Patent Application
20160317791
The present application is related to an application entitled “Sinus Treatment” to Gross et al., filed on even date herewith.
Applications of the present invention relate generally to treatment of sinus disorders, and specifically to methods and apparatus for opening a natural ostium of a sinus.
Sinusitis is a common condition, characterized by symptoms such as nasal discharge, facial and ear pressure and pain, headache, loss of smell, fever, cough and fatigue. Physiological clearing of paranasal sinuses is via mucociliary transport through the ostia (natural sinus openings into a nasal cavity). Disruption of this function, often associated with partial blockage of an ostium, allows stagnation of mucous secretions and alteration of pH and other physiologic parameters, making the sinus conditions more favorable to microbiological growth and, therefore, susceptible to sinusitis. Treatment of chronic sinusitis typically includes antibiotics, steroids, decongestants and, in some cases, surgical procedures such as lavage.
U.S. 2013/0030545 to Gross et al., which is incorporated herein by reference, describes paranasal sinus apparatus, including a hole-forming member configured to form a hole through a bone wall of a paranasal sinus of a subject. An implant is provided, having a proximal end and a distal end, and which is shaped to define a lumen. The implant is couplable to the hole-forming member, and is securable to the wall and extendable through the hole, such that the proximal end is disposed external to the paranasal sinus and the distal end is disposed within the paranasal sinus. The implant includes a biodegradable material.
Applications of the present invention include a method for opening a natural ostium of a maxillary sinus of a subject. A tube is inserted into the subject's nasal cavity, and is aligned with respect to the sinus such that an aperture in a wall of the tube is aligned generally opposite to the ostium. Subsequently, one or more seals are deployed near the aperture. For example, a first balloon may be inflated proximally to the aperture, and a second balloon may be inflated distally to the aperture. The deployment of the seals fluidly isolates the portion of the nasal cavity that is adjacent to the ostium. Subsequently, a stream of fluid is passed out of the aperture and into the fluidly isolated portion of the nasal cavity. The pressure of the fluid increases, until the ostium is opened.
There is therefore provided, in accordance with some applications of the present invention, apparatus for treating a maxillary sinus of a subject, the apparatus including;
a tube shaped to define a lumen thereof, a lateral wall of the tube at a distal portion of the tube being shaped to define an aperture;
a first radially-deployable seal, coupled to the tube proximally to the aperture; and
a second radially-deployable seal, coupled to the tube distally to the aperture,
In some applications, at least one of the first and second seals is an annular seal.
In some applications, both of the first and second seals are annular seals.
In some applications, at least one of the first and second seals includes a balloon.
In some applications, the first seal includes a first balloon and the second seal includes a second balloon.
In some applications, respective interiors of the first and second balloons are permanently in fluid communication with each other.
In some applications, at least one of the first and second seals includes a flap.
In some applications, the second seal includes a flap.
In some applications, the apparatus further includes an introducer sheath shaped to cover the flap, and the flap is configured to be radially deployed by uncovering the flap by withdrawing the introducer sheath.
In some applications, an outside diameter of the first seal is 3-10 mm, upon the first seal being maximally radially deployed.
In some applications, an outside diameter of the second seal is 3-10 mm, upon the second seal being maximally radially deployed.
In some applications, an outside diameter of the first seal is at least 10% larger than an outside diameter of the second seal, upon the first and second seals being maximally radially deployed.
In some applications, the outside diameter of the first seal is less than 100% larger than the outside diameter of the second seal, upon the first and second seals being maximally radially deployed.
In some applications, the apparatus further includes a deflector disposed within the lumen of the tube, the deflector being shaped to deflect out of the aperture a wire that is advanced distally within the lumen of the hollow tube.
In some applications, the deflector includes an appendage extending from an inside wall of the tube.
In some applications, the deflector includes a curved channel.
In some applications, the apparatus further includes an imaging device coupled to the distal portion of the tube.
In some applications, at least a portion of the tube is transparent.
In some applications, a distance between the first and second seals, upon the first and second seals being maximally radially deployed, is 10-30 mm.
In some applications, a diameter of the aperture is 1-5 mm.
In some applications, a length of the tube is 2-30 cm.
In some applications, an outer diameter of the tube is 2-6 mm.
In some applications, the tube is placeable over a distal end of an endoscope.
In some applications, the apparatus further includes the endoscope.
There is further provided, in accordance with some applications of the present invention, a method for treating a natural ostium of a maxillary sinus of a subject, the method including:
opening the ostium, by pumping fluid into a nasal cavity of the subject such that the pumped fluid is in direct contact with the nasal cavity and reaches a maximum pressure; and
subsequently, rinsing the sinus, by pumping rinsing fluid into the sinus at a pressure that is less than the maximum pressure.
In some applications, rinsing the sinus includes using a syringe to alternatingly (i) pump the rinsing fluid into the sinus, and (ii) not pump any fluid into the sinus.
In some applications, using the syringe includes using the syringe to alternatingly (i) pump the rinsing fluid into the sinus, and (ii) draw fluid from the sinus.
In some applications,
the syringe includes a first channel and a second channel,
pumping the rinsing fluid into the sinus includes pumping the rinsing fluid into the sinus through the first channel, and
drawing fluid from the sinus includes drawing fluid from the sinus through the second channel.
In some applications, the method further includes forming an artificial hole in a bone wall of the sinus, and rinsing the sinus includes causing the rinsing fluid to pass out of the sinus through the artificial hole.
There is further provided, in accordance with some applications of the present invention, a method for treating a natural ostium of a maxillary sinus of a subject, the method including;
inserting a tube into a nasal cavity of the subject, a wall of the tube at a distal portion of the tube being shaped to define an aperture;
subsequently, moving the tube such that the aperture is aligned generally opposite to the ostium;
subsequently, fluidly isolating a portion of the nasal cavity that is adjacent to the ostium from (a) a lung of the subject, and (b) an outer opening of a nostril of the subject, by deploying one or more seals near the aperture; and
subsequently, opening the ostium, by passing a stream of fluid out of the aperture and into the fluidly-isolated portion of the nasal cavity.
In some applications, the method further includes, before inserting the tube:
performing a computed tomography (CT) scan on the subject;
in response to anatomical detail shown in the CT scan, identifying a desired property of one or more of the seals; and
causing the seals to be manufactured such that the seals have the desired property.
In some applications, the desired property is selected from the group consisting of: a shape, and a diameter, the method including identifying the desired property.
In some applications, the method further includes, before inserting the tube:
performing a computed tomography (CT) scan on the subject; and
in response to anatomical detail shown in the CT scan, selecting one or more of the seals from a plurality of seals that differ from each other in a particular property.
In some applications, the particular property is selected from the group consisting of: a shape, and a diameter, the method including selecting one or more of the seals from a plurality of seals that differ from each other in the selected property.
In some applications, moving the tube such that the aperture is aligned generally opposite to the ostium includes aligning the aperture with respect to the ostium by using an imaging device disposed within the nasal cavity of the subject.
In some applications, moving the tube such that the aperture is aligned generally opposite to the ostium includes aligning the aperture with respect to the ostium by (i) passing a guidewire out of the aperture, and (ii) probing tissue of the nasal cavity with the guidewire.
In some applications, deploying the one or more seals includes deploying one or more annular seals.
In some applications, passing the stream of fluid includes passing a stream of saline.
In some applications, the method further includes:
using an imaging device to view the ostium while passing the stream of fluid out of the aperture; and
stopping to pass the stream of fluid, upon viewing, using the imaging device, that the ostium has been opened.
In some applications, the method further includes, before inserting the tube into the nasal cavity of the subject, forming an artificial hole in a bone wall of the sinus.
In some applications, the method further includes stopping to pass the stream of fluid in response to fluid exiting a nose of the subject.
In some applications, at least one of the seals includes a balloon, and deploying the seals includes inflating the balloon.
In some applications, deploying the one or more seals includes radially deploying (a) a first seal, coupled to the tube proximally to the aperture, and (b) a second seal, coupled to the tube distally to the aperture.
In some applications, radially deploying the first and second seals includes radially deploying the first and second seals by passing the stream of fluid out of the aperture.
In some applications,
the first seal includes a first flap,
the second seal includes a second flap, and
radially deploying the first and second seals includes radially deploying the first and second flaps by causing the fluid to apply a force to the first and second flaps.
In some applications,
the first seal includes a first balloon,
the second seal includes a second balloon, and
radially deploying the seals includes inflating the first and second balloons.
In some applications, inflating the first and second balloons includes (a) inflating the first balloon to a first diameter, and (b) inflating the second balloon to a second diameter that is less than the first diameter.
In some applications, inflating the first and second balloons includes (a) inflating the first balloon to a first pressure, and (b) inflating the second balloon to a second pressure that is less than the first pressure.
In some applications, inflating the first and second balloons includes inflating the first and second balloons to a single pressure.
In some applications, inflating the first and second balloons includes:
using a syringe that includes a pressure sensor to inflate the first and second balloons; and
inflating the first and second balloons until the pressure sensor detects that respective internal pressures of the first and second balloons have reached respective thresholds.
In some applications, the syringe is configured to automatically stop inflating the first and second balloons in response to the respective internal pressures reaching the respective thresholds, the method including using the syringe to inflate the first and second balloons.
In some applications, the respective thresholds are different from one another, the method including inflating the first and second balloons until the pressure sensor detects that the respective internal pressures have reached the respective thresholds.
In some applications, the respective thresholds are equal to one another, the method including inflating the first and second balloons until the pressure sensor detects that the respective infernal pressures have reached the respective thresholds.
In some applications, at least one of the seals includes a flap, and deploying the seals includes radially deploying the flap by uncovering the flap.
In some applications, the method further includes, following the opening of the ostium, passing a tool through the tube and into the ostium.
In some applications, the tool includes a guidewire, the method including passing the guidewire into the ostium.
In some applications, the fool includes a balloon, the method further including inflating the balloon within the ostium.
In some applications, the tool includes a rinsing tube, the method further including using the rinsing tube to rinse the sinus.
In some applications,
the rinsing tube is shaped to define a first tube lumen and a second, tube lumen,
using the rinsing tube to rinse the sinus includes passing fluid through the first tube rumen, and
the method further includes draining the sinus through the second tube lumen.
In some applications, the tool includes an imaging device, the method further including using the imaging device to image an interior of the sinus.
In some applications,
inserting the tube includes inserting the tube while the tube surrounds a distal end of an endoscope, and
moving the tube includes moving the tube while the tube surrounds the distal end of the endoscope.
In some applications, the method further includes, before opening the ostium, withdrawing the endoscope without withdrawing the tube.
There is further provided, in accordance with some applications of the present invention, apparatus for treating a maxillary sinus of a subject, the apparatus including:
a tube shaped to define a lumen thereof, a lateral wall of the tube at a distal portion of the tube being shaped to define an aperture; and
exactly one balloon coupled to the tube, the balloon being configured to, when inflated inside a nasal cavity of the subject, generally prevent flow of fluid that passes out of the aperture from a portion of the nasal cavity that is adjacent to the ostium (a) to a lung of the subject, and (b) to an outer opening of a nostril of the subject.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is made to
Reference is now made to
Apparatus 20 comprises tube 22, shaped to define a lumen 24 thereof. A lateral wall 26 of tube 22 at a distal portion of the tube is shaped to define an aperture 28, which, in some applications, has a diameter DA of 1-5 mm. (In other applications, diameter DA is less than 1 mm or greater than 5 mm. In yet other applications, aperture 28 is not circular, but is instead of a different shape, e.g., aperture 28 may be a horizontal or vertical slit.) Apparatus 20 further comprises a first radially-deployable seal 30a, coupled to the tube proximally to aperture 26, and a second radially-deployable seal 30b, coupled to the tube distally to the aperture. As described hereinabove with reference to
Typically, at least one of the first and second seals is an annular seal, e.g., both of the seals may be annular seals. In some applications, at least one of the first and second seals comprises a balloon. For example, as shown in
Typically, the balloons are inflated with a fluid (i.e., a gas, such as air, and/or a liquid, such as saline), e.g., using a syringe 60. In some applications, the syringe includes a pressure sensor (e.g., a mechanical pressure gauge 62), and the first and second balloons are inflated until the pressure sensor detects that respective internal pressures of the first and second balloons have reached respective thresholds. (As described hereinabove, the respective thresholds may be different from one another, or alternatively, equal to one another.) In some applications, the syringe automatically stops inflating the first and second balloons in response to the respective internal pressures reaching the respective thresholds.
In some applications, the first and second seals are deployed to their maximum deployment diameters ODa and ODb. In other applications, at least one of the seals is not deployed to its maximum deployment diameter. In any case, upon being deployed, the outside diameter of the first seal is typically larger (e.g., 10%-100% larger) than that of the second seal, since, as noted above, the inner diameter of the nasal cavity is typically greater proximally to the ostium than distally to the ostium. In other words, typically, the first balloon is inflated to a first diameter (e.g., ODa), and the second balloon is inflated to a second diameter (e.g., ODb) that is less than the first diameter. Typically, apparatus 20 does not comprise circuitry to inflate the balloons repeatedly in alternation.
Typically, the distance D0 between the first and second seals, upon the first and second seals being maximally radially deployed, is at least 10 mm and/or less than 30 mm. D0 is typically fixed for a given tube, i.e., it cannot be changed without disassembling the device. D0 is large enough such that the seals do not prevent the fluid from being passed out of the aperture, yet D0 is also small enough such that the ostium may be opened quickly and efficiently, i.e., only a relatively small amount of fluid needs to be passed out of the tube before the ostium is opened, since the size of fluidly-isolated portion 59 is not too large.
In some applications, as shown in
In some applications, apparatus 20 further comprises an imaging device 44 (e.g., a camera or fiber-optic array) coupled to the distal portion of the tube. Imaging device 44 facilitates the advancement of the tube inside the nasal cavity, by providing images of the nasal cavity as the tube is advanced. To facilitate the imaging, at least a portion of the tube (e.g., the distal wall 46 of the tube) may be transparent. The images may be transmitted wirelessly, or via a wire 64, as shown in
In some applications, as shown in
Reference is now made to
Reference is now made to
Reference is now made to
In some applications, a fluid-delivery system 68 of the endoscope is used to deliver the fluid to the aperture. As shown in
Reference is now made to
The scope of the present invention includes various methods of verifying that the ostium has been opened. For example, an imaging device, such as imaging device 44 (
In some applications, the sinus is rinsed following the opening of the ostium. Typically, a syringe or electromechanical pump is used to rinse the sinus. In some applications, the syringe or pump is used to alternatingly (i) pump rinsing fluid into the sinus, and (ii) not pump any fluid into the sinus. For example, the syringe or pump may be used to alternatingly (i) pump rinsing fluid into the sinus, and (ii) draw fluid from the sinus. In some applications, the syringe includes a first channel, through which the rinsing fluid is pumped, and a second channel, through which the fluid is released.
Reference is again made to
Reference is now made to
Reference is now made to
The scope of the present invention includes any appropriate shape for balloon 31, in addition to the shape shown in
In some applications, a preoperative computed tomography (CT) scan is performed on the subject. In response to anatomical detail shown in the scan, the physician identifies a desired property (e.g., a diameter and/or shape) of one or more of the seals. The physician then selects the seals from a plurality of seals that differ from each other in the particular property. For example, the physician may choose a seal having a particular diameter from a plurality of seals having different respective diameters. Alternatively or additionally, the physician may cause the seals to be manufactured such that the seals have the desired property. Choosing and/or manufacturing the seals in response to the CT scan increases the likelihood that the seals will properly seal the nasal cavity at the desired sites. For example, the diameters and/or shapes of the first and second balloons (
The preoperative scan may also help the physician to properly align the tube during the procedure. For example, the desired insertion depth of the tube may be determined by viewing the preoperative scan. Alternatively or additionally, if the first (proximal) balloon does not inflate to the expected volume, the physician may conclude that the tube has been advanced too far, such that the first balloon is disposed distally to the ostium, where the nasal cavity is narrower. Alternatively or additionally, the alignment of the tube may be facilitated by using an imaging device disposed within the nasal cavity (e.g., imaging device 44, shown, for example, in
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
