# Patent

## Title
Endoscopic methods and devices for transnasal procedures

## Abstract

Medical devices, systems and methods that are useable to facilitate transnasal insertion and positioning of guidewires and various other devices and instruments at desired locations within the ear, nose, throat, paranasal sinuses or cranium. Direct viewing of such placements via an endoscope.

## Background
CROSS-REFERENCE
This application is a divisional application of Application Serial No. 11/803,695, filed May 14, 2007, which claims the benefit of Provisional Application Ser. No. 60/844,874, filed Sep. 15, 2006, and which is a continuation-in-part application of application Ser. No. 11/725,151, filed Mar. 15, 2007, which is a continuation-in-part application of application Ser. No. 11/647,530, filed Dec. 27, 2006, which is a continuation-in-part application of application Ser. No. 11/522,497, filed Sep. 15, 2006, now U.S. Pat. No. 7,559,925 and also a continuation-in-part application of application Ser. No. 11/193,020, filed Jul. 29, 2005 which is a continuation-in-part of application Ser. Nos. 10/829,917, filed Apr. 21, 2004 now U.S. Pat. No. 7,654,997; Ser. No. 10/944,270, filed Sep. 17, 2004 now abandoned; Ser. No. 11/116,118, filed Apr. 26, 2005 now U.S. Pat. No. 7,720,521; and Ser. No. 11/150,847, filed Jun. 10, 2005 now U.S. Pat. No. 7,803,150. All of the aforementioned applications are hereby expressly incorporated herein, in their entireties, by reference thereto, and to which applications we claim priority under 35 USC §120 and 35 USC §119, respectively.
This application also claims the benefit of U.S. Provisional Application No. 60/844,874, filed Sep. 15, 2006, which application is expressly incorporated herein, in its entirety, by reference thereto and to which we claim priority under 35 USC §119.


FIELD OF THE INVENTION
The present invention relates generally to medical apparatus and methods and more particularly to devices and methods that are useable to facilitate transnasal insertion and positioning of guidewires and various other apparatus at desired locations within the ear, nose, throat, paranasal sinuses or cranium.
BACKGROUND OF THE INVENTION
Functional endoscopic sinus surgery (FESS) is currently the most common type of surgery used to treat chronic sinusitis. In a typical FESS procedure, an endoscope is inserted into the nostril along with one or more surgical instruments. The surgical instruments are then used to cut tissue and/or bone, cauterize, suction, etc. In most FESS procedures, the natural ostium (e.g., opening) of at least one paranasal sinus is surgically enlarged to improve drainage from the sinus cavity. The endoscope provides a direct line-of-sight view whereby the surgeon is typically able to visualize some but not all anatomical structures within the surgical field. Under visualization through the endoscope, the surgeon may remove diseased or hypertrophic tissue or bone and may enlarge the ostia of the sinuses to restore normal drainage of the sinuses. FESS procedures can be effective in the treatment of sinusitis and for the removal of tumors, polyps and other aberrant growths from the nose.
The surgical instruments used in the prior art FESS procedures have included; applicators, chisels, curettes, elevators, forceps, gouges, hooks, knives, saws, mallets, morselizers, needle holders, osteotomes, ostium seekers, probes, punches, backbiters, rasps, retractors, rongeurs, scissors, snares, specula, suction cannulae and trocars. The majority of such instruments are of substantially rigid design.
In order to adequately view the operative field through the endoscope and/or to allow insertion and use of rigid instruments, many FESS procedures of the prior art have included the surgical removal or modification of normal anatomical structures. For example, in many prior art FESS procedures, a total uncinectomy (e.g., removal of the uncinate process) is performed at the beginning of the procedure to allow visualization of and access to the maxillary sinus ostium and/or ethmoid bulla and to permit the subsequent insertion of the rigid surgical instruments. Indeed, in most traditional FESS procedures, if the uncinate process is allowed to remain, such can interfere with endoscopic visualization of the maxillary sinus ostium and ethmoid bulla, as well as subsequent dissection of deep structures using the available rigid instrumentation.
More recently, new devices, systems and methods have been devised to enable the performance of FESS procedures and other ENT surgeries with minimal or no removal or modification of normal anatomical structures. Such new methods include, but are not limited to, uncinate-sparing procedures using Balloon SinuplastyTM tools and uncinate-sparing ethmoidectomy procedures using catheters, non-rigid instruments and advanced imaging techniques (Acclarent, Inc., Menlo Park, Calif.). Examples of these new devices, systems and methods are described in incorporated U.S. patent application Ser. Nos. 10/829,917 filed Apr. 21, 2004 now U.S. Pat. No. 7,654,997, entitled Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat; 10/944,270 entitled Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures; 11/116,118 filed Apr. 26, 2005 now U.S. Pat. No. 7,720,521, entitled Methods and Devices for Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses filed Apr. 26, 2005 and 11/150,847 filed Jun. 10, 2005 now U.S. Pat. No. 7,803,150, each of which is hereby incorporated herein, in its entirety. Procedures using Balloon SinuplastyTM tools such as those described in the above-noted applications, for example, are performable using various types of guidance including but not limited to C-arm fluoroscopy, transnasal endoscopy, optical image guidance and/or electromagnetic image guidance.
In FESS procedures, the surgeon typically holds or navigates the endoscope with one hand while using the other hand to handle the surgical instruments. Recognizing the desirability of integrating an endoscope with an operative device so that both could be moved with a single hand, application Ser. No. 11/234,395 filed Sep. 23, 2005 now U.S. Pat. No. 7,410,480 describes a number of transnasally insertable sinus guides that have endoscopes attached thereto or integrated therewith.
There remains a need for further development of new devices and methodology to facilitate the integration of endoscopes with sinus guides and/or other instruments to facilitate endoscopic viewing of guidewires and/or other devices/instruments as they are transnasally inserted, positioned and used to treat disorders of the ear, nose, throat, paranasal sinuses or other intracranial disorders that are transnasally accessible.
SUMMARY OF THE INVENTION
A beneficial aspect of the present invention is to allow a user to be able to see an adjustable view, with an endoscope, that is generally aligned with the same axis of movement of the user's working device. This is particularly useful when the axis of movement is at an angle with respect to the axis of entry into the patient. This aspect allows the user to see “around the corner” of anatomy that ordinarily would block his/her view and which would therefore require removal in a traditional FESS procedure to allow visualization. This aspect of the invention allows the user to also verify the location of his/her Balloon SinuplastyTM tools without having to use fluoroscopy or image guidance systems, so that the procedure does not have to be performed in an operating room. Another beneficial aspect of the present invention is that it enables a reduction in the amount of fluoroscopy that needs to be performed by the user doing the procedure, resulting in a reduction in radiation exposure to the user and the patient.
Another beneficial aspect of the present invention is that it allows a user to hold a tool with an endoscope attached or incorporated therein, such that both can be held with one hand while allowing the user to manipulate another tool with the other hand, thereby eliminating the need for an assistant.
A method for positioning a guide device useful for delivering at least one working device therethrough to deliver a working end portion thereof to a desired location within the ear, nose, throat or cranium of a human or animal patient is provided, including the steps of: inserting an endoscope into or through an endoscope channel of the guide device that includes an elongated shaft; inserting the guide device into an internal space of the patient; and viewing through the endoscope to guide positioning and delivery of the guide device to an intended location in the patient.
A method for locating a sinus ostium is provided, including the steps of: inserting an endoscope through a nostril of a patient and advancing the endoscope toward a location of the sinus ostium; inserting a guidewire through the nostril and advancing a distal end portion of the guidewire distally of a distal end of the endoscope; and viewing, through the endoscope, the advancement of the distal end portion of the guidewire to facilitate guidance of the advancement of the guidewire along a desired path.
A method for treating a patient is provided, including the steps of: inserting an endoscope into or through an endoscope channel of a guide device that includes an elongated shaft; inserting the guide device through a nostril of the patient; advancing a distal end portion of the guide device toward a sinus ostium of the patient; advancing a distal end portion of the endoscope distally of the distal end portion of the guide device, and navigating the distal end portion of the endoscope through the sinus ostium, said navigating being assisted by visualization through the endoscope.
A method of visually inspecting a sinus cavity is provided, including the steps of: inserting an endoscope through a lumen of a working device having previously been inserted through a nostril of a patient, through a sinus ostium and into the sinus cavity; and viewing the sinus cavity through the endoscope.
A method of directing a guidewire to a target location within the ear, nose, throat or cranium of a patient is provided, including the steps of: inserting an illuminating guidewire internally of the patient; emitting light from a distal end portion of the guidewire; and tracking movements of the distal end portion of the guidewire by tracking movements of an illumination spot visible externally of the patient, wherein movements of the illumination spot correspond to movements of the distal end portion of the guidewire internally of the patient.
A guide device useable to position a working device at a desired location within the ear, nose, throat or cranium of a human or animal subject is provided, including: a transnasally insertable elongate shaft having a proximal end and a distal end; a first channel into which an endoscope may be inserted so that the endoscope may be used to view at least an area beyond the distal end of the shaft; and a second channel through which the working device may be advanced, wherein the first channel is statically located relative to the second channel.
A flexible microendoscope is provided, including: an elongated shaft; a plurality of image fibers; a lens attached at distal end of said image fibers; and a plurality of light transmitting fibers; wherein the microendoscope has a cross-sectional area permitting insertion into a nasal cavity of a patient.
An illuminating guidewire device is provided, including: a flexible distal end portion; at least one light emitting element in the distal end portion; at least one structure extending from a proximal end of the device through a proximal end portion of the device and at least part of the distal end portion to connect the at least one light emitting element with a power source; a coil; and at least one coil support within the coil, with at least a portion of each coil support fixed to the coil.
A method of making an illuminating guidewire is provided, including the steps of: providing a coil having a predetermined length and diameter; inserting mandrels through an annulus of the coil; inserting a first core support into the coil and fixing a portion of the first core support at a predetermined length from a distal end of the coil; removing a mandrel and inserting a second core support; fixing said second core support at predetermined locations along a length thereof, to the coil and fixing the first core support at additional locations along the length thereof to the coil; and inserting illumination fibers.
A transnasally insertable guide system for positioning an endoscope at a desired location within the ear, nose, throat or cranium of a human or animal subject is provided, including: a tubular guide having an elongate shaft and a lumen, at least a portion of the elongate shaft having a predetermined shape; a sheath sized to be inserted into the lumen of the tubular guide, the sheath comprising an elongate flexible body having a distal end and a scope lumen; and an endoscope that is advanceable through the scope lumen of the sheath, wherein the endoscope is useable to view the anatomy when advanced through the scope lumen of the sheath having been inserted into the guide and the guide having been inserted into an internal space within the patient; and wherein the sheath and endoscope are thereafter removable leaving the tubular guide in place.
A guide device useable to position a working device at a desired location within the ear, nose, throat or cranium of a human or animal subject is provided, including: a transnasally insertable elongate shaft having a proximal end and a distal end; a channel through which the working device may be advanced, wherein the shaft comprises an oblique distal tip.
These and other features of the invention will become apparent to those persons skilled in the art upon reading the details of the devices, methods and systems as more fully described below.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of one embodiment of a guide system of the present invention.
FIG. 2 is a perspective view of the guide system of the present invention in use on a human subject.
FIG. 3A is a side view of the guide catheter of the system of FIG. 1.
FIG. 3B is a cross sectional view through line 3B-3B of FIG. 3A.
FIG. 3C is a cross sectional view through line 3C-3C of FIG. 3A.
FIG. 3D is a side view of the endoscope of the system of FIG. 1.
FIG. 3E is a cross sectional view through line 3D-3D of FIG. 3C.
FIG. 3F is a cross-sectional view of a low profile endoscope.
FIG. 3G is a cross-sectional view of another embodiment of a low profile endoscope.
FIG. 3H illustrates a steering mechanism provided in an endoscope that can be operated from a proximal end portion of the endoscope.
FIG. 3I illustrates a guide device according to one embodiment of the present invention.
FIG. 3J illustrates a distal portion of a guide device having a removably attached endoscope channel.
FIG. 3K illustrates a snap fitting that may be used to releasably attach an endoscope channel to a main tube of a sinus guide.
FIG. 3L is a side view of the connector/camera/light cable assembly of the system of FIG. 1.
FIG. 3M illustrates a snap fitting that may be used to releasably connect an endoscope and a sinus guide in a coaxial orientation.
FIG. 4A shows a distal portion of a guide device configured with a static channel, for accessing a sphenoid sinus.
FIG. 4B shows a distal portion of a guide device configured with a static channel, for accessing a frontal sinus.
FIG. 5A illustrates a partial plan view of guide device showing one embodiment of a handle.
FIG. 5B illustrates a longitudinal sectional view of FIG. 5A.
FIG. 6A illustrates another embodiment of a guide device.
FIG. 6B illustrates another embodiment of a guide device.
FIGS. 7A-7C illustrate distal end portions of guide devices having curved sections, each with a different radius of curvature.
FIGS. 8A-8D are cross-sectional illustrations showing various placement locations of an endoscope channel within a main tube of a guide device.
FIG. 9A illustrates a guide device having a distal end with a circular tip.
FIG. 9B illustrates a guide device having a distal end with an oblique tip.
FIG. 9C illustrates an end view of the device of FIG. 9A.
FIG. 9D illustrates an end view of the device of FIG. 9B.
FIG. 10A illustrates the reduced profile of a device having an oblique tip relative to the profile of the device having a circular end that is substantially perpendicular to the tubing at the end in FIG. 10B.
FIG. 10B shows a device in which both tubes have circular ends that are substantially perpendicular to the walls of the tubing.
FIGS. 10C-10D show reduced profiles of oblique tip devices including a set back endoscope channel.
FIG. 11 is a partial perspective view of a guide device of the present invention with an optional linking apparatus for linking the endoscope to a working device to deter divergence of the endoscope away from the path of the working device.
FIG. 12 is a side view of a guidewire having an angled distal tip.
FIG. 13A shows a step in a method for using a guide system of the present invention in conjunction with the guidewire of FIG. 10.
FIG. 13B shows another step in a method for using a guide system of the present invention in conjunction with the guidewire of FIG. 10.
FIG. 14 illustrates an example of a procedure in which a guide device has been introduced through a nostril and an endoscope has been delivered through a sinus ostium.
FIG. 15 illustrates a working device having been inserted through the guide device of FIG. 14 and into a sinus cavity.
FIG. 16 illustrates a method in which an endoscope has been inserted through a lumen of a working device to enter a sinus cavity.
FIGS. 17A-17D are illustrations of partial sagittal sectional views through a human head showing various steps of one embodiment of a method of gaining access to a paranasal sinus using a sinus guide.
FIG. 18 illustrates use of an endoscope inserted through the guide device for visualization.
FIG. 19 shows an illuminating guidewire according to one embodiment of the present invention.
FIG. 20 illustrates an end view of a semi-cylindrical illumination fiber.
FIG. 21A shows a core support that may be used to support an illuminating guidewire.
FIG. 21B shows a core support that may be used to support an illuminating guidewire.
FIGS. 21C-21D illustrate a variation of the core support shown in FIG. 21A.
FIG. 22A shows an example of a core support formed from an oval wire.
FIG. 22B illustrates a proximal end view of the core support of FIG. 22A.
FIG. 23A shows a distal portion of a coil having been stretched to break tension between adjacent coils and to form an open-pitch portion.
FIG. 23B illustrates insertion of mandrels and a first core support into a coil.
FIG. 23C shows a cross-sectional view taken along line 23C-23C of FIG. 23B.
FIGS. 24A-24B illustrate the sliding ability of core supports relative to one another during bending of the coil.
FIG. 25A illustrates an embodiment of an illuminating guidewire in production showing solder joints employed in this embodiment.
FIG. 25B is a longitudinal sectional view of the guidewire of FIG. 25A taken along line 25B-25B.
FIG. 25C is an enlarged view of the portion of FIG. 25A surrounded by line 25C.
FIG. 25D is an enlarged view of the portion of FIG. 25B surrounded by line 25D.
FIG. 26 illustrates a step of melting a polymer tube into the open-pitched portion of the coil.
FIGS. 27A-27B illustrate steps for mounting a connector to a proximal end of the illuminating guidewire.
FIG. 28 illustrates insertion of illumination fibers and formation of a distal lens.
FIG. 29 illustrates finishing steps at a proximal end of the illuminating guidewire.
FIG. 30 shows an embodiment of an illuminating guidewire without a proximal connector.
FIG. 31 illustrates an example of a permanently attached rotating male luer connector that is attached to a proximal end portion of an illuminating guidewire.
FIG. 32 shows the illumination guidewire of FIG. 30 with a proximal connector permanently connected thereto.
FIGS. 33A-33B illustrate formation of a preset bend in a core support.
FIG. 34 illustrates a resulting bend in an illumination guidewire employing a core support having a preset bend.
FIG. 35 illustrates etching the coil.
FIG. 36 illustrates connection of a light cable to an illuminating guidewire according to one embodiment.
FIG. 37 illustrates a light cable having another connector embodiment.
FIG. 38 illustrates a light cable having another connector embodiment.
FIG. 39 illustrates connection of a light cable to an illuminating guidewire according to another embodiment.
FIG. 40 shows an illuminating guidewire according to another embodiment of the present invention.
FIG. 41 illustrates an alternative transparent portion that may be included in a device shown in FIG. 40.
FIG. 42 illustrates another alternative transparent portion that may be included in a device shown in FIG. 40.
FIGS. 43A-43C are illustrations of partial coronal sectional views through a human head showing various steps of a method for inserting an illuminating guidewire into an ostium that opens to a frontal sinus.
FIG. 44 illustrates a situation where a scope has been inserted as far as possible without causing significant trauma to the patient.
FIGS. 45-47 show additional embodiments of transnasally insertable guide systems useable to position an endoscope.



DETAILED DESCRIPTION OF THE INVENTION
Before the present devices and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a channel” includes a plurality of such channels and reference to “the endoscope” includes reference to one or more endoscopes and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
Sinus Guide with Continuous Endoscope Channel
FIG. 1 shows one embodiment of a sinus guide system 10 of the present invention. This sinus guide system 10 comprises a sinus guide 12 and a camera/transmission/endoscope assembly 14. This embodiment of the sinus guide 12 is shown in more detail in FIGS. 3A-3C. As shown, this sinus guide 12 comprises a sinus guide body 26 and an endoscope channel 28 in generally side-by-side arrangement. The sinus guide body 26 comprises a tube 44 having a lumen 45 (e.g., see FIG. 3B), such as a polymer tube made of biocompatible polymeric material. A distal end portion 44d, e.g. a length of about 2 mm may be made of stainless steel, for example, to increase durability, as illustrated in FIG. 3I. Similarly, a distal end portion 28d of channel 28 can be formed of stainless steel. Alternatively, channel 28 and/or tube 44 can be formed of stainless steel along the entire length thereof. Further alternatively, tube 44 and/or channel 28 may be formed over an entire length thereof of stainless steel or other biocompatible metal, except for a polymer distal tip. Optionally, a liner 46 (FIG. 3B) may be disposed within the lumen 45 of the tube 44. Such liner may be formed of lubricious or smooth material such as polytetrafluoroethylene (PTFE). Also, optionally, a proximal portion of the tube 44 may be surrounded by an outer tube member 42 formed of material such as stainless steel hypotube. In the embodiment shown, a distal portion of tube 44 extends out of and beyond the distal end of outer tube 42. This protruding distal portion of tube 44 may be straight or curved. Also, it may be pre-formed at the time of manufacture or malleable to a desired shape at the time of use. When intended for use in accessing the ostium of a paranasal sinus, the distal portion of tube 44 may be curved to form an angle A from about 0 degrees to about 120 degrees. For example, a series of sinus guides 12 having angles A of 0, 30, 70, 90 and 110 degrees may be provided thereby allowing the physician to select the sinus guide angle A that is most appropriate for the particular paranasal sinus ostium to be accessed. Additionally, in some embodiments, a rotation grip 60 may be positioned about a proximal portion of the sinus guide 10, as seen in FIGS. 1, 3A and 3B. This rotation grip 60 may have a smooth or textured round outer surface (e.g., it may be a cylindrical tube), or it may have a contoured shape, raised at a distal end portion thereof (as well as, optionally, raised at a proximal end thereof), e.g., see FIG. 3I, to prevent slipping of an operator's hand during pushing (or pulling) on the handle 60. In any case, handle 60 may be grasped between the fingers of the operator's hand and easily rotated, thereby facilitating rotation (e.g., rolling) of the sinus guide 12 as it is being used. Such rotation of the sinus guide 12 may be desirable for a number of reasons including but not limited to positioning of the distal end of the sinus guide 12 at a desired location and/or maneuvering the location of an endoscope 30 that is inserted through the endoscope channel 28.
The endoscope channel 28 may comprise any structure (e.g., tube, track, groove, rail, etc.) capable of guiding the advancement of a flexible endoscope. In the particular examples shown in these figures, the endoscope channel 28 comprises a tube (e.g., a polymer tube or stainless steel tube or combination of polymer and metal, as noted above) having a lumen 29 extending therethrough. In the embodiment seen in FIGS. 1-3C, the endoscope channel 28 is attached to and extends along substantially the entire length of the sinus guide body 26. In another embodiment, the endoscope channel 28 can be inside the sinus guide body 26. In other embodiments, such as described with regard to FIGS. 4A-4C in application Ser. No. 11/647,530, the endoscope channel 28 may be interrupted, non-continuous or may extend over less than the entire length of the sinus guide body 26. In the embodiment of FIG. 3I, the channel 28 extends along the majority of the length of guide body tube 44 and has a distal end portion that conforms to and hugs the curvature of the curved distal end portion of tube 44. However, the distal end of channel 28 ends proximally of the distal end of tube 44. This setback provides multiple advantages that are described in more detail below. Optionally, the distal end portion of channel 28 can be angled or biased relative to the direction or orientation of the distal end portion of tube 44. This angling or biasing can thus allow the image provided by an endoscope mounted in or on the channel 28 to be aimed toward a particular part of the surgical field. For example, the distal end portion of channel 28 may be angled or biased slightly inwards (i.e., pointing slightly towards the distal end of tube 44) so that devices present on the side of the guide opposite the location of channel 28 can be more easily visualized. An outer skin 40 may be heat shrunk or otherwise disposed around the sinus guide body 26 and endoscope channel 28 to hold the endoscope channel 28 at a desired position on the outer surface of the sinus guide body 26. In FIG. 3I, heat shrink tube or overlamination 40 surrounds the tubes 44,28 over a majority of the length of the straight portions of the tubes. Optionally, all or a portion of the curved distal end portions of tubes 44,28 may be surrounded by heat shrink tubing or overlamination 40d. Proximal end portions of tubes 44,28 are routed through separate channels in handle 60 that angles the tubes apart as they travel proximally through handle 60, so that luer fittings 45, at the proximal ends of tubes 40, 28 are spread apart further to make it easier to insert tools into the tubes 28, 40 and connect to the luers 45 with less interference from the other channel 28,40/luer 45. Additionally, the luer 45 for tube 28 can be connected to an irrigation source (saline-filled syringe or other irrigation source) to input irrigation fluid through the lumen of tube 28 to deliver fluid across the viewing tip of endoscope 30 having been inserted in the tube 28, in order to clean the viewing lens. Luer 45 can then be connected to a vacuum source to withdraw the fluid from the lens. Alternatively, irrigation or vacuum may be applied separately, to rinse debris off of the lens or the suction debris off of the lens, respectively. Further alternatively, a suction/irrigation catheter may be inserted through tube 44 to perform these same functions. This may be advantageous when the distal tip of the endoscope 30 has been extended distally of the end of tube 28 and optionally, distally of tube 44.
Alternatively, the endoscope channel 28 may be attached to the sinus guide body 26 at one or more locations by any other suitable attachment substance, apparatus or technique, including but not limited to adhesive, soldering, welding, heat fusion, coextrusion, banding, clipping, etc. The particular circumferential location of the endoscope channel 28 can be important in some applications, particularly when the sinus guide body 26 includes a curve formed in its distal portion 44. In this regard, for some applications, the endoscope channel 28 may be affixed at a particular circumferential location on the sinus guide body 26 to allow a flexible fiber endoscope 30 inserted through the endoscope channel 28 to provide a view from a desired or optimal vantage point, without obstruction from adjacent anatomical structures. This is described in more detail in application Ser. No. 11/647,530. Alternatively, channel 28 may be located interiorly of the lumen of tube 44, and may be positioned at various locations circumferentially about the inner wall of the tube 44. FIGS. 8A-8D show channel 28 mounted to the inner wall of tube 44 at 6 o'clock, 3 o'clock, 12 o'clock and 9 o'clock positions, respectively with regard to tube 44. It is noted that placement is not limited to the four relative locations shown, as the channel may be positioned intermediate of any two of the adjacent locations shown.
The curve in the distal end portion of channel 28d, when fixed/static with regard to tube 44, must accommodate the rigidity of a distal tip portion of an endoscope as it is passed therethrough, as the endoscope 30, although flexible over the majority of its length, is rigid over a small length extending from the distal tip that contains a lens. In one example, an endoscope channel 28 having an inside lumen diameter of about 0.045′′ can accommodate a rigid distal tip length of about 0.125′′ on a flexible endoscope 30 having an outside diameter of about 0.0375′′ with the curved portion of the channel 28 having a radius of curvature as low as about 0.28′′. In one particular example, the radius of curvature is about 0.40′′. For an endoscope having a rigid distal tip length of about 0.150′′, channel 28 having an inside lumen diameter of about 0.045′′ can have a curved portion having a radius of curvature as low as about 0.40′′ when the outside diameter of the endoscope is about 0.0375′′. In one particular example, the radius of curvature is about 0.58′′ for the rigid distal tip length of about 0.150′′.
A camera/cable/endoscope assembly 14 is attachable to arm 43a or the lower luer fitting 45 shown in FIG. 3I. In the particular embodiment shown in FIGS. 1 and 3L, the camera/cable/endoscope assembly 14 comprises an adjustable scope/lock extension 16, an endoscope 18 having an elongate flexible scope body 30 and integrated light cable 50, a camera 20 and a monitor cable 24. The scope body 30 is advanced through the scope/lock extension 16 and through the lumen 29 of the endoscope channel 28. As shown in FIG. 2, the light cable 50 and monitor cable 24 may be connected to console 34 that houses a monitor 36, light source 38 and video recorder 40.
FIGS. 3D and 3E show a flexible endoscope 30 attached to a proximal body member 52 that engages and attaches to the adjustable scope/lock extension 16. As seen in the cross section of FIG. 3E, the scope 30 comprises a flexible shaft having an image fiber bundle 54 that extends coaxially through the center with light transmitting fibers 56 disposed about the periphery. In one embodiment, the flexible shaft is a braided polyimide sheathing that has a maximum outer diameter of 0.0375 inches and a length of two feet. The image fiber bundle may be made up of about 10,000 thin image fibers and the light transmitting fibers may be illumination fibers with a diameter of between about 0.008 and 0.020 inches, with a minimum lux of about 10,000. Of course, fewer or more than 10,000 fibers may be used to make up the image fiber bundle. Preferably, the distal end of the flexible shaft has a lens with a minimum field of view of about seventy degrees. FIG. 3F is a cross-sectional illustration of a flexible endoscope 30 having a low profile configuration. In this arrangement, the flexible shaft has an image fiber bundle 54 that extends coaxially through the center of the shaft with light transmitting fibers 56 disposed laterally of the image fiber bundle. Although light transmitting fibers are shown disposed laterally on both sides of image fiber bundle 54, light transmitting fibers 56 may alternatively be located all on one side of optical fiber bundle 54, as illustrated n FIG. 3G. With either of these arrangements, the height profile of the endoscope shaft 30 is reduced which allows channel 28 to, in turn be lower profile, thereby reducing the cross-sectional size of the device 12 allowing for it to be more easily advanced through the patient anatomy. For example, the cross-sectional shape of such a low profile endoscope 30 may be substantially oval, as shown in FIGS. 3F-3G, or elliptical Additionally this lowered profile makes the shaft of endoscope 30 easier to bend/more flexible when bending in the direction of the arrows shown, and this may allow for a smaller radius of curvature in the curved portion of channel 28 when channel 28 is provided with a curve in a distal portion thereof. It should be further noted that the light transmitting fibers may be physically separated from the image fibers in further alternative arrangements. For example, image fibers may extend through an image fiber light bundle 54, like illustrated in any of FIGS. 3E-3G, while light transmitting fibers 56 may run along a different part of the guide or instrument. This separation may allow for some advantages with respect to fiber flexibility and space constraints. For example, the image fibers can be positioned together at a proximal end portion of the endoscope, but separate along different arms of a Y-shaped path so that the image fibers are inserted through one lumen on the side of the guide or in a main lumen of the guide, while the light fibers are inserted through a separate lumen on the side of the guide or in the main lumen of the endoscope, but along a different part of the wall of the endoscope than the part of the wall along which the image fibers run. Thus, rather than providing an endoscope having a single lumen with both light fibers and image fibers banded together in the single lumen of the endoscope shaft, the image fibers and the light (illumination) fibers can be decoupled and inserted separately, at least at the distal end portions, with the proximal end portions being connected to a traditional light source and camera coupler. Alternatively, the image fibers and illumination fibers can be run separately along the entire lengths thereof, with an image fiber bundle connect to a camera at the proximal end thereof and a separate image fiber bundle can be connected at the proximal end thereof to a light source. The separate light fiber and illumination fiber bundles can be run through different sides, lumens or parts of the guide.
FIG. 3H illustrates a steering mechanism provided in endoscope 30 that can be operated from a proximal end portion of endoscope 30, outside the patient's body, to steer a distal tip 30d or portion thereof (e.g., lens barrel 30e) to allow directional control of the visual field provided by endoscope 30. As shown, steering mechanism 30s includes a wire extending through endoscope shaft 30 and attached to a side of lens barrel 30e, so that when tension is applied via a user pulling on a proximal end portion of wire 30s, lens barrel 30e is deflected or angularly directed in the direction shown by the arrow in FIG. 3H. Upon release of tension on wire 30s, lens barrel 30e resiliently returns to its unbiased orientation and direction. The unbiased orientation and direction of lens barrel 30e may be axially aligned with the longitudinal axis of the endoscope 30 shaft. Alternatively, lens barrel may be oriented to point angularly away (downward, in FIG. 3H) from the direction that it is biased toward when tension is applied via steering mechanism 30e. In this way, an intermediate amount of tension may be applied to align the lens barrel 30e with the longitudinal axis of endoscope 30 shaft, and a greater amount of tension can be applied to steer the lens barrel 30e still further in that direction (e.g., pointing angularly upwardly in FIG. 3H). Further alternatively, more than one wire or other steering actuators 30s may be attached to lens barrel 30e for directionally pointing the lens barrel 30e. In different directions. As one non-limiting example, a second wire 30s can be mounted on an opposite side of lens barrel 30e to the side in which the first wire 30s is shown mounted in FIG. 3H. As another example, four wires 30s can be mounted at ninety degree intervals around the circumference of barrel 30e. Further arrangements for controlling along different directions may also be provided, as would be apparent to one of ordinary skill in the art, after reading the above description.
FIG. 3J is a partial view of a sinus guide 12 in which channel 28 is detachable from tube 44. For example, channel 28 may be attachable to and detachable from tube 44 via snap fit, such as by assembling one or more snap fittings 51 on tube 44. Snap fitting 51 includes an enclosed lumen 441 through which tube 44 is received, and which forms a friction fit with tube 44, and a lumen 281 with an opening that allows channel 28 to be inserted therethrough. The width of the opening 28o is less than the outside diameter of channel 28, so that when channel 28 is pushed therethrough, the legs on opposite sides of the opening 28o are deformed outwardly to allow tube to pass therethrough. When channel 28 has seated in lumen 281, the legs resiliently snap back into the configuration shown in FIG. 3K, thereby retaining tube in lumen 281 by a snap fit. Alternatively, lumen 281 can be enclosed and lumen 441 provided with an opening, in which case snap fitting 51 would be slid longitudinally over channel 28 to form a friction fit therewith and tube 44 would be inserted through an opening to perform the snap fit. Further alternatively, both lumens 281 and 441 can be provided with openings to allow snap fitting of both components in the respective lumens. Still further alternatively, channel 28 may be provided as attachable and detachable to and from tube 44 via hook and loop type fasteners, adhesives that remain sticky and are thus reusable, or other quick release mechanical fasteners. FIG. 3M illustrates a snap fitting 51 that includes a lumen 441 in which tube 44 is received forms a friction fit with tube 44, and a lumen 301 in which endoscope 30 is received to form a friction fit with endoscope 30. Both lumens 441 and 301 include openings 40o and 30o, respectively. The openings 441 and 301 allow the tube 44 and endoscope 30 to be passed therethrough, respectively. The widths of the openings 44o and 30o are less than the outside diameters of tube 44 and endoscope 30, respectively. Thus, when tube 44 is pushed through opening 44o, the legs on opposite sides of the opening 44o are elastically deformed outwardly to allow tube 44 to pass therethrough. Likewise, when endoscope 30 is pushed through opening 30o, the legs on opposite sides of the opening 30o are elastically deformed outwardly to allow endoscope 30 to pass therethrough.
The provision of attachable/detachable tube 28 makes it easier to match the curve of the distal end portion of channel 28 to the rigidity characteristics of the endoscope 30 to be inserted therethrough, particularly the length of the rigid distal tip portion. Thus, for example, a kit of tubes 28 having distal end portions of varying curvatures (and, optionally, having varying lumen diameters) may be provided so that an appropriate channel 28 can be selected by a surgeon to accommodate the rigidity characteristics of the particular endoscope to be inserted therethrough, and then the selected tube can be attached to tube 44.
Alternatively, channel 28 may be inserted independently of tube 44, which may make it easier to locate the distal end portion of channel 28 in a target cavity. However, when used separately, this requires use of a second hand, one to manipulate tube 44 and a second to manipulate channel 28.
As noted above, the distal end of channel 28 can end proximally of the location of the distal end of tube 44, so that the distal end of channel 28 is located proximally of the distal end of tube 44 by a setback distance 53. Setback distance 53 may be about one mm to about four mm, typically about two mm, for sinus guides having statically placed tubes 28. As noted above, placement of channel 28 on a relative location about the circumference of tube 44 may vary, for example for various uses in the frontal, maxillary and/or sphenoid sinuses. Setback 53 allows the distal end of endoscope 30 to be advanced distally beyond the distal end of channel 28 without extending distally beyond the distal end of guide body tube 44, thereby adding protection to the distal end of the endoscope 30 while allowing better visualization when the tip is distally extended from the distal end of channel 28. This can be particularly advantageous during advancement of the device 12, for example.
Additionally, setback 53 also reduces the distal profile of the guide device 12, facilitating entry and passage through smaller openings than allowable by a device that has a distal tip cross sectional area formed by the combined cross sectional areas of tube 44 and channel 28. Setback 53 also provides a tapering effect, reducing the physical impact from endoscope channel 28 as it is traversed through the patient's anatomy.
A distal end portion of channel 28 (including at least distal tip portion 28d, but which may extend proximally thereof) may be colored with a color that contrasts with a color of the remainder of the channel. This provides visible notice to the user, during traversal of endoscope 30 over or through channel 28, when the viewing (distal) tip of endoscope 30 has reached the portion having the contrasting color, as the contrasting color can be visualized on the inner wall surface of the channel (e.g., lumen), so that the user is aware that the tip of the endoscope is about to be delivered distally of the distal end of channel 28. This is possible even when channel 28 is a stainless steel tube. As the scope 30 travels through the steel tube 28, even abrasions in the steel on the inner surface (lumen) are visible. When the endoscope transitions from the steel tube 28 to the polymer atraumatic tip that is colored with a contrasting color, a colored ring is visible, which is the inner wall surface of the colored polymer distal tip 28d. Additionally, or alternatively, a distal tip portion of tube 44 can be colored with a contrasting color so that this can be visualized as the distal tip of endoscope is exiting the distal end of channel 28, especially in situations where the distal end of channel 28 is proximally set back from the distal end of tube 44.
The distal tip of channel 28d is preferably formed as an atraumatic tip, having a rounded distal edge. As noted, tip 28d may be formed of stainless steel or other hard material. In this case the rounded edge makes the tip more atraumatic. Alternatively, tip 28d may be formed of a softer material such as PEBAXTM, SANOPRENETM (synthetic rubber), silicone, PELLETHANETM (thermoplastic polyurethane elastomers), or other soft plastic, which, when formed with a rounded distal edge, even further increases atraumaticity. By providing the atraumatic distal edge, this helps prevent cutting and other damage to tissues as guide device 12 is advanced through the patient's anatomy, which may include pushing through tissue, where the atraumatic tip(s) act more like blunt dissectors than cutting instruments. The distal tip of tube 44 can be formed similarly to any of the embodiments of the atraumatic distal tip of channel 28 described above. FIG. 4A shows a distal portion of device 12 configured with a static channel 28, for accessing a sphenoid sinus, for example, having tube 44 and channel 28 provided with atraumatic, rounded tips, and wherein a distal tip portion 28d of channel 28 is colored with a color that contrasts with a portion of channel 28 immediately proximal of tip 28d. FIG. 4B shows a distal portion of device 12 configured with a static channel 28, for accessing a frontal sinus, for example, having tube 44 and channel 28 provided with atraumatic, rounded tips, and wherein a distal tip portion 28d of channel 28 is colored with a color that contrasts with a portion of channel 28 immediately proximal of tip 28d. 
FIG. 5A illustrates a partial plan view of device 12 showing one embodiment of handle 60. FIG. 5B illustrates a longitudinal sectional view of FIG. 5A. Handle 60 accommodates channel 28 and tube 44 to pass therethrough and extend proximally thereof to join with connectors 45. Handle 60 may be molded over tube 44 and channel 28 in the configuration shown, or may be molded separately with channels configured and dimensioned to receive channel 28 and tube 44 therethrough (e.g., molded in halves and then assembled over the tube 44 and channel 28, using screws, clamps, adhesives, press fitting, and/or other connectors). Alternatively, the handle can be molded or machined as one piece and the lumens can then be slid into place and fixed with adhesive and/or threaded connection, etc. Handle 60 is shaped to fit a user's hand, and to be easily rotated by the user. Accordingly, handle 60 may be substantially barrel-shaped, cylindrical, or other shape that lends itself to rotation about its longitudinal axis (e.g., rounded about the longitudinal axis, or octagonal or other extruded polygonal cross-section).
The outer surface of handle 60 can be smooth for easy sliding within the hand, or can be provided with a roughened surface to enhance the grip, for pushing on the handle 60 and/or torquing it. The distal end portion is formed with an uplift, “bump” or increased cross-sectional area 60b, relative to the mid portion of the handle, to act as a stop against the hand of the user, thereby preventing the hand from sliding distally off of the handle 60 during use.
Channel 28 is guided away from tube 44 at the proximal end portions thereof, such as by an angled or curved channel 60c that directs the proximal end portion of channel 28 away from tube 44 as channel 28 passes through the channel 60c. This provides greater separation between the connectors 45, facilitating easier insertion of endoscope into channel 28 and tools or devices (e.g., balloon catheter, or any of the other devices or tools described herein or in application Ser. Nos. 11/647,530; 11/522,497; 11/193,020; 10/829,917; 11/116,118; and/or 11/150,847; without interference from the other connector 45. Bend or curve 60c also creates force feedback and acts as a frictional braking system as endoscope 30 is advanced through channel 28 at the location of the bend or curve in channel 60c, facilitating greater control of the advancement of the endoscope 30 by the user, with less risk of inserting too quickly or impulsively, or overshooting the amount of insertion. Additionally, this helps maintain the endoscope in longitudinal position relative to channel 28 even when an additional locking mechanism or valve is not provided.
Both tube 44 and channel 28 may be provided with a luer connector 45 on proximal ends thereof, to allow for attachment of a syringe for flushing, or attachment of other tools. A Touhy valve or other valve can be alternatively fitted on the proximal end of channel 28 to facilitate locking of the endoscope 30 in a position relative to channel 28. Further alternatively, a Y-adapter may be fitted to the proximal end of channel 28 to permit fixation of luer 45 to one arm of the Y and a valve to the other arm. Numerous other accessories can be attached to either channel 28 or tube 44, including drip systems, pop-off valves, etc.
FIG. 6A illustrates an embodiment of sinus guide device 12 wherein endoscope channel 28 is fixed relative to handle 60 and tube 44 is rotatable about its longitudinal axis within handle 60. Accordingly, the location of channel 28 relative to tube 44 can be varied by rotating handle 60 and holding the luer connector 45 that connects to tube 44 stationary as the handle 60 is rotated. This causes channel 28 to revolve about the longitudinal axis of tube 44, thereby repositioning the radial position of channel 28 relative to tube 44. For example, with channel 28 in a radial position at the top of tube 44 as illustrated in FIG. 6A, luer 45 connected to tube 44 can be grasped and prevented from rotating while rotating handle 60. By rotating handle 60 by 180 degrees, this results in channel 28 being positioned at the bottom side of tube 44. This rotatability to reposition channel 28 provides re-orientation of the view provided through endoscope 30 that is positioned through or over channel 28. The channel in handle 60 receiving tube 44 provides some frictional resistance to rotation of tube 44 relative thereto, so that tube 44 will not rotate relative to handle 60 during use of device 12, except when the user deliberately holds the connector 45 or tube 44 to prevent it from rotating and then rotates handle 60. Additionally, or alternatively, the channel in handle 60 receiving tube 44 and tube 44 may be provided with at cooperating detents and recesses which engage at predetermined rotational positions of the tube 44 relative to the channel. Thus, as the user rotates the handle 60 around tube 44, there are predetermined configurations where the detents engage the recesses to provide friction resistance to rotation. These detents and recesses can be placed in strategically important locations with respect to the angle of the distal end portion of tube 44. For example, it may be advantageous to have on such predetermined position/orientation with the endoscope channel 28 lined up with the greater curvature of the distal end portion 44, “riding the back of the guide”, as illustrated in FIG. 6A. Another predetermined position/orientation may be 180 degrees rotated relative to the previously described position. Of course, the placement of detents and recesses can be configured to provide additional, or alternative orientations, as desired. FIG. 6A also shows channel 28 having a distal tip positioned proximally of the curved section of tube 44. This may be advantageous for example, for use in the maxillary sinus, to provide a larger, or wider angle view of the maxillary sinus by setting the distal tip of channel 28 proximally away from the curve. It is noted that the rotatability functions and features described with regard to FIG. 6A are not limited to this embodiment with a shortened channel 28. For example, this rotatability can also be provided with a device 12 like that shown in FIG. 4A.
FIG. 6B illustrates a variation of a rotatable device 12. In this arrangement, a second handle 61 is provided proximally of handle 60. Handle 61 is fixed relative to tube 44, so that the user can hold handle 61 to prevent it and the tube 44 from rotating as the user rotates handle 60 to revolve channel 28 about tube 44. Optionally, handle 61 may be spring-biased into contact with handle 60 to act as a brake to prevent handle 60 from rotating relative to handle 61. In order to perform a rotation in this case, the user pulls handle 61 proximally out of contact with handle 60 to relieve the braking force and allow the user to rotate handle 60 while holding handle 61 stationary. Further optionally, the frictional force imposed by handle 61 against handle 60 may be great enough to prevent relative rotation during use of device 12, but can be overcome by the user twisting on handle 60 and holding handle 61 stationary, without the need to retract or reposition handle 61 relative to handle 60. As with the embodiment of FIG. 6A, the embodiments of the rotational features described with regard to FIG. 6B can be employed in other guide device 12 embodiments, and are not limited to a device having a channel 12 that ends proximally of a bend in tube 44.
For devices 12 in which distal end portions of tube 44 and channel 28 are curved, and channel 28 comprises a tube, the radius of curvature can be designed to readily allow the endoscope 30 (and particularly the distal tip portion that includes the lens, which may be rigid) to move through the lumen of tube 28 and around the curve without the need to increase the inside diameter of the lumen, so that the lumen can be designed with an inside diameter having only a small tolerance around the outside diameter of endoscope 30. Typically, standard 18 gauge hypotube is used having an outside diameter of about 0.050′′. The wall thickness is selected is as thin as possible, to maximize the inside diameter of the tube without risking buckling of the tube. Typically the wall thickness is about 0.003′′. In one particular example, the tube is 18 Gauge UTS with an outside diameter of 0.050′′+0.001′′/−0.0005′′, with an inside diameter of about 0.044′′ and therefore a tolerance of about +0.0015/−0.001′′. Alternatively, the inside diameter of tube 28 can be increased if the curvature of the distal end portion is required to have a radius of curvature that would not allow the endoscope to pass otherwise. The amount of curvature that can be successfully used with a lumen of normal tolerance relative to the outside diameter of endoscope 30 will also vary with the degree of flexibility of the endoscope 30 and the length of the lens barrel 30e. In other words, the longer that the stiff section (lens barrel and adhesive) is, the bigger is the required inside diameter of tube 28 and/or the bigger the required radius of curvature of a bend in a tube 28 to allow easy passage of the stiff section. FIGS. 7A-7C illustrate exemplary distal end portions of devices 12 in which the curvatures of tubes 28,40 are varied, wherein the larger the radius of curvature, the easier it is to pass endoscope therethrough, with all other variables being constant. In FIG. 7A, the radius of curvature is about 0.25 inches, in FIG. 7B, the radius of curvature is about 0.5 inches, and in FIG. 7C, the radius of curvature is about 0.75 inches. The insider diameters of the tubes 28 in these examples are 0.044′′+0.0015′′/−0.001′′.
In order to reduce the distal end profile of the guide device 12, tube 44 may be provided with a non-circular cross-section at the distal end thereof. By reducing the distal end profile, this facilitates entry and passage through smaller openings or relatively more constrained spaces, such as may be encountered in the passages leading to the frontal or maxillary sinuses, or other spaces relatively constrained by the patient's anatomy, as the reduced cross-sectional profile of the distal end of tube 44 is more readily able to be introduced into smaller or partially obstructed spaces, compared to tubes having a full circular distal end cross-section. FIG. 9A illustrates tube 44 having a standard, circular cross-section at its distal end. FIG. 9B illustrates tube 44 having a reduced cross-sectional area at its distal end, in this case formed by an oblique tip (e.g., a scooped-tip) 44t. Because a portion of the distal end of tube 44 is cut away to form the scooped tip, the profile of the distal end of tip 44t is significantly less than that of the tube 44, as it recedes obliquely over a cross-section thereof, as illustrated by comparing FIGS. 9C and 9D, which illustrate the distal end profiles of the tube 44 in FIGS. 9A and 9B, respectively. Accordingly, the cross-sectional profile of the oblique tip 44t tapers down from that of a circular profile, at a proximal end of the oblique tip 44t, to a semi-circle or less at the distal end of the oblique tip 44t. In addition to the advantages noted above, a tube 44 having a reduced-profile tip, such as an oblique tip 44t, for example, may facilitate entry into, or closer position to ostia by the distal end of a guide device 12. The oblique tip 44t design may also facilitate balloon retraction (of a balloon catheter), back into tube 44 after performing an ostial dilatation procedure, for example.
In particular, with regard to the maxillary sinus, the tapered cross-section provided by oblique tip 44t allows the distal end of tube 12 to be easily passed behind the uncinate process. In the frontal recess, the oblique tip 44t may provide additional freedom of movement of device 12.
In addition to providing a significantly reduced cross-sectional area at the distal end, oblique tip 44t of FIG. 9B also provides a larger opening than the circular opening of the standard tube end, like shown in FIG. 9A, for tubes 44 having the same inside diameter. Accordingly, as mentioned above, this may make it easier to retract a balloon portion of a balloon catheter back into the lumen of tube 44, e.g., after performing a dilatation procedure and deflating the balloon. Additionally, the curvature of the sides of the oblique tip (scoop shape), tapering down to the proximal end of the oblique tip (scoop shape) can facilitate folding of the balloon as it is retracted into the lumen of tube 44.
The oblique tip 44t can be provided on a guide device 12 that does not include an endoscope channel, as illustrated above with regard to FIG. 9B. Further the advantages discussed above can also be provided to a guide device 12 that does include a channel 28 integrated therewith. The channel 28 may be fixed relative to tube 44 and may be removably fixed, as described previously. FIG. 10A illustrates an example of guide device 12 having a fixed channel 28 that extends so that the distal end of channel 28 is substantially flush with the distal end of oblique tip 44t. Although this arrangement is not preferred as it is preferred to provide a setback, even with this arrangement, the reduced cross-sectional profile at the end of oblique tip 44t compensates, or helps to compensate for the additional cross-section profile of the end of channel 28. That is, the cross sectional dimension 12×1 is less than the cross-sectional dimension 12×2 measured across the distal ends of tubes 44 and 28 when tube 44 has a circular profile distal end as shown in FIG. 10B.
An even greater advantage in reducing the distal end profile of a device 12 having both tube 44 and channel 28 can be obtained by orienting the distal end of channel 28 with a setback 53 as described above and as illustrated in FIGS. 10C and 10D. Regardless of whether the bend in the tube 44 and channel 28 is an acute angle or an obtuse angle (or right angle), the distal end cross-sectional dimension 12×1 is greatly reduced relative to 12×2 in FIG. 10B, and even the cross-sectional dimension 12×3 that includes the profile of channel 28, but is set back from the distal end of device 12, is reduced relative to 12×2.
Optional Linkage of Endoscope to Working Device
In some applications, it may be desirable to advance the flexible endoscope 30 out of and beyond the distal end of the endoscope channel 28, 28d, and even beyond the distal end of tube 44. For example, as shown in FIG. 11, the endoscope 30 may sometimes be advanced along side a working device, such as a guidewire 110, so as to view the advancement, positioning and/or use of the working device. In such instances, it is desirable to prevent the endoscope from diverging away from the working device and/or to maintain the endoscope 30 at a specific spaced distance away from the working device. To accomplish this, an optional linkage device 62 may be used to link (e.g., couple, connect or attach) the endoscope 30 to the guidewire 110 or other working device. Other working devices that may be inserted through tube 44, and optionally linked to endoscope 30 via linkage device 62, include, but are not limited to: graspers, catheters, instrument or other device useable to perform or facilitate a therapeutic or diagnostic task such as local or regional drug delivery, biopsy, suction, irrigation, polyp removal, fungal ball removal or other mass removal.
Operation and Positioning of the Endoscope and Working Device
As noted, the flexible fiber endoscope 30 may be freely advanced to or beyond the end of the sinus guide 12 and retracted during use, in order to facilitate endoscopic viewing of the desired anatomical structures and/or to view, guide and/or verify the positioning of the sinus guide device 12 or a working device that has been inserted through the sinus guide. The ability to advance the tip of the flexible fiber endoscope 30 beyond the end of the sinus guide allows the tip to be positioned closer to anatomy or to reach spaces in the paranasal sinuses that the sinus guide tip cannot travel to due to size constraints.
In some instances, it may be desired to advance a guidewire 110 into or through a specific body opening, such as an opening of a paranasal sinus. In such applications, as shown in FIG. 12, it is sometimes desirable to form a bend in the guidewire 110 near its distal end DE so that rotation of the guidewire in situ will redirect its distal end DE. The guidewire may be maneuvered into the opening by simply rotating the guidewire 110. FIGS. 13A and 13B show an example of such a procedure, wherein the guide device 12 is advanced to a position where its distal end is a spaced distance D from the opening O into which the guidewire 110 is to be inserted. In some instances, the user may use fluoroscopy and/or a surgical navigation system to position the guide device as described in previous applications to which this application claims priority and which have been incorporated herein by reference. With the guide device 12 so positioned, an endoscope inserted through the endoscope channel 28 may be used to view the distal end DE of the guidewire 110 as it advances out of the distal end of the sinus guide body tube 44. With the flexible endoscope 30 so positioned, the user has a view generally along the same axis as the distal opening of the guide device, rather than the proximal axis of the guide device. Furthermore the view can be from behind anatomy that normally would block a conventional endoscope view. In FIG. 13A, the view provided by the endoscope allows the operator to see that the distal end of the guidewire 110 is not directed into the opening O. As a result, the operator may rotate the guidewire 110 causing its distal end DE to be directed into the opening O as verified by the view provided from the endoscope. Thus, in these sorts of applications, it is desirable to place the distal end of the sinus guide device 12 at a spaced distance D back from the opening O rather than advancing it to a point where the distal end of the sinus guide body is immediately adjacent to or within the opening O. In an alternative embodiment, the guidewire can be an illuminating guidewire as described in co-pending application Ser. Nos. 11/522,497 and 11/647,530, or as described herein.
Use of Flexible Endoscope with Intra-Sinus Procedures
Many current FESS procedures are performed to open sinus ostia. Also, balloon dilatation of sinus ostia can be performed in a balloon sinuplasty procedure, embodiments of which have been discussed previously in co-pending applications incorporated by reference herein. The flexible endoscopes described herein can be utilized, with or without guide device 12 to facilitate direct visualization of such procedures.
However, until now, the number of procedures performed inside a sinus cavity have been limited, due to challenges with visualizing such procedures, since direct visualization was not possible, due to the prohibitive profile sizes and rigidity of endoscopes conventionally used in the procedures. The current invention provides flexible endoscopes 30 as small as about one mm outside diameter and may be semi-rigid. This small outside diameter of endoscope 30 permits it to be inserted through an ostium either pre- or post-dilation of the ostium to provide direct visualization inside the sinus cavity. This visualization capability may therefore facilitate direct viewing of intra-sinus therapies, treatments and procedures.
FIG. 14 illustrates an example of a procedure in which sinus guide device 12 has been introduced through a nostril 2 of a patient 1 and through a nasal cavity to a location close to an ostium 1014 of a sinus 1016. Endoscope 30 may be used in a position where the distal tip of the endoscope is flush with the opening 28d of channel 28, extends distally beyond distal end 28d, but not distally beyond the distal end of tube 44, or slightly distally beyond the distal end of tube 44 to provide direct visualization of a procedure to dilate the ostium 1014, for example. In some cases, intra-sinus procedures may be commenced without dilating the ostium 1014. Accordingly, either without dilatation of the ostium 1014, or before of after dilatation of ostium 1014, endoscope 30 is further distally advanced through the ostium to position the distal viewing tip of the endoscope within the sinus 1016, as shown in FIG. 14. A variety of therapies may be delivered into the sinus with direct visualization thereof provided by endoscope 30 positioned in the sinus 1016, including, but not limited to: local or regional drug delivery, biopsy, suction, irrigation, polyp removal, fungal ball removal and/or removal of other mass. Endoscope 30, when positioned in a sinus 1016 may also be useful for intra-sinus diagnosis to assess an underlying disease, to evaluate ciliary function by viewing transport of a dyed fluid, or other diagnostic procedure. These therapeutic and diagnostic procedures may additionally be facilitated by insertion of one or more tools, instruments or devices through the lumen of tube 44 to deliver a working end portion of the tool, device or instrument through the ostium 1014 and into the sinus 1016. A variety of tools, instruments or devices may be inserted through tube 44, including, but not limited to: graspers, cutters, punches, flexible microdebriders, dissectors, electrodes for energy delivery (RF, heat, cryotherapy, ultrasound, or microwave), lasers, suction catheters, irrigation catheters, balloon catheters, etc.
FIG. 15 illustrates an intra-sinus procedural step in which endoscope 30 has been positioned intra-sinusly, in sinus 1016 in a manner as described above with regard to FIG. 12. Additionally a flexible graspers instrument 1007 has been inserted through a lumen of tube 44 and advanced to deliver the distal, working end into the sinus 1016. By viewing the working end of the graspers 1007 through endoscope 30, an operator can advance the working end and operate the grasping jaws 1007j to approach a mass 1016m in the sinus that is desired to be removed, position the jaws 1007 around the mass 1016m or a portion thereof, and clamp the jaws to capture the mass 1016m or a portion thereof. By then retracting tool 1007, the mass 1016m or a portion thereof that has been captured by jaws 1007j can be withdrawn through ostium 1014, with visualization of all of these steps being facilitated through endoscope 30. The mass 1016m or a portion thereof having been captured and torn away or otherwise removed from the sinus 1016 and through ostium 1014 is then withdrawn through tube 44. Alternatively, viewing of retraction of the mass into the tube 44 can be performed by retracting the distal end of endoscope 30 to a location just proximal of ostium 1014 or just proximal of the distal end of tube 44. Further alternatively, if the mass 1016m is too large to be retracted through tube 44, device 12 can be removed simultaneously with the removal of tool 1007 and the mass 1016m. 
It is noted that FIG. 15 is only one example of procedures that can be performed intra-sinusly and that the present invention is by no means limited to this procedure, as many other procedures can be performed, some examples of which were listed above.
FIG. 16 illustrates an alternative procedure in which endoscope 30 is inserted through a lumen of a tool, device or instrument having been inserted through tube 44 of guide device 12 and into a sinus cavity 1016. In the example shown, endoscope 30 has been inserted through the lumen of an irrigation catheter 330. Note also that device 12 may include an integrated endoscope channel 28, but need not, since the endoscope, in this example, is delivered through the same lumen in tube 44 that the working tool is delivered through. In the example shown in FIG. 16, device 12 does not include an endoscope channel 28. It is further noted that this technique is not limited to insertion of endoscope 30 through an irrigation catheter, as endoscope 30 may be similarly inserted through any other tool, instrument or device having been inserted through tube 44 and which has a lumen with a sufficient inside diameter to allow endoscope 30 to pass therethrough. Also, although reference here is made to the tool, instrument or device having a distal end portion inserted into a sinus cavity 1016, endoscope 30 may be used similarly to view locations outside of an ostium 1014, when the distal end of the tool, instrument or device ahs not been inserted through the ostium, or to view some other cavity or space, for example.
In the example shown, an irrigation procedure is first performed in the sinus 1016 prior to insertion of endoscope 30 into the lumen of the irrigation catheter 330. In this particular example, irrigation catheter has a lumen having a diameter of about 0.050′′ and endoscope 30 has an outside diameter of about 0.0375′′. Accordingly, after performing irrigation with the distal end of irrigation catheter 330 in the sinus 16, endoscope 30 is inserted through the lumen of the irrigation catheter 330 and advanced to deliver the distal (viewing) tip into the sinus cavity 1016, as shown. The user can then view through endoscope 30 to confirm whether the sinus 1016 has been cleaned out sufficiently by the irrigation process, and/or to inspect the sinus for other potential issues or ailments that might be addressed.
Illuminating Guidewire
FIGS. 17A through 17D are illustrations of partial sagittal sectional views through a human head showing various steps of one embodiment of a method of gaining access to a paranasal sinus using a sinus guide 12. In FIG. 17A, a first introducing device in the form of a sinus guide 12 is introduced through a nostril and through a nasal cavity 1012 to a location close to an ostium 1014 of a sphenoid sinus 1016. Sinus guide 12 may be straight, malleable, deflectable or shapeable at the tip, or it may incorporate one or more preformed curves or bends as further described above, as well as in U.S. Patent Publication Nos. 2006/004323; 2006/0063973; and 2006/0095066, for example, each of which are incorporated herein, in their entireties, by reference thereto. In embodiments where sinus guide 12 is curved or bent, the deflection angle of the curve or bend may be in the range of up to about 135 degrees.
In FIG. 17B, a second introduction device comprising a guidewire 110 is introduced through the first introduction device (i.e., sinus guide 12) and advanced so that the distal end portion of guidewire 110 enters the sphenoid sinus 1016 through the ostium 1014.
In FIG. 17C, a working device 1006, for example a balloon catheter 100, is introduced over guidewire 110 and advanced to extend the distal end portion of device 1006, 100 into the sphenoid sinus 1016. Thereafter, in FIG. 17D, working device 1006, 100 is used to perform a diagnostic or therapeutic procedure. In this particular example, the procedure is dilatation of the sphenoid sinus ostium 1014, as is illustrated in FIG. 17D, where the balloon of device 1006 is expanded to enlarge the opening of the ostium 1014. After completion of the procedure, sinus guide 12, guidewire 110 and working device 1006, 100 are withdrawn and removed. It will be appreciated that the present invention may also be used to dilate or modify any sinus ostium or other man-made or naturally occurring anatomical opening or passageway within the nose, paranasal sinuses, nasopharynx or adjacent areas. As will also be appreciated by those of ordinary skill in the art, in this or any of the procedures described in this patent application, the operator may additionally advance other types of catheters, and that guidewire 110 may be steerable (e.g. torquable, actively deformable) or shapeable or malleable.
FIGS. 17B-17D show endoscope 30 having been inserted through channel 28 to provide visualization of advancement of sinus guide 12 and/or inserted alongside sinus guide 12 to provide visualization of all or at least a portion of working tool 1006, 100. It is to be appreciated that scope 30 may comprise any suitable types of rigid or flexible endoscope and such optional scope may be separate from or incorporated into the working devices and/or introduction devices of the present invention, as further described herein. In one preferred embodiment, endoscope 30 is a flexible fiber endoscope 30 as described herein.
In cases where a scope 30 provided is not capable of being inserted into a particular sinus cavity of interest, or to extend the view of endoscope or otherwise assist visualization through the endoscope, and/or to provide visualization for guiding guidewire 110 into the sinus cavity either prior to insertion of endoscope in the cavity or where endoscope 30 is incapable of being inserted into that particular cavity, an illumination guidewire 110 may be utilized to enhance visualization.
Further, depending upon the particular configuration of the sinus passageways to be traversed to gain access to a target ostium, the scope 30, due to physical limitations (e.g., outside diameter, degree of rigidity, etc.) may be unable to visualize as deep as the location of the ostium of interest. For example, FIG. 18 illustrates a situation where scope 30 has been inserted as far as possible without causing significant trauma to the patient. The range of adequately illuminated visibility in this case does not extend all the way to ostium 1020, as indicated schematically by the rays 1009 shown extending distally from scope 30. In this case, adequately illuminated visualization of guidewire 110 into ostium 1020 would not be possible via scope 30. Additionally, if sinus guide 12 is physically capable of being extended further distally to place the distal end thereof at the approach to ostium 1020, scope 30 would also not be capable of adequately visualizing this. Thus, prior to the provision of an illuminated guidewire 110 as described herein, fluoroscopic or other x-ray visualization of these procedures was required, in order to ensure that the devices approach (and extend through) the appropriate ostium 1020 and not another adjacent opening, such as opening 1024.
In order to overcome these and other problems, the guidewire devices 110 of the present invention include their own light emitting capability. By illuminating a distal end portion of guidewire 110, a process known as transillumination occurs as guidewire 110 traverses through the sinus passageways, passes through an ostium and enters a sinus cavity. Transillumination refers to the passing of light through the walls of a body part or organ. Thus, when guidewire 110 is located in a sinus, the light emitted from guidewire 110 passes through the facial structures and appears as a glowing region on the skin (e.g., face) of the patient. It is noted that the light emitted from scope 30, such as positioned in FIG. 18, for example, results in transillumination as well, but the resultant glow is much more diffuse and larger in area. As the light source in guidewire 110 gets closer to the surface of the structure that it is inserted into (e.g., the surface of the sinus), the transillumination effect becomes brighter and more focused (i.e., smaller in area). Additionally, the movements of the guidewire 110 can be tracked by following the movements of the transillumination spot produced on the skin of the patient. For example, the light emission portion of illumination guidewire can cause transillumination as guidewire 110 is being manipulated to gain access to an ostium and sinus. By tracking movements of a transillumination spot that moves as the illuminating portion of the guidewire 110 is moved during the manipulation, this can provide feedback to the user about steering and positioning and whether or not they are successful in entering through the ostium and into the sinus of interest. For example, transillumination may be visible on the bridge of the nose when gaining access to the frontal sinus. If the user positions the illuminating guidewire 110 medially, transillumination may show in the medial aspect. As the user looks for the frontal recess, he may then move the illuminating guidewire 110 laterally. Transillumination can then confirm that the distal end portion of the guidewire has indeed been moved laterally, as the user tracks the lateral movement of the illumination spot.
FIG. 19 shows an illuminating guidewire 110 according to one embodiment of the present invention. Device 10 includes a flexible distal end portion 110d that provides a similar degree of flexibility to a standard, non-illuminating type of guidewire. Distal end portion 110d may include a coil 110c as an exterior portion thereof, to help provide the desired flexibility to this portion. The proximal end portion 110p of device 110 extends the device to provide a sufficient length so that device 110 extends proximally out of the patient (and, when inserted through another device, such as a sinus guide 12, proximally out of the device into which guidewire 110 is inserted), at all times, including the deepest location into which the distal end of device 110 is placed. The proximal end portion 110p can have visible markings, preferably spaced at equal intervals, that can be observed by the user to confirm how far the guidewire 110 has been placed in the patient. Proximal end portion 110p also provides the necessary mechanical properties required to make the guidewire function properly. These mechanical properties include torquability, i.e., the ability to torque the proximal end portion 110p from a location outside of the patient and have that torque transmitted to the distal end portion 110p; pushability, i.e., sufficient rigidity, so that when an operator pushes on the proximal end portion 110p from a location outside of the patient, the pushing force transmits to the distal portion 110d to advance the distal portion 110d without buckling the device 110; and tensile strength so that an operator can pull on the proximal end portion 110p from a location outside of the patient and withdraw device 110 from the patient without significant plastic deformation or any disintegration of the device.
Coil 110c may be formed from a stainless steel wire, for example. In the examples shown, coil 110c is formed as a single wind coil, i.e., from a single wire. Alternatively, coil 110c may be formed by multiple wires coiled simultaneously to form a single coil 110c from multiple wires. The diameter of the coil wire can be between about 0.004 and about 0.008 inches, typically about 0.006 inches. In one particular embodiment, coil 110c is made of stainless steel wire having a diameter of about 0.006 inches, coiled into a coil having an outside diameter of about 0.033 inches. Use of wire having a larger diameter provides added strength to the coil, but at the same time requires a larger outside diameter coil, which makes the overall device 110 more difficult to advance through small openings, but also allows more space in the inside diameter of the coil. Alternative materials from which coil 110c may be formed include, but are not limited to: ELGILOY®, CONICHROME® or other biocompatible cobalt-chromium-nickel alloy; nickel-titanium alloys, or other known biocompatible metal alloys having similar characteristics. Further alternatively, distal end portion may comprise a braided metallic construction of any of the aforementioned materials in lieu of a coil.
The external casing of the proximal portion 110p can be made from a polyimide sheath, a continuous coil (optionally embedded in polymer or having polymer laminated thereon), a hypotube (e.g., stainless steel hypotube), a laser-cut hypotube, a cable tube, or a tube made from PEBAX® (nylon resin) or other medical grade resin. In any of these cases the construction needs to meet the required torquability, pushability and tensile requirements of the device.
In the example shown, coil 110c is joined to proximal portion 110p by solder, epoxy or other adhesive or mechanical joint. One or more illumination channels 110i are provided in device 110 and extend the length thereof. Illumination channels 110i are configured to transport light from the proximal end of device 110 to and out of the distal end of device 110. In the example shown, two illumination channels are provided, each comprising a plastic illumination fiber. The plastic used to make the illumination fibers is compounded for light transmission properties according to techniques known and available in the art. As one example, ESKATM (Mitsubishi Rayon), a high performance plastic optical fiber may be used, which has a concentric double-layer structure with high-purity polymethyl methacrylate (PMMA) core and a thin layer of specially selected transparent fluorine polymer cladding. In one example, illumination fibers each have an outside diameter of about 0.010′′. In one example, two acrylic light fibers each having an outside diameter of about 0.10′′ are used. The illumination fibers can have an outside diameter in the range of about 0.005 inches to about 0.010 inches. Alternatively, a single plastic illumination fiber 101 may be used that has an outside diameter of about 0.020′′. As another alternative, a single light fiber having an outside diameter of about 0.010′′ can be used. This provides additional internal space for other components, but halves the light output compared to embodiments using two 0.010′′ fibers. FIG. 20 illustrates another alternative, in which a single, semi-cylindrical light (illumination) fiber is used, wherein the diameter 109 is about 0.020′′. This half-round or semi-cylindrical fiber frees up additional internal space in the device, relative to use of two cylindrical fibers of 0.010′′ each, and provides about the same illumination output. However, these fibers are expensive and time consuming to manufacture. Other illumination fibers 110 having custom-shaped cross sections may be alternatively used, but again may be expensive and difficult to manufacture. Further alternatively, glass illumination fibers may be substituted which are much smaller in outside diameter, e.g., about 0.002′′. In this case, more illumination fibers may be provided in a bundle, e.g., about six to fifty glass fibers 110i may be provided.
The distal end of device 110 is sealed by a transparent (or translucent) seal 110s which may be in the form of epoxy or other transparent or translucent adhesive or sealing material, which may also function as a lens. For example, seal 110s may be formed of a translucent, ultra-violet curing adhesive to form a distal lens of the guidewire 110. Alternatively, other translucent or transparent and biocompatible adhesives or epoxies may be substituted. Seal 110s maintains the distal ends of illumination fibers 110i coincident with the distal end of device 110 and also provides an atraumatic tip of the device 110. Further, seal 110s prevents entrance of foreign materials into the device. The distal end can be designed to either focus or distribute the light as it emanates therefrom, to achieve maximum transillumination effects. In this regard, the distal end can include a lens, prism or diffracting element.
The proximal end of device 110 may also be sealed by a transparent (or translucent) seal 110ps which may be in the form of epoxy or other transparent or translucent adhesive or sealing material. Seal 110ps maintains the proximal ends of illumination fibers 110i coincident with the proximal end of device 110. The proximal end of device 110 may be further prepared by grinding and polishing to improve the optical properties at the interface of the proximal end of device 110 with a light source. The illumination fibers 110i at locations intermediate of the proximal and distal ends need not be, and typically are not fixed, since no mapping of these fibers is required, as device 110 provides only illumination, not a visualization function like that provided by an endoscope. Further, by leaving illumination fibers free to move at locations between the proximal and distal ends, this increases the overall flexibility and bendability of device 110 relative to a similar arrangement, but where the illumination fibers 110i are internally fixed.
The outside diameter of device 110 may be in the range of about 0.025 inches to about 0.040 inches, typically about 0.030 to 0.038 inches, and in at least one embodiment, is about 0.035′′±0.005′′. At least the proximal portion 110p of device 110 is provided with a core support 110cw that is contained therein. In the example shown in FIG. 19, core support 110cw is a wire that is fixed to proximal section 110p such as by laser welding, epoxy or other adhesive or mechanical fixture. Core support 110cw may extend substantially the full length of device 110. In any case, core support 110cw is typically formed from stainless steel NITINOL (nickel-titanium alloy) or other biocompatible nickel-titanium alloys, cobalt-chromium alloys, or other metal alloys that are biocompatible and provide the necessary rigidity and torquability. Core support 110cw may be formed as a wire, as in the example shown in FIG. 19, or alternatively, may be braided from any of the same materials or combination of materials mentioned above. Core support 110cw, when formed as a wire can be ground to different diameters to provide varying amounts of rigidity and torquability. When formed as a braid, the braid can be formed to have varying amounts of rigidity and torquability along the length thereof. For example, core wire 110cw has a larger outside diameter at the proximal end portion than at the distal end portion so that it is more rigid and transfers more torque from the proximal portion of device 110, whereas at the distal end portion, core 110cw is relatively more flexible and twistable. For core supports 110cw that extend through proximal portion 110p, the portion of core support near the proximal end of device 110 may have an even larger outside diameter. It may be advantageous to shrink the illumination fibers 110i by heating them above a predetermined temperature (e.g., greater than about 52 degrees C.) before sealing them on both ends.
In at least one embodiment, two core supports 110cw and 111cw are provided in guidewire 110. FIGS. 21A-21B illustrate an embodiment of the first 110cw and second 111cw core supports, respectively. In FIG. 21A, core support 110cw may be formed from a nickel titanium alloy core wire having a diameter of about 0.008′′, although a similar configuration can be made starting with a core wire of different material and/or different diameter. A proximal portion 1130p of core support 110cw is maintained as the full wire profile having the diameter of 0.008′′. An intermediate section 1130i is ground down to a 0.006′′ diameter for greater flexibility in a distal end portion of the guidewire 110. The distal end portion 1130d is flattened, which facilitates soldering core support 110cw to coil 110c. The length of flattened section 1130d is maintained small, e.g., about 0.8 cm to prevent guidewire whipping. Alternatively, flattened section 1130d may be eliminated altogether with the reduced diameter round cross section 1130i extending to the distal end of core support 110cw. The length of the section 1130i (whether or not flattened section 1130d is employed) may be varied to customize the length of a flexible distal end portion of guidewire 110.
In FIG. 21B, core support 111cw that may be formed from a nickel titanium alloy core wire having a diameter of about 0.006′′, although a similar configuration can be made starting with a core wire of different material and/or different diameter. Proximal portion 1130p of core support 111cw is maintained as the full wire profile having the diameter of 0.006′′. A distal end portion 1130d is flattened, which facilitates soldering core support 111cw to coil 110c and provides flexibility at the tip of the guidewire 110 for atraumatic interaction with tissue. The length of flattened section 1130d can be about two centimeters, for example. Dual core support designs have an advantage, relative to single core designs, of leaving openings in the cross-section of the guidewire for routing illumination fibers while keeping the overall outside diameter of the guidewire less than or equal to a desired maximum outside diameter.
FIGS. 21C-21D illustrate a variation of the core support 110cw shown in FIG. 21A, in which FIG. 21C shows the core support 110cw in the same orientation as the one shown in FIG. 21A, while FIG. 21D shows the core support of FIG. 21C having been rotated by ninety degrees about the longitudinal axis. In the example of FIGS. 21C-21D, wire 1130, proximal of the flattened distal end portion 1130d and distal of the unground proximal portion 1130p has been ground to provide multiple sections of varying diameter that decrease in a direction from proximal portion 1130p to distal portion 1130d to form a tapering effect.
Alternative to the use of two core supports 110cw and 111cw, a single core support may be used, as already noted above with regard to FIG. 19. Further alternatively, such a single core support 110cw can be made from an oval-shaped or elliptical-shaped (in cross-section) core wire if enough space is available, which may be made available by eliminating one of the illumination fibers 110i, for example. FIG. 22A shows an example of a core support 110cw formed from an oval wire and FIG. 22B illustrates a proximal end view of core support 110cw, showing the oval profile at the proximal end of core support 110cw. Proximal portion 1130p of core support 110cw is maintained as the full wire profile having the oval-shaped cross-section, wherein the height 1130h of the wire is about 0.015′′ and the width 1130w of the wire is about 0.010′′, see FIG. 22B. Intermediate section 1130i is ground down to a round cross-section having a diameter of about 0.010′′ for greater flexibility in a distal end portion of the guidewire 110. Distal end portion 1130d is flattened, and may have a length of about 0.2 cm to about 1.2 cm, for example, typically about 1 cm, which facilitates soldering core support 110cw to coil 110c. The length of flattened section 1130d is maintained small, e.g., about 0.8 cm to prevent guidewire whipping. Alternatively, flattened section 1130d may be eliminated altogether with the reduced diameter round cross section 1130i extending to the distal end of core support 110cw. The length of the section 1130i (whether or not flattened section 1130d is employed) may be varied to customize the length of a flexible distal end portion of guidewire 110. The dimensions of the oval or elliptical cross section may be varied depending upon the amount of space available inside coil 110c, accounting for all other components to be contained therein, as well as performance characteristics (e.g., flexibility, stiffness, torquability, etc) desired.
Coil 110c may be overlaminated, such as by melting nylon (or other polymer, such as PEBAX, GRILLAMID (nylon resin), or other medical grade resin) into open-pitched areas of the coil 110c to fill in these areas. The overlamination material increases the steerability of guidewire 110, increases torquability of guidewire 110 and provides an area that can be easily gripped by the user.
FIGS. 23A-31 are now referred to in describing manufacturing steps that may be carried out during the manufacture of certain embodiments of illuminating guidewire 110. In these embodiments, coil 110c extends over substantially the entire length of guidewire 110 and at least one of core supports 110cw and 111cw extends into a proximal portion of guidewire 110. In FIG. 23A, a distal portion of coil 110c is stretched to break tension between adjacent coils and to form an open-pitch portion 110co of coil 110c to provide greater flexibility or “floppiness” in this portion, relative to the remainder of the coil not having been stretched. Next, two mandrels 1132 (which may be coated with a lubricious material such as polytetrafluoroethylene, or the like), having dimensions about the same as illumination fibers 110i that will later replace them, are inserted into coil 110c, as illustrated in the longitudinal sectional schematic of FIG. 23B. The core support 111cw having the smaller cross-sectional proximal portion dimension (e.g., core support 111cw formed from a 0.006′′ core wire, as described with regard to FIG. 21B above), referred to here as the “first core support” 111cw, is inserted into the coil 110c such that a distal end of distal portion 1130d is set back proximally from a distal end of coil 10c by a predetermined distance. In one example, this predetermined distance is about seven cm. In another example this predetermined distance is about nine cm. However, this predetermined distance may be varied depending upon the desired performance characteristics of the distal end portion of illuminating guidewire 110. By decreasing the predetermined distance, this increases the stiffness, or moves the stiff section more distal on the distal end portion of the guidewire 110. Increasing the predetermined distance moves the stiff section more proximal and leaves a greater flexible length at the distal end portion of the guidewire 110.
A third mandrel 1132, which may be made the same as the above-described mandrels 1132, but which has dimensions to occupy a space that will later be occupied by the second core support 110cw, is inserted, which appears as the bottom mandrel 1132 shown in FIG. 23B. FIG. 23C shows a cross-sectional view of this arrangement, with the bottom mandrel 1132 being the mandrel that occupies the space that will be later filled by the second core support 110cw, and the other two mandrels 1132 occupying the spaces that will be later filled by illumination fibers 110i. The distal end 1130d of the core support 111cw may then be soldered to coil 110c. 
In cases such as this, where coil 110c is stainless steel and core support is made of a nickel-titanium alloy, oxide on the nickel-titanium material, in regions to be soldered can be removed, prior to soldering, to improve solder joint strength. This removal can be accomplished using a highly acidic flux. For example, a phosphoric acid-based flux (about 65% to about 75%, by weight, phosphoric acid) was found to achieve satisfactory removal of the oxide. To further improve the solder joint strength, the regions on the nickel-titanium material that are to be soldered can be manually cleared of oxide, such as by removal using sandpaper or grinding. Further alternatively, or additionally, a chemical etch may be used.
One example of a solder used to form the solder joints is a tin/silver eutectic solder (96.5% Sn, 3.5% Ag, 0.5% Cu). This eutectic alloy works well as the solder in this case because strength is desired, and the eutectic alloy has no liquidus/solidus transition range, so the solder joint solidifies all at once, which greatly reduces the chances, making it almost impossible for the joint to be disrupted as it is solidifying.
Next, the mandrel 1132 occupying the space for the second core support 110cw is removed and the second core support 110cw (e.g., core support 110cw formed from a 0.008′′ core wire, as described with regard to FIG. 21A above, referred to here as the “second core support” 110cw) is inserted into the coil 110c in the opening left by removal of the mandrel 1132. The first and second core supports 111cw and 110cw are then soldered to coil 10c at multiple locations over the length of the core supports. In one particular example, soldering of the second core support 110cw includes a distal-most solder joint made about two to about five coils back from a distal end of coil 110c, a second solder joint is made about two cm distal of the location along coil 10c where the distal solder joint for the first core support 111cw was made, a third solder joint is made proximal of the distal solder joint of the first core support, but distal of the transition between the open-pitch coil section 110co and the remainder of the coil 110c (closed-pitch section), a fourth solder joint is made proximal of the open-pitch coil section 110co, and a fifth solder joint is made at the proximal end of coil 110c. The third, fourth and fifth solder joint locations join both of the core supports 111cw and 110cw to the coil 10c for added strength and rigidity.
By making the solder joint for the distal end of the first core support 111cw and the second solder joint of the second core support 110cw at locations on coil 10c that are at unequal locations along the longitudinal dimension of coil 110c, this allows the core supports 111cw and 110cw to slide independently of each other during bending of the distal end portion of the illumination guidewire 110. For example, FIGS. 24A and 24B illustrate this independent sliding capability. As shown, the distal end solder joint 1136 of the smaller core support 111cw (core support 111cw formed from the 0.006′′ wire described in the example above) is illustrated at the bottom of coil 110c, the solder joint 1134 just distal of solder joint 1136 made between the second core support 110cw and coil 110c is shown at the top side of the illustration, and both core supports 111cw and 110cw are soldered to coil 10c at a location distal of the transition between the open-pitch coil section 110co and the closed-pitch section, in this case, about sixteen cm from the distal end of coil 110c. FIG. 24A shows the relative positions of the solder joints when coil 110c is in a straight configuration. FIG. 24B shows coil 110c in a bent configuration, and illustrates the ability of the core supports 111cw and 110cw to slide independently of one another, as it can be observed that the solder joints 1134 and 1136 have moved closer together, as compared to the space between these joints shown in FIG. 24A when coil 110c is straight. Thus, when bending toward the first core support 111cw, the first core support 111cw is allowed to slide distally in relation to the second core support 110cw at the bend, because the cores are located together (same longitudinal fix point) at solder joints 1138, and the first core support 111cw does not extend all the way to the distal end of the coil 110c. If the solder joints 1134 and 1136 of the two core supports 111cw and 110cw were soldered at the same longitudinal location, this would make the arrangement much stiffer and less flexible in this region. This would also result in greater amounts of “whip” upon torquing the device.
By soldering the core supports 111cw and 110cw at locations 1134 and 1136 as shown in FIGS. 24A-24B and described above, the coils of coil 110c are prevented from substantial separation even when coil 110c is bent. This greatly increases the stiffness of guidewire 110/coil 110c in a segment between the solder joints 1134 and 1138, but still allows a distal section (distal of joint 1134 to the distal solder joint of the second core support 110cw) to remain floppy. Alternatively, to further increase the stiffness of the region between joints 1134 and 1138, the coils between joints 1134 and 1138 or between 1136 and 1138, or between 1134 and 1136 can be placed under compression during the soldering of the joints.
Further alternative soldering arrangements include, but are not limited to: soldering both core supports 111cw and 110cw at the distal end of coil 110c. This increases the distal stiffness of the coil 110c/guidewire 110 and thus also reduces distal flexibility. This may also greatly increase whipping of the distal end when torquing the illuminating guidewire 110.
Further alternatively, the solder locations (locations longitudinally along the coil 110c) can be varied. For example, by moving joints 1134 and 1136 distally with respect to coil 110c, but keeping the same separation distance between coils 1134 and 1136, this moves the stiff section between the joints 1134 and 1136 closer to the distal end of guidewire 110, reducing the flexible section at the distal end portion of guidewire 110. Conversely, moving joints 1134 and 1136 proximally with respect to coil 110c, but keeping the same separation distance between coils 1134 and 1136, moves the stiff section between the joints 1134 and 1136 further from the distal end of guidewire 110, increasing the length of the flexible section at the distal end portion of guidewire 110 and reducing the length of the stiff section.
FIG. 25A illustrates an embodiment of an illuminating guidewire 110 in production showing solder joints employed in this embodiment. As noted above, solder joint 1136 is made first to solder the first core support 111cw to coil 10c. This solder joint is typically made while the mandrel 1132 that occupies the space for the second core support 110cw is still in place within the coil, to ensure that solder joint 1136 does not solder the second core support 110cw to coil 110c. In the embodiment shown in FIG. 25A, solder joint 1136 was made at a length of about eight cm from the distal end of coil 110c, although this length may vary in other embodiments, as noted above. The mandrel occupying the space for the second core support 110cw was a Teflon-coated mandrel having an outside diameter of about 0.0075′′.
After making the solder joint 1136, the mandrel 1132 occupying the space for the second core support 110cw can be removed and the second core support 110cw is then inserted in its place within the coil 110c. The distal solder joint 1134 can then be performed to solder the second core support 110cw to coil 110c in the location shown, and the remaining solder joints 1138, 1139, and 1141 can be performed to solder both core supports 111cw and 110cw to the coil 110c in the locations shown.
FIG. 25B is a longitudinal sectional view of the guidewire 110 of FIG. 25A taken along line 25B-25B. This view more clearly shows the solder joint 1134 to the more distally extending core support (second core support) 110cw as well as solder joint 1138 to solder the first core support 111 cw to coil 110c. FIG. 25C is an enlarged view of the portion of FIG. 25A surrounded by line 25C. This enlarged view more clearly shows the solder joint 1134 that solders the second core support 110cw to coil 110c and also shows the distal end of the second core support 110cw extending distally of the distal end of coil 110c by a distance 25x. For example, distance 25x may be in the range of about 0.005 to about 0.015 inches. FIG. 25D is an enlarged view of the portion of FIG. 25B surrounded by line 25D, to more clearly show the solder joint 1136 connecting the first core support member 111cw (top core support member in FIG. 25D) to coil 110c. 
Once core supports 111cw and 110cw have been soldered to coil 110c according to any of the techniques described above, the open-pitch coil section 110co of coil 110c can next be laminated. A nylon (or other meltable polymer) tube 1140 is slid over the open-pitched coil section 110co, as illustrated in FIG. 26, and then a FEP (fluorinated ethylene propylene) heat shrink tube 1142 is slid over the meltable polymer tube 1140. Tubing 1142 is heated until it shrinks down around the coils of the open coil section 110co and melts the polymer tubing into the spaces between the coils. After cooling, the shrink tubing 1142 is removed.
FIGS. 27A-27B illustrate steps that may be performed to install connector 1120 to the proximal end of guidewire 110. These steps may be performed while at least the mandrels 1132 that are to be replaced by illumination fibers 110i are still inserted through coil 110c. A heat shrink tube (e.g., FEP heat shrink material) 1140 is shrunk down around a proximal end portion of coil 110c as illustrated in FIG. 26A which shows a longitudinal sectional view of the heat shrink tubing, and a plan view of coil 110c and mandrels 1132. The tubing 1142 extends proximally beyond the proximal end of coil 110c by a predetermined distance, e.g. about two mm. Mandrels 112 act to keep the proximal end of tubing 1142 from shrinking closed during heating.
Next, connector 1120 is slid over tubing 1142 so as to substantially align the proximal end of connector 1120 with the proximal end of tubing 1142, as illustrated. Tubing 1142 help to center coil 110c within the connector 1120 and also functions as a strain relief. Adhesive 1144 can be applied to adhere connector 1120 to tubing 1142. Another shrink tubing 1146 (e.g., polyeolefin shrink tubing) is slid over the distal end portion 1120d of connector 1120 and shrunk down around the distal end portion 1120d, tubing 1142 and coil 110c, thereby securing connector 1120 to coil 110c and also functioning as a strain relief. Connector 1120 may include a rotatable (relative to coil 110) or non-rotatable female luer connector, or rotatable (relative to coil 110) or non-rotatable male luer connector, for example.
At this time, the remaining mandrels 1132 can be removed from coil 110c in preparation for installation of the light (illumination) fibers 110i. After removal of the mandrels 1132, two light fibers 110i are installed in their place and extended distally beyond the distal end of coil 110c. The illumination fibers 110i are then cut to extend a predetermined distance distally of the distal end of coil 110c. In one example, this predetermined distance is about 0.5 mm, although this predetermined distance may vary. An adhesive lens 110s is then formed by applying ultra-violet curable adhesive (or other transparent or translucent adhesive) over the portions of illumination fibers extending distally from the distal end of coil 110c to completely encapsulate these fiber portions, as shown in FIG. 28. Note that, for simplicity of illustration, core supports have not been shown in the illustration of FIG. 28, however, these would, of course, also be contained within the coil 110c. Adhesive lens 110s will typically be formed to have a hemispherical distal surface, as shown, although the curvature and shape of this distal surface can be varied, depending upon the characteristics of light patterns desired to be emitted therefrom. Note that adhesive is also applied so as to spread over at least one coil of the coil 110c and at least one space between coils. Adhesive lens 110s is then cured to complete the formation of the adhesive lens 110s. 
The same or a similar adhesive can be used to apply to the proximal end portion of coil 110c and portions of the illumination fibers 110i in the proximal end 110ps vicinity, as illustrated in FIG. 29. Adhesive can be applied in amounts enough attach/encapsulate up to about one-half of the proximally exposed portions of illuminating fibers 110i that extend proximally from the proximal end of coil 110c. The illumination fibers are then cut substantially flush with the proximal end of connector 1120, as shown in FIG. 29. Optionally, after curing the adhesive, the portion of shrink tubing 1142 extending proximally from the proximal end of coil 110c, may next be shrunk down around the proximally extending portions of illumination fibers 110i, for example, to an outside diameter of about 0.022′′, to lower the light input into device 110 and allow light input substantially only through the illumination fibers 110i. Alternatively, and also optionally, a grommet 1148 (shown in phantom) can be inserted over illumination fibers and inside of shrink tubing 1142, with or without subsequent further shrinking of the shrink tubing, to accomplish the same function.
Further optionally, the proximally extending portions of light fibers 110i may be completely encapsulated in adhesive or epoxy, in the same manner as described above with regard to adhesive lens 110s. This proximal adhesive lens 110sp can be configured to function as a lens to direct light into light fibers 110i, for example, but the adhesive or epoxy used in this instance must be able to withstand heat generated by the light cable when connected to connector 1120 during use.
FIG. 30 shows an embodiment of an illuminating guidewire 110, but without connector 1120. In this embodiment, the more distally extending core support 110cw, also referred to above as the second core support 110cw extends distally of the distal end of coil 110c by about 0.005′′ to about 0.015′′ (about one to two coil widths). The illumination fibers 110i extend distally beyond the distal end of coil 110c by about 0.010′′ to about 0.020′′, and the distal adhesive lens 110s covers the protruding distal end portion of the second core support 111cw as well as the protruding distal end portions of the illumination fibers 110i. A stiff grip region 110sr may optionally be provided by an overlamination (of a type described above, such as heat shrink tubing, or the like) to act as a strain relief, although it is not necessary. Proximal adhesive lens 110sp is also shown.
FIG. 31 illustrates an example of a permanently attached rotating male luer connector 1120 that is attached to a proximal end portion of illuminating guidewire 110 and is rotatable with respect thereto. One non-limiting example of a rotatable connector 1120 that may be used is Quosina Rotating Male Luer 71632 (Quosina Corp., Edgewood, N.Y.). By providing connector 120 as a permanently attached connector to device 110, this ensures permanent alignment of the proximal lens 110sp with the proximal interface of the light source and thereby ensures alignment of the light transmitted through the proximal lens 110sp. Alternatively, a rotatable male luer connector 1120 or other connector 1120 may be made detachable from the illuminating guidewire 110. Advantages to a removable or detachable arrangement include, but are not limited to: allowing a balloon catheter or other tool or instrument to be guided over guidewire 110 to be loaded from the proximal end of the illuminating guidewire 110; allowing illuminating guidewire 110 to be successfully inserted into a target sinus before even opening the packaging of one or more tools, devices or instruments to be delivered thereover; and exchanging tools, devices or instruments on the illumination guidewire 110 without having to remove the illumination guidewire from the target surgical site and reinserting after exchange.
FIG. 32 shows the illumination guidewire 110 of FIG. 30 with connector 1120 permanently connected thereto so that connector 1120 is rotatable with respect to the flexible coil portion 110c of the device 110. In one non-limiting, exemplary embodiment, a distal end portion of device 110 is coated with silicone to reduce friction against the inner surface of the irrigation catheter 10 in use. In the example shown in FIG. 32, a length 1145 of about 16±1 cm, starting from the distal tip of device 110, is coated with silicone. As noted, this is a non-limiting example, as greater or lesser lengths may be coated with silicone. Further alternatively, the silicone coating may be eliminated altogether. In the example shown in FIG. 32, the length 1147 of device 110 from the distal tip to the distal end of shrink tubing 1142 is about 95 cm and the overall length 1149 of the device 110 is about 100 cm. Of course, the present invention is not limited to these lengths, as length 1147, as well as length 1149 may be greater or less than that described in the example of FIG. 32. In FIG. 32, tubing 1142 is 3/64′′ polyolefin shrink tubing and tubing 1146 is 1⁄4′ polyolefin shrink tubing, although the present invention is neither limited to these sizes nor materials. The stiffened region 110sr is formed by melting a nylon tube into the region shown in a manner described above with regard to melting a nylon tube into the stretched region 110co. This tubing may be colored for easy visualization. In the example shown, the nylon tubing is purple. Core wires 110cw and 111cw in this example are made of Nitinol, coil 110c is made of stainless steel and snag solder 1143 (i.e., solder comprising tin and silver). Distal lens 110s is made of UV Adhesive 204 (Dymax Corporation, Torrington, Conn.).
Optionally, illuminating guidewire may be manufactured to have a preset curve or bend in a distal end portion thereof. For example, the larger core support 110cw in the process described above can be set with a curve or bend to form a resulting bend in the distal end portion of guidewire 110 once constructed. FIG. 33A is a partial view of the core support 110cw described with regard to FIG. 21A, while still in a straight configuration. FIG. 33B illustrates one method of forming a preset curve in core support 110cw or 111cw in which the flatted distal end section 1130d is bent at an angle of about ninety degrees by bending it around a mandrel 1150. In one example, mandrel 50 had a outside diameter of about 0.05′′. By cold working (i.e., plastically deforming) the distal portion about the mandrel 1150 and setting it a about ninety degrees, a curve of about twenty degrees will result in the finished illuminating guidewire device 110 employing this core support in a manner as described above. Alternatively, the nickel-titanium distal end portion 1130d can be bent in the same manner as shown in FIG. 33B, but rather than cold working, the distal end portion can be heated to its annealing temperature and then bent around the mandrel 1150 and quenched.
FIG. 34 illustrates a distal portion of an illuminating guidewire 110 manufactured with a core support have a preset bend from either of the techniques described above with regard to FIGS. 33A-33B. The bend in the distal end portion makes it more steerable, as discussed above and in application Ser. No. 11/647,530.
FIG. 35 is a partial view of coil 110c illustrating two portions of coil 110c that have been etched 10e. Etching may be performed over all, or one or more select portions of coil 110c to lower reflectance of the coil where etched, such as when viewed by endoscopy, for example, and/or to act as a marker band to identify a particular location along the coil 110c. 
As noted above, all or a portion of illumination guidewire 110 may be externally coated with a silicone coating to reduce friction (add lubricity) between guidewire 110 and the tissues, guides and/or other instruments that it is slid against during use. Other lubricious coatings may be substituted, including, but not limited to: polytetrafluoroethylene, parylene, hydrophilic coatings, any of which may be spray coated or dipped, for example, or may be pre-coated on the wire from which the coil is made by the wire manufacturer, or may be pre-coated on the coil 10c if the coil is manufactured by an outside source.
The illumination fibers 110i, as noted previously, can be free to move about radially within the device 110. Further, there is no need to center the illumination fibers 110i with respect to device 110 even at the distal and proximal ends of the device. The plastic or glass illumination fibers 110i are typically used to transmit light from a light source such as one provided in an operating room for use by endoscopes, e.g., xenon light source, halogen light source, metal halide light source, etc. Alternatively, device 110 may be configured to transmit light from other light sources, such as a laser light source, wherein laser fibers would be substituted for the illumination fibers described above, and extend through device 110 in a fiber optic bundle. The fiber optic bundle, like the illumination fibers 110i, contributes to stiffness (in both bending and torquing motions) of device 110, thereby enhancing trackability, steering and other torquing. Alternatively, device 110 may employ one or more light emitting diodes used to emit light, as described in more detail in application Ser. No. 11/647,530.
A light cable 1032 optically connects connector 1120 with light source 1030 to deliver light from the light source 1030 through connector 1120 and illumination fibers 110i. The light cable 1032 must transmit enough light to allow the illuminating guidewire 110 to transilluminate the sinuses, but at the same time, not transmit so much light that the light fibers become damaged. Research has shown that very bright light sources 1030 (e.g., 300 Watt Xenon, new bulb) can damage the light fibers 110i with a light cable surrounding a glass illumination fiber bundle wherein the light cable has a diameter of greater than about 2 mm. One way to concentrate the light coming from light cable 1032 down to a size more nearly matching that needed for the illumination fibers 110i is to provide a taper (which may be made of glass, for example) 1126 as illustrated in phantom in FIG. 36. For example, taper 1126 may taper the diameter of the incoming light from about 2 mm down to about 1 mm. While the taper 1032 can concentrate or focus the light down, as noted, there are light losses that result in heat generation at the location of the taper 1126.
Alternatively, a light cable 1032, in this embodiment, has a connector 1320 at the distal end of light cable 1032 which is provided with a male luer 1322, for connection to the connector 1120 of illumination guidewire 110. The provision of a male luer is non-standard, as most operating room light cables are provided connectors specific to the manufacturer of the light cable, which are often proprietary to that manufacturer and which do not include a luer connector. Accordingly, when the connector 1120 of illuminating guidewire 110 is configured to mate with this male luer 1322, this prevents a standard operating room light cable from accidentally being connected to the guidewire 110. The light fiber bundle in light cable 1032 is sized to provide sufficient illumination through illuminating guidewire 110 to transilluminate the sinuses, but an insufficient amount of light to damage the illumination fibers 110i. Also, a taper 1026 is not required since the light cable 1032 is sized to substantially match the illumination fibers 110i, and therefore the heat generation problem caused by tapering does not arise with this embodiment. In one example, the light fiber bundle 1324 has a diameter of about 1 mm.
Alternatively, the embodiment shown in FIG. 37 may also be provided with a taper 1126 to further funnel the light from light bundle 1324 down to a smaller diameter, as illustrated in FIG. 38.
FIG. 39 shows connector 1320 of light cable 1302 provided with a female luer mated with a male luer of connector 1120 of the illuminating guidewire 110. This arrangement allows the proximal ends of illumination fibers 110i to be placed flush in abutment with the light bundle 1324 or taper 1126 (as shown) when connector 1120 is screwed or snapped onto connector 1320.
Any of the devices 110 described herein may optionally include one or more radiopaque markers and/or electromagnetic coils on the tip of the device 110 and/or elsewhere along the device for enhancing visibility by fluoroscopy systems, image guided surgery (IGS) systems, or other visualization systems.
FIG. 40 shows an alternative design of device 110 in which light is emitted proximally of the distal end of the device. This configuration may employ any of the various light transmission means described above (e.g., illumination fibers, laser fibers, LED). The proximal portion 110p may be constructed in any of the manners described above with regard to other embodiments of device 110. The distal portion 110d includes a transparent proximal end portion 110dp that mounts over the distal end of proximal end portion 110p of the device 110. The transparent portion 110dp permits the illumination emitted from illumination member 110i or 110id to pass out of the device 110 at the location of transparent portion 110dp. The illumination member(s) 110i or 110id thus terminate at the proximal end portion 110dp of the distal end portion of device 110. Distally of this transparent portion 110dp, the distal portion 110dd of distal end portion 110d of device 110 extends as a floppy guidewire leader or tip. This floppy guidewire leader or tip 110dd may include a coiled section 110c and may optionally include a core support 110cw/111cw. The light emitted from illumination fibers will disperse naturally through the transparent portion 110dp. Optionally, a deflector 111, such as a convex mirror (e.g., parabolic or other convex) shape or other reflective surface may be provided distally of illumination fibers/light emitting portion 110i, 110id of device 110 to deflect light rays out of the transparent portion. Additionally, or further alternatively, illumination fibers 110i may be angled at the distal end portions thereof to direct the emitted light out through the transparent portion.
This configuration may be beneficial in further protecting the illumination emitter(s) 110i from foreign materials inside the body, as well as from trauma that may be induced by bumping the illumination emitter up against structures within the body. Further, a floppy guidewire leader 110dd of this type may provide more flexibility and maneuverability than a device in which the illumination emitter is located on the distal tip of the device.
Transparent portion 110dp may be provided as a clear plastic or glass integral tube, or may have openings or windows 110t provided therein (see the partial view of FIG. 41). Further alternatively, transparent portion may be formed by a plurality of struts 110st circumferentially arranged to interconnect the distal floppy tip 110dd with the proximal end portion 110p of device 110 as shown in the partial illustration of FIG. 42. Alternatively members 110st may be intersecting in a criss-crossing cage like configuration or other cage configuration. In any of these alternative configurations, members 110st may be transparent, but need not be and could be formed of non-transparent materials, such as metals or opaque plastics, for example.
Turning now to FIGS. 43A-43C, illustrations of partial coronal sectional views through a human head showing various steps of a method for inserting an illuminating guidewire 110 into an ostium that opens to a frontal sinus are shown. The methods described here, and all other methods disclosed herein may also comprise a step of cleaning or lavaging anatomy within the nose, paranasal sinus, nasopharynx or nearby structures including but not limited to irrigating and suctioning. The step of cleaning the target anatomy can be performed before and/or after a diagnostic or therapeutic procedure. The methods of the present invention may also include one or more preparatory steps for preparing the nose, paranasal sinus, nasopharynx or nearby structures for the procedure, such as spraying or ravaging with a vasoconstricting agent (e.g., 0.025-0.5% phenylephyrine or Oxymetazoline hydrochloride (Neosynephrine or Afrin) to cause shrinkage of the nasal tissues, an antibacterial agent (e.g., provodine iodine (Betadine), etc. to cleanse the tissues, etc.
In FIG. 43A, a first introducing device in the form of a sinus guide 12 is introduced through a nostril and through a nasal cavity 1012 to a location close to an ostium 1034 of a frontal sinus 1036. Sinus guide 12 may be as described previously herein, or as described in the applications incorporated herein by reference. The advancement of sinus guide 12 can be visualized with a scope inserted into the nasal cavity 1012 (e.g., through channel 28, not shown in FIG. 43A) and advanced as close to the ostium 1034 as possible without causing significant trauma to the tissues therein.
Once the surgeon is satisfied that the distal end of the sinus guide 12 is positioned close enough to the appropriate ostium 1034, illuminating guidewire 110, connected to a light source as described by any of the techniques mentioned above, is inserted through sinus guide 12 and advanced therethrough, see FIG. 43B. There may be some transillumination from the light emitted from the scope which can be used to confirm that the sinus guide 12 is positioned in the correct general area, which confirmation can be made even before the distal tip of guidewire 110 exits the distal end of sinus guide 12. However, much more specific transillumination effects are produced when the tip of guidewire 110 exits the distal end of guide 12 and especially when the light emitting portion of guidewire 110 touches or approximates an intended target surface, such as an inner wall of a sinus, for example. As the guidewire 110 is advanced, transillumination on the face of the patient can be observed as a glowing spot that moves as the distal end portion of device 110 moves, thereby making it possible to visibly track the location of the light emitting portion of device 110 without the need to use radiographic imaging, such as by fluoroscopy, for example.
While there may be some diffuse transillumination on the forehead of the patient overlying the frontal sinus 1036 as the light emitting portion of device 110 approaches the ostium 1034, the glow on the forehead becomes brighter and smaller in dimension (more focused) as the light emitting portion passes through the ostium 1034 and enters the frontal sinus 1036, FIG. 43C. As device 110 is further advanced, the glowing spot becomes most defined and brightest as the light emitting portion approaches and contacts a wall of the frontal sinus 1036. Further, as noted, the movement of the transilluminated spot can be visibly followed to confirm that the guidewire 110 is indeed moving within the location of the frontal sinus, as can be confirmed by the surgeon's knowledge of the particular anatomy of the patient being treated. In this regard, a CAT scan or other image of the sinus anatomy can be performed prior to this procedure and studied by the surgeon, to apprise the surgeon of any distinctive or unusual patterns in the individual patient's sinus anatomy which might be useful in tracking and confirmation of where the guidewire is located, as indicated by the transillumination.
Illuminating guidewire device 110 can also be used to facilitate visualization and placement of the sinus guide 12 in the procedure described above with regard to FIGS. 43A-43C, or in another procedure in which a sinus guide, sinus guide or guide tube is placed in the sinus pathways. FIG. 44 illustrates a situation where scope 30 has been inserted as far as possible without causing significant trauma to the patient. The range of visibility in this case does not extend all the way to ostium 1034, as indicated schematically by the rays 1009 shown extending distally from scope 30. By inserting illuminating guidewire 110 through sinus guide 12 (tube 44) as shown in FIG. 44, additional illumination can be provided distally of the illuminating range of scope 30. This additional illumination can be received by scope 30 to enable visualization up to the illumination portion of device 110 and potentially even extending to illumination range of device 110, as long as there is a straight pathway of the field of view. Thus, placement of the guidewire 110 can be visualized up to and into the desired ostium 1034 via scope 30 in this case. Alternatively, this can be carried out without the sinus guide 12, wherein the guidewire 110 is inserted and the scope 30 can be used to visualize placement of guidewire 110 into the target ostium with the assistance of the light emitted by the scope 30 in addition to the light emitted by guidewire 110.
In any of these procedures where a scope 30 is used for visualization and an illuminating guidewire 110 is inserted, some transillumination of the target sinus may occur from the light emitted by the scope 30 alone. However, this transillumination will be diffuse and show a rather dim, large area of transillumination on the patient's skin. When the illumination guidewire 110 is inserted and advanced, as noted earlier, a smaller, brighter transillumination spot will be visible when the illuminating portion of the guidewire has entered the sinus. Additionally, even before entering the sinus, the light emitted from the guidewire 110 will produce a moving transillumination spot as guidewire 110 is advanced, which also helps distinguish the location of the distal portion of the guidewire 110, relative to any diffuse transillumination produced by the scope light.
If the guidewire 110 is advanced into an ostium other than the target ostium (e.g., ostium 1035 shown in FIG. 44), this may be possible to be viewed by scope 30, depending upon the line of sight. However, even if it is not, the transillumination resulting from entrance into a different sinus than the target sinus will be evident by the different location on the patient's face. Also, in the example shown, guidewire 110 would not be able to be advanced very far through ostium 135 before it was diverted and curled by the relatively small sinus space that ostium 135 leads into. Thus, by tracking the movement of the illumination spot produced by guidewire 110, the surgeon could confirm that guidewire 110 was misplaced as the guidewire would be diverted by a much smaller space then that characterized by the target frontal sinus 1036.
Thus, by using an illuminating guidewire device 110 in the methods as described above, the use of fluoroscopy or other X-ray visualization can be reduced as it is not required to confirm proper placement of the guidewire in some cases.
Another optional feature that guidewire 110 may be provided with is the ability to emit strobed, flashing or flickering light, as described in detail in application Ser. No. 11/647,530. Additionally, or alternatively, the light emitted may have a different wavelength (i.e., color) than light emitted by endoscope 30 or may be configured to change colors over time. The transillumination produced by a flashing and/or colored and/or color changing light can be further distinguished from diffuse transillumination produced by other light sources, such as endoscopes, for example, since the transillumination produced by the guidewire 110 in this case will flicker or vary in intensity between bright and dim and/or vary in color.
Guide Systems with Removable Endoscope/Guidewire Sheaths
FIGS. 45-47 show additional embodiments of transnasally insertable guide systems useable to position an endoscope 30 at a desired location within the ear, nose, throat or cranium of a human or animal subject, to view anatomy for diagnostic purposes or for confirmation that a procedure has been successfully accomplished. In FIG. 45, guide device 12 includes a single tube 28 having a lumen sized to receive endoscope 30. Guide 12 may be preshaped to be straight or curved, or may be configured to be deflectable or steerable.
FIGS. 46-47 illustrate a guide system comprising a straight or curved transnasal sinus guide 12 and a sheath 90 that is insertable through the sinus guide 12. The sheath 90 has a single lumen sized and configured to receive endoscope 30 therethrough. Thus, endoscope 30 may be inserted through sheath 90 to extend distally of the distal end of guide 12, as illustrated in the partial view of FIG. 47, to view anatomy or visually verify the results of a procedure, for example. Examples of transnasal sinus guides 12 useable in this system include those described in U.S. patent application Ser. No. 11/193,020 and herein, as well as those currently available commercially as RelievaTM Sinus Guide Catheters from Acclarent, Inc., Menlo Park, Calif.
Sheath 90, illustrated in FIG. 46, includes an elongate flexible shaft 92 through which the endoscope lumen 85 extends. A proximal hub 94 may be provided with having two arms 96, 98, and is mounted on the proximal end of the flexible shaft 92. Arm 96 leads into the endoscope lumen 85 and arm 98 also leads to the endoscope lumen 85 and can be used, for example to attach a suction or irrigation source thereto. Alternatively, hub 94 may be provided with only a single arm 96.
It is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to these examples and embodiments and or equivalents may be substituted 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 to do so would render the embodiment or example unsuitable for its intended use. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

## Claims

1. A method of making an illuminating guidewire, said method comprising the steps of:
providing a coil having a predetermined length and diameter;
inserting mandrels through an annulus of the coil;
inserting a first core support into the coil and fixing a portion of the first core support at a predetermined length from a distal end of the coil;
removing a mandrel and inserting a second core support;
fixing said second core support at predetermined locations along a length thereof, to the coil and fixing the first core support at additional locations along the length thereof to the coil; and
inserting illumination fibers.

2. The method of claim 1, wherein mandrels are inserted into the coil after the coil is formed.

3. The method of claim 1, wherein inserting the first core support into the coil occurs after inserting mandrels through the annulus of the coil.

4. The method of claim 1, wherein removing the mandrel occurs after inserting the first core support into the coil.

5. The method of claim 1, wherein fixing said second core support occurs after removing the mandrel.

6. The method of claim 1, wherein the illuminating fibers emit light energy.

7. The method of claim 1, further comprising inserting first, second and third mandrels through the annulus of the coil.

8. The method of claim 7, further comprising replacing the first mandrel with the second core support.

9. The method of claim 8, further comprising replacing the second mandrel with a first illuminating fiber.

10. The method of claim 9, further comprising replacing the third mandrel with a second illuminating fiber.

11. The method of claim 1, further comprising opening a pitch between adjacent coils of the coil.