Patent Grant
9089631
The invention relates generally to the field of medical devices. More particularly, the invention relates to irrigation devices useful in the identification and treatment of bodily passages, such as sinus cavities. The invention also relates to methods of identifying and treating bodily passages.
It is sometimes necessary or otherwise desirable to aspirate and/or flush bodily passages, such as sinus cavities, using a catheter. For example, when sinus cavities become infected, sinus irrigation provides an approach to address the infection. In conventional sinus irrigation procedures, a caregiver navigates a catheter over a previously-placed guidewire. Prior to irrigation, the caregiver must verify positioning of the catheter and/or guidewire using separate visualization equipment, such as a laryngoscope, fluoroscopy, or other suitable devices or techniques. This complicates the procedure by requiring the placement of multiple devices within the area of treatment and may provide less than ideal information about the area to be irrigated.
To facilitate position verification, lighted guidewires have been developed to facilitate visualization of the guidewire prior to irrigation. However, the use of such guidewires presents significant drawbacks. For example, while the guidewire can be visualized transcutaneously following placement in the sinus cavity, the light of the guidewire is blocked once the catheter is tracked over the tip of the guidewire, preventing the user from confirming final placement of the catheter prior to irrigating the sinus. Furthermore, the lighted guidewire does not convey any information to the user about the location of the catheter or the area of the cavity that will be treated during the irrigation procedure.
Therefore, a need exists for improved devices and methods of identifying and treating bodily passages.
Several exemplary irrigation devices adapted to be used with a light source for the identification and treatment of bodily passages, such as sinus cavities, are described herein. In addition, several exemplary methods of identifying and treating bodily passages, such as sinus cavities, are described herein. In particular, irrigation devices including an elongate tubular member and an optical fiber are provided.
Irrigation devices with various elongate tubular member configurations are described, including elongate tubular members with single or double lumen configurations. Other examples include irrigation devices with multiple elongate tubular members. Further examples include elongate tubular members which define one or more apertures and/or curves and include a soft distal tip.
Irrigation devices with various optical fiber configurations are also described, including examples that have one or more optical fibers disposed within a lumen of an elongate tubular member. Other examples include configurations in which one or more optical fibers are disposed within lumens defined by the wall of the elongate tubular member and/or embedded within the wall of the elongate tubular member.
Additional understanding of the devices and methods contemplated and/or claimed by the inventor can be gained by reviewing the detailed description of exemplary embodiments, presented below, and the referenced drawings.
The following detailed description and the appended drawings are provided to describe and illustrate exemplary embodiments of the invention for the purpose of enabling one of ordinary skill in the relevant art to make and use the invention. The description and drawings are not intended to limit the scope of the invention, or its protection, in any manner.
As used herein, the terms “proximal” and “distal” are used to describe opposing axial ends of the particular elements or features being described. The term “bodily passage” refers to any passage within the body of an animal, including, but not limited to humans, and includes elongate passages, such as blood vessels, and cavities, such as the sinus cavities. The term “irrigation” refers to aspiration and/or flushing of bodily passages. The term “attached” refers to the fixed, releasable, or integrated association of two or more elements and/or devices. Thus, the term “attached” includes releasably attaching or fixedly attaching two or more elements and/or devices.
The elongate tubular member 120 has a lengthwise axis and comprises proximal 122 and distal 124 ends, and a circumferential wall 125. The circumferential wall 125 defines a plurality of apertures 130 and a lumen 126 which extends between openings at the proximal end 122 and the distal end 124. The elongate tubular member 120 is formed of a rigid material and defines a curve 128 and includes and a soft distal tip 132. The curve 128 is disposed along the lengthwise axis of the elongate tubular member 120, comprises an apex 129, and is angled to provide advantageous positioning of the distal end 124 of the elongate tubular member 120 in bodily passages, such as sinus cavities. The elongate tubular member 120 can define a curve 128 which has any angle considered suitable for a particular application, or can define a suitable number of loops (e.g., one, two, three, four, and any other number considered suitable for a particular application). Examples of angles considered suitable include angles in the range from about 1° to 360°. An exemplary light emitting irrigation device that includes a 180° curve is illustrated in
While the elongate tubular member 120 has been described as having an opening at its distal end 124, the opening can be omitted and the distal end 124 can be sealed with a clear material which is attached to the distal end 124 of the elongate tubular member 120. The clear material can be formed of a soft, or semi-rigid material, and can comprise any suitable transparency.
The elongate tubular member 120 can include one or more markers (not shown) to indicate the length of the elongate tubular member 120 disposed within a bodily passage when in use. For example, one or more markers, relating to any form of measurement, can be embedded within, or disposed on the interior or exterior surface of the elongate tubular member 120.
While the elongate tubular member 120 has been described as formed of a rigid material and defining a single curve, the elongate tubular member 120 can be formed of a malleable material which allows for the user to bend the elongate tubular member 120 before or during a procedure. For example, the entirety, or segments of, the elongate tubular member 120, such as near and/or at the curve 128, can vary in stiffness and flexibility. In addition, the elongate tubular member 120 can include portions formed of a braided material which allows for torqueability of the elongate tubular member 120 during use to provide irrigation to varying portions of a treatment site. For example, the elongate tubular member 120 can include a braided portion from the proximal end 122 to the curve 128, or from the proximal end 122 to a location proximal to the apertures 130. Skilled artisans will be able to select appropriate materials for the elongate tubular member 120, and an appropriate number of, and angle for, the curve(s), according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, the location of the bodily passage being identified and/or treated, and the location of the curve and/or apertures.
The elongate tubular member 120 can have any suitable length, and skilled artisans will be able to select an appropriate length for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the irrigation device, and the location of the bodily passage being identified and/or treated, among others. Examples of suitable lengths for the elongate tubular member 120 include lengths in the range from about 1 cm to 20 cm. Additional exemplary lengths for the elongate tubular member include lengths in the range from about 12 cm through 15 cm.
The plurality of apertures 130 are disposed between the apex 129 of the curve 128 and the distal end 124 of the elongate tubular member 120, extend through the circumferential wall 125 of the elongate tubular member 120, and provide access to the lumen 126. The plurality of apertures 130 assist in irrigating bodily passages. For example, the plurality of apertures 130 assist with flushing bodily passages by discharging a treatment material radially from the elongate tubular member 120.
The plurality of apertures 130 can be disposed in various configurations on the elongate tubular member 120. For example, the plurality of apertures 130 can be disposed circumferentially, linearly, and/or staggered on the circumferential wall 125. In a further example, at least three apertures of the plurality of apertures 130 can be disposed circumferentially about the elongate tubular member 120, disposed on the circumferential wall 125 in a linear configuration, and/or disposed on the circumferential wall 125 in a staggered configuration. In addition, at least two of the plurality of apertures 130 can vary in diameter to assist in providing even aspiration and/or distribution of treatment material to bodily passages.
While a plurality of apertures 130 have been described and illustrated as located between the apex 129 of the curve 128 and the distal end 124 of the elongate tubular member 120, any suitable location and number of apertures can be included, and skilled artisans will be able to select an appropriate number of apertures and a suitable location on the elongate tubular member for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated. Examples of suitable numbers of apertures include one, two, three, four, five, six, seven, eight, nine, ten and any number determined suitable for a particular application. Examples of suitable locations for the plurality of apertures 130 include locations where at least one aperture of the plurality of apertures 130 is defined by the circumferential wall 125 at a point between the curve 128 (e.g., apex 129) and the distal end 124 of the elongate tubular member 120, at a point within the curve 128, or at a point between the curve (e.g., apex 129) and the proximal end 122 of the elongate tubular member 120. Alternatively, the apertures 130 can be omitted from the light emitting irrigation device 100.
The distal end 124 of the elongate tubular member 120 includes a soft distal tip 132 (e.g., an atraumatic tip) that is formed of a flexible material which can be translucent, or have partial to no transparency. While, the soft distal tip 132 is illustrated as not including any apertures 130, the soft distal tip 132 can define one or more apertures 130 which extend through the wall of the soft distal tip 132 providing access to lumen 126. The soft distal tip 132 can be attached with the distal end 124 of the elongate tubular member using various methods, and skilled artisans will be able to select an appropriate method for attaching the soft distal tip 132 to the elongate tubular member 120 according to various considerations, including the intended use of the light emitting irrigation device, and the location of the treatment site, among others. Examples of suitable methods for attaching the soft distal tip 132 to the elongate tubular member 120 include heat bonding, adhesively affixing, using threaded components, and the like. For example, the soft distal tip 132 can be formed of the same, or different, material as the elongate tubular member 120 and disposed over a portion of the elongate tubular member 120, or attached to the distal end 124 of the elongate tubular member 120. In an additional example, the distal end 124 of the elongate tubular member 120 can be cut at an angle and the proximal end of the soft distal tip 132 can be cut at angle which mirrors the cut in the elongate tubular member 120. The soft distal tip 132 can then be attached to the elongate tubular member along the mirror surfaces.
The soft distal tip 132 can be configured in any manner considered suitable for a particular application. For example, the soft distal tip 132 can be configured as tapered, rounded, or squared, and skilled artisans will be able to select an appropriate configuration based on various considerations, including the intended use of the light emitting irrigation device, and others. While the soft distal tip 132 has been described as formed of a flexible material, the soft distal tip 132 can be formed of any suitable material, and skilled artisans will be able to select an appropriate material according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated, among other considerations. Alternatively, the light emitting irrigation device 100 can omit the inclusion of the soft distal tip 132 and the distal end 124 can be formed of a soft, or semi-rigid material.
The adapter 140 comprises first 142 and second 144 proximal ends, a distal end 146 and defines first 148 and second 150 lumens. The distal end 146 of the adapter 140 is rotatably connected to the proximal end 122 of the elongate tubular member 120. The adapter 140 can be, however, otherwise attached to the elongate tubular member 120. The first lumen 148 extends between the first proximal end 142 and the first distal end 146 and is in communication with the lumen 126 of the elongate tubular member 120. The second lumen 150 extends between the second proximal end 144 and the first lumen 148 and is in communication with the first lumen 148. The first 142 and second 144 proximal ends include a connector 152 for releasably or fixedly connecting one or more elements and/or devices. The connectors 152 can include a sealing member 153 to prevent fluid from flowing out of lumens 148 and 150 and/or provide a seal around any element and/or device traversing the first 142 and/or second 144 proximal ends. For example, the sealing member 153 can comprise a one-way valve which prevents the back flow of materials. Skilled artisans will be able to select a suitable connector 152 for each of the ends of the adapter 140 according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the devices being used in combination with the light emitting irrigation device.
An exemplary structure for rotatably connecting the elongate tubular member 120 and the adapter 140 is shown at 143. The elongate tubular member 120 has a proximal end 122 that defines a projection 123 that is received by a socket 147 defined by the distal end 146 of the adapter 140. The projection 123 and socket 147 advantageously fit together in a manner that permits rotation of the elongate tubular member 120 relative to the adapter 140 but does not permit axial disconnection of these elements. The connection advantageously includes a degree of play between the elements to facilitate navigation of the elongate tubular member 120 to a point of treatment. While the rotatable component has been described and illustrated at 143, and as having a degree of play, the light emitting irrigation device can include a rotatable component at other suitable locations along the length of the elongate tubular member 120, and include various degrees of play, and skilled artisans will be able to select a suitable location for the rotatable connection and the extent of play incorporated into any particular light emitting irrigation device 100 according to a particular embodiment based on various considerations, including the intended use of the device, and the location of the bodily passage being identified and/or treated. Examples of suitable positions for the rotatable component include positions located between the proximal end 122 of the elongate tubular member 120 and the proximal end of the soft distal tip 132.
While the adapter 140 has been illustrated as having a bifurcated configuration, the adapter can include any suitable number of branches, and skilled artisans will be able to select an appropriate number of branches for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the number of lumens defined by the elongate tubular member, and the number of devices attached to and/or traversing the adapter, among others. Examples of suitable numbers of branches include one, two, three, four and any number determined suitable for a particular application. For example, the adapter can comprise a single shaft defining one or more lumens in communication with one another or separate from one another.
Any suitable material can be used to form the elongate tubular member 120, soft distal tip 132, the adapter 140, and the connectors 152, and skilled artisans will be able to select appropriate materials for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated. Examples of materials considered suitable include plastics, biocompatible materials, metals, and other materials used in the manufacture of conventional catheters, sheaths, connectors, adapters, and the like.
The optical fiber 160 extends between proximal 162 and distal 164 ends and defines a light path extending through its length which allows axially-directed light to emanate from the distal end 164 of the optical fiber 160. The optical fiber 160 extends through the first lumen 148 of the adapter 140 and is disposed within the lumen 126 of the elongate tubular member 120. The proximal end 162 of the optical fiber 160 is adapted to be operatively connected or attached to the light source 180. The distal end 164 of the optical fiber 160 is attached to the circumferential wall 125 of the elongate tubular member 120 at a point between the plurality of apertures 130 and the distal end 124 relative to the lengthwise axis. The optical fiber 160 can be, however, attached along its entire length, or at multiple locations along its length, to the circumferential wall 125. For example, the optical fiber 160 can be attached to the circumferential wall 125 between at least two of the plurality of apertures 130, within the curve 128, and/or proximal to the curve 128.
Attaching the optical fiber 160 to the elongate tubular member 120 can be accomplished using various methods and materials. For example, attaching the optical fiber 160 to the circumferential wall 125 can be accomplished by inserting the optical fiber 160 past the distal end 124 of the elongate tubular member 120, attaching the optical fiber 160 to the circumferential wall 125, and cutting the optical fiber 160 flush with the elongate tubular member 120. Skilled artisans will be able to select appropriate methods and materials for attaching the optical fiber 160 to the circumferential wall 125 of the elongate tubular member 120 according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the desired length of the elongate tubular member and/or optical fiber. Examples of other suitable methods for attaching the optical fiber 160 to the elongate tubular member 120 include using adhesive, heat fusing, and other methods considered suitable. For example, the optical fiber can be attached to the elongate tubular member 120 by heating a portion of the circumferential wall 125 with a heated building wire and attaching the optical fiber 160 to the heated portion of the circumferential wall 125.
The configuration of lumen 148 of the adapter 140 can be altered subsequent to the attachment of the optical fiber 160 to the circumferential wall 125 of the elongate tubular member 120 to prevent material from flowing out of proximal end 142 of the adapter 140. For example, the portion of the lumen 148 from the proximal end 142 to the converging point of lumen 148 and lumen 150 can be tapered from the proximal end 142 to the converging point. Alternatively, lumen 148 can include multiple sealing members and/or be filled with material from the proximal end 142 to the converging point to prevent the back flow of materials.
While only the distal end 164 of the optical fiber 160 has been described as emitting light generated by the light source 180, the optical fiber 160 and elongate tubular member 120 can be adapted to emit light radially from the light emitting irrigation device 100. For example, the radially-directed light can be emitted through the plurality of apertures 132 allowing a user to transcutaneously visualize the position of the plurality of apertures 132 at the treatment site. In addition, while the optical fiber 160 has been illustrated as extending through the first lumen 148 of the adapter 140, the optical fiber 160 can alternatively extend through the second lumen 150 of the adapter 140.
Any suitable optical fiber 160 can be used in the light emitting irrigation devices described herein. Commercially available optical fibers considered suitable for use in the devices described herein include plastic optical fibers and glass optical fibers, with or without cladding. The optical fiber 160 can have any suitable length, and skilled artisans will be able to select an appropriate length for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the irrigation device, and the location of the bodily passage intended to be identified and/or treated. For example, alternative to a flush configuration as described above, the optical fiber 160 can have a length that allows for a portion of the optical fiber 160 to extend beyond, or proximal to, the distal end 124 of the elongate tubular member 120 and/or a length that allows a portion of the optical fiber 160 to extend beyond the proximal end 122 of the elongate tubular member 120 and/or the proximal end 142 of the adapter 140 to the light source 180. When the optical fiber 160 extends beyond the proximal end 122 of the elongate tubular member 120 and/or the proximal end 142 of the adapter 140, an extension sheath (not shown) can be disposed over the optical fiber 160 from the proximal end 122 of the elongate tubular member 120 and/or the proximal end 142 of the adapter 140 to the light source 180.
The lumen 126 of the elongate tubular member 120 is configured to have a diameter that allows the optical fiber 160 to extend through a portion, or the entirety, of its length while also providing sufficient irrigation capabilities. Examples of suitable diameters for lumen 126 include diameters in the range from about 0.010 inch to about 0.25 inch. An exemplary elongate tubular member 120 includes a lumen 126 with a diameter in the range from about 0.020 inch to about 0.050 inch. An additional exemplary elongate tubular member 120 includes a lumen 126 with a diameter of about 0.038 inch.
The effectiveness of the light emitting irrigation device 100 can be altered based on the size of the lumen 126 and apertures 130, and skilled artisans will be able to select appropriate dimensions for the lumen 126 and the apertures 130 according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the size and/or location of the bodily passage to be identified and/or treated.
The light source 180 is operatively connected or attached to the proximal end 162 of the optical fiber 160 and includes a fiber coupling 182 which provides communication between the light source 180 and the optical fiber 160. Light generated by the light source 180 travels through the light path defined by the optical fiber 160 and is emitted axially from the distal end 164 of the optical fiber 160. Alternatively, the proximal end 122 of the elongate tubular member 120, or a proximal end 142 or 144 of the adapter 140, can include one or more connectors for attaching the light source 180. While the light source 180 has been described and illustrated as attached to the proximal end 162 of the optical fiber 160, the light source 180 can, alternatively, be omitted from the irrigation device and provided separately.
Any suitable light source 180 can be used with the light emitting irrigation device 100. Commercially-available light sources considered suitable for use with the light emitting irrigation device 100 include xenon, laser, LED, halogen, and other suitable light sources. While particular light sources have been described, skilled artisans will be able to select an appropriate light source for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the location of the bodily passage being identified and/or treated, among others.
It is noted that, while a single optical fiber 160 is described and illustrated in the figures, two or more different optical fibers can be used to independently provide axially-directed and/or radially directed light. The two optical fibers can extend through lumen 126 defined by the wall 125 of the elongate tubular member 120 and can be operatively connected or attached to the same or two different light sources. In addition, the light source can include one or more switches to allow a user to selectively turn on and off, or dim, a selected optical fiber.
When using the light emitting irrigation device 100, a user is able to identify the placement of the elongate tubular member 120 within a bodily passage by activating the light source 180 and locating the axially and/or radially-directed light emitting from the optical fiber 160. In addition, by visualizing the axially and/or radially-directed light, the user can identify the portion of the bodily passage that will be subject to the irrigation procedure. Once the treatment site has been identified and located, the user can irrigate the bodily passage. For example, a user can flush a treatment site by injecting treatment material through the lumen 126 of the elongate tubular member 120, forcing the treatment material to exit through the plurality of apertures 130 and/or the opening at the distal end 124 of the elongate tubular member 120.
The first lumen 226 is not in communication with the second lumen 228 and is disposed substantially parallel to the second lumen 228. However, while the first lumen 226 has been described as being disposed substantially parallel to the second lumen 228, the elongate tubular member 220 can include various other lumen configurations, and skilled artisans will be able to select an appropriate configuration according to a particular embodiment based on various considerations, including the intended use of the irrigation device, and the location of the treatment site, among others. Examples of suitable configurations include first and second lumens that are disposed at an angle with respect to one another, and/or first and second lumens that wrap around one another.
A soft distal tip 230 can be attached to the distal end 224 of the elongate tubular member 220 and has a wall which defines an aperture 229. However, while a single aperture 229 has been illustrated and described as defined by the wall of the soft distal tip 230, the wall of the soft distal tip 230 and/or the elongate tubular member 220 can define one or more apertures, or the soft distal tip 230 and/or elongate tubular member 220 can omit the inclusion of one or more apertures, and skilled artisans will be able to select an appropriate number of apertures according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated.
The soft distal tip 230 can be attached in a variety of manners, as described above. For example, the soft distal tip can include two lumens and have a proximal end cut at an angle which mirrors a cut on the distal end 224 of the elongate tubular member 220. The soft distal tip 230 can then be attached to the distal end 224 of the elongate tubular member 220. In a further example, the soft distal tip 230 can comprise two pieces of material, each of which includes a lumen, cut at an angle to match cuts made at the distal end 224 of the elongate tubular member 220 with respect to each lumen 226 and 228. Each piece of the soft distal tip 230 can be attached to the distal end 224 of the elongate tubular member so that the lumens of each piece of the soft distal tip 230 are in communication with lumen 226 or 228 of the elongate tubular member 220. In a further example, another piece of material could cover the two pieces of the soft distal tip 230 to provide a uniform structure at the distal end 224 of the elongate tubular member 220.
The adapter 240 comprises first 242 and second 244 proximal ends, a distal end 246 and defines first 248 and second 250 lumens. The adapter 240 is attached to the proximal end 222 of the elongate tubular member 220. The adapter 340 can be, however, rotatably connected to the elongate tubular member 320. The first lumen 248 extends between openings located on the first proximal end 242 and the first distal end 246 and is in communication with the first lumen 226 of the elongate tubular member 220. The second lumen 250 extends between openings located on the second proximal end 244 and the first distal end 246 and is in communication with the second lumen 228 of the elongate tubular member 220.
The optical fiber 260 extends between proximal 262 and distal 264 ends and defines a light path extending through its length. The optical fiber 260 extends through the first lumen 248 of the adapter 240 and is disposed within first lumen 226 of the elongate tubular member 220. The proximal end 262 of the optical fiber 260 is adapted to be operatively connected or attached to the light source 280. The distal end 264 of the optical fiber 260 is attached to the wall 225 of the elongate tubular member 220. Attaching the optical fiber 260 to the elongate tubular member 220 can be accomplished using any suitable method, including those described above with respect to
While the optical fiber 260 has been described and illustrated as extending through the first lumen 248 of the adapter 240 and being disposed within first lumen 226 of the elongate tubular member 220, the optical fiber 260 can alternatively extend through the second lumen 250 of the adapter 240 and be disposed within the second lumen 228 of the elongate tubular member 220.
The light source 280 is operatively connected or attached to the proximal end 262 of the optical fiber 260 such that light generated by the light source 280 is able to travel through the light path defined by the optical fiber 260. While the light source 280 has been described and illustrated as attached to the proximal end 262 of the optical fiber 260, the light source 280 can, alternatively, be omitted from the irrigation device and provided separately.
It is noted that, while a single optical fiber 260 is described and illustrated in the figures, two or more different optical fibers can be used to independently provide axially-directed and/or radially directed light. The two optical fibers can be disposed within the same or different lumens defined by the wall 225 of the elongate tubular member 120 and can be operatively connected or attached to the same or two different light sources. In addition, one or more switches can be provided to allow a user to selectively turn on and off, or dim, a selected optical fiber.
The light emitting irrigation device 300 comprises an elongate tubular member 320, an adapter 340, an optical fiber 360, and a light source 380. The elongate tubular member 320 has a lengthwise axis and comprises proximal 321 and distal 322 ends, an irrigation port 323, and a wall 329 which defines first 324 and second 325 lumens. The irrigation port 323 branches off of the elongate tubular member 320 distal to the proximal end 321, has a proximal end 326, and defines an aperture 327 and a portion of the first lumen 324. The aperture 327 extends through the wall of the irrigation port 323 and provides access to the lumen 324. The first lumen 324 extends from openings located at the proximal end 326 and distal end 322 of the elongate tubular member 320. The second lumen 325 extends between openings located at the proximal end 321 and distal 322 end of the elongate tubular member 320. The proximal end 321 of the elongate tubular member 320 and the proximal end 326 of the irrigation port 323 include connectors 328 for releasably or fixedly connecting one or more elements and/or devices.
While the first lumen 324 is shown as having a semi-circular configuration, each of the lumens described herein can be configured in any suitable manner, and skilled artisans will be able to select a suitable configuration for a lumen for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the type of treatment being provided to a bodily passage. Examples of suitable lumen configurations which can be defined by the wall of the elongate tubular members described herein include, but are not limited to, circular, semi-circular, triangular, square, rectangular, pentagonal, hexagonal, heptagonal, octagonal, and any other configuration considered suitable for a particular application.
The second lumen 325 is not in communication with the first lumen 324 and is disposed substantially parallel to the first lumen 324. However, while the second lumen 325 has been described as being disposed substantially parallel to the first lumen 324, various other configurations can be used, and skilled artisans will be able to select an appropriate configuration according to a particular embodiment based on various considerations, including the intended use of the irrigation device, and the location of the treatment site, among others. Examples of suitable configurations include first and second lumens that are disposed at an angle with respect to one another, and/or first and second lumens that wrap around one another.
The adapter 340 comprises first 342 and second 344 proximal ends, a distal end 346 and defines first 348 and second 350 lumens. The adapter 340 is attached to the proximal end 321 of the elongate tubular member 320. The adapter 340 can be, however, rotatably connected to the elongate tubular member 320. The first lumen 348 extends between openings located at the first proximal end 342 and the first distal end 346 and is in communication with the second lumen 325 of the elongate tubular member 320. The second lumen 350 extends between openings located at the second proximal end 344 and the first lumen 348 and is in communication with the first lumen 348. The first 342 and second 344 proximal ends include a connector 352 for releasably or fixedly connecting one or more elements and/or devices. The connectors 328 and/or 352 can include a sealing member to prevent fluid from flowing out of lumens 324, 325, 348, and 350 and/or provide a seal around any element and/or device traversing these elements.
While a single irrigation port 323 and an adapter 340 having a bifurcated configuration have been illustrated and described, the light emitting irrigation device 300 can include any suitable number of irrigation ports and/or adapters with any suitable number of branches, and skilled artisans will be able to select an appropriate number of irrigation ports and branches for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the number of lumens defined by the elongate tubular member, and the intended use of the light emitting irrigation device. Examples of suitable numbers of irrigation ports and branches include one, two, three, four and any number determined suitable for a particular application.
The optical fiber 360 extends between proximal 362 and distal 364 ends and defines a light path extending through its length. The optical fiber 360 extends through the first lumen 348 of the adapter 340 and is disposed within the second lumen 325 of the elongate tubular member 320. The proximal end 362 of the optical fiber 360 is adapted to be operatively connected or attached to the light source 380.
While the optical fiber 360 has been described and illustrated as extending through the first lumen 348 of the adapter 340 and being disposed in the second lumen 325 of the elongate tubular member 320, the optical fiber 360 can alternatively extend through the second lumen 350 of the adapter 340 and be disposed within the second lumen 325 of the elongate tubular member 320.
In use, the configuration of the light emitting device 300 advantageously allows for a user to simultaneously provide suctioning and flushing at a treatment site. For example, the proximal end 326 of the irrigation port 323 and/or connector 328 can be adapted to receive and/or attach a portion of a suctioning device, while the second proximal end 344 of the adapter 340 and/or connector 352 can be adapted to receive and/or attach a portion of an infusion device, or vice versa. When suction is being applied through the irrigation port 323, the aperture 327 of the irrigation port 323 advantageously allows for the user to increase or decrease the amount of suction being applied to a treatment site.
While the elongate tubular member 320 has been described and illustrated as not including an aperture(s), the wall 329 of the elongate tubular member 320 and/or an attached soft distal tip 330 can define one or more apertures, and skilled artisans will be able to select an appropriate number of apertures according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated.
The light emitting irrigation device 400 comprises a first elongate tubular member 420, a second elongate tubular member 440, an optical fiber 460, and a light source 480. The first elongate tubular member 420 has a lengthwise axis and comprises proximal 421 and distal 422 ends, an irrigation port 423, and a circumferential wall 429. The circumferential wall 429 defines a lumen 424 extending from openings located at the proximal 421 and distal 422 ends. The irrigation port 423 branches off of the first elongate tubular member 420 distal to the proximal end 421, has a proximal end 425, and defines a lumen 426 and an aperture 427. The lumen 426 of the irrigation port 423 extends from an opening located at the proximal end 425 of the irrigation port 423 and is in communication with lumen 424 of the elongate tubular member 420. The aperture 427 extends through the wall of the irrigation port 423 and provides access to lumen 426. The proximal end 421 of the first elongate tubular member 420 and the proximal end 425 of the irrigation port 423 include connectors 428 which allow for releasably or fixedly connecting one or more elements and/or devices.
The second elongate tubular member 440 has a lengthwise axis and comprises proximal 441 and distal 442, a second irrigation port 443, and a wall 448. The wall 448 defines a lumen 444 which extends between openings located at the proximal 441 and distal 442 ends. The second irrigation port 443 branches off of the second elongate tubular member 440 distal to the proximal end 441, has a proximal end 445, and defines a lumen 446. The lumen 446 of the second irrigation port 443 extends from an opening located at the proximal end 445 of the second irrigation port 443 and is in communication with lumen 444. The proximal end 441 of the second elongate tubular member 440 and the proximal end 445 of the second irrigation port 443 include connectors 447 which allow for releasably or fixedly connecting one or more elements and/or devices. The connectors 428 and/or 447 can include a sealing member to prevent fluid from flowing out of lumens 424, 426, 444, and 446 and/or provide a seal around any element and/or device traversing these elements. The second elongate tubular member 440 extends through the proximal end 421 of the first elongate tubular member 420 and is attach at connector 428. The distal end 442 of the second elongate tubular member 440 is disposed flush with the distal end 422 of the first elongate tubular member 420. The distal end 442 of the second elongate tubular member can be, however, disposed proximal or distal to the distal end 422 of the first elongate tubular member 420. The lumen 444 of the second elongate tubular member 440 is not in communication with the lumen 426 of the first elongate tubular member 420.
While each elongate tubular member 420 and 440 includes a single irrigation port, the light emitting irrigation device 400 can include any suitable number of irrigation ports, and skilled artisans will be able to select an appropriate number of irrigation ports according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the treatment site. Examples of suitable numbers of irrigation ports include one, two, three, four and any number determined suitable for a particular application.
The optical fiber 460 extends between proximal 462 and distal 464 ends and defines a light path extending through its length. The proximal end 462 of the optical fiber 460 is adapted to be operatively connected or attached to the light source 480 and its distal end 464 is disposed within the lumen 444 of the second elongate tubular member 440. While the optical fiber 460 has been illustrated as extending through the proximal end 441 of the second elongate tubular member 440, the optical fiber 460 can alternatively extend through the second irrigation port 443 of the second elongate tubular member 440.
In use, the configuration of the light emitting irrigation device 400 advantageously allows for a user to simultaneously provide suctioning and flushing at a treatment site. For example, the proximal end 425 of the irrigation port 423 and/or connector 428 can be adapted to receive and/or attach a portion of a suctioning device, while the proximal end 445 of the second irrigation port 443 and/or connector 447 can be adapted to receive and/or attach a portion of an infusion device, or vice versa. During use, the aperture 427 of the irrigation port 423 advantageously allows for the user to increase or decrease the amount of suction being applied to a treatment site.
While the elongate tubular member 420 has been described and illustrated as not including an aperture(s), the wall 429 of the elongate tubular member 420 can define one or more apertures, and skilled artisans will be able to select an appropriate number of apertures according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated.
While a plurality of apertures 527 have been illustrated and described, the elongate tubular member 520 can include a single aperture, or omit the inclusion of the apertures, and skilled artisans will be able to select an appropriate number of apertures according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated.
Each of the plurality of optical fibers 560 extends between proximal 562 and distal 564 ends and defines a light path extending through its length. Each of the plurality of optical fibers 560 is embedded within the wall 526 of the elongate tubular member 520 and has a proximal end 562 in communication with the light source 580 and a distal end 562 disposed flush with, proximal to, or distal to, the distal end 524 of the elongate tubular member 520. Alternatively, the proximal ends 562 of the optical fibers 560 can be gathered in a trunk and operatively connected or attached to the light source 580. While the optical fibers 560 have been described as embedded within the wall of the elongate tubular member 520, the optical fibers 560 can be disposed and attached within lumens that have been extruded within the wall 526 of the elongate tubular member 520.
The plurality of apertures 527 are illustrated as being disposed in a linear configuration and located in a position where an optical fiber 560 has been omitted from the wall 526 of the elongate tubular member 520. The plurality of apertures 527 can be, however, disposed at other various locations depending on the number and location of the optical fibers 560 included in the light emitting irrigation device 500.
The light source 580 is operatively connected or attached to the proximal end 522 of the elongate tubular member 520 such that light generated by the light source 580 is able to travel through the light path defined by each of the plurality of optical fibers 560. While the light source 580 has been described and illustrated as attached to the proximal end 522 of the elongate tubular member 520, the light source 580 can alternatively be omitted from the irrigation device and provided separately.
It is noted that the plurality of optical fibers 560 can be used to independently or in combination with one another to provide axially-directed and/or radially directed light. For example, additional apertures can be disposed along the length of the elongate tubular member in communication with one or more of the optical fibers 560 to allow radially directed light to emit from the light emitting irrigation device 500. The plurality of optical fibers 560 can be operatively connected or attached to the same or two different light sources, which can include one or more switches to allow a user to selectively turn on and off, or dim, a selected optical fiber.
The elongate tubular member 620 has a lengthwise axis and comprises proximal 621 and distal 622 ends, and a circumferential wall 627. The elongate tubular member defines a curve 624 having an apex 630 and includes a soft distal tip 626. The circumferential wall 627 defines a lumen 623 which extends between openings at the proximal end 621 and the distal end 622, and a plurality of apertures 625. The curve 624 is disposed along the lengthwise axis of the elongate tubular member 620 and configured at 180° to provide advantageous positioning of the distal end 624 of the elongate tubular member 620 in bodily passages, such as sinus cavities. While a 180° curve has been described and illustrated, other suitable angles can be included in a light emitting irrigation device, and skilled artisans will be able to select a suitable angle according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the size and/or location of the bodily passage be identified and/or treated.
The plurality of apertures 625 are disposed proximal to the distal end 622 of the elongate tubular member 620, extend through the wall 627 of the elongate tubular member 620, and provide access to lumen 623. Alternatively, the plurality of apertures 625 can also be disposed within the soft distal tip 626 to assist in irrigating a treatment site. Alternatively, the plurality of apertures 625 can be disposed in various other locations along the length of the elongate tubular member 620, as described above.
While a plurality of apertures 625 have been described and illustrated as located proximal to the distal end 622 of the elongate tubular member 620, any suitable location and number of apertures can be included, and skilled artisans will be able to select an appropriate number of apertures and a suitable location on the elongate tubular member for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated. Examples of suitable numbers of apertures include one, two, three, four, five, six, seven, eight, nine, ten and any number determined suitable for a particular application.
The distal end 622 of the elongate tubular member 620 includes a soft distal tip 626 (e.g., an atraumatic tip) having proximal 633 and distal 634 ends. The soft distal tip 626 is a solid member formed of a clear flexible material, and has a tapered configuration from its proximal end 633 to its distal end 634. The soft distal tip 626 can be attached with the distal end 622 of the elongate tubular member 620 in various manners. For example, the soft distal tip 626 can be rotatably attached to the elongate tubular member 620, or can be formed from the same material as the elongate tubular member 620. Attaching the soft distal tip 626 to the elongate tubular member 620 can be accomplished in various ways, and skilled artisans will be able to select an appropriate method for attaching the soft distal tip 626 to the elongate tubular member 620 according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the treatment site, among others. Examples of suitable methods for attaching the soft distal tip 626 with the elongate tubular member 620 include heat bonding, adhesively affixing, using threaded components, a projection and socket, and the like.
While the soft distal tip 626 has been described as composed of a clear flexible material, the soft distal tip can be manufactured from any suitable material and have any suitable transparency, and skilled artisans will be able to select an appropriate material and transparency for the soft distal tip according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the bodily passage being identified and/or treated.
The fitting 640 is attached to the proximal end 621 of the elongate tubular member 620 and has proximal 641 and distal 642 ends and defines a lumen 643 which extends between openings located at the proximal end 641 and the distal end 642. The fitting 640 can be, however, rotatably connected to the elongate tubular member 620. Alternatively, the fitting 640 can be omitted and the elongate tubular member 620 can be directly attached to the adapter 660.
The adapter 660 comprises first 661 and second 662 proximal ends, a distal end 663 and defines first 664 and second 665 lumens which converge into a third lumen 666. The first lumen 664 extends between an opening located at the first proximal end 661 and the third lumen 666 and is in communication with the third lumen 666. The second lumen 665 extends between an opening located at the second proximal end 662 and the third lumen 666 and is in communication with the third lumen 666. The third lumen 666 extends from the converging point of the first 664 and second 665 lumens to the distal end 663 of the adapter 660 and is in communication with the lumen 643 of the fitting 640. The first 661 and second 662 proximal ends include a connector 667 for releasably or fixedly connecting one or more elements and/or devices. The connectors 667 can include a sealing member to prevent fluid from flowing out of lumens 664 and 665 and/or provide a seal around any device traversing the adapter 660.
The distal end 663 of the adapter 660 is rotatably connected to the proximal end 641 of the fitting 640. Alternatively, the adapter 660 can be otherwise attached to the proximal end 641 of the fitting. An exemplary structure for rotatably connecting the adapter 660 to the fitting 640 is shown at 669, and includes a projection 643 and socket 670 configuration, as previously described herein.
While the adapter 660 has been illustrated as having a bifurcated configuration, the adapter 660 can include any suitable number of branches, and skilled artisans will be able to select an appropriate number of branches for inclusion in a light emitting irrigation device according to a particular embodiment based on various considerations, including the number of lumens defined by the elongate tubular member and/or fitting, and the intended use of the light emitting irrigation device. Examples of suitable numbers of branches for inclusion in an adapter include one, two, three, four and any number determined suitable for a particular application. For example, the adapter can comprise a single shaft defining one or more lumens in communication with one another or separate from one another.
The optical fiber 680 extends between proximal 682 and distal 684 ends and defines a light path extending through its length. The optical fiber 680 extends through the first lumen 664 and third lumen 666 of the adapter 660, through the lumen 643 of the fitting 640, through the lumen 623 of the elongate tubular member 620, and is disposed within the soft distal tip 626. The proximal end 682 of the optical fiber 680 is adapted to be operatively connected or attached to the light source 690. The distal end 684 of the optical fiber 680 is attached to soft distal tip 626. While the optical fiber 680 has been described and illustrated as extending through the first lumen 664 of the adapter 660, the optical fiber 680 can alternatively extend through the second lumen 665 of the adapter 660.
The light source 690 is operatively connected or attached to the proximal end 682 of the optical fiber 680 such that light generated by the light source 690 is able to travel through the light path defined by the optical fiber 680. While the light source 690 has been described and illustrated as attached to the proximal end 682 of the optical fiber 680, the light source 690 can alternatively be omitted from the irrigation device and provided separately.
The light emitting irrigation devices described and illustrated herein can be used in conjunction with a guidewire to assist in advancement of the device to a point of treatment. In addition, it is noted that all structure and features of the various described and illustrated elements can be combined and/or omitted in any suitable configuration for inclusion in a light emitting irrigation device. While particular configurations have been described and illustrated, skilled artisans will be able to select an appropriate configuration for a light emitting irrigation device according to a particular embodiment based on various considerations, including the intended use of the light emitting irrigation device, and the location of the treatment site, among others.
For example, an irrigation device can be adapted to include an elongate tubular member which omits the inclusion of a curve. In an additional example, the irrigation device can be adapted to omit the inclusion of a fitting and/or adapter, or adapted to include a fitting and/or adapter. In a further example, the elongate tubular member, adapter, and/or fitting can be adapted to include any suitable number of lumens in communication with one another or separate from one another. In another example, the irrigation device can be adapted to omit the inclusion of the light source.
In the first step 702 a user activates a light emitting irrigation device according to an embodiment described herein, causing axially-directed light to travel through a light path defined by an optical fiber to emit from the distal end of the optical fiber.
In another step 704, a user inserts and advances the light emitting irrigation device into a bodily passage of a patient using conventional interventional techniques, such as by placing it on and advancing it over a previously-placed guidewire, or passing it through a guiding catheter to direct the light emitting irrigation device to a point of treatment. Alternatively, the user advances the light emitting irrigation device independent of any other device.
In another step 706, the user visualizes the axially-directed light transcutaneously, or by using a scope.
In another step 708, the user advances the distal end of the light emitting irrigation device into the portion of the bodily passage intended to be irrigated by visualizing the intensity of the axially-directed light and determining if the intensity of the axially-directed light is indicative of the positioning of the distal end of the light emitting irrigation device in the portion of the bodily passage intended to be treated.
In another step 710, the user irrigates the bodily passage. For example, in a sinus irrigation procedure, this step can be used to aspirate and/or flush a sinus cavity. When flushing the sinus cavity the user can use a variety of treatment materials, agents, and/or medications, such as saline, therapeutic agents, and the like. The treatment material can be injected into a portion of the light emitting irrigation device using a syringe or other device. The treatment material flows through the light emitting irrigation device and exits through the opening at its distal end and/or through one or more apertures. Examples of suitable treatment materials include drugs, bioactives, and/or other compounds, such as steroids, and/or anti-biotics, and/or any other suitable compound.
In another step 712, the user withdraws the light emitting irrigation device from the bodily passage.
Any of the light emitting irrigation devices described above with respect to
In addition, the method 700 can include various additional steps, as detailed above with respect to
The foregoing detailed description provides exemplary embodiments of the invention and includes the best mode for practicing the invention. The description and illustration of embodiments is intended only to provide examples of the invention, and not to limit the scope of the invention, or its protection, in any manner.
This application claims the benefit of U.S. Provisional application No. 61/510,611, filed on Jul. 22, 2011. The entire contents of this related application are hereby incorporated into this disclosure by reference.
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