Localization tag deployment system and method

Abstract

A deployment system for accurate placement of localization tags within biological tissue is disclosed. The system comprises a catheter hub with sheath, a stylet, and a loader. The catheter hub provides an interface for system components, while the flexible sheath allows navigation to target sites. The stylet, operable in multiple positions, guides the sheath and assists in tag deployment. The loader houses the localization tag and acts as a safety spacer during deployment. The system is compatible with endoscopes and various imaging modalities, offering improved accuracy and efficiency over traditional wire localization techniques. The localization tags may be passive or active, with potential for advanced functionalities such as biosensing or drug delivery. This minimally invasive system finds applications in tumor marking, lymph node localization, and targeted therapy delivery across multiple medical specialties.

Description

Atty. Docket. No. ELCT-43065.601LOCALIZATION TAG DEPLOYMENT SYSTEM AND METHODCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 722870, filedNovember 20, 2024, the contents of which are incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates generally to medical devices and procedures, and more particularly to systems and methods for deploying localization tags within biological tissue.BACKGROUND

[0003] Accurate localization of treatment areas remains a significant challenge in many medical procedures. For example, precisely identifying the location of lesions or tumors that require treatment, including surgical resection, continues to present difficulties for the medical community. Existing localization systems are often expensive, complex, time-consuming, and frequently uncomfortable for patients.

[0004] One common technique used for tumor localization, particularly in breast tumor surgery, is wire localization. This procedure involves inserting a wire into the breast to mark the location of an abnormality prior to surgery. While effective, wire localization has several drawbacks. It typically requires multiple imaging steps, can be painful for patients, and leaves the wire protruding from the patient’s body - sometimes for hours - as they wait for surgery. This can cause discomfort and anxiety for patients. Other localization methods, such as radioactive seed localization or radar reflector localization, have been developed to address some of these issues. However, these techniques often require specialized equipment for detection and may have limitations in terms of accuracy or ease of use.

[0005] In other types of surgeries and medical procedures, physicians may struggle to locate a target prior to removal or manipulation. Examples include the removal of masses, fluid collections, foreign bodies, or diseased tissues. Additionally, placement of catheters or other percutaneous procedures are sometimes performed without direct visualization or with limited guidance modalities. Performing procedures without precise guidance can increase damage to normal tissues and negatively impact patient outcomes.Atty. Docket. No. ELCT-43065.601

[0006] There is a need for improved systems and methods for tissue localization that are accurate, minimally invasive, and compatible with existing medical imaging and surgical techniques. One such example system is contemplated by U.S. Pat. 11,344,382, which is incorporated by reference in its entirety. Ideally, such systems would allow for precise placement of localization devices or agents with minimal discomfort to patients and would facilitate subsequent surgical or therapeutic interventions.SUMMARY

[0007] The present disclosure provides, in at least one respect, systems for deploying a localization tag within biological tissue including a catheter hub, a sheath extending from the catheter hub, the sheath having a cannula, a stylet configured to move within the cannula of the sheath, and a loader removably attached to the catheter, the loader configured to house a localization tag.

[0008] In some embodiments, the stylet is operable in at least two positions relative to the sheath: a first position where a tip of the stylet is substantially aligned with a tip of the sheath, and a second position where the tip of the stylet extends beyond the tip of the sheath.

[0009] In some embodiments, the system further comprises a clip disposed along the stylet configured to prevent the stylet from translating from the first position to the second position.

[0010] In some embodiments, the system further comprises a localization tag housed within the loader.

[0011] In some embodiments, the loader comprises an internal cavity for housing a localization tag, and the tag comprises a securing element configured to secure the tag within the cavity.

[0012] In some embodiments, the localization tag comprises at least one of: a biosensor, a drugeluting coating, or a biodegradable material.

[0013] In some embodiments, the loader is configured to act as a spacer to prevent the stylet from extending beyond the sheath during deployment of the localization tag.

[0014] In some embodiments, the sheath comprises radiopaque markers along its length. In some embodiments, the sheath comprises a steerable tip.Atty. Docket. No. ELCT-43065.601

[0015] In some embodiments, the stylet comprises a tapered tip to facilitate penetration into the biological tissue. In some embodiments, the stylet comprises a hollow core configured for fluid injection or aspiration.

[0016] In some embodiments, the loader is configured to house multiple localization tags for sequential deployment.

[0017] The present disclosure provides, in at least one aspect, methods for deploying a localization tag within biological tissue, including navigating a catheter system to a target location within a patient’s body, the catheter system comprising a catheter hub, a sheath extending from the catheter hub, and a stylet disposed within the sheath, removing the stylet from the sheath, attaching a loader containing a localization tag to the catheter hub, reinserting the stylet into the sheath, and advancing the stylet to deploy the localization tag from the loader through the sheath and into the target location.

[0018] In some embodiments, the method further comprises translating the stylet between a first position, where a tip of the stylet is substantially aligned with a tip of the sheath during navigation to the target location, and a second position where the tip of the stylet extends beyond the tip of the sheath to penetrate tissue at the target location.

[0019] In some embodiments, the method further comprises using imaging guidance to navigate the system to the target location.

[0020] In some embodiments, the method further comprises confirming placement of the localization tag using imaging after deployment.

[0021] In some embodiments, the loader acts as a spacer to prevent the stylet from translating from the first position to the second position.

[0022] Other aspects of the disclosure will become apparent by consideration of the detailed description and accompanying drawings.DEFINITIONS

[0023] The terms “substantially” or “generally” are used to provide flexibility by recognizing that a given characteristic need not be perfectly embodied to have the desired result. Those of ordinary skill in the art will recognize that many characteristics described herein may be essentially present without strict adherence to the characteristic’s definition.Atty. Docket. No. ELCT-43065.601

[0024] The term “coupled,” as used herein, is defined as “connected,” although not necessarily directly, and not necessarily mechanically. The term coupled is to be understood to mean physically, magnetically, chemically, fluidly, electrically, or otherwise coupled, connected or linked and does not exclude the presence of intermediate elements between the coupled elements absent specific contrary language.

[0025] The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. The singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. The present disclosure also contemplates other embodiments “comprising,” “consisting of’ and “consisting essentially of,” the embodiments or elements presented herein, whether explicitly set forth or not.

[0026] As used herein, the term “subject,” “patient,” or “user” broadly refers to any animal, including but not limited to, human and non-human animals (e.g., dogs, cats, cows, horses, sheep, poultry, fish, crustaceans, etc.). As used herein, the term “patient” typically refers to a subject that is being treated for a disease or condition.

[0027] As used herein, a “system” refers to a plurality of real and / or abstract components operating together for a common purpose. In some embodiments, a “system” is an integrated assemblage of hardware and / or software components. In some embodiments, each component of the system interacts with one or more other components and / or is related to one or more other components. In some embodiments, a system refers to a combination of components and software for controlling and directing methods.

[0028] A “connection” by which two components of a system, e.g., an electrical system, a data system, a computer system, a circuitry system, etc., are connected will generally be an “operable connection”, or a connection by which entities are “operably connected”. The term “operable connection” and equivalents is one in which signals, physical communications, and / or logical communications may be sent and / or received. An operable connection may include a physical interface, an electrical interface, and / or a data interface. An operable connection may include differing combinations of interfaces and / or connections sufficient to allow operable control. For example, two entities can be operably connected to communicate signals to each other directly orAtty. Docket. No. ELCT-43065.601 through one or more intermediate entities (e.g., processor, operating system, logic, software). Logical and / or physical communication channels can be used to create an operable connection.

[0029] “Tissue” refers to an aggregate of cells, usually of a particular type, together with their intercellular substance that form one of the structural materials of a human, animal, plant, or other living organism.

[0030] “Proximal” refers to a part of a device or anatomy situated nearer to the point of attachment or origin or to a central point, while “distal” refers to a part of a device or anatomy situated away from the point of attachment or origin or from a central point.

[0031] As used herein the terms “memory” generally refer to a physical and / or logical entity that can store data, e.g., any memory storage of a computer and is a non-transitory computer readable medium. A data store may be, for example, a database, a table, a file, a list, a queue, a heap, a memory, a register, and so on. A data store may reside in one logical and / or physical entity and / or may be distributed between multiple logical and / or physical entities. Software included in the implementation of the methods disclosed herein can be stored in the memory. The software includes, for example, firmware, one or more applications, program data, filters, rules, one or more program modules, and other executable instructions. For example, the computer can be configured to retrieve from the memory and execute, among other things, instructions related to the processes and methods described herein.

[0032] Suitable software for implementing various components of example systems and methods described herein may be developed using programming languages and tools (e.g., Java, C, C#, C++, C, SQL, APIs, SDKs, Swift, NEXTStep, SmallTalk, Unix, Objective C, assembler). Software, whether an entire system or a component of a system, may be embodied as an article of manufacture and maintained or provided as part of a computer-readable medium. Software may include signals that transmit program code to a recipient over a network or other communication medium. Thus, in one example, a computer-readable medium may be signals that represent software / firmware as it is downloaded from a server (e.g., web server).

[0033] In the foregoing description of preferred embodiments, specific terminology has been resorted to for the sake of clarity. However, the present disclosure is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose.Atty. Docket. No. ELCT-43065.601

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present disclosure. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG. 1 is a perspective view of a system 100 for deploying a localization tag within biological tissue in accordance with the present disclosure, including a catheter hub 120, a stylet assembly 140, and a loader 170.

[0036] FIG. 2A is a front view of the catheter hub 120 of FIG. 1 shown with sheath 122 truncated.

[0037] FIG 2B is a cross-sectional view of the catheter hub 120 of FIG. 2A.

[0038] FIG. 3A is a front view of the stylet assembly 140 of FIG. 1 shown with stylet 144 truncated.

[0039] FIG. 3B is a cross-sectional view of the stylet assembly 140 of FIG. 3 A.

[0040] FIG. 4A is a side view of loader 170 of FIG. 1.

[0041] FIG. 4B is a cross-sectional view of loader 170 of FIG. 4A.

[0042] FIG. 4C is a side view of a localization tag 180 in accordance with the present disclosure.

[0043] FIG. 5A is a side view of a deployment system in accordance with the present disclosure with stylet tip 146 substantially aligned with sheath tip 130.

[0044] FIG. 5B is a side view of a deployment system in accordance with the present disclosure with clip 162 removed and stylet tip 146 extending past sheath tip 130.

[0045] FIG. 5C is a side view of a deployment system in accordance with the present disclosure with loader 170 installed and localization tag 180 at sheath tip 130.Atty. Docket. No. ELCT-43065.601

[0046] FIG. 5D is a side view of a deployment system in accordance with the present disclosure with localization tag 180 deployed.

[0047] Before any embodiments are explained in detail, it is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the accompanying drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways.DETAILED DESCRIPTION

[0048] As depicted in FIG 1, is the localization tag deployment system 100 comprises three main components: a catheter hub 120 with sheath 122, a stylet assembly 140 with handle 142, and a loader 170. The system 100 provides smooth and accurate localization tag deployment while improving upon traditional wire localization techniques in terms of accuracy, patient comfort, and procedural efficiency.

[0049] Shown in greater detail in FIGS. 2A and 2B, the catheter hub 120 serves as the primary interface between the user and the deployment system 100 and provides easy manipulation and secure connection of other components. In the pictured embodiment, the hub 120 is constructed from durable, biocompatible materials such as medical-grade polycarbonate or stainless steel, and features a generally hollow and ergonomically shaped elongated body 124 for secure gripping and precise control. On one end of the body 124 is an adapter 126 sized and configured to securely attach to other components of the system 100. In the pictured embodiment, the adapter 126 is a nut with internal threading on one end configured to interface with body 124, and a locking mechanism on the opposite end configured to interface with plunger tip 160 (shown in FIGS. 3A-3B). In some embodiments, the hub 120 may incorporate advanced features like integrated electronic components or sensors for improved functionality, such as real-time positioning feedback or compatibility with electromagnetic tracking systems. The hub 120 may also feature a modular design, allowing for quick interchange of different sheath types or lengths to suit various procedural needs.

[0050] Extending from body 124, opposite the adapter 126, is the sheath 122. In some embodiments, the sheath 122 is a flexible yet sturdy tube typically ranging from 10 to 30 cm in length but may extend past 50 cm for deep tissue applications. In some embodiments, sheath 122Atty. Docket. No. ELCT-43065.601 is made from low-friction polymers like polytetrafluoroethylene (PTFE) or polyether block amide (PEBAX), allowing for smooth insertion and navigation through body tissues. Its outer diameter usually varies between 3 to 7 French (1 to 2.3 mm) to accommodate different anatomies and procedural requirements. Shown more clearly in the cross-section of FIG. 2B, the sheath 122 defines an internal cannula 128, configured to minimize friction and ensure smooth passage of the stylet 144 and localization tag 180 (not shown). Alternative embodiments may include radiopaque markers for enhanced visibility under imaging, varying degrees of flexibility along its length, or even a steerable tip 130 for navigation in complex anatomical structures. Yet other embodiments may feature shape-memory alloys in the sheath 122 construction, allowing for pre-determined sheath configurations activated by temperature changes or electrical stimuli, enhancing navigation capabilities in difficult anatomical pathways.

[0051] Shown in FIGS 3A and 3B is the stylet assembly 140, including a handle 142 and stylet 144. In the pictured embodiments, the stylet 144 is a thin, rigid rod configured to extend through the sheath’s cannula 128 when the system 100 is in operation. The stylet 144 serves to guide the sheath 122 to the target location and assist in tag 180 deployment. Typically made from medicalgrade stainless steel or nitinol, the stylet 144 is translatable between at least two positions relative to the sheath 122: one where its distal tip 146 aligns with or is slightly withdrawn from the sheath tip 130 for safe navigation through tissue (FIG. 5A), and a second where it protrudes beyond the sheath tip 130 for tissue penetration before tag deployment (FIG. 5B). Some embodiments may include multiple extension positions or a continuously variable extension mechanism for precise depth control. The stylet’s tip 146 can be configured in various ways to suit specific clinical needs, from sharp points for better tissue penetration to rounded tips for atraumatic navigation. The stylet’s proximal end terminates in handle 142, which may include markers or locking mechanisms to indicate and secure the stylet’s position. In the pictured embodiment, handle 142 is a two-part design with an outer handle 142 operably connected to the stylet 144 and a nested plunger 150 that moves along a track 148 formed into the handle 142. The plunger 150 includes a mechanical connector 160 corresponding and configured to interface with the adapter 126 on the hub 120. The plunger 150 further comprises a biasing member 152 sized and configured to translate between two holes 156,158 formed in the outer sleeve 148, corresponding to the two stylet tip 146 positions in shown in FIGS. 5A and 5B. A clip 162 (not shown in FIG. 3B) is connected to the plunger 150Atty. Docket. No. ELCT-43065.601 and is configured to maintain the plunger 150 in its first position during storage and to prevent unwanted advancement of the stylet tip 146 during operation.

[0052] Some embodiments may incorporate integrated actuator mechanisms for precise control of the stylet tip’s 146 extension and retraction. Alternative embodiments could include a hollow core 162 for fluid injection or aspiration for specialized applications. In yet other embodiments, the stylet assembly 140 may incorporate fiber optic elements for direct visualization or spectroscopic tissue analysis, or ultrasound transducers for real-time imaging of the immediate deployment area.

[0053] The system 100 may include a loader 170, shown in FIGS. 4A and 4B. The loader 170 houses the localization tag 180 in an internal cavity 172 prior to deployment. Shown in greater detail in FIG. 4C, the tag 180 may be secured in place using an anchor 182, or securing element, made from surgical steel, aluminum, or a shape-memory alloy like nitinol, which is expandable to fill the cavity 172. The loader 170 serves a dual purpose as both a safety and usability mechanism. When acting as a spacer between the handle 124 and adapter 126, the loader 170 prevents premature deployment of the tag 180 that might otherwise occur during assembly of the handle components (120, 140, 170). This spacing function ensures that when the stylet handle 142 is in its retracted position and all components are assembled, the marker is precisely positioned at the end of the sheath, ready for controlled deployment. The user can then deliberately advance the stylet handle 142 to deploy the tag 180, providing precise control over the deployment process, as shown in FIG. 5C. The loader 170 connects securely to the handle 124 using a mechanical connector 174, ensuring proper alignment of the tag 180 with the sheath's cannula 128 for smooth deployment. In the pictured embodiment, loader 170 uses the same threading as adapter 126 for compatibility. Some embodiments of the loader 170 may house multiple tags 180 for sequential deployment, incorporating a linear magazine mechanism for rapid, multiple tag 180 placements. Other embodiments may incorporate visual or tactile indicators for confirmation of proper alignment and successful deployment or include transparent sections for visual confirmation of the tag's presence and position. In yet other embodiments, the loader 170 might feature an electronic tag 180 verification system, using RFID or similar technology to confirm the identity, type, and integrity of each tag 180 before deployment.Atty. Docket. No. ELCT-43065.601

[0054] Shown in FIG. 4C, is a localization tag 180 in accordance with the present disclosure. In some embodiments, the localization tag 180 is a miniature device, typically ranging from about 2 to about 5 mm in its largest dimension, designed to be detectable by various imaging or sensing modalities after deployment in the patient’s body. Tags 180 may be passive, relying on their physical properties for detection, or active, incorporating power sources and signal-generating capabilities. In some embodiments, the tags 180 might include biosensors for real-time physiological data, such as pH levels, oxygen saturation, or specific biomarkers, providing diagnostic information post-deployment. Some tags 180 may incorporate drug-eluting coatings or reservoirs for localized therapy delivery, potentially with remotely activatable release mechanisms. Biodegradable materials could be used for temporary marking, with degradation rates tailored to specific clinical needs. In some embodiments, the tags 180 are multi-modal tags, detectable by various imaging techniques simultaneously (e g., ultrasound, MRI, and CT), could enhance versatility and reduce the need for multiple procedures.

[0055] FIGS. 5A-5D depict an illustrative example of operation of the deployment system 100, shown being carried out in multiple discrete steps, ensuring accurate and safe placement of the localization tag 180. FIGS. 5A-5D depict both the manipulation of the catheter hub 120 and the surrounding components during operation on the left-hand side, as well as a corresponding, magnified, cross-sectional view of the sheath tip 130 and associated components on the right-hand side. In some embodiments, the procedure begins with patient preparation and imaging-guided identification of the target area, potentially utilizing multiple imaging techniques for enhanced accuracy. The deployment system 100 is then assembled and navigated to the target site taking advantage of the sheath’s 122 flexibility and the stylet’s 146 rigidity, with the clip 162 in place to prevent unintended advancement of the stylet tip 146 past the sheath tip 130 (FIG. 5A). Once at the desired location, the clip 162 is removed and the outer handle 148 is pushed towards the catheter hub 120, forcing the stylet tip 146 to extend past the sheath tip 130 and puncture the surrounding tissue to create a pocket (FIG. 5B). After puncturing the tissue, the stylet 144 is withdrawn, and the loader 170, pre-loaded with the tag 180, is attached to the catheter hub 120 between the handle 124 and the adapter 126. In some embodiments, this attachment process may incorporate error-checking mechanisms to ensure proper alignment. The stylet 144 is then reinserted to push the tag 180 through the system 100 until the tag 180 reaches the sheath tip 130 (FIG. 5C). The handle 148 is then pushed again towards the catheter hub 120 and the tag 180 isAtty. Docket. No. ELCT-43065.601 forced into the pocket formed in the target tissue. The anchor 182 expands and secures the tag 180 in position (FIG. 5D). Finally, the entire system is withdrawn, and the tag’s position is confirmed through imaging and may include functionality testing for active tags.

[0056] This comprehensive system provides a minimally invasive, accurate method for placing localization tags. Its compatibility with various imaging modalities and endoscopic procedures enhances its versatility across a wide range of medical applications, from tumor marking and lymph node localization to targeted therapy delivery and long-term physiological monitoring. The system may be utilized in various medical specialties, including interventional radiology, surgical oncology, and emerging fields in personalized medicine. By offering improved accuracy, patient comfort, and procedural efficiency in tissue localization procedures, this system will improve diagnostic accuracy, treatment planning, and patient outcomes across a broad spectrum of medical conditions.

[0057] Various features and advantages are set forth in the following claims.

Claims

Atty. Docket. No. ELCT-43065.601CLAIMSWhat is claimed is:

1. A system for deploying a localization tag within biological tissue, comprising: a catheter hub, a sheath extending from the catheter hub, the sheath having a cannula; a stylet configured to move within the cannula of the sheath; and a loader removably attached to the catheter, the loader configured to house a localization tag.

2. The system of claim 1, wherein the stylet is operable in at least two positions relative to the sheath: a first position where a tip of the stylet is substantially aligned with a tip of the sheath; and a second position where the tip of the stylet extends beyond the tip of the sheath.

3. The system of claim 2, further comprising a clip disposed along the stylet configured to prevent the stylet from translating from the first position to the second position.

4. The system of claim 1, further comprising a localization tag housed within the loader.

5. The system of claim 4, wherein the loader comprises an internal cavity for housing the localization tag, and the tag comprises a securing element configured to secure the tag within the cavity.

6. The system of claim 4, wherein the localization tag comprises at least one of: a biosensor, a drug-eluting coating, or a biodegradable material.

7. The system of claim 1, wherein the loader is configured to act as a spacer to prevent the stylet from extending beyond the sheath during deployment of the localization tag.Atty. Docket. No. ELCT-43065.6018. The system of claim 1, wherein the sheath comprises radiopaque markers along its length.

9. The system of claim 1, wherein the sheath comprises a steerable tip.

10. The system of claim 1, wherein the stylet comprises a tapered tip to facilitate penetration into the biological tissue.

11. The system of claim 1, wherein the stylet comprises a hollow core configured for fluid injection or aspiration.

12. The system of claim 1, wherein the loader is configured to house multiple localization tags for sequential deployment.

13. A method for deploying a localization tag within biological tissue, comprising: navigating a catheter system to a target location within a patient’s body, the catheter system comprising a catheter hub, a sheath extending from the catheter hub, and a stylet disposed within the sheath; removing the stylet from the sheath; attaching a loader containing a localization tag to the catheter hub; reinserting the stylet into the sheath; and advancing the stylet to deploy the localization tag from the loader through the sheath and into the target location.

14. The method of claim 13, further comprising translating the stylet between a first position, where a tip of the stylet is substantially aligned with a tip of the sheath during navigation to the target location, and a second position where the tip of the stylet extends beyond the tip of the sheath to penetrate tissue at the target location.

15. The method of claim 13, further comprising using imaging guidance to navigate the system to the target location.Atty. Docket. No. ELCT-43065.60116. The method of claim 13, further comprising confirming placement of the localization tag using imaging after deployment.

17. The method of claim 14, wherein the loader acts as a spacer to prevent the stylet from translating from the first position to the second position.

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