Not applicable.
Not applicable.
Not applicable.
This invention is directed to
A study from the National Center for Health Statistics at the CDC showed that 39.6% of US adults age 20 and older were obese as of 2015-2016 (37.9% for men and 41.1% for women). Additionally, studies correlate heart attacks not just to being overweight, but to the amount of intraperitoneal fat (also called visceral fat).
Obesity in the United States is a major health issue, resulting in numerous diseases, specifically increased risk of certain types of cancer, coronary artery disease, type 2 diabetes, stroke, as well as significant economic costs.
If a surgical procedure to remove intraperitoneal fat could be developed there would be fewer heart attacks and improved health.
Currently, there is no surgical method available to remove intraperitoneal fat. The use of liposuction is not desirable as the process includes mechanical liquification of fat, which would damage internal organs.
Intraperitoneal fat is known to be difficult to remove by diet and exercise.
Cryosurgery is one method of killing tissue and is used for cancer treatments. It is a candidate for removal of intraperitoneal fat under the right conditions. However, current methods and equipment is inadequate to avoid internal organ damage when organs are interspersed in the intraperitoneal fat. Internal organs are likely to be damaged from freezing fat tissue if there is no methodology to identify organ positions to ensure that no damage is created. Additionally, current cryosurgery methods do not address removal of frozen tissue during surgery.
Others have worked in the field of cryogen treatments such as U.S. Pat. No. 6,041,787 where the system is described and its benefits. U.S. Pat. No. 5,531,742 describes computerized methods to monitor the frozen region and provide feedback to the surgeon.
U.S. Pat. No. 5,112,302 describes liposuction, which is used for removal of subcutaneous fat. The removal of fat is based on mechanical liquification of fat and then the fat is removed by vacuum. This motion of the cannula in the fat is very traumatic, and complications such as seromas, numbness, skin infections, or an internal puncture from the moving cannula can occur.
Cryosurgery is used in cancer treatment by utilizing liquid nitrogen or argon gas on cancerous tissue to destroy it. The gas is used to cool a cryoprobe which in turn is used to freeze an internal tumor and surrounding tissue. For an external tumor, liquid nitrogen is sprayed directly to the cancer cells or swabbed onto the tumor with a cotton swab.
There is need in the art for a way to surgically remove intraperitoneal and subcutaneous fat without damage to internal organs for improved health.
The embodied invention is a method of removing intraperitoneal fat by using a cryoprobe and inserting it into the abdominal cavity. The cryoprobe is covered by a vacuum sleeve which provides for a method for intraperitoneal fat removal once the cells are damaged. A multi-step surgical procedure is used to freeze, irrigate, and remove the destroyed fat tissue. Also, an ultrasonic transmitter is inserted into an outer cryoprobe sheath to assess organ position with the advantage of an internal transmitter which greatly aids in organ identification.
When cryogenically treating cancer tumors inside the body, liquid nitrogen or argon flows through a hollow instrument called a cryoprobe, which is placed inside (or in contact with) the tumor to freeze it. Similarly, a cryoprobe can be used to freeze fat tissue.
In the embodied invention, a surgeon uses internal imaging equipment (ultrasound or MRI) to guide the cryoprobe to the correct location and monitor the freezing of the fat cells to avoid damage to nearby organs. When the cryogen (argon or nitrogen) cooled cryoprobe contacts the fat tissue, a ball of frozen tissue forms around the cryoprobe, killing the cells. The cryoprobe is put into the fat tissue through the skin (percutaneously). The frozen tissue is then thawed and removed. Sometimes, more than one freeze-thaw cycle is be used.
The uninsulated length 101 is a cryocooler and freezes fat tissue from the cryoprobe surface outward. When the desired amount of tissue has been frozen, cryogen flow is stopped, and the tissue is allowed to thaw internally. When high pressure argon gas is used as the cryogen to cool the tip of the cryoprobe, it flows through a small diameter inner tube 105, and expands at the end of the inner tube 106. The expanding Argon gas cools the cryoprobe to a very low temperature due to the Joule-Thompson effect. The low pressure Argon gas is then routed through an exhaust chamber 104 to be vented away from the patient. No Argon gas is released inside the patient's body. U.S. Pat. Nos. 7,479,139 and 7,846,154 are examples of cryoprobes.
The term “high-pressure gas” refers to gas pressures that will cause a Joule-Thomson cooling of cryoprobes to −40° C. and lower. In the case of argon gas, for example, “high-pressure” argon is typically between 3000 psi and 4500 psi, though somewhat higher and lower pressures may be used. For a warming gas such as Helium, the working high pressure range is typically 1800-2500 psi.
Since freezing originates from the small uninsulated tip of the cryoprobe, cryosurgery can be confined to a small region of tissue, sparing the surrounding healthy tissue. The freezing process is precise and controlled, as the freezing interface in the fat tissue is sharp and propagates slowly from the tip. A small cryoprobe having a diameter of around 4 mm can produce a 3.5 cm diameter frozen ellipsoid ball to treat a relatively large tissue region in a few minutes. In general, cryosurgery does not create a lot of complications and has low patient morbidity. Cryosurgery produces excellent therapeutic results with less distress at a lower cost. In addition, retreatment is possible.
In the surgical procedure, the Argon gas typically creates a cryoprobe end temperature of −40° C. for freezing fat tissue. However, only a temperature of −10° C. (or lower) is needed for cell destruction, and the cryoprobe end is alternately designed for less than −10° C. As shown in
The cryoprobe temperature is monitored via a temperature sensor 409 located inside the cryoprobe tip, which is connected by a wire 410 to the control system 404. Thermal sensors include thermocouples and thermistor types.
Body heat will unfreeze the frozen fat ball (passive thawing) in about 6-12 minutes. In an alternate embodiment, helium is connected to the cryoprobe and operated to warm the cryoprobe for faster thawing (about 2-4 minutes). Helium properties are different than Argon, as it will heat, not cool, when expanded to atmospheric pressure. An alternate method of warming is to use radio frequency (RF). In this case the cryoprobe temperature measurement is used, and the radio frequency is adjusted to create the desired cryoprobe warming temperature. RF can also be used to increase the heat to a level that will stop any bleeding. Generally, heating tissue to a temperature of least 42° C. to 45° C. causes the irreversible cellular damage needed for thermal ablation.
Multiple freezing sites can be done in a single surgical session. An efficient method is to divide the abdomen into quadrants as shown in
The cryoprobe is either straight or curved. A curved cryoprobe is straight when inside the body, but some cryoprobes have a 90 degree bend outside of the body entry. The vacuum sleeve incorporates holes in the very end of the cryoprobe. The vacuum sleeve is preferably made from a surgical metal such as stainless steel. Alternately it could be made from a surgical plastic. The diameter of the cryoprobes is preferably 4 to 5 mm.
The surgical procedure comprises:
Imaging is preferably done with an ultrasound transducer operating at 12 megahertz. The ultrasound transducer optionally incorporates an imaging sensor to receive the image signals. Typically, a surgeon will be able to see about 4-10 cm depth around the ultrasound cryoprobe. The preferred method for imaging is ultrasound because it is more mobile and radiation free. X-Ray imaging (CT Scan) is not preferred as it emits radiation, and is a large, immobile machine.
Cryosurgery does not require any special patient preparation. It is important that the patient does not eat prior to surgery for four hours due to being sedated.
As a quality check, and before use, the cryoprobe is checked by inserting it into sterile water and a cold temperature created by utilizing the cryogen gas for cooling. If a normal ice ball occurs in the water without leaking Argon, it is ready to be used.
Argon is the preferred cryogen, but Nitrogen (gas or liquid) may also be used.
There is no particular limitation to amount of procedures that can be performed to remove fatty tissue.
To aid in pain control, lidocaine is used to numb the insertion area.
In an additional embodiment, the irrigating solution includes lidocaine for numbing and epinephrine for blood clotting. In an exemplary embodiment, the irrigating solution is a mixture of:
The amount of the irrigating mixture used for irritation is as needed.
Fat tissues of specific anatomical landmarks are divided into areas and shown in
In
It is important that a specially trained physician performs the surgical procedure. Preferably it is done on an outpatient basis. The surgical procedure begins when the cryogenic equipment is ready, and the cryoprobe has been confirmed to be functional.
During the procedure, the patient is connected to monitors that track heart rate, blood pressure, and pulse. The area where the applicators or cryoprobe are to be inserted will be shaved, sterilized, and covered with a sterile drape.
The surgeon only needs to make a very small skin incision is made at the site. The surgeon then performs a percutaneous procedure and inserts the thin, needle-size cryoprobes.
In a preferred embodiment, aside from the cryoprobe(s), transducer, irrigating fluid, and vacuum sleeve, nothing else enters the body.
The entire procedure will only take one to three hours.
In an alternate embodiment, RF warming is used to free up any sticking of the cryoprobe. A different cryoprobe (not illustrated) is used that is capable of RF heating.
The computer is capable of communicating with a temperature sensor and utilizing the temperature sensor for control. Additionally, the computer receives the ultrasound transducer output signal and interprets it into a visual image. The computer may be a desktop computer, a lap top computer, a server, a workstation, a handheld computer, a tablet computer, a single board computer, etc. Preferably the computer is in near proximity to the cryogenic supply unit and integrated into the equipment as shown in
As used herein the terms central computer or computer system are intended to refer to a computer-related entity, comprising either hardware, a combination of hardware and software, software, or software in execution capable of performing the embodiments described. The disclosed embodiments which use the central computer refer to being interfaced to and controlled by a computer readable storage medium having stored thereon a computer program. The computer readable storage medium may include a plurality of components such as one or more of electronic components, hardware components, and/or computer software components. These components may include one or more computer readable storage media that generally store instructions such as software, firmware and/or assembly language for performing one or more portions of one or more implementations or embodiments of an algorithm as discussed herein. These computer readable storage media are generally non-transitory and/or tangible. Examples of such a computer readable storage medium include a recordable data storage medium of a computer and/or storage device. The computer readable storage media may employ, for example, one or more of a magnetic, electrical, optical, biological, and/or atomic data storage medium. Further, such media may take the form of, for example, floppy disks, magnetic tapes, CD-ROMs, DVD-ROMs, hard disk drives, and/or solid-state or electronic memory. Other forms of non-transitory and/or tangible computer readable storage media not list may be employed with the disclosed embodiments.
A number of such components can be combined or divided in an implementation of a computer system. Further, such components may include a set and/or series of computer instructions written in or implemented with any of a number of programming languages, as will be appreciated by those skilled in the art. Computer instructions are executed by at least one central processing unit. In addition, other forms of computer readable media such as a carrier wave may be employed to embody a computer data signal representing a sequence of instructions that when executed by one or more computers causes the one or more computers to perform one or more portions of one or more implementations or embodiments of a sequence.
While various embodiments of the present invention have been described, the invention may be modified and adapted to various operational methods to those skilled in the art. Therefore, this invention is not limited to the description and figure shown herein, and includes all such embodiments, changes, and modifications that are encompassed by the scope of the claims.
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