Medical system and apparatus for supporting an anchoring balloon

Abstract

To enable real-time observation of a tissue sampling or drug delivery procedure in a patient beyond the viewing range of an endoscope that may be used to transport the device.SOLUTION: An elongate access device for use in a medical system includes a medical device and an ultrasound probe disposed therein, the sheath including a first lumen configured to receive the ultrasound probe, a second lumen configured to receive the medical device, and a lumen liner configured to extend beyond a distal surface of the sheath, and a tip configured to be attached to the sheath, the tip including at least one coupling device, a hub, the hub including a probe lumen and a ramp lumen, a nose device, and a ramp device configured to be received within the ramp lumen and configured to receive at least a portion of the lumen liner.SELECTED DRAWING: Figure 2

Description

[Background technology]

[0001] Currently available medical devices for ultrasound visualization and sampling of peripheral lung tumors are limited in their range of motion and diagnostic capabilities. Typically, during peripheral sampling, a guide sheath is advanced through the bronchoscope and extended far beyond the reach of the bronchoscope, so that the distal end of the guide sheath is not visible. A small probe from a radial endobronchial ultrasound (EBUS) is used to penetrate the guide sheath and determine the approximate location of the tumor.

[0002] Unfortunately, peripheral tumors located off to one side of the airway, as opposed to tumors centered around the airway, have a substantially lower diagnostic yield, in part due to limitations of current radial EBUS technology, which allows the operator to perceive depth from the probe but not the direction of the tumor or lesion. The sampling needle extends off-axis from the sheath, thus requiring knowledge of the rotational orientation of the needle and the subject. Radial ultrasound probes do not indicate the orientation of the needle relative to the lesion. Radial ultrasound images are 360° images that allow the user to see the lesion, but the user cannot distinguish whether the needle is pointing at the lesion or not. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2018 / 106787 [Patent Document 2] International Publication No. 2018 / 106789 [Patent Document 3] International Publication No. 2018 / 157038 [Patent Document 4] International Publication No. 2018 / 003242 [Patent Document 5] Japanese Patent Application Publication No. 10-118072 [Patent Document 6] Special Publication No. 2018-519902 [Patent Document 7] Japanese Patent Application Laid-Open No. 2000-152940 Summary of the Invention [Problem to be solved by the invention]

[0004] Embodiments of the technology disclosed herein are directed to a flexible device for enabling real-time observation of tissue sampling or drug delivery procedures in a patient beyond the field of view of an endoscope that may be used to deliver the device. [Means for solving the problem]

[0005] Accordingly, one aspect of the disclosed technology is directed to an elongated access device for use in a medical system, having respective proximal and distal ends. The elongated access device receives a medical tool and an ultrasonic probe within separate lumens. The elongated access device includes a sheath and an intraluminal tip attached to the sheath. The intraluminal tip includes a hub and a nose device spaced apart to form an ultrasonic probe cavity formed by an oversleeve. One or more orientation pins may engage the hub and the nose device and be secured within the sheath. A tilting device is received within the hub. The medical tool is configured to deflect off-axis when engaged with the tilting device. The ultrasonic probe is received within the ultrasonic probe cavity of the intraluminal tip to ensure that the deflected medical tool is directed toward a target during a medical procedure based on proximity to an imaging abnormality associated with the one or more pins.

[0006] Other features and aspects of the disclosed technology will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which, by way of example, illustrate features according to embodiments of the disclosed technology. The Abstract is not intended to limit the scope of any inventions described herein, which are defined solely by the claims appended hereto. [Brief explanation of the drawings]

[0007] [Figure 1] 1 illustrates an example of an elongated access device for use in a bronchoscope system in accordance with an embodiment of the disclosed technology. [Figure 2] FIG. 10 is a plan view of a distal end of an elongated access device in accordance with one embodiment of the disclosed technology. [Figure 3] 3 is a side view of the distal end of the elongated access device of FIG. 2. [Figure 4] FIG. 10 is an isometric view of the distal end of the elongated access device showing how the orientation pin and respective angled donut and tip donut portions are engaged with one another when the sheath and elongated sleeve are both removed. [Figure 5] 10 illustrates an embodiment of an orientation pin and respective angled and tip donut portions engaged with one another. [Figure 6] 10 illustrates an embodiment of an orientation pin and respective angled and tip donut portions engaged with one another. [Figure 7] 1 illustrates a portion of an exemplary sheath for an elongated access device. [Figure 8] 1 shows an example of a lung portion of a body where the distal end of an elongated access device and a bronchoscope are engaged in sampling a peripheral tumor located off one side of the airway. [Figure 9] 9 is an exemplary image produced by a radial ultrasound probe used with the components shown in FIGS. 1-8. [Figure 10] 1 is an isometric view of a distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 11] FIG. 11 is a cross-sectional view of the device shown in FIG. [Figure 12] FIG. 12 is a zoomed-in view of a portion of the device shown in FIG. [Figure 13] FIG. 11 is a cross-sectional view of the device shown in FIG. [Figure 14] FIG. 11 is an isometric view of the components of the device shown in FIG. 10. [Figure 15] FIG. 11 is an isometric view of the distal end of a sheath forming part of the device shown in FIG. 10. [Figure 16]11 is a cross-sectional view of a portion of the distal end of the elongated access device shown in FIG. 10. [Figure 17] 11 is an x-ray view of the distal end of the elongated access device shown in FIG. 10. [Figure 18] 1 is an isometric view of a distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 19] 1 is an isometric view of a distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 20] 1 is an isometric view of a distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 21] 1 is an isometric view of a distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 22] 1 is an isometric view of a distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 23] 1 is a side partial x-ray view of the distal end of an elongated access device formed in accordance with one embodiment of the technology described herein. [Figure 24] FIG. 24 is an isometric view of the hub portion of the device shown in FIG. 23. [Figure 25] FIG. 25 is an isometric cross-sectional view of the hub portion shown in FIG. 24. [Figure 26] FIG. 24 is an isometric view of the angled insert of the device shown in FIG. 23. [Figure 27] FIG. 27 is an isometric cross-sectional view of the angled insert shown in FIG. 26. [Figure 28] FIG. 2 is a cross-sectional view of the distal end of the dual lumen sheath device in a first mode of operation. [Figure 29] FIG. 29 is a cross-sectional view of the device of FIG. 28 in a second mode of operation. DETAILED DESCRIPTION OF THE INVENTION

[0008] The technology disclosed herein, in accordance with one or more various embodiments, will be described in detail with reference to the following figures. The drawings are provided for illustrative purposes only and merely depict typical or exemplary embodiments of the disclosed technology. These drawings are provided to facilitate the reader's understanding of the disclosed technology and should not be considered limiting of its breadth, scope, or applicability. It should be noted that for clarity and ease of illustration, these drawings have not necessarily been made to scale.

[0009] In the following description, various embodiments of the present technology are described. For purposes of explanation, specific configurations and details are set forth to provide a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that the technology disclosed herein may be practiced without the specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the described embodiments.

[0010] 1, a bronchoscope system 10 includes a bronchoscope 12 with an insertion tube 14, a radial ultrasound system 16, and an elongated access device 20. The radial ultrasound system 16 includes a signal processor 24, a display device 18, and a radial ultrasound probe 22. The radial ultrasound probe 22 and a medical device 30 (e.g., a tissue sampling and / or drug delivery needle) are received within the bronchoscope 12 via a handle component of the elongated access device 20.

[0011] Display device 18 is in wired or wireless signal communication with bronchoscope 12 and / or signal processor 24. Display device 18 presents images based on information received from bronchoscope 12 and / or signal processor 24, which receives image information from a radial ultrasound transducer at the distal end of radial ultrasound probe 22. A diagnostic bronchoscope (e.g., Olympus® BF-X190) is an example of a bronchoscope 12, and an Olympus® Endobronchial Radial Ultrasound (EBUS) miniature probe is an example of a radial ultrasound system 16.

[0012] FIG. 2 is a plan view and FIG. 3 is a side view of the distal end of an elongated access device 20 in accordance with one embodiment of the disclosed technology. A medical device 30 and an ultrasound probe 22 are slidably received within the elongated access device 20. The elongated access device 20 includes a sheath 32 and an intraluminal tip 21 configured to be attached to one another at the distal end of the sheath 32. The sheath 32 includes multiple lumens, e.g., four lumens 33a, 33b, 33c, and 33d, each of which receives various components therethrough, as best shown in FIG. 7 and described below. The intraluminal tip 21 includes an angled donut portion 34 and a tip donut portion 36 that are spaced apart from one another and configured to be disposed within a sleeve 28. The sleeve 28 includes an exit opening / port 29 that allows the medical device 30 to protrude therethrough, as shown in FIG. 3. The sleeve 28 defines an ultrasound-transparent window between the donut sections 34, 36 that encases the ultrasound probe 22. Ultrasound gel 44 or other suitable fluid, such as isotonic saline, is inserted into the tip 21 to ensure continuous and reliable transmission of ultrasound energy. The sleeve 28 is made of a commercially available ultrasound-transparent material such as Pebax®, a thermoplastic elastomer made from flexible polyether, the stiffest commercially available grade of polyamide component, providing maximum mechanical performance in various molded components used in medical devices.

[0013] FIG. 4 is an isometric view of a portion of one embodiment of the tip 21 with the sleeve 28 removed to show how the orientation pin 26 and the angled donut portion 34 and tip donut portion 36 are engaged with one another. The angled donut portion 34 is generally cylindrical in shape with a first plurality of passages 38a, 38b, and 38c formed therein to allow the ultrasound probe 22 and orientation pin 26 to pass therethrough. The angled donut portion 34 includes angled grooves 42 formed on its outer surface 43. The angled grooves 42 are angled to deflect the medical device 30 away from the longitudinal axis of the endoluminal tip 21 when the medical device 30 engages the angled donut portion 34 during a medical procedure. The angled grooves 42 have a central axis that diverges from the longitudinal axes of the endoluminal tip 21 and sheath 32. The angled grooves 42 enable repeated peripheral sampling, for example, using a needle without the angled grooves 42. The angled donut portion 34 and the tip donut portion 36 may be made of stainless steel, polyphenylsulfonic acid (PPSU), or an equivalent material. In one embodiment, the passage 38a is used to receive the ultrasonic probe 22, and the respective passages 38b, 38c are used to pass the orientation pin 26 therethrough.

[0014] The distal donut portion 36 is generally cylindrical in shape with a plurality of passages 40a, 40b, and 40c. In one embodiment, the passage 40a receives and flows ultrasound gel 44 and provides a bottom point for inserting the ultrasound probe 22, which blocks the passage 40a to prevent leakage of the ultrasound gel 44 (e.g., FIGS. 2 and 3). The passages 40b and 40c are attached to the orientation pin 26. In one embodiment, the orientation pin 26 may be formed from a single continuous pin of material formed into a U-shape, as shown in FIGS. 2-4.

[0015] The orientation pin 26 may be made of nitinol, stainless steel, stainless steel braid, or a similar material with ultrasound-reflective properties. The orientation pin 26 may have echogenic properties for reflecting ultrasound signals transmitted from the ultrasound probe, thus providing a shading effect similar to a "headlight" in the ultrasound image. The headlight effect indicates where the medical device 30 exits the angled groove 42. The orientation pin 26 may include reflective features (e.g., etchings or grooves) to increase the echogenicity of the pin 26. As described above, the orientation pin 26 is flexible and returns to its original shape after being bent. The orientation pin 26 may be secured within the sheath 32 to help hold the angled donut portion 34 and the tip donut portion 36 in place. The orientation pin 26 may have various shapes, such as circular, oval, or rectangular, with multiple passages of similar shapes.

[0016] FIG. 5 is similar to FIG. 4 except that pin 26-1 is two separate pins.

[0017] FIG. 6 is similar to FIG. 5 , except that the angled donut portion 34-1 and the tip donut portion 36-1 have different configurations. The tip donut portion 36-1 includes one or more slits 72 along the pin passages 40-1b, 40-1c. The slits 72 can be crimped after each of the orientation pins 26-1 is inserted into its respective passage 40-1b, 40-1c. A crimping or peening process is used to apply force between the tip donut portion 36-1 and the orientation pin 26-1. In one embodiment, after the orientation pin 26-1 is inserted into the passages in place, a cryogenic press-fit operation is performed to apply a securing force to the angled donut portion 34-1 and the tip donut portion 36-1. In one embodiment, a laser spot weld may be applied between the pin 26-1 and the angled donut portion 34-1 through the slits 72 and the cavity 70 and / or the tip donut portion 36-1.

[0018] 7 shows a portion of the sheath 32 attached to the intraluminal tip 21. As previously described, the sheath 32 includes multiple lumens, e.g., four lumens 33a, 33b, 33c, and 33d, which respectively receive various components, such as the medical device 30, the orientation pin 26, and the ultrasound probe 22. For example, each of the orientation pins 26 is fixed within lumens 33a and 33b, while the ultrasound probe 22 slidably passes through lumen 33c. The medical device 30 slidably passes through lumen 33d. The sheath 32 extends from a handle portion (not shown). All of the lumens 33a, 33b, 33c, and 33d are accessible through the distal face of the sheath 32. Lumens 33c and 33d extend to a proximal port located in the handle (such as a port on the handle of a bronchoscope or other scoping device) or to a proximal port (not shown) located at a location accessible by the operator or medical professional. Lumens 33c and 33d allow a device to be inserted from the proximal end all the way to the distal end of sheath 32. As mentioned above, radial probe (i.e., ultrasound) lumen 33c is sized to slidably receive radial ultrasound probe 22, as best seen in FIG. 8 . Sheath 32 is made of a flexible material, such as a braided (stainless steel) sheath with a PTFE liner within the lumen, and a thermoplastic elastomer material (e.g., Pebax® material) that constitutes the sheath body and outer jacket. Sheath 32 and intraluminal tip 21 are joined together via orientation pin 26 and / or sleeve 28, which are made of a thermoplastic elastomer material, such as Pebax®, that provides a strong joining mechanism.

[0019] FIG. 8 illustrates an example of a portion of a lung body 60 in which the distal end of the elongated access device 20 and bronchoscope 12 are engaged for sampling a tissue target or peripheral tumor 62 located off to one side of the airway. FIG. 9 illustrates an example image generated by a radial ultrasound probe 22 used with the components shown in FIGS. 1-8. The distal end of the elongated access device 20 is flexible and can be moved through the articulating bronchoscope 12. As previously mentioned, the sleeve 28 creates an ultrasound window that encloses the ultrasound probe 22 surrounded by ultrasound gel 44, so that during a procedure, when the ultrasound window of the tip 21 is in contact with the tissue target 62 or the airway wall, with no air gap between them, ultrasound signals are transmitted directly into the target 62. It should be noted that the orientation pin 26 is visible on the ultrasound image 90 during the procedure and is used to ensure that the medical device 30 protrudes from the sheath 32 in the correct location relative to the tissue target 62 for biopsy.

[0020] When the radial ultrasonic probe 22 is positioned within the tip 21, it can generate a 360° image. The 360° image includes a reflection of the orientation pin 26. Because the orientation pin 26 is located in the same half of the first lumen 33c, any medical device 30 passing through the second lumen 33d will then interact with the target 62, visually located on the 360° image, between the shortest arc distance between the reflections of the orientation pin 26, as best seen in FIG. 9. As discussed above, the disclosed technology uses an echogenic orientation pin 26 that is visible on the ultrasound image and thus alerts the user to the rotational orientation of the distal end of the access device 20 and the medical device 30 relative to the target 62. Furthermore, one advantage of the disclosed technology is that during operation, ultrasound signals are transmitted directly into the target 62 when the ultrasound window is in contact with the target 62 or the airway wall, with no air gap between them.

[0021] Continuing with reference to FIG. 8, in operation, and by way of non-limiting example, the bronchoscope 12 is advanced through the trachea of ​​a patient or other subject into a bronchial passageway near the target 62. The elongated access device 20 of FIG. 2 (e.g., sheath 32 and endoluminal tip 21) is advanced distally through one of the lumens of the bronchoscope 12 and beyond to provide an ultrasound image of the bronchial airway. As the endoluminal tip 21 approaches the target 62, the ultrasound probe 22 provides an ultrasound image of the peripheral target 62, as best seen in FIG. 9. With the ultrasound probe 22 in ultrasonic contact with the peripheral target 62, the user or medical professional orients the tip 21 so that an observation image indicative of feedback associated with the tissue target 62 is located within the echo shadow produced by the reflection of the ultrasound signal of the pin 26, and then advances the medical device 30 distally through the passageway 31d. As mentioned above, the ultrasound probe 22 is configured to engage the endoluminal tip 21 to ensure that the orientation of the medical device 30 is aimed directly at the biological tissue target during operation. Finally, after the biopsy or other procedure is completed, the medical device 30 is then retracted into the sheath 32 and the distal end of the elongated access device 20 is retracted proximally into the bronchoscope 12 and removed from the patient.

[0022] Referring back to FIG. 9, an image 90 is shown output on the display device 18. The image 90 is generated by the radial ultrasound system 16 (FIG. 1) when the insertion tube 14, with an ultrasound transducer received at its distal end, is positioned within a body cavity, such as the lung body 60 shown in FIG. 8. The image 90 shows an image from a 360° imaging mechanism. The image 90 also includes feedback 92 identifying the orientation pins 26. The passage 33d is located between the orientation pins 26, where the arc between the pin feedback 92 is minimal. Therefore, an operator or user, typically a medical professional, will know that any medical device 30 exiting the passage 33d and the ramp 42 will always exit around this minimal arc. In the image 90, the medical device 30 will exit the tip 21 between approximately 350° and 080°. In the image 90, 000° is considered to be the 12 o'clock position. Thus, when a target is identified in the radial ultrasound image, all the user needs to do to interact with the medical device with that target 62 is to rotate the sheath 32 via the handle until the target 62 is located within the smallest pie of the 360° image, as outlined by the orientation pin feedback 92.

[0023] Furthermore, in one embodiment, the disclosed technology relates to a method for fabricating an intraluminal tip section 21 attached to a sheath 32. The method includes forming, by molding, machining, or printing, a beveled donut section 34 and a tip donut section 36, each having a first plurality of passages 38a, 38b, 38c and a second plurality of passages 40a, 40b, and 40c, respectively. An orientation pin 26 is then inserted through each of the second plurality of passages 38a, 38b, 38c and 40a, 40b, and 40c. The pin 26 is then attached to the donut sections 34 and 36. A mandrel (not shown) is used to fabricate a sleeve 28 by forming a thermoplastic elastomer material over each beveled donut section 34 and tip donut section 36, over the orientation pin 26, and over at least a portion of the mandrel. The formed thermoplastic elastomer material may be thermally reflowed onto a portion of the sheath 32, thus bonding the tip portion 21 to the sheath 32. Other bonding methods may be used, such as gluing pins 26 into respective lumens within the sheath 32. Next, the ultrasonic probe 22 is inserted through one of the first plurality of passages 38 a of the angled donut portion 34, and ultrasound gel 44 is injected through one of the second plurality of passages 40 a of the tip donut portion 36, providing a bottoming point for the inserted ultrasonic probe 22, which blocks one of the second plurality of passages of the tip donut portion 36 to prevent the ultrasound gel 44 from leaking out.

[0024] 10-17 show an alternative distal tip 120. The distal tip 120 is attached to the distal end of the sheath 122 by an oversleeve 130. The distal tip 120 includes a distal cap 126 that allows ultrasound gel to be inserted into the ultrasound probe cavity. The distal tip 120 includes a proximal hub 124 that receives the ultrasound probe and allows it to pass into the ultrasound probe cavity. The distal tip 120 also includes an orientation pin 128 that connects to the distal cap 126 and hub 124 and may be received / connected to a lumen within the sheath 122. The orientation pin 128 may be glued (e.g., with epoxy), insert molded, and / or press-fit into the hub 124, cap 126, and / or sheath 122.

[0025] The cap 126 has a rounded distal surface for atraumatic tissue interaction. A lumen 152 extends from the rounded distal surface to the proximal surface. The lumen 152 is a port for receiving ultrasound gel from an insertion device (e.g., a syringe). The cap 126 also includes a rounded interior surface on its proximal side, which is sized to allow docking of the distal end of an ultrasound probe.

[0026] Hub 124 includes two lumens 162 for receiving orientation pins 128, an ultrasound probe passageway 160, a beveled locking lumen 164, and a beveled lumen 138 that connects to beveled locking lumen 164. An instrument exit port is located on the side of hub 124 in beveled lumen 138. Hub 124 and cap 126 may be molded plastic or an equivalent material.

[0027] As shown in FIGS. 14-17 , the tilt device 140 is received within the tilt lumen 138 and the locking lumen 164. As shown in FIG. 14 , the tilt device 140 includes a distal section 174, a tilt section 170, and a proximal section 172. The distal section 174 has an elliptical cross-section. The locking lumen 164 has an elliptical cross-sectional configuration that corresponds to the configuration of the distal section 174. Thus, the distal section 174, when seated within the tilt locking lumen 164, limits rotation of the distal section 174 within the tilt locking lumen 164, thus properly aligning the tilt section 170 within the hub 124. Other shapes of locking components can be used to provide this anti-rotation mechanism.

[0028] The tilt device 140 is positioned longitudinally within the hub 124 in the angled lumen 138 such that the distal edge of the periphery of the angled section 170 is positioned proximal to the distal edge of the instrument exit port of the hub 124 and the proximal edge of the periphery of the angled section 170 is positioned proximal to the proximal edge of the instrument exit port. The proximal and / or distal edges of the instrument exit port may be angled (i.e., not perpendicular to the longitudinal axis of the hub 124) to facilitate easier exit of an instrument such as a sampling needle. The tilt device 140 may be made of molded / machined metal or plastic.

[0029] 15-17, sheath 122 includes probe lumen 182 and instrument lumen 184. Instrument liner 180 surrounds instrument lumen 184. Instrument liner 180 extends beyond the distal surface of sheath 122. Proximal section 172 of tilt device 140 has an inner diameter that is the same as or larger than the outer diameter of instrument liner 180. Instrument liner 180 is received by proximal section 172 of tilt device 140 and secured thereto by one of pressure / snap fit, adhesive, or some other means.

[0030] In one embodiment, an oversleeve material (e.g., Pebax®) 130 is applied (i.e., thermally reflowed via a heat source (e.g., laser)) over the proximal relief / flange portion of the hub 124 and the distal relief / flange portion of the sheath 122. In one embodiment, a gap is included between the distal end of the sheath 122 and the proximal end of the hub 124. This increases flexibility between the tip 120 and the sheath 122. A distal oversleeve or ultrasound window 132 is applied to the proximal relief / flange section of the distal tip 126 and the distal relief / flange section of the hub 124 in a manner similar to the oversleeve 130 on the orientation pin 128. The oversleeves 130, 132 may be glued and / or thermally reflow bonded to the relief / flange sections. The orientation pin 128 may extend proximally from the hub 124 and into a receiving cavity in the sheath 122 to provide greater rigidity between the components.

[0031] Unlike the embodiment shown in Figures 10-17, as shown in Figure 18, the distal tip 198 and proximal hub 195 are primarily formed from injection molded material 192, which houses an orientation pin 194, a ramp 196 extending from the instrument lumen (i.e., needle liner) of the sheath 200, and a probe (i.e., ultrasound) lumen 197 extending from the probe lumen of the sheath 200. The ramp 196 may be formed from the distal end of the needle liner. The reflowed material 192 is molded / formed to form the orientation pin 194, the ultrasound liner 197, and a support for the ramp 196. The reflowed material 192 also forms a distal cap 198 shaped similarly to the cap 126 of Figure 10.

[0032] 19 , the distal tip 204 includes a hub 206, a distal cap 208 partially surrounded by a first heat-reflow material 210 between the hub 206 and the cap 208, and a second heat-reflow material 212 between the hub 206 and the sheath 200. The hub 206 supports a ramp 214 that extends from the instrument lumen of the sheath 200. The hub 206 may also support a liner that extends from the probe lumen of the sheath 200. A pin connects between the hub 206 and the cap 208 and is surrounded by the material 210. The hub 206 and / or the cap 208 are insert molded into the oversleeve material 210, 212.

[0033] As shown in FIG. 20 , the distal tip 220 is similar to the distal tip 204 shown in FIG. 19 , except that the outer diameter of the hub 222 is reduced to allow a single heat reflow material 224 to extend from a distal cap 226 on the hub 222 to the sheath 200. A lip 228 surrounds the exit port. The lip 228 has a larger radius from the centerline of the hub 222 than the remainder of the hub 222. The hub 222 supports a ramp 230 that extends from the instrument channel of the sheath 200.

[0034] 21 shows a distal tip 236 that is similar to the distal tip 204 shown in FIG. 19, except that the tilting device does not extend from the sheath 200. The tilting mechanism 238 is formed or machined into the hub 240.

[0035] 22 shows a distal tip 250 similar to the distal tip 220 shown in FIG. 20, except that the tilting device does not extend from the sheath 200. The tilting mechanism 252 is formed or machined into the hub 254.

[0036] FIG. 23 shows an x-ray view of an exemplary distal tip 318 attached to a sheath 319. The distal tip 318 is similar to the distal tip 120 shown in FIGS. 10-17. The distal tip 318 includes a hub 320, a distal tip 350, and a pair of orientation pins 352. The pins 352 are attached between the distal tip 350 and the hub 320 to define a space for receiving an ultrasonic probe. The hub 320 includes a probe lumen 322 and an instrument lumen 324 that receives a tilting device 340. As shown in FIGS. 23-27, the tilting device 340 includes a proximal hollow section 342, a distal end 344, a tilting section 346, and a distal protrusion 348. The distal protrusion 348 may be integral with the other section of the tilt device 340 or may be a separate piece mounted within a cavity in the distal section 344 of the tilt device 340 .

[0037] Hub 320 includes an instrument window 326, which is the exit port for instrument lumen 324. Instrument lumen 324 transitions distally into a smaller projection lumen 330. Tilt device 340 is received within instrument lumen 324 with distal projection 346 received within lumen 330.

[0038] 28 shows a side x-ray view of a dual lumen sheath 400 having a beveled first lumen at its distal end for slidably receiving a needle 404. The dual lumen sheath 400 includes a second lumen that opens to the distal end of the sheath 400. The second lumen slidably receives a radial ultrasound probe 402. A flexible balloon 410 is located outside the sheath 400, just proximal to the beveled section of the first lumen. The balloon 410 is provided with a third lumen (not shown).

[0039] First, the sheath 400 is advanced into the airway 406 adjacent to the target 408, and then the balloon 410 is inflated to seal the airway 406. Next, a fluid (e.g., saline) 424 or another material that propagates ultrasound signals is inserted into the airway 406 via the needle 404 through the first or second lumen of the sheath 400. The ultrasound probe 402 is then advanced beyond the distal end of the sheath 400. The fluid 424 is held within the airway 406 by the isolation balloon 410, allowing the ultrasound signal 412 to propagate to the target 408.

[0040] A further aspect of the disclosed technology relates to a method for fabricating an intraluminal tip configured to be attached to a sheath. The method includes forming, by molding or machining, a beveled donut section and a tip donut section, each having a first plurality of passages and a second plurality of passages. An orientation pin is then inserted through the passages. A tilting mechanism is inserted into the beveled lumen of the beveled donut section to stabilize movement of the tilting mechanism. The tip section is then attached to a mechanism of the sheath via the tilting mechanism. Using a mandrel (not shown), a thermoplastic elastomer material is formed over at least a portion of each beveled donut section and tip donut section, the orientation pin, at least a portion of the mandrel, and at least a portion of the sheath, creating an elongated sleeve. Next, an ultrasound probe is inserted through one of the first plurality of passages in the angled donut portion, and ultrasound gel is injected through one of the second plurality of passages in the tip donut portion to provide a bottoming point for the inserted ultrasound probe, which blocks one of the second plurality of passages in the tip donut portion to prevent the ultrasound gel from leaking out.

[0041] A. An elongated access device for use in a medical system having respective proximal and distal ends, the elongated access device having a medical implement and an ultrasonic probe disposed therein, the distal end of the elongated access device comprising: a sheath comprising a first lumen configured to receive the ultrasonic probe, a second lumen configured to receive the medical implement, a lumen liner configured to extend beyond a distal surface of the sheath, and a tip configured to be attached to the sheath, the tip comprising: at least one coupling device, a hub having a probe lumen and a sloped lumen, a nose device, and a sloped device configured to be received within the sloped lumen and configured to receive at least a portion of the lumen liner.

[0042] B. The device described in A, wherein the tilt device comprises a proximal end having a lumen, a distal end, and a tilt section located between the proximal and distal ends, the tilt section comprising an outlet port and a tilt portion in fluid communication with the lumen of the proximal end.

[0043] C. The device of A or B, wherein the hub comprises a proximal end, a distal end, and an exit port located between the proximal and distal ends of the hub adjacent the angled lumen.

[0044] D. The device described in C, wherein the angled lumen comprises a first lumen configured to receive the proximal end and angled section of the angled device, and a second lumen configured to receive the distal end of the angled device.

[0045] E. The device of D, wherein the distal end of the tilt device received within the second lumen limits movement of the tilt device relative to the hub.

[0046] F. The device of E, wherein the distal end of the tilt device and the second lumen have an elliptical cross-sectional configuration.

[0047] G. A device described in any of A-F, wherein the hub comprises a proximal end having a proximal section and a distal section (the proximal section having an outer diameter smaller than the outer diameter of the distal section), and a distal end having a proximal section and a distal section (the distal section having an outer diameter smaller than the outer diameter of the proximal section).

[0048] H. The device described in G, wherein the nose device comprises a proximal section, a distal section, and a central section located between the proximal and distal sections of the nose device, and the proximal section has an outer diameter smaller than the outer diameter of the central section.

[0049] I. The device of H, wherein the sheath comprises a proximal section and a distal section, the distal section having an outer diameter smaller than the outer diameter of the proximal section.

[0050] J. The device of I, wherein the at least one coupling device comprises a proximal oversleeve and a distal oversleeve, the proximal oversleeve being at least one of adhesively bonded, insert molded, or thermally bonded to the distal section of the sheath and the proximal section of the proximal end of the hub, and the distal oversleeve being at least one of adhesively bonded, insert molded, or thermally bonded to the distal section of the distal end of the hub and the proximal section of the nose device.

[0051] K. A device described in any of H-J, wherein the distal section of the nose device is rounded for atraumatic tissue interaction.

[0052] L. A device described in any of H-K, wherein the nose device has a longitudinal axis and includes a port configured to receive ultrasound gel.

[0053] M. A device described in any of H-L, wherein the nose device has a proximal surface configured to mate with the distal end of an ultrasound probe.

[0054] N. The apparatus of any of A-M, wherein the nose device and at least one oversleeve form a monolithic material.

[0055] O. A device described in any of A-N, wherein the tip further comprises one or more orientation pins configured to be engaged with the hub and nose device and at least partially encased by at least one oversleeve.

[0056] P. A medical device comprising: a sheath comprising: a sheath having a first lumen configured to receive an imaging device, a second lumen configured to receive a medical implement, a lumen liner configured to extend beyond a distal surface of the sheath; a tip configured to attach to the sheath, the tip comprising: at least one oversleeve; a hub having a proximal end, a distal end, a beveled lumen, an exit port located between the proximal and distal ends of the hub adjacent the beveled lumen, and a probe lumen; a nose device; and a beveled device configured to be received within the beveled lumen and to receive at least a portion of the lumen liner, the beveled device having a proximal end with a lumen, a distal end, and a beveled section located between the proximal and distal ends of the beveled device, the beveled section comprising an exit port and a beveled section in fluid communication with the lumen of the proximal end.

[0057] Q. The medical device of P, wherein the angled lumen comprises a first lumen configured to receive the proximal end and angled section of the angled device, and a second lumen configured to receive the distal end of the angled device and limit movement of the angled device relative to the hub.

[0058] R. The medical device of Q, wherein the distal end of the tilt device and the second lumen have an elliptical cross-sectional configuration.

[0059] S. The hub comprises a proximal end having a proximal section and a distal section, the proximal section having an outer diameter smaller than the outer diameter of the distal section, and a distal end having a proximal section and a distal section, the distal section having an outer diameter smaller than the outer diameter of the proximal section; the nose device comprises a proximal section, a distal section, and a central section located between the proximal and distal sections of the nose device, the proximal section of the nose device having an outer diameter smaller than the outer diameter of the central section; the sheath comprises a proximal section and a distal section, the distal section A medical device described in any of P to R, wherein the proximal section has an outer diameter smaller than the outer diameter of the proximal section, and at least one oversleeve comprises a proximal oversleeve and a distal oversleeve, wherein the proximal oversleeve is attached to the distal section of the sheath and the proximal section of the proximal end of the hub by at least one of adhesive or thermal bonding, and the distal oversleeve is attached to the distal section of the distal end of the hub and the proximal section of the nose device by at least one of adhesive or thermal bonding.

[0060] T. A medical device as described in any of P to S, wherein the tip further comprises one or more orientation pins configured to be engaged with the hub and nose device and at least partially encased by at least one oversleeve.

[0061] While various embodiments of the disclosed technology have been described above, it should be understood that they are presented by way of example only, and not limitation. Similarly, various figures may depict exemplary or other configurations for the disclosed technology, which aid in understanding features and functionality that may be included in the disclosed technology. The disclosed technology is not limited to the structure or configuration of the illustrated exemplary embodiment, but desired features may be implemented using a variety of alternative structures and configurations. Indeed, it will be apparent to those skilled in the art how alternative functional, logical, or physical distributions and configurations can be implemented to implement desired features of the technology disclosed herein. Also, many different component names other than those shown herein may be applied to various components. Furthermore, with respect to flowcharts, operational descriptions, and claimed methods, the order in which the steps described herein are presented does not require that various embodiments be practiced to perform the recited functions in the same order, unless the context dictates otherwise.

[0062] While the disclosed technology has been described above in terms of various exemplary embodiments and implementations, it should be understood that various features, aspects, and functions described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment for which they are described, but may be applied alone or in various combinations to one or more other embodiments of the disclosed technology, whether or not such an embodiment is described and whether or not such features are presented as part of a described embodiment. Thus, the breadth and scope of the technology disclosed herein should not be limited by any of the exemplary embodiments described above.

[0063] Terms and phrases used herein, and variations thereof, unless expressly stated otherwise, should be construed as open-ended, as opposed to limiting. For example, the term "including" should be read to mean "including without limitation," etc. The term "example" is used to provide illustrative instances of items under description, but is not exhaustive or limiting the enumeration thereof; the terms "a" or "an" should be read to mean "at least one," "one or more," etc.; and terms such as "conventional," "traditional," "normal," "standard," "known," and similar terms should not be construed as limiting items to those described or available at a given time, but instead should be read to encompass conventional, traditional, usual, or standard technology that may be available or known at any time now or in the future. Similarly, when this document refers to technology that would be apparent or known to one of ordinary skill in the art, such technology encompasses technology that would be apparent or known to one of ordinary skill in the art now or at any time in the future.

[0064] In some cases, the presence of broader words and phrases such as "one or more," "at least," "but not limited to," or other similar phrases should not be read to imply that a narrower case is intended or required by the circumstances in the absence of such broader phrase. [Explanation of symbols]

[0065] 120 Distal tip 122 Sheath 124 Proximal Hub 128 Orientation Pin 126 Distal Cap 152 Lumen 162 Lumen 164 Slanted locking lumen 21 Tip 22 Ultrasound probe 26 Orientation pin 28 sleeve 29 Openings / Ports 30 Medical Devices 32 Sheath 33a, 33b, 33c, 33d lumen 34 Inclined donut section 36 Tip donut part 38a, 38b, 38c aisles 40a, 40b, 40c aisle 42 Slant groove 70 hollow 72 Slit

Claims

1. 1. An elongated access device for use in a medical system, the elongated access device having a proximal end and a distal end, the elongated access device having a medical implement and an ultrasound probe disposed therein, the elongated access device comprising: A sheath, a first lumen configured to receive the ultrasound probe; a second lumen configured to receive the medical device; and a luminal liner configured to extend beyond a distal surface of the sheath; a sheath comprising: a tip configured to be attached to the sheath, at least one coupling device; a hub comprising a probe lumen and a beveled lumen; a nose device; a tilting device configured to be received within the tilted lumen and configured to receive at least a portion of the lumen liner; a tip portion comprising:

1. An elongated access device comprising:

2. The tilting device is a proximal end portion having a lumen; a distal end; and 10. The device of claim 1, further comprising: a sloped section located between the proximal end and the distal end, the sloped section comprising an outlet port and a sloped portion in fluid communication with the lumen of the proximal end.

3. The hub is a proximal end; a distal end; and 3. The device of claim 2, further comprising an exit port located between the proximal and distal ends of the hub adjacent the angled lumen.

4. The angled lumen is a first lumen configured to receive the proximal end and the tilt section of the tilt device; and a second lumen configured to receive the distal end of the tilt device.

5. The device of claim 4 , wherein the distal end of the tilt device received within the second lumen of the tilt lumen limits movement of the tilt device relative to the hub.

6. The device of claim 5 , wherein the distal end of the tilt device and the second lumen of the tilt lumen have an elliptical cross-sectional configuration.

7. The hub is a proximal end portion having a proximal section and a distal section, the proximal section having an outer diameter smaller than an outer diameter of the distal section; The device of claim 1 , comprising a distal end portion having a proximal section and a distal section, the distal section having an outer diameter smaller than an outer diameter of the proximal section.

8. 8. The device of claim 7, wherein the nose device comprises a proximal section, a distal section, and a central section located between the proximal and distal sections of the nose device, the proximal section having an outer diameter smaller than an outer diameter of the central section.

9. The device of claim 8 , wherein the sheath comprises a proximal section and a distal section, the distal section having an outer diameter smaller than an outer diameter of the proximal section.

10. the at least one coupling device comprises a proximal oversleeve and a distal oversleeve; the proximal oversleeve is at least one of glued, insert molded, or thermally bonded to the distal section of the sheath and the proximal section of the proximal end of the hub; 10. The device of claim 9, wherein the distal oversleeve is at least one of glued, insert molded, or thermally bonded to the distal section of the distal end of the hub and the proximal section of the nose device.

11. The device of claim 8 , wherein the distal section of the nose device is rounded for atraumatic tissue interaction.

12. The device of claim 8 , wherein the nose device has a longitudinal axis and includes a port configured to receive ultrasound gel.

13. The device of claim 8 , wherein the nose device comprises a proximal surface configured to mate with a distal end of the ultrasound probe.

14. The tip portion is The device of claim 1 , further comprising one or more orientation pins configured to be engaged with the hub and the nose device, the orientation pins being at least partially encased by at least one oversleeve.

15. A medical device, comprising: A sheath, a first lumen configured to receive an imaging device; a second lumen configured to receive a medical device; and a sheath comprising: a lumen liner configured to extend from the second lumen beyond a distal surface of the sheath; a tip configured to be attached to the sheath, at least one oversleeve; It is a hub, a proximal end; a distal end; and a sloped lumen; an exit port located between the proximal end and the distal end of the hub adjacent the angled lumen; a hub comprising a probe lumen; a nose device; a tilting device configured to be received within the tilted lumen and configured to receive at least a portion of the lumen liner, a proximal end portion having a lumen; a distal end; and a tilt device comprising: a tilt section located between the proximal end and the distal end of the tilt device, the tilt section comprising an outlet port and a tilt portion in fluid communication with the lumen of the proximal end; a tip portion comprising: A medical device comprising:

16. The angled lumen is a first lumen configured to receive the proximal end and the angled section; a second lumen configured to receive the distal end of the tilt device and limit movement of the tilt device relative to the hub.

17. 17. The medical device of claim 16, wherein the distal end of the tilt device and the second lumen of the tilt lumen have an elliptical cross-sectional configuration.

18. The hub is a proximal end portion having a proximal section and a distal section, the proximal section having an outer diameter smaller than an outer diameter of the distal section; a distal end portion having a proximal section and a distal section, the distal section having an outer diameter smaller than an outer diameter of the proximal section; the nose device comprises a proximal section, a distal section, and a central section of the nose device located between the proximal and distal sections, the proximal section of the nose device having an outer diameter smaller than an outer diameter of the central section; the sheath comprising a proximal section and a distal section, the distal section having an outer diameter smaller than an outer diameter of the proximal section; the at least one oversleeve comprising a proximal oversleeve and a distal oversleeve; the proximal oversleeve is at least one of adhesively or thermally bonded to the distal section of the sheath and the proximal section of the proximal end of the hub; 16. The medical device of claim 15, wherein the distal oversleeve is at least one of adhesively or thermally bonded to the distal section of the distal end of the hub and the proximal section of the nose device.

19. The tip portion is 16. The medical device of claim 15, further comprising one or more orientation pins configured to engage the hub and the nose device, the orientation pins being at least partially encased by the at least one oversleeve.

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