DIRECT VISION CRYOSURGICAL PROBE AND METHODS OF USE
A direct vision cryosurgical and methods of use are described herein where the device may generally comprise an elongated rigid structure with a distal end, a proximal end, and a central lumen. The distal end may comprise a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen. The distal end may also house at least one imaging device configured for distal imaging. A proximal end of the device may comprise a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes.
This application claims priority to U.S. Prov. Pat. App. 61/858,104 filed Jul. 24, 2013, which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTIONThe present invention relates to cryosurgical probes and their methods of use. More particularly, the present invention relates to cryosurgical probes which are configured to be advanced into a body lumen while providing for direct visualization.
BACKGROUND OF THE INVENTIONAccessing and treating regions within a body lumen such as the nasal cavities are often performed by utilizing a probe which is cooled via a chilled fluid, a cryo-fluid such as Nitrous Oxide, or through some other cooling mechanism. The cooled tip can be placed into contact against the tissue region to be treated. However, proper positioning of the cooling probe relative to the tissue may be difficult to achieve due to a number of factors such as limited space, lack of visual contact, anatomical obstructions, etc.
Accordingly, devices and methods which can overcome such obstacles to effectively treat tissue regions in body lumens through cryo-therapy are needed.
SUMMARY OF THE INVENTIONIt is an object of this invention to provide a surgical system for image guided cryo-ablation of a discrete anatomical structure within a mammalian body, through a surgically created or natural body orifice, for the purpose of diagnosing or treating disease or injury.
In accordance with one aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the needle tip is configured for advancement towards a surgical target through a facial boundary between two or more discrete anatomical structures in a substantially atraumatic manner, and the imaging device is used to guide the advancement of the needle tip.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and further comprising an inflatable structure proximal to the needle tip; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryosurgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, and a means for inflating the inflatable structure, whereby the needle tip is configured for advancement towards a surgical target through a facial boundary between two or more discrete anatomical structures in a substantially atraumatic manner, and the imaging device is used to guide the advancement of the needle tip, and the inflatable structure is configured to further separate the anatomical structure(s) as the needle tip is advanced.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the objective lens, a CMOS imaging sensor, and at least one light emitting diode configured for tissue illumination.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the imaging device is an endoscope comprising an objective lens, a coherent fiber optic bundle configured for imaging, and a second optical bundle configured for illumination.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the imaging device is an endoscope comprising an objective lens, and at least one relay lens configured for tissue imaging, and a fiber optic bundle configured for tissue illumination.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the minor dimension of the lateral fenestration approximates the working diameter of the central lumen.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-surgical probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the lateral fenestration is substantially perpendicular to the axis of the central lumen.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is a clear ionic liquid.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for delivering or removing fluid to/from the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is pressurized to facilitated dissection and distal advancement.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for delivering or removing fluid from the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is an evaporated liquid refrigerant that is introduced to the distal region by the cryosurgical probe during distal tissue freezing.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging, and at least one cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for delivering or removing fluid to/from the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the fluid is comprises an anesthetic.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing by means of direct application of liquid refrigerant to the target distal tissue.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing comprising a distal refrigerant evaporation chamber in direct contact with the target distal tissue, with the evaporation chamber comprising a hollow metallic structure.
In accordance with another aspect of this invention is a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, whereby the handle, central lumen, and lateral fenestration are configured to receive a surgical probe for surgical access to distal tissue, wherein the surgical probe may be a cryosurgical probe configured for distal tissue freezing comprising a distal refrigerant evaporation chamber in direct contact with the target distal tissue, with the evaporation chamber comprising an inflatable balloon.
In accordance with another aspect of this invention is a method for accessing a distal region in a mammalian body through a natural dissection plane in order to perform at least one diagnostic or therapeutic cryosurgical step comprising inserting into the body a surgical device comprising an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, and housing at least one imaging device configured for distal imaging, and housing at least one removable cryosurgical probe configured for distal tissue freezing; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s); then advancing the surgical device in the direction of the distal region while maneuvering the distal tip between the facial boundaries of intervening anatomical structures using images from the imaging device(s) and imaging display(s) to guide the maneuvering.
In accordance with another aspect of this invention is a method for accessing a distal region in a mammalian body through a natural dissection plane in order to perform at least one diagnostic fenestration in communication with the central lumen, and housing at least one imaging device configured for distal imaging, and further comprising an inflatable structure proximal to the needle tip; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes, and a means for inflating the inflatable structure; then advancing the surgical device in the direction of the distal region while maneuvering the distal tip between the facial boundaries of intervening anatomical structures using images from the imaging device(s) and imaging display(s) to guide the maneuvering, and inflating the inflatable structure as needed to facilitate distal advancement.
In accordance with an alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas.
An alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas.
In accordance with one aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby, the imaging device is configured for lateral imaging.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby, the imaging device comprises at least one coherent optical fiber bundle, configured for transmitting an image from within the inflatable balloon to a camera in the vicinity of the proximal end.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby, the imaging device comprises a probe with a distal end and a proximal end configured for removable insertion into the inflatable balloon through a central lumen, with the distal end comprising an imaging means, and the proximal end comprising a means for connecting the probe to an image display.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising a substantially rigid elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby the cryosurgical probe is configured for insertion into the targeted surgical site.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising a substantially flexible elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby the cryosurgical probe is configured for insertion into the targeted surgical site by means of a tortuous insertion pathway.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas, whereby the predetermined pressure is maintained by a pressure relief valve in line between the interior of the balloon and the ambient atmosphere, wherein the cryosurgical probe is configured for lateral tissue freezing by means of spraying a liquid refrigerant at an interior radial segment of the balloon from a central lumen cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas, whereby the outer balloon is fabricated from a substantially non-elastic material, and the inner balloons are fabricated from a substantially elastic material.
In accordance with another aspect of the alternative embodiment of this invention is a cryosurgical probe comprising an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one removably insertable optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas, whereby the inner balloons are configured to conform to the inner surface of the outer balloon when pressurized with refrigerant.
It is further an object of this invention to provide a method for performing a cryosurgical procedure comprising inserting a cryosurgical probe into the body of a patient, and then advancing the distal end of the probe into the vicinity of the surgical target, with the cryosurgical probe comprising: an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical probe at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the balloon with a liquid or a gas; then inflating the balloon and imaging the anatomy surrounding the balloon, then determining whether the cryosurgical probe is in a correct position for cryosurgical ablation based at least in part on the imaging, then, if the determination is that the cryosurgical probe is in a correct position then proceeding with the cryosurgical ablation, and alternatively, if the determination is that the cryosurgical probe is not in the correct position, then repositioning the cryosurgical probe until the cryosurgical probe is in a correct position, as determined at least in part by the imaging, whereby determining correct position may comprise determining the position of a lateral tissue freezing zone of the cryosurgical probe in relation to the adjacent anatomy.
An additional object of this invention is a method for cryosurgical ablation of the function of a nerve comprising inserting a cryosurgical probe between the target nerve and the artery and vein associated with the nerve; with the cryosurgical probe having an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas; then inflating the outer balloon to create distance between the nerve and the vein and artery; then using the imaging device, position the inner cryo balloon proximate to the nerve, and the inner insulation balloon proximate to the vein and artery; then introducing liquid refrigerant into the cryo balloon causing inflation of the inner cryo balloon and the inner insulation balloon; then maintaining the flow of refrigerant for a period of time sufficient for affecting the nerve function in the desired manner, whereby, the vein and artery remain unaffected by cold due to the separation between the target nerve end the vein and artery, and the thermal insulating effect of the inner thermal insulation balloon.
The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modifications of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.
Claims
1. A cryosurgical apparatus, comprising:
- an elongated rigid structure having a distal end, a proximal end, and a lumen defined through the structure;
- a non-coring optically transparent tip located at the distal end, wherein the tip presents a curved distal surface which curves to a side of the tip and terminates in at least one opening defined along a side relative to the structure such that the at least one opening is in communication with the lumen;
- at least one imaging device positioned proximal or adjacent to the tip and angled to image through the tip and along a region coincident with the at least one opening; and,
- a cryo-ablation probe positioned through the lumen with a distal probe tip in proximity to the at least one opening.
2. The apparatus of claim 1 further comprising a lateral tissue thermal protection barrier located in apposition to the cryo-ablation probe.
3. The apparatus of claim 1 wherein the tip is configured for blunt atraumatic dissection between tissue fascia.
4. The apparatus of claim 3 wherein a distal edge of the at least one opening defines a radius which is configured to smooth the curved distal surface and the at least one opening.
5. The apparatus of claim 1 wherein the tip comprises a polycarbonate or glass material.
6. The apparatus of claim 1 wherein the at least one imaging device comprises a CMOS camera or fiberscope.
7. The apparatus of claim 1 wherein the cryo-ablation probe comprises a lumen configured to spray a liquid refrigerant through a tip of the probe.
8. The apparatus of claim 1 wherein the cryo-ablation probe comprises an inflatable balloon member configured to inflate upon introduction of a liquid refrigerant into an interior of balloon.
9. The apparatus of claim 1 wherein the cryo-ablation probe comprises an enclosed probe member.
10. A cryosurgical apparatus, comprising:
- an elongated structure having a distal end, a proximal end, and a lumen defined through the structure;
- an outer balloon positioned near or at the distal end, wherein the outer balloon is comprised of an optically transparent material;
- at least one imaging device adjustably positioned within the outer balloon; and
- at least one cryogenic probe positioned within the lumen such that one or more openings defined along the cryogenic probe are directed to a treatment region defined along an inner surface of the outer balloon; and
- at least one inner balloon positioned within the outer balloon such that inflation of the inner balloon expands the inner balloon into conformance against the inner surface of the outer balloon at a location opposite to the treatment region to thermally insulate areas adjacent to the treatment region.
11. The apparatus of claim 10 further comprising a relief valve in fluid communication with the lumen, wherein the relief valve is configured to open at a predetermined pressure.
12. The apparatus of claim 10 wherein the outer balloon is configured to have a burst strength of between 4 and 12 atmospheres of pressure and at a cryogenic temperature between 0° and −100° C.
13. The apparatus of claim 10 further comprising an inner cryo balloon positioned within the outer balloon and enclosing the at least one cryogenic probe.
14. The apparatus of claim 13 wherein the inner cryo balloon is configured to expand into conformance against the inner surface of the outer balloon.
15. The apparatus of claim 10 wherein the outer balloon is inflatable via a liquid refrigerate.
16. The apparatus of claim 10 wherein the outer balloon is inflatable to have an outer diameter between 6 mm and 20 mm or more.
17. The apparatus of claim 16 wherein the outer balloon has a length between 1 cm and 6 cm or more.
18. The apparatus of claim 10 wherein the at least one imaging device is removably insertable within the outer balloon.
19. The apparatus of claim 10 wherein the one or more openings are defined in a linear array along the cryogenic probe.
20. The apparatus of claim 19 wherein the one or more openings each have a diameter of between 50 and 150 microns.
21. The apparatus of claim 19 wherein the one or more openings number between 1 and 20 or more.
22. A method for cryosurgical ablation of an anatomical structure in the body of a patient comprising the steps of:
- a. inserting a cryosurgical apparatus into the body of the patient, with said cryosurgical apparatus comprising an elongated structure with a distal end, a proximal end, a means for lateral tissue freezing disposed in the vicinity of the distal end, a means for lateral tissue thermal protection disposed in the vicinity of the distal end in diametric opposition to said lateral freezing means, an imaging device mounted in the vicinity of the distal end configured for distal imaging, a means for connecting the lateral freezing means to a source of cryogenic fluid, and a means for connecting the imaging device to an imaging console disposed in the vicinity of the proximal end;
- b. advancing said distal end into close proximity of the target anatomical structure;
- c. imaging distal tissue with said imaging device, and using said imaging to orient the lateral freezing means adjacent to the target anatomical structure;
- d. freezing the anatomical structure with said lateral freezing means,
- whereby said lateral tissue thermal protection means prevents cryogenic injury to tissue adjacent to the target anatomical structure.
23. The method of claim 22 wherein the target anatomical structure is a nerve associated with chronic pain, and said adjacent tissue comprises blood vessels associated with said nerve.
24. The method of claim 22 wherein the target anatomical structure comprises a facial boundary separating one or more anatomical structures.
25. The method of claim 22 wherein the cryosurgical apparatus comprises an elongated rigid structure with a distal end, a proximal end, and a central lumen; with said distal end comprising a non-coring optically transparent needle tip with at least one lateral fenestration in communication with the central lumen, housing at least one imaging device configured for distal imaging; said proximal end comprising a handle with a means for connecting the imaging device(s) to an imaging display(s), and a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s) for diagnostic or therapeutic purposes.
26. The method of claim 25 wherein tissue diametrically opposed to the lateral fenestration is thermally protected from cryogenic injury due to the distance created between the target tissue and the opposing tissue by the intervening apparatus.
27. The method of claim 22 wherein the cryosurgical apparatus comprises an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an inflatable balloon structure configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device; with said proximal end comprising a means for introducing a liquid refrigerant into the distal balloon through a central lumen, a means of removing evaporated refrigerant from the cryosurgical apparatus at a predetermined pressure, a means for connecting the optical imaging device(s) to an imaging display, a means for inflating the balloon with a liquid or a gas, and a means spraying liquid refrigerant at a lateral interior portion of the balloon for the purpose of lateral tissue freezing.
28. The method of claim 27 wherein tissue diametrically opposed to the lateral tissue freezing is thermally protected from cryogenic injury due to the distance created between the target tissue and the opposing tissue by the balloon, or the thermal insulating properties of the refrigerant gas within the balloon.
29. The method of claim 22 wherein the cryosurgical apparatus comprises an elongated structure with a distal end, a proximal end, and at least one central lumen; with said distal end comprising an outer inflatable balloon structure configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon; with said proximal end comprising a means for introducing a liquid refrigerant into the cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas, and a means spraying liquid refrigerant at a lateral interior portion of the inner cryogenic evaporator balloon for the purpose of lateral tissue freezing.
30. The method of claim 29 wherein tissue diametrically opposed to the lateral tissue freezing is thermally protected from cryogenic injury due to the distance created between the target tissue and the opposing tissue by the outer balloon, or the thermal insulating properties of the refrigerant gas within the inner thermal insulation balloon.
31. A cryosurgical apparatus comprising:
- a. an elongated rigid structure with a distal end, a proximal end, and a central lumen;
- b. a non-coring optically transparent needle tip located at the distal end and having at least one lateral fenestration in communication with the central lumen, and housing at least one imaging device configured for distal imaging;
- c. a handle located at the proximal end and having a means for connecting the imaging device(s) to an imaging display(s); and
- d. a means for accessing bodily tissue in the vicinity of the distal end with a cryo-ablation probe through the central lumen and the lateral fenestration(s).
32. A cryosurgical apparatus comprising:
- a. an elongated structure with a distal end, a proximal end, and at least one central lumen;
- b. an inflatable balloon structure located at the distal end and configured as a refrigerant evaporation chamber, and as an optical imaging window, enclosing at least one optical imaging device;
- c. an introducing means located at the proximal end for introducing a liquid refrigerant into the distal balloon through a central lumen;
- d. a removal means located at the proximal end for removing evaporated refrigerant from the cryosurgical apparatus at a predetermined pressure;
- e. a connecting means located at the proximal end for connecting the optical imaging device(s) to an imaging display;
- f. an inflation means located at the proximal end for inflating the balloon with a liquid or a gas; and
- g. a spraying means located at the proximal end for spraying liquid refrigerant at a lateral interior portion of the balloon for the purpose of lateral tissue freezing.
33. A cryosurgical apparatus comprising:
- a. an elongated structure with a distal end, a proximal end, and at least one central lumen,
- b. an outer inflatable balloon structure located at the distal end and configured as an optical imaging window, and as a tissue dilator enclosing at least one optical imaging device, at least one inner cryogenic evaporator balloon, and at least one inner thermal insulation balloon;
- c. an introducing means located at the proximal end for introducing a liquid refrigerant into the inner cryogenic evaporator balloon through a central lumen, a means of removing evaporated refrigerant from the cryogenic evaporator balloon through a central lumen at a predetermined pressure, a means for inflating the thermal insulation balloon with the pressurized evaporated refrigerant gas, a means for connecting the optical imaging device(s) to an imaging display, and a means for inflating the outer balloon with a liquid or a gas; and
- d. a spraying means located at the proximal end for spraying liquid refrigerant at a lateral interior portion of the inner cryogenic evaporator balloon for the purpose of lateral tissue freezing.
Type: Application
Filed: Jul 23, 2014
Publication Date: Jan 29, 2015
Inventors: Vahid SAADAT (Atherton, CA), Matthew Herron (Menlo Park, CA), Richard C. Ewers (Fullerton, CA)
Application Number: 14/339,024
International Classification: A61B 18/02 (20060101); A61B 1/05 (20060101); A61B 1/00 (20060101); A61B 1/313 (20060101);