APPARATUS AND METHODS FOR ACCESSING AND TREATING BODILY VESSELS AND CAVITIES

Abstract

Devices and methods for accessing and treating bodily vessels and cavities are disclosed. The devices can have everting balloon catheters that can deliver heating or cooling to biological vessels.

Claims

1. A thermal treatment system comprising: a radially outer catheter; a radially inner catheter slidably translatable inside the outer catheter; an everting balloon attached at a first end to the outer catheter and at a second end to the inner catheter; a heater; a first fluid media heated above 55 C., wherein the first fluid media is exposed to the heater and inside of the everting balloon; and a pump configured to pressurize the fluid media.

2. The system of claim 1, wherein the fluid media is heated above 80 C.

3. The system of claim 1, wherein the heater comprises an electrode.

4. The system of claim 3, wherein the electrode comprises a coil.

5. The system of claim 1, wherein at least part of the heater is attached to the inner catheter.

6. The system of claim 1, wherein at least part of the heater is located inside of the everting balloon.

7. The system of claim 1, wherein the heater is radially expandable.

8. The system of claim 7, wherein the heater is configured to radially bow outward when in a radially expanded configuration.

9. The system of claim 1, wherein the everting balloon has an everting balloon membrane, and wherein at least part of the heater is embedded in the everting balloon membrane.

10. The system of claim 1, further comprising a cooler, and a second fluid media, wherein the second fluid media is cooled below 10 C.

11. A thermal treatment device comprising: a radially outer catheter; a radially inner catheter slidably translatable inside the outer catheter; an everting balloon attached at a first end to the outer catheter and at a second end to the inner catheter; a cooler; a fluid media cooled below 10 C., wherein the fluid media is exposed to the heater and inside of the everting balloon; and a pump configured to pressurize the fluid media.

12. The system of claim 11, wherein the fluid media is cooled below 5 C.

13. The system of claim 11, wherein the fluid media is cooled below 0 C.

14. A method for thermal treatment of biological tissue comprising: positioning a device in a target site, wherein the device comprises an outer catheter, an inner catheter slidably translatable inside of the outer catheter, and an everting balloon, wherein a first end of the everting balloon is attached to the outer catheter, and wherein a second end of the everting balloon is attached to the inner catheter; delivering a media under pressure to the everting balloon; everting the everting balloon at the target site; and heating the media to or above 55 C.

15. The method of claim 14, wherein the heating comprises heating the media before the delivering the media.

16. The method of claim 14, wherein the heating comprises heating the media after the delivering the media.

17. The method of claim 16, wherein the heating comprises heating the media with an electrode inside of the everting balloon.

18. The method of claim 16, wherein the heating of the media is when the media is in the everting balloon.

19. The method of claim 14, further comprising dilating the target site.

20. The method of claim 19, wherein the dilating comprises expanding the everting balloon at the target site, and wherein the dilating comprises expanding an electrode in the balloon when the balloon is at the target site, and wherein the target site comprises a fallopian tube.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] FIG. 1 is a schematic drawing of a variation of the thermal delivery system.

[0045] FIGS. 2a and 2b are cross-sectional views of a variation for deploying the device in a target site.

[0046] FIGS. 3a and 3b are cross-sectional views of variations of the distal end of the device in an everted configuration.

[0047] FIGS. 4a and 4b are cross-sectional views of a variation of the distal end of the device in an everted configuration with the electrode in radially contracted and radially expanded configurations, respectively.

[0048] FIGS. 5a and 5b are cross-sectional views of a variation of the distal end of the device in an everted configuration with the electrode in radially contracted and radially expanded configurations, respectively.

[0049] FIGS. 6a through 6c are cross-sectional views of variations of the distal end of the device in an everted configuration.

DETAILED DESCRIPTION

[0050] FIG. 1 illustrates that an energy delivery system can have a media reservoir in fluid communication with a heater. The heater can be in fluid communication with a pump. The pump can be in fluid communication with a media pressure valve. The media pressure valve can be in fluid communication with the energy delivery device. The heater, pump, and media pressure valve can be placed in orders other than shown in FIG. 1 (e.g., the media reservoir can connect directly to the pump, the pump can then connect downstream directly to the heater, and then the heater can connect downstream to the media pressure valve). The media reservoir, heater, pump, media pressure valve, or combinations thereof can be combined into a single element (e.g., the reservoir can be a pressurized heater with an integrated pump and media pressure valve).

[0051] The media reservoir can hold media, such as a fluid (e.g., liquid and/or gas), gel, solids (e.g., solid diagnostic agent particles, such as radiopaque and/or echogenic particles), or combinations thereof. The media can be used to pressurize the balloon of the device. The media can be saline solution, glycerine, oil, gels, or combinations thereof.

[0052] The heater can be a storage tank heater, heat pump heater, or a tankless on-demand heater. The heater can be integrated into the device, such as an on-demand heater in the balloon or inner catheter (e.g., an electrode heater). The heater can heat the media from about 55 C. to about to about 100 C., more narrowly from about 50 C. to about 65 C., or from about 80 C. to about 100 C., for example the heater can heat the media, for example, to about 55 C., 80 C. or 100 C. The heater can heat the media above 55 C., 80 C., or 100 C. The system can be thermally insulated so the media temperature in the balloon can be substantially equal to the media temperature in the heater. The surface of the balloon membrane can be substantially equal to the media temperature. Tissue being treated can also be changed to substantially the same temperature as the media.

[0053] The heater can instead be a cooler, such as a known vapor-compression, evaporative (e.g., swamp) cooler, or thermoelectric refrigeration unit. For example, the heater can be a peltier junction that can heat and/or cool the media. The heater can be gas heater and the system can have a separate vapor-compression refrigeration unit. The cooler can cool the media from about 40 C. to about 20 C., more narrowly from about 10 C. to about 10 C., yet more narrowly from about 5 C. to about 5 C. The cooler can cool the media, for example, to about 40 C., 5 C., 0 C., or 5 C. The cooler can cool the media below 40 C., 5 C., 0 C., 5 C., or 10 C.

[0054] The media can be cycled between a heater and a cooler, for example delivering hot media to the balloon for a fixed time and then delivering cool media for a fixed time. The hot and cold cycling can be repeated (e.g., hot media for a fixed time, then cold media for a fixed time, then hot media again for a fixed time, then cold media again for a fixed time). The temperature of the media can be controlled by the operator, for example with a temperature control on a handle of the device.

[0055] The media pressure valve can be a gate, globe, ball, butterfly, diaphragm, check, needle, or relief valve. The valve can be integrated into the device. The valve and/or pump can be controlled to control pressure levels in the balloon.

[0056] The device can have an outer catheter, an inner catheter, an everting balloon having a balloon membrane, and an adapter. The distal end of the inner catheter can be attached to the proximal end of the radially inner portion of the balloon. The radially outer portion of the balloon can be attached to the distal end of the outer catheter. The inner catheter can be slidably translatable within the outer catheter. The proximal end of the outer catheter can be in fluid communication with the remainder of the system. The inner lumen or through-lumen of the inner catheter can be accessed through the adapter. The adapter can be a Tuohy-Borst adapter and/or Y-connector.

[0057] FIG. 2a illustrates that the distal end of the device can be positioned in a biological lumen at the proximal end of a target site having target tissue. The target tissue can partially or completely obstruct the biological lumen.

[0058] FIG. 2b illustrates that the pressurized media can flow, as shown by arrows, into the balloon, inflating the balloon membrane. For example, the media pressure valve can be opened and/or the pump can be turned on to pressurize the media, pushing the media into the balloon.

[0059] The inner catheter can translate distally, as shown by arrow. The inner catheter can be pushed distally and/or the media pressure can cause the balloon to evert and unroll (e.g., hydraulic propulsion), as shown by arrows. The unrolling of the balloon can extend the length of the balloon distal to the outer catheter. The pressured balloon membrane can expand or distend, as shown by arrows, the radially inner surface of the target tissue. The balloon membrane can be in contact with or adjacent to the surface of the target tissue. The pressure can be sufficient to close a possible radially inner lumen of the balloon. As shown in FIG. 3, the radially inner lumen of the lumen can be open and patent, for example, allowing easier passage of agents (e.g., fluid therapeutic or diagnostic agents) or instruments through the through lumen of the inner catheter and balloon. Force can be applied to push agents and instruments through the closed lumen of the balloon shown in FIG. 2b and into or distal to the target site.

[0060] The heated or cooled media can fill the balloon, heating and/or cooling the balloon membrane. The balloon membrane can then heat and/or cool the target tissue. The media can be heated and/or cooled by the heater and/or cooler in the remainder of the system outside of the device and/or by heating and/or cooling elements in the device.

[0061] FIG. 3a illustrates that the outer catheter can thermally insulate the media from affecting unintended areas of the patient's body, e.g., not at the target site. The balloon membrane can reduce thermal energy transfer to unintended areas of the patient's body by varying the balloon membrane insulation or thickness in the areas where greater insulation and protection is desired (e.g., at the proximal end of the balloon adjacent to the outer catheter). The membrane thickness can be tapered, as shown in FIG. 3a, or discretely stepped, as shown in FIG. 3b. The balloon membrane can be coated with insulating material in the areas of desired thermal protection. The thermal insulation and/or coating can be flexible and expandable enough to evert with the balloon membrane. The balloon outer diameter can be made with smaller diameter sections (i.e., waists) to provide less or no tissue contact in certain areas for thermal protection.

[0062] One or more thermometers, such as thermocouples, can be attached to the external surface of, embedded in, and/or attached to the internal surface of the balloon membrane. The thermometers can be used to determine the temperature of the surface of the target tissue. The thermometers can be located spread angularly and longitudinally about the balloon membrane. For example, the thermometers can be evenly spaced apart longitudinally along a length of the balloon membrane and angularly evenly spaced around the balloon membrane,

[0063] When the desired location or locations of the target tissue reach the desired temperatures for the desired amounts of time (the physician may wish to make the target tissue a particular temperature merely instantaneously or for an extended time period), the pump and/or valve be reversed and/or the pump can be turned off to reduce the media pressure in the balloon. The heater (e.g., heater external to the device and/or electrode or other heater internal to the device) and/or cooler can be turned off. The inner catheter can be proximally translated and retracted to frictionles sly invert the balloon into the outer catheter. The outer catheter can then be withdrawn from the target site.

[0064] The device can have one or more electrodes. The electrode can have a cylindrical (as shown) or rod shape. The electrode can be made from an expandable material (e.g., a mesh) that can evert with the balloon membrane. The electrode can be attached to the distal end of the inner catheter. An electric lead or wire (not shown) extending along the surface of or in the wall of the inner catheter can deliver power to the electrode. The electrode can be powered by an electrical power source in the system inside or outside of the device.

[0065] When the balloon is in an everted configuration, the electrode can be positioned along all or part of the length of the balloon. The electrode can extend past the distal end of the balloon or be longitudinally coincidental or, as shown in FIG. 3a, terminate longitudinally proximal to the terminal distal end of the balloon.

[0066] When the balloon is everted and positioned in contact or adjacent to the target tissue, the electrode can be activated by an electrical power source or generator in the system. The electrode can then provide RF, microwave, or direct current heating to the media. In RF and microwave applications, for example, the thermal energy can also travel beyond the media and into tissue. Bipolar and monopolar energy can be employed, for example, with the electrode in or attached to the inner catheter. RF and microwave energy, for example, can traverse layers of tissue to provide direct heating and thermal treatment deeper than the surface of the target tissue. Different wave forms can be used during a single treatment.

[0067] The inner catheter can have or be attached to a laser that can deliver laser energy through the balloon membrane to the target tissue. The laser can deliver collimated laser light through the inner catheter at various angles for optimal tissue effect. The media can have chromophores. The laser can heat the media, for example by being directed into the media that has chromophores.

[0068] FIG. 3b illustrates that the electrode can be in the wall of or attached to the surface of the inner catheter, and not longitudinally extend past the distal terminal end of the inner catheter. The inner catheter can longitudinally extend past the distal terminal end of the outer catheter. The electrode can be located in the through-lumen of the inner catheter and/or balloon.

[0069] FIG. 4a illustrates that the electrode can be radially expandable and in a radially contracted, unexpanded, unbiased, or relaxed configuration. The electrode can change shape after the balloon is everted.

[0070] The electrode can be attached to and extend distally from the distal end of the inner catheter. The electrode can extend into the volume of the balloon. The balloon can be inflated sufficiently to distend the target tissue. One or more pull lines (obscured in FIG. 4a by the electrode) or a pull cylinder or tube can be attached to the distal end of the electrode and extend proximally to a control mechanism in or proximal to the inner catheter.

[0071] FIG. 4b illustrates that the pull lines can be proximally pulled or retracted, as shown by arrows. The retraction force exerted on the distal end of the electrode by the pull lines can bow out or radially expand, as shown by arrows, the electrode. A length or area of the electrode can contact or be adjacent to the radially inner surface of the balloon membrane.

[0072] Instead or in combination with the pull lines, the electrode can be made from a shape memory alloy. When electrical energy is delivered to the electrode, the electrode can heat and change to a heated shape. The electrode can also be heated by the body heat of the patient to attain the heated shape. The heated shape can bow out or radially expand as shown in FIG. 4b. When the electrode returns to the original temperature, for example after the electrical energy is no longer delivered to the electrode, the electrode can return to the radially unexpanded configuration.

[0073] Instead or in combination with the pull lines and shape memory alloy, the electrode can be made from helical coils that unwind for expansion or members that expand when compressed and retract under tension. For example, the electrode can be a helical coil spring. The electrode can be unwound to bow or radially expand. The electrode can be rewound to radially contract.

[0074] When the electrode is in the radially expanded configuration, electrical energy can be delivered to the electrode as described above to heat the media and/or the target tissue.

[0075] The radially expanding electrode can deliver a radially outward force to the balloon membrane and the target tissue. For example, the radially expanding electrode can push the balloon membrane radially outward to dilate the biological lumen (e.g., an obstructed blood vessel) in which the device is located.

[0076] The electrode can have multiple members. The multiple members can be configured to deliver bipolar RF energy with alternative members being connected to the electrosurgical generator as positive or negative for the delivery of energy.

[0077] Once the vessel is dilated, the tissue wall can become stretched or more uniform before delivery of thermal energy. The device can be used to dilate and deliver thermal energy to the walls of the esophagus, GI tract, urethra, other bodily vessels and cavities, and combinations thereof.

[0078] FIG. 5a illustrates that the radially expandable electrode can be attached to the radially outside surface of the inner catheter. The distal terminal end of the radially expandable electrode can be equal or proximal to the longitudinal location of the distal terminal end of the inner catheter.

[0079] FIG. 5b illustrates that the inner catheter can have two parts longitudinally slidable with respect to each other. A first part of the inner catheter can be attached to the distal end of the electrode. A second part of the inner catheter can be attached to the proximal end of the electrode. The first part of the inner catheter can be longitudinally retracted, as shown by arrow, while the second part of the inner catheter is held in a longitudinally constant position with respect to the remainder of the device. The retraction of the distal part of the inner catheter radially expandable electrode can bow out or radially expand, as shown by arrows, the electrode. The retraction of the inner catheter can be used to radially expand the catheter in combination with any of the other methods described herein.

[0080] FIG. 6a illustrates that the electrode can be attached to the radially inner surface of the everted balloon membrane. FIG. 6b illustrates that the electrode can be attached to the radially outer surface of the everted balloon membrane. FIG. 6c illustrates the electrode is embedded in the balloon membrane.

[0081] The balloon membrane can have an integrated electrically conductive material. For example, a conductive (e.g., metal) plating or wire can be attached to the surface to the balloon membrane. Also for example, the balloon membrane can be painted or coated with a conductive material, and/or internally embedded wiring or plating can be embedded into the balloon membrane to act as the electrode.

[0082] The electrode can be connected to a generator to provide direct heating, RF, or microwave energy. The electrode can be configured to be deliver energy in only certain areas or sections of the balloon membrane, for example at controllable longitudinal locations along the balloon and angular locations around the balloon.

[0083] All or part of the everting balloon itself can become the electrode, for example if the balloon membrane contains appropriate conductive media. The electrode, for example, when the balloon membrane acts as the electrode, can deliver uniform heat throughout the entire radially internal surface of the target tissue of a vessel or cavity, for example with varying morphology or curvature. This can provide an electrode that fits the available space and is formed in place inside the vessel or cavity with the media pressure.

[0084] The pressure of the media can be increased during use to further inflate the balloon, increasing the balloon outer diameter. The distension pressure (i.e., media pressure) can be increased to increase the rigidity of the balloon and decrease the flexibility of the balloon. The distension pressure can be reduced to decrease the rigidity and increase the flexibility of the balloon. For example, before repositioning the balloon in the target site, the media pressure can be reduced. After repositioning the balloon, the media pressure can be increased.

[0085] The balloon electrode can be configured as a monopolar electrode with a return pad attached to the patient. As a bipolar electrode, the return electrode can be placed on the outer catheter near the distal end of the outer catheter.

[0086] The term thermal energy and thermal treatment are used herein to refer to the application of heat and/or cold.

[0087] It is apparent to one skilled in the art that various changes and modifications can be made to this disclosure, and equivalents employed, without departing from the spirit and scope of the invention. Elements of systems, devices and methods shown with any embodiment are exemplary for the specific embodiment and can be used in combination or otherwise on other embodiments within this disclosure. Furthermore, unless specified otherwise, the elements of methods described can be performed in various orders, not just the disclosed order.