US 20060009712 A1
A device for diagnosis and treatment of tumors and lesions within the body. A cannula adapted to apply suction through the lumen of the catheter to the tumor or lesion is described. The lumen has a self sealing valve through which a cryoprobe is inserted while the suction is being applied. The cryoprobe is then inserted into the lesion, and operated to ablate the lesion.
1. A system for treating or sampling a mass of tissue within a human patient, said device comprising:
a cannula having a distal end adapted for insertion into the body of the patient, a proximal end, and a first lumen extending through the cannula and defining a first lumen distal opening in the cannula, and a second lumen extending through the cannula and defining a second lumen proximal opening and a second lumen distal opening in the cannula, said second lumen distal opening being proximate the first lumen distal opening;
a fitting disposed on the proximal end of the cannula, said fitting adapted for connection to a vacuum source to the first lumen;
at least one elongate medical device sized and dimensioned to pass into the second lumen through second lumen distal opening and extend beyond the distal end of the cannula, said elongate medical device having a distal tip adapted for penetration into body tissue proximate the distal end of the cannula.
2. The system of
3. The system of
4. The system of
5. The system of
6. A method for treating or sampling a mass of tissue within a human patient, said method comprising:
providing a cannula having
a distal end adapted for insertion into the body of the patient, a proximal end, and a first lumen extending through the cannula and defining a first lumen distal opening in the cannula, and a second lumen extending through the cannula and defining a second lumen proximal opening and a second lumen distal opening in the cannula, said second lumen distal opening being proximate the first lumen distal opening;
a fitting disposed on the proximal end of the cannula, said fitting adapted for connection to a vacuum source to the first lumen;
an elongate medical device sized and dimensioned to pass into the second lumen through second lumen distal opening and extend beyond the distal end of the cannula, said elongate medical device having a distal tip adapted for penetration into body tissue proximate the distal end of the cannula;
inserting the cannula into the body of the patient so that the distal end of the cannula is proximate the mass;
selectively drawing the mass toward the cannula by applying suction to the first lumen of the cannula;
inserting the elongate medical device through the second lumen of the cannula and into the vicinity of the mass;
operating the elongate medical device treat or sample the mass.
7. The method of
providing the elongate medical device in the form of a cryoprobe;
extending the distal tip of the cryoprobe beyond the distal tip of the cannula; and
operating the cryoprobe to treat the mass.
8. The method of
locating the distal tip of the cryoprobe such that the mass is superficial to the distal tip upon extension from the distal end of the cannula.
This application is a continuation of U.S. application Ser. No. 10/321,136, filed Dec. 16, 2002, now U.S. Pat. No. 6,945,942, which is a continuation of U.S. application Ser. No. 09/598,124, filed Jun. 21, 2000, now U.S. Pat. No. 6,494,844.
The devices and method described below relate to the diagnosis and treatment of breast lesions, and more generally, to the diagnosis and treatment of tumors and lesions throughout the body.
Biopsy is an important procedure used for the diagnosis of patients with cancerous tumors, pre-malignant conditions, and other diseases and disorders. Typically, in the case of cancer, when the physician establishes by means of procedures such as palpation, mammography or x-ray, or ultrasound imaging that suspicious circumstances exist, a biopsy is performed. The biopsy will help determine whether the cells are cancerous, the type of cancer, and what treatment should be used to treat the cancer. Biopsy may be done by an open or percutaneous technique. Open biopsy, which is an invasive surgical procedure using a scalpel and involving direct vision of the target area, removes the entire mass (excisional biopsy) or a part of the mass (incisional biopsy). Percutaneous biopsy, on the other hand, is usually done with a needle-like instrument through a relatively small incision, blindly or with the aid of an imaging device, and may be either a fine needle aspiration (FNA) or a core biopsy. In FNA biopsy, individual cells or clusters of cells are obtained for cytologic examination and may be prepared such as in a Papanicolaou smear. In core biopsy, as the term suggests, a core or fragment of tissue is obtained for histologic examination which may be done via a frozen section or paraffin section. One important area where biopsies are performed is the diagnosis of breast tumors.
Traditionally, the biopsy technique for breast tumors involves placing a biopsy device multiple times into the breast and taking several samples of tissue from a mass or tumor which is suspected of being cancerous. Several samples are required to be sure that some tissue from the suspect mass has been captured, and enough tissue has been sampled to ensure that, if disperse cancer cells exist in the suspect mass some of those cancer cells will be captured in the samples. Each time the device is placed the physician must locate and direct the device with ultrasound imaging into the correct position near the suspect mass. Some breast tumors and lesions are very well defined, hard spherical masses which grow within the soft, compliant breast tissue. It is difficult to force a needle into these lesions because they are resistant to puncture and fairly mobile. Forcing the biopsy needle into the lesion is like trying to spear an apple floating in water.
Vacuum assisted biopsy system proposed by Biopsys involves sucking a breast lesion into a cannula and shearing off the captured edge of the lesion to obtain a biopsy sample. The device uses a vacuum to collect tissue into the side of an open tubular device, and then uses a rotating corer to cut the tissue collected. The rotating corer is slidable within the tubular section and can be pulled back to remove the tissue collected in the rotating corer. An additional stylet inside the rotating corer can be used to push the tissue out of the core. The device can be rotated on its axis to remove a sample, 360 degrees around the central placement of the device. Typically, physicians sample six to eight cores. One advantage of this device is that the physician does not have to remove the device for additional biopsy samples. However, the tumor itself must be re-engaged after every coring operation, which entails substantial effort in relocation and confirmation that the target suspect mass has been engaged by the side aperture. Tumors may be too tough to yield to the suction and deform as necessary to enter the side opening of the cannula. Doctors also currently use the device to take a circular sequence of cores by rotating the device about its long axis or by sideways movement of the suction head to take a line of cores.
After biopsy and analysis, the tumor must be treated with a separate device, as Biopsys teaches that their coring device should not be used for resection. Indeed, the device is not designed to perform resection with assurance that complete resection of a suspect mass has been accomplished. Mechanical cutting and disruption of the tissue structure and cancer cell dispersion (that is, tearing of the tissue around the cancer and movement of the cancer cells amongst normal tissue) will result in unintentional delivery of cancer cells into healthy tissue adjacent the lesion.
The devices and methods described below provide for diagnosis and treatment of tumors within the breast. The devices include structures which permit the surgeon to secure a suspect mass or tumor within the breast for an extended period of time and for several biopsies, coring procedures, or resections. The suspect mass or tumor is secured to a cannula for the entire diagnostic and treatment procedure, or subsets of the procedure such as biopsy or ablation. This allows the placement of the cannula with a single step utilizing methods such as ultrasound to guide the cannula toward the tumor.
The cannula includes a lumen adapted to be connected to a source of vacuum, which can be used to secure a breast lesion to the cannula. A ring seal on the proximal end of the catheter permits biopsy needles, cryoprobes or other ablation devices to be inserted through the cannula and into the lesion while the vacuum on the cannula is maintained. In this manner, the needles and ablation devices may be inserted into the lesion while the lesion in held securely in place by the suction applied to the cannula.
In use, the devices described above are used in place of traditional biopsy, coring and ablation devices. Prior to use, the patient is prepared and the breast is appropriately prepped and draped. The site is prepared using local anesthesia and, optionally, intravenous sedation. The patient is positioned on an operating table in the supine position, with the patient on her back. (If the procedure is accomplished under stereotactic guidance, the patient may be prone on a stereotactic table, exposing the breast below the table.) The breast is imaged, if not previously imaged, to determine the location of lesions. A small incision is made in the breast to allow the cannula to be easily inserted into the skin. The surgeon inserts the cannula into the patient's breast through the incision, pushes it into the breast until the distal edge of the cannula is proximate to the boundary of the tumor. An ultrasound scanner, MRI, stereotactic, mammographic, infrared or other imaging device is used to obtain an image of the breast, including the tumor and any device inserted into the breast, and the surgeon uses the display from the imaging device to assist in guidance of the cannula to the tumor. With the cannula distal edge in position near the tumor, the surgeon applies vacuum to the cannula through the side port on the cannula. The vacuum draws the tumor toward the cannula, and the cannula securely engages the tumor until the suction is broken at the end of the procedure. The surgical biopsy needle can be inserted through the cannula and into the tumor to retrieve a sample of tissue for analysis. Because coring can be accomplished without removing the portion of the tumor engaged by the cannula, or otherwise disrupting the suction between the cannula and the tumor, several biopsy samples may be taken without having to relocate and re-engage the tumor.
Depending on the analysis of the biopsy (whether or not the samples obtained contain cancerous cells or other conditions), treatment of the tumor may be required. If analysis can be accomplished intra-operatively (that is, during a period of time in which it is feasible to keep the patient in the operating room and maintain the tumor engaged with the cannula), and indicates the presence of cancerous cells or other condition for which ablation is indicated, an ablation instrument can be inserted through the cannula and into the tumor. If so, the surgeon inserts an ablation instrument, such as a small caliber cryoprobe, into the tumor. Preferably, the surgeon inserts a cryoprobe through the valve and cannula and into the tumor, while maintaining suction on the cannula. The surgeon initiates cooling of the cryoprobe, and cools the tumor through one or more cycles of cooling to cryogenic temperatures and subsequent warming and thawing. A double freeze-thaw cycle is currently recommended. Each cycle consists of a 6 to 15 minute freeze followed by thawing until the internal cryoprobe temperature reaches 0° C. (approximately 6 to 15 minutes). The device may also be used without regard to biopsy results. Patients prefer to have these lesions treated, even if they prove to be benign. In current practice, should biopsy results indicate the presence of cancer, the patient must return to the operating room shortly after the biopsy, undergo preparation, anesthesia, relocation of the lesion and ablation. Instead, the lesions may be ablated intraoperatively with the biopsy, immediately after biopsy and without interrupting the procedure to await the biopsy results. Should the biopsy prove negative for the presence of cancer, the patient will have received a substantially cosmetic treatment. Should the biopsy prove positive, the patient will have received a necessary therapeutic procedure. In addition to the ablative procedure, the positive biopsy may indicate the need for additional monitoring and treatment.
For lesions deeper than 1 cm from the skin surface, the cryoprobe is advanced until the distal tip is located approximately in the center of the lesion or just beyond the lesion. For smaller lesions (<2 cm diameter) the ice ball may grow beyond the margins of the tumor, while for larger lesions, the ice ball may remain within the confines of the tumor. The cryoprobe tip temperatures and skin mounted thermocouple readings are monitored throughout the ablation procedure. If the temperature of the skin overlying the cryoprobe measures below freezing, freezing operation of the cryoprobes should be paused until it returns to 10° C. (the temperature at the edge of the ice ball edge is 0° C. and exposure to such a temperature for the few minutes will not harm the skin, but caution should always be employed).
The procedure may be augmented with additional steps. Just prior to ablation treatment, prophylactic antibiotics can be administered at the surgeon's discretion. Just prior to cryosurgical ablation, cryogenic enhancement agents may be injected directly into the tumor through a hypodermic needle inserted through the valve and cannula and into the tumor while it is secured by suction to the cannula. During cooling operation of the cryoprobes, warm saline may be washed over the skin overlying the tumor and iceball to prevent freezing of the skin.
If the lesion being treated is close to the skin such that cryoablation of the lesion entails a danger of cryoablation of the overlying skin, several milliliters of a resorbable material such as sterile saline may be injected or inserted into the subcutaneous tissue between the skin and the lesion. This will create a thermally protective mass or barrier layer between the tumor and the skin. Thermal protection may arise from insulative effect of the thermally protective mass or merely by the distension or separation of the skin away from the tumor and thus away from the iceball. As illustrated in
The cannula illustrated above is preferably 10 to 20 cm in length and about 3 mm in diameter with an internal diameter of 2.8 mm, and a clearance of about 0.25 mm between the inner bore of the cannula and any device inserted through the cannula during suction. The cryoprobes may be Joule-Thomson probes, liquid cryogen probes, or probes of other designs. Various other ablative devices may be used in place of the cryoprobe, including laser ablation devices, RF ablation devices, chemical ablation catheters and any other ablative technology proposed for use to destroy tumors and lesions. The vacuum applied is preferably in the range of 14 to 21 inches of mercury vacuum.
The devices and methods illustrated above have been illustrated in relation to the treatment of tumors and lesions within the breast. However, they may be used to treat tumors and lesions throughout the body wherever the tumors which are difficult to secure and locate are encountered, and wherever nearby tissue must be protected from freezing. Thus the devices and methods may be used for tumors and lesions of the uterine tube (such as uterine fibroids), kidney, liver, prostate or brain.
Thus, while the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.