Patent Application
20110004057
The present invention relates generally to medical devices and methods and particularly to balloon catheters and other devices that may be inserted through the nose and used to dilate the ostia of paranasal sinuses for treatment of sinusitis.
The paranasal sinuses are hollow cavities in the skull connected by small openings, known as ostia, to the nasal canal. Each ostium between a paranasal sinus and the nasal cavity is formed by bone covered by a layer of mucosal tissue. Normally, air passes into and out of the paranasal sinuses through the ostia. Also, mucus is continually formed by the mucosal lining of the sinuses and drains through the ostia and into the nasal canal.
Sinusitis is a general term that refers to inflammation in one or more of the paranasal sinuses. Acute sinusitis can be associated with upper respiratory infections or allergic conditions, which may cause tissue swelling and temporarily impede normal trans-ostial drainage and ventilation of the sinuses, thereby resulting in some collection of mucus and possibly infection within the sinus cavities. Chronic sinusitis is a long term condition characterized by persistent narrowing or blockage of one or more sinus ostia, resulting in chronic infection and inflammation of the sinuses. Chronic sinusitis is often associated with longstanding respiratory allergies, nasal polyps, hypertrophic nasal turbinates and/or deviated internasal septum. While acute sinusitis is typically caused by infection with a single pathogen (e.g., one type of bacteria, one type of virus, one type of fungus, etc.), chronic sinusitis is often associated with multiple pathogen infections (e.g., more than one type of bacteria or more than genus of microorganism).
Chronic sinusitis, if left untreated, can result in irreparable damage to the tissues and/or bony structures of the paranasal anatomy. The initial treatment of chronic sinusitis usually involves the use of drugs such as decongestants, steroid nasal sprays and antibiotics (if the infection is bacterial). In cases where drug treatment alone fails to provide permanent relief, surgical intervention may be indicated.
The most common surgical procedure for treating chronic sinusitis is functional endoscopic sinus surgery (FESS). FESS is commonly performed using an endoscope and various rigid instruments inserted through the patient's nostril. The endoscope is used to visualize the positioning and use of various rigid instruments used for removing tissue from the nasal cavity and sinus ostia in an attempt to improve sinus drainage.
Recently, a technique known as the Balloon Sinuplasty™ procedure and a system for performing the procedure have been developed by Acclarent, Inc. of Menlo Park, Calif. for treatment of sinusitis. A number of copending United States patent applications, including parent application Ser. No. 11/789,704, 11/355,512, 11/150,874, 10/944,270 and 10/829,917, describe various embodiments of the Balloon Sinuplasty™ procedure as well as various devices useable in the performance of such procedure. In the Balloon Sinuplasty™ procedure, a guide catheter is inserted into the nose and positioned within or adjacent to the ostium of the affected paranasal sinus. A guidewire is then advanced through the guide catheter and into affected paranasal sinus. Thereafter, a dilation catheter having an expandable dilator (e.g., an inflatable balloon) is advanced over the guidewire to a position where the dilator is positioned within the ostium of the affected paranasal sinus. The dilator is then expanded, causing dilation of the ostium and remodeling of bone adjacent to the ostium, without required incision of the mucosa or removal of any bone. The catheters and guidewire are then removed, and the dilated ostium allows for improved drainage from and ventilation of the affected paranasal sinus.
Parent application Ser. Nos. 11/789,704, 11/355,512, 11/150,874, 10/944,270 and 10/829,917 also describe methods for transnasal dilation of other passageways in the ear, nose and/or throat, such as the Eustachian tube and nasolacrimal duct.
It would be desirable to have improved methods, devices and systems for dilating paranasal sinus ostia. Ideally such improved methods, devices and systems would be easier to use and/or more effective than prior versions. At least some of these objectives will be met by the embodiments described below.
In one embodiment, there is provided a dilation catheter device and system that is useable for dilating the ostium of a paranasal sinus, or other passageway within the ear, nose or throat. This dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator, thereby minimizing the number of personnel required for the procedure. Additionally, the dilation catheter device and system of the present invention is useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be attached to the dilation catheter or to a guide catheter through which the dilation catheter is inserted and such handle may be graspable along with another device (e.g., an endoscope) by a single hand. In this manner, the operator may control the dilation catheter and another device (e.g., an endoscope) with one hand while being free to use his other hand for other purposes.
Further in one embodiment, there are provided systems for treating a disease or disorder of the ear, nose or throat of a human or animal subject. Such systems generally comprise a guide catheter and a working catheter. The working catheter is advanceable through the guide catheter. The guide catheter has a substantially rigid shaft and the working catheter has a proximal portion that is substantially rigid. The working catheter also has a distal portion that is more flexible than the substantially rigid proximal portion. The working catheter is sized relative to the guide catheter so that, at least when the distal portion of the working catheter is advanced out of a distal opening of the guide catheter and the working element is being used to perform a desired diagnostic or therapeutic task, only the substantially rigid proximal portion (or some portion thereof) will extend out of the proximal opening of the guide catheter. In some embodiments, the working catheter may additionally be sized relative to the guide catheter so that the working catheter is initially advanceable to a first position where its distal end of the working catheter has not yet emerged out of the distal end of the guide catheter but only the substantially rigid proximal portion of the working catheter is protruding out of the proximal end of the guide catheter.
Still further in accordance with another embodiment, there are provided sinus ostium dilation catheter devices that generally comprise an elongate catheter shaft having proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section. In some embodiments, the proximal shaft section may extend along at least about 50% of the overall length of the device. A guidewire lumen extends through at least a portion of the catheter shaft to facilitate advancement of the catheter over a guidewire. A dilator is located on the distal shaft section, such dilator having a non-expanded configuration and an expanded configuration.
Still further in accordance with one embodiment, there are provided methods for dilating the ostia of paranasal sinus and other passageways within the ear, nose or throat of a human or animal subject. In general, such methods comprise the steps of a) inserting a guide catheter having a proximal end and a distal end through one of the subject's nostrils and positioning the guide catheter within or near the passageway to be dilated, b) inserting, through the guide catheter, a dilation catheter comprising i) an elongate catheter shaft having a proximal end, a distal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, ii) a guidewire lumen extending through at least a portion of the catheter shaft to facilitate advancement of the catheter over a that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, ii) a guidewire lumen extending through at least a portion of the catheter shaft to facilitate advancement of the catheter over a guidewire and iii) a dilator located on the distal shaft section, said dilator being in a non-expanded configuration, c) positioning the dilator within the passageway and d) causing the dilator to expand to an expanded configuration, thereby dilating the passageway.
In still a further embodiment, a balloon dilation catheter device is provided that is useable for dilating an opening in a paranasal sinus. The dilation catheter device includes a catheter shaft having a longitudinal axis, an inflation lumen, a distal end, a proximal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section. Also, the catheter shaft is dark in color. An inflatable balloon is disposed on the distal shaft section. The inflatable balloon is connected to the inflation lumen and the inflatable balloon has a non-circular cross-sectional shape when partially inflated. In this embodiment, the balloon dilation catheter includes a first proximal shaft marker disposed on the proximal shaft section, and the first shaft marker having a significantly lighter color than the catheter shaft. The first proximal shaft marker allows a user to approximate, using direct visualization of the first proximal shaft marker, a position of the balloon relative to a guide catheter through which the balloon catheter is advanced. There is also a first distal shaft marker disposed on the distal shaft section proximal to a proximal end of the balloon and the first distal shaft marker has a significantly lighter color than the catheter shaft. The first distal shaft marker enables a user to approximate, using endoscopic visualization of the first distal shaft marker, a position of the balloon relative to an opening of a paranasal sinus.
In one embodiment, a second proximal shaft marker is disposed on the proximal shaft section distally from the first proximal shaft marker and having a significantly lighter color than the catheter shaft. The first proximal shaft marker has a greater length than the second proximal shaft marker. Further, the length of the first proximal shaft marker is equal to the length from a proximal end of the inflatable balloon to the distal end of the catheter shaft. The first proximal shaft marker is spaced from the distal end of the catheter shaft such that it allows the user to approximate when the distal end of the catheter shaft is located at a distal end of the guide catheter and when the proximal end of the balloon exits a guide catheter, and wherein the second proximal shaft marker allows the user to approximate when the distal end of the catheter shaft is located just proximal to a curve in the guide catheter
The balloon dilation catheter device may also include a second distal shaft marker disposed on the distal shaft section proximal to the first distal shaft marker and having a significantly lighter color than the catheter shaft. The first distal shaft marker is disposed at a known distance proximally from the proximal end of the balloon, and the second distal shaft marker is disposed at a known distance proximally from the first distal shaft marker. Also, the first and second distal shaft markers have different appearances. In one embodiment, the first distal shaft marker is disposed approximately one centimeter from the proximal end of the balloon and the second distal shaft marker is disposed approximately two centimeters from the proximal end of the balloon. A third distal shaft marker also may be disposed on the distal shaft section at the proximal end of the balloon.
The balloon dilation catheter device may also include a first radiopaque marker disposed on the distal shaft section and within the inflatable balloon. There may be a second radiopaque marker disposed on the distal shaft section distally from the first radiopaque marker within the balloon. The first and second radiopaque markers are disposed a distance apart from one another to indicate the effective length of the inflatable dilator.
Also, in one embodiment, the inflatable balloon of the balloon dilator catheter device has an approximately triangular cross-section in a partially inflated state. The balloon may also have a balloon neck extending from the balloon proximally along the catheter shaft. The balloon neck allows an endoscopic marker to be disposed on the distal shaft section and underneath the balloon neck.
In an embodiment of a system for treating a disease or disorder of the ear, nose or throat of a human or animal subject, the system includes a guide catheter that is insertable into a head of the subject and has a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening. The system also includes a balloon catheter device as described above that is advanceable out of the distal opening of the guide catheter. The balloon catheter device also includes a guidewire lumen and the system includes a guidewire that is advanceable through the guidewire lumen. Also, the inflation lumen of the catheter shaft is sized so that, after the inflatable balloon has been inflated to a working diameter, the inflatable balloon will deflate in less than 5 seconds with application of negative pressure to the inflation lumen by a conventional balloon catheter inflation and deflation device.
The system may also include an irrigation catheter sized for advancement through the guide catheter into a paranasal sinus.
Furthermore, in an embodiment of a method for dilating a paranasal sinus ostium of a paranasal sinus of a patient, the method includes advancing a guide catheter into a head of a patient such that a distal end of the guide catheter is positioned within or near a paranasal sinus ostium of a paranasal sinus. By “paranasal sinus ostium,” it is meant the anatomical, non-manmade opening into the sinus ostium. A paranasal sinus ostium is formed by mucosal tissue overlying bone. For the purposes of this application the bone forming the paranasal sinus ostium is unfractured when initially addressed using the devices and methods described herein, although the described devices and methods may in some embodiments be used to fracture said bone. Also, the method includes inserting an endoscope into the patient's head and advancing a balloon catheter through a lumen of the guide catheter such that a balloon of the catheter passes out of the distal end of the guide catheter. With the endoscope, a first distal shaft marker disposed on a shaft of the balloon catheter a first known distance from the balloon may be viewed, and also, a second distal shaft marker disposed on the shaft a second known distance from the balloon may be viewed. The method may include approximating a location of the balloon relative to the paranasal sinus ostium, using the first and second distal shaft marker and their known distances from the balloon. The balloon of the balloon catheter may be expanded to remodel or break bone underlying mucosa of the paranasal sinus ostium and dilate the ostium.
The method may also include viewing a first proximal shaft marker during the step of advancing the balloon catheter. When a distal end of the first proximal shaft marker enters a proximal end of the guide catheter a distal end of the balloon catheter shaft is located approximately at the distal end of the guide catheter. Also, when a proximal end of the distal shaft marker enters the proximal end of the guide catheter a proximal end of the balloon of the catheter is located approximately at the distal end of the guide catheter.
Further, the method includes viewing a second proximal shaft marker during the step of advancing the balloon catheter. The second proximal shaft marker is disposed distal to the first proximal shaft marker, and when the second proximal shaft marker is located approximately at the proximal end of the guide catheter, the distal end of the balloon catheter is located immediately proximal to a curve in the distal end of the guide catheter. The first distal shaft marker is located proximal to the balloon and the second distal shaft marker is located distal to the balloon.
In another embodiment, the first and second distal shaft markers are located proximal to the balloon. The first distal shaft marker, may be located approximately one centimeter proximal to a proximal end of the balloon and the second distal shaft marker may be located approximately two centimeters proximal to the proximal end of the balloon. The method may also include viewing a third distal shaft marker located at the proximal end of the balloon.
The method may further include advancing a guidewire through the guide and through the ostium before advancing the balloon catheter. After the guidewire is in place, the balloon catheter is advanced over the guidewire and through the guide.
Also, the method may include removing the balloon catheter through the guide catheter and advancing an irrigation catheter through the guide catheter into the paranasal sinus. Once the irrigation catheter is in position, the sinus may be irrigated using the irrigation catheter.
Still further embodiments, aspects, features and details of the present invention will be understood upon reading of the detailed description and examples set forth herebelow.
The following detailed description and the accompanying drawings are provided for the purpose of describing some, but not necessarily all, examples or embodiments of the invention. The contents of this detailed description and the accompanying drawings are exemplary in nature and do not limit the scope of the invention in any way.
Although, in the particular example shown in the drawings, the expandable dilator comprises a balloon 14, it is to be appreciated that various other types of expandable dilators such as expandable cages, struts and other expandable mechanical assemblies may be used as an alternative to a balloon 14. Some non-limiting examples of expandable dilators other than balloons have previously been described in parent U.S. patent application Ser. No. 11/355,512, 11/150,874, 10/944,270 and 10/829,917, which are expressly incorporated herein by reference.
For use in teenage or adult humans, the overall length of the catheter shaft 12 may be in the range of about 15 cm to about 25 cm, the proximal shaft section 12prox may have a length in the range of about 10 cm to about 15 cm and the distal shaft section 12dist may have a length in the range of about 5 cm to about 10 cm. In the particular example shown in the drawings and described herein, the catheter shaft 12 has an overall length of 21.2 cm, the proximal shaft section 12prox being 12.5 cm in length and the distal shaft section 12dist being 8.7 cm in length. These optimal lengths of the proximal shaft section 12prox and distal shaft section 12dist have been arrived at based on a number of considerations, which will be discussed more fully herebelow in relation to the concurrent use of this dilation catheter 10 with a trans-nasal guide catheter.
As may be appreciated from the cross sectional view of
The outer tube 30 terminates at the end of the proximal shaft section 12prox. The middle tube 32 and inner tube 36 extend beyond the distal end of the outer tube 30, forming the distal shaft section 12dist.
As seen in the enlarged break-out segment of
The proximal end of the middle tube 32 extends into and is secured to the hub 16, distal to side arm Luer connector 22. The proximal end of the inner tube 36 extends into and is secured within hub 16, proximal to the side arm Luer connector 22 and in direct alignment and fluid communication with proximal Luer connector 20. The distal end of the middle tube 32 terminates within the balloon 14 and the proximal end of the dilator is secured to the outer surface of the middle tube. The distal end of the inner tube 36 also extends through the balloon 14 and protrudes distally beyond the balloon 14, forming the relatively flexible distal tip member 18 as shown in
The inner tube lumen 38 may be lined or coated with a lubricious material to facilitate passages of the guidewire GW through that lumen 38. The diameter of the inner tube 36 may be changed to accommodate guidewires of different diameter. In the particular embodiment described, the inner tube lumen 38 is sized to receive a 0.035 inch diameter guidewire GW. The inner tube lumen 38 may be internally lined or coated with a 2% solution of linear polydimethylsiloxane (PDMS) (e.g., Dow Corning® 360 Medical Fluid, Dow Corning Corporation, Midland, Mich.) diluted in isopropyl alcohol or another silicone material (such as a 2% solution of Dow-Corning MDX4-4159 in isopropyl alcohol). The coating is cured at room temperature.
The luminal space 34 between the outer surface of the inner tube 36 and the inner surface of the middle tube 32 is in fluidic communication with the side arm Luer connector 22 and extends to the interior of the balloon 14. Thus, this luminal space 34 serves as the passageway through which inflation fluid passes into and out of the balloon 14. The size of this luminal space 34 and the relatively short length of the catheter shaft 12 are optimized to minimize drag on inflation fluid passing through this luminal space 34 and allow for rapid deflation of the balloon 14. The clearance of 0.006 to 0.007 inches between the inner and outer members is desired for catheter length of 20-35 cm. The desired deflation time is 5-10 seconds, and the deflation time is measured with application of negative pressure on the inflation/deflation lumen using a 20 cc inflation device that is filled with 10 cc contrast/saline mixture.
Balloon Construction and Coating
The tapered end regions 46prox, 46dist are tapered at angle A relative to the longitudinal axis LA of the catheter shaft 12 on which the balloon 14 is mounted. This angle of taper A may be in the range of about 10 degrees to about 30 degrees. In the particular example shown in the drawings, such angle of taper A is 20 degrees. This 20 degree angle of taper provides an improved transition from the balloon working length to the balloon necks, lower profile, improved crossing, improved tracking, and easier withdrawal of the balloon into the sinus guide catheter after balloon inflation and deflation. It also provides optimal performance with minimum increase of overall balloon length.
In some embodiments, it may be desirable for the relatively stiff proximal shaft portion 12prox to extend all the way to or near the proximal end of the balloon 14 or other dilator. Such catheter having a rigid shaft from its proximal end to or near the dilator may be advanced directly into the sphenoid sinus ostium with or without the use of a guide catheter. In some embodiments, the proximal end of the balloon 14 could be bonded to the relatively rigid proximal shaft portion 12prox. Such a construction would allow the flexible distal tip 18 to track turns in the anatomy and may be useable to dilate certain passageways (e.g., the sphenoid sinus ostium) without disrupting the normal anatomy. Additionally, embodiments with relatively short distal shaft sections (e.g., 1-2 cm beyond the distal end of the rigid proximal shaft portion) are particularly suitable for dilating the ostia of frontal sinuses. Also, in some embodiments, the proximal shaft section 12prox may be malleable so that it may be shaped (e.g., bent or formed to a desired curve or multi-curve shape) to facilitate access to any desired passageways or locations.
Endoscopically Visible Markers and Anti-Glare Coatings
In some embodiments, a visible distal shaft marker 19 may optionally be placed adjacent the proximal end of the balloon 14 and/or on the distal shaft portion 12dist, such as at the location where the proximal end of the balloon 14 is bonded to the distal shaft portion 12dist. Additionally or alternatively, one or more proximal shaft markers 24, 26 may also be placed along the proximal shaft portion 12prox. Generally, the distal shaft marker 19 is positioned to be viewed using an endoscope while the distal shaft portion 12dist resides within a patient, and thus the marker 19 may be referred to as an “endoscopic marker.” The other visible markers 24, 26, formed on the proximal shaft portion 12prox, are specifically designed for use in conjunction with a guide catheter, as will be discussed in detail below.
In one embodiment, these visible markers 19, 24, 26 are preferably of a color (e.g., black or blue) that contrasts with the pink color of the nasal mucosa so as to be easily visible within the nose. In an alternative embodiment, the catheter shaft 12 may be of a dark color, and the markers 19, 24, 26 may be of a light color, so that their contrasting colors facilitate visualization of the markers 19, 24, 26. The optional marker 19 on the proximal end of the balloon 14 allows the operator to endoscopically view the proximal end of the balloon even when the remainder of the balloon is within the ostium of a paranasal sinus.
In some cases, endoscopic images obtained of the marker 19, other portions of the dilation catheter 10, a guidewire GW and/or a guide catheter 70a-70f used in a dilation procedure may have areas of glare, which can obscure visualization of certain portions of the endoscopic marker 19 or devices during performance of the procedure. To minimize such glare, an anti-glare (e.g., anti-reflective) treatment or coating may be applied to all or part of the sinus guide catheter 70a-70f, sinus guidewire GW and/or dilation catheter 10. Such anti-glare treatment could be applied by etching or sand-blasting and therefore does not add profile to the device. Such anti-glare coating could be applied by dip or spray coating and is very thin. The treatment or coating does not change the mechanical or functional properties of these devices. It may be selectively applied. For example, a black polytetrafluoroethylene (PTFE) coating on the sinus guidewire GW may provide good anti-reflective characteristics. Some of the commercially available anti-glare or anti-reflective coating can be applied. In some embodiments, an anti-glare surface treatment (e.g., roughening, etching, etc.) may be used or an anti-glare component such as a sheath, ring, paint, etc. may be used.
The advantages and benefits of including visible markers and/or the anti-glare coating include, improved endoscopic visualization, safer and easier performance of the procedure, reduced balloon burst or damage to critical structures, accuracy of placement of devices and reduced fluoroscopy time or elimination of fluoroscopy.
Dilation Catheter/Guide Catheter System
As explained above, in this example, the rigid proximal shaft segment 12prox of the dilation catheter 10 is 11.3 cm in length and the guide catheter 70c is 12.7 cm in length. Thus, when inserted into the subject's body, the overall length of the portion of the system that remains exposed (e.g., the proximal part of the guide catheter 10 extending out of the subject's nose and the proximal part of the dilation catheter 10 extending out of the proximal end of the guide catheter 70c) is not only rigid, but sufficiently short (e.g., typically less than 9 cm) to be easily manageable and capable of being held or supported by a single hand of the operator, thereby allowing the operator's other hand to be used for other purposes, such as for advancing/retracting the guidewire GW or advancing/retracting the dilation catheter 10 in the manner described below in connection with
The second shaft marker 24 correlates to the position of the balloon. If the dilation catheter 10 is advanced to a position where the distal edge of the second shaft marker 24 is flush with the proximal end of the guide catheter 10, the distal tip of the balloon catheter will be flush with the distal tip of the guide catheter 70c. When the proximal edge of the second shaft marker 24 is flush with the proximal end of the guide catheter 10, the entire balloon 14 will have advanced out of the distal end of the guide catheter 70c, and the operator will know that it is safe to inflate the balloon. Typically, as seen in
In some applications of the system 1 shown in
Optionally, a member 61 may be attached to the guidewire. Such member may serve to prevent the dilation catheter 10 and/or guide catheter 70c from inadvertently sliding off of the proximal end of the guidewire. Also, such member 61 may limit the length of guidewire GW that may be advanced through the dilation catheter 10. This will prevent the operator from advancing too much of the guidewire GW into the subject's sinus, which may injure or damage the mucosa lining the sinus cavity. In some embodiments, this member 61 may be a standard guidewire torquer of the type commercially available and well known in the fields of interventional cardiology and/or radiology. One example of a commercially available guidewire torquer that is useable with the catheter 10 in this application is a two part torquer available as Part No. 97333 from Qosina, Corp., Edgewood, N.Y.
Alternatively, the member 61 may comprise a guidewire stop/connector apparatus 61a as shown in
Alternatively or additionally, if desired, another stop/connector apparatus 61a of larger size (or another suitable locking apparatus such as a Touhy-Borst valve) may be mounted on the rigid proximal shaft section 21prox of the dilation catheter 10 and received within the proximal end of the guide catheter 70a-70f to limit the advancement of the dilation catheter 10 through the guide catheter 70a-f and to frictionally lock the dilation catheter 10 to the guide catheter 70a-f in the same manner.
Dilation Catheter/Guide Catheter System with Optional Handle
Alternative embodiments of the handle are shown in
In embodiments where the handle member 78 is shapeable (e.g., malleable or bendable), the shape of the handle member 78 may be modified one or more times prior to or during the procedure to facilitate comfortable grasping of the handle by the operator's scope hand and/or to adjust the position or angle of the endoscope relative to the guide catheter. In this regard, in
The optional handle 72 may also be useful with other dilation catheters and other trans-nasal devices described in any or all of the parent applications of which this application is a continuation-in-part and/or those currently available commercially under the trademark Relieva from Acclarent, Inc., Menlo Park, Calif.
In some applications, the handle 72 may be designed to connect by way of a unique or proprietary connector to the guide catheter or other device. Alternatively, in some embodiments, the handle 72 may be pre-attached, integrally formed with or otherwise designed as a part or portion of the guide catheter or other device. In embodiments where the handle 72 is not detachable from the guide catheter or other device, it may nonetheless be rotatable and/or lockable in a desired position
Modes of Use of the System
Mode 1—Inserting Guide Catheter, Guidewire and Dilation Catheter Separately
In the example of
After the guide catheter 70a-70f has been positioned, the operator will insert the distal end of the guidewire into the proximal end of the guide catheter 70a-70d and will advance the guidewire GW through the guide catheter 70a-70d such that a distal portion of the guidewire GW passes through the sinus ostium and becomes coiled within the sinus cavity. Fluoroscopy (or any other suitable technique) may be used to verify that the guidewire has become coiled within the intended sinus cavity.
Thereafter, the proximal end of the guidewire GW is inserted into the distal end of the dilation catheter 10, and the dilation catheter 10 (with its balloon 14 or other dilator in its non-expanded state) is advanced over the guidewire and through the guide catheter 70a-70d to a position where the dilator 14 is positioned within the sinus ostium. The endoscope 60 may be used to view the advancement and positioning of the dilation catheter 10. Although the distal portion of the balloon 14 or other dilator will be within the sinus and out of the field of view of the endoscope 60, the endoscope 60 may be used to view the proximal end of the balloon 14 or other dilator and/or the optional marker 19 (if present) on the proximal end of the balloon 14 or other dilator. Fluoroscopy may be used to image the radiographic markers 40, 42 and the ostium to confirm that the mid-region 44 of the balloon 14 (or the appropriate portion of any other type of dilator) is positioned within the ostium.
After the balloon 14 or other dilator has been positioned within the ostium, the balloon is inflated (or the other dilator is expanded) thereby dilating the ostium.
The balloon is then deflated (or the dilator is returned to its non-expanded state) and the successful dilation of the ostium may be confirmed visually using the endoscope 60 and/or radiographically using a fluoroscope.
Thereafter, the dilation catheter 10, guidewire GW and guide catheter 70a-70f are removed.
Mode 2—Preloading Dilation Catheter into Guide Catheter then Inserting Guidewire Separately
In the example of
Thereafter, the guide catheter 70a-70f in combination with the pre-inserted dilation catheter 10 is inserted transnasally (along with an endoscope 60) and is advanced to a position that is within or near the ostium to be dilated. The endoscope 60 is used to view the advancement and positioning of the guide catheter 70a-70f, and fluoroscopy may also be used to verify that the guide catheter is properly positioned near or within the ostium. Optionally, a handle 72 may be attached to the guide catheter 70a-70f, as described above, or the operator may simply grasp the guide catheter 70a-70f as well as the endoscope 60 with the scope hand, thus leaving the operator's other hand free to be used for subsequent handling and manipulation of the other devices used in this procedure. Alternatively, a scope holder or assistant may be used to hold the endoscope 60 in the desired position, thus freeing both of the operator's hands for handling and manipulation of the other devices.
After the guide catheter 70a-70f and pre-inserted dilation catheter 10 have been positioned, the operator will insert the distal end of the guidewire GW into the proximal Luer 20 of the dilation catheter 10 and will advance the guidewire GW through the dilation catheter 10, out of the distal end of the guide catheter 70a-70f and through the sinus ostium, causing a distal portion of the guidewire GW to become coiled within the sinus cavity. Fluoroscopy (or any other suitable technique) may be used to verify that the guidewire GW has become coiled within the intended sinus cavity.
Thereafter, the dilation catheter 10 (with its balloon 14 or other dilator still in its non-expanded state) is advanced over the guidewire GW to a position where the balloon 14 or other dilator is positioned within the sinus ostium. The endoscope 60 may be used to view the advancement and positioning of the dilation catheter 10. Although the distal portion of the balloon 14 or other dilator will be within the sinus and out of the field of view of the endoscope 60, the endoscope 60 may be used to view the proximal end of the balloon 14 or other dilator and/or the optional marker 19 (if present) adjacent the proximal end of the balloon 14 or other dilator. Fluoroscopy may be used to image the radiographic markers 40, 42 and the ostium to confirm that the midregion 44 of the balloon 14 (or the appropriate portion of any other type of dilator) is positioned within the ostium.
After the balloon 14 or other dilator has been positioned within the ostium, the balloon is inflated (or the other dilator is expanded) thereby dilating the ostium.
The balloon is then deflated (or the dilator is returned to its non-expanded state) and the successful dilation of the ostium may be confirmed visually using the endoscope 60 and/or radiographically using a fluoroscope.
Thereafter, the dilation catheter 10, guidewire GW and guide catheter 70a-70f are removed.
Mode 3—Preloading Guidewire and Dilation Catheter into Guide Catheter
In the example of
Thereafter, the guide catheter 70a-70f with the dilation catheter 10 and guidewire pre-inserted therein is inserted through a nostril (along with an endoscope 60) and is advanced to a position that is within or near the ostium to be dilated. The endoscope 60 is used to view the advancement and positioning of the guide catheter 70a-70f, and fluoroscopy may also be used to verify that the guide catheter 70a-70f is properly positioned near or within the ostium. Optionally, a handle 42 may be attached to the guide catheter 70a-70f, as described above, or the operator may simply grasp the guide catheter 70a-70f as well as the endoscope 60 with the scope hand, thus leaving the operator's other hand free to be used for subsequent handling and manipulation of the other devices used in this procedure. Alternatively, a scope holder or assistant may be used to hold the endoscope 60 in the desired position, thus freeing both of the operator's hands for handling and manipulation of the other devices.
After the guide catheter 70a-70f and pre-inserted dilation catheter 10 and guidewire GW have been positioned, the operator will advance the guidewire GW out of the distal end of the guide catheter 70a-70f and through a sinus ostium, causing a distal portion of the guidewire GW to become coiled within the sinus cavity. Fluoroscopy (or any other suitable technique) may be used to verify that the guidewire GW has become coiled within the intended sinus cavity.
Thereafter, the dilation catheter 10 (with its balloon 14 or other dilator still in its non-expanded state) is advanced over the guidewire GW to a position where the balloon 14 or other dilator is positioned within the sinus ostium. The endoscope 60 may be used to view the advancement and positioning of the dilation catheter 10. Although the distal portion of the balloon 14 or other dilator will be within the sinus and out of the field of view of the endoscope 60, the endoscope 60 may be used to view the proximal end of the balloon 14 or other dilator and/or the optional marker 19 (if present) adjacent the proximal end of the balloon 14 or other dilator. Fluoroscopy may be used to image the radiographic markers 40, 42 and the ostium to confirm that the midregion 44 of the balloon 14 (or the appropriate portion of any other type of dilator) is positioned within the ostium.
After the balloon 14 or other dilator has been positioned within the ostium, the balloon 14 is inflated (or the other dilator is expanded) thereby dilating the ostium.
The balloon 14 is then deflated (or the dilator is returned to its non-expanded state), and the successful dilation of the ostium may be confirmed visually using the endoscope 60 and/or radiographically using a fluoroscope.
Thereafter, the dilation catheter 10, guidewire GW and guide catheter 70a-70f are removed.
Although the above described examples refer to use of a guide catheter 70a-70f and/or guidewire GW to guide the advancement of the dilation catheter 10 to its intended position within the ear, nose or throat, in some subjects and/or in some applications, the dilation catheter may be advanceable or maneuverable to its intended position without the use of a guide catheter 70a-70f and/or guidewire GW. For example, in some subjects, the dilation catheter 10 may be advanced into the sphenoid sinus ostium without the use of a guidewire GW or guide catheter 70a-70f. Alternatively, the flexible balloon portion may be manipulated with forceps to enable insertion in the ostium. Similar techniques may apply to access of the frontal and maxillary paranasal sinus ostia.
The fact that the system described herein includes a guide catheter 70a-70f that is separate from the dilation catheter 10 has certain advantages. For example, by having two separate devices, the operator has separate control of guide catheter placement and may, in some cases, elect not to actually advance the guide catheter 70a-70f into the ostium or (or frontal recess in the case of the frontal sinus). Rather, the operator may in some instances elect to maneuver the guide catheter 70a-70f to a position that is close to (e.g., aligned with) but not within the ostium or recess, and may then advance just the relatively flexible dilation catheter 10 into the ostium or recess. This may avoid damaging mucosal tissue and/or bone in the nasal cavity and/or of the ostium itself. Thus, the use of a guide catheter 70a-70f that is separate from the dilation catheter 10 allows flexibility of positioning and potentially less trauma than where a single rigid device (e.g., a rigid shafted dilation catheter) must be navigated to the desired location and then actually inserted into the ostium or other passageway to be dilated.
In various embodiments, the overall length of the catheter shaft 122 may be in the range of about 24 cm to about 30 cm and in one embodiment about 25 cm. The proximal shaft section 122prox may have a length in the range of about 9 cm to about 15 cm, and the distal shaft section 122dist may have a length in the range of about 5 cm to about 10 cm. In the embodiment shown in
The “ineffective tip length” of the distal shaft section 122dist, from the distal shoulder 125dist of the balloon to the end of the distal tip member 128, is 1.1 cm±0.2 cm for a 7 mm balloon. For different balloon sizes, the ineffective tip length is 0.75 cm±0.2 cm for a 3.5 mm balloon, 0.9 cm±0.2 cm for a 5 mm balloon, and 1.0 cm+0.2 cm for a 6 mm balloon. Also, the distal tip member 128 is sufficiently flexible so that it is largely atraumatic (i.e., causes little or no damage to mucosal tissue upon contacting it during a procedure) and may have a radius shaped distal end.
Referring now to the cross sectional view of
The outer tube 90 terminates at the end of the proximal shaft section 122prox. The middle tube 92 and inner tube 96 extend beyond the distal end of the outer tube 90, forming the distal shaft section 122dist.
As seen in
The proximal end of the middle tube 92 extends into and is secured to the hub 126, distal to side arm Luer connector 82. The proximal end of the inner tube 96 extends into and is secured within hub 126, proximal to the side arm Luer connector 82 and in direct alignment and fluid communication with proximal Luer connector 80. The distal end of the middle tube 92 terminates within the balloon 124, and the proximal end of the dilator is secured to the outer surface of the middle tube. The distal end of the inner tube 96 also extends through the balloon 124 and protrudes distally beyond the balloon 124, forming the relatively flexible distal tip member 128 as shown in
The inner tube lumen 98 may be lined or coated with a lubricious material to facilitate passage of the guidewire GW through the lumen 98. The diameter of the inner tube 96 may be changed to accommodate guidewires of different diameter. In the particular embodiment described, the inner tube lumen 98 is sized to receive a 0.035 inch diameter guidewire GW. The inner tube lumen 98 may be internally lined or coated with a 2% solution of linear polydimethylsiloxane (PDMS) (e.g., Dow Corning® 360 Medical Fluid, Dow Corning Corporation, Midland, Mich.) diluted in isopropyl alcohol or another silicone material (such as a 2% solution of Dow-Corning MDX4-4159 in isopropyl alcohol). The coating is cured at room temperature.
The luminal space 94 between the outer surface of the inner tube 96 and the inner surface of the middle tube 92 is in fluidic communication with the side arm Luer connector 82 and extends to the interior of the balloon 124. Thus, this luminal space 94 serves as the passageway through which inflation fluid passes into and out of the balloon 124. The size of the luminal space 94 and the relatively short length of the catheter shaft 122 are optimized to minimize drag on inflation fluid passing through the luminal space 94 and allow for rapid deflation of the balloon 124. The clearance of 0.006 to 0.007 inches between the inner and outer members is desired for catheter length of 20-35 cm. The desired deflation time is less than or equal to about 5 seconds, and the deflation time is measured with application of negative pressure on the inflation/deflation lumen using a 20 cc inflation device that is filled with 10 cc contrast/saline mixture.
Referring to
The balloon 124 also includes tapered proximal and distal end regions 106prox and 106dist. In some embodiments, each of the two tapered end regions 106prox, 106dist may have the same length. This length of the tapered regions 106prox, 106dist may be different for differently sized balloons 124. For example, in one set of balloon 124 embodiments, a balloon 124 having a diameter of at about 7 mm may have a taper length of about 6 mm, a balloon 124 having a diameter of at about 6 mm may have a taper length of about 5 mm, a balloon 124 having a diameter of at about 5 mm may have a taper length of about 4 mm, and a balloon 124 having a diameter of at about 3.5 mm may have a taper length of about 2.5 mm.
The tapered end regions 106prox, 106dist are tapered at angle A relative to the longitudinal axis LA of the catheter shaft 122 on which the balloon 124 is mounted. This angle of taper A may be in the range of about 10 degrees to about 30 degrees. In the particular example shown in the drawings, such angle of taper A is 20 degrees. This 20 degree angle of taper provides improved transition from balloon working length to the necks, lower profile, improved crossing, improved track, easier withdrawal in the sinus guide after balloon deflation. It also provides optimal performance with minimum increase of overall balloon length.
As best shown in
As shown in
Direct visualization markers can be positioned in a number of locations along the catheter shaft 122. Although one embodiment is described here with reference to
In one embodiment, there may be a first distal shaft marker 112 (or “endoscopic marker,” since it is typically viewed during use via an endoscope) disposed on the shaft 122 at a location such that its distal edge aligns with the location where the proximal taper of the balloon 124 meets the catheter shaft 122. The extended balloon neck 127 allows the first endoscopic marker 112 to be placed on the shaft and away from any adhesive bonding used to secure the proximal end of the balloon neck to the shaft. The first endoscopic marker 112 indicates to the user the ending location of the balloon 124 and indicates that the balloon has exited the guide during a procedure. In one embodiment, the first endoscopic marker 112 may be about 2 mm wide.
A second distal shaft marker 114 is disposed on the shaft 122 such that the distal edge of the marker is 1 cm±0.2 cm from the location where the proximal taper of the balloon 124 meets the catheter shaft 122. This marker indicates to the user that the shaft location is 1 cm away from the end of the balloon indicating that the balloon has extended from the guide during the procedure. In one embodiment, the second distal shaft marker may be about 2 mm wide and white in color, while the first marker is about 2 mm and green in color. Of course, any of a number of different size and color combinations may be used alternatively.
A third distal shaft marker 116 is disposed on the shaft 122 such that the distal edge of the marker is 1 cm±0.1 cm from the distal edge of the second distal shaft marker 114. As shown in
In some embodiments, in addition to one or more distal shaft markers, one or more proximal shaft markers may be disposed along the proximal portion of catheter shaft 122. In general, such proximal shaft markers may be viewed directly by a physician, without using an endoscope, to indicate to the physician a location of the balloon 124 of the catheter 120 relative to a guide catheter through which the balloon catheter 120 is being advanced. As with the distal shaft markers, the proximal shaft markers may have any suitable width, color, number, position and the like. In one embodiment, for example, as shown in
In one embodiment, the first proximal shaft marker 118 is disposed on the shaft 122 such that the length from the proximal end of the proximal balloon taper 106 to the proximal end of the first shaft marker is 13.1 cm±0.2 cm. The first proximal shaft marker is 4.1 cm±0.1 cm in length for a 7×24 mm balloon catheter. The length of the first proximal shaft marker 118 can vary depending on the size of the balloon catheter. The length of the first proximal shaft marker 118 may be determined by adding the length of the distal tip 128, the effective or working length of the balloon 124, and the lengths of the two balloon taper sections. Also, the first proximal shaft marker is preferably white in color, however, other light colors, such as grey, can be used as well.
The second proximal shaft marker 121 is disposed on the shaft 122 distally from the first proximal shaft marker 118. The second proximal shaft marker 121 is positioned such that the distal tip of the catheter 120 is 11.4 cm±0.2 cm from the distal edge of the second proximal shaft marker 121. Also, the second proximal shaft marker 121 has a length of 3 mm±2 mm. It is preferred that the second shaft proximal marker 121 is white in color, however, other light colors, such as grey, can be used as well.
When the balloon catheter 120 is inserted into a guide, a user may visualize the first and second proximal shaft markers 118 and 121 to determine the position of the distal tip and the balloon 124 of the balloon catheter 120 relative to the sinus guide catheter. For instance, when the second proximal shaft marker 121 is aligned with the proximal opening of the guide catheter, the user will know that the balloon 124 is proximal to the curve of the guide catheter. The position of the second proximal shaft marker 121 helps to visually ensure that the balloon catheter 120 is properly loaded into the sinus guide catheter. When the distal edge of the first proximal shaft marker 118 is aligned with the proximal opening of the guide catheter, the user knows that the distal tip of the balloon catheter 120 is beginning to exit the guide catheter, and when the proximal edge of the first proximal shaft marker is aligned with the proximal opening of the guide catheter, the user knows that the balloon is completely out of the guide catheter.
The visible markers 114, 116, 118 and 121 are preferably light in color, such as white as indicated above, to contrast with a dark color of the shaft 122, which is preferably black. The high contrast between these visible markers and the shaft helps view the markers in a low light environment. Also, the high contrast allows the user to view directly with an endoscope the markers and know where the balloon 124 is located relative to a sinus ostium. Furthermore, the color contrast is useful during the procedure when the field is full of blood and/or mucus to view the markers and know the position of the balloon. Of course, any other suitable contrasting color combination may be used. In one embodiment, for example, the catheter shaft 122 may be light colored, and the markers 114, 116, 118 and 121 may be dark colored.
The alternative embodiment of the balloon catheter 120 is used in a similar manner to the first embodiment of the balloon catheter 10 as described above. Further, separate features of the balloon catheters 10 and 120 may be incorporated into or used with either embodiment.
The invention has been described with reference to certain examples or embodiments of the invention, but various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless otherwise specified or if to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or process have been described or listed in a particular order, the order of such steps may be changed unless otherwise specified or unless doing so would render the method or process unworkable for its intended purpose. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.
This application is a continuation in part of U.S. patent application Ser. No. 11/789,704 entitled “Systems and Methods for Transnasal Dilation of Passageways in the Ear, Nose and Throat,” filed Apr. 24, 2007, which is a continuation in part of U.S. patent application Ser. No. 11/355,512 entitled “Devices, Systems and Methods Useable for Treating Frontal Sinusitis,” filed Feb. 16, 2006, which is a is a continuation in part of Ser. No. 11/150,874 entitled “Devices, Systems and Methods Useable for Treating Sinusitus,” filed on Jun. 10, 2005, which is a continuation in part of Ser. No. 10/944,270 entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures,” filed on Sep. 17, 2004, which is a continuation in part of Ser. No. 10/829,917 entitled “Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat,” filed on Apr. 21, 2004, the entire disclosures of each such application being expressly incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12496226 | Jul 2009 | US |
| Child | 12793352 | US | |
| Parent | 11789704 | Apr 2007 | US |
| Child | 12496226 | US | |
| Parent | 11355512 | Feb 2006 | US |
| Child | 11789704 | US | |
| Parent | 11150874 | Jun 2005 | US |
| Child | 11355512 | US | |
| Parent | 10944270 | Sep 2004 | US |
| Child | 11150874 | US | |
| Parent | 10829917 | Apr 2004 | US |
| Child | 10944270 | US |
