The present invention relates to a method of treatment of sinusitis, especially chronic recurrent sinusitis using an irrigating, self-expandable catheter to express/expel materials from the paranasal sinuses.
Sinusitis is an inflammatory disease of the paranasal sinuses. The paranasal sinuses are connected hollow cavities in the skull. Referring to
Chronic Recurring Sinusitis (“CRS”) is persistent inflammation of the sinus and nasal passages that is defined as lasting longer than 12 weeks or occurring more than 4 times per year with symptoms usually lasting more than 20 days. In clinical practice, there is a significant subpopulation of patients with CRS who remain resistant to cure despite rigorous treatment regimens including surgery, allergy therapy and prolonged antibiotic therapy. The reason for treatment failure is thought to be related to the destruction of the sinus mucociliary defense by bacteria that are not cleared from the sinuses.
The use of balloon catheters to treat sinus diseases has been disclosed. For example, U.S. Pat. No. 8,114,113 disclosed the use of a balloon catheter to dilate an ostium or duct, or the choana, to create a new opening (ostium) from a sinus to the nasal cavity, and to conduct sinusotomy. These methods often cause damage to the mucosal tissue and trauma to the underlying bone and treatment area.
The present invention provides a method to treat sinusitis, especially CRS, that reduces or even prevents tissue damage and trauma to the treatment area by using an irrigating self-expandable catheter to fill the majority of the unoccupied volume of a sinus cavity and to create an irrigating fluid flow circumferentially around its expanded volume in order to improve the evacuation of materials residing on the surface of the sinus mucosa of the sinus cavity. The present invention has successfully treated sinusitis including acute sinusitis and CRS.
This application is related to and claims the benefit of the filing date of U.S. Provisional Application Ser. No. 62/546,854, filed Aug. 17, 2017, the contents of that application being hereby incorporated by reference herein for all purposes.
The irrigating self-expandable catheter used for the present invention can be any art-disclosed device that not only provides irrigation but also can enter a sinus cavity and then can expand into a desired volume so as to create an irrigating fluid flow circumferentially around the expanded volume
In one exemplary embodiment and referring to
The connector 112 is located at proximate end of the catheter 100. The proximate end of the connector connects the catheter 100 to a fluid source 114. In one embodiment, the fluid source 114 provides separate reservoirs in order to separate the fluid going into the catheter 100 and the fluid coming out of the catheter 100. For example, the reservoir for inflating of the balloon 110 is sized to properly inflate the balloon 110 without over-inflation (e.g., approximately 20 mL). The volume of the reservoir for irrigation can vary considerably (e.g., approximately 60 mL) based on irrigation needs and user preference. The connector 112 can include any suitable art-disclosed connector or connectors (e.g., luer lock(s), ferrule(s), or the like).
Referring to
Referring to
During operation, the balloon 110 is in fluid communication with the balloon lumen 105. The balloon 110 is constructed of resilient biocompatible material such as urethane, polyethylene terephthalate, or the like. Depending on the size and shape of the sinus(es) designated for treatment (“sinus treatment area”), the balloon 110 can be any size and shape suitable for the sinus treatment area. For example, the balloon 110 can be generally ellipsoidal shape, spherical with taped ends, cylindrical with taped ends, or the like. The diameter, length, and total volume of the inflated balloon 110 depend upon the anatomy of the patent's paranasal sinuses. For example, the diameter of the inflated balloon 110 may range from about 2 mm to about 10 mm, and from about 3 mm to about 9 mm or the like. The length of the inflated balloon may range from about 5 mm to about 50 mm, from about 9 mm to about 40 mm, and from about 20 to about 30 mm. The deflated balloon 110 has a size and shape that can gain access to the treatment site.
Referring to
Referring to
The fluid control assembly 128 uses art-disclosed fluid control means to control (i) the fluid communication between the fluid source 114 and the balloon lumen 105, and (ii) the fluid communication between the fluid source 114 and the irrigation lumen 108. Furthermore, the fluid control assembly 128 also serves as a handle for a user to hold and control the catheter 100.
During operation, the fluid control assembly 128 allows the fluid source 114 to be in fluid communication with the irrigation lumen 108 and/or the balloon lumen 105. When the connector 112 is connected to the fluid source 114, the fluid control assembly 128 allows the irrigation lumen 108 and/or the balloon lumen 105 to be in fluid communication with the fluid source 114 and can deliver (i) fluid from the fluid source 114 to the balloon 110 via the balloon lumen 105 for inflation of the balloon 110; (ii) from the balloon 110 to the fluid source 114 for deflation of the balloon 110; (iii) fluid from the fluid source 114 to the irrigation lumen 108 for dispensing fluid out of the catheter 100 in order to create an circumferential irrigating fluid flow around the inflated balloon 110.
Referring to
Unlike the circumferential irrigation method described above, the fluid exiting the end of a conventional irrigation catheter is not constrained and travels in a direction approximately normal (i.e., generally perpendicular) direction to the mucosal surface 144. Furthermore, even in the case of an irrigation catheter in which the irrigation fluid exits through multiple side holes and is directed in multiple directions towards the mucosal surface 144, the resulting fluid stream will impact the mucosal surface 144 only in a generally perpendicular direction.
The circumferential irrigation method uses the combination of the inflated balloon 110 and irrigation fluid 146 dispensed from the catheter 100 under pressure to optimally channel the flow of irrigation fluid 146 tangentially (e.g., not in a direct perpendicular direction) along the mucosal surface 144 creating a tangential or circumferential irrigation flow that is atraumatic to mucosal surface 144 but more effectively dislodges and expresses the sinus contents 142 (e.g., debris, biofilms, mucus, etc.) from the mucosal surface 144. Compared to conventional irrigation, the present invention's method further improves lumenal expression of the sinus contents 142 by more effectively detaching the sinus contents 142 from the mucosa surface 144 and pushing the resulting material through the sinus ostium 138 and out of the sinus cavity.
The present invention also contemplates that to deflate the balloon 100, fluid contained within the balloon 110 can be alternatively transported from the balloon 110 out of the catheter 100, via the inner lumen 108, the fluid control assembly 128 and the connector 112, into other disposal means (i.e., not the fluid source 114).
Referring to
Other art-disclosed balloon catheters may be used in accordance to the present invention, including but not limited to, the balloon catheters disclosed in U.S. Pat. No. 8,114,113. In addition to balloon catheters, other art-disclosed self-expandable catheters may also be used in accordance to the present invention such as the expandable nasal stent (using expandable foam) as described in U.S. Pat. No. 5,336,163 or the like. To avoid unnecessary trauma to the patient, it may be desired that the diameter of the catheter 100 that enters the nasal cavity and into the any of the sinuses is sized sufficiently small in order to fit into the nasal passages including ostia.
To treat sinusitis, including acute sinusitis and CRS, the clinician normally identifies a particular sinus of interest to treat via CT, endoscopic evaluation and patient report. Once the sinus of interest has been identified, the clinician may optionally open the ostium to such sinus via a standard uncinectomy and antrostomy procedure, and the patient allowed to heal. Alternatively, this option step of opening the ostium may be omitted and the clinician proceeds directly to the method of the present invention.
The method of the present invention includes the first step of inserting a portion of the catheter (100, 200) having the balloon (110, 212) or another expandable material in a deflated state endoscopically into a sinus (e.g., the maxillary sinus 2, the ethmoid sinus 4, the frontal sinus 6, or the sphenoid sinus) through the sinus' ostium (such as the maxillary ostium 138 shown on
Once the balloon (110, 212) is placed into the sinus 2 endoscopically, the second step of the present invention includes inflating the balloon (110, 212) with fluid from the fluid source 114 via the port(s) 118 using the fluid control assembly 128 or via the connector 208 and the reservoir for the fluid source 114 (e.g., syringe or the like) under endoscopic visualization until the balloon (110, 212) inflates to fill a portion of the sinus 2, that portion being dependent on the sinus 2 being treated and the amount of sinus contents 142. If using an expandable material other than the balloon (110, 212), the expandable material shall be expanded at the desired location to fill a portion of the sinus 2. The method does not require the balloon (110, 212) or the other type of expandable material to exert direct pressure on the mucosal surfaces 144 of the sinus 2 (e.g., fill up the entire space or cavity within the sinus 2. The method also does not require the balloon (110, 212) or the other type of expandable material to physically compress the mucosal surface 144. Furthermore, the balloon (110. 212) or the other type of expandable material should not inflate/expand to a point that it occludes the sinus ostium 138.
Referring to
Once the clinician feels that the treated sinus 2 has been sufficiently cleared of its sinus contents 142, the fourth step of the present invention includes deflating the balloon (110, 212) by transporting the fluid contained within the balloon 110 back out of the catheter 100 to either the fluid source 114 or other disposal means. If a non-balloon expandable material is used, then other art-disclosed methods of deflation may be used. The fifth and final step of the present invention includes removing the inserted catheter 100 from the patient.
The method of the present invention set forth above can be repeated to treat the remaining affected paranasal sinuses.
The particulars shown herein are by way of example and for purposes of illustrative discussion of the invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for the fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. It is understood that the present invention as described and claimed herein can be used for many additional purposes, therefore the invention is within the scope of other fields and uses and not so limited. The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the invention, its principles, and its practical application. Those skilled in the art may adapt and apply the invention in its numerous forms, as may be best suited to the requirements of a particular use. Accordingly, the specific embodiments of the present invention as set forth are not intended as being exhaustive or limiting of the invention. The scope of the invention should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes.
This application claims the benefit of the filing date of U.S. Provisional Application Ser. No. 62/546,854 titled: “CIRCUMFERENTIAL IRRIGATION METHOD OF SINUSITIS TREATMENT” filed on Aug. 17, 2018, which is incorporated herein by reference for all purposes.
Number | Date | Country | |
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62546854 | Aug 2017 | US |