Catheter port

Abstract

The present disclosure provides medical devices for facilitating the introduction, removal, and / or exchange of accessories and / or tools, such as guidewires.SOLUTION: In one embodiment, a catheter port for introducing an accessory comprises a body comprising a proximal end, a distal end, a longitudinal axis extending through the body, and a main channel extending along the longitudinal axis along a length of the body. The main channel may be substantially coaxial with the lumen of the catheter. The extension can extend from the body. The extension may include an accessory channel extending through the extension. The accessory channel may be in fluid communication with the main channel. The accessory channel may be configured to receive an accessory. The positive stop may be disposed along the accessory channel. The positive stop can be configured to abut a distal end of the accessory.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of medical devices, and more particularly to medical devices for facilitating the introduction, removal, and / or exchange of accessories and / or tools, such as guidewires, within catheters. [Background technology]

[0002] In some medical procedures, a catheter may be inserted into a patient with and / or along a guidewire for treatment. The guidewire may be introduced through or along a catheter or other device prior to or during the procedure. The guidewire may be cumbersome to orient and introduce during insertion into a device, system, and / or patient.

[0003] Furthermore, if a second catheter or other medical device is required during a procedure, an exchange of the catheter or other device may be necessary. Exchange may involve, for example, removing a first catheter from the endoscope over a guidewire and advancing a second catheter or device over the guidewire to the desired treatment site. To maintain a grip on the proximal end of the guidewire or other tool to control the procedure, the portion of the guidewire that remains outside the patient may need to be longer than the length of the first catheter that is removed. Therefore, medical systems suitable for these procedures may require the use of excessively long guidewires, which can be cumbersome to operate, clutter the operating room, and / or increase procedure times to accommodate complex device exchanges.

[0004] Thus, a variety of beneficial medical outcomes may be achieved with the devices, systems, and methods of the present disclosure. Summary of the Invention

[0005] In one aspect of the present disclosure, a catheter port for introducing an accessory includes a body having a proximal end, a distal end, a longitudinal axis extending through the body, and a main channel extending along the longitudinal axis along the length of the body. The main channel may be substantially coaxial with a lumen of the catheter. An extension may extend from the body. The extension may include an accessory channel extending therethrough. The accessory channel may be in fluid communication with the main channel. The accessory channel may be configured to receive an accessory. A positive stop may be disposed along the accessory channel. The positive stop may be configured to abut a distal end of the accessory. A slit may extend from the distal end of the body to the proximal end of the body. The slit may extend through the extension. The slit may be in fluid communication with the accessory channel.

[0006] In the described and other aspects of the present disclosure, the slit may be configured to accept a tool that can be removed laterally from the main channel, through the slit, and out of the catheter port. The extension may include a pair of guides disposed on either side of the slit along the body about the longitudinal axis. The body may include a thinned portion along the wall of the main channel. The thinned portion is disposed along the length of the body opposite the slit, and the body and the pair of guides may include an open configuration in which the pair of guides are spaced apart about the thinned portion, and a closed position in which the pair of guides are positioned toward each other about the thinned portion. The accessory channel may have a larger transverse width dimension at the proximal portion and a smaller transverse width dimension at the distal portion. The proximal end of the accessory channel may have a funnel shape with a larger maximum transverse width dimension than the remainder of the accessory channel. The main channel may further include at least one of a distal shoulder configured to abut the distal end of the catheter opening and a proximal shoulder configured to abut the proximal end of the catheter opening. The positive stop may include an annular opening having a diameter tangent to the outer diameter of the accessory and large enough to accommodate the diameter of a tool positioned within the accessory. The extension may include at least one recess along an outer surface of the extension. The extension may include a flap forming a funnel shape extending laterally from the body along the body. The flap may have a lateral width dimension of the funnel shape toward the proximal end that is greater than the lateral width dimension of the funnel shape toward the distal end. The slit may be disposed along a distal proximal end of the flap. The slit may be disposed laterally along the funnel shape. The flap may further include a thinned portion along a wall of the flap. The thinned portion may extend along the flap where the flap extends laterally from the body.

[0007] In one aspect of the present disclosure, a catheter port for introducing an accessory may include a body having a proximal end, a distal end, a longitudinal axis extending through the body, and a main channel extending along the longitudinal axis along the length of the body. The main channel may be substantially coaxial with a lumen of the catheter. An extension may extend from the body. The extension may include an accessory channel extending therethrough. The accessory channel may be in fluid communication with the main channel. The accessory channel may be configured to receive an accessory. A positive stop may be disposed along the accessory channel. The positive stop may include an annular opening having a diameter tangent to the outer diameter of the accessory and large enough to receive the diameter of a tool disposed within the accessory.

[0008] In the described and other aspects of the present disclosure, the slit may extend from the distal end of the body to the proximal end of the body. The slit may extend through the extension and be in fluid communication with the accessory channel. The extension may include a pair of guides disposed on either side of the slit along the body about the longitudinal axis. The accessory channel may have a larger dimension at the proximal portion and a smaller dimension at the distal portion. The extension may include a flap forming a funnel shape along the body. The flap may have a larger dimension of the funnel shape toward the proximal end and a smaller dimension of the funnel shape toward the distal end. The slit may be disposed along the terminal end of the flap. The slit may be disposed laterally along the funnel shape.

[0009] In one aspect of the present disclosure, a catheter system may include a catheter port. The catheter port may include a body. The body may have a proximal end, a distal end, a longitudinal axis extending through the body, and a main channel extending along the longitudinal axis along the length of the body. An extension may extend from the body. The extension may include an accessory channel extending therethrough. The accessory channel may be in fluid communication with the main channel. A positive stop may be disposed along the accessory channel. A catheter may be disposed through the main channel. The accessory may be insertable into the accessory channel such that the accessory abuts the positive stop.

[0010] In the described and other aspects of the present disclosure, the main channel may include a shoulder configured to extend into the lumen of the catheter such that the shoulder abuts the end of the radial opening of the catheter. The catheter port may include a slit extending from the distal end of the body to the proximal end of the body. The slit may extend through the extension. The slit may be in fluid communication with the accessory channel. The extension may include flaps forming a funnel shape along the length of the body, the flaps having a larger dimension of the funnel toward the proximal end and a smaller dimension of the funnel toward the distal end. [Brief explanation of the drawings]

[0011] Non-limiting examples of the present disclosure will be described with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each of the identical or nearly identical components shown is typically represented by a single numeral. For purposes of clarity, not every component will be labeled in every figure, and not every component in each embodiment of the present disclosure will be shown unless illustration is necessary to enable those skilled in the art to understand the disclosure. [Figure 1A] FIG. 1 is a perspective view of a catheter being removed from a guidewire in accordance with an embodiment of the present disclosure. [Figure 1B] FIG. 1B is a perspective view of a guidewire being introduced into the port of FIG. 1A. [Figure 2] FIG. 10 is a perspective view of a guidewire being introduced into a port in accordance with an embodiment of the present disclosure. [Figure 3] FIG. 1 is a perspective view of a port according to an embodiment of the present disclosure. [Figure 4A] FIG. 1 is a perspective view of a port according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B is a right side view of the port of FIG. 4A with an accessory disposed within the port. [Figure 4C] FIG. 4C is a perspective view of an accessory introducer in which the accessory of FIGS. 4A and 4B is placed. [Figure 5A] FIG. 1 is a perspective view of a port according to one embodiment of the present disclosure. [Figure 5B] FIG. 5B is another perspective view of the port of FIG. 5A. [Figure 6A] FIG. 1 is a perspective view of a catheter and port according to an embodiment of the present disclosure. [Figure 6B] FIG. 6B shows the radial openings of the catheter of FIG. 6A. [Figure 7A] FIG. 10 is a cross-sectional view of a guidewire being introduced through a port into an opening in a catheter, according to an embodiment of the present disclosure. [Figure 7B] 7B is a cross-sectional view of a guidewire being introduced into an opening in the catheter through the port of FIG. 7A and along different locations in the catheter. [Figure 8A] FIG. 10 is a right side view of a port according to an embodiment of the present disclosure. [Figure 8B] FIG. 8B is a perspective view of the port of FIG. 8A. [Figure 8C] FIG. 8C is a perspective view of the port of FIGS. 8A and 8B. [Figure 9A] FIG. 10 is a right side view of a port according to an embodiment of the present disclosure. [Figure 9B] FIG. 9B is a perspective view of the port of FIG. 9A. [Figure 9C] FIG. 9C is a perspective view of the port of FIGS. 9A and 9B. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present disclosure is not limited to the specific embodiments described. The terms used herein are intended only to describe specific embodiments and are not intended to limit the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which the present disclosure belongs. The detailed description should be read with reference to the drawings, which are not necessarily to scale and depict illustrative embodiments and are not intended to limit the scope of the present invention.

[0013] As used herein, "proximal end" refers to the end of a device along the device that is closest to a medical professional when the device is being introduced, removed, or replaced within a patient, and "distal end" refers to the end of a device or object along the device that is farthest from a medical professional during implantation, positioning, or delivery.

[0014] As used in this disclosure and the appended claims, the singular forms "a," "an," "the," and "said" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is used in its general sense including "and / or" unless the content clearly dictates otherwise.

[0015] References herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include that particular feature, structure, and / or characteristic. Furthermore, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly stated, unless expressly stated to the contrary.

[0016] As used herein, all numerical values ​​are deemed to be modified by the term "about," whether or not explicitly stated. The term "about" in the context of numerical values ​​generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" can include numerical values ​​that are rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) can be assumed to have the ordinary and customary definition understood from and consistent with the context of the specification, unless otherwise specified. The recitation of numerical ranges by upper and lower limits includes all numbers within that range, inclusive of the upper and lower limits (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0017] Although embodiments of the present disclosure are described with specific reference to catheters, guidewires, and funnel accessories, it should be understood that other medical devices and / or accessories may be used in various medical procedures. For example, a catheter or guidewire herein may instead be an endoscope, colonoscope, duodenoscope, sheath, working channel of a device, or the like.

[0018] Introducing a medical instrument, such as a guidewire, into a device, such as a catheter, can be cumbersome because the guidewire must enter the lumen of the catheter through a radial opening (e.g., as shown in FIG. 6 and described below), which can cause misalignment with the guidewire during introduction. Additionally, the guidewire may have a shape-memory curve (e.g., a J-curve distal end, as illustrated in FIG. 1B and described below). Embodiments of the presently disclosed ports can aid in introducing a guidewire or other tool into a catheter, as described herein.

[0019] In a procedure in which a medical professional desires to exchange a first device within a patient for a second device, the medical professional may need to withdraw the first device proximally from the patient over the guidewire until the distal end of the first device exits the patient. The medical professional may then introduce the second device over the guidewire toward the treatment area of ​​the patient. It may be desirable to exchange the first device for the second device in a more time-efficient manner and / or with a shorter travel distance over the guidewire. To aid in catheter exchange, the catheter may include a "rapid-exchange" feature. As used herein, "rapid-exchange" may refer to a feature of a device (e.g., a catheter, accessory introducer, or related component of a device or system) that reduces the travel distance, time required, or cumbersome effort to exchange a device within a patient compared to a device that does not have such a feature(s). For example, the rapid-exchange feature may include openings, slots, slits, channels, flaps, perforations, weakened regions, etc. along the length of the catheter and / or port, configured to allow lateral / radial removal of the catheter from around the guidewire (and / or vice versa). To exchange the catheter for another device while maintaining the position of the guidewire within the body, the catheter can be removed from the guidewire by separating it from the guidewire in such a way that the guidewire exits the catheter along the rapid-exchange feature (e.g., through a slit, etc.). The second catheter or device can then be advanced over the guidewire, for example, by inserting the proximal end of the guidewire into an opening in a guidewire lumen at the distal end of a second catheter and advancing it distally along the guidewire.

[0020] Various procedures may involve guidewire exchange. Guidewire exchange may be desirable, for example, when a first guidewire is too thick or too large to fit through a desired body lumen, or when the first guidewire includes a geometry that is otherwise lacking desired characteristics. In such circumstances, a medical professional may leave the catheter substantially in place, withdraw the first guidewire from the catheter, and insert a second guidewire through the catheter to the treatment site. During this procedure, the catheter guides the guidewire to the treatment site. Once the catheter is positioned at the treatment site, it is desirable to substantially maintain the catheter's position during the guidewire exchange procedure so that the second guidewire can be guided to the treatment site in the shortest possible time.

[0021] 1A, a perspective view of a catheter 130 being detached from a guidewire 140 is shown, in accordance with one embodiment of the present disclosure. The catheter 130 includes a port 100 along a proximal end of the catheter 130. The port 100 is substantially aligned with the longitudinal axis 1 of the catheter 130 and includes a main channel 102 in fluid communication with a lumen 134 of the catheter 130. The catheter 130 is detached from the guidewire 140 by moving the catheter 130 away from the guidewire 140 substantially in the direction of arrow 136, although additionally or alternatively, the guidewire 140 may be moved away from the catheter 130 in a direction substantially opposite to arrow 136. When the catheter 130 is removed from the guidewire 140, the guidewire 140 exits radially from the lumen 134 through the slit 108 in the port 100, and the guidewire exits radially from the lumen 134 along the catheter 130 through a rapid exchange mechanism 138 (e.g., a slit or other mechanism as described above).

[0022] Referring to FIG. 1B, a perspective view of a guidewire 140 being introduced into the catheter 130 of FIG. 1A is shown, according to one embodiment of the present disclosure. The guidewire 140 includes a distal end 142 having a shape-memory J-curve that can be cumbersome to insert into the port 100 and the lumen 134 of the catheter 130, although any shape of guidewire 140 may be employed. An accessory 150 having a funnel shape is inserted into the accessory channel 104 of the port 100 to help guide the guidewire 140. The accessory 150 includes a lumen 152 extending therethrough. The lumen 152 has a wider diameter at the proximal end 154 of the accessory 150 than at the distal end 154. The distal end 142 of the guidewire 140 may be introduced into the lumen 152 of the accessory 150. For example, the J-curve at distal end 142 can be substantially straightened by hooking the J-curve onto proximal end 154 and inserting guidewire 140 distally into accessory 150. As guidewire 140 is translated distally through lumen 152, guidewire 140 transitions along a wider portion of lumen 152 at proximal end 154 to a narrower portion of lumen 152 at distal end 156. The narrowing transition of lumen 152 can help guide guidewire 140 into accessory channel 104 of port 100. Continuing distal movement of guidewire 140 through accessory channel 104 can advance guidewire 140 into lumen 134 of catheter 130.

[0023] Referring to FIG. 2 , a perspective view of a guidewire 240 being introduced into a catheter 230 is shown, according to one embodiment of the present disclosure. An accessory 250, identical to accessory 150 of FIG. 1B , is inserted into accessory channel 204 of port 200 to assist in guiding guidewire 240. Accessory channel 204 of FIG. 2 has a wall formed on its inner surface that corresponds to the outer surface of accessory 250. The corresponding inner surface of accessory channel 204 may provide better support for accessory 150 compared to accessory channel 104 of FIG. 1B , which provides more loose support for accessory 250. For example, while accessory 150 may require assistance from a medical professional to effectively introduce guidewire 140 therein, accessory 250, due to the shape of accessory lumen 204, may not require any assistance from a medical professional to introduce guidewire 240 therein.

[0024] Referring to FIG. 3 , a perspective view of a port 300 according to one embodiment of the present disclosure is shown. The port 300 includes a body 306 having a proximal end 306 p, a distal end 306 d, and a longitudinal axis l extending therethrough. The port 300 is shown in an unassembled, open configuration in which the body 306 is opened along a hinge 316 extending along the body 306 parallel to the longitudinal axis l. The hinge 316 is a thinned portion of the wall of the body 306. The body 302 is closable along the hinge 316 to form a main channel 302 extending along the longitudinal axis l, which is configured to be coaxial with the lumen of the catheter. A protrusion 314 extends from the body 306 and is configured to mate with an opening 318 when the port 300 is transitioned to a closed configuration by closing the body 306 about the hinge 316. An extension 308 extends from the body 306. The extension 308 includes an accessory channel 304 extending therethrough. The accessory channel 304 is in fluid communication with the main channel 302 such that the accessory channel 304 can receive an accessory therein and guide the accessory toward the main channel 302. The accessory channel 304 is positioned along the extension 308 such that the accessory channel 304 merges with the main channel 302 distal to the protrusion 314 and the opening 318. The accessory channel 304 includes a positive stop 310 positioned along the accessory channel 304. The positive stop 310 is configured to abut against the distal end of an accessory introduced into the accessory lumen 304 to prevent the accessory from entering the main channel 302. The accessory lumen 304 includes a proximal portion 304p having a maximum lateral width dimension that is wider than the remainder of the accessory lumen 304, which may provide additional space for, for example, introducing an accessory into the accessory lumen 304.The intermediate portion 304m of the accessory lumen 304 has a smaller diameter than the proximal portion 304p and may be dimensioned, for example, to receive, house, interface with, correspond with, or friction fit an accessory. The positive stop 310 has a smaller diameter than the intermediate portion 304m. The positive stop 310 transitions from a larger diameter toward the intermediate portion 304m and tapers to a smaller diameter toward the distal portion 304d of the accessory channel 304. The tapering diameter of the positive stop 310 may help ensure that the distal end of the accessory forms an interference fit with the positive stop 310 as the accessory moves along the tapering diameter of the positive stop 310. Distal portion 304d provides a conduit for accessory channel 304 to fluidly communicate with main channel 302 and may assist in directing a tool into main channel 302 and / or the catheter lumen at a desired angle, e.g., toward longitudinal axis 1. Distal portion 304d has a smaller diameter than intermediate portion 304m and may accommodate a tool from an accessory, such as guidewire 240 through accessory 250 in FIG. 2. Main channel 302 includes proximal shoulder 302p and distal shoulder 302d. Shoulders 302p, 302d may be configured to abut opposite ends of an opening in a catheter extending through main channel 302, as described herein.

[0025] 4A-4C, perspective and right side views of a port 400 according to one embodiment of the present disclosure are shown. The port 400 is shown in an open configuration in FIGS. 4A and 4B and in a closed configuration in FIG. 4C. The open and closed configurations of the port 400 are transitionable along a hinge 416 and are connected by a protrusion 414 and an opening 418, substantially similar to the configuration of the hinge 316 of FIG. 3. The port 400 includes a body 406 having a proximal end 406p, a distal end 406d, and a longitudinal axis 1 extending therethrough. The main channel 402 extends along the longitudinal axis 1 of the body 406, configured to be coaxial with the lumen of the catheter. An extension 408 extends from the body 406. The extension 408 includes an accessory channel 404 extending therethrough. The accessory channel 404 is in fluid communication with the main channel 402 such that the accessory channel 404 can receive an accessory therein and guide the accessory toward accessing the main channel 402. The accessory channel 404 is disposed along the extension 408 such that the accessory channel 404 meets the main channel 402 distal to the protrusion 414 and the opening 418. The accessory channel 404 includes a positive stop 410 disposed along the accessory channel 404. The positive stop 410 is configured to abut the distal end 450d of an accessory introduced within the accessory lumen 404 such that the accessory is prevented from entering the main channel 402. The accessory lumen 404 includes a proximal portion 404p having a wider lateral width dimension than the remainder of the accessory lumen 404, which may, for example, aid in introducing the accessory 450 into the accessory lumen 404. Intermediate portion 404m of accessory lumen 404 has a smaller diameter than proximal portion 404p and may be dimensioned, for example, to receive, accommodate, interface with, correspond to, friction-fit with, etc. Positive stop 410 has a smaller diameter than intermediate portion 404m.The distal portion 404d of the accessory channel 404 provides a conduit for fluid communication between the accessory channel 404 and the main channel 402 and may assist in directing a tool into the main channel 402 and / or the catheter lumen at a desired angle, e.g., toward or along the longitudinal axis 1. The diameter of the distal portion 404d is smaller than the diameter of the intermediate portion 404m and may accommodate a tool from an accessory 450, such as the guidewire 240 of FIG. 2 , passing through the accessory 450. The main channel 402 includes a proximal shoulder 402p and a distal shoulder 402d. The shoulders 402p, 402d may be configured to abut opposite ends of a radial aperture of a catheter extending through the main channel 402, as described herein. In the closed configuration, the slit 410 extends through the extension 408, through the accessory channel 404, and into the main channel 402 of the port 400. The slit 410 may be, for example, a quick-change mechanism as described herein for removing tools and / or accessories. In various embodiments, the slit 410 may be one or more of an opening, slot, channel, flap, perforation, weakened region, etc. along the length of the port 400. As best shown in FIG. 4C , the extension 408 includes a pair of guides 411, 412 disposed on either side of the slit 410 about the longitudinal axis 1. The slit 410 is formed along the extension 408 on the side opposite the hinge 416 in the closed configuration. The pair of guides 411, 412 are spaced apart about the hinge 416 in the open configuration (e.g., as shown in FIGS. 4A and 4B ) and are positioned toward each other in the closed position.

[0026] 5A and 5B, perspective views of a port 500 according to one embodiment of the present disclosure are shown. The port 500 is illustrated in an open configuration that can be transitioned to a closed configuration along a hinge 516 substantially similar to the hinges 316, 416 of FIGS. 3 and 4A-4C. The port 500 includes a body 506 having a proximal end 506p, a distal end 506d, and a longitudinal axis 1 extending therethrough. A main channel 502 extends along the longitudinal axis 1 of the body 506 configured to be coaxial with the lumen of the catheter. An extension 508 extends from the body 506. The extension 508 includes an accessory channel 504 extending therethrough. The accessory channel 504 is in fluid communication with the main channel 502 such that the accessory channel 504 can receive an accessory therein and guide the accessory toward accessing the main channel 502. Extension 508 includes a pair of guides 511, 512, each having an outer surface. The outer surfaces of guides 511, 512 of extension 508 each include a recess 514. Recess 514 may assist a user (e.g., a medical professional) in stabilizing, manipulating, and / or assembling port 500 during or in preparation for a procedure by accommodating one or more fingers of the user. Additionally or alternatively, recesses 514 may be pressed toward each other to temporarily close a slit (or other quick-exchange mechanism) between guides 511, 512, for example, when the port is in a closed configuration, to introduce accessories and / or tools into port 500 without prematurely dislodging the slit.

[0027] Referring to FIG. 6A, a perspective view of a catheter 630 and a port 600 is shown in accordance with one embodiment of the present disclosure. The catheter 630 is coupled to a handle 660 at the proximal end of the catheter 630. The port 600 is coupled to the catheter 630 such that an accessory channel 604 of the port 600 can provide guided access to the lumen of the catheter 630. Referring also to FIG. 6B, a portion of the catheter 630 that is not visible by the port 600 in FIG. 6A is shown. In FIG. 6B, the catheter 630 includes radial openings 632 (e.g., skived cuts along the catheter 630) that allow external access into the lumen 634 of the catheter 630. Because the accessory lumen 604 is in fluid communication with the radial openings 632, a user can introduce accessories and / or tools through the accessory channel 640, for example, such that the tool can enter the lumen 634 through the radial openings 632. To ensure alignment, positioning, and / or connection between the port 600 and the radial opening 632, one or more shoulders (e.g., shoulders 302p, 302d, 402p, 402d in Figures 3, 4A, and 4B) may abut one or more of the proximal end 632p and / or distal end 632d of the opening 632.

[0028] 7A and 7B, cross-sectional views of a guidewire 740 being introduced into an opening 732 of a catheter 730 are shown, according to an embodiment of the present disclosure. In FIG. 7A, the catheter 730 extends through the main channel 702 of the port 700. The guidewire 740 is introduced into the lumen 734 of the catheter 730 through the accessory channel 704 of the port 700. The distal end 742 of the guidewire 740 enters the opening 732 at a first distance d1 from the proximal end 704p of the accessory channel 704 and at a first height y1 from the catheter 730. The angle α of the guidewire 740 entering the opening 732 may not be axially aligned with the catheter lumen 734, resulting in failed access of the guidewire 740 and prolonged setup of the guidewire and catheter for tool use. FIG. 7B shows the port 700 positioned along the catheter 730 more proximally than the position shown in FIG. 7A. In FIG. 7B , the distal end 742 of the guidewire 740 enters the opening 732 at a distance d2 from the proximal end 704p of the accessory channel 704, which is greater than the distance d1 in FIG. 7A . Additionally, the first coincidence point where the guidewire 740 contacts the accessory channel 704 proximal to its entry point through the opening 732 is at a height y2, which is less than the height y1 in FIG. 7A . The greater second distance d2 and smaller second height y2 may allow slack and / or restraint of the guidewire 740 for a straighter, more aligned orientation within the lumen 734 (i.e., axially aligned with the lumen itself), which has a more linear angle β compared to the angle α in FIG. 7A . In various embodiments, the heights y1, y2 may be between about 0.1 inches (2.54 millimeters) and about 0.2 inches (5.08 millimeters).

[0029] 8A-8C, right side and perspective views of a port 800 according to one embodiment of the present disclosure are shown. The port 800 includes a body 806 having a proximal end 806p, a distal end 806d, and a longitudinal axis 1 extending therethrough. The main channel 802 extends along the longitudinal axis 1 of the body 806, which is configured to be coaxial with the lumen of the catheter. The port 800 is constructed of an elastic material (e.g., flexible and capable of being manipulated by the user's hands to form, attach, or replace the device, and / or made of, for example, silicone, rubber, TPE, urethane, polymer, combinations thereof, or the like) to allow various catheters of different diameters to be placed within the main channel 802, for example, by manipulating the ends 806p, 806d of the body 806 around the catheter. Another advantage of the elastic material construction of the port 800 is ease of assembly. For example, adhesives / heat shrink need not be used to attach the port unless desired. An extension 808 extends from the body 806. The extension 808 includes an accessory channel 804 extending therethrough. The accessory channel 804 is in fluid communication with the main channel 802 such that the accessory channel 804 can receive an accessory therein and guide the accessory toward accessing the main channel 802. The accessory channel 804 tapers to a smaller inner diameter toward the distal end 806d so that the accessory can have, for example, an interference fit with the accessory channel 804. In various embodiments, the accessory channel 804 can include structure, such as a positive stop of the embodiments described herein, disposed along the accessory channel 804 to prevent the accessory from entering the main channel 802. The accessory lumen 804 includes a proximal portion 804p having a wider lateral width dimension than the remainder of the accessory lumen 804, which can, for example, aid in introducing the accessory into the accessory lumen 804. The main channel 802 includes a proximal shoulder 802p and a distal shoulder 802d.Shoulders 802p, 802d can be configured to abut opposite ends of a radial opening of a catheter extending through main channel 802, as described herein. A slit 810 extends through extension 808, through accessory channel 804, and into main channel 802 of port 800. Slit 810 can be, for example, a quick-exchange mechanism, as described herein, for transferring tools and / or accessories. In various embodiments, slit 810 can be one or more of an opening, slot, channel, flap, perforation, weakened region, etc. along the length of port 800. Extension 808 includes a pair of guides 811, 812 disposed on either side of slit 810 about longitudinal axis 1. The pair of guides 811, 812 can be resiliently manipulated, for example, to accommodate, insert, remove, or exchange accessories and / or tools.

[0030] 9A-9C, perspective and right side views of a port 900 are shown in accordance with one embodiment of the present disclosure. The port 900 includes a body 906 having a proximal end 906p, a distal end 906d, and a longitudinal axis 1 extending therethrough. The main channel 902 extends along the longitudinal axis 1 of the body 906, which is configured to be coaxial with the lumen of the catheter. The port 900 is shown in a closed configuration and is transitionable to an open configuration along a hinge 916 disposed along a thinned portion of the wall of the body 906. The port 900 is made of a resilient material (e.g., flexible and capable of being manually manipulated by a user to form, attach, or replace the device, and / or made of, for example, silicone, rubber, TPE, urethane, polymer, combinations thereof, or the like), and advantageously is made of a relatively rigid resilient or inelastic material, so that various catheters of different diameters can be placed within the main channel 902, for example, by manipulating the ends 906p, 906d of the body 906 around the catheter. An extension 908 extends from the body 906. The extension 908 is a flap that forms a funnel shape along the body 906 and defines the accessory channel 904. The flap of the extension 908 has a larger funnel-shaped dimension at the proximal end 904p and a smaller funnel-shaped dimension toward the distal end 904d. The extension 908 includes a slit 908s along the end of the flap that extends laterally along the funnel shape. The accessory channel 904 is in fluid communication with the main channel 902 such that the accessory channel 904 can receive an accessory therein and guide the accessory toward accessing the main channel 902. The funnel shape of the accessory channel 904 tapers from a larger inner diameter at the proximal end 904p to a smaller inner diameter toward the distal end 904d so that the accessory can have an interference fit with the accessory channel 904. The proximal portion 904p has a wider inner diameter than the remainder of the accessory lumen 904, which can, for example, aid in introducing the accessory into the accessory lumen 904.In various embodiments, the accessory channel 904 can include structures, such as positive stops of the embodiments described herein, disposed along the accessory channel 904 to prevent accessories from entering the main channel 902. The main channel 902 includes a proximal shoulder 902p and a distal shoulder 902d. The shoulders 902p, 902d can be configured to abut opposite ends of an opening in a catheter extending through the main channel 902, as described herein. A slit 910 extends through the body 906 and into the main channel 902 of the port 900. The slit 910 in the body 906, in combination with the slit 908s in the extension 908, can be, for example, a quick-exchange mechanism, as described herein, for moving tools and / or accessories through the slit 910 in the body 906 and the slit 908s in the extension 908. In various embodiments, the slits 910, 908s can be one or more of openings, slots, channels, flaps, perforations, weakened areas, etc. along the length of the port 900. The flaps of the extensions 908 can be resiliently manipulated to accommodate, insert, remove, or replace accessories and / or tools, for example, by moving the flaps about hinges 912 of the extensions 908, which are thinned portions along the walls of the extensions 908. The hinges 912 extend along the extensions 908, which are coupled to the body 906.

[0031] In various embodiments, a port may be coupled to a catheter by closing the port around the catheter along a hinge of the port. The port may additionally or additionally be coupled to a catheter, for example, by applying a heat shrink sleeve around the proximal and / or distal ends of the body of the port and the catheter. The port may additionally or additionally be coupled to a catheter by manipulating the port onto the catheter to form an interference fit and / or a friction fit. The port may be formed along the catheter during manufacture of the catheter device. In various embodiments, the port material may include a lubricious additive and / or coating (e.g., hydrophilic thermoplastic polyurethane elastomer, cast nylon with a semi-crystalline material filled with an oil lubricant, etc.) to aid in coupling the port to the catheter and / or introducing accessories or tools.

[0032] An embodiment of a method for introducing a tool into a catheter may include inserting an accessory into an accessory channel of a port. A distal portion of the accessory may interface with and / or abut a portion of the accessory channel, such as a positive stop, so that the accessory is stopped and / or retained within the accessory channel and the tool may advance within the main channel of the port. The tool may be inserted through the accessory into the lumen of the catheter. The tool may be introduced into the accessory by the user, or the tool may already be at least partially loaded into the accessory before introducing the accessory into the port. The tool may be laterally removed from the catheter through a rapid exchange mechanism of the catheter and / or port. A second tool, catheter, or guidewire may be introduced into the catheter.

[0033] All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of the present disclosure have been described with reference to specific embodiments, it will be apparent to those skilled in the art that variations can be applied to the devices and / or methods and to the steps or sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the scope of the present disclosure.

Claims

[Claim 1] The invention described in the specification.

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