Surgery – Instruments
Reexamination Certificate
1999-09-13
2001-06-19
Gilbert, Samuel G. (Department: 3736)
Surgery
Instruments
Reexamination Certificate
active
06248101
ABSTRACT:
TECHNICAL FIELD
This invention relates generally to a support apparatus for precision medical instruments, and more particularly to an adjustable support apparatus and system for ultrasound imaging probes and other instruments for use in surgery.
BACKGROUND ART
As advances are made in the medical field, surgical procedures requiring precise positioning of monitoring and surgical tools become necessary. For example, radiologists perform numerous percutaneous guided biopsies using ultrasound and computer aided tomography (“CAT”) scanning techniques, magnetic resonance imaging techniques and fluoroscopic imaging techniques. Biopsies and other percutaneous procedures are performed using a variety of needle-like instruments. It would be advantageous to stabilize such instruments or at least be able to manipulate them in a more precise manner than with manual operation.
For example, one currently widely applied and popular method for the treatment of prostate cancer is the percutaneous transperineal implantation of radioactive seeds of either Iodine-125 or Palladium-103. This procedure is performed with the patient in the lithotomy position, using an ultrasound imaging probe placed in the rectum to monitor seed placement. A template arrangement which is kept in precise linear orientation with the ultrasound probe must be accurately oriented adjacent to the perineum in relation to the prostate, and locked in position throughout the procedure to achieve optimum seed placement. Precise and reproducible orientation of the ultrasound imaging probe in the rectum is the key element in both the calculations required for determining the number and distribution of radioactive seeds required for treatment and their subsequent placement using pre-loaded needles guided by the perineal template and real time ultrasound imaging. This form of treatment for prostate cancer has been increasing in popularity because of minimal patient morbidity compared to other available treatments and the potential for improved efficacy due to increasingly accurate methods of seed placement.
Presently, there are many homemade and commercially available devices for holding, manipulating and stabilizing the various commercially available ultrasound imaging probes designed for use in this procedure. None of these devices have achieved wide acclaim because of significant limitations in their ease of use. In general, these devices suffer from the same basic limitation in that they are “post-insertion” probe fixation devices where the probe is first inserted into the rectum and then affixed to a stand. This inevitably leads to a reorientation of the probe, vis-à-vis the insertion cavity, and valuable time is wasted in recreating mechanically the desired probe orientation that was readily achieved with the freedom of omni-directional manual movement.
In an attempt to remedy these shortcomings, certain “pre-insertion” fixation devices have been developed. In these devices, the probe is first affixed to a stand and then the combination of the fine adjustment mechanism with the probe affixed is released to the free “omni-directional” mode to enhance insertion of the probe into the body of the patient. For prostate cancer treatment, for example, the probe is manually inserted into the rectum and, once the desired orientation is achieved as viewed and confirmed by the monitored ultrasound images, the device is then “set” in the “fixed” mode.
Many currently available devices provide multi-axis movement, but movement in one or more of these axes is clumsy, inaccurate and risks significant loss of orientation in other axes during adjustment, or control of the fine adjustment is severely limited. Moreover, such current devices are cumbersome and tend to either be heavy and/or broad-based to achieve floor stand based stability or spatially cumbersome table-mounted structures which tend to obstruct the surgeon's movements and patient access.
Several presently available examples of post-insertion cumbersome devices for prostate treatment are available in the marketplace. One such device is available from Seed Plan Pro of Seattle, Wash. called the Northwest Transperineal Prostate Implant Stabilization Device. Another such currently marketed device very similar thereto is offered by Hutchinson Medical Designs. A third similar immobilization device offered by Mick Radio-Nuclear Instruments, Inc. of Bronx, N.Y. is called the Cotan Stabilizing Device. Mick also distributes the Martin Immobilization Device which can be used as a “pre-insertion” fixation device but has no fine adjustment mechanism for positioning after insertion. Thus, there remains a need for improved holding, manipulation and stabilizing devices for use in this procedure. In addition, there are numerous other medical procedures where enhanced holding, manipulation and/or stabilizing devices can be helpful.
SUMMARY OF THE INVENTION
The present invention overcomes the above prior art shortcomings and includes the following features:
1. A universal mounting platform on which a variety of commercially available imaging probes, needles or similar instruments may be attached prior to insertion of the instrument into the body of the patient;
2. Six axis, fine adjustment for the mounting platform, which provides positive control of probe movement in the X, Y and Z directions and rotation about the X, Y and Z axes for optimum probe orientation and allows for any probe or instrument to be properly “zeroed” at the desired location for accurate measurement, seeding biopsy or other treatment;
3. A set of lockable two-segment articulating arms having end universal joints allowing for low resistance, free-hand, manual instrument placement while the instrument remains fully engaged to the platform apparatus and floor and/or operating table whereupon the ideal manual placement may be quickly fixed in place and secured to two fixed points;
4. A universal stabilizing arm which adapts to any table without modification and, in combination with the portable floor stand, provides a multi-functional unit which can be used with or without the floor stand or, after initial placement, transferred from the floor stand to full table mounting support without loss of position;
5. A light, freely mobile, wheeled, stable floor stand with adjustable feet and one-step lockdown mechanism; and
6. An offset base of the stand to provide wide-base stability while allowing the operator to stand close thereto without interference.
The present invention has applicability to other surgical procedures which require steady, but mobile instrumentation such as cryosurgery, thermotherapy and laser surgery and any procedure where precision movement of imaging or operating instrumentation is required. In addition to the application with prostate cancer seed implantation described above, this omni-directional precision instrument platform apparatus can be used in minimally invasive surgery for prostate cancer and BPH, including laser ablation of benign prostatic hyperplasia, transurethral needle oblation of the prostate, microwave therapy for both BPH and prostatic carcinoma, and cryosurgery for prostatic carcinoma. Furthermore, this apparatus is useful in percutaneous surgical biopsies. Radiologists typically perform such procedures utilizing any one of a wide variety of radiological instruments or probes to assist in locating or contacting the organ or tissue to be biopsied. CAT scanning and ultrasound x-ray, fluoroscopic or MRI imaging can be used to perform precision biopsies with the present apparatus. In all these minimally invasive procedures, and in other fields of surgery as well, there is great need and potential for an instrument fixation device which is as versatile and precise as that which is disclosed and claimed herein.
This invention is specifically directed to an apparatus and system for supporting and facilitating accurate manual positioning, both linearly and angularly, of an ultrasound probe, needle biopsy guide or other instruments used during surgical or diagnostic procedures and, thereafter for
Barzell Winston E.
Whitmore, III Willet F.
Wilson Roger
Barzell Whitmore Maroon Bells, Inc.
Gilbert Samuel G.
Pennie & Edmonds LLP
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