SYSTEMS AND METHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE
A catheter includes multiple primary leads to deliver energy for ligating a hollow anatomical structure. Each of the primary leads includes a resistive element located at the working end of the catheter. Separation is maintained between the leads such that each lead can individually receive power. The catheter can include a lumen to accommodate a guide wire or to allow fluid delivery. Energy is applied until the diameter of the hollow anatomical structure is reduced to the point where occlusion is achieved. In one embodiment, a balloon is inflated to place the resistive elements into apposition with a hollow anatomical structure and to occlude the structure before the application of energy. The inflated balloon impairs blood flow and facilitates the infusion of saline, or medication, to the hollow anatomical structure in order to reduce the occurrence of coagulation and to improve the heating of the structure by the catheter.
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This application is a continuation of copending U.S. application Ser. No. 13/300,725, filed on Nov. 21, 2011, entitled “SYSTEMS AND METHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE,” which is a continuation of U.S. application Ser. No. 13/151,950, filed on Jun. 2, 2011, now abandoned, entitled “SYSTEMS AND METHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE,” which is a continuation of U.S. application Ser. No. 12/206,649, filed on Sep. 8, 2008, now U.S. Pat. No. 7,955,369, entitled “SYSTEMS AND METHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE,” which is a continuation of U.S. application Ser. No. 11/236,316 filed on Sep. 27, 2005, now abandoned, entitled “SYSTEMS AND METHODS FOR TREATING A HOLLOW ANATOMICAL STRUCTURE,” which claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Application Nos. 60/613,415, filed on Sep. 27, 2004, entitled “RESISTIVE ELEMENT SYSTEM,” and 60/701,303, filed on Jul. 21, 2005, entitled “RESISTIVE ELEMENT SYSTEM,” all of which are hereby incorporated by reference in their entirety and are to be considered a part of this specification.
BACKGROUND OF THE INVENTION Field of the InventionThe invention relates generally to a method and apparatus for applying energy to constrict and/or shrink a hollow anatomical structure such as a vein, and more particularly, a method and apparatus to conduct electrical current and/or heat to the wall of the hollow anatomical structure.
SUMMARY OF THE INVENTIONIn one embodiment, a catheter comprises an elongate shaft and a resistive heating element located near the distal end of the elongate shaft. A temperature-sensing element is located in proximity to the resistive heating element, and may be centered along the length of the heating element, or offset from center. The resistive heating element may comprise a coil, and the coil may be of a constant pitch or of a varying pitch.
In one embodiment, a catheter comprises an elongate shaft and a resistive heating element located near the distal end of the elongate shaft. A sheath is slidably disposed on the shaft. The sheath and catheter are relatively moveable between a first configuration in which the sheath covers substantially all of the resistive heating element, and a second configuration in which the sheath covers less than substantially all of the resistive heating element. The resistive heating element may comprise a coil, and the coil may be of a constant pitch or of a varying pitch.
In another embodiment, a catheter system comprises an elongate shaft and an energy-emission element located near the distal end of the elongate shaft. The energy-emission element optionally includes a plurality of emission segments, and each of the segments is independently operable to emit energy into the surroundings of the energy-emission element. Optionally, the catheter system further comprises a power source drivingly connected to the emission segments. The power source is operable pursuant to a multiplexing algorithm to deliver power to, and operate, the emission segments in a multiplexed fashion. In one embodiment, the energy-emission element comprises a resistive element such as a resistive coil. In another embodiment, the energy-emission element comprises an RF emitter.
In another embodiment, a catheter system comprises an elongate shaft and an energy-emission element located distal of the elongate shaft. The energy-emission element has an effective axial length along which the energy-emission element emits energy. The effective axial length is adjustable.
In another embodiment, a catheter comprises an elongate shaft and an expandable shaft located on a distal portion of the elongate shaft. A number of heater elements are expandable by a balloon. The heater elements may have a wavy, sinusoidal or serpentine configuration.
The features of the system and method will now be described with reference to the drawings summarized above. The drawings, associated descriptions, and specific implementation are provided to illustrate embodiments of the invention and not to limit the scope of the invention.
In addition, methods and functions described herein are not limited to any particular sequence, and the acts or states relating thereto can be performed in other sequences that are appropriate. For example, described acts or states may be performed in an order other than that specifically disclosed, or multiple acts or states may be combined in a single act or state.
In one embodiment, an energy source 2 comprises an alternating current (AC) source, such as an RF generator. In other embodiments, the energy source 2 comprises a direct current (DC) power supply, such as, for example, a battery, a capacitor, or other energy source. The power source 2 may also incorporate a controller that, by use of a microprocessor, applies power using a temperature sensor (e.g. a thermocouple or a resistance temperature device) located in the working portion of the catheter 1. For example, the controller may heat the tissue of a hollow anatomical structure to a set temperature. In an alternate embodiment, the user selects a constant power output of the energy source 2. For example, the user may manually adjust the power output relative to the temperature display from the temperature sensor in the working portion of the catheter 1.
The distal section 4 in
In one embodiment, the resistive element 8 is made of resistive wire that generates heat when the energy source is connected and applied to the catheter. As shown in
The resistive element 8 illustrated in
In one embodiment, the resistive element 8 comprises a constant, closed-pitch coil. Alternatively, the resistive element may have a varying pitch and/or a varying inter-coil spacing. For example, a varying coil pitch and/or spacing may be advantageously used to vary the heat output over the axial length of the heating element. An axially (and/or radially) varying heat output from the resistive element is useful in providing a substantially uniform tissue and/or device temperature during treatment. For example, such a variation in coil pitch may be advantageous in situations involving fluid flow within the hollow anatomical structure. In such cases, the fluid tends to absorb heat output from the proximal portion of the resistive element to a greater degree than heat output from the distal portion. This can result in a reduction of the heat actually applied to the wall of the hollow anatomical structure adjacent to the proximal portion of the resistive element relative to the central and distal sections. As the fluid flows past the proximal section of the heating element, the fluid itself will be heated. The heated fluid then flows across the middle and distal sections of the resistive element 8, thereby increasing the temperature of treatment for these sections. One embodiment, intended to counteract this effect, comprises a close-pitch wind of the heating element in the proximal portion (implying a higher heat output in the proximal portion) while the middle and distal sections may have a comparatively more open-pitch wind (i.e., the inter-coil spacing increases in the distal direction). This configuration decreases the heat output along portions of the coil in order to compensate for the added heat from the proximal adjacent sections. That is, the variable coil pitch may be used to correct for higher temperatures of the middle sections of the resistive element in comparison with lower temperatures of the end sections of the resistive element. A thermally-insulating material (such a natural rubber, silicone, or an elastomer) may be used to shield the internal lumen from heating, or to selectively reduce external heat transfer from the resistive element.
In another embodiment, portions of the resistive element having a close-pitch wind are used to heat larger portions of an anatomical structure (e.g., portions having a larger diameter) while portions of the resistive element having an increased coil spacing are used to heat smaller portions of the anatomical structure (e.g., portions having a smaller diameter).
In other embodiments, the coil wind comprises more than one radially displaced layer. For example, as shown in
In one embodiment, the resistive element 8 comprises a bifilar wire coil, which is advantageous in processing as it can be wound as a single filament. A bifilar wire also maintains a constant distance between the two embedded wires, which can help to maintain accurate overall spacing in order to provide uniform heat distribution. In some embodiments, the wind of the bifilar wire coil may comprise a variable pitch, as discussed previously. The bifilar wire coil may also combine wire connections (i.e., connections between the multiple wires in the wire coil) at one end of the catheter, preferably the proximal end. For example, the distal end may comprise an electrical connection between the two wire ends in order to create a continuous loop. In alternative embodiments, the bifilar wire can comprise more than 2 wires.
In other embodiments of the invention, energy is applied separately to each wire of the bifilar wire coil. For example, applying energy separately to each wire may be used to vary and control the power and heat transferred from the device to the vessel. In one embodiment, a single coil is used for smaller hollow anatomical structures, while both coils are used with larger hollow anatomical structures.
In another embodiment, the resistive element 8 comprises multiple coils, which are sequentially placed axially on the catheter shaft represented by the resistive elements 21 through 28, as shown in
Alternatively the sequential resistive elements may be used in a power control mode that relies on manual energy control.
Alternatively, in one embodiment of the invention having multiple resistive elements, a temperature sensor is located on the most distal resistive element. For example, the most distal resistive element may be used for the initial treatment and the successive coil electrodes may use the same and/or a predetermined energy-time profile.
In one embodiment, a method of use of the resistive element system includes multiplexing through each of the resistive elements 21-28 shown in
Alternatively, at least one of the eight resistive elements is energized to treat the hollow anatomical structure until treatment is complete. Then, the next resistive element(s) apply a similar treatment time, and so on moving along the treatment zone. For the eight resistive elements illustrated in
In other embodiments of the invention, alternate treatment cycles may be used. For example, resistive elements 21 and 22 may concurrently treat the hollow anatomical structure for approximately 20 seconds. Then resistive elements 23 and 24 apply a similar treatment, and so forth through resistive elements 27 and 28 to complete the cycle.
In one embodiment, the catheter is placed in the hollow anatomical structure, and then the balloon 47 is inflated through the ports 49. Once the balloon is inflated, the fluid ports 50 clear the hollow anatomical structure of native fluid, such as blood, distal to the balloon 47, by injecting a displacing fluid, such as, for example, saline. In one embodiment, the displacing fluid is followed by another injection of a venoconstrictor, which reduces the hollow anatomical structure lumen size prior to treatment. By temporary reduction of the hollow anatomical structures size, the treatment time used for the resistive element 48 is reduced, thereby resulting in a more effective and safe treatment.
Expandable Resistive Element Devices:
Serpentine:
Another embodiment is shown in
The resistive element 32 is a serpentine component, which is placed circumferentially around the exterior of the balloon 31 and catheter shaft. In one embodiment, the serpentine component expands circumferentially as the silicone balloon expands. In one embodiment, the serpentine component 32 is made of NITINOL®. For example, the shape memory aspect of NITINOL® may be advantageously utilized to help the component remember its expanded or collapsed position. In other embodiments, other nickel based spring alloys, other spring alloys, 17-7 stainless steel, Carpenter 455 type stainless steel, beryllium copper, or other similar materials may also be used.
In an alternate embodiment, the serpentine component 32, is located within the wall of the balloon material or between two layers of the silicone balloon material. This embodiment results in the serpentine resistive element being more integral to the assembly.
A temperature sensor 33 is attached to the serpentine component for temperature control during application of the energy. In
This embodiment of
For improved viewing of the balloon during expansion, a contrast medium may be used for fluoroscopy or an ultrasonic contrast. For example, micro bubbles may be employed as part of the balloon fluid for expansion. This can be applicable to any expandable resistive element using a fluid filled balloon.
In one embodiment, the balloon is capable of displacing a substance, such as blood, from a treatment area. In another embodiment, the balloon is further capable of directing heat toward the wall of an anatomical structure by bringing at least a portion of the resistive element in proximity with, or in contact with, the wall. In yet other embodiments, the balloon is configured to collapse in response to the collapsing or narrowing of the anatomical structure and/or is configured to collapse manually.
In one embodiment, an indicator in the handle of the resistive element system shows the state of inflation of the balloon. For example, the indicator may comprise a substance or display that moves axially to show deflation of a balloon. For instance, the indicator may be coupled to the expandable member (e.g., the balloon), such that expansion of the expandable member causes corresponding changes (e.g., movement) of the indicator. In other embodiments, the out-flowing saline is employed in a pressure or level-gauge like configuration (e.g., a thermometer-like configuration) to indicate the state of inflation of the balloon.
Expandable Braid:
In one embodiment, the braid wire is sleeved in polyimide to isolate the wires from each other where they overlap. In other embodiments, other materials may be used, such as for example, TEFLON®, urethane, and the like. The braid component may be created using standard braiding technology. Alternatively, a single wire may be woven into the braid component. The method is relevant for the overall resistance or impedance of the device for the energy source.
The proximal and distal ends of the braid 36 component are captured in a two-part crimp sleeve, 39 and 41, in order to anchor the ends to the catheter tube, 40 and 37. The braid 36 in this embodiment is expanded by the use of the catheter stylet 37, which runs the internal axial length of the catheter, from the distal tip 41 to the proximal handle 5. The proximal end of the stylet passes through a Touhy Borst type fitting on the catheter handle 5 and in turn is a handle for stylet manipulation. In this case, pushing the stylet 37 distally collapses the braid (illustrated in the upper figure of
In the embodiment of the invention illustrated in
It should be noted that the typical silicone extrusion may expand axially and radially when inflated. This causes the balloon to become “S” shaped for a set axial length of tubing, thus causing the braid to have non-uniform tissue apposition with the hollow anatomical structure. To compensate for this issue, the extrusion 38 may be pre stretched axially just prior to anchoring on the catheter tubing to the stylet component 37. The stretched tube may then expand radially with little to no axial expansion, depending on the amount of pre-stretch done. The balloon may be used to occlude the vessel to impair blood flow and to remove blood from the braid portion of the catheter. This creates a static fluid volume and makes the heat treatment more efficient. Also, the balloon promotes braid apposition with the hollow anatomical structure. In other embodiments, the balloon is at least partially expanded and contracted through expansion and compression of the ends 51, 54.
In one embodiment, a temperature sensor 42 is attached to the braid wire along its axial length. The sensor 42 may be used for temperature control during the application of energy for the controller. Although the sensor 42 is shown attached near the proximal end of the braid wire, the sensor 42 may be located along other portions of the braid wire. In addition, more than one sensor may be used.
In another embodiment, the balloon is a separate device from the braid device. For example, the balloon device may fit within the lumen of the braid device, and the tips of both devices may connect and anchor to one another. For example, the anchor mechanism may include a set of male and female threads appropriately sized. Alternatively the device tips may be anchored together by use of axially aligned holes in both tips, through which a wire is placed and tied off. Alternatively, the tips may be designed with a spring ball detent to anchor the tips together. Alternatively, strong magnets of opposite polarity may be used to locate the tips and hold them together.
Expandable Loop:
Another embodiment, shown in
The loop 54 may comprise a resistive element similar to the element 4 of
Wavy Expandable Length:
Another embodiment is shown in
In one embodiment, the spline 73 is straightened by withdrawing it proximally into the tube 70. For example, the tube 70 may comprise an inner liner 72, which extends out of the tube end and is formed into an outer lip 71. In addition,
Expandable Floating Ribbon:
The device is designed to collapse by use of an outer sheath, which in
Alternatively, the device comprises a stylet wire similar to the braid device of
Each spline 52 is made of a resistive material as previously defined. Alternately, each spline 52 may have a resistive coil wire wrapped around it, as is previously described. A temperature sensor may also be attached to at least one spline for temperature controlled energy delivery.
In one embodiment, one long expandable section makes up the resistive element set 52. To support the length during treatment, a balloon is placed inside the spline set. For example, this balloon may use an internal lumen of the catheter (not shown) for inflation and deflation. Alternatively, as described for the braid device, the balloon may be a separate device inserted into the long expandable spline set.
As discussed earlier with respect to the fixed diameter resistive element, spline resistive elements, when individually wired for power, may be used in conjunction with a multiplexing process. Such an embodiment allows for the sequential or “cascading” heating of specific resistive element subsets of the spline set. This may involve energizing at least one spline for a specific dwell time and then cascading or moving to the next adjacent spline(s) until the end spline is reached. The cycle is then repeated until the complete treatment time is reached.
Super Elastic Expanding Ribbon:
In one embodiment, for tube 57 to rotate and move axially, it is connected to a torquable stylet wire (not shown). This stylet runs internal to the catheter shaft and is accessible at the catheter handle. In one embodiment, the handle also allows these movements and locks the stylet in position in order to hold the resistive element collapsed or expanded.
In another embodiment, the resistive element 55 is made of NITINOL®. Using the shape memory property when heated, the resistive element 55 returns to its pre-shaped expanded coil form upon heating. In this embodiment, one end of the coil 55 is tethered to the catheter, such as for example, the proximal end. The expanded coil may also “auto collapse” as the hollow anatomical structure shrinks and/or constricts during the treatment. In another embodiment, a sheath is used to retrieve the coil after treatment.
As previously described, one or more temperature sensors may be attached to at least one strip for temperature-controlled energy delivery. In addition, these strip resistive elements may be used in conjunction with the multiplexing process to heat specific subsets of the group of resistive elements.
In an alternative embodiment, a resistive heating device can be configured such that the resistive heating element also acts as a resistance temperature device (RTD). Certain metals exhibit predictably varying electrical resistance properties at varying temperatures. If this relationship is known for a given resistive heating element, a temperature of the element can be determined by measuring an electrical resistance across it. Such a system may advantageously eliminate the need for additional thermocouples or other temperature sensing devices, or it may provide an independent sensing of temperature as may be used for high-temperature limitation.
In some embodiments, it is desirable to provide a heating element configured to treat a relatively short length of an HAS at a single time. Such an embodiment can be progressively moved through the HAS in a series of discrete steps from a first position to a final position in order to treat a desired length of an HAS. The process of moving a heating element through an HAS in a series of discrete steps between treatment steps is referred to herein as “indexing.”
The general process can proceed by providing an elongate catheter with a short-length heating element at a distal portion thereof. The heating element and catheter can be inserted through an introducer sheath into a hollow anatomical structure such as a vein. The heating element is then advanced to a distal-most position, and power is applied. The heating element is allowed to ramp up to a desired temperature, and remains in place for a desired dwell time. Once the desired dwell time is reached, the element can be powered down, and the element can be indexed proximally to a second position, at which point at least one of the ramp up, dwell, power down, and indexing procedures can be repeated.
In some embodiments the heating element 73 is an electrically resistive heating element such as those described elsewhere herein. For example, the heating element 73 can comprise a single, bifilar or other electrically resistive wire 75, as shown in
In order to accurately index the heating element by a desired amount, it is desirable to provide a means for repeatedly moving the heating element proximally by a desired distance. In some cases, this desired distance is less than the overall length of the heating element in order to effectively double-treat regions that may receive less heat energy as a result of an uneven heating profile along the axial length of a heating element. It may also be desirable to double treat a portion of an initial and/or final treatment region in order to arrange for the indexing distances to correspond with catheter shaft markings or to arrange that after the full series of indexed treatments the final treatment region is in alignment with the end of the introducer sheath. In addition, it is desirable to have a means for preventing the heating element from being powered up while it is within the introducer sheath. Some examples of embodiments achieving these goals will now be described with reference to
In some embodiments, as illustrated for example in
Each of the embodiments in
An alternative embodiment comprising a slideable datum pointer is illustrated in
In use, if the stop-treatment marker 112 is pulled proximally out of the proximal end of the sheath, the user will know that the heating element is positioned within the introducer sheath. The user can then push the catheter distally until the stop-treatment marker is hidden within the hub of the introducer sheath.
In alternative embodiments, with reference to
Alternatively, the stop-treatment markers on the catheter shaft can be arranged such that the index step marks are actually shorter than a length of a heating element. This encourages intentional overlapping of indexed treatments. For example, for a heating element length of about 7 cm, the shaft markers can be arranged to indicate a 6.5 cm index step. This can create a substantially consistent ½ cm treatment overlap.
In use, the catheter of this embodiment is placed within an HAS at a desired treatment position for an initial treatment. When treatment is about to start the physician notes which catheter shaft color segment is adjacent to the introducer sheath hub. If the initial shaft marker segment is a first color (e.g. blue in the above example) then the index step for the second treatment is at the start of next blue mark on the catheter shaft. Thus, the physician can pull the catheter proximally for the full length of one white segment. If only a partial length of the visible segment initially extends out of the hub, then the physician can simply perform a partial-length index step after the initial treatment, as it is not believed to be detrimental to double-treat a short section of the HAS. Alternatively, the alternating shaft markers 113 and 114 as shown in
Another embodiment, illustrated in
In an alternative embodiment, illustrated for example in
Just prior to the initial treatment, as shown in
In an alternative embodiment,
In an alternative embodiment, illustrated for example in
In the embodiment of
In use, the catheter 74 of
By placing the temperature sensors in the coil, the indexed treatments may create an overlap of adjacent treatment sections. In alternative embodiments, the temperature sensors may be positioned at or closer to the proximal 164 and distal 162 extents of the heating element 163 in order to eliminate or reduce the amount of overlap in adjacent indexing positions.
Another alternative embodiment, illustrated for example in
The system of this embodiment generally operates by movement of the o-rings after a treated section has been completed. In certain embodiments, before moving the catheter, both o-rings 170 and 173 should be placed against the introducer hub 172 by sliding them on the catheter shaft. Next the more proximal o-ring 173 and the catheter shaft are moved in tandem proximally away from the distal O-ring and introducer hub (also in tandem) until its motion is arrested by the string or rod 171 or 172. This places the therapeutic element in a new adjacent section for treatment.
In certain embodiments, the o-ring adjacent the introducer hub can be held against the introducer sheath hub manually. Alternatively, the first o-ring may be configured to have an interference fit or mechanical luer lock fit in order to attach to the introducer sheath hub.
If the o-rings 178 and 179 shown in
Alternatively, the O-rings 170 and 173 can be shaped like a turkey wish bone. The side legs may fit around the catheter shaft in such a way that it can be easier to slide axially along the shaft than come off of it. An appropriate elastic type of material such as silicone, KRATON®, urethane, or the like can be used so that the component can be pushed onto the shaft and have an interference fit in order to help anchor the component in place until it is manually moved. As previously mentioned, the single short tab of the wishbone can be the extended tab with the hole 178 in it. The string or the sliding stop can use these holes as mentioned above.
Once the catheter is in position so that the heating element is at an initial treatment site, both markers 170 and 173, shown in
This illustrated linkage 191 is connected to an anchor component 192 which attaches to the introducer hub 172. The linkage 191 to anchor connection may also comprise a hinge. A grip component 193 is attached to the opposite end 194 of the linkage 190. This grip 193 is attached by a hinge connection 194 and is used to maneuver the catheter shaft 174. The linkage 195 may also have a spring or elastic component further linking the two arms 190 and 191 and can keep the device in a preferred position when not in use. Such a preferred position involves the grip component 193 being located adjacent to the anchor 192 and introducer hub 172.
In one embodiment, the grip 193 is a component which straddles the catheter shaft 174, and may be, for example, cylindrical. In one embodiment, the grip 193 is not a complete circle and comprises an open section configured to receive the catheter therein without the need for threading the catheter through the center of the grip 193. In certain embodiments, the hinged end 194 of the linkage arm 190 is attached to an extended set of tabs 195 at one end of the grip 193. The physician can effectively pinch the grip tabs 195 with the thumb and forefinger, which in turn captures the catheter shaft. The inner radial surface of the grip 193 can be, for example, a soft tacky type of silicone or KRATON.
As previously mentioned, the two linkage arms sets are each made of two rods of substantially equal length, such that all four arms are equal. Each pair is hinged together. The range of movement is preferably about 0 to about 180 degrees, although the device can be limited to narrower ranges as desired.
The grip component 205 may be attached by a hinge for each of the two arms. An alternative embodiment may include a complete cylindrical component that is threaded over the catheter shaft. As shown in
For ease of use of this mechanism, in certain embodiments, the apex of both linkage arms may have an additional component 208 that the thumb and finger can push against to make the device work.
In the embodiment of
An alternative embodiment of the index handle is illustrated in
Methods of using an indexing HAS treatment system will now be described. The methods described herein can employ any suitable device described above or otherwise known to the skilled artisan. For example, in one embodiment, an indexing method can comprise inserting a heating element with a length of about 5 to about 7 cm into a distal-most section of an HAS to be treated. Power can then be applied to the heating element for a desired length of time to treat the segment of the HAS adjacent to the heating element. After a desired dwell time, the power supply to the heating element can be reduced or shut off. With the power off (or substantially reduced), the heating element may be indexed proximally (i.e., the heating element can be moved proximally until the distal end of the heating element is adjacent to the proximal end of the segment of the HAS that was just treated).
An example of an index treatment includes treatment at a temperature between approximately 95° C. and approximately 110° C. for a dwell time of approximately 20 seconds or less. In a more preferred embodiment, the preferred index treatment is performed at approximately 95° C. for a dwell time of approximately 20 seconds. The ramp time to temperature may be approximately 10 seconds or less, with a preferred time of approximately 5 seconds or less. The intent is to reach and maintain the treatment temperature quickly in order to apply heat to the HAS in a local manner. Once a section is treated, the distal therapeutic portion of the catheter is moved to the adjacent section. In certain embodiments, the catheter has an overlap portion of approximately 1 cm or less to substantially reduce or eliminate the number of under-treated sections or gaps as mentioned earlier. This process is repeated until the treatment of the HAS is complete. Temperatures like 110° C. at a shorter dwell time are also possible, but the depth of treatment varies.
Except as further described herein, any of the catheters disclosed herein may, in some embodiments, be similar to any of the catheters described in U.S. Pat. No. 6,401,719, issued Jun. 11, 2002, titled METHOD OF LIGATING HOLLOW ANATOMICAL STRUCTURES; or in U.S. Pat. No. 6,179,832, issued Jan. 30, 2001, titled EXPANDABLE CATHETER HAVING TWO SETS OF ELECTRODES; or in U.S. patent application Ser. No. 11/222,069, filed Sep. 8, 2005, titled METHODS AND APPARATUS FOR TREATMENT OF HOLLOW ANATOMICAL STRUCTURES. In addition, any of the catheters disclosed herein may, in certain embodiments, be employed in practicing any of the methods disclosed in the above-mentioned U.S. Pat. No. 6,401,719 or 6,179,832, or the above-mentioned U.S. patent application Ser. No. 11/222,069 filed Sep. 8, 2005. The entirety of each of these patents and application is hereby incorporated by reference herein and made a part of this specification.
While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions.
Claims
1. (canceled)
2. An apparatus for treatment of a hollow anatomical structure (HAS), the apparatus comprising:
- a catheter sized for insertion into the HAS, the catheter including an elongate shaft having a proximal end, a distal end, and a working length adjacent the distal end; and
- a plurality of energy application devices positioned sequentially along a longitudinal axis of the catheter along the working length;
- wherein the energy application devices are configured to be energized sequentially, such that each energy application device is energized for a preset dwell time, and after the dwell time has elapsed a next one of the energy application devices is energized for the preset dwell time.
3. The apparatus of claim 2, wherein the dwell time is approximately 0.2 seconds.
4. The apparatus of claim 3, wherein each of the energy application devices is energized for a total of approximately 0.6 seconds during each cycle.
5. The apparatus of claim 2, wherein three of the energy application devices are energized at a time.
6. The apparatus of claim 5, wherein during a first treatment cycle a first one, a second one, and a third one of the energy application devices are energized, and during a second treatment cycle the second one, the third one, and a fourth one of the energy application devices are energized.
7. The apparatus of claim 6, wherein during a third treatment cycle the third one, the fourth one, and a fifth one of the energy application devices are energized.
8. The apparatus of claim 2, wherein the energy application devices comprise electrically resistive coils.
9. The apparatus of claim 8, further comprising at least one insulative outer sleeve encasing the resistive coils so as to prevent electrical contact and electrical conduction with tissue.
10. The apparatus of claim 2, further comprising at least one temperature sensor.
11. The apparatus of claim 10, further comprising a plurality of temperature sensors, each of the temperature sensors corresponding to one of the energy application devices, such that each of the energy application devices is individually temperature controlled.
12. The apparatus of claim 2, wherein the sequential energy application devices may be used in a power control mode that relies on manual energy control.
13. The apparatus of claim 2, further comprising a temperature sensor associated with a distal-most one of the energy application devices, wherein the distal-most one of the energy application devices is used for an initial treatment, and successive ones of the energy application devices use a same energy-time profile as the distal-most one of the energy application devices.
14. The apparatus of claim 2, wherein energizing each of the energy application devices comprises multiplexing through each of the energy application devices.
15. The apparatus of claim 2, wherein the dwell time spans a duration from a start of a treatment of an adjacent portion of the HAS until a completion of the treatment of the adjacent portion of the HAS.
16. A method for treating a hollow anatomical structure (HAS), the method comprising:
- inserting a catheter into the HAS, the catheter including an elongate shaft having a proximal end, a distal end, and a working length adjacent the distal end; and a plurality of energy application devices positioned sequentially along a longitudinal axis of the catheter along the working length;
- advancing the catheter through the HAS until the working length is located at a treatment site; and
- applying energy sequentially to the energy application devices, such that each energy application device is energized for a preset dwell time, and after the dwell time has elapsed a next one of the energy application devices is energized for the preset dwell time, thereby heating and constricting a lumen of the HAS at the treatment site.
17. The method of claim 16, wherein the dwell time is approximately 0.2 seconds.
18. The method of claim 17, wherein each of the energy application devices is energized for a total of approximately 0.6 seconds during each cycle.
19. The method of claim 16, wherein three of the energy application devices are energized at a time.
20. The method of claim 19, wherein during a first treatment cycle a first one, a second one, and a third one of the energy application devices are energized, and during a second treatment cycle the second one, the third one, and a fourth one of the energy application devices are energized.
21. The method of claim 20, wherein during a third treatment cycle the third one, the fourth one, and a fifth one of the energy application devices are energized.
22. The method of claim 16, wherein the energy application devices comprise electrically resistive coils.
23. The method of claim 22, wherein the energy application devices further comprise at least one insulative outer sleeve encasing the resistive coils so as to prevent electrical contact and electrical conduction with tissue.
24. The method of claim 16, wherein the energy application devices further comprise at least one temperature sensor.
25. The method of claim 24, wherein the energy application devices further comprise a plurality of temperature sensors, each of the temperature sensors corresponding to one of the energy application devices, such that each of the energy application devices is individually temperature controlled.
26. The method of claim 16, further comprising using the sequential energy application devices in a power control mode that relies on manual energy control.
27. The method of claim 16, further comprising a temperature sensor associated with a distal-most one of the energy application devices, wherein the distal-most one of the energy application devices is used for an initial treatment, and successive ones of the energy application devices use a same energy-time profile as the distal-most one of the energy application devices.
28. The method of claim 16, wherein energizing each of the energy application devices comprises multiplexing through each of the energy application devices.
29. The method of claim 16, wherein the dwell time spans a duration from a start of a treatment of an adjacent portion of the HAS until a completion of the treatment of the adjacent portion of the HAS.
Type: Application
Filed: Aug 26, 2013
Publication Date: Jun 19, 2014
Applicant: Covidien LP (Mansfield, MA)
Inventors: Russell Blake Thompson (Los Altos, CA), Arthur Wayne Zikorus (San Jose, CA), Fiona Maria Sander (Los Altos Hills, CA), Vijay Kumar Dhaka (Boston, MA), Brady David Esch (San Jose, CA)
Application Number: 14/010,108