Patent Application
20150257810
The present invention relates generally to the medical treatment technology field and, in particular, to a device for use in cryo-therapeutic procedures.
Cryotherapy is an effective yet minimally invasive alternative to radical surgery and radiation therapy. In this minimally invasive procedure, the destructive forces of freezing are utilized to ablate unwanted tissue in a way that decreases hospitalization time, reduces postoperative morbidity, decreases return interval to daily activities, and reduces overall treatment cost compared to conventional treatments.
Cryosurgery has been shown to be an effective therapy for a wide range of tumor ablation as well as its use to treat atrial fibrillation. Since the early 1960s, treatment of tumors and unwanted tissue has developed around freezing techniques and new instrumentation and imaging techniques to control the procedure. As a result, the complications of cryoablation have been reduced and the efficacy of the technique has increased.
Improved developments in cryoablation instrumentation have led to the advancement in using cryogenic medical devices. The cryogenic medical devices have been designed to deliver subcooled liquid cryogen to various configurations of cryoprobes for the treatment of damaged, diseased, cancerous or other unwanted tissues. The closed or semi-closed systems allow various cryogens to be contained in both the supply and return stages.
Recently, instrumentation has been discovered to convert liquid nitrogen to supercritical nitrogen (SCN) in a cylinder/cartridge cooled by atmospheric liquid nitrogen (−196° C.), the SCN of which can be subcooled and tuned to the liquid phase, attaining an excess temperature. When the SCN is injected into one or more flexible cryoprobes, the SCN flows with minimal friction to the tip of the probe. In the tip, SCN pressure drops due to an increased volume and outflow restriction, heat is absorbed (nucleate boiling) along the inner surface of the tip, micro bubbles of nitrogen gas condense back into a liquid, and the warmed SCN reverts to pressurized liquid nitrogen as it exits the return tube and resupplies the dewar containing atmospheric liquid nitrogen. This flow dynamic occurs within a few seconds, typically in the order of 1 to 10 seconds depending on the probe or attachment configuration, and is regulated by a high pressure solenoid valve. Once instruments are in place, the cryosurgical procedure can be performed with freeze times in ranges of about 15 seconds to 5 minutes (or ranges thereof), a drastic improvement over current known methods.
Current surgical probes are made of rigid metal materials. If the probes are to be bent or curved, the shape must be pre-formed by tooling and/or bent manually prior to introduction of the probe into the site of treatment in a patient's body. Current probe designs do not address real-time shaping or steering of a probe while at the site of treatment or by any internal control mechanisms. As such, the procedures to date cannot provide a minimally invasive treatment or time effective treatment option since the probes must be manually shaped and positioned repeatedly (with entry and withdrawal from a surgical cavity/opening) to achieve the proper placement.
There exists a need for flexible probes in the surgical ablation field of medicine, specifically in cryo-therapeutic procedures. The flexible cryogenic probes would provide a highly flexible probe tip which can be shaped and steered for proper positioning inside a patient's body. The flexible probe tips would desirably have integrated deflection mechanisms to allow for precise placement of the probes in a minimally invasive manner. In addition, the flexible probes would be capable of being miniaturized so that various cryo-procedures can implement the use of the flexible tip in a safe manner and for a variety of treatment options in the medical environment. The flexible tip would also be capable of being electronically or computer operated to fine-tune its placement and use in surgical procedures.
One embodiment of the invention is a flexible cryogenic probe tip. The flexible probe tip has a linear freeze zone at a distal end of the probe that allows for its placement and precisely controlled movements. The flexible cryogenic probe tip conforms to the target tissue surface to create a linear lesion. In addition, the probe tip is steerable to facilitate proper placement with minimal access points into a patient's body. Various configurations of the flexible probe tip, however, allow it to conform and ablate tissue of many sizes, shapes, and/or dimensions.
One embodiment of the ablation instrument comprises: a longitudinal body having one or more sidewalls which form a flexible sleeve, the longitudinal body having a proximal end, a distal end, and a central axis; a luminary space formed within the flexible sleeve; and at least one internal component inserted through the proximal end of the longitudinal body and extending through the luminary space to the distal end; wherein the internal component is interconnected with a deflection mechanism for controlling the distal end of the longitudinal body such that the distal end is capable of multi-planar movement.
In another embodiment, the ablation instrument has a distal end of the longitudinal body that is closed while the proximal end has an open configuration. The internal component can be a deflection wire interconnected with the distal end of the longitudinal body or in connection with any portion of the longitudinal body for control and mobility of the body. In one aspect, the deflection wire is integral with a sidewall of the longitudinal body.
Another embodiment of the invention utilizes a distal end as a flexible linear freeze zone comprising one or more cryolines positioned within the luminary space. The internal component as integrated with the deflection mechanism flexibly positions the distal end within the range of about 0° to about 90° away from the central axis. In addition, the distal end is capable of movement 360° movement about the central axis of the longitudinal body.
Multiple internal components may include a plurality of deflection wires, a manual pull-wire, a pulley or gear system, an electronic or a motorized component, or a wire having electrical response properties, utilized alone or in combination to effect movement. Any number and combination of internal components may be utilized to effect greater mobility. In one aspect, the wire which has electrical response properties comprises shape memory alloys to facilitate contraction or expansion of the wire.
Another embodiment also comprises integrated temperature sensors, electrical monitors, optical visualization materials, or other sensing devices.
In yet another embodiment, the longitudinal body comprises segmented portions, including a multi-segment distal end. In one aspect, the multi-segment distal end comprises a plurality of the internal components anchored upon the one or more sidewalls. In another aspect, the distal end loops back toward the central axis to form a polygonal shape or lasso.
Further, embodiments of the invention have internal components and deflection mechanisms that are cryo-compatible. The internal component, the deflection mechanisms, and the parts and components of the ablation instrument are compatible with supercritical nitrogen.
An embodiment of the invention includes a method of utilizing a flexible probe tip, comprising the steps of: providing an ablation instrument comprising: a longitudinal body having one or more sidewalls which form a flexible sleeve, the longitudinal body having a proximal end, a distal end, and a central axis; a luminary space formed within the flexible sleeve; and at least one internal component inserted through the proximal end of the longitudinal body and extending through the luminary space to the distal end; wherein the internal component is interconnected with a deflection mechanism for controlling the distal end of the longitudinal body such that the distal end is capable of multi-planar movement; positioning the distal end at a tissue site for at least one ablative procedure; and flexibly maneuvering the distal end to precisely treat the tissue site.
A method of the invention also utilizes an ablation instrument by positioning the distal end at a tissue site for at least one ablative procedure; maneuvering the distal end to the tissue site; directing a cryogen from the supply source to the distal end at a pressure above the critical pressure and a temperature below the critical temperature for the cryogen; controlling a flow of cryogen from the supply source to the distal end and back to the supply source; and segmenting control of the distal end mechanically or through the step of controlling the flow of cryogen. In one embodiment, the pressure is reduced within the distal end and through the return portion back to the supply source or vented.
In one embodiment, the ablative procedure is a cryo-treatment. One cryo-treatment includes a step of encircling one or more vessels with the distal end. Another embodiment includes multiple ablative procedures being performed at multiple tissue sites. Further, a step of visualizing placement of the distal end and flexibly positioning the distal end at the tissue site, may include visualization techniques of MRI, X-ray, or optically integrated cameras, alone or in combination.
Various embodiments of the ablative instrument and its method of use include cryo-treatments for cardiovascular (endocardial and epicardial) and cardiac tissue, prostate, kidney, liver, lung, bone, esophageal, pancreatic lymphatic, vascular disease, uterine cancer, fibroids, breast, among others. Any tissue or solid tumor, or growth (benign or cancerous) can be treated. The flexible probe may also be used to target and destroy fat cells as an alternative to liposuction (fat reduction).
The invention is best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion.
In the following detailed description, for purposes of explanation and not limitation, exemplary embodiments disclosing specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one having ordinary skill in the art that the present invention may be practiced in other embodiments that depart from the specific details disclosed herein. In other instances, detailed descriptions of well-known devices and methods may be omitted so as not to obscure the description of the present invention.
A perspective sideview of a flexible cryogenic ablation probe 10 in accordance with one embodiment of the present invention is illustrated in
In one embodiment, the probe 10 is comprised of flexible plastic and malleable metal compositions of parts and components to allow it to be steerable in situ. A deflection wire 15 allows for the probe's precise positioning and placement within a patient's body. The flexible probe 10 facilitates minimally invasive access for treatment of diseased tissue, such as in the surgical or electrophysiological treatment of atrial fibrillation (i.e. epi-cardial and endo-cardial treatment options). As illustrated in
As shown in the embodiment of
In an exemplary embodiment, multiple deflection wires of varying lengths may extend through to the distal end of the probe. Multiple deflection points and junctions may allow for a multi-segment distal end of the probe, each segment controllable by a different deflection/steering wire. In one embodiment, the distal end is a bi-directional multi-planar deflection tip having multiple steering wires anchored at various points in the sidewall 12. An individual anchoring point, however, would also be useful such that multiple deflection wires extend at different lengths therefrom. Any number of wires, however, may also be positioned or anchored to any fixation point within the internal vacuum space 25, supply line 24, or return line 23. By integrating the segmentation, the movement capabilities of the distal end allow it to create any number of shapes or achieve positions that are desirable. In one embodiment, the distal end loops back around itself to form a polygonal shape or lasso formation, such as may be desirable in looping the cryo-segment around a vein or artery. Various shapes of the distal end may include an S formation, J or U shape, circle, or any number or combinations of such arrangements, alone or in combination with other probes. The deflection of the probe tip in three-dimensions along the X, Y, and Z planes, and/or in a rotational configuration, provides for various treatment positions and treatment angles.
The mechanism for moving the deflection wire may be by manual wire shortening, such as a pulley or gear system; electronic or motor operation; and/or use of wires with electrical response properties to facilitate contraction or expansion of the wire to effect movement. In one embodiment, Ni—Ti alloys (nickel and titanium alloys, including nitinol which may encompass Co—Ni—Ti alloys) and such compositions are utilized to effect movement. As a shape memory alloy, nitanol has superelasticity to bend and flex as if a biological muscle fiber, and having the bio/physiological and chemical compatibility with the internal human body. Ni—Ti memory alloys can be utilized similar to flex-wires and/or flex-tubes comprising bio-metals.
In another aspect, other metallic compositions, including plastics, aluminum, and copper make the probe MR (magnetic resonance) compatible. Any metal or plastic compositions that are cryo-compatible may be utilized to structure and design a flexible probe tip. In addition, approaches using micro-motors, pneumatics, hydrolics, and/or electric to generate movement may be implemented with the device.
The cryo-probe device may take many forms and be of any size, shape, or dimension. Further, the embodiments of the present invention may be modified to accommodate the size, shape, and dimension of any device or apparatus currently used in the industry. Any number of sensors and/or control mechanisms may also be utilized to facilitate operation of the device at the distal end or throughout the length of the entire probe.
As presented, the multiple embodiments of the present invention offer several improvements over standard cryo-probe devices currently used in the medical industry. The improved cryogenic probes disclosed herein enhance the shaping and steerable functionality of the probe while in use internally within a patient. The integrated deflection mechanism, whether mechanically or electrically controlled allows for precise placement of the probe in a minimally invasive manner. Improvements in the flexible probe design enable easy handling, accessibility, and miniaturization.
The invention being thus described, it would be obvious that the same may be varied in many ways by one of ordinary skill in the art having had the benefit of the present disclosure. Such variations are not regarded as a departure from the spirit and scope of the invention, and such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims and their legal equivalents.
| Number | Date | Country | Kind |
|---|---|---|---|
| PCT/US09/62928 | Nov 2009 | US | national |
This is a nonprovisional patent application claiming benefit of International PCT Application No. US2009/062928 filed on Nov. 2, 2009 and titled A Cryogenic System and Method of Use under 35 U.S.C. §365(c), which claims priority to U.S. Non-provisional patent application Ser. No. 12/553,005 filed on Sep. 2, 2009, which claims priority to U.S. Provisional Patent Application Ser. No. 61/093,916 filed on Sep. 3, 2008, and titled Modular Pulsed Pressure Device for the Transport of Liquid Cryogen to a Cryoprobe, which is incorporated herein by reference; further claiming priority to U.S. Non-provisional patent application Ser. No. 12/562,301 filed on Sep. 18, 2009, which claims priority to U.S. Provisional Patent Application Ser. No. 61/098,244 filed on Sep. 19, 2008, and titled Nucleation Enhanced Surface Modification to Support Physical Vapor Deposition to Create a Vacuum, which is incorporated herein and also by reference; further claiming priority to U.S. Provisional Patent Application Ser. No. 61/319,525 filed on Mar. 31, 2010, and titled Flexible Cryogenic Probe Tip, which is incorporated herein.
| Number | Date | Country | |
|---|---|---|---|
| 61319525 | Mar 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13077399 | Mar 2011 | US |
| Child | 14715092 | US |
