Patent Application
20210244495
The present application relates to surgical marker devices and methods for implanting surgical marker devices.
During examinations of the intestine, an endoscope is used to visualize the lining of the intestines of a subject. Typically when a polyp or abnormal tissue is encountered, under visualization with the endoscope, the polyp is grasped by a tool arranged on the endoscope and removed from the wall of the intestine. It is generally important at the time of removal of a polyp to mark the location of the removed tissue on the lining of the intestines. A resection or other medical procedures may be required to be performed at the marked location of the polyp removal, depending on the results of a biopsy of the polyp or abnormal tissue, medical recommendations, or pursuant to other follow-up procedures.
Historically, these marks to the intestinal wall have been achieved using a liquid stain/dye injected onto the intestinal wall to create a contrasting mark. This has been viewed as a relatively imprecise method due to the fact that the dye may be released over large areas of the intestinal wall, which may cause excessive streaking, rather than placing the dye within the wall of the intestine. Furthermore, it is possible for the dye to flow to adjacent areas of the polyp removal site, making the marked location of the polyp removal site less precise. Due to the imprecision of the dying process, it is frequently difficult to identify and differentiate one marked site from the next if multiple polyp removal sites are in close proximity. Also, the dye used in the marking procedure is not radiopaque, and therefore, may make it extremely difficult to locate the marked polyp removal site when returning to the subject for further resection, either by colonoscopy or by laparoscopic surgery. Even further, dye used in marking procedures can fade over time, preventing identification of the previously marked site.
An alternative technique to using a dye involves securing a metallic clip marker to the mucosal layer (i.e., the inner wall of the intestine). In many cases, it is desirable for a user to locate the site of a previous soft tissue/polyp removal, especially if the need to locate the previous removal site occurs frequently. However a potential complication of this method is that the metallic clip marker can break loose from the mucosal layer, which leaves the removal site unmarked. In particular, since metallic clip markers are clamped to the surface of the inner wall of the intestine, the clip markers may become dislodged due to normal bodily activity, such as when waste products pass through the intestine. As a result, clip markers may become dislodged from the inner intestinal wall with little to no warning to the subject. Dislodgement of the clip marker may interfere or impede subsequent location and re-examination of the site of a soft tissue removal. In many cases, it is critical for a user to locate and re-examine the site of a soft tissue removal year after year. Other techniques for tracking the location of a soft tissue removal site may include measuring the distance from a fixed point on the subject, such as the anus, to the soft tissue removal site along the intestines. However, this technique has also proved to be highly inaccurate, especially after a prior intestinal resection.
A soft tissue removal site that was marked during a previous colonoscopy (i.e., internal to the intestine) may have to be relocated laparoscopically (i.e., external to the intestine within the peritoneal cavity). Therefore the marker that is used to mark the site during the previous colonoscopy must be able to be found when working from the exterior of the intestinal wall. This may be difficult to do when a portion of the intestine has moved or folded on itself, since there are no visual means of identification visible, such as during a laparoscopic procedure.
Implementations of the present disclosure provide marker systems and corresponding methods for implanting a marker in tissue.
In one embodiment, a marker system is provided having an elongate cannulated tube, a marker capsule, and a driver member. The cannulated tube has a lumen extending therethrough and can have a piercing feature arranged at a distal end of the tube that is configured to create a working portal through tissue such that fluid can be delivered into the tissue to form a bleb. The marker capsule can be removably disposed within the lumen of the cannulated tube, and it can include a transmission antenna, and an arranging feature disposed on an external surface of the capsule and configured to facilitate rotation of the marker capsule within the bleb. The driver member can be arranged within the lumen of the cannulated tube proximal to the marker capsule, and it can be configured to advance distally to displace the marker capsule through the working portal and into the bleb.
The arranging feature can have a variety of configurations, and the marker can include any number of arranging features. In one embodiment, the arranging feature can be in the form of a fin extending from the external surface of the marker capsule. The driver member can include jaws configured to grasp the fin to rotate the marker capsule. In another embodiment, the arranging feature can be in the form of a notch arranged on a distal end of the marker capsule and a thread arranged within the notch and configured to apply a tension to the marker capsule to rotate the marker capsule. In another embodiment, the arranging feature can be in the form of a threaded loop arranged on a distal end of the marker capsule and configured to apply tension to the marker capsule to rotate the marker capsule. The marker can include any combination of the aforementioned arranging features.
In another embodiment, a marker system is provided and includes an elongate cannulated tube, a marker capsule, a driver member, and a cannulated needle. The elongate cannulated tube can have a lumen extending through the tube, with a distal end of the tube including a hook-shaped member with an internal curved surface. The marker capsule can be removably disposed within the lumen of the cannulated tube, and it can include a transmission antenna. The driver member can be arranged within the lumen of the cannulated tube proximal to the marker capsule, and it can be configured to be advanced distally to advance the marker capsule along the internal curved surface of the hook-shaped member such that the marker capsule is caused to rotate. The cannulated needle can be arranged along the elongate cannulated tube and it can be configured to be slidably advanced from a distal end of the elongate cannulate tube to penetrate tissue.
The marker system can have a variety of configurations and can include various features. In one implementation, the cannulated needle can be slidably disposed through a second lumen formed in a sidewall of the cannulated tube. In other aspects, the hook-shaped member can be positioned to block distal advancement of the marker capsule, and the hook-shaped member can be flexible to deflect when the marker capsule is advanced distally. In another implementation, the marker system can include a tether coupled to the hook-shaped member and configured to apply a force to the hook-shaped member to cause the hook-shaped member to deflect and thereby allow distal advancement of the marker capsule.
In another embodiment, a marker system is provided having an elongate cannulated tube, a marker capsule, a thread, and a driver member. The elongate cannulated tube can have a lumen extending through the tube, and the marker capsule can be removably disposed within the lumen of the cannulated tube. The marker capsule can have a notch formed in a distal surface of the capsule, and a transmission antenna can be disposed within the capsule. The thread can be arranged within the notch of the marker capsule. The driver member can be arranged within the lumen of the cannulated tube proximal to the marker capsule, and it can be configured to distally advance to displace the marker capsule from the distal end of the cannulated tube.
The thread can have a variety of configurations. In one implementation, the thread can be coupled to an energy source and it can be configured to apply an electrical energy to a tissue surface to create a working portal. The thread can also be configured to apply tension to the marker capsule to rotate the marker capsule.
In other aspects, the marker system can include a receiver member have a short-range transmission receiver and a long-range transmission antenna. The receiver member can be configured to receive a data set from the marker capsule via the short-range transmission receiver, and it can be configured to transmit the data set via the long-range transmission antenna. The receiver member can be disposed within a water-proof cap configured to couple to an end of an endoscope. In one embodiment, the short-range transmission receiver can be a RFID receiver, and the long-range transmission can be a short-link radio antenna.
Methods for implanting a marker in tissue are also provided. In one embodiment, the method can include inserting an elongate cannulated tube into a tissue surface to create a working portal through the tissue surface. A fluid can be injected through the cannulated tube into the tissue surface to create a bleb. A marker capsule can be ejected from a distal end of the cannulated needle into the bleb. The marker capsule can have a transmission antenna within the marker capsule. The marker capsule can be rotated within the bleb such that a length of the marker capsule extends adjacent to the working portal to prevent passage of the marker capsule through the working portal.
In one embodiment, the fluid can be injecting through a cannulated needle extending through the cannulated tube. The method can also include, prior to inserting the elongate cannulated tube into a tissue surface, advancing a needle from a distal end of the cannulated tube. The cannulated needle can be removed from the bleb prior to rotation of the marker capsule.
In another embodiment, rotating the marker capsule can include applying tension to a tether coupled to the marker capsule to cause the marker capsule to rotate. In other aspects, rotating the marker capsule can include grasping a fine on the marker capsule with a grasper and manipulating the grasper to rotate the marker capsule. The method can also include positioning a receiver member adjacent to the marker capsule such that the receiver member receives a data set from the marker capsule via the short-range transmission receiver.
These and other features will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
It is noted that the drawings are not necessarily to scale. The drawings are intended to depict only typical aspects of the subject matter disclosed herein, and therefore should not be considered as limiting the scope of the disclosure.
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Various devices and methods are provided for inserting a marker capsule into tissue, and for rotating the marker capsule to prevent the capsule from backing out the working portal made to insert the capsule. The devices and methods disclosed herein are particularly advantageous as they allow a marker capsule to be placed under the surface of the tissue, while also preventing the capsule from being expelled from the tissue after insertion. In certain exemplary embodiments, the marker capsule has features arranged on its exterior surface that facilitate rotation of the capsule once inserted under the tissue. In this way, the marker capsule can be inserted in a first position, having a width smaller than the working portal to aid in insertion, and rotated to a second position, where the length of the capsule is larger than the width of the working portal, preventing backing out of the capsule. With the marker capsule inserted and rotated, the marker capsule can wirelessly transmit data about the insertion site to a receiver member. The data set can include information about the insertion site, such as date, time, etc., and can be located wirelessly during a subsequent procedure, and without the need of visual reference points. This may avoid the deficiencies of the prior art techniques discussed above. By placing the marker capsule beneath the tissue surface, and rotating the capsule to prevent backing out, loss of the marker capsule may be reduced, and identification of the marker capsule during subsequent procedures may also be simplified, thereby shortening the procedure.
Various embodiments of marker systems are disclosed herein. In general,
In this embodiment, the cannulated tube 103 is disposed through an insertion device 102, which in is in the form of an endoscope having various working channels 103A extending therethrough and a camera 103B on a distal end thereof. The endoscope can aid in facilitating delivering of the marking system into a body lumen. However, a person skilled in the art will appreciate that any delivering device can be used or that the marker system can be advanced into a body lumen without a delivery device.
The elongate cannulated tube 103 can have a variety of configurations, but is generally in the form a flexible member with at least one lumen extending therethrough. As indicated above, the cannulated tube 103 shown in
The driver member 112 extends through the cannulated tube 103, and can have a variety of configurations but is generally in the form a flexible member having an end effector. The driver member 112 can include a flexible section adjacent the distal end for allowing the end effector to be articulated. In order to articulate the end effector, control devices such as steering wires could be run within the driver member 112 to the end effector in order to steer the end effector. The end effector can be a grasper which can actuate its grasping mechanism in order to grab onto the capsule and adjust the capsule, or the end effector can be a pushing mechanism which can apply a pressure to the capsule in order to move the capsule. However, a person skilled in the art will appreciate that a variety of grasper devices are known in the art and can be used to manipulate the capsule.
As indicated above, a marker capsule can be slidably disposed within the tube 103, e.g., within the needle 104. The marker capsule can have a variety of configurations.
In addition to having internal electronics within the marker capsule,
In the embodiment illustrated in
In addition to the fin 120, a notch 122 can be arranged on the distal end 109B of the marker capsule 108 to also aid in stabilization and rotation of the marker capsule 108. As shown, the notch 122 is in the form of a channel formed in an exterior surface of the distal end of the marker capsule. The notch has a configuration that allows a thread to be arranged within the notch 122, as shown in
As indicated above, the marker capsule can include any number of arranging features. By way of non-limiting example,
In another embodiment, the arranging feature can be in the form of a threaded loop 124 arranged on the marker capsule 108 for stabilization and to facilitate rotation of the marker capsule 108.
Referring back to
Various methods for inserting the marker capsule are also provided herein. In general, a bleb is created in a tissue surface in order to create a space to insert the marker capsule. The marker capsule is then inserted within the bleb and rotated to prevent backing out of the marker capsule. The bleb can then be sealed shut to further prevent backing out of the marker capsule.
As depicted in
Once the marker capsule 108 is ejected from the distal end of the tube 103, the marker capsule 108 can be rotated within the bleb 14. As illustrated in
After the marker capsule 108 is fully rotated within the bleb 14, the driver member 112 is removed from the bleb. As illustrated in
In other embodiments, the marker system can be configured to penetrate into a bleb without the use of a needle and without delivering fluid into the bleb.
In other embodiments, the rotation of the marker capsule can be caused automatically when the marker capsule is pushed distally from the cannulated tube.
Additionally, the inner shaft 301 can include a lumen 303 formed through a sidewall thereof and having a needle 302 slidably disposed therein. The needle 302 can be flexible and can thus bend within the lumen 303. The needle 302 can be extended from and retracted into the lumen 303, and can be used to pierce and create the bleb 14 within the tissue 10 in the same manner as described above. Additionally, the needle 302 can be removed from the lumen 303 during the insertion of the marker capsule 308 in order to make the inner shaft 301 and the hook-shaped member 306 more flexible. A marker capsule 308 can be arranged within the lumen 305 of the outer shaft 304. A drive member, similar to those described above, can be arranged proximally within the lumen 305 and configured to distally displace the marker capsule 308 out of the lumen 305.
As illustrated in
After insertion of the marker capsule is complete, it may be advantageous to relocate the marker capsule during a subsequent procedure. In order to locate the marker capsule, a receiver member arranged on an insertion device may be used. As illustrated in
Certain exemplary implementations have been described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the systems, devices, and methods disclosed herein. One or more examples of these implementations have been illustrated in the accompanying drawings. Those skilled in the art will understand that the systems, devices, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary implementations and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary implementation may be combined with the features of other implementations. Such modifications and variations are intended to be included within the scope of the present invention. Further, in the present disclosure, like-named components of the implementations generally have similar features, and thus within a particular implementation each feature of each like-named component is not necessarily fully elaborated upon.
Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about,” “approximately,” and “substantially,” are not to be limited to the precise value specified. In at least some instances, the approximating language may correspond to the precision of an instrument for measuring the value. Here and throughout the specification and claims, range limitations may be combined and/or interchanged, such ranges are identified and include all the sub-ranges contained therein unless context or language indicates otherwise.
One skilled in the art will appreciate further features and advantages of the invention based on the above-described implementations. Accordingly, the present application is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated by reference in their entirety.
The present application claim priority to U.S. Application No. 62/971,652, filed on Feb. 7, 2020 and entitled “SYSTEMS AND METHODS FOR MARKING AND LOCATING SITES OF BIOPSIES USING RADIO FREQUENCY IDENTIFICATION TRANSPONDER,” which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62971652 | Feb 2020 | US |
