CA2258619A1 - Method and apparatus for cryosurgery - Google Patents
Method and apparatus for cryosurgery Download PDFInfo
- Publication number
- CA2258619A1 CA2258619A1 CA002258619A CA2258619A CA2258619A1 CA 2258619 A1 CA2258619 A1 CA 2258619A1 CA 002258619 A CA002258619 A CA 002258619A CA 2258619 A CA2258619 A CA 2258619A CA 2258619 A1 CA2258619 A1 CA 2258619A1
- Authority
- CA
- Canada
- Prior art keywords
- cryoneedle
- cryofluid
- shell
- tube
- tip
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
- 238000000034 method Methods 0.000 title claims abstract description 51
- 238000002681 cryosurgery Methods 0.000 title claims abstract description 24
- 238000009413 insulation Methods 0.000 claims abstract description 38
- 238000007710 freezing Methods 0.000 claims abstract description 18
- 230000008014 freezing Effects 0.000 claims abstract description 18
- 238000012546 transfer Methods 0.000 claims abstract description 13
- 230000009467 reduction Effects 0.000 claims abstract description 9
- 230000002265 prevention Effects 0.000 claims abstract description 6
- 230000007246 mechanism Effects 0.000 claims description 19
- 238000003384 imaging method Methods 0.000 claims description 14
- 238000009529 body temperature measurement Methods 0.000 claims description 3
- 238000009428 plumbing Methods 0.000 claims 2
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 238000013022 venting Methods 0.000 claims 1
- 238000003780 insertion Methods 0.000 abstract description 13
- 230000037431 insertion Effects 0.000 abstract description 13
- 239000012530 fluid Substances 0.000 abstract description 6
- 239000002826 coolant Substances 0.000 description 34
- 230000004807 localization Effects 0.000 description 20
- 238000009835 boiling Methods 0.000 description 12
- 238000001816 cooling Methods 0.000 description 11
- 239000007789 gas Substances 0.000 description 10
- 206010028980 Neoplasm Diseases 0.000 description 9
- 238000002604 ultrasonography Methods 0.000 description 9
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 7
- 230000007423 decrease Effects 0.000 description 7
- 230000006378 damage Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 230000008569 process Effects 0.000 description 6
- 238000010257 thawing Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 239000010935 stainless steel Substances 0.000 description 5
- 229910001220 stainless steel Inorganic materials 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 4
- 230000008859 change Effects 0.000 description 4
- 238000012544 monitoring process Methods 0.000 description 4
- 229910052757 nitrogen Inorganic materials 0.000 description 4
- 238000001574 biopsy Methods 0.000 description 3
- 238000010276 construction Methods 0.000 description 3
- 239000012212 insulator Substances 0.000 description 3
- 230000037361 pathway Effects 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 229920003023 plastic Polymers 0.000 description 3
- 241001593730 Acacia salicina Species 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 2
- 229910001369 Brass Inorganic materials 0.000 description 2
- 229910001006 Constantan Inorganic materials 0.000 description 2
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 2
- 238000001949 anaesthesia Methods 0.000 description 2
- 230000037005 anaesthesia Effects 0.000 description 2
- 239000010951 brass Substances 0.000 description 2
- 210000000481 breast Anatomy 0.000 description 2
- 239000010949 copper Substances 0.000 description 2
- 229910052802 copper Inorganic materials 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- 229920005372 Plexiglas® Polymers 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000003444 anaesthetic effect Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000008081 blood perfusion Effects 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 235000011089 carbon dioxide Nutrition 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 208000014617 hemorrhoid Diseases 0.000 description 1
- 210000000987 immune system Anatomy 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000012774 insulation material Substances 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 229910001092 metal group alloy Inorganic materials 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 230000008450 motivation Effects 0.000 description 1
- QJGQUHMNIGDVPM-UHFFFAOYSA-N nitrogen group Chemical group [N] QJGQUHMNIGDVPM-UHFFFAOYSA-N 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 229940061319 ovide Drugs 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000001959 radiotherapy Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 230000037390 scarring Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000010959 steel Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 230000009278 visceral effect Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/10—Instruments, 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 for stereotaxic surgery, e.g. frame-based stereotaxis
- A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
- A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0293—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle
Abstract
The present invention pertains to an apparatus for cryosurgery. The apparatus comprises a cryo-needle (1) having a diameter less than 3.2 mm. The apparatus is also comprised of a thermal insulation shell (5) disposed about a portion of the cryo-needle for reduction of heat transfer from surrounding tissues, or freezing prevention of surrounding tissues during application of the cryo-needle with the shell. The cryo-needle and shell are configured for insertion into a body of a patient. The present invention pertains to a method for freezing tissues. The method comprises the steps of bringing into contact a cryo-needle having a diameter of less than 3.2 mm with a patient's body. Next, there is the step of flowing the cryo-fluid through the cryo-needle.
Description
CA 022~8619 1998-12-21 METHOD AND APPARATUS FOR CRYOSURGERY
FIELD OF THE INVENTION
The present invention is related to cryosurgery.
More specifically, the present invention is related to a method and apparatus for cryosurgery involving a cryoneedle having an outlet tube adjacent an inlet tube for cryofluid which cools the cryoneedle.
BACKGROUND OF THE INVENTION
This invention relates to minimally invasive cryosurge~y. More particularly, this invention concerns the structure and the method of operation of a cryosurgical ~ apparatus, which consists of one or more cryoprobes and a pressurized cryofluid source.
Cryosurgery, or the destruction of undesired biological tissues by freezing, has long been accepted as an important alternative technique of surgery (Orpwood, 1981;
Rubinsky and Onik, 1991; Gage, 1992). Compared with conventional means of destroying tissues, such as surgical excision, radiotherapy and chemotherapy, visceral cryosurgery ''20 (especially minimal-invasive cryosurgery) offers the following potential advantages: simplicity of the procedure, minimal ~leeding, anaesthetic effect of low temperatures, CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 short period of patient recovery, low cost, minimal scarring, and possible stimulation of the body's immune system.
James Arnott, an English physician, was the first to introduce the technique of destruction of biological tissues by freezing in 1865. Since Arnott's first report, numerous cryodevices and techniques have been suggested.
These have included pre-cooled metal blocks, spray/pour freezing with compressed or liquefied gases, refrigeration systems, thermoelectric methods, dry ice applications, cryogenic heat pipes, Joule-Thompson effect based cryoprobes and boiling effect based cryoprobes. However, as a result of the high cooling power usually needed for cryosurgery, and especially of internal organs, the boiling e_fect and the Joule-Thompson effect have been found to ~e the preferable cooling technique by most cryosurgeons.
Minimally invasive cryosurgery is monitored by ultrasound, CT or MRI; however, ultrasound is the most accepted imaging technique among cryosurgeons today.
Utilizing these techniques, the cryosurgeon inserts the cryoprobe(s) into the region to be cryotreated. Then, the cryosurgeon acti~ates the cryoprobe(s) according to a cooling protocol and monitors the frozen region growth ~which is also termed "ice-ball"). When the undesired tissues are completely frozen, or when there is a danger of cryodestruction to 2~ important surrounding tissues, the cryosurgeon terminates the _ . ~ . . .
CA 022~8619 1998-12-21 W 097/49344 PCT~US97/10375 cooling process and the thawing stage follows. In some cases the cooling\thawing stages are repeated in order to increase cryodestruction.
The application of minimal-invasive cryosurgery calls for: a cryoprobe insertion technique that causes minimal damage to the surrounding healthy tissues, an accurate localization of the cryoprobe tip, and a precise monitoring of the frozen region formation. These criteria have served a the motivation for the continued efforts toward the reduction of cryoprobe diameter and improvement in imaging techniques. Ultimately, the cryoprobe diameter is a result o the diameter of the cryofluid tubes and by the cryoprobe's thermal insulator thickness. Since a typical cryoprobe diameter is relatively large, a pathway must be provide or the cryoprobe into the cryotreated region. An alternative solution for this problem is given by the invention presented hereby.
, CA 022~8619 1998-12-21 W 097/49344 PCT~US97/10375 SU~ RY OF THE IN~rENTION
The objective of the invention is to provide a method and apparatus for minimal-invasive cryosurgery. More particularly, the objective of the invention is to provide a method and a cryoprobe that minimize the damage caused to the surrounding tissues due to either preparations for the cryoprocedure or cryoprobe penetration.
Another objective of the invention is to provide a method and cryoprobe that will enable a precise localization of the cryotreatment.
A further objective of the invention is to provide a simpli~ied and compact apparatus for cryosurgery.
The present invention pertains to an apparatus for cryosurgery. The apparatus comprises a cryoneedle having a diameter less than 3.2 mm. The apparatus is also comprised of a thermal insulation shell disposed about a portion of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell. The cryoneedle and shell are configured for insertion into a body of a patient.
.
-The present invention pertains to a ~ethod for freezing tissues. The method comprises the steps of inser_ing a cryoneedle having a diameter of less than 3.2 mm into a patient's body. Next, there is the step of flowing the c-yofluid through the cryoneedle.
CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 BR~EF DESCRIPTION OF T~E DRAWINGS
In the accompanying drawings, the preferred embodiment of the invention and preferred methods of practicing the -nvention are illustrated in which:
Figure 1 is a side view of the cryoprobe A of the invention.
Figure 2 is a side view of the cryoprobe B of the invention.
Figure 3 is a schematic view of the cryosurgical appara_us with ~ single cryoprobe.
Figur_ is a schematic view of the cryosurgical appara_us with 3 cryoprobes.
Figure 5 is a diagrammatic representation showing some s_ages in s~yoprobe insertion and localization: Figure 5.a insertion o cryoneedle 1 using an imaging device and a localization teshnique (such as ultrasound and stereotactic localization te-hnique, respectively); Figure 5.b insertion of the-mal insulation shell 4; Figure 5.c completion of the cryoprobe assem~ly and connection to a pressurized cryofluid source.
W097/49344 PCT~S97/10375 Figure 6 is a schematic representation of the construction of the cryoprobe tip: Figure 6.a first the ends are cut at an angle ¢; and then Figure 6.b the tube's tips are bent, one towards the other. Finally the tube's walls, 35 and 36, are welded together in a way that will allow fluid -low from one tube to the other.
CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 ~ESCRIPTION OF T~ PR~FERRED EMBOPIMENT
Referring now to the drawings wherein like reference numerals refer to similar or identical parts throughout the several views, and more specifically to figures 1-4 thereof, there is shown an apparatus 100 for cryosurgery. The apparatus 100 comprises a cryoneedle 1 having a diameter less than 3.2 mm. The apparatus 100 is also comprised of a thermal insulation shell 4 disposed about a portion of the cryoneedle 1 for reduction of heat transfer from su-rounding tissues, or freezing prevention of surrounding tissues, during application of the cryoneedle 1 with the shell . The cryoneedle 1 and shell 4 are configured for conLact wlth and preferably insertion into a body of G patient.
Preferably, the cryoneedle 1 has a tip 33.
Preferably, the tip 33 is pointed. Additionally, the apparatus 100 preferably includes a protection tube 6 for protection of an operator's hand during application of the cryoneedle 1. The shell 4 is disposed between the protection tube 6 and the tip 33. The protection tube 6 is disposed about the cryoneedle 1 and configured with the cryoneedle 1 and the shell 4 to be outside the body when the cryoneedle 1 and the shell 4 are inserted into the body of the patient during application. The protection tube 6 and the shell 4 can be s~idably at_ached to the cryoneedle 1 as is presented CA 022~86l9 l998-l2-2l W097/49344 PCTrUS97/10375 in figure 1. Alternatively, the insulation shell 4 can be rigidly connected to the cryoneedle 1 as is presented in figure 2. The cryoneedle 1 preferably has an inlet tube 35 through which cryofluid flows during application of the cryoneedle 1 to the tip 33 and an outlet tube 36 through which cryofluid flows during application of the cryoneedle 1 from the tip 33. The outlet tube 36 preferably has a vent tube 7 which releases the cryofluid to the environment.
Preferably, the cryoneedle 1 has a bridging connector portion, such as u-shaped channel connector portion 34 disposed in conjunction with the tip 33 and connected with the inlet ~ube 35 and the outlet tube 36 to connect the inlet tube 35 an~ the outlet tube 36 and to allow cryofluid to flow from the in~let tube 35 to engage the tip 33 and flow out to the outle~ tube 36. The inlet tube 35 preferably has an inside diameter between 0.8 mm and 2 mm. The outlet tube 36 preferably has an inside diameter between 0.8 mm and 2 mm.
Preferably, the inlet tube 35 is in parallel with the outlet tube 36 and the inlet tube 35 is attached to the outlet tube 36.
The tip 33 is formed by taking two separate tubes and cutting their ends at an angle of about 15~, as shown in figure 6a. The cut angled ends are then connected, for example, by being soldered or welded together to form the tip 33, as shown in figure 6b.
CA 022~8619 1998-12-21 W 097/49344 PCT~US97/10375 The apparatus 100 preferably includes a pressurized cryofluid source mechanism 30 connected to the inlet tube 3~
via feeding tube 9 for providing pressurized cryofluid to the inlet tube 35. The pressurized cryofluid source mechanism 30 preferably includes a container 11 of cryofluid connected to the '~eeaing tube 9. The pressurized cryofluid source mechanism 30 preferab~y also includes a tank 15 of pressurized gas connected to the container 11 to pressurize the cryorluid in the container 11. Additionally, the source mechanism 30 preferably includes a pump 31 connected to the tank 15 to pressurize the tank 15. The source mechanism 30 preferably also includes a control valve 10 disposed on the feeding _ube 9 to control the flow of cryofluid from the containe- 11.
Additionally, the apparatus 100 preferably includes a tem~era~ure sensor mechanism 40 in contact with the cryoneedl_ 1 adjacent the tip 33 for sensing the active surface _emperature of the cryoneedle 1. The temperature sensor mechanism 40 preferably includes a temperature sensor 2 disposed adjacent the tip 33 and in contact with the cryoneedle 1. The temperature sensor mechanism 40 preferably also includes sensor wires 3 connected to the sensor 2 and extendin~ from the sensor 2. Furthermore, the temperature sensor ~.~chanism 40 preferably includes a temperature measureme~t unit 22 connected to the sensor wires 3 for identi~yin~ the temperature sensed by the sensor 2.
CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 The apparatus lO0 can also include an imaging mechanism 44 for managing the cryoneedle l as it penetrates into the body of a patient. The apparatus lO0 can also include at least a second cryoneedle l and a second thermal insulation shell 4 disposed about a portion of the second cryoneedle l, as is presented in figure 4. The second cryoneedle l is connected to the source mechanism 30.
The present invention pertains to a method for freezing tissues. The method comprises the steps of bringing into contact and preferably inserting a cryoneedle l having a diameter of less than 3.2 mm with or into a patient's body.
Next, there is the step of flowing the cryofluid through the cryoneedle l. Preferably, the cryofluid is vented to the environment.
Preferably, after the inserting step, there is the step of sliding an insulation shell 4 in place over a predetermined portion of the cryoneedle l in the body of the patient. After the sliding step, there is preferably the step of sliding a protection tube 6 in place over the cryoneedle l until it is adjacent to the shell 4. The protection tube 6 is outside the patient's body. In an - 25 alternative preference, the inserting step includes the step of inserting the cryoneedle l with an insulation shell 4 positioned abou' the cryoneedle l at a predetermined location CA 022~8619 1998-12-21 W097149344 PCT~S97/10375 simultaneously into the body of the patient. Additionally, the inserting step preferably includes the step of imaging the cryoneedle l as it is inserted into the patient's body.
In the operation of the preferred embodiment, an apparatus lO0, which has a cryoprobe such as a cryoprobe A, as shown in figure l, is comprised of three main components:
a cryoneedle l, a thermal insulation shell 4, and a protection tube 6. The cryoprobe is assembled during, and as a part, of the cryosurgical procedure, as will be described in detail hereafter. Cryoneedle l has a U shape configuration and a sharp pointed tip 33, which is made of very fine tubes.
Cryoneedle l leads the cryofluid forward, from feeding tube 9, through the inlet tube 35 of cryoneedle l, to the cryotreated region, and backward, through outlet tube 36, to vent tube 7. Insulation shell 4 surrounds a part of cryoneedle l to reduce heat transfer from the surrounding tissues to the cryoneedle. Insulation shell 4 contains thermal insulator 5. Protection tube 6 surrounds an other part of cryoneedle l, adjacent to insulation shell 4 but outside of the body, to protect the operator's hands and to reduce heat transfer from the surroundings to the cryoneedle.
Insulation shell 4 as well as protection tube 6 are free to slide axially along cryoneedle l. Feeding tube 9 feeds cryoneedle l with pressurized cryofluid, which is connected by fitting 8 to the inlet tube 35 of cryoneedle l. The CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 cryofluid exits from cryoneedle 1 through flexible vent tube 7, which is preferably connected under a pressure fitting.
The tubing from the coolant container 11 to fitting 8 is made of stainless steel, but copper, brass, steel or any other metallic alloy is suitable. The stainless steel can guarantee flexibility in the cryogenic temperature range and a long life. Flexible metallic tubes have a unique configuration and are available for commercial usage. Some plastics are brittle materials at cryogenic temperature range and therefore are generally not suitable for this task. The feeding tube 9 should be insulated by vacuum in order to reduce heat losses between the coolant container 11 and the cryoprobe. The simplest way of constructing a flexible and vacuum insulated tube is by using two standard flexible tubes, one inside the other. The space between the tubes is then sealed by sealing, for example, welding, while the air in between the tubes is pumped out to achieve a vacuum between the inner and outer tubes. A diameter ratio of 1 to 2 between the inner and the outer flexible tubes is suitable.
The internal diameter of the inner flexible tube of the feeding tube 9 should be about 3 times the inner diameter of the cryoneedle tubes, for a single cryoprobe operation.
This ratio should be increased to about 5 for a multi-cryoprobe operation. This large diameter of flexible tube is chosen to reduce pressure losses between the coolant CA 022~8619 1998-12-21 W O 97/49344 PCTrUS97110375 container and the cryoprobe. It is noted that the heat losses from the feeding tube 9 increase with the diameter.
Cryoprobe A can actually work without the protection tube 6, which does not affect significantly the performance of the apparatus. Protection tube 6 is mainly used for safety reasons, to protect the cryosurgeon's hands.
This tube should be made of a plastic material like Teflon or Plexiglass which have low thermal conductivities. Typical thermal conductivity value of plastics is about 0.1 W/m-~C.
The cooling process in cryoprobe A takes place as -ollows. Cryofluid is forced from a cryofluid source into the sryoprobe through feeding tube 9. The cryofluid flows along cryoneedle I through the inlet tube 35 towards the cryoneedle tip 33 and then backwards through outlet tube 36 towards vent 1~ tube 7. Inside protection tube 6 and insulation shell 4, in both flow directions, the heat transfer from the surroundings and from the surrounding tissues, respectively, is minimal.
The only significant heat transfer occurs where cryoneedle 1 is in direct contact with the tissue, and therefore this area is designated herein as the cryoprobe active surface.
Downstream heat convection takes place along the cryoprobe active surface, with or without the boiling ph~no~n~n inside the cryoneedle, and causes freezing of the undesired tissues.
The te~perature of the c~voprobe active surface is monitored CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 by temperature sensor 2 and the signals are transferred through temperature sensor wires 3 to temperature measurement unit 22, as shown in figure 3. Monitoring of the temperature near the cryoprobe tip 33 is required for controlling the coolant (liquefied gas) flow rate. The temperature of the cryoprobe active surface, to which the temperature sensor is attached, is expected to be very close to the coolant boiling temperature at extremely high flow rates. The temperature is not expected to drop much while reducing the flow rate, until a certain point of which the boiling rate is higher than the flow rate and the flow of the liquefied coolant turns entirely into yas. The flow rate at which this phenomenon occurs is defined here as the critical flow rate; applying flow rates above the critical flow rate will result in a waste of coolan~ while applying flow rates below the critical flow rate will result in a significant reduction of the cooling power. Therefore, the temperature sensor at the cryoprobe tip 33 acts as a flow rate indicator, telling the operator to increase or decrease the coolant flow rate via control valve 10. The usage of a thermocouple as a temperature sensor 2 is convenient and inexpensive. The couples copper-constantan or iron-constantan are suitable for the cryogenic temperature range. The temperature measurement unit 22 is a standard unit that amplifies the thermocouple signal and translates them into temperature values. This unit should be able to operate between normal body temperature rznge, i.e. at least 40~C, down to the boiling CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 temperature of the coolant, i.e. - 196~C for the liquid nitrogen case.
The cooling effect of the cryoneedle is achieved by a boiling phenomenon lnside the cryoneedle's tubes. The boiling phenomenon, or liquid-gas phase change, takes place at a constant temperature and de~n~.~ a relatively high energy, known as latent heat. For example, at a standard atmospheric pressure, nitrogen boils at -196CC and demands an energy of 161 kJ per liter of liquid. The cooling process in the cryoneedle takes place as follows: the coolant enters the inlet tube of the cryoneedle at its liquid state; because of temperature differences, heat is transferred from the warm surrounding tissues through the cryoneedle ~ubes' walls to the coolant. This heat transfer causes energy release from the surrounding tissues, which lowers their temperature and essentially causes the formation of the ice-ball. On the other hand, the same heat transfer causes energy absorption in the coolant, which changes the coolant phase from liquid to gas. More and more energy is absorbed by the coolant as it flows, which continually contributes to the coolant phase change process. In case of a high flow rate, relative to the heat transfer from the surrounding tissue and the total length of the cryoneedle tubes, the coolant will not be transformed completely into gas inside the cryoprobe's tubes and therefore its balk temperature will be relatively close to the coolant boiling tempera.ure. At relatlvely low flow CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 rates, however, the phase change will be completed at some downstream point in the tubes, the boiling effect will vanish and the gas will warm up.
In general, liquid nitrogen is widely accepted as a coolant for cryosurgical applications since it has no side e~fects (79% of the air is nitrogen). Other cryogenic coolants may be used as well, such as liquefied air and liquefied helium, which boil at -178~C and -267~C, respectively.
Cryoprobe B configuration, as shown in figure 2, is similar to cryoprobe A with the only exception that insulation shell 4 is rigidly connected to cryoneedle 1.
Thermal insulation shell 4 contains thermal insulation material 5 such as minerals, gas, or vacuum. However, the preferable insulation technique is vacuum for both apparatus A and B. The cooling process in cryoprobes B is similar to that in cryoprobe A, as described above. All tubes' walls should be made as thin as possible. Using stainless steel, a wall thickness of 0.1 mm should be sufficient.
Three typical dimensions characterize the cryoprobe: (1) the diameter of the cryoneedle's inlet and outlet tubes; (2) the diameter of the thermal insulation; and ~3) the length of the cryoprobe active surface. An outer diameter of 1 mm is sufficient for bo_h the cryoneedle's CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 inlet and outlet tubes, for some applications, in cases where stainless steel tubes with extra-thin walls are used (which have a wall thickness of 0.1 mm). However, the longer dimension of the cryoneedle cross section will be the sum of the diameters of the two ad~acent tubes, i.e. 2 mm, in this case.
An outer diameter of 3.2 mm is sufficient for the thermal insulation shell, for the above case. Taking in account the thermal insulation wall thickness, this configuration should leave about 0.5 mm clearance from each side o~ the cryoneedle, in the direction of the longer dimension of the cryoneedle cross section. This clearance will p-ovide a sufficient space for the vacuum to be effective as a thermal insulator.
It is noted that the 3.2 mm thermal insulation is not inserted all along the cryoneedle. Therefore, the cross section dimensions along the active cryoprobe surface are 1 x 2 mm, while along the thermal insulation the cryoprobe diameter is 3.2 mm. A cross section of 1 x 2 mm is about the smallest cryoprobe cross section available at this time.
The cryoneedle should be made of stainless steel for the general application of cryosurgery. However, for the special application of an MRI controlled cryosurgery, the cryoneedle should be made of copper or brass which are CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 compatible with the MRI environment. In this case, the cryoneedle should be gold coated to protect the cryotreated tissue.
Currently, there is only one main well known concept for the design and construction of a boiling effect based cryoprobe, which was invented by Cooper at 1961.
Cooper's approach is to place three tubes one inside the other, where the inner tube carries the coolant to the cryoprobe tip, the second tube carries the coolant gas back ,rom the tip, and the space between the latter tube and the most outer tube is used for vacuum insulation.
The cryoprobe described herein has a very different configuration, which is based on a u-shaped cryoneedle. The cryoneedle comprises two adjunct tubes and not one inside the other. One form of the cryoprobe (cryoprobe A of the invention) is assembled during the cryoprocedure which allows a minimal destruction to the cryotreated tissue, due to cryoprobe penetration, and an accurate localization of the cryoprobe tip 33.
The term "cryoneedle" is used herein for the presentation of the present invention, however, one must not be confused between this particular cryoneedle and a simple needle which carries a cryo-fluid. An ordinary needle has an inlet on one end and an outlet on the other end. The CA 022~8619 1998-12-21 cryoneedle has the inlet in adjunct with its outlet, on the same end while the cryoprobe tip 33 is on the other end. The unique U-shape configuration of the cryoneedle requires a special design and construction for this particular S application.
The term cryoneedle appears in the literature for two other but different applications: (1) for dermatology applications (Weshahy, A. H., 1993, 'IInterlesional Cryosurgery: A New Technique Using Cryoneedles", J. Dermatol.
10 Surg. Oncol., Vol. 19, pp. 123-126), where a banded needle is inserted through the skin and below a tumor. In this case, the cryoneedle is a simple needle which carries a cryofluid.
(2) For ar. application on hemorrhoids (Gao, X. K., Sun, D.
K., Sha, R. J., Ding, Y. Sh., Yan, Q. Y., and Zhu, C. D., 15 1986, I'Precooled, Spring-Driven Surgical Cryoneedle: A New Device for Cryohaemorrhoidectomy", Proceedings of the 11th International Cryogenic Engineering Conference, IECE 11, Berlin, West Germany, pp. 825-829, incorporated by reference herein), where a pre-cooled needle is inserted into an 20 undesired tissue. The cryoneedle does not actually carry any cryofluid in the latter case.
One form of a pressurized cryofluid source is presented in figure 3. The cryofluid is contained in a thermal insulated container 11. Container 11 is pressurized 25 by com~ressed air from air tank 15, through flexible air CA 022~8619 1998-12-21 W 097/49344 PCTrUS97/1037S
pressure pipe 13 and valve 14. Air tank 15 is pre-charged with compressed air by an external pressure source like an electric pump 31. Air tank 15 is designed to have much larger volume than cryofluid container 11. Therefore, the change in total gas volume during the entire cryosurgical operation is relatively small and is approximately the volume ratio of cryofluid container 11 to air tank 15. Under isothermal conditions, the total air pressure decrease will be proportional to the above volume ratio. However, this is not exactly the case since the air which enters container 11 contracts due to temperature decrease and therefore contributes to the overall pressure drop. Pressure decreases are compensated for by high pressure air tank 20. High pressure air tank 20 is connected to air tank 15, through pipe 19 and pressure regulator 18. Pressure regulator 18 keeps the pressure in air tank 15 on some set point. By analogy between fluid pressure and electrical potential, the setup of air tanks 15 and 20 can be viewed as a "pressure battery". The usage of air tank 20 is optional but not necessary. It is needed only when the volume ratio of air tank 15 to container 11 is not large enough, or in cases where a very accurate pressure control is required. The '~pressure battery" may include the electric pump 31, or may be pre-charged by an external source.
Contrary to practice, the pressurized coolant system Or the apparatus, as presented above, is separated CA 022~8619 1998-12-21 WO 97149344 PCTrUS97/10375 into two main components: the coolant container 11 and the "pressure battery". This set-up has the following advantages: (1) the larger part of the system - the pressure battery - can be moved far from the cryosurgeon, possibly to S another room, thus leaving more space in the operating room;
(2) the coolant container is placed very close to the cryotreated tissue which reduces undesired coolant boiling along the feeding pipes. This reduces both the coolant consumption and the working pressure required to force the coolan through the feeding pipe. In turn, the reduction of the coolant consumption reduces the volume of the coolant container. Ordinary cryosurgery systems include the pressu~ized system and the coolant container in one unit.
Any ordinary air compressor could serve as an air pressu~e source for the cryofluid container 11. However, the air pressure system as presented here has advantages as a part of a surgical apparatus in that it can be very light in weight, small in dimension, very quiet in operation, and independent in power supply.
Practically, feeding tube 9 has to be as short as possible and therefore container 11 should be placed as close as possible to the cryotreated tissues. This can be compensated by a long air pressure pipe 13. This arrangement will decrease the heat losses along feeding tube 9 to the surro~-dings, which will decrease the required cryofluid flow CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 rate, and which in turn will decrease the required volume of cryofluid container 11 for a specific operation. Low flow rates and short feeding tubes will require lower working pressures in the air pressure system. Furthermore, a smaller cryofluid container will require a smaller air tank volume.
Moreover, the closer the cryofluid container is to the cryotreated tissues, the more compact apparatus 100 becomes in regard to dimensions and the safer the apparatus becomes in terms of pressure. One liter of coolant is generally needed for a triple cryoprobe operation, for a duration of 15 minutes under a pressure of 30 psi. A 2-liter vacuum insulated coolant container, a 34-liter low air pressure tank and a 22-liter high pressure air tank ~ere used with the apparatus 100. However, the high pressure air tank was not needed for a single usage of the coolant container due to the high volume ratio of the low pressure air .ank to the coolant container, as aescribed above.
Before commencing the cryosurgery, the cryosurgeon will typically study the location, depth and configuration of the undesired tissues. The cryosurgeon will study the surrounding healthy tissues as well, and especially the vital tissues. This study can be performed via ultrasound, CT or MR
imaging techniques. Based on this study, one or more appropriately configured cryoprobes will be chosen.
CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 A schematic view of the cryosurgical apparatus with 3 cryoprobes is shown in figure 4. The pressurized coolant source rem~in~ in the same configuration as for a single cryoprobe operation, as presented above. For a multi-cryoprobe, parallel feeding tubes lead the coolant to thecryoprobe and the temperature is monitored at the tip 33 of each cryoprobe separately. Each cryoprobe has a temperature sensor and a control valve on its reeding tube 9 in a multi-cryoprobe operation. All the cryoprobes flow rates are operated at the same techni~ue presented above, at the beginning of the cryoprocedure. As cryosurgery proceeds, a need to reduce the cooling power of one or more cryoprobes may arise due to the presence of vital organs around the cryotreated tissue, or due to an irregularity in shape of the cryotreated tissue (tumor). At this stage, the cryosurgeon compares the frozen region formation with the cryotreated tissue shape via an imaging device such as ultrasound and operates the control valves accordingly.
The method of operation of cryoprobe A is addressed first. Utilizing a needle localization technique or a stereotactic localization technique, cryoneedle 1 will be inserted into the undesired tissue, as shown in figure 5a and as described hereafter. The fine diameter of the cryoneedle and its sharp pointed tip 33 are suitable for a straightforward insertion, without any cutting. The cryoneedle insertion procedure will be repeated in case of a CA 022~8619 1998-12-21 4 rcTrusg7/lo375 multi-cryoprobe operation. Cryoneedles can be relocated at this stage with no significant damage to surrounding tissues.
The insertion of insulation shell 4 is next.
Insulation shell 4 will be slide along cryoneedle 1 and will be inserted in~o the tissue, figure 5b. A small incision in the skin may be needed for the insertion of tube 4. The insertion of insulation tube 4 will be monitored by an imaging technlque, to leave the appropriate cryoprobe active surface near the tip 33 of the cryoneedle. The other end of the irsulation shell will remain outside of the body. The length of the insulation shell will be chosen for a particular cryotreatment according to the length of the cryon~edle, the depth of the undesired tissues, and the requi-ed cryc?robe active surface. Insertion of the insula_ion shell will be repeated in case o,~ multi-cryoprobe operation.
Protection tube 6 will then be placed along cryoneedle 1, adjacent to insulation shell 4, figure 5c.
Flexible vent tube 7 will be connected to the cryoneedle under a pressure fit. The length of protection tube 6 will be chosen to fit between insulation shell 4 and vent tube 7.
Lastly, the inlet tube 35 of cryoneedle 1 will be connected to feeding tube 9 and the cryoprobe will be ready for operation. Container 11 will be filled with cryofluid and air CA 022~86l9 l998-l2-2l tanks 15 and 20 will be charged with compressed air in advance.
The freezing stage is then started. While monitoring the frozen region formation, the cryosurgeon will operate the cryoprobe by means of valve 10. In case of a multi-cryoprobe operation, each cryoprobe will be controlled independently. The freezing process will continue until the entire target region is frozen, or until a danger of cryodestruction to surrounding tissues appears. Control valve 10 should be a standard needle valve which is designed for cryogenic temperatures. These valves are available in a wide range for commercial usage.
The thawing stage is then started. Thawing can be performed by either natural thawing, i.e. leaving the tissue to be thawed due to blood perfusion and metabolic activities, or by forcing warm fluid through the cryoprobe passageway, i.e. disconnecting the cryoneedle from feeding tube 9 and re-connecting it to a pressurized warm fluid source.
The cryoprobe(s) can now be cooled again, in case of repeated freezing/thawing cycles cryotreatment.
The method of operation of cryoprobe B is addressed next. The method of operation of cryoprobe B is similar to the metho~ presented above for cryoprobe A with the only CA 022~8619 1998-12-21 W O 97/49344 PCTrUS97/10375 exception that cryoneedle 1 and thermal insulation shell 4 are inserted and extracted from the body together, as a one unit. This operation is suitable for cases in which the outer diameter of thermal insulation shell 4 is relatively small.
Any minimal-invasive cryoprocedure has to rely on an imaging technique such as ultrasound, CT or MRI. The ultrasound is widely accepted by cryosurgeons. The imaging technique is desired for two different tasks: (1) the localization of the cryoneedle(s), and (2) monitoring the cryolesion growth (the freezing front propagation). The uniqueness of the cryoneedle configuration of the invention, as being assembled during the cryoprocedure and/or as having small dimensions, offers a major advantage for an easy and precise localization of the tip 33. Two cryoneedle localization techniques are discussed below: needle localization and stereotactic.
Needle localization technique: This technique is currently used for guidance of the surgeon to the tumor, and towards the extraction of a tumor of the breast, as follows.
First, the tumor is located on the ultrasound image. Then, monitored by the ultrasound, a needle is inserted into the center of the tumor (while the patient is treated with a ~ local anaesthesia). Lastly, the patient is transferred to the operation room and a surgery is performed to extract the tumor. The tumor is found by dissecting along the needle.
CA 022~8619 1998-12-21 WO 97/49344 PCT~US97tlO375 Localization of a standard cryoprobe by means of the needle localization technique should be performed as described above, where a pathway for the cryoneedle is dissected along the needle.
Localization of the cryoneedle of the invention by means of the needle localization technique is performed in one of the two alternative ways: (1) By using the cryoneedle as the needle for the needle localization procedure. (2) First by inserting the standard needle, and then by replacing it with the cryoneedle. In both cases, a pathway is not needed for the cryoneedle, however, a small incision may be required on the skin. The apparatus will be assembled after the localization of the cryoneedle, in situ, as described above.
Stereotactic localization technique: The cryoneedle is guided to the tumor by stereotactic technique. This requires the use of a stereotactic breast imaging/biopsy table which provides digital mammographic images of the breast. The cryoneedle is mounted on a needle holder which is mounted on the stereotactic table. Using computer generated coordinates obtained from a stereo images, the biopsy needle or cryoneedle is positioned into the tumor and therapy is carried out. This can be performed under a local anaesthesia. In this case, the cryoneedle has to be designed to be compatible, in size and shape, with the standard biopsy . .
CA 022~8619 1998-12-21 WO 97/49344 PCT~US97/10375 needle used with the stereotactic device. The apparatus will then be assembled, in situ, as described above.
Although the invention has been described in detail in the foregoing embodiments for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention except as it may be described by the following claims.
FIELD OF THE INVENTION
The present invention is related to cryosurgery.
More specifically, the present invention is related to a method and apparatus for cryosurgery involving a cryoneedle having an outlet tube adjacent an inlet tube for cryofluid which cools the cryoneedle.
BACKGROUND OF THE INVENTION
This invention relates to minimally invasive cryosurge~y. More particularly, this invention concerns the structure and the method of operation of a cryosurgical ~ apparatus, which consists of one or more cryoprobes and a pressurized cryofluid source.
Cryosurgery, or the destruction of undesired biological tissues by freezing, has long been accepted as an important alternative technique of surgery (Orpwood, 1981;
Rubinsky and Onik, 1991; Gage, 1992). Compared with conventional means of destroying tissues, such as surgical excision, radiotherapy and chemotherapy, visceral cryosurgery ''20 (especially minimal-invasive cryosurgery) offers the following potential advantages: simplicity of the procedure, minimal ~leeding, anaesthetic effect of low temperatures, CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 short period of patient recovery, low cost, minimal scarring, and possible stimulation of the body's immune system.
James Arnott, an English physician, was the first to introduce the technique of destruction of biological tissues by freezing in 1865. Since Arnott's first report, numerous cryodevices and techniques have been suggested.
These have included pre-cooled metal blocks, spray/pour freezing with compressed or liquefied gases, refrigeration systems, thermoelectric methods, dry ice applications, cryogenic heat pipes, Joule-Thompson effect based cryoprobes and boiling effect based cryoprobes. However, as a result of the high cooling power usually needed for cryosurgery, and especially of internal organs, the boiling e_fect and the Joule-Thompson effect have been found to ~e the preferable cooling technique by most cryosurgeons.
Minimally invasive cryosurgery is monitored by ultrasound, CT or MRI; however, ultrasound is the most accepted imaging technique among cryosurgeons today.
Utilizing these techniques, the cryosurgeon inserts the cryoprobe(s) into the region to be cryotreated. Then, the cryosurgeon acti~ates the cryoprobe(s) according to a cooling protocol and monitors the frozen region growth ~which is also termed "ice-ball"). When the undesired tissues are completely frozen, or when there is a danger of cryodestruction to 2~ important surrounding tissues, the cryosurgeon terminates the _ . ~ . . .
CA 022~8619 1998-12-21 W 097/49344 PCT~US97/10375 cooling process and the thawing stage follows. In some cases the cooling\thawing stages are repeated in order to increase cryodestruction.
The application of minimal-invasive cryosurgery calls for: a cryoprobe insertion technique that causes minimal damage to the surrounding healthy tissues, an accurate localization of the cryoprobe tip, and a precise monitoring of the frozen region formation. These criteria have served a the motivation for the continued efforts toward the reduction of cryoprobe diameter and improvement in imaging techniques. Ultimately, the cryoprobe diameter is a result o the diameter of the cryofluid tubes and by the cryoprobe's thermal insulator thickness. Since a typical cryoprobe diameter is relatively large, a pathway must be provide or the cryoprobe into the cryotreated region. An alternative solution for this problem is given by the invention presented hereby.
, CA 022~8619 1998-12-21 W 097/49344 PCT~US97/10375 SU~ RY OF THE IN~rENTION
The objective of the invention is to provide a method and apparatus for minimal-invasive cryosurgery. More particularly, the objective of the invention is to provide a method and a cryoprobe that minimize the damage caused to the surrounding tissues due to either preparations for the cryoprocedure or cryoprobe penetration.
Another objective of the invention is to provide a method and cryoprobe that will enable a precise localization of the cryotreatment.
A further objective of the invention is to provide a simpli~ied and compact apparatus for cryosurgery.
The present invention pertains to an apparatus for cryosurgery. The apparatus comprises a cryoneedle having a diameter less than 3.2 mm. The apparatus is also comprised of a thermal insulation shell disposed about a portion of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell. The cryoneedle and shell are configured for insertion into a body of a patient.
.
-The present invention pertains to a ~ethod for freezing tissues. The method comprises the steps of inser_ing a cryoneedle having a diameter of less than 3.2 mm into a patient's body. Next, there is the step of flowing the c-yofluid through the cryoneedle.
CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 BR~EF DESCRIPTION OF T~E DRAWINGS
In the accompanying drawings, the preferred embodiment of the invention and preferred methods of practicing the -nvention are illustrated in which:
Figure 1 is a side view of the cryoprobe A of the invention.
Figure 2 is a side view of the cryoprobe B of the invention.
Figure 3 is a schematic view of the cryosurgical appara_us with ~ single cryoprobe.
Figur_ is a schematic view of the cryosurgical appara_us with 3 cryoprobes.
Figure 5 is a diagrammatic representation showing some s_ages in s~yoprobe insertion and localization: Figure 5.a insertion o cryoneedle 1 using an imaging device and a localization teshnique (such as ultrasound and stereotactic localization te-hnique, respectively); Figure 5.b insertion of the-mal insulation shell 4; Figure 5.c completion of the cryoprobe assem~ly and connection to a pressurized cryofluid source.
W097/49344 PCT~S97/10375 Figure 6 is a schematic representation of the construction of the cryoprobe tip: Figure 6.a first the ends are cut at an angle ¢; and then Figure 6.b the tube's tips are bent, one towards the other. Finally the tube's walls, 35 and 36, are welded together in a way that will allow fluid -low from one tube to the other.
CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 ~ESCRIPTION OF T~ PR~FERRED EMBOPIMENT
Referring now to the drawings wherein like reference numerals refer to similar or identical parts throughout the several views, and more specifically to figures 1-4 thereof, there is shown an apparatus 100 for cryosurgery. The apparatus 100 comprises a cryoneedle 1 having a diameter less than 3.2 mm. The apparatus 100 is also comprised of a thermal insulation shell 4 disposed about a portion of the cryoneedle 1 for reduction of heat transfer from su-rounding tissues, or freezing prevention of surrounding tissues, during application of the cryoneedle 1 with the shell . The cryoneedle 1 and shell 4 are configured for conLact wlth and preferably insertion into a body of G patient.
Preferably, the cryoneedle 1 has a tip 33.
Preferably, the tip 33 is pointed. Additionally, the apparatus 100 preferably includes a protection tube 6 for protection of an operator's hand during application of the cryoneedle 1. The shell 4 is disposed between the protection tube 6 and the tip 33. The protection tube 6 is disposed about the cryoneedle 1 and configured with the cryoneedle 1 and the shell 4 to be outside the body when the cryoneedle 1 and the shell 4 are inserted into the body of the patient during application. The protection tube 6 and the shell 4 can be s~idably at_ached to the cryoneedle 1 as is presented CA 022~86l9 l998-l2-2l W097/49344 PCTrUS97/10375 in figure 1. Alternatively, the insulation shell 4 can be rigidly connected to the cryoneedle 1 as is presented in figure 2. The cryoneedle 1 preferably has an inlet tube 35 through which cryofluid flows during application of the cryoneedle 1 to the tip 33 and an outlet tube 36 through which cryofluid flows during application of the cryoneedle 1 from the tip 33. The outlet tube 36 preferably has a vent tube 7 which releases the cryofluid to the environment.
Preferably, the cryoneedle 1 has a bridging connector portion, such as u-shaped channel connector portion 34 disposed in conjunction with the tip 33 and connected with the inlet ~ube 35 and the outlet tube 36 to connect the inlet tube 35 an~ the outlet tube 36 and to allow cryofluid to flow from the in~let tube 35 to engage the tip 33 and flow out to the outle~ tube 36. The inlet tube 35 preferably has an inside diameter between 0.8 mm and 2 mm. The outlet tube 36 preferably has an inside diameter between 0.8 mm and 2 mm.
Preferably, the inlet tube 35 is in parallel with the outlet tube 36 and the inlet tube 35 is attached to the outlet tube 36.
The tip 33 is formed by taking two separate tubes and cutting their ends at an angle of about 15~, as shown in figure 6a. The cut angled ends are then connected, for example, by being soldered or welded together to form the tip 33, as shown in figure 6b.
CA 022~8619 1998-12-21 W 097/49344 PCT~US97/10375 The apparatus 100 preferably includes a pressurized cryofluid source mechanism 30 connected to the inlet tube 3~
via feeding tube 9 for providing pressurized cryofluid to the inlet tube 35. The pressurized cryofluid source mechanism 30 preferably includes a container 11 of cryofluid connected to the '~eeaing tube 9. The pressurized cryofluid source mechanism 30 preferab~y also includes a tank 15 of pressurized gas connected to the container 11 to pressurize the cryorluid in the container 11. Additionally, the source mechanism 30 preferably includes a pump 31 connected to the tank 15 to pressurize the tank 15. The source mechanism 30 preferably also includes a control valve 10 disposed on the feeding _ube 9 to control the flow of cryofluid from the containe- 11.
Additionally, the apparatus 100 preferably includes a tem~era~ure sensor mechanism 40 in contact with the cryoneedl_ 1 adjacent the tip 33 for sensing the active surface _emperature of the cryoneedle 1. The temperature sensor mechanism 40 preferably includes a temperature sensor 2 disposed adjacent the tip 33 and in contact with the cryoneedle 1. The temperature sensor mechanism 40 preferably also includes sensor wires 3 connected to the sensor 2 and extendin~ from the sensor 2. Furthermore, the temperature sensor ~.~chanism 40 preferably includes a temperature measureme~t unit 22 connected to the sensor wires 3 for identi~yin~ the temperature sensed by the sensor 2.
CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 The apparatus lO0 can also include an imaging mechanism 44 for managing the cryoneedle l as it penetrates into the body of a patient. The apparatus lO0 can also include at least a second cryoneedle l and a second thermal insulation shell 4 disposed about a portion of the second cryoneedle l, as is presented in figure 4. The second cryoneedle l is connected to the source mechanism 30.
The present invention pertains to a method for freezing tissues. The method comprises the steps of bringing into contact and preferably inserting a cryoneedle l having a diameter of less than 3.2 mm with or into a patient's body.
Next, there is the step of flowing the cryofluid through the cryoneedle l. Preferably, the cryofluid is vented to the environment.
Preferably, after the inserting step, there is the step of sliding an insulation shell 4 in place over a predetermined portion of the cryoneedle l in the body of the patient. After the sliding step, there is preferably the step of sliding a protection tube 6 in place over the cryoneedle l until it is adjacent to the shell 4. The protection tube 6 is outside the patient's body. In an - 25 alternative preference, the inserting step includes the step of inserting the cryoneedle l with an insulation shell 4 positioned abou' the cryoneedle l at a predetermined location CA 022~8619 1998-12-21 W097149344 PCT~S97/10375 simultaneously into the body of the patient. Additionally, the inserting step preferably includes the step of imaging the cryoneedle l as it is inserted into the patient's body.
In the operation of the preferred embodiment, an apparatus lO0, which has a cryoprobe such as a cryoprobe A, as shown in figure l, is comprised of three main components:
a cryoneedle l, a thermal insulation shell 4, and a protection tube 6. The cryoprobe is assembled during, and as a part, of the cryosurgical procedure, as will be described in detail hereafter. Cryoneedle l has a U shape configuration and a sharp pointed tip 33, which is made of very fine tubes.
Cryoneedle l leads the cryofluid forward, from feeding tube 9, through the inlet tube 35 of cryoneedle l, to the cryotreated region, and backward, through outlet tube 36, to vent tube 7. Insulation shell 4 surrounds a part of cryoneedle l to reduce heat transfer from the surrounding tissues to the cryoneedle. Insulation shell 4 contains thermal insulator 5. Protection tube 6 surrounds an other part of cryoneedle l, adjacent to insulation shell 4 but outside of the body, to protect the operator's hands and to reduce heat transfer from the surroundings to the cryoneedle.
Insulation shell 4 as well as protection tube 6 are free to slide axially along cryoneedle l. Feeding tube 9 feeds cryoneedle l with pressurized cryofluid, which is connected by fitting 8 to the inlet tube 35 of cryoneedle l. The CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 cryofluid exits from cryoneedle 1 through flexible vent tube 7, which is preferably connected under a pressure fitting.
The tubing from the coolant container 11 to fitting 8 is made of stainless steel, but copper, brass, steel or any other metallic alloy is suitable. The stainless steel can guarantee flexibility in the cryogenic temperature range and a long life. Flexible metallic tubes have a unique configuration and are available for commercial usage. Some plastics are brittle materials at cryogenic temperature range and therefore are generally not suitable for this task. The feeding tube 9 should be insulated by vacuum in order to reduce heat losses between the coolant container 11 and the cryoprobe. The simplest way of constructing a flexible and vacuum insulated tube is by using two standard flexible tubes, one inside the other. The space between the tubes is then sealed by sealing, for example, welding, while the air in between the tubes is pumped out to achieve a vacuum between the inner and outer tubes. A diameter ratio of 1 to 2 between the inner and the outer flexible tubes is suitable.
The internal diameter of the inner flexible tube of the feeding tube 9 should be about 3 times the inner diameter of the cryoneedle tubes, for a single cryoprobe operation.
This ratio should be increased to about 5 for a multi-cryoprobe operation. This large diameter of flexible tube is chosen to reduce pressure losses between the coolant CA 022~8619 1998-12-21 W O 97/49344 PCTrUS97110375 container and the cryoprobe. It is noted that the heat losses from the feeding tube 9 increase with the diameter.
Cryoprobe A can actually work without the protection tube 6, which does not affect significantly the performance of the apparatus. Protection tube 6 is mainly used for safety reasons, to protect the cryosurgeon's hands.
This tube should be made of a plastic material like Teflon or Plexiglass which have low thermal conductivities. Typical thermal conductivity value of plastics is about 0.1 W/m-~C.
The cooling process in cryoprobe A takes place as -ollows. Cryofluid is forced from a cryofluid source into the sryoprobe through feeding tube 9. The cryofluid flows along cryoneedle I through the inlet tube 35 towards the cryoneedle tip 33 and then backwards through outlet tube 36 towards vent 1~ tube 7. Inside protection tube 6 and insulation shell 4, in both flow directions, the heat transfer from the surroundings and from the surrounding tissues, respectively, is minimal.
The only significant heat transfer occurs where cryoneedle 1 is in direct contact with the tissue, and therefore this area is designated herein as the cryoprobe active surface.
Downstream heat convection takes place along the cryoprobe active surface, with or without the boiling ph~no~n~n inside the cryoneedle, and causes freezing of the undesired tissues.
The te~perature of the c~voprobe active surface is monitored CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 by temperature sensor 2 and the signals are transferred through temperature sensor wires 3 to temperature measurement unit 22, as shown in figure 3. Monitoring of the temperature near the cryoprobe tip 33 is required for controlling the coolant (liquefied gas) flow rate. The temperature of the cryoprobe active surface, to which the temperature sensor is attached, is expected to be very close to the coolant boiling temperature at extremely high flow rates. The temperature is not expected to drop much while reducing the flow rate, until a certain point of which the boiling rate is higher than the flow rate and the flow of the liquefied coolant turns entirely into yas. The flow rate at which this phenomenon occurs is defined here as the critical flow rate; applying flow rates above the critical flow rate will result in a waste of coolan~ while applying flow rates below the critical flow rate will result in a significant reduction of the cooling power. Therefore, the temperature sensor at the cryoprobe tip 33 acts as a flow rate indicator, telling the operator to increase or decrease the coolant flow rate via control valve 10. The usage of a thermocouple as a temperature sensor 2 is convenient and inexpensive. The couples copper-constantan or iron-constantan are suitable for the cryogenic temperature range. The temperature measurement unit 22 is a standard unit that amplifies the thermocouple signal and translates them into temperature values. This unit should be able to operate between normal body temperature rznge, i.e. at least 40~C, down to the boiling CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 temperature of the coolant, i.e. - 196~C for the liquid nitrogen case.
The cooling effect of the cryoneedle is achieved by a boiling phenomenon lnside the cryoneedle's tubes. The boiling phenomenon, or liquid-gas phase change, takes place at a constant temperature and de~n~.~ a relatively high energy, known as latent heat. For example, at a standard atmospheric pressure, nitrogen boils at -196CC and demands an energy of 161 kJ per liter of liquid. The cooling process in the cryoneedle takes place as follows: the coolant enters the inlet tube of the cryoneedle at its liquid state; because of temperature differences, heat is transferred from the warm surrounding tissues through the cryoneedle ~ubes' walls to the coolant. This heat transfer causes energy release from the surrounding tissues, which lowers their temperature and essentially causes the formation of the ice-ball. On the other hand, the same heat transfer causes energy absorption in the coolant, which changes the coolant phase from liquid to gas. More and more energy is absorbed by the coolant as it flows, which continually contributes to the coolant phase change process. In case of a high flow rate, relative to the heat transfer from the surrounding tissue and the total length of the cryoneedle tubes, the coolant will not be transformed completely into gas inside the cryoprobe's tubes and therefore its balk temperature will be relatively close to the coolant boiling tempera.ure. At relatlvely low flow CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 rates, however, the phase change will be completed at some downstream point in the tubes, the boiling effect will vanish and the gas will warm up.
In general, liquid nitrogen is widely accepted as a coolant for cryosurgical applications since it has no side e~fects (79% of the air is nitrogen). Other cryogenic coolants may be used as well, such as liquefied air and liquefied helium, which boil at -178~C and -267~C, respectively.
Cryoprobe B configuration, as shown in figure 2, is similar to cryoprobe A with the only exception that insulation shell 4 is rigidly connected to cryoneedle 1.
Thermal insulation shell 4 contains thermal insulation material 5 such as minerals, gas, or vacuum. However, the preferable insulation technique is vacuum for both apparatus A and B. The cooling process in cryoprobes B is similar to that in cryoprobe A, as described above. All tubes' walls should be made as thin as possible. Using stainless steel, a wall thickness of 0.1 mm should be sufficient.
Three typical dimensions characterize the cryoprobe: (1) the diameter of the cryoneedle's inlet and outlet tubes; (2) the diameter of the thermal insulation; and ~3) the length of the cryoprobe active surface. An outer diameter of 1 mm is sufficient for bo_h the cryoneedle's CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 inlet and outlet tubes, for some applications, in cases where stainless steel tubes with extra-thin walls are used (which have a wall thickness of 0.1 mm). However, the longer dimension of the cryoneedle cross section will be the sum of the diameters of the two ad~acent tubes, i.e. 2 mm, in this case.
An outer diameter of 3.2 mm is sufficient for the thermal insulation shell, for the above case. Taking in account the thermal insulation wall thickness, this configuration should leave about 0.5 mm clearance from each side o~ the cryoneedle, in the direction of the longer dimension of the cryoneedle cross section. This clearance will p-ovide a sufficient space for the vacuum to be effective as a thermal insulator.
It is noted that the 3.2 mm thermal insulation is not inserted all along the cryoneedle. Therefore, the cross section dimensions along the active cryoprobe surface are 1 x 2 mm, while along the thermal insulation the cryoprobe diameter is 3.2 mm. A cross section of 1 x 2 mm is about the smallest cryoprobe cross section available at this time.
The cryoneedle should be made of stainless steel for the general application of cryosurgery. However, for the special application of an MRI controlled cryosurgery, the cryoneedle should be made of copper or brass which are CA 022~8619 1998-12-21 W097/49344 PCT~S97/10375 compatible with the MRI environment. In this case, the cryoneedle should be gold coated to protect the cryotreated tissue.
Currently, there is only one main well known concept for the design and construction of a boiling effect based cryoprobe, which was invented by Cooper at 1961.
Cooper's approach is to place three tubes one inside the other, where the inner tube carries the coolant to the cryoprobe tip, the second tube carries the coolant gas back ,rom the tip, and the space between the latter tube and the most outer tube is used for vacuum insulation.
The cryoprobe described herein has a very different configuration, which is based on a u-shaped cryoneedle. The cryoneedle comprises two adjunct tubes and not one inside the other. One form of the cryoprobe (cryoprobe A of the invention) is assembled during the cryoprocedure which allows a minimal destruction to the cryotreated tissue, due to cryoprobe penetration, and an accurate localization of the cryoprobe tip 33.
The term "cryoneedle" is used herein for the presentation of the present invention, however, one must not be confused between this particular cryoneedle and a simple needle which carries a cryo-fluid. An ordinary needle has an inlet on one end and an outlet on the other end. The CA 022~8619 1998-12-21 cryoneedle has the inlet in adjunct with its outlet, on the same end while the cryoprobe tip 33 is on the other end. The unique U-shape configuration of the cryoneedle requires a special design and construction for this particular S application.
The term cryoneedle appears in the literature for two other but different applications: (1) for dermatology applications (Weshahy, A. H., 1993, 'IInterlesional Cryosurgery: A New Technique Using Cryoneedles", J. Dermatol.
10 Surg. Oncol., Vol. 19, pp. 123-126), where a banded needle is inserted through the skin and below a tumor. In this case, the cryoneedle is a simple needle which carries a cryofluid.
(2) For ar. application on hemorrhoids (Gao, X. K., Sun, D.
K., Sha, R. J., Ding, Y. Sh., Yan, Q. Y., and Zhu, C. D., 15 1986, I'Precooled, Spring-Driven Surgical Cryoneedle: A New Device for Cryohaemorrhoidectomy", Proceedings of the 11th International Cryogenic Engineering Conference, IECE 11, Berlin, West Germany, pp. 825-829, incorporated by reference herein), where a pre-cooled needle is inserted into an 20 undesired tissue. The cryoneedle does not actually carry any cryofluid in the latter case.
One form of a pressurized cryofluid source is presented in figure 3. The cryofluid is contained in a thermal insulated container 11. Container 11 is pressurized 25 by com~ressed air from air tank 15, through flexible air CA 022~8619 1998-12-21 W 097/49344 PCTrUS97/1037S
pressure pipe 13 and valve 14. Air tank 15 is pre-charged with compressed air by an external pressure source like an electric pump 31. Air tank 15 is designed to have much larger volume than cryofluid container 11. Therefore, the change in total gas volume during the entire cryosurgical operation is relatively small and is approximately the volume ratio of cryofluid container 11 to air tank 15. Under isothermal conditions, the total air pressure decrease will be proportional to the above volume ratio. However, this is not exactly the case since the air which enters container 11 contracts due to temperature decrease and therefore contributes to the overall pressure drop. Pressure decreases are compensated for by high pressure air tank 20. High pressure air tank 20 is connected to air tank 15, through pipe 19 and pressure regulator 18. Pressure regulator 18 keeps the pressure in air tank 15 on some set point. By analogy between fluid pressure and electrical potential, the setup of air tanks 15 and 20 can be viewed as a "pressure battery". The usage of air tank 20 is optional but not necessary. It is needed only when the volume ratio of air tank 15 to container 11 is not large enough, or in cases where a very accurate pressure control is required. The '~pressure battery" may include the electric pump 31, or may be pre-charged by an external source.
Contrary to practice, the pressurized coolant system Or the apparatus, as presented above, is separated CA 022~8619 1998-12-21 WO 97149344 PCTrUS97/10375 into two main components: the coolant container 11 and the "pressure battery". This set-up has the following advantages: (1) the larger part of the system - the pressure battery - can be moved far from the cryosurgeon, possibly to S another room, thus leaving more space in the operating room;
(2) the coolant container is placed very close to the cryotreated tissue which reduces undesired coolant boiling along the feeding pipes. This reduces both the coolant consumption and the working pressure required to force the coolan through the feeding pipe. In turn, the reduction of the coolant consumption reduces the volume of the coolant container. Ordinary cryosurgery systems include the pressu~ized system and the coolant container in one unit.
Any ordinary air compressor could serve as an air pressu~e source for the cryofluid container 11. However, the air pressure system as presented here has advantages as a part of a surgical apparatus in that it can be very light in weight, small in dimension, very quiet in operation, and independent in power supply.
Practically, feeding tube 9 has to be as short as possible and therefore container 11 should be placed as close as possible to the cryotreated tissues. This can be compensated by a long air pressure pipe 13. This arrangement will decrease the heat losses along feeding tube 9 to the surro~-dings, which will decrease the required cryofluid flow CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 rate, and which in turn will decrease the required volume of cryofluid container 11 for a specific operation. Low flow rates and short feeding tubes will require lower working pressures in the air pressure system. Furthermore, a smaller cryofluid container will require a smaller air tank volume.
Moreover, the closer the cryofluid container is to the cryotreated tissues, the more compact apparatus 100 becomes in regard to dimensions and the safer the apparatus becomes in terms of pressure. One liter of coolant is generally needed for a triple cryoprobe operation, for a duration of 15 minutes under a pressure of 30 psi. A 2-liter vacuum insulated coolant container, a 34-liter low air pressure tank and a 22-liter high pressure air tank ~ere used with the apparatus 100. However, the high pressure air tank was not needed for a single usage of the coolant container due to the high volume ratio of the low pressure air .ank to the coolant container, as aescribed above.
Before commencing the cryosurgery, the cryosurgeon will typically study the location, depth and configuration of the undesired tissues. The cryosurgeon will study the surrounding healthy tissues as well, and especially the vital tissues. This study can be performed via ultrasound, CT or MR
imaging techniques. Based on this study, one or more appropriately configured cryoprobes will be chosen.
CA 022~8619 1998-12-21 W O 97/49344 PCT~US97/10375 A schematic view of the cryosurgical apparatus with 3 cryoprobes is shown in figure 4. The pressurized coolant source rem~in~ in the same configuration as for a single cryoprobe operation, as presented above. For a multi-cryoprobe, parallel feeding tubes lead the coolant to thecryoprobe and the temperature is monitored at the tip 33 of each cryoprobe separately. Each cryoprobe has a temperature sensor and a control valve on its reeding tube 9 in a multi-cryoprobe operation. All the cryoprobes flow rates are operated at the same techni~ue presented above, at the beginning of the cryoprocedure. As cryosurgery proceeds, a need to reduce the cooling power of one or more cryoprobes may arise due to the presence of vital organs around the cryotreated tissue, or due to an irregularity in shape of the cryotreated tissue (tumor). At this stage, the cryosurgeon compares the frozen region formation with the cryotreated tissue shape via an imaging device such as ultrasound and operates the control valves accordingly.
The method of operation of cryoprobe A is addressed first. Utilizing a needle localization technique or a stereotactic localization technique, cryoneedle 1 will be inserted into the undesired tissue, as shown in figure 5a and as described hereafter. The fine diameter of the cryoneedle and its sharp pointed tip 33 are suitable for a straightforward insertion, without any cutting. The cryoneedle insertion procedure will be repeated in case of a CA 022~8619 1998-12-21 4 rcTrusg7/lo375 multi-cryoprobe operation. Cryoneedles can be relocated at this stage with no significant damage to surrounding tissues.
The insertion of insulation shell 4 is next.
Insulation shell 4 will be slide along cryoneedle 1 and will be inserted in~o the tissue, figure 5b. A small incision in the skin may be needed for the insertion of tube 4. The insertion of insulation tube 4 will be monitored by an imaging technlque, to leave the appropriate cryoprobe active surface near the tip 33 of the cryoneedle. The other end of the irsulation shell will remain outside of the body. The length of the insulation shell will be chosen for a particular cryotreatment according to the length of the cryon~edle, the depth of the undesired tissues, and the requi-ed cryc?robe active surface. Insertion of the insula_ion shell will be repeated in case o,~ multi-cryoprobe operation.
Protection tube 6 will then be placed along cryoneedle 1, adjacent to insulation shell 4, figure 5c.
Flexible vent tube 7 will be connected to the cryoneedle under a pressure fit. The length of protection tube 6 will be chosen to fit between insulation shell 4 and vent tube 7.
Lastly, the inlet tube 35 of cryoneedle 1 will be connected to feeding tube 9 and the cryoprobe will be ready for operation. Container 11 will be filled with cryofluid and air CA 022~86l9 l998-l2-2l tanks 15 and 20 will be charged with compressed air in advance.
The freezing stage is then started. While monitoring the frozen region formation, the cryosurgeon will operate the cryoprobe by means of valve 10. In case of a multi-cryoprobe operation, each cryoprobe will be controlled independently. The freezing process will continue until the entire target region is frozen, or until a danger of cryodestruction to surrounding tissues appears. Control valve 10 should be a standard needle valve which is designed for cryogenic temperatures. These valves are available in a wide range for commercial usage.
The thawing stage is then started. Thawing can be performed by either natural thawing, i.e. leaving the tissue to be thawed due to blood perfusion and metabolic activities, or by forcing warm fluid through the cryoprobe passageway, i.e. disconnecting the cryoneedle from feeding tube 9 and re-connecting it to a pressurized warm fluid source.
The cryoprobe(s) can now be cooled again, in case of repeated freezing/thawing cycles cryotreatment.
The method of operation of cryoprobe B is addressed next. The method of operation of cryoprobe B is similar to the metho~ presented above for cryoprobe A with the only CA 022~8619 1998-12-21 W O 97/49344 PCTrUS97/10375 exception that cryoneedle 1 and thermal insulation shell 4 are inserted and extracted from the body together, as a one unit. This operation is suitable for cases in which the outer diameter of thermal insulation shell 4 is relatively small.
Any minimal-invasive cryoprocedure has to rely on an imaging technique such as ultrasound, CT or MRI. The ultrasound is widely accepted by cryosurgeons. The imaging technique is desired for two different tasks: (1) the localization of the cryoneedle(s), and (2) monitoring the cryolesion growth (the freezing front propagation). The uniqueness of the cryoneedle configuration of the invention, as being assembled during the cryoprocedure and/or as having small dimensions, offers a major advantage for an easy and precise localization of the tip 33. Two cryoneedle localization techniques are discussed below: needle localization and stereotactic.
Needle localization technique: This technique is currently used for guidance of the surgeon to the tumor, and towards the extraction of a tumor of the breast, as follows.
First, the tumor is located on the ultrasound image. Then, monitored by the ultrasound, a needle is inserted into the center of the tumor (while the patient is treated with a ~ local anaesthesia). Lastly, the patient is transferred to the operation room and a surgery is performed to extract the tumor. The tumor is found by dissecting along the needle.
CA 022~8619 1998-12-21 WO 97/49344 PCT~US97tlO375 Localization of a standard cryoprobe by means of the needle localization technique should be performed as described above, where a pathway for the cryoneedle is dissected along the needle.
Localization of the cryoneedle of the invention by means of the needle localization technique is performed in one of the two alternative ways: (1) By using the cryoneedle as the needle for the needle localization procedure. (2) First by inserting the standard needle, and then by replacing it with the cryoneedle. In both cases, a pathway is not needed for the cryoneedle, however, a small incision may be required on the skin. The apparatus will be assembled after the localization of the cryoneedle, in situ, as described above.
Stereotactic localization technique: The cryoneedle is guided to the tumor by stereotactic technique. This requires the use of a stereotactic breast imaging/biopsy table which provides digital mammographic images of the breast. The cryoneedle is mounted on a needle holder which is mounted on the stereotactic table. Using computer generated coordinates obtained from a stereo images, the biopsy needle or cryoneedle is positioned into the tumor and therapy is carried out. This can be performed under a local anaesthesia. In this case, the cryoneedle has to be designed to be compatible, in size and shape, with the standard biopsy . .
CA 022~8619 1998-12-21 WO 97/49344 PCT~US97/10375 needle used with the stereotactic device. The apparatus will then be assembled, in situ, as described above.
Although the invention has been described in detail in the foregoing embodiments for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention except as it may be described by the following claims.
Claims (30)
1. An apparatus for cryosurgery comprising:
a cryoneedle having an external surface; and a thermal insulation shell disposed about a portion of the external surface of the cryoneedle for reduction of heat transfer from surrounding tissues of a body of a patient or freezing prevention of surrounding tissues of the body of the patient during application of the cryoneedle with the shell, said cryoneedle and shell configured for contact with the body of the patient, said shell about the portion of the external surface of the cryoneedle having an outer diameter of less than 3.2 mm.
a cryoneedle having an external surface; and a thermal insulation shell disposed about a portion of the external surface of the cryoneedle for reduction of heat transfer from surrounding tissues of a body of a patient or freezing prevention of surrounding tissues of the body of the patient during application of the cryoneedle with the shell, said cryoneedle and shell configured for contact with the body of the patient, said shell about the portion of the external surface of the cryoneedle having an outer diameter of less than 3.2 mm.
2. An apparatus as described in Claim 1 wherein the cryoneedle has a tip at a first end, and including a protection tube for protection of a user's hand during application of the cryoneedle, said shell disposed between the protection tube and the tip, said protection tube disposed about the cryoneedle and configured with the cryoneedle and the shell to be outside the body when the cryoneedle and the shell are inserted into the body of the patient during application.
3. An apparatus as described in Claim 2 wherein the cryoneedle has an inlet tube through which cryofluid flows during application of the cryoneedle to the tip and an outlet tube through which cryofluid flows during application of the cryoneedle from the tip.
4. An apparatus as described in Claim 3 wherein the cryoneedle has a bridging connector portion disposed in conjunction with the tip and connected with the inlet tube and the outlet tube to connect the inlet tube and the outlet tube and to allow cryofluid to flow from the inlet tube to engage the tip and flow out to the outlet tube.
5. An apparatus as described in Claim 4 wherein the bridging connector portion comprises a u-shaped channel connector.
6. An apparatus as described in Claim 5 wherein the tip is pointed.
7. An apparatus as described in Claim 6 wherein the inlet tube has an inside diameter less than 3 mm.
8. An apparatus as described in Claim 7 wherein the outlet tube has an inside diameter less than 3 mm.
9. An apparatus as described in Claim 8 wherein the inlet tube is in parallel with the outlet tube and the inlet tube is connected to the outlet tube.
10. An apparatus as described in Claim 9 including a pressurized cryofluid source mechanism connected to the inlet tube for providing pressurized cryofluid to the inlet tube.
11. An apparatus as described in Claim 10 wherein the pressurized cryofluid source mechanism includes a container of cryofluid connected to the inlet tube, and a tank of pressurized gas connected to the container to pressurize the cryofluid in the container.
12. An apparatus as described in Claim 11 wherein the source mechanism includes a pump connected to the tank to pressurize the tank.
13. An apparatus as described in Claim 12 wherein the source mechanism includes plumbing connected between the container and the inlet tube and a control valve disposed between the inlet tube and the container and connected to the plumbing to control the flow of cryofluid from the container.
14. An apparatus as described in Claim 13 including a temperature sensor mechanism in contact with the cryoneedle adjacent the tip for sensing the active surface temperature of the cryoneedle.
15. An apparatus as described in Claim 14 wherein the temperature sensor mechanism includes a temperature sensor disposed adjacent the tip and in contact with the cryoneedle, sensor wires connected to the sensor and extending from the sensor, and a temperature measurement unit connected to the sensor wires for identifying the temperature sensed by the sensor.
16. An apparatus as described in Claim 15 including at least a second cryoneedle and a second thermal insulation shell disposed about a portion of the second cryoneedle, said second cryoneedle connected to the source mechanism.
17. An apparatus as described in Claim 16 wherein the outlet tube has a vent end which releases the cryofluid to the environment.
18. An apparatus as described in Claim 17 wherein the protection tube and the shell are slidably attached to the cryoneedle.
19. An apparatus as described in Claim 17 wherein the insulation shell is rigidly connected to the cryoneedle.
20. An apparatus as described in Claim 17 including an imaging mechanism for imaging the cryoneedle as it penetrates into the body of a patient.
21. A method for freezing tissues comprising the steps of:
bringing into contact a cryoneedle having a diameter of less than 5 mm to a patient's body; and flowing cryofluid through the cryoneedle.
bringing into contact a cryoneedle having a diameter of less than 5 mm to a patient's body; and flowing cryofluid through the cryoneedle.
22. A method as described in Claim 21 wherein the flowing step includes the step of flowing cryofluid through the cryoneedle and venting the cryofluid into the environment.
23. A method as described in Claim 22 wherein the bringing step includes the step of inserting the cryoneedle into the patient's body.
24. A method as described in Claim 23 including after the inserting step, there is the step of sliding an insulation shell in place over a predetermined portion of the cryoneedle in the body of the patient.
25. A method as described in Claim 24 including after the sliding step, there is the step of sliding a protection tube in place over the cryoneedle until it is adjacent to the shell but the protection tube is outside the patient's body.
26. A method as described in Claim 23 wherein the inserting step includes the step of inserting the cryoneedle with an insulation shell positioned about the cryoneedle at a predetermined location simultaneously into the body of the patient.
27. A method as described in Claim 23 wherein the inserting step includes the step of imaging the cryoneedle as it is inserted into the patient's body.
28. A pressurized cryofluid source mechanism which connects to a cryoneedle for providing pressurized cryofluid to the cryoneedle comprising:
a container of cryofluid maintained at essentially a constant pressure which connects to the cryoneedle;
a tank of pressurized gas connected to but remote from the container to pressurize the cryofluid in the container; and a compression pump connected to the tank to pressurize the tank.
a container of cryofluid maintained at essentially a constant pressure which connects to the cryoneedle;
a tank of pressurized gas connected to but remote from the container to pressurize the cryofluid in the container; and a compression pump connected to the tank to pressurize the tank.
29. An apparatus for cryosurgery comprising:
a cryoneedle having an external surface;
a tip;
an inlet tube through which cryofluid flows during application of the cryoneedle to the tip and an outlet tube through which cryofluid flows during application of the cryoneedle from the tip;
a u-shaped channel connector disposed in conjunction with the tip and connected with the inlet tube and the outlet tube to connect the inlet tube and the outlet tube and to allow cryofluid to flow from the inlet tube to engage the tip and flow out to the outlet tube; and a thermal insulation shell disposed about a portion of the external surface of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell, said cryoneedle and shell configured for contact with a body of a patient.
a cryoneedle having an external surface;
a tip;
an inlet tube through which cryofluid flows during application of the cryoneedle to the tip and an outlet tube through which cryofluid flows during application of the cryoneedle from the tip;
a u-shaped channel connector disposed in conjunction with the tip and connected with the inlet tube and the outlet tube to connect the inlet tube and the outlet tube and to allow cryofluid to flow from the inlet tube to engage the tip and flow out to the outlet tube; and a thermal insulation shell disposed about a portion of the external surface of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell, said cryoneedle and shell configured for contact with a body of a patient.
30. An apparatus for cryosurgery comprising:
a cryoneedle having an external surface, said cryoneedle has a tip at a first end, and including a protection tube for protection of a user's hand during application of the cryoneedle, said shell disposed between the protection tube and the tip, said protection tube disposed about the cryoneedle and configured with the cryoneedle and the shell to be outside the body when the cryoneedle and the shell are inserted into the body of the patient during application; and a thermal insulation shell disposed about a portion of the external surface of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell, said cryoneedle and shell configured for contact with a body of a patient, said shell about the portion of the external surface of the cryoneedle having an outer diameter of less than 3.2 mm.
a cryoneedle having an external surface, said cryoneedle has a tip at a first end, and including a protection tube for protection of a user's hand during application of the cryoneedle, said shell disposed between the protection tube and the tip, said protection tube disposed about the cryoneedle and configured with the cryoneedle and the shell to be outside the body when the cryoneedle and the shell are inserted into the body of the patient during application; and a thermal insulation shell disposed about a portion of the external surface of the cryoneedle for reduction of heat transfer from surrounding tissues or freezing prevention of surrounding tissues during application of the cryoneedle with the shell, said cryoneedle and shell configured for contact with a body of a patient, said shell about the portion of the external surface of the cryoneedle having an outer diameter of less than 3.2 mm.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/668,692 US6039730A (en) | 1996-06-24 | 1996-06-24 | Method and apparatus for cryosurgery |
US08/668,692 | 1996-06-24 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2258619A1 true CA2258619A1 (en) | 1997-12-31 |
Family
ID=24683361
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002258619A Abandoned CA2258619A1 (en) | 1996-06-24 | 1997-06-20 | Method and apparatus for cryosurgery |
Country Status (6)
Country | Link |
---|---|
US (2) | US6039730A (en) |
EP (1) | EP0917447A4 (en) |
JP (1) | JP2000513963A (en) |
AU (1) | AU3571197A (en) |
CA (1) | CA2258619A1 (en) |
WO (1) | WO1997049344A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8382698B2 (en) | 2004-04-16 | 2013-02-26 | Nuvue Therapeutics, Inc. | Systems and methods for improving image-guided tissue ablation |
Families Citing this family (121)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050228367A1 (en) * | 1999-01-25 | 2005-10-13 | Marwan Abboud | Leak detection system for catheter based medical device |
US6592577B2 (en) | 1999-01-25 | 2003-07-15 | Cryocath Technologies Inc. | Cooling system |
US6471694B1 (en) | 2000-08-09 | 2002-10-29 | Cryogen, Inc. | Control system for cryosurgery |
US7004936B2 (en) | 2000-08-09 | 2006-02-28 | Cryocor, Inc. | Refrigeration source for a cryoablation catheter |
NO994363L (en) * | 1999-09-09 | 2001-03-12 | Optomed As | Fiber optic probe for temperature measurements in biological media |
US6312392B1 (en) * | 2000-04-06 | 2001-11-06 | Garrett D. Herzon | Bipolar handheld nerve locator and evaluator |
US6503246B1 (en) * | 2000-07-05 | 2003-01-07 | Mor Research Applications Ltd. | Cryoprobe and method of treating scars |
US20070088247A1 (en) * | 2000-10-24 | 2007-04-19 | Galil Medical Ltd. | Apparatus and method for thermal ablation of uterine fibroids |
US20020068929A1 (en) * | 2000-10-24 | 2002-06-06 | Roni Zvuloni | Apparatus and method for compressing a gas, and cryosurgery system and method utilizing same |
US6706037B2 (en) * | 2000-10-24 | 2004-03-16 | Galil Medical Ltd. | Multiple cryoprobe apparatus and method |
US20080045934A1 (en) * | 2000-10-24 | 2008-02-21 | Galil Medical Ltd. | Device and method for coordinated insertion of a plurality of cryoprobes |
US20020188287A1 (en) * | 2001-05-21 | 2002-12-12 | Roni Zvuloni | Apparatus and method for cryosurgery within a body cavity |
US20080051776A1 (en) * | 2001-05-21 | 2008-02-28 | Galil Medical Ltd. | Thin uninsulated cryoprobe and insulating probe introducer |
US20080051774A1 (en) * | 2001-05-21 | 2008-02-28 | Galil Medical Ltd. | Device and method for coordinated insertion of a plurality of cryoprobes |
US6936045B2 (en) * | 2001-09-20 | 2005-08-30 | Endocare, Inc. | Malleable cryosurgical probe |
TW557219B (en) * | 2002-06-28 | 2003-10-11 | Jiun-Guang Luo | Quick-freezing medical device |
US6789545B2 (en) * | 2002-10-04 | 2004-09-14 | Sanarus Medical, Inc. | Method and system for cryoablating fibroadenomas |
ES2442445T3 (en) * | 2003-01-15 | 2014-02-11 | Cryodynamics, Llc. | Cryotherapy system |
US7410484B2 (en) * | 2003-01-15 | 2008-08-12 | Cryodynamics, Llc | Cryotherapy probe |
US7083612B2 (en) * | 2003-01-15 | 2006-08-01 | Cryodynamics, Llc | Cryotherapy system |
US7273479B2 (en) * | 2003-01-15 | 2007-09-25 | Cryodynamics, Llc | Methods and systems for cryogenic cooling |
US6936048B2 (en) * | 2003-01-16 | 2005-08-30 | Charlotte-Mecklenburg Hospital Authority | Echogenic needle for transvaginal ultrasound directed reduction of uterine fibroids and an associated method |
US20040199129A1 (en) * | 2003-04-07 | 2004-10-07 | Scimed Life Systems, Inc. | Vascular access port |
US20040215177A1 (en) * | 2003-04-24 | 2004-10-28 | Scimed Life Systems, Inc. | Therapeutic apparatus having insulated region at the insertion area |
US7160291B2 (en) * | 2003-06-25 | 2007-01-09 | Endocare, Inc. | Detachable cryosurgical probe |
US7207985B2 (en) * | 2003-06-25 | 2007-04-24 | Endocare, Inc. | Detachable cryosurgical probe |
US7381207B2 (en) * | 2003-06-25 | 2008-06-03 | Endocare, Inc. | Quick disconnect assembly having a finger lock assembly |
US7608071B2 (en) | 2003-06-25 | 2009-10-27 | Endocare, Inc. | Cryosurgical probe with adjustable sliding apparatus |
US7794454B2 (en) * | 2003-07-11 | 2010-09-14 | Medtronic Cryocath Lp | Method and device for epicardial ablation |
US8007847B2 (en) * | 2004-01-13 | 2011-08-30 | Eytan Biderman | Feeding formula appliance |
US8491636B2 (en) | 2004-03-23 | 2013-07-23 | Medtronic Cryopath LP | Method and apparatus for inflating and deflating balloon catheters |
US7727228B2 (en) * | 2004-03-23 | 2010-06-01 | Medtronic Cryocath Lp | Method and apparatus for inflating and deflating balloon catheters |
US8206345B2 (en) * | 2005-03-07 | 2012-06-26 | Medtronic Cryocath Lp | Fluid control system for a medical device |
CN100408001C (en) * | 2005-04-14 | 2008-08-06 | 北京库蓝医疗设备有限公司 | Disposable freezing probe |
US7713266B2 (en) | 2005-05-20 | 2010-05-11 | Myoscience, Inc. | Subdermal cryogenic remodeling of muscles, nerves, connective tissue, and/or adipose tissue (fat) |
US7850683B2 (en) * | 2005-05-20 | 2010-12-14 | Myoscience, Inc. | Subdermal cryogenic remodeling of muscles, nerves, connective tissue, and/or adipose tissue (fat) |
US7572268B2 (en) * | 2005-10-13 | 2009-08-11 | Bacoustics, Llc | Apparatus and methods for the selective removal of tissue using combinations of ultrasonic energy and cryogenic energy |
US7842032B2 (en) | 2005-10-13 | 2010-11-30 | Bacoustics, Llc | Apparatus and methods for the selective removal of tissue |
US20070088386A1 (en) * | 2005-10-18 | 2007-04-19 | Babaev Eilaz P | Apparatus and method for treatment of soft tissue injuries |
WO2007057724A1 (en) * | 2005-11-17 | 2007-05-24 | Dieter Steinfatt | Hollow pin for the creation of frozen zones |
JP4744284B2 (en) * | 2005-12-19 | 2011-08-10 | 株式会社デージーエス・コンピュータ | Treatment child |
US20070149959A1 (en) * | 2005-12-23 | 2007-06-28 | Sanarus Medical, Inc. | Cryoprobe for low pressure systems |
US20090292279A1 (en) * | 2006-01-26 | 2009-11-26 | Galil Medical Ltd. | Device and Method for Coordinated Insertion of a Plurality of Cryoprobes |
EP2010084A2 (en) * | 2006-04-24 | 2009-01-07 | Thomas Jefferson University | Cryoneedle and cryotherapy system |
US20090221955A1 (en) * | 2006-08-08 | 2009-09-03 | Bacoustics, Llc | Ablative ultrasonic-cryogenic methods |
US20080039727A1 (en) | 2006-08-08 | 2008-02-14 | Eilaz Babaev | Ablative Cardiac Catheter System |
ATE489048T1 (en) * | 2006-09-08 | 2010-12-15 | Arbel Medical Ltd | DEVICE FOR COMBINED TREATMENT |
US20080114346A1 (en) * | 2006-09-18 | 2008-05-15 | Arbel Medical Ltd. | Cryosurgical Instrument |
US8142426B2 (en) | 2006-10-16 | 2012-03-27 | Syneron Medical Ltd. | Methods and devices for treating tissue |
US8133216B2 (en) | 2006-10-16 | 2012-03-13 | Syneron Medical Ltd. | Methods and devices for treating tissue |
US8273080B2 (en) | 2006-10-16 | 2012-09-25 | Syneron Medical Ltd. | Methods and devices for treating tissue |
US8007493B2 (en) | 2006-10-16 | 2011-08-30 | Syneron Medical Ltd. | Methods and devices for treating tissue |
US7909227B2 (en) * | 2006-12-19 | 2011-03-22 | Endocare, Inc. | Cryosurgical probe with vacuum insulation tube assembly |
US9254162B2 (en) | 2006-12-21 | 2016-02-09 | Myoscience, Inc. | Dermal and transdermal cryogenic microprobe systems |
US20080208181A1 (en) * | 2007-01-19 | 2008-08-28 | Arbel Medical Ltd. | Thermally Insulated Needles For Dermatological Applications |
US8409185B2 (en) | 2007-02-16 | 2013-04-02 | Myoscience, Inc. | Replaceable and/or easily removable needle systems for dermal and transdermal cryogenic remodeling |
KR100851274B1 (en) | 2007-03-08 | 2008-08-08 | 주식회사 엘바이오 | Probe for local anaesthetic system |
US20100162730A1 (en) * | 2007-06-14 | 2010-07-01 | Arbel Medical Ltd. | Siphon for delivery of liquid cryogen from dewar flask |
US20090036958A1 (en) * | 2007-08-01 | 2009-02-05 | Primaeva Medical, Inc. | Methods and devices for treating tissue |
US20080312647A1 (en) * | 2007-06-15 | 2008-12-18 | Primaeva Medical, Inc. | Methods and devices for treating tissue |
US8845630B2 (en) | 2007-06-15 | 2014-09-30 | Syneron Medical Ltd | Devices and methods for percutaneous energy delivery |
US20100324546A1 (en) * | 2007-07-09 | 2010-12-23 | Alexander Levin | Cryosheath |
US20090112205A1 (en) * | 2007-10-31 | 2009-04-30 | Primaeva Medical, Inc. | Cartridge electrode device |
US8298216B2 (en) | 2007-11-14 | 2012-10-30 | Myoscience, Inc. | Pain management using cryogenic remodeling |
WO2009066292A1 (en) * | 2007-11-21 | 2009-05-28 | Arbel Medical Ltd. | Pumping unit for delivery of liquid medium from a vessel |
US20090156958A1 (en) * | 2007-12-12 | 2009-06-18 | Mehta Bankim H | Devices and methods for percutaneous energy delivery |
US20110015624A1 (en) * | 2008-01-15 | 2011-01-20 | Icecure Medical Ltd. | Cryosurgical instrument insulating system |
WO2009128014A1 (en) | 2008-04-16 | 2009-10-22 | Arbel Medical Ltd | Cryosurgical instrument with enhanced heat exchange |
US8328804B2 (en) | 2008-07-24 | 2012-12-11 | Covidien Lp | Suction coagulator |
US20100281917A1 (en) * | 2008-11-05 | 2010-11-11 | Alexander Levin | Apparatus and Method for Condensing Contaminants for a Cryogenic System |
KR20110119640A (en) | 2008-12-22 | 2011-11-02 | 마이오우사이언스, 인크. | Integrated cryosurgical system with refrigerant and electrical power source |
EP2202472A1 (en) * | 2008-12-29 | 2010-06-30 | Ludwig-Maximilians-Universität München | Freeze dryer monitoring device |
US7967814B2 (en) | 2009-02-05 | 2011-06-28 | Icecure Medical Ltd. | Cryoprobe with vibrating mechanism |
WO2010105158A1 (en) * | 2009-03-12 | 2010-09-16 | Icecure Medical Ltd. | Combined cryotherapy and brachytherapy device and method |
US20100305439A1 (en) * | 2009-05-27 | 2010-12-02 | Eyal Shai | Device and Method for Three-Dimensional Guidance and Three-Dimensional Monitoring of Cryoablation |
WO2010144811A1 (en) * | 2009-06-11 | 2010-12-16 | Florida State University | Zero delta temperature thermal link |
US7967815B1 (en) | 2010-03-25 | 2011-06-28 | Icecure Medical Ltd. | Cryosurgical instrument with enhanced heat transfer |
US20120089211A1 (en) * | 2010-04-08 | 2012-04-12 | Myoscience, Inc. | Methods and apparatus for cryogenically treating multiple tissue sites with a single puncture |
US7938822B1 (en) | 2010-05-12 | 2011-05-10 | Icecure Medical Ltd. | Heating and cooling of cryosurgical instrument using a single cryogen |
US8080005B1 (en) | 2010-06-10 | 2011-12-20 | Icecure Medical Ltd. | Closed loop cryosurgical pressure and flow regulated system |
ES2910440T3 (en) | 2010-11-16 | 2022-05-12 | Tva Medical Inc | Devices to form a fistula |
WO2013106859A1 (en) | 2012-01-13 | 2013-07-18 | Myoscience, Inc. | Cryogenic needle with freeze zone regulation |
CA2861116A1 (en) | 2012-01-13 | 2013-07-18 | Myoscience, Inc. | Cryogenic probe filtration system |
CA2860893A1 (en) | 2012-01-13 | 2013-07-18 | Myoscience, Inc. | Skin protection for subdermal cryogenic remodeling for cosmetic and other treatments |
US9017318B2 (en) | 2012-01-20 | 2015-04-28 | Myoscience, Inc. | Cryogenic probe system and method |
US20150094700A1 (en) * | 2012-04-27 | 2015-04-02 | Dgs Computer Co., Ltd. | Cylindrical probe outer casing for cryosurgery device, and treatment unit |
JP2015532152A (en) | 2012-10-11 | 2015-11-09 | ティーブイエー メディカル, インコーポレイテッド | Apparatus and method for fistula formation |
WO2014153229A1 (en) | 2013-03-14 | 2014-09-25 | Tva Medical, Inc. | Fistula formulation devices and methods therefor |
US20210128220A1 (en) * | 2013-03-14 | 2021-05-06 | Cpsi Holdings Llc | Endoscopic cryoablation catheter |
US10918432B2 (en) * | 2013-03-14 | 2021-02-16 | Cpsi Holdings Llc | Endoscopic cryoablation catheter |
US9877767B2 (en) * | 2013-03-14 | 2018-01-30 | Cpsi Holdings Llc | Endoscopic cryoablation catheter |
US9295512B2 (en) | 2013-03-15 | 2016-03-29 | Myoscience, Inc. | Methods and devices for pain management |
US10016229B2 (en) | 2013-03-15 | 2018-07-10 | Myoscience, Inc. | Methods and systems for treatment of occipital neuralgia |
CN105208954B (en) | 2013-03-15 | 2019-06-04 | 肌肉科技股份有限公司 | Low temperature Blunt dissection method and apparatus |
US9610112B2 (en) * | 2013-03-15 | 2017-04-04 | Myoscience, Inc. | Cryogenic enhancement of joint function, alleviation of joint stiffness and/or alleviation of pain associated with osteoarthritis |
AU2014327045B2 (en) | 2013-09-24 | 2019-08-08 | Adagio Medical, Inc. | Endovascular near critical fluid based cryoablation catheter and related methods |
US10130409B2 (en) | 2013-11-05 | 2018-11-20 | Myoscience, Inc. | Secure cryosurgical treatment system |
US10695534B2 (en) | 2014-03-14 | 2020-06-30 | Tva Medical, Inc. | Fistula formation devices and methods therefor |
US10054262B2 (en) * | 2014-04-16 | 2018-08-21 | Cpsi Holdings Llc | Pressurized sub-cooled cryogenic system |
US10617459B2 (en) | 2014-04-17 | 2020-04-14 | Adagio Medical, Inc. | Endovascular near critical fluid based cryoablation catheter having plurality of preformed treatment shapes |
WO2016033374A1 (en) * | 2014-08-27 | 2016-03-03 | Tva Medical, Inc. | Cryolipopysis devices and methods therefor |
US11020098B2 (en) * | 2014-09-09 | 2021-06-01 | Boston Scientific Scimed, Inc. | Methods, systems and devices for cryogenic biopsy |
BR112017009586B1 (en) | 2014-11-13 | 2022-09-20 | Adagio Medical, Inc. | CRYOABLATION SYSTEM |
US10603040B1 (en) | 2015-02-09 | 2020-03-31 | Tva Medical, Inc. | Methods for treating hypertension and reducing blood pressure with formation of fistula |
EP3349676A4 (en) | 2015-09-18 | 2019-05-15 | Adagio Medical, Inc. | Tissue contact verification system |
US10864031B2 (en) | 2015-11-30 | 2020-12-15 | Adagio Medical, Inc. | Ablation method for creating elongate continuous lesions enclosing multiple vessel entries |
AU2017208069B2 (en) | 2016-01-15 | 2021-11-25 | Tva Medical, Inc. | Devices and methods for forming a fistula |
AU2017207507B2 (en) | 2016-01-15 | 2021-11-11 | Tva Medical, Inc. | Devices and methods for advancing a wire |
US10874422B2 (en) | 2016-01-15 | 2020-12-29 | Tva Medical, Inc. | Systems and methods for increasing blood flow |
US11311327B2 (en) | 2016-05-13 | 2022-04-26 | Pacira Cryotech, Inc. | Methods and systems for locating and treating nerves with cold therapy |
AU2017331090C1 (en) | 2016-09-25 | 2023-08-03 | Tva Medical, Inc. | Vascular stent devices and methods |
US11413085B2 (en) | 2017-04-27 | 2022-08-16 | Medtronic Holding Company Sàrl | Cryoprobe |
CN111225626B (en) | 2017-09-05 | 2023-11-14 | 艾达吉欧医疗公司 | Ablation catheter with shape memory probe |
WO2019099677A1 (en) | 2017-11-15 | 2019-05-23 | Myoscience, Inc. | Integrated cold therapy and electrical stimulation systems for locating and treating nerves and associated methods |
WO2019139917A1 (en) | 2018-01-10 | 2019-07-18 | Adagio Medical, Inc. | Cryoablation element with conductive liner |
WO2020056221A1 (en) * | 2018-09-14 | 2020-03-19 | Atricure, Inc. | Cryoprobe |
EP3863546A4 (en) * | 2018-10-08 | 2022-08-03 | Vitatrop Inc. | Cryogenic applicator |
US10610280B1 (en) | 2019-02-02 | 2020-04-07 | Ayad K. M. Agha | Surgical method and apparatus for destruction and removal of intraperitoneal, visceral, and subcutaneous fat |
US11633224B2 (en) | 2020-02-10 | 2023-04-25 | Icecure Medical Ltd. | Cryogen pump |
CN111437029B (en) * | 2020-04-27 | 2022-03-08 | 深圳半岛医疗有限公司 | Cold-freezing therapeutic device in scar and control method thereof |
US20230381015A1 (en) * | 2022-05-31 | 2023-11-30 | Icecure Medical Ltd. | Cryogenic system with multiple submerged pumps |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR1418132A (en) * | 1964-09-28 | 1965-11-19 | Air Liquide | Device for cooling a small region of a body |
US3298371A (en) * | 1965-02-11 | 1967-01-17 | Arnold S J Lee | Freezing probe for the treatment of tissue, especially in neurosurgery |
US3421508A (en) * | 1966-08-31 | 1969-01-14 | Union Mfg Co | Cryosurgical probe |
US3830239A (en) * | 1972-09-12 | 1974-08-20 | Frigitronics Of Conn Inc | Cryosurgical device |
US3859986A (en) * | 1973-06-20 | 1975-01-14 | Jiro Okada | Surgical device |
US3889680A (en) * | 1974-02-07 | 1975-06-17 | Armao T A | Cryoadhesion preventing cryosurgical instruments |
SU532976A1 (en) * | 1974-05-05 | 1978-11-05 | Киевский Государственный Институт Усовершенстовования Врачей Министерства Здравоохранения Ссср | Apparatus for local refrigeration of tissue |
US4043341A (en) * | 1975-12-09 | 1977-08-23 | Tromovitch Theodore A | Portable cryosurgical instrument |
GB1534162A (en) * | 1976-07-21 | 1978-11-29 | Lloyd J | Cyosurgical probe |
US4306568A (en) * | 1979-12-04 | 1981-12-22 | Torre Douglas P | Method and apparatus for congelation cryometry in cryosurgery |
SU1563684A1 (en) * | 1986-05-26 | 1990-05-15 | Томский государственный медицинский институт | Cryosurgical scalpel |
ZA917281B (en) * | 1990-09-26 | 1992-08-26 | Cryomedical Sciences Inc | Cryosurgical instrument and system and method of cryosurgery |
US5520682A (en) * | 1991-09-06 | 1996-05-28 | Cryomedical Sciences, Inc. | Cryosurgical instrument with vent means and method using same |
GB9123415D0 (en) * | 1991-11-05 | 1991-12-18 | Clarke Brian K R | Cryosurgical apparatus |
US5531742A (en) * | 1992-01-15 | 1996-07-02 | Barken; Israel | Apparatus and method for computer controlled cryosurgery |
US5386447A (en) * | 1992-09-23 | 1995-01-31 | Fischer Imaging Corporation | Mammographic screening and biopsy apparatus |
US5647868A (en) * | 1994-02-02 | 1997-07-15 | Chinn; Douglas Owen | Cryosurgical integrated control and monitoring system and method |
-
1996
- 1996-06-24 US US08/668,692 patent/US6039730A/en not_active Expired - Fee Related
-
1997
- 1997-06-20 AU AU35711/97A patent/AU3571197A/en not_active Abandoned
- 1997-06-20 CA CA002258619A patent/CA2258619A1/en not_active Abandoned
- 1997-06-20 JP JP10503196A patent/JP2000513963A/en active Pending
- 1997-06-20 WO PCT/US1997/010375 patent/WO1997049344A1/en not_active Application Discontinuation
- 1997-06-20 EP EP97932189A patent/EP0917447A4/en not_active Withdrawn
-
2000
- 2000-03-16 US US09/527,491 patent/US6786902B1/en not_active Expired - Fee Related
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8382698B2 (en) | 2004-04-16 | 2013-02-26 | Nuvue Therapeutics, Inc. | Systems and methods for improving image-guided tissue ablation |
Also Published As
Publication number | Publication date |
---|---|
US6039730A (en) | 2000-03-21 |
WO1997049344A1 (en) | 1997-12-31 |
JP2000513963A (en) | 2000-10-24 |
EP0917447A4 (en) | 2001-08-01 |
US6786902B1 (en) | 2004-09-07 |
AU3571197A (en) | 1998-01-14 |
EP0917447A1 (en) | 1999-05-26 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6039730A (en) | Method and apparatus for cryosurgery | |
WO1997049344A9 (en) | Method and apparatus for cryosurgery | |
EP0602188B1 (en) | Cryosurgical instrument with vent holes and method | |
EP0550666B1 (en) | Cryosurgical system | |
US5520682A (en) | Cryosurgical instrument with vent means and method using same | |
US8298221B2 (en) | Disposable sheath with replaceable console probes for cryosurgery | |
US20190117288A1 (en) | Cryotherapy probe | |
EP2904986B1 (en) | Cryotherapy system | |
EP1003430B1 (en) | Endoscopic cryospray device | |
US20080027422A1 (en) | Closed-Loop Cryosurgical System and Cryoprobe | |
WO1999015092A9 (en) | Method and apparatus for heating during cryosurgery | |
EP1768593A4 (en) | System and method for varying return pressure to control tip temperature of a cryoablation catheter | |
US20080115509A1 (en) | Methods and Apparatus for Forming and Connecting Cryoprobes for use with Cryosurgical Treatment Systems | |
EP1508309A1 (en) | Cryoprobe with reshapeable tip | |
Rabin et al. | A compact cryosurgical apparatus for minimally invasive procedures | |
US8298220B2 (en) | Cryoprobe with coaxial chambers | |
US20080110182A1 (en) | Coaxial Cryogenic Refrigeration Coupler | |
AU649741C (en) | Cryosurgical instrument and system and method of cryosurgery |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
FZDE | Discontinued |