Medical devices for accessing the central nervous system

Abstract

A suitable medical device for accessing the central nervous system is provided. [Solution] Medical devices for accessing the central nervous system, and methods for making and using the medical devices, are disclosed. An exemplary medical device may include an expandable access sheath having a proximal end region and a distal end region. The expandable access sheath may be configured to transition between a first configuration and an expanded configuration. The expandable access sheath may include a tubular body having one or more axial support members disposed along the tubular body. The medical device may include an expansion member configured to transition the expandable access sheath between the first configuration and the expanded configuration.

Description

[Technical field]

[0001] The present disclosure relates to medical devices and methods of making medical devices, and more particularly to medical devices for accessing the central nervous system. [Background technology]

[0002] A wide variety of medical devices have been developed for medical use. Some of these devices include access sheaths, guidewires, catheters, and the like. These devices may be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There remains a need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0003] This disclosure provides alternatives for medical device configurations, materials, methods of manufacture, and uses. A medical device for accessing the central nervous system is disclosed. The medical device includes an expandable access sheath having a proximal end region and a distal end region, the expandable access sheath including a tubular body configured to transition between a first configuration and an expanded configuration and having one or more axial support members disposed along the tubular body, and an expander member configured to transition the expandable access sheath between the first configuration and the expanded configuration.

[0004] Alternatively or in addition to any of the above embodiments, the first configuration is a collapsed configuration. Alternatively, or in addition to any of the above embodiments, the expandable access sheath is biased into the first configuration.

[0005] Alternatively or in addition to any of the above embodiments, the expandable access sheath is configured to be in a first configuration when not subjected to an outward radial expansion force, to expand to an expanded configuration when subjected to an outward radial expansion force, and to return to the first configuration when the outward radial expansion force is removed.

[0006] Alternatively or in addition to any of the above embodiments, the expandable access sheath is configured to be in a first configuration in the absence of the expansion member, to expand to an expanded configuration when the expansion member is disposed within the tubular body, and to return to the first configuration when the expansion member is removed from the tubular body.

[0007] Alternatively, or in addition to any of the above embodiments, the one or more axial support members are configured to limit foreshortening of the tubular body. Alternatively, or in addition to any of the above embodiments, the one or more axial support members are configured to fix the length of the tubular body.

[0008] Alternatively or in addition to any of the above embodiments, when the expandable access sheath is in the first configuration, the tubular body has a first length, and when the expandable access sheath is in the expanded configuration, the tubular body has a second length.

[0009] Alternatively, or in addition to any of the above embodiments, the first length is substantially the same as the second length. Alternatively or in addition to any of the above embodiments, the tubular body includes a polymeric sleeve.

[0010] Alternatively, or in addition to any of the above embodiments, at least some of the one or more axial support members are substantially straight. Alternatively, or in addition to any of the above embodiments, all of the one or more axial support members are substantially straight.

[0011] Alternatively or in addition to any of the above embodiments, at least some of the one or more axial support members have a proximal curved region. Alternatively or in addition to any of the above embodiments, each of the one or more axial support members has a proximal curved region.

[0012] Alternatively or in addition to any of the above embodiments, the one or more axial support members include a first axial support member and a second axial support member, further comprising one or more struts extending between the first axial support member and the second axial support member.

[0013] Alternatively or in addition to any of the above embodiments, the expansion member includes a trocar. Alternatively or in addition to any of the above embodiments, the expansion member includes a cannula.

[0014] Alternatively or in addition to any of the above embodiments, the expansion member comprises a trocar or cannula. Alternatively or in addition to any of the above embodiments, the expansion member includes a proximal iris member coupled to the one or more axial support members.

[0015] Alternatively or additionally to any of the above embodiments, actuation of the proximal iris member transitions the expandable access sheath from the first configuration to the expanded configuration. Alternatively or in addition to any of the above embodiments, the expansion member includes a rotatable bolt coupled to the one or more axial support members.

[0016] Alternatively or additionally to any of the above embodiments, rotation of a rotatable bolt transitions the expandable access sheath from the first configuration to the expanded configuration. Alternatively or in addition to any of the above embodiments, at least some of the one or more axial support members include a curved region, and rotation of the rotatable bolt causes the rotatable bolt to engage the curved region.

[0017] Alternatively or additionally to any of the above embodiments, engaging the rotatable bolt with the curved region transitions the expandable access sheath from the first configuration to the expanded configuration.

[0018] Alternatively or in addition to any of the above embodiments, the device further comprises a stylet extending at least partially through the expandable access sheath. Alternatively or in addition to any of the above embodiments, the expandable access sheath is in the first configuration when the stylet extends at least partially through the expandable access sheath.

[0019] Alternatively or in addition to any of the above embodiments, the stylet includes a distal camera. Alternatively, or in addition to any of the above embodiments, the stylet includes one or more marker members or sensors.

[0020] Alternatively, or in addition to any of the above embodiments, at least some of the one or more marker members include a visual marker. Alternatively, or in addition to any of the above embodiments, at least some of the one or more marker members include markers detectable by fluoroscopic imaging.

[0021] Alternatively or additionally to any of the above embodiments, at least some of the one or more marker members include markers detectable by magnetic resonance imaging. Alternatively or in addition to any of the above embodiments, at least some of the one or more marker members include markers detectable by optical coherence tomography imaging.

[0022] Alternatively or additionally to any of the above embodiments, the device further comprises a device orienting assembly coupled to the expandable access sheath. Alternatively or in addition to any of the above embodiments, the device orienting assembly includes a base configured to engage with the patient.

[0023] Alternatively, or in addition to any of the above embodiments, the device orienting assembly includes one or more adjustable legs configured to engage the patient. Alternatively or in addition to any of the above embodiments, the device orienting assembly includes a stylet.

[0024] Alternatively or additionally to any of the above embodiments, the device further comprises a locking arm coupled to the device orienting assembly. Alternatively or in addition to any of the above embodiments, the device orienting assembly includes a base and an adjustable member coupled to the base.

[0025] Alternatively, or in addition to any of the above embodiments, the adjustable member is axially adjustable relative to the base. Alternatively, or in addition to any of the above embodiments, the adjustable member may be pivotally adjustable relative to the base.

[0026] A medical device for accessing a target region in the brain is disclosed, the medical device comprising: an expandable brain port configured to reversibly transition between a first configuration and an expanded configuration, the expandable brain port including a polymer sleeve and a stent-like lattice coupled to the polymer sleeve, the stent-like lattice including one or more axial support members, and an expansion member configured to transition the expandable brain port between the first configuration and the expanded configuration.

[0027] Alternatively or in addition to any of the above embodiments, the first configuration is a collapsed configuration. Alternatively or in addition to any of the above embodiments, the expandable brain port is biased into the first configuration.

[0028] Alternatively or in addition to any of the above embodiments, the expandable brain port is configured to be in a first configuration when not subjected to an outward radial expansion force, to expand to an expanded configuration when subjected to an outward radial expansion force, and to return to the first configuration when the outward radial expansion force is removed.

[0029] Alternatively or in addition to any of the above embodiments, the expandable brain port is configured to be in a first configuration in the absence of the expansion member, expand to an expanded configuration when the expansion member is disposed within the expandable brain port, and return to the first configuration when the expansion member is removed from the expandable brain port.

[0030] Alternatively or in addition to any of the above embodiments, the one or more axial support members are configured to limit foreshortening of the expandable brain port. Alternatively, or in addition to any of the above embodiments, the one or more axial support members are configured to fix the length of the expandable brain port.

[0031] Alternatively or in addition to any of the above embodiments, when the expandable brain port is in the first configuration, the expandable brain port has a first length, and when the expandable brain port is in the expanded configuration, the expandable brain port has a second length.

[0032] Alternatively, or in addition to any of the above embodiments, the first length is substantially the same as the second length. Alternatively or in addition to any of the above embodiments, at least some of the one or more axial support members are substantially straight. Alternatively or in addition to any of the above embodiments, all of the one or more axial support members are substantially straight.

[0033] Alternatively or in addition to any of the above embodiments, at least some of the one or more axial support members have a proximal curved region. Alternatively or in addition to any of the above embodiments, each of the one or more axial support members has a proximal curved region.

[0034] Alternatively or in addition to any of the above embodiments, the one or more axial support members include a first axial support member and a second axial support member, further comprising one or more struts extending between the first axial support member and the second axial support member.

[0035] Alternatively or in addition to any of the above embodiments, the expansion member includes a trocar. Alternatively or in addition to any of the above embodiments, the expansion member includes a cannula.

[0036] Alternatively or in addition to any of the above embodiments, the expansion member comprises a trocar or cannula. Alternatively or in addition to any of the above embodiments, the expansion member includes a proximal iris member coupled to the one or more axial support members.

[0037] Alternatively or additionally to any of the above embodiments, actuation of the proximal iris member transitions the expandable brain port from the first configuration to the expanded configuration. Alternatively or in addition to any of the above embodiments, the expansion member includes a rotatable bolt coupled to the one or more axial support members.

[0038] Alternatively or additionally to any of the above embodiments, rotation of a rotatable bolt transitions the expandable brain port from the first configuration to the expanded configuration. Alternatively or in addition to any of the above embodiments, at least some of the one or more axial support members include a curved region, and rotation of the rotatable bolt causes the rotatable bolt to engage the curved region.

[0039] Alternatively or additionally to any of the above embodiments, engaging the rotatable bolt with the curved region transitions the expandable brain port from the first configuration to the expanded configuration. Alternatively or additionally to any of the above embodiments, the device further comprises a stylet that at least partially penetrates the expandable brain port.

[0040] Alternatively or additionally to any of the above embodiments, when the stylet at least partially penetrates the expandable brain port, the expandable brain port is in the first configuration.

[0041] Alternatively or in addition to any of the above embodiments, the stylet includes a distal camera. Alternatively, or in addition to any of the above embodiments, the stylet includes one or more marker members or sensors.

[0042] Alternatively, or in addition to any of the above embodiments, at least some of the one or more marker members include a visual marker. Alternatively or in addition to any of the above embodiments, at least some of the one or more marker members include markers detectable by fluoroscopic imaging.

[0043] Alternatively or additionally to any of the above embodiments, at least some of the one or more marker members include markers detectable by magnetic resonance imaging. Alternatively or in addition to any of the above embodiments, at least some of the one or more marker members include markers detectable by optical coherence tomography imaging.

[0044] Alternatively or additionally to any of the above embodiments, the device further comprises a device orienting assembly coupled to the expandable brain port. Alternatively or in addition to any of the above embodiments, the device orienting assembly includes a base configured to engage with the patient.

[0045] Alternatively, or in addition to any of the above embodiments, the device orienting assembly includes one or more adjustable legs configured to engage the patient. Alternatively or in addition to any of the above embodiments, the device orienting assembly includes a stylet.

[0046] Alternatively or additionally to any of the above embodiments, the device further comprises a locking arm coupled to the device orienting assembly. Alternatively or in addition to any of the above embodiments, the device orienting assembly includes a base and an adjustable member coupled to the base.

[0047] Alternatively, or in addition to any of the above embodiments, the adjustable member is axially adjustable relative to the base. Alternatively, or in addition to any of the above embodiments, the adjustable member may be pivotally adjustable relative to the base.

[0048] A method for accessing a target area is disclosed that comprises advancing an expandable access sheath through body tissue to a location adjacent a target area in the central nervous system, and advancing an expansion member through the expandable access sheath to transition the expandable access sheath from a first configuration to an expanded configuration.

[0049] Alternatively or in addition to any of the above embodiments, a stylet is disposed within the expandable access sheath, and advancing the expandable access sheath through body tissue to a position adjacent the region of interest in the central nervous system includes advancing the expandable access sheath and the stylet to a position adjacent the region of interest.

[0050] Alternatively or in addition to any of the above embodiments, when the stylet is disposed within the expandable access sheath, the expandable access sheath is in the first configuration. Alternatively or additionally to any of the above embodiments, the method further comprises removing the stylet from the expandable access sheath.

[0051] Alternatively or additionally to any of the above embodiments, the method further comprises securing the expandable access sheath to the device orienting assembly. Alternatively or additionally to any of the above embodiments, further comprising adjusting the axial position of the expandable access sheath relative to the device orienting assembly.

[0052] Alternatively or additionally to any of the above embodiments, the method further comprises advancing a medical device at least partially through the expandable access sheath while the expandable access sheath is in the expanded configuration.

[0053] A method for accessing a target region is disclosed that comprises advancing an expandable brain port through body tissue to a location adjacent the target region in the brain, and advancing an expansion member through the expandable brain port to transition the expandable brain port from a first configuration to an expanded configuration.

[0054] Alternatively or in addition to any of the above embodiments, a stylet is disposed within the expandable brain port, and advancing the expandable brain port through body tissue to a position adjacent the region of interest in the brain includes advancing the stylet of the expandable brain port and imaging device to a position adjacent the region of interest.

[0055] Alternatively or in addition to any of the above embodiments, when the stylet is disposed within the expandable brain port, the expandable brain port is in the first configuration. Alternatively or additionally to any of the above embodiments, the method further comprises removing the stylet from the expandable access sheath.

[0056] Alternatively or additionally to any of the above embodiments, the method further comprises securing the expandable brain port to the device orienting assembly. Alternatively or additionally to any of the above embodiments, the method further comprises adjusting the axial position of the expandable brain port relative to the device orienting assembly.

[0057] Alternatively or additionally to any of the above embodiments, the method further comprises advancing a medical device at least partially through the expandable brain port while the expandable brain port is in the expanded configuration.

[0058] A medical device for accessing the central nervous system is disclosed, the medical device comprising: an expandable access sheath including a plurality of axially extending support members, the expandable access sheath configured to transition between a first configuration and an expanded configuration, each of the axially extending support bars including a distal end region and a curved proximal end region, a hub disposed adjacent the curved proximal end region and including a first thread, and a bolt coupled to the hub, the bolt including a second thread configured to threadably couple with the first thread, and a bolt such that rotation of the bolt engages the curved proximal end region of the axially extending support bars to transition the expandable access sheath from the first configuration to the expanded configuration.

[0059] An expandable access port is disclosed that includes a housing having a plurality of prongs coupled to the housing, the plurality of prongs including a first prong, an actuation member coupled to the housing, the actuation member configured to transition the plurality of prongs between a first configuration and an expanded configuration, and a nose cone coupled to the first prong.

[0060] Alternatively or in addition to any of the above embodiments, the housing includes a threaded region. Alternatively, or in addition to any of the above embodiments, the actuation member includes a nut that threadably engages the threaded region.

[0061] Alternatively or in addition to any of the above embodiments, at least one of the plurality of pawls is secured to the housing using a pivot member. Alternatively or in addition to any of the above embodiments, the pivot member includes a pivot pin.

[0062] Alternatively or in addition to any of the above embodiments, at least one of the plurality of prongs includes a proximal end region having a sloped surface. Alternatively or in addition to any of the above embodiments, the actuation member includes an actuation surface configured to engage the ramp surface.

[0063] Alternatively or additionally to any of the above embodiments, the device may further comprise a sleeve extending along at least some of the plurality of prongs. Alternatively, or in addition to any of the above embodiments, the sleeve extends along an outer surface of each of the plurality of claws.

[0064] Alternatively or in addition to any of the above embodiments, the sleeve comprises an elastomeric material. Alternatively or in addition to any of the above embodiments, at least one of the plurality of claws includes a gripping region configured to engage the sleeve.

[0065] Alternatively or in addition to any of the above embodiments, the housing defines a central axis and when the plurality of claws are in the first configuration, the nosecone is aligned with the central axis. Alternatively or in addition to any of the above embodiments, the housing defines a central axis and the nosecone is radially offset from the central axis when the plurality of claws are in the extended configuration.

[0066] Alternatively or in addition to any of the above embodiments, the housing has a proximal opening formed therein and the plurality of prongs define a distal opening. Alternatively or in addition to any of the above embodiments, when the multiple prongs are in the first configuration, the distal opening has substantially the same width as or less than the proximal opening.

[0067] Alternatively or additionally to any of the above embodiments, when the multiple prongs are in the expanded configuration, the distal opening has substantially the same width as or greater than the proximal opening.

[0068] Alternatively or in addition to any of the above embodiments, the device further comprises one or more stabilizing members coupled to the housing. Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members are configured for axial displacement relative to the housing.

[0069] Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members include a stabilizing bar extending radially from the housing. An expandable access port is disclosed that includes a housing having an expandable conduit coupled to the housing, the expandable conduit including a first prong, an actuation member coupled to the housing, the actuation member configured to transition the expandable conduit between a first configuration and an expanded configuration, and a nose cone coupled to the first prong.

[0070] Alternatively or in addition to any of the above embodiments, the housing includes a threaded region. Alternatively, or in addition to any of the above embodiments, the actuation member includes a nut that threadably engages the threaded region.

[0071] Alternatively or in addition to any of the above embodiments, the first pawl is secured to the housing using a pivot member. Alternatively or in addition to any of the above embodiments, the pivot member includes a pivot pin.

[0072] Alternatively or in addition to any of the above embodiments, the first prong includes a proximal end region having a sloped surface. Alternatively or in addition to any of the above embodiments, the actuation member includes an actuation surface configured to engage the ramp surface.

[0073] Alternatively or in addition to any of the above embodiments, the expandable conduit further comprises a sleeve extending along at least some of the plurality of prongs. Alternatively or in addition to any of the above embodiments, the sleeve extends along an outer surface of the first prong.

[0074] Alternatively or in addition to any of the above embodiments, the sleeve comprises an elastomeric material. Alternatively or in addition to any of the above embodiments, the first claw includes a gripping region configured to engage the sleeve.

[0075] Alternatively or in addition to any of the above embodiments, the housing defines a central axis, and when the expandable conduit is in the first configuration, the nosecone is aligned with the central axis.

[0076] Alternatively or in addition to any of the above embodiments, the housing defines a central axis and the nosecone is radially offset from the central axis when the expandable conduit is in the expanded configuration.

[0077] Alternatively or in addition to any of the above embodiments, the housing has a proximal opening formed therein and the expandable conduit defines a distal opening. Alternatively or in addition to any of the above embodiments, when the expandable conduit is in the first configuration, the distal opening has substantially the same width as or less than the proximal opening.

[0078] Alternatively or in addition to any of the above embodiments, when the expandable conduit is in the expanded configuration, the distal opening has substantially the same width as or greater than the proximal opening.

[0079] Alternatively or in addition to any of the above embodiments, the device further comprises one or more stabilizing members coupled to the housing. Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members are configured for axial displacement relative to the housing.

[0080] Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members include a stabilizing bar extending radially from the housing. A system for accessing the central nervous system is disclosed that includes an expandable access port including a housing having a plurality of prongs coupled to the housing, a plurality of prongs including a first prong, and an actuation member coupled to the housing, the actuation member configured to transition the plurality of prongs between a first configuration and an expanded configuration, and a holder configured to pass through the housing, the holder including a tubular base, a shaft extending from the tubular base, and a nose cone attached to the shaft.

[0081] Alternatively or in addition to any of the above embodiments, the housing includes a threaded region. Alternatively, or in addition to any of the above embodiments, the actuation member includes a nut that threadably engages the threaded region.

[0082] Alternatively or in addition to any of the above embodiments, at least one of the plurality of pawls is secured to the housing using a pivot member. Alternatively or in addition to any of the above embodiments, the pivot member includes a pivot pin.

[0083] Alternatively or in addition to any of the above embodiments, at least one of the plurality of prongs includes a proximal end region having a sloped surface. Alternatively or in addition to any of the above embodiments, the actuation member includes an actuation surface configured to engage the ramp surface.

[0084] Alternatively or additionally to any of the above embodiments, the device may further comprise a sleeve extending along at least some of the plurality of prongs. Alternatively, or in addition to any of the above embodiments, the sleeve extends along an outer surface of each of the plurality of claws.

[0085] Alternatively or in addition to any of the above embodiments, the sleeve comprises an elastomeric material. Alternatively or in addition to any of the above embodiments, at least one of the plurality of claws includes a gripping region configured to engage the sleeve.

[0086] Alternatively or in addition to any of the above embodiments, the housing defines a central axis and when the plurality of claws are in the first configuration, the nosecone is aligned with the central axis. Alternatively or in addition to any of the above embodiments, the housing defines a central axis and the nosecone is radially offset from the central axis when the plurality of claws are in the extended configuration.

[0087] Alternatively or in addition to any of the above embodiments, the housing has a proximal opening formed therein and the plurality of prongs define a distal opening. Alternatively or in addition to any of the above embodiments, when the multiple prongs are in the first configuration, the distal opening has substantially the same width as or less than the proximal opening.

[0088] Alternatively or additionally to any of the above embodiments, when the multiple prongs are in the expanded configuration, the distal opening has substantially the same width as or greater than the proximal opening.

[0089] Alternatively or in addition to any of the above embodiments, the device further comprises one or more stabilizing members coupled to the housing. Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members are configured for axial displacement relative to the housing.

[0090] Alternatively or in addition to any of the above embodiments, the one or more stabilization members include a stabilization bar extending radially from the housing.Alternatively or in addition to any of the above embodiments, the holder includes a proximal flange.

[0091] Alternatively or in addition to any of the above embodiments, the nosecone has a tapered proximal end region. Alternatively or in addition to any of the above embodiments, the nosecone has a tapered distal end region.

[0092] A system for accessing the central nervous system is disclosed that includes an expandable access port including a housing having an expandable conduit coupled to the housing and an actuation member coupled to the housing, the expandable conduit including a plurality of prongs including a first prong, the actuation member configured to transition the expandable conduit between a first configuration and an expanded configuration, and a holder configured to at least partially pass through the expandable conduit, the holder including a tubular base, a shaft extending from the tubular base, and a nose cone attached to the shaft.

[0093] Alternatively or in addition to any of the above embodiments, the housing includes a threaded region. Alternatively, or in addition to any of the above embodiments, the actuation member includes a nut that threadably engages the threaded region.

[0094] Alternatively or in addition to any of the above embodiments, the first pawl is secured to the housing using a pivot member. Alternatively or in addition to any of the above embodiments, the pivot member includes a pivot pin.

[0095] Alternatively or in addition to any of the above embodiments, the first prong includes a proximal end region having a sloped surface. Alternatively or in addition to any of the above embodiments, the actuation member includes an actuation surface configured to engage the ramp surface.

[0096] Alternatively or in addition to any of the above embodiments, the expandable conduit further comprises a sleeve extending along at least some of the plurality of prongs. Alternatively or in addition to any of the above embodiments, the sleeve extends along an outer surface of the first prong.

[0097] Alternatively or in addition to any of the above embodiments, the sleeve comprises an elastomeric material. Alternatively or in addition to any of the above embodiments, the first claw includes a gripping region configured to engage the sleeve.

[0098] Alternatively or in addition to any of the above embodiments, the housing defines a central axis, and when the expandable conduit is in the first configuration, the nosecone is aligned with the central axis.

[0099] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and the nosecone is radially offset from the central axis when the expandable conduit is in the expanded configuration.

[0100] Alternatively or in addition to any of the above embodiments, the housing has a proximal opening formed therein and the expandable conduit defines a distal opening. Alternatively or in addition to any of the above embodiments, when the expandable conduit is in the first configuration, the distal opening has substantially the same width as or less than the proximal opening.

[0101] Alternatively or in addition to any of the above embodiments, when the expandable conduit is in the expanded configuration, the distal opening has substantially the same width as or greater than the proximal opening.

[0102] Alternatively or in addition to any of the above embodiments, the device further comprises one or more stabilizing members coupled to the housing. Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members are configured for axial displacement relative to the housing.

[0103] Alternatively, or in addition to any of the above embodiments, the one or more stabilizing members include a stabilizing bar extending radially from the housing. Alternatively or in addition to any of the above embodiments, the holder includes a proximal flange.

[0104] Alternatively or in addition to any of the above embodiments, the nosecone has a tapered proximal end region. Alternatively or in addition to any of the above embodiments, the nosecone has a tapered distal end region.

[0105] An expandable access port is disclosed that includes a housing having an expandable conduit coupled to the housing, the expandable conduit including a plurality of prongs and a sleeve coupled to the plurality of prongs, an actuation member coupled to the housing, the actuation member configured to transition the expandable conduit between a first configuration and an expanded configuration, and a cap coupled to the housing, the cap including an attachment region configured to have an adjustment mechanism removably attached to the attachment region.

[0106] Alternatively or additionally to any of the above embodiments, the device may further comprise an adjustment mechanism removably coupled to the attachment region. Alternatively or in addition to any of the above embodiments, the cap further includes a second attachment area and further comprises a second adjustment mechanism removably coupled to the second attachment area.

[0107] Alternatively, or in addition to any of the above embodiments, the adjustment mechanism includes a set screw. Alternatively or in addition to any of the above embodiments, the adjustment mechanism includes a stabilizing bar.

[0108] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief description of the drawings]

[0109] The present disclosure may be more fully understood when considered in conjunction with the following detailed description, in which: [Figure 1A] FIG. 1A is a perspective view of a portion of an exemplary medical device showing an exemplary expandable access sheath. [Figure 1B] FIG. 1B is a perspective view of a portion of an exemplary medical device showing an exemplary expandable access sheath. [Figure 1C] FIG. 1C illustrates an exemplary medical device for accessing the central nervous system. [Figure 1D] FIG. 1D illustrates an exemplary medical device for accessing the central nervous system. [Figure 1E] FIG. 1E illustrates an exemplary medical device for accessing the central nervous system. [Figure 1F] FIG. 1F shows an exemplary medical device for accessing the central nervous system. [Figure 2A] FIG. 2A shows an exemplary medical device for accessing the central nervous system. [Figure 2B] FIG. 2B illustrates an exemplary medical device for accessing the central nervous system. [Figure 2C] FIG. 2C illustrates an exemplary medical device for accessing the central nervous system. [Figure 2D] FIG. 2D illustrates an exemplary medical device for accessing the central nervous system. [Figure 3A] FIG. 3A shows an exemplary medical device for accessing the central nervous system. [Figure 3B] FIG. 3B illustrates an exemplary medical device for accessing the central nervous system. [Figure 3C] FIG. 3C illustrates an exemplary medical device for accessing the central nervous system. [Figure 3D] FIG. 3D illustrates an exemplary medical device for accessing the central nervous system. [Figure 4A] FIG. 4A illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 4B] FIG. 4B illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 4C] FIG. 4C illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 4D] FIG. 4D illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 4E] FIG. 4E illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 5A] FIG. 5A illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 5B] FIG. 5B illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 5C] FIG. 5C illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 5D]FIG. 5D illustrates an exemplary medical device system and a use of the exemplary medical device system. [Figure 6A] FIG. 6A is a perspective view of an exemplary expandable access port. [Figure 6B] FIG. 6B is a cross-sectional view of an exemplary expandable access port. [Figure 6C] FIG. 6C is a perspective view of an exemplary expandable access port. [Figure 6D] FIG. 6D is a cross-sectional view of an exemplary expandable access port. [Figure 6E] FIG. 6E is a cross-sectional view of an exemplary expandable access port. [Figure 6F] FIG. 6F is a close-up view of an exemplary expandable access port. [Figure 7A] FIG. 7A shows a system for accessing the central nervous system. [Figure 7B] FIG. 7B shows a system for accessing the central nervous system. [Figure 7C] FIG. 7C shows a system for accessing the central nervous system. [Figure 8A] FIG. 8A shows a system for accessing the central nervous system. [Figure 8B] FIG. 8B shows a system for accessing the central nervous system. [Figure 8C] FIG. 8C shows a system for accessing the central nervous system. [Figure 9] FIG. 9 is a perspective view of an exemplary expandable access port. [Figure 10] FIG. 10 illustrates an exemplary expandable access port. [Figure 11] FIG. 11 illustrates an exemplary expandable access port. [Figure 12] FIG. 12 illustrates an exemplary expandable access port. [Figure 13] FIG. 13 illustrates an exemplary expandable access port. [Figure 14A] FIG. 14A illustrates an exemplary expandable access port. [Figure 14] FIG. 14 illustrates an exemplary expandable access port. [Figure 15] FIG. 15 illustrates an exemplary expandable access port. [Figure 16] FIG. 16 shows a system for accessing the central nervous system. [Figure 17] FIG. 17 shows a system for accessing the central nervous system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0110] While the disclosure is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

[0111] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values, whether expressly stated or not, are assumed to be modified by the term "about". The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numerical values ​​that are rounded to the nearest significant figure.

[0112] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0113] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such enumeration does not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic. Furthermore, when a particular feature, structure, and / or characteristic is described in connection with a particular embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not expressly described, unless expressly stated to the contrary.

[0114] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0115] Brain lesions, clots, tumors, and / or other malformations can be difficult to treat. At least a portion of the challenges associated with such treatments can be related to gaining access to the target area. For example, to access a clot in the brain, a treatment device must be guided through a region of the brain. This may require a relatively delicate traverse through the brain tissue. It is desirable to access a region of the brain in a manner that reduces trauma to the brain tissue, enhances the ability to image / visualize the region of the brain, and / or otherwise provides better access to the target region. Disclosed herein are medical devices configured to provide improved access to regions of the body, including regions along the central nervous system and / or the brain. Methods for making and using such devices are also disclosed.

[0116] FIG. 1A is a perspective view of a portion of an exemplary medical device 10 for accessing the central nervous system. In this example, an exemplary expandable access sheath 12 is shown. Generally, the expandable access sheath 12 can be configured to be inserted into an opening, cavity, or the like in the body to provide access to a target region. For example, the expandable access sheath 12 can be configured to be inserted through an opening in the patient's head, through the skull, and into the brain to provide access to a target (e.g., a lesion, a clot, a tumor, or the like) in the brain. Furthermore, because the expandable access sheath 12 is "expandable," the expandable access sheath 12 can be positioned near a target site (e.g., in the brain) and expanded. In doing so, the expandable access sheath 12 can be pushed, moved, and / or stretched without traumatizing brain tissue adjacent to the target site, thereby providing better access to the target site, visualization (including, for example, direct visualization by a clinician through the expandable access sheath 12), and the like.

[0117] The expandable access sheath 12 may include a tubular body 14 having a proximal end region 16 and a distal end region 18. A hub or flange 20 may be disposed at the proximal end region 16. The hub 20 may have a variety of shapes and / or configurations. In some examples, the hub 20 may include one or more apertures 19 that may be used to secure the expandable access sheath 12 to another component of the medical device 10 and / or to a portion of a medical device system (e.g., a system that includes the medical device 10). For example, the apertures 19 may have a size or shape (e.g., may include threads, a tapered or narrowed shape, etc.) configured to engage a fastener or set screw.

[0118] The tubular body 14 of the expandable access sheath 12 may include a sheath or sleeve 21. In some examples, the sleeve 21 may include a polymer or silicone material. The material of the sleeve 21 may be elastic and / or stretchable in nature, thereby allowing for appropriate expansion and / or contraction as desired without significant plastic deformation. Some examples of polymeric materials that may be used for other components of the sleeve or sheath 12 are provided below. Other materials are also contemplated. One or more axial support members 22 may be disposed along, coupled to, or embedded in the sleeve 21. The axial support members 22 may take the form of a rod or wire. The axial support members 22 may have a circular cross-sectional shape or a non-circular cross-sectional shape, for example, rectangular, square, or other polygonal. The expandable access sheath 12 may include 1, 2, 3, 4, 5, 6, 7, 8, or more axial support members 22. In some examples, one or more struts 24 may extend between adjacent axial support members 22. The struts 24 may be substantially straight or may include one or more bends or turns. In some examples, the axial support member 22 and struts 24 may resemble or otherwise form a stent-like lattice or configuration. Additionally, the sleeve 21 and / or one or more axial support members 22 may be made from and / or may include an elastic and / or stretchable and / or superelastic material that may provide a bias toward a closed configuration, for example, as described in connection with one example use of the sheath 12 below.

[0119] FIG. 1B is a perspective view of a portion of another exemplary medical device 110 for accessing the central nervous system. The exemplary medical device 110 may be similar in form and function to the medical device 10 such that the attributes of the device 10 may be appropriately applied to the device 110. In this example, another exemplary expandable access sheath 112 is shown. The expandable access sheath 112 may include a tubular body 114 having a proximal end region 116 and a distal end region 118. A hub or flange 120 may be disposed at the proximal end region 116. The tubular body 114 of the expandable access sheath 112 may include a sheath or sleeve 121. One or more axial support members 122 may be disposed along, coupled to, or embedded in the sleeve 121. Unlike the expandable access sheath 12 shown in FIG. 1A, the expandable access sheath 112 may be devoid of struts (e.g., similar to struts 24) extending between the axial support members 122. Additionally, the sleeve 121 and / or one or more axial support members 122 may be made from and / or may include an elastic and / or stretchable and / or superelastic material that may provide a bias toward the closed configuration, for example, as described in connection with the sheath 12 below.

[0120] 1C shows the expandable access sheath 12 and several other components of the medical device 10. For example, the medical device may include an expansion member or assembly 25. In this example, the expansion member 25 may include a cannula 26 and / or a trocar 28. The cannula 26 may include a tubular body 30 having a proximal end region 32 and a distal end region 34. A hub 36 may be disposed in the proximal end region 32. The hub 36 may include a flange region 38. The trocar 28 may include a body region 40 having a proximal end region 42 and a distal end region 44. The hub 46 may be disposed in the proximal end region 42. A tip 48 may be disposed in the distal end region 44. The tip 48 may have a tapered or atraumatic shape.

[0121] The expandable access sheath 12 may be configured to transition between a first configuration (e.g., as shown in FIGS. 1A and 1C; e.g., as shown for the expandable access sheath 112 in FIG. 1B) and a second or expanded configuration. In some examples, the expandable access sheath 12 may be configured to be in the first configuration when in a natural state or in the absence of a force tending to expand the expandable access sheath 12. In other words, the expandable access sheath 12 may be understood to be biased to the first configuration. In at least some examples, the expandable access sheath 12 may be described as "collapsible" in that the expandable access sheath 12 may return or transition from the expanded configuration to the first configuration when the expansion force / mechanism is removed from the expandable access sheath 12. In some embodiments, the material of the sleeve 21 may be elastic and / or stretchable and / or superelastic as possible in nature to provide a biasing force against the collapsed configuration of the sheath. For example, at rest, the sleeve 21 may be biased to a collapsed configuration, but may be expandable to an expanded configuration with some force. However, once the expansion force is removed, the elastic and / or stretchable nature of the sleeve 21 allows the sleeve 21 to return to the collapsed configuration. The material of the sleeve 21 may allow for adequate expansion and / or contraction as desired without significant plastic deformation. In some embodiments, one or more of the axial support members 22 and / or struts 24 may also be made from and / or include elastic and / or stretchable and / or possibly superelastic materials, which may provide the necessary biasing force for the collapsed configuration in combination with and / or in place of the material of the sleeve 21.

[0122] In at least some instances, the expandable access sheath 12 may be transitioned to the expanded configuration by advancing or otherwise disposing an expansion member 25 within the expandable access sheath 12, as shown in FIG. 1D. For example, transitioning the expandable access sheath to the expanded configuration may include disposing only the cannula 26 within the expandable access sheath 12, disposing only the trocar 28 within the expandable access sheath 12, extending both the cannula 26 and the trocar 28 within the expandable access sheath 12, and / or expanding the expandable access sheath 12 with another structural mechanism, such as a balloon. In some instances, the trocar 28 is removed from the expandable access sheath 12, leaving only the cannula 26 within the expandable access sheath 12, as shown in FIG. 1E. In at least some instances, the cannula 26 may be sufficient to maintain the expandable access sheath 12 in the expanded configuration.

[0123] A cross-sectional view of the expandable access sheath 12 is shown in FIG. IF. Here, the sleeve 21, axial support member 22, and cannula 26 can be seen. In this example, the axial support member 22 is disposed along the inner surface of the sleeve 21. However, other configurations (e.g., recessed, outer surface, etc.) are also contemplated. In at least some examples, the axial support member 22 can provide axial support to the sleeve 21 (and / or the expandable access sheath 12 generally) during navigation, expansion, and use. This can include the axial support member 22 helping to substantially reduce the likelihood of the sleeve 21 foreshortening during expansion. For example, the axial support member 22 can be understood to substantially fix the length of the sleeve 21 (and / or the expandable access sheath 12 generally). In some aspects, the axial support member 22 can function to maintain a generally fixed length of the sheath 12 even during radial expansion and / or contraction of the sheath 12.

[0124] 2A-2D show another exemplary medical device 210 that may be similar in form and function to other medical devices disclosed herein. The medical device 210 may include an expandable access sheath 212. The expandable access sheath 212 may include a tubular body 214 having a proximal end region 216 and a distal end region 218. The tubular body 214 of the expandable access sheath 212 may include a sheath or sleeve 221. One or more axial support members 222 may be disposed along, coupled to, or embedded in the sleeve 221.

[0125] The dilation mechanism and / or member 225 may be disposed in or otherwise coupled to the proximal end region 216. The dilation member 225 may resemble or otherwise take the form of an iris mechanism and / or dilation device and / or valve. Iris mechanisms are commonly known and can be generally described as an adjustable mechanism of multiple blades that can be moved by rotational movement of a support to change the diameter of a central opening formed by the blades. For example, the exemplary iris dilation member 225 may include an annular member 250 and a top base 252. A groove or slot 253 may be formed in the annular member 250 (e.g., as shown in FIGS. 2B and 2D). The dilation member 225 may also include multiple blade members 254. In this example, the multiple blade members 254 are coupled to the top base 252 by a pin 255. A linkage 257 may extend between the annular member 250 and the multiple blade members 254. Another pin 259 may extend between the annular member 250 and the upper base 252. This is just one example of a possible configuration for the extension member 225. Several different iris mechanism types for the extension member 225 are contemplated. Examples of some of these iris extension structures that may be suitable for use as part of the extension member 225 are disclosed in U.S. Pat. No. 4,130,113, U.S. Pat. No. 5,779,681, U.S. Patent Application Publication No. 2011 / 0054405, and U.S. Patent Application Publication No. 2014 / 0114138, the entire disclosures of which are incorporated herein by reference.

[0126] 2B and 2D are end views from the distal end region 218 of the expandable access sheath 212. From these figures, it can be seen that pivoting of the upper base 252 relative to the annular member 250 can cause the plurality of blade members 254 to pivot or otherwise "open" and move the axial support members 222 radially outward, transitioning the expandable access sheath 212 from a first configuration (e.g., as shown in FIG. 2A) to an expanded configuration, as shown in FIGS. 2C-2D. For example, pivoting of the upper base 252 relative to the annular member 250 exerts a force on the linkage 257, causing the plurality of blade members 254 to pivot about the pin 255. As the plurality of blade members 254 pivot radially outward, the axial support members 222 also shift radially outward, transitioning the expandable access sheath 212 from the first configuration to the expanded configuration. It should be noted that the iris expansion device (e.g., expansion member 225) may allow for gradual changes in the level of expansion of the expandable access sheath 12. Thus, the expansion member 225 may allow the expandable access sheath 212 to shift between a first configuration and an expanded configuration, as well as multiple positions (e.g., essentially infinite positions) therebetween. The expansion mechanism may include a lock or other mechanism to maintain the sheath 212 in a desired position. Additionally, as described above in connection with the sheath 12, the sleeve 221 and / or one or more axial support members 222 may be made from and / or include an elastic and / or stretchable and / or superelastic material that may provide a biasing force toward the closed configuration.

[0127] 3A-3D show another exemplary medical device 310 that may be similar in form and function to other medical devices disclosed herein. The medical device 310 may include an expandable access sheath 312. The expandable access sheath 312 may include a tubular body 314 having a proximal end region 316 and a distal end region 318. A hub or flange 320 may be disposed at the proximal end region 316. The tubular body 314 of the expandable access sheath 312 may include a sheath or sleeve 321. The sheath or sleeve 321 may be made of and / or include multiple materials and / or function similarly to the sheath or sleeve 21, 121, 221 as described above. One or more axial support members 322 may be disposed along, coupled to, or embedded in the sleeve 321. The one or more axial support members 322 may be made of and / or include multiple materials and / or function similarly to support members 22, 122, 222 as described above. In at least some examples, the hub 320 may be defined by and / or attached to a proximal end of the axial support member 322. In this embodiment, the support member 322 includes an inwardly curved and / or bent region near its proximal end.

[0128] The expansion mechanism and / or member 325 may be disposed at or otherwise coupled to the proximal end region 316. In this example, the expansion member 325 may include a threaded actuation mechanism and / or bolt 356 having a threaded region 358. The threaded region 358 may be configured to engage threads along a proximal region (e.g., at or near the hub 320) of the hub 320 and / or axial support member 322. Actuation / rotation of the actuation mechanism and / or bolt 356 may cause a distal end region 362 of the mechanism and / or bolt 356 to engage an inwardly bent and / or curved region 364 of the axial support member 322. Because the axial support member 322 may be substantially rigid, engagement of the distal end region 362 of the actuation mechanism 356 with the curved region 364 may bias or deflect the axial support member 322 radially outward (e.g., transitioning the expandable access sheath 312 to an expanded configuration). Similar to the expansion member 225, the expansion member 325 may allow the expandable access sheath 312 to shift between a first configuration and an expanded configuration, as well as multiple positions (e.g., essentially infinite positions) therebetween. The expandable access sheath 312 may be biased to the first configuration and / or the collapsed configuration. For example, the axial support member 322 may be made of a stretchable and / or elastic and / or superelastic material and may include a shape, such as an inwardly arcuate and / or curved region, that biases the sheath 312 to the first configuration and / or the collapsed configuration. The actuation mechanism may provide a force to overcome this bias to bring the sheath into the expanded configuration. When the actuation mechanism and / or the bolt 356 is retracted and / or moved proximally such that the distal end region 362 moves proximally out of the inwardly arcuate and / or curved region 364, the access sheath 312 may return to the first configuration and / or the collapsed configuration. In some embodiments, the sleeve 121 may be made from and / or may include an elastic and / or stretchable and / or superelastic material that may provide a bias toward the closed configuration instead of and / or in addition to the bias of the axial support member 322.

[0129] 4A-4E show several examples of a medical device system 400 and methods for using the system 400 and / or the medical device 10 and / or the expandable access sheath 12. The system 400 may include the expandable access sheath 12 (and / or other expandable access sheaths disclosed herein). The system 400 may also include an expansion member 25 (e.g., may include a cannula 26 and / or a trocar 28).

[0130] The system 400 may also include a stylet 466. The stylet 466 may be an elongated tool used to assist in navigating to an object within the anatomy and may assist in the placement and / or orientation of other devices, such as the access sheath 12. The stylet 466 includes a distal shaft 468, a tip member 470, and a proximal shaft 472. In some examples, the tip member 470 may include a camera or other type of imaging member. The stylet 466 may include and / or be used with a surgical navigation and / or tracking system to assist a user in navigating and / or tracking the stylet 466 to a desired location and / or orientation within the anatomy. For example, the stylet may include and / or be usable with an optical and / or electromagnetic tracking system. In such a system, the stylet may include a series or multiple markers and / or sensors 476 disposed on the proximal shaft 472. These markers and / or sensors 476 are registered with respect to the position and / or orientation of the tip member 470. In an exemplary optical navigation system, the markers 476 are passive / reflective optical markers and the operating suite includes an array of cameras that detect the position and orientation of the markers 476, which are used to determine the position of the tip member 470. In an exemplary electromagnetic navigation system, the sensors 476 are electromagnetic field sensors and the operating suite includes one or more electromagnetic field generators. The positions of the multiple sensors are determined relative to the electromagnetic field to provide the position of the tip member 470.

[0131] In some embodiments, the stylet may also include other markers and / or reference points, such as visual markers, markers detectable by magnetic resonance imaging, markers detectable by optical coherence tomography, markers detectable by fluoroscopy, or markers detectable by another mechanism. In at least some examples, the markers 476 may be used to track, detect, and / or otherwise record the position of the stylet 466 (e.g., relative to the patient).

[0132] The system 400 may also include a device orienting assembly 478. The device orienting assembly 478 may include a base 480 and one or more adjustable legs 482 coupled thereto. The adjustable legs 482 may be used to adjust the position, height, tilt or angle, and / or otherwise orient the base 480. A locking arm 484 may also be coupled to the base 480. The base 480 may also include an opening or passage 486 for accommodating the expandable access sheath 12. A locking member (not shown) may be disposed at or near the opening 486. The locking member may be used to secure the expandable access sheath 12 to the device orienting assembly 478.

[0133] In use, the base 480 may be placed on a suitably prepared surface of the patient, such as along the head. The adjustable legs 482 and the locking arms 484 may be used to orient the base 480 in a desired manner to guide the expandable access sheath 12 toward the target area (including, for example, a desired angle, height, etc.). As shown in FIG. 4B, the expandable access sheath 12, penetrating the stylet 466, may extend into the patient through the opening 486. In doing so, the stylet 466 may be used to assist in locating the target. In some medical interventions, the distance from the device orienting assembly 478 may be different from the length of the expandable access sheath 12. In such instances, the axial position of the expandable access sheath 12 may be adjusted by shifting the position of the adjustable legs relative to the base 480. This may raise or lower the expandable access sheath 12 in the anatomical structure to assist in guiding the expandable access sheath 12 to a desired depth in the brain.

[0134] Once the target is reached, the stylet 466 can be removed. The expansion member 25 can be placed within the expandable access sheath 12, as shown in Figures 4C-4D. Upon doing so, the expandable access sheath 12 can be transitioned to an expanded configuration. If desired, the trocar 28 can be removed, as shown in Figure 4E. An appropriate treatment device can be passed through the expandable access sheath 12 to treat the target area.

[0135] 5A-5D show several examples of a medical device system 500 and methods for using the system 500 and / or the medical device 10 and / or the expandable access sheath 12. The system 500 may include the expandable access sheath 12 (and / or other expandable access sheaths disclosed herein). The system 500 may also include an expansion member 25 (e.g., may include a cannula 26 and / or a trocar 28). The system 500 may also include a stylet 466.

[0136] The system 500 may also include a device orienting assembly 578. The device orienting assembly 578 may include a base 580. A locking arm 584 may also be coupled to the base 580. An adjustable member 590 may also be coupled to the base 580. The adjustable member 590 may include an adjustment mechanism 592 configured to engage with a corresponding adjustment mechanism 594 disposed along the base 580. The adjustment mechanism 592 on the adjustable member 590 and the adjustment mechanism 594 on the base 580 may include a plurality of corresponding teeth that interlock and / or resemble a ratcheting system. The base 580 may also include an actuator 596. The actuator 596 may take the form of a pinchable arm or spring clip that can open, spread, and / or otherwise unlock the adjustment mechanism 594 on the base 580. In doing so, an axial position of the adjustment member 590 may be shifted relative to the base 580. When the actuation portion 596 is released, the adjustment mechanism 594 on the base 580 may close, shorten, or otherwise lock such that the axial position of the adjustable member 590 is fixed relative to the base 580. When the expandable access sheath 12 is coupled to the adjustable member, the axial position of the expandable access sheath 12 can be adjusted relative to the base 580. In some examples, the device orienting assembly 578 may also allow the expandable access sheath 12 to pivot (e.g., change the angle of the expandable access sheath 12 relative to the patient).

[0137] In use, the base 580 may be placed on a suitably prepared surface of the patient, such as along the head. As shown in FIG. 5B, the expandable access sheath 12, through which the stylet 466 penetrates, may extend into the patient through the device orienting assembly 578. In doing so, the stylet 466 may be used to assist in viewing and / or locating the object. In some medical interventions, the distance from the device orienting assembly 578 may be different from the length of the expandable access sheath 12. In such instances, the axial position of the expandable access sheath 12 may be adjusted by shifting the position of the adjustable member 590 relative to the base 580. This may assist in guiding the expandable access sheath 12 to a desired depth within the brain.

[0138] The device orienting assembly 578 can be oriented relative to the patient's surface 588. Once the target is reached, the stylet 466 can be removed. The expansion member 25 can be placed within the expandable access sheath 12, as shown in FIG. 5C. In doing so, the expandable access sheath 12 can be transitioned to an expanded configuration. If desired, the trocar 28 can be removed, as shown in FIG. 5D. An appropriate treatment device can be passed through the expandable access sheath 12 to treat the target area.

[0139] FIG. 6A is a perspective view of an exemplary expandable access port 610. The expandable access port 610 may be similar in form and function to other medical devices, expandable access sheaths, expandable access ports, etc., as disclosed herein. Generally, the expandable access port 610 may be used to access a region of interest along the central nervous system. The term "port" may be understood to indicate that the expandable access port 610 may take the form of an access point or hub that allows a clinician to access a region of the brain. It may be appropriate to describe the expandable access port 610 as an access sheath or other similar device. In some examples, the expandable access port 610 may include a base or housing 612. An expandable conduit 614 may be coupled to the housing 612. Generally, the expandable conduit 614 may be configured to transition between a first configuration and an expanded configuration. The first configuration is suitable for guiding the expandable access port 610 to a region of interest, such as a region along the central nervous system. In some examples, the first configuration may be understood to be a collapsed configuration, a partially collapsed configuration, or an unexpanded configuration. The expanded configuration is generally larger than the first configuration (e.g., the expandable conduit 614 has a larger diameter in the expanded configuration than in the first configuration). The expanded configuration can help open up space around the expandable access port 610 to aid in visualization, diagnosis, provide access to other devices, and aid in the delivery of drugs or other active agents.

[0140] The expandable conduit 614 may include multiple arms or tines 616. The multiple tines 616 may be circumferentially disposed around the housing 612 to form or define the expandable conduit 614. The multiple tines 616 may take the form of wires, ribbons, rods, and the like. The expandable access port 610 may include any suitable number of tines 616. For example, the expandable access port 610 may include 2, 3, 4, 5, 6, 7, 8, 9, 10, or more tines 616. In some examples, all of the tines 616 have the same shape, size, and / or configuration. In other words, in some examples, all of the tines 616 are the same. In other examples, one or more tines may differ in shape, size, and / or configuration from one or more of the other of the multiple tines 616. In other words, in some examples, some tines 616 are different from one or more of the multiple tines 616. In some examples, the multiple pawls 616 may be evenly spaced around the housing 612. Alternatively, the multiple pawls 616 may be non-uniformly spaced around the housing 612.

[0141] In some examples, the sleeve 618 may extend along the plurality of claws 616 and / or the expandable conduit 614. Indeed, in some examples, the sleeve 618 may help define the expandable conduit 614 (e.g., together with the plurality of claws 616). The sleeve 618 may extend along an outer surface of the plurality of claws 616. In some examples, the sleeve 618 may extend to and be secured to a distal end of the plurality of claws 616. In other examples, the sleeve 618 may be wrapped around the distal end of the plurality of claws 616 and along a portion of an inner surface of the plurality of claws 616. In these examples, the sleeve 618 may be secured to an inner surface of the plurality of claws 616.

[0142] In some examples, the sleeve 618 may be formed from or otherwise include an elastomeric material. For example, the sleeve 618 may include silicone, urethane, polytetrafluoroethylene, other materials such as those disclosed herein, and / or other suitable materials. In some examples, the sleeve 618 may be described as compliant and / or fully elastic. In such cases, the sleeve 618 may be described as being stretchable and capable of recovering / returning to its original unstressed shape when stress is no longer applied. In other examples, the sleeve 618 may be described as partially compliant and / or partially elastic. In such cases, the sleeve 618 may be stretchable or partially stretchable, and when stress is removed, the sleeve 618 may partially recover its original unstressed shape. In yet other examples, the sleeve 618 may be described as non-compliant and / or non-elastic. In such cases, the sleeve 618 may plastically deform when stressed beyond a predetermined limit.

[0143] A plurality of adjustment mechanisms may be coupled to the housing 612, including a first adjustment mechanism 620 and a second adjustment mechanism 622. In some examples, the first adjustment mechanism 620 may take the form of a set screw that secures the stabilizing member 624 to the housing 612. The set screw 620 may be used to move the stabilizing member 624 axially (e.g., translate and / or otherwise raise or lower) relative to the housing 612. Each stabilizing member 624 may be coupled to the housing with its own set screw 620 such that each stabilizing member 624 may be adjusted independently of one another. In this example, a plurality of stabilizing members 624 may be disposed about the housing 612. For example, one, two, three, four, five, six, or more stabilizing members 624 may be disposed about the housing 612. The form of the stabilizing member 624 may vary. The stabilizing member 624 may take the form of an arm. In some examples, the stabilizing member 624 may include a bent region or an elbow region. The expansion member 624 may also include a tissue contacting region. Other variations are contemplated. The stabilization member 624 may be configured to contact the patient and help stabilize the position of the expandable access port 610 relative to the patient.

[0144] In some examples, the second adjustment mechanism 622 can take the form of a set screw configured to adjust the position of one of the pawls 616. As described in more detail herein, the set screw 622 can be used to move / pivot one of the pawls 616.

[0145] The actuating member 626 may be coupled to the housing 612. Generally, the actuating member 626 may be used to transition the expandable conduit 614 and / or the plurality of pawls 616 between a first configuration and an expanded configuration. In some examples, the actuating member 626 takes the form of a nut configured to threadingly engage with the housing 612. Pivoting of the actuating member 626 may move a position (e.g., axial position) of the actuating member 626 along the housing 612. This movement / displacement may cause the actuating member 626 to interact with the plurality of pawls 616 to move / pivot the plurality of pawls 616, as described in more detail herein.

[0146] Other features of the expandable access port 610 are shown in FIG. 6A. For example, the housing 612 may include a proximal end region or flange 628. The housing 612 may have a proximal opening 630. The proximal opening 630 may be in fluid communication with the expandable conduit 614. In some examples, the proximal opening 630 may be shaped and / or configured to mechanically mate with another device configured to extend therethrough. For example, the proximal opening 630 may include one or more radial slots that allow another device to mechanically engage or "key" with the proximal end region 628.

[0147] A nose cone 632 may be disposed at the distal end of the expandable conduit 614. Generally, the nose cone 632 may assist in forming an atraumatic distal end of the expandable conduit 614. In some examples, the nose cone 632 may be coupled to one of the prongs 616. In other examples, the nose cone 632 may be coupled to another portion of the expandable access port 610 or to another structure for use with the expandable access port 610. The nose cone 632 may have a tapered distal end region and / or a tapered proximal end region. Such a shape may allow the expandable access port 610 to be advanced into the anatomy in a manner that reduces trauma.

[0148] 6B is a cross-sectional view of the expandable access port 610. Here it can be seen that the housing 612 can include a threaded region 634. The actuation member 626 can include a corresponding threaded region 636 configured to engage with the threaded region 634 of the housing 612.

[0149] The plurality of pawls 616 may be coupled to the housing 612 by a pivot member 638. In at least some examples, the pivot member 638 may take the form of a pivot pin. The pivot member 638 may allow the plurality of pawls 616 to pivot to transition between the first configuration and the expanded configuration. In some examples, each of the plurality of pawls 616 may have a proximal end region 640 having an angled surface 642. The actuating member 626 may have a corresponding angled surface 644 configured to engage with the angled surface 642 of the proximal end region 640. Thus, as the actuating member 626 begins to rotate and displace along the housing 612, the angled surface 644 of the actuating member 626 may engage with the angled surface 642 of the proximal end region 640 of the plurality of pawls 616. In doing so, the proximal end region 640 of the plurality of pawls 616 may be biased radially inward toward the housing 612. In some examples, the housing 612 may include a number of slots formed therein that allow the proximal end regions 640 of the plurality of pawls 616 to move further radially inward. When the proximal end regions 640 of the plurality of pawls 616 are biased radially inward, the distal end regions may shift radially outward due to pivoting of the plurality of pawls 616 about the pivot member 638, as shown in FIGS. 6C-6D. In some examples, more or less expansion of each pawl 616 may be achieved independently using one of the plurality of second adjustment mechanisms (e.g., set screws) 622. When in the expanded configuration, the expandable conduit 614 may define a distal opening 648. In some examples, when the expandable conduit 614 is in the first configuration, the distal opening 648 may be the same size as or smaller than the proximal opening 630. In some of these and other examples, when the expandable conduit 614 is in the expanded configuration, the distal opening 648 may be the same size as or larger than the proximal opening 630.

[0150] In some examples, the plurality of claws 616 may include a first claw 616'. The nose cone 632 may be coupled to the first claw 616'. For example, the first claw 616' may include a curved region 646, and the nose cone 632 may be coupled to the curved region 646. Thus, the first claw 616' may differ in shape from at least one of the other claws 616. The location of the nose cone 632 may be described as being positioned at a center and / or longitudinal axis of the housing 612 when the expandable conduit 614 is in a first configuration (e.g., as shown in FIGS. 6A-6B). The nose cone 632 may be described as being offset (radially offset) from a center and / or longitudinal axis of the housing 612 when the expandable conduit 614 is in an expanded configuration (e.g., as shown in FIGS. 6C-6D).

[0151] At least some of the plurality of claws 616 may include a gripping region 650. Generally, the gripping region 650 may be configured to secure the sleeve 618 to the plurality of claws 616 and / or the expandable conduit 614. For example, the gripping region 650 may take the form of a slot or groove into which the sleeve 618 may be inserted. In some examples, the sheath 618 may be secured to the gripping region 650 by crimping the gripping region 650. In other examples, the sheath 618 may be secured to the plurality of claws 616 in another manner, such as by adhesive bonding, thermal bonding, stitching, etc., as desired.

[0152] As noted above, shifting the expandable conduit 614 and / or the plurality of claws 616 to or toward the expanded configuration may include actuating an actuation member 626. Additionally, a second adjustment mechanism 622 may be utilized to independently adjust one of the plurality of claws 616. For example, FIG. 6E illustrates a configuration of the expandable conduit 614 in which the second adjustment mechanism 622 (e.g., one of the plurality of set screws 622) is adjusted to further adjust (e.g., further extend) one of the plurality of claws 616′.

[0153] 6F is an exploded view of the expandable access port 610. Here, some structural features of the expandable access port 610 can be seen from different perspectives. For example, one or more slots 615 can be seen in the housing 612. The one or more slots 615 can allow the proximal end region 640 to shift further radially inward relative to the housing 612, for example, as the actuation member 626 rotates and displaces along the housing 612.

[0154] 7A-7C show a system for accessing the central nervous system 600. The system 600 may include an expandable access port 610 (e.g., as shown in FIGS. 6A-6F). In this example, the expandable access port 610 is shown with a stabilizing bar 652 that may be used to couple / secure the expandable access port 610 to a stabilizing system 654. Some exemplary stabilizing systems that may be used with the stabilizing bar 652 may include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, as well as systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, and others. The stabilizing bar 652 may take the form of a rod or shaft that protrudes from the housing 612.

[0155] System 600 may also include a holder 656. Holder 656 may include a tubular body 658 and a flange 660 disposed along tubular body 658. Generally, flange 660 is configured to engage proximal end region 628 of housing 612 and acts as a stop to limit further movement of holder 656 into expandable access sheath 610.

[0156] In some examples, the system 600 may also include a visual navigation probe 662. The visual navigation probe 662 may include a base 664. A shaft 666 may extend from the base 664. The shaft 666 may include a tip 668. The tip 668 may be a rounded tip, a beveled tip, etc. One or more additional shafts 670 may extend from the base 664. The base 664 and / or the shaft 670 may include one or more visualization members 672.

[0157] The visual navigation probe 662 may be inserted into the holder 656, and the holder 656 may be inserted into the expandable access port 610. The system 600 may then be positioned along the patient 674 and / or guided towards the area of ​​interest as shown in FIG. 7B. Once properly positioned, the holder 656 and visual navigation probe 662 may be removed. The actuation member 626 may be actuated to transition the expandable conduit 614 to an expanded configuration as shown in FIG. 7C.

[0158] 8A-8C show a system for accessing the central nervous system 700. The system 700 may include an expandable access port 710. The expandable access port 710 may be similar in form and function to other access ports disclosed herein. In this example, the expandable access port 710 is shown with a stabilizing bar 752 that may be used to couple / secure the expandable access port 710 to a stabilizing system 754. Some exemplary stabilizing systems that may be used with the stabilizing bar 752 may include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, as well as systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, and others. Also, in this example, the expandable access port 710 may be without a nose cone. Some additional description regarding the expandable access port 710 can be found herein with reference to FIG. 9.

[0159] The system 700 may also include a holder 756. The holder 756 may include a tubular body 758 and a flange 760 disposed along the tubular body 758. In some examples, the set screw 780 may be disposed along the tubular body 758. As noted above, the expandable access port 710 may be devoid of a nose cone. In this case, the holder 756 may include a shaft 776 extending from the tubular body 758, and a nose cone 778 may be coupled to the shaft 776. The shaft 776 and the nose cone 778 are configured such that the holder 756 can be inserted into the expandable access port 710, and the nose cone 778 may be disposed at a distal end of the expandable access sheath 710. In some examples, the nose cone 778 may have a generally atraumatic shape. For example, the nose cone 778 may include a tapered proximal end region and / or a tapered distal end region. This may allow the nose cone 778 to be more easily inserted into and through and / or removed from the expandable access sheath 710. When doing so, the expandable access sheath 710 may partially expand or flex while allowing the nose cone 778 to pass therethrough. Additionally, the nose cone 778 (and / or the holder 756 generally) can be inserted into or removed from the expandable access sheath 710 without having to transition the expandable conduit 714 to an expanded configuration.

[0160] The system 700 may also include a visual navigation probe 762. The visual navigation probe 762 may include a base 764. A shaft 766 may extend from the base 764. The shaft 766 may include a tip 768. One or more additional shafts 770 may extend from the base 764. The base 764 and / or shaft 770 may include one or more visualization members 772. The visual navigation probe 762 may be inserted into a holder 756, which may be inserted into the expandable access port 710. The system 700 may then be positioned along the patient 774 and / or navigated towards the area of ​​interest as shown in FIG. 8B. The holder 756 and visual navigation probe 762 may be removed. The actuation member 726 may be actuated to transition the expandable conduit 714 to an expanded configuration, as shown in FIG. 8C.

[0161] 9 illustrates an expandable access port 710. The expandable access port 710 may include some structural features of the expandable access port 610. For example, the expandable access port 710 may include a housing 712 and an expandable conduit 714 coupled to the housing 712. The expandable conduit 714 may include a plurality of prongs 716. The sleeve 718 may be disposed along the plurality of prongs 716. The housing 712 may include a flange region 728 and a distal opening 730. An actuating member 726 may be coupled to the housing 712 and function similarly to the actuating member 626. An adjustment mechanism 722 may be coupled to the housing 712.

[0162] As noted above, the expandable access port 710 may lack a nose cone and, in at least some examples, may be used with another device, such as the holder 756 (e.g., including a nose cone 778). Because the expandable access port 710 may lack a nose cone, all of the plurality of prongs 716 may be substantially similar. Alternatively, one or more of the plurality of prongs 716 may be different from one or more of the other of the plurality of prongs 716.

[0163] In some examples, the housing may lack a first adjustment mechanism (e.g., set screw 620) coupled to the stabilizing member (e.g., stabilizing member 624) and / or lack a stabilizing member similar to stabilizing member 624. Instead, stabilizing bar 752 may be coupled to housing 712 and protrude radially therefrom. Stabilizing bar 752 may be used to secure expandable access port 710 to a stabilizing system. Some exemplary stabilizing systems that may be used with stabilizing bar 752 may include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, as well as systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, and the like. The form of stabilizing bar 752 may vary. In some examples, a stabilizing bar similar to stabilizing bar 752 may be utilized with expandable access port 610.

[0164] 10-15 illustrate an expandable access port 810 that may be similar in shape and function to other access ports / sheaths disclosed herein (e.g., the expandable access port 810 may also be described as an expandable access sheath 810). The expandable access port 810 may include a housing 812 and an expandable conduit 814 coupled to the housing 812. The expandable conduit 814 may include a plurality of prongs 816. A sleeve 818 may be disposed along the plurality of prongs 816. The housing 812 may include a cap 828 and a distal opening 830. An actuating member 826 is coupled to the housing 812 and may function similarly to other actuating members disclosed herein to transition the expandable conduit between a first configuration (e.g., as shown in FIG. 10) and a second or expanded configuration (e.g., as shown in FIG. 11).

[0165] One or more adjustment mechanisms, for example, the first adjustment mechanism 822a and the second adjustment mechanism 822b, may be coupled to the cap 828. The form of the first adjustment mechanism 822a, the second adjustment mechanism 822b, or both may vary. For example, in some examples, the first adjustment mechanism 822a may include a threaded foot 882 used to adjust the position of the expandable access port 810 relative to the patient. The first adjustment mechanism 822a may also include a stabilizing bar 852 used to couple / secure the expandable access port 810 to a stabilizing system (not shown). Some exemplary stabilizing systems that may be used with the stabilizing bar 852 may include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, as well as systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, and the like. The second adjustment mechanism 822b may include one or more threaded feet 882 used to adjust the position of the expandable access port 810 relative to the patient. Other adjustment mechanisms are contemplated, including a single threaded leg 882, two or more threaded legs 882, no threaded leg 882, a single stabilizing bar 852, two or more stabilizing bars 852, no stabilizing bar 852, etc.

[0166] 12-13 show the expandable access port 810 with the first adjustment mechanism 822a and the second adjustment mechanism 822b detached from the cap 828. Here, it can be seen that the cap 828 can include a first attachment region 883a and a second attachment region 883b. In at least some examples, the first attachment region 883a and the second attachment region 883b allow various adjustment mechanisms to be removably coupled thereto. For example, the first attachment region 883a and / or the second attachment region 883b can take the form of a flange configured to have an adjustment mechanism (e.g., the first adjustment mechanism 822a, the second adjustment mechanism 822b, or both) removably attached to the cap 828. The adjustment mechanism 822a / 822b can include a spring-release attachment / detachment mechanism including a spring or elastic member 833 and a lever member 835, as shown in FIG. 14A. In some examples, the resilient member 833 takes the form of an O-ring used as or as a spring to hold the lever member 835 (e.g., to allow the adjustment mechanism 822a / 822b to be securely attached to the mounting area 883a / 883b). The lever member 835 can be depressed to enlarge or otherwise expand the resilient member 833. This allows the adjustment mechanism 822a / 822b to be easily and securely attached / detached from the mounting area 883a / 883b as needed.

[0167] In use, the clinician can choose to attach an appropriate number of adjustment mechanisms to the cap 828 (e.g., the first attachment area 883a and / or the second attachment area 883b). The form or type of adjustment mechanism can vary, and in at least some examples, the type of adjustment mechanism can be selected to best fit the needs of a particular medical intervention. For example, the first adjustment mechanism 822a may be attached to the first attachment area 883a as shown in FIG. 14. In this example, the adjustment mechanism is not attached to the second attachment area 883b. Further illustrating contemplated adjustment mechanism variations, FIG. 15 shows another adjustment mechanism 822a' attached to the cap 828 (e.g., the first attachment area 883a) of the expandable access port 810. In this example, the adjustment mechanism 822a' includes a stabilizing bar 852 but does not include a set screw. Other variations are also contemplated.

[0168] 16-17 show a system 800 including an expandable access port 810 with a holder 856. The holder 856 can include a tubular body 858 and a flange 860 disposed along the tubular body 858. In some examples, a nut or gripping region 880 can be disposed along the tubular body 858. The holder 856 can include a shaft 876 extending from the tubular body 858, and a nose cone 878 can be coupled to the shaft 876. The shaft 876 and the nose cone 878 are configured such that the holder 856 can be inserted into the expandable access port 810, and the nose cone 878 can be disposed at a distal end of the expandable access sheath 810. In some examples, the nose cone 878 can have a generally atraumatic shape. For example, the nose cone 878 can include a tapered proximal end region and / or a tapered distal end region. This may allow the nose cone 878 to be more easily inserted into and through and / or removed from the expandable access port 810. When doing so, the expandable access port 810 may partially expand or flex while allowing the nose cone 878 to pass therethrough. Furthermore, the nose cone 878 (and / or holder 856 generally) can be inserted into or removed from the expandable access port 810 without having to transition the expandable conduit 814 to the expanded configuration.

[0169] Materials that may be used for the various components of medical device 10 (and / or other medical devices / systems disclosed herein) may include those generally associated with medical devices. For brevity, the following description is directed to medical device 10. However, this is not intended to limit the devices and methods described herein, as the description may also be applied to other similar medical devices and / or systems disclosed herein.

[0170] The medical device 10 may be fabricated from metals, metal alloys, polymers (examples of which are described below), metal-polymer blends, ceramics, combinations thereof, and the like, or other suitable materials. Examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DuPont's DELRIN®), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-esters (e.g., DSM Enginerrings), and the like. Polyamides (DURETHAN® available from Bayer, CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear ...polyethylene) (REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (KEVLAR®), polysulfone, nylon, nylon-12 (GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) Examples of suitable materials include poly(styrene-b-isobutylene-b-styrene) (such as SIBS and / or SIBS50A), polycarbonate, ionomers, biocompatible polymers, or other suitable materials, or blends, combinations, copolymers thereof, polymer / metal blends, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the blend can include up to about 6% LCP.

[0171] Examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, nickel-chromium-molybdenum alloys (such as UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®), nickel-copper alloys (such as UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel- Other nickel alloys such as cobalt-chromium-molybdenum alloys (such as UNS: R30035, such as MP35-N®), nickel-molybdenum alloys (UNS: N10665, such as HASTELLOY® ALLOYB2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (such as UNS: R30003, such as ELGILOY®, PHYNOX®), platinum enriched stainless steel, titanium, combinations thereof, and the like, or any other suitable material.

[0172] In at least some embodiments, portions or all of the medical device 10 may also be doped with, fabricated from, or otherwise contain radiopaque materials. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists the user of the medical device 10 in determining its location. Some examples of radiopaque substances may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the configuration of the medical device 10 to achieve the same results.

[0173] In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is provided to the medical device 10. For example, the medical device 10, or portions thereof, may be fabricated from materials that do not substantially distort images and do not create substantial artifacts (e.g., voids in the image). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in MRI images. The medical device 10, or portions thereof, may also be made from materials that MRI machines can image. Some materials that exhibit these characteristics may include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®), nitinol, etc., and others.

[0174] It will be understood that this disclosure is in many respects merely illustrative. Changes may be made in details, particularly with respect to shape, size and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in other embodiments. The scope of the invention is, of course, defined in the terms in which the appended claims are expressed.

Claims

1. 1. An expandable access port, comprising: a housing having a plurality of prongs coupled to the housing; a cap coupled to the housing, the cap including a mounting area; an actuation member coupled to the housing, the actuation member configured to transition the plurality of pawls between a first configuration and an extended configuration; an adjustment mechanism secured to the attachment region, the adjustment mechanism including an attachment mechanism that attaches the adjustment mechanism to the attachment region and an adjustable leg that adjusts a position of the expandable access port relative to a patient; the housing includes a threaded region; the threaded region includes external threads; The actuation member includes a nut threadably engaged with the threaded region.

2. The expandable access port of claim 1 , wherein at least one of the plurality of claws is secured to the housing with a pivot member.

3. The expandable access port of claim 2 , wherein the pivot member includes a pivot pin.

4. At least one of the prongs includes a proximal end region; The expandable access port of any one of claims 1 to 3, wherein the proximal end region has an inclined surface that is inclined relative to an outer surface of a portion of the corresponding claw adjacent to the proximal end region.

5. The expandable access port of claim 4 , wherein the actuation member includes an actuation surface configured to engage the ramp surface.

6. The expandable access port of any one of claims 1 to 5, further comprising a sleeve extending along at least some of the plurality of prongs.

7. An expandable access port as described in any one of claims 1 to 6, further comprising one or more stabilizing members for fixing the expandable access port to a stabilizing system that stabilizes the expandable access port, the one or more stabilizing members being coupled to the housing.

8. The attachment area comprises: two substantially parallel lateral surfaces extending radially outward from the cap; The expandable access port of any one of claims 1 to 7, further comprising end faces at end regions of the two substantially parallel lateral sides.

9. the cap further comprises a second attachment area; The expandable access port of any one of claims 1 to 8, further comprising a second adjustment mechanism removably coupled to the second attachment region, the second adjustment mechanism including one or more threaded legs used to adjust a position of the expandable access port relative to a patient.

10. The adjustment mechanism includes: The expandable access port of any one of claims 1 to 8, including a resilient member and a lever member for removably coupling the adjustment mechanism directly to the attachment region.

11. The expandable access port of any one of claims 1 to 8, wherein the adjustable legs include threaded legs.

Images