Patent Application
20100241028
Identifying and treating lung tissue abnormalities presents challenges that are somewhat unique to the lungs. If a tissue lesion or tumor is to be identified and excised surgically, the chest wall must be opened to provide access to the lungs. Opening the chest wall is a common procedure but one that presents risks of infection and lengthy recovery time, nonetheless. If a tissue lesion or tumor is to be identified endoscopically, the complicated bronchial maze must be navigated.
Technology has been developed that allows a physician to track, in real-time, the position of a probe (hereinafter “locatable guide” or “LG”) traveling through the airways. This technology incorporates a plurality of coils at the end of an LG and a magnetic field generator outside of the patient. The patient is placed in the magnetic field created by the generator. As the LG is navigated through the airways, electrical current is induced in the coils and sent via conductors to a computer. The computer can calculate the position and orientation of the probe based on the relative strengths of the current being induced. This technology is shown and described in greater detail in U.S. Pat. Nos. 7,233,820 6,226,543, 6,188,355, 6,380,732, 6,593,884, 6,711,429, 6,558,333, 6,887,236, 6,615,155, 6,574,498, 6,947,788, 6,996,430, 6,702,780, and 6,833,814; and U.S. Patent Publications 20050171508, 20030074011, 20020193686, each of which is incorporated by reference herein in its entirety and also PCT application WO 03/086498 titled “Endoscope Structure and Techniques for Navigation in Branched Structure” to Gilboa, fully incorporated herein by reference.
One type of tool used with the above-described system is a biopsy tool. Biopsy tools are designed to remove and retrieve small tissue samples from a suspected lesion for analysis and identification in a laboratory. Several factors are considered when taking biopsies of tissue such as biopsy location, biopsy size, and the number of samples needed from a suspected lesion.
The above system and apparatus are aimed at the first consideration, target location, and provide a system that enables a physician to navigate standard bronchoscopic tools, such as biopsy tools, to a target located in the lung. In its basic operation, the target is first identified in the CT data, and then the locatable guide is navigated to the target. The locatable guide is then removed from a sheath surrounding the LG and the sheath is then used as an extended working channel (“EWC”) through which a biopsy tool may be passed to the target location.
Once the LG is removed, however, the locating system is no longer useful in identifying the location of the tip of the EWC. Hence, with regard to the biopsy tool, the physician is effectively “operating in the blind.” Additionally, quite often it is desired to take multiple samples from various locations within a lesion so as to ensure a representative sampling of tissue.
It would be therefore advantageous to develop biopsy tools that have improved capabilities that address these identified needs. Namely, it would be advantageous to develop a biopsy, or tissue treatment tool that retrieves biopsy samples from or otherwise treats tissue in a variety of locations within a lesion simultaneously. It would also be advantageous to develop a biopsy tool that retrieves an adequate tissue sampling without requiring the removal of the LG from the EWC.
The present invention represents a step forward in endoscopic biopsy and treatment procedures by providing tools designed for use with a three-dimensional locating system. The tools of the present invention are constructed to obviate the need for multiple navigation steps when taking one or more samples from a biopsy site, or performing one or more treatment procedures.
One aspect of the present invention provides a tool that attaches to the end of an LG. Such a device provides many advantages. First, a small, attachable tool presents a cost savings when compared to a more traditional tool long enough to be routed through a catheter. Typically, LGs and biopsy tools are single-use disposable devices. Reducing the material and complexity of a disposable is always preferred in order to reduce costs. Second, because the attachable tool is attached to the LG, the LG maintains its functionality and, therefore, can be used to monitor the location of the tool throughout a procedure. Moreover, the locatable tool may be used to take samples from or treat tissue in multiple locations in a lesion without retracting the tool and repositioning the EWC. Also, because the tool is not removed from the lungs between samples, a single tool may be used. Third, input from the LG may be used to map and display the places in the lesion where samples have been taken.
Another aspect of the present invention provides a biopsy tool that includes multiple extensions that radiate from its distal tip when deployed. These extensions are designed to take individual samples from multiple locations in a target site simultaneously. This device may be used in the EWC after the LG is removed, as the multiple extensions effectively biopsy an entire lesion simultaneously, thereby reducing the need for location and tracking during the biopsy. Alternatively, this “flowering” biopsy tool may be incorporated into an LG, such that the LG does not need to be removed from the EWC prior to deployment.
Referring now to
Referring to the general embodiment of a generic tool, tool 16 has a proximal attachment portion 17 that is attachable to, or configured to mate with, the distal end 15 of the LG 14 by an end user, such as a physician or physician's assistant. In preferred embodiments, the attachment portion 17 includes a proximal skirt 18 that is sized to fit over the distal end 15 of the LG 14. If it is desired to create a permanent attachment between the tool 16 and the LG 14, an appropriate adhesive may be used to affix the tool 16 to the LG 14. Alternatively, the distal end 15 of the LG may be configured to removably mate with the tool 16. For example, distal end 15 may include a snap connector, a threaded connector, a luer lock, etc. Similarly, the skirt 18 may be configured appropriately to accept whatever configuration is formed on the distal tip 15 of the LG 14. As shown, the distal tip 15 serves as a male component while the skirt 18 serves as a female component. One skilled in the art will understand that the distal tip 15 of the LG 14 may be configured as a female component for accepting a corresponding male component of the biopsy tool 16.
In a preferred embodiment, the LG 14 is a standard LG and the tool 16 is available in a variety of forms. Hence, a physician is able to attach any of several tools 16 to the distal end 15 of a standard LG 14 using either a permanent or removable adhesive. Each of the various embodiments of tools described herein generally include a tool portion and an attachment portion. In the example shown in
Another preferred embodiment of a device 20 is shown in
It is envisioned that the sheath 22 may comprise an LG that has been modified to include a lumen for accommodating the biopsy tool 24. The device 20 is designed such that, after the tissue samples are taken, the biopsy tool is partially retracted into the sheath 22 until the tines 24 are brought together. The tines 24 and the sheath 22 may then be retracted into the EWC 12. Leaving the tines 24 partially extended prevents the loss of the tissue samples taken.
Referring first to
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.
This application claims priority to U.S. Provisional Application Ser. No. 61/139,501 filed Dec. 19, 2008 entitled Biopsy Tools, which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61139501 | Dec 2008 | US |
