Dilators for use with self-healing seals and connector ports

Abstract

A dilator for use with the self-healing seal and connector port includes a first portion having a first diameter and a first length, and second and third portions disposed at opposite ends of the first portion and having a second diameter greater than the first diameter, the first diameter and first length being sized based at least in part on the size of a hole or passage hole included in the self-healing seal in a direction in which the dilator is inserted through the self-healing seal and the thickness of the self-healing seal in that direction.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS: This disclosure claims the benefit of U.S. Provisional Patent Application No. 63 / 441,566, filed January 27, 2023, entitled "Self-Healing Seal and Dilator for Use With Connector Port," which is hereby incorporated by reference in its entirety. [Background technology]

[0002] When aspirating bodily fluids and entrained solids (e.g., blood emboli), negative pressure is maintained in the bodily fluid object (e.g., a vein) to draw out the bodily fluids and solids. The catheter carries these trapped bodily fluids and solids to the port, but continuous application of negative pressure may require periodic removal of the solids and liquid to avoid clogging of the negative pressure source or to identify when the solids have been successfully extracted from the bodily fluid object. Additionally, to guide the catheter to a desired location within the bodily fluid object, a dilator is inserted through the catheter to open the bodily fluid object and allow the catheter to move through the bodily fluid object to the desired location. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure generally relates to a dilator for use with a self-healing connector seal and port that allows a user to insert a needle or other instrument through the connector (e.g., to clear a clog or to withdraw a solid object from a port used with a catheter for suction), thereby allowing the needle or other instrument to be removed while maintaining negative pressure in the biological object. The dilator interacts with the seal to provide the user with additional control over the depth of insertion of the dilator into the biological object, and improves the seal's sealing when a passage hole for the dilator (and other instruments) to pass through is introduced through the seal.

[0004] One embodiment of the present disclosure is a port adapter comprising: a plurality of ports; a self-repairing seal secured over one of the plurality of ports, the self-repairing seal comprising: a circular surface having a first diameter; a raised ridge disposed on a first side of the circular surface, the raised ridge having a second diameter at an outer base that is smaller than the first diameter and a third diameter at a raised portion of the raised ridge that is smaller than the second diameter, defining a slope of an inverted cone; and a tear guide disposed on the second side of the circular surface at the center of a base of the slope of the inverted cone. wherein the self-healing seal has a first thickness at the outer base between the first side and a second side opposite the first side and a second thickness at the ridge that is greater than the first thickness between the first side and the second side; and a dilator including a first portion of a third diameter smaller than the second diameter, a second portion of a fourth diameter smaller than the third diameter, and a third portion of the third diameter positioned opposite the second portion from the first portion.

[0005] One embodiment of the present disclosure is a device comprising: a dilator comprising a first portion having a first diameter, a second portion having a second diameter smaller than the first diameter and a first length, and a third portion having the first diameter and disposed on an opposite side of the second portion relative to the first portion; and a sealing means having a circular surface comprising: a first region having a first thickness between a first side of the circular surface and a second side of the circular surface opposite the first side; and a second region defined coaxially around an outer diameter of the first region and having a second thickness smaller than the first thickness; a pass-through hole defined through the second region, the pass-through hole conforming to the second diameter when the second portion is positioned through the pass-through hole; and the first length being approximately equal to the first thickness.

[0006] 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 surface and a second side of the circular surface opposite the first side, a second region having a second thickness less than the first thickness, the second region being coaxially defined around an outer diameter of the first region, and a pass-through hole having a first diameter in a first configuration, a second diameter greater than the first diameter in a second configuration, and a third diameter greater than the second diameter in a third configuration, the pass-through hole being defined in the first region between the first and second sides of the circular surface, the dilator comprising: a first portion of the third diameter; a second portion of the third diameter and a first length at least as long as the second diameter and the first thickness; and a third portion of the third diameter disposed opposite the second portion relative to the first portion. [Brief explanation of the drawings]

[0007] The accompanying drawings depict various elements of one or more embodiments of the present disclosure, but are not intended to limit the scope of the disclosure.

[0008] In the drawings, some elements may be shown not to scale relative to other elements to more clearly show detail. Further, wherever possible, the same reference numerals will be used throughout the figures to refer to similar elements.

[0009] Elements and features of one embodiment may be beneficially incorporated in other embodiments without additional description or illustration. For example, if the figures show alternate perspectives or time periods, the omission of various elements depicted in a first drawing from the illustration depicted in a second drawing does not disclaim the inclusion of those elements in the embodiment depicted or discussed with respect to the second drawing.

[0010] [Figure 1A] FIG. 1A illustrates a cross-sectional view of an assembled port adapter with a dilator inserted through an associated catheter according to an embodiment of the present disclosure. [Figure 1B]FIG. 1B illustrates a cross-sectional view of an assembled port adapter with a dilator inserted through an associated catheter according to an embodiment of the present disclosure. [Figure 1C] FIG. 1C illustrates a cross-sectional view of an assembled port adapter with a dilator inserted through an associated catheter according to an embodiment of the present disclosure. [Figure 1D] FIG. 1D illustrates a cross-sectional view of an assembled port adapter with a dilator inserted through an associated catheter according to an embodiment of the present disclosure. [Figure 1E] FIG. 1E illustrates a cross-sectional view of an assembled port adapter with a dilator inserted through an associated catheter according to an embodiment of the present disclosure. [Figure 1F] FIG. 1F illustrates a cross-sectional view of an assembled port adapter with a dilator inserted through an associated catheter according to an embodiment of the present disclosure. [Figure 2] FIG. 2 shows a detailed view of a dilator according to an embodiment of the present disclosure. [Figure 3A] FIG. 3A shows a detailed view of a reduced diameter portion of a dilator according to an embodiment of the present disclosure. [Figure 3B] FIG. 3B shows a detailed view of a reduced diameter portion of the dilator according to an embodiment of the present disclosure. [Figure 3C] FIG. 3C shows a detailed view of a reduced diameter portion of the dilator according to an embodiment of the present disclosure. [Figure 3D] FIG. 3D shows a detailed view of a reduced diameter portion of the dilator according to an embodiment of the present disclosure. [Figure 3E] FIG. 3E shows a detailed view of a reduced diameter portion of the dilator according to an embodiment of the present disclosure. [Figure 3F] FIG. 3F shows a detailed view of a reduced diameter portion of the dilator according to an embodiment of the present disclosure. [Figure 3G] FIG. 3G shows a detailed view of a reduced diameter portion of the dilator according to an embodiment of the present disclosure. [Figure 4A] FIG. 4A shows a diagram of a self-healing seal according to an embodiment of the present disclosure. [Figure 4B] FIG. 4B shows a diagram of a self-healing seal according to an embodiment of the present disclosure. [Figure 4C] FIG. 4C shows a diagram of a self-healing seal according to an embodiment of the present disclosure. [Figure 4D] FIG. 4D shows a diagram of a self-healing seal according to an embodiment of the present disclosure. [Figure 4E] FIG. 4E shows a diagram of a self-healing seal according to an embodiment of the present disclosure. [Figure 4F] FIG. 4F shows a diagram of a self-healing seal according to an embodiment of the present disclosure. [Figure 5A] FIG. 5A illustrates a cross-sectional view of a self-healing seal having various through-hole forming paths according to an embodiment of the present disclosure. [Figure 5B] FIG. 5B illustrates a cross-sectional view of a self-healing seal having various through-hole forming paths according to an embodiment of the present disclosure. [Figure 5C] FIG. 5C illustrates a cross-sectional view of a self-healing seal having various through-hole forming paths according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present disclosure generally relates to a dilator for use with a self-healing connector seal and port that allows a user to insert a needle or other instrument through the connector (e.g., to clear a blockage or to withdraw a solid object from a port used with a catheter for suction), thereby allowing the needle or other instrument to be removed while maintaining negative pressure in the biological object. The dilator interacts with the seal to provide the user with additional control over the depth of insertion of the dilator into the biological object, and improves the seal's sealing when a passage hole for the dilator (and other instruments) to pass through is introduced through the seal.

[0012] 1A-1F illustrate cross-sectional views of an assembled port adapter 100 with a dilator 150 inserted into an associated catheter 110, according to an embodiment of the present disclosure. In each of FIGS. 1A-1F, the catheter 110 is secured to a body 120, and the dilator 150 is inserted through one or more self-healing seals 140a-b (generally collectively referred to as self-healing seals 140), which are held in place on the body 120 via a cap 130. The body 120 defines a first passageway 122 through which the dilator 150 is directed into (and out of) the catheter, and a second passageway 124 that connects the first passageway 122 (and the bodily fluid object in fluid communication with the catheter 110) to a pressure source 160, such as a vacuum pump or syringe. The self-healing seal 140 functions as a sealing means for the port adapter 100, allowing the dilator 150 to be inserted and removed without compromising effective pressure application to the bodily fluid object. In other words, the self-healing seal 140 operates in both an intact state and a punctured state, isolating the first passageway 122 from the ambient air so that the pressure source 160 applies pressure to the bodily fluid target and does not draw excess air through the first passageway 122. When in the punctured state, the self-healing seal 140 may conform around the body of the dilator 150 or other instrument inserted through the self-healing seal 140, or may collapse inwardly to maintain a fluid-tight or air-tight seal under various applied pressures.

[0013] Dilator 150 is configured to interact with self-healing seal 140 such that the applied negative pressure will force ambient air through self-healing seal 140 and out of self-healing seal 140 (e.g., when navigating to a target location within a biological target's vasculature), further reducing the risk of being pulled into first passageway 112 and aiding the operator in determining how far catheter 150 is inserted into catheter 110. In various embodiments, dilator 150 is adapted to the configuration of self-healing seal 140 used in port adapter 100.

[0014] 1C-1F, the body 120 includes an additional third passageway 126 (with an associated fourth port) secured by a Luer-lock valve 170, which selectively seals the passageway from the external environment while allowing an operator to inject fluids (e.g., dye, saline, contrast) into the system. While the third passageway 126 is shown secured by a Luer-lock valve 170, various embodiments may secure the third passageway 126 using a securement means other than the Luer-lock valve 170 (e.g., a valve or stopcock), or may omit the third passageway 126 and securement means entirely (e.g., as shown in FIGS. 1A-1B). The first and second self-healing seals 140a-b function as a sealing means for the port adapter 100, allowing for the insertion and removal of a dilator 150 without compromising the effective application of pressure to the bodily fluid target. In other words, the self-healing seal 140 operates in both an intact state and a punctured state, allowing the pressure source 160 to apply pressure to the bodily fluid target and isolate the first passageway 122 from the ambient air so as not to draw excess air through the first passageway 122. The use of two (or more) self-healing seals 140 creates an airlock 128 between the pair of self-healing seals 140. This airlock 128 provides an intermediate pressure differential (e.g., between the external pressure and the airlock pressure, and between the airlock pressure and the pressure inside the passageway) that allows the pair of self-healing seals 140 to maintain a seal when a pressure differential applied by the pressure source 160 is greater than a single self-healing seal 140 can provide.

[0015] 1A and 1B, port adapter 100 includes a single self-healing seal 140, and dilator 150 includes a portion having a reduced diameter (compared to the remainder of dilator 150) adapted to fit into the cavity of single self-healing seal 140. When inserted into single self-healing seal 140, other portions of dilator 150 having larger diameters (compared to the portion having the reduced diameter) are positioned on either side of self-healing seal 140. By having portions with larger diameters positioned on either side of self-healing seal 140, dilator 150 provides several advantages to the operator.

[0016] For example, the dilator 150 design described reduces the likelihood of the dilator 150 being inadvertently advanced or retracted within the catheter 110 (e.g., the larger diameter section holds the dilator 150 in place against the self-healing seal 140). Similarly, when the dilator 150 includes multiple sections of reduced diameter, the operator has a tactile indication of how deeply the dilator 150 is inserted into the catheter 110 relative to the self-healing seal 140, and the operator has a wider field of view in the operating room. Other advantages include providing the operator with tactile feedback that the dilator 150 is in place when the reduced section is positioned to pass through the self-healing seal 140 and blocking the passage holes in the self-healing seal 140, reducing the likelihood of air or fluid passing through the self-healing seal 140 while the dilator 150 is being inserted.

[0017] 1C and 1D, port adapter 100 includes first and second self-repairing seals 140a and 140b that are concentrically arranged and in contact with each other, and dilator 150 includes a portion having a reduced diameter (compared to the remainder of dilator 150) adapted to fit into cavities on either side of airlock 128 defined by the two self-repairing seals 140a-b. Similar to dilator 150 depicted in FIGS. 1A and 1B, dilator 150 depicted in FIGS. 1C and 1D includes two portions of larger diameter than the reduced diameter portion, one portion interacting with a portion of self-repairing seal 140 (e.g., first self-repairing seal 140a) in a circumferential direction and the other portion interacting with a portion of the seal (e.g., second self-repairing seal 140b) in a direction toward first passageway 122. The reduced diameter portion passes through a passage hole introduced into the self-healing seal 140 and the space between the self-healing seal 140 (e.g., airlock 128). In various embodiments, the length of the reduced diameter portion is at least equal to the length of the airlock 128. An additional advantage of this design of the dilator 150 is that only one self-healing seal 140 is stretched at a time to accommodate the larger diameter portion of the dilator 150, allowing the dilator 150 to fail-safely pass through two self-healing seals 140a-b.

[0018] In Figures 1E and 1F, port adapter 100 includes first and second self-repairing seals 140a and 140b that are concentrically arranged and in contact with each other, and dilator 150 includes two portions with reduced diameters (compared to the remainder of dilator 150) adapted to fit into the respective cavities of the two self-repairing seals 140a-b. Similar to the design using a single self-repairing seal 140 shown in Figures 1A and 1B, the design depicted in Figures 1C and 1D with multiple reduced-diameter portions includes a larger-diameter portion (relative to the reduced-diameter portion) that interacts with the surface of self-repairing seal 140a. In the multiple-seal design, the larger-diameter portion of dilator 150 interacts with each of the self-repairing seals 140, with the larger-diameter portion positioned on either side of each self-repairing seal 140. Additional advantages of this dilator design include the maneuverability of the port adapter 100 with either a multiple seal or single seal design and enhanced retention of the dilator 150 against inadvertently pushing it too far into the catheter 110 or pulling it out of the catheter 110.

[0019] 2 is a detailed view of a dilator 150 according to an embodiment of the present disclosure. As shown, 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 the operator using the dilator 150) that is used to guide the insertion of the catheter 110 through the biological object to a target location (e.g., to guide the catheter 110 through a blood vessel to an occlusion in that or a connected blood vessel). The control section 230 is generally the proximal portion of the dilator 150 (relative to the operator) that the operator may grasp or manipulate to further insert the dilator 150 into the catheter 110 or biological object, or to withdraw the dilator 150 from the biological object while leaving the catheter 110 in place (e.g., to aspirate the occlusion).

[0020] The insertion section 210 has a substantially first diameter and terminates in a tapered tip 240. The tapered tip 240 is provided to dilate various blood vessels or to facilitate guiding the dilator 150 and catheter 110 through these blood vessels. In various embodiments, the tapered tip 240 may terminate in a rounded end, for example, to reduce the likelihood of tearing or puncturing the blood vessel when the dilator 150 is forced through the blood vessel.

[0021] The control section 230 has a substantially first diameter and terminates in a rounded tip 250. The rounded tip 250 is provided to reduce the risk of injury to the operator and to visually distinguish the two sides of the dilator 150. In various embodiments, the control section 230 may terminate in a tapered end 240 that is different from the tapered end 240 of the insertion section 210 or in a flat end, for example, to provide different tapered tips 240 that the operator can select between when navigating the dilator 150 to a target location on a biological object (e.g., to switch between the insertion section 210 and the control section 230).

[0022] Reduced diameter section 220 is disposed between insert 210 and control section 230 and has a second diameter that is substantially smaller than the first diameter of insert 210 and control section 230. In various embodiments, the transition between the first and second diameters may be abrupt or gradual. Accordingly, reduced diameter section 220 may include one or more beveled surfaces 224a-b (collectively, beveled surfaces 224) from insert 210 or control section 230 to passage seal section 222. Additionally or alternatively, beveled surfaces 224 may be considered part of insert 210 or control section 230, respectively, to which they are connected, and passage seal section 222 may be considered second portion 220.

[0023] 3A-3G are detailed views of reduced diameter sections of a dilator according to an embodiment of the present disclosure, each showing the connection of one or more reduced diameter sections 220a-c, insertion section 210, control section 230, various (optional) intermediate sections 340a-b (collectively intermediate section 340), and various (optional) bevels 224a-f between the various diameters 310a-b (collectively diameters 310) of the various sections.

[0024] 3A shows a dilator 150 having an insertion section 210 and a control section 230 with a first diameter 310a that is larger than a second diameter 310b of a reduced diameter section 220. The first and second sloped surfaces 224a, 224b gradually change from the first diameter 310a to the second diameter 310b along the longitudinal length of the dilator 150.

[0025] 3B shows a dilator 150 having an insertion section 210 and a control section 230 with a first diameter 310a that is larger than a second diameter 310b between 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. The first and second sloped surfaces 224a and 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 the third and fourth sloped surfaces 224c and 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.

[0026] 3C shows a dilator 150 having an insertion section 210 and a control section 230 with a first diameter 310a that is larger than a second diameter 310b of 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 reduced diameter sections 220a-b and 220b-c, respectively. Each of the reduced diameter sections 220a-c includes a slope 224 that gradually changes from the first diameter 310a to the second diameter 310b along the longitudinal length of the dilator 150 between the insertion section 210, the control section 230, or the intermediate section 340.

[0027] Although FIGS. 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 the dilator 150.

[0028] Figures 3D and 3E show a dilator 150 similar to the dilator of Figure 3B, with two reduced diameter sections 220, but omitting one or more of the bevels 224 (either one or none) between the first diameter 310a and the second diameter 310b. Figure 3F shows a dilator 150 similar to the dilator of Figure 3F, with two reduced diameter sections 220, but with different slopes of the bevels 224 in different directions of movement of the dilator 150. Varying the presence or slope of the bevels 224 allows the dilator 150 to resist being pulled in opposite directions with different magnitudes of force (either steeper slopes or no slopes).

[0029] For example, the dilator 150 in FIG. 3D may require more force to withdraw from the catheter 110 than to insert it deeper into the catheter 110. The dilator 150 shown in FIG. 3D does not have a beveled surface 224 between the reduced diameter section 220 and the larger diameter section at the front (e.g., toward the insertion section 210), so the face of the larger diameter section may resist being pulled rearward (e.g., toward the control section 230). In contrast, because the dilator 150 shown in FIG. 3D includes a beveled surface 224 between the reduced diameter section 220 and the larger diameter section at the rear, the beveled surface 224 may make it easier for the operator to expand the pass-through hole and allow the portion of the first diameter 310a to be pushed through the self-healing seal 140.

[0030] For any dilator 150, the lengths 320a-b of the reduced diameter sections 220 and the length 330 of any intermediate sections 340 may vary across different embodiments to reflect different thicknesses of the self-healing seals 140 through which the dilator 150 passes, whether the reduced diameter section 220 passes through one self-healing seal 140 (e.g., as in FIGS. 1A and 1B) or multiple self-healing seals 140 (e.g., as in FIGS. 1C-1F), the desired slope of any bevels 224 included in the design, and the length of any airlock 128 defined between the two seals.

[0031] When two larger diameter sections are used in contact with opposite sides of a single seal (e.g., FIGS. 1A, 1B, 1E, and 1F), the second length 320b may be determined based on the thickness of the self-healing seal 140 at the location of the through hole (e.g., thickness 495f shown in FIG. 4C) or the thickness of a face of the self-healing seal 140 (e.g., thickness 495a shown in FIG. 4C). Similarly, when the airlock 128 is included in an apparatus design using a single reduced thickness section 220, the second length 320b of the reduced thickness section 220 may be determined based on the thickness of both self-healing seals 140a-b (e.g., twice thickness 495f) and the distance between the faces of the two self-healing seals 140a-b (e.g., distance 495e shown in FIG. 4D). When the dilator 150 includes one or more intermediate portions 340 defined between the reduced diameter portions 220 (e.g., as in Figures 1E and 1F), the length 330 of the intermediate portions 340 may be based on the distance between the faces of the two self-healing seals 140a-b (e.g., distance 495e shown in Figure 4D).

[0032] Additionally, in some embodiments, the slope of the sloped surface 224 (or the plane, omitting the sloped surface 224) is designed to follow the shape of the self-healing seal 140 against which the sloped surface 224 or surface abuts when the dilator 150 is inserted into the self-healing seal 140. For example, if the slope of the self-healing seal 140 (e.g., from the base of the inverted cone's slope to the ridge) is X degrees, the slope of the sloped surface 224 can also be X degrees, increasing the surface area over which the two surfaces contact each other and maintain a seal. In another example, if the surface of the self-healing seal 140 is flat, the surface of the dilator 150 that interfaces with the surface of the self-healing seal 140 is also flat, allowing a larger area of ​​contact between the two surfaces and promoting seal maintenance.

[0033] 3G illustrates a dilator 150 having different diameters 310a-c on either side of the reduced diameter section 220. In various embodiments, the control section 230 may have a diameter 310c that is larger or smaller than the diameter 310a of the insertion section 210. Additionally or alternatively, the middle section 340 may have a diameter 310b that is larger or smaller than the diameter 310b of one or both of the insertion section 210 and the control section 230. By selecting a diameter 310c for the control section 230 that is larger than the diameter 310 of the insertion section 210 or the middle section 340, the dilator 150 advantageously resists being over-inserted through the catheter 120.

[0034] 4A-4F are diagrams of a self-repairing seal 140 according to an embodiment of the present disclosure. FIG. 4A is an isometric view of the self-repairing seal 140, FIG. 4B is a cross-sectional view of the self-repairing seal 140 detailing various surfaces and features of the self-repairing seal 140, FIG. 4C is a cross-sectional view of the self-repairing seal 140 detailing various surfaces and thicknesses according to an embodiment of the present disclosure, FIG. 4D is a cross-sectional view of a pair of self-repairing seals 140 detailing the placement of the self-repairing seals 140 and the distance between their various surfaces, FIG. 4E is a detailed view of a tear guide, and FIG. 4F is a top view of the self-repairing seal 140.

[0035] In various embodiments, the self-repairing seal 140 is fabricated from a variety of flexible materials that allow the cap 130 and body 120 to compress the self-repairing seal 140 (thereby forming a sheet around the periphery of the self-repairing sheet 140) and allow the self-repairing seal to bend or collapse toward the lower pressure side under applied pressure. For example, the self-repairing seal 140 is fabricated from a variety of rubbers, silicones, nylons, and other materials selected to have a high modulus and a low durometer. In various embodiments, a material selected to have a "high modulus" refers to a material having a modulus of elasticity of at least 400%, preferably at least 500%, more preferably at least 600%, and even more preferably at least 700%. In various embodiments, a material selected to have a "low durometer" refers to a material having a Shore hardness of 55A or less, preferably 50A or less, and more preferably 40A or less.

[0036] Various features of the self-healing seal 140 control the size and location of any induced passage hole, and when the instrument is removed, i.e., the passage hole is sealed, the self-healing seal 140 collapses in a controlled manner around the passage hole.

[0037] 4A-4F, the self-repairing seal 140 has a substantially circular surface and includes a first ring 410 disposed at the outer edge of the circular surface extending from a first side and a second side of the self-repairing seal 140. In various embodiments, the first ring 410 extends to the ridges equally on the first and second sides of the self-repairing seal 140, although in other embodiments, the first ring 410 may extend to the ridges unequal.

[0038] The self-repairing seal 140 also includes a second ring 420 centrally disposed on the first side and a tear guide 470 centrally disposed on the second side. The second ring 420 includes a raised ridge that defines a slope 440 of an inverted cone. The slope 440 of the cone is aligned (e.g., centered) with the tear guide 470 on the second side and provides a sealing surface after a passage hole is drilled through the self-repairing seal 140 (see, e.g., FIGS. 5A-5C ). Additionally, the slope 440 of the cone facilitates orienting the dilator 150 toward the center of the self-repairing seal 140 during insertion. In some embodiments, the self-repairing seal 140 includes a first recess 450 on the first side and a second recess 460 on the second side, as shown in more detail in FIG. 4E , although some embodiments may omit one or both of the first recess 450 and the second recess 460. The first recess 450 and / or the second recess 460 define an area of ​​reduced thickness in the self-healing seal 140 that may be more easily penetrated by a cutting instrument during insertion, allowing a pass-through hole to be formed with less tearing in other directions, and therefore reducing the size of the pass-through hole to be sealed.

[0039] A third ring 430 of reduced thickness (relative to the thickness of the first ring 410 and the second ring 420 in the X direction) is disposed between the first ring 410 and the second ring 420. The reduced thickness of the third ring 430 promotes deflection of the self-healing seal 140, which occurs more easily in the third ring 430 than in the other rings 410 / 420. For reference, as shown in FIG. 4B , a first surface 490a of the first ring 410 is located on a first side of the self-healing seal 140, and a second surface 490b is located on a second side of the self-healing seal 140.

[0040] The second ring 420 has a leg relative to the third ring 430, which is raised above the first surface 490a of the third ring 430 and extends (from the first side) to a highest point (in the X direction) equal to the highest point of the first ring 410. The base of the inverted cone slope 440 is located above the leg of the second ring 420 or at its highest point (e.g., the inverted cone slope 440 does not extend beyond the plane defined by the third ring 430 on the first side of the self-repairing seal 140 when in the intermediate position). In contrast, when in the intermediate position, the tear guide 470 extends inward from the surface of the third ring 430 on the second side of the self-repairing seal 140, and the second recess 460 extends flush with the plane defined by the third ring 430 on the first side of the self-repairing seal 140.

[0041] In various embodiments, the self-healing seal 140 is fabricated from a variety of rubbers or plastics that allow the self-healing seal 140 to flex, bend, or otherwise deform when pushed or pulled by the pressure applied to the first passageway 122 by the pressure source 160.

[0042] 4C illustrates an intermediate position of the self-healing seal 140 when the pressure applied to the first and second sides is substantially equal and the ring does not flex in response to the applied pressure. In various embodiments, the self-healing seal 140 is designed to operate at various pressures to partially collapse over the passage hole to re-establish a seal after the passage hole is introduced through the self-healing seal 140, preventing or reducing the amount of external air passing through the self-healing seal 140 into the first passage 122 or the amount of internal air (or other fluid) passing through the self-healing seal 140 and out of the first passage 122. In various embodiments, the self-healing seal 140 is configured to operate at an applied pressure of plus or minus 20 pounds per square inch (psi), plus or minus 40 psi, etc. The self-healing seal 140 is also configured to operate at an applied pressure to seal around the dilator 150 while the dilator 150 occupies the passage hole.

[0043] The various distances 485a-h (collectively distance 495) between the surfaces of the self-healing seal 140 are selected based on the dimensions of the dilator 150 so that the self-healing seal 140 will self-heal and close any passage holes when the dilator 150 is removed, helping to improve interactivity with the dilator 150 during insertion.

[0044] The self-healing seal 140 includes a first surface 415 extending circumferentially on one side of the first ring 410 and a sixth surface 465 extending circumferentially on the other side of the first ring 410. The overall height (in the X direction) of the self-healing seal 140 is a first distance 495a combined with a second distance 495b, a third distance 495c, and a fourth distance 495d.

[0045] The second surface 425 on the second ring 420 is depicted as being substantially flush with the first surface 415, and the third surface 435 on the third ring 430 is depicted as being a second distance 495b from the highest point of the first and second surfaces 415, 425. The base 445 of the second ring 420 (e.g., flush with the third surface 435) is located a sixth distance 495f from the fifth surface 455 at the bottom of the inverted cone slope 440. The fifth surface 445 is located an eighth distance 495h from the eighth surface 485 at the bottom of the tear guide 470. The second surface 490b of the third ring 430 is located a fourth distance 495d from the sixth surface 465 of the first ring 410. The third distance 495 represents the thickness of the reduced-thickness portion of the self-healing seal 140 between the third surface 435 and the fourth surface 475.

[0046] The diameter of the tear guide 470 is a ninth distance 495i, and the diameter of the opening of the inverted cone slope 440 is a tenth distance 495j. In various embodiments, the ratio (e.g., (d 10-d9) / (d2-d8)) is set to be equal to the slope of the slope 224 on the posterior side of the dilator 150 (e.g., the side closer to the control unit 230) to ensure a tight fit between the dilator 150 and the self-healing seal 140 and block the flow of air or fluid through the self-healing seal 140 while the dilator 150 is inserted.

[0047] Although shown as generally flat, the various surfaces described herein are also contemplated to include various irregularities, bumps, indentations, or other interlocking features that increase surface friction or interlock with other surfaces. Additionally, the various surfaces are also contemplated to be curved and may be shown flat to represent the surfaces in a compressed state (e.g., being pressed against another surface).

[0048] In various embodiments, the cap 130 is sized to accommodate two or more self-repairing seals 140, such as the first and second self-repairing seals 140a and 140b shown in FIG. 4D, which illustrates two self-repairing seals 140a-b in intermediate positions. Each of the self-repairing seals 140a-b is concentrically aligned (e.g., coaxially aligned) on a common axis such that a dilator 150 is inserted through each inverted cone's bevel 440 and tear guide 470 to form a centered passage hole. The self-repairing seals 140a-b are configured to interact with each other via their respective outer first rings 410 to define an airlock 128 between the inner surfaces (e.g., the second side of the first self-repairing seal 140a and the first side of the second self-repairing seal 140b), and the airlock 128 provides an intermediate pressure differential (e.g., between the external air pressure and the airlock pressure, and between the airlock pressure and the inner passage pressure) such that the pair of self-repairing seals 140a-b can maintain a seal when a pressure differential greater than that which a single self-repairing seal 140 can provide is applied.

[0049] The volume of the airlock 128 is determined by the geometry of the two self-repairing seals 140. For example, when using two self-repairing seals 140 where the height 495e (shown in the first direction in FIG. 4D ) between the inner surfaces of the self-repairing seals 140a-b is 0.20 inches, the distances from the top and bottom of the outer ring to the circular face are each 0.065 inches, the outer diameter (shown in the Z direction in FIG. 4D ) is 0.75 inches, and the thickness of the outer ring (shown in the Z direction in FIG. 4D ) is 0.06 inches, the volume would be approximately 0.07 cubic inches. As can be appreciated, this approximate volume does not take into account any volume occupied by an inserted dilator 150 or the relative volume occupied or vacated by the raised ridges and tear guide features of the self-repairing seals 140.

[0050] The pair of self-healing seals are designed to operate at various pressures to partially collapse over the passage hole and re-establish a seal after the passage hole is introduced through the pair of self-healing seals 140a-b, preventing or reducing the amount of external air entering the airlock 128 through the first self-healing seal 140a and entering the first passageway 122 through the second self-healing seal 140b, or the amount of internal air (or other fluid) exiting the first passageway 122 through the self-healing seals 140a-b. In various embodiments, the pair of self-healing seals 140 are configured to operate at applied pressures of plus or minus 40 psi, plus or minus 80 psi, etc.

[0051] In various embodiments, the pair of self-repairing seals 140a-b are identical in design, although in some embodiments the first self-repairing seal 140a may be manufactured from a different material than the second self-repairing seal 140b, with different dimensions, or a combination thereof.

[0052] Although generally described for use with a dilator 150 having a substantially circular cross-section with a tapered tip 240, the tapered tip 240 is designed not to have a cutting surface. Accordingly, various other cutting instruments (e.g., a sharp-tipped needle, a razor blade) may be used to pierce the self-repairing seal 140. Thus, in various embodiments, as shown in FIG. 4F , the self-repairing seal 140 may include a perforation slit 480 to facilitate insertion of a cutting instrument through the self-repairing seal 140 and to form an opening through which the dilator 150 can later be inserted. The perforation slit 480 may be a non-circular feature located in the center of the self-repairing seal 140 that defines a region of reduced thickness in the self-repairing seal 140 that is suitable for the cutting instrument to pierce the self-repairing seal 140 in a regular and controllable manner (e.g., to reduce tearing of the outer circular surface of the region when forming a pass-through hole).

[0053] As shown in FIG. 4F , the perforation slit 480 extends a length (as viewed in the Y direction) that includes a location within the cone's bevel 440, although in various embodiments, the perforation slit 480 may extend a different (longer or shorter) length than shown. When extending across different portions of the self-healing seal 140's projection (e.g., height in the Z direction), the perforation slit 480 may extend to a uniform depth from the surface or to a uniform location defined by the Z axis. In various embodiments, the perforation slit 480 may be a score line that does not entirely penetrate the self-healing seal 140 (until an instrument is passed through it), or may be manufactured to penetrate the self-healing seal 140 without the dilator 150 (e.g., a through-hole is pre-formed).

[0054] 4F on a first side of the self-repairing seal 140, in some embodiments, the perforation slits 480 may instead be defined on a second side of the self-repairing seal 140, or a pair of perforation slits 480 may be included (side by side) on opposite sides of the self-repairing seal 140. In various embodiments, one or more perforation slits 480 may be included in addition to or instead of one or both of the first recess 450 and the second recess 460.

[0055] In various embodiments, perforation slit 480 terminates at both ends with tear restraints 482a-b to reduce the likelihood of perforating self-mending seal 140 with a through hole that extends beyond the ends of perforation slit 480. Tear restraints 482a-b define regions of reduced thickness in self-mending seal 140 that have a width greater than the major length of perforation slit 480 (e.g., circular holes or voids in the material of self-mending seal 140 that have a diameter greater than the height (as shown in the Y direction in FIG. 4F ) of the remainder of perforation slit 480).

[0056] 5A illustrates perforation paths 510a-b (collectively perforation paths 510) passing through the self-repairing seal 140. Depending on the size and cross-sectional shape of the dilator 150 to be inserted through the self-repairing seal 140, the perforation paths 510 may be of different sizes and shapes to accommodate the dilator 150. For example, a razor blade may be inserted through the first perforation path 510a guided by the perforation slit 480 to create a passage hole through which various dilators 150 or other instruments may be inserted and passed. In another example, a sharp-tipped needle may be inserted through the second perforation path 510b guided by the first recess 450 to create a passage hole through which various dilators 150 or other instruments may be inserted and passed.

[0057] 5B and 5C show a passage hole 520 created between a first side and a second side of the self-repairing seal 140 using a razor blade and a needle, respectively, as a cutting instrument (e.g., by inserting a dilator 150 or cutting instrument from the first side, shown on the left, to the second side, shown on the right). The inverted cone slope 440 facilitates alignment of the cutting instrument because the passage hole 520 is substantially aligned with the centerline of the self-healing seal 140, and the first and second recesses 450 and 460 (not shown in FIGS. 5B or 5C) aid in tear alignment and reduce unintended or secondary tears. Depending on the size of the cutting instrument and whether the cutting instrument is hollow or solid, the cross-sectional area of ​​the passage hole 520 may be larger or smaller than the cross-sectional area shown in FIGS. 5B and 5C.

[0058] In various embodiments, an operator may select from a variety of dilators 150 and self-healing seals 140 for use with port adapter 100 having different dimensions to match the dimensions of other components. The size of the selected dilator 150 may be based on the size of the selected self-healing seal 140 that will be secured to the port of port adapter 100 to pass through the dilator 150, or vice versa.

[0059] For example, a different dilator 150 having a different diameter 310b for the reduced diameter section 220 or different diameters 310a for the insertion section 210 and the control section 230 can be selected based on the hole size or gauge of the passage hole 520 defined in the self-healing seal 140 and the ability of the self-healing seal 140 to pass (without undesired tearing) and secure a larger or smaller dilator 150 while maintaining a seal. Similarly, a different dilator 150 having a different length 320 for the reduced diameter section 220 (or a different length 330 for the middle section 340) can be selected based on the thickness 495c of the self-healing seal 140 (or the length 495e of the airlock 128) where the passage hole 520 defined in the self-healing seal 140 will pass (without undesired tearing) or secure a longer or shorter dilator 150 while maintaining a seal. Thus, the various dimensions of the dilator 150 and the self-healing seal 140 can be selected together to interact and connect with one another, improving the sealing ability of the dilator 150 and user control.

[0060] In various embodiments, a designer may select different materials for the self-healing seal 140 and adjust the absolute or relative circumferences (e.g., in the ZY plane) of the various rings 410 / 420 / 430 to adjust the absolute or relative thicknesses of the various rings 410 / 420 / 430, thereby affecting how easily (e.g., at what threshold pressure) the self-healing seal 140 closes the through-hole 520 when a pressure differential is applied to the self-healing seal 140. Additionally or alternatively, a designer may change the location of the edge of the through-hole in the cap 130 relative to the diameter of the second ring 420, which positions the cap 130 so that the self-healing seal 140 will sooner or later contact the raised ridge when flexed outward. Additionally or alternatively, the designer may change the position where the end of the third port fits against the second side of the self-healing seal 140 (e.g., by adjusting the diameter and angle of its opening) to sooner or later start or end contact with the third ring 430 as the self-healing seal 140 flexes inward.

[0061] This disclosure can also be understood with reference to the following numbered items:

[0062] (Item 1) A port adapter (100), Multiple ports and a self-repairing seal (140) secured over one of the plurality of ports, a circular surface of a first diameter; a raised ridge disposed on a first side of the circular surface, the raised ridge having a second diameter at an outer base that is smaller than the first diameter and a third diameter at a raised portion of the raised ridge that is smaller than the second diameter, the raised ridge defining a slope of an inverted cone; a tear guide disposed on a second side of the circular surface at the center of the bottom of the inverted cone; Equipped with the self-healing seal has a first thickness at the outer base between the first side and a second side opposite the first side, and a second thickness at the ridge between the first side and the second side that is greater than the first thickness; Self-healing seal (140) and a port adapter (100); A dilator (150), a first portion having a third diameter smaller than the second diameter; a second portion having a fourth diameter smaller than the third diameter; a third section of the third diameter disposed on an opposite side of the second section relative to the first section; a dilator (150) including: An apparatus comprising:

[0063] (Item 2) The self-repairing seal comprises: an outer ring defined about the first diameter, having a first height on the first side aligned with the raised portion of the raised ridge, and having a second height on the second side equal to the first height; The device according to any one of items 1 and 3 to 10 further comprises:

[0064] (Item 3) a second circular surface of the first diameter; and a second raised ridge disposed on a first side of the second circular surface, the second raised ridge having the second diameter at a second outer base and the third diameter at a second raised portion of the second raised ridge, defining a slope of a second inverted cone; a second tear guide disposed on a second side of the second circular surface and at the center of a second base of the slope of the second inverted cone; a second outer ring defined about the first diameter of the second circular surface, the second outer ring having the first height on the first side aligned with the second raised portion of the second raised ridge and the second height on the second side; a second self-repairing seal (140b) comprising: the second self-repairing seal has the first thickness at the second outer base between the first side of the second circular surface and a second side opposite the first side, and the second thickness at the second raised portion between the first side and the second side of the second circular surface; the second outer ring on the second side of the second circular surface contacts and is concentrically aligned with the outer ring on the first side of the self-healing seal; The device according to any one of items 1 to 2 and 4 to 10.

[0065] (Item 4) The expander comprises: a fourth portion (220b) of the fourth diameter; a fifth portion (330) of the third diameter disposed between the second portion and the fourth portion; Further preparation, a first length of the second portion substantially equal to the second thickness; a second length of the fourth portion is approximately equal to the second thickness; a third length of the fifth portion is approximately equal to the second height; The device according to any one of items 1 to 3 and 5 to 10.

[0066] (Item 5) a length of the second portion is approximately equal to the sum of the first height, the second height, and the first thickness; The device according to any one of items 1 to 4 and 6 to 10.

[0067] (Item 6) The length of the second portion is approximately equal to the second thickness. The device according to any one of items 1 to 5 and 7 to 10.

[0068] (Item 7) the dilator further comprises a tapered tip at a first end of the first portion opposite a second end connected to the second portion; The device according to any one of items 1 to 6 and 8 to 10.

[0069] (Item 8) the dilator further comprises a bevel (224) defined between the second portion and at least one of the first portion and the third portion; The device according to any one of items 1 to 7 and 9 to 10.

[0070] (Item 9) the tear guide has a diameter that is approximately the fourth diameter; The device according to any one of items 1 to 8 and 10.

[0071] (Item 10) the first side of the circular surface includes a slit disposed at the center of the tear guide and having a length approximately equal to the third diameter; The device according to any one of items 1 to 9.

[0072] (Item 11) A dilator (150), a first portion (210) of a first diameter; a second portion (220) having a second diameter smaller than the first diameter and a first length; a third portion (230) of the first diameter disposed on the opposite side of the second portion relative to the first portion; a dilator (150) comprising: A sealing means (140) having a circular surface, a first region having a first thickness between a first side of the circular surface and a second side of the circular surface opposite the first side; a second region defined coaxially about an outer diameter of the first region and having a second thickness less than the first thickness; a sealing means (140) comprising: Preparation, a through hole is defined through the second region and conforms to the second diameter when the second portion is in a position through the through hole; the first length is approximately equal to the first thickness; Device.

[0073] (Item 12) the second portion includes a slope that transitions from the first diameter to the second diameter between the first portion and the second portion. 15. The device according to items 11 and 13-14.

[0074] (Item 13) the first region defines an inverted cone slope on a first side of the circular surface, the inverted cone slope having a first slope approximately equal to a second slope of the slope defined between the first portion and the second portion; 15. The device according to any one of items 11 to 12 and 14.

[0075] (Item 14) The sealing means is a third region coaxially defined about the second outer diameter of the second region, the third region having a third thickness greater than the first thickness; Furthermore, the third region substantially aligns with the ridge of the first region extending from the first side of the circular surface. Any of the devices in items 11 to 13.

[0076] (Item 15) 1. A dilator (150) for insertion through a sealing means (140) having a first region having a first thickness between a first side of a circular surface and a second side of the circular surface opposite the first side, a second region having a second thickness less than the first thickness, the second region being coaxially defined around an outer diameter of the first region, and a pass-through hole having a first diameter in a first configuration, a second diameter greater than the first diameter in a second configuration, and a third diameter greater than the second diameter in a third configuration, the pass-through hole being defined in the first region between the first and second sides of the circular surface, a first portion (210) of said third diameter; a second portion (220) of a first length at least as long as said second diameter and said first thickness; a third portion (230) of the third diameter disposed on the opposite side of the second portion relative to the first portion; A dilator (150) comprising:

[0077] (Item 16) a first slope (224a) defined between the first and second portions and having a first slope that substantially corresponds to the slope of the inverted cone defined in the first region of the sealing means; The expander according to any one of items 15 and 17 to 20, further comprising:

[0078] (Item 17) a fourth portion (220b) defined between the first portion and the second portion and having the second diameter and the first length; a fifth portion (330) of the third diameter defined between the fourth portion and the second portion; The device according to any one of items 15 to 16 and 18 to 20, further comprising:

[0079] (Item 18) the first length is approximately equal to the first thickness; The expander according to any one of items 15 to 17 and 19 to 20.

[0080] (Item 19) the first length is approximately equal to three times the first thickness; The expander according to any one of items 15 to 18 and 20.

[0081] (Item 20) the sealing means includes a third region having the first thickness between a first side of a second circular surface and a second side of the second circular surface opposite the first side, the circular surface being disposed substantially parallel to the second circular surface; a fourth region having the second thickness and defined coaxially around a second outer diameter of the third region; and a second through hole having the first diameter in the first structure, the second diameter in the second structure, and the third diameter in the third structure, the second through hole defined in the third region between the first and second sides of the second circular surface, the second part being inserted through the through hole and the second through hole in the second structure. 20. The expander according to any one of items 15 to 19.

[0082] The description and illustration of one or more embodiments described in this disclosure are intended to fully and completely disclose the entire scope of the subject matter to those skilled in the art and are not intended to limit or restrict the scope of the claimed subject matter in any way. The aspects, examples, and details described in this disclosure are believed to be sufficient to convey ownership and enable those skilled in the art to practice the best mode of the claimed subject matter. Descriptions of structures, resources, operations, and acts that are considered well-known to those skilled in the art may be simplified or omitted so as not to obscure lesser-known or unique aspects of the disclosed subject matter. The claimed subject matter should not be construed as limited to the embodiments, aspects, examples, or details described in this disclosure unless explicitly stated herein. Various features (both structural and methodological), whether shown or described collectively or separately, are intended to be selectively included or omitted to produce embodiments having particular sets of features. Furthermore, any and all functions and acts shown or described may be performed in any order or simultaneously.

[0083] Given the description and illustrations of this disclosure, those skilled in the art will envision variations, modifications, and other embodiments that fall within the spirit of the broader aspects of the general inventive concepts described in this disclosure without departing from the broader scope of the disclosure.

[0084] As used in this disclosure, the phrase "at least one" in a list of items refers to any set of those items, including sets of single elements, and all potential combinations thereof. For example, when referring to "at least one of A, B, or C" or "at least one of A, B, or C," it is intended to include the sets "A," "B," "C," "A and C," "B and C," and "A, B, and C," which may include one or more instances of a given element (e.g., "A and A," "A and A and A," "A and A and B," "A, A, B, B, C, and C," etc.), and any permutation thereof.

[0085] As used in this disclosure, the term "determining" encompasses various acts that may include calculating, computing, processing, deriving, examining, 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, probability, and the like.

[0086] As used in this disclosure, the terms "substantially," "approximately," "about," and other relative terms encompass values ​​within plus or minus 5% of the stated quantity, percentage, or range, unless a different approximation is explicitly stated for the quantity, percentage, or range, or when the context of the value dictates a different approximation where that approximation would be more appropriate. For example, a value specified as approximately X% would be understood to include values ​​between 0.95×X% and 1.05×X%, or between X−0.05X and X+0.05X percent, but may stop at zero or 100 percent in various contexts. In other examples, a feature described as substantially parallel or perpendicular to another feature would be understood to be within plus or minus 9 degrees of parallelism or perpendicularity. Values ​​expressed in relative terms will be understood to include any range or subrange between the stated value and the stated or implied extreme value.

[0087] All numerical values ​​used in this disclosure and shown in examples (whether or not indicated as approximations) inherently include values ​​within the range of precision and rounding errors of that numerical value. For example, the numerical value 4.5 will be understood to include a range of 4.45 to 4.54, while the numerical value 4.50 will be understood to include values ​​from 4.495 to 4.504. Additionally, any numerical value or range indicated explicitly or by context as an integer value (e.g., approximately X users, between about Y and Z states) will be understood to be rounded down or up to the next integer value (e.g., X plus or minus 1 user, Y-1 and Z+1 states).

[0088] The following claims are not intended to be limiting to the embodiments set forth herein, but are to be accorded the full scope consistent with the language of the claims. In the claims, reference to an element in the singular is not intended to mean "only one" unless expressly so expressly stated, but rather "one or more" or "at least one." The term "some" refers to one or more unless otherwise stated. Claim elements are not to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for" or "step for." All structural and functional equivalents known or later known to those skilled in the art to the elements of various aspects described herein are expressly incorporated herein by reference and intended to be encompassed by the claims. Furthermore, the subject matter disclosed in this disclosure is not intended to be disclosed to the public, whether or not expressly recited in the claims.

Claims

1. A port adapter (100), Multiple ports and a self-repairing seal (140) secured over one of the plurality of ports, a circular surface of a first diameter; a raised ridge disposed on a first side of said circular surface, said raised ridge having a second diameter at an outer base that is smaller than said first diameter and a third diameter at a raised portion of said raised ridge that is smaller than said second diameter, said raised ridge defining a slope of an inverted cone; a tear guide disposed on a second side of the circular surface at the center of the bottom of the inverted cone; Equipped with the self-repairing seal has a first thickness at the outer base between the first side and a second side opposite the first side, and a second thickness at the raised portion between the first side and the second side that is greater than the first thickness; a self-healing seal (140); a port adapter (100) including: A dilator (150), a first portion having a third diameter smaller than the second diameter; a second portion having a fourth diameter smaller than the third diameter; a third section of the third diameter disposed on an opposite side of the second section relative to the first section; a dilator (150) including: An apparatus comprising:

2. The self-repairing seal comprises: an outer ring defined about the first diameter, having a first height on the first side aligned with the raised portion of the raised ridge, and having a second height on the second side equal to the first height; The apparatus of claim 1 further comprising:

3. a second circular surface of the first diameter; and a second raised ridge disposed on a first side of the second circular surface, the second raised ridge having the second diameter at a second outer base and the third diameter at a second raised portion of the second raised ridge, defining a slope of a second inverted cone; a second tear guide disposed on a second side of the second circular surface and at the center of a second base of the second inverted cone; a second outer ring defined about the first diameter of the second circular surface, the second outer ring having the first height on the first side aligned with the second raised portion of the second raised ridge, and the second height on the second side; a second self-repairing seal (140b) comprising: the second self-repairing seal has the first thickness at the second outer base between the first side of the second circular surface and a second side opposite the first side, and the second thickness at the second raised portion between the first side and the second side of the second circular surface; the second outer ring on a second side of the second circular surface contacts and is concentrically aligned with the outer ring on the first side of the self-healing seal; 3. The apparatus of claim 2.

4. The expander comprises: a fourth portion (220b) of the fourth diameter; a fifth portion (330) of the third diameter disposed between the second portion and the fourth portion; Further preparation, a first length of the second portion substantially equal to the second thickness; a second length of the fourth portion substantially equal to the second thickness; a third length of the fifth portion is approximately equal to the second height; 4. The apparatus of claim 3.

5. a length of the second portion is approximately equal to the sum of the first height, the second height, and the first thickness; 4. The apparatus of claim 3.

6. The length of the second portion is approximately equal to the second thickness.

10. The apparatus of claim 1.

7. the dilator further comprises a tapered tip at a first end of the first portion opposite a second end connected to the second portion.

10. The apparatus of claim 1.

8. the dilator further comprises a bevel (224) defined between the second portion and at least one of the first portion and the third portion; 10. The apparatus of claim 1.

9. the tear guide has a diameter that is approximately the fourth diameter; 10. The apparatus of claim 1.

10. the first side of the circular surface includes a slit disposed at the center of the tear guide and having a length approximately equal to the third diameter; 10. The apparatus of claim 1.

11. A dilator (150), a first portion (210) of a first diameter; a second portion (220) having a second diameter smaller than the first diameter and a first length; a third portion (230) of the first diameter disposed on the opposite side of the second portion relative to the first portion; a dilator (150) comprising: A sealing means (140) having a circular surface, a first region having a first thickness between a first side of the circular surface and a second side of the circular surface opposite the first side; a second region defined coaxially about an outer diameter of the first region and having a second thickness less than the first thickness; a sealing means (140) comprising: Preparation, a through hole is defined through the second region and conforms to the second diameter when the second portion is in a position through the through hole; the first length is approximately equal to the first thickness; Device.

12. the second portion includes a slope that transitions from the first diameter to the second diameter between the first portion and the second portion.

12. The apparatus of claim 11.

13. the first region defines an inverted cone slope on a first side of the circular surface, the inverted cone slope having a first slope approximately equal to a second slope of the slope defined between the first portion and the second portion; 13. The apparatus of claim 12.

14. The sealing means is a third region defined coaxially about the second outer diameter of the second region, the third region having a third thickness greater than the first thickness; Furthermore, the third region substantially aligns with the ridge of the first region extending from the first side of the circular surface.

12. The apparatus of claim 11.

15. 1. A dilator (150) for insertion through a sealing means (140) having: a first region having a first thickness between a first side of a circular surface and a second side of the circular surface opposite the first side; a second region having a second thickness less than the first thickness, the second region being coaxially defined around an outer diameter of the first region; and a pass-through hole having a first diameter in a first configuration, a second diameter greater than the first diameter in a second configuration, and a third diameter greater than the second diameter in a third configuration, the pass-through hole being defined in the first region between the first and second sides of the circular surface, a first portion (210) of said third diameter; a second portion (220) of a first length at least as long as said second diameter and said first thickness; a third portion (230) of said third diameter disposed on the opposite side of said second portion relative to said first portion; A dilator (150) comprising:

16. a first bevel (224a) defined between the first and second portions and having a first slope that substantially corresponds to the slope of the inverted cone defined in the first region of the sealing means; The dilator of claim 15 further comprising:

17. a fourth portion (220b) defined between the first portion and the second portion and having the second diameter and the first length; a fifth portion (330) of the third diameter defined between the fourth portion and the second portion; The apparatus of claim 15 further comprising:

18. the first length is approximately equal to the first thickness; 16. The expander of claim 15.

19. the first length is approximately equal to three times the first thickness; 16. The expander of claim 15.

20. the sealing means includes a third region having the first thickness between a first side of a second circular surface and a second side of the second circular surface opposite the first side, the third region being substantially parallel to the second circular surface; a fourth region having the second thickness and defined coaxially around a second outer diameter of the third region; and a second through hole having the first diameter in the first structure, the second diameter in the second structure, and the third diameter in the third structure, the second through hole being defined in the third region between the first and second sides of the second circular surface, the second part being inserted through the through hole and the second through hole in the second structure.

16. The expander of claim 15.

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