Stent delivery systems, medical device systems and systems

Abstract

To provide systems of allowing a distal portion of a catheter to be visualized within a body using a colored marker and one or more secondary markers.SOLUTION: The present disclosure relates to the field of endoscopy. Specifically, the present disclosure relates to systems of allowing a distal portion of a catheter to be visualized within a body using a colored marker and one or more secondary markers. In particular, the present disclosure relates to systems which indicate when a medical device is properly positioned for deployment within a body lumen.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to the field of endoscopy. Specifically, the present disclosure relates to a system and method that enable visualization of the tip portion of a catheter within the body using a color marker and one or more secondary markers.

Background Art

[0002] Medical devices such as stents are frequently used to create and / or maintain conduits between adjacent body lumens or cavities. For example, a drainage stent is used to drain the contents of a pancreatic pseudocyst, gallbladder, or bile duct into the stomach or duodenum. Placing a drainage stent within the body using ultrasound generally involves a two-step procedure where a catheter carrying the stent is inserted through the wall of a first body lumen (e.g., the gastrointestinal tract) under ultrasound guidance to an adjacent lumen (e.g., a pseudocyst) where a tip holding member is deployed. Thereafter, the catheter is retracted to deploy a proximal holding member within the gastrointestinal (GI) tract. A medical professional confirms that the catheter has been sufficiently retracted by switching to an endoscopic visualization mode that enables direct visualization of the catheter and the gastrointestinal wall. For example, the appearance of a color marker on the tip portion of the catheter within the first body lumen indicates that the catheter has been sufficiently retracted to enable proper deployment of the proximal holding member within the gastrointestinal tract. However, depending on various circumstances, the proximal holding member may be deployed within an incorrect anatomical location

[0003] Sometimes it can get lost. Medical professionals use ultrasound visualization mode to determine the stent's position. Making the wrong decision, forgetting to switch to endoscopic viewing mode, and accidentally or prematurely preserving the basal end To release the retaining member and / or to allow viscous or cloudy fluid to pass through the drainage stent The flow of opaque fluids (such as bile) can make it difficult to visualize color markers. An improperly deployed drainage stent can cause problems, for example, from within a pseudocyst or gastrointestinal tract. Retrieval from the body cavity outside the tube may be difficult, and / or the next stent may need to be placed. If necessary, the treatment will be prolonged, a second treatment will be required, and further additional time, effort, and This incurs additional costs and likely adds further risks to the patient. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] Special Publication No. 2015-518741 [Patent Document 2] U.S. Patent Application Publication No. 2012 / 0221093 [Patent Document 3] Special Publication No. 2000-511444 [Patent Document 4] U.S. Patent Application Publication No. 2008 / 0183272 [Patent Document 5] Special Publication No. 2011-512994 [Patent Document 6] Special Publication No. 2007-500554 [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] Therefore, to indicate the location of the medical device within the patient's body, color markers and one or more A delivery system that allows visualization of the catheter tip using a secondary marker, and Depending on the method, various advantages can be obtained. [Means for solving the problem]

[0006] This disclosure, in various aspects, shows that medical devices are appropriate in the medical field, such as in endoscopic examinations. To indicate the point in time when it is positioned for deployment, the tip of the catheter can be moved inside the body. This brings the advantages of systems and methods that enable visualization.

[0007] In one embodiment, the disclosure includes a base portion, a tip portion, and a lumen extending between them. Regarding the system, including the catheter. The tip of the catheter has a main marker and less Each may contain one sub-marker. At least one sub-marker may be located within the main marker. At least one secondary marker, once loaded into the catheter, is positioned approximately midway along the medical device. It may be placed on or inside the tip portion of the corresponding catheter. When loaded into the catheter, the tip of the catheter corresponds to approximately the tip of the medical device. It may be placed on or inside the catheter. At least one secondary marker is on the outer circumference of the catheter. It may include multiple sub-markers placed on it. The main marker may include a color marker. At least 1 One of the sub-markers may contain an echogenic material. At least one sub-marker may contain a light sensor. It is visible.

[0008] In another aspect, the disclosure includes a base portion, a tip portion, and a lumen extending between them. The system includes a catheter. The tip of the catheter has a main marker and a small It may include at least one secondary marker. The inner catheter slides within the catheter lumen. It can be arranged in a formula, and the medical device can be arranged above the tip portion of the inner catheter. At least one secondary marker can be arranged within the primary marker. At least one secondary marker can be arranged on or within the tip portion of the catheter corresponding to the approximate midpoint of the medical device. At least one secondary marker can be arranged on or within the tip portion of the catheter corresponding to the approximate tip of the medical device. At least one secondary marker can include a plurality of secondary markers arranged on the outer circumference of the catheter. The primary marker can include a color marker. At least one secondary marker can include a light sensor. At least one secondary marker can include an echo - genic substance. The medical device can include a self - expanding stent configured to transition between a first configuration when disposed within the catheter lumen and a second expanded configuration when not disposed within the catheter lumen. The system can further include a handle attached to the proximal end of the catheter and the proximal end of the inner catheter, the handle including a first lock configured to releasably engage the inner catheter and a second lock configured to releasably engage the catheter. The catheter can move proximally relative to the inner catheter when the first lock is engaged and the second lock is disengaged. The catheter and the inner catheter can be immobilized relative to each other when the first and second locks are engaged. In another aspect, the present disclosure relates to a method including advancing a delivery system through a body passage to a first lumen, where the delivery system includes a primary marker and at least one secondary marker.

[0009] In another aspect, the present disclosure relates to a method including advancing a delivery system through a body passage to a first lumen, where the delivery system includes a primary marker and at least one [[ID=3�]] secondary marker. Includes a catheter with a tip portion including a secondary marker, and a medical device placed inside the catheter. It can be seen. The method further involves using ultrasound to image the second body adjacent to the first tubular body. This involves advancing the catheter through the wall of the first tubular body into the second part of the body, and the second part To deploy the tip-holding member of the medical device inside the body, and to retract the delivery system towards the proximal end, At least a portion of the color marker located on the tip of the catheter is positioned within the first lumen. This includes, and deploying the proximal end retaining member of the medical device inside the first tubular body. It can be seen. The method further involves deploying at least one of the second body before deploying the tip-holding member. The method may further include imaging a secondary marker before deploying the base-end retaining member. This may include imaging at least one secondary marker within a single tubular lumen.

[0010] Examples of the non-limiting nature of this disclosure are described with reference to the accompanying drawings, which are schematic and The figures are not shown to scale. In the drawings, each figure is either identical or nearly identical to the one shown. Components are generally represented by a single symbol. For clarity, in all drawings... Not all components are denoted by reference numerals, nor are all components of each embodiment of the illustrated disclosure shown in the diagrams. However, this is not necessary to enable a person skilled in the art to understand this disclosure. [Brief explanation of the drawing]

[0011] [Figure 1] A schematic diagram of a stent delivery system according to one embodiment of this disclosure is provided. [Figure 2] This disclosure provides a schematic diagram of a stent partially deployed from a stent delivery system according to one embodiment of this disclosure. [Figure 3]This disclosure provides a schematic diagram of a fully deployed stent from a stent delivery system according to one embodiment of this disclosure. [Figure 4] A schematic diagram of a stent delivery system according to another embodiment of the present disclosure is provided. [Figure 5A] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5B] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5C] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5D] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5E] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5F] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5G] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 5H] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 6A] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 6B] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 6C] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Figure 6D] This invention illustrates the steps involved in the deployment of a stent using a stent delivery system according to one embodiment of this disclosure. [Modes for carrying out the invention]

[0012] The drawings shall show only typical or exemplary embodiments of the present disclosure. The drawings do not limit the scope of this disclosure. This disclosure refers to the attached drawings as described herein. It will be explained in more detail.

[0013] Before providing further details about this disclosure, please note that this disclosure is subject to change. This specification is not limited to any particular embodiment. The terminology used herein does not describe any particular embodiment. This is for clarification purposes only and is not intended to limit the scope beyond the attached claims. This does not mean that. Unless otherwise defined, all technical terms used herein are defined in this publication. The meaning of "indication" is the same as that generally understood by those skilled in the art. Finally, this opening The embodiments shown will be described with particular reference to the deployment of a drainage stent between adjacent body tubular lumens. However, the systems and methods disclosed herein include, but are not limited to, stents. It can be used to position various medical devices within various anatomical locations.

[0014] In this specification, the singular forms "a," "an," and "th" are used. e) Unless otherwise explicitly indicated by the context, this includes the plural form. The terms "comprises" and / or "comprising" , or "includes" and / or "including" It identifies the presence of the described features, regions, steps, elements and / or components, but 1 One or more other features, regions, integers, steps, actions, elements and / or components and / This does not exclude the existence or addition of those groups.

[0015] In this specification, the term "distal" refers to the point when a device is introduced into a patient's body. The term "proximal" refers to the end furthest from a medical professional. This refers to the end of a device that is closest to the medical professional when it is being introduced into the patient's body.

[0016] This disclosure generally uses color markers and one to indicate the location of a medical device within a patient's body. The above secondary markers are used to enable visualization of the catheter tip in the delivery system. Provides a method and a method.

[0017] Referring to Figure 1, in one embodiment, the present disclosure includes a base portion (not shown) and a tip portion 112 A delivery system including a catheter 110 having a lumen 116 extending between them. The TEM 100 is provided. The tip portion 114 of the catheter 110 is a main marker, for example, a color area. This includes, and this is different in color from the rest of the catheter. As a non-limiting example, the catheter The tip portion 114 of the tel 110 includes a dark color (e.g., black), and the remaining catheter The part that is illuminated by the light source has a light color (for example, white) that contrasts with the dark color. Includes. The main markers are the anatomical location and / or the thickness of the body wall of one or more target body lumens. Depending on the circumstances, it extends along the tip portion 114 of the catheter at various distances (for example, approximately (10mm or more, approximately 20mm or more, approximately 30mm or more). Catheter 110 also has a tip. As part of the main marker on the tip portion, or located on or within portion 114 Separately from that, one of the following includes at least one sub-marker 118. For example, multiple The sub-markers 118 are arranged (uniformly or unevenly) around the outer circumference of the tip portion. -CA 118 is suitable for injection molding and / or adhesive glues, resins, etc., as known in the art. Even if it is embedded in the outer surface of the tip portion 114 using oil or epoxy, it will adhere to it. The tip portion 114 of the catheter 110 may be formed separately or integrally therewith. The arrangement configuration of the secondary markers 118 around them is not limited to the embodiment shown in Figure 1, and various different configurations are possible. More or fewer sub-margins arranged in shape, position, configuration and / or orientation It may include multiple sub-markers. For example, multiple sub-markers may be in one or more uniformly or unevenly spaced columns. Alternatively, it is positioned around the circumference and / or length of the catheter within the band. In one embodiment, At least one sub-marker is a light sensor configured to transmit a signal to an external receiver. This includes (for example, photodiodes).

[0018] Furthermore, referring to Figure 1, the delivery system 100 also has within the lumen 116, The inner catheter 120 is slidably positioned relative to the catheter 110. The medical device 130 is located inside the lumen 116, above the tip portion 124 of the inner catheter 120. It is positioned to cover the side. In one embodiment, the medical device 130 is positioned over the lume of the catheter 110. The first (e.g., contracted) configuration when placed (e.g., constrained) within n116 and between the second (e.g., extended) configuration when not positioned within Lumen 116 This is a stent configured to move the inner catheter 120. Furthermore, tissue cutting to penetrate one or more walls of the first tubular body and the second body. Includes cross-section 126 (e.g., pointed surface, electrocautered surface, etc.).

[0019] The delivery system 100 further includes the catheter 110 and the inner catheter 120. Each base end (not shown) includes a handle (not shown) connected to it. The handle is A first lock configured to secure the inner catheter 120, and the inner catheter A second rod configured to fix the catheter 110 along / above the tel 120 Includes a lock. With the first and second locks engaged, the catheter 110 is endoscopically accessible. The endoscope is inserted through the working channel, and the handle is fixed to the proximal end of the endoscope. Ensure that neither the inner catheter 120 nor the catheter 110 can move. The second lock is not released, and by releasing the first lock, the inner catheter Move the tel 120 and catheter 110 together through the endoscopic working channel. This makes it possible to do so (Figures 2-3). The first lock does not disengage, and the second lock By disengaging, the catheter 110 is moved to an immobile (e.g., locked) position. Retract the stent 130 along / above the inner catheter 120 towards the proximal end. The tip and base portions 134 and 132 can be released sequentially.

[0020] In one embodiment, at least one sub-marker 118 is wireless, or the length of the catheter It transmits signals to an external receiver via embedded circuit components that extend along the curve. It includes an optical sensor configured to receive appropriate signals from one or more sub-markers 118. The external receiver then disengages the second lock (but does not disengage the first lock). Referring to Figure 2, as an example, with the second lock disengaged (the first lock is (Not disengaged), catheter 110 is along the inner catheter 120 / The tip portion 134 of the stent is retracted towards the proximal end across the upper side, and the catheter 11 It exits from the 0 lumen 116 (for example, unrestrained) and forms the tip holding member 135. Referring to Figure 3, the catheter 110 is further retracted towards the proximal end, forming a stent. The proximal end portion 132 exits the lumen 116 of the catheter 110, and the proximal end holding member 133 To form.

[0021] The stents of the systems described herein are not limited to any particular configuration or design. In one embodiment, the stent is self-expanding, and the tip portion 134 of the stent extends radially. Expanded to form the tip retaining member 135 of the second configuration, and the base end portion 132 of the stent The tip expands radially to form the base end retaining member 133 of the second configuration. In the second configuration, the length of the stent between the 134 and the proximal portion 132 becomes shorter. This allows the first tubular body and the second body to be positioned side by side between the retaining members. The stent interface is presented. The diameter increases in the second configuration (below the diameter of the tip and base retaining members 133, 135) ), defining lumen 136, which is formed by juxtaposing the second body and the first tubular body. It provides a flow path for fluids and substances between walls.

[0022] Referring to Figure 4, in one embodiment, at least one sub-marker 118 is a catheter Echo-sources (for example,) located within one or more bands on the outer circumference of the tip portion 114 of 110 It contains highly echogenic materials. Echo-generating materials include various reflective materials (e.g., metals, metal powders, etc.). ) and / or patterns (e.g., etching, dimples, cross-hatching, etc.) This includes, and thereby, as is known in the art, the ultrasonic transducer emits The ultrasound waves are reflected or "echoed". The delivery systems in Figures 1 and 4 are Each of the following: The image shows a secondary marker 118 which includes one of the above, but in various embodiments, the tip portion of the catheter 110 114, along with the main marker, for example, the color marker, various patterns, positions, orientations and / or Or one or more optical sensors and one or more echo-source sensors arranged in the configuration This includes both sides of the equation.

[0023] In one embodiment, the delivery system 100 of the present disclosure passes through the working channel of the endoscope. It is delivered (for example, slidably positioned inside it). Referring to Figure 5A, during use For example, the endoscope 140 passes through the esophagus to the first tubular body 2 (e.g., the stomach). The tip 142 of the endoscope 140 is equipped with a camera 147, a light source 148, and an ultrasound sensor. Includes transducer 149. In various embodiments, the endoscope is an ultrasonic transducer. The part is bent or torqued so that it is in flush contact with the wall of the first tubular body. Conventional ultrasonic endoscopic imaging, including configurations that include an ultrasonic transducer with a bendable arm. It may also be an endoscope (EUS). Use the endoscopic viewing mode (for example, light source 148 and Camera 147), the tip 142 of the endoscope 140, previously identified (or suspected) It is positioned adjacent to the wall portion of the first tubular body 2, which is adjacent to the body 4 of 2 (for example, a pseudocyst). Next, switch to ultrasonic visualization mode (for example, ultrasonic transducer 149) By activating the system, the second body 4 is imaged through the wall of the first tubular body 2. With the first and second locks of the handle engaged, the delivery system 100 is internally viewing It is advanced through the working channel 146 of the mirror 140. Alternatively, the delivery system 100 indicates the working state of the endoscope 140 when the endoscope is advanced into the first tubular body 2. It is located within channel 146. Referring to Figure 5B, the first and second locks are still While engaged, the delivery system 100 is advanced towards the tip under ultrasonic guidance. As a result, the tissue cross section 126 penetrates the wall of the first tubular body 2 and extends into the second body 4. Referring to Figure 5C, the second lock on the handle is released (the first lock is released). (Not done), the catheter 110 moves along / above the inner catheter 120 at its proximal end. It is retracted in that direction, and the tip portion 134 of the stent is in the lumen 116 of the catheter 110. Exiting (for example, then being in an unrestrained state), the tip holding member 135 is inside the second body 4. As shown in Figure 5D, the catheter 110 and the tip holding member 135 form the second It appears in ultrasound images within the body.

[0024] Referring to Figure 5E, the second lock is re-engaged, and the delivery system 100 (e.g., Catheter (Stent 110, Inner Catheter 120, and partially deployed stent) are endoscopically The tip holding member 135 is retracted towards the proximal end through the mirror working channel 146. It is positioned so as to be in contact with the inner wall of the second body 4. The first and second locks remain engaged. In this state, the endoscope 140 is switched to endoscopic viewing mode, and the catheter 110 and The wall of the first tubular body 2 can be visualized by the camera 147. Delivery system 1 00 means that at least a portion of the main color marker of the tip portion 114 is visible inside the first tubular body 2. It is further retracted until it reaches this position (Figure 5F). The tip portion 114 of the catheter 110 is When the light source 148 moves from the second body 4 to the first tubular body 2, the secondary marker 118 (for example, Illuminate one or more of the light sensors. One or more illuminated sub-markers, once When they enter the first lumen, they sense light from the light source, and then an external receiver (shown in the diagram) A signal is sent to the catheter 11, thereby deploying the proximal holding member 133. 0 emits a signal indicating that it is properly positioned within the first tubular body 2. For example, outside The receiver automatically disengages the second lock (the first lock is not disengaged). It emits a signal. Alternatively, the external receiver can securely disengage the second lock by a separate mechanism. It emits a signal indicating that it is being released. Referring to Figure 5G, the second lock is released. In this state, catheter 110 is further along / above inner catheter 120 It is retracted toward the end, and the proximal end retaining member 133 of the stent is deployed within the first tubular body 2. Referring to Figure 5H, the second lock is re-engaged, and the delivery system 100 (e.g., cat) The stent (110, inner catheter 120) is inserted through the deployed stent to the endoscope 14 It is retracted proximal to the working channel 146 of 0 and removed from the body (Figure) 5H). Alternatively, the first lock is released, and the inner catheter is deployed. The first and second rods are retracted proximal to the catheter through the inserted stent. Both locks may be engaged, and the delivery system enters the working channel of the endoscope. It is then retracted towards the proximal end and removed from the patient as described above. In various embodiments, Figure The steps outlined in 5A-5H may be in a different order, and / or may have additional steps. This can be done in any order, including being combined or further subdivided. ru.

[0025] In some medical procedures, the second stent is partially deployed through lumen 136. A fairly cloudy and / or opaque fluid from body 4 (e.g., bile, blood, pus, etc.) The flow of ) obstructs the light source and / or camera, thereby obstructing the tip of catheter 110 Visualization of minute 114 and / or illumination of one or more sub-markers within the first tubular body 2 This may interfere with or impair the function. In one embodiment, the delivery system 100 is shown in Figures 1-3. Instead of an optical sensor, or in addition to them, a sub-marker including an echogenic marker as shown in Figure 4. Including Ka. Using the endoscopic viewing mode, the color area of ​​the tip portion 114 of the catheter 110 is If reliable visualization is not possible, or as an additional safety device, the endoscope may use ultrasound. In visual mode, echogenic masses are detected within the first tubular lumen 2 through a turbid / opaque fluid. It is used to visualize the echogenic marker. Therefore, the echogenic marker is no longer a second lumen. When it is not visible within 4, or when it is visible within the first tubular body 2 as described above, The proximal retaining member is deployed. In another embodiment, the tip portion 114 of the catheter 110 is Includes both echogenic and optical sensor sub-markers. The endoscope may, if necessary, include a second To determine when the catheter is properly positioned to deploy the retaining member, It switches between endoscopic viewing mode and ultrasound viewing mode. Alternatively, it can switch between endoscopy and ultrasound. The visual mode is used simultaneously to provide alternative direct visualization of the catheter's position within the first lumen. It also provides an imaging view.

[0026] Referring to Figure 6A, in one embodiment, the present disclosure includes a base portion (not shown) and a tip portion 11 A delivery system including a catheter 110 which includes 2 and a lumen 116 extending between them, The TEM200 is provided. The tip portion 114 of the catheter 110 is a main marker, for example, a color area. This color includes and is different from the color of the rest of the catheter. As a non-limiting example, the catheter The tip portion 114 of the catheter 110 contains a dark color (e.g., black), and the rest of the catheter The part that is illuminated by the light source has a light color (for example, white) that contrasts with the dark color. Includes. The main markers are the anatomical location of one or more target body lumens and / or the thickness of the body wall. Depending on the circumstances, it extends along the tip portion 114 of the catheter at various distances (for example, approximately (10mm or more, approximately 20mm or more, approximately 30mm or more). Catheter 110 is further, Sub-markers 118 and 119 are located on or inside the tip portion 114 of the terminal 110. Includes. For example, auxiliary markers 118 and 119 are on the outer circumference of the tip portion 114 of the catheter 110. Contains echogenic (e.g., hyperechoic) material located in one or more bands. The material is a variety of reflective materials (e.g., metals, metal powders, etc.) and / or patterns (e.g., This includes etching, dimples, cross-hatching, etc., and thus in the art. As is well known, ultrasonic waves emitted from an ultrasonic transducer are reflected or "echoed (e cho)"

[0027] Still referring to Figure 6A, the delivery system 200 further includes the catheter 110. Includes an inner catheter 120 that is slidably positioned within a lumen 116. Medical device 13 0 is located above the tip portion 124 of the inner catheter 120 within the lumen 116. It is positioned. In one embodiment, the medical device 130 is located inside the lumen 116 of the catheter 110. The first (e.g., collapsed) configuration when positioned (e.g., constrained), and lumens To transition between a second (e.g., extended) configuration when it is not located within 116. This is the constructed stent. The secondary marker 118 is approximately at the midpoint of the medical device 130 (for example, the saddle). A portion of the tip portion 114 corresponding to the shaped region may be placed on or inside the tip portion 114, and a The marker 119 is located approximately at the tip (for example, the tip) of the medical device 130 which is positioned within the lumen 116. The end retaining member may be positioned on or inside another portion of the tip portion 114 that corresponds to it. The tip 112 of the inner catheter 120 is further connected to one or more first tubular bodies. Tissue cutting surfaces 126 (e.g., pointed surfaces, electrocautery surfaces) for penetrating the wall and the second body Includes (do).

[0028] When the delivery system 200 is advanced towards the tip under ultrasound guidance, the tissue cross-section 12 6 penetrates the first tubular body and extends into the second body 4 as described above. See Figure 6B. When both sub-markers 118 and 119 are located within the second body 4, in ultrasound visualization mode... As can be confirmed, the second lock on the handle is disengaged (the first lock is disengaged). (Not removed), and catheter 110 along / on the inner catheter 120. When the stent is retracted towards the proximal end, the tip portion 134 of the stent becomes the lumen of the catheter 110. Exiting from Men 116 (for example, thereby becoming unrestrained), the tip is inside the second body 4 A retaining member 135 is formed.

[0029] Referring to Figure 6C, the second lock is re-engaged, and the delivery system 200 (for example) (Catheter 110, inner catheter 120 and partially deployed stent) When retracted towards the proximal end through the endoscopic working channel 146, the tip holding member Position 135 in contact with the inner wall of the second body 4. The delivery system 200 uses ultrasonic imaging. Move back further until sub-markers 118 and 119 are no longer visible within the second body 4. In addition, or instead, the endoscope switches to endoscopic viewing mode. This visualizes at least a portion of the color region of the tip portion 114 within the first tubular body 2. Referring to Figure 6D, the second lock is disengaged, and the catheter 110 moves to the inner catheter. When the first tubular body 2 is moved further back towards the proximal end along / above the -tel 120, the first tubular body 2 The stent base end retaining member 133 is deployed inside. As a result, the second lock is re-engaged. Furthermore, the delivery system 100 (for example, catheter 110, inner catheter 120) Through the deployed stent and into the working channel 146 of the endoscope 140 It is retracted towards the end and removed from the body as described above. In various embodiments, see Figure 6B~ The steps outlined in 6D can be combined in a different order and / or with additional steps. This can be done in any order, including being combined or further subdivided.

[0030] The medical devices disclosed herein are not limited to endoscopes, but include, for example, catheters, bronchoscopes, ureteroscopes, Access to the body's passages, including duodenoscopy, colonoscopy, arthroscopy, cystoscopy, and hysteroscopy. This may include various systems and / or medical devices for any of these systems. This may include or operate within an ultrasonic transducer, and one or more thereof. The working channel may exit from the front or side portion of the system or scope, or or extends along its outer surface. Furthermore, the system and method of this disclosure are visible X It can be used in various medical procedures requiring fluoroscopy and / or ultrasound visualization. Finally, although embodiments of this disclosure have been described in relation to use with an endoscope, The disclosure delivery system can be positioned within the patient's body without the presence of accompanying medical devices. .

[0031] All devices and / or methods disclosed and claimed herein are in light of this disclosure. Therefore, it can be fabricated and carried out without excessive experimentation. The apparatus and methods of this disclosure are preferable. While embodiments have been described, those skilled in the art will not deviate from the concepts, spirit, and scope of this disclosure. Without using the apparatus and / or method, and the steps of the method described herein It will become clear that variations may be applied in the order of the steps. All such similar substitutions and modifications, which are obvious to the user, are permitted by the attached claims. It is deemed to fall within the intent, scope, and concept of this disclosure as defined.

Claims

1. A stent delivery system, A catheter having a tip portion including a main marker and at least one secondary marker, An inner catheter slidably disposed within the lumen of the aforementioned catheter, wherein the inner catheter can be retracted relative to the inner catheter such that a portion of the inner catheter extends from the tip of the aforementioned catheter; The system comprises a stent positioned on a portion of the inner catheter, The stent is constrained to a contracted configuration when the inner catheter is positioned within the lumen of the catheter. The tip portion of the stent expands to become a tip-holding member when the catheter retracts in the proximal direction relative to the inner catheter and the reference position. The proximal end portion of the stent expands to become a proximal end retaining member when the catheter retracts beyond the reference position relative to the inner catheter in the proximal direction. The auxiliary marker is positioned at the tip of the catheter so that by confirming the auxiliary marker within the body lumen, it can be seen that the entire proximal holding member can be deployed close to the reference position. A stent delivery system in which the at least one auxiliary marker includes a plurality of auxiliary markers arranged circumferentially on the outer circumference of the catheter.

2. The stent delivery system according to claim 1, further comprising a handle coupled to the catheter and the inner catheter, the handle having a first lock and a second lock, which, when the first lock and the second lock are engaged, secures the catheter to the inner catheter.

3. The stent delivery system according to claim 2, wherein when the second lock is released, the catheter retracts relative to the inner catheter and the tip retaining member expands from a contracted configuration.

4. The stent delivery system according to claim 3, wherein when the second lock is released, the catheter retracts relative to the inner catheter and the proximal retaining member expands from a contracted configuration.

5. The stent delivery system according to claim 1, wherein the main marker is darker in color than the catheter.

6. The stent delivery system according to claim 1, wherein the main marker has a length of 10 mm to 30 mm.

7. The stent delivery system according to claim 1, wherein the at least one sub-marker is positioned on the proximal end portion of the main marker.

8. A medical device system, A catheter having a tip portion including a main marker and at least one secondary marker, An inner catheter slidably disposed within the lumen of the aforementioned catheter, wherein the inner catheter can be retracted relative to the inner catheter such that a portion of the inner catheter extends from the tip of the aforementioned catheter; The medical device comprises a medical device positioned on a portion of the inner catheter, The medical device is constrained to a contracted configuration when the inner catheter is positioned within the lumen of the catheter. The tip portion of the medical device expands to become a tip-holding member when the catheter retracts in the proximal direction relative to the inner catheter and the reference position. The proximal end portion of the medical device expands to become a proximal end retaining member when the catheter retracts beyond the reference position relative to the inner catheter in the proximal direction. The auxiliary marker is positioned at the tip of the catheter so that by confirming the auxiliary marker within the body lumen, it can be seen that the entire proximal holding member can be deployed close to the reference position. A medical device system in which the at least one sub-marker is positioned on the proximal end portion of the main marker.

9. The medical device system according to claim 8, further comprising a handle coupled to the catheter and the inner catheter, the handle having a first lock and a second lock, which, when the first lock and the second lock are engaged, secures the catheter to the inner catheter.

10. The medical device system according to claim 9, wherein when the second lock is released, the catheter retracts relative to the inner catheter and the tip retaining member expands from a contracted configuration.

11. The medical device system according to claim 10, wherein when the second lock is released, the catheter retracts relative to the inner catheter and the proximal retaining member expands from a contracted configuration.

12. The medical device system according to claim 8, wherein the at least one auxiliary marker includes a plurality of auxiliary markers arranged circumferentially on the outer circumference of the catheter.

13. The medical device system according to claim 8, wherein the medical device is a self-expanding stent.

14. It is a system, A catheter having a tip portion including a main marker and at least one secondary marker, An inner catheter slidably disposed within the lumen of the catheter, wherein the catheter can be retracted relative to the inner catheter such that a portion of the inner catheter extends from the tip of the catheter. The system comprises a stent positioned on a portion of the inner catheter, The stent is constrained to a contracted configuration when the inner catheter is positioned within the lumen of the catheter. The tip portion of the stent expands to become a tip-holding member when the catheter retracts in the proximal direction relative to the inner catheter and the reference position. The proximal end portion of the stent expands to become a proximal end retaining member when the catheter retracts beyond the reference position relative to the inner catheter in the proximal direction. The auxiliary marker is positioned relative to the tip of the catheter so that by confirming the auxiliary marker within the body lumen, it can be seen that the entire proximal holding member can be deployed close to the reference position. A system in which the at least one auxiliary marker includes a plurality of auxiliary markers arranged circumferentially on the outer circumference of the catheter.

15. The system according to claim 14, wherein the main marker is darker in color than the catheter.

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