Patent Grant
9155492
The present invention relates generally to medical devices, systems and methods and more particularly to methods and devices for performing minimally invasive procedures that reduce the need to provide fluoroscopic or other radiographic visualization.
The skull contains a series of cavities known as paranasal sinuses that are connected by passageways. The paranasal sinuses include frontal sinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses. The paranasal sinuses are lined with mucus-producing mucosal tissue and ultimately open into the nasal cavity. Normally, mucus produced by the mucosal tissue slowly drains out of each sinus through an opening known as an ostium. If the mucosal tissue of one of these passageways becomes inflamed for any reason, the cavities which drain through that passageway can become blocked. This blockage can be periodic (resulting in episodes of pain) or chronic. This interference with drainage of mucus (e.g., occlusion of a sinus ostium) can result in mucosal congestion within the paranasal sinuses. Chronic mucosal congestion of the sinuses can cause damage to the epithelium that lines the sinus with subsequent decreased oxygen tension and microbial growth (e.g., a sinus infection).
The term “sinusitis” refers generally to any inflammation or infection of the paranasal sinuses caused by bacteria, viruses, fungi (molds), allergies or combinations thereof. It has been estimated that chronic sinusitis (e.g., lasting more than 3 months or so) results in 18 million to 22 million physician office visits per year in the United States. Patients who suffer from sinusitis typically experience at least some of the following symptoms: headaches or facial pain; nasal congestion or post-nasal drainage; difficulty breathing through one or both nostrils; bad breath; and/or pain in the upper teeth.
One of the ways to treat sinusitis is by restoring the lost mucus flow. The initial therapy is typically drug therapy using anti-inflammatory agents to reduce the inflammation and antibiotics to treat the infection. A large number of patients do not respond to drug therapy. Currently, the gold standard for patients with chronic sinusitis that do not respond to drug therapy is a corrective surgery called Functional Endoscopic Sinus Surgery (FESS).
During FESS, an endoscope is inserted into the nose and, 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 are typically performed with the patient under general anesthesia.
Although FESS continues to be the gold standard therapy for surgical treatment of severe sinus disease, FESS does have several shortcomings. For example, FESS can cause significant post-operative pain. Also, some FESS procedures are associated with significant postoperative bleeding and, as a result, nasal packing is frequently placed in the patient's nose for some period of time following the surgery. Such nasal packing can be uncomfortable and can interfere with normal breathing, eating, drinking etc. Also, some patients remain symptomatic even after multiple FESS surgeries. Additionally, some FESS procedures are associated with risks of iatrogenic orbital, intracranial and sinonasal injury. Many otolaryngologists consider FESS an option only for patients who suffer from severe sinus disease (e.g., those showing significant abnormalities under CT scan). Thus, patients with less severe disease may not be considered candidates for FESS. One of the reasons why FESS procedures can be bloody and painful relates to the fact that instruments having straight, rigid shafts are used. In order to target deep areas of the anatomy with such straight rigid instrumentation, the physician needs to resect and remove or otherwise manipulate any anatomical structures that may lie in the direct path of the instruments, regardless of whether those anatomical structures are part of the pathology.
New devices, systems and techniques are being developed for the treatment of sinusitis and other disorders of the ear, nose, throat and paranasal sinuses. For example, various catheters, guidewires and other devices useable to perform minimally invasive, minimally traumatic ear, nose and throat surgery have been described in U.S. patent application Ser. No. 10/829,917, entitled “Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat;” Ser. No. 10/912,578, entitled “Implantable Device and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders;” Ser. No. 10/944,270, entitled “Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures;” Ser. No. 11/037,548, entitled “Devices, Systems and Methods For Treating Disorders of the Ear, Nose and Throat;” and Ser. No. 11/116,118, entitled “Methods and Devices For Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses.” Each of these applications is hereby incorporated herein, in its entirety, by reference thereto. Many of these new devices, systems and techniques are useable in conjunction with endoscopic, radiographic and/or electronic assistance to facilitate precise positioning and movement of catheters, guidewires and other devices within the ear, nose, throat and paranasal sinuses and to avoid undesirable trauma or damage to critical anatomical structures such as the eyes, facial nerves and brain.
For example, in one new procedure (referred to in this patent application as a “Flexible Transnasal Sinus Intervention” or FTSI), a dilatation catheter (e.g., a balloon catheter or other type of dilator) is advanced through the nose to a position within the ostium of a paranasal sinus or other location, without requiring removal or surgical alteration of other intranasal anatomical structures. The dilatation catheter is then used to dilate the ostium or other anatomical structures to facilitate natural drainage from the sinus cavity. In some cases, a tubular guide may be initially inserted through the nose and advanced to a position near the sinus ostium and a guidewire may then be advanced through the tubular guide and into the affected paranasal sinus. The dilatation catheter may then be advanced over the guidewire and through the tubular guide to a position where its dilator (e.g., balloon) is positioned within the sinus ostium. The dilator (e.g., balloon) is then expanded causing the ostium to dilate. In some cases, such dilatation of the ostium may fracture, move or remodel bony structures that surround or are adjacent to the ostium. Optionally, in some procedures, irrigation solution and/or therapeutic agents may be infused through a lumen of the dilatation catheter and/or other working devices (e.g., guidewires, catheters, cannula, tubes, dilators, balloons, substance injectors, needles, penetrators, cutters, debriders, microdebriders, hemostatic devices, cautery devices, cryosurgical devices, heaters, coolers, scopes, endoscopes, light guides, phototherapy devices, drills, rasps, saws, etc.) may be advanced through the tubular guide and/or over the guidewire to deliver other therapy to the sinus or adjacent tissues during the same procedure in which the FTSI is carried out. It is to be understood that, in FTSI procedures, structures and passageways other than sinus ostia may be dilated using the tools described above, tissue may be resected or ablated, bone may be restructured, drugs or drug delivery systems may be deployed, etc., as described in the documents incorporated herein by reference. Thus, for the purposes of this application the term FTSI will be generally used to refer broadly to all of those procedures, not just dilation of sinus ostia.
In FTSI procedures that include positioning of a guidewire into a paranasal sinus, the placement of the guidewire is typically confirmed by visualizing the procedure under fluoroscopy or other x-ray visualization technique, for example. Appropriate positioning of the tubular guide at the position near the sinus ostium may also be confirmed via fluoroscopy. Reaching and accessing target anatomy can be a challenge in general and more so in particular patients as anatomy can both be variable and unpredictable. Additionally, the devices employed in a medical procedure must be durable to withstand stresses during normal operating conditions as well as those resulting from unexpected challenges. In order to reduce the radiation exposure to the patient undergoing the procedure, and particularly to the surgeon and other personnel that carry out many of these types of procedures, there is a need for methods and devices that eliminate or reduce the need to use fluoroscopic visualization during such procedures. There is also a need for a medical device that embodies acceptable torquability and pushability. Further, there is a need for a device that has structure which facilitates the accommodation of forces placed thereon. At least some of these objectives will be met by the present invention.
Briefly and in general terms, the present disclosure is directed towards an apparatus and method for facilitating visualization of target anatomy. In one approach, the apparatus is embodied in an illuminating device configured to be positioned at or adjacent anatomy within a patient's body. The illuminating device can be employed to provide transillumination.
In one aspect, the illuminating device is embodied in an elongate member having proximal and distal portions, where the distal portion is configured to be placed at an interventional site. At the proximal portion of the device is configured a connector. The elongate member can further include an internal bore for receiving substructures of the device.
In one embodiment an illuminating guidewire device comprises:
an elongate flexible housing having a proximal end, a distal end configured to be placed at the site within a patient's body, and a lumen extending through the housing from the proximal end to the distal end, wherein the housing comprises at least a first portion of a first material (e.g., a coil) and a second portion of a second material (e.g., a cable tube) which first and second portions are joined together by a first joint and a second joint;
at least one illuminating fiber extending through the lumen of the housing;
at least one supporting member (e.g., a core wire) extending at least through the lumen of the housing where the first joint and second joint are located and wherein the first joint bonds the first portion of the housing to the supporting member and the second joint bonds the first portion of the housing to the second portion of the housing and the supporting member.
In another embodiment, the invention is directed toward a proximal assembly of an illuminating guidewire comprising:
a first tube (e.g., a hypotube) having a lumen extending therethrough;
an elongate flexible housing (e.g., a cable tube) having a lumen extending therethrough, the housing being received within the first tube but not extending proximally beyond the proximal end of the first tube;
a second tube (e.g., a bonding tube) having a lumen therethrough and positioned within the lumen of the first tube at the proximal end and extending beyond the proximal end of the first tube, but not beyond the distal end of the first tube;
at least one illuminating fiber extending through and proximally beyond the lumen of the housing and the lumen of the first tube and into the lumen of the second tube; and
wherein the housing is not fixably attached to the first tube and is free to rotate within the first tube and the distal end of the second tube and the proximal end of the first tube are fixably attached.
Yet another embodiment relates to a connector adapted to receive an illuminated guidewire having an outer diameter and comprising:
In a specific embodiment of an illuminating device, the distal portion includes a coil and the proximal portion includes a cable tube. Extending longitudinally within the proximal and distal portions is one or more illumination fibers, a distal end of which is affixed within the coil and a proximal end. Also configured within certain portions of the proximal and distal portions are a core wire and a stranded wire. Various approaches to receiving the illumination fibers within the connector and profiles of the core wire are contemplated as are points of attachment and relative movements between the components.
Another specific embodiment includes design of the proximal end of the illuminating device which connects to a light source through a detachable connector which receives the illuminated device and then connects to the light cable of the light source and certain features of the detachable connector are contemplated
In a specific embodiment of an illuminating device with an end connector, the distal portion includes a coil and the proximal portion includes a cable tube. Extending longitudinally within the proximal and distal portions is one or more illumination fibers, a distal end of which is affixed within the coil and a proximal end being received within the connector. Also configured within the proximal and distal portions is a core wire. Various approaches to receiving the illumination fibers within the connector and profiles of the core wire are contemplated as are points of attachment and relative movements between the components. Moreover, various embodiments of the connector are contemplated.
Further, approaches to compensating for changing lengths of an illumination fiber are contemplated as are approaches to facilitating the operation of the illuminating device. In that regard, structure can be incorporated into the illuminating device to accommodate changes in length or steps can be taken to treat the illumination fiber to control length changes. Also, drugs can be injected at an interventional site to aid the illumination process.
A method for visually confirming the positioning of a distal end portion of a device placed within a patient is provided to include: inserting a distal end portion of an illuminating device internally into a patient, emitting light from the distal end portion of the illuminating device; observing transillumination resulting from the light emitted from the distal end portion of the illuminating device that occurs on an external surface of the patient; and correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination, to confirm positioning of the distal end portion of the illuminating device.
In at least one embodiment, the observation is performed by direct line of sight human observation, without the need for fluoroscopy.
In at least one embodiment, the observation is performed by direct line of sight human observation, without the need for any visualization equipment.
In at least one embodiment, the illuminating device comprises a guidewire.
In at least one embodiment, the illuminating device comprises an ostium seeker device.
In at least one embodiment, the illuminating device comprises a sinus suction instrument.
In at least one embodiment, the illuminating device comprises an integrated wire dilatation catheter, wherein an integrated illuminating guidewire extends distally of a distal end of a dilatation catheter.
In at least one embodiment, the distal end portion of the illuminating guidewire is inserted into a sinus passageway of the patient.
In at least one embodiment, the distal end portion of the illuminating guidewire is inserted through an ostium opening to a sinus of the patient, and the distal end portion is advanced into the sinus.
In at least one embodiment, the distal end portion of the illuminating guidewire is initially inserted through a nostril of the patient and then advanced into a sinus.
In at least one embodiment, a scope is inserted through the nostril of the patient, wherein the guidewire is inserted adjacent the scope, and visualization of the advancement of the distal end portion of the guidewire is performed via the scope as the distal end portion is advanced toward an ostium of the sinus.
In at least one embodiment, transillumination is observed when a light emitting portion of the distal end portion is located in the sinus of the patient.
If observation of transillumination and correlation reveals that the distal end portion of the illumination device has been misrouted to a location other than a target location, the distal end portion of the device can be retracted and re-routed to the target location, which can be confirmed by observing transillumination and correlating.
In observing transillumination, the motion of the transillumination spot resulting from the light emitted from the distal end portion of the illuminating device can be observed and tracked or followed visually, as the distal end portion is moved relative to the patient, and this can be one way of confirming that the transillumination spot in motion correlates to a position of the distal end portion. This technique can be particularly useful when there are additional sources of transillumination, such as a light from a scope, for example.
Further, transillumination resulting from the light emitted from the distal end portion of the device can be distinguished from transillumination resulting from light emitted from a scope by identifying a transillumination spot that is at least one of brighter, smaller or more well-defined than other transillumination effects observed. Alternatively, the transillumination resulting from the light emitted from the distal end portion of the device can be distinguished from transillumination resulting from light emitted from a scope by turning off or down the light source to the scope.
In at least one embodiment, a sinus guide is inserted within the patient prior to inserting the device, and the distal end portion of the illuminating device is inserted through the sinus guide.
In at least one embodiment, the illuminating device is preloaded in the guide, and the guide and preloaded illuminating device are inserted together into the patient. Advancement of the illuminating device relative to the guide can then be performed to extend a distal end portion of the illuminating device distally of a distal end of the guide.
A scope may be inserted within the patient, wherein the sinus guide is inserted adjacent the scope, and advancement of the sinus guide can be visualized via the scope.
In at least one embodiment, visualization of the advancement of the sinus guide is through use of the scope, up to a limit of adequate illumination by the scope. After that, the light emitted by the distal end portion of the illuminating device, having been advanced distally of a distal end of the sinus guide, extends the limit of adequate illumination of the scope, thereby extending a length of the adequate illumination of the scope.
In at least one embodiment, the sinus guide can be further distally advanced under visualization by the scope as facilitated by the extended length of the adequate illumination.
In at least one embodiment, visualization of the advancement of the illuminating device distally of the sinus guide can be performed via the scope, as facilitated by the light emitted from the distal end portion of the device.
In at least one embodiment, the scope is inserted into a nostril of the patient, and the sinus guide is inserted adjacent the scope.
In at least one embodiment, the scope and sinus guide are advanced into a sinus passageway of the patient.
In at least one embodiment, the sinus guide is further advanced toward an ostium of a sinus, and the advancement of the sinus guide is visually observed via the scope.
In at least one embodiment, the scope is inserted into a nostril of the patient, and the sinus guide is inserted adjacent the scope. The advancement of the sinus guide into a sinus passageway is visualized via the scope until a distal end of the sinus guide has reached a distal limit of illumination emitted by the scope.
In at least one embodiment, further advancement of the sinus guide toward an ostium of a sinus is visualized via the scope as facilitated by the extended length of adequate illumination provided by the illumination device.
In at least one embodiment, the scope is inserted into a nostril of the patient, and the sinus guide is inserted adjacent the scope. The advancement of the sinus guide to place a distal end of the sinus guide adjacent an approach to an ostium of a sinus is visualized via the scope.
In at least one embodiment, the distal end portion of the illuminating device is advanced further distally of a distal end of the sinus guide and distal of the limit of illumination of the scope to emit illumination, thereby extending a length of a space that is visualizable by the scope.
In at least one embodiment, the distal end portion of the device is further advanced into and through the ostium, and visualization of the advancement of the distal end portion into the ostium is performed via the scope.
In at least one embodiment the device comprises an illuminating guidewire, a working device is advanced over the guidewire to position a working end of the working device at a target location, and a surgical procedure is performed with the working device at the target location. The working device is removed from the patient after performing the surgical procedure. Optionally, an implant can be left at the target location.
A method of performing a minimally invasive surgical procedure is provided, including the steps of: inserting a distal end portion of an illuminating guidewire internally into a patient; emitting light from the distal end portion of the illuminating guidewire, wherein a proximal end portion is connected to a power source to enable the distal end portion to emit light; observing transillumination resulting from the light emitted from the distal end portion of the illuminating guidewire that occurs on an external surface of the patient; correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination, to confirm positioning of the distal end portion of the illuminating guidewire; disconnecting the proximal end portion of the illuminating guidewire from the power source; advancing a working device over the guidewire so that a proximal end of the guidewire extends proximally from the working device; reconnecting the proximal end portion of the illuminating guidewire to the power source so that the distal end portion of the guidewire again emits light; positioning a working end of the working device at a target location; and performing a surgical procedure with the working device at the target location.
After performing the surgical procedure, the proximal end portion of the illuminating guidewire is disconnected from the power source; and the working device is removed from the patient and from the guidewire. Optionally, an implant can be left at the target location.
In at least one embodiment, a second working device is advanced over the guidewire after removing the first working device therefrom, so that a proximal end of the guidewire extends proximally from the second working device. Then the proximal end portion of the illuminating guidewire is reconnected to the power source so that the distal end portion of the guidewire again emits light.
In at least one embodiment, the illuminating guidewire includes at least one illumination fiber extending from a proximal end of the guidewire to the distal end portion, and the power source is a light source.
In at least one embodiment, the illuminating guidewire includes at least one laser fiber extending from a proximal end of the guidewire to the distal end portion, and the power source is a laser light source.
In at least one embodiment, the illuminating guidewire includes a light emitting diode at the distal end portion and electrical wires extending through the guidewire, electrically connecting the light emitting diode to the power source, and wherein the power source is an electrical power source.
A method for diagnosing and/or treating sinusitis or another disorder affecting a nose, a sinus or other anatomical structure of the ear, nose or throat in a human or animal patient is provided, including the steps of: advancing an introducing device through the nose and to a position where the distal end of the introducing device is near an opening of a sinus; advancing a distal end portion of an illuminating device that emits light from the distal end portion thereof through the introducing device while a proximal end of the illuminating device is connected to a power source; and monitoring a position of the distal end portion of the illuminating device distally of the distal end of the introducing device, by observing transillumination on an external surface of the patient that results from the light emitted by the distal end portion. The light emitted can be a desired wavelength in the visible spectrum and/or infrared spectrum.
In at least one embodiment, the distal end portion of the illuminating device is advanced through the opening of the sinus; and placement of the distal end portion of the illuminating device in the sinus is confirmed by observing the transillumination resulting from the light emitted from the distal end portion of the illuminating device that occurs on the external surface of the patient, and correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination.
In at least one embodiment, the external surface on which the transillumination is observed is on the face of the patient.
In at least one embodiment, the external surface on which the transillumination is observed is on the palate of the patient.
In at least one embodiment the illuminating device comprises an illuminating guidewire, and a working device is provided that is positionable in an operative location and useable to perform a diagnostic or therapeutic procedure there. The proximal end of the illuminating guidewire is disconnected from the power source, while maintaining the distal end portion of the illuminating guidewire in its current position, and the working device is advanced over the guidewire so that a proximal end of the guidewire extends proximally from the working device. The proximal end of the illuminating guidewire is then reconnected to the power source so that the distal end portion of the guidewire again emits light. The working device is further advanced to position a working end of the working device at the operative location, and a diagnostic or therapeutic procedure is performed with the working device at the operative location.
In at least one embodiment, the operative location is the opening to the sinus.
An illuminating guidewire device is provided, including: a flexible distal end portion; a relatively less flexible proximal end portion; at least one light emitting element in the distal end portion; and at least one structure extending from a proximal end of the device through the proximal end portion and at least part of the distal end portion to connect the at least one light emitting element with a power source located proximally of the device.
In at least one embodiment, the at least one light emitting element comprises a distal end of at least one illumination fiber, and the at least one structure comprises the at least one illumination fiber running proximally of the distal end of the fiber to the proximal end of the device.
In at least one embodiment, the power source is a light source.
In at least one embodiment, the at least one light emitting element of the illuminating guidewire comprises a distal end of at least one laser fiber, and the at least one structure comprises the at least one laser fiber running proximally from the distal end of the fiber to the proximal end of said device.
In at least one embodiment, the power source is a laser light source.
In at least one embodiment, the at least one light emitting element comprises a light emitting diode, and the at least one structure comprises at least one electrical wire electrically connected to the light emitting diode and extending proximally of the light emitting diode to the proximal end of the device.
In at least one embodiment, the power source is an electrical power source.
In at least one embodiment, the distal end portion of the guidewire has an outside diameter configured and dimensioned to pass through an ostium of a sinus.
In at least one embodiment, the distal end portion of the guidewire has an outside diameter less than about 0.038 inches.
In at least one embodiment, the distal end portion of the guidewire has an outside diameter of about 0.035″±0.005″.
In at least one embodiment, the illuminating guidewire has a maximum outside diameter of less than about 0.038 inches.
In at least one embodiment, the illuminating guidewire has a maximum outside diameter of less than about 0.035 inches.
In at least one embodiment, the illuminating guidewire has a maximum outside diameter of about 0.035″±0.005″.
In at least one embodiment, the distal end portion of the device comprises a flexible coil. In at least one embodiment, the distal end portion further comprises a core wire extending internally of the coil. In at least one embodiment, the core wire is fixed to the coil.
In at least one embodiment, a core wire extends within the distal and proximal end portions of the device. In at least one embodiment, core wire extends within substantially the full length of the distal and proximal end portions.
In at least one embodiment, the distal end portion of the device includes a bend, such that a proximal part of the distal end portion is substantially aligned with a longitudinal axis of the device, and a distal part of the distal end portion is angled with respect to the longitudinal axis.
In at least one embodiment, the distal end of at least one illumination fiber is configured to emit light from a distal tip of the distal end portion of the device. The distal tip can be designed to either focus or distribute the light to achieve maximum transillumination. The distal tip can include a lens, prism or diffracting element.
In at least one embodiment, the distal end of at least one illumination fiber is positioned proximally of a distal tip of the distal end portion of the device.
In at least one embodiment, a flexible distal portion of the distal end portion extends distally of the distal end of the at least one illumination fiber.
In at least one embodiment, the distal end of at least one laser fiber is configured to emit light from a distal tip of the distal end portion of the device.
In at least one embodiment, the distal end of at least one laser fiber is positioned proximally of a distal tip of the distal end portion of the device.
In at least one embodiment, a flexible distal portion of the distal end portion extends distally of the distal end of at least one illumination fiber.
In at least one embodiment, a light emitting diode is mounted at a distal tip of the distal end portion of the device.
In at least one embodiment, a light emitting diode is positioned proximally of a distal tip of the distal end portion of the device. In at least one embodiment, a flexible distal portion of the distal end portion extends distally of the light emitting diode.
In at least one embodiment, an electrical power source is removably, electrically connected to at least one structure to provide electrical power to at least one light emitting element.
In at least one embodiment, at least one light conducting tube delivers light from a proximal end portion of the device to a distal end of the tube, where it is emitted.
In at least one embodiment, each light conducting tube is sealed in a proximal end of the device.
In at least one embodiment, each light emitting element is sealed at a distal tip of the device.
In at least one embodiment, a quick release connector is mounted over at least part of the proximal end portion of the guidewire. The quick release connector is adapted to be connected to a power source and to quickly connect to and release from the proximal end portion of the guidewire.
In at least one embodiment, the quick release connector is optically coupled with a light source.
In at least one embodiment, the proximal end portion of the quick release connector is adapted to connect with a light source.
In at least one embodiment, the proximal end portion of the quick release connector comprises an ACMI Corporation light post.
In at least one embodiment, the connector is rotatable with respect to a light channel extending from a light source, when the connector is connected to the light channel. In at least one embodiment, the light cable comprises a fluid filled light cable.
In at least one embodiment, a distal end portion of the connector comprises an opening configured to slidably receive the proximal end portion of the guidewire device; and a quick release locking mechanism is configured to fix the proximal end portion received in the connector.
In at least one embodiment, the quick release locking mechanism is movable between an unlocked configuration in which the proximal end portion can be slid from the connector to disconnect therefrom, and a locked configuration that maintains the proximal end portion in connection with the connector. In at least one embodiment, the quick release locking mechanism is biased toward the locked configuration.
In at least one embodiment, a radiopaque marker is provided on the distal end portion of the guidewire.
In at least one embodiment, an electromagnetic coil is provided at the distal end portion of the guidewire. Alternatively, a magnet, radiofrequency emitter or ultrasound crystal can be provided at the distal end portion of the guidewire.
An illuminating device is provided, including a distal end portion having an outside diameter configured and dimensioned to pass through an ostium of a sinus, at least one light emitting element in the distal end portion, and at least one structure extending from a proximal end of the device through the proximal end portion and at least part of the distal end portion to connect the at least one light emitting element with a power source.
In at least one embodiment, the illuminating device comprises an illuminating guidewire.
In at least one embodiment, the illuminating device comprises an ostium seeker device, and the distal end portion is rigid or malleable.
In at least one embodiment, the illuminating device comprises an ostium seeker device, and the distal end portion comprises a ball tip at a distal end thereof.
In at least one embodiment, the illuminating device comprises a sinus suction instrument, and the distal end portion further comprises a suction lumen configured and adapted to apply suction therethrough.
In at least one embodiment, the illuminating device comprises an integrated wire dilatation catheter, wherein an integrated illuminating guidewire extends distally of a distal end of a dilatation catheter of the device.
An illuminating guidewire device is provided including: a guidewire including an elongated main body having a flexible distal end portion and a relatively less flexible proximal end portion; at least one light conducting channel extending the length of the elongated body, and configured and dimensioned to deliver light from a proximal end of the guidewire to a distal end of the guidewire and to emit light from the distal end of the guidewire.
In at least one embodiment, the at least one light conducting channel comprises at least one illumination fiber.
In at least one embodiment, the at least one light conducting channel comprises at least two illumination fibers.
In at least one embodiment, the illumination fibers are formed of plastic.
In at least one embodiment, the at least one illumination fiber is formed of glass.
In at least one embodiment, the at least one light conducting channel comprises at least one laser fiber.
In at least one embodiment, a quick release connector is mounted over at least part of the proximal end portion of the elongated body, and is adapted to be connected to a light channel extending from a light source; and to quickly connect to and release from the proximal end portion of the elongated body.
In at least one embodiment, the quick release connector is optically coupled with the light source.
In at least one embodiment, a proximal end portion of the connector comprises a tapering light channel configured to adapt a relatively larger inside diameter of the light channel to a relatively smaller diameter of the proximal end of the elongated body.
In at least one embodiment, a proximal end portion of the quick release connector is adapted to connect with a light source. In at least one embodiment, the proximal end portion of the quick release connector includes an ACMI light post.
In at least one embodiment, the connector is rotatable with respect to the light channel extending from the light source, when the connector is connected to the light channel.
In at least one embodiment, the distal end portion of the connector comprises an opening configured to slidably receive the proximal end portion of the elongated body, and a quick release locking mechanism is configured to fix the proximal end portion received in the connector.
In at least one embodiment, the quick release locking mechanism, in a locked configuration, maintains a proximal end of the elongated body in alignment with a distal end of the tapering light channel of the connector.
In at least one embodiment, the quick release locking mechanism is movable between an unlocked configuration in which the proximal end portion can be slid from the connector to disconnect therefrom, and a locked configuration that maintains the proximal end portion in connection with the connector.
In at least one embodiment, a core wire extends at least within the distal end portion of the elongated body of the guidewire. In at least one embodiment, the core wire further extends within the proximal end portion.
An illuminating guidewire device is provided, including: a guidewire having an elongated main body with a flexible distal end portion and a relatively less flexible proximal end portion; a light emitting diode mounted in the distal end portion and configured to emit light from a distal tip of the distal end portion; and at least one electrical wire extending the length of the elongated body, being electrically connected to the light emitting diode, and extending proximally of a proximal end of the elongated body.
In at least one embodiment, the illuminating guidewire device includes at least two such electrical wires.
In at least one embodiment, a core wire extends at least within the distal end portion of the elongated body. In at least one embodiment, the core wire further extends within the proximal end portion.
In at least one embodiment, a radiopaque marker is provided on the distal end portion. In at least one embodiment, an electromagnetic coil is provided on the distal end portion.
An illuminating guidewire device is provided, including: a guidewire having a flexible distal end portion, a relatively less flexible proximal end portion, and a transparent portion interconnecting the distal and proximal end portions; at least one light emitting element mounted in the guidewire and configured to emit light through the transparent portion; and at least one structure extending from a proximal end of the device through the proximal end portion and connecting with the at least one light emitting element.
In at least one embodiment, the transparent portion comprises a clear tube.
In at least one embodiment, the clear tube includes cut out windows therein.
In at least one embodiment, the transparent portion comprises a plurality of struts interconnecting the proximal and distal end portions of the guidewire.
In at least one embodiment, a deflector is mounted distally of the at least one light emitting element in the transparent portion.
In at least one embodiment, a quick release connector is mounted over at least part of the proximal end portion, and is adapted to be connected to a light channel extending from a light source, and to quickly connect to and release from the proximal end portion of the guidewire.
In at least one embodiment, a core wire extends at least within the distal end portion. In at least one embodiment, the core wire further extends within the proximal end portion.
A quick release connector for use with an illuminating guidewire is provided to include: a main body having a proximal end portion and a distal end portion; a channel in the distal end portion and opening to a distal end of the main body, wherein the channel is configured and dimensioned to slidably receive a proximal end portion of the illuminating guidewire; and a quick release locking mechanism configured to assume a locked position and an unlocked position, wherein when in the locked position, the quick release locking mechanism fixes the proximal end portion of the illuminating guidewire in the channel.
In at least one embodiment, the quick release locking mechanism is biased to the locked position.
In at least one embodiment, upon inserting the proximal end portion of the illuminating guidewire into the channel, the proximal end portion contacts portions of the quick release locking mechanism, driving the portions apart to allow the proximal end portion to be slid into the channel.
In at least one embodiment, the quick release locking mechanism comprises a locking arm that extends into the channel and a portion that extends out of the housing, wherein the portion extending out of the housing is manually retractable to move the locking arm from the locked position to the unlocked position.
In at least one embodiment, the quick release locking mechanism includes at least two locking arms provided circumferentially about the distal end portion of the main body of the connector.
In at least one embodiment, the quick release locking mechanism comprises a pin vise.
In at least one embodiment, the proximal end portion of the connector is adapted to be connected to a light channel extending from a light source.
In at least one embodiment, the proximal end portion of the main body is optically coupled with a light source.
In at least one embodiment, the proximal end portion of the main body includes a tapering light channel configured to adapt a relatively larger inside diameter of a light channel to a relatively smaller diameter of the proximal end of the illuminating guidewire.
In at least one embodiment, the proximal end portion of the main body comprises an ACMI light post.
In at least one embodiment, the quick release connector is rotatable with respect to a light channel extending from a light source, when the connector is connected to the light channel.
These and other advantages and 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.
Other features and advantages will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate by way of example, the features of the various embodiments.
The present disclosure provides an apparatus and method which eliminates or reduces a need for remote imaging techniques. To accomplish this, there is disclosed a medical device having desirable pushability and torquability so that an interventional site is accessed. The disclosed medical device embodies structure or includes components which are pre-treated so that it can accommodate forces applied thereto during operation.
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 tube” includes a plurality of such tubes and reference to “the shaft” includes reference to one or more shafts 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.
Turning now to
Next guidewire or elongated probe 1004 is inserted through catheter or tube 1002 and distally advanced to extend the distal end of guidewire or elongated probe through the ostium to be treated and into the sinus that the ostium opens to. Proper placement often involves advancement and retraction of the distal end of guidewire or elongated probe, under fluoroscopic visualization, until it has been visually confirmed that the distal end of the guidewire or elongated probe is located where the surgeon believes the appropriate sinus to be located, relative to the other features of the patient's head that are visualized under fluoroscopy.
Once guidewire or elongated probe 1004 has been properly placed, working device 1006 is next passed over the guidewire or elongated probe 1004, under visualization via fluoroscope 1000 and/or an endoscope (not shown) that has been inserted adjacent catheter or tube 1002, to place the working end of working device 1006 in the target location where a surgical procedure is to be performed. Typically, the guidewire or elongated probe remains in place during the procedure. Under the same type(s) of visualization, the working (distal) end of working device is then actuated to perform the desired surgical procedure. In the case of a dilatation catheter, the balloon at the distal end portion of catheter 1006 is expanded once it has been located across the ostium. This expansion acts to open the ostium to allow proper mucus flow, as was described in more detail above.
After performance of the desired surgical procedure, the working device 1006 is deactivated and withdrawn from the patient, after which the remaining devices are withdrawn to complete the procedure.
By using the devices and methods described herein, at least the need for fluoroscopic visualization of the placement of the guidewire/elongated probe can be reduced or eliminated. Further optionally, all fluoroscopic visualization needs may be eliminated in some surgical circumstances.
It is to be appreciated that the devices and methods of the present invention relate to the accessing and dilatation or modification of sinus ostia or other passageways within the ear, nose and throat. These devices and methods may be used alone or may be used in conjunction with other surgical or non-surgical treatments, including but not limited to the delivery or implantation of devices and drugs or other substances as described in co-pending U.S. patent application Ser. No. 10/912,578.
In
In
Although scope 1008 may be useful to reduce or eliminate the need for fluoroscopic visualization during placement of sinus guide 1002 and/or for visualization of the procedure performed by working device 1006, it does not provide stand-alone capability to see inside the sinus (e.g., sphenoid sinus 1016 or other sinus of interest), and therefore cannot provide sufficient visual feedback for use in guiding guidewire 10 into the desired sinus (e.g., frontal sinus, or some other sinus of interest) or sufficient visual image confirmation of correct placement of guidewire 10 into the desired sinus.
Further, depending upon the particular configuration of the sinus passageways to be traversed to gain access to a target ostium, the scope 1008, 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,
In order to overcome these and other problems, the guidewire devices 10 of the present invention include their own light emitting capability. By illuminating a distal end portion of guidewire 10, a process known as transillumination occurs as guidewire 10 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 10 is located in a sinus, the light emitted from guidewire 10 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 1008, such as positioned in
Coil 10c may be formed from a stainless steel wire, for example. The diameter of the coil wire can be between about 0.004 and about 0.008 inches, typically about 0.006 inches. Alternative materials from which coil 10c 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, the 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 10p 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 10c is joined to proximal portion 10p by solder, epoxy or other adhesive or mechanical joint. One or more illumination channels 10i are provided in device 10 and extend the length thereof. Illumination channels 10i are configured to transport light from the proximal end of device 10 to and out of the distal end of device 10. 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, ESKA™ (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″. 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 10i may be used that has an outside diameter of about 0.020″. 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 10i may be provided.
The distal end of device 10 is sealed by a transparent (or translucent) seal 10s which may be in the form of epoxy or other transparent or translucent adhesive or sealing material. Seal 10s maintains the distal ends of illumination fibers 10i coincident with the distal end of device 10 and also provides an atraumatic tip of the device 10. Further, seal 10s 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 10 is also sealed by a transparent (or translucent) seal 10ps which may be in the form of epoxy or other transparent or translucent adhesive or sealing material. Seal 10ps maintains the proximal ends of illumination fibers 10i coincident with the proximal end of device 10. The proximal end of device 10 may be further prepared by grinding and polishing to improve the optical properties at the interface of the proximal end of device 10 with a light source. The illumination fibers 10i 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 10 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 10 relative to a similar arrangement, but where the illumination fibers 10i are internally fixed.
The outside diameter of device 10 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 distal portion 10p of device 10 is provided with a core wire 10cw that is contained therein. In the example shown in
Core wire 10cw particularly increases the pushability and the torquability of coil 10c which, by itself, is quite flexible and twistable. Combined with core wire 10cw, the distal portion is much more effective at transferring pushing and torquing forces without buckling or twisting. Additionally, core wire 10cw may be plastically deformed or memory set into a bent shape, an example of which is shown in
The illumination fibers, as noted above, can be free to move about radially within the device. Further, there is no need to center the illumination fibers 10i with respect to device 10 even at the distal and proximal ends of the device.
The plastic or glass illumination fibers 10i of the device shown in
Device 10 in
Any of the devices 10 described herein may optionally include one or more radiopaque markers and/or electromagnetic coils on the tip of the device 10 and/or elsewhere along the device for enhancing visibility by fluoroscopy systems, image guided surgery (IGS) systems, or other visualization systems.
This configuration may be beneficial in further protecting the illumination emitter(s) 10i, 10id 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 10dd 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 10dp may be provided as a clear plastic or glass integral tube, or may have openings or windows 10t provided therein (see the partial view of
Device 10 should be readily connectable to and disconnectable from a power source to enable attachment for providing illumination for positioning the guidewire 10 and/or other devices during a procedure, detachment to allow another device to be slid onto the guidewire 10 from a free proximal end thereof, and reattachment to again provide illumination, to assist in guidance/visualization of the device being passed over the guidewire 10, for example.
Connector 20 includes a proximal channel, slot or bore 22 that has an inside dimension or circumference that is slightly greater than the outside diameter or circumference of device 10 at the proximal end portion 10p. A quick release locking mechanism 24 is provided for locking and unlocking device 10 within connector 20. Quick release locking mechanism 24 is biased toward the locking position shown in
Light cable 1032 generally has a much larger inside diameter than the inside diameter or combined inside diameters of the illumination fibers 10i. Accordingly, the proximal end portion of connector 20 provides a tapering or funnel shaped pathway 26 having a proximal inside diameter that is substantially equivalent to the inside diameter of cable 1032 or greater, and which tapers to a distal inside diameter that is about the same or only slightly greater than the inside diameter or combined inside diameters of the illumination fiber(s), or alternatively, that is about the same or only slightly greater than the outside diameter of the proximal end of device 10. The light cable 1032 generally has a larger diameter bundle of illumination fibers than that contained within the illuminating guidewire 10. Accordingly, the taper 26 is used to transition between the larger bundle in the light cable 1032 and the smaller bundle in the guidewire 10 With this arrangement, light delivered through light cable 1032 is concentrated or focused down to a pathway where most of the light can be transmitted through the illumination fibers.
To insert device 10 into connector 20, an operator retracts quick connect locking mechanism 24 to the open position shown in
In the example shown in
The proximal end of connector 20 is provided with a light post 28 that is configured to mate with a connector on the distal end of a light cable extending from a conventional endoscope light source. For example, light post 28 may be an ACMI light post (ACMI Corporation) or other standard connector typically used to connect endoscopes to operating room light sources. Because the cable extending from an operating room light source generally has a much larger inside diameter than the inside diameter or combined inside diameters of the illumination fibers of device 10, and larger than the diameter of the proximal end of guidewire 10, the proximal end portion of connector 20 includes a light tapering or funnel-shaped pathway 26 like that described above with regard to
The quick release locking mechanism 24 in this example includes a collet 24c that is configured to center the proximal end of device 10 with the distal end of tapering pathway 26. A threaded cap 24d is threaded over mating threads 24t on the body of connector 20, so that when cap 24d is torqued in a direction to advance cap 24d proximally with respect to the body of connector 20, inner ramped or cammed surfaces 24e of cap 24d ride over outer ramped or cammed surfaces 24f of collet 24c, thereby functioning as a pin vise and clamping collet 24c against the proximal end portion of device 10 to clamp and maintain device 10 in its current position relative to connector 20. To insert device 10, cap 24d is rotated in a reverse direction from that described above to open the distal opening of the inner channel 24g of collet 24c to a dimension larger than the outside diameter of the proximal end of device 10, so that device 10 can be easily slid through the channel 24g until the proximal end of device 10 abuts the proximal end portion of collet 24c, or approximates the same. The cap 24d is then turned with respect to the body of connector 20 to clamp device 10 into position, as described above. Removal of device 10 can be performed by turning cap 24d in a reverse direction relative to connector body 20, thereby loosening the grip of collet 24c on device 10, after which device 10 can be easily slid out from connection with connector 20. Components of connector 20 may be made from metal, such as stainless steel or other biocompatible metals, or temperature-resistant thermosetting polymer, for example.
Light post 28 is rotatable with respect to the light cable 1032 of the light source 1030 when connector 20 is connected to the distal end connector of the light cable 1032. This allows device 10, when connected to connector 20 in this arrangement, to be rotated during use without building up significant twisting or rotational counter forces within the light cable 1032. For example, in the light post 28 shown, the female receptacle (not shown) of the light cable 1032 couples over light post 28 and engages in groove 28g, about which the female receptacle is then rotatable relative to light post 28.
Turning now to
In
Once the surgeon is satisfied that the distal end of the sinus guide 1002 is positioned close enough to the appropriate ostium 1034, illuminating guidewire 10, connected to a light source as described by any of the techniques mentioned above, is inserted through sinus guide 1002 and advanced therethrough, see
As shown in
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 10 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,
Once properly positioned, the proximal end of device 10 is disconnected from connector 20, while leaving guidewire 10 in its current position. A working device 1006, for example a balloon catheter, is the introduced over guidewire 10 and advanced thereover so that the proximal end of device 10 extends proximally beyond a proximal end of device 1006. Device 10 is then reconnected to connector 20 so that light is again emitted from the light emission portion of the distal end portion of device 10 Thus it can be visually confirmed, without radiography, that the distal end portion of the guidewire 10 remains properly in the frontal sinus 1036 as the working device 1006 is advanced toward ostium 1034 and the balloon of working device 1006 is extended across the ostium,
Once proper placement of the working device 1006 has been confirmed, working device 1006 is used to perform a diagnostic or therapeutic procedure. In this particular example, the procedure is dilatation of the frontal sinus ostium 1034 by expansion of the balloon thereagainst, to enlarge the opening of the ostium 1034. However, 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. Further, other working tools may be inserted and used according to these same techniques. After the completion of the procedure, sinus guide 1002, guidewire 10 and working device 1006 are withdrawn and removed, completing the procedure, see
Illuminating guidewire device 10 can also be used to facilitate visualization and placement of the sinus guide 1002 in the procedure described above with regard to
Additionally, this technique can be used to visualize placement of the guidewire 10 up to and into the desired ostium 1034. Alternatively, this can be carried out without the sinus guide 1002, wherein the guidewire 10 is inserted and the scope 1008 can be used to visualize placement of guidewire 10 into the target ostium with the assistance of the light emitted by the scope 1008 in addition to the light emitted by guidewire 10.
In any of these procedures where a scope 1008 is used for visualization and an illuminating guidewire is inserted, some transillumination of the target sinus may occur from the light emitted by the scope 1008 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 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 will produce a moving transillumination spot at guidewire 10 is advance, which also helps distinguish the location of the distal portion of the guidewire, relative to any diffuse transillumination produced by the scope light.
If the guidewire 10 is advanced into an ostium other than the target ostium (e.g., ostium 1035 shown in
Thus, by using an illuminating guidewire device 10 in the methods as described above, the use of fluoroscopy or other X-ray visualization can be reduced and is not required to confirm proper placement of the guidewire in some cases.
Similar procedures may be carried out in other sinuses. For example, a similar procedure to that described above with regard to
It is further noted that some wavelengths of light may be more effective in producing the transillumination effects described herein, for the purpose of locating the position of the guidewire. In this regard, particular wavelengths of visible light can be selected for this purpose. Alternatively, or in addition, infrared wavelengths may be particularly effective. In this regard, guidewires that employ illuminating fibers may be provided with a filter 12 to define the color/wavelength of the light emitted by device 10. As schematically shown in
Another optional feature that guidewire 10 may be provided with is the ability to emit strobed, flashing or flickering light. The transillumination produced by a flashing 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 10 in this case will flicker or vary in intensity between bright and dim. To produce this type of light, either a light source having strobing capability could be connected to the device 10, or connector 20 may be provided with this capability. When using a laser light source or an LED as the light emitter, as described in embodiments above, a blinking or strobing effect can be electronically generated according to techniques known in the electronics and lighting arts.
Alternatively, shutter 27 can be configured so that vanes 27v extend through a slot in connector 20 whereby a user can manually rotate the shutter to cause the light emitted from device 10 to flicker.
Other instruments that are designed to be inserted into a sinus, or at least to be positioned at the ostium of a sinus can also be provided with illumination capability according to any or all of the features described above with regard to illumination guidewires.
In one preferred embodiment for adult applications, balloon catheter 120 has an overall length of approximately 43.5 cm and its shaft 126 has an outer diameter of about 0.058 inches. Further details about integrated wire dilatation catheters that may be configured with a light emitter in a manner as described herein can be found in co-pending application Ser. No. 11/438,090 filed May 18, 2006 and titled “Catheters with Non-Removable Guide Members Useable for Treatment of Sinusitis. Application Ser. No. 11/438,090 is hereby incorporated herein, in its entirety, by reference thereto.
Turning now to
Generally, distal end portion 210d may be more flexible than proximal end portion 210p to provide a desired degree of flexibility for leading the device to a site within a paranasal sinus or other location in the body. The distal end portion 210d may include a coil 210c as an exterior portion thereof, to help provide the desired flexibility to this portion. A proximal end portion 210p of illuminating guidewire 210 provides a sufficient length so that the device extends proximally out of the patient (and, when inserted through another device, such as a sinus guide, proximally out of the device into which illuminating guidewire 210 is inserted), at all times, including the deepest contemplated location into which the distal end of device is placed. As before, the proximal end portion 210p can have visible markings, preferably spaced at equal intervals, which can be observed by the user to confirm how far the illuminating guidewire 210 has been placed into the patient. Proximal end portion 210p generally provides: torquability, i.e., the ability to torque the proximal end portion 210p from a location outside of the patient and have that torque transmitted to the distal end portion 210p; pushability, i.e., sufficient rigidity, so that when an operator pushes on the proximal end portion 210p from a location outside of the patient, the pushing force transmits to the distal portion 210d to advance the distal portion 210p without buckling the device 210; and tensile strength so that an operator can pull on the proximal end portion 210p from a location outside of the patient and withdraw the device from the patient without significant plastic deformation or any destruction of the device.
The coil 210c formed at the distal end portion 210d of the illuminating device 210 may be formed from a stainless steel wire. The diameter of the coil wire can be between about 0.004 and about 0.008 inches, typically about 0.006 inches. Alternative materials from which coil 210c may be formed include, but are not limited to: ELGILOY®, CONICHROME® or other biocompatible cobalt-chromium-nickel alloys; nickel-titanium alloys; or other known biocompatible metal alloys having similar characteristics. In one approach, the coil is formed from a 0.006 inch stainless steel wire defining a 0.034 inch outer diameter (0.035 inch maximum) and a 0.021 inch inner diameter.
In one embodiment, the proximal portion 210p can be made from a cable tube 211 (See also
The distal end of the illumination guidewire 210 is sealed by a transparent (or translucent) seal 210s which may be in the form of epoxy or other transparent or translucent adhesive or sealing material. The seal 210s maintains the distal ends of illumination fibers 210i coincident with the distal end of the device and provides a lens 213 to provide an atraumatic tip. In one approach, an UV adhesive is employed to bond the illumination fibers 210i to the coiled wire 210c as well as to a core wire. Further, the seal 210s prevents entrance of foreign materials into the device. The lens 213 formed at the distal end can be designed to either focus or distribute the light as it emanates therefrom, to achieve maximum transillumination effects. Moreover, the distal end can also include a prism or diffracting element.
Still referring to
Core wire 210cw particularly increases the pushability and the torquability of coil 210c which, by itself, is quite flexible and twistable. Combined with the core wire 210cw, distal portion 210d is much more effective at transferring pushing and torquing forces without buckling or twisting. Additionally, core wire 210cw may be plastically deformed or memory set into a bent shape, an example of which is shown in
As shown in
With reference to
In an alternative embodiment, referring now to
Turning now to
In an alternate embodiment, as shown in
With reference to
It has been observed that the illuminating fibers 210i can be subjected to thermal cycling. This is due to sterilization, aging, shipping, illumination of the fibers, and other factors. Such thermal cycling can result in longitudinal shrinkage of the illuminating fibers 210i. In fact, shrinkage of from 0.5 to 1% can occur when illuminating fibers are heated above 40° C. In conventional approaches, illuminating fiber shrinkage can result in damage where the fibers are anchored in a manner which does not compensate for shrinkage. Ends of the fibers can become shredded or frayed which thereby adversely affects the functioning of the fibers. Various approaches are contemplated to address shrinkage of illuminating fibers. In one approach, a fiber can be pre-heat treated at approximately 70° C. for 48 hours. By doing so, the fiber can be pre-shrunk. This can minimize or eliminate further shrinkage at lower temperatures.
In other approaches, referring now to
The connector 220 further includes an internal bore 227 having first 229, second 232, and third 234 sections, the first 229 and third 234 having generally equal diameter and the second section 232 having a diameter less than first 229 and third 234. The first bore section 229 is formed at a front end of the connector 220 and is diametrically sized to receive a centering sleeve 236. The sleeve 236 includes a bore sized to accept the cable tube 226 and functions to center the cable tube 236 within the first section 229.
The third bore section 234 of the connector 220 extends distally from a proximal end of the connector 220. Received at a back end of the third bore section 229 is a centering grommet 240 which attachingly engages the illuminating fibers 210i. The grommet 240 centers the light fiber 210i through a connection point 242.
Further, attached to a proximal portion of the cable tube 226 is a collet 244. The collet 244 is sized and shaped to slide within the third bore section 234 which has a length substantially larger than a length of the collet. Through its smaller diameter when compared to the adjacently arranged first and third bore sections 229, 234, the second bore section 232 acts as a stop for both the distally arranged centering sleeve 236 and the proximally positioned collet 244.
As stated, a proximal end of the illuminating fiber 210i is attached to the centering grommet. Its distal end is bonded to a distal end of guidewire 210 The cable tube 226, however, has a floating proximal end by way of its connection to slidable collet 244. Should the illuminating fiber 210i shrink in length, such length shrinkage is taken up by collet 241 (and cable tube 226, which is connected to collet 244) moving proximally within the third bore section 234 of the connector 220. In this way, structural damage to the shorter length illuminating fiber 210i is avoided.
Referring now to
Additionally, slidably configured within the first bore section is a rigid grommet 247 including a first component of a rotational stop 249. Also disposed in the first bore section is a second component of a rotational stop 252 formed therein. The grommet 247 is thus keyed with the connector 220 to control the degree to which the components can rotate with respect to each other. In one approach, rotation can be limited to 220 degrees or to 150 degrees where two rotational stops 249 and 252 are configured within the connector 220. A cap 253 retains the grommet 247 within the connector bore 245. As so configured, the cap 253 prevents the grommet 247 from moving in response to a tension applied on the illuminating guidewire 210 Additionally, the bore 245 permits longitudinal translation of the cable tube which is attached to the grommet 247. Moreover, as stated, the keyed grommet relationship of the connector 220 controls the permissible rotation of the cable tube 226 and thus the fiber 210i. Accordingly, the illuminating fiber 210i is protected should it tend to shrink as well as when tension and rotational forces are placed on the device.
Turning now to
Generally, distal end portion 310d may be more flexible than proximal end portion 310p to provide a desired degree of flexibility for leading the device to a site within a paranasal sinus or other location in the body. The distal end portion 310d may include a coil 310c as an exterior portion thereof, to help provide the desired flexibility to this portion. A proximal end portion 310p of illuminating guidewire 310 provides a sufficient length so that the device extends proximally out of the patient (and, when inserted through another device, such as a sinus guide, proximally out of the device into which illuminating guidewire 310 is inserted), at all times, including the deepest contemplated location into which the distal end of device is placed. As before, the proximal end portion 310p can have visible markings, preferably spaced at equal intervals, which can be observed by the user to confirm how far the illuminating guidewire 310 has been placed into the patient. Proximal end portion 310p generally provides: torquability, i.e., the ability to torque the proximal end portion 310p from a location outside of the patient and have that torque transmitted to the distal end portion 310d; pushability, i.e., sufficient rigidity, so that when an operator pushes on the proximal end portion 310p from a location outside of the patient, the pushing force transmits to the distal portion 310d to advance the distal portion 310d without buckling the device 310; and tensile strength so that an operator can pull on the proximal end portion 310p from a location outside of the patient and withdraw device from the patient without significant plastic deformation or any destruction of the device.
Again referring to
In one embodiment, the proximal portion 310p can be made from a cable tube 311. “Cable tube,” as used in the present application, means any tubular structure other than a tube made from a single coil (such as coil 310c). The cable tube 311 can define an approximate 0.021 inch constant inner diameter to match the inner diameter of the coil 310c. Also, cable tube 311 can be formed from 5-20 filars of steel wire wound together with 12-13 filars selected to achieve a preferred stiffness. A distal portion of the cable tube 311 can be tapered to provide a smoother connection to the coil 310c. This tapered profile can be formed by grinding an exterior of cable tube 311. In one embodiment, proximal portion 310p, made of cable tube 311, may provide significantly more torquability and pushability than distal end portion 310d, made of coil 310c. Conversely, distal end portion 310d may be more flexible than proximal portion 310p.
In some embodiments, coil 310c has a length in the range of 5-15 cm and the cable tube (i.e., proximal portion 310p) is 60-100 cm in length. One or more illumination channels for an illumination fiber 310i are provided in guidewire 310 and extend the length thereof. The illumination channels are configured to transport light from the proximal end of illumination guidewire 310 to and out of the distal end of device. One or more illumination channels can be provided, each comprising a plastic illumination fiber. As previously described, the plastic used to make the illumination fibers is compounded for light transmission properties according to techniques known and available in the art. Accordingly, ESKA™ (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 a preferred approach, the assembly includes two illumination fibers each having an outside diameter of about 0.010″. It is to be noted, however, that 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 may be used that has an outside diameter of about 0.020″. Moreover, 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 may be provided.
In some embodiments, guidewire 310 may further include an inner core wire 310cw (or “core wire”) in certain sections and may extend from the distal end of distal portion 310d to the proximal end of proximal portion 310p of guidewire 310 and may be attached to coil 310c and cable tube 311 at the distal end, at a junctions between coil 310c and cable tube 311, and at a proximal end. In various embodiments, core wire 310cw may be attached by any suitable means, such as by laser welding, epoxy or other adhesive or mechanical fixture. In one embodiment, core wire 310c w may be formed from NITINOL (nickel-titanium alloy) metal alloys that are biocompatible and provide the necessary rigidity and torquability. In a preferred embodiment discussed hereinafter, core wire 310cw terminates at a point approximately midway through device 310 with a fixed distal end and a floating (i.e., not fixed or bonded) proximal end. As noted in the ensuing description, core wire 310cw may be bonded at various other points along device 310 such as those identified as 301sj1, 301sj1 and 301sj3.
Core wire 310cw particularly increases the pushability and the torquability of coil 310c which, by itself, is quite flexible and twistable. Combined with the core wire 310cw, distal portion 310d is much more effective at transferring pushing and torquing forces without buckling or twisting. Additionally, core wire 310cw may be plastically deformed or memory set into a bent shape allowing an operator to direct the distal end of device 310 in different directions by torquing device about the longitudinal axis of the device.
Analogous to
More particularly,
As shown in
Referring to
In a preferred embodiment, the stranded wire 310sw has an overall diameter of approximately 0.005 inches. By varying the number and thickness of the strands comprising stranded wire 310sw, flexibility and ability to wind (twist) illuminating guidewire 310 is achieved. In most preferred embodiments, seven strands of stainless steel having a diameter of approximately 0.002 inches or 19 strands of stainless steel having approximately a diameter of approximately 0.001 inches, provide satisfactory strength and flexibility to withstand abrupt jerking or pulling and the ability to twist during use.
Floating tube 310ft functions to provide a surface where illuminating guidewire 310 is grasped or otherwise engaged by a locking or securing mechanism of a light connector. Floating tube 310ft is fixably bonded at its proximal end (as described in
Floating tube 310ft may be made of any suitable, medically safe material that imparts sufficient rigidity and strength to house the various internal elements of illuminating guidewire 310 and sustain engagement by a light connector. Examples of such materials are those used to manufacture hypotubes for medical applications and include stainless steel, titanium, elgiloy, and PEEK tubing.
Bonding tube 310bt functions to fixably bond all of illuminating guidewire 310's elements that are present at the proximal end of the device as explained in the discussion of
Bonding tube 310bt may be any suitable, medically safe material that imparts sufficient rigidity and strength to house the various internal elements of illuminating guidewire 310 and provide a surface for bonding materials (such as epoxy or other medically safe adhesives) to join the internal elements in the proximal end of the device. Examples of such medically safe materials including block copolymers such as those sold under the tradename PEBAX, nylon, polycarbonates, polyimides and other plastics such as acrylonitrile-butadiene-styrene copolymer (ABS).
Referring to
Finally,
It has been observed that illumination connectors, i.e., devices that join an illumination guidewire device to a light cable of a light source, are prone to heating which could be detrimental to components of an illuminated guidewire as well as to the illumination device's effectiveness to provide adequate lighting at the distal end. In some instance temperatures of greater than 250° F. have been observed. The illumination connector hereinafter described helps to better control heat buildup.
It should be noted that having body 320 made of a translucent material aids in errant light dissipation. Preferably, body 320 is made of a translucent material that has a translucency of greater or equal to 70%. These levels of translucency are easily obtained with medically safe plastics and may be adjusted incorporating varying levels of dye to achieve a desired translucency.
It has been observed that the illuminating fibers 310i can be subjected to thermal cycling. This is due to sterilization, aging, shipping, illumination of the fibers, and other factors. Such thermal cycling can result in longitudinal shrinkage of the illuminating fibers 310i. In fact, shrinkage of from 0.5 to 1% can occur when illuminating fibers are heated above 40° C. In conventional approaches, illuminating fiber shrinkage can result in damage where the fibers are anchored in a manner which does not compensate for shrinkage. Ends of the fibers can become shredded or frayed which thereby adversely affects the functioning of the fibers.
Various approaches are contemplated to address shrinkage of illuminating fibers. In one approach, a fiber can be pre-heat treated at approximately 70° C. for 48 hours. By doing so, the fiber can be pre-shrunk. This can minimize or eliminate further shrinkage at lower temperatures.
In still other contemplated approaches to compensate for changes in illuminating fiber length, the core wire can be alternatively or additionally collapsible and include such structure as a spring or corrugated section. The core wire can also be severed in places to accommodate length changes.
The disclosed illuminating guidewire assembly can be used in a myriad of applications. In addition to use in the sinuses, the assembly can be employed in vascular applications such as by providing a way to map or help diagnose anatomy while it is advanced therethrough. Also, the device can be useful in illuminating deep tissue or can be used in the gastrointestinal track for similar purposes.
Moreover, while the present invention has been described with reference to the specific embodiments thereof, various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. 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.
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| 20120078118 A1 | Mar 2012 | US |
