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The present invention relates to surgical resection of tissue and in particular to an apparatus using microwave coagulation to control bleeding during the resection of a portion of an organ.
The liver is a common site for both primary and metastatic cancer. Surgical resection (hepatectomy) is currently the preferred treatment for liver cancer. During resection, the surgeon typically removes a lobe of the liver, a time consuming procedure where the surgeon must cut through tissue while avoiding or closing large blood vessels. Blood loss during this procedure can adversely affect patient survival, increase hospital stay, and increase complication rates.
Some studies have investigated the use of radio frequency (RF) ablation or microwave (MW) ablation to coagulate tissue before resection. In RF ablation, one or more electrodes are inserted into the tissue and current passing from the electrodes through the patient to a large area ground pad on the patient's skin coagulates the tissue near the electrode through resistive heating, sealing it against blood flow. In order to ablate the necessary area of tissue, the electrode is removed and reapplied at a series of locations along the tissue slice. The time required for this procedure is generally too long for clinical practice.
Pending US patent application 2006/0064084 published Mar. 13, 2006 and entitled: “Electrode Array for Tissue Ablation” describes a system for RF ablation using multiple electrodes positioned within a holder for insertion into the tissue along an ablation line. The use of multiple electrodes greatly reduces the time required for this procedure.
The present invention provides a microwave horn antenna that may be used in lieu of insertable electrodes for creating a coagulated zone for bloodless resection. The horn antenna is compact for easy manipulation by a surgeon and produces a fan-shaped microwave radiation pattern leading to heating in a region conforming to a resection plane and minimizing the generation of high temperature water vapor such as makes the coagulation process less controllable. A dielectric within the horn allows the use of lower frequencies which propagate more deeply into the tissue. A quarter wavelength stub provides improved shaping of the emission pattern and an insulating coating allows handheld operation with inevitable heating of the horn at the necessary power.
Specifically, the present invention provides a method for bloodless resection of an organ by applying microwave energy along a resection line through a microwave horn antenna emitting a generally fan-shaped microwave beam having an elongated cross-section whose longest dimension is aligned with the resection line. After the resection line is coagulated, a cut is made along the resection line within the coagulated tissue to resect the organ.
It is thus one object of the invention to provide a rapid method of coagulating a zone within an organ for bloodless resection without the need for the placement of electrode arrays.
The coagulation and cutting steps may be repeated to continue resection of the organ at an increasing depth along a plane aligned with the resection line.
It is thus an object of the invention to provide a method that accommodates limited microwave penetration and that provides a flexible and incremental procedure that accommodates variances and uncertainty in tissue depth.
The longest cross-sectional dimension of the microwave horn may be more than twice the height of the cross-section perpendicular to the longest dimension.
It is thus an object of the invention to provide a microwave emission pattern that reduces internal heat concentrations in the tissue such as generate migrating high temperature water vapor.
The microwave horn may be filled with a solid dielectric material such as Macor® and the microwave energy may be substantially at a frequency of less than 4 GHz.
It is thus an object of the invention to permit the microwave horn to be used with lower frequency microwave energy for greater penetration while maintaining a compact size that may be inserted between partially resected tissue walls for movement along the resection line by the surgeon.
The horn is sized to be held within a surgeon's hand and has an outer surface tactility indicating the orientation of the longest dimension and the direction of microwave emission.
It is thus an object of the invention to provide a system amenable to use by a single individual who may wield both the microwave horn and a scalpel.
The method may move the microwave horn along the resection line and apply sequential microwave applications over a distance larger than the longest dimension.
It is thus an object of the invention to provide a system that can work for arbitrary organ sizes while maintaining a compact form factor.
The microwave horn may include a flexible coaxial cable removably connected to the horn to provide microwave power thereto in an amount greater than 50 W.
It is thus an object of the invention to provide a high power microwave device that allows relatively quick coagulation of tissue.
The dielectric of the microwave horn may further include metal inserts within the dielectric for field shaping.
It is thus an object of the invention to permit cross-sections of high aspect ratio enabling faster coagulation of longer sections.
The horn may have its outer surfaces covered by a thermally insulating coating.
It is thus an object of the invention to manage transmission inefficiencies while preserving handheld operation.
These particular objects and advantages may apply to only some embodiments falling within the claims and thus do not define the scope of the invention.
a-2c are perspective views of the device of
Referring now to
A standard N-type flanged microwave connector 16 is attached to a rear vertical wall of the housing 11 to releaseably connect the microwave applicator 10 to a flexible coaxial microwave cable 18. This attachment allows the cable 18 to pass over the hand 14 and be supported and guided thereby. The outer dimensions of the housing 11 of the microwave applicator 10 and its orthogonal walls provide tactile feedback indicating the orientation of the housing 11.
A generally fan shaped microwave beam is emitted from the microwave applicator 10 providing a coagulation region 20 approximately 1.8 cm long in a direction aligned with the transverse axis 17 and approximately 1.1 cm in depth along the axis 12, when the microwave applicator 10 is placed with its lower face 15 against tissue.
Referring now to
Referring to
In this case, and referring to
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The stub 36 may be received within a solid dielectric material 38 filling the inner volume, the dielectric material preferably being Macor®, a machinable glass ceramic material available from Corning Inc. having offices worldwide. Macor® generally provides a dielectric constant greater than 5.5, a dielectric strength of approximately 9.4 kV/mm and a coefficient of expansion of approximately 93×10−7/° C.
The metallic shell 32 connects electrically to the outer conductor of the waveguide formed by the microwave coaxial cable 18 and together with the quarter wavelength stub 36, creates a tuned cavity controlling the coagulation region 20. The solid dielectric material 38 permits the waveguide to operate at the lower frequency microwaves of 2.45 GHz while retaining a compact handheld form factor.
Referring now to
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It is specifically intended that the present invention not be limited to the embodiments and illustrations contained herein, but include modified forms of those embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims.
This invention was made with United States government support awarded by the following agency: NIH DK058839 The United States government has certain rights in this invention.
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