Patent Application
20090131815
The present disclosure relates generally to marker deployment devices for biopsy procedures. More specifically, the present disclosure relates to a marker deployment system including a cannula, a site marker and at least one wire selectively interposed within the cannula.
In the diagnosis and treatment of breast cancer, it is often necessary to perform a biopsy to remove tissue samples from a suspicious mass. The suspicious mass is typically discovered during a preliminary examination involving visual examination, palpation, X-ray, magnetic resonance imaging (MRI), ultrasound imaging or other detection means.
When a suspicious mass is detected, a sample is taken by biopsy, and then tested to determine whether the mass is malignant or benign. This biopsy procedure can be performed by an open surgical technique, or through the use of a specialized biopsy instrument. To minimize surgical intrusion, a small specialized instrument such as a biopsy needle is inserted in the breast while the position of the needle is monitored using fluoroscopy, ultrasonic imaging, X-rays, MRI or other suitable imaging techniques.
Regardless of the method or instrument used to perform the biopsy, subsequent examination of the surgical site may be necessary, either in a follow up examination or for treatment of a cancerous lesion. Treatment often includes a mastectomy, lumpectomy, radiation therapy, or chemotherapy procedure that requires the surgeon or radiologist to direct surgical or radiation treatment to the precise location of the lesion. Because this treatment might extend over days or weeks after the biopsy procedure, and the original features of the tissue may have been removed or altered by the biopsy, it is desirable to insert a site marker into the surgical cavity to serve as a landmark for future identification of the location of the lesion.
However, some biopsy site markers may not be visible under all available modalities. When cancer is found at a biopsy site that has been previously marked with a site marker, the poor visibility of the biopsy site marker under ultrasound or other visualization modalities, may require that the patient undergo an additional procedure that places an additional device at the biopsy site to enable the surgeon to find the biopsy site in subsequent procedures. One known technique has been to place a breast lesion localization wire at the biopsy site. The localization wire is typically placed at the biopsy site via mammography and/or ultrasound.
Commonly assigned U.S. patent application Ser. No. 11/242,334 discloses a variety of markers. In some illustrations disclosed therein, expandable portions ‘hold’ a site marker in place within a biopsy cavity. That is, a site marker may include a bio-absorbable expandable portion with a marker, where the marker is visible under multiple modalities and the expandable portion will inhibit migration of the marker within the biopsy cavity. The expandable portions of these structures typically define a site marker diameter that is greater than the outer diameter of a cannula of a marker deployment device used to insert the site marker into the biopsy site.
In most cases, the marker deployment device is shipped with the site marker aligned with a distal opening of the cannula, and not with the site marker interposed within the cannula. This is because the site marker may take a heat set during sterilization. That is, when the site marker is sterilized within the cannula and then deployed into the biopsy site, the expandable portions of the site marker are unable to expand because the site marker has undergone the heat set during sterilization. During shipment, a wire may be used to hold the site marker in place along the distal opening.
The site marker sometimes separates from the distal opening during shipment, and hangs loose on the wire, away from the cannula distal opening. If the site marker separates from the distal opening, it is difficult to get the marker properly positioned and/or compressed for deployment of the site marker into a biopsy site. This is because it is difficult to re-align the site marker with the distal opening of cannula, as well as compress the marker into a desired configuration.
Accordingly, there is a need for deployment devices that retain the site marker in place along the distal opening of the cannula during shipment, and prior to deployment.
Referring now to the discussion that follows and also to the drawings, illustrative approaches to the disclosed systems and methods are shown in detail. Although the drawings represent some possible approaches, the drawings are not necessarily to scale and certain features may be exaggerated, removed, or partially sectioned to better illustrate and explain the present disclosure. Further, the descriptions set forth herein are not intended to be exhaustive or otherwise limit or restrict the claims to the precise forms and configurations shown in the drawings and disclosed in the following detailed description.
According to various exemplary illustrations described herein, a marker deployment system including a cannula, a site marker and at least one wire is provided. The cannula includes a tubular side-wall and a distal opening, and defines at least one aperture extending through the side-wall. The wire is selectively interposed within the cannula, and a distal wire end extends through the aperture. A portion of the wire is secured to an end portion of the site marker.
Turning now to the drawings and in particular to
The wire 24 is selectively interposed within the inner cannula 28 as well as the outer cannula 26, and includes a distal end 42 and a proximate end 44. The proximate end 44 of the wire 24 is secured to a proximate end 46 of the marker deployment system 20. In the illustration of
A portion of the wire 24 is secured to an end portion 48 of the site marker 30. The distal end 42 of the wire 24 is then guided to the aperture 32 of the outer cannula 26, and the distal end 42 extends through the aperture 32. More specifically, the distal end 42 of the wire 24 is either aligned with or protrudes from the aperture 32.
The wire 24 is then pulled taut between the distal end 42 and the proximate end 44 of the outer cannula 26. That is, the wire 24 is pulled taut at the aperture 32, thereby tightening the portion of the wire 24 that is located within the outer cannula 26. Because the wire 24 is pulled tightly, the site marker 30 is thereby at least partially aligned with the distal opening 50. More specifically, the wire 24 is pulled through the aperture 32, thereby aligning the end portion 48 of the site marker 30 with a distal end 52 of the outer cannula 26. Typically, the wire 24 is pulled tight during assembly of the marker deployment system 20, prior to shipment. Because the wire 24 is pulled tightly during assembly, the site marker 30 can not separate from the distal opening 50 during shipment.
In the illustration as shown in
In one exemplary illustration, the distal end 42 of the wire 24 is first pulled taut and extends past the aperture 32, as seen in
The wire 24 is constructed from any material that is sufficiently stiff to be held in place inside of the outer cannula 26, such as, but not limited to, a metal or a polymer that will substantially retain stiffness. The wire 24 may also include a locating feature for orienting the distal end 42 of the wire 24 at the aperture 32. For example,
In one exemplary illustration, as seen in
The site marker 230 is an expandable marker. That is, the site marker 230 is able to expand and compress. In the illustration as shown, the expendable marker 230 is displayed as an expendable filament type marker. However, it is understood that other types of expendable markers may also be used with the marker deployment device 20.
Prior to deployment of the site marker 230, the wire 224 is retracted inside of the inner cannula 228. In the illustration of
As seen in
When the wire 224 is retracted, the site marker 230 is urged inside the outer cannula 226. That is, the site marker compresses from the first dimension D1 to the second dimension D2, where the first dimension D1 is greater than the second dimension D2. The first dimension D1 is also greater than a diameter DC of the outer cannula 226, thus the site marker 230 is unable to be wholly interposed within the outer cannula 226 when the site marker 230 includes the first dimension D1. When the site marker 230 is compressed to the second dimension D2, the site marker 230 is able to fit within the outer cannula 226. In the illustration as shown in
The system 390 includes a packaging 392. In the illustration as shown, the site marker 330 is prevented from moving or shifting outside of the distal end 350 of the outer cannula 326. More importantly, the site marker 330 is retained in place until the deployment device 322 is removed from the packaging 392, and the wire 342 is retracted into the inner cannula 328. Collectively, the site marker 330, the deployment device 322, and the packaging 392 comprise the system 390.
In general, the site markers described herein may be made from biocompatible materials such as, but not limited to, titanium, stainless steel, and platinum. These materials have appropriate densities for radiographic imaging, appropriate surface characteristics for ultrasonic imaging, and appropriate magnetic characteristics for magnetic resonance imaging. The site markers are preferably made from titanium; however, it is understood that any suitable biocompatible material may be used. Portions of the site markers may be made from bioabsorbable materials. Commonly owned U.S. patent application Ser. Nos. 11/242,334, 10/964,087 and 11/561,919 disclose a variety of site markers that may be used in conjunction with the deployment device 322.
While the present disclosure has been particularly shown and described with reference to the foregoing preferred embodiments, it should be understood by those skilled in the art that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure without departing from the spirit and scope of the disclosure as defined in the following claims. It is intended that the following claims define the scope of the disclosure embodiments within the scope of these claims and their equivalents be covered thereby. This description of the disclosure should be understood to include all novel and non-obvious combinations of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. The foregoing embodiment is illustrative, and no single feature or element is essential to all possible combinations that may be claimed in this or a later application.
