Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/84—Drainage tubes; Aspiration tips
  • A61M1/86—Connectors between drainage tube and handpiece, e.g. drainage tubes detachable from handpiece
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

• the present disclosure generally relates to a dilator for use with self- healing connector seal and port(s) that allow a user to insert a needle or other instrument through the connector (e.g., to unclog or extract solids from a port used with a catheter for aspiration) and then remove the needle or other instrument while maintaining negative pressure on the fluid target.
• the dilator interacts with the seal(s) to provide addition control for a user in insertion depth of the dilator into a biological subject, and improve the sealing-ability of the seals once through-holes for the passage of the dilator (and other instruments) are introduced through the seals.
• One embodiment of the present disclosure is a device, comprising: a port adapter including a plurality of ports and a self-healing seal secured over one port of the plurality of ports, the self-healing seal comprising: a circular face of a first diameter; a raised ridge located on a first side of the circular face having a second diameter less than the first diameter at an outer base, and a third diameter less than the second diameter at a prominence of the raised ridge from which an inverted conic bevel is defined; a tearing guide on a second side of the circular face centered on a nadir of the inverted conic bevel; and wherein the self-healing seal has a first thickness between the first side and a second side, opposite to the first side, at the outer base and a second thickness, greater than the first thickness, between the first side and the second side at the prominence; and a dilator including: a first section of a third diameter, less than the second diameter; a second section of a fourth
• One embodiment of the present disclosure is a device, comprising: a dilator, comprising: a first section of a first diameter; a second section of a second diameter, less than the first diameter, and a first length; and a third section of the first diameter located on an opposite side of the second section relative to the first section; a sealing means having a circular face, comprising: a first region having a first thickness between a first side of the circular face and a second side of the circular face, opposite to the first side; a second region defined coaxially around an outer diameter of the first region having a second thickness, less than the first thickness; and wherein: a through-hole is defined through the second region and conforms to the second diameter when the second section is positioned through the through-hole; and the first length is approximately equal to the first thickness.
• One embodiment of the present disclosure is a dilator for insertion through a sealing means having a first region having a first thickness between a first side of a circular face and a second side of the circular face, opposite to the first side, a second region defined coaxially around an outer diameter of the first region having a second thickness, less than the first thickness, and a through-hole of a first diameter in a first configuration, a second diameter in a second configuration, greater than the first diameter, and a third diameter in a third configuration, greater than the second diameter, defined between the first side and the second side of the circular face in the first region, the dilator comprising: a first section of the third diameter; a second section of the second diameter and a first length at least as long as the first thickness; and a third section of the third diameter located on an opposite side of the second section relative to the first section.
• Figures 1A-1 F provide cross-sectioned views of an assembled port adapter with the dilator being inserted through the associated catheter, according to embodiments of the present disclosure.
• Figures 5A-5C provide cross-sectional views a self-healing seal with various through-hole formation pathways, according to embodiments of the present disclosure.
• the present disclosure generally relates to a dilator for use with self- healing connector seal and port(s) that allow a user to insert a needle or other instrument through the connector (e.g., to unclog or extract solids from a port used with a catheter for aspiration) and then remove the needle or other instrument while maintaining negative pressure on the fluid target.
• the dilator interacts with the seal(s) to provide addition control for a user in insertion depth of the dilator into a biological subject, and improve the sealing-ability of the seals once through-holes for the passage of the dilator (and other instruments) are introduced through the seals.
• Figures 1A-1 F provide cross-sectioned views of an assembled port adapter 100 with the dilator 150 being inserted through the associated catheter 110, according to embodiments of the present disclosure.
• a catheter 110 is secured in the body 120, and an dilator 150 is inserted through one or more self-healing seals 140a-b (generally of collectively, self- healing seals 140) held in place to the body 120 via a cap 130.
• self-healing seals 140a-b generally of collectively, self- healing seals 140
• the body 120 defines a first passage 122 through which the dilator 150 is guided into (and out of) the catheter 110 and a second passage 124 that connects the first passage 122 (and a fluid target in fluid communication with the catheter 110) with a pressure source 160, such as, for example, a vacuum pump or syringe.
• the self-healing seal 140 acts as a sealing means to the port adapter 100 that allows for the insertion and removal of the dilator 150 without loss of effective pressure application on the fluid target. Stated differently, the self-healing seal 140 operates in both an intact state and a punctured state to isolate the first passage 122 from ambient air so that the pressure source 160 exerts pressure on the fluid target and does not draw in excess air through the first passage 122.
• the self-healing seal 140 When in a punctured state, the self-healing seal 140 may conform around a body of a dilator 150 or other instrument inserted through the self-healing seal 140 or collapse inward upon itself to maintain a fluid-tight or airtight seal at various exerted pressured.
• the dilator 150 is constructed to interact with the self-healing seals 140 to further reduce the risk of ambient air being drawn into the first passage 122 through the self-healing seals 140 via the exerted negative pressure, from being pushed out of the self-healing seals 140 (e.g., when navigating a blood vessel of the biological subject to a target location), and to aid an operator in identifying how far the catheter 150 has been inserted into the catheter 110.
• the dilator 150 is adapted to the configuration of the self-healing seals 140 used in the port adapter 100.
• the body 120 includes an additional third passage 126 (with an associated fourth port), which is secured with a Luer activated valve 170, which selectively seals off the passages from the external environment, but allows an operator to inject fluids (e.g., dyes, saline, contrasts) into the system.
• a Luer activated valve 170 which selectively seals off the passages from the external environment, but allows an operator to inject fluids (e.g., dyes, saline, contrasts) into the system.
• fluids e.g., dyes, saline, contrasts
• various embodiments may use a different securing means (e.g., valve or plug) than a Luer activated valve 170 to secure the third passage 126, or omit the third passage 126 and securing means altogether (e.g., as shown in Figures 1A-1 B).
• the first and second self-healing seals 140a-b act as a sealing means to the port adapter 100 that allows for the insertion and removal of the dilator 150 without loss of effective pressure application on the fluid target.
• the self- healing seal 140 operates in both an intact and punctured state to isolate the first passage 122 from ambient air so that the pressure source 160 exerts pressure on the fluid target and does not draw in excess air through the first passage 122.
• the use of two (or more) self-healing seals 140 provides for an airlock 128 between a pair of self-healing seals 140.
• This airlock 128 provides for a medial pressure differential (e.g., between external air pressure and airlock pressure, and between airlock pressure internal passage pressure), which allows a pair of self-healing seals 140 to maintain a seal when a greater pressure differential is applied by the pressure source 160 that a single self-healing seal 140 may be able to provide.
• a medial pressure differential e.g., between external air pressure and airlock pressure, and between airlock pressure internal passage pressure
• the port adapter 100 includes a single self-healing seal 140, in which the dilator 150 includes a section having a reduced diameter (compared to the rest of the dilator 150) adapted to fit into the cavities of the single self-healing seal 140.
• the dilator 150 When inserted through the single self-healing seal 140, other sections of the dilator 150 having greater diameters (compared to the section with reduced diameter) are located on either side of the self-healing seal 140.
• the dilator 150 provides several advantages to the operator.
• the dilator 150 of the described design reduces the likelihood of the dilator 150 inadvertently advancing or retreating in the catheter 110 (e.g., the larger diameter sections hold the dilator 150 in place relative to the self-healing seal 140).
• the operator can determine via touch how deep the dilator 150 has been inserted into the catheter 110 relative to the self-healing seal 140, allowing the operator to maintain vision elsewhere in an operating theater.
• the port adapter 100 includes a first self-healing seal 140a and a second self-healing seal 140b that are concentrically aligned and in contact with one another, in which the dilator 150 includes a section having a reduced diameter (compared to the rest of the dilator 150) adapted to fit into the cavities on either side of an airlock 128 defined by the two self-healing seals 140a- b.
• the dilator 150 shown in Figures 1C and 1 D includes two sections of a greater diameter than the section or reduced diameter, in which one section interacts with a portion of a self-healing seal 140 (e.g., the first self-healing seal 140a) facing the environment, and another section that interacts with a portion of a seal (e.g., the second self-healing seal 140b) facing the first passage 122.
• the reduced section runs through the through- holes introduced in the self-healing seals 140 and the space between the self- healing seals 140 (e.g., an airlock 128).
• the length of the reduced diameter section is at least as long as the length of the airlock 128.
• An additional benefit of this design of dilator 150 includes failsafe passage of the dilator 150 through the two self-healing seals 140a-b as only one self-healing seal 140 at a time is stretched to accommodate the larger diameter sections of the dilator 150.
• the port adapter 100 includes a first selfhealing seal 140a and a second self-healing seal 140b that are concentrically aligned and in contact with one another, in which the dilator 150 includes two sections having reduced diameters (compared to the rest of the dilator 150) adapted to fit into the individual cavities of the two self-healing seals 140a-b.
• the design shown in Figures 1 C and 1 D with multiple sections of reduced diameter includes sections of a greater diameter (relative to the sections of reduced diameter) that interact with the faces of the self-healing seals 140a.
• the greater diameter sections of the dilator 150 interact with each self-healing seal 140, such that the greater diameter sections are located on either side of each self-healing seal 140. Additional benefit of this design of dilator include operability with multi-seal or single-seal designs of the port adapter 100, and greater holding power to resist the dilator 150 being inadvertently pushed too far into the catheter 110 or pulled out of the catheter 110.
• FIG. 2 provides a detailed view of a dilator 150, according to embodiments of the present disclosure.
• the dilator 150 includes an insertion section 210, a reduced-diameter section 220, and a control section 230.
• the insertion section 210 is generally the distal portion of the dilator 150 (relative to an operator using the dilator 150) that is used to lead the insertion of a catheter 110 through a biological subject to a target location (e.g., for navigating a blood vessel to an obstruction in that blood vessel or a connected blood vessel).
• the control section 230 is generally the proximal portion of the dilator 150 (relative to an operator) that the operator may grip or interact with to insert the dilator 150 further into the catheter 110 or the biological subject, or to withdraw the dilator 150 from the biological subject while leaving the catheter 110 in place (e.g., to aspirate an obstruction).
• the insertion section 210 is provided substantially at a first diameter, and terminates at a tapered tip 240.
• the tapered tip 240 is provided to expand various blood vessels or ease navigation through those blood vessels by the dilator 150 and the catheter 110.
• the tapered tip 240 may terminate with a rounded end, for example, to reduce the likelihood of tearing or piercing a blood vessel when the dilator 150 is pushed through the blood vessel.
• the control section 230 is provided substantially at the first diameter, and terminates at a rounded tip 250.
• the rounded tip 250 is provided to reduce the risk of injury to the operator and to visually differentiate each side of the dilator 150 from the other.
• the control section 230 may terminate with a flattened end or with a tapered tip 240 of a different slope that the tapered tip 240 of the insertion section 210, for example, to provide an operator with differently tapering tapered tips 240 to select between to use when guiding the dilator 150 to a target location in a biological subject (e.g., switching which section is the insertion section 210 and the control section 230).
• the reduced-diameter section 220 is located between the insertion section 210 and the control section 230, and is provided substantially at a second diameter, less than the first diameter of the insertion section 210 and control section 230.
• the transition between the first diameter and the second diameter may be sudden or gradual.
• the reduced- diameter section 220 may include one or more bevels 224a-b (generally or collectively, bevel 224) from the insertion section 210 or the control section 230 to a through-seal portion 222.
• the bevels 224 may be considered to be part of the respective insertion section 210 or control section 230 to which they connect, and the through-seal portion 222 may be considered to be the second section 220.
• Figures 3A-3G provide detailed views of the sections of reduced diameter in the dilators, according to embodiments of the present disclosure.
• Each of Figures 3A-3G show the juncture between one or more reduced diameter sections 220a-c, an insertion section 210, a control section 230, (optionally) various intermediate sections 340a-b (generally or collectively, intermediate section 340), and (optionally) various bevels 224a-f between the different diameters 310a-b (generally or collectively, diameter 310) of the various sections.
• Figure 3A illustrates a dilator 150 having an insertion section 210 and a control section 230 of a first diameter 310a that is greater than a second diameter 310b of the reduced-diameter section 220.
• a first bevel 224a and a second bevel 224b gradually transition from the first diameter 310a to the second diameter 310b along the longitudinal length of the dilator 150.
• Figure 3B illustrates a dilator 150 having an insertion section 210 and a control section 230 of a first diameter 310a that is greater than a second diameter 310b of the a first reduced-diameter section 220a and a second reduced-diameter section 220b.
• An intermediate section 340 of the first diameter 310a is disposed between the first reduced-diameter section 220a and the second reduced- diameter section 220b.
• a first bevel 224a and a second bevel 224b gradually transition from the first diameter 310a to the second diameter 310b along the longitudinal length of the dilator 150 between the intermediate section 340 and the insertion section 210, and a third bevel 224c and a fourth bevel 224d gradually transition from the first diameter 310a to the second diameter 310b along the longitudinal length of the dilator 150 between the intermediate section 340 and the control section 230.
• Figure 3C illustrates a dilator 150 having an insertion section 210 and a control section 230 of a first diameter 310a that is greater than a second diameter 310b of the a first reduced-diameter section 220a, a second reduced-diameter section 220b, and a third reduced-diameter section 220c.
• a first intermediate section 340a and a second intermediate section 340b of the first diameter 310a are disposed between the two respective reduced-diameter sections 220a-b and 220b-c.
• Each of the reduced-diameter sections 220a-c include bevels 224 that gradually transition from the first diameter 310a to the second diameter 310b along the longitudinal length of the dilator 150 between the insertion section 210, control section 230, or intermediate section 340.
• Figures 3A-3C show one, two, and three reduced-diameter sections 220, respectively, the present disclosure contemplates that any number of reduced diameter sections 220 may be included in a dilator 150.
• Figures 3D and 3E illustrate dilators 150 similar to the dilator in Figure 3B, having two reduced-diameter sections 220, but that omit one or more bevels 224 (and retains one or no bevels 224) between the first diameter 310a and the second diameter 310b.
• Figure 3F illustrates a dilator 150 similar to the dilator in Figure 3F, having two reduced-diameter sections 220, but exhibits different slopes for the bevels 224 in different directions of travel for the dilator 150.
• the dilator 150 can resist (with a steeper slope or no bevel) being pulled in an opposing direction with differing amounts of feree.
• the dilator 150 in Figure 3D may require more force to be pulled out of the catheter 110 than to be inserted deeper into the catheter 110. Because the dilator 150 shown in Figure 3D lacks of a bevel 224 between the reduced-diameter sections 220 and the frontward (e.g., in a direction towards the insertion section 210) greater-diameter sections, the face of the greater-diameter sections may resist being pulled in a rearward direction (e.g., in a direction towards the control section 230).
• the dilator 150 shown in Figure 3D includes a bevel 224 between the reduced-diameter sections 220 and the rearward greater-diameter sections, the bevels 224 may ease the operator in widening a through-hold to permit a section of the first diameter 310a being pushed through the self-healing seal 140.
• the lengths 320a-b of the reduced-diameter section(s) 220 and the lengths 330 of any intermediate sections 340 may vary across different embodiments to reflect different thickness(es) of the self-healing seal(s) 140 that the dilator 150 is passed through, whether the reduced-diameter section 220 is to pass through one self-healing seal 140 (e.g., as in Figures 1A and 1 B) or multiple self-healing seals 140 (e.g., as in Figures 1 C-1 F), a desired slope of any bevels 224 included in the design, and a length of any airlock 128 defined between two seals.
• one self-healing seal 140 e.g., as in Figures 1A and 1 B
• multiple self-healing seals 140 e.g., as in Figures 1 C-1 F
• a desired slope of any bevels 224 included in the design e.g., as in Figures 1 C-1 F
• the second length 320b may be defined based on a thickness of the self-healing seal 140 at a point where a through-hole is formed (e.g., thickness 495f shown in Figure 4C) or the thickness of a face of the self-healing seal 140 (e.g., thickness 495a shown in Figure 4C).
• the second length 320b of the reduced- thickness section 220 may be defined based on the thicknesses of both self- healing seals 140a-b (e.g., 2x thickness 495f) and the distance between the faces of the two self-healing seals 140a-b (e.g., distance 495e shown in Figure 4D).
• the length 330 of the intermediate sections 340 may be based on the distance between the faces of the two self-healing seals 140a-b (e.g., distance 495e shown in Figured 4D).
• the slope of the bevels 224 are designed to conform to the shape of the self- healing seal 140 that the bevel 224 or face rest against when the dilator 150 is inserted through the self-healing seal 140.
• the slope of the self- healing seal 140 e.g., from the nadirto the prominence of the inverted conic bevel
• the slope of the bevels 224 may also be X degrees so that the two surfaces contact one another for the extent of the sloped regions to increase the surface area over which a seal can be maintained.
• the face of the dilator 150 that interfaces with the face of the self-healing seal 140 may also be flat, so that the two surfaces contact each other over a greater area to help maintain a seal.
• Figure 3G illustrates a dilator 150 with differently sized diameters 310a- c on either side of a reduced diameter section 220.
• the control section 230 may have a larger or smaller diameter 310c than the diameter 310a of the insertion section 210.
• the intermediate section 340 may have a larger or smaller diameter 310b than one or both of the diameters 310 of the insertion section 210 and the control section 230.
• the dilator 150 may advantageously resist being over-inserted through the catheter 120.
• Figures 4A-4F provide views of a self-healing seal 140, according to embodiments of the present disclosure.
• Figure 4A provides an isometric view of a self-healing seal 140
• Figure 4B provides a cross-sectional view of the self-healing seal 140 detailing various surfaces and features of the self-healing seal 140
• Figure 4C provides a cross-sectional view of the self-healing seal 140 detailing various surfaces and thicknesses
• Figure 4D provides a cross-section view of a pair of self-healing seals 140 detailing placement of the self-healing seals 140 and distances between various surfaces thereof
• Figure 4E provides a detailed view of the tearing guides
• Figure 4F provides a planar view of a self-healing seal 140.
• the self-healing seal 140 is made of various flexible materials that allow for cap 130 and the body 120 to compress the self- healing seal 140 (thereby forming a seal around the outer circumference of the self-healing seal 140) and for an applied pressure bend or collapse the self-healing seal towards a lower pressure side.
• the self-healing seal 140 may be made of various rubbers, silicones, nylons, and other materials, which are selected to have a high elasticity and a low durometer.
• the material being selected to have a “high elasticity” refers the material having an elasticity ratio of at least 400%, preferably of at least 500%, more preferably of at least 600%, and even more preferably of at least 700%.
• the material being selected to have a “low durometer” refers the material having a Shore hardness of 55A or below, preferably of 50A or below, more preferably of 40A or below.
• Various features of the self-healing seal 140 control the size and location of any induced through-holes and provide for the controlled collapse of the self- healing seal 140 around that through-hole when an instrument is removed - thereby sealing the through-hole.
• the self-healing seal 140 has a substantially circular face and includes a first ring 410 that located on an outer edge of the circular face extending from a first side and a second side of the self-healing seal 140.
• the first ring 410 extends to an equal prominence relative to the first and second sides of the self-healing seal 140, but may extend to unequal prominences in other embodiments.
• the self-healing seal 140 also includes a second ring 420 that is located centrally on the first side, and a tearing guide 470 that is located centrally on the second side.
• the second ring 420 includes a raised ridge that defines an inverted conic bevel 440.
• the conic bevel 440 is aligned with (e.g., centered on) the tearing guide 470 on the second side, which provide sealing surfaces after a through-hole is made through the self-healing seal 140 (see e.g., Figures 5A-5C).
• the conic bevel 440 helps direct the dilator 150 to the center of the self-healing seal 140 during insertion, which in some embodiments, such as is shown in greater detail in Figure 4E, includes a first dimple 450 on the first side and a second dimple 460 on the second side, although in some embodiments one or both of the first dimple 450 and the second dimple 460 may be omitted.
• the first dimple 450 and/or the second dimple 460 define a region of reduced thickness in the self-healing seal 140 that may be more readily pierced by a cutting instrument during insertion, and which allow for a through-hole to be formed with less tearing in other directions, thereby reducing the size of the through-hole to be sealed.
• a third ring 430 of a reduced thickness (relative to the thicknesses of the first ring 410 and the second ring 420 in the X direction) is located between the first ring 410 and the second ring 420.
• the reduced thickness of the third ring 430 encourages flexion of the self-healing seal 140 to occur more readily in the third ring 430 than the other rings 410/420.
• a first surface 490a of the first ring 410 is positioned on the first side of the self-healing seal 140, and a second surface 490b is positioned on the second side of the self-healing seal 140, as is shown in Figure 4B.
• the second ring 420 has a foot based on the third ring 430, so that the second ring 420 rises above the first surface 490a of the third ring 430 and extends to a peak (in the X direction) that is equal to the peak of first ring 410 (from the first side).
• the nadir of the inverted conic bevel 440 is positioned above or the peak of the foot of the second ring 420 (e.g., the inverted conic bevel 440 does not extend past a plane defined by the third ring 430 on the first side of the self-healing seal 140 when in a neutral position).
• the tearing guide 470 extends inward from the face of the third ring 430 on the second side of the self-healing seal 140 and extends the second dimple 460 to be even with the plan defined by the third ring 430 on the first side of the self-healing seal 140 when in a neutral position.
• the self-healing seal 140 is made of various rubbers or plastics to allow the self-healing seal 140 to bend, flex, or otherwise deform when pushed or pulled by a pressure exerted by the pressure source 160 in the first passage 122.
• the self-healing seal 140 is configured to operate at imparted pressures of ⁇ 20 pounds per square inch (psi), ⁇ 40 psi, or the like.
• the self-healing seal 140 is also configured to operate at the imparted pressures while a dilator 150 occupies the through-hole; sealing around the dilator 150.
• the various distances 495a-h (generally or collectively distance 495) between the surfaces of the self-healing seal 140 are chosen to allow the self- healing seal 140 to self-heal and close any through-holes when the dilator 150 is removed, and serve to improve interactivity with the dilator 150 while inserted based on the dimensions of the dilator 150.
• the self-healing seal 140 includes a first surface 415 that runs the circumference of one side of the first ring 410 and a sixth surface 465 that runs the circumference of the other side of the first ring 410.
• the total height (in the X direction) of the self-healing seal 140 is a first distance 495a, which is a combination of a second distance 495b, third distance 495c, and fourth distance 495d.
• a second surface 425 on the second ring 420 is shown as being substantially level with the first surface 415, and a third surface 435 on the third ring 430 is shown at the second distance 495b from the peak of the first surface 415 and the second surface 425.
• a base 445 of the second ring 420 (e.g., level with the third surface 435) is positioned a sixth distance 495f from a fifth surface 455 at the nadir of the inverted conic bevel 440.
• the fifth surface 455 is located an eighth distance 495h from an eighth surface 485 at the nadir of the tearing guide 470.
• the second surface 490b of the third ring 430 is located the fourth distance 495d from the sixth surface 465 of the first ring 410.
• the third distance 495 describes the thickness of the reduced-thickness section of the self-healing seal 140 between the third surface 435 and the fourth surface 475.
• the diameter of the tearing guide 470 is a ninth distance 495i
• the diameter of the opening to the inverted conic bevel 440 is a tenth distance 495j.
• the ratio of the tenth distance 495j less the ninth distance 495i divided by the second distance 495b less the eighth distance 495h is set to equal the slope of the bevel 224 on the rearward side (e.g., the side closer to the control section 230) of the dilator 150 to ensure a snug fit between the dilator 150 and the self-healing seal 140 to block air or fluid flow through the self-healing seal 140 while the dilator 150 is inserted.
• various surfaces described herein are also contemplated as including various irregularities, nodules, divots, or other engagement features for increasing surface friction or engagement with other surfaces. Additionally, various surface are contemplated as being curved, and may be shown in as flat to represent a compressed state of the surface (e.g., as held against another surface).
• the cap 130 is sized to accommodate two or more self-healing seals 140, such as a first self-healing seal 140a and a second self-healing seal 140b illustrated in Figure 4D.
• Figure 4D illustrates a neutral position for two self-healing seals 140a-b.
• Each of the self-healing seals 140a-b are positioned to be concentrically aligned on a shared axis (e.g., coaxially aligned) to allow insertion of a dilatorl 50 through the respective inverted conic bevels 440 and tearing guides 470 to create a centrally aligned through-hole.
• the self-healing seals 140a-b are configured to interface with each other via the respective outer first rings 410 to define an airlock 128 between the inner surfaces (e.g. , the second side of the first self-healing seal 140a and the first side of the second self-healing seal 140b) to provide for a medial pressure differential (e.g., between external air pressure and airlock pressure, and between airlock pressure internal passage pressure), which allows a pair of self-healing seals 140a-b to maintain a seal when a greater pressure differentials are applied than a single self-healing seal 140 may be able to provide.
• a medial pressure differential e.g., between external air pressure and airlock pressure, and between airlock pressure internal passage pressure
• the volume of the airlock 128 is determined by the geometry of the two self-healing seals 140.
• the volume would be approximately 0.07 cubic inches.
• this approximate volume does not account for any volume occupied by an inserted dilator 150, or the relative volumes occupied or vacated by the raised ridges and tear-guiding features of the self-healing seals 140.
• the pair of self-healing seals are designed to operate with various pressures to reestablish a seal after through-holes are introduced through the pair of self-healing seals 140a-b by partially collapsing over the through-holes to prevent or reduce the amount of outside air entering the airlock 128 through the first self-healing seal 140a and first passage 122 through the second self-healing seal 140b or the amount of internal air (or other fluid) exiting the first passage 122 through the self-healing seals 140a-b.
• the pair of self- healing seal 140 is configured to operate at imparted pressures of ⁇ 40 psi, ⁇ 80 psi, or the like.
• the paired self-healing seals 140a-b are identical in design, although in some embodiments, the first self-healing seal 140a may be made of a different material, with different dimensions, or combinations thereof, than the second self-healing seal 140b.
• the tapered tip 240 is designed to not possess a cutting surface. Accordingly, various other cutting instruments may be used to pierce the self-healing seal 140 (e.g., a needle with a sharpened tip, a razor blade). Accordingly, in various embodiments, and as shown in Figure 4F, the self-healing seal 140 may include a puncturing slit 480 to aid in allowing the cutting instrument to be inserted through the self-healing seal 140 and form an opening through with the dilator 150 can be later inserted.
• a puncturing slit 480 to aid in allowing the cutting instrument to be inserted through the self-healing seal 140 and form an opening through with the dilator 150 can be later inserted.
• the puncturing slit 480 is a non-circular feature that is centered in the self-healing seal 140, which may define a region of reduced thickness in the self-healing seal 1 0 adapted for a cutting instrument to pierce the self-healing seal 140 in a regular and controllable manner (e.g., to reduce tearing of the circular face outside of the region when forming a through-hole).
• the puncturing slit 480 extends for a length (shown in the Y direction) that includes portions within the conic bevel 440, but may extend for different lengths (greater or lesser) in various embodiments than that shown.
• the puncturing slit 480 may extend for a uniform depth from the surface or to a uniform position defined on the Z axis.
• the puncturing slit 480 may be a score line that does not fully penetrate the self-healing seal 140 (until at instrument is passed through) or may be manufactured to penetrate the self-healing seal 140 without the dilator 150 (e.g., providing a pre-formed through-hole).
• the puncturing slit 480 may instead be defined on the second side of the self-healing seal 140, or a pair of puncturing slits 480 may be included on opposing sides of the self-healing seal 140 (aligned with one another).
• one or more puncturing slits 480 may be included in addition to or instead of one or both of the first dimple 450 and the second dimple 460.
• the puncturing slit 480 terminates with tear arrestors 482a-b on either end, which reduce the likelihood of a through-hole opened in the self-healing seal 140 extending past the edges of the puncturing slit 480.
• the tear arrestors 482a-b define a region of reduced thickness in the self- healing seal 140 of a greater width than the main length of the puncturing slit 480 (e.g., circular holes or voids in the material of the self-healing seal 140 of greater diameter than the height (shown in Figure 4F in the Y direction) than the rest of the puncturing slit 480).
• Figure 5A illustrates puncturing pathways 510a-b (generally or collectively, puncturing pathways 510) through a self-healing seal 140.
• the puncturing pathway 510 may be of different sizes and shapes to accommodate the dilator 150.
• a razor may be inserted through the first puncturing pathway 510a guided by the puncturing slit 480 to create a through-hole through which various dilators 150 or other instruments may be inserted.
• a needle with a sharpened end may be inserted through the second puncturing pathway 510b guided by the first dimple 450 to create a through-hole through which various dilators 150 and other instruments may be inserted.
• Figures 5B and 5C show through-holes 520 created between the first side and the second side of the self-healing seal 140 (e.g. , via inserting of an dilator 150 or a cutting instrument from the first side, shown on the left, to the second side, shown on the right) using a razor and a needle respectively as the cutting instrument.
• the inverted conic bevel 440 helps align the cutting instrument so that the through-hole 520 is substantially aligned on the centerline of the self-healing seal 140, with the first dimple 450 and second dimple 460 (not illustrated in Figures 5B or 5C) helping to align the tear, and reduce unintended or secondary tearing.
• the through-hole 520 may have a larger or smaller cross-sectional area than is shown in Figures 5B and 5C.
• an operator may select from various dilators 150 and self-healing seals 140 for use in a port adapter 100 having different dimensions matched to the dimensions of the other component.
• the selected dimensions for a dilator 150 may be based on the dimensions of the selected self- healing seal 1 0 that is secured to the port of the port adapter 100 to pass through dilator 150 through, or vice versa.
• different dilators 150 with different diameters 310b for the reduced-diameter section 220 or different diameters 310a for the insertion section 210 and control section 230 can be chosen based on the bore size or gauge of the through-hole 520 defined in the self-healing seal 140 and the ability of the self- healing seal 140 to pass and secure (without undesired tearing) larger or smaller dilators 150 while maintaining a seal.
• different dilators 150 with different lengths 320 for the reduced-diameter section 220 can be chosen based on the thickness 495c of self-healing seal 140 (or the length 495e of the airlock 128) where the through- hole 520 is defined in the self-healing seal 140 to pass and secure (without undesired tearing) longer or shorter dilators 150 while maintaining a seal.
• various dimensions of the dilator 150 and the self-healing seal 140 may be co-selected to interact and interface with one another to provide improved sealing capabilities and user control of the dilator 150.
• the designer may select different materials for the self-healing seal 140, adjust the absolute and relative circumferences of the various rings 410/420/430 (e.g., in the ZY plane), and adjust the absolute and relative thicknesses of the various rings 410/420/430, to affect how readily (e.g., at what threshold pressure) the self-healing seal 140 closes a through-hole 520 when a pressure differential is applied to the self-healing seal 140. Additionally or alternatively, the designer may change where the edges of the through-hole in the cap 130 are located relative to the diameter of the second ring 420 to position the cap 130 to contact the raised ridge sooner or later when the self-healing seal 140 flexes outward.
• the designer may change where the edges of the third port (e.g., adjusting bores and angles of the openings thereto) are mated relative to the second side of the self-healing seal 140 to make and break contact with the third ring 430 sooner or later when the self-healing seal 140 flexes inward.
• the edges of the third port e.g., adjusting bores and angles of the openings thereto
• a device comprising: a port adapter including a plurality of ports and a self-healing seal secured over one port of the plurality of ports, the self- healing seal comprising: a circular face of a first diameter; a raised ridge located on a first side of the circular face having a second diameter less than the first diameter at an outer base, and a third diameter less than the second diameter at a prominence of the raised ridge from which an inverted conic bevel is defined; a tearing guide on a second side of the circular face centered on a nadir of the inverted conic bevel; and wherein the self-healing seal has a first thickness between the first side and a second side, opposite to the first side, at the outer base and a second thickness, greater than the first thickness, between the first side and the second side at the prominence; and a dilator including: a first section of a third diameter, less than the second diameter; a second section of a fourth diameter, less than the
• Clause 2 The device of any of clauses 1 and 3-10, wherein the self- healing seal further comprises: an outer ring defined around the first diameter and having a first height on the first side aligned with the prominence of the raised ridge and a second height on the second side equal to the first height.
• Clause 3 The device of any of clauses 1-2 and 4-10, further comprising: a second self-healing seal, comprising: a second circular face of the first diameter; a second raised ridge located on a first side of the second circular face having the second diameter at a second outer base, and the third diameter at a second prominence of the second raised ridge from which a second inverted conic bevel is defined; a second tearing guide on a second side of the second circular face centered on a second nadir of the second inverted conic bevel; and an second outer ring defined around the first diameter of the second circular face and having the first height on the first side aligned with the second prominence of the second raised ridge and the second height on the second side; wherein the second self-healing seal has the first thickness between the first side and a second side of the second circular face, opposite to the first side, at the second outer base and the second thickness between the first side and the second side of the second circular face at the second prominence; and wherein the second
• Clause 4 The device of any of clauses 1-3 and 5-10, further comprising: a fourth section of the fourth diameter; a fifth section of the third diameter, located between the second section and the fourth section; and wherein: a first length of the second section is approximately equal to the second thickness; a second length of the fourth section is approximately equal to the second thickness; and a third length of the fifth section is approximately equal to the second height.
• Clause 5 The device of any of clauses 1-4 and 6-10, wherein a length of the second section is approximately equal to the first height plus the second height plus the first thickness.
• Clause 7 The device of any of clauses 1 -6 and 8-10, the dilator further comprising a tapered tip on a first end of the first section opposite to a second end connected to the second section.
• Clause 8 The device of any of clauses 1 -7 and 9-10, the dilator further comprising a bevel defined between the second section and at least one of the first section and the third section.
• Clause 9 The device of any of clauses 1 -8 and 10, wherein the tearing guide is of approximately of the fourth diameter.
• Clause 10 The device of any of clauses 1 -9, wherein the first side of the circular face includes a slit centered on the tearing guide having a length approximately equal to the third diameter.
• a device comprising: a dilator, comprising: a first section of a first diameter; a second section of a second diameter, less than the first diameter, and a first length; and a third section of the first diameter located on an opposite side of the second section relative to the first section; a sealing means having a circular face, comprising: a first region having a first thickness between a first side of the circular face and a second side of the circular face, opposite to the first side; a second region defined coaxially around an outer diameter of the first region having a second thickness, less than the first thickness; and wherein: a through-hole is defined through the second region and conforms to the second diameter when the second section is positioned through the through-hole; and the first length is approximately equal to the first thickness.
• Clause 12 The device of any of clauses 11 and 13-14, wherein the second section includes a bevel that transitions the first diameter to the second diameter between the first section and the second section.
• Clause 13 The device of any of clauses 11-12 and 14, wherein the first region defines an inverted conic bevel on the first side of the circular face having a first slope approximately equal to a second slope of the bevel defined between the first section and the second section.
• Clause 14 The device of any of clauses 11-13, wherein the sealing means further comprises: a third region defined coaxially around a second outer diameter of the second region having a third thickness greater than the first thickness, wherein the third region is substantially aligned with a prominence of the first region extending from the first side of the circular face.
• a dilator for insertion through a sealing means having a first region having a first thickness between a first side of a circular face and a second side of the circular face, opposite to the first side, a second region defined coaxially around an outer diameter of the first region having a second thickness, less than the first thickness, and a through-hole of a first diameter in a first configuration, a second diameter in a second configuration, greater than the first diameter, and a third diameter in a third configuration, greater than the second diameter, defined between the first side and the second side of the circular face in the first region, the dilator comprising: a first section of the third diameter; a second section of the second diameter and a first length at least as long as the first thickness; and a third section of the third diameter located on an opposite side of the second section relative to the first section.
• Clause 16 The dilator of any of clauses 15 and 17-20, further comprising a first bevel defined between the first section and the second section that has a first slope approximately matched to a slope of an inverted conic bevel defined in the first region of the sealing means.
• Clause 17 The dilator of any of clauses 15-16 and 18-20, further comprising: a fourth section of the second diameter and the first length, defined between the first section and the second section; and a fifth section of the third diameter, defined between the fourth section and the second section.
• Clause 18 The dilator of any of clauses 15-17 and 19-20, wherein the first length is approximately equal to the first thickness.
• Clause 19 The dilator of any of clauses 15-18 and 20, wherein the first length is approximately equal to three times the first thickness.
• Clause 20 The dilator of any of clauses 15-19, wherein the sealing means includes a third region having the first thickness between a first side of a second circular face and a second side of the second circular face, opposite to the first side, wherein the circular face is disposed substantially parallel to the second circular face, a fourth region defined coaxially around a second outer diameter of the third region having the second thickness and a second through-hole of the first diameter in the first configuration, the second diameter in the second configuration, and the third diameter in the third configuration defined between the first side and the second side of the second circular face in the third region, wherein the second section is inserted through the through-hole and the second through-hole in the second configuration.
• a phrase referring to “at least one of” a list of items refers to any set of those items, including sets with a single member, and every potential combination thereof.
• the phrase is intended to cover the sets of: A, B, C, A-B, B-C, and A-B-C, where the sets may include one or multiple instances of a given member (e.g., A-A, A-A-A, A-A-B, A-A-B-B-C-C-C, etc.) and any ordering thereof.
• determining encompasses a variety of actions that may include calculating, computing, processing, deriving, investigating, looking up (e.g., via a table, database, or other data structure), ascertaining, receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), retrieving, resolving, selecting, choosing, establishing, and the like.
• a feature described as being substantially parallel or perpendicular to another feature shall be understood to be within ⁇ 9 degrees of parallel or perpendicular. Any value stated in relative terms shall be understood to include the stated value and any range or subrange between the indicated or implicit extremes.

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• 2024
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