Patent Application
20060241450
1. Field of the Invention
The invention relates to a tissue diagnostic system for determining tissue type or state that uses ultrasound imaging to guide placement of the measurement probe.
2. Description of Related Art
Various methods and devices have been developed to measure physical characteristics of tissue in an effort to distinguish between cancerous and non-cancerous tissue. For example, U.S. Pat. No. 5,303,026 to Strobl et al. (the Strobl patent) is directed to an apparatus and method for spectroscopic analysis of scattering media such as biological tissue. More specifically, the Strobl patent is directed to an apparatus and method for real-time generation and collection of fluorescence, reflection, scattering, and absorption information from a tissue sample to which multiple excitation wavelengths are applied.
U.S. Pat. No. 5,349,954 to Tiemann et al. is directed to an instrument for characterizing tissue. The instrument includes a hollow needle for delivering light, from a monochromator, through the needle to a desired tissue region. Mounted in the shaft of the needle is a photodiode having a light sensitive surface facing outward from the shaft for detecting back-scattered light from the tissue region.
U.S. Pat. No. 5,800,350 to Coppleson et al. is directed to an apparatus for tissue type recognition. In particular, the patent discusses apparatus intended to include a probe configured to contact the tissue and subject the tissue to a plurality of different stimuli such as electrical, light, heat, sound and magnetism and to detect plural physical responses to the stimuli. The patent discusses the use of a processor for processing the responses in combination in order to categorize the tissue. The processing is to occur in real-time with an indication of the tissue type (e.g., normal, pre-cancerous/cancerous, or unknown) intended to be provided to an operator of the apparatus.
U.S. Pat. No. 6,109,270 to Mah et al. (the Mah patent) is directed to a multimodality instrument for tissue characterization. In one configuration, a system with a multimodality instrument for tissue identification is intended to include a computer-controlled motor driven heuristic probe with a multisensory tip. U.S. patent application Ser. No. 09/947,171 to Hular et al. is directed to a probe intended to incorporate optical fibers and electrical conductors into a compact needle like probe to measure the optical and electrical properties of tissue.
All these devices are positioned or located by the physician by palpating the lesion or in some cases with x-ray or ultrasound guided imaging. Ultrasound imaging alone now provides accurate guidance but lacks the contrast to accurately determine tissue state. U.S. Pat. No. 6,171,249 to Chin et al. is directed to an ultrasound imaging device intended to include an integrated working channel for guiding core biopsies. Unfortunately, the working channel as described is impractical for a stiff multi-sensor needle probe. Therefore, there is a need for an integrated ultrasound imaging and tissue measurement device that can provide the physician with the information to guide the diagnostic procedure. The present invention addresses this need.
It is an object of the present invention to provide a method and a system that can be used by physicians to accurately position a tissue measurement probe and provide a diagnosis.
It is another object of the invention to provide a system that can be used by surgeons to determine whether a suspicious lesion is cancer or normal tissue.
These and other objects will be apparent to those skilled in the art based on the disclosure herein.
In normal use the present invention is used by a physician to measure tissue properties along a desired path. The desired path is determined by the physician based on ultrasound imaging of the area of interest. In one embodiment the system is used to diagnose breast cancer. In this embodiment the ultrasound imaging transducer is placed in contact with the breast such that the suspicious lesion is visible in the ultrasound image. The physician then inserts the probe into the tissue and moves it within the image plane of the ultrasound transducer until it reaches the desired point within the lesion. Measurements made by the probe are then combined with information from the ultrasound image to determine whether the lesion is cancer or normal tissue.
In one embodiment of the system the tissue measurement probe is constrained by a probe guide that includes an angle encoder. The angle is measured by the control electronics and used by the image display software to show the predicted path of the probe.
In another embodiment of the system the probe guide is motorized to drive the probe into the tissue at a selected velocity. This has the advantage of sampling tissue properties in a more uniform manner.
The accompanying drawings, which are incorporated into and form part of this disclosure, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.
The present invention provides a system that can be used by physicians to accurately position a tissue measurement probe and provide a diagnosis.
The ultrasound imaging transducer 20 can be mechanically scanned or a phased array design (see, e.g., “The Physics of Medical Imaging” Ed. Steve Webb (1988), incorporated herein by reference and “Ultrasound in Medicine” Ed. F. A. Duck, A. C. Baker, H. C. Starritt (1997), incorporated herein by reference). Although a two dimensional imaging ultrasound transducer is sufficient, a three dimensional imaging ultrasound transducer could also be used. The ultrasound transducer operating frequency is selected to effectively image to the maximum tissue depth necessary for probe placement. For most applications the ultrasound frequency will be in the range of 1-10 MHz.
The tissue measuring probe 40 can be any needle like device with at least one sensor near or at the tip of the probe. The sensor must be capable of measuring tissue properties. One possible such probe is a cancer optical biopsy probe as described in, Bigio et al., “Diagnosis Of Breast Cancer Using Elastic-Scattering Spectroscopy: Preliminary Clinical Results”, Jour. Biomed. Optics 5, 221-228 (2000), incorporated herein by reference, and U.S. Pat. No. 5,303,026, incorporated herein by reference. Another possible probe is a multi sensor cancer biopsy probe of U.S. Pat. No. 6,109,270, incorporated herein by reference or U.S. patent application Ser. No. 09/947,171, incorporated herein by reference. For improved contrast, the probe 40 is coated with an echogenic layer (e.g., ECHO—COAT® produced by STS Biopolymers Inc., 336 Summit Point Drive, Henrietta, N.Y. 14467) that enhances the reflection and scatter of ultrasound.
When the ultrasound transducer is a two dimensional imager, then it is important that the probe lies within the imaging plane of the transducer. The width of the image plane is controlled by the transducer design and is typically less than 5 mm. To insure that the probe is within the image plane the ultrasound transducer can incorporate a probe guide 3 as shown in
The foregoing applications, and all documents cited therein or during their prosecution (“appln cited documents”) and all documents cited or referenced in the appln cited documents, and all documents cited or referenced herein (“herein cited documents”), and all documents cited or referenced in herein cited documents, together with any manufacturer's instructions, descriptions, product specifications, and product sheets for any products mentioned herein or in any document incorporated by reference herein, are hereby incorporated herein by reference, and may be employed in the practice of the invention.
The foregoing description of preferred embodiments of the invention is presented for purposes of illustration and description and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described to best explain the principles of the invention and its practical application to thereby enable others skilled in the art to best use the invention in various embodiments and with various modifications suited to the particular use contemplated.
This application claims priority to U.S. Provisional Patent Application Ser. No. 60/674,135, titled: “Ultrasound Guided Tissue Measurement System”, filed Apr. 21, 2005, incorporated herein by reference. This application is a continuation-in-part of U.S. patent application Ser. No. 11/375,873, filed Mar. 13, 2006, titled “Optical Biopsy System With Single Use Needle Probe”, incorporated herein by reference. This application is a continuation-in-part of U.S. patent application Ser. No. 10/803,574 filed Mar. 17, 2004, incorporated herein by reference. This application claims priority to U.S. Provisional Patent Application Ser. No. 60/455,536, filed Mar. 17, 2003, incorporated herein by reference. This application claims priority to U.S. Provisional Patent Application Ser. No. 60/760,196, filed Jan. 18, 2006, incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60455536 | Mar 2003 | US | |
| 60674135 | Apr 2005 | US | |
| 60760196 | Jan 2006 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11375873 | Mar 2006 | US |
| Child | 11408353 | Apr 2006 | US |
| Parent | 10803574 | Mar 2004 | US |
| Child | 11375873 | Mar 2006 | US |
