Stent structure and placement method
The stent deployment system uses suction and RF energy to stabilize and manipulate tissue walls, addressing precision and leakage issues in stent placement, ensuring controlled deployment and reduced risk of damage.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- GYRUS ACMI INC
- Filing Date
- 2026-01-23
- Publication Date
- 2026-07-30
AI Technical Summary
Existing stent deployment techniques face challenges in precisely manipulating and stabilizing tissue walls during inter-luminal procedures, particularly in sensitive or fluid-filled organs, leading to potential leakage and damage.
A stent deployment system utilizing suction and radiofrequency (RF) energy to grasp and stabilize tissue walls, allowing controlled deployment of flanges that engage the tissue, with independent deployment of proximal and distal flanges to maintain apposition and prevent leakage.
Enables precise control over tissue apposition, reduces the risk of leakage and damage to sensitive tissues, and facilitates stent placement in challenging anatomical locations.
Smart Images
Figure US2026012283_30072026_PF_FP_ABST
Abstract
Description
STENT STRUCTURE AND PLACEMENT METHODPRIORITY CLAIM
[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 749,440 filed January 24, 2025 and U.S. Provisional Patent Application Serial No. 63 / 917,441 filed November 14, 2025; the contents of which are incorporated herein by reference.TECHNICAL FIELD
[0002] The present disclosure relates to devices and methods for deploying a stent between adjacent body lumens.BACKGROUND
[0003] Inter-luminal procedures can involve placement of tissue anchors or stents (described herein collectively as stents). One class of stents are luminal apposing metal stents or LAMS. Some stent placement procedures may be performed by entering the gastrointestinal (GI) tract through a first organ or structure, such as the esophagus, stomach, duodenum, small intestine, or large intestine, and delivering the stent to one or more adjacent organs and structures such as the bile duct, the pancreatic duct, the gallbladder, the pancreas, cysts, pseudocysts, abscesses, or the like.SUMMARY
[0004] Some stent deployment techniques can push or pull tissue walls together.
[0005] As discussed herein, a method for stent placement can include manipulating a first tissue wall relative to a second tissue wall by applying suction through a deployment device to grasp the first tissue wall. The method can include deploying a proximal portion of a stent against a proximal side of the suctioned first tissue wall. An opening can be formed through the first tissue wall for example by using radiofrequency (RF) or other energy, allowing advancement of the deployment device. The method can include deploying a distal portion of the stent against a distal side of the second tissue wall.
[0006] The method can include applying suction through the deployment device or a medical scope to grasp the first tissue wall. Manipulation of the first tissue wall can include pushing the first tissue wall toward the second tissue wall. The method can include applying suction to grasp and manipulate (e.g., pulling) the second tissue wall toward the first tissue wall.
[0007] Opening formation in the tissue walls can use an RF electrode located or positioned at a tip (a distal tip) of the deployment device. The method can apply suction to stabilize tissue walls during opening formation and remove fluid to prevent leakage. When stabilizing tissue, the method can grasp the second tissue wall with suction and position it relative to the first tissue wall.
[0008] Deploying the proximal portion can include retracting a sheath to allow expansion of a proximal flange. Deploying the distal portion can include advancing the sheath to allow expansion of a distal flange. The stent can include an anchoring member such as a protrusion on an inner region of a flange that engages tissue. The anchoring member can help to stabilize the flanges against the tissue walls to hold the tissue walls in a desired position or orientation. When deployed, the stent can assume a concave shape.
[0009] A stent deployment system can include a deployment device with an elongate shaft and overlaying sheath. The device can include a suction lumen and RF electrode for tissue penetration. A stent constrained between the shaft and sheath can include a proximal flange, a central portion, and a distal flange.
[0010] The deployment device can include an actuation member with a handle including a coaxial slide member for controlling flange deployment. The handle can include a lock for securing the slide member. The stent can extend circumferentially around the shaft.
[0011] The suction lumen can grasp a tissue wall, stabilize tissue for penetration, and remove fluid during deployment. The sheath can allow independent deployment of the proximal and distal flanges. In some examples, the deployment device can advance through a working channel of a medical scope such as an endoscope. In such anexample, the suction can be provided via the endoscope (or a system connected to the endoscope) as opposed to through the deployment device.
[0012] The disclosed systems and methods may provide several potential advantages. Deploying the proximal flange first can allow lifting of tissue to connect it to a target organ, which can be particularly beneficial with movable organs like the colon or stomach. When the target organ location makes visualization difficult, lifting both the scope and stent can enable bringing them closer to the target until it appears in an image such as an endoscopic image, an ultrasound image, or the like. The suction capability can help stabilize tissue for precise penetration. The suction can aid in preventing fluid leakage, which can reduce the risk of infection particularly when working with fluid-filled organs like the gallbladder. The ability to manipulate tissue walls through suction rather than pushing or pulling tissue with a needle or other end effector can help protect sensitive tissues like the pancreas and biliary ducts.BRIEF DESCRIPTION OF THE DRAWINGS
[0013] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
[0014] FIG. 1A illustrates an example cross-sectional view of a stent deployment device including an elongate shaft, a luminal apposing metal stent (LAMS) encircling the elongate shaft, and a catheter covering the LAMS according to some examples.
[0015] FIG. IB illustrates an example of the stent deployment device of FIG. 1 A with the catheter retracted and a distal flange of the LAMS deployed.
[0016] FIGS. 2A-2F illustrate an example sequence for manipulation of tissue and deployment of a LAMS according to some examples.
[0017] FIG. 3 illustrates an example of a handle assembly for controlling deployment of a LAMS stent according to some examples.
[0018] FIG. 4 illustrates an example method for stent placement in accordance with some examples described herein.
[0019] FIG. 5 shows a schematic diagram of an endoscopy system comprising an imaging and control system and an endoscope.
[0020] FIG. 6 shows a schematic diagram of the endoscopy system of FIG. 5 comprising the endoscope connected to a control unit of the imaging and control system.
[0021] FIG. 7 illustrates and example method for stent placement in accordance with some examples described herein.DETAILED DESCRIPTION
[0022] The disclosed systems and methods relate to appositional stent placement between adjacent body lumens. As used herein, the term "appositional" refers to the ability to manipulate and position tissue walls relative to each other to achieve a desired spatial relationship during stent deployment.
[0023] A stent deployment system can include a luminal apposing metal stent (LAMS) that extends circumferentially around an elongate shaft. The LAMS can include proximal and distal flanges configured to engage opposing tissue walls when deployed. The system can use suction to grasp and manipulate tissue walls into apposition before, during, and after stent deployment.
[0024] The appositional capabilities can help allow for more precise control over the relative positioning of adj acent tissue walls during a medical procedure. This can include pulling a first tissue wall proximally using suction, pushing it toward a second tissue wall, or manipulating the second tissue wall to achieve proper apposition or alignment. The system can help maintain tissue walls in a desired appositional relationship. The system can help in forming openings and deploying the stent flanges.
[0025] FIG. 1A illustrates an example cross-sectional view of a stent deployment device including an elongate shaft, a LAMS encircling the elongate shaft, and a catheter covering the LAMS. The elongate shaft 100 can include a cylindrical configuration that extends along a longitudinal axis of the device. The LAMS 102 cancircumferentially surround and encircle the elongate shaft 100, with the LAMS 102 including a proximal portion or flange positioned toward a proximal side or end of the device and a distal portion or flange positioned toward a distal side or end. A cylindrical sheath or catheter 104 (or similar device) can overlay and cover the LAMS 102, with the catheter 104 being movable relative to the elongate shaft to selectively expose portions of the stent during deployment.
[0026] FIG. IB illustrates an example of the stent deployment device of FIG. 1 A with the catheter retracted and a distal flange of the LAMS deployed. In an example, controlled movement of the catheter 104 can selectively expose portions of the stent for deployment. For example, the catheter 104 can move longitudinally relative to the elongate shaft and LAMS 102 to control deployment of the flanges. In one example, the catheter 104 can be retracted to deploy the distal portion of the LAMS 102 (as illustrated in FIG. IB).
[0027] In another example, movement of a portion of the catheter 104 in a proximal direction (toward the proximal side) can allow the proximal flange of the LAMS 102 to expand radially outward from its constrained configuration. Similarly, movement of another portion of the catheter 104 in a distal direction can permit the distal flange of the LAMS 102 to expand. This controlled movement of the catheter 104 can help enable precise positioning and deployment of the stent between adjacent tissue walls.
[0028] The LAMS 102 can assume a compressed, cylindrical configuration when constrained between the elongate shaft 100 and the catheter 104. When released from this constraint by catheter movement, the proximal and distal portions of the LAMS 102 can expand to engage adjacent tissue walls. The proximal and distal portions can, when deployed, form flanges that extend radially outward from the central longitudinal axis to secure the LAMS 102 in position between the tissue walls.
[0029] FIGS. 2A-2F illustrate an example sequence for manipulation of tissue and deployment of a LAMS. The sequence shows two tissue walls (e.g., apposing walls of tissues from substantially adjacent organs such as the stomach and small intestine) being manipulated with suction during LAMS deployment.
[0030] FIG. 2A shows a first tissue wall 202 and a second tissue wall 204 in an initial position. The deployment device can include the elongate shaft 100 with an RF electrode 200 at its distal end. The device can apply suction through an opening in the tip of the elongate shaft 100 to grasp and stabilize the first tissue wall 202. The guide wire can protrude from the tip of the elongate shaft 100 by passing through the opening. The guide wire can be removed from the elongate shaft 100 so that an efficiency of the applied suction is enhanced. The sheath discussed in FIGS. 1A-1B can be retracted proximally (to the left in FIG. 2 A) to deploy a proximal flange 208 of the LAMS 102, which can include an anchoring protrusion 206 on its inner region to help engage tissue. In an example, multiple anchoring protrusions can be included at multiple locations on the proximal flange 208, such as at each tip of the proximal flange 208. In another example, the deployment device can be advanced through a working channel of a medical scope such as an endoscope, with suction provided through the endoscope rather than the deployment device. The protrusions 206 can be made of in the manufacturing process of making LAMS, or added on the inner region of proximal flange 208 or distal flange 210 alternatively. The protrusions 206 can be, for example, part of wire protruding from a surface of the stent or a particle. The protrusions 206 can make a vacuum between the proximal flange 208 to enhance the strength of suctioning the first tissue wall 202 to the opening of the elongate shaft 100.
[0031] FIG. 2B illustrates the first tissue wall 202 being pushed toward the second tissue wall 204. Suction through the opening in the tip of the elongate shaft 100 helps maintain contact between the first tissue wall 202 and the deployment device. Using suction to manipulate the first tissue wall 202 with respect to the second tissue wall 204 can allow the RF electrode 200 to remain positioned for precise alignment of the first tissue wall 202 with respect to the second tissue wall 204 and for precise penetration of the first tissue wall 202 by the RF electrode 200. In an example, the suction capability can be used to help prevent fluid leakage during the procedure.
[0032] FIG. 2C illustrates the deployment device positioned between the first tissue wall 202 and the second tissue wall 204 after penetrating through the first tissue wall 202. Because the first tissue wall 202 is pulled proximally by the suctioning through the opening in the tip of the elongate shaft 100, this positioning can create spacebetween the two tissue walls (first tissue wall 202 and second tissue wall 204), which can help prevent the deployment device from accidentally piercing the second tissue wall 204. The deployment device can remain in this intermediate position to allow precise positioning and alignment of the RF electrode 200 with respect to the second tissue wall 204 before forming an opening through the second tissue wall 204. The proximal flange 208 can maintain control of the first tissue wall 202 during this positioning phase, for example by using the anchoring protrusion 206 on the proximal flange 208. This controlled positioning can enable the user to accurately target a desired location on the second tissue wall 204. The suction capability helps maintain tissue stabilization and prevent fluid leakage.
[0033] FIG. 2D depicts the RF electrode 200 positioned against the second tissue wall 204 in preparation for forming an opening through the second tissue wall 204. With the deployment device positioned between the first tissue wall 202 and the second tissue wall 204, the RF electrode 200 can be aligned and placed against a target location on the second tissue wall 204. The proximal flange 208 can maintain control of the first tissue wall 202 during this positioning, for example by using the anchoring protrusion 206 on the proximal flange 208. The suction capability can help stabilize both tissue walls and maintain the position of the deployment device. Once positioned, the RF electrode 200 can be energized with radio frequency energy to cut and / or cauterize tissue, enabling controlled penetration through the second tissue wall 204. The energized RF electrode 200 can help with controlling bleeding through cauterization of blood vessels at the penetration site.
[0034] When working with sensitive tissues like the pancreas, the ability to manipulate tissue through suction rather than pushing or pulling with a needle or a forceps can help protect the tissue. The suction can be maintained with the first tissue wall during device advancement through several mechanisms. The suction can be applied through a separate lumen from the RF electrode 200, allowing continued tissue engagement while the electrode penetrates the tissue wall. In an example, the catheter 104 can be configured to provide suction at multiple locations, such as at the tip or circumference, and can be radially or transversely directed to maintain the fixed relationship with the tissue. The deployed proximal flange can contribute to maintaining tissue control andposition during device advancement through the first wall opening. This multi-point engagement system can help the device to retain tissue stabilization and positioning while advancing through the penetrated tissue wall.
[0035] FIG. 2E shows a deployment configuration with both tissue walls secured. The proximal flange 208 can engage the first tissue wall 202. The distal flange 210 extends radially to secure the second tissue wall 204. In an example, when deployed, the LAMS 102 can assume a concave shape that can help maintain tissue apposition. The suction through the elongate shaft tip can remove fluid during the procedure to prevent leakage between the tissue walls. FIG. 2F illustrates the final deployed state of the stent with both the proximal flange 208 and the distal flange 210 securing the first tissue wall 202 and the second tissue wall 204, with the deployment device and endoscope removed, leaving the deployed stent to maintain the connection between the tissue structures.
[0036] The catheter 104 can be configured to deploy the proximal flange 208 first by retracting the catheter 104, which can allow lifting of tissue to connect it to a target organ. This approach can be particularly beneficial with movable organs like the colon or stomach, as it enables bringing the deployment device and LAMS 102 closer to the target organ until it appears in an image (e.g., an endoscopic image or an ultrasound image). The distal flange 210 can then be deployed by advancing the catheter 104. In some examples, the distal flange 210 can be deployed first by advancing at least a portion of the catheter 104, followed by deploying the proximal flange 208 by retracting at least a portion of the catheter 104. In other examples, the flanges can be deployed simultaneously or substantially simultaneously.
[0037] FIG. 3 illustrates an example of a handle assembly (actuation member) for controlling deployment of a LAMS. The handle assembly can help provide precise control over the deployment sequence discussed in FIGS. 2A-2C. The handle 300 can be attached to the catheter 104 with the catheter 104 extending distally from the body of the handle 300. The handle 300 can include at least one coaxial slide member (slide member 302) configured to control movement of portions of the catheter 104 for deploying the proximal flange 208 and distal flange 210 of the LAMS 102.
[0038] The handle 300 can include a lock 304 for securing the slide member 302 in position during deployment. The lock 304 can help maintain the position of the catheter 104 after retracting a portion of the catheter 104 to deploy the proximal flange 208 and before advancing a portion of the catheter 104 to deploy the distal flange 210.
[0039] In an example, the catheter 104 can include multiple portions configured to move independently relative to each other. For example, a first portion of the catheter 104 can be retracted proximally using the slide member 302 to allow expansion of the proximal flange 208. A second portion can be advanced distally to allow expansion of the distal flange 210. This independent movement capability can enable sequential deployment of the flanges. In one example, retracting a portion of the catheter 104 using the slide member 302 can deploy the proximal flange 208. The lock 304 can secure this position while manipulating tissue. Subsequently, advancing another portion of the catheter 104 can deploy the distal flange 210. It is understood that the handle 300 may include multiple slide members and locks as appropriate, which can be used when deploying the flanges of the LAMS 102.
[0040] FIG. 4 illustrates an example method 400 for stent placement. The method can include or comprise a number of Operations. The Operations described herein are examples only, and the method can omit one or more of the listed Operations, can repeat Operations, or can include other Operations. The Operations can be executed concurrently, substantially simultaneously, or in another order as appropriate or desired.
[0041] At Operation 402, the method 400 can include manipulating a first tissue wall relative to a second tissue wall. The tissue walls can be walls from adjacent or apposing organs, such as the stomach and small intestine, pancreas and small bowel, or bile duct and duodenum. The manipulation can include applying suction through an opening in the tip of a stent deployment device to grasp and stabilize the first tissue wall. Alternatively suction can be applied through an endoscope working channel or using another external suction member. The manipulation can include pushing the first tissue wall toward the second tissue wall while maintaining suction contact with the first tissue wall.
[0042] The method can include forming openings through the tissue walls using an RF electrode located at a tip (e.g., a distal tip) of the stent deployment device. The RF electrode can form a first opening through the first tissue wall 202. Suction can stabilize the tissue to enable precise penetration. The deployment device can advance through the first opening toward the second tissue wall. Suction can be used to grasp and manipulate the second tissue wall, positioning it relative to the first tissue wall (e.g., aligning a portion of the second tissue wall relative to the first tissue wall). The RF electrode 200 can then be used to form a second opening through the second tissue wall 204.
[0043] At Operation 404, the method 400 can include manipulating the first tissue wall including applying suction to the first tissue wall toward the stent deployment device located proximal to the first tissue wall. The suction can create adherence between the first tissue wall and the suction outlet of the deployment device, enabling precise control and positioning of the first tissue wall relative to the second tissue wall.
[0044] At Operation 406, the method 400 can include deploying a proximal portion or proximal flange of a stent (e.g., a luminal apposing metal stent (LAMS)) against a proximal side of the suctioned first tissue wall. The deployment can include retracting a sheath, a catheter, or the like, to allow expansion of the proximal flange. The proximal flange can include an anchoring member such as a protrusion on its inner region to help engage the first tissue wall.
[0045] At Operation 408, the method 400 can include forming a first opening through the first tissue wall using an RF electrode located at a tip (e.g., a distal tip) of the stent deployment device. The RF electrode can form the first opening through the first tissue wall. Suction stabilizes the tissue to enable precise penetration. The RF electrode can be energized with radio frequency energy to cut or cauterize tissue, enabling controlled penetration through the first tissue wall.
[0046] At Operation 410, the method 400 can include advancing the stent deployment device through the first opening toward the second tissue wall. The proximal flange can maintain control of the first tissue wall during advancement of the deployment device, for example by using the anchoring protrusion on the proximal flange. Theadvancement can position the deployment device between the first tissue wall and the second tissue wall.
[0047] At Operation 412, the method 400 can include manipulating the second tissue wall, including applying suction through at least one of the stent deployment device or a scope to grasp the second tissue wall. Suction can be used to grasp and manipulate the second tissue wall, positioning it relative to the first tissue wall (e.g., aligning a portion of the second tissue wall relative to the first tissue wall). The RF electrode can then be used to form a second opening through the second tissue wall.
[0048] At Operation 414, the method 400 can include deploying a distal portion or flange of the stent against a distal side of the second tissue wall. The deployment can include advancing the catheter to allow expansion of the distal flange. The method can optionally include using the suction to remove fluid and prevent leakage during opening formation.
[0049] FIGs 5 and 6 show an example of an endoscopy system. FIG. 5 is an example of a schematic diagram of endoscopy system 500, and FIG. 6 is an example of a schematic diagram of the endoscopy system 500 including the endoscope connected to a control unit of the imaging and control system. The endoscopy system 10 can include an imaging and control system 12 and an endoscope 14. The system of FIGs 5 and 6 is an illustrative example of an endoscopy system suitable for use with the systems, devices and methods described herein. According to some examples, endoscope 14 can be insertable into an anatomical region for imaging and / or to provide passage of one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region. Endoscope 14 can, in advantageous aspects, interface with and connect to imaging and control system 12. In the illustrated example, endoscope 14 comprises a duodenoscope, though other types of endoscopes can be used with the features and teachings of the present disclosure.
[0050] Imaging and control system 12 can comprise controller 16, output unit 18, input unit 20, light source 22, fluid source 24, and suction pump 26.
[0051] Imaging and control system 12 can include various ports for coupling with endoscopy system 10. For example, controller 16 can include a data input / output port for receiving data from and communicating data to endoscope 14. Light source 22 can include an output port for transmitting light to endoscope 14, such as via a fiber optic link. Fluid source 24 can include a port for transmitting fluid to endoscope 14. Fluid source 24 can comprise a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. Suction pump 26 can comprise a port used to draw a vacuum from endoscope 14 to generate suction, such as for withdrawing fluid from the anatomical region into which endoscope 14 is inserted. Output unit 18 and input unit 20 can be used by an operator of endoscopy system 10 to control functions of endoscopy system 10 and view output of endoscope 14. Controller 16 can be used to generate signals or other outputs from treating the anatomical region into which endoscope 14 is inserted. In examples, controller 16 can generate electrical output, acoustic output, a fluid output and the like for treating the anatomical region with, for example, cauterizing, cutting, freezing and the like.
[0052] Endoscope 14 can comprise insertion section 28, functional section 30 and handle section 32, which can be coupled to cable section 34 and coupler section 36.
[0053] Insertion section 28 can extend distally from handle section 32 and cable section 34 can extend proximally from handle section 32. Insertion section 28 can be elongate and include a bending section, and a distal end to which functional section 30 can be attached. The bending section can be controllable (e.g., by control knob 38 on handle section 32) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, etc.). Insertion section 28 can include one or more working channels (e.g., an internal lumen) that can be elongate and support insertion of one or more therapeutic tools of functional section 30. The working channel can extend between handle section 32 and functional section 30. fluid passages, guide wires, and pull wires can be provided by insertion section 28 (e.g., via suction or irrigation passageways, and the like).
[0054] Handle section 32 can comprise knob 38 as well as ports 40. Knob 38 can be coupled to a pull wire extending through insertion section 28. Ports 40 can beconfigured to couple various electrical cables, fluid tubes and the like to handle section 32 for coupling with insertion section 28. In examples, port 40 can be used to feed an auxiliary catheter, such as a sphincterotome or cannula, into insertion section 28.
[0055] Imaging and control system 12, according to examples, can be provided on a mobile platform (e.g., cart 41) with shelves for housing light source 22, suction pump 26, image processing unit 42, etc. Alternatively, several components of imaging and control system 12 shown in FIGS. 5 and 6 can be provided directly on endoscope 14 so as to make the endoscope “self-contained.”
[0056] Functional section 30 can comprise components for treating and diagnosing anatomy of a patient. Functional section 30 can comprise an imaging device, an illumination device and an elevator, as is described further below.
[0057] As shown in FIG. 6, the imaging and control system 12 can comprise controller 16, which can include or be coupled to image processing unit 42, treatment generator 44 and drive unit 46, as well as light source 22, input unit 20 and output unit 18.
[0058] Image processing unit 42 and light source 22 can each interface with endoscope 14 (e.g., at functional unit 30) by wired or wireless electrical connections. Imaging and control system 12 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on display unit 18. Imaging and control system 12 can include light source 22 to illuminate the anatomical region using light of desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). Imaging and control system 12 can connect (e.g., via an endoscope connector) to endoscope 14 for signal transmission (e.g., light output from light source, video signals from imaging system in the distal end, diagnostic and sensor signals, and the like).
[0059] Fluid source 24 can comprise one or more sources of air, saline or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (barb fittings, fluid seals, valves and the like). Imaging and control system 12 can include drive unit 46, which can be an optional component.Drive unit 46 can comprise a motorized drive for advancing a distal section of endoscope 14.
[0060] FIG. 7 illustrates an example method 700 for controlling a catheter during stent deployment. The method can include or comprise a number of Operations. The Operations described herein are examples only, and the method can omit one or more of the listed Operations, can repeat Operations, or can include other Operations. The Operations can be executed concurrently, substantially simultaneously, or in another order as appropriate or desired.
[0061] At Operation 702, the method 700 can include turning on a suctioning function to pull a first target proximally toward the catheter. The suctioning function can be activated through an opening in the tip of the catheter or deployment device to grasp and stabilize a first tissue wall. The suction can create adherence between the first tissue wall and the catheter, enabling precise control and positioning.
[0062] At Operation 704, the method 700 can include turning on a cauterizing function to poke a first hole through a portion of the first target. The cauterizing function can include energizing an RF electrode located at a tip of the catheter with radio frequency energy to cut and / or cauterize tissue. The RF energy application can provide precise tissue cutting. The RF energy application can aid in controlling bleeding through cauterization of blood vessels at the penetration site.
[0063] At Operation 706, the method 700 can include retracting a sheath to allow expansion of a proximal flange of a stent. The retraction can enable the proximal flange to expand and engage the first tissue wall. The proximal flange can include an anchoring member such as a protrusion on its inner region to help engage and secure the first tissue wall.
[0064] At Operation 708, the method 700 can include turning on the suctioning function to pull a second target proximally toward the catheter. With the catheter advanced through the first hole, suction can be applied to grasp and stabilize a second tissue wall. The suction can position the second tissue wall relative to the first tissue wall and the deployed proximal flange.
[0065] At Operation 710, the method 700 can include turning on the cauterizing function to poke a second hole through a portion of the second target. The RF electrode can be energized to form an opening through the second tissue wall. Suction stabilizes the tissue to enable precise penetration. The cauterizing function can provide controlled tissue cutting and hemostasis at the second penetration site.
[0066] At Operation 712, the method 700 can include advancing the sheath to allow expansion of a distal flange of the stent. The advancement can enable the distal flange to expand against the second tissue wall, securing both tissue walls between the proximal and distal flanges to complete the stent deployment.ADDITIONAL NOTES & EXAMPLES
[0067] Example l is a stent deployment device comprising: an elongate shaft; a sheath overlaying the elongate shaft; at least one suction lumen extending through the stent deployment device; at least one radio frequency electrode for tissue penetration; and a stent constrained between the elongate shaft and sheath, the stent comprising: a proximal flange; a central portion; and a distal flange.
[0068] In Example 2, the subject matter of Example 1 optionally includes subject matter wherein the stent deployment device includes an actuation member for controlling deployment of at least one of the proximal flange or the distal flange.
[0069] In Example 3, the subject matter of Example 2 optionally includes subject matter wherein the actuation member includes a handle including at least one coaxial slide member.
[0070] In Example 4, the subject matter of Example 3 optionally includes subject matter wherein the handle comprises at least one lock for securing the at least one coaxial slide member.
[0071] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include subject matter wherein the stent extends in a circumferential direction around the elongate shaft.
[0072] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include subject matter wherein the at least one suction lumen is configured to: permit suction to be applied to at least one tissue wall; stabilize tissue for penetration; and remove at least one fluid during deployment.
[0073] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include subject matter wherein the sheath is retractable and configured to allow independent deployment of the proximal flange and the distal flange.
[0074] In Example 8, the subject matter of any one or more of Examples 1-7 optionally include subject matter wherein the stent deployment device is configured to be advanced through a working channel of an endoscope.
[0075] In Example 9, the subject matter of any one or more of Examples 1-8 optionally include subject matter wherein the at least one radio frequency electrode is configured to form at least one opening in at least one tissue wall stabilized by suction.
[0076] In Example 10, the subject matter of any one or more of Examples 1-9 optionally include subject matter wherein the stent comprises at least one protrusion on an inner region of at least one flange.
[0077] Example 11 is a method for stent placement, the method comprising: applying suction to a first tissue wall with a suction outlet to adhere the first tissue wall to the suction outlet; manipulating the first tissue wall relative to a second tissue wall using the suction outlet, deploying at least one of a proximal portion or a distal portion of a stent with a stent deployment device; and deploying at least another of the distal portion or the proximal portion of the stent.
[0078] In Example 12, the subject matter of Example 11 optionally includes subject matter wherein manipulating the first tissue wall includes applying the suction through at least one of the stent deployment device or a medical scope to grasp the first tissue wall.
[0079] In Example 13, the subject matter of any one or more of Examples 11-12 optionally include subject matter wherein manipulating the first tissue wall includes pushing the first tissue wall toward the second tissue wall.
[0080] In Example 14, the subject matter of any one or more of Examples 11-13 optionally include forming a first opening through the first tissue wall; advancing the stent deployment device through the first opening; manipulating the second tissue wall, including applying suction through at least one of the stent deployment device or a scope to grasp the second tissue wall; forming a second opening through the second tissue wall; and advancing the stent deployment device through the second opening.
[0081] In Example 15, the subject matter of Example 14 optionally includes subject matter wherein forming at least one of the first opening or the second opening includes activating at least one RF electrode.
[0082] In Example 16, the subject matter of any one or more of Examples 11-15 optionally include applying suction through the stent deployment device to at least one of: i) stabilize at least one of the first tissue wall or the second tissue wall during formation of at least one opening, or ii) remove fluid to prevent leakage during formation of at least one of the first opening or the second opening.
[0083] In Example 17, the subject matter of Example 16 optionally includes wherein applying suction through the stent deployment device to stabilize at least one of the first tissue wall or the second tissue wall during formation of at least one opening includes: applying suction through the stent deployment device to grasp the second tissue wall; and positioning the suctioned second tissue wall relative to the first tissue wall.
[0084] In Example 18, the subject matter of any one or more of Examples 11-17 optionally include subject matter wherein deploying the proximal portion includes retracting a sheath to allow expansion of a proximal flange, and wherein deploying the distal portion comprises advancing the sheath to allow expansion of a distal flange.
[0085] In Example 19, the subject matter of any one or more of Examples 11-18 optionally include subject matter wherein the stent includes at least one protrusion on an inner region of at least one flange that engages tissue.
[0086] In Example 20, the subject matter of any one or more of Examples 11-19 optionally include subject matter wherein the stent assumes a concave shape when deployed.
[0087] Example 21 is a method for controlling a catheter, where a stent with a proximal flange and distal flange is constrained by a sheath, with a function of suctioning and a function of cauterizing, the method comprising: turning the function of suctioning on to pull a first target proximally where the catheter is located; turning the function of cauterizing on to create a first hole in the first target; retracting the sheath to allow expansion of the proximal flange; turning the function of suctioning on again to pull a second target proximally which positions distally from the first target and the catheter; turning the function of cauterizing on again to poke a second hole in the second target; and advancing the sheath to allow expansion of the distal flange.
[0088] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. Examples in which those elements shown or described can be implemented. Moreover, examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein can be implemented.
[0089] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
[0090] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the embodiments should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
CLAIMSWhat is claimed is:
1. A stent deployment device comprising:an elongate shaft;a sheath overlaying the elongate shaft;at least one suction lumen extending through the stent deployment device;at least one radio frequency electrode for tissue penetration; and a stent constrained between the elongate shaft and sheath, the stent comprising:a proximal flange;a central portion; anda distal flange.
2. The stent deployment device of claim 1, wherein the stent deployment device includes an actuation member for controlling deployment of at least one of the proximal flange or the distal flange.
3. The stent deployment device of claim 2, wherein the actuation member includes a handle including at least one coaxial slide member.
4. The stent deployment device of claim 3, wherein the handle comprises at least one lock for securing the at least one coaxial slide member.
5. The stent deployment device of claim 1, wherein the stent extends in a circumferential direction around the elongate shaft.
6. The stent deployment device of claim 1, wherein the at least one suction lumen is configured to:permit suction to be applied to at least one tissue wall;stabilize tissue for penetration; andremove at least one fluid during deployment.
7. The stent deployment device of claim 1, wherein the sheath is retractable and configured to allow independent deployment of the proximal flange and the distal flange.
8. The stent deployment device of claim 1, wherein the stent deployment device is configured to be advanced through a working channel of an endoscope.
9. The stent deployment device of claim 1, wherein the at least one radio frequency electrode is configured to form at least one opening in at least one tissue wall stabilized by suction.
10. The stent deployment device of claim 1, wherein the stent comprises at least one protrusion on an inner region of at least one flange.
11. A method for stent placement, the method comprising:applying suction to a first tissue wall with a suction outlet to adhere the first tissue wall to the suction outlet;manipulating the first tissue wall relative to a second tissue wall using the suction outlet,deploying at least one of a proximal portion or a distal portion_of a stent with a stent deployment device; anddeploying at least another of the distal portion or the proximal portion of the stent.
12. The method for stent placement of claim 11, wherein manipulating the first tissue wall includes applying the suction through at least one of the stent deployment device or a medical scope to grasp the first tissue wall.
13. The method for stent placement of claim 11, wherein manipulating the first tissue wall includes pushing the first tissue wall toward the second tissue wall.
14. The method for stent placement of claim 11, comprising:forming a first opening through the first tissue wall;advancing the stent deployment device through the first opening; manipulating the second tissue wall, including applying suction through at least one of the stent deployment device or a scope to grasp the second tissue wall;forming a second opening through the second tissue wall; and advancing the stent deployment device through the second opening.
15. The method for stent placement of claim 14, wherein forming at least one of the first opening or the second opening includes activating at least one RF electrode.
16. The method for stent placement of claim 11, further comprising:applying suction through the stent deployment device to at least one of: i) stabilize at least one of the first tissue wall or the second tissue wall during formation of at least one opening, or ii) remove fluid to prevent leakage during formation of at least one of the first opening or the second opening.
17. The method for stent placement of claim 16, wherein applying suction through the stent deployment device to stabilize at least one of the first tissue wall or the second tissue wall during formation of at least one opening includes:applying suction through the stent deployment device to grasp the second tissue wall; andpositioning the suctioned second tissue wall relative to the first tissue wall.
18. The method for stent placement of claim 11, wherein deploying the proximal portion includes retracting a sheath to allow expansion of a proximal flange, and wherein deploying the distal portion comprises advancing the sheath to allow expansion of a distal flange.
19. The method for stent placement of claim 11, wherein the stent includes at least one protrusion on an inner region of at least one flange that engages tissue.
20. The method for stent placement of claim 11, wherein the stent assumes a concave shape when deployed.
21. A method for controlling a catheter, where a stent with a proximal flange and distal flange is constrained by a sheath, with a function of suctioning and a function of cauterizing, the method comprising:turning the function of suctioning on to pull a first target proximally where the catheter is located;turning the function of cauterizing on to create a first hole in the first target;retracting the sheath to allow expansion of the proximal flange; turning the function of suctioning on again to pull a second target proximally which positions distally from the first target and the catheter;turning the function of cauterizing on again to poke a second hole in the second target; andadvancing the sheath to allow expansion of the distal flange.