Real-time sampling device

Abstract

To provide an apparatus and a system for collecting a tissue sample, and a manufacturing method therefor.SOLUTION: Various disclosed embodiments include illustrative apparatuses and systems for performing multi-lumen catheter functions and methods for making the apparatuses. An illustrative apparatus includes a multi-lumen sheath, a cap having a proximal end attachable to a distal end of the multi-lumen sheath, and a liner. The cap includes a ramp section having a ramp and an exit port and an imaging section disposed distally from the ramp section. The ramp allows travel of a medical device from within the liner to the exit port. The distal ramp section extends distally from the flexible proximal section and is received by the ramp of the ramp section. The distal ramp section has a curved portion. The cap includes a socket for receiving a tab of the distal ramp section. The curved portion includes bending relief features.SELECTED DRAWING: Figure 2

Description

Technical Field

[0005]

[0001] Claims of Priority This application claims the benefit of U.S. Provisional Patent Application No. 63 / 150,708, filed on Feb. 18, 2021, the content of which is incorporated herein by reference.

Background Art

[0002] The description in this section merely provides background information regarding the present disclosure and does not constitute prior art.

[0003] Inserting and manipulating thin, elongated instruments within a living body or other object enables a continuously improving type of analysis, diagnosis, and treatment of these bodies or objects using minimally invasive techniques. According to two examples, endoscopic imaging and catheter treatment have enabled the evaluation and treatment of numerous internal lesions without performing invasive surgery.

[0004] Similarly, elongated instruments can also be used to collect samples from within the body in a relatively non-invasive manner. For example, if a biopsy from the lung is required to determine whether a detected lesion is cancerous, instead of making an incision in the patient's chest to obtain a sample, an insertion device such as a bronchoscope can be used to guide one or more elongated instruments to a location near the lesion to obtain a sample. However, simply transporting an elongated instrument to a location near a lesion may only indicate part of what is necessary to sample the lesion itself.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0006] Various disclosed embodiments include exemplary apparatus and systems for collecting tissue samples.

[0007] In an exemplary embodiment, the device includes a multi-lumen sheath, a cap having a proximal end that can be attached to the distal end of the multi-lumen sheath, and a liner. The cap includes a ramp section having a ramp and an exit port, and an imaging section located distal to the ramp section. The ramp allows the medical device to move from within the liner to the exit port. The liner includes a flexible proximal section and a distal ramp section having a C-shaped cross-section. The distal ramp section extends distally from the flexible proximal section and is received by the ramp of the ramp section of the cap. The distal ramp section includes a longitudinal axis having a predetermined radius of curvature along at least a portion of the distal ramp section.

[0008] In another exemplary embodiment, the cap includes a socket located at the distal end of the ramp. The liner further includes a tab positioned distally from the distal ramp section. The tab is received into the socket during assembly. The liner further includes a neck section positioned between the distal ramp section and the tab.

[0009] In another exemplary embodiment, the system includes a medical device and a multi-lumen device. The multi-lumen device includes a multi-lumen sheath, a cap having a proximal end that can be attached to the distal end of the multi-lumen sheath, and a liner. The cap includes a ramp section having a ramp and an exit port, and an imaging section located distal to the ramp section. The ramp allows the medical device to move from within the liner to the exit port. The liner includes a flexible proximal section and a distal ramp section having a C-shaped cross-section. The distal ramp section extends distally from the flexible proximal section and is received by the ramp of the ramp section of the cap. The distal ramp section includes a longitudinal axis having a predetermined radius of curvature along at least a portion of the distal ramp section.

[0010] In another exemplary embodiment, a process for creating the apparatus described above is provided.

[0011] The above summary is illustrative and not intended to be limiting. Further embodiments, features, and characteristics beyond those described above will become apparent by reference to the drawings and the detailed description below.

[0012] Exemplary embodiments are shown in the drawings referenced herein. The embodiments and drawings disclosed herein are intended to be considered illustrative and not limiting. [Brief explanation of the drawing]

[0013] [Figure 1] This is a side view of an exemplary sampling system. [Figure 2] This is an X-ray image of the distal end of a portion of an exemplary multi-lumen catheter used in the system shown in Figure 1. [Figure 3] Figure 1 is a plan view of the system components. [Figure 4] Figure 3 is an isometric view of the constituent elements. [Figure 5] Partial isometric X-ray view of a portion of the distal end of the distal tip used in the system of FIG. 1. [Figure 6] Partial lateral X-ray view of the distal end and a portion of the distal tip of an exemplary multi-lumen catheter used in the system of FIG. 1. [Figure 7] Partial isometric X-ray view of a portion of the distal end of an exemplary multi-lumen catheter. [Figure 8] Partial isometric X-ray view of a portion of the distal end of an exemplary multi-lumen catheter. [Figure 9] Partial isometric X-ray view of a portion of the distal end of an exemplary multi-lumen catheter. [Figure 10] Partial isometric X-ray view of a portion of the distal end of an exemplary multi-lumen catheter. [Figure 11] Flow diagram showing an exemplary method for creating an exemplary multi-lumen catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Like reference symbols in the various drawings generally indicate like elements.

[0015] The following description is not limiting, but is for illustrative purposes only, and describes various embodiments of an apparatus and system for obtaining a tissue sample using a multi-lumen device that can be inserted into the body.

[0016] It will be appreciated that the various embodiments of the systems described herein can assist in the process of deploying and controlling an elongate instrument. In various embodiments, the system includes a multi-lumen device that can include a sheath surrounding an imaging probe and a sampling needle. The sheath is insertable into the body to reach a target tissue from which a sample is to be taken. The imaging probe can be used to identify the location of the target tissue, or a portion of the tissue, from which a sample is to be taken. A sampling needle can be used to obtain a sample of that tissue.

[0017] In various embodiments, the system can be coupled to an insertion device, such as an endoscope or a bronchoscope, that includes an insertion conduit that can be inserted into the body through a hole or other opening. The insertion device enables the insertion conduit to be inserted into the body and sent to a desired location within the body. The insertion conduit can be configured to receive a multi-lumen device that can extend through the insertion conduit. The multi-lumen device can be inserted into the body through the insertion device to obtain a tissue sample at a desired location within the body. Exemplary multi-lumen devices are described below.

[0018] In various embodiments, as shown in FIG. 1, an exemplary system 12 includes an insertion device 18 (only a portion of which is shown in FIG. 1), such as an endoscope or a bronchoscope. As previously described, the insertion device 18 includes an insertion conduit that can be inserted into the body through a hole or other opening (none of which are shown in FIG. 1). The insertion device 18 receives a multi-lumen catheter device 14 that can receive a medical device 16 that can extend through the lumen of the multi-lumen catheter device 14 to a desired location. As also previously described, in various embodiments, the medical device 16 can include an imaging probe and / or a sampling needle that is connected to a handle and housed within a sheath (neither of which are individually shown in FIG. 1). The medical device 16 can be inserted through the multi-lumen catheter device 14 and the insertion device 18 to obtain a tissue sample at a desired location within the body.

[0019] It will be understood that the insertion device 18 may be any number of different types of scopes used in a medical procedure. Scopes may include multi-use or single-use endoscopes, such as bronchoscopes, laparoscopes, and pharyngoscopes. The multi-lumen catheter device 14 may be any device containing two or more lumens located within an insertion tube attached to a handle device. The lumens of the multi-lumen catheter device 14 may be suitable for receiving imaging devices and medical devices 16. The imaging devices to be received may include cameras or ultrasound devices such as radial ultrasound probes or similar devices. In various embodiments, the multi-lumen catheter device 14 may include a base section rotatably coupled to the insertion device 18 and ports slidably received by the base section. An exemplary multi-lumen catheter system is shown and described in Patent Document 1, filed December 10, 2020, the contents of which are incorporated herein by reference.

[0020] In various embodiments, the insertion tube of the multi-lumen catheter device 14 is received into the working channel port of the insertion device 18. The multi-lumen catheter device 14 can be attached to the working channel port. The medical device 16 may include a flexible sheath attached to a first portion of the handle, and an operating tool received within the flexible sheath and attached to the actuator portion of the handle. The operating tool may include a tissue aspiration device, such as a flexible needle, a cell sample brush, or the like. The operating tool may include a lumen that communicates with a corresponding lumen contained in the first portion of the actuator portion of the handle.

[0021] Further reference, as shown in Figure 2, the multi-lumen catheter device 14 includes a flexible multi-lumen sheath having a lumen liner 20 which includes a proximal portion 52 attached at the proximal end to a handle (not shown) of the multi-lumen catheter device 14, and a distal inclined section 50 extending distally from the distal end of the proximal portion 52. The distal inclined section 50 and a small portion of the proximal portion 52 adjacent to the distal inclined section 50 are received within the cap section 60.

[0022] The cap section 60 includes a proximal ramp section 62 and a distal cap section 70. The proximal end of the proximal ramp section 62 is attached to a multi-lumen sheath. The multi-lumen sheath 22 receives the lumen liner 20 and extends from the handle of the multi-lumen catheter device 14. The proximal ramp section 62 includes a first lumen 68 having a proximal end that, when attached, coincides with the lumen of the multi-lumen sheath 22. The first lumen 68 includes a ramp 63 that connects the proximal end of the first lumen 68 to the exit port 64 of the proximal ramp section 62 of the cap section 60. The first lumen 68 is described in more detail below. The distal cap section 70 includes two directional pins 54 that extend into the proximal ramp section 62.

[0023] The proximal ramp section 62 also includes a second lumen that allows the imaging device to pass from the handle through the multi-lumen sheath 22 to the distal cap section 70.

[0024] The proximal ramp section 62 includes a plug cavity 66 located distal to the ramp 63 of the first lumen 68. The distal end of the distal ramp section 50 of the lumen liner 20 includes a bendable tab 40. After the distal ramp section 50 is inserted into the proximal ramp section 62 of the cap section 60, the tab 40 is bent into the plug cavity 66. The tab 40 can be sized to apply frictional force against the wall of the plug cavity 66. After the tab 40 is bent inward, a medical-grade adhesive may be placed inside the plug cavity 66.

[0025] In various embodiments, as shown in Figures 3 and 4, the exemplary lumen liner includes a distal ramp section 80 attached to a proximal section 82. The distal ramp section 80 and proximal section 82 can be formed from medical-grade metals such as stainless steel, nitinol, or similar materials. The proximal section 82 can be tubular in shape and may include reliefs (not shown) configured to improve flexibility. The distal ramp section 80 is trough-shaped. The distal ramp section 80 includes a bendable section 84 and a straight ramp section 86. The bendable section 84 includes a curved relief structure, such as a laser or machined cut, to cause the distal ramp section 80 to bend at the location of the bendable section 84. The number and type of curved relief structures used in the bendable section 84 can be selected from any number of variations to produce the desired flexibility and radius of curvature.

[0026] The straight ramp section 86 extends distally from the bendable section 84. The distal end of the straight ramp section 86 includes a tab 100 connected via a neck section 90. The neck section 90 may be partially defined by a slit cut longitudinally into the distal end of the straight ramp section 86. The shape and length of the neck section 90 are selected by the manufacturer to allow the tab 100 to be easily bent into a plug cavity, such as the plug cavity 66 shown in Figure 2.

[0027] In various embodiments, the upper edge of the distal end of the proximal section 82 includes a relief cutout 106. The relief cutout 106 is designed to reduce friction with the medical device as it moves back and forth through the proximal section 82 and deflects along the curved section 84 before passing through the exit port.

[0028] In various embodiments, as shown in Figures 5 and 6, the ramp section 182 of the distal cap section for a multi-lumen catheter device is molded or formed to include a ramp 184 extending from near the proximal opening 188 of the lumen of the cap section. The ramp 184 includes an adhesive relief 186 located along the upper surface of the ramp 184, closer to the distal end of the ramp 184 than to the proximal end. The plug cavity 166 is located distally from the distal end of the ramp 184. The ramp 184 and the plug cavity 166 are exposed to the environment surrounding the ramp section 182 via an exit port.

[0029] In various embodiments, the distal end of the lumen liner 180 can be pre-bent to a desired angle to conform to the ramp 184 before the distal end of the lumen liner 180 is inserted into the ramp section 182. Furthermore, before the distal end of the lumen liner 180 is inserted into the ramp section 182, adhesive 196 can be applied to the ramp 184 on both sides of the adhesive relief 186. The adhesive relief 186 allows a space to be created between the ramp and the lumen liner 180 due to the layer of adhesive 196. If the lumen liner 180 is straight during insertion into the ramp section 182, a curved relief structure, such as those shown and described above in Figures 3 and 4, can be used to curve the lumen liner 180 according to the angle of the ramp 184. When the adhesive relief 186 and adhesive 196 are present, a joint is formed between the ramp 184 and the distal end of the lumen liner 180.

[0030] After the lumen liner 180 is properly positioned within the ramp section 182, the distal tab 194 attached to the distal end of the lumen liner 180 is mechanically bent into the plug cavity 166. The plug cavity 166 is then filled with adhesive to form an adhesive plug 190, which thus firmly holds the tab 194 within the plug cavity 166.

[0031] In various embodiments, as shown in Figure 7, the ramp section 206 of the cap section 208 for a multi-lumen catheter device includes a ramp 202 that is joined to the distal end of the lumen liner 200. The ramp 202 includes a deep groove section 204 located along a portion of the ramp 202. The deep groove section 204 is used to receive adhesive before inserting the distal end of the lumen liner 200.

[0032] In various embodiments, as shown in Figure 8, the ramp section 226 of the cap section 218 for a multi-lumen catheter device includes a ramp 219, a plug cavity 222 located distal to the ramp 219, a pin lumen 224, and a locking pin 220. The pin lumen 224 connects the distal surface of the ramp section 226 to the distal wall of the plug cavity 222. After the lumen liner 212, which has a distal tab 214, is inserted into the ramp section 226, the tab 214 is mechanically bent into the plug cavity 222, similar to the other tabs described above. After the tab 214 is bent, the locking pin 220 is inserted into the pin lumen 224 so that the proximal end of the locking pin 220 protrudes into the plug cavity 222. The locking pin 220 provides a locking mechanism for the tab 214. At this point, adhesive can be applied to the plug cavity 222 around the tab 214 and locking pin 220.

[0033] In various embodiments, as shown in Figure 9, the ramp section 264 of the cap section 260 of a multi-lumen catheter device includes a ramp and plug cavity 262 for receiving the distal end of the lumen liner 252 and the associated distal tab 254. After the tab 254 is bent into the plug cavity 262, a pin 266 is inserted into the plug cavity 262. The pin 266 includes a pointed distal end. Thus, when the pin 266 is forced into the plug cavity 262, the pointed distal end may be partially or completely embedded in the distal wall of the plug cavity 262. The pin 266 provides a locking mechanism for the tab 254. After the pin 266 is inserted, adhesive may be applied to the plug cavity 262 around the tab 254 and the pin 266.

[0034] In various embodiments, as shown in Figure 10, the ramp section 268 of the cap section 267 of a multi-lumen catheter device includes a ramp and plug cavity 262 for receiving the distal end of the lumen liner 270 and an associated elongated distal tab 272 extending therefrom. The ramp section 268 also includes a tab receiving area 274 located distal to the plug cavity 262. The tab receiving area 274 may include a more flexible material than that used to form the cap section 267. The tab receiving area 274 may also include an additional lumen or permeable wall. The elongated distal tab 272 has a length greater than the length of the plug cavity 262. After the lumen liner 270 is inserted into the desired position within the ramp section 268, the elongated distal tab 272 is bent into both the plug cavity 262 and the tab receiving area 274. The elongated distal tab 272 provides a locking mechanism for the lumen liner 270. After the elongated distal tab 272 is inserted, adhesive may be applied around the tab 272 into the plug cavity 262.

[0035] As shown in Figure 11, in various embodiments, Method 290 illustrates the operational steps for creating one or more of the dual lumen catheter devices shown and described above. First, in block 292, the distal end of the lumen liner is inserted into the inclined section of the distal cap component for the dual lumen catheter. In various embodiments, the lumen liner may need to be bent before being inserted into the inclined section. In the following block 294, the inclined section of the distal end of the lumen liner is secured to the cap section. In block 296, the proximal end of the lumen liner is inserted into the lumen of the multi-lumen sheath. Then, in block 298, the proximal end of the distal cap component is attached to the distal end of the multi-lumen sheath. Attachment of the distal cap component to the multi-lumen sheath can be achieved with various adhesives or by applying heat-shrink material around the component.

[0036] From the preceding discussion and the accompanying drawings, it will be understood that various embodiments are disclosed and illustrated. Therefore, and without implying any limitation (which is not presumed), the following paragraphs provide a non-limiting summary of the various embodiments disclosed herein, not as limitations but merely as examples.

[0037] A. A device comprising: a multi-lumen sheath; a cap having a proximal end that can be attached to the distal end of the multi-lumen sheath; and a liner comprising a flexible proximal section and a distal ramp section having a C-shaped cross-section, the liner including the distal ramp section which extends distally from the flexible proximal section and is configured to be received by the cap.

[0038] B. The apparatus of A, comprising a ramp section having a ramp and an exit port, wherein the ramp section is configured to allow a medical device to move from inside the liner to the exit port, and an imaging section positioned distal to the ramp section and configured to receive an imaging device, the distal ramp section includes a longitudinal axis having a predetermined radius of curvature along at least a portion of the distal ramp section.

[0039] Apparatus B, wherein the cap further includes a socket located at the distal end of the ramp, and the liner further includes a tab located distally from the distal ramp section, the tab being configured to be receivable into the socket.

[0040] D. Reiner further includes a neck section positioned between a distal ramp section and a tab, in the apparatus of C.

[0041] Device D, wherein the tab includes a first dimension and the neck section includes a second dimension, and both the first and second dimensions are perpendicular to the longitudinal axis of the distal ramp section, and the first dimension is greater than the second dimension.

[0042] F. The distal ramp section further includes a curved section and a straight section, apparatus A.

[0043] G. The bent section includes a bent relief structure, as per the apparatus of F.

[0044] H. The bent relief structure is an apparatus G, which includes multiple laser-cut sections.

[0045] I. The cap further contains an adhesive that can be accepted into the socket, as per the apparatus of C.

[0046] J. A system comprising a medical device and a multi-lumen device, the multi-lumen device being a handle comprising a handle having at least two lumens, a first port communicating with a first lumen of the at least two lumens, and a second port communicating with a second lumen of the at least two lumens, the second port and the second lumen of the at least two lumens being configured to slidably receive a portion of the medical device; a multi-lumen sheath attachable to the handle; a cap having a proximal end attachable to the distal end of the multi-lumen sheath; and a liner comprising a flexible proximal section and a distal inclined section having a C-shaped cross-section, extending distally from the flexible proximal section and configured to be receiveable by the cap.

[0047] K. Cap is a ramp section having a ramp and an exit port, further comprising: a ramp section configured to allow a medical device to move from inside a liner to an exit port; and an imaging section positioned distal to the ramp section and configured to receive an imaging device, wherein the distal ramp section includes a longitudinal axis having a predetermined radius of curvature along at least a portion of the distal ramp section, the system of J.

[0048] L. The cap includes a socket located at the distal end of the ramp, and the liner further includes a tab located distally from the distal ramp section, the tab being configured to be receivable into the socket, in the system of K.

[0049] M. Reiner further includes a neck section positioned between the distal ramp section and the tab in a system of L.

[0050] The system of N. tab includes a first dimension, and the neck section includes a second dimension, and the first and second dimensions are perpendicular to the longitudinal axis of the distal ramp section, and the first dimension is greater than the second dimension.

[0051] O. The distal ramp section is part of the J system, which further includes curved sections and straight sections.

[0052] P. The bent section is a system of O including a bent relief structure.

[0053] Q. The bent relief structure is a system of P that includes multiple laser-cut sections.

[0054] R. The cap is part of the L system, which further includes an adhesive that can be accepted inside the socket.

[0055] S. A method comprising the steps of: providing a multi-lumen sheath, a cap having a proximal end attachable to the distal end of the multi-lumen sheath, the cap including a ramp section having a ramp and an outlet port, and an imaging section positioned distal to the ramp section; and a liner including a flexible proximal section and a distal ramp section having a C-shaped cross-section; inserting the distal ramp section into the cap; fixing the distal ramp section within the cap; inserting the proximal end of the liner into the lumen of the multi-lumen sheath; and fixing the proximal end of the cap to the distal end of the multi-lumen sheath.

[0056] Method S, further comprising the step of performing an action selected from bending the distal ramp section and reducing the bending force on the distal ramp section, prior to the step of inserting the distal ramp section into the cap.

[0057] In some examples, one or more components may be referred to herein as “configured,” “composed of,” “can be configured,” “operable to,” “adaptable to,” “can be adapted to,” etc. Those skilled in the art will recognize that such terms (e.g., “configured to,” etc.) generally encompass active components and / or inactive components and / or standby components, unless the context requires otherwise.

[0058] While specific aspects of the subject matter described herein have been shown and described, modifications and alterations can be made based on the teachings herein without departing from the subject matter and its broader aspects described herein. Therefore, it will be apparent to those skilled in the art that the appended claims encompass all such modifications and alterations as being within the true spirit and scope of the subject matter described herein. In general, those skilled in the art will understand that the terms used herein, and in particular in the appended claims (e.g., in the text of the appended claims), are generally intended to be “open” terms (for example, “including” should be interpreted as “including but not limited to,” “having” should be interpreted as “having at least,” and “includes” should be interpreted as “including but not limited to,” and so on). Where a particular number is intended in the description of an introduced claim, such intention will be explicitly stated in the claim; where there is no such statement, such intention will not be present, as will be further understood to those skilled in the art. For example, for ease of understanding, the attached claims below may include the use of the introductory phrases “at least one” and “one or more” to introduce the claim description. However, the use of such phrases should not be interpreted as suggesting that the introduction of the claim description by the indefinite article “a” or “an” implies that any particular claim containing such introduced description is limited to only one such description, even if the same claim contains the introductory phrases “one or more” or “at least one” and the indefinite article “a” or “an” (for example, “a” and / or “an” should generally be interpreted as meaning “at least one” or “one or more”), and the same is true for the use of the definite article used to introduce the claim description.In addition, even when a specific number of claims introduced is explicitly stated, it will be recognized by those skilled in the art that such statements should generally be interpreted as meaning at least the stated number (for example, the mere statement “two statements” without other modifiers usually means at least two statements, or two or more statements). Furthermore, in examples where notation similar to “at least one of A, B, and C, etc.” is used, such constructions are generally intended to have a meaning that those skilled in the art should understand (for example, “a system having at least one of A, B, and C” would include, but not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). It will also be recognized by those skilled in the art that disjunctive words and / or phrases presenting two or more alternative terms, whether in a description, claim, or drawing, should generally be understood, unless otherwise specifically indicated, as constrained to potentially include one of the terms, either of the terms, or both of the terms. For example, the phrase "A or B" is usually understood to include the possibilities of "A," "B," or "A and B."

[0059] With respect to the attached claims, those skilled in the art will understand that the actions described herein can generally be performed in any order. Furthermore, even when a sequence of actions is presented sequentially, it should be understood that the actions can be performed in other orders than those indicated, or simultaneously. Examples of such alternative orderings include overlapping, alternating, interrupting, reordering, increasing, pre-empting, capturing, doing simultaneously, reversing, or other different orderings, unless the context specifies otherwise. Moreover, terms such as “corresponding to,” “related to,” or other past tense adjectives are generally not intended to exclude such variations, unless the context specifies otherwise.

[0060] While the disclosed subject matter is described by exemplary embodiments, those skilled in the art will understand that various modifications can be made thereto without departing from the scope of the claimed subject matter as defined in the claims. [Explanation of Symbols]

[0061] 12 Systems 14. Multi-tubular catheter devices 16 Medical Devices 18 Insertion Devices 20 Lumen Liner 22 Multi-tubular sheath 40 tabs 50 Ramp Sections 52 Proximal portion 54 Directional Pins 60 Cap Sections 62 Proximal ramp section 63 ramp 64 Exit Ports 66 Plug cavity 68 First lumen 70 Distal cap section 80 Distal ramp section 82 Proximal Section 84 Flexible Sections 86. Straight ramp section 90 Neck Section 100 tabs 106 Relief Cutouts 166 Plug cavity 180 Lumen Liner 182 Ramp Section 184 Ramp 186 Adhesive relief 188 Proximal opening 190 Adhesive Plugs 194 tabs 196 Adhesives 200 Lumen Liner 202 ramp 204 Deep groove section 206 Ramp Section 208 Cap Section 212 Lumen Liner 214 tabs 218 Cap Section 219 ramp 220 locking pins 222 Plug cavity 224 Pin Lumen 226 Ramp Section 252 Lumen Liner 254 tabs 260 Cap Section 262 Plug cavity 264 Ramp Section 266 pins 267 Cap Section 268 Ramp Section 270 Lumen Liner 272 tabs 274 Tab acceptance area

Claims

1. It is a device, A sheath having a lumen, A cap having a proximal end that can be attached to the distal end of the sheath, It's Raina, A tubular proximal section aligned coaxially with the lumen, and A distal ramp section having a C-shaped cross-section, wherein the distal ramp section extends distally from the tubular proximal section and terminates with a tab, the tab being receivable in a socket for securing the distal end of the distal ramp section within the cap. Including Raina, A device equipped with the following features.

2. The aforementioned cap is A ramp section having a ramp and an exit port, wherein the ramp is configured to allow a medical device to move from the liner to the exit port, An imaging section is positioned distal to the ramp section and configured to receive an imaging device, It further includes, The apparatus according to claim 1, wherein the distal ramp section includes a longitudinal axis having a predetermined radius of curvature along at least a portion of the distal ramp section.

3. The cap further includes the socket located at the distal end of the ramp, and The apparatus according to claim 2, wherein the liner further includes the tabs positioned distally from the distal ramp section, the tabs being configured to be receivable within the sockets.

4. The apparatus according to claim 3, wherein the liner further includes a neck section positioned between the distal ramp section and the tab.

5. The apparatus according to claim 4, wherein the tab includes a first dimension, and the neck section includes a second dimension, the first and second dimensions being perpendicular to the longitudinal axis of the distal ramp section, and the first dimension being greater than the second dimension.

6. The apparatus according to claim 1, wherein the distal ramp section further includes a curved section and a straight section.

7. The apparatus according to claim 6, wherein the bent section includes a bent relief structure.

8. The apparatus according to claim 7, wherein the bent relief structure includes a plurality of laser-cut sections.

9. The apparatus according to claim 3, wherein the cap further comprises an adhesive that can be received in the socket.

10. It is a system, Medical devices, and The device comprises a multitubular lumen device, and the multitubular lumen device is It is a handle, At least two lumens, A first port communicating with the first lumen of the at least two lumens, and A handle and a second port communicating with a second lumen of the at least two lumens, wherein the second port and the second lumen of the at least two lumens are configured to slidably receive a portion of the medical device. A multi-tube lumen sheath that can be attached to the handle, A cap having a proximal end that can be attached to the distal end of the multi-tubular lumen sheath, It's Raina, A tubular proximal section aligned coaxially with the second lumen of the multi-lumen sheath, and A distal ramp section having a C-shaped cross-section, wherein the distal ramp section extends distally from the tubular proximal section and terminates with a tab, the tab being receivable in a socket for securing the distal end of the distal ramp section within the cap. Including Raina, A system that includes this.

11. The aforementioned cap is A ramp section having a ramp and an exit port, wherein the ramp is configured to allow a medical device to move from the liner to the exit port, An imaging section is positioned distal to the ramp section and configured to receive an imaging device, It further includes, The system according to claim 10, wherein the distal ramp section includes a longitudinal axis having a predetermined radius of curvature along at least a portion of the distal ramp section.

12. The cap includes the socket located at the distal end of the ramp, and The system according to claim 11, wherein the liner further includes the tabs positioned distally from the distal ramp section, the tabs being configured to be receivable within the sockets.

13. The system according to claim 12, wherein the liner further includes a neck section positioned between the distal ramp section and the tab.

14. The system according to claim 13, wherein the tab includes a first dimension, and the neck section includes a second dimension, the first and second dimensions being perpendicular to the longitudinal axis of the distal ramp section, and the first dimension being greater than the second dimension.

15. The system according to claim 10, wherein the distal ramp section further includes a curved section and a straight section.

16. The system according to claim 15, wherein the bent section includes a bent relief structure.

17. The system according to claim 16, wherein the bent relief structure includes a plurality of laser-cut portions.

18. The system according to claim 12, wherein the cap further comprises an adhesive that can be received in the socket.

19. It is a method, A sheath having a lumen, A cap having a proximal end that can be attached to the distal end of the sheath, A ramp section having a ramp and an exit port, and Imaging section located distal to the aforementioned ramp section A cap including, and It's Raina, A tubular proximal section aligned coaxially with the lumen, and A distal ramp section having a C-shaped cross-section, extending distally from the tubular proximal section and terminating with a tab. including, Rainer The steps to provide, A step of inserting the distal ramp section into the cap, comprising inserting the tab into the socket to secure the distal end of the distal ramp section inside the cap, The steps include fixing the distal ramp section inside the cap, The steps include inserting the proximal end of the liner into the lumen of the sheath, The steps include fixing the proximal end of the cap to the distal end of the sheath, A method that includes this.

20. The method according to claim 19, further comprising the step of performing an action to bend the distal ramp section before inserting the distal ramp section into the cap.

Images