasing the drug into the airway from the media after the discharging.
3. The method of claim 2, wherein the drug includes an antimicrobial agent, an analgesic, and/or an anesthetic.
4. The method of claim 1, wherein occluding the airway causes diseased tissue of the airway to necrose.
5. The method of claim 4, wherein an ability of remaining tissue of the lung to expand increases after necrosis of the diseased tissue of the airway.
6. The method of claim 1, wherein an outer surface of the shell includes one or more surface modifications.
7. The method of claim 6, wherein the one or more surface modifications of a plurality of media are configured to interlock with one another.
8. The method of claim 7, wherein the one or more surface modifications are configured to anchor an outer surface of the shell to tissue defining the airway.
9. The method of claim 6, wherein the one or more surface modifications on the outer surface transition from a non-anchoring position to an anchoring position only after deployment of the media into the airway.
10. The method of claim 9, wherein the one or more surface modifications include a barb that transitions after coming into contact with humidity in the airway.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The drawings illustrate the design and utility of exemplary embodiments of the present disclosure, in which similar elements are referred to by common reference numerals. In order to better appreciate how the above-disclosed and other advantages and objects of the present disclosure are obtained, a more detailed description of the present embodiments will be rendered by reference to the accompanying drawings. Understanding that these drawings depict only exemplary embodiments of the disclosure and are not therefore to be considered limiting in scope, the disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
(12) The present disclosure is drawn to devices and methods for the treatment of diseased tissue. Such diseased tissue may suffer from COPD and/or other lung conditions, such as asthma. Exemplary embodiments are drawn to devices and methods for the treatment of diseased tissue in the lungs. In some embodiments, the treatment may include repairing or rejuvenating the diseased tissue to improve overall lung function. In other embodiments, the treatment may include occluding (or blocking) one or more airways of the lungs to prevent inhaled air from reaching diseased tissue. As inhaled air is no longer directed to the diseased tissue, the remaining healthy tissues receive more air, and lung function improves. While the principles of the present disclosure are described with reference to treatments for the lungs of a patient, it should be understood that the disclosure is not limited thereto. Rather, the devices and methods may find applicability for the treatment of any luminal tissue structure.
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(14) In some embodiments, the sheath 30 may include a retention member such as, for example, balloon 32, configured to transition between an uninflated (or deflated) configuration (not shown), and an inflated configuration (as shown in
(15) An exemplary medical tool may be introduced into the airway 28 through the sheath 30. In some embodiments, the medical tool may include a steerable catheter 40. The catheter 40 may extend from a proximal end 44, positioned external to the airway 28, to a distal end 46 that extends out of the sheath 30. The distal end 46 of the catheter 40 may be positioned proximate the desired treatment site (for example, diseased tissue) in the airway 28. The catheter 40 may also include one or more radiopaque markers 52 to assist in suitably positioning the catheter 40 in the airway 28. The catheter 40 may be configured to direct an injectable media 48 into the airway 28 through its distal end 46. The proximal end 44 of the catheter 40 may include one or more steering dials (or other mechanisms) configured to articulate (or turn) the distal end 46 of the catheter 40 in different directions. This steering capability enables the catheter 40 to release the media 48 in any desired direction (for example, towards a bronchiole 20 leading to diseased alveoli 22 (see
(16) The distal end 46 of the catheter 40 may include one or more orifice(s) 50 adapted to discharge the media 48 into the airway 28. In general, the orifice(s) 50 may be of any size and shape, and arranged in any pattern. In some embodiments, as illustrated in
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(18) The injectable media 48 may be delivered to the distal end 46 of the catheter (40, 140, 240) from its proximal end 44.
(19) Media 48 may be discharged into the airway 28 continuously or in batches. That is, in some embodiments, the catheter 40 may deliver a first batch of media 48 at a first time and a second batch at a second time after the first time. Each batch may include any suitable amount (number, volume, etc.) of media 48. In some embodiments, a pressurized fluid may assist in pushing the media 48 out of the catheter 40. In such embodiments, the media 48 may be released into the airway 28 along with the pressurized fluid. In such embodiments, the catheter 40 may be coupled to a pressurized fluid source (not shown).
(20) In addition to, or in place of injector 58, in some embodiments, the proximal end 44 of the catheter 40 may be fluidly coupled to a pump that is programmed to discharge a desired quantity of the media 48 through the catheter 40. For instance, the user may activate the pump to discharge a desired quantity of the media at the desired site. Although
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(22) To form a desired pattern of the media on the airway wall at the desired site, the catheter 340 (and tip 56) may be moved as the media 48 is released. For instance, to deposit the media 48 along a straight line, the catheter 340 may be advanced into, or retracted from, the airway 28 as the media 48 is released. To deposit the media 48 as an annular ring on the airway wall, the catheter 340 may be rotated as the media 48 is discharged. In some embodiments, the catheter 340 may be rotated and translated (advanced and/or retracted) as the media 48 is being discharged. In such embodiments, the discharged media 48 may form a helicoidal coating or pattern on the airway wall. In some embodiments, the catheter 340 may be moved (rotation, translation, etc.) manually by the user as the media 48 is released. In other embodiments, a mechanism may assist in moving the catheter 340 as the media 48 is discharged. Any suitable mechanism may be used to move the catheter 340. In some embodiments, as illustrated in
(23) Any suitable injectable media 48 may be delivered to the airway 28 using the catheter (40, 140, 240, 340). In some embodiments, media 48 may be a drug suspension mixed with a biodegradable polymer having a low glass transition temperature (T.sub.g), such as for example about 45° C. In an exemplary embodiment, media 48 (in the form of a drug suspension in a biodegradable polymer) may be heated and maintained in a semi-fluid (or gel) state in the injector 58 of
(24) Any drug, without limitation, may be mixed with the biodegradable polymer to form the media 48. In some embodiments, the drug may include long acting corticosteroids, glucocorticoids, long acting beta2-adrenergic (LABA) receptor argonists, and combinations thereof. Exemplary drugs that may be present in some embodiments of media 48 may include hydrocortisones (such as, for example, hydrocortisone, hydrocortisone acetate, cortisone acetate, tixocortol pivalate, prednisolone, methylprednisolone, and prednisone), acetonides (such as, for example, triamcinolone acetonide, triamcinolone alcohol, mometasone, amcinonide, budesonide, desonide, flucocinonide, fluocinolone acetonide, and halcinonide), betamethasones (such as, for example, betamethasone, betamethasone sodium phosphate, dexamethasone, dexamethasone sodium phosphate, and fluocortolone), halogenated drugs (such as, for example, hydrocortisone-17-valerate, aclometasone dipropionate, betamethasone valerate, betamethasone dipropionate, predenicarbate, clobetasone-17-butyrate, clobetasol-17-propionate, flucortolone caproate, flucorortolone pivalate, and flupredenidene acetate), labile producing esters (such as, for example, hydrocortisone-17-butyrate, 17-aceponate, 17-buteprate, and prednicarbate), steroids (such as, for example, flunisolide, fluticasone propionate, triamcinolone acetonide, beclomethasone dipropionate, budesonide), and other drugs (such as, for example ciclesonide, salmeterol, formoterol, bambuterol, clenbuterol, etc.).
(25) Depositing a helicoidal pattern of media 48 on airway walls may have advantages. The tissue of the airway walls is composed of mucus-producing goblet cells and a ciliated epithelium (cells with hair like protrusions or cilia protruding into the airway 28). The cilia continually flex (or beat) and push mucus up and out of the airway 28 into the throat. This upward movement of mucus on the airway walls, called the mucociliary escalator, is a major barrier against infection. Microorganisms that enter the respiratory tract are caught in the sticky mucus and moved up by the mucociliary escalator. When the solidified media 48 in the airway wall contacts the mucus, the solidified polymer undergoes hydrolysis and releases the drugs mixed in the polymer. Depositing a helicoidal pattern of the media 48 on the airway wall may provide the required treatment for the wall tissue without blocking the mucociliary escalator.
(26) In some embodiments, the injectable media 48 may be a pulmonary surfactant. Pulmonary surfactant is a compound that is naturally produced in the lungs, and is critical for proper respiratory function. Surfactants are a complex mixture of phospholipids and proteins. Surfactant reduces surface tension in the lung (which is necessary to prevent the collapse of the alveoli and other airways 28) and reduces the effort needed to expand the lungs during inhalation. The absence of sufficient surfactant leads to collapse of airways 28 and compromised pulmonary function. Exogenous replacement surfactants possess the properties needed to lower the surface tension in the lungs. In some embodiments of the current disclosure, a surfactant may be injected into, or on, airway 28 tissue to rejuvenate diseased tissue in the airway 28. The injected surfactant may help the airway 28 maintain its shape and reduce surface tension, and improve (or restore) its elasticity. Improving the elasticity of the airway may enable the airway to elastically recoil during exhalation.
(27) In some embodiments, the injectable media 48 may include air or another fluid. In such embodiments, air or another fluid may be injected on an airway 28 (such as the alveoli 22) to chemically wash the airway 28. This chemical washing may smooth muscle tone of the tissue in the airway, and restore at least some elasticity of the tissue. Improving the elasticity of the diseased tissue may restore some function to the airway 28. It is also contemplated that, in some embodiments, a drug or a chemical may be injected into the airway 28 to flush and thereby unclog an airway 28. Any chemical suitable for unclogging the airway 28 may be injected into the airway 28 for this purpose. Although the air and the chemicals may be discharged into the airway 28 by using any of the devices discussed with reference to
(28) In some embodiments, the injectable media 48 may be a polymer, an oil, or a gel. In such embodiments, the injectable media 48 may be discharged proximate diseased tissue in the airway 28, or injected (for example, by using needle 54 of
(29) In some embodiments, media 48 in the form of a polymer, oil, or gel may also be used to necrose diseased tissue in an airway 28. For instance, an increased amount of the media 48 may be delivered to an airway 28 (such as a bronchi 18 or bronchioles 20) to occlude the airway 28 and cause diseased airway tissue (for example, in an associated alveoli 22) to necrose. By removing poorly functioning tissue, the remaining lung tissue may work more efficiently and improve overall pulmonary function.
(30) In some embodiments, as illustrated in
(31) In some embodiments, the fillers (media 48) may be configured to expand (such as, for example, radially outward) or swell when deployed in the airway 28 (for example, when the fillers come into contact with humidity in the airway 28). In such embodiments, a relatively small-sized filler discharged at a site (for example, a bronchiole 20) may travel downstream and gradually expand to fill an airway 28 (for example, an alveoli 22) downstream of the discharge site. In some embodiments, the media 48 may include expandable microspheres comprising a thermoplastic shell encapsulating a low boiling point liquid hydrocarbon. When the temperature of the microsphere reaches a threshold value, the thermoplastic shell softens. The increasing pressure of the hydrocarbon within the microsphere will then cause the microsphere to expand in volume. In some embodiments, the microsphere dissolves to expose a constrained (unexpanded) state of another material. This material may expand then expand to fill the airway 28. In some embodiments, as illustrated in
(32) Any of the devices discussed with reference to
(33) In some embodiments, an entire portion of an airway may be occluded using media 48. In other embodiments, only a discrete portion of the airway 28 may be occluded. In such embodiments, a space in front of the occluded portion (or beside the occluded portion) may be left open. In some embodiments, instead of occluding an entire area, the media 48 may be used to reduce a cross-sectional area of an airway 28. In some embodiments, air in an airway 28 may be removed prior to being occluded by injecting media 48.
(34) In some embodiments, instead of directly discharging the media 48 into an airway 28, an occluder filled with a suitable media 48 may be positioned in the airway 28 to occlude the airway 28.
(35) Although the exemplary embodiments described above have been disclosed in connection with devices for manipulating lung airways, those skilled in the art will understand that the principles set out above can be applied to any bronchial device and can be implemented in different ways without departing from the scope of the disclosure as defined by the claims. In particular, constructional details, including manufacturing techniques and materials, are well within the understanding of those of skill in the art and have not been set out in any detail here. These and other modifications and variations are well within the scope of the present disclosure and can be envisioned and implemented by those of skill in the art.
(36) Moreover, while specific exemplary embodiments may have been illustrated and described herein, it should be appreciated that combinations of the above embodiments are within the scope of the disclosure. Other exemplary embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the exemplary embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, and departures in form and detail may be made without departing from the scope and spirit of the present disclosure as defined by the following claims.