|Publication number||US7591794 B2|
|Application number||US 10/757,703|
|Publication date||Sep 22, 2009|
|Filing date||Jan 15, 2004|
|Priority date||Jan 14, 2003|
|Also published as||DE60315135D1, DE60315135T2, EP1477207A1, EP1477207B1, US20050085726|
|Publication number||10757703, 757703, US 7591794 B2, US 7591794B2, US-B2-7591794, US7591794 B2, US7591794B2|
|Inventors||Francois Lacoste, Antoine Tetard, Christian Chaussy, Jean-Yves Chapelon|
|Original Assignee||Edap S.A.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (44), Non-Patent Citations (1), Referenced by (7), Classifications (15), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to treatment of tissue by ultrasound and, more particularly, to apparatus for delivering ultrasound.
U.S. Pat. No. 6,379,320 discloses a probe for coagulating tissue by therapeutic ultrasound delivered from a planar transducer. Other ultrasound delivery apparatuses are disclosed in U.S. Pat. No. 5,630,837 which uses at least one annular piezoelectric element or U.S. Pat. No. 5,762,066 in which the piezoelectric elements are arranged in two chambers.
Focused transducers for bringing about high-temperature heating (the “HIFU” technique) are disclosed in the following French patent applications: 2,673,542, 2,700,878; 2,717,942; 2,750,340; 2,778,573; 2,778,574; 2,794,018; 2,807,827; 2,679,125; 2,715,822.
It has also been proposed to use cylindrical transducers in probes—in particular urethral probes—for producing radial emission, U.S. Pat. No. 5,391,197 states that the piezoelectric elements are cylindrical and focusing, U.S. Pat. No. 5,522,869 discloses tissue temperature measurement, U.S. Pat. No. 5,549,638 employs cylindrical piezoelectric elements and measures temperature in the tissue, U.S. Pat. No. 5,620,479 discloses tubular piezoelectric elements, U.S. Pat. No. 5,733,315 states that the piezoelectric elements are arranged around a central tube some of them being deactivated to avoid heating of the rectum. U.S. Pat. No. 5,895,356 states that the piezoelectric elements are circular and focusing. These various apparatuses have the disadvantage of the ultrasound field being diverging which can be harmful to the depth effectiveness of treatment.
Therapy transducers associated with imaging for guiding purposes are also proposed. U.S. Pat. No. 5,697,897 discloses an endoscope provided with a therapeutic ultrasound source. U.S. Pat. No. 5,471,988 discloses various endoscope configurations provided with a therapy transducer. However, in each case this transducer is focusing. The transducer is associated with an imaging transducer or optical system. U.S. Pat. No. 6,050,943 discloses piezoelectric elements having three functions: imaging, therapy and temperature control.
Vibrating instruments are also known, these comprising a transducer coupled to a tool via an ultrasound conductor. The tool can be a knife or pincer-like instrument for cutting or coagulating tissue. Coagulation results from the temperature rise of the tissue in contact with the tool, by friction. Coagulation depth depends on tissue thermal conduction and is consequently low. An instrument known as the “Harmonic scalpel” which is activated by ultrasound is marketed by the HS company, Ethicon Endo-surgery, Cincinatti, Ohio, US.
Various medical instruments employ radiofrequencies. Radiofrequency coagulators employ alternating current. An alternating current is caused to pass through the tissue, which heats up by ohmic heating. A distinction is made between bipolar coagulators (the effect is in the area between two electrodes) and monopolar coagulators (heating occurs in the immediate surroundings of the tip, the current return path being via a ground plate in contact with the patient). Endoscopic scalpels all are provided with a loop that is activated by a current and which cuts or coagulates the tissue depending on the current used. Recently, bipolar loops have appeared. Numerous other apparatuses, identified below by their commercial name, used radio frequencies:
Laser coagulators have also been proposed using different types of laser for coagulating veins or small blood vessels.
Various applications of ultrasound to treatment are discussed in the following Articles:
LAFON C; CHOSSON S;
The feasibility of constructing
PRAT F; THEILLERE Y;
a cylindrical array with a plane
37(9): 615-21 2000
CHAPELON JY; BIRER A;
rotating beam for interstitial
LAFON C. CHAVRIER F.
Theoretical comparison of two
Med Biol Eng
PRAT F. CHAPELON JY.
interstitial ultrasound applicators
designed to induce cylindrical
zones of tissue ablation
LAFON C. PRAT F.
In vivo effects of interstitial
CHAPELON JY. GORRY F.
ultrasound plane applicator on
LAFON C. PRAT F.
Cylindrical thermal coagulation
CHAPELON JY. GORRY F.
necrosis using an interstitial
applicator with a plane ultrasonic
transducer: in vitro
and in vivo experiments versus
LAFON C. CHAPELON JY.
Design and in vitro results of a
PRAT F. GORRY F.
high intensity ultrasound interstitial
LAFON C. CHAPELON JY.
Design and preliminary results
PRAT F. GORRY F.
of an ultrasound applicator for
medicine & biology,
interstitial thermal coagulation
vol. 24, no1,
LAFON C. THEILLERE Y.
Ultrasound interstitial applicator
PRAT F. AREFIEV A.
for digestive endoscopy:
in vivo destruction of bilary
LAFON C. THEILLERE Y.
Development of an interstitial
PRAT F. AREFIEV A.
ultrasound applicator for endoscopic
medicine & biology,
vol. 26, no4,
LAFON C; CHAPELON JY;
Design and preliminary results
PRAT F; GORRY F;
of an ultrasound applicator for
Biol, 24(1): 113-22
interstitial thermal coagulation.
PRAT F. LAFON C.
A high-intensity US probe designed
MARGONARI J. GORRY F.
for intraductal tumor
destruction: experimental results.
PRAT F. LAFON C.
Destruction of a bile duct carcinoma
THEILLERE Y. FRITSCH J.
by intraductal high
CHOURY AD. LORAND I.
intensity ultrasound during
Jun, 53(7): 797-800
LAFON C.; MELO DE
Optimizing the shape of ultrasound
Med. Phys. 29 (3),
LIMA D.; THEILLERE Y.;
sound transducers for interstitial
PRAT F. CHAPELON JY;
Known devices raised certain problems which are not necessarily identified in the state-of-the-art.
Limit Risks of Hemorrhage
The surgeon is always faced with the problem of hemostasis. He should coagulate the vessels during surgery and ensure they will remain sealed after intervention. Arterial bleeding is frequently easy to identify as blood flows is pulsed. Veins are problematic because they can be difficult to seal. The danger of bleeding is particularly serious in endoscopic surgery because it is more difficult to master.
Reduce Risk of Glycine Resorption
Endoscopic surgery is frequently performed in aqueous medium: saline solution or glycine; glycine is a liquid used during endoscopic surgery; it is an electrical insulator. When pressure increases, glycine can be resorbed by the patient's venal system which can lead to the so-called TURP syndrome. This is a reason why, during endoscopic surgery (of the prostate, endometer) the amount of electrolyte in the blood is monitored and duration of treatment is limited. For these reasons also, it is important to successfully coagulate the veins.
Limit Risk of Recurrence
During cancer surgery, the insertion of a surgical instrument introduces a risk of spreading tumor cells in the organism. In bladder cancer for example, it is suspected that the simple fact of touching the tumor can increase the risk of recurrence. It would consequently be useful to coagulate tissue remotely without touching it.
Conventional instruments have the same effect whether the tissue is normal or tumor. One consequently looks for an instrument which could selectively destroy certain tissue, for example tumor tissue.
In some of its various embodiments, the invention provides a solution to one or several of these problems.
Therefore, the invention provides a laparoscopy probe having at least one planar transducer. Preferred embodiments comprise one or several of the following features:
The invention also provides a coagulation apparatus having an ultrasound transducer and a scalpel blade movable with respect to said transducer. In an embodiment, the apparatus further has an imaging transducer.
The invention further provides a coagulation instrument having a planar ultrasound transducer without a membrane, mounted in the region of an end of a cable. In an embodiment, the coagulation instrument has a diameter less than 1 to 5 mm. In another embodiment, the cable is flexible.
The invention furthermore provides an endoscopic apparatus comprising the above instrument and a cooling and coupling fluid circuit, with fluid inlet and outlet openings preferably in the region of the transducer.
Other characteristics and advantages of the invention will become more clear from the description which follows of some embodiments of the invention provided solely by way of example with reference to the attached drawings.
In a first embodiment, the invention employs a planar transducer for endoscopic coagulation. The transducer is used without a separating membrane, coupling as well as cooling being provided by the liquid surrounding the organ to be treated. The instrument is fitted with a cable at the end of which the transducer is mounted. The transducer is powered via the cable. It is flexible to be able to be inserted in endoscopic apparatus; the cable can be rigid or partially rigid if it is simultaneously to provide forward-and-back or rotary guiding of the transducer.
In view of the small dimensions, it is preferable to choose a high-frequency (8-20 MHz) transducer, to ensure the field does not diverge.
Cooling and coupling liquid circulation can be provided by the circuits conventionally provided in endoscopic apparatus. An inlet circuit terminates close to the transducer; an outlet circuit is also provided for drawing off or receiving liquid. The settings of the openings can allow the liquid flow to be directed. The liquid simultaneously provides cooling and ultrasound coupling.
The absence of a membrane facilitates insertion and improves coupling with the organ or tissue to be treated by eliminating one interface and ensuring that the liquid extends continuously between the transducer and the tissue. All windowing is also avoided so that vision (in the case of endoscopy) is not limited; nor is the treatment region limited by a window.
In one needle or interstitial coagulator application, the apparatus of
In the example of
For use, the surgeon will choose that probe which is best adapted to the patient. The probe, connected to the electronics housing is introduced into the urethra. The surgeon can employ various techniques for guiding the probe: the probe is inserted like any other urethral probe and held in position by the balloon which is inflated in the bladder, at vessel neck level. The surgeon can check probe position using transrectal ultrasound imaging, or abdominal or transurethral ultrasound imaging. In the latter case, the probe will also include an imaging transducer, for example integral with the firing transducer, as shown in
The follow-up to operation is simple. Coagulation can be followed by ablation of the coagulated tissue, using a conventional instrument or the apparatus sold under the name Rotosect by Karl Storz. As the tissue is coagulated, hemorrhaging is limited and the conventional instrument operates more simply, better controlled by the surgeon.
The following alternative embodiments are possible:
Similarly, multiple transducers can be arranged with the electric circuit being in parallel.
A flexible mechanical assembly for introduction into the prostate is preferred. A transducer of considerable length can also be divided into several shorter transducers aligned along the axis of the catheter, but mounted on a flexible support, as discussed below.
The probe sheath can be left in place after treatment. Thermal tissue treatment and in particular treatment of the prostate generally causes edema with the result that the patient frequently experiences urinary retention after treatment. The sheath is chosen to be of a material and have a thickness such that it plays the part of an endourethral prothesis or stent, pushing back treated tissue.
The apparatus is adapted for non-invasive, non-surgical treatment of benign prostatic hyperplasia (BPH). Compared to other non-invasive treatments of the prostate, the advantages are:
With reference to
This apparatus can be used
The apparatus can coagulate the paranchime as well as vessels. The aim of this coagulation tool is to save on time for resection, and limit risks. Coagulation is more effective than when radiofrequency resection apparatus is used as the energy is delivered at a greater depth. All the adenoma regions of the prostate (or organ to be treated) are directly or indirectly coagulated by necrosis of the vessels irrigating them.
The advantages are:
In a first example, the device has no resection cutter. It comprises ultrasound delivery means connected to a housing with the electronics. The housing contains the HF power electrical signal generation and control circuits. The delivery means are designed to be brought into contact with the tissue to be treated under optical monitoring.
The sterile or sterilizable delivery means are adapted for use on rectoscopes. Coagulation is performed with visual monitoring. The tool coagulates adenoma tissue and vessels irrigating the prostate in the intermediate region. Changeover from coagulation to resection and vice-versa is very easy and very fast.
Optionally, the securing lugs are hinged so that the ultrasound beam can be directed parallel, obliquely or along the axis of the instrument. The transducer can perform a to-and-fro movement on the instrument axis in the same way as a resection loop.
In a second example, the device has, apart from the planar transducer, a resection loop. The surgeon can select tissue coagulation before or after resection. The transducer is mounted in addition to the resection loop, the advantage being that the same instrument performs resection and deep coagulation. The resection loop cuts and the transducer coagulates.
The transducer can be mounted either:
Numerous constraints can be taken account of in the design of an ultrasound coagulation resection tool:
In one alternative embodiment, the transducer emits downwards and acoustic coupling is via the rinsing liquid; there is consequently no balloon, membrane or window. The transducer is integral with the resection tool body and the resection loop is movable with respect to the transducer.
Depth of shots and speed of displacement: accuracy of surgical intervention is extremely important, for example in the case of the prostate when one approaches the sphincter. Depth of “shooting” can be adapted without changing transducer, by adapting time and/or frequency of shooting. Coagulation depth, during movement, is adjustable between preferably 1 and 3 mm, without change of coagulation tool.
Regarding wiring, ideally, the transducer and coagulator are wired to the same power network, controlled by the same foot pedal, the generator responsible for coagulation being arranged in parallel on the habitual generator, each operating at its frequency and being relatively insensitive to the frequency of the other. A T-junction on the resection loop power cable enables the ultrasound transducer excitation current to be fed into the same cable as that for the resection loop. At the distal end, the two circuits can be split by suitable electronics, for example resonant circuits or filters only allowing the passage of each tool's operating frequencies. This has the advantage of reducing bulk and amount of wiring.
In a fourth embodiment, a coagulator/scalpel is provided. It consists of an ultrasound coagulator associated with a scalpel as shown in
In the example of
The aim of this coagulation tool is to be able to perform more readily partial nephrectomy in particular for laparoscopy. Partial kidney ablation is currently rarely practised using laparoscopic techniques due to the significant vascularisation of the organ. As there is a high risk of hemorrhaging, laparoscopic intervention is more dangerous. The coagulation accessory allows this intervention to be performed using laparoscopy and limits the time needed to perform vessel suturing. The sterile or sterilizable applicator is inserted into a trocar. Coagulation is performed with visual observation. The tool coagulates the renal parenchyma and the vessels passing therethrough in a section allowing the tumor to be isolated as
The part that contains a tumor is excised after cutting on the coagulation section. Normal pathological analysis can be performed provided a sufficient margin has been allowed between the tumor and the renal parenchyma section. Expected benefits for the patient are those of partial nephrectomy and those of laparoscopic surgery, compared to ablation of a kidney in open surgery. For one type of given surgery, the advantages are:
In a fifth embodiment, the invention provides laparoscopic apparatus. This has one or several planar transducers on a probe which may or may not be articulated.
Pre-clinical trials have been conducted on rabbit livers in-vivo with the following parameters:
The percentage of coagulation of vessels compared to healthy tissue as control was determined.
The influence of shooting power can be seen on the graph of
It was also observed that the major portion of vessels located inside the tissue lesion was coagulated for both amounts of acoustic power applied.
To conclude, it is not necessary to increase power excessively as, beyond a certain threshold, the total volume coagulated decreases. One can thus limit coagulation depth by increasing power.
The influence of short duration can be seen on the graph
To conclude, lesion depth is intimately related to ultrasound application time and it is sufficient to provide minimal energy to ensure vessel obstruction, thanks to the shape of the transducer.
Obviously, the invention is not limited to the embodiments which have been described by way of example.
Further, other inventions described above are defined as follows.
A first one provides an endo-urethral probe having, in the region of its extremity, a balloon and a planar ultrasound transducer. Preferred embodiments comprise one or several of the following features:
Another invention provides an apparatus comprising an endo-urethral probe according to this first other invention, a coupling and cooling fluid circuit associated with said probe, and a radiofrequency generator connected to said probe. In an embodiment, the apparatus is characterized by an imaging generator connected to the imaging transducer of said probe.
A further invention provides a coagulator having a rectoscope tube with an ultrasound transducer at an end of said tube. Preferred embodiments comprise one or several of the following features:
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4206763 *||Aug 1, 1978||Jun 10, 1980||Drexel University||Ultrasonic scanner for breast cancer examination|
|US5013312 *||Mar 19, 1990||May 7, 1991||Everest Medical Corporation||Bipolar scalpel for harvesting internal mammary artery|
|US5322055 *||Jan 27, 1993||Jun 21, 1994||Ultracision, Inc.||Clamp coagulator/cutting system for ultrasonic surgical instruments|
|US5324299 *||Feb 3, 1992||Jun 28, 1994||Ultracision, Inc.||Ultrasonic scalpel blade and methods of application|
|US5335663 *||Dec 11, 1992||Aug 9, 1994||Tetrad Corporation||Laparoscopic probes and probe sheaths useful in ultrasonic imaging applications|
|US5391197||Jun 25, 1993||Feb 21, 1995||Dornier Medical Systems, Inc.||Ultrasound thermotherapy probe|
|US5437283 *||Apr 15, 1994||Aug 1, 1995||Tetrad Corporation||Endosurgical ultrasonic probe with integrated biopsy actuator|
|US5469853 *||Jun 22, 1994||Nov 28, 1995||Tetrad Corporation||Bendable ultrasonic probe and sheath for use therewith|
|US5471988||Dec 23, 1994||Dec 5, 1995||Olympus Optical Co., Ltd.||Ultrasonic diagnosis and therapy system in which focusing point of therapeutic ultrasonic wave is locked at predetermined position within observation ultrasonic scanning range|
|US5522869||Mar 8, 1995||Jun 4, 1996||Burdette; Everette C.||Ultrasound device for use in a thermotherapy apparatus|
|US5527331||Sep 15, 1995||Jun 18, 1996||Femrx||Method for prostatic tissue resection|
|US5549638||May 17, 1994||Aug 27, 1996||Burdette; Everette C.||Ultrasound device for use in a thermotherapy apparatus|
|US5620479||Jan 31, 1995||Apr 15, 1997||The Regents Of The University Of California||Method and apparatus for thermal therapy of tumors|
|US5624382||Feb 15, 1993||Apr 29, 1997||Siemens Aktiengesellschaft||Method and apparatus for ultrasound tissue therapy|
|US5630837||Mar 31, 1995||May 20, 1997||Boston Scientific Corporation||Acoustic ablation|
|US5697897||Jan 6, 1995||Dec 16, 1997||Siemens Aktiengesellschaft||Endoscope carrying a source of therapeutic ultrasound|
|US5733315||Nov 1, 1994||Mar 31, 1998||Burdette; Everette C.||Method of manufacture of a transurethral ultrasound applicator for prostate gland thermal therapy|
|US5762066||May 22, 1995||Jun 9, 1998||Ths International, Inc.||Multifaceted ultrasound transducer probe system and methods for its use|
|US5776092 *||Mar 22, 1995||Jul 7, 1998||Erbe Elektromedizin Gmbh||Multifunctional surgical instrument|
|US5882302 *||Jun 24, 1996||Mar 16, 1999||Ths International, Inc.||Methods and devices for providing acoustic hemostasis|
|US5895356||Nov 15, 1995||Apr 20, 1999||American Medical Systems, Inc.||Apparatus and method for transurethral focussed ultrasound therapy|
|US5938612 *||May 5, 1997||Aug 17, 1999||Creare Inc.||Multilayer ultrasonic transducer array including very thin layer of transducer elements|
|US5967984||Nov 27, 1996||Oct 19, 1999||Boston Scientific Corporation||Ultrasound imaging catheter with a cutting element|
|US6050943||Oct 14, 1997||Apr 18, 2000||Guided Therapy Systems, Inc.||Imaging, therapy, and temperature monitoring ultrasonic system|
|US6066096 *||May 8, 1998||May 23, 2000||Duke University||Imaging probes and catheters for volumetric intraluminal ultrasound imaging and related systems|
|US6293945 *||Mar 6, 2000||Sep 25, 2001||Everest Medical Corporation||Electrosurgical instrument with suction capability|
|US6379320 *||Jun 11, 1998||Apr 30, 2002||Institut National De La Santa Et De La Recherche Medicale I.N.S.E.R.M.||Ultrasound applicator for heating an ultrasound absorbent medium|
|US6589174 *||Oct 20, 2000||Jul 8, 2003||Sunnybrook & Women's College Health Sciences Centre||Technique and apparatus for ultrasound therapy|
|US20020188196 *||Apr 16, 2002||Dec 12, 2002||Burbank Fred H.||Cavity-filling biopsy site markers|
|US20050004589 *||Aug 29, 2003||Jan 6, 2005||Olympus Optical Co., Ld.||Ultrasound treatment system|
|EP0446645A1||Feb 15, 1991||Sep 18, 1991||Acoustic Imaging Technologies Corporation||Method and apparatus for ultrasonically probing a prostate|
|EP0453071A1||Feb 25, 1991||Oct 23, 1991||Everest Medical Corporation||Bipolar scalpel for harvesting internal mammary artery|
|EP0472368A2||Aug 15, 1991||Feb 26, 1992||Med Institute, Inc.||Ablation catheter|
|EP0983749A2||Aug 20, 1999||Mar 8, 2000||Rubicor Medical, Inc.||Excisional biopsy devices and methods|
|FR2673542A1||Title not available|
|FR2679125A1||Title not available|
|FR2700878A1||Title not available|
|FR2715822A1||Title not available|
|FR2717942A1||Title not available|
|FR2759340A1||Title not available|
|FR2778573A1||Title not available|
|FR2778574A1||Title not available|
|FR2794018A1||Title not available|
|FR2807827A1||Title not available|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8277379 *||Apr 13, 2007||Oct 2, 2012||Mirabilis Medica Inc.||Methods and apparatus for the treatment of menometrorrhagia, endometrial pathology, and cervical neoplasia using high intensity focused ultrasound energy|
|US8439907||Apr 30, 2008||May 14, 2013||Mirabilis Medica Inc.||Hemostatic tissue tunnel generator for inserting treatment apparatus into tissue of a patient|
|US8942781||Apr 9, 2009||Jan 27, 2015||Universite Pierre Et Marie Curie (Paris 6)||Medical system comprising a percutaneous probe|
|US9144421||Dec 17, 2009||Sep 29, 2015||Mirabilis Medica Inc.||Optimization of acoustic window and target depth for transabdominal ultrasound treatment or imaging of the uterus|
|US20070232913 *||Apr 13, 2007||Oct 4, 2007||Mirabilis Medica Inc.||Methods and apparatus for the treatment of menometrorrhagia, endometrial pathology, and cervical neoplasia using high intensity focused ultrasound energy|
|US20110040172 *||Apr 9, 2009||Feb 17, 2011||Alexandre Carpentier||Medical system comprising a percutaneous probe|
|US20130296847 *||Oct 30, 2012||Nov 7, 2013||Arqos Surgical, Inc.||Tissue extraction devices and methods|
|U.S. Classification||601/2, 600/459, 600/439, 600/411|
|International Classification||A61B5/05, A61B8/12, A61B8/14, A61B18/00, A61N7/02, A61B8/00, A61H1/00|
|Cooperative Classification||A61N7/02, A61B2018/00035, A61N7/022|
|Jun 24, 2004||AS||Assignment|
Owner name: EDAP S.A., FRANCE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LACOSTE, FRANCOIS;TETARD, ANTOINE;CHAUSSY, CHRISTIAN;ANDOTHERS;REEL/FRAME:015489/0842;SIGNING DATES FROM 20040606 TO 20040610
|Feb 26, 2013||FPAY||Fee payment|
Year of fee payment: 4