This invention relates to a system and method for marking a tissue site.
A minimally invasive procedure can be used to explore tissue within a patient's body to search for suspected unhealthy tissue, for example, cancer cells. One example of such a minimally invasive procedure is a ductoscopy within the mammary ducts of breast tissue. A micro-endoscope can be advanced through the mammary ducts providing endoscopic visualization of cells and tissue within the ducts. If a suspected tissue site is located, a biopsy can be performed intraductally. However, the amount of tissue that can be excised using an intraductal procedure can be limited due to the size of the instruments involved. The physician may choose not to perform a biopsy at that time, but rather perform a subsequent ductoscopy at a later time to observe whether any changes in the suspect tissue have occurred. Due to physical changes that can occur within the ducts and the multiple ductal branching and tissue between the two ductoscopies, the physician may be unable to definitively locate the suspect tissue site a second time.
A system and method for marking a tissue site are described. In general, in one aspect, the invention features a method for marking a tissue site internally in a patient's body. An internal tissue site is identified using an internal imaging device. A marker is deployed into or near the tissue site, where the marker can be later located using an imaging device external to the patient's body. After withdrawing the internal imaging device, the location of the marker is identified using an external imaging device. A biopsy of the internal tissue site is performed based on the location of the marker.
Implementations of the invention may include one or more of the following features. The internal imaging device can be a micro-endoscope and the internal tissue site can be located within a patient's duct. Deploying a marker into or near the tissue site can include: inserting a needle loaded with the marker at a distal end of the needle into a working channel within the micro-endoscope; advancing the distal end of the needle to the internal tissue site; and, while maintaining a position of the marker relative to the internal tissue site, withdrawing the needle relative to the marker thereby deploying the marker into the internal tissue site. The marker can include one or more self-expanding components and deploying the marker can include releasing the marker from within the needle such that the one or more self-expanding components expand from a compacted position into an expanded position.
In general, in another aspect, the invention features a system for marking a tissue site internally in a patient's body. The system includes an internal imaging device, a marker and a deployment system. The internal imaging device is configured to assist a user in visualizing an internal tissue site. The marker is configured to embed within or near the tissue site and is configured to be visible by an imaging device external to the patient's body. The deployment system is configured to deploy the marker to the tissue site.
Implementations of the invention may include one or more of the following features. The internal imaging device can be a micro-endoscope and the internal tissue site can be located within a duct. The marker can include one or more self-expanding components such that when the marker is deployed by the deployment system, the one or more self-expanding components expand from a compacted position into an expanded position. The marker can include a core having a first end and second end, and the one or more self-expanding components can include one or more barbs located at each of the first and second ends of the core. The marker can include four barbs located at the first end of the core spaced approximately 90° from one another, and four barbs located at the second end of the core spaced approximately 90° from one another. The four barbs located at the first end of the core can be offset from the four barbs located at the second end of the core by approximately 45°. The one or more barbs can project radially inwards toward a center of the core and expand above the core. Alternatively, the one or more barbs can project radially outwards away from a center of the core.
In another implementation, the one or more barbs can project from the first and second ends of the core approximately orthogonally relative to a longitudinal axis of the core. The core can be formed at least partially from a radiopague material and/or at least partially from a Nitinol tube. The marker can include a core formed from a radiopaque material and the one or more self-expanding components can include one or more longitudinal wings located along the core. The marker can include a core formed from a radiopaque material and one or more fixed barbs extending outwardly from the core. The marker can include a core formed from a radiopaque material and one or more raised ridges formed along an exterior surface of the core. The one or more raised ridges can be a plurality of mono-directional ridges or a plurality of bi-directional ridges. The marker can include a core formed from a radiopaque material and have a dumb-bell shape, which may or may not include one or more barbs projecting from a first end and a second end of the core. The marker can include an expandable core formed at least partially from a radiopaque material. The expandable core can include an expandable braid formed at least partially from Nitinol wire. In another implementation, the expandable core can include an expandable stent formed at least partially from Nitinol wire. The marker can include a first end having a corkscrew configuration and a second end configured to detachably connect to a shaft.
In one implementation, the deployment system included in the system is a needle and the marker is an injectable radiopaque material, e.g., a biocompatible epoxy. In another implementation, the marker is a shape set wire configured to ball up upon release from the deployment mechanism, e.g., the shape set wire can be formed from Nitinol. In another implementation, the marker can include a first component that embeds at or near the tissue site and a second component providing a trail to the tissue site. For example, the second component can be a guidewire or a biocompatible ink.
In one implementation, the internal imaging device includes a working channel and the deployment system can be positioned within the working channel of the internal imaging device.
The deployment mechanism can include: a housing having an interior cavity; a handle extending from the interior cavity of the housing and slidably moveable relative to the housing; a first locking mechanism configured to lock the handle in position relative to the housing; a needle positioned within a lumen of the handle and protruding from a distal end of the housing; a push rod positioned within a lumen of the needle; a second locking mechanism configured to lock the push rod in a position; and a needle mover mechanism configured to move the needle relative to the handle and the push rod.
Implementations of the invention can realize one or more of the following advantages. Tissue that may be a candidate for a future external biopsy that is identified during a ductoscopy can be marked to facilitate identification during the biopsy. A trail to the candidate tissue can be left within the duct, to facilitate locating the tissue during a subsequent ductoscopy under endoscopic visualization. For example a guidewire attached to a marker left at the tissue site, or an ink trail leading to the tissue site, can be used.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
Like reference symbols in the various drawings indicate like elements.
A method and system for marking a tissue site within a patient's body are described. Referring to
In one implementation, the internal imaging device can be a micro-endoscope for performing a ductoscopy. For example, mammary ductoscopy is a procedure that uses a micro-endoscope including a tiny scope with a lens to look inside the milk ducts of the breast. Abnormalities can be observed and changes in the cell lining monitored.
Although preferably, a biopsy sample is taken intraductally under direct endoscopic visualization, it may not be possible to excise enough tissue sample under such conditions to perform a definitive diagnosis. Accordingly, a marker is placed into or near a suspect site (i.e., a site for a potential subsequent biopsy) under endoscopic visualization. An external biopsy can then be performed using an external imaging device for guidance, e.g., ultrasound or fluoroscopy, by locating the marker, and therefore the suspect site, and extracting enough tissue volume to improve the chances of making a definitive diagnosis.
The technique can be implemented as follows. If a suspect tissue site is observed during the ductoscopy, i.e., a site including a tissue mass that is a candidate for a biopsy, then a marker is introduced into or near the suspect site. In one implementation, once the micro-endoscope is inside a duct and the suspect site has been observed, a marker deployment device can be advanced down a working channel of the micro-endoscope. Under endoscopic visualization, the marker deployment device can be advanced into or near the suspect site and the marker deployed into a location in or near the suspect site. The marker is configured so as to be detectable by an imaging device external to the patient's body, e.g., using an ultrasound transducer or by fluoroscopy. By detecting the marker, the suspect site identified by ductoscopy can be located and an external biopsy performed to extract tissue from the suspect site.
Referring to
The introducer sheath 126 includes a lumen 128 for receiving the micro-endoscope 114 through an inlet end 130. Optionally, the introducer sheath 126 can include tubing, e.g., PVC tubing having a connector 134, e.g., a luer connector, to connect to an irrigation fluid source. Irrigation fluid can thereby be pumped through the introducer sheath 126 to provide irrigation of the duct during, before or after the ductoscopy, as required.
One implementation of a marker 200 is shown in
Referring to
When the handle 206 and pushrod 209 are locked into a position, a needle mover 211 can be activated to move the needle relative to the pushrod 209 and handle 206 in the direction of arrow 216. In the implementation shown, the needle mover 211 is a thumb slide device that slides the needle 215, although in other implementations, other configurations of needle mover 211, e.g., a threaded configuration, can be used.
Referring to
The needle 205 is advanced through the working channel 118 of the micro-endoscope 114 (Step 78). The handle 206 is locked to the Y-connector 102 using the locking mechanism 208 when the needle 205 is inserted into the working channel 118 (Step 80), which allows the physician to move the needle tip 207 by sliding the handle 206 forward. Under endoscopic visualization, e.g., fiberoptics, the needle tip 207 is advanced into or near the suspect site (Step 82). In one implementation, depth markers, e.g., on the needle 205 or on the handle 206, can guide the insertion depth. With the needle tip 207 in the desired location at or near the suspect site, the push rod 209 is locked into place using the locking mechanism 214 (Step 84). A lever or slide (e.g., thumbslide 211) is then activated to withdraw the needle tip 207 relative to the marker 200, which is held in place by the locked pushrod 209 (Step 86). Once the marker 200 is exposed, i.e., released from the needle tip 207, the marker is deployed into the tissue site (Step 88). In the implementation shown of the marker 200, the barbs 202 self-expand upon deployment and fix the marker 200 within the surrounding tissue.
The deployment handle 206 can then be unlocked and the needle 205 removed from the working channel 118 (Step 90). Optionally, an external biopsy can be performed, e.g., under fluoroscopic or ultrasonic guidance, by locating the marker 200 and excising tissue at the suspect site as identified by the marker 200. The marker 200 can be removed with the tissue excised at the time of the biopsy.
In one implementation, a “bread crumb” trail can be left to the suspected site. For example, a guide wire, attached to or separate from the marker 200, can be left in the patient's duct to mark the trail from the duct inlet to the suspect tissue site. In another implementation, a permanent biocompatible ink is used to mark the trail within the duct to the suspect tissue site. The guidewire or ink trail allows a physician to return to the suspect site for future follow-up during a subsequent ductoscopy.
The marker 200 described above is illustrative-other configurations of marker can be used. Some alternative embodiments of the marker 200 are shown in
FIGS. 18A-C show one implementation of a marker and deployment system 242 configured with a corkscrew marker 244 positioned at an end of a deployment shaft 246.
To deploy the marker 244, the physician turns the shaft 246 and capture rod 250 simultaneously with a handle attached to a proximal end of the shaft 246. Once the marker 244 is positioned with the tissue site, the handle can be used to slide the shaft 246 to uncover the keyed joint between the marker 244 and the capture rod 250. The marker 244 can thereby be released from the capture rod 250, e.g., by rotating the rod 250. The shaft 246 and capture road 250 can then be removed from the patient.
The above described markers are some examples of configurations of markers that can be embedded in or near a suspected tissue site. Other configurations can be used, including combinations of two or more of the above described implementations.
Referring again to
The method and system for internally marking a tissue site with a marker that can be located with an external imaging device for a subsequent external biopsy has been described for illustrative purposes in the context of an intraductal tissue site identified by a ductoscopy. However, the method and system described herein can be implemented in other contexts where an internal imaging device is used to locate the tissue site, the marker is introduced internally and can be visualized using an external imaging device. The intraductal system described herein is exemplary and not limiting.
A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. For example, the steps set forth in
This application claims priority to pending U.S. Provisional Application Ser. No. 60/667,390, entitled “Intraductal Biopsy Marking” , filed on Mar. 31, 2005, the entire contents of which are hereby incorporated by reference.
Number | Date | Country | |
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60667390 | Mar 2005 | US |