Frontal sinus dilation catheter

[0001] The field of the invention generally relates to balloon balloon devices. More specifically, the field of the invention relates to balloon balloon devices for the treatment of sinusitis.

Background of the Invention [0002] Sinusitis is a disease affecting over 35 million Americans and a similarly large population in other developed countries. Sinusitis occurs when one or more of the four pairs of paranasal sinuses (i.e., maxillary sinuses, ethmoid cells, frontal sinuses, and sphenoid sinuses) become blocked or otherwise have poor drainage. Usually, the sinuses, each of which is covered with a mucosa, produce mucus, which the moving cilia move from the sinus to the nasal cavity and further down the throat. Connected sinuses produce approximately a liter of mucus per day, so the efficient transport of said mucus is important for sinus health.

[0003] Each bay has a drainage channel or exit route to the nasal passage. This drainage channel may include an outlet, as well as a "transitional space" in the area of ​​the mouth, such as "frontal abduction" in the frontal sinus or "sieve funnel" in the maxillary sinus. When inflammation of the mucosa of one of the orifices or areas near the mouth occurs, the mucus outflow is interrupted, creating conditions for infection and / or sinusitis, i.e. sinusitis. Although many cases of sinusitis can be treated with appropriate medications, in some cases sinusitis lasts for months or longer, a condition called chronic sinusitis, and may not respond to medical therapy. Some patients are also prone to multiple episodes of sinusitis in a given period of time, a condition called recurrent sinusitis.

[0004] Ballooning is used to treat narrowed sinus channels in the treatment of sinusitis. Endoscopic catheterization (ballooning) devices usually include a filled balloon located at the distal end of the catheter, such as a balloon dilatation catheter. Usually, the inflated balloon is introduced into the narrowed sinus channel in an empty state. The balloon is then filled to open or reduce the degree of narrowing of the sinus canal being treated to allow better drainage and ventilation of the sinus. At the same time, most, if not all, of the functioning mucosa lining the sinuses and their drainage channels is preserved.

[0005] Exemplary devices and methods particularly adapted to dilate anatomical structures associated with maxillary sinuses and anterior ethmoidal cells are disclosed, for example, in US Patent No. 7,520,876 and US Patent Application No. 20080172033. Other systems for treating other sinus including frontal sinus. For example, US Patent Application No. 2008-0097295 discloses a guide catheter for a frontal sinus (Fig. 6B) and a method of treatment of frontal sinuses (e.g. Figures 8B-8C). US Patent Application Publication No. 2008-0125626 discloses another guiding device (e.g., Figures 10C and 10C ') for transnasal access to frontal sinuses for treatment.

[0006] Other known devices are disclosed in US2005075661 and in WO 2009065085.

Summary of the Invention

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[0007] In a first embodiment of the invention, the balloon dilatation catheter comprises a substantially rigid inner guide member and a movable shaft connected to a balloon that is slidably mounted on the substantially rigid inner guide member. For the treatment of the sinus drainage channel (e.g. frontal sinus) of the patient, using a dilating balloon catheter, a substantially rigid internal guiding element is introduced into the patient's drainage channel through the nasal passage. The stem and balloon are then introduced in a distant direction over the substantially rigid inner guide member to place the balloon in the drainage channel. This enables the balloon to be guided over the inner guide element. The balloon is filled to expand or otherwise remodel the drainage channel. When the sinus is a frontal sinus, the drainage channel is a frontal abduction.

[0008] In another aspect of the invention, the device for expanding the sinus outlet conduit comprises a substantially rigid internal guiding element having a proximal end and a distal end, and a shaft connected to a balloon, the shaft has a first lumen at least along its portion comprising a substantially rigid internal guide element, the shaft has a second lumen connected to the inside of the balloon. The handle is positioned along the proximal portion of the substantially rigid inner guide member, the handle comprising a movable slider operatively connected to the shaft, in which the slide slide outward extension of the slide and the balloon on the substantially rigid inner guide piece in the distance away.

Brief description of the figures [0009]

FIG. 1 illustrates a perspective view of a dilating balloon catheter in accordance with one embodiment.

FIG. 2A illustrates a side view of the dilating balloon catheter of FIG. 1. The ejection slide is illustrated in a retracted position, closer.

FIG. 2B illustrates a cross-sectional view through the dilating balloon catheter of FIG. 2A.

FIG. 3A illustrates a side view of the dilating balloon catheter of FIG. 1. The slide slide is illustrated in the extended position.

FIG. 3B illustrates a cross-sectional view through the dilating balloon catheter of FIG. 3A.

FIG. 4 is a cross-sectional view of the handle portion (dashed portion) of FIG. 3B.

FIG. 5A is a cross-sectional view through the dilating balloon catheter taken along the line AA 'of FIG. 2B.

FIG. 5B is a cross-sectional view through the dilating balloon catheter taken along the line BB 'of FIG. 4.

FIG. 6A is a side view of an inner guide element in accordance with one embodiment.

FIG. 6B is a side view of an inner guide element in accordance with another embodiment.

FIG. 6C is a side view of an inner guide element in accordance with another embodiment.

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FIG. 7 illustrates a perspective view of a dilating balloon catheter in accordance with another embodiment.

FIG. 8 illustrates a cross-sectional view of the patient's frontal sinus with an internal guiding element of the dilating balloon catheter inserted into the patient's frontal recess.

FIG. 9 illustrates a cross-sectional view of the patient's frontal sinus with an internal guiding element of the dilating balloon catheter located in the patient's frontal aperture. The guide wire is shown when the catheter is extended into the patient's frontal sinus.

FIG. 10 illustrates a cross-sectional view through the frontal sinus of a patient with a balloon (in an emptied state) and the stipe introduced into the patient's frontal recess.

FIG. 11 illustrates a cross-sectional view through the frontal sinus of a balloon patient of FIG. 10 when filled to expand and remodel frontal abnormalities.

FIG. 12 illustrates a cross-sectional view of the patient's frontal sinus after dilating the frontal sinus and removing the dilating balloon catheter.

Detailed Description of Illustrated Embodiments [0010] Fig. 1 illustrates one embodiment of a dilating balloon catheter 10 that is particularly suited to the treatment of the outlet duct (frontal sinus mouth and frontal cuff) of the patient's frontal sinus. The balloon dilatation catheter 10 includes a handle 12 that is adapted to be held or otherwise manipulated by an operator. The elongated inner guide element 14 extends longitudinally from the handle 12 in a distant direction. The inner guide element 14 is formed of a suitably rigid material such as a stainless steel tube. The inner guide member 14 protrudes or otherwise extends remotely from the handle 12 by a specified distance. The inner guide element 14 may be shaped such that its distal portion 16 is curved, as illustrated in Figures 1, 2A, 2B, 3A, 3B, 6A, 6B, 7, 8 and 9. For example, the shape and degree of curvature of the curved distal part 16 may be adapted to the frontal sinus outlet duct or frontal abduction.

[0011] Alternatively, the inner guide member 14 may have a degree of compliance so that the user can bend or give the distal end of the inner guide member 14 a certain desired shape or orientation. As explained in more detail here, the inner guide element 14 may include an optional lumen 18 (best seen in Fig. 5A) that extends to the length of the inner guide element 14. More specifically, the inner guide element 14 and the included lumen 18 may extend from the distal end 20 to the proximal end 21 (best seen in Figures 2B and 3B) which penetrates the sealing system with the connector 22 located at the proximal end 24 of the handle 12. Connector 22 may be equipped with a typical connection such as a Luer connector. Connector 22 may be used as an aspiration connector or delivery connector for fluids and / or drugs, or to insert a guide wire.

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[0012] Still with reference to Fig. 1, the stem 30 is attached around the inner circumference of the guide member 14. More specifically, the stem 30 has dimensions such that it slides on the inner guide member 14 in response to moving the slide slide 32 placed on the handle 12. The slide slide 32 can move within the gap 42 in the surface of the handle 12. The distal end 34 of stem 30 includes a balloon 36 that is adapted to selectively fill and empty as explained herein. In use, the inner guiding element 14 is manipulated and moved through or into the target anatomical space. The stem 30 as well as the attached balloon 36 are illustrated in Fig. 1 in an offset position. FIG. 1 illustrates the balloon 36 in a filled state for better visibility, however, when the stem 30 is in a proximal position, the balloon 36 is usually in an empty state, as illustrated in Figures 2A and 2B. When the inner guide element 14 is properly positioned, the user moves the slide slide 32, moving it in a distant direction, which in turn extends the stem 30 and balloon 36 in a distant direction over the previously positioned inner guide element 14. When the balloon 36 is properly positioned, the balloon is filled. The filling of the balloon 36 is performed using a filling device (not shown) which is connected to the connector 38 located at the proximal end 24 of the handle 12. One example of filling devices that can be used in connection with the balloon dilatation catheter 10 is described in US Patent Application No. 12 / 372,691. Of course, other filling devices may be used. The filling clearance 48 contained in the stem 30 (described in more detail below) fluidly connects the connector 38 to the inner portion of the balloon 36.

[0013] Still with reference to Fig. 1, an optional tube support 40 may be positioned around the outer periphery of the stem portion 30 to provide additional rigidity to the balloon catheter 10. The exact length of the support 40 may vary depending on the application and it may extend along part or all of the shank 30. The support element 40 may be made of a metal material such as a stainless steel tube that is attached to the stem 30. Generally, the support element 40 does not cover the helical portion (described in more detail below) of the stem 30 that is contained within the handle 12.

[0014] Figures 2A and 2B illustrate, respectively, side views and cross-section through the dilating balloon catheter 10 with the slide slide 32 and thus with the balloon 36, in a proximal position. In actual use, as explained, when the slide slide 32 is in the proximal position, the balloon 36 is usually in an empty state, as illustrated in Figures 2A and 2B. As best shown in Fig. 1, the eject slide 32 is slidably positioned along the length of the handle 12 inside the slot 42. The eject slide 32 is therefore capable of sliding forward and backward in the distancing / approaching direction along the length of the slot 42. The slot 42 may include a blockage or the like (not shown) ) to prevent the balloon 36 from extending too far along the inner length of the guide member 14. The length of the gap 42 may vary in different devices to adjust the length by which the balloon 36 can be extended. Generally, the gap 42 has a length in the range of about 25.4 mm (1 inch) to about 50.8 mm (2 inches), however other dimensions may be within the scope of the invention.

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[0015] As can be seen in Fig. 2B, the slide slide 32 can be connected directly to the support element 40 which is mounted on the stem 30. Alternatively, slide slide 32 can be connected to the stem 30. The slide slide 32 can be adapted or otherwise shaped to allow the user's finger (e.g., index finger or thumb) to be able to easily extend or retract the slider 32 along the slot 42 located in the handle 12.

[0016] Figures 3A and 3B illustrate, respectively, side views and cross-sections of the dilating balloon catheter 10 with the slide slide 32 and thus with the balloon 36, in a distant position. Thus, in contrast to the arrangement of Figures 2A and 2B, the eject slide 32 is located at or near the distal end 36 of the handle 12. The extension of the eject slide 32 also extends the stem 30 and the attached balloon 36 in the distal direction (arrow A in Fig. 3A) along the inner guide element 14. The balloon 36 is thus positioned at or near the distal end of the inner guide element 14. The dilating balloon catheter 10 can be designed such that the slide slide 32 can be positioned at a proximal or distal end, as illustrated in Figures 2A, 2B, 3A, 3B. Alternatively, the slide slide 32 may be positioned between two ends. For example, the optimal position of the balloon 36 can be achieved by extending the ejecting slide 32 by a certain fraction (e.g., ¾) of the entire length of the gap 42.

[0017] With reference to Figures 2B and 3B, the inner guide element 14 of the dilating balloon catheter 10 extends from a distal end 20 to the proximal end 21, which is terminated by a sealing surface with a connector 22 located at the proximal end 24 of the handle 12. The inner guide element 14 it optionally includes a lumen 18 located therein that can be used to provide a suction function by a suction device (not shown) connected to the connector 22. The suction function allows you to remove blood and other secretions. This makes it easier to visualize the position of the dilating balloon catheter 10. The inner guide member 14 is preferably rigid to allow placement of the dilating balloon catheter 10 without the need for a separate guide catheter or guide wire in most, and possibly all, cases.

[0018] The inner guide member 14 may have a length of about 7 inches to about 11 inches from the distal end 20 to the proximal end 21 when inserted into the handle 12, but other dimensions may be used. The inner guide member 14 may be formed of a stainless steel tube with an inner diameter ranging from about 0.5080 mm (0.020 inches) to about 1.270 mm (0.050 inches), and more preferably between about 0.9144 mm (0.036 inches) and 1 , 0160 mm (0.040 inches), and wall thicknesses ranging from about 0.1270 mm (0.005 inches) to about 0.5080 mm (0.020 inches), and more preferably from about 0.2032 mm (0.008 inches) to about 0, 3048 mm (0.012 inch). The bent distal portion 16 of the inner guide member 14 may be formed to the right of the distal end 20 and may have a radius of curvature from about 6.35 mm (0.25 inches) to about 38.1 mm (1.5 inches), and more preferably from about 19.05 mm (0.75 inches) to about 31.75 mm (1.25 inches).

[0019] The length of the inner guide member 14 that protrudes remotely from the furthest distant part of the balloon 36 is from about 12.7 mm (0.5 inches) to about 50.80 mm (2.0 inches), and more preferably from about 20 , 32 mm (0.8 inches) to about 30.48 mm (1.2 inches) when the balloon 36 is in the maximum retracted position (e.g., illustrated in Figures 2A and 2B). As seen in Figures 1, 2A, 2B,

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3A, 3B, 6A-6C, 7-11, the distal end 20 of the inner guide member 14 may include an optional bulged end 44, so that the distal end 20 is more traumatized. The bulged tip 44 further serves to limit the movement of the balloon 36 connected to the stem 30 when they are extended remotely. The outer diameter of the tip 44 is preferably between about 1 mm and about 3 mm.

[0020] The balloon 36 is attached to the stem 30 so as to form a flow seal between the two elements. The balloon 36 can be attached to the stem with a weld, glue and the like. Alternatively, the balloon 36 may be attached to the stem by a mechanical connection. Generally, any method known to those skilled in the art can be used to attach the balloon 36 to the stem 30. If the balloon 36 is attached directly to the stem 30, both structures are slidably mounted on the inner guide element 14. The balloon 36 usually has a cylindrical shape when filled. Although not limited to specific dimensions, the filled balloon 36 has a diameter in the range of about 3 mm to about 9 mm, and more preferably a diameter in the range of about 5 mm to 7 mm. The length of the balloon 36 may generally be in the range of about 10 mm to 25 mm, however other lengths may be used. Both stem 30 and balloon 36 are preferably formed of durable but flexible polymer materials such as polyamides (e.g., Nylon), PEBAX and the like. The balloon 36 can be "blow-molded" to a relatively thin wall thickness and able to withstand relatively high pressures from about 6 atmospheres to about 20 atmospheres of filling pressure. The balloon 36 is filled with a liquid, which is usually a liquid such as water or saline.

[0021] Referring to Fig. 4, an enlarged cross-sectional view of a part of the handle 12 is illustrated. At the proximal end 24 of the handle 12, connectors 22 and 38 are arranged. Connector 22 may be provided with a typical connection, such as a Luer connector or any other known connector specialists in the field. The connector 22 may be formed integrally with the handle 12 or, alternatively, the connector 22 may be a separate structure that is attached to the handle 12 during assembly. As can be seen in Fig. 4, the proximal end 21 of the inner guide member 14 forms a sealing system with the connector 22. As explained, the connector 22 may be used as an aspiration or delivery connector for fluids and / or drugs.

[0022] Fig. 4 also illustrates a connector 38 that can be made in the same or similar way as the connector 22 as described above. The connector 38 is in fluid communication with the fill gap 48 of the stem 30. Thus, the fill fluid from the filler device (not shown) has the ability to flow through the connector 38 into the fill clearance 48 of the stem 30. The connector 38 can be equipped with a typical connection such as a Luer connector . The fluid can then flow along the length of the stem 30 through the lumen 48, where the fluid enters the interior of the balloon 36. The filling fluid can therefore fill the balloon 36 by the action of the filling device.

[0023] As best seen in Fig. 4, part of the handle 12 includes a recessed area 50 that receives both the inner guide element 14 and the stem 30. In the recessed area 50 of the handle 12, the stem 30 is wound helically around the outer circumference of the inner guide element 14, forming the helical portion 52. The helical portion 52 allows distal extension and closer retraction of the stem 30 and the attached balloon 36 along the inner guide member 14, but still holds

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EP 2 437 843 B1 of the shaft 30, which is arranged close to the extension slide 32, has a spiral shape that wraps around the inner guide element 14 and is adapted to lengthen and shorten due to the movement of the slide slide 32 Fig. 4 illustrates the state of the helical portion 52 after the displacement of the slide slide 32. Thus, in the elongated state, the length of the helical portion 52 covers most, or possibly the entirety, of the recessed area 50. This can be compared to Fig. 2B, which illustrates the helical portion 52 shortened to the proximal portion of the recessed area 50 because the slide slide 32 is in a proximal position. Thus, the helical portion 52 is capable of lengthening and shortening in a spring-like manner in response to tensile or compressive loads. One or both of the inner guide member 14 and the helical portion 52 of the stem 30 may optionally be coated or coated with a slip coating to prevent unwanted seizing of contact surfaces and the like.

[0024] The helical portion 52 of the shank 30 may be formed by "wiping" the shank portion 30. Fig. 5A illustrates a cross-sectional view through the shank 30, the inner support guide 14, and the support member 40 along the line AA 'in Fig. 3B. As can be seen in Fig. 2B, this area is spaced relative to the position of the helical portion 52 of the shank 30. Referring to Fig. 5, the stem 30 includes an additional clearance 54, which is dimensioned so that its diameter is slightly larger than the outer diameter of the inner support guide 14. The additional clearance 54 therefore allows the stem 30 to be extended and retracted above the inner support guide 14 in a fitted connection. The outer diameter of the shank 30 may generally be in the range of from about 1.270 mm (0.050 inches) to about 2.794 mm (0.110 inches) or in the range of from about 1.7780 mm (0.070 inches) to about 2.5400 mm (0.100 inches). One or both of the outer surface of the inner guide member 14 and the inner surface of the additional lumen 54 may optionally be covered with a slip coating to reduce contact frictional forces. FIG. 5B illustrates a cross-sectional view through the inner support guide 14 and the helical portion 52 of the stem 30 along the line BB 'of Fig. 4. As can be seen in Fig. 5B, the stem portion 30 having an additional clearance 54 is worn. As a result, a single lumen (fill lumen 48) remains in the shank 30, which is wound in a spiral around the inner support guide 14.

[0025] Figures 6A-6C illustrate various embodiments of the inner guide member 14. The inner guide member 14 may have different shapes and settings depending on the particular application or patient. Different shapes of the inner guide element 14 can be factory-made in a specific shape and offered as a fully assembled, separate model or, alternatively, the inner guide element 14 can be changed or modular elements can be provided that can be inserted into the additional clearance 54 and inserted to connector 22 in a sealing system of the fitted type. In yet another alternative, the shapes could specify the desired shapes in which the flexible inner guide member 14 could be formed by the user to be better suited to the particular application or anatomy of the patient.

[0026] Fig. 6A illustrates an internal guiding element 14 that includes a curved distal portion 16 that ends in a straight segment 46. In the embodiment of Fig. 6A, the curvature in the curved distal portion 16 is pronounced and rounded in the shape of "U", through which the distant end turns back

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Retrograde. This embodiment may be useful for treating hard-to-reach outlets and other structures, e.g., maxillary solution or sieve funnel, if the nasal structure allows transnasal access. Although Fig. 6A illustrates U-shaped curvature, other degrees of curvature can be considered. Fig. 6B illustrates the inner guide member 14 in accordance with another embodiment. In this embodiment, the curved distal portion 16 also ends with a straight segment 46, however the radius of curvature is less pronounced. In this embodiment, the straight section 46 may have a length in the range of about 8 mm to about 10 mm, however other lengths may be used. This embodiment is believed to be particularly suited to most frontal cuff anatomy. Fig. 6C illustrates an embodiment in which the inner guide member 14 is substantially straight. The latter embodiment may be particularly adapted for the treatment of patient's sphenoid bones or frontal abduction with simple anatomy.

[0027] Fig. 7 illustrates a dilating balloon catheter 10 in accordance with another embodiment. In this embodiment, the tracking element 60 is positioned on the holder 12 of the balloon catheter 10. The tracking element 60 may include an antenna, transmitter, optical reflectors or the like which transmits a wireless signal which is then received and processed to determine orientation and / or position of dilating balloon catheter 10. In certain embodiments, more than one tracking element 60 may be positioned on the dilating balloon catheter 10. Data regarding the orientation and / or position of the dilating balloon catheter 10 may then be processed and displayed on the screen for viewing by a physician. For example, image-guided surgery is becoming more common, enabling doctors to see real or virtual images of a specific device inside a patient in real-time during surgery.

[0028] For example, US Patent Nos. 5,391 199 and 5,443,489 describe a system in which the coordinates of the probe inside the body are determined by means of one or more field sensors such as devices using a Hall effect, coils or antennas that are placed on the probe . U.S. Patent Application No. 2002-0065455 describes a system that is capable of generating a six-dimensional representation of the position and orientation of the catheter tip using a combination of sensor and radiation coils. U.S. Patent Application No. 2008-0269596 describes yet another monitoring system that is used particularly in orthopedic surgery. Commercial systems such as LANDMARX Element (Medtronic Xomed Products, Inc., Jacksonville, Florida) are available for use in conjunction with ENT treatments.

[0029] In the embodiment of Fig. 7, the tracking element 60 enables accurate tracking of the distal end of the dilating balloon catheter 10, so that an image of the distal portion of the dilating balloon catheter 10 can be superimposed on the imaging of the patient's anatomy. For example, a computed tomography (CT) scan may be used to generate an image of areas of interest to the patient's anatomy. Based on the position of the manipulator 60, the image guided surgery (IGS) may then superimpose the image of the dilating balloon catheter 10 on the image to allow the physician to better manipulate and orient the dilating balloon catheter 10.

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[0030] Other commercial systems may be used in conjunction with the balloon dilatation catheter 10 illustrated in Fig. 7. For example, INSTATRAK 3500 Plus - ENT from GE Healthcare, Chalfont St. Giles, United Kingdom can be integrated and / or used together with a balloon dilating catheter 10. The use of a TK guide to position the dilating balloon catheter 10 is advantageous because the device can be positioned by the operator with only one hand, watching the TK image generating link (e.g., a screen monitor) when manipulating the handle 12. Optionally, the dilating balloon catheter 10 can be pre-positioned placed using an endoscope or other visualization tool. For example, a conventional Hopkins endoscope (not shown) may be manipulated with a dilating balloon catheter to assist placement.

[0031] Figures 8-12 illustrate various cross-sectional views (sagittal plane) of the patient's frontal sinus during treatment with the dilating balloon catheter 10. Section views illustrate the nasal passage 100, frontal abduction 102 and frontal sinus 104. Referring to Fig. 8, balloon dilatation catheter 10 is introduced into the nasal passage 100 with the extension slide 32 in the retracted position (e.g., illustrated in Fig. 1, 2A, 2B), so that stem 30 and balloon 36 are also approaching retracted. Furthermore, the balloon 36 is in an empty state, as seen in Fig. 8. The curved portion 16 of the inner guide member 14 is then placed in the patient's frontal slant 102, as seen in Fig. 8. This position of the inner guiding element 14 can be achieved with endoscopic visualization using a conventional endoscope such as a Hopkins type endoscope which is positioned with the dilating balloon catheter 10. Alternatively, the inner guide member 14 may be positioned using IGS techniques that track the position of the dilating balloon catheter 10 with one or more tracking members 60, as illustrated, for example, in the embodiment of Fig. 7. For example, the inner guide element 14 can be extended thanks to the guidance from the CT display.

[0032] Referring to Fig. 9, confirmation of the appropriate position of the inner guide element 14 in the front slope 102 can be obtained by placing the fluoroscopy guide wire 64 through the lumen 18 of the inner guide 14. The guide wire 64 can be guided into the lumen 18 via connector 22. Fluoroscopic visualization shows the insertion of the guide wire 64 into the frontal sinus 104 when the inner guide element 14 is appropriately positioned in the frontal slit 102. If the guide wire 64 does not slide into the frontal sinus 104, the balloon dilatation catheter 10 is displaced and the confirmation attempt is then repeated . As an alternative to fluoroscopically visible guide wire 64, guide wire 64 could be a glowing guide wire such as disclosed in US Patent Application No. 2007-0249896. Of course, the guide wire 64 is optional, because the inner guide element 14 can be placed without its help or the need for it. Alternatively, the guide wire 64 could be placed in the frontal sinus at the beginning, prior to insertion of the dilating balloon catheter 10.

[0033] Referring to Fig. 10, when the curved portion 16 of the inner guide member 14 is appropriately positioned, the slide slide 32 is slide out in the distance away (arrow A

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(Fig. 3A), thereby inserting the stem 30 and the attached balloon 36 into the front cuff 102. This is illustrated in Fig. 10. After the balloon 36 is placed in the front cuff 102, the balloon 36 is filled as shown in Fig. 11. Filling is achieved by connecting a filling device (not shown) to connector 38. The filling device may include a syringe or the like that is pressed to force fluid into the filling lumen 48, which then flows into the balloon 36 to cause balloon 36 to expand as illustrated in Fig. 11. The pressures typically used to achieve expansion and change frontal creep 102 shapes range from about 3 atmospheres to about 12 atmospheres. The balloon 36 can be filled only once or, alternatively, the balloon 36 can be filled, emptied and refilled many times to achieve the desired degree of expansion. Each filling step can be carried out after placing the balloon 36 in a different position in the front slope 102.

[0034] After widening or changing the shape of the frontal cuff 102, the balloon 36 is emptied and removed as illustrated in Fig. 12. It is believed that the expanded frontal cusp 102 illustrated in Fig. 12 restores drainage and ventilation functions and the healthy state of the frontal sinus 104. Emptying the balloon 36 is achieved by reducing the fluid pressure inside the balloon 36. For example, the syringe plunger or the like is fluidly connected to the connector 38 can be retracted to remove fluid from inside the balloon 36. The dilating balloon catheter 10 can then be retracted from the nasal passage 100.

[0035] In some patients, treatment of one or both frontal sinuses 104 as described above may be appropriate. Other patients may need treatment for additional sinuses, in particular maxillary and / or anterior sieve cells. A combined treatment may be appropriate for these patients. The maxillary sinuses and / or anterior sieve cells can be treated with a system such as that described in US Patent No. 7,520,876 and US Patent Application No. 2008-0172033, commercially available as a FinESS system from Entellus Medical, Inc. in Maple Grove, Minnesota. Alternatively, other sinuses could be treated more conventionally using surgical techniques such as, for example, functional endoscopic sinus surgery (FESS). functional endoscopic sinus surgery).

[0036] With the embodiment of the balloon dilatation catheter 10 described above, the spheres of the sphenoid and / or maxillary sinus could also be dilated. The use of a dilating balloon catheter 10 is also contemplated, particularly the embodiment of Fig. 7 using the appropriate IGS device and having the appropriate shape of the internal support 14, preferably straight, as illustrated in Fig. 6C, to dilate the maxillary sinus outlet conduit through the supralithal. Suitable access devices are described in U.S. Patent Application No. 12/038 719 in parallel. This could be done without the use of additional endoscopic visualization, enabling treatment via a relatively small diameter sinus access pathway in the supralithal region. A small endoscope (not shown) could be used, if desired, through the lumen 18 of the internal support 14 to further assist visualization of the maxillary sinus outlet duct.

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[0037] Although embodiments of the present invention have been shown and described, various modifications can be made without departing from the scope of the present invention. The invention should therefore not be limited, except in the following claims.

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