Seal bypass tools for use with medical devices

Abstract

The present disclosure provides systems and methods including a bypass tool to facilitate insertion of a medical device into vasculature of a patient for performing a medical procedure. The medical device includes a distal tip assembly at a distal portion, a handle at a proximal portion, and a shaft that extends between the distal tip assembly and the handle. The bypass tool includes a body defining a bypass lumen therethrough, a seal having an aperture sized and shaped to receive the shaft of the medical device therethrough, and a cap configured to secure the seal relative to the body such that the aperture of the seal aligns with the lumen of the body. Various embodiments of the present disclosure provide a sealed bypass tool that minimizes blood loss and leakage from access introducers / sheaths.

Description

PATENT Attorney Docket No. 108606-020010PC-1527872Client Ref. No. 15866WOO1SEAL BYPASS TOOLS FOR USE WITH MEDICAL DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U. S. Provisional Patent Application No. 63 / 723,896 filed November 22, 2024; the full disclosures of which are incorporated herein by reference in their entirety for all purposes.BACKGROUND

[0002] Conventional bypass tools are generally used to protect delicate medical devices (e.g., diagnostic or therapeutic catheters) as they are inserted into sheaths or introducers that provide intravascular access and navigation to a desired anatomical location (e.g., within the heart chamber for mapping and / or ablation of conductive tissue). The present invention provides design improvements to such conventional bypass tools for use with medical devices (e.g., catheters, sheaths, and introducers) in intravascular surgical procedures.BRIEF SUMMARY

[0003] The present invention is generally related to systems and methods including a bypass tool to facilitate insertion of a medical device into vasculature of a patient for performing a medical procedure. The present invention includes a bypass tool for use with diagnostic or therapeutic medical devices (e.g., mapping and / or ablation catheters) and medical access and / or navigation devices (e.g., introducers or sheaths). Introducers or sheaths generally establish safe and reliable access and navigation to a desired blood vessel or anatomical structure, thus allowing for repetitive exchange (e.g., insertion and / or withdrawal) of various interventional medical devices into and from the patient’s vasculature during a medical procedure. Various embodiments of the present disclosure provide optimized seal bypass tools that minimize blood loss and any leakage that may occur from coupling with the access introducer or sheath. Additionally, the sealed bypass tools of the present invention reduce the risk of introducing any air into the patient and accordingly increases the safety profile of various procedures while protecting interventional diagnostic or therapeutic devices (e.g., distal expansible tip) during introducer insertion.

[0004] A system according to the present disclosure includes a medical device. The medical device includes a distal tip assembly at a distal portion, a handle at a proximal portion, and a shaft that extends between the distal tip assembly and the handle. The system further includes a bypass tool including a body defining a bypass lumen therethrough, a seal having an aperture sized and shaped to receive the shaft of the medical device therethrough, and a cap configured to secure the seal relative to the body such that the aperture of the seal aligns with the bypass lumen of the body.

[0005] The system may include various optional features. The system may further include a sheath defining a sheath lumen and having a proximal portion and a distal portion. The body may be configured to engage with the sheath. The bypass tool may be preloaded onto the shaft of the medical device between the distal tip assembly and the handle such that the medical device and bypass tool are slidably movable relative to each other. This prevents damage to a distal tip assembly of the medical device as the bypass tool is preloaded onto the shaft of the medical device between the distal tip assembly and the handle such that the distal tip assembly never passes through a seal of the bypass tool. Furthermore, the distal tip assembly may not pass through the seal of the bypass tool during a medical procedure.

[0006] The body may further include a proximal section and a distal section. The distal section may include one or more stepped features for engagement with sheaths having different inner diameters. The seal may be disposed between the cap and the proximal section of the body. The bypass lumen may be tapered at least a portion of a length between the proximal section to the distal section of the body. Alternatively, the entire length of the bypass lumen may include a constant diameter or a constant taper. The bypass lumen may further include a straight section having a constant inner diameter and a tapered section proximal to the straight section. A taper of the tapered section may be less than or equal to 0.5°. The tapered section may refer to a gradual decrease in inner diameter along the length of the bypass lumen. The distal tip assembly of the medical device may be configured to be proximally retracted into the bypass lumen via the straight section of the bypass lumen. The straight section of the bypass lumen may be configured to be proximally advanced over the distal tip assembly of the medical device. The bypass lumen may vary between straight and tapered sections along the length of the bypass lumen. For example, the bypass lumen may include a second proximal tapered section proximal to the first tapered section and proximal to the straight section. The second proximal tapered section may be used for cases where the bypass tool is accidentally removed entirely from the medical device or if the bypass tool isprovided separately and not pre-loaded on the medical device. The seal and the body may be integrated to form a single unitary piece. Optionally, the seal and the body may be molded together to form a single unitary' piece. The seal may include a stepped configuration (e.g. a variation of width along a longitudinal axis of the seal). The seal may include a level (or flush) configuration along a plane transverse to a longitudinal axis of the seal (e.g. having a constant width in plane transverse to the longitudinal axis of the seal). An aperture may be any shape, for example it may include one of a circle shape, a plus shape, or a minus shape. The aperture of the seal may have diameter in a range from 0.014 to 0.060 inches. The aperture may include a constant diameter along the length of the aperture. Or the aperture may be tapered for wedging the shaft of the medical device as the medical device is slid relative to bypass tool. The distal tip assembly may include a self-expanding planar structure having four longitudinally extending arms.

[0007] The seal may further include one or more sloped surfaces sloped toward an inner portion of the seal. Alternatively, a surface connecting the inner portion of the seal and an outer portion of the seal is parallel to the longitudinal axis of the seal. The seal may include a duckbill seal that opens at a positive gauge pressure greater than or equal to 0 torr (0 mm HG). The duckbill seal may close at a negative gauge pressure of less than 0 torr (0 mm HG). The seal may include one or more projections extending from a surface of the seal. The one or more projections may extend into corresponding detents in the cap when the seal is disposed between the body and the cap in an assembled configuration. A duckbill projection may include a slot that opens and closes depending on the pressure in the bypass tool.Additional projections on the body of the bypass tool may provide better fixation of the aperture 530 to prevent the seal 500 from unintentionally opening.

[0008] A method of introducing a medical device into vasculature of a patient for performing a medical procedure is provided. The method includes providing a medical device having an expandable distal tip assembly and a bypass tool preloaded onto a shaft of the medical device, retracting the medical device proximally into a straight section of the bypass tool such that the bypass tool compresses the distal tip assembly of the medical device within a bypass lumen of the bypass tool without the distal tip assembly passing through a proximal seal of the bypass tool, inserting the straight section of the bypass tool together with the distal tip assembly of the medical device disposed therein through a sheath hub, and advancing the distal tip assembly of the medical device distally into the sheath for deployment at a desired location in the patient. A proximal seal may include a duckbill seal that opens at a positivegauge pressure greater than or equal to 0 torr (0 mm HG). The duckbill seal may close at a negative gauge pressure of less than 0 torr (0 mm HG). Deployment of the distal tip assembly may include transitioning the distal tip assembly self-expanding from a collapsed configuration to a deployed configuration. Furthermore, the distal tip assembly may not pass through the seal of the bypass tool during a medical procedure. During or following the medical procedure, the method may include proximally retracting the bypass tool from the sheath hub. Alternatively, the bypass tool may include a tear away material or feature that enables the bypass tool to be removed from the shaft after deployment of the distal tip assembly. Following the medical procedure, the method may include proximally retracting the medical device into the bypass tool.

[0009] The method may include various optional steps. The inserting may comprise distally advancing the straight section past a valve of the sheath hub so that the distal tip assembly bypasses the valve of the sheath hub without damage thereto. The method prevents damage to a distal tip assembly of the medical device as the bypass tool is preloaded onto the shaft of the medical device between the distal tip assembly and the handle such that the distal tip assembly never passes through a seal of the bypass tool.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a perspective view of a bypass tool, according to various embodiments of the present disclosure.

[0011] FIGS. 2A-2C are cross-sections of the bypass tool of FIG. 1, according to various embodiments of the present disclosure.

[0012] FIG. 3 is an exploded view of the bypass tool of FIG. 1, according to various embodiments of the present disclosure.

[0013] FIGS. 4A-4C illustrate exemplary seals, according to various embodiments of the present disclosure.

[0014] FIGS. 5A-5C illustrate an alternative seal configuration, according to various embodiments of the present disclosure.

[0015] FIGS. 6A-6E illustrate exemplary insertion steps of a bypass tool into a sheath, according to embodiments of the present disclosure.

[0016] FIG. 7 is an exemplary tip assembly for use with a bypass tool, according to various embodiments of the present disclosure.

[0017] FIG. 8 is a flowchart of a method of introducing a medical device into vasculature of a patient for performing a medical procedure, according to various embodiments of the present disclosure.

[0018] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.DETAILED DESCRIPTION

[0019] In the following description, various systems and methods of the present invention will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the systems and methods. However, it will also be apparent to one skilled in the art that the present invention may be practiced without the specific details. Furthermore, well-known features may be omitted or simplified in order not to obscure the system or method being described.

[0020] The present disclosure provides a bypass tool that minimizes blood loss and leakage from access / navigation introducers or sheaths. Bypass tools described herein further prevent or minimize air introduction during a surgical procedure. FIG. 1 is a perspective view of a bypass tool 100. A bypass tool 100 can be used for introducing a medical device into vasculature of a patient for performing a medical procedure. The bypass tool 100 includes a body 102 defining a bypass lumen 104 therethrough. A medical device may be inserted into the bypass lumen 104 of the body 102 before transitioning into a sheath, to be described in further detail below.

[0021] The body 102 of the bypass tool 100 extends between a proximal section 106 and a distal section 108. The distal section 108 may further include one or more stepped features 110 for engagement with sheaths having different inner diameters. A first stepped feature 110a may be an 8.5 F sheath lock and a second stepped feature 110b may be a 13 F sheath lock. For example, an outer diameter of the second stepped feature 110b may be 0.23" for coupling to a 13 F sheath. The bypass tool 100 may further include a cap 112 configured tosecure a seal (not visible in this view) relative to the body 102 such that an aperture of the seal aligns with the bypass lumen 104 of the body 102.

[0022] FIGS. 2A-2B are cross-sections of the bypass tool of FIG. 1. FIG. 2A illustrates a cross-section showing a seal 202 having an aperture 204 sized and shaped to receive a shaft of a medical device therethrough. The seal 202 may be disposed between the cap 112 and the proximal section 106 of the body 102. As further illustrated by the cross-section of FIG. 2A, the cap 112 secures the seal 202 relative to the body 102 such that the aperture 204 of the seal 202 aligns with the bypass lumen 104 of the body 102. The seal 202 and the body 102 may be molded together or otherwise integrated to form a single unitary piece.

[0023] The bypass lumen 104 may include a straight section 206 having a constant inner diameter. The inner diameter of the straight section 206 may between 0.10" and 0.20".Optionally, the inner diameter is 0.107". The bypass lumen 104 may also include a tapered section 208 proximal to the straight section 206. FIG. 2A further illustrates the tapered section 208 of the bypass lumen 104. The tapered section 208 may refer to a gradual decrease in inner diameter along the length of the bypass lumen 104. The bypass lumen 104 may be tapered at least a portion of the length between the proximal section 106 to the distal section 108 of the body 102. The taper of the tapered section 208 may be less than or equal to 0.5°, less than or equal to 1.0°, less than or equal to 1.5°, etc. Optionally, the taper of the tapered section 208 is less than or equal to 0.5°. Alternatively, the entire length of the bypass lumen 104 may include a constant diameter or a constant taper. Further alternatively, the bypass lumen 104 may vary between straight and tapered sections along the length of the bypass lumen 104.

[0024] The body 102 of the bypass tool may include various outer diameters. The outer diameter of the proximal section 106 may between 0.20" and 0.50". In an exemplary embodiment, the outer diameter of the proximal section 106 is 0.25". The distal section 108 may include one or more outer diameters for forming the one or more stepped features 110. For example, an outer diameter of the first stepped feature 110a may be 0.15” for coupling to an 8.5 F sheath and an outer diameter of the second stepped feature 110b may be 0.23" for coupling to a 13 F sheath.

[0025] FIG. 2C illustrates a further bypass tool of FIG. 1. The bypass lumen 104 may also include a second proximal tapered section 210 proximal to the tapered section 208 and proximal to the straight section 206. FIG. 2C further illustrates the second proximal taperedsection 210 of the bypass lumen 104. The second proximal tapered section 210 may refer to a gradual decrease in inner diameter along the length of the bypass lumen 104. The taper of the second proximal tapered section 210 may be between 18.7° to 2.2°. In an exemplary embodiment, the second proximal tapered section 210 has an opening greater than or equal to 0.52 inches. The second proximal tapered section 210 may be used for cases where the bypass tool 100 is accidentally removed entirely from the medical device or if the bypass tool 100 is provided separately and not pre-loaded on the medical device.

[0026] FIG. 3 is an exploded view of the bypass tool of FIG. 1. FIG. 3 further illustrates the aperture 204 of the seal 202. The aperture 204 may be sized and shaped to receive a shaft of a medical device therethrough. The aperture 204 may be any shape including a circle, a plus sign (e.g., "+"), a minus signa rectangle, a triangle, etc. As shown in FIG. 3, the aperture 204 has a circle shape for receiving a corresponding circle shape of the shaft of the medical device. The aperture 204 of the seal 202 has a diameter in a range from 0.014 to 0.060 inches. The seal 202 may be disposed between the cap 112 and the proximal section 106 of the body 102. As further illustrated by the cross-section of FIG. 3, the cap 112 secures the seal 202 relative to the body 102 such that the aperture 204 of the seal 202 aligns with the bypass lumen 104 of the body 102. The seal 202 and the body 102 may be molded together or otherwise integrated to form a single unitary piece.

[0027] FIGS. 4A-4C illustrate exemplary seals. FIG. 4A illustrates an exemplary seal 410 having a stepped configuration (e.g., a variation of width along a longitudinal axis of the seal 410). For example, Wo > WJ. More than two widths may be present in the seal 410.Exemplary seal 410 may further include one or more sloped surfaces 414 sloped toward an inner portion 416 of the seal 410. Alternatively, a surface connecting the inner portion 416 and an outer portion 418 may be parallel to the longitudinal axis of the exemplary seal 410.

[0028] As shown in FIG. 4A, the seal 410 includes an aperture 412. The aperture 412 may be sized and shaped to receive a shaft of a medical device therethrough. The aperture 412 of the seal 410 has a diameter in a range from 0.014 to 0.060 inches. The aperture 412 may be any shape including a circle, a plus sign (e.g., "+"), a minus sign ("-"), a rectangle, a triangle, etc. As shown in FIG. 4A, the aperture 412 has a circle shape for receiving a corresponding circle shape of the shaft of the medical device. FIG. 4B illustrates a cross-section of the seal 410 of FIG. 4A. As further illustrated in FIG. 4B, the aperture 412 includes a constant diameter along the length of the aperture 412. The aperture 412 may be tapered for wedgingthe shaft of the medical device as the medical device is slid relative to bypass tool 100, to be described in further detail below.

[0029] FIG. 4C illustrates an exemplary seal 430. Exemplary seal 430 may include a level or flush configuration having a constant width in plane transverse to the longitudinal axis of the seal 430. For example, PF is constant across the seal 430. PF may have a width in a range between 0.02 to 0.025 inches. The seal 430 further includes an aperture 432. The aperture 432 may be sized and shaped to receive a shaft of a medical device therethrough. The aperture 432 of the seal 430 has a diameter in a range from 0.014 to 0.060 inches. The aperture 432 may be any shape including a circle, a plus shape (e.g.,a minus shape ("-"), a rectangle, a triangle, etc. As shown in FIG. 4C, the aperture 432 has a circle shape for receiving a corresponding circle shape of the shaft of the medical device. The aperture 432 may include a constant diameter along the length of the aperture 432. The aperture 432 may be tapered for wedging the shaft of the medical device as the medical device is slid relative to bypass tool 100, to be described in further detail below.

[0030] FIGS. 5A-5C illustrate an alternative seal configuration. An exemplary seal 500 may include a duckbill seal that is open at a positive gauge pressure greater than or equal to 0 torr (0 mm HG) and that is closed at a negative gauge pressure of less than 0 torr (0 mm HG). The seal 500 may include one or more projections 502 extending from a surface 504 of the seal 500. A duckbill projection 503 may include a slot 505 that opens and closes depending on the pressure in the bypass tool. For example, the slot 505 of the duckbill projection 503 may open to release excess pressure into a space 507 between the seal 500 and the cap 510, as shown in FIG. 5B.

[0031] The seal 500 may further include an aperture 530. The aperture 530 may be sized and shaped to receive a shaft of a medical device therethrough. The aperture 530 of the seal 500 has a diameter in a range from 0.014 to 0.060 inches. The aperture 530 may be any shape including a circle, a plus sign (e.g.,a minus sign ("-"), a rectangle, a triangle, etc. As shown in FIG. 5A, the aperture 530 has a circle shape for receiving a corresponding circle shape of the shaft of the medical device. The aperture 432 may include a constant diameter along the length of the aperture 530. The aperture 530 may be tapered for wedging the shaft of the medical device as the medical device is slid relative to bypass tool 100, to be described in further detail below.

[0032] FIG. 5B is an exploded view of seal 500 of FIG. 5 A. As shown in FIG. 5C, the body 520 may include further projections 522 extending from the body 520 of the bypass tool that extends into the seal 500. The projections 522 provide better fixation of the aperture 530 to prevent the seal 500 from unintentionally opening. The cap 510 may have a primary opening 524 and a secondary opening 526. The primary opening 524 may be configured for receiving at least a portion of the medical device such that the medical device is slidable relative to the primary opening 524. The secondary opening 526 may be configured as a separate lumen that aligns with the slot 505 of the duckbill projection 503. The secondary opening 526 enables positive pressure, blood, saline, etc., or a combination thereof to escape from the bypass tool.

[0033] FIG. 5C is the cross-sectional view of seal 500 of FIG. 5 A. The one or more projections 502 may extend into corresponding detents 508 in the cap 510 when the seal 500 is disposed between the body 520 and the cap 510 in an assembled configuration as shown in FIG. 5C. As shown in FIG. 5C, the slot 505 of the duckbill projection 503 may open to release excess pressure into the space 507 between the seal 500 and the cap 510.

[0034] FIGS. 6A-6E illustrate exemplary insertion steps of a bypass tool into a sheath. As shown in FIG. 6A-6E, a system 600 including a medical device 602 having a distal tip assembly 604 at a distal portion 606, a handle 608 at a proximal portion 610, and a shaft 612 that extends between the distal tip assembly 604 and the handle 608. The system 600 may further include a bypass tool 614 (such as bypass tool 100 described at least in FIGS. 1-3). The bypass tool 614 may include a body 616 defining a lumen 618 therethrough. The bypass tool 614 may further include a seal 620 having an aperture 622 sized and shaped to receive the shaft 612 of the medical device 602 therethrough. The bypass tool 614 may further include a cap 624 configured to secure the seal 620 relative to the body 616 such that the aperture 622 of the seal 620 aligns with the lumen 618 of the body 616. The system 600 may further include a sheath 626 defining a sheath lumen 628 and having a proximal portion 630 and a distal portion 632.

[0035] FIG. 6A illustrates the bypass tool 614 preloaded onto the shaft 612 of the medical device 602. As shown in FIG. 6A, the bypass tool 614 is preloaded onto the shaft 612 of the medical device 602 such that the distal tip assembly 604 of the medical device 602 does not pass through the seal 620 of the bypass tool 614 during a medical procedure. The bypass tool 614 may be slidably moveable relative to the medical device 602.

[0036] FIG. 6B illustrates the distal tip assembly 604 of the medical device 602 that is configured to be proximally retracted into the lumen 618 of the body 616 of the bypass tool 614. The lumen 618 of the body 616 may include a straight section and a tapered section as described and shown at least with respect to FIGS. 2A-2B. The lumen 618 of the body 616 further includes a tapered proximal section as shown in FIG. 2C for use in cases such as when the bypass tool 614 is accidentally removed entirely from the catheter shaft of the medical device 602 or if the bypass tool is provided separately and not pre-loaded onto the medical device 602.

[0037] The distal tip assembly 604 of the medical device 602 is configured to be proximally retracted into the lumen 618 via the straight section of the lumen 618. The medical device 602 may be retracted proximally into a straight section of the bypass tool 614 such that the bypass tool 614 compresses the distal tip assembly 604 of the medical device 602 within a lumen 618 of the bypass tool 614 without the distal tip assembly 604 passing through the seal 620 of the bypass tool 614.

[0038] FIG. 6C illustrates inserting the straight section of the bypass tool 614 together with the distal tip assembly 604 of the medical device 602 disposed therein through the sheath lumen 628 of the sheath 626, Inserting may include distally advancing the straight section past a valve 640 of the sheath 626 so that the distal tip assembly 604 bypasses the valve 640 of the sheath 626 without damage to the distal tip assembly 604.

[0039] FIG. 6D illustrates advancing the distal tip assembly 604 of the medical device 602 distally through the sheath 626 for deployment at a desired location in the patient.

[0040] FIG. 6E illustrates, during or following the medical procedure, proximally retracting the bypass tool 614 from the sheath 626. The bypass tool 614 may remain surrounding the shaft 612 until the medical procedure is over. For example, the distal tip assembly 604 may be retracted back into the bypass tool 614 during its removal from the vasculature of the patient. Alternatively, the bypass tool 614 may include a tear away material or feature that enables the bypass tool 614 to be removed from the shaft 612 after deployment of the distal tip assembly 604.

[0041] FIG. 7 is an exemplary tip assembly for use with a bypass tool. The tip assembly for use with a bypass tool may include any combination of embodiments as described in WO PCT / US2014 / 011940 entitled, “FLEXIBLE HIGH-DENSITY M APPING CATHETER TIPS AND FLEXIBLE ABLATION CATHETER TIPS WITH ONBOARD HIGH-DENSITY"MAPPING ELECTRODES,” which is incorporated by reference in its entirety. The tip assembly 700 may be configured for diagnostic (e.g., mapping or the like) or therapeutic (e.g., ablation including pulsed field ablation, RF ablation, etc.). The tip assembly 700 may be self-expanding. For example, the tip assembly 700 may be compressed into a collapsed configuration when the tip assembly is retracted into the bypass tool (or when the bypass tool is advanced distally over the tip assembly) and the tip assembly 700 may expand to a deployed configuration when the tip assembly 700 is distally advanced into the vasculature of a patient. As shown in FIG. 7, the tip assembly 700 includes a self-expanding planar structure having four longitudinally extending arms 702. Each arm may include one or more electrodes 704 for performing diagnostic and / or therapeutic procedures. The tip assembly 700 include other configurations such as balloon structures, basket structures, flexible linear structures, etc., other than those explicitly shown or described herein.

[0042] The tip assembly may include flexible electrodes. For example, flexible electrodes or conductive traces may be configured for detecting electrophysiological characteristics of the tissue. In some cases, a portion of the conductive traces and flexible electrodes may also be configured as / 'for use with sensors (e.g., position, pacing, strain, temperature, and the like). The catheter or the multi-electrode assembly can further include components such as, without limitation, a temperature sensor, force sensors, additional sensors or electrodes. For example, a thermocouple can be attached to each electrode to provides temperature readings of the electrode. Flexible and direct printed electrodes for use on a multi-electrode assembly of the present disclosure include those described in US2016 / 0278923A1, US2017 / 0112405A1, US2018 / 0008821A1, US2018 / 0055631, US2019 / 0328245A1, US2020 / 0107878 Al, US2021 / 0022803A1, US2021 / 0153932A1, WO2018150374A1, and W02020095250A1, the disclosures of which are incorporated herein in their entireties.

[0043] FIG. 8 is a flowchart of a method 800 of introducing a medical device into vasculature of a patient for performing a medical procedure. Method 800 includes operation 802. Operation 802 includes providing a medical device having an expandable distal tip assembly and a bypass tool preloaded onto a shaft of the medical device. For example, the bypass tool is preloaded onto a shaft of the medical device during manufacturing." Preloaded" refers to loading during manufacturing, prior to being provided to a health care professional. The medical device may be configured for performing diagnostic and / or therapeutic procedures. The medical device may be a self-expanding planar structure. The bypass tool may include any of the embodiments of the present disclosure. Bypass tools ofthe present disclosure prevent damage to a distal tip assembly of the medical device as the bypass tool is preloaded onto the shaft of the medical device between the distal tip assembly and the handle such that the distal tip assembly never passes through a seal of the bypass tool.

[0044] Operation 804 includes retracting the medical device proximally into a uniform diameter section of the bypass tool such that the bypass tool compresses the distal tip assembly of the medical device within a lumen of the bypass tool without the distal tip assembly passing through a proximal seal of the bypass tool. The distal tip assembly of the medical device may be configured to be proximally retracted into the lumen via the straight section of the lumen. Alternatively, method 800 may proceed to operation 805 including advancing a distal section having a uniform diameter lumen of the bypass tool such that the bypass tool compresses the distal tip assembly of the medical device within a lumen of the bypass tool without the distal tip assembly passing through a proximal seal of the bypass tool. The medical device and bypass tool may be slidably movable relative to each other.Alternatively, or in addition to, a tapered proximal section of the lumen is configured to be proximally advanced over the distal tip assembly of the medical device.

[0045] Operation 806 includes inserting the straight section of the bypass tool together with the distal tip assembly of the medical device disposed therein through a sheath hub.Operation 806 may include distally advancing the straight section past a valve of the sheath hub so that the distal tip assembly bypasses the valve of the sheath hub without damage thereto.

[0046] Operation 808 includes advancing the distal tip assembly of the medical device distally through the sheath for deployment at a desired location in the patient. Deployment of the distal tip assembly may include transitioning the distal tip assembly self-expanding from a collapsed configuration to a deployed configuration. The bypass tool may remain surrounding the shaft of the medical device until the medical procedure is over. For example, the distal tip assembly may be retracted back into the bypass tool during its removal from the vasculature of the patient. The bypass tool may include a tear away material or feature that enables the bypass tool to be removed from the shaft after deployment of the distal tip assembly. During or following the medical procedure, method 800 may include proximally retracting the bypass tool from the sheath hub. Further, following the medical procedure, method 800 may include proximally retracting the medical device into the bypass tool.Alternatively, the medical device may be advanced distally through the proximal end of the bypass tool.

[0047] The proximal seal may include a duckbill seal that is configured to open at a positive gauge pressure greater than or equal to 0 torr and configured to close at a negative gauge pressure of less than 0 ton’. Various embodiments of FIGS, 6A and 6B may be implemented into method 800 described herein.

[0048] Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated systems and methods thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.

[0049] The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. The term "connected" is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0050] Preferred systems and methods according to this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred systems and methods may become apparent to those of ordinary skill in theart upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[0051] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0052] The following relate to numbered aspects of the invention:1. A system, comprising:a medical device having a distal tip assembly at a distal portion, a handle at a proximal portion, and a shaft that extends between the distal tip assembly and the handle; anda bypass tool comprising:a body defining a bypass lumen therethrough;a seal having an aperture sized and shaped to receive the shaft of the medical device therethrough; anda cap configured to secure the seal relative to the body such that the aperture of the seal aligns with the lumen of the body.2. The system of aspect 1, further comprising a sheath defining a sheath lumen and having a proximal portion and a distal portion, wherein the body is configured to engage with the sheath.3. The system of aspect 1 or 2, wherein the bypass tool is preloaded onto the shaft of the medical device between the distal tip assembly and the handle, and the medical device and bypass tool are slidably movable relative to each other.4. The system of any of aspects 1 to 3, wherein the distal tip assembly does not pass through the seal of the bypass tool during a medical procedure.The system of any of aspects 1 to 4, wherein the body comprises a proximal section and a distal section, the distal section comprising one or more stepped features for engagement with sheaths having different inner diameters.The system of aspect 5, wherein the seal is disposed between the cap and the proximal section of the body.The system of aspect 5 or 6, wherein the bypass lumen is tapered at least a portion of a length between the proximal section to the distal section of the body.The system of aspect 7, wherein the bypass lumen comprises a straight section having a constant inner diameter and a tapered section proximal to the straight section.The system of aspect 8, wherein a taper of the tapered section is less than or equal to 0.5°.The system of aspect 8 or 9, wherein the distal tip assembly of the medical device is configured to be proximally retracted into the bypass lumen via the straight section of the lumen.The system of aspect 8, 9, or 10, wherein the straight section of the lumen is configured to be proximally advanced over the distal tip assembly of the medical device.The system of any preceding aspect, wherein the seal and the body are integrated to form a single unitary piece.The system of any preceding aspect, wherein the seal comprises a stepped configuration.The system of any of aspects 1 to 12, wherein the seal comprises a level configuration along a plane transverse to a longitudinal axis of the body.The system of any preceding aspect, wherein the aperture comprises one of a circle shape, a plus shape, or a minus shape.The system of any preceding aspect, wherein the aperture of the seal has a diameter in a range from 0.014 to 0.060 inches.The system of any preceding aspect, wherein the seal comprises a duckbill seal that is configured to open at a positive gauge pressure greater than or equal to 0 torr and configured to close at a negative gauge pressure of less than 0 torr.The system of any preceding aspect, wherein the seal comprises one or more projections extending from a surface of the seal, wherein the one or more projections extend into corresponding detents in the cap when the seal is disposed between the body and the cap in an assembled configuration.The system of any preceding aspect, wherein the distal tip assembly comprises a self¬ expanding planar structure having four longitudinally extending arms.A method of introducing a medical device into vasculature of a pati ent for performing a medical procedure, comprising:providing a medical device having an expandable distal tip assembly and a bypass tool preloaded onto a shaft of the medical device;retracting the medical device proximally into a straight section of the bypass tool such that the bypass tool compresses the distal tip assembly of the medical device within a lumen of the bypass tool without the distal tip assembly passing through a proximal seal of the bypass tool;inserting the straight section of the bypass tool together with the distal tip assembly of the medical device disposed therein through a sheath hub of a sheath; and advancing the distal tip assembly of the medical device distally into the sheath for deployment at a desired location in the patient.The method of aspect 20, wherein inserting comprises distally advancing the straight section past a valve of the sheath hub so that the distal tip assembly bypasses the valve of the sheath hub without damage thereto.The method of aspect 20 or 21, wherein the proximal seal comprises a duckbill seal that is configured to open at a positive gauge pressure greater than or equal to 0 torr and configure to close at a negative gauge pressure of less than 0 torr.The method of any of aspects 20 to 22, further comprising deploying the distal tip assembly from the sheath to transition the distal tip assembly from a collapsed configuration to a deployed configuration.The method of any of aspects 20 to 23, further comprising, during or following the medical procedure, proximally retracting the bypass tool from the sheath hub.The method of any of aspects 20 to 24, further comprising, following the medical procedure, proximally retracting the medical device into the bypass tool.

Claims

WHAT IS CLAIMED IS:

1. A system, comprising:a medical device having a distal tip assembly at a distal portion, a handle at a proximal portion, and a shaft that extends between the distal tip assembly and the handle; and a bypass tool comprising:a body defining a bypass lumen therethrough;a seal having an aperture sized and shaped to receive the shaft of the medical device therethrough; anda cap configured to secure the seal relative to the body such that the aperture of the seal aligns with the lumen of the body.

2. The system of claim 1, further comprising a sheath defining a sheath lumen and having a proximal portion and a distal portion, wherein the body is configured to engage with the sheath.

3. The system of claim 1 or 2, wherein the bypass tool is preloaded onto the shaft of the medical device between the distal tip assembly and the handle, and the medical device and bypass tool are slidably movable relative to each other.

4. The system of any one of claims 1 to 3, wherein the distal tip assembly does not pass through the seal of the bypass tool during a medical procedure.

5. The system of any one of claims 1 to 4, wherein the body comprises a proximal section and a distal section, the distal section comprising one or more stepped features for engagement with sheaths having different inner di meters.

6. The system of claim 5, wherein the seal is disposed between the cap and the proximal section of the body.

7. The system of claim 5 or 6, wherein the bypass lumen is tapered at least a portion of a length between the proximal section to the distal section of the body.

8. The system of claim 7, wherein the bypass lumen comprises a straight section having a constant inner diameter and a tapered section proximal to the straight section.

9. The system of claim 8, wherein a taper of the tapered section is less than or equal to 0.5°.

10. The system of claim 8 or 9, wherein the distal tip assembly of the medical device is configured to be proximally retracted into the bypass lumen via the straight section of the lumen.

11. The system of any one of claim 8, 9, or 10, wherein the straight section of the lumen is configured to be proximally advanced over the distal tip assembly of the medical device.

12. The system of any one of the preceding claims, wherein the seal and the body are integrated to form a single unitary piece.

13. The system of any one of the preceding claims, wherein the seal comprises a stepped configuration.

14. The system of any one of claims 1 to 12, wherein the seal comprises a level configuration along a plane transverse to a longitudinal axis of the body.

15. The system of any one of the preceding claims, wherein the aperture comprises one of a circle shape, a plus shape, or a minus shape.

16. The system of any one of the preceding claims, wherein the aperture of the seal has a diameter in a range from 0.014 to 0.060 inches.

17. The system of any one of the preceding claims, wherein the seal comprises a duckbill seal that is configured to open at a positive gauge pressure greater than or equal to 0 torr and configured to close at a negative gauge pressure of less than 0 torr.

18. The system of any one of the proceeding claims, wherein the seal comprises one or more projections extending from a surface of the seal, wherein the one or more projections extend into corresponding detents in the cap when the seal is disposed between the body and the cap in an assembled configuration.

19. The system of any one of the proceeding claims, wherein the distal tip assembly comprises a self-expanding planar structure having four longitudinally extending arms.

20. A method of introducing a medical device into vasculature of a patient for performing a medical procedure, comprising:providing a medical device having an expandable distal tip assembly and a bypass tool preloaded onto a shaft of the medical device;retracting the medical device proximally into a straight section of the bypass tool such that the bypass tool compresses the distal tip assembly of the medical device within a lumen of the bypass tool without the distal tip assembly passing through a proximal seal of the bypass tool;inserting the straight section of the bypass tool together with the distal tip assembly of the medical device disposed therein through a sheath hub of a sheath; andadvancing the distal tip assembly of the medical device distally into the sheath for deployment at a desired location in the patient.

21. The method of claim 20, wherein inserting comprises distally advancing the straight section past a valve of the sheath hub so that the distal tip assembly bypasses the valve of the sheath hub without damage thereto.

22. The method of claim 20 or 21, wherein the proximal seal comprises a duckbill seal that is configured to open at a positive gauge pressure greater than or equal to 0 torr and configure to close at a negative gauge pressure of less than 0 torr.

23. The method of any one of claims 20 to 22, further comprising deploying the distal tip assembly from the sheath to transition the distal tip assembly from a collapsed configuration to a deployed configuration.

24. The method of any one of claims 20 to 23, further comprising, during or following the medical procedure, proximally retracting the bypass tool from the sheath hub.

25. The method of any one of claims 20 to 24, further comprising, following the medical procedure, proximally retracting the medical device into the bypass tool.

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