Vascular access device

Abstract

To provide an access device that has improved mechanisms for safely achieving medical device placement within the vasculature.SOLUTION: The device (20) includes a dilator (24) comprising having a valve component configured to at least inhibit fluid flow through the dilator in a distal direction, while not inhibiting the passage of articles (e.g., a guide wire 28) through the dilator in a proximal direction.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] <Incorporation by Reference> The entire contents of U.S. Provisional Patent Application No. 62 / 485,797, filed on April 14, 2017, are hereby incorporated by reference in their entirety and form a part of this disclosure. Any features, structures, materials, methods, or steps described and / or illustrated in any embodiment of the foregoing provisional patent application may be used with, or instead of, any features, structures, materials, methods, or steps described in the following paragraphs of this specification and / or illustrated in the accompanying drawings.

[0002] The present disclosure is generally directed to access devices for introducing and / or delivering medical articles (such as catheters, cannulas, sheaths, etc.) into body spaces such as, for example, arteries, veins, blood vessels, body cavities, or drainage sites, and more particularly to devices including valve members for substantially sealing one or more fluid pathways.

Background Art

[0003] For delivering fluid to or withdrawing fluid from a patient, various medical devices such as catheters, cannulas, sheaths, etc. are often introduced into a patient's arteries, veins, body cavities, or drainage sites, for example. For example, using the Seldinger or modified Seldinger technique, a catheter or vascular sheath can be introduced into a patient's blood vessel. These techniques involve inserting an access needle into the patient's blood vessel and then inserting a guidewire through the needle into the blood vessel. The dilator and sheath are inserted through the guidewire into the blood vessel from the tissue, either combined or separately. The needle can be removed before or after inserting the dilator and sheath. The dilator and guidewire are then removed and discarded. The sheath can be left in the blood vessel, for example, for delivering a medical fluid to the patient, or a catheter or other medical article can be inserted through the sheath to a desired location in the blood vessel.

[0004] A variety of access devices for performing the Seldinger or modified Seldinger technique are known. Some access devices provide needles, dilators, and / or sheaths that are coaxially arranged with respect to each other. Some such devices provide a mechanism for confirming vascular access. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0005] The access devices described herein advantageously provide an improved mechanism for safely achieving the placement of medical devices within a vasculature. Without limiting the scope of this disclosure, some of its more prominent features will be briefly considered. After considering this discussion, and particularly after reading the following detailed description section in combination with this section, it will be understood how the features and aspects of these embodiments provide several advantages over prior access devices.

[0006] One aspect is an access device for placing a medical article within a body space. The access device includes a dilator having a hub and an elongated dilator body extending from the hub defining an internal lumen having a distal lumen portion and a proximal lumen portion. The access device further includes a valve component having an open position and a closed position, the valve component including an attachment portion configured to be supported by the dilator hub and a sealing portion extending radially inwardly from a side of the internal lumen, the sealing portion being biased toward the closed position. The valve component can be configured to prevent fluid flow between the distal lumen portion and the proximal lumen portion when the valve component is in the closed position. The valve component can enable the movement of a guidewire through the dilator hub in a distal-proximal direction with respect to the dilator.

[0007] The access device may include one or more of the following features. The valve component may be disposed at least partially between a distal portion of the internal cavity and a proximal portion of the internal cavity. The sealing portion can include a first sealing surface, the dilator hub can include a second sealing surface, and the first sealing surface can contact the second sealing surface so as to substantially seal the distal cavity portion from the proximal cavity portion when the valve component is in the closed position. At least one of the first sealing surface and the second sealing surface can extend across the entire inner circumference of the internal cavity. The sealing portion can include a raised portion. When the valve component is in the closed position, the raised portion can extend into the distal portion of the internal cavity. The raised portion can include a substantially dome-like shape. The valve component can include a fold line, and the sealing portion and the attachment portion can bend relative to each other along this fold line. The valve component can include a flexible material having properties that reduce the likelihood of cold hardening when held in a bent position for an extended period of time. When the valve component is in the closed position, movement of the guide wire in the proximal direction relative to the dilator can be impeded. The access device can include a sheath disposed with respect to the dilator.

[0008] Another aspect is an access device for placing a medical article within a body space. The access device includes a dilator having a hub and an elongated dilator body extending from the hub defining an internal cavity having a distal cavity portion and a proximal cavity portion. The access device further includes a sheath coaxially disposed with respect to the dilator and a valve component including an attachment portion supported within the internal cavity and a sealing portion extending within the internal cavity, the sealing portion including a first sealing surface biased toward a first position in contact with a second sealing surface on at least one of the dilator body and the dilator hub to substantially seal at least a portion of the internal cavity from the dilator body, and the sealing portion being movable from the first position to a second position when at least one of a needle and a guide wire is extended through the internal cavity.

[0009] The access device may include one or more of the following features. The valve component may be at least partially disposed between a distal portion of the internal cavity and a proximal portion of the internal cavity. At least one of the first sealing surface and the second sealing surface may extend across the entire inner circumference of the internal cavity. The sealing portion may include a raised portion. When the valve component is in the first position, the raised portion may extend into the dilator body. The raised portion may include a substantially dome-like shape. The valve component can include a fold line, and the sealing portion and the attachment portion can bend relative to each other along this fold line. The valve component may include a flexible material having properties that reduce the likelihood of cold hardening when held in the bent position for an extended period of time. When the valve component is in the closed position, movement of at least one of the needle and the guide wire in the proximal direction relative to the dilator may be impeded.

[0010] One aspect is a method of providing an access device for placing a medical article within a body space. The method includes providing a dilator having a hub and an elongated dilator body extending from the hub defining an internal cavity having a distal cavity portion and a proximal cavity portion. The dilator may further include a valve component including an attachment portion supported within the internal cavity and a sealing portion extending within the internal cavity, the sealing portion including a first sealing surface biased toward a first position in contact with a second sealing surface on at least one of the dilator body and the dilator hub to substantially seal at least a portion of the internal cavity from the dilator body, and the sealing portion being movable from the first position to a second position when at least one of a needle and a guide wire is extended through the internal cavity. The method may further include providing a sheath configured to be coaxially disposed with respect to the dilator.

[0011] The access device may include one or more of the following features. The valve component may be at least partially disposed between the distal portion of the internal cavity and the proximal portion of the internal cavity. At least one of the first sealing surface and the second sealing surface may extend across the entire inner circumference of the internal cavity. The sealing portion may include a raised portion. When the valve component is in the first position, the raised portion may extend into the dilator body. The raised portion may include a substantially dome-like shape. The valve component may include a fold line, and the sealing portion and the attachment portion may bend relative to each other along this fold line. The valve component may include a flexible material having properties that reduce the likelihood of cold hardening when held in a bent position for an extended period of time. When the valve component is in the closed position, movement of at least one of the needle and the guide wire in the proximal direction relative to the dilator may be impeded.

[0012] This method may further include providing an access device that includes one or more of the following features. The valve component may be at least partially disposed between the distal portion of the internal cavity and the proximal portion of the internal cavity. At least one of the first sealing surface and the second sealing surface may extend across the entire inner circumference of the internal cavity. The sealing portion may include a raised portion. When the valve component is in the first position, the raised portion may extend into the dilator body. The raised portion may include a substantially dome-like shape. The valve component may include a fold line, and the sealing portion and the attachment portion may bend relative to each other along this fold line. The valve component may include a flexible material having properties that reduce the likelihood of cold hardening when held in a bent position for an extended period of time. When the valve component is in the closed position, movement of at least one of the needle and the guide wire in the proximal direction relative to the dilator may be impeded.

[0013] These and other aspects of the invention will become readily apparent to those skilled in the art from the following detailed description of the embodiments disclosed with reference to the accompanying drawings. However, the invention is not limited to the specific embodiments disclosed.

[0014] The foregoing and other features, aspects, and advantages of embodiments of the present invention will be described in detail below with reference to the drawings of various embodiments, which are intended to illustrate rather than limit the embodiments of the present invention. The drawings include the following figures.

Brief Description of the Drawings

[0015]

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[0016] In various situations, a physician may desire to introduce a catheter or sheath into a space within a patient's body, such as a blood vessel or a drainage site, to introduce fluid into or remove fluid from that space. In the art, various access devices are known. Examples of improved access devices are described in U.S. Patent Application No. 14 / 207,120, entitled "VASCULAR ACCESS DEVICE," filed Mar. 12, 2014, and currently U.S. Patent No. 9,566,087, the entire contents of which are incorporated herein by reference and form a part of this specification. FIGS. 1A and 1B of U.S. Patent No. 9,566,087 show an access device 20 that can be used, for example, to perform a Seldinger or modified Seldinger technique for introducing a catheter or sheath into a patient's blood vessel. Although the access device is described herein in the context of vascular access, the access device can also be used to access other locations within a patient's body (e.g., a drainage site) to place a medical article (e.g., a catheter or sheath) and for other purposes (e.g., draining an abscess).

[0017] The present disclosure of the access device is disclosed in the context of placing an exemplary single-piece tubular medical article within a patient's body space. After being placed, the tubular article is then used to receive other medical articles (e.g., catheters, guidewires, etc.) and provide access into the body space and / or to provide a passageway for introducing fluid into or removing fluid from (e.g., draining) the body space. In the illustrated embodiments, the tubular medical article is a sheath or catheter configured primarily to provide a fluid passageway to a vein. However, the principles of the present invention are not limited to the placement of a single-piece sheath or catheter, nor to the subsequent insertion of medical articles through the sheath or catheter. Instead, in view of the present disclosure, the access device disclosed herein can be advantageously used in connection with placing one or more other types of medical articles, including other types of sheaths, fluid drainers, and delivery tubes, as well as single-lumen or multi-lumen catheters, directly into a patient or indirectly through another medical article.

[0018] By way of example and not limitation, the access device disclosed herein can be configured to be placed directly or indirectly for a central venous catheter, a peripherally inserted central catheter, a hemodialysis catheter, a surgical drain tube, a peel-away sheath, a multi-piece sheath, a PICC line, an IV line, a scope, and a wire or cable conduit for an external or implanted electronic device or sensor. As described above, the medical articles listed above may be placed directly into a patient through the access device's dilator, needle, and guidewire, or may be placed later into the patient through a medical article placed into the patient through the access device's dilator, needle, and guidewire.

[0019] Furthermore, the embodiments disclosed herein are not limited to the coaxial insertion of a single medical article. For example, two catheters may be inserted into a patient through an inserted sheath, or a second catheter may be inserted into a patient through an inserted first catheter. Further, in addition to providing a conduit to a blood vessel or other body space, medical articles inserted through dilators, needles, and guidewires can form additional lumens for the lumen of a subsequently inserted medical article. One of ordinary skill in the art may find additional applications for the devices and systems disclosed herein. Thus, the exemplification and description of access devices related to a sheath (e.g., for micro-puncture applications) are merely examples of one possible application of an access device.

[0020] Figure 1 is a perspective view of an embodiment of an access device 20 including a dilator 24 coaxially aligned with a sheath 26. A guidewire 28 is also shown. The components of the access device 20 shown in Figure 1 include the dilator 24 and the sheath 26. In the embodiment shown, the access device 20 also includes a guidewire 28. The sheath 26 can be coaxially mounted on the dilator 24. The nested nature of the components of the access device can also be achieved by arranging the components such that the axes of the components are arranged substantially parallel rather than coaxially (e.g., a monorail type design).

[0021] Each of these components includes a lumen fitting (e.g., a hub) at a terminal or transition portion and an elongated structure extending from that fitting. Thus, in the exemplified embodiments shown in Figures 3A and 8B, the dilator 24 includes a dilator shaft 36 extending distally from a dilator hub 38, and the sheath 26 includes a sheath body 40 extending distally from a sheath hub 42. In certain embodiments, the guidewire 28 includes a guidewire hub or cap.

[0022] Figure 2A is a side view of a needle 22 that can be used to facilitate insertion of the guide wire 28 of FIG. 1 into a patient. FIG. 2B is a side cross-sectional view of the needle 22 of the embodiment shown in FIG. 2A taken along line 2B-2B. The needle 22 includes a needle body 32 and a needle hub 34. As best seen in FIG. 2B, the needle hub 34 is disposed at the proximal end of the needle body 32. The needle body 32 terminates at a distal end near the distal portion 48 of the needle 22, and the needle hub 34 is located in the proximal portion of the needle 22.

[0023] The needle body 32 has an elongated tubular shape having a circular constant-diameter inner bore 54 and a circular constant-diameter outer surface. However, in other embodiments, the needle body 32 may have other bores and outer shapes (such as, but not limited to, an elliptical cross-sectional shape). The interior and exterior of the needle 22 may also include grooves or channels. These grooves or channels may direct fluid within the needle bore around the needle 22 or to its particular structure, or within the needle 22 (e.g., around the guide wire 28). In some embodiments, the grooves or channels may assist in maintaining the desired orientation of the needle 22 with respect to the dilator 24.

[0024] The needle body 32 has a length sufficient to access the targeted subcutaneous body space and a gauge size sufficient to withstand the insertion force without causing excessive trauma when accessing the body space. For many applications, the needle body 32 may have a length between 3 cm and 20 cm (e.g., between 3 cm and 10 cm). For example, to access the body space (e.g., blood vessel) of an adult's chest, the needle body 32 may have a length of 7 cm or more, 9 cm or more, and / or a length of 9 - 10 cm. The size of the needle 22 may be 18 gauge or less (e.g., between 18 gauge and 28 gauge or between 18 gauge and 26 gauge for micro-puncture applications (peripheral IV)). For applications by a neonate, the length and gauge of the needle body 32 should be significantly shorter and smaller, such as between 3 cm and 4 cm and between 26 gauge and 28 gauge, for example. The needle body 32 may have an angled tip 52 disposed at the distal portion 48.

[0025] As will be described in more detail below, the guide wire 28 passes through the hollow portion 68 of the needle hub 34, through the needle body 32, and is introduced into the punctured blood vessel. After removing the needle 22 from the patient, the remaining guide wire 28 enables the healthcare provider to guide the dilator 24 and the sheath 26 into the blood vessel.

[0026] FIG. 3A is a plan view of a dilator 24 that can be used with the access device 20 of FIG. 1, the dilator 24 including a valve component 300 (not shown in FIG. 3A). FIG. 3B is a side cross-sectional view taken along line 3B-3B of FIG. 3A, showing the valve component 300. The dilator 24 shown includes a dilator shaft 36, a dilator hub 38, and an internal cavity 74 including a distal portion 73 and a proximal portion 72.

[0027] FIG. 4A is an enlarged perspective view of a portion of the dilator hub 38 shown in FIG. 3A when the valve component 300 is in the closed position. FIG. 4B is a side cross-sectional view of the dilator hub 38 shown in FIG. 3B surrounded by line 4B-4B. FIG. 4C is an end view of the dilator hub 38 shown in FIG. 3A viewed in the distal direction. The dilator 24 includes an internal cavity 74. In certain embodiments, as described herein, the internal cavity 74 is configured to receive the valve component 300. The internal cavity 74 can be sized and shaped such that the valve component 300 can be received within the dilator hub 38. However, the valve component 300 need not be present within the dilator hub 38. In certain embodiments, the valve component 300 is located at the proximal end (e.g., top) of the dilator 24 or outside the dilator 24 as long as the guide wire 28 passes along the valve component 300.

[0028] Continuing to refer to FIGS. 3A - 4C, the valve component 300 can be configured to substantially seal at least a portion of the internal cavity 74 of the expander hub 38 or other passageways within the expander through which a guide wire can pass. In some cases, the valve component 300 can be positioned between the proximal portion 72 and the distal portion 73 of the internal cavity 74 such that the valve component 300 is configured to substantially seal the distal portion 73 from the proximal portion 72. The portions 72, 73 can include any of a variety of sizes and shapes and are shown with a generally circular cross - sectional shape for illustrative purposes only. In some embodiments, to facilitate sealing of the valve component 300 against the distal portion 73, the distal portion 73 of the internal cavity 74 includes at least a region having a smaller cross - sectional area than the proximal portion 72. In this arrangement, the valve component 300 can be configured as a one - way valve structure by substantially preventing the flow of fluid through the internal cavity 74 in the distal direction, without substantially preventing the passage of an article (e.g., guide wire 28 shown in FIGS. 5 - 6B) through the internal cavity 74 in the proximal direction.

[0029] As shown in FIGS. 3B - 6B, the illustrated valve component 300 includes a sheath or disk (e.g., the sealing surface 75 described herein) configured to interact with at least a portion of the expander hub 38. The valve component 300 can be positioned on, in contact with, or around any portion of the expander hub 38 to seal at least a portion of the internal cavity 74. The valve component 300 can be made as a single unitary body.

[0030] As shown in FIGS. 3B and 5 respectively, the valve component may have a first configuration and a second configuration (e.g., a closed position and an open position respectively). The valve component 300 may be adapted to flex, flexure, or flex the sealing portion 308 of the valve component 300 through flexation, between a closed position or a substantially sealed position (e.g., as shown in FIGS. 3B - 4C) and an open position or an unsealed position (e.g., as shown in FIGS. 5 - 6B). The valve component 300 may move between the open position and the closed position for the passage of the dilator hub 38 and / or a device (e.g., guidewire 28) through user operation. In some embodiments, the valve component 300 may include an elastomeric material and / or a flexible structure that can be deformed or moved when a device (e.g., guidewire) abuts against the valve component 300 and extends therethrough.

[0031] As shown in FIG. 3B, when the valve component 300 is in the first configuration (e.g., closed position), the valve component 300 may be disposed along a portion of the dilator hub 38. For example, when in the closed position, the sealing surface 309 of the valve component 300 located on the distal surface of the sealing portion 308 may contact or otherwise engage with the corresponding sealing surface 75 of the dilator hub 38 located on the surface facing proximally of the dilator hub 38. The interaction of the respective sealing surfaces 309, 75 may be sufficient to prevent the passage of fluid through the internal cavity 74 in the proximal and / or distal directions.

[0032] The valve component 300 may include an attachment portion 304 that supports a sealing portion 308. The attachment portion 304 may be supported by a portion of the expander hub 38 such that the sealing portion 308 extends (e.g., radially inwardly) into the internal cavity 74 and can substantially seal an opening within the internal cavity 74. The attachment portion 304 of the valve component 300 may include any of a variety of materials having sufficient rigidity to support the sealing portion 308. As described herein, this material may include sufficient flexibility to allow the sealing portion 308 to bend or move between an open position and a closed position. The attachment portion 304 may also include a biocompatible metal or plastic, or various composites or combinations thereof. The attachment portion 304 may include a material that is less susceptible to cold hardening. For example, in some applications, the medical article can extend through the internal cavity 74 by the valve component 300 in the open position without compromising the characteristics of the valve (e.g., its flexibility and ability to seal the internal cavity 74 when in the closed position) and can be packaged while within the expander 24. For example, the access device can be pre-assembled and packaged with a guide wire 28 coaxially disposed within the expander 24.

[0033] The valve component 300 may be sized and configured to extend along and surround any portion and / or length of the internal cavity 74 of the dilator hub 38 so as to substantially seal the proximal portion 72 of the internal cavity 74 from the distal portion 73. For example, the valve component 300 may be configured to be positioned over and surround the distal portion 73 of the internal cavity 74 at the distal end of the proximal portion 72 of the internal cavity 74. The attachment portion 304 of the valve component 300 is positioned along a first portion of the dilator hub 38, and the sealing portion 308 of the valve component 300 is positioned along a second portion of the dilator hub 38 such that the valve component 300 is configured to substantially surround the distal portion 73 of the internal cavity 74. The valve component 300 may be configured to adhere to the dilator hub 38 when in the open position and / or the closed position. In some embodiments, as described herein, the attachment portion 304 of the valve component 300 may include an adhesive for at least adhering to the dilator hub 38.

[0034] The valve component 300 may include a restoring force that biases the valve component 300 toward the closed position. In particular, the restoring force can press the sealing surface 309 against the sealing surface 75. In some embodiments, this mechanism can be sufficiently resilient to withstand the pressures associated with a human blood vessel to prevent blood from passing proximally through the valve component 300 when the valve component 300 is closed. Thus, this mechanism advantageously prevents blood loss through the valve component 300 when it is closed. This mechanism may also be sufficient to maintain the placement of a device (e.g., a guide wire) within the dilator hub 38 when the device is inserted through the dilator 24 (shown in FIG. 5). For example, the restoring force can engage the valve component 300 with the device to prevent unintended movement of the device relative to the dilator 24.

[0035] In some embodiments, as described herein, the valve component 300 is configured such that the sealing surface 309 of the sealing portion 308 contacts the sealing surface 75 of the expander hub 38 and is preloaded so that the valve component 300 is preloaded in the closed position. This biasing can enhance the above-described obstruction of the passage of substances in the distal and / or proximal directions. This biasing can help the valve component 300 to impede the passage of substances such as, for example, the flow of fluid (e.g., blood or air) or the passage of a device in the proximal and / or distal directions (e.g., longitudinal direction) within the internal cavity 74. For example, the biasing towards the closed position can be strong enough to resist the proximal and / or distal forces (or cracking pressure) to open the valve component 300. In some embodiments, the preloading or biasing of the valve component 300 can be sufficient to prevent gas from being drawn distally through the internal cavity 74 into the patient, for example, by the negative pressure generated by a human during normal pulsation. In particular, drawing gas into a blood vessel can have serious health implications such as, for example, embolism.

[0036] FIG. 5 is a side cross-sectional view similar to FIG. 3B, where the expander 24 and the sheath 26 are passed over the guide wire 28, and the guide wire 28 abuts against and extends through the valve component 300, moving the valve component 300 from the closed position to the open position. FIG. 6A is an enlarged perspective view of a portion of the expander hub 38 shown in FIG. 5 as viewed in the distal direction when the valve component is in the open position. FIG. 6B is a side cross-sectional view of the expander hub 38 shown in FIG. 5 taken along line 6B-6B. In the embodiment shown, the expander 24 is slid distally relative to the guide wire 28 until the valve component 300 engages the guide wire 28. As the guide wire 28 passes through the expander hub 38 and extends through the valve component 300, the sealing surface 309 of the valve component 300 can engage the outer surface of the guide wire 28.

[0037] As discussed herein, the valve component 300 can be biased toward a closed position. The degree of biasing of the valve component 300 toward the closed position can be selected such that the guide wire 28 can slide easily through the valve component 300 when the dilator 24 is passed through the guide wire 28. In certain embodiments, when the guide wire 28 is first passed through the dilator hub 38, the valve component 300 abuts against the outer surface of the guide wire 28 and compresses the guide wire 28. In some cases, this biasing force may be insufficient to effectively impede the guide wire 28 passed through the valve component 300. That is, the biasing force of the valve component 300 against the guide wire 28 can still allow movement of the guide wire 28 relative to the valve component 300. For example, the valve component 300 may not sufficiently resist the guide wire 28 passing through the dilator hub 38 in the proximal direction relative to the dilator hub 38.

[0038] The sealing portion 308 may include a raised portion such as a substantially dome-shaped portion adjacent to and / or along at least a portion of the sealing surface 309. This dome-shaped portion can prevent or reduce the possibility of contact between the sealing surface 309 and a device (e.g., guide wire 28) when the device passes through and / or extends through the internal cavity 74. For example, when the dilator 24 is stored with a device that extends through the internal cavity 74, the device may engage and / or contact the raised portion directly and may not contact the sealing surface 309 primarily. Thus, the raised portion can prevent damage to the sealing surface 309 of the sealing portion 308 caused by long-term strong contact with the stored device, and thus can extend the sealing ability and lifespan of the valve component 300.

[0039] The sealing portion 308 of the valve component 300 can include any of a variety of materials that can substantially seal the internal cavity 74 when contacting or being urged against the sealing surface 75. In some embodiments, the sealing portion 308 can include metal, plastic, rubber, or other suitable biocompatible materials, such as polyisoprene, silicone, polyurethane, or other elastic polymers. In some embodiments, the sealing portion 308 can be coated or include other surface treatments, such as a silicon-treated surface to facilitate low-friction sliding of various components (such as the guide wire 28) along its surface, for example. In some cases, the attachment portion 304 and the sealing portion 308 can be formed of the same material so that the valve component 300 can optionally be a single unitary part. In some embodiments, the valve component 300 can include a separate biasing component configured to bias the valve component 300 toward the closed position.

[0040] The valve component 300 can be formed in several different ways, such as by molding (e.g., injection) and stamping, and can be formed separately from or integrally with the expander hub 38. The attachment portion 304 and the sealing portion 308 can be attached to each other and / or to the expander hub 38 in a variety of ways, such as by adhesion, bonding (e.g., ultrasonic, thermal, etc.), fasteners, and overmolding. A primer or anti-adhesion coating or surface treatment can be applied to the attachment portion 304 and / or the sealing portion 308 to facilitate their attachment to each other during manufacture. Regarding the flexural characteristics of the sealing portion 308 described above, in some embodiments, the sealing portion 308 can be pretreated to have specific mechanical characteristics before being combined with the attachment portion 304.

[0041] The valve component 300 shown by the attachment part 304 can be attached to the expander hub 38 by various means. In some embodiments, the attachment part 304 can be adhered or coupled to the expander hub 38. In other embodiments, the attachment part 304 can be attached to the expander hub 38 by molding or overmolding. In further embodiments, the attachment part 304 can be integrally molded with the expander hub 38 (or a part thereof). When integrally formed, it may be desirable to give the expander hub 38 a substantially greater thickness than the attachment part 304 so that the expander hub 38 maintains higher rigidity. In other embodiments, the attachment part 304 can be attached to the expander hub 38 by mechanical compression. For example, the expander hub 38 may have a groove for receiving the attachment part 304 to allow press-fitting into a predetermined position.

[0042] As shown in FIG. 7, in some embodiments, the valve component 300 may engage the expander hub 38 through the attachment member 50. The valve component 300 may be attached to an attachment member 50 inserted into the internal cavity 74 of the expander hub 38. The attachment member 50 may include a central bore configured to engage the sealing portion 308 of the valve component 300 when the valve component 300 is in the closed position. The surface facing distally of the attachment member 50 may be substantially straight or flat for engaging the sealing surface 75 of the expander hub 38. Since the attachment member 50 is disposed in contact with the sealing surface 75, in the closed position, the sealing portion 308 seals in contact with the attachment member 50 rather than the sealing surface 75. The attachment member 50 can be made of a relatively soft material and can be soft enough to allow press-fitting into the internal cavity 74 of the attachment member 50.

[0043] The attachment member 50 is substantially circular or donut-shaped and can allow for flexibility at its rotational position within the expander hub 38. However, in other embodiments, the attachment member 50 can be rotationally fixed within the expander hub 38, i.e., it can be fixed by a non-circular insertion portion and a corresponding non-circular receiving portion in the expander hub 38. Further, the outer edge of the attachment member 50 is shaped to substantially conform to the sealing surface 75 of the expander hub 38 to form a seal that prevents fluid leakage between at least the two of them. In some embodiments, a taper along the attachment member 50 and / or a taper within the expander hub 38 can facilitate the seal between the attachment member 50 and the expander hub 38.

[0044] The attachment member 50 can advantageously compensate for molding imperfections and / or misalignment that can occur in the manufacture and assembly of the expander hub 38, such as, for example, being constructed of a relatively soft and flexible material. Additionally, the attachment member 50 can advantageously reduce the size of the opening to be sealed by the sealing portion 308 compared to the sealing surface 75. Additionally, the attachment member 50 can function as a seal around a device inserted through the expander hub 38 to maintain the seal when the valve component 300 is in the open position to accommodate the device. Thus, the attachment member 50 can function as a seal independent of the sealing portion 308. In some embodiments, the attachment member 50 can extend to accommodate and / or conform to various devices that can be introduced through the expander hub 38.

[0045] In some embodiments, the sealing portion 308 can be made of a relatively rigid material such as, for example, polyurethane or polycarbonate. The inclusion of the relatively flexible attachment member 50 can advantageously enable the sealing portion 308 to be made of a relatively rigid material. This is because the more flexible attachment member 50 can compensate for molding imperfections and maladjustments such as those that a relatively rigid sealing portion 308 might not be able to effectively compensate for. The relatively rigid material can advantageously reduce the damage that can be imparted to the valve component 300 and can better resist tearing and / or other wear. Such tearing or wear can negatively affect the effectiveness of the seal.

[0046] The attachment member 50 can be removably engaged with at least a portion of the expander hub 38 in some cases to enable movement of the attachment member 50 into or out of the internal cavity 74. For example, the attachment member 50 may be removably retained within the internal cavity 74 via any suitable interaction (e.g., interference, engagement, friction, mechanical coupling, adhesion, etc.). The attachment member 50 may be sufficiently engaged with the expander hub 38 to prevent unintentional removal of the attachment member 50 from the internal cavity 74. In some embodiments, when the guide wire 28 abuts the valve component 300, further proximal movement of the guide wire 28 relative to the expander 24 may be insufficient to overcome the interaction forces that removably retain the attachment member 50 within the internal cavity 74. For example, after the guide wire 28 has pushed past and extended beyond the valve component 300, the attachment member 50 may remain within the internal cavity 74. In certain embodiments, one or more walls, such as the sealing surface 75 of the internal cavity 74, for example, prevent distal movement of the attachment member 50 relative to the internal cavity 74.

[0047] The dilator hub 38 may include a locking structure along the proximal region and / or the distal region 70 of the dilator hub 38. Each locking structure may be a luer type or other type of connection. In the illustrated embodiment, the dilator hub 38 includes a luer connection 78. In some embodiments, the luer connection 78 (e.g., male luer slip connector) may be configured to engage a sheath hub 42 (e.g., female luer slip connector) of the sheath 26 shown in FIGS. 8A and 8B. Additionally, the male-female luer slip connectors in these components may be reversed.

[0048] The color of the dilator 24 may be selected to enhance the contrast between the blood or other fluid and the dilator 24. For example, in some applications, during a blood flush, blood flowing between the dilator 24 and the sheath 26 is observed to confirm proper placement into the blood vessel. To increase the visibility of the fluid as a fluid flow between the sheath 26 and the dilator 24, the sheath 26 is preferably manufactured from a transparent or permeable material and the dilator 24 has a color that contrasts with the color of the fluid. For example, the dilator 24 may have a white color to enhance the contrast with red blood. Depending on the color of the fluid and the desired degree of contrast, dilators 24 of other colors may also be used. Further, only the portion of the dilator 24 in the region of the blood flush may have a contrasting color and the remainder may have a different color.

[0049] During use, the dilator 24 expands an opening or passage created by the needle 22. The expanded passage facilitates the subsequent introduction of the sheath 26. The needle 22 introduces the guidewire 28, then the dilator 24, and finally the sheath 26 into the patient's body.

[0050] FIG. 8A is an end view of sheath 26, looking distally, which may be used with access device 20 of FIG. 1. FIG. 8B is a side view of sheath 26 shown in FIG. 8A. Sheath 26 may include a sheath body 40, a sheath hub 42, a distal region 86, and a proximal region 88. Sheath body 40 may be made, in part or in whole, from a transparent, translucent, transmissive, or substantially opaque material. Additionally, sheath body 40 may include one or more radiopaque markers such as, for example, barium sulfate stripes. In a preferred embodiment, the sheath includes two such radiopaque stripes disposed on opposite diametric sides of body 40.

[0051] Sheath body 40 may be a single-piece sheath through which a catheter or other medical article (e.g., guidewire 28) may be inserted into sheath 26. In such embodiments, sheath body 40 forms a conduit for insertion of a catheter or other medical article. In addition to providing a conduit, sheath 26 or a portion of the sheath may form an additional lumen for a catheter lumen. For example, by inserting a dual-lumen catheter through sheath body 40 and having sheath body 40 itself form a third lumen, an equivalent of a triple-lumen catheter may be formed. To enable a physician or healthcare provider to view blood flowing within dilator 24 through sheath body 40, sheath body 40 may be manufactured from a transparent or at least somewhat transmissive material.

[0052] In some embodiments, such as those shown in FIGS. 8A and 8B, the sheath can be a separable sheath 26A. For example, depending on the type of catheter or medical article to be inserted into a blood vessel after using the access device 20, it may be advantageous to remove a portion or all of the sheath body 40. For example, after a catheter or other medical article has been inserted into a blood vessel, a portion of the sheath body 40 can be separated or peeled off and removed to reduce clutter at the access site. The peel-away sheath can include perforations, serrated cuts, skives, or other structures, or other materials (e.g., PTFE and bismuth) to enable a physician or healthcare provider to easily remove a portion or all of the sheath body 40.

[0053] The sheath hub 42 may include a luer slip connection 90. The luer slip connection 90 may include a locking or attachment structure that mates or engages with a corresponding structure. For example, the luer slip connection 90 can be configured to engage the luer connection 78 of the dilator hub 38.

[0054] As best seen in FIG. 8A, the sheath hub 42 is preferably designed such that the luer connection 78 of the dilator hub 38 can enter the sheath hub 42 without substantial interference. However, once the sheath hub 42 is positioned at a desired location on the dilator shaft 36 during use, a physician or healthcare provider can push, pull, or twist the sheath hub 42 and potentially disconnect or engage the luer slip connection 90 with a corresponding connector of another medical article. The luer slip connection 90 creates a mechanical fit such that the dilator hub 38 and the sheath hub 42 are releasably coupled. The sheath hub 42 engages the corresponding luer connection 78 of the dilator hub 38. By pulling, pushing, pressing, or twisting the dilator hub 38 relative to the sheath hub 42, the lock position can be disengaged or engaged.

[0055] In additional embodiments, to enable easy release and removal of the sheath body 40 from other portions of the access device 20, the sheath hub 42 may include a radially extending wing or handle structure. In some applications, the wing is sized to provide a levering action for the healthcare provider to pull the sheath hub 42 away. The sheath hub 42 and / or the sheath body 40 may include two or more portions (e.g., halves) connected by a thin membrane. This membrane may be sized to hold together two or more portions of the sheath hub 42 and / or the sheath body 40 until the healthcare provider decides to remove the sheath hub 42 and / or the sheath body 40 from the access device. The healthcare provider manipulates the wing to break the membrane and separate the sheath hub 42 into removable halves.

[0056] FIG. 9 is a side cross-sectional view of the access device 20 after the access device 20 has been passed over the guidewire 28. Thus, in the illustrated embodiment, the dilator 24 includes a dilator shaft 36 that extends distally from the dilator hub 38, and the sheath 26 includes a sheath body 40 that extends distally from the sheath hub 42. In certain embodiments, the guidewire 28 includes a guidewire hub or cap (not shown). In the illustrated embodiment, the dilator 24 and the sheath 26 are releasably coupled at the proximal end of the access device 20. In some embodiments, the releasable coupling between the dilator 24 and the sheath 26 is a linear coupling where the sheath 26 is locked to the dilator 24. The relative positioning of the distal ends of the dilator 24 and the sheath 26 is shown in FIG. 9. For example, the distal end of the dilator body 36 extends beyond the distal end of the sheath 26.

[0057] FIG. 10A is a cross-sectional view of the needle 22 shown in FIG. 2A penetrating the body 118. FIG. 10B is an enlarged partial cross-sectional view of the distal end of the needle 22 from FIG. 10A. In FIG. 11A, the needle 22 is penetrating a vascular structure. FIG. 11B is an enlarged partial cross-sectional view of the distal end of the needle 22 from FIG. 11A. In use, the bevel tip 52 enters the blood vessel 122.

[0058] FIG. 12 is a cross-sectional view similar to FIG. 10A, where the guide wire 28 is supplied through the needle 22 into the patient's blood vessel 122. When a physician or healthcare provider places the needle 22 within the target blood vessel 122, the physician or healthcare provider supplies the guide wire 28 into the vasculature. While the guide wire 28 is being supplied through the needle 22 to the patient, the needle 22 is held stationary. During the insertion procedure, the guide wire 28 passes through the inner bore 54 of the needle 22.

[0059] When supplying the guide wire 28 through the needle 22, a guide wire advancer known in the art may be used. For example, when the guide wire 28 has a curved tip or a J-tip, an advancer may be used to straighten the tip to facilitate the supply of the guide wire 28 into the inner bore 54 of the needle 22. FIG. 13 is a cross-sectional view similar to FIG. 12, except that the guide wire 28 is further extended within the patient's vasculature.

[0060] FIG. 14A is a cross-sectional view similar to FIG. 13, where the needle 22 has been removed and the dilator 24 and sheath 26 are being slid along the outer portion of the guide wire 28 to move the valve component 300 to the open position. FIG. 14B is an enlarged partial cross-sectional view from FIG. 14A. As the dilator 24 is slid along the outer portion of the guide wire 28, the sealing portion 308 of the valve component 300 within the inner cavity 74 of the dilator 24 is effectively moved proximally with respect to the dilator 24.

[0061] FIG. 15 is a cross-sectional view similar to FIG. 14A, where the dilator 24 and the sheath 26 are further slid along the outer portion of the guide wire 28 and into the patient's vasculature. While passing the sheath 26 and the dilator 24 over the guide wire 28 and into the blood vessel 122, the guide wire 28 can slide freely along the valve component 300. The dilator 24 and the sheath 26 may be inserted into the patient's vasculature at any of a variety of angles relative to the patient's body 118. The insertion angle shown in FIG. 15 is for illustrative purposes only. In some embodiments, the dilator 24 and the sheath 26 may be introduced at a lower profile angle relative to the body 118 compared to the insertion angles shown in FIGS. 15-20. In this arrangement, the dilator 24 and the sheath 26 may be inserted such that the portion of the distal end of the dilator 24 and / or the sheath 26 does not (or only slightly) need to bend after being inserted into the blood vessel 122 (e.g., as compared to the dilator 24 and the sheath 26 shown in FIGS. 15-20).

[0062] FIG. 16 is a cross-sectional view similar to FIG. 15, where the guide wire 28 has been withdrawn from the dilator 24 and the sheath 26. As described herein, the valve component 300 can be biased toward the center of the dilator hub 38. Due to this biasing, when the guide wire 28 is removed, the valve component 300 can move toward the closed position. Thus, as shown in FIG. 16, upon removal of the guide wire 28, the valve component 300 may move to the closed position and substantially seal at least the distal portion 73 of the internal cavity 74 by contacting the sealing surface 75.

[0063] FIG. 17 is a cross-sectional view similar to FIG. 16, where the dilator 24 has been removed from the patient and the sheath 26. The sheath 26 is left properly inserted within the blood vessel 122. The dilator 24 may be removed after or in cooperation with the removal of the guide wire 28.

[0064] FIG. 18 is a cross-sectional view similar to FIG. 17, where the catheter 120 is aligned with the sheath 26 for insertion into the patient's vasculature. FIG. 19 is a cross-sectional view similar to FIG. 18, where the catheter 120 is inserted through the sheath 26 and into the patient's vasculature, specifically into the target vessel 122.

[0065] FIG. 20 is a cross-sectional view similar to FIG. 19, where two portions of the sheath 26 are pulled apart from each other to remove the sheath 26 surrounding the catheter 120. The sheath 26 is divisible along one or more dividing lines. The divisible sheath 26 provides the advantage that a portion or all of the sheath body 40 can be removed depending on the type of catheter or medical article to be inserted into the vessel after using the access device 20. For example, after the catheter 120 is inserted into the vessel 122, a portion of the sheath body 40 is separated or pulled off and removed to reduce the clutter at the access site. The peel-away sheath 26 can be slid proximally along the catheter 120 until the sheath 26 is first removed from the patient and then divided. Alternatively, the sheath 26 can be first divided before the entire sheath 26 is removed from the patient. After the remaining sheath 26 is removed from the patient, the physician or healthcare provider can continue to divide the sheath 26. As shown in FIG. 20, the sheath 26 can be divided in coordination with removal from the patient. In certain embodiments, the sheath 26 is not divisible.

[0066] As noted above, the access device can be used to place a catheter in other locations within the patient's body. Thus, by way of example and not limitation, the access device can be used as or with various catheters for drainage of fluid from an abscess, drainage of air from a pneumothorax, and access to the peritoneal cavity.

[0067] Although this disclosure has been described in the context of specific embodiments and examples, it will be understood by those skilled in the art that the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and their obvious modifications and equivalents. Additionally, while some variations of the disclosed embodiments have been shown and described in detail, other modifications within the scope of the disclosure will readily become apparent to those skilled in the art. Various combinations or sub-combinations of the specific features and aspects of the embodiments may be made, and these are also expected to be within the scope of the disclosure. It should be understood that the various features and aspects of the disclosed embodiments may be combined with or replaced by one another to form modes of variation of the disclosed embodiments. Accordingly, it is intended that the scope of the disclosure herein not be limited by the specific embodiments described above.

Claims

1. 1. An access device for placing a medical article within a body space, the access device comprising: a dilator, the dilator An expander body; a dilator hub extending from a proximal end of the dilator body; The dilator hub defines an internal cavity having a distal portion and a proximal portion along a longitudinal axis defined by the dilator body and the dilator hub, and the access device further comprises: a sheath disposed coaxially with respect to the dilator; a mounting member that is inserted into the internal cavity and has a communication hole that communicates between the distal portion and the proximal portion, and a valve component that is attached to the mounting member and has an open position and a closed position that open and close the communication hole, the mounting member is removably held within the internal space of the dilator hub, the valve component is engaged with the dilator hub through the mounting member, and the valve component is a mounting portion supported by the mounting member; a sealing portion extending into the interior cavity, the sealing portion including a first sealing surface; the first sealing surface is biased toward a first position against a second sealing surface of the attachment member to substantially seal at least a portion of the interior cavity from the dilator body; The sealing portion is movable from the first position to the second position when at least one of a needle and a guidewire is extended through the internal cavity.

2. The access device of claim 1 , wherein the mounting member includes a central bore configured to engage the sealing portion of the valve component when the valve component is in a closed position.

3. The access device of claim 1 , wherein the attachment member is press fit into the internal cavity.

4. The access device of claim 1 , wherein the valve component is at least partially disposed between a distal portion of the internal cavity and a proximal portion of the internal cavity.

5. The access device of claim 1 , wherein at least one of the first sealing surface and the second sealing surface extends around an entire inner circumference of the internal cavity.

6. The access device of any one of claims 1 to 5, wherein the sealing portion comprises a raised portion.

7. The access device of claim 6 , wherein the raised portion extends into the dilator body when the valve component is in the first position.

8. The access device of claim 6 or 7, wherein the raised portion comprises a substantially dome-like shape.

9. The access device of any one of claims 1 to 8, wherein the valve component includes a fold line, and the sealing portion and the attachment portion are bendable relative to one another along the fold line.

10. The access device of any one of claims 1 to 9, wherein the valve component comprises a flexible material having properties that reduce the likelihood of cold hardening when held in a bent position for an extended period of time.

11. The access device of any one of claims 1 to 10, wherein when the valve component is in the closed position, movement of at least one of the needle and the guidewire in a proximal direction relative to the dilator is prevented.

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