WO1998041157A1 - Freezing method for controlled removal of fatty tissue by liposuction - Google Patents

Freezing method for controlled removal of fatty tissue by liposuction Download PDF

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Publication number
WO1998041157A1
WO1998041157A1 PCT/US1998/005216 US9805216W WO9841157A1 WO 1998041157 A1 WO1998041157 A1 WO 1998041157A1 US 9805216 W US9805216 W US 9805216W WO 9841157 A1 WO9841157 A1 WO 9841157A1
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WO
WIPO (PCT)
Prior art keywords
probe
fatty tissue
freezing
monitoring
tissue
Prior art date
Application number
PCT/US1998/005216
Other languages
French (fr)
Inventor
Boris Rubinsky
Original Assignee
Boris Rubinsky
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boris Rubinsky filed Critical Boris Rubinsky
Priority to AU65618/98A priority Critical patent/AU6561898A/en
Publication of WO1998041157A1 publication Critical patent/WO1998041157A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00106Sensing or detecting at the treatment site ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00041Heating, e.g. defrosting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231Characteristics of handpieces or probes
    • A61B2018/0262Characteristics of handpieces or probes using a circulating cryogenic fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/08Lipoids

Definitions

  • the invention relates to liposuction and, more specifically, relates to an apparatus and method for destroying and removing fatty tissue in a body.
  • the skin insulates and protects the entire body from mechanical, chemical and thermal damage.
  • Beneath the dermis is the subcutaneous tissue which contains many fat cells.
  • subcutaneous tissue serves as a "shock absorber" and insulates the deeper tissues from extreme
  • the subcutaneous tissue is also responsible for the outer appearance of the body surface.
  • Another major function of the fat cells is to accumulate fat, as a means for storing food. However, for cosmetic or aesthetic reasons, it may be desirable to reduce the volume of
  • Liposuction is a surgical procedure that permanently removes localized deposits of fat
  • a catheter connected to a high vacuum device is introduced into the fatty tissue through an incision in the skin, and the fat is removed by aspiration. This procedure requires
  • Lidocaine is a local anesthetic, and epinephrine causes lipolysis and vasoconstriction. Lipolysis is destruction of fatty structures.
  • the surgeon tries to remove the fatty tissue in such a way that a desired sculpted tissue structure is achieved. During this step, it
  • cryosurgery is a procedure for destroying tissue. In cryosurgery, undesirable tissues are
  • the technique is minimally invasive, usually requiring an insertion of only
  • the probes are cooled internally with a cryogen and are insulated except at the tip.
  • the uninsulated tip is inserted
  • freezing originates from small uninsulated tip of a probe, the procedure can be confined to a region of the diseased tissue, thereby sparing surrounding healthy tissue.
  • the freezing process can be precise and controlled, as the freezing interface is sharp and propagates slowly (in the order of mm/min).
  • liver cryosurgery is currently performed with five 3 mm diameter probes. Multiple sites can be
  • cryosurgery does not create a lot of complications and patient morbidity is low. Cryosurgery can produce excellent medical results with less distress and disfiguration at a lower cost. In addition, cryosurgery is not dose limited, therefore retreatment is possible.
  • Intraoperative ultrasound can image the progress of freezing during
  • cryosurgery by virtue of the fact that the interface between frozen tissue and non-frozen tissue is
  • cryosurgery is now almost universally carried out under ultrasound guidance.
  • Another recent improvement in imaging technology for use with cryosurgery is magnetic resonance imaging (MRI). This
  • interface with a resolution of 200 gm, and can control its shape through MRI feedback.
  • cryosurgery is gaining acceptance as a first-line therapy for prostate, liver and other cancer therapy.
  • Mazur's two factor theory explains destruction of tissue by freezing.
  • the intracellular solution can remain supercooled and unfrozen, when the extracellular solution begins
  • An object of this invention is to develop a method, and the related apparatus to further reduce the morbidity associated with liposuction and to facilitate greater control over the
  • the invention combines cryosurgery with
  • the invention features a novel method for removing fatty tissue in a body. According to the method, fatty tissue is first destroyed and subsequently removed from the body.
  • fatty tissue is first destroyed using cryosurgery, and the destroyed fatty tissue
  • tissue prior to liposuction facilitates the removal step.
  • fatty tissue is destroyed using cryosurgery, and the destroyed tissue is left in the body for the body's natural immune system to remove.
  • a cryosurgical probe is inserted in the fatty tissue, and the probe is
  • the cryosurgical probe freezes the fatty tissue at a rate which
  • the freezing process propagates the freezing interface in the order of approximately several millimeters per minute.
  • the freezing process is monitored to control the extent of freezing.
  • Monitoring may be performed using palpation, image monitoring or temperature monitoring.
  • heat is applied to a skin area surrounding the fatty tissue
  • a tumescent fluid is introduced in the fatty tissue prior to freezing the fatty tissue.
  • the tumescent fluid functions as an anesthetic and also assists in
  • a tumescent fluid is combination of lidocaine and
  • the invention features an apparatus for removing a fatty tissue inside a body.
  • the apparatus includes a first probe for freezing and destroying the fatty tissue and a
  • the first probe for removing the destroyed fatty tissue.
  • the first probe is a probe for removing the destroyed fatty tissue.
  • cryosurgical probe internally cooled with a cryogen
  • the second probe comprise a
  • the cryosurgical probe may be a thin cylindrical probe insertable in a tissue and connected to a source of cryogen.
  • the liposuction probe may be an aspiration
  • the first probe and the second probe are assembled into a single unit.
  • the second probe for example, comprises an outer sleeve surrounding an inner probe.
  • the inner probe is the first probe.
  • the apparatus includes a third probe for inserting a tumescent fluid into the fatty tissue. In still another embodiment, the apparatus includes monitoring probes
  • FIG. 1 shows one embodiment of a cryoliposuction apparatus of the present invention.
  • FIG. 2 shows a cross-section of one embodiment of a cryoliposuction probe of the present
  • FIG. 3 shows another embodiment of a cryoliposuction apparatus of the present invention.
  • a cryoliposuction apparatus 10 includes a first probe 14 for freezing
  • the first probe 14 is a cryosurgical probe which is internally cooled with a cryogen.
  • the cryosurgical probe 14 may be in communication with an external source of cryogen 22.
  • the cryosurgical probe 14 may include the cryogen inside the probe 14.
  • the first probe 14 is shaped to facilitate the destruction of fatty tissue, without contacting surrounding tissue or skin.
  • the first probe 14, for example, comprises a thin cylindrical probe insertable in tissue.
  • the thin cylindrical probe 14, may have a diameter of
  • the cryosurgical probe 14 and the cryogen 22 may be in communication with a controller 30 to control the amount of cryogen delivered to the probe 14.
  • the cryosurgical probe 14 may be any conventional cryosurgical probe known in the art capable of cooling tissue upon contact.
  • the second probe 18 comprises a conventional liposuction probe.
  • a conventional liposuction probe 18 includes an aspiration needle in communication with an external source of vacuum 26 such as a vacuum pump.
  • the cryoliposuction apparatus 10 may further include a monitoring system 34.
  • monitoring system 34 includes one or more monitoring probes 38 in communication with a monitor 42.
  • the monitoring probes 38 contact the body during the cryoliposuction process and
  • the monitoring probes 38 are ultrasound surface probes, and the monitor 42 is an ultrasound imaging machine. Ultrasound imaging
  • cryoliposuction apparatus 10 imaging, MRI, ultrasound, and thermocouples, suitable for monitoring the freezing process may be used with the cryoliposuction apparatus 10.
  • a plurality of warm pads 70 may be used with the cryoliposuction apparatus 10.
  • the warm fluid are perfused with warm fluid and disposed on surfaces of the monitoring probes 38.
  • the warm fluid are perfused with warm fluid and disposed on surfaces of the monitoring probes 38.
  • the warm pads 70 may be connected to a source of warm fluid 71, and flow of the warm fluid to the pads 70 may be
  • the first probe and the second probe of the cryoliposuction apparatus are identical to FIG. 2, the first probe and the second probe of the cryoliposuction apparatus
  • an external sleeve 50 fits around a probe
  • the probe 54 may be a cryosurgical probe, and the sleeve 50 and the probe 54 may form a passageway 58 for removing destroyed tissue.
  • the cryoliposuction apparatus 60 includes a first probe 62, a second probe 64, and a third probe 66.
  • the first probe 62 destroys the tissue by freezing it, and the
  • the second probe 64 removes the destroyed tissue.
  • the third probe 66 is in communication with a tumescent fluid 68 and is used for inserting the tumescent fluid into the fatty tissue .
  • the tumescent fluid provides two benefits. One, the fluid acts as a local anesthetic. Two, the fluid
  • tumescent fluid is combination of lidocaine and epinephrine.
  • the second probe 64 may be used for both inserting a tumescent fluid into the fatty tissue and for removing destroyed
  • the cryoliposuction apparatus of the present invention may be used in any of the
  • cryoliposuction apparatus 10 is inserted in the fatty tissue 11.
  • Cryogen from the cryogen source 22 is delivered to the tip of the first probe 14, and the fatty tissue 11 in contact with the probe 14 begins to freeze.
  • the rate of freezing or the freezing interface propagation is in
  • tissue 11 can be controlled. Once the fatty tissue 11 has been destroyed, the fatty tissue 11 is removed from the body. In one embodiment, a conventional liposuction is performed to remove
  • the second probe 18 or the liposuction probe connected to a vacuum source 26 is inserted in the destroyed fatty tissue 11, and aspiration of the destroyed fatty
  • tissue 11 is performed.
  • the destroyed fatty tissue 11 is left in the body for the body's natural immune system to remove.
  • a limited amount of fat is destroyed, as for
  • cryosurgery of the fat without aspiration may be sufficient to remove the destroyed fat.
  • the process of freezing is monitored to control the extent of freezing.
  • the freezing process can be monitored using palpation, image monitoring or temperature monitoring.
  • image monitoring processes are magnetic resonance imaging,
  • Heat may be
  • a tumescent fluid is introduced into the fatty tissue
  • the treated tissue region was immediately resected, and the
  • cryosurgical probe After freezing, the cryosurgical probe was removed, and through the same incision, a 3 mm
  • Experiment 3 demonstrates the ability to control the amount of tissue removed with cryoliposuction.
  • the experimental steps comprise: (1) introducing a 3.5 mm cryosurgical probe in the fatty
  • tissue through an incision (2) freezing a 1 cm diameter circular region of fat under ultrasound monitoring; (3) removing the cryosurgical probe; (4) introducing an aspiration needle to the tissue through the same incision; and (5) sweeping the aspiration needle connected to a vacuum pump
  • tissue is resected, embedded in formalin and examined with histological
  • cryosurgery different sites of the animal adipose, using cryosurgery, cryoliposuction and liposuction.
  • cryosurgical probe into the fatty tissue; and (3) freezing the fatty tissue under ultrasound
  • cryosurgery prior to liposuction facilities insertion of the aspiration needle to the fatty
  • cryosurgery was replaced by dense fibrous connective tissue.

Abstract

A method for removing fatty tissue in a body combines cryosurgery and liposuction. Cryosurgery first destroys fattty tissue to be removed by controllably freezing the tissue, and facititates removal of the fatty tissue. Liposuction subsequently removes the destroyed fatty tissue by aspiration.

Description

FREEZING METHOD FOR CONTROLLED REMOVAL OF FATTY TISSUE BY LIPOSUCTION
Field of the Invention The invention relates to liposuction and, more specifically, relates to an apparatus and method for destroying and removing fatty tissue in a body.
Background of the Invention
The skin insulates and protects the entire body from mechanical, chemical and thermal damage. Beneath the dermis is the subcutaneous tissue which contains many fat cells. The
subcutaneous tissue serves as a "shock absorber" and insulates the deeper tissues from extreme
temperature changes. The subcutaneous tissue is also responsible for the outer appearance of the body surface. Another major function of the fat cells is to accumulate fat, as a means for storing food. However, for cosmetic or aesthetic reasons, it may be desirable to reduce the volume of
fatty tissue in the body. Exercise and diet can sometimes reduce accumulation of fat in the fat
cells, but they cannot reduce the number of fat cells or their distribution. The number of fat cells
in the subcutaneous tissue is relatively constant. Furthermore, fat accumulation persists despite
diet or exercise for many people. Liposuction is a surgical procedure that permanently removes localized deposits of fat
cells, thereby producing a desirable shape of the body or the face through sculpturing. In a typical
liposuction, a catheter connected to a high vacuum device is introduced into the fatty tissue through an incision in the skin, and the fat is removed by aspiration. This procedure requires
general anesthesia, involves significant blood loss, and has relatively high morbidity and mortality. This problem has been resolved to some extent with the more recent tumescent liposuction. In
tumescent liposuction, large volumes of dilute lidocaine and epinephrine are infiltrated into the subcutaneous fatty tissue before the suction stage. Lidocaine and epinephrine are delivered
through a canulated hollow tube inserted through a small skin incision into the fatty tissue
between the skin and the muscle. Lidocaine is a local anesthetic, and epinephrine causes lipolysis and vasoconstriction. Lipolysis is destruction of fatty structures. Following the infiltration of the mixture of lidocaine and epinephrine, a catheter connected to a high vacuum device is introduced
to the fatty tissue and moved rapidly through the tissue to break up the fat cells that are aspired
through the catheter. This procedure has significantly less morbidity and has no reported mortality.
During the aspiration part of the liposuction procedure, the surgeon tries to remove the fatty tissue in such a way that a desired sculpted tissue structure is achieved. During this step, it
is important not only to remove the fat from the various areas to obtain the desired shape, but also
to create a final tissue appearance of the skin that is regular and smooth. Creating a smooth final tissue appearance, however, is not an easy task. The sculpting of the tissue and the final aesthetic appearance of the body are strongly dependent on the technical skill of the surgeon. Cryosurgery is a procedure for destroying tissue. In cryosurgery, undesirable tissues are
frozen and destroyed. The technique is minimally invasive, usually requiring an insertion of only
one or more thin, cylindrical, cryosurgical probes into the undesirable tissue. The probes are cooled internally with a cryogen and are insulated except at the tip. The uninsulated tip is inserted
in a tumor or other undesirable tissue, and the tissue is frozen from the probe surface outward. When the desired amount of tissue has been frozen, cryogen is prevented from flowing to the
probe, and the tissue is allowed to thaw. After cryosurgery, the frozen tissue is left in situ to be
reabsorbed by the immune system over time. Since freezing originates from small uninsulated tip of a probe, the procedure can be confined to a region of the diseased tissue, thereby sparing surrounding healthy tissue. The freezing process can be precise and controlled, as the freezing interface is sharp and propagates slowly (in the order of mm/min). A small probe having a
diameter of around 3 mm can produce a 3.5 cm ice ball, and therefore treat a relatively large tissue region. When the shape of the pathological tissue is large and complex, several probes can be used simultaneously to generate a frozen region of a desired shape. For example, prostate and
liver cryosurgery is currently performed with five 3 mm diameter probes. Multiple sites can be
treated separately or together. Because the only physical invasion of the tissue is the insertion of
the cryoprobes, cryosurgery does not create a lot of complications and patient morbidity is low. Cryosurgery can produce excellent medical results with less distress and disfiguration at a lower cost. In addition, cryosurgery is not dose limited, therefore retreatment is possible.
Until recently, a major impediment to the extensive use of cryosurgery on internal tissues has been the inability to observe the frozen region deep inside the body, which could cause complications of over or under freezing. Breakthroughs in non-invasive imaging technology,
however, have made possible major advances in cryosurgery in general, and prostate and liver
cryosurgery in particular. Intraoperative ultrasound can image the progress of freezing during
cryosurgery by virtue of the fact that the interface between frozen tissue and non-frozen tissue is
associated with a change in acoustic impedance that reflects ultrasound waves. Cryosurgery is now almost universally carried out under ultrasound guidance. Another recent improvement in imaging technology for use with cryosurgery is magnetic resonance imaging (MRI). This
technique, which images the process of freezing in three dimensions, can monitor the freezing
interface with a resolution of 200 gm, and can control its shape through MRI feedback.
Additional methods of imaging are being continuously developed. One such method under development is the use of light to image freezing. Cryosurgery can be performed with greater
accuracy and control with the assistance of the imaging techniques. Therefore, cryosurgery is gaining acceptance as a first-line therapy for prostate, liver and other cancer therapy. Mazur's two factor theory explains destruction of tissue by freezing. Much of the
research on the effects of freezing on biological materials has focused on the use of freezing for preservation of cells (such as red blood cells, embryos, sperm). This work has shown that an
important thermal variable is the cooling rate (change in temperature per unit time) during freezing. The correlation between cell survival and cooling rate is an "inverse U" shape. Cell
survival is greatest for the cooling rate at the peak of the inverse "U", and destruction increases above or below this optimal cooling rate for survival. However, different types of cells have
different optimal cooling rates for survival. This difference is associated with the structure and
mass transfer properties of the cell membrane and the size of the cells. These general findings are incorporated in Mazur's "two factor" theory, which explains how cooling rates relate to cellular
damage.
Mazur proposed that since the probability for an ice crystal to form at any temperature is a function of volume during freezing of cells in a cellular suspension, ice will form first in the much
larger extracellular space, before each individual cell freezes. Since ice does not incorporate solutes, the ice that forms in the extracellular space will reject the solutes into the remaining
unfrozen solution. The concentration of solutes in the extracellular solution will consequently
increase. The small volume of intracellular solution results in a correspondingly low probability
for ice nucleation to occur inside the cell. Therefore, with sufficiently low cooling rates, the intracellular solution can remain supercooled and unfrozen, when the extracellular solution begins
to freeze and exclude solutes. Under these circumstances, the unfrozen cells will be surrounded
by a hypertonic solution. To equilibrate the difference in chemical potential between the
intracellular and the extracellular solution, water will pass through the cell membrane, which is permeable to water but impermeable to ions and other organic solutes. Therefore, as the
temperature of the solution is lowered and additional ice forms in the extracellular solution, water will leave the cell to equilibrate the intracellular and the extracellular concentration, and the cell
will dehydrate and shrink. The intracellular solution will remain unfrozen and become hypertonic, causing chemical damage involving denaturation of intracellular proteins. Since chemical damage
is a function of time and temperature, the damage will increase with lower cooling rates. Because water transport is a rate dependent process, faster freezing with higher cooling rates decreases the
amount of time a cell is exposed to the chemically damaging conditions and increases survival.
This explains the increase in cell viability with an increase in cooling rate toward an optimum.
However, increasing the cooling rate also results in a more rapid decrease in temperature. The unfrozen water in cells will therefore experience a greater thermodynamic supercooling. The
supercooled intracellular solution is thermodynamically unstable, and after reaching a certain
value it will nucleate and freeze. It is thought that the intracellular ice formation damages cells.
The probability for intracellular ice formation increases with increasing cooling rate, and
consequently the survival of frozen cells decreases with increasing cooling rate.
These two modes of damage, chemical at low cooling rates and intracellular ice formation
at high cooling rates, form the basis of the "two factor" theory of cellular damage proposed by
Mazur. Survival of cells is optimal during freezing with thermal conditions in which these two
conflicting modes of damage are minimized.
An object of this invention is to develop a method, and the related apparatus to further reduce the morbidity associated with liposuction and to facilitate greater control over the
appearance of the body surface after liposuction. The invention combines cryosurgery with
liposuction.
Summary of the Invention In one aspect, the invention features a novel method for removing fatty tissue in a body. According to the method, fatty tissue is first destroyed and subsequently removed from the body.
In one embodiment, fatty tissue is first destroyed using cryosurgery, and the destroyed fatty tissue
is subsequently removed using a conventional liposuction procedure. Destruction of the fatty
tissue prior to liposuction facilitates the removal step. In another embodiment, fatty tissue is destroyed using cryosurgery, and the destroyed tissue is left in the body for the body's natural immune system to remove.
In one embodiment, a cryosurgical probe is inserted in the fatty tissue, and the probe is
internally cooled with a cryogen. The cryosurgical probe freezes the fatty tissue at a rate which
propagates the freezing interface in the order of approximately several millimeters per minute. In another embodiment, the freezing process is monitored to control the extent of freezing.
Monitoring may be performed using palpation, image monitoring or temperature monitoring.
In still another embodiment, heat is applied to a skin area surrounding the fatty tissue
during the freezing process in order to prevent the skin area from freezing. Heat may be applied
to the skin area by placing a warm pad perfused with warm fluid on surfaces of monitoring
probes, and placing the monitoring probes on the body prior to inserting the cryosurgical probe into the fatty tissue. In still another embodiment, a tumescent fluid is introduced in the fatty tissue prior to freezing the fatty tissue. The tumescent fluid functions as an anesthetic and also assists in
destroying the fatty tissue. An example of a tumescent fluid is combination of lidocaine and
epinephrine. In another aspect, the invention features an apparatus for removing a fatty tissue inside a body. The apparatus includes a first probe for freezing and destroying the fatty tissue and a
second probe for removing the destroyed fatty tissue. In one embodiment, the first probe
comprises a cryosurgical probe internally cooled with a cryogen, and the second probe comprise a
conventional liposuction probe. The cryosurgical probe may be a thin cylindrical probe insertable in a tissue and connected to a source of cryogen. The liposuction probe may be an aspiration
needle connected to a source of vacuum. In another embodiment, the first probe and the second probe are assembled into a single unit. The second probe, for example, comprises an outer sleeve surrounding an inner probe. The inner probe is the first probe.
In still another embodiment, the apparatus includes a third probe for inserting a tumescent fluid into the fatty tissue. In still another embodiment, the apparatus includes monitoring probes
in communication with a monitor for monitoring the freezing process.
Brief Description of the Drawings
The foregoing and other objects, features and advantages of the present invention, as well as the invention itself, will be more fully understood from the following description of preferred
embodiments, when read together with the accompanying drawings, in which:
FIG. 1 shows one embodiment of a cryoliposuction apparatus of the present invention. FIG. 2 shows a cross-section of one embodiment of a cryoliposuction probe of the present
invention. FIG. 3 shows another embodiment of a cryoliposuction apparatus of the present invention.
Detailed Description Referring to FIG. 1, a cryoliposuction apparatus 10 includes a first probe 14 for freezing
and destroying fatty tissue, and a second probe 18 for removing the destroyed fatty tissue. In one embodiment, the first probe 14 is a cryosurgical probe which is internally cooled with a cryogen.
The cryosurgical probe 14 may be in communication with an external source of cryogen 22.
Alternatively, the cryosurgical probe 14 may include the cryogen inside the probe 14. In one embodiment, the first probe 14 is shaped to facilitate the destruction of fatty tissue, without contacting surrounding tissue or skin. The first probe 14, for example, comprises a thin cylindrical probe insertable in tissue. The thin cylindrical probe 14, may have a diameter of
approximately several millimeters. The cryosurgical probe 14 and the cryogen 22 may be in communication with a controller 30 to control the amount of cryogen delivered to the probe 14.
According to the invention, the cryosurgical probe 14 may be any conventional cryosurgical probe known in the art capable of cooling tissue upon contact.
In one embodiment, the second probe 18 comprises a conventional liposuction probe. A conventional liposuction probe 18 includes an aspiration needle in communication with an external source of vacuum 26 such as a vacuum pump.
The cryoliposuction apparatus 10 may further include a monitoring system 34. The
monitoring system 34 includes one or more monitoring probes 38 in communication with a monitor 42. The monitoring probes 38 contact the body during the cryoliposuction process and
monitors the freezing process. In one embodiment, the monitoring probes 38 are ultrasound surface probes, and the monitor 42 is an ultrasound imaging machine. Ultrasound imaging
technique is well known to those skilled in the art. Other imaging techniques such as light
imaging, MRI, ultrasound, and thermocouples, suitable for monitoring the freezing process may be used with the cryoliposuction apparatus 10. In one embodiment, a plurality of warm pads 70
are perfused with warm fluid and disposed on surfaces of the monitoring probes 38. The warm
pads 70 and the monitoring probes 38 are then placed on the body near the cryosurgical probe 14
to prevent adjacent skin area from freezing during cryoliposuction. The warm pads 70 may be connected to a source of warm fluid 71, and flow of the warm fluid to the pads 70 may be
controlled.
Referring to FIG. 2, the first probe and the second probe of the cryoliposuction apparatus
may be assembled into a single unit. In this embodiment, an external sleeve 50 fits around a probe
54. The probe 54 may be a cryosurgical probe, and the sleeve 50 and the probe 54 may form a passageway 58 for removing destroyed tissue.
Referring to FIG. 3, the cryoliposuction apparatus 60 includes a first probe 62, a second probe 64, and a third probe 66. The first probe 62 destroys the tissue by freezing it, and the
second probe 64 removes the destroyed tissue. The third probe 66 is in communication with a tumescent fluid 68 and is used for inserting the tumescent fluid into the fatty tissue . The tumescent fluid provides two benefits. One, the fluid acts as a local anesthetic. Two, the fluid
comprises a chemical capable of assisting in destroyed the fatty tissue. An example of the
tumescent fluid is combination of lidocaine and epinephrine. Alternatively, the second probe 64 may be used for both inserting a tumescent fluid into the fatty tissue and for removing destroyed
fatty tissue.
The cryoliposuction apparatus of the present invention may be used in any of the
following manner to perform liposuction. Referring to FIG. 1, an incision on the skin 13 is made
to provide access to the fatty tissue 11 to be removed. The first probe 14 or the cryosurgical
probe of the cryoliposuction apparatus 10 is inserted in the fatty tissue 11. Cryogen from the cryogen source 22 is delivered to the tip of the first probe 14, and the fatty tissue 11 in contact with the probe 14 begins to freeze. The rate of freezing or the freezing interface propagation is in
the order of approximately several millimeters per minute. In this manner, freezing of the fatty
tissue 11 can be controlled. Once the fatty tissue 11 has been destroyed, the fatty tissue 11 is removed from the body. In one embodiment, a conventional liposuction is performed to remove
the destroyed fatty tissue 11. The second probe 18 or the liposuction probe connected to a vacuum source 26 is inserted in the destroyed fatty tissue 11, and aspiration of the destroyed fatty
tissue 11 is performed. In another embodiment, the destroyed fatty tissue 11 is left in the body for the body's natural immune system to remove. When a limited amount of fat is destroyed, as for
example in a face, cryosurgery of the fat without aspiration may be sufficient to remove the destroyed fat.
In one embodiment, the process of freezing is monitored to control the extent of freezing.
The freezing process can be monitored using palpation, image monitoring or temperature monitoring. Examples of suitable image monitoring processes are magnetic resonance imaging,
CT imaging and ultrasound imaging. In another embodiment, heat is applied to skin area 13
surrounding the fatty tissue 11 in order to prevent the skin area 13 from freezing. Heat may be
applied by placing warm pads 70 perfused with warm fluid on surfaces of the monitoring probes 38 and placing the probes 38 on the body before inserting the cryosurgical probe 14 in the fatty tissue 11. In still another embodiment, a tumescent fluid is introduced into the fatty
tissue 11 prior to or after freezing the fatty tissue 11.
Experiments Experiment 1
This experiment demonstrates that cryosurgery facilitates controlled and easy destruction
of fatty tissue. To this end, experiment was performed on the back fat of piglets. An incision was
made on the back of a piglet to expose a fatty tissue. A circular region of the fatty tissue having a
diameter of about 1 cm was frozen with a 3.5 mm cryosurgical probe, manufactured by Candela
Corporation of Wayland, MA. The tissue froze in the shape of a cylinder. Freezing was controlled by monitoring with an ultrasound surface probe. After freezing and thawing, the tissue was resected in a direction normal to the axis of the frozen cylinder, and the treated area was
fixed in formalin for histological examination. The results showed that fat cells and connective tissue in an area that roughly corresponds to the extent of tissue damage as seen under ultrasound
imaging were destroyed. Follow up studies performed over a period of six weeks showed that scar tissue formed and replaced the fatty tissue. Thus, this experiment further showed that cryosurgery, in conjunction with the body's own immune system, can be used for destroying and removing fat.
Experiment 2
This experiment demonstrates that cryosurgery facilitates controlled and easier removal of fatty tissue. To this end, experiments were performed on the back fat of pigs.
In the first part of this experiment, a 3 mm aspiration needle connected to a controlled vacuum pump was introduced in the fatty layer of a pig, and a standard liposuction was
performed. After the procedure, the treated tissue region was immediately resected, and the
treated area was fixed in formalin for histological examination. The results showed that a relatively small amount of fat was removed by simple aspiration and that there was significant bleeding.
In the second part of the experiment, tissue was first frozen as described in Experiment 1.
After freezing, the cryosurgical probe was removed, and through the same incision, a 3 mm
aspiration needle was introduced into the center of the frozen circular region. The aspiration needle entered the fatty tissue with tremendous ease. In performing liposuction, physicians
encounter difficulty in inserting the liposuction probes into the fat. This makes a standard liposuction procedure physically demanding for the physicians. When the fat was first frozen
prior to liposuction, however, there was no difficulty in inserting the liposuction probe. After
applying the vacuum pump for similar extent of time as in the first part of the experiment, the tissue was resected, fixed in formalin and examined histologically. The results showed that aspiration removes a significantly larger amount of fatty tissue when prior cryosurgery is
performed.
Experiment 3
Experiment 3 demonstrates the ability to control the amount of tissue removed with cryoliposuction.
The experimental steps comprise: (1) introducing a 3.5 mm cryosurgical probe in the fatty
tissue through an incision; (2) freezing a 1 cm diameter circular region of fat under ultrasound monitoring; (3) removing the cryosurgical probe; (4) introducing an aspiration needle to the tissue through the same incision; and (5) sweeping the aspiration needle connected to a vacuum pump
over the previously frozen tissue region under ultrasound monitoring. After the procedure is
completed, the tissue is resected, embedded in formalin and examined with histological
examination. The results would show that the extent of fatty tissue that has been removed corresponds to the extent of the frozen region observed under ultrasound imaging.
Experiment 4
This experiment demonstrates the feasibility of using cryosurgery as a fat conditioning step prior to liposuction and also as an alternative to liposuction in removing fatty tissue.
Two saws were used in this experiment. Fourteen sub-experiments were performed on
different sites of the animal adipose, using cryosurgery, cryoliposuction and liposuction.
In the first part of the experiment, two sites were treated with standard liposuction by: (1) making an incision on the animal skin to provide access to a fatty tissue; (2) inserting a 3.5 mm
diameter 20 cm long cylindrical liposuction probe into the fatty tissue under palpation; (3) introducing a tumescent fluid to the fatty tissue through the liposuction probe; and (4) removing
the fatty tissue through aspiration.
In the second part of the experiment, six sites were treated with cryosurgery by: (1)
making an incision on the animal skin to provide access to a fatty tissue; (2) inserting a
cryosurgical probe into the fatty tissue; and (3) freezing the fatty tissue under ultrasound
monitoring. In the third part of the experiment, two sites were treated with cryoliposuction.
Cryosurgery was first performed on the sites as described above with respect to the second part of the experiment, and liposuction was subsequently performed to remove the fatty tissue
previously destroyed by cryosurgery as described above with respect to the first part of the
experiment.
The results showed that microscopic appearances of the tissue treated by liposuction and tissue treated by cryoliposuction were similar. They both induced an inflammatory response, which eventually replaced the damaged fat cells with fibrous connective tissue. Cryoliposuction,
however, has the advantage over the standard liposuction in that cryoliposuction allows treatment
area to be viewed and treatment process to be controlled under ultrasonic monitoring. In addition, cryosurgery prior to liposuction facilities insertion of the aspiration needle to the fatty
tissue such that the aspiration process is not strenuous for the physicians. The results further showed that cryosurgery alone can be used to remove the fatty tissue. Monitoring of the fatty
tissue treated by cryosurgery over a six week period showed that most of the fat tissue destroyed
by cryosurgery was replaced by dense fibrous connective tissue.
Equivalents
While the invention has been particularly shown and described with reference to specific
preferred embodiments, it should be understood by those skilled in the art that various changes in
form and detail may be made therein without departing from the spirit and scope of the invention
as defined by the appended claims.

Claims

ClaimsWhat is claimed is:
1. A method of removing fatty tissue in a body comprising: controllably freezing the fatty tissue at a cooling rate sufficient to destroy the fatty tissue; and removing the destroyed fatty tissue from the body.
2. The method of claim 1 wherein controllably freezing the fatty tissue comprises: inserting a probe in the fatty tissue; and
internally cooling the probe.
3. The method of claim 1 wherein the probe is a cryosurgical probe, and the probe is
internally cooled with a cryogen.
4. The method of claim 1 wherein controllably freezing the fatty tissue comprises freezing at a rate which propagates a freezing interface in the order of approximately several millimeters per
minute.
5. The method of claim 1 wherein removing the destroyed fatty tissue comprises performing
a conventional liposuction procedure on the destroyed fatty tissue.
6. The method of claim 1 wherein removing the destroyed fatty tissue comprises using a body's own immune system to remove the destroyed fatty tissue.
7. The method of claim 1 wherein removing the destroyed fatty tissue comprises:
inserting a probe into the destroyed fatty tissue, wherein the probe is connected to
a vacuum source; and performing an aspiration of the destroyed fatty tissue using the probe and the
vacuum.
8. The method of claim 1 further comprising monitoring the freezing process to control the extent of freezing the fatty tissue.
9. The method of claim 8 wherein monitoring comprises monitoring through palpation,
image monitoring, or temperature monitoring.
10. The method of claim 9 wherein image monitoring comprises magnetic resonance imaging, CT imaging, light imaging or ultrasound imaging.
11. The method of claim 1 further comprising applying heat to a skin area surrounding the
fatty tissue to prevent the skin area from freezing.
12. The method of claim 11 further comprising monitoring the freezing process, wherein monitoring comprises ultrasound imaging using one or more surface monitoring electrodes and applying heat to a skin area comprises placing a warm pad perfused with warm fluid on surfaces of the monitoring electrodes before placing the monitoring electrodes on the body and before
inserting the probe into the fatty tissue.
13. The method of claim 11 wherein applying heat to a skin comprises controlling a flow of
warm fluid to a skin area underneath the monitoring electrodes.
14. The method of claim 1 further comprising introducing a tumescent fluid in the fatty tissue
prior to controllably freezing the fatty tissue.
15. The method of claim 1 further comprising introducing a tumescent fluid in the fatty tissue
after controllably freezing the fatty tissue.
16. The method of claim 15 wherein the tumescent fluid comprises a local anesthetic and a chemical capable of destroying fatty tissue.
17. The method of claim 15 wherein the tumescent fluid comprises lidocaine and epinephrine
18. An improved method of performing liposuction comprising:
applying heat to a skin area outside a fatty tissue to be removed;
controllably freezing the fatty tissue at a cooling rate sufficient to destroy the fatty tissue;
monitoring the freezing process to control the extent of freezing the fatty tissue; and
removing the destroyed fatty tissue through a conventional liposuction procedure.
19. An apparatus for removing a fatty tissue inside a body comprising: a first probe for freezing and destroying the fatty tissue; and
a second probe for removing the destroyed fatty tissue.
20. The apparatus of claim 19 wherein the first probe comprises a cryosurgical probe
internally cooled with a cryogen.
21. The apparatus of claim 19 wherein the first probe is shaped to prevent contact between the probe and a skin area near the probe when the probe is inserted in the fatty tissue during the
freezing process.
22. The apparatus of claim 19 wherein the first probe comprises a thin cylindrical probe
insertable into a tissue.
23. The apparatus of claim 19 wherein the second probe comprises a conventional liposuction
probe.
24. The apparatus of claim 19 wherein the second probe comprises an aspiration needle
connected to a source of vacuum.
25. The apparatus of claim 19 wherein the first probe and the second probe are assembled into
a single unit.
26. The apparatus of claim 19 wherein the second probe comprises an external sleeve
disposed along a body of the first probe.
27. The apparatus of claim 19 further comprising a third probe for inserting a tumescent fluid.
28. The apparatus of claim 19 wherein the second probe performs both removal of destroyed fatty tissue and insertion of a tumescent fluid.
29. The apparatus of claim 19 further comprising:
monitoring probes and a monitor for monitoring the freezing process.
30. The apparatus of claim 19 wherein a plurality of warm pads perfused with warm fluid are disposed on surfaces of the monitoring probes to be in contact with the body.
31. An improved liposuction apparatus comprising:
a cryosurgical probe connected to a cryogen source; a conventional liposuction apparatus;
an ultrasound surface probe connected to an ultrasound imaging machine; and
a device for heating a skin area near the cryosurgical probe to prevent the skin area from freezing.
PCT/US1998/005216 1997-03-17 1998-03-17 Freezing method for controlled removal of fatty tissue by liposuction WO1998041157A1 (en)

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Applications Claiming Priority (2)

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US4085997P 1997-03-17 1997-03-17
US60/040,859 1997-03-17

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