# Patent

## Title
Nerve and soft tissue ablation device

## Abstract

Ablation devices useful for destroying nerve and soft tissue via a minimally invasive procedure to alleviate pain are provided. The device comprises a probe comprising an outer tube having an exterior surface comprising a tip and an interior surface that defines an internal passage. An inner tube is disposed within the outer tube and comprises an interior surface that defines an internal passage having a filament disposed therein. The filament has an opening configured to release a pressurized material into the interior surface of the probe so as to cool the exterior surface of the outer tube to a selected temperature. Disposal of the inner tube within the internal passage of the outer tube produces an air gap that surrounds the exterior surface of the inner tube, and the tip is configured for ablating nerve and/or soft tissue. Methods for ablating nerve and/or soft tissue utilizing the ablation devices are also provided.

## Background
FIELD
The present invention relates generally to devices and methods for ablating a material or substance. More specifically, the devices and methods are useful for removing nerve and/or soft tissue via a minimally invasive procedure to alleviate pain.
BACKGROUND
Acute and chronic pain management has been a concern for as long as medicine has been practiced. Several methods of inducing analgesia and anesthesia have been developed. For example, the use of chemical substances is perhaps the most common approach to pain relief which requires suitable substances that are effective, safe to humans, and do not cause complications or abnormal reactions. Despite the great advances that have been made in the field of anesthesiology, and in the field of pain relief in general, there are still some drawbacks to chemical-based approaches. For instance, the anesthetics generally available today must be administered in carefully graduated doses to assure the patient's well being, require extended periods of fasting prior to treatment, and are often accompanied by undesirable after effects such as nausea.
One alternative approach that is commonly used for providing pain relief is ablation in which nerves and/or tissue is removed and/or destroyed. Two approaches to removing tissue via ablation are through cold or hot ablation procedures and techniques. Various categories of ablation include but are not limited to electrical, radiation, light, radiofrequency, ultrasound, cryotherapy, thermal, microwave and hydromechanical. One form of hot ablation is radiofrequency ablation. During radiofrequency (RF) ablation, current passing through tissue from the active electrode leads to ion agitation, which is converted by means of friction into heat. The process of cellular heating includes almost immediate and irreparable cellular damage, which leads to coagulation necrosis. Because ion agitation, and thus tissue heating, is greatest in areas of highest current density (e.g., closest to the active electrode tip), necrosis is limited to a relatively small volume of tissue surrounding the RF electrode.
Another form of ablation uses cold ablation and is called cryoablation. During cryoablation, tissue is frozen or rapid freeze/thaw cycles are inflicted upon the tissue. There are many advantages to using cryoablation instead of radiofrequency ablation. For example, cryoablation is safer especially near critical vasculature and there is less risk of post-procedure neuritis or neuromas following neuroablation for the treatment of pain. Cryoablation allows treatment mapping pre and post procedure where areas of tissue can be mapped by limited, reversible and/or freezing. Cryoablation can be monitored and visualized on ultrasonography, CT and MRI. Moreover, because nerve cooling is anesthetic, cryoablation is a less painful procedure than thermal ablation techniques.
The current procedures and techniques using cryoablation used destroy tissue due to rupturing of cells and/or cell organelles within the tissue. Deep tissue freezing is affected by insertion of a tip of a cryosurgical device into the tissue, either transperineally, endoscopically or laproscopically, and a formation of, what is known in the art as, an ice ball around the tip. During freezing, ice formation within the extracellular space creates an osmotic gradient, resulting in cellular dehydration. Ice crystals then form within the cells causing cell membranes to rupture resulting in cell death.
In addition, when the adjacent tissues are present at opposite borders with respect to the freeze treated tissue and since the growth of the ice ball is in a substantially similar rate in all directions toward its periphery, if otherwise, the ice ball reaches one of the borders before it reaches the other border, and decision making must be made on whether to continue the process of freezing, risking damage to close healthy tissues, or to halt the process of freezing, risking a non-complete destruction of the treated tissue.
Traditional cryoablation systems can provide removal capabilities of soft tissue via the application of single needles that form an ice ball centered around a tip, but because the needles are not insulated, the procedures cause an increase in heat loss for adjacent tissues at a surgical site. The heat loss will lead to tissue freezing and potential necrosis. In addition, there is an increase in radiation exposure to the surgical site.
Another problem with currently available cryoablation devices is that they are not cost effective. The needles used during a procedure are disposed of after use and are not reusable. Further, if a single needle is used for a procedure, contamination of the surgical site can occur.
Accordingly, there is a need for devices and methods to provide efficient removal of nerve and/or soft tissue without damage and/or necrosis to tissue surrounding a surgical site. There is a need for an insulated device where ablation is focused to a tip of the probe, thereby allowing a medical practitioner to position the components of the device at various locations, such as, for example, multiple facet joints and/or multiple spinal levels to isolate a particular ablation area without residual damage to healthy tissue. Moreover, a device is needed for use during a minimally invasive procedure and/or during an open surgical procedure. Further, there is a need for devices and methods that provide fine ablation capabilities of nerve and/or soft tissue. Devices and methods that assist in the control of necrosis in a tissue being treated are also needed.
SUMMARY
Ablation devices and methods are provided that deliver improved ablation with minimal unwanted destruction to adjacent nerve and/or soft tissue. The ablation devices and methods provided allow the tips of the device to be easily positioned in an optimal location.
In some embodiments, the ablation devices and methods provided allow destruction of nerves and other soft tissue via a minimally invasive procedure to alleviate pain. The ablation devices and methods disclosed comprise a probe comprising an outer tube having an exterior surface that comprises a tip and an interior surface that defines an internal passage. An inner tube is disposed within the outer tube and comprises an interior surface that defines an internal passage having a filament disposed therein. The filament has an opening configured to release a pressurized material into the interior surface of the probe so as to cool the exterior surface of the outer tube to a selected temperature. The disposal of the inner tube within the internal passage of the outer tube produces an air gap that surrounds the exterior surface of the inner tube, and the tip is configured for ablating nerve and/or soft tissue.
In some embodiments, a cryoablation device comprises an insulated probe comprising an interior surface that defines an internal passage having a filament disposed therein. The filament has an opening configured to release a pressurized material into the interior surface of the probe so as to cool an exterior surface of the probe to a selected temperature. The exterior surface comprises a tip that is configured for ablating nerve and/or soft tissue.
In certain embodiments, methods for destroying nerves and/or other soft tissue via a minimally invasive procedure to alleviate pain are also provided. Destruction of the target nerve or soft tissue can eliminate and/or reduce pain symptoms. Specific clinical applications of the disclosed ablation instrument include destruction of nerves causing facet and discogenic back and leg pain, destruction of soft tissue causing stenosis pain symptoms, and many other orthopedic, oral maxillofacial, and ENT pains and pathologies.
In some embodiments, methods of ablating a nerve and/or soft tissue include disposing a probe at a surgical site, wherein the probe comprises an outer tube having an exterior surface comprising a tip and an interior surface that defines an internal passage, and an inner tube is disposed therein, the inner tube comprising an interior surface that defines an internal passage having a filament disposed therein having an opening configured to release a pressurized material into the interior surface of the probe so as to cool the exterior surface of the outer tube to a selected temperature, wherein the disposal of the inner tube within the internal passage of the outer tube produces an air gap that surrounds the exterior surface of the inner tube, and wherein the tip is configured for ablating nerve and/or soft tissue; and placing the device adjacent to the nerve and/or soft tissue to ablate the nerve and/or soft tissue
Additional features and advantages of various embodiments will be set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practice of various embodiments. The objectives and other advantages of various embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the description and appended claims.



BRIEF DESCRIPTION OF THE DRAWINGS
In part, other aspects, features, benefits and advantages of the embodiments will be apparent with regard to the following description, appended claims and accompanying drawings where:
FIG. 1 illustrates a cross-sectional view of an ablation device in accordance with one embodiment of the present disclosure;
FIG. 2 illustrates a front view of an ablation device in accordance with one embodiment of the present disclosure; and
FIG. 3 illustrates a front view of an ablation device in accordance with one embodiment of the present disclosure.



It is to be understood that the figures are not drawn to scale. Further, the relation between objects in a figure may not be to scale, and may in fact have a reverse relationship as to size. The figures are intended to bring understanding and clarity to the structure of each object shown, and thus, some features may be exaggerated in order to illustrate a specific feature of a structure.
DETAILED DESCRIPTION
Devices for efficient destruction and/or removing of a material or substance such as nerve and soft tissue suitable for use in open surgical and/or minimally invasive procedures for the treatment of pain are disclosed. The following description is presented to enable any person skilled in the art to make and use the present disclosure. Descriptions of specific embodiments and applications are provided only as examples and various modifications will be readily apparent to those skilled in the art.
The present disclosure may be understood more readily by reference to the following detailed description of the disclosure presented in connection with the accompanying drawings, which together form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure.
DEFINITIONS
As used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise.
Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value.
Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure.
For purposes of the description contained herein, with respect to components and movement of components described herein, “forward” or “distal” (and forms thereof) means forward, toward or in the direction of the forward, distal end of the probe portion of the device that is described herein, and “rearward” or “proximal” (and forms thereof) means rearward or away from the direction of the forward, distal end of the probe portion of the device that is described herein. However, it should be understood that these uses of these terms are for purposes of reference and orientation with respect to the description and drawings herein, and are not intended to limit the scope of the claims.
Spatially relative terms such as “under”, “below”, “lower”, “over”, “upper”, and the like, are used for ease of description to explain the positioning of one element relative to a second element. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as “first”, “second”, and the like, are also used to describe various elements, regions, sections, etc and are also not intended to be limiting. Like terms refer to like elements throughout the description.
As used herein, the terms “having”, “containing”, “including”, “comprising” and the like are open ended terms that indicate the presence of stated elements or features, but do not preclude additional elements or features.
The headings below are not meant to limit the disclosure in any way; embodiments under any one heading may be used in conjunction with embodiments under any other heading.
Reference will now be made in detail to certain embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the illustrated embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover all alternatives, modifications, and equivalents that may be included within the invention as defined by the appended claims.
Cryoablation
Cryoablation devices have been available to surgeons to treat many medical conditions, for example, in the treatment of tumors in lung, liver, kidney and other body organs. Cryoablation has also been used for treatment of tumors, cardiac arrhythmias, chronic and post-operative pain, bone fracture and soft tissue wounds.
Cold temperatures have been used to decrease inflammation and to relieve pain since the ancient Egyptians. Liquid air and carbon dioxide were used to treat skin lesions in the beginning of the twentieth century. In 1950, liquid nitrogen was introduced into clinical practice for the cryosurgical ablation of a variety of skin diseases and allowed for deeper tissue to be treated with cryoablation. In 1961, a liquid nitrogen probe was developed and was used to treat Parkinson's disease as well as inoperable brain tumors. From 1980-2000, systems emerged based on an advanced gas expansion method known as the Joule-Thomson Principle. This principle allows for temperature change of a gas or liquid when it is forced through a valve or porous plug while being kept insulated so that no heat is exchanged with the environment. The refrigerant could be stored at room temperature and the difficulties associated with supplying liquid nitrogen to the operating room disappeared. Three main refrigerants were utilized: nitric oxide, liquid nitrogen and argon. For over 20 years, rigid cryoprobes have existed for percutaneous use or in open invasive surgical procedures. For example, cryoprobes are used for freezing a range of lesions from prostate tissue to metastatic cancers in liver. Neuronal tissue has been frozen with such devices for the relief of pain.
Current cryoablation procedures and technique employ cryoprobes that utilize single needles that form an ice ball centered around a tip that are disposed at a surgical site. Because current cryoablation probes are not insulated, there is an increase in heat loss for adjacent tissues at a surgical site. The heat loss leads to tissue freezing and potential necrosis. In addition, there is an increase in radiation exposure to the surgical site. Therefore, the probe of the present disclosure decreases the amount of tissue damage and/or destruction, as well as contamination that potentially can occur for enhanced ablation.
The present disclosure includes an insulated probe capable of efficiently ablating multiple areas of a surgical site without damaging and/or destroying adjacent tissues. As illustrated in FIGS. 1-3, the present ablation device 10 comprises a probe 12. In various embodiments, device 10 includes multiple probes. The dimensions of the device, among other things, will depend on the site that needs ablation. For example, the width of the cervical facet is only about 0.5-1.0 cm and about 1.0-2.0 cm for the lumbar facet region. Thus, the device, in various embodiments, can be designed for these specific areas.
Some examples of lengths of the probe, may include, but are not limited to, from about 50 to 150 mm in length, for example, about 50 mm for cervical facet use, about 100 mm for lumbar facet use for a standard adult and about 150 mm for an obese adult patient. The thickness of the probe will depend on the site that needs ablation and/or the particular embodiment of the device. The thickness of the probe is about 20 gauge. In some embodiments, the probe can be about 17 to about 22 gauge. In various embodiments, the thickness includes, but is not limited to, from about 0.05 to about 1.655. In some embodiments the probe can be increasing and or decreasing in thickness throughout the probe. In some embodiments, the probe may be tapered and/or angled. The probe may be the widest or smallest diameter or a diameter in between for insertion into a human or animal body. In some embodiments, the widest diameter is typically about 14 gauge, while the smallest diameter is about 26 gauge.
Suitable materials that probe 12 can be made from for example are, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, tungsten, molybdenum, metal alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics or a combination thereof.
Probe 12 includes an outer tube 14 comprising of an interior surface 16 and an exterior surface 18 (FIG. 1). The interior surface defines an internal passage 20. In some embodiments, outer tube 14 can have one or more passages defined by the interior surface for a pressurized material to be released into the probe as well as recirculation throughout the probe. Exterior surface 18 comprises a tip 22 positioned at a distal end of the outer tube. The tip is pointed to allow for easy pushing through tissues.
Probe 12 includes an inner tube 24 disposed within internal passage 20 of the outer tube. In various embodiments, the inner tube comprises a nonconductive material such as, for example, a plastic, glass, ceramic, porcelain, composite polymers and/or rubber. The inner tube includes an exterior surface 26 and an interior surface 28 that defines an internal passage 30 and an opening 32 disposed at a distal end of the internal passage. A filament 34 is disposed within the inner tube. The filament is about 0.016 inches in diameter. In some embodiments, the filament is about 0.010 to 0.015 or about 0.17 to about 0.25 inches in diameter. The filament is a conduit for cooling and expansion of the pressurized material that is released and passed into the probe.
The filament includes an opening 36 configured to release the pressurized material into the interior surface of the prong. The opening may be shaped as a regular or irregular polygon including arcuate, round, square, oblong, kidney shaped, crescent, or beveled shaped. The pressurized material is released and enters into the passage cooling and expanding within the passage via the filament.
The material is pressurized and in some embodiments, the pressure is from about 3,000 to about 6,000 pounds per square inch (PSI). In various embodiments, the material is in the form of argon, liquid nitrogen, nitric oxide, helium, air, krypton, carbon dioxide, tetrafluoromethane or xenon. When a high pressure material such as argon is used, argon will expand within the interior and will liquefy so as to form a cryogenic pool at the tip, cooling the surface of the tip. The temperature of the material is coldest at the tip of probe 12, where formation of an ice ball 38 occurs. The ice ball is spherical or oval in shape.
In various embodiments, engagement between the outer tube and the inner tube produces an air gap 39 between the internal passage of the outer tube and the exterior surface of the inner tube. The air gap forms an air seal that creates insulation around the probe and facilitates ice ball formation at the end of the air gap. In various embodiments, the air gap diminishes and/or prevents collateral tissue damage at a surgical site.
In various embodiments, probe 12 comprises only outer tube 14 (FIG. 2). The probe comprises an insulated material such as, for example, a heat resistant plastic. Examples of such heat resistant plastics include, but are not limited to PMMA, PET, PEEK, PLA, PLGA, PVC and/or HDPE. In various embodiments, the tube comprises other insulated materials including, but not limited to glass, ceramic, porcelain, composite polymers and/or rubber. Examples of such rubbers include, but are not limited to silicone, flurosilicone, isobutylene-isoprene copolymer, chlorobutyl, fluroelastomers, and/or polychloroprene. In some embodiments, filament 34 is disposed within internal passage 20 of tube 14. In various embodiments, tip 22 of the probe is configured for threaded engagement 37 with a distal end of the probe. The tip may be disposed within the probe via a friction fit, lock and key, male/female, clip, keyway, and/or bracket engagement. In some embodiments, tip 22 comprises a temperature conducting material such as metal so as to enable the formation of the ice ball. In various embodiments, the metal tip may comprise of stainless steel, titanium, copper, silver, gold, aluminum, brass, platinum, molybdenum and/or tungsten. In some embodiments, the tip is approximately 1-2 cm in length and is the same diameter as the probe.
In some embodiments, probe 12 comprises only outer tube 14 that is insulated by an air gap 40 formed by at least one expandable balloon 42 disposed on exterior surface 18 of tube 14 (FIG. 3). The balloon will inflate after the probe is inserted into a surgical site, creating an insulated barrier that protects tissue surrounding the surgical site from being damaged and/or destroyed. Before the probe is removed from the surgical site, the balloon can be deflated. In various embodiments, multiple balloons are disposed on the exterior surface of the probe. In some embodiments, one balloon is disposed on the exterior surface of the probe.
In some embodiments, tip 22 is pointed to allow for easy pushing through tissues. In some embodiments, the tip is hollow comprising an interior surface configured for the material to expand in. In various embodiments, the tip can include openings to inject material into a surgical site in order to facilitate ice ball formation. The openings may be shaped as a regular or irregular polygon including arcuate, round, square, oblong, kidney shaped, crescent, or beveled shaped. In some embodiments, therapeutic agents can be delivered to the surgical site via the openings. In various embodiments, the tip of the probe can be round or tapered.
In some embodiments, a lubricant is provided to assist in the insertion of the device within the nerve and/or soft tissue. In some embodiments, the lubricant can be, without limitation, polyethylene glycol (PEG), hyaluronic acid, hyaluronan, lubricin, polyethylene glycol, and any combinations thereof.
The temperature for cryoablation of the device can be selected by the user and can vary as needed. For example, the temperature that can be selected can be from −180°, −170°, −160°−150° C., −140° C., −130° C., −120° C., −110° C., −100° C., −50° C., −40° C., −3° C., −2° C., −1° C., −5° C. or to about 0° C. or any temperature in between these numbers. The device comprises an air gap between at least portions or all of the inner and outer tube to provide insulation from these temperatures. However, in FIG. 1, the tip of the device does not have insulation as this is where the maximum cryoablation temperature will be directed.
After a period of time, the ice ball forms and begins to ablate when a portion of the tip of the probe is adjacent to nerve and/or soft tissue and when the temperature of the tip of the probe decreases from about −40° C. to about −160° C. The temperature at the surface of the ice ball is 0° C. The temperature declines exponentially towards a cool center where it reaches about −170° C. The ice ball will be formed at about 2 to about 8 minutes after the material has been released into probe 12. The sphere creates a zone of complete ablation (approximately −20° C.) typically located within the ice ball at approximately half way between the center of the ball and its outer surface. In various embodiments, nerve and or soft tissue is completely ablated in about 3 to about 16 minutes. In various embodiments, nerve and or soft tissue is completely ablated in about 3 to about 9 minutes. In some embodiments, the ice ball is not a complete ice ball, for example, a partial or half an ice ball can be formed for complete ablation.
In some embodiments, a heated material can pass through the internal passage of the probe to heat the pressurized material thereby increasing temperature.
In various embodiments, the device is coated with an antimicrobial coating and/or agents. The antimicrobial coating can include, for example, antibiotics, antifungal, antiviral agents or the like. Antimicrobial agents to treat infection include by way of example and not limitation, antiseptic agents, antibacterial agents; quinolones and in particular fluoroquinolones (e.g., norfloxacin, ciprofloxacin, lomefloxacin, ofloxacin, etc.), aminoglycosides (e.g., gentamicin, tobramycin, etc.), glycopeptides (e.g., vancomycin, etc.), lincosamides (e.g., clindamycin), cephalosporins (e.g., first, second, third generation) and related beta-lactams, macrolides (e.g., azithromycin, erythromycin, etc.), nitroimidazoles (e.g., metronidazole), penicillins, polymyxins, tetracyclines, or combinations thereof.
Some exemplary antimicrobial agents include, by way of illustration and not limitation, acedapsone; acetosulfone sodium; alamecin; alexidine; amdinocillin; amdinocillin pivoxil; amicycline; amifloxacin; amifloxacin mesylate; amikacin; amikacin sulfate; aminosalicylic acid; aminosalicylate sodium; amoxicillin; amphomycin; ampicillin; ampicillin sodium; apalcillin sodium; apramycin; aspartocin; astromicin sulfate; avilamycin; avoparcin; azithromycin; azlocillin; azlocillin sodium; bacampicillin hydrochloride; bacitracin; bacitracin methylene disalicylate; bacitracin zinc; bambermycins; benzoylpas calcium; berythromycin; betamicin sulfate; biapenem; biniramycin; biphenamine hydrochloride; bispyrithione magsulfex; butikacin; butirosin sulfate; capreomycin sulfate; carbadox; carbenicillin disodium; carbenicillin indanyl sodium; carbenicillin phenyl sodium; carbenicillin potassium; carumonam sodium; cefaclor; cefadroxil; cefamandole; cefamandole nafate; cefamandole sodium; cefaparole; cefatrizine; cefazaflur sodium; cefazolin; cefazolin sodium; cefbuperazone; cefdinir; cefepime; cefepime hydrochloride; cefetecol; cefixime; cefinenoxime hydrochloride; cefinetazole; cefinetazole sodium; cefonicid monosodium; cefonicid sodium; cefoperazone sodium; ceforanide; cefotaxime sodium; cefotetan; cefotetan disodium; cefotiam hydrochloride; cefoxitin; cefoxitin sodium; cefpimizole; cefpimizole sodium; cefpiramide; cefpiramide sodium; cefpirome sulfate; cefpodoxime proxetil; cefprozil; cefroxadine; cefsulodin sodium; ceftazidime; ceftibuten; ceftizoxime sodium; ceftriaxone sodium; cefuroxime; cefuroxime axetil; cefuroxime pivoxetil; cefuroxime sodium; cephacetrile sodium; cephalexin; cephalexin hydrochloride; cephaloglycin; cephaloridine; cephalothin sodium; cephapirin sodium; cephradine; cetocycline hydrochloride; cetophenicol; chloramphenicol; chloramphenicol palmitate; chloramphenicol pantothenate complex; chloramphenicol sodium succinate; chlorhexidine phosphanilate; chloroxylenol; chlortetracycline bisulfate; chlortetracycline hydrochloride; cinoxacin; ciprofloxacin; ciprofloxacin hydrochloride; cirolemycin; clarithromycin; clinafloxacin hydrochloride; clindamycin; clindamycin hydrochloride; clindamycin palmitate hydrochloride; clindamycin phosphate; clofazimine; cloxacillin benzathine; cloxacillin sodium; chlorhexidine, cloxyquin; colistimethate sodium; colistin sulfate; coumermycin; coumermycin sodium; cyclacillin; cycloserine; dalfopristin; dapsone; daptomycin; demeclocycline; demeclocycline hydrochloride; demecycline; denofungin; diaveridine; dicloxacillin; dicloxacillin sodium; dihydrostreptomycin sulfate; dipyrithione; dirithromycin; doxycycline; doxycycline calcium; doxycycline fosfatex; doxycycline hyclate; droxacin sodium; enoxacin; epicillin; epitetracycline hydrochloride; erythromycin; erythromycin acistrate; erythromycin estolate; erythromycin ethylsuccinate; erythromycin gluceptate; erythromycin lactobionate; erythromycin propionate; erythromycin stearate; ethambutol hydrochloride; ethionamide; fleroxacin; floxacillin; fludalanine; flumequine; fosfomycin; fosfomycin tromethamine; fumoxicillin; furazolium chloride; furazolium tartrate; fusidate sodium; fusidic acid; ganciclovir and ganciclovir sodium; gentamicin sulfate; gloximonam; gramicidin; haloprogin; hetacillin; hetacillin potassium; hexedine; ibafloxacin; imipenem; isoconazole; isepamicin; isoniazid; josamycin; kanamycin sulfate; kitasamycin; levofuraltadone; levopropylcillin potassium; lexithromycin; lincomycin; lincomycin hydrochloride; lomefloxacin; lomefloxacin hydrochloride; lomefloxacin mesylate; loracarbef; mafenide; meclocycline; meclocycline sulfosalicylate; megalomicin potassium phosphate; mequidox; meropenem; methacycline; methacycline hydrochloride; methenamine; methenamine hippurate; methenamine mandelate; methicillin sodium; metioprim; metronidazole hydrochloride; metronidazole phosphate; mezlocillin; mezlocillin sodium; minocycline; minocycline hydrochloride; mirincamycin hydrochloride; monensin; monensin sodiumr; nafcillin sodium; nalidixate sodium; nalidixic acid; natainycin; nebramycin; neomycin palmitate; neomycin sulfate; neomycin undecylenate; netilmicin sulfate; neutramycin; nifuiradene; nifuraldezone; nifuratel; nifuratrone; nifurdazil; nifurimide; nifiupirinol; nifurquinazol; nifurthiazole; nitrocycline; nitrofurantoin; nitromide; norfloxacin; novobiocin sodium; ofloxacin; onnetoprim; oxacillin and oxacillin sodium; oximonam; oximonam sodium; oxolinic acid; oxytetracycline; oxytetracycline calcium; oxytetracycline hydrochloride; paldimycin; parachlorophenol; paulomycin; pefloxacin; pefloxacin mesylate; penamecillin; penicillins such as penicillin g benzathine, penicillin g potassium, penicillin g procaine, penicillin g sodium, penicillin v, penicillin v benzathine, penicillin v hydrabamine, and penicillin v potassium; pentizidone sodium; phenyl aminosalicylate; piperacillin sodium; pirbenicillin sodium; piridicillin sodium; pirlimycin hydrochloride; pivampicillin hydrochloride; pivampicillin pamoate; pivampicillin probenate; polymyxin b sulfate; porfiromycin; propikacin; pyrazinamide; pyrithione zinc; quindecamine acetate; quinupristin; racephenicol; ramoplanin; ranimycin; relomycin; repromicin; rifabutin; rifametane; rifamexil; rifamide; rifampin; rifapentine; rifaximin; rolitetracycline; rolitetracycline nitrate; rosaramicin; rosaramicin butyrate; rosaramicin propionate; rosaramicin sodium phosphate; rosaramicin stearate; rosoxacin; roxarsone; roxithromycin; sancycline; sanfetrinem sodium; sarmoxicillin; sarpicillin; scopafungin; sisomicin; sisomicin sulfate; sparfloxacin; spectinomycin hydrochloride; spiramycin; stallimycin hydrochloride; steffimycin; streptomycin sulfate; streptonicozid; sulfabenz; sulfabenzamide; sulfacetamide; sulfacetamide sodium; sulfacytine; sulfadiazine; sulfadiazine sodium; sulfadoxine; sulfalene; sulfamerazine; sulfameter; sulfamethazine; sulfamethizole; sulfamethoxazole; sulfamonomethoxine; sulfamoxole; sulfanilate zinc; sulfanitran; sulfasalazine; sulfasomizole; sulfathiazole; sulfazamet; sulfisoxazole; sulfisoxazole acetyl; sulfisboxazole diolamine; sulfomyxin; sulopenem; sultamricillin; suncillin sodium; talampicillin hydrochloride; teicoplanin; temafloxacin hydrochloride; temocillin; tetracycline; tetracycline hydrochloride; tetracycline phosphate complex; tetroxoprim; thiamphenicol; thiphencillin potassium; ticarcillin cresyl sodium; ticarcillin disodium; ticarcillin monosodium; ticlatone; tiodonium chloride; tobramycin; tobramycin sulfate; tosufloxacin; trimethoprim; trimethoprim sulfate; trisulfapyrimidines; troleandomycin; trospectomycin sulfate; tyrothricin; vancomycin; vancomycin hydrochloride; virginiamycin; zorbamycin; or combinations thereof.
In some embodiments, the device can be coated with an antiviral agent. Antiviral agents can include, but are not limited to, vidarabine, acyclovir, famciclovir, valacyclovir, gancyclovir, valganciclovir, nucleoside-analog reverse transcriptase inhibitors (such as AZT (zidovudine), ddI (didanosine), ddC (zalcitabine), d4T (stavudine), and 3TC (lamivudine)), nevirapine, delavirdine, protease inhibitors (such as, saquinavir, ritonavir, indinavir, and nelfinavir), ribavirin, amantadine, rimantadine, neuraminidase inhibitors (such as zanamivir and oseltamivir), pleconaril, cidofovir, foscarnet, and/or interferons.
Depending on the particular embodiment, the size of the probe tip determines the size of the ice ball formed. In some embodiments, the length of the tip is about 0.5 to about 2 mm for smaller ice balls and from about 3 to about 6 mm for larger ice balls.
In various embodiments, the tip of device 10 comprises a telescopic configuration. The tips can be manually or electronically movable so as to place the tips into a particular position within a surgical site. In certain embodiments, all or some of the tips comprise a telescopic configuration. In some embodiments, the tip is a navigational tool used to guide device 10 into a surgical site.
In some embodiments, the tips of device 10 each comprise indicia, for example a depth indicator that may include an analog, such as, for example, a dial with a numerical indicator of angle and/or digital display, such as, for example, LED and/or LCD. The graduations may represent various indicia, such as, for example, numerical, alphabetic and/or specific conditions/orientations, such as, initial depth and/or final depth of penetration into the nerve and/or tissue.
In certain embodiments, device 10 may include switches for manually controlling the operation of device 10 by a medical practitioner. The switches can provide functions such as on/off, cooling, and predetermined cycles of heating and cooling by selectively and controllably communicating device 10 with an external material container.
In some embodiments, different monitors of temperature, gas pressure and location on device 10 can be attached to device 10. In some embodiments, thermal sensors may be used for measuring the temperature of the material and/or the tips. In some embodiments, device 10 can be operatively connected to semi-steerable or navigational sources for easier guidance into tissues. In various embodiments, the navigational sources can be coupled with a pre-procedure such as for example, CT, MRI, PET scan, etc. so that the target nerve or soft tissue to be ablated can be identified and accurately located during the procedure.
In some embodiments, device 10 is attached to a pressure source that is configured to supply the pressurized material described above. In some embodiments, without limitation, the pressure source can be a pump, a cannula and or a catheter.
In various embodiment, at a proximal end, device 10 can be operatively connected to a vacuum (not shown) for providing suction to ablated nerve and/or tissue. The vacuum may be used to transmit vacuum from a vacuum source (not shown) to a receiving aperture (not shown) connected to device 10. Any suitable aspirator, cylindrical or otherwise, or other mechanism that creates vacuum upon the movement of an actuating member thereof, may be utilized as a vacuum source. The vacuum can be in communication with the tips of device 10 for providing suction to remove ablated nerve and/or soft tissue.
With further reference to FIGS. 1-3, not shown is an overall glass or other insulating layer covering most of the structure. In some embodiments, the coating or insulating layer can be glass or ceramic having a thickness from about 0.005 to about 0.5 mm thick or from about 0.01 to about 0.2 mm thick.
The glass type insulation is typically applied by a conventional process of dipping each relevant component prior to assembly in liquid (molten) glass and then annealing the glass. In some embodiments, the coating or insulation layer does not cover the entire probe. In some embodiments, the coating or insulation layer does cover the entire probe.
In various embodiments, the device may include radiographic markers to help indicate position on imaging procedures (e.g., CT scan, X-ray, fluoroscopy, PET scan, etc.). These may be disposed on or a portion of the device and include, but are not limited to, barium, calcium phosphate, and/or metal beads.
In some embodiments, device 10 can also have a blunt probe tip. As a result, the surgeon or health practitioner can eliminate any difficulty in positioning the tip in the optimal location to get an optimal and consistent clinical result. The use of device 10 also results in avoiding necrosis of adjacent tissue, which can lead to clinical adverse events and requires these adjacent tissues to have to repair themselves. Positioning of the tip allows cryoablation to be applied near the tips and avoids hemisphere spacing around the tips to avoid unwanted necrosis.
In some embodiments, the probe tip can comprise grooves (not shown). Grooves can have edges shaped as a regular or irregular polygon including arcuate, round, square, oblong, oval, kidney shaped, beveled, or crescent shaped. The grooves can also include ridges or have no ridges. In various embodiments, the grooves are located at the tip and can be closed when device 10 is inactive as device 10 is inserted towards the desired location. Once the nerve or soft tissue to ablate is reached, grooves open, the material becomes activated to ablate the nerve or tissue protruding into each groove as device 10 is manually pushed into it.
In certain embodiments, device 10 can be provided with a tube or small channel (not shown) configured to deliver at the location of the severed nerve and/or soft tissue cement or polymer which can provide a physical barrier to prevent the temporary or permanent re-growth of nerve and/or soft tissue so that the pain symptoms do not return. This channel can be adjacent to the internal passage of the sleeve and can run parallel to the internal passage such that the device can ablate and deliver a therapeutic material or barrier (e.g., polymer, cement, gel, etc.) to the area after ablating it.
Methods for Ablation
The present disclosure also provides methods for destroying or removing nerve and/or soft tissue. The methods comprise disposing a probe at a surgical site, wherein the probe comprises an outer tube having an exterior surface comprising a tip and an interior surface, wherein an inner tube is disposed therein, the inner tube comprising an interior surface that defines an internal passage having a filament disposed therein having an opening configured to release a pressurized material into the interior surface of the probe so as to cool the exterior surface of the outer tube to a selected temperature, wherein the disposal of the inner tube within the interior surface of the outer tube produces an air gap that surrounds the exterior surface of the inner tube, and wherein the tip is configured for ablating nerve and/or soft tissue; and moving the device across the nerve and/or soft tissue to ablate the nerve and/or soft tissue.
In various embodiments, the inner tube is hollow and insulated and comprises an opening at a distal end, and the hollow tube comprises a nonconductive material comprising plastic, glass, ceramic, porcelain, composite polymers and rubber.
In some embodiments, the site is a facet joint or a plurality of facets joints and the tip of the probe is placed adjacent to nerve and or soft tissue to form an asymmetrical ice ball configured for ablating the nerve and/or the soft tissue. In various embodiments, ice ball forms at about 2-8 minutes and the nerve is ablated from about 3 to about 16 minutes.
In other embodiments, the methods of the present disclosure further include delivering cement and/or a polymer through a small channel, for injection at the site of the nerve and/or soft tissue destruction to provide a physically barrier at the location of nerve destruction to prevent temporary or permanent nerve regrowth, repair and return of the pain symptoms.
The barrier material utilized can be any suitable material effective to prevent or at least substantially inhibit the migration of substances that regrow tissue. Illustratively the barrier material can comprise a biodegradable synthetic polymer, in either flowable (and potentially hardenable) or non-flowable form. Illustratively, preferred barrier materials can have a first relatively flowable state during delivery and a second relatively less flowable state after implantation. For example, the barrier material may remain in an uncured, deformable, or otherwise configurable state during introduction, and rapidly cure, become harder or solidify after being introduced. Suitable materials that may be used for the barrier material include tissue sealants, adhesives, or implant materials made from natural or synthetic materials, including, for example, fibrin, albumin, collagen, elastin, silk and other proteins, polyethylene glycols (e.g. PEG gels), polyethylene oxide, cyanoacrylate, polylactic acid, polyglycolic acid, copolymers of polylactic acid and polyglycolic acid, polypropylene fumarate, tyrosine-based polycarbonate, ceramics, and combinations thereof. In some embodiments, the barrier material can be a cement.
In several embodiments, the methods disclosed herein include operatively coupling the device to a source of navigational capability to allow easier pushing through the tissues. In various embodiments, the methods of ablation disclosed herein can include a pre-procedure step wherein the device can be coupled to a CT or MRI machine so that the target nerve and/or soft tissue to be ablated can be identified and accurately located during the ablation procedure.
The methods for ablation described hereinabove allow complete destruction of the nerve avoiding the problems and partial effectiveness of current cryoablation and RF devices available in the art, and also allow for more complete removal of soft tissue that is causing stenosis pain symptoms.
In various embodiments, kits are provided that include device 10. The kits can include at least one probe and at least one tip. In some embodiments, the probe and/or the tip is made reusable for multiple procedures after cleaning and sterilization.
Specific clinical application of this instrument include destruction of nerves causing facet and discogenic back and leg pain, destruction of soft tissue causing stenosis pain symptoms, and many other orthopedic and oral maxillofacial pain. Many other painful conditions associated with arthroscopic, otolaryngological or spinal procedures could use the ablation devices and methods of using these ablation devices described herein.
It will be apparent to those skilled in the art that various modifications and variations can be made to various embodiments described herein without departing from the spirit or scope of the teachings herein. Thus, it is intended that various embodiments cover other modifications and variations of various embodiments within the scope of the present teachings.

## Claims

1. An ablation device comprising:
a probe comprising:
an outer tube having a first exterior surface, the first exterior surface comprising a proximal end and a distal end, and a pointed tip defined at the distal end;
a first interior surface, the first interior surface defining a first internal passage, the first internal passage having an inner tube disposed therein, the inner tube comprising a second exterior surface and a second interior surface, the second interior surface defining a second internal passage, the second internal passage having an opening at a distal end thereof; and
a filament disposed in the second internal passage, the filament having a distal end proximate the opening, and configured to release a pressurized material into at least the second internal passage the pressurized material adapted to cool at least a portion of the first exterior surface of the outer tube to a selected temperature;

wherein the ablation device further comprises an air gap between at least a portion of the second exterior surface of the inner tube and the first internal passage so as to insulate the at least the portion of the second exterior surface from the select selected temperature; and
wherein the pointed tip is configured for piercing, pushing through, and ablating at least one of nerve and soft tissue.

2. An ablation device of claim 1, wherein the pointed tip comprises approximately a 20 gauge needle and the probe comprises one of titanium, stainless steel, tungsten, molybdenum and alloys thereof.

3. An ablation device of claim 1, wherein the pointed tip is a metal temperature conductive tip comprising one of stainless steel, titanium, copper, silver, gold, aluminum, brass, platinum, molybdenum and tungsten.

4. An ablation device of claim 1, wherein the inner tube is hollow and insulated.

5. An ablation device of claim 1, wherein the inner tube comprises a nonconductive material comprising at least one of plastic, glass, ceramic, porcelain, composite polymers, rubber, and a combination thereof.

6. An ablation device of claim 1, wherein the pressurized material comprises one of a liquid and a gas, the gas comprising one of argon, liquid nitrogen, nitric oxide, helium, air, krypton, carbon dioxide, tetrafluoromethane, and xenon.

7. An ablation device of claim 1, wherein the filament is about 0.016 inches in diameter and the pressurized material expands within an interior surface of the pointed tip to cause a decrease in the temperature of the pressurized material.

8. An ablation device of claim 1, wherein the temperature of the pressurized material decreases at or near the pointed tip and wherein the pressurized material is cooled at the probe pointed tip at approximately −100° to approximately −180° C.

9. An ablation device of claim 1, wherein the pointed tip of the probe is further configured to contact one of the nerve and the soft tissue at a facet joint to form an ice ball, the ice ball being configured for ablating the one of the nerve and the soft tissue at the facet joint, the ice ball forming in about 2 to about 8 minutes and the one of the nerve and the soft tissue becoming ablated in about 3 to about 16 minutes.

10. An ablation device as in claim 9, wherein the ice ball is directional.

11. An ablation device of claim 1, wherein the pointed tip is hollow.

12. A cryoablation device comprising:
an insulated probe, the insulated probe comprising an exterior surface and an interior surface, the interior surface defining an internal passage, the internal passage having a filament disposed therein, the filament having an opening configured to release a pressurized material into at least the internal passage of the probe so as to cool the exterior surface of the probe to a selected temperature, wherein the exterior surface comprises a pointed tip configured for piercing, pushing through, and ablating one of nerve and soft tissue.

13. A cryoablation device of claim 12, wherein the pointed tip is about approximately a 20 gauge needle and the probe comprises one of stainless steel, titanium, tungsten, molybdenum and alloys thereof.

14. A cryoablation device of claim 12, wherein the insulated probe comprises a heat resistant plastic material comprising one of PMMA, PET, PEEK, PVC and HDPE.

15. A cryoablation device of claim 14, wherein the pointed tip of the probe contacts the one of the nerve and the soft tissue at a facet joint to form an ice ball, the ice ball being configured for ablating the one of the nerve and the soft tissue at the facet joint, wherein the ice ball forms in about 2 minutes to about 8 minutes and wherein the one of the nerve and the soft tissue is ablated in about 3 minutes to about 16 minutes.

16. A cryoablation device as in claim 15, wherein the ice ball is symetrical.

17. A cryoablation device of claim 12, wherein the pointed tip is a metal temperature conductive tip comprising one of stainless steel, titanium, copper, silver, gold, aluminum, brass, platinum, molybdenum, tungsten and alloys thereof.

18. A cryoablation device of claim 17, wherein the pointed tip is disposed at a distal end of the probe via a threaded engagement.

19. A cryoablation device of claim 12, wherein at least a portion of the exterior surface of the probe is insulated by an air gap, the air gap being formed by at least one expandable balloon disposed on the at least a portion of the exterior surface of the probe.

20. A cryoablation device of claim 12, wherein the temperature of the pressurized material decreases at or near the pointed tip and wherein the pressurized material is cooled at the pointed tip at approximately −100° to about −180° C.

21. A method of ablating one of nerve and soft tissue, comprising:
disposing a probe at a surgical site, the probe comprising an outer tube having a first exterior surface comprising a pointed tip and a first interior surface, the first interior surface defining a first internal passage, and an inner tube is disposed in the first internal passage, the inner tube comprising a second exterior surface and a second interior surface, the second interior surface defining a second internal passage, the second internal passage having a first opening at a distal end thereof, and a filament disposed therein, the filament having a second opening proximate the first opening, the filament being configured to release through the second opening a pressurized material into at least the second internal passage of the probe, the pressurized material adapted to cool the exterior surface of the outer tube to a selected temperature, wherein the disposal of the inner tube within the first internal passage of the outer tube produces an air gap that surrounds the second exterior surface of the inner tube, and the pointed tip is configured for piercing, pushing through, and ablating the one of the nerve and the soft tissue; and
one of piercing, pushing the pointed tip through the one of the nerve and the soft tissue, and placing the pointed tip adjacent to the one of the nerve and the soft tissue; and
using the pointed tip to ablate the one of the nerve and the soft tissue.

22. A method of claim 21, wherein the inner tube is hollow and insulated and comprises a nonconductive material comprising one of plastic, glass, ceramic, porcelain, composite polymers and rubber.

23. A method of claim 21, wherein the surgical site is a facet joint or a plurality of facets joints, and wherein placing the pointed tip of the probe adjacent to the one of the nerve and the soft tissue further comprises:
forming an ice ball proximate the pointed tip, the ice ball being configured for ablating the one of the nerve and the soft tissue, the ice ball at forming in about 2 minutes to about 8 minutes and the nerve being ablated in about 3 minutes to about 16 minutes.

24. A method of claim 23, wherein forming an ice ball further comprises forming an asymmetrical ice ball.