Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-12-21
2004-10-26
Smith, Ruth S. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S407000, C600S436000, C600S473000, C600S549000
Reexamination Certificate
active
06810281
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates in general to a mapping system and method useful for mapping identifying anatomic members such as tissues, nerves, vessels or any other anatomic body part. This mapping can assist in the manipulation of a medical instrument, catheter, or the like, either under direct or robotic control.
BACKGROUND OF THE INVENTION
Part of the “art” of surgery is knowing where to cut and where the “danger zones” are located. The surgeon relies on visual clues to determine where important anatomical structures are located. He also relies upon palpation. Landmarks such as bony prominence, ligament insertions, position of muscles and solid organs, and other landmarks guide the surgeon during tissue dissection (also referred to as transection).
One of the major complications of surgery is inadvertent transection of sensory nerves, motor nerves, arteries, veins and hollow viscus. In most cases this occurs when key structures are poorly visualized by the surgeon, or due to inexperience or altered anatomical structures (e.g., surgical landrnarks). Blunt dissection is performed either manually using the fingers or using an instrument, and sharp dissection is performed using a scissors, electrical-surgical device, or scalpel.
A common side effect or complication of much surgery is neurological trauma, paresis or permanent paralysis occasioned by the severing of nerves. Over 5% of major head and neck surgeries (e.g., parotidectomy) result in damage to the facial nerve resulting in weakness of the facial muscles or partial paralysis of the face. A frequent consequence of prostate surgery is damage to the sacral nerves, which control erectile function and ejaculation. Almost 40% of men undergoing prostatectomy are left impotent or have significant problems with erectile function.
Inadvertent perforation of the aorta, or of the superior or inferior Vena Cava, can cause a major hemorrhage which may result in death. The Vena Cava may be ruptured during dissection of the spleen or resection of tissues on the posterior surface of the liver. Transection of smaller arteries and veins, while less life-threatening, are a cause of significant morbidity, often require transfuision to compensate for blood loss, and can significantly increase the length of hospitalization following a procedure. Similarly, transection of the ureter results in major morbidity, requires multiple operations to correct, may result in renal failure and significantly impairs quality of life. Perforation of other hollow viscus, such as the bowel or bladder wall, may result in peritonitis and death.
Electrical transducers are commonly used in medical practice to measure electrical impulses within nerve bundles. These instruments include: electroencephalograms (EEG), electrocardiogram (EKG), electromyography (EMG), and others. All these devices have in common the ability to measure electrical impulses generated by nerve structures. The electrical fields vary with motor nerve, sensory nerve, the degree of myelinization and the number of nerves in the particular neural bundle. The electrical impulses are typically in the form of a waveform that is examined and interpreted by a surgeon or physician. Such a readout is primarily used as a diagnostic tool in determining irregularities in organs such as the heart or brain.
Subtle temperature variations also exist within different anatomical compartments. Venous blood returning from an extremity is cooler than arterial blood. Sites of infection tend to be slightly warmer than healthy tissues. Abscess pockets tend to be somewhat cooler than surrounding tissues. These temperature variations are generally below the threshold of human proprioception. The variations can be less than a tenth of a degree. A number of different thermistors, which can measure temperature variation to a hundredth of a degree, are used in medicine to monitor vital signs, cardiac output, and other functions. Again, such use is primarily diagnostic.
Gallium and technetium, as well as other isotopes, are used for tracking infection, lymphatic drainage and to provide contrast during magnetic resonance imaging (MRI) These isotopes are gamma emitters and, in general patients undergoing these scans are evaluated by gamma counters which then measure the degree of radioactive uptake. This data is then graphically displayed as an x-ray film.
During sentinel node biopsy, lymphoscintigraphy is used to localize the regional draining nodal basin in breast cancer and melanoma therapy. A small incision is then made in the skin overlying the “hot” node. Blunt and sharp dissection is used to reach the nodal basin. A sterile-wrapped Geiger counter is then inserted into the wound to identify the affected node(s). Further dissection and Geiger counter testing is performed until the radioactive sites are fully identified and resected. This is a time-consuming and laborious process, with the operative field landmarks and lymph nodes shifting in space with each insertion/removal of instruments.
In these various techniques, there is a need for a better method of identifying anatomic structures or parts, particularly when these structures or parts are not visible to the surgeon's eye. By identifying these structures or parts, one can avoid the aforementioned problems that can lead to tissue, organ, or nerve damage, paresis, permanent paralysis, or other injuries that impair the quality of life of the patient.
SUMMARY OF THE INVENTION
In one embodiment, what is sensed is a non-visible field and what is provided is a combined display of virtual and visual images. In this embodiment, a system is provided for generating the display of a body structure. The system includes a sensor positionable at an internal body site for sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the field. A transformation system transforms the sensor signal into virtual image data. A source of visual image data for the site is also provided. A visual system enables combined display of the visual image data and the virtual image data.
According to a corresponding method, steps are provided for sensing at an internal body site a non-visible field of a body structure at the site and generating a sensed signal indicative of the field, transforming the sensed signal into virtual image data, providing visual image data for the site, and displaying in combination the visual image data and the virtual image data.
In another embodiment, what is sensed is a non-visible field by a sensor positioned with a computer-controlled instrument, and what is provided is virtual image data. In this embodiment, a system is provided for obtaining virtual image data of a body structure. The system includes a computer-controlled instrument for positioning a sensor at an internal body site, the sensor sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the site, and a transformation system is provided for transforming the sensor signal into virtual image data.
According to a corresponding method, steps are provided for positioning by computer control a sensor at an internal body site, sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the field, and transforming the sensor signal into virtual image data.
In another embodiment, what is sensed is a non-visible field and what is provided is a tactile feedback for controlling manipulation of a medical implement. In accordance with this embodiment, a system is provided for controlling manipulation of a medical implement including a sensor positionable at an internal body site for sensing a non-visible field of a body structure at the site and generating a sensor signal indicative of the field, a transformation system for transforming the sensor signal into a feedback signal, and a control system, including a haptic user interface, for manipulating a medical implement at the site, the control system receiving the feedback signal and in response ther
Brock David L.
Rogers Gary
endoVia Medical Inc.
Hamilton Brook Smith & Reynolds P.C.
Smith Ruth S.
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