Patent Application
20090069819
The present disclosure relates generally to site markers for breast biopsy procedures. More specifically, the present disclosure relates to a cannula for a marker deployment device including a tubular sidewall and at least one slit intersecting through the sidewall.
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 embodiments disclosed therein, expandable filament portions ‘hold’ a site marker in place within a biopsy cavity. That is, a site marker may include a bio-absorbable filament portion with a marker, where the marker is visible under multiple modalities and the filament portion will inhibit migration of the marker within the biopsy cavity. The filament portions of these structures typically define a site marker diameter that is greater than the outer diameter of the cannula. To insert a site marker within a biopsy site, the site marker is first compressed to a dimension that will permit the site marker to be interposed within the cannula. Next, the site marker is interposed within an opening of the cannula and the site marker and cannula are sterilized. The cannula is then inserted within the biopsy pathway such that the opening is positioned within the biopsy site, and the marker is deployed into the biopsy site. Once deployed, the site marker expands as the filament portions exit the cannula.
The site marker and delivery cannula must be sterile in order to be placed into a biopsy cavity. However, in some instances the filament portions, or other materials, plastically deform within the cannula due to the heat of sterilization, therefore the filament portions may not properly expand upon exiting the cannula. Lack of proper expansion may permit migration within the biopsy cavity.
Accordingly, there is a need for site markers and delivery systems that are compatible with sterilization and packaging techniques.
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 invention. 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.
Turning now to the drawings and in particular to
As best seen in
The deployment device 140 may be used with the site marker 124. The site marker 124 is elastically deformable such that the site marker 124 may be interposed through the distal opening 130 in a marker retracted configuration. As illustrated in
In a representative embodiment as illustrated, the site marker 124 includes a filament member 194 having a marker element, or a permanent marker, 196 attached thereto. Alternatively the filament member could be a permanent element. It is understood that the filament member 194 and the permanent marker 196 may be omitted. It should also be noted that while
At least one of the filament members 180 serve to permit site marker 124 to be selectively configurable between a marker deployed configuration (
As best seen in
The deployment device 140 is selectively configurable between a deployed configuration and a protuberant configuration.
As best seen in
At least a portion of the sidewall 162 of the cannula 142 may define the protuberant configuration of
As seen in
The wire W may be omitted, as illustrated in
As best seen in
During insertion of the cannula 142 into the outer cannula 38, the cannula 142 is urged into the deployment configuration. At least a portion of the sidewall 162 is directed radially inwardly towards the axis A-A of the cannula 142 when the sidewall 162 interferes with a distal end 62 of the outer cannula 38. More specifically, the filament members 180 of the site marker 124 are urged inwardly toward the axis A-A, and into the marker retracted position. When the deployment device 140 is in the sterilization configuration the site marker 124 can not be disengaged from the first inner diameter DC of the cannula 142.
Thus positioned, the site marker 124 may be sterilized while the filament members 180 are elastically deformed. Indeed,
In addition to the retaining ring 340, the packaging 320 includes a proximate retainer portion 322 and a distal retainer portion 324. In the embodiment illustrated, both of the proximate retainer portion 322 and the distal retainer portion 324 bindingly retain the cannula 142 and the push-rod 200 such that the push-rod 200 is prevented from moving in the direction D relative to the cannula 142. More importantly, the site marker 124 is retained in the sterilization configuration, until the deployment device 140 is removed from the packaging 320. Collectively, the site marker 124, the deployment device 140, and the packaging 320 comprise a system 330.
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 140.
Although the steps of the method of deploying the site markers described herein are listed in a preferred order, the steps may be performed in differing orders or combined such that one operation may perform multiple steps. Furthermore, a step or steps may be initiated before another step or steps are completed, or a step or steps may be initiated and completed after initiation and before completion of (during the performance of) other steps.
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.
