The present invention relates to a medical template device and method for use in positioning therapeutic probes at a target tissue.
Prior art medical template devices, such as those used for brachytherapy and 3D pathologic mapping of the prostate, consist of rows and columns of pre-formed holes typically spaced 5 mm apart. The holes are intended to enable accurate placement of probes, such as electrodes or radioactive seed delivery probes.
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In addition, once a probe is removed from a prior art medical template device, it is not possible to determine where it was originally placed without having previously manually noted or marked the location.
Therefore, it is desirable to provide a medical template device and method for use in positioning therapeutic probes at a target tissue which overcomes the problems mentioned above.
Throughout the present teachings, any and all of the one, two, or more features and/or components disclosed or suggested herein, explicitly or implicitly, may be practiced and/or implemented in any combinations of two, three, or more thereof, whenever and wherever appropriate as understood by one of ordinary skill in the art. The various features and/or components disclosed herein are all illustrative for the underlying concepts, and thus are non-limiting to their actual descriptions. Any means for achieving substantially the same functions are considered as foreseeable alternatives and equivalents, and are thus fully described in writing and fully enabled. The various examples, illustrations, and embodiments described herein are by no means, in any degree or extent, limiting the broadest scopes of the claimed inventions presented herein or in any future applications claiming priority to the instant application.
Disclosed herein are medical template devices and methods for use in positioning therapeutic probes at a target tissue. In particular, according to one embodiment of the present invention, a medical treatment device includes a frame and a pierceable probe guide secured by the frame and having a probe guide pattern thereon, wherein the pierceable probe guide is capable of being pierced at any location along its surface by a therapeutic probe. In one embodiment, the pierceable probe guide is a film which is devoid of any apertures.
According to one embodiment, the invention includes a method for positioning one or more probes in target tissue using a medical template device. A frame is secured in a fixed position relative to the target tissue, wherein the frame carries a pierceable probe guide secured by the frame and has a probe guide pattern thereon. One or more locations are selected on the pierceable probe guide for inserting the one or more probes. The pierceable probe guide is pierced with the one or more probes at the selected locations. The one or more probes that have pierced the pierceable probe guide are then positioned in the target tissue. The target tissue can be treated by the therapeutic probes by any number of treatment modalities.
The present invention can be understood by reference to
In one embodiment, the pierceable probe guide includes a film. The film can be a plastic film, which forms a continuous plane of material. In another embodiment, the pierceable probe guide includes a woven mesh of plastic material, having small closely spaced holes which are formed between each of the weaves of the material. Therefore, one advantage of the woven mesh material is that the therapeutic probe would not require a sharp needle tip as there is nothing to pierce. For example, probes having blunt tips can be inserted through the woven mesh material.
The pierceable probe material which is used should limit translational movement and exhibit high tear resistance. Examples of suitable material for the pierceable probe guide include, but are not limited to, TYVEK™, MYLAR™, and NYLON. The minimum thickness of the pierceable probe guide is dependent upon its resistance to tearing. In one embodiment the pierceable probe guide is a film which has a thickness of 0.004 inches or greater. The maximum thickness of the pierceable probe guide is dependent upon its puncture force and its ability for allowing the therapeutic probe to rotate freely about the puncture hole so as to permit the probe to be steered at a desired angle relative to the surface of the pierceable probe guide.
In another embodiment, the pierceable probe guide can include a combination of a woven mesh and a film. For example, the woven mesh can be provided with a probe guide pattern and the film can be used to provide the probe placement history via the holes created therein. Even though this embodiment would include a combination of a woven mesh and a film, the physician is still able to steer the probes to the target tissue.
Compared to the prior art medical template devices (see
Another advantage of the present invention is that the pierceable probe guide can accommodate a variety of probes 50 having many different diameters. Because the pierceable probe guide is devoid of any apertures and can be pierced at any location along its surface, any diameter probe can be inserted through the pierceable probe guide. Near the lower right quadrant of
As also discussed above, once a probe is removed from a prior art medical template device, it is not possible to determine where it was originally placed without having previously manually noted or marked the location. On the other hand, with the present invention the physician is able to easily identify each of the locations in which the probes were previously placed by simply identifying the presence of each hole through the surface of the pierceable probe guide. If holes are present then they represent the locations where the probes were previously inserted through the pierceable probe guide.
As discussed above, prior art template devices typically limit the ability of the physician to steer or direct the probe 50 into the desired position during insertion and also do not allow the control of the position of the distal end of the probe after it is inserted through the device (see
In one embodiment, the probe guide pattern of the pierceable probe guide 30 differs from the probe guide pattern of the second pierceable probe guide 35 and the pierceable probe guide 30 is substantially transparent. In this embodiment, the physician can plan a probe trajectory in advance and use the probe guide patterns of each pierceable probe guide, respectively, to execute the desired trajectory of the probe while it is being inserted into the target tissue. For example, the physician can calculate the angle at which the probe is to be placed and then use the indicia of the second pierceable probe guide 35 relative to the pierceable probe guide 30 to place the probe at the correct angle. In one embodiment, the second pierceable probe guide 35 can include indicators which are positioned relative to the probe guide pattern of the pierceable probe guide 30 in such a way as to represent pre-determined angles of insertion. The angle calculated by the indicators would of course depend on the distance between the pierceable probe guide 30 and the second pierceable probe guide 35.
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Once the probes are positioned, the probes can deliver any of a number of therapeutic treatments to the target tissue. In one embodiment, the probes can be electrodes which apply electrical pulses between the probes in an amount sufficient to subject cells within the target tissue to irreversible electroporation (106). The electrical pulses can have an amplitude in the range of 500 Volt/cm and 1500 Volt/cm and can have a duration in a range of 50 microseconds and 150 microseconds. In another embodiment, the probes can be needles which deliver radioactive materials such as radioactive rods into the target tissue for treating cancer via brachytherapy (107). In another embodiment, the probes are cryoneedles and can deliver cryotherapy treatment to the target tissue (108) which freezes the target tissue. In one embodiment, an Argon gas is circulated through the tips of the cryoneedles. The freezing gas creates ice balls on the tips of the needles. The freeze cycle lasts about 10 minutes or until the temperature reaches negative 40 degrees Celsius. Then, the target tissue is thawed. This freeze-thaw cycle can be repeated several times. In another embodiment, the probes can be used to deliver radiofrequency energy to the target tissue.
In another embodiment, the probes can be used to deliver a curable liquid polymer to the target tissue (109). Once the polymer is delivered, it can be cured (e.g., by ultraviolet light) to form a solid substance to fill any void that is created from removing tissue in a target zone. In another embodiment, the probes are used for 3D pathologic mapping of the prostate or other area of the patient.
The probes are then removed from the target tissue and the procedure is complete (110).
The present invention affords several advantages as discussed herein. The probes can be spaced as close or as far apart as desired without having to follow any preselected locations. The device can accept probes of various diameters. The device allows the probes to be inserted at an angle to the surface. The physician can easily determine the locations where previous probes were placed. Also, the physician can adjust the position of the probe after it is inserted through the pierceable probe guide.
The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many modifications, variations, and alternatives which may be made by persons having ordinary skill in this art without departing from the scope of the invention. Those familiar with the art may recognize other equivalents to the specific embodiments described herein. Accordingly, the scope of the invention is not limited to the foregoing specification.