Systems and methods for treating hollow anatomical structures

An apparatus for treating a hollow anatomical structure can include a light delivery device. The light delivery device comprises an optical fiber that is located in a lumen of a shaft suitable for insertion into the hollow anatomical structure and has a fiber tip located proximal of a distal end of the shaft during treatment of the hollow anatomical structure. The apparatus can further include a liquid source for providing a liquid flow over the optical fiber at a predetermined liquid flow rate.

BACKGROUND

Optical fibers have been used in conjunction with laser systems to treat venous reflux for several years. The procedure involves placing an optical fiber in the vein and transmitting laser light through the fiber to the vein walls, causing the vein to close. In current vein ablation systems, an optical fiber is inserted into the vein, either bare or through an introducer sheath. In the latter case, the fiber tip is positioned outside and distal of the distal end of the introducer sheath during the procedure. In either case, when laser light is transmitted to the fiber, the fiber tip may become very hot, potentially causing its cladding and/or buffer material to burn inside the patient's body. In addition, if a hot fiber tip contacts the vein wall, it may cause perforations which can result in bruising and patient discomfort.

SUMMARY

The present disclosure includes, in one embodiment, an apparatus for treating a hollow anatomical structure. The apparatus comprises a shaft suitable for insertion into the hollow anatomical structure. The shaft has an internal lumen, a proximal end and a distal end. The apparatus further comprises an optical fiber located in the lumen. The optical fiber has a light emitting tip which is located in a distal region of the shaft lumen and proximal of the distal end of the shaft.

At least a portion of a sidewall of the shaft distal of the light emitting tip can optionally be transmissive of light. In such a variation the apparatus can optionally further comprise a laser light generator coupled to the optical fiber, wherein the portion of the sidewall is transmissive of at least one wavelength of light output by the generator.

The shaft of the apparatus can optionally further comprise an opening in the distal end of the shaft, and the distal tip of the optical fiber can optionally be spaced proximally from the opening by a distance suitable to substantially prevent buildup of proteins, coagulum and/or carbonization on the optical fiber tip, e.g., 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or 3 mm. The apparatus can further optionally comprise a fluid flow space in the shaft between the optical fiber and a sidewall of the shaft, and the fluid flow space can be in fluid communication with the opening such that fluid in the space can flow distally through the shaft and exit the shaft via the opening. Such an apparatus can further optionally comprise a liquid source in fluid communication with the fluid flow space and located proximal of the space. Such an apparatus can further optionally comprise a flow of liquid proceeding from the liquid source to the fluid flow space and out the opening of the shaft. The flow of liquid can optionally have a flow rate in the fluid flow space suitable to substantially prevent carbonization and protein buildup on the distal tip of the optical fiber; e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. Where employed, the liquid source can be configured to provide a fixed and predetermined flow rate, such as any of the flow rates specified above.

In another embodiment, an apparatus for treating a hollow anatomical structure comprises a cannula suitable for insertion into the hollow anatomical structure. The cannula has a distal end and a proximal end, and a lumen therein. The apparatus further comprises a light delivery device located at least partially in the cannula. The light delivery device has a light emitting portion. The light emitting portion of the light delivery device is located in the lumen of the cannula proximal of the distal end of the cannula. The apparatus further comprises a light field emanating distally from the light emitting portion of the light delivery device.

The cannula can optionally comprise an opening at the distal end of the cannula, and the light field can extend through the opening.

The cannula can optionally comprise a light-transmissive distal portion, and at least a portion of the light field can extend through the light-transmissive distal portion. The light-transmissive distal portion can optionally be sufficiently transmissive of light (optionally including one or more of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, or 1470 nm, or the wavelength ranges 400-3000 nm or 800-1500 nm) to permit heating and reduction in diameter of a target hollow anatomical structure such as a vein.

The light delivery device can optionally comprise an optical fiber, and the light emitting portion can comprise a tip of the optical fiber. In such an apparatus the light can optionally comprise laser light.

The cannula can optionally comprise an opening at the distal end of the cannula, and the apparatus can further comprise a flow of liquid proceeding distally through the cannula, out the opening, and through at least a portion of the light field. The flow of liquid can optionally have a flow rate suitable to substantially prevent carbonization and protein buildup on the distal tip of the light delivery device; e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. Where employed, a liquid source can be configured to provide a fixed and predetermined flow rate in the cannula, such as any of the flow rates specified above. In such an apparatus, the light delivery device can optionally comprise an optical fiber, and the light emitting portion can comprise a tip of the optical fiber. The light can optionally comprise laser light. Such an apparatus can further optionally comprise a laser light generator coupled to the optical fiber.

The distal tip of the light delivery device can optionally be spaced proximally from the cannula opening by a distance suitable to substantially prevent buildup of proteins, coagulum and/or carbonization on the light delivery device tip, e.g., 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm.

In another embodiment, an apparatus for treating a hollow anatomical structure comprises a kit including a sheath and an optical fiber. The sheath has a distal end suitable for insertion into the hollow anatomical structure, a reference point located proximal of the distal end on a portion of the sheath intended to remain outside the hollow anatomical structure during use, and a lumen configured to receive the optical fiber. The lumen extends to the distal end of the sheath. The optical fiber has a distal tip suitable for light emission. The optical fiber bears a mark which is positioned along the length of the fiber such that, when the mark is aligned with the reference point, the distal tip of the fiber is located within the lumen, proximal of the distal end of the sheath.

The distal tip of the fiber can optionally be located 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm proximal of the distal end of the sheath when the mark is aligned with the reference point.

The lumen can optionally extend through a shaft of the sheath, and at least a distal portion of the shaft can be transmissive of the wavelength(s) of light emitted by the apparatus during use. The distal portion can optionally be sufficiently transmissive of light (optionally including one or more of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, or 1470 nm, or the wavelength ranges 400-3000 nm or 800-1500 nm) to permit heating and reduction in diameter of a target hollow anatomical structure such as a vein.

The lumen can optionally extend through a shaft of the sheath, and at least a distal portion of the shaft can be formed from material which is substantially transparent or translucent to visible light.

The kit can optionally be contained in a sterile package.

The sheath can optionally comprise an introducer sheath. In such an apparatus, the sheath can optionally comprise a hub and a sidearm connected to the hub, with the sidearm being in fluid communication with the lumen of the sheath.

The sheath can optionally have an opening at its distal end.

In another embodiment, an apparatus for treating a hollow anatomical structure comprises a kit including a sheath and an optical fiber. The sheath has a distal end suitable for insertion into the hollow anatomical structure, and a lumen configured to receive the optical fiber. The lumen extends to the distal end of the sheath. The lumen has a sidewall, and at least a distal portion of the sidewall is transmissive of visible or infrared light. The distal portion can optionally be sufficiently transmissive of light (optionally including one or more of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, or 1470 nm, or the wavelength ranges 400-3000 nm or 800-1500 nm) to permit heating and reduction in diameter of a target hollow anatomical structure such as a vein.

At least the distal portion of the sidewall can optionally be substantially transparent or translucent to visible light.

The optical fiber can optionally have a distal tip suitable for light emission. In such an apparatus the optical fiber can bear a mark which is positioned along the length of the fiber such that, when the mark is aligned with a reference point of the sheath, the distal tip of the fiber is located within the lumen, proximal of the distal end of the sheath. In such an apparatus the distal tip of the fiber can optionally be located 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm proximal of the distal end of the sheath, when the mark is aligned with the reference point.

The kit can optionally be contained in a sterile package.

The sheath can optionally comprise an introducer sheath. In such an apparatus, the sheath can optionally comprise a hub and a sidearm connected to the hub, wherein the sidearm is in fluid communication with the lumen of the sheath.

The sheath can optionally have an opening at its distal end.

The kit can optionally further comprise a liquid source configured for connection to and fluid communication with the lumen of the sheath. The liquid source can be further configured to provide a fixed and predetermined liquid flow rate in the sheath. The fixed and predetermined liquid flow rate can optionally be suitable to substantially prevent carbonization and protein buildup on the distal tip of the optical fiber; e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

In another embodiment, an apparatus for treating a hollow anatomical structure comprises a sheath and a light delivery device. The sheath is configured to receive the light delivery device, and the sheath has an at least partially optically transmissive distal region. The distal region can optionally be sufficiently transmissive of light (optionally including one or more of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, or 1470 nm, or the wavelength ranges 400-3000 nm or 800-1500 nm) to permit heating and reduction in diameter of a target hollow anatomical structure such as a vein. The light delivery device has a light emission portion, and the light emission portion is located in the distal region of the sheath, proximal of a distal end of the distal region.

The distal region of the sheath can optionally comprise a tube. Such a tube can optionally be formed from a material which is transmissive of visible or infrared light, or from a material which is substantially transparent or translucent to visible light.

The distal region of the sheath can optionally comprise a plurality of expandable members surrounding the light emission portion. The expandable members can optionally be spaced apart from each other to permit light to pass therebetween.

The light delivery device can optionally comprise an optical fiber. In such an apparatus the light emission portion can optionally comprise a distal tip of the fiber.

The apparatus can optionally further comprise a fluid delivery path in the sheath, which fluid delivery path extends distally to and beyond the light emission portion. The apparatus can further optionally comprise a flow of liquid proceeding distally through the sheath. The flow of liquid can optionally have a flow rate suitable to substantially prevent carbonization and protein buildup on the distal tip of the light delivery device; e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. Where employed, a liquid source can be configured to provide a fixed and predetermined flow rate in the sheath, such as any of the flow rates specified above.

In another embodiment, a method of treating a hollow anatomical structure comprises inserting into the hollow anatomical structure an apparatus comprising a sheath having a distal end, and a light emission portion disposed in the sheath proximal of the distal end. The method further comprises heating a wall of the hollow anatomical structure by emitting light from the light emission portion, while the light emission portion is disposed in the sheath proximal of the distal end.

The method can optionally further comprise delivering a liquid through the sheath and past the light emission portion. In such a method, emitting light can optionally comprise passing at least a portion of the light through the liquid, and heating the liquid with the light. Such a method can further optionally comprise delivering the heated liquid to the wall of the hollow anatomical structure and thereby heating the wall of the hollow anatomical structure.

Delivering the liquid can further optionally comprise delivering the liquid at a flow rate in the sheath suitable to substantially prevent carbonization and protein buildup on the distal tip of the light emission portion; e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. The liquid can be delivered via a liquid source can be configured to provide a fixed and predetermined flow rate in the sheath, such as any of the flow rates specified above.

In the method, emitting light can optionally comprise passing at least a portion of the light through a sidewall of the sheath.

The light emission portion of the apparatus can optionally comprise a tip of an optical fiber, with the optical fiber being disposed in the sheath.

In the method, the hollow anatomical structure can optionally comprise a vein or a varicose vein.

The method can optionally further comprise preventing, with the sheath, the light emission portion from contacting the wall of the hollow anatomical structure during the emitting light.

In another embodiment, a method of treating a hollow anatomical structure comprises positioning in the hollow anatomical structure a treatment system comprising a sheath and an optical fiber with a distal tip located in a lumen of the sheath; and establishing a liquid flow of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour proceeding distally through the sheath lumen, past the distal tip of the optical fiber. The method further comprises: while the distal tip is located in the lumen of the sheath and the liquid flow is present, emitting light energy from the optical fiber, and thereby heating a wall of the hollow anatomical structure.

The sheath can optionally comprise a distal tip opening and the distal tip of the optical fiber can be located 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm proximal of the distal tip opening of the sheath, when emitting the light energy from the optical fiber.

The method can optionally further comprise reducing the diameter of the hollow anatomical structure via the heating. The hollow anatomical structure can optionally comprise a vein.

Establishing the liquid flow can comprise establishing the liquid flow with a liquid source configured to provide liquid at a fixed and predetermined flow rate. The flow rate can be 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

The method can optionally further comprise contacting the liquid flow with the distal tip of the optical fiber. At least a portion of the distal tip of the optical fiber can comprise bare core material of the fiber, and contacting the liquid flow with the distal tip of the fiber can comprise contacting the liquid flow with the bare core material. Establishing the liquid flow can comprise establishing the liquid flow distally along the length of the sheath, and then through a space between the distal tip of the optical fiber and an inner wall of the sheath. Establishing the liquid flow can further comprise establishing the flow out an opening in a distal region of the sheath. The opening can be located in a distal tip of the sheath and oriented transverse to a longitudinal axis of the sheath.

In one variation of the method, emitting light energy from the optical fiber can comprise passing at least a portion of the light energy through a sidewall of the sheath. The portion of the light energy passing through the sidewall can be sufficient to reduce the diameter of the hollow anatomical structure.

In one variation of the method, establishing the liquid flow can comprise establishing the liquid flow in a space in the sheath lumen between the optical fiber and an inner wall of the sheath.

One variation of the method further comprises minimizing carbonization on the distal tip of the optical fiber.

In another embodiment, a method of treating a hollow anatomical structure comprises positioning in the hollow anatomical structure a treatment system comprising a sheath and an optical fiber with a distal tip located in a lumen of the sheath; inhibiting carbonization and protein buildup on the distal tip of the optical fiber by establishing a liquid flow proceeding distally through the sheath lumen, past the distal tip of the optical fiber; and, while the distal tip is located in the lumen of the sheath and the liquid flow is present, emitting light energy from the optical fiber, and thereby heating a wall of the hollow anatomical structure.

In variations of the method, establishing the liquid flow comprises establishing a flow of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

In variations of the method, the sheath comprises a distal tip opening and the distal tip of the optical fiber is located 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm proximal of the distal tip opening of the sheath, when emitting the light energy from the optical fiber.

The method can further optionally comprise reducing the diameter of the hollow anatomical structure via the heating. The hollow anatomical structure can optionally comprise a vein.

The method can further comprise contacting the liquid flow with the distal tip of the optical fiber. Optionally, at least a portion of the distal tip of the optical fiber comprises bare core material of the fiber, and contacting the liquid flow with the distal tip of the fiber comprises contacting the liquid flow with the bare core material. As a further option, establishing the liquid flow can comprise establishing the liquid flow distally along the length of the sheath, and then through a space between the distal tip of the optical fiber and an inner wall of the sheath. Establishing the liquid flow can still further comprise establishing the flow out an opening in a distal region of the sheath. The opening can be located in a distal tip of the sheath and oriented transverse to a longitudinal axis of the sheath.

In one variation of the method, emitting light energy from the optical fiber can comprise passing at least a portion of the light energy through a sidewall of the sheath. The portion of the light energy passing through the sidewall can be sufficient to reduce the diameter of the hollow anatomical structure.

In one variation of the method, establishing the liquid flow comprises establishing the liquid flow in a space in the sheath lumen between the optical fiber and an inner wall of the sheath.

Establishing the liquid flow can comprise establishing the liquid flow with a liquid source configured to provide liquid at a fixed and predetermined flow rate. The flow rate can be 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

Another embodiment comprises an apparatus for treating a hollow anatomical structure. The apparatus comprises a sheath having an inner lumen, the sheath being sized and configured for insertion into the hollow anatomical structure; an optical fiber positioned in the lumen of the sheath, a distal tip of the fiber being positioned in a distal portion of the sheath; and a liquid flow advancing distally along the lumen of the sheath, the distal tip of the fiber contacting the liquid flow, the liquid flow having a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

In one variation of the apparatus, at least the distal portion of the sheath has a sidewall which is highly transmissive of light. The sidewall can be sufficiently transmissive of light to allow heating and reduction in diameter of the hollow anatomical structure. Additionally the sidewall can be sufficiently transmissive of light in at least one of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, and 1470 nm, or in at least one of the wavelength ranges 400-3000 nm and 800-1500 nm to permit heating and reduction in diameter of the hollow anatomical structure.

The sheath can optionally comprise a distal tip opening and the distal tip of the optical fiber can be located 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm proximal of the distal tip opening of the sheath. The liquid flow can optionally advance through the distal tip opening and out the sheath.

The apparatus can optionally further comprise a beam of light emanating from the optical fiber, the beam of light having sufficient intensity to facilitate heating and reduction in diameter of the hollow anatomical structure. At least a portion of the beam of light can pass through a sidewall of the sheath.

The hollow anatomical structure can optionally comprise a vein.

At least a portion of the distal tip of the optical fiber can comprise bare core material of the fiber, and the liquid flow can contact the bare core material.

The liquid flow can extend distally within the lumen of the sheath, and through a space between the distal tip of the optical fiber and a sidewall of the sheath. At least a portion of the sidewall alongside the distal tip of the optical fiber can be sufficiently transmissive of light to allow heating and reduction in diameter of the hollow anatomical structure. The sidewall portion can be sufficiently transmissive of light in at least one of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, and 1470 nm, or at least one of the wavelength ranges 400-3000 nm and 800-1500 nm to permit heating and reduction in diameter of the hollow anatomical structure.

The apparatus can optionally further comprise a liquid source in fluid communication with the lumen of the sheath. The liquid source can be configured to provide a fixed and predetermined liquid flow rate in the sheath, e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

Another embodiment comprises an apparatus for treating a hollow anatomical structure. The apparatus comprises a sheath having an inner lumen, the sheath being sized and configured for insertion into the hollow anatomical structure; an optical fiber positioned in the lumen of the sheath, a distal tip of the fiber being positioned in a distal portion of the sheath; and a liquid flow advancing distally along the lumen of the sheath, the distal tip of the fiber contacting the liquid flow, the liquid flow having a flow rate suitable to inhibit carbonization and protein buildup on the distal tip of the optical fiber.

At least the distal portion of the sheath can have a sidewall which is highly transmissive of light. Such a sidewall can be sufficiently transmissive of light to allow heating and reduction in diameter of the hollow anatomical structure. Such a sidewall can be sufficiently transmissive of light in at least one of the wavelengths 810 nm, 940 nm, 980 nm, and 1320 nm, or at least one of the wavelength ranges 400-3000 nm and 800-1500 nm to permit heating and reduction in diameter of the hollow anatomical structure.

The sheath can optionally comprise a distal tip opening and the distal tip of the optical fiber can be located 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or about 3 mm proximal of the distal tip opening of the sheath. The liquid flow can advance through the distal tip opening and out the sheath.

The apparatus can optionally further comprise a beam of light emanating from the optical fiber, the beam of light having sufficient intensity to facilitate heating and reduction in diameter of the hollow anatomical structure. At least a portion of the beam of light can pass through a sidewall of the sheath.

The hollow anatomical structure can comprise a vein.

In one variation of the apparatus, at least a portion of the distal tip of the optical fiber comprises bare core material of the fiber, and the liquid flow contacts the bare core material.

In one variation of the apparatus, the liquid flow extends distally within the lumen of the sheath, and through a space between the distal tip of the optical fiber and a sidewall of the sheath.

In one variation of the apparatus, at least a portion of the sidewall alongside the distal tip of the optical fiber is sufficiently transmissive of light to allow heating and reduction in diameter of the hollow anatomical structure. The sidewall portion can be sufficiently transmissive of light in at least one of the wavelengths 810 nm, 940 nm, 980 nm, 1320 nm, and 1470 nm, or at least one of the wavelength ranges 400-3000 nm or 800-1500 nm to permit heating and reduction in diameter of the hollow anatomical structure.

The apparatus can optionally further comprise a liquid source in fluid communication with the lumen of the sheath. The liquid source can be configured to provide a fixed and predetermined liquid flow rate in the sheath, e.g., a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour.

In another embodiment, an apparatus for treating a hollow anatomical structure comprises a sheath having an elongate shaft defining an internal lumen. The shaft has a sidewall, a proximal portion, and a distal portion, the sidewall being more transmissive of therapeutic light energy in the distal portion than in the proximal portion. The distal portion of the shaft forms a distal tip of the shaft and has a distal-facing opening at the distal tip. The apparatus further comprises an optical fiber disposed within and movable along the lumen. The optical fiber has a fiber tip located in the distal portion of the shaft at a firing position which is 2-20 mm proximal of the distal tip of the shaft. The apparatus further comprises a light propagation path which extends distally from the fiber tip and through the distal-facing opening.

The firing position can be a static firing position relative to sheath.

The sidewall can be made from a first material in the proximal portion and from a second material in the distal portion, the second material being more transmissive of therapeutic light than the first material. In such a variation, the first material can be more flexible than the second material. The second material can be one of quartz, sapphire, synthetic fused silica, polycarbonate, polyetherethereketone, polysufone, polyarylethersulfone, polyetherimide, and polyamide-imide. The second material can optionally be transmissive of wavelengths of light from 400 to 3000 nm, or from 800 to 1500 nm.

The optical fiber can be insertable into the hollow anatomical structure separately from the sheath.

The shaft can be sized for insertion into a vein. In such a variation, the outer diameter of the shaft can be less than 5 mm.

The apparatus can further comprise a liquid flow advancing distally along the shaft lumen and contacting the fiber tip. Such an apparatus can further comprise a liquid source in fluid communication with the lumen, the liquid source being configured to provide the liquid flow at a fixed and predetermined liquid flow rate. The liquid flow rate can optionally be 5-60 cc/hr. In one variation, the liquid source can comprise a saline bag fluidly coupled to the shaft lumen through a flow regulator. The flow regulator can comprise a flow restriction fluidly coupling the saline bag to the lumen. The flow restriction can comprise an orifice having a predetermined effective opening that is sized to provide the predetermined liquid flow rate. The liquid source can comprise a liquid reservoir and a liquid flow path from the reservoir to the shaft lumen, and the flow restriction comprises an orifice of a fixed size positioned in the flow path, the orifice size being smaller than that of the rest of the liquid flow path.

The apparatus can further comprise a position limiter configured to limit the position of the fiber tip relative to the distal tip of the shaft at the firing position. In one variation, the position limiter can comprise a stop configured to limit the distal movement of the optical fiber within the shaft lumen when the fiber tip is at the firing position The stop can comprise cooperating structures of the optical fiber and the distal shaft portion that are configured to limit the relative insertion of the fiber tip within the lumen to the firing position. The stop can optionally be located 12 mm from the distal tip of the optical fiber, or within 10-20 mm of the distal tip of the optical fiber.

The fiber tip can be optically coupled to the distal-facing opening to form the light propagation path.

In another embodiment, a method of treating a hollow anatomical structure comprises inserting a sheath with a distal end into the hollow anatomical structure, inserting an optical fiber into the sheath, and positioning a tip of the optical fiber at a firing position anywhere from 2-20 mm proximal of the distal end. The method further comprises emitting light energy from the fiber tip while the tip is disposed in the sheath proximal of the distal end and withdrawing the sheath and optical fiber along the hollow anatomical structure while emitting the light energy.

The method can further comprise maintaining the position of the fiber tip in the firing position during the emitting and the withdrawing.

The insertion of the optical fiber in the sheath optionally occurs prior to inserting the sheath into the hollow anatomical structure. In such a method, the optical fiber can be moveable with respect to the sheath after the optical fiber is inserted into the sheath.

The insertion of the sheath into the hollow anatomical structure optionally occurs prior to inserting the optical fiber into the sheath.

The emitting can comprise emitting light energy through a sidewall of the sheath.

The emitting can comprise emitting light energy through a distal portion of a sidewall of the sheath that is more transmissive of light energy than is a proximal portion of the sidewall.

The method can further comprise establishing a liquid flow proceeding distally through the sheath and past the tip of the optical fiber. In such a method, the establishing can further comprise providing a predetermined liquid flow rate via a liquid source. The predetermined flow rate can be fixed. The predetermined liquid flow rate can optionally be provided at 5-60 cc/hour.

The emitting can comprise emitting light energy distally from the fiber tip. In one variation, the emitting light energy distally can comprise emitting light energy through a distal-facing opening formed in the distal end of the sheath.

The emitting can comprise emitting light energy into a wall of the hollow anatomical structure.

In another embodiment, an apparatus for treating a blood vessel comprises a sheath defining an inner lumen and having a proximal portion and a distal portion, with the sheath configured for insertion into the blood vessel. The apparatus further comprises an optical fiber positioned in the lumen and having a distal tip positioned in the distal portion. The apparatus further comprises a liquid flow advancing distally along the lumen and contacting the distal tip, and a liquid source in fluid communication with the inner lumen, the liquid source configured to provide the liquid flow at a predetermined liquid flow rate of 5-60 cc/hour.

The predetermined liquid flow rate can be fixed.

The proximal portion of the sheath can be formed from a first material and the distal portion of the sheath can be formed from a second material that is more transmissive of light energy than the first material. The proximal portion and the distal portion can have approximately the same outer diameter.

The apparatus can further comprise a flow path from the liquid source to the sheath, the flow path having a flow passage of a predetermined size that restricts the liquid flow to provide the predetermined liquid flow rate. In one variation, at least a portion of the flow passage can be smaller than the remainder of the flow path from the liquid source to the sheath. The flow passage can comprise a channel having a fixed size. The channel can optionally comprise a capillary tube. Such an apparatus can further comprise a flow restrictor member disposed in the channel. In another variation, the liquid source can be non-motorized. Such a liquid source can comprise a liquid reservoir, and the flow of liquid from the liquid reservoir can be driven by at least one of gravity and compression of the liquid reservoir. The liquid reservoir can comprise a saline bag. The saline bag can be fluidly coupled to the inner lumen through a flow regulator. The flow regulator can comprise a flow restriction fluidly coupling the saline bag to the lumen. The flow restriction can comprise an orifice having a predetermined effective opening that is sized to provide the predetermined liquid flow rate.

The optical fiber can be moveable with respect to the sheath.

The distal sheath portion can form a distal tip of the sheath and can have a distal-facing opening at the distal tip of the sheath through which the liquid flow can pass. In one variation, the distal tip of the optical fiber and the sheath can define a light propagation path which extends distally from the distal tip of the optical fiber and through the distal-facing opening.

In another embodiment, a method of treating a hollow anatomical structure comprises positioning a treatment system in the hollow anatomical structure, the treatment system comprising a sheath having a lumen and an optical fiber with a distal tip located in the lumen. The method further comprises establishing a liquid flow at a liquid flow rate of 5-60 cc/hour proceeding distally through the lumen and past the distal tip. The method further comprises emitting light energy from the optical fiber, thereby causing heating of a wall of the hollow anatomical structure, while the distal tip is located in the lumen and the liquid flow is present. The method further comprises withdrawing the treatment system along the hollow anatomical structure while emitting the light energy.

The establishing can further comprise providing the liquid flow at predetermined liquid flow rate. The predetermined liquid flow rate can optionally be fixed. The providing can further comprise restricting the liquid flow from a liquid reservoir to the sheath lumen to provide the fixed and predetermined liquid flow rate. In one variation, the restricting can further comprise flowing liquid through a smaller diameter portion of a flow passage coupling the liquid reservoir to the sheath lumen. In another variation, the restricting can further comprise flowing liquid through a channel having a fixed size. The channel can optionally be rigid. The restricting can further comprise flowing liquid through a capillary tube. The restricting can further comprise flowing liquid past a flow restrictor member disposed in the channel.

The establishing can further comprise providing the liquid flow rate from a non-motorized liquid source. In one variation, the liquid source can comprise a liquid reservoir and the providing further comprises driving the flow of liquid from the liquid reservoir by at least one of gravity and compression of the liquid reservoir. In another variation, the providing can further comprise flowing liquid from a saline bag.

The method can further comprise maintaining the position of the distal fiber tip relative to the distal end of the sheath during the emitting and the withdrawing.

The positioning can comprise sequentially inserting the optical fiber in the sheath and inserting the sheath into the hollow anatomical structure.

The positioning can comprise sequentially inserting the sheath into the hollow anatomical structure and inserting the optical fiber into the sheath.

The emitting can comprise emitting light energy through a sidewall of the sheath.

The emitting can comprise emitting light energy through a distal portion of the sheath. In such a method, the emitting light energy through a distal portion of the sheath can comprise emitting light energy through a portion of the distal portion that is transmissive of light energy.

The emitting can comprise emitting light energy distally from the distal tip. In such a method, the emitting can comprise emitting light energy through a distal-facing opening formed in a distal portion of the sheath.

The emitting can comprises emitting light energy into a wall of the hollow anatomical structure.

The emitting can comprise emitting light energy radially from the distal tip.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The features of the systems and methods will now be described with reference to the drawings summarized above. The drawings, associated descriptions, and specific implementation are provided to illustrate preferred embodiments of the invention(s) disclosed herein, and not to limit the scope of the patent protection sought in connection with this specification.

In addition, methods and functions of treatment systems or devices described herein are not limited to any particular sequence, and the acts relating thereto can be performed in other sequences that are appropriate. For example, described acts may be performed in an order other than that specifically disclosed, or multiple acts may be combined in a single act.

One embodiment of a system100for treating a hollow anatomical structure or “HAS” (e.g., a blood vessel, a vein, a varicose vein, a fallopian tube, ovarian vein, etc.) is depicted inFIGS. 1,2and3. The depicted embodiment of the system100includes an introducer sheath110having a preferably tubular and flexible shaft112, a distal end of which includes a protective distal tip portion114. The sheath110preferably further comprises a hub120attached to a proximal end of the shaft112, and a sidearm122which can include a port124to facilitate introduction of fluids into the sidearm122. In the depicted embodiment the hub120is configured to permit fluid communication between the sidearm122and the shaft112such that a fluid introduced into the port124of the sidearm122can flow into a lumen116(seeFIG. 3) of the shaft112. An appropriate connector, such as a Luer fitting (not shown) can be included at the port124(or on the hub120instead of the sidearm122) to permit connection of medical apparatus, fluid sources, etc. to the sidearm122. The sheath110can be sized for insertion into a HAS, and can have an outer diameter of 1-5 mm.

The system100depicted inFIGS. 1-3can further comprise a light delivery device150disposed in the lumen116of the shaft112. In the depicted embodiment the light delivery device150comprises an optical fiber152, which can be coupled to a laser light generator154. Where employed, the optical fiber152can extend proximally through the hub120of the introducer sheath110to the laser light generator154, to conduct laser energy output by the generator154through the shaft112to the desired treatment area as will be discussed in greater detail below. A hemostatic seal or the like can be provided in the hub120to provide a seal around the fiber152and prevent fluid in the shaft lumen116from escaping proximally beyond the hub120. As an alternative to the depicted optical fiber152, the light delivery device150can comprise a small laser light source or other light source disposed in the lumen116of the shaft112.

In the depicted embodiment, the optical fiber152comprises a light-conducting optical core156formed from glass, silica or other suitable light-conducting material(s), surrounded by cladding158made from silica or polymers or the like, to promote internal reflection within the core156. A protective jacket160surrounds the cladding158and the core156. The jacket160is optionally stripped back to expose a distal tip portion of the cladding158and core156, and this distal tip portion is typically between about 2 mm and 8 mm in length. Alternatively, the optical fiber152can be employed without any of the jacket160stripped from the distal fiber tip, e.g. with only the distal face of the core156exposed at the distal tip. The core156preferably terminates in an unclad, distal light emitting tip162. In operation, light170(e.g. laser light) propagates distally down the core156of the fiber152, exits the core156at the light emitting tip162and advances generally distally from the tip162. The tip162is preferably a generally flat surface oriented generally orthogonal to the longitudinal axis of the fiber152. Alternatively, however, the tip162can also be formed, shaped, or ground to create facets, or a spherical or prismatic tip face to direct a portion of the light in the radial direction.

The distal tip portion114of the shaft112is preferably transparent to, or otherwise highly transmissive of, the wavelength(s) of light170emitted via the tip162of the fiber152(or other light delivery device150) during operation of the system100. Such wavelengths of light170can optionally range from 400 to 3000 nm, or from 800 to 1500 nm. The distal tip portion114can also be sufficiently transmissive of such wavelength(s) of light (or of specific suitable therapeutic wavelengths such as 810 nm, 940 nm, 980 nm, 1320 nm and/or 1470 nm) to permit heating and reduction in diameter of a target hollow anatomical structure such as a vein, and/or to avoid melting and/or burning the distal tip portion114when light (optionally including light in the above-noted wavelength(s) is emanating from the fiber152at sufficient intensity to lead to heating and reduction in diameter of the HAS or vein. Suitable materials for use in forming the distal tip portion114include, without limitation, quartz, sapphire, borosilicate glass (PYREX(™)), synthetic fused silica, polycarbonate, polyetheretherketone, polysulfone, polyarylethersulfone, polyetherimide, and polyamide-imides. The distal tip portion114can optionally comprise a tube with a wall thickness of 0.2-1.0 mm.

Some or all of the light170can propagate from the tip162, distally and/or outwardly through the sidewalls and/or end of the distal tip portion114and to the desired treatment area. The fiber tip162can therefore remain disposed within the distal tip portion114of the shaft112during treatment, and the distal tip portion114can protect the hot fiber tip162from contact with the inner wall of the vein or other target HAS (and vice versa).

In the depicted embodiment, the fiber tip162is spaced proximally from a distal end172of the distal tip portion114by a distance X of 2 mm to 20 mm. The distal tip portion114can further optionally include an opening174to permit light and/or liquids to flow from the tip portion114, and/or a tapered tip region176to facilitate easy and atraumatic insertion of the shaft112into small-diameter HAS's.

Preferably, the light delivery device150and the lumen116of the shaft112/tip portion114are sized so that a fluid delivery space178is provided between the light delivery device150and the inner wall of the shaft112/tip portion114. In such an embodiment, a liquid such as saline (or any other suitable liquid) can be delivered distally through the shaft112and tip portion114, and out the opening174, during delivery of light170from the device150. The delivered liquid can optionally absorb the wavelength(s) of light170emitted from the device150, to a sufficient degree to induce heating and/or boiling of the delivered liquid as it flows through the delivery space178and light170, and out the opening174. The hot/boiling liquid will also tend to heat the tip portion114. Thus, this embodiment of the system100can be capable of providing at least three mechanisms of therapeutic HAS wall heating: (1) hot or boiling fluid heating of the HAS walls, (2) conductive heating from the hot sheath tip114, and (3) light or laser energy170transmitted directly to the HAS walls.

By controlling the light/laser power, the distance X, liquid flow rate, and liquid starting temperature, the HAS heating zone/length can be controlled and an optimized thermal therapy can be accomplished. Also, by selecting a preferentially water absorbing light/laser wavelength (e.g. 1320 nm, etc.) the therapy can be one in which substantially all of the light/laser energy is absorbed by the (aqueous) liquid which both flows from the sheath opening174and heats the sheath tip114to create a heat zone for effecting tissue thermal therapy. The aforementioned parameters are preferably varied to ensure that the heating is maintained at or around 100° C., providing a controlled therapy with minimal complications (e.g., minimizing uncontrolled high temperatures that cause increased depth of thermal injury leading in turn to potential pain and bruising; and avoiding fiber tip wall contact and perforations that lead to blood extravasations and bruising).

In one embodiment of a method of use of the system100, the target HAS (e.g. a vein such as the greater saphenous vein) can first be accessed by using a suitable access technique (e.g. the standard Seldinger technique). A guide wire is passed into the target HAS, and the introducer sheath110is fed over the guidewire into the target HAS and advanced to the desired start location. In the case of the greater saphenous vein, the desired start location is just below the sapheno-femoral junction. The guidewire is then withdrawn from the sheath110and the light delivery device150is advanced distally through the hub120and down the shaft112until the device150is appropriately positioned within the sheath tip114. Where the light delivery device150comprises the optical fiber152, the fiber tip162is positioned so that it is proximal of the distal end172of the tip114by the distance X. An appropriate mark (or a projection such as a flange, slidable collar or “donut”) can be provided on a proximal region of the fiber152to facilitate positioning of the fiber tip162, such that alignment of the mark with the proximal edge of the hub indicates that the desired position of the fiber tip162has been reached. A suitable lock, clamp or Touhy-Borst valve can be provided in the hub120to prevent longitudinal movement of the fiber152within the sheath, and this lock or clamp can be activated after positioning of the fiber tip162within the sheath110as described above. Alternatively, the sheath110and light delivery device150can be combined prior to insertion and advanced into the target HAS together, without need for a guidewire.

Before or after placement of the optical fiber152or other light delivery device, the position of the sheath110relative to the desired treatment location can be verified using appropriate techniques such as ultrasound. In addition, the target HAS can optionally be prepared for treatment by using any desired combination of manual compression, compression bandages, and/or injection of tumescent anesthesia into the tissues surrounding the target HAS, to exsanguinate the HAS lumen (in the case of treating blood vessels) and reduce the lumenal diameter in preparation for heat treatment.

If desired, a liquid flow via the sidearm122, through the sheath110and into the HAS lumen can be commenced as described above. The light delivery device150is activated, providing light, such as laser light, at one or more appropriate wavelengths or wavelength ranges such as 810 nm, 940 nm, 980 nm, 1320 nm, and/or 1470 nm, and/or 400-3000 nm or 800-1500 nm, and at an appropriate power level. The assembly of the sheath110and device150is slowly withdrawn through the HAS lumen, preferably at a rate about of 0.5-5 millimeters per second. As the assembly is moved along the lumen, therapeutic heat is delivered to the HAS walls via one or more of the following: (1) heating of the HAS walls via any hot or boiled delivered liquid, (2) conductive heating from the hot sheath tip114, and (3) light or laser energy170transmission directly to the HAS walls. After the desired length of the target HAS has been treated with the therapeutic heat, the sheath110and device150can be removed and appropriate post-procedural care can be administered.

In one embodiment of the method of use of the system100, a liquid flow suitable to minimize, inhibit or substantially prevent buildup of proteins, coagulum and/or carbonization on the fiber tip162(e.g., having a flow rate of 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour) is established in the sheath110during treatment of a target HAS. As discussed in further detail below, this liquid flow has also been found suitable to minimize, inhibit or substantially prevent perforation of the hollow anatomical structure being treated (including veins in particular). When employed with the system100depicted inFIGS. 1-3, this liquid flow advances distally, along and in contact with the distal portion of the fiber152, in the (typically annular) fluid delivery space178between the distal portion of the fiber and the inner wall of the distal tip portion114. Where the fiber152of the system100includes a stripped distal portion as shown inFIGS. 2-3, the liquid flow advances along and in contact with the cladding158; and/or the unclad, distal light emitting tip162points or faces distally toward a portion of the liquid flow located in the sheath tip114distal of the tip162such that the bare, unclad core material which forms the tip162contacts this distal portion of the liquid flow. The liquid flow can comprise saline or any other suitable liquid disclosed herein.

The method of use of the system100can also optionally include positioning the fiber tip162in the sheath112such that the tip162is spaced proximally from the distal end172and/or opening174of the distal tip portion114by the distance X (seeFIG. 3) of 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or 3 mm; or otherwise by a distance suitable to minimize, inhibit or substantially prevent buildup of proteins, coagulum and/or carbonization on the fiber tip162. This tip spacing has also been found suitable to minimize, inhibit or substantially prevent perforation of the hollow anatomical structure being treated (including veins in particular).

It has been found that providing an appropriate fluid flow over the distal portion of the fiber152, and/or properly spacing the fiber tip162from the distal end172and/or opening174of the distal tip portion114helps to minimize buildup of coagulum and/or carbonized blood components on the fiber tip162. This in turn minimizes perforation of the treated hollow anatomical structure, particularly in veins, possibly due to the elimination of the enlarged hot carbonized mass often observed on the tip of an optical fiber used in treatment of a hollow anatomical structure. Accordingly, a method of minimizing carbonization on the fiber tip162and/or minimizing HAS/vein perforation (or a step of minimizing carbonization and/or HAS/vein perforation, as part of a method of use of the system100) can comprise establishing a liquid flow as specified above, and/or spacing the fiber tip162from the distal end172and/or opening174as specified above.

In addition, a low-carbonization or no-carbonization (or low-perforation or no-perforation) system100can include the optical fiber152disposed within the sheath110, with the distal portion of the fiber152(including at least a portion of the exposed cladding158, and/or the light emitting tip162) located in the distal tip portion114(which can be transparent or otherwise highly transmissive of the wavelength(s) of light emitted from the fiber tip162) and surrounded by (and/or in contact with) the liquid flow specified above. The fiber tip162can be spaced from the distal end172and/or distal tip opening174(if present) of the distal tip portion114, by the distance X specified above. Where both the fluid flow and the fiber tip spacing are employed, there can exist a distal portion of the fluid flow within the distal tip portion114of the sheath110, which distal portion of the fluid flow extends distally from the fiber tip162by the distance X. The distal portion of the fluid flow preferably contacts the fiber tip162; where the fiber tip162is an unclad portion of the fiber core material, the distal portion of the fluid flow contacts the fiber core material at the fiber tip162.

FIG. 4depicts an alternative embodiment of the system100, which can be similar in structure, use and function to any of the variations of the system100ofFIGS. 1-3, except as further described herein. In the system100ofFIG. 4, the distal tip portion114of the shaft112of the sheath110is substantially non-transparent to the wavelength(s) of light emitted from the device150during use. The distance X between the tip162and the sheath distal end172, and the angle θ through which the light170is propagated, can be selected to ensure that most or all of the light170will not be transmitted to the sheath tip walls, but will exit through the opening174and be transmitted to the target HAS walls.

As a further variation of the system100ofFIGS. 1-3, a light-absorbing coating can be applied to the distal tip portion114. The coating can be selected to absorb, highly or completely, the wavelength(s) of light emitted by the device150. Thus the emitted light is converted to heat in the tip portion114and any delivered liquid, and energy is delivered to the target HAS walls via the hot and/or boiled liquid and/or contact with the heated tip portion114.

As a variation of the systems100ofFIGS. 1-4, the shaft112of the sheath110can include two, preferably concentric, lumens. In such a sheath110, the inner lumen provides space for the fiber152or other light delivery device and the outer lumen provides a conduit for any liquid(s) to flow. At the distal end of the shaft112, the outer lumen communicates with the inner lumen and sheath tip114, allowing saline to flow around the tip162of the fiber152or other device150.

As another variation of the systems100ofFIGS. 1-4, the light delivery device150can be replaced with another energy application device in the form of, e.g., an electrically driven heater wire or heater coil positioned in the sheath tip114in a similar manner as the stripped portion of the optical fiber152depicted inFIGS. 2-4. Such an electrically driven heater wire or coil can be employed to heat the delivered liquid and/or sheath tip as described elsewhere herein, and thereby therapeutically heat the walls of the target HAS.

As another variation of the systems100ofFIGS. 1-4, the light delivery device150can be replaced with a thermally insulated conduit for the flow of a pre-heated liquid (e.g., saline, etc.) out the distal end of the sheath110and to treatment site. The temperature of the liquid and its flow rate can be controlled to optimize the temperature and length of the treatment zone at the sheath tip.

FIG. 4Adepicts an alternative embodiment of the system100, which can be similar in structure, use and function to any of the variations of the system100ofFIGS. 1-3, except as described herein. In the system100ofFIG. 4A, a liquid source300is provided which may be used to facilitate delivery of the liquid flow at a desired flow rate as discussed above. The depicted liquid source300is in fluid communication with the inner lumen116of the sheath112via the sidearm122or other suitable connection to the sheath112.

FIG. 4Bdepicts one embodiment of the liquid source300. The depicted liquid source300generally comprises a liquid reservoir310coupled to a plumbing network320which is operable to control the flow of liquid into and out of the reservoir310. The liquid reservoir310, which optionally can be housed in a suitable housing312, preferably comprises a pressurizable liquid reservoir310, such as an elastic bladder or a cylinder with a spring-loaded piston received therein. Alternatively a non-elastic reservoir310can be employed, which can rely on gravity to drive liquid flow out of the liquid source300.

In the depicted embodiment, the plumbing network320comprises a primary passage322and a secondary passage324which are interconnected by a three-way stopcock326. The primary passage322can be coupled to and in fluid communication with the liquid reservoir310via a source connector328, while the secondary passage324terminates in a fill connector330, which preferably comprises a luer fitting but can comprise any suitable connector to facilitate connection to a syringe for filling the reservoir310. The primary passage322terminates in an outlet332, which can comprise a luer connector or other hardware suitable for facilitating fluid communication between the outlet332and the sheath110or sidearm122.

A flow regulator340is preferably located on the primary passage322, and is operable to regulate the rate at which liquid flows from the liquid source300. The flow regulator preferably provides a fixed and predetermined flow rate through the primary passage322, e.g., 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. This can be implemented via, for example, a restricted passage through the flow regulator340that, in combination with the fluid pressure applied by the pressurizable or gravity-driven liquid reservoir310, yields the desired liquid flow rate. In one embodiment, the flow regulator340can provide two or more such fixed and predetermined flow rates with, for example, a rotatable disc that can be turned to select and position one of a number of restricted passages, provided as holes through the disc, in alignment with the primary passage322. The selected restricted passage thus determines the flow rate through the regulator340. In one such embodiment, the flow regulator can provide one relatively large fixed and predetermined flow rate, designated as a “prime” setting, which can be used to quickly prime the sheath110and the rest of the system100with liquid before beginning a treatment of a hollow anatomical structure. This “prime” flow rate can be larger than any of those specified herein for use when treating an HAS. The “prime” flow rate can be provided along with one or more “treatment” flow rates.

To use the liquid source300, the practitioner can first connect the source300to the sheath100via the outlet332and the sidearm122or other apparatus suitable to provide fluid communication between the source300and the lumen of the sheath110. Alternatively, the connection can be made later in the process. The practitioner charges the liquid reservoir by setting the stopcock326to provide fluid communication only between the secondary passage324and the reservoir310, and connecting a syringe or other appropriate apparatus to the fill connector330. Notably, a syringe with a graduated barrel can be employed to fill the reservoir310with a precise predetermined volume of liquid. The syringe is operated to pump a desired volume (e.g. less than 100 cc, or less than 50 cc) of liquid through the plumbing network320and into the reservoir310. Where the reservoir310is of the pressurizable type, the inflow of liquid pressurizes the reservoir310(e.g., by expanding the elastic bladder or forcing the piston back against the spring). Once the reservoir310is full, the practitioner can place the stopcock326in the closed position, preventing any outflow from the liquid source300, and if desired remove the syringe or other apparatus from the fill connector330. The sheath110can be primed directly from the syringe, or with the liquid in the reservoir310, or from the syringe while still connected to the fill connector330and with the stopcock326at a proper setting. Where suitable, the flow regulator340can be placed in the “prime” setting and the stopcock326opened to allow liquid to flow from the reservoir310to the sheath lumen at the “prime” flow rate until the priming is complete, and the stopcock closed. However primed, the system100or sheath110is inserted into the target hollow anatomical structure as disclosed elsewhere herein. At the appropriate time after insertion, the stopcock is opened (and the flow regulator340set to the appropriate fixed and predetermined flow rate) to deliver liquid from the reservoir310and into the lumen of the sheath110at an appropriate fixed and predetermined treatment flow rate as discussed herein, e.g., 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. The flow rate is then sustained, either at a constant rate or within a desirable range, for as long as necessary during the treatment.

Advantageously, the liquid source300and flow regulator340can be employed to quickly and conveniently provide a liquid flow at a desired flow rate for treating an HAS. In contrast, a conventional saline bag and tubing set can require a great deal of setup and adjustment before the desired flow rate is achieved. This increases the time and cost expended when performing a treatment.

FIGS. 4C and 4Ddepict one embodiment of the flow regulator340usable with the liquid source300. The flow regulator340ofFIGS. 4C-4Dcomprises a reservoir chamber342having an inlet port370, a drip chamber346having an outlet port368, and a flow restriction350. The inlet port370is in fluid communication with the liquid reservoir310(FIG. 4B) and supplies liquid to the reservoir chamber342, which is in fluid communication with the drip chamber346via the flow restriction350. The flow restriction350regulates the flow rate of liquid into the drip chamber346. From the drip chamber346, liquid is fed via the outlet port368to the sidearm122(FIG. 4A) of the system100via, for example, a length of tubing (not shown) interconnecting the flow regulator340and the sidearm122. Thus the flow regulator340, tubing and sidearm122can form a flow path between the liquid reservoir310and the sheath lumen116. The flow regulator340can be fabricated from multiple injection-molded pieces which are joined or fixed together to form the illustrated flow regulator340. At least the drip chamber346can be formed from a transparent material so that a user may visually confirm the presence of saline in the drip chamber346.

The reservoir chamber342defines an internal lumen344that is in fluid communication with an internal lumen348defined by the drip chamber346. The inlet port370can comprise a spike372that can be directly coupled to a liquid reservoir310(FIG. 4B) such as a saline bag. The spike372defines an internal channel374forming a flow passage for liquid between the liquid reservoir310and the lumen344. Other suitable connectors, such as luer fittings, can be used in place of the spike372in other embodiments.

The flow restriction350can be configured to provide a fixed and predetermined liquid flow rate at a desired flow rate for treating an HAS. The flow restriction350can comprise a restricted passage with an orifice having a predetermined effective opening that is sized to provide the desired liquid flow rate. As illustrated, the flow restriction350comprises a channel352having an inlet orifice354and an outlet orifice356and defining a flow passage358between the lumens344,348. The flow passage358can be sized to provide an appropriate fixed and predetermined treatment flow rate as discussed herein, e.g., 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. For example, the cross-sectional area of the flow path through the flow regulator340can decrease from that of the lumen344to that of the flow passage358to provide a desired treatment flow rate. The flow passage358through the channel352can have a fixed size. Optionally, the outlet orifice356can have a diameter of approximately 0.5 mm. In another variation, the channel352can be a rigid member such as a rigid tube or a rigid (e.g. glass) capillary tube.

The flow restriction350can further comprise a flow restrictor member360positioned in the channel352to provide an appropriate fixed and predetermined treatment flow rate as discussed herein, e.g., 5-60 cc/hour, 5-40 cc/hour, 10-30 cc/hour, 15-25 cc/hour, or about 20 cc/hour. As illustrated, the flow restrictor member360can comprise a channel restrictor362inserted into the inlet orifice354of the channel352and extending at least partially into the flow passage358. The channel352and channel restrictor362can be sized to provide a gap therebetween for the passage of fluid. The gap can be on the order of 0.025 mm. The gap can form an annulus extending around the channel restrictor362and bordered by the channel. Optionally the annulus can include an annular gap between the channel restrictor362and the channel352of approximately 0.025 mm.

The channel restrictor362can comprise a first portion364that is inserted into the flow passage358and a second portion366that is bent with respect to the first portion364to hold the restrictor362in place in the flow passage358. The length of the first portion364, i.e. how far the channel restrictor362protrudes into the flow passage358, can be selected to control the flow rate. As a general rule, increasing the length of the first portion364will decrease the flow rate. The cross-sectional size of the first portion364can also affect the flow rate. Thus, both the cross-sectional size and length of the first portion364of the channel restrictor362may be used to control the flow rate through the flow passage. Optionally, the channel restrictor362can comprise a wire that is bent to form the first portion364and second portion366. The first portion364can itself be slightly bent to impart a springlike characteristic to the first portion that helps to retain the restrictor362in the flow passage358.

FIGS. 4E-Fdepict an alternate embodiment of the flow regulator340, which can be similar in structure, use and function to the flow regulator340ofFIGS. 4C-D, except as further described herein. In the flow regulator340ofFIGS. 4E-F, a bypass chamber376is provided for selectively bypassing the flow restriction350. The bypass chamber376defines a bypass channel378that fluidly communicates with the lumen344of the reservoir chamber342via an inlet orifice380and with the lumen348of the drip chamber346via an outlet orifice382.

By bypassing the flow restriction350using the bypass chamber376, a higher flow rate can be provided than that used during delivery of energy to a HAS to flush out the system100. Flushing the system100may be done before a treatment procedure to rid the system100of any air bubbles by filling the system100with fluid or during a treatment procedure to remove a blockage from the system100.

A bypass controller384can be provided that selectively opens one of the orifices380,382to allow fluid flow through the bypass channel378to flush the system100. As illustrated inFIG. 4F, the bypass controller384selectively opens that orifice380to allow fluid from the reservoir chamber to enter the bypass chamber376and pass through the open outlet orifice382and into the drip chamber346. The bypass controller384can comprise a spring-biased valve386having a valve stem388with a push button head390at one end and a closure element392spaced from the push button head390. The valve386is biased to a closed position, shown inFIG. 4E, in which the closure element392is seated against the orifice380and prevents fluid flow into the bypass channel378, by a spring394positioned between the closure element392and the channel352. The valve386can be moved to an open position, shown inFIG. 4F, in which the closure element392is spaced from the orifice380, permitting fluid flow into the bypass channel378, by depressing the push button head390. A sealing element396can be placed between the valve stem388and the exterior wall of the bypass chamber376to prevent fluid leakage.

In a variation of the embodiment ofFIGS. 4C and 4D, the channel352can comprise a capillary tube that utilizes capillary action to pass liquid through the channel352. The channel352comprising a capillary tube can be sized to provide an appropriate fixed and predetermined treatment flow rate with or without the need for the flow restrictor member360.

FIGS. 5-7Bdepict another embodiment of the system100, which can be similar in structure, use and function to any of the variations of the systems100ofFIGS. 1-4, except as further described herein. In the system100ofFIG. 5, the distal tip portion114of the shaft112of the sheath110comprises a number of radially expanded or expandable members115. The expandable members115preferably comprise strips of an appropriate metallic or polymeric material having a springlike bias toward a radially expanded configuration. When the expandable members115are in the expanded configuration (FIGS. 5-7A), the members115surround and are radially spaced from the emitting tip162of the optical fiber152(or other light delivery device). The tip162is preferably spaced proximally from the distal end of the expandable members115by a distance X of 2 mm to 20 mm. The fiber tip162can therefore remain disposed within the set of expandable members115during treatment, and the expandable members115can protect the hot fiber tip162from contact with the inner wall of the vein or other target HAS (and vice versa).

As can be seen fromFIGS. 6 and 7B, the members115are preferably retractable into the shaft112by drawing an inner tube assembly180proximally into a surrounding outer tube182. The outer tube182forces the members115radially inward as the inner tube assembly180is drawn into the lumen of the outer tube182. As depicted, the inner tube assembly180can comprise an inner tube184, and the expandable members115, which are preferably attached to the distal end of the inner tube184. The inner tube184receives the optical fiber152or other light delivery device within its inner lumen, in a manner similar to the lumen116of the shaft112shown inFIGS. 1-4. Preferably, the lumen of the inner tube184is sized to accommodate a space for liquid flow between the inner tube184and the fiber152, to facilitate optional delivery of liquid during treatment with the system100ofFIGS. 5-7B, as described above in connection with the embodiments ofFIGS. 1-4.

The system100ofFIGS. 5-7Bcan be used in a manner generally similar to the systems100ofFIGS. 1-4, except as follows. With the expandable members115in the retracted configuration as shown inFIG. 7B, the sheath110can be delivered over a guidewire (or otherwise) to the desired treatment location. Once the sheath110is in position, the guidewire can be withdrawn and the members115can be expanded by moving the outer and inner tubes182,184relative to each other such that the members115move distally beyond the end of the outer tube182. Free of the constraint of the outer tube182, the members115then self-expand to the expanded configuration shown inFIGS. 5-7A. The optical fiber152or other light delivery device can then be advanced through the hub120and down the shaft112and positioned so that the tip162is disposed within the members115, and spaced proximally by the distance X from the distal ends of the members115. As discussed above, the fiber152can include a mark (or a projection such as a flange, slidable collar or “donut”) appropriately spaced from the tip162to indicate proper positioning of the tip162relative to the expanded members115upon alignment of the mark with a reference point such as the proximal edge of the hub120.

Once the tip162is in position, the treatment can proceed as discussed elsewhere herein. After completion of the treatment, the members115can be retracted by drawing the inner tube assembly180into the outer tube182. The system100can then be withdrawn from the patient in the usual manner.

FIGS. 8A-8Bdepict the distal portion of an alternative embodiment of a sheath110for use with the system100. The sheath110ofFIG. 8includes an expandable collar190which is expandable via compression created by interaction of an outer tube192and an inner tube194. The tubes192,194are slidable relative to each other so that the collar190can be compressed (FIG. 8B) between the distal end of the outer tube192and a flange196fixed to the distal end of the inner tube194. The optical fiber152or other light delivery device can be received in an inner lumen of the inner tube194. Preferably, during use, the collar190is in the expanded configuration and the light emitting tip162of the fiber152is positioned close to (e.g., about 2 mm to 20 mm proximal of) a distal opening198of the inner tube194. The expanded collar190prevents contact between the hot fiber tip and the HAS wall during treatment. If desired, a liquid flow can be provided via the inner lumen of the inner tube194(around the fiber152) during application of light/laser energy, as discussed elsewhere herein. In various embodiments, the expandable collar190can comprise a fluid filled annular balloon, or an annular, solid member formed from a compliant and compressible polymer material, or the like.

FIGS. 9A-9Bdepict another embodiment of a sheath110which can be similar in structure, function and use to the sheath110ofFIGS. 8A-8B, except for the use of an expandable coil191in place of the expandable collar190. The coil191can alternatively comprise a preshaped memory coil which can be deployed by a technique other than the compression depicted inFIGS. 9A-9B, such as by retraction of an overlying sheath, or a coil formed from power-induced or resistive-heating-induced memory material such as Nitinol or compatible materials, to facilitate expansion of the coil to its “remembered” expanded configuration by passing an electrical current through the coil through electrical leads (not shown) connected thereto.

FIGS. 10A-10Bdepict another embodiment of a sheath110which can be similar in structure, function and use to the sheath110ofFIGS. 8A-8B, except that the expandable collar190is a balloon which is inflatable and deflatable via one or more inflation passages (not shown) disposed in the outer tube192. In this embodiment, the outer tube192and inner tube194are preferably not movable relative to each other. In another embodiment, the collar190is a mass of compliant, hydrophilic material (e.g. a sponge) that can be expanded by supplying a fluid to it from conduit(s) formed in the sheath110.

FIG. 11depicts another embodiment of the system100which can be similar in structure, function and use to the systems100shown inFIGS. 1-4, except as further discussed below. In this embodiment, the distal tip portion114of the sheath110contains one or more holes199in its sidewall. Where employed, the holes199communicate hot or boiling liquid outward to the HAS at location(s) along the length of the sheath tip114. The holes199can be arranged in one or more circumferential bands as depicted. The size of the holes199, the number of holes in each band, the number of bands, and the position of the bands relative to the distal end of the sheath tip114can be varied to control the length of the treatment zone. The holes199provide a pressure relief of the hot and/or boiling liquid inside the sheath110, to reduce the pressure and velocity of the fluid ejected through the opening174in the distal end of the tip portion114during treatment.

FIGS. 12A and 12Bdepict another embodiment of the system100, which can be similar in structure, function, and use to the systems100shown inFIGS. 1-3, except as further discussed below. In this embodiment, the distal tip portion114of the shaft112preferably has a generally constant inner and outer diameter and is transparent to, or otherwise highly transmissive of, the wavelength of light emitted via the fiber tip162. The fiber tip162includes a shaped surface200having at least one face or portion oriented non-perpendicularly to the longitudinal axis A of the optical fiber152. The shaped surface200can be configured in accordance with a desired light dispersion pattern. For example, angle refraction physics and/or other scientific principles governing light behavior can be employed to determine a desired configuration for the shaped surface200and, thereby, control the emission of light from the light delivery device150to the HAS walls, the sheath distal tip portion114, and/or delivered liquid.

In the illustrated embodiment, the shaped surface200has a generally conical configuration that terminates at a point coincident with the distal end of the optical fiber152. The fiber tip172with the conical shaped surface200provides for more radial dispersion of the light as compared to, for example, a blunt end fiber tip162, such as the fiber tip162shown inFIG. 3. In other words, more of the light is directed radially toward the adjacent HAS walls rather than axially into the lumen of the HAS located distally of the system100. Other configurations are within the scope of the present disclosure. For example, the angled surface200can have a generally conical configuration that terminates proximally of the most distal end of the optical fiber152such that the fiber tip162terminates at a blunt surface orthogonal to the longitudinal axis of the optical fiber152and having a transverse sectional area less than that of portion of the core156covered by the jacket160, which can sometimes be referred to as a frustoconical configuration. Other contemplated configurations include pyramidal, prismatic, and spherical surfaces.

Factors to consider when determining the configuration of the shaped surface200include the configuration and material of the distal tip portion114of the sheath110. In some variations of this embodiment, the shape and material of the distal tip portion114can affect the path of the light emitted from the fiber tip162. Conversely, the configuration and material of the distal tip portion114can be selected based on a predetermined configuration of the shaped surface200. The shape and material of the distal tip portion114shown inFIGS. 12A and 12Bare provided for illustrative purposes and are not intended to limit the present disclosure. The optical fiber152with the tip162having the shaped surface200can be utilized with any suitable sheath110, including any of the sheaths110in the embodiments ofFIGS. 1-11.

FIGS. 13-16depict other embodiments of the system100, which can be similar in structure, function, and use to the systems100shown inFIGS. 1-3, except as further discussed below. Each of the embodiments ofFIGS. 13-16can comprise a distally closed sheath110as depicted; differences between each of the embodiments ofFIGS. 13-16andFIGS. 1-3are described below.

In the embodiment ofFIG. 13, a plug210located at the open distal end172of the distal tip portion114effectively closes the distal end of the sheath110. The distal tip portion114is transparent to, or otherwise highly transmissive of, the wavelength(s) of light emitted via the fiber tip162, while the plug210is substantially not transmissive or substantially opaque to the wavelength(s) of light. Any suitable material or combination of materials can constitute the plug210, and one suitable material for the plug210is a metal.

The plug210includes a reflective body214extending proximally toward and aligned with the direction of light emission from the fiber tip162. The reflective body214reflects the light emitted from the fiber tip162and disperses the light radially outward toward the HAS walls. Additionally, the reflective body214effectively disperses or spreads the light beam, thereby decreasing the flux density of the light relative to that of the light as it exits the fiber tip162, which can contribute to minimizing blood boiling effects and coagulation problems, such as deep vein thrombosis. The reflective body214can be configured to reflect the light radially, radially and proximally, and/or radially and distally. In the illustrated embodiment, the reflective body214has a generally conical configuration, which provides 360-degree radial and radial/proximal reflection of the light from the fiber tip162. The shape of the reflective body214shown inFIG. 13is provided as an example; other configurations of the reflective body214are within the scope of the invention. Other examples of the reflective body214include, but are not limited to, pyramidal, prismatic, and spherical or hemispherical bodies. Further, the surface of the reflective body214can be treated, such as by polishing or coating, to provide a surface texture having a desired reflectivity.

In the illustrated embodiment, the plug210and the distal end172of the distal tip portion114both have a curved distal surface216,218that together form a rounded distal end of the sheath. The rounded configuration facilitates insertion of the system100into a guide sheath or into the HAS.

The system100ofFIG. 13can employ any suitable light delivery device and is not limited to the light delivery device with the optical fiber152having the blunt fiber tip162. For example, the system100can alternatively use the optical fiber152ofFIGS. 12A and 12Bhaving the fiber tip162with the shaped surface200, which can further contribute to dispersion of the light beam. Other optical fibers152described and not described in this application can be used with the system100ofFIG. 13.

In a variation of the embodiment of the system100ofFIG. 13, the sheath110can include one or more ports, such as a port formed in the distal tip portion114, for fluidly communicating the fluid delivery space178with the HAS lumen to render the system100suitable for fluid delivery into the HAS lumen. One or more such ports can additionally or alternatively be located in the plug210.

In another variation, the plug210or a portion thereof can be formed of a material at least partially transmissive of the wavelength of light emitted via the fiber tip162such that a portion of the light reflects from the reflective body214and a portion transmits through the plug210. For example, the reflective body214can be made opaque while the rest of the plug210can be made transmissive.

In yet another variation of the embodiment of the system100ofFIG. 13, one or both of the plug210and the distal tip portion114can be removable from the shaft112. Optionally, the plug210and/or the distal tip portion114can be modular or replaceable with other types of plug210and distal tip portion114. The removable and replaceable features of the distal tip portion114and structures associated therewith can be applied to any of the embodiments of the system100described in this application.

In the embodiment of the system100inFIG. 14A, the distal tip portion114of the sheath110comprises a cylindrical region220terminating at a rounded distal end222that distally closes the sheath110. The distal tip portion114is transparent to, or otherwise highly transmissive of, the wavelength(s) of light emitted via the fiber tip162, except that the rounded distal end222, or at least a portion of the rounded distal end222, includes a light absorbing body224arranged within the path of the light emitted from the fiber tip162. The light absorbing body224prevents or at least inhibits transmission of light therethrough, and the light absorbed by the body224heats the body224, which in turn heats the HAS walls in contact with (and/or nearby) the body224, as described in more detail below. The light absorbing body224can have any suitable form, such as a material deposited, coated, or otherwise attached to the rounded distal end222and can be located on a proximal and/or a distal surface of the rounded distal end222. In the illustrated embodiment, the light absorbing body224is provided on both the proximal and distal surfaces of the rounded distal end222. The material of the light absorbing body224is highly absorbent of the wavelength of light emitted via the fiber tip162such that the light heats the material. As a result of this configuration, light emitted from the fiber tip162can both be absorbed by the light absorbing body224and transmit through other areas of the distal tip portion114. The light absorbed by the light absorbing body224heats the light absorbing body224, which can thereby conductively heat the HAS walls in contact with the light absorbing body224(and/or otherwise heat the nearby HAS walls). The light transmitted through the distal tip portion114can heat the HAS walls via light energy transmission directly to the HAS walls.

The fiber152and the distal tip portion114can have any suitable relative size and positioning. As an example, a distance Y of the optical fiber152between the jacket160and the fiber tip162can be about 1-2 mm, the distance X between the fiber tip162and the most distal portion of the rounded distal end222can be about 3-5 mm, and a distance Z corresponding to the length of the distal tip portion114can be about 5-10 mm.

The system100ofFIG. 14Acan employ any suitable light delivery device and is not limited to the light delivery device with the optical fiber152having the blunt fiber tip162. For example, the system100can alternatively use the optical fiber152ofFIGS. 12A and 12Bhaving the fiber tip162with the shaped surface200. In such a variation, the light absorbing body224can be adapted according to the direction of light emission from the shaped surface200of the fiber tip162. For example, a portion of the light absorbing body224can be extended to the cylindrical region220of the distal tip portion114. Other optical fibers152described and not described in this application can be used with the system100ofFIG. 14A.

In a variation of the embodiment of the system100ofFIG. 14A, a light scattering material located in the space178between the optical fiber152and the distal tip portion114, as illustrated inFIG. 14B, can facilitate transmission of the light to the light absorbing body224and through the distal tip portion114. The light scattering material can be a liquid, a solid, or combination of a liquid and a solid. For example, the light scattering material can be a translucent liquid with a reflective solid particulate suspended in the liquid. For such a light scattering material, the liquid transmits the light for reflection by the solid particulate. The aggregate effect of the suspended particulate is to scatter the light incident on the scattering material from the fiber152. This can include scattering the light radially, radially and distally, or radially and proximally.

In another variation of the embodiment of the system100ofFIG. 14A, the light absorbing body224can be a body separate from and closing the distal tip portion114, similar to the manner in which the plug210closes the distal tip portion114in the embodiment ofFIG. 13. Further, the light absorbing body224and the rounded distal end222need not be rounded; other configurations, such as blunt and tapered, are within the scope of the invention.

In yet another variation of the embodiment of the system100ofFIG. 14A, the sheath110can include one or more ports, such as a port formed in a sidewall of the distal tip portion114, for fluidly communicating the fluid delivery space178with the HAS lumen. One or more ports can additionally or alternatively be located in the light absorbing body224.

In the embodiment of the system100inFIG. 15, the distal tip portion114of the sheath110comprises the cylindrical region220terminating at the rounded distal end222that distally closes the sheath110, similar to the sheath110in the embodiment of the device100shown inFIG. 14A. The distal tip portion114of the sheath110inFIG. 15, however, lacks the light absorbing body224ofFIG. 14A. Instead, the entire distal tip portion114can transmit the light emitted from the fiber tip162. The cylindrical region220and the rounded distal end222can be integrally formed, as illustrated, or formed of separate bodies joined in any suitable manner. In one variation, the rounded distal end222can be formed as a separate body removably coupled to the cylindrical region220.

The system100ofFIG. 15includes the light delivery device150having the shaped surface200at the fiber tip162shown in the embodiment ofFIGS. 12A and 12Band described above in detail. The system100ofFIG. 15, however, can employ any suitable light delivery device and is not limited to the light delivery device with the optical fiber152having the fiber tip162with the shaped surface200. For example, the system100can alternatively use the optical fiber152having the blunt fiber tip162. Other optical fibers152described and not described in this application can be used with the system100ofFIG. 15.

As described above for variations of the embodiment ofFIG. 14A, variations of the embodiment of the system100inFIG. 15can include other features, including a light scattering material in the space178between the optical fiber152and the distal tip portion114and/or one or more ports in the distal end or sidewall of the distal tip portion114. In another variation, the rounded distal end222can have a configuration other than rounded, as discussed below with respect to the embodiment of the system100inFIG. 16.

The embodiment of the system100inFIG. 16can be similar to the embodiment of the system100inFIG. 15, except that the distal end222has a generally conical configuration rather than a rounded configuration. The distal end222shown inFIG. 16comprises a tapered region230that terminates at a closed tip232. The tapered region230can be configured to transmit the light emitted from the fiber tip162in a desired pattern. For example, the tapered region230can be designed to refract the light distally and radially, completely radially, or proximally and radially. In the illustrated embodiment, the shape of the tapered region230effectively redirects the light emitted from the fiber tip162to provide more radial transmission of the light to the adjacent HAS walls, as indicated by the radially oriented arrows inFIG. 16, than would be present without the tapered region230. The tapered region230can have any suitable configuration, and, as one example and as illustrated, the tapered region230can be angled differently than the shaped surface200of the fiber tip162. As another example, the tapered region230can be angled at the same angle employed with the shaped surface200of the fiber tip162.

The system100ofFIG. 16includes one suitable manner of joining the distal tip portion114and the shaft112of the sheath110different from that shown in the previous embodiments. While the distal end portion114and the shaft112can be joined in any suitable manner, a heat shrinkable sleeve240joins the distal tip portion114and the shaft112of the system100illustrated inFIG. 16. An adhesive, such as an epoxy, can be employed independently or in combination with the sleeve240to facilitate joining the distal tip portion114and the shaft112.

The system100ofFIG. 16includes the light delivery device150having the shaped surface200at the fiber tip162shown in the embodiment ofFIGS. 12A and 12Band described above in detail. The system100ofFIG. 16, however, can employ any suitable light delivery device and is not limited to the light delivery device with the optical fiber152having the fiber tip162with the shaped surface200. For example, the system100can alternatively use the optical fiber152having the blunt fiber tip162. Other optical fibers152described and not described in this application can be used with the system100ofFIG. 16.

In a variation of the embodiment of the system100ofFIG. 16, the tip232of the tapered region230can be opened rather than closed. The opened tip232can facilitate delivery of fluid from the fluid delivery space178while still redirecting the light emitted from the fiber tip162and preventing contact of the fiber tip162with the HAS walls. As an alternative or addition, the distal tip portion114can include one or more fluid ports in the distal end or sidewall of the tip portion114, as described above with respect to other embodiments. In another variation of the system100ofFIG. 16, the system100can include a light scattering material in the space178between the optical fiber152and the distal tip portion114, as described above for the embodiment ofFIG. 14A.

FIGS. 17A-20Bdepict other embodiments of the light delivery device150, which can be similar in structure, function, and use to the light delivery devices150shown inFIGS. 1-16, except as further discussed below.

The light delivery device150ofFIGS. 17A and 17Bcan be similar to the light delivery device150in the embodiment ofFIGS. 12A and 12B, except that the light delivery device150ofFIGS. 17A and 17Bincludes a lumen250formed in the optical core156of the optical fiber152and terminating at a distal opening252at the fiber tip162. While the lumen250can have any suitable size and cross-sectional shape, in one example, the optical fiber152can have an outer diameter in a range of about 300-1000 μm, and the lumen250can have a circular cross-section with an inner diameter in a range of about 300-600 μm. Further, the fiber tip162of the light delivery device150can include any desired configuration for the shaped surface200and is not limited to the generally conical shape shown inFIGS. 17A and 17B. For example, the fiber tip162can be prismatic, rounded, etc., according to a desired light emission pattern. Alternatively, the fiber tip162can be blunt.

In one variation of the embodiment, the lumen250can be fluidly coupled to the sidearm122(FIG. 1) or other fluid source such that fluid supplied to the lumen250via the fluid source flows through the lumen250and exits the lumen250at the distal opening252for delivery to the HAS. Internal reflection of the light in the lumen250can heat the fluid as it flows through the lumen250.

In another variation of the light delivery device150ofFIGS. 17A and 17B, the internal surface of the optical core156forming the lumen250can be coated with a material to prevent internal reflection of the light in the lumen250. Such a coating can be beneficial when using the lumen250for fluid delivery if heating of the fluid is not desired.

The light delivery device150ofFIGS. 17A and 17Bcan be employed with any suitable sheath, including any of the sheaths110shown with respect to the embodiments ofFIGS. 1-16and other sheaths not illustrated or described in this application, and used in a manner generally similar to that described above for the system100ofFIGS. 1-3.

Embodiments of the light delivery device150illustrated inFIGS. 18-20Bcan be employed without a sheath to treat an HAS as described elsewhere herein. These embodiments are designed to prevent direct contact between the HAS walls and the fiber tip162. Each of these embodiments, particularly the differences between them and the embodiments of the light delivery devices150previously presented are described below.

The embodiment of the light delivery device150shown inFIG. 18can be similar to the light delivery device150of the embodiment inFIGS. 1-3, except that the light delivery device150ofFIG. 18includes a distal tip portion260extending from the jacket260to a distal end262projecting beyond the fiber tip162a predetermined distance. The distal tip portion260, similar to the distal tip portion114of the shaft112in previous embodiments, is transparent to, or otherwise highly transmissive of, the wavelength of light emitted via the fiber tip162. Extension of the distal end262beyond the fiber tip162prevents contact between the HAS walls and the fiber tip162. The distal end262can be blunt, as illustrated, or otherwise configured for a desired light emission pattern. The distal tip portion260can be coupled to the jacket160in any suitable manner, such as by a heat shrinkable sleeve264optionally combined with an adhesive, including epoxy adhesives.

The embodiment of the light delivery device150inFIG. 19provides an example of modifying the distal end262of the distal tip portion260. The light delivery device150ofFIG. 19can be otherwise similar to that ofFIG. 18. The distal end262shown inFIG. 19has a rounded configuration and includes an annular projection266extending radially inward distally of the fiber tip162. The projection266inhibits inadvertent distal movement of the optical core156and the cladding158relative to the jacket160and the distal tip portion260beyond the position shown inFIG. 19, and the rounded configuration facilitates smooth insertion of the light delivery device into the HAS. While the rounded configuration can provide such a benefit, it is within the scope of the present disclosure for the distal end262and/or the projection266to be shaped otherwise.

Referring now toFIGS. 20A and 20B, another embodiment of the light delivery device150comprises the optical fiber152having the optical core156, the cladding158, and the jacket160as described above for the other embodiments of the light delivery device150and further includes a distal body270enclosing a distal portion of the optical fiber152including at least the fiber tip162. In the illustrated embodiment, the distal body270encloses the portion of the optical core156not covered by the cladding158and the jacket160. In a variation, the cladding158can extend along the portion of the optical core156enclosed by the distal body270, except for the fiber tip162. The distal body270can assume any suitable shape and is shown by way of example as having a tubular configuration with a rounded distal end272.

The distal body270prevents direct contact between the fiber tip162and the HAS walls and can be transparent to, highly transmissive of, or absorbing of the wavelength of light emitted from the fiber tip162. In one variation, the distal body270can contain a material, such as a fluid, a solid, or a combination fluid and solid, that absorbs the wavelength of light emitted by the fiber tip162such that the light energy heats the distal body270. The heated distal body270conductively heats the HAS walls when in contact therewith. Alternatively or additionally, the heated distal body270can heat fluid in the HAS lumen, including fluid delivered by the system100. In another variation, the distal body270can contain a material, such as a fluid, a solid, or a combination fluid and solid, at least partially transmissive of the light emitted from the fiber tip162such that the light travels through the distal body270to the HAS walls, thereby heating the HAS walls via light energy transmission. Optionally, the material can include reflective/scattering particles to facilitate in the dispersion of light to the HAS walls.

As stated above, the light delivery devices150ofFIGS. 18-20Bcan be employed without a sheath. Each of these embodiments can include an element that precludes direct contact between the HAS walls and the fiber tip162. For the embodiments ofFIGS. 18 and 19, the projection of the distal end262beyond the fiber tip162inhibits contact between the HAS walls and the fiber tip162. In the embodiment ofFIGS. 20A and 20B, the distal body270provides a physical barrier between the HAS walls and the fiber tip162. The manner of using the light delivery devices150of these embodiments without a sheath is substantially the same as described above for the embodiments ofFIGS. 1-3, except that the process can be adapted slightly to accommodate the absence of the sheath. For example, a guide sheath can be inserted along the guide wire for purposes of introducing the light delivery device150and then withdrawn once the light delivery device150is situated in the HAS. Alternatively, the light delivery device150can be adapted for insertion along the guide wire such that a guide sheath or similar element is not needed. As still another alternative, the light delivery devices150ofFIGS. 18-20Bcan be employed to treat an HAS (such as a vein) as described elsewhere herein, but without use of a guidewire or a sheath.

Alternatively, the embodiments of the light delivery devices150inFIGS. 18-20Bcan be used with a sheath, including the sheaths110shown with respect to the embodiments ofFIGS. 1-16and other sheaths not illustrated or described in this application. In such a case, the systems100with the light delivery device150of any ofFIGS. 18-20Bcan be used in a manner generally similar to that described above for the system100ofFIGS. 1-3.

FIGS. 21A-28depict an alternative embodiment of the system100, which can be similar in structure, use and function to the systems100shown inFIGS. 1-4Aand11-16, except as further discussed below. For each of the embodiments ofFIGS. 21A-28, the system100is provided with a position limiter400which is configured to limit the position of the fiber tip162to a predetermined position suitable for emitting light from the optical fiber152, which can also be termed a firing position. The firing position can comprise a position proximal of the distal end172of the distal tip portion114. The position limiter400can be configured to assist the user in placing the fiber tip in the firing position by spacing the fiber tip162from the distal end172by the distance X of 2 mm to 20 mm, 2 mm to 10 mm, 2 mm to 8 mm, 2 mm to 5 mm, 2 mm to 4 mm, or 3 mm; or otherwise by a distance suitable to minimize, inhibit, or substantially prevent buildup of proteins, coagulum and/or carbonization on the fiber tip162. The spacing can also be suitable to minimize, inhibit, or substantially prevent perforation of the HAS being treated (including veins in particular). The position limiter400is advantageous when the optical fiber152is inserted into the sheath110after the sheath100has been positioned in a HAS because the position limiter400provides tactile feedback to a user who is not able to visually determine when the fiber tip162reaches the firing position and further prevents the fiber tip162from being advanced distally beyond the firing position and into the HAS.

The position limiter400can be located anywhere along the length of the optical fiber152or the introducer sheath110. It can be beneficial to place the position limiter nearer the fiber tip162or the distal tip portion114, respectively, than the proximal end of either. Thus the distance between the position limiter400and the fiber tip162is minimized, which facilitates manufacture by minimizing the dimension requiring control during assembly of the position limiter to the fiber. With a smaller distance between the position limiter400and the fiber tip162, that distance can be manufactured to a greater degree of precision and with less expense.

As illustrated, the position limiter400can comprise a stop configured to limit the relative movement of the optical fiber152within the lumen116when the fiber tip162is at the firing position or distance X. The stop can comprise cooperating structures on the optical fiber152and the sheath110that are configured to prevent the insertion or distal movement of the distal tip of the optical fiber152into the lumen116beyond the firing position. As illustrated, the cooperating structure on the optical fiber152can include a tube402or other protrusion at least partially surrounding the jacket160of the optical fiber152and having a fixed position relative to the fiber tip162. The cooperating structure on the sheath110can include a shoulder404formed in a portion of the shaft112by inserting a distal end of the shaft112into the distal tip portion114to create a narrowed portion of the lumen116which tapers in the distal direction toward the distal tip portion114. The outer diameter of the shaft112proximal of the shoulder404can be approximately equal to the outer diameter of the distal tip portion114, which can optionally be approximately 1.75 mm. The wall of the shaft112can optionally be approximately 0.005 mm thick.

In the embodiment ofFIGS. 21A and 21B, the tube402comprises an open-ended hollow cylinder having an annular sidewall405with a distal face406, a proximal face408, and a channel410extending between the distal and proximal faces406,408. The tube402is mounted to the optical fiber152with the optical fiber152extending through the channel410and the fiber tip162spaced a predetermined distance from the distal face406selected such that upon insertion of the optical fiber152into the lumen116, the distal face406will cooperate with the shoulder404to prevent movement of the fiber tip162beyond the predetermined firing position. The distal face406can optionally be located within 10-20 mm of the fiber tip162, or 12 mm from the fiber tip162.

In the embodiment ofFIGS. 22A-22C, the tube402comprises an open-ended hollow cylinder similar to the tube402ofFIGS. 21A and 21B, with the exception that the sidewall405comprises one or more recesses412formed adjacent the distal face406. The recesses412provide flow passages that permit the passage of liquid from a liquid source, for example, liquid source300(FIGS. 4A and 4B) distally past the junction of the cooperating structures402,404and into the fluid delivery space178. The size of the recesses412can be selected to provide a fixed and predetermined liquid flow rate so that the tube402(or the cooperating structures402,404) function(s) as a liquid flow regulator in addition to a position limiter or stop. In this case, the flow rate of fluid to the fluid delivery space178can be controlled without the need for or use of a flow regulator (FIGS. 4B-4F) upstream of the sheath112.

In the embodiment ofFIGS. 23A and 23B, the tube402comprises an open-ended hollow cylinder similar to the tube402ofFIGS. 21A and 21B, with the exception that the tube402is fabricated from a porous material providing pores416through the tube402through which the liquid can flow. The pore size can be selected to provide a fixed and predetermined liquid flow rate through the tube walls so that the porous tube402can function as both a liquid flow regulator and a position limiter or stop. In this case, the flow rate of fluid to the fluid delivery space178can be controlled without the use of or need for a flow regulator340(FIGS. 4B-4F) upstream of the sheath112. Suitable porous materials include ceramics and polymers such as UHMWPE, HDPE, LDPE, PP, PC, EVA, PVDF, and TPU. With this configuration, the fluid may enter the sidewall405or proximal face408and pass through the pores416to exit through the distal face406. This configuration does not require the discrete flow paths through or around the tube402as found in the embodiment ofFIGS. 22A-22C.

In the embodiment ofFIGS. 24A and 24B, the tube402is similar to the porous tube402ofFIGS. 23A and 23B, with the exception that the sidewall405comprises a distal conical section418tapering toward the distal face406and a proximal conical section420tapering toward the proximal face408. The taper of the distal conical section418can be generally complementary to the taper of the shoulder404, as illustrated, so that the distal conical section418will match the shoulder404when the fiber tip162is in the predetermined firing position. With this configuration, the fluid may enter the sidewall405, proximal face408, or proximal conical section420and pass through the pores416to exit through the distal face406. Alternately, if the taper of the distal conical section418is not complementary to the taper of the should404, fluid may also exit through the distal conical section418. Either configuration does not require the discrete flow paths through or around the tube402as found in the embodiment ofFIGS. 22A-22C. The tube402can optionally be approximately 5 mm long, with an outer diameter of 1.2 mm. The channel410can optionally have an inner diameter of 0.8 mm.

In the embodiment ofFIGS. 25A-25D, the tube402comprises an open-ended hollow cylinder similar to the tube402ofFIGS. 21A and 21B, with the exception that the tube402comprises two angled faces422cut through the distal face406and the sidewall405at an angle with respect to the longitudinal axis A of the optical fiber152. The angled faces422form two spaces424that permit the passage of liquid from a liquid source, for example, liquid source300(FIGS. 4A and 4B) between the angled faces422distally past the junction of the cooperating structures402,404and into the fluid delivery space178. The size of the spaces424can be selected to provide a fixed and predetermined flow rate so that the tube402(or the cooperating structures402,404) can function as both a liquid flow regulator and a position limiter or stop. In this case, the flow rate of fluid to the fluid delivery space178can be controlled without the need for or use of a flow regulator (FIGS. 4B-4F) upstream of the sheath110. The size of the spaces424can be selected by changing the angle of the angled faces422with respect to the longitudinal axis A. The tube402can optionally have an outer diameter of 1.2 mm and an inner diameter of 0.85 mm. The angled face422can optionally extend approximately 3 mm proximally from the distal face406and be formed at an angle of 30-45 degrees to the longitudinal axis A.

In the embodiment ofFIGS. 26A-26D, the tube402comprises an open-ended hollow cylinder similar to the tube402ofFIGS. 21A and 21B, with the exception that the distal face406formed at an angle with respect to the longitudinal axis A of the optical fiber152. The angled distal face406comprises a distal-most tip414that will cooperate with the shoulder404to prevent movement of the fiber tip162beyond the predetermined firing position. The angled distal face406recedes proximally from the distal-most tip414to provide a space between the angled distal face406and the shoulder404that permits the passage of liquid from a liquid source, for example, liquid source300(FIGS. 4A and 4B) into the fluid delivery space178. The tube402can optionally have an outer diameter of 1.2 mm and an inner diameter of 0.85 mm. The angled distal face406can optionally extend approximately 3 mm along the longitudinally axis A and be formed at an angle of 20-45 degrees to the longitudinal axis A.

While the embodiments ofFIGS. 21A-26Dillustrate various position limiters400comprising tubes402cooperating with a portion of the shaft112to limit the position of the fiber tip162, it is also understood that the distal tip portion114can be configured to cooperate with the tubes402ofFIGS. 21A-26Dto limit the position of the fiber tip162. In the embodiment ofFIG. 27, the cooperating structure on the optical fiber152comprises the open-ended tube402ofFIGS. 21A and 21B, although any of the tubes402shown herein could be used, and the cooperating structure on the sheath110comprises a shoulder426formed in the distal tip portion114that creates a narrowed portion of the lumen116which tapers in the distal direction toward the distal end172. The distal face406of the tube402will cooperate with the shoulder426to prevent movement of the fiber tip162beyond the predetermined firing position.

In the embodiment ofFIG. 28, the cooperating structure on the optical fiber152comprises the open-ended tube402ofFIGS. 21A and 21B, although any of the tubes402shown herein could be used, and the cooperating structure on the sheath100comprises a proximal face428of the distal tip portion114. The distal face406of the tube402will cooperate with the proximal face428of the distal tip portion114to prevent movement of the fiber tip162beyond the predetermined firing position.

Additional embodiments comprise methods of sterilization. Certain such methods can comprise sterilizing, either terminally or sub-terminally, any of the apparatus disclosed herein that are intended for insertion into (or other contact with) the patient or that are intended for use at or near the surgical field during treatment of a patient. Any suitable method of sterilization, whether presently known or later developed, can be employed.

Accordingly, certain methods comprise sterilizing, either terminally or sub-terminally, any of the embodiments of the system100or any of the components or subsystems thereof disclosed herein, including but not limited to any of the embodiments of the sheath110or light delivery device150disclosed herein. Any suitable method of sterilization, whether presently known or later developed, can be employed. For example, the method can comprise sterilizing any of the above-listed apparatus with an effective dose of a sterilant such as cyclodextrin (Cidex(™)), ethylene oxide (EtO), steam, hydrogen peroxide vapor, electron beam (E-beam), gamma irradiation, x-rays, or any combination of these sterilants.

The sterilization methods can be performed on the apparatus in question while the apparatus is partially or completely assembled (or partially or completely disassembled); thus, the methods can further comprise partially or completely assembling (or partially or completely disassembling) the apparatus before applying a dose of the selected sterilant(s). The sterilization methods can also optionally comprise applying one or more biological or chemical indicators to the apparatus before exposing the apparatus to the sterilant(s), and assessing mortality or reaction state of the indicator(s) after exposure. As a further option, the sterilization methods can involve monitoring relevant parameters in a sterilization chamber containing the apparatus, such as sterilant concentration, relative humidity, pressure, and/or apparatus temperature.

In view of the foregoing discussion of methods of sterilization, further embodiments comprise sterile apparatus. Sterile apparatus can comprise any of the apparatus disclosed herein that are intended for insertion into (or other contact with) the patient or that are intended for use at or near the surgical field during treatment of a patient. More specifically, any one or combination of the following can be provided as a sterile apparatus: any of the embodiments of the system100or any of the components or subsystems thereof disclosed herein, including but not limited to any of the embodiments of the sheath110or light delivery device150disclosed herein.