Medical devices for accessing the central nervous system

Abstract

Disclosed herein are medical devices for accessing the central nervous system and the manufacture and use of medical devices. An example medical device may include an expandable access sheath having a proximal region and a distal region. The expandable access sheath may be designed 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 designed to transition the expandable access sheath between the first configuration and the expanded configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Patent Application No. 62 / 631,339, filed on February 15, 2018, U.S. Provisional Application No. 62 / 703,180, filed on July 25, 2018, and U.S. Provisional Application No. 62 / 734,043, filed on September 20, 2018, the entire disclosures of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to medical devices and methods for making medical devices. More particularly, the present invention relates to medical devices for accessing the central nervous system. Background Art

[0004] 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 are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0005] The present invention provides designs, materials, manufacturing methods and use alternatives for medical devices. The present invention discloses a medical device for accessing the central nervous system. The medical device comprises: an expandable access sheath having a proximal region and a distal region; wherein the expandable access sheath is designed to switch between a first configuration and an expanded configuration; wherein the expandable access sheath comprises a tubular body having one or more axial support members disposed along the tubular body; and an expansion member designed to switch the expandable access sheath between the first configuration and the expanded configuration.

[0006] Alternatively or additionally to any of the above embodiments, the first configuration is a collapsed configuration.

[0007] Alternatively or additionally to any of the above embodiments, the expandable access sheath is biased in a first configuration.

[0008] Alternatively or additionally to any of the above embodiments, the expandable entry sheath is designed to be in a first form when not subjected to a radially outward expansion force, to expand to an expanded form when subjected to a radially outward expansion force, and to return to the first form when the radially outward expansion force is removed.

[0009] Alternatively or additionally to any of the above embodiments, the expandable access sheath is designed to be in a first configuration in the absence of an 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.

[0010] Alternatively or additionally to any of the above embodiments, the one or more axial support members are designed to limit shortening of the tubular body.

[0011] Alternatively or additionally to any of the above embodiments, the one or more axial support members are designed to fix the length of the tubular body.

[0012] Alternatively or additionally to any of the above embodiments, when the expandable access sheath is in the first configuration, the tubular body has a first length, and wherein when the expandable access sheath is in the expanded configuration, the tubular body has a second length.

[0013] Alternatively or additionally to any of the above embodiments, the first length is substantially the same as the second length.

[0014] Alternatively or additionally to any of the above embodiments, the tubular body comprises a polymer sleeve.

[0015] Alternatively or additionally to any of the above embodiments, at least some of the one or more axial support members are substantially straight.

[0016] Alternatively or additionally to any of the above embodiments, all of the one or more axial support members are substantially straight.

[0017] Alternatively or additionally to any of the above embodiments, at least some of the one or more axial support members have a proximal curved region.

[0018] Alternatively or additionally to any of the above embodiments, each of the one or more axial support members has a proximal curved region.

[0019] Alternatively or additionally 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, and further include one or more struts extending between the first axial support member and the second axial support member.

[0020] Alternatively or additionally to any of the above embodiments, the dilation member comprises a trocar.

[0021] Alternatively or additionally to any of the above embodiments, the expansion member comprises a cannula.

[0022] Alternatively or additionally to any of the above embodiments, the dilation member comprises a trocar and a cannula.

[0023] Alternatively or additionally to any of the above embodiments, the expansion member includes a proximal iris member coupled to the one or more axial support members.

[0024] 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.

[0025] Alternatively or additionally to any of the above embodiments, the expansion member comprises a rotatable bolt coupled to the one or more axial support members.

[0026] Alternatively or additionally to any of the above embodiments, rotation of the rotatable bolt transitions the expandable access sheath from the first configuration to the expanded configuration.

[0027] Alternatively or additionally to any of the above embodiments, at least some of the one or more axial support members include curved regions, and wherein rotation of the rotatable bolt engages the rotatable bolt with the curved regions.

[0028] Alternatively or additionally to any of the above embodiments, engagement of the rotatable bolt with the bend region transitions the expandable access sheath from the first configuration to the expanded configuration.

[0029] Alternatively or additionally to any of the above embodiments, further comprising a stylet extending at least partially through the expandable access sheath.

[0030] Alternatively or additionally to any of the above embodiments, when the stylet is at least partially extended through the expandable access sheath, the expandable access sheath is in the first configuration.

[0031] Alternatively or additionally to any of the above embodiments, the stylet includes a distal camera.

[0032] Alternatively or additionally to any of the above embodiments, the stylet includes one or more marking members or sensors.

[0033] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include visual markings.

[0034] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include markers detectable by fluoroscopic imaging.

[0035] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include markers detectable by magnetic resonance imaging.

[0036] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include markers detectable by optical coherence tomography.

[0037] Alternatively or additionally to any of the above embodiments, further comprising a device orientation assembly coupled to the expandable access sheath.

[0038] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes a base designed to engage a patient.

[0039] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes one or more adjustable legs designed to engage a patient.

[0040] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes a stylet.

[0041] Alternatively or additionally to any of the above embodiments, further comprising a locking arm coupled to the device orientation assembly.

[0042] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes a base and an adjustable member coupled to the base.

[0043] Alternatively or additionally to any of the above embodiments, the adjustable member is axially adjustable relative to the base.

[0044] Alternatively or additionally to any of the above embodiments, the adjustable member may be pivotally adjustable relative to the base.

[0045] The present invention discloses a medical device for accessing a target area in the brain. The medical device comprises: an expandable brain port, which is designed to reversibly transform between a first configuration and an expanded configuration; wherein the expandable brain port comprises a polymer sleeve and a stent-like lattice coupled to the polymer sleeve, wherein the stent-like lattice comprises one or more axial support members; and an expansion member, which is designed to transform the expandable brain port between the first configuration and the expanded configuration.

[0046] Alternatively or additionally to any of the above embodiments, the first configuration is a collapsed configuration.

[0047] Alternatively or additionally to any of the above embodiments, the expandable brain port is biased in a first configuration.

[0048] Alternatively or additionally to any of the above embodiments, the expandable brain port is designed to be in a first form when not subjected to a radially outward expansion force, to expand to an expanded form when subjected to a radially outward expansion force, and to return to the first form when the radially outward expansion force is removed.

[0049] Alternatively or additionally to any of the above embodiments, the expandable brain port is designed to be in a first form in the absence of an expansion member, to expand to an expanded form when the expansion member is disposed within the expandable brain port, and to return to the first form when the expansion member is removed from the expandable brain port.

[0050] Alternatively or additionally to any of the above embodiments, one or more axial support members are designed to limit shortening of the expandable brain port.

[0051] Alternatively or additionally to any of the above embodiments, one or more axial support members are designed to fix the length of the expandable brain port.

[0052] Alternatively or additionally 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 wherein when the expandable brain port is in the expanded configuration, the expandable brain port has a second length.

[0053] Alternatively or additionally to any of the above embodiments, the first length is substantially the same as the second length.

[0054] Alternatively or additionally to any of the above embodiments, at least some of the one or more axial support members are substantially straight.

[0055] Alternatively or additionally to any of the above embodiments, all of the one or more axial support members are substantially straight.

[0056] Alternatively or additionally to any of the above embodiments, at least some of the one or more axial support members have a proximal curved region.

[0057] Alternatively or additionally to any of the above embodiments, each of the one or more axial support members has a proximal curved region.

[0058] Alternatively or additionally 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, and further include one or more struts extending between the first axial support member and the second axial support member.

[0059] Alternatively or additionally to any of the above embodiments, the dilation member comprises a trocar.

[0060] Alternatively or additionally to any of the above embodiments, the expansion member comprises a cannula.

[0061] Alternatively or additionally to any of the above embodiments, the dilation member comprises a trocar and a cannula.

[0062] Alternatively or additionally to any of the above embodiments, the expansion member includes a proximal iris member coupled to the one or more axial support members.

[0063] 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.

[0064] Alternatively or additionally to any of the above embodiments, the expansion member comprises a rotatable bolt coupled to the one or more axial support members.

[0065] Alternatively or additionally to any of the above embodiments, rotation of the rotatable bolt transitions the expandable brain port from the first configuration to the expanded configuration.

[0066] Alternatively or additionally to any of the above embodiments, at least some of the one or more axial support members include curved regions, and wherein rotation of the rotatable bolt engages the rotatable bolt with the curved regions.

[0067] Alternatively or additionally to any of the above embodiments, engagement of the curved region with the rotatable bolt transitions the expandable brain port from the first configuration to the expanded configuration.

[0068] Alternatively or additionally to any of the above embodiments, further comprising a stylet extending at least partially through the expandable brain port.

[0069] Alternatively or additionally to any of the above embodiments, the expandable brain port is in a first configuration when the stylet is at least partially extended through the expandable brain port.

[0070] Alternatively or additionally to any of the above embodiments, the stylet includes a distal camera.

[0071] Alternatively or additionally to any of the above embodiments, the stylet includes one or more marking members or sensors.

[0072] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include visual markings.

[0073] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include markers detectable by fluoroscopic imaging.

[0074] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include markers detectable by magnetic resonance imaging.

[0075] Alternatively or additionally to any of the above embodiments, at least some of the one or more marking members include markers detectable by optical coherence tomography.

[0076] Alternatively or additionally to any of the above embodiments, further comprising a device orientation assembly coupled to the expandable brain port.

[0077] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes a base designed to engage a patient.

[0078] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes one or more adjustable legs designed to engage a patient.

[0079] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes a stylet.

[0080] Alternatively or additionally to any of the above embodiments, further comprising a locking arm coupled to the device orientation assembly.

[0081] Alternatively or additionally to any of the above embodiments, the device orientation assembly includes a base and an adjustable member coupled to the base.

[0082] Alternatively or additionally to any of the above embodiments, the adjustable member is axially adjustable relative to the base.

[0083] Alternatively or additionally to any of the above embodiments, the adjustable member may be pivotally adjustable relative to the base.

[0084] The present invention discloses a method for accessing a target area, comprising: advancing an expandable access sheath through body tissue to a position adjacent to the target area in the central nervous system; and advancing an expansion member through the expandable access sheath to transform the expandable access sheath from a first configuration to an expanded configuration.

[0085] Alternatively or additionally to any of the above embodiments, a stylet is disposed within an expandable access sheath, and wherein advancing the expandable access sheath through body tissue to a position adjacent to a target region in the central nervous system includes advancing the expandable access sheath and the stylet to a position adjacent to the target region.

[0086] Alternatively or additionally to any of the above embodiments, when the stylet is disposed within the expandable access sheath, the expandable access sheath is in a first configuration.

[0087] Alternatively or additionally to any of the above embodiments, further comprising removing the stylet from the expandable access sheath.

[0088] Alternatively or additionally to any of the above embodiments, further comprising securing the expandable access sheath to the device orientation assembly.

[0089] Alternatively or additionally to any of the above embodiments, further comprising adjusting an axial position of the expandable access sheath relative to the device orientation assembly.

[0090] Alternatively or additionally to any of the above embodiments, further comprising advancing the medical device at least partially through the expandable access sheath when the expandable access sheath is in the expanded configuration.

[0091] The present invention discloses a method for accessing a target area, comprising: advancing an expandable brain port through body tissue to a position adjacent to the target area in the brain; and advancing an expansion member through the expandable brain port to transform the expandable brain port from a first configuration to an expanded configuration.

[0092] Alternatively or additionally to any of the above embodiments, a stylet is disposed within an expandable brain port, and wherein advancing the expandable brain port through body tissue to a position adjacent to a target region in the brain includes advancing the expandable brain port and the stylet to a position adjacent to the target region.

[0093] Alternatively or additionally to any of the above embodiments, when the stylet is disposed within the expandable brain port, the expandable brain port is in a first configuration.

[0094] Alternatively or additionally to any of the above embodiments, further comprising removing the stylet from the expandable access sheath.

[0095] Alternatively or additionally to any of the above embodiments, it also includes securing the expandable brain port to the device orientation assembly.

[0096] Alternatively or additionally to any of the above embodiments, further comprising adjusting an axial position of the expandable brain port relative to the device orientation assembly.

[0097] Alternatively or additionally to any of the above embodiments, further comprising advancing a medical device at least partially through the expandable brain port when the expandable brain port is in the expanded configuration.

[0098] The present invention discloses a medical device for accessing the central nervous system. The medical device comprises: an expandable access sheath comprising a plurality of axially extending support members; wherein the expandable access sheath is designed to transform between a first configuration and an expanded configuration; wherein each of the axially extending support rods comprises a distal region and a curved proximal region; a hub disposed adjacent to the curved proximal region, the hub comprising a first thread; a bolt coupled to the hub, the bolt comprising a second thread designed to threadably engage with the first thread; and wherein rotation of the bolt causes the bolt to engage the curved proximal region of the axially extending support rod and transform the expandable access sheath from the first configuration toward the expanded configuration.

[0099] An expandable access port is disclosed. The expandable access port includes: a housing having a plurality of tines coupled thereto, the plurality of tines including a first tine; an actuation member coupled to the housing, the actuation member being designed to transition the plurality of tines between a first configuration and an expanded configuration; and a nose cone coupled to the first tine.

[0100] Alternatively or additionally to any of the above embodiments, the housing includes a threaded region.

[0101] Alternatively or additionally to any of the above embodiments, the actuation member comprises a nut threadedly engaged with the threaded region.

[0102] Alternatively or additionally to any of the above embodiments, at least one of the plurality of tines is secured to the housing with a pivot member.

[0103] Alternatively or additionally to any of the above embodiments, the pivot member comprises a pivot pin.

[0104] Alternatively or additionally to any of the above embodiments, at least one of the plurality of tines comprises a proximal region having an angled surface.

[0105] Alternatively or additionally to any of the above embodiments, the actuation member comprises an actuation surface designed to engage with the angled surface.

[0106] Alternatively or additionally to any of the above embodiments, further comprising a sleeve extending along at least some of the plurality of tines.

[0107] Alternatively or additionally to any of the above embodiments, a sleeve extends along an outer surface of each of the plurality of tines.

[0108] Alternatively or additionally to any of the above embodiments, the sleeve comprises an elastomeric material.

[0109] Alternatively or additionally to any of the above embodiments, at least one of the plurality of tines includes a gripping region designed to engage the cannula.

[0110] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is aligned with the central axis when the plurality of tines are in the first configuration.

[0111] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is radially offset from the central axis when the plurality of tines are in the expanded configuration.

[0112] Alternatively or additionally to any of the above embodiments, the housing has a proximal opening formed therein and wherein the plurality of tines define a distal opening.

[0113] Alternatively or additionally to any of the above embodiments, when the plurality of tines are in the first configuration, the distal opening has substantially the same width as or a smaller width than the proximal opening.

[0114] Alternatively or additionally to any of the above embodiments, when the plurality of tines are in the expanded configuration, the distal opening has substantially the same width as or a greater width than the proximal opening.

[0115] Alternatively or additionally to any of the above embodiments, it also includes one or more stabilization members coupled to the housing.

[0116] Alternatively or additionally to any of the above embodiments, one or more stabilization members are designed to translate axially relative to the housing.

[0117] Alternatively or additionally to any of the above embodiments, the one or more stabilizing members include stabilizing rods extending radially from the housing.

[0118] An expandable access port is disclosed. The expandable access port includes: a housing having an expandable catheter coupled thereto, the expandable catheter including a plurality of tines, the plurality of tines including a first tine; an actuation member coupled to the housing, the actuation member being designed to transition the expandable catheter between a first configuration and an expanded configuration; and a nose cone coupled to the first tine.

[0119] Alternatively or additionally to any of the above embodiments, the housing includes a threaded region.

[0120] Alternatively or additionally to any of the above embodiments, the actuation member comprises a nut threadedly engaged with the threaded region.

[0121] Alternatively or additionally to any of the above embodiments, the first tine is secured to the housing with a pivot member.

[0122] Alternatively or additionally to any of the above embodiments, the pivot member comprises a pivot pin.

[0123] Alternatively or additionally to any of the above embodiments, the first tine comprises a proximal region having an angled surface.

[0124] Alternatively or additionally to any of the above embodiments, the actuation member comprises an actuation surface designed to engage with the angled surface.

[0125] Alternatively or additionally to any of the above embodiments, the expandable catheter includes a sheath extending along at least some of the plurality of tines.

[0126] Alternatively or additionally to any of the above embodiments, the sleeve extends along an outer surface of the first tine.

[0127] Alternatively or additionally to any of the above embodiments, the sleeve comprises an elastomeric material.

[0128] Alternatively or additionally to any of the above embodiments, the first tine includes a gripping region designed to engage the cannula.

[0129] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is aligned with the central axis when the expandable catheter is in the first configuration.

[0130] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is radially offset from the central axis when the expandable catheter is in the expanded configuration.

[0131] Alternatively or additionally to any of the above embodiments, the housing has a proximal opening formed therein and wherein the expandable catheter defines a distal opening.

[0132] Alternatively or additionally to any of the above embodiments, when the expandable catheter is in the first configuration, the distal opening has substantially the same width as or a smaller width than the proximal opening.

[0133] Alternatively or additionally to any of the above embodiments, when the expandable catheter is in the expanded configuration, the distal opening has a width that is substantially the same as or greater than the proximal opening.

[0134] Alternatively or additionally to any of the above embodiments, it also includes one or more stabilization members coupled to the housing.

[0135] Alternatively or additionally to any of the above embodiments, one or more stabilization members are designed to translate axially relative to the housing.

[0136] Alternatively or additionally to any of the above embodiments, the one or more stabilizing members include stabilizing rods extending radially from the housing.

[0137] The present invention discloses a system for accessing the central nervous system. The system includes an expandable access port, the expandable access port includes a housing having a plurality of tines coupled thereto, the plurality of tines including a first tine; an actuating member coupled to the housing, the actuating member being designed to transition the plurality of tines between a first configuration and an expanded configuration; and a retainer, which is designed to extend through the housing, the retainer including a tubular base, a shaft extending from the tubular base, and a nose cone attached to the shaft.

[0138] Alternatively or additionally to any of the above embodiments, the housing includes a threaded region.

[0139] Alternatively or additionally to any of the above embodiments, the actuation member comprises a nut threadedly engaged with the threaded region.

[0140] Alternatively or additionally to any of the above embodiments, at least one of the plurality of tines is secured to the housing with a pivot member.

[0141] Alternatively or additionally to any of the above embodiments, the pivot member comprises a pivot pin.

[0142] Alternatively or additionally to any of the above embodiments, at least one of the plurality of tines comprises a proximal region having an angled surface.

[0143] Alternatively or additionally to any of the above embodiments, the actuation member comprises an actuation surface designed to engage with the angled surface.

[0144] Alternatively or additionally to any of the above embodiments, further comprising a sleeve extending along at least some of the plurality of tines.

[0145] Alternatively or additionally to any of the above embodiments, a sleeve extends along an outer surface of each of the plurality of tines.

[0146] Alternatively or additionally to any of the above embodiments, the sleeve comprises an elastomeric material.

[0147] Alternatively or additionally to any of the above embodiments, at least one of the plurality of tines includes a gripping region designed to engage the cannula.

[0148] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is aligned with the central axis when the plurality of tines are in the first configuration.

[0149] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is radially offset from the central axis when the plurality of tines are in the expanded configuration.

[0150] Alternatively or additionally to any of the above embodiments, the housing has a proximal opening formed therein and wherein the plurality of tines define a distal opening.

[0151] Alternatively or additionally to any of the above embodiments, when the plurality of tines are in the first configuration, the distal opening has substantially the same width as or a smaller width than the proximal opening.

[0152] Alternatively or additionally to any of the above embodiments, when the plurality of tines are in the expanded configuration, the distal opening has substantially the same width as or a greater width than the proximal opening.

[0153] Alternatively or additionally to any of the above embodiments, it also includes one or more stabilization members coupled to the housing.

[0154] Alternatively or additionally to any of the above embodiments, one or more stabilization members are designed to translate axially relative to the housing.

[0155] Alternatively or additionally to any of the above embodiments, the one or more stabilizing members include stabilizing rods extending radially from the housing.

[0156] Alternatively or additionally to any of the above embodiments, the retainer includes a proximal flange.

[0157] Alternatively or additionally to any of the above embodiments, the nose cone has a tapered proximal region.

[0158] Alternatively or additionally to any of the above embodiments, the nose cone has a tapered distal region.

[0159] The present invention discloses a system for accessing a central nervous system. The system includes an expandable access port, the expandable access port includes a housing having an expandable catheter coupled thereto, the expandable catheter including a plurality of tines, the plurality of tines including a first tine; an actuating member coupled to the housing, the actuating member being designed to convert the expandable catheter between a first configuration and an expanded configuration; and a retainer, which is designed to extend at least partially through the expandable catheter, the retainer including a tubular base, a shaft extending from the tubular base, and a nose cone attached to the shaft.

[0160] Alternatively or additionally to any of the above embodiments, the housing includes a threaded region.

[0161] Alternatively or additionally to any of the above embodiments, the actuation member comprises a nut threadedly engaged with the threaded region.

[0162] Alternatively or additionally to any of the above embodiments, the first tine is secured to the housing with a pivot member.

[0163] Alternatively or additionally to any of the above embodiments, the pivot member comprises a pivot pin.

[0164] Alternatively or additionally to any of the above embodiments, the first tine comprises a proximal region having an angled surface.

[0165] Alternatively or additionally to any of the above embodiments, the actuation member comprises an actuation surface designed to engage with the angled surface.

[0166] Alternatively or additionally to any of the above embodiments, the expandable catheter includes a sheath extending along at least some of the plurality of tines.

[0167] Alternatively or additionally to any of the above embodiments, the sleeve extends along an outer surface of the first tine.

[0168] Alternatively or additionally to any of the above embodiments, the sleeve comprises an elastomeric material.

[0169] Alternatively or additionally to any of the above embodiments, the first tine includes a gripping region designed to engage the cannula.

[0170] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is aligned with the central axis when the expandable catheter is in the first configuration.

[0171] Alternatively or additionally to any of the above embodiments, the housing defines a central axis and wherein the nose cone is radially offset from the central axis when the expandable catheter is in the expanded configuration.

[0172] Alternatively or additionally to any of the above embodiments, the housing has a proximal opening formed therein and wherein the expandable catheter defines a distal opening.

[0173] Alternatively or additionally to any of the above embodiments, when the expandable catheter is in the first configuration, the distal opening has substantially the same width as or a smaller width than the proximal opening.

[0174] Alternatively or additionally to any of the above embodiments, when the expandable catheter is in the expanded configuration, the distal opening has a width that is substantially the same as or greater than the proximal opening.

[0175] Alternatively or additionally to any of the above embodiments, it also includes one or more stabilization members coupled to the housing.

[0176] Alternatively or additionally to any of the above embodiments, one or more stabilization members are designed to translate axially relative to the housing.

[0177] Alternatively or additionally to any of the above embodiments, the one or more stabilizing members include stabilizing rods extending radially from the housing.

[0178] Alternatively or additionally to any of the above embodiments, the retainer includes a proximal flange.

[0179] Alternatively or additionally to any of the above embodiments, the nose cone has a tapered proximal region.

[0180] Alternatively or additionally to any of the above embodiments, the nose cone has a tapered distal region.

[0181] An expandable access port is disclosed. The expandable access port includes: a housing having an expandable catheter coupled thereto, the expandable catheter including a plurality of tines and a cannula coupled to the plurality of tines; an actuation member coupled to the housing, the actuation member being designed to transition the expandable catheter between a first configuration and an expanded configuration; and a cap coupled to the housing, the cap including an attachment region being designed to have an adjustment mechanism releasably attached thereto.

[0182] Alternatively or additionally to any of the above embodiments, it also includes an adjustment mechanism releasably coupled to the attachment area.

[0183] Alternatively or additionally to any of the above embodiments, the cap further includes a second attachment area, and further includes a second adjustment mechanism releasably coupled to the second attachment area.

[0184] Alternatively or additionally to any of the above embodiments, the adjustment mechanism comprises a set screw.

[0185] Alternatively or additionally to any of the above embodiments, the adjustment mechanism includes a stabilizing bar.

[0186] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0187] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0188] Figure 1A is a perspective view of a portion of an example medical device and depicts an example expandable access sheath.

[0189] Figure 1B is a perspective view of a portion of an example medical device and depicts an example expandable access sheath.

[0190] Figures 1C to 1F An example medical device for accessing the central nervous system is shown.

[0191] Figures 2A to 2D An example medical device for accessing the central nervous system is shown.

[0192] Figures 3A to 3D An example medical device for accessing the central nervous system is shown.

[0193] Figures 4A to 4E Example medical device systems and uses of example medical device systems are shown.

[0194] Figures 5A to 5D Example medical device systems and uses of example medical device systems are shown.

[0195] Fig. 6A is a perspective view of an example expandable access port.

[0196] Figure 6B is a cross-sectional view of an example expandable access port.

[0197] Figure 6C is a perspective view of an example expandable access port.

[0198] Fig.6Dis a cross-sectional view of an example expandable access port.

[0199] Fig. 6E is a cross-sectional view of an example expandable access port.

[0200] Fig. 6F is an exploded view of an example expandable access port.

[0201] Figures 7A to 7C A system for accessing the central nervous system is shown.

[0202] Figures 8A to 8C A system for accessing the central nervous system is shown.

[0203] Fig. 9 is a perspective view of an example expandable access port.

[0204] Figures 10 to 15 An example expandable access port is shown.

[0205] Figures 16 to 17 A system for accessing the central nervous system is shown.

[0206] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0207] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0208] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include values ​​that are rounded to the nearest significant figure.

[0209] 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).

[0210] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0211] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures, or characteristics. However, such a description does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Additionally, when specific features, structures, and / or characteristics are described in conjunction with one embodiment, it should be understood that such features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0212] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0213] Lesions, clots, tumors, and / or other malformations in the brain may be challenging to treat. At least some of the challenges associated with such treatments may be associated with gaining access to a target area. For example, accessing a clot within the brain may require navigating a treatment device through an area of ​​the brain. This may require relatively delicate traversal through brain tissue. It may be desirable to access an area of ​​the brain in a manner that reduces trauma to brain tissue, increases the ability to image / visualize an area of ​​the brain, and / or otherwise provides better access to a target area. Disclosed herein are medical devices designed to provide improved access to areas of the body, including areas along the central nervous system and / or the brain. Also disclosed are methods for making and using such devices.

[0214] Figure 1Ais a stereoscopic view of a portion of an example medical device 10 for accessing the central nervous system. In this example, an example expandable access sheath 12 is depicted. Typically, the expandable access sheath 12 can be designed to be inserted into a body opening, cavity, etc., in order to provide access to a target area. For example, the expandable access sheath 12 can be designed to be inserted through an opening in the patient's head, through the skull and into the brain, in order to provide access to a target within the brain (e.g., a lesion, a clot, a tumor, etc.). In addition, because the expandable access sheath 12 is "expandable," the expandable access sheath 12 can be placed near a target site (e.g., within the brain) and expanded. When doing so, the expandable access sheath 12 can non-destructively push, move, and / or otherwise expand brain tissue adjacent to the target site, which can provide better access to the target site, visualization (e.g., including direct visualization by a clinician through the expandable access sheath 12), etc.

[0215] The expandable access sheath 12 can include a tubular body 14 having a proximal region 16 and a distal region 18. A hub or flange 20 can be disposed at the proximal region 16. The hub 20 can have a variety of shapes and / or configurations. In some cases, the hub 20 can include one or more openings 19 that can be used to secure the expandable access sheath 12 to another component of the medical device 10 and / or a portion of a medical device system (e.g., a system that includes the medical device 10). For example, the opening 19 can have a size or shape designed to engage a fastener or set screw (e.g., can include threads, a tapered or narrowed shape, etc.).

[0216] The tubular body 14 of the expandable access sheath 12 may include a sheath or sleeve 21. In some cases, the sleeve 21 may include a polymer or silicone material. The nature of the material of the sleeve 21 may be elastic and / or resilient, which may allow for appropriate expansion and / or contraction as needed without significant plastic deformation. Some examples of polymer materials that can be used for other components of the sleeve or sheath 12 are given below. Other materials may also be envisioned. One or more axial support members 22 may be arranged along the sleeve 21, connected to the sleeve 21 or embedded in the sleeve 21. The axial support member 22 may take the form of a rod or wire. The axial support member 22 may have a circular cross-sectional shape or a non-circular cross-sectional shape, for example, a rectangular, square or other polygonal shape. The expandable access sheath 12 may include 1, 2, 3, 4, 5, 6, 7, 8 or more axial support members 22. In some cases, 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 corners. In some cases, the axial support members 22 and struts 24 can be similar or otherwise form a stent-like lattice or configuration. Additionally, the sleeve 21 and / or one or more axial support members 22 can be made of and / or include an elastic and / or resilient and / or superelastic material that provides a biasing force to a closed configuration—e.g., as discussed below with respect to an example use of the sheath 12.

[0217] Figure 1B is a perspective view of a portion of another example medical device 110 for accessing the central nervous system. Example medical device 110 can be similar in form and function to medical device 10 such that attributes of device 10 can be applied to device 110 as appropriate. In this example, another example expandable access sheath 112 is depicted. Expandable access sheath 112 may include a tubular body 114 having a proximal region 116 and a distal region 118. A hub or flange 120 may be disposed at the proximal 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 sleeve 121. As in Figure 1A Unlike the expandable access sheath 12 depicted in , the expandable access sheath 112 may lack struts (e.g., similar to struts 24) extending between axial support members 122. Additionally, the sleeve 121 and / or one or more axial support members 122 may be made of and / or include an elastic and / or resilient and / or superelastic material that provides a biasing force to a closed configuration—e.g., as discussed below with respect to the sheath 12.

[0218] Figure 1CThe expandable access sheath 12 is shown, as are some of the other components of the medical device 10. For example, the medical device can include an expansion member or assembly 25. In this example, the expansion member 25 can include a cannula 26 and / or a trocar 28. The cannula 26 can include a tubular body 30 having a proximal region 32 and a distal region 34. A hub 36 can be disposed in the proximal region 32. The hub 36 can include a flange region 38. The trocar 28 can include a body region 40 having a proximal region 42 and a distal region 44. The hub 46 can be disposed in the proximal region 42. A tip 48 can be disposed in the distal region 44. The tip 48 can have a tapered or atraumatic shape.

[0219] The expandable access sheath 12 can be designed to be in a first configuration (e.g., Figure 1A and Figure 1C as depicted in; for example, as in Figure 1B ) and a second or expanded form. In some cases, the expandable entry sheath 12 can be designed to be in the first form when in a natural state or when there is no tendency to expand the expandable entry sheath 12. In other words, the expandable entry sheath 12 can be understood to be biased into the first form. In at least some cases, the expandable entry sheath 12 can be described as "collapsible" because the expandable entry sheath 12 can return or convert back to the first form from the expanded form when the expansion force / mechanism is removed from the expanded entry sheath 12. In some embodiments, the properties of the material of the sleeve 21 can be elastic and / or resilient and / or may be superelastic, and can provide a biasing force toward the collapsed form of the sleeve. For example, at rest, the sleeve 21 can be biased to the collapsed form, but can be expanded to the expanded form with some force. However, when the expansion force is removed, the elastic and / or resilient properties of the sleeve 21 will allow it to return to the collapsed form. The material of the sleeve 21 can allow for appropriate expansion and / or contraction as needed without significant plastic deformation. In some embodiments, one or more axial support members 22 and / or struts 24 can also be made of and / or include a material that is elastic and / or resilient and / or may be superelastic in nature and can provide the necessary biasing force to the collapsed configuration - in combination with and / or as a substitute for the material of the sleeve 21.

[0220] In at least some cases, the expandable access sheath 12 can be converted to the expanded configuration by advancing the expansion member 25 or otherwise disposing the expansion member 25 within the expandable access sheath 12, such as Figure 1DFor example, converting the expandable access sheath to the expanded configuration may include placing only the cannula 26 within the expandable access sheath 12, placing 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 cases, the trocar 28 may be removed from the expandable access sheath 12, such as in Figure 1E , thereby leaving only cannula 26 within expandable access sheath 12. In at least some cases, cannula 26 may be sufficient to maintain expandable access sheath 12 in the expanded configuration.

[0221] exist Figure 1F A cross-sectional view of the expandable access sheath 12 is shown in . Here, the cannula 21, the axial support member 22, and the cannula 26 can be seen. In this example, the axial support member 22 is arranged along the inner surface of the cannula 21. However, other configurations (e.g., embedded, outer surface, etc.) can also be envisioned. In at least some cases, the axial support member 22 can provide axial support to the cannula 21 (and / or generally the expandable access sheath 12) during navigation, expansion, and use. This can include an axial support member 22 that helps to greatly reduce the possibility of the cannula 21 shortening during expansion. For example, the axial support member 22 can be understood to substantially fix the length of the cannula 21 (and / or generally the expandable access sheath 12). In some aspects, the axial support member 22 can serve to maintain the generally fixed length of the sheath 12, even during radial expansion and / or contraction of the sheath 12.

[0222] Figures 2A to 2D Another example medical device 210 is shown, which can be similar in form and function to other medical devices disclosed herein. The medical device 210 can include an expandable access sheath 212. The expandable access sheath 212 can include a tubular body 214 having a proximal region 216 and a distal region 218. The tubular body 214 of the expandable access sheath 212 can include a sheath or sleeve 221. One or more axial support members 222 can be disposed along the sleeve 221, coupled to the sleeve 221, or embedded in the sleeve 221.

[0223] The expansion mechanism and / or member 225 can be disposed at or otherwise coupled to the proximal region 216. The expansion member 225 can be similar to or otherwise take the form of an iris mechanism and / or expansion device and / or valve. Iris mechanisms are generally known and are generally described as an adjustable mechanism of multiple blades that can be moved by rotational movement of a support member to change the diameter of the central opening formed by the blades. For example, the example iris expansion member 225 can include a ring member 250 and a top base 252. A groove or slot 253 can be formed in the ring member 250 (e.g., as in Figure 2B and 2D ). The expansion member 225 may also include a plurality of blade members 254. In this example, the blade members 254 are linked to the top base 252 by pins 255. A connecting rod 257 may extend between the ring member 250 and the blade members 254. Another pin 257 may extend between the ring member 250 and the top base 252. This is just one example of a possible configuration for the expansion member 225. A plurality of different iris mechanism types for the expansion member 225 may be envisioned. Some examples of these iris expansion structures that may be suitable for use as part of the expansion member 225 are disclosed in U.S. Patent No. 4,130,113, U.S. Patent No. 5,779,681, U.S. Patent Application Publication No. US 2011 / 0054405, and U.S. Patent Application Publication No. US 2014 / 0114138, the entire disclosures of which are incorporated herein by reference.

[0224] Figure 2B and 2D 2 is an end view from the distal region 218 of the expandable access sheath 212. It can be seen from these figures that rotation of the top base 252 relative to the ring member 250 can rotate or otherwise "open" the blade members 254, which can move the axial support members 222 radially outward and move the expandable access sheath 212 from the first configuration (e.g., as in Figure 2A ) to an expanded configuration (as depicted in Figures 2C to 2D). For example, rotation of the top base 252 relative to the ring member 250 exerts a force on the link 257 and causes the blade member 254 to rotate about the pin 255. When the blade member 254 rotates radially outward, the axial support member 222 also shifts radially outward, thereby converting the expandable access sheath 212 from the first form to the expanded form. It should be noted that the iris expansion device (e.g., the expansion member 225) can allow incremental changes in the expansion level of the expandable access sheath 12. Thus, the expansion member 225 can allow the expandable access sheath 212 to shift between the first form and the expanded form, and between multiple positions therebetween (e.g., essentially infinite positions). The expansion member may include a lock or other mechanism for maintaining the sheath 212 in a desired position. Additionally, as discussed above with respect to the sheath 12, the sleeve 221 and / or one or more axial support members 222 can be made of and / or include an elastic and / or resilient and / or superelastic material that can provide a biasing force to the closed form.

[0225] Figures 3A to 3D Another example medical device 310 is shown, which can be similar in form and function to other medical devices disclosed herein. The medical device 310 can include an expandable access sheath 312. The expandable access sheath 312 can include a tubular body 314 having a proximal region 316 and a distal region 318. A hub or flange 320 can be disposed in the proximal region 316. The tubular body 314 of the expandable access sheath 312 can include a sheath or sleeve 321. The sheath or sleeve 321 can be made of and / or include a material similar to the sheath or sleeve 21, 121, 221 discussed above and / or can have functions similar to the sheath or sleeve 21, 121, 221 discussed above. One or more axial support members 322 can be disposed along the sleeve 321, coupled to the sleeve 321, or embedded in the sleeve 321. One or more axial support members 322 can be made of and / or include materials similar to and / or can have functions similar to support members 22, 122, 222 as discussed above. In at least some cases, hub 320 can be defined by and / or attached to the proximal ends of axial support members 322. In this example, support member 322 includes an inwardly curved and / or arched region proximal to its proximal end.

[0226] The expansion mechanism and / or member 325 can be disposed at or otherwise coupled to the proximal region 316. In this example, the expansion member 325 can include a threaded actuation mechanism and / or bolt 356 having a threaded region 358. The threaded region 358 can be designed 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 can cause a distal region 362 of the mechanism and / or bolt 356 to engage an inwardly arched and / or curved region 364 of the axial support member 322. Because the axial support member 322 can be substantially rigid, the engagement of the distal region 362 of the actuation mechanism 356 and the curved region 364 can push or deflect the axial support member 322 radially outward (e.g., and cause the expandable access sheath 312 to shift toward the expanded configuration). Like the expansion member 225, the expansion member 325 can allow the expandable entry sheath 312 to be transferred between a first configuration and an expanded configuration, and between a plurality of positions (e.g., substantially infinite positions) therebetween. The expandable entry sheath 312 can be biased toward a first and / or collapsed configuration. For example, the axial support member 322 can be made of and / or include an elastic and / or resilient and / or superelastic material, and can include a shape, such as an inwardly arched and / or curved region, that will bias the sheath 312 into a first and / or collapsed configuration. The actuation member can provide a force to overcome the bias and force the sheath into the expanded configuration. When the actuation mechanism and / or bolt 356 is withdrawn and / or moved proximally, causing the distal region 362 to move proximally and separate from the inwardly arched and / or curved region 364, the entry sheath 312 can return to the first and / or collapsed configuration. In some embodiments, the sleeve 121 can be made of and / or include an elastic and / or resilient and / or possibly superelastic material that can provide a biasing force into a closed form - in lieu of and / or in addition to the bias of the axial support member 322.

[0227] Figures 4A to 4E Some examples of medical device system 400 and methods for using system 400 and / or medical device 10 and / or expandable access sheath 12 are shown. System 400 may include expandable access sheath 12 (and / or other expandable access sheaths disclosed herein). System 400 may also include expansion member 25 (e.g., which may include cannula 26 and / or trocar 28).

[0228] System 400 may also include a stylet 466. Stylet 466 may be an elongated tool for assisting navigation to a target within an anatomical structure and may assist other devices, such as placement and / or orientation of an entry sheath 12. Stylet 466 includes a distal shaft 468, a top member 470, and a proximal shaft 472. In some cases, top member 470 may include a camera or other type of imaging member. 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 stylet 466 to a desired position and / or orientation within an anatomical structure. For example, stylet may include and / or be used with an optical and / or electromagnetic tracking system. In such a system, stylet may include a series of markers and / or sensors 476 disposed on proximal shaft 472. These markers and / or sensors 476 are aligned relative to the position and / or orientation of top member 470. In the case of an example optical navigation system, marker 476 will be a passive / reflective optical marker, and the operating kit will include a series of cameras that detect the position and orientation of marker 476, which are then used to determine the position of tip 470. In the case of an example electromagnetic navigation system, sensor 476 will be an electromagnetic field sensor, and the operating kit will include one or more electromagnetic field generators. The position of the sensor will be determined relative to the electromagnetic field and thus provide the position of tip 470.

[0229] In some embodiments, the stylet may also include other markings and / or reference points, such as a visual marking, a marking detectable by magnetic resonance imaging, a marking detectable by optical coherence tomography, a marking detectable by fluoroscopy, or a marking detectable by another mechanism. In at least some cases, the marking 476 may be used to track, detect, and / or otherwise track the position of the stylet 466 (e.g., relative to the patient).

[0230] The system 400 may also include a device orientation assembly 478. The device orientation 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, inclination or angle and / or other orientation of 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 positioned at or near the opening 486. The locking member may be used to secure the expandable access sheath 12 to the device orientation assembly 478.

[0231] In use, the base 480 can be placed onto a properly prepared surface of the patient, such as along the head. The adjustable legs 482 and locking arms 484 can be used to orient the base 480 in a desired manner to guide the expandable access sheath 12 toward the target area (e.g., including a desired angle, height, etc.). The expandable access sheath 12 having the stylet 466 extending therethrough can be extended through the opening 486, such as Figure 4B and into the patient's body. When doing so, the guide needle 466 can be used to help locate the target. In some interventions, the distance from the device orientation component 478 can be different from the length of the expandable access sheath 12. In this case, the axial position of the expandable access sheath 12 can be adjusted by shifting the position of the adjustable legs relative to the base 480. This can raise or lower the expandable access sheath 12 within the anatomical structure and can help guide the expandable access sheath 12 to the desired depth within the brain.

[0232] When the target is reached, the stylet 466 can be removed. Figures 4C to 4D As depicted in FIG. 1 , the expansion member 25 can be disposed within the expandable access sheath 12. When doing so, the expandable access sheath 12 can be transformed into the expanded configuration. If desired, the trocar 280 can be removed, such as Figure 4E A suitable treatment device may be passed through the expandable access sheath 12 to treat the target area.

[0233] Figures 5A to 5D Some examples of medical device systems 500 and methods for using systems 500 and / or medical devices 10 and / or expandable access sheaths 12 are shown. System 500 can include expandable access sheath 12 (and / or other expandable access sheaths disclosed herein). System 500 can also include expansion member 25 (e.g., which can include cannula 26 and / or trocar 28). System 500 can also include stylet 466.

[0234] The system 500 may also include a device orientation assembly 578. The device orientation assembly 578 may include a base 580. A locking arm 584 may be coupled to the base 580. An adjustable member 590 may be coupled to the base 580. The adjustable member 590 may include an adjustment mechanism 592 designed to engage 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 may interlock and / or resemble a ratchet system. The base 580 may also include an actuator 596. The actuator 596 may take the form of a clampable arm or spring clip that allows the adjustment mechanism 594 on the base 580 to open, widen, and / or otherwise unlock. When doing so, the axial position of the adjustable member 590 may be shifted relative to the base 580. When the actuator 596 is released, the adjustment mechanism 594 on the base 580 can be closed, shortened, or otherwise locked so that the axial position of the adjustable member 590 can be 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 cases, the device orientation assembly 578 can also allow the expandable access sheath 12 to pivot (e.g., to change the angle of the expandable access sheath 12 relative to the patient).

[0235] In use, the base 580 can be placed on a properly prepared surface of the patient, such as along the head. The expandable access sheath 12 having the stylet 466 extending therethrough can be extended through the device orientation assembly 578, such as Figure 5B and into the patient's body. When doing so, the guide needle 466 can be used to help observe and / or locate the target. In some interventions, the distance from the device orientation component 578 can be different from the length of the expandable access sheath 12. In this case, the axial position of the expandable access sheath 12 can be adjusted by shifting the position of the adjustable member 590 relative to the base 580. This can help guide the expandable access sheath 12 to the desired depth within the brain.

[0236] The device orientation assembly 578 can be oriented relative to the patient's surface 588. When the target is reached, the stylet 466 can be removed. Figure 5C As depicted in FIG. 1 , the expansion member 25 can be disposed within the expandable access sheath 12. When doing so, the expandable access sheath 12 can be transferred to the expanded configuration. If desired, the trocar 280 can be removed, such as Figure 5D A suitable treatment device may be passed through the expandable access sheath 12 to treat the target area.

[0237] Fig. 6A610 is a stereogram of an example 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. disclosed herein. Typically, the expandable access port 610 may be used to access a target area 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 physician to access a brain region. It may be appropriate to describe the expandable access port 610 as an access sheath or other similar device. In some cases, the expandable access port 610 may include a base or housing 612. An expandable catheter 614 may be coupled to the housing 612. Typically, the expandable catheter 614 may be designed to convert between a first configuration and an expanded configuration. The first configuration may be suitable for navigating the expandable access port 610 toward a target area, such as along a region of the central nervous system. In some cases, the first configuration may be understood as a collapsed configuration, a partially collapsed configuration, or an unexpanded configuration. The expanded configuration is typically larger than the first configuration (e.g., the expandable catheter 614 has a larger diameter in the expanded configuration than in the first configuration). The expanded configuration can help open up the space around the expandable access port 610 to aid in visualization, diagnosis, provide access for another device, aid in the delivery of a drug or other active agent, etc.

[0238] The expandable conduit 614 may include a plurality of arms or tines 616. The tines 616 may be disposed circumferentially around the housing 612 to form or define the expandable conduit 614. The tines 616 may take the form of wires, bands, rods, etc. The expandable access port 610 may include a suitable number of tines 616. For example, the expandable access port 610 may include two, three, four, five, six, seven, eight, nine, ten, or more tines 616. In some cases, all of the tines 616 have the same shape, size, and / or configuration. In other words, in some cases, all of the tines 616 are identical. In other cases, the shape, size, and / or configuration of one or more of the tines may be different from other tines in the tines 616. In other words, in some cases, some of the tines 616 are different from other tines in the tines 616. In some cases, the tines 616 may be evenly spaced around the housing 612. Alternatively, the tines 616 may be unevenly spaced around the housing 612.

[0239] In some cases, the sleeve 618 can extend along the tines 616 and / or the expandable conduit 614. Of course, in some cases, the sleeve 618 can help define the expandable conduit 614 (e.g., together with the tines 616). The sleeve 618 can extend along the outer surface of the tines 616. In some cases, the sleeve 618 can extend to the distal end of the tines 616 and can be fixed to the distal end. In other cases, the sleeve 618 can wrap around the distal end of the tines 616 and along a portion of the inner surface of the tines 616. In these cases, the sleeve 618 can be fixed to the inner surface of the tines 616.

[0240] In some cases, sleeve 618 can be formed by elastomeric material or otherwise include elastomeric material. For example, sleeve 618 can include silicone, polyurethane, polytetrafluoroethylene, other materials such as disclosed herein, etc. and / or other suitable materials. In some cases, sleeve 618 can be described as compliant and / or fully elastic. In this case, sleeve 618 can be described as stretchable and can recover / return to the original unstressed shape when no longer exposed to stress. In other cases, sleeve 618 can be described as partially compliant and / or partially elastic. In this case, sleeve 618 can be stretched or partially stretched, and when stress is removed, sleeve 618 can partially recover the original unstressed shape. In other cases, sleeve 618 can be described as non-compliant and / or inelastic. In this case, sleeve 618 can be plastically deformed when subjected to stress exceeding a predetermined limit.

[0241] 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 cases, the first adjustment mechanism 620 may take the form of a set screw that fixes the stabilizing member 624 to the housing 612. The use of the set screw 620 may allow the stabilizing member 624 to be axially displaced (e.g., translated and / or otherwise raised or lowered) relative to the housing 612. Each of the stabilizing members 624 may be coupled to the housing with its own set screw 620, so that each stabilizing member 624 may be adjusted independently of one another. In this example, a plurality of stabilizing members 624 may be disposed around the housing 612. For example, one, two, three, four, five, six or more stabilizing members 624 may be disposed around 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 cases, the stabilizing member 624 may include a bend or elbow region. The stabilizing member 624 may also include a tissue contact region. Other variations may be envisioned. The stabilization member 624 can be designed to contact the patient and help stabilize the position of the expandable access port 610 relative to the patient.

[0242] In some cases, the second adjustment mechanism 622 can take the form of a set screw that adjusts the position of one of the tines 616. The use of the set screw 622 can allow one of the tines 616 to be displaced / pivoted, as described in more detail herein.

[0243] The actuation member 626 can be coupled to the housing 612. Generally, the actuation member 626 can be used to translate the expandable catheter 614 and / or the tines 616 between the first configuration and the expanded configuration. In some cases, the actuation member 626 takes the form of a nut that is designed to threadably engage the housing 612. Rotation of the actuation member 626 can translate the position (e.g., axial position) of the actuation member 626 along the housing 612. This movement / translation can cause the actuation member 626 to interact with the tines 616 in a manner that causes the tines 616 to shift / pivot (as described in more detail herein).

[0244] exist Fig. 6A 628. Other features of the expandable access port 610 are shown in FIG. 629. For example, the housing 612 can include a proximal region or flange 628. The housing 612 can have a proximal opening 630. The proximal opening 630 can be in fluid communication with the expandable catheter 614. In some cases, the proximal opening 630 can be shaped and / or configured to mechanically cooperate with another device designed to extend therethrough. For example, the proximal opening 630 can include one or more radial slots that allow another device to mechanically engage or "key" with the proximal region 628.

[0245] A nose cone 632 can be disposed at the distal end of the expandable catheter 614. Typically, the nose cone 632 can help form an atraumatic distal end for the expandable catheter 614. In some cases, the nose cone 632 can be coupled to one of the tines 616. In other cases, the nose cone 632 can be coupled to another portion or another structure of the expandable access port 610 for use with the expandable access port 610. The nose cone 632 can have a tapered distal region and / or a tapered proximal region. Such a shape can allow the expandable access port 610 to be advanced into the anatomical structure in a manner that reduces trauma.

[0246] Figure 6B 634 is a cross-sectional view of an example 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 designed to engage the threaded region 634 of the housing 612.

[0247] The plurality of tines 616 can be coupled to the housing 612 by a pivot member 638. In at least some cases, the pivot member 638 can take the form of a pivot pin. The pivot member 638 can allow the tines 616 to pivot so as to transition between the first configuration and the expanded configuration. In some cases, each of the plurality of tines 616 can have a proximal region 640 having an angled surface 642. The actuation member 626 can have a corresponding angled surface 644 designed to engage the angled surface 642 of the proximal region 640. Thus, when the actuation member 626 rotates and begins to translate along the housing 612, the angled surface 644 of the actuation member 626 can engage the angled surface 642 of the proximal region 640 of the tines 616. When doing so, the proximal region 640 of the tines 616 can be pushed radially inward toward the housing 612. In some cases, the housing 612 may include a plurality of slots formed therein that allow the proximal region 640 of the tine 616 to move further radially inward. When the proximal region 640 of the tine 616 is pushed radially inward, the distal region may be displaced radially outward due to the pivoting action of the tine 616 about the pivot member 638, as shown in FIG. Figures 6C to 6D . In some cases, more or less expansion of each of the tines 616 can be independently achieved using one of the second adjustment mechanisms (e.g., set screws) 622. When in the expanded configuration, the expandable catheter 614 can define a distal opening 648. In some cases, when the expandable catheter 614 is in the first configuration, the distal opening 648 can have the same size as or a smaller size than the proximal opening 630. In some of these cases and in other cases, when the expandable catheter 614 is in the expanded configuration, the distal opening 648 can have the same size as or a larger size than the proximal opening 630.

[0248] In some cases, the plurality of tines 616 can include a first tine 616'. The nose cone 632 can be coupled to the first tine 616'. For example, the first tine 616' can include a curved region 646, and the nose cone 632 can be coupled to the curved region 646. Thus, the shape of the first tine 616' can be different from at least one of the other tines 616. The arrangement of the nose cone 632 can be described as when the expandable catheter 614 is in a first configuration (e.g., as Figures 6A to 6B 614 is aligned with the central axis and / or longitudinal axis of the housing 612 when the housing 612 is in the expanded configuration (e.g., as depicted in FIG. 614 ). Figures 6C to 6D ), deviates from the central axis and / or longitudinal axis of the shell 612.

[0249] At least some of the tines 616 can include a gripping region 650. Generally, the gripping region 650 can be designed to secure the cannula 618 to the tines 616 and / or the expandable catheter 614. For example, the gripping region 650 can take the form of a slot or groove into which the cannula 618 can be inserted. In some cases, the sheath 618 can be secured to the gripping region 650 by crimping the gripping region 650. In other cases, the sheath 618 can be secured to the tines 616 in another manner, such as by adhesive bonding, heat bonding, suturing, etc., as desired.

[0250] As described above, moving the expandable catheter 614 and / or the tines 616 to or toward the expanded configuration may include actuating the actuation member 626. Additionally, the second adjustment mechanism 622 may be used to independently adjust one of the tines 616. For example, Fig. 6E The configuration of the expandable catheter 614 is shown, wherein a second adjustment mechanism 622 (e.g., one of the set screws 622) is adjusted to further adjust (e.g., further expand) one of the tines 616".

[0251] Fig. 6F 610. Here, many of the structural features of the expandable access port 610 can be seen from different angles. For example, one or more slots 615 can be seen in the housing 612. The slots 615 can allow the proximal region 640 to be further displaced radially inward relative to the housing 612, for example, when the actuation member 626 is rotated and translated along the housing 612.

[0252] Figures 7A to 7C A system for accessing a central nervous system 600 is shown. The system 600 may include an expandable access port 610 (e.g., Figures 6A to 6F ). In this example, the expandable access port 610 is shown with a stabilizing rod 652 that can be used to couple / secure the expandable access port 610 to a stabilizing system 654. Some example stabilizing systems that can be used with the stabilizing rod 652 can include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, and systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, etc. The stabilizing rod 652 can take the form of a rod or shaft that protrudes from the housing 612.

[0253] The system 600 can also include a retainer 656. The retainer 656 can include a tubular body 658 and a flange 660 disposed along the tubular body 658. Generally, the flange 660 can be designed to engage the proximal region 628 of the housing 612 and act as a stop that limits further movement of the retainer 656 into the expandable access sheath 610.

[0254] In some cases, the system 600 can also include a visual navigation probe 662. The visual navigation probe 662 can include a base 664. A shaft 666 can extend from the base 664. The shaft 666 can include a tip 668. The tip 668 can be a rounded tip, an angled tip, etc. One or more additional shafts 670 can extend from the base 664. The base 664 and / or the shaft 670 can include one or more visualization members 672.

[0255] The visual navigation probe 662 can be inserted into the holder 656, and the holder 656 can be inserted into the expandable access port 610. The system 600 can then be placed along the patient 674 and / or otherwise guided toward the target area, such as Figure 7B When properly positioned, the retainer 656 and the visual navigation probe 662 can be removed. The actuation member 626 can be actuated to displace the expandable catheter 614 to the expanded configuration, such as Figure 7C as shown in .

[0256] Figures 8A to 8C A system for accessing a central nervous system 700 is shown. The system 700 can include an expandable access port 710. The expandable access port 710 can be similar in form and function to other access ports disclosed herein. In this example, the expandable access port 710 is shown as having a stabilization rod 752, which can be used to couple / secure the expandable access port 710 to a stabilization system 754. Some example stabilization systems that can be used with the stabilization rod 752 can include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, and systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, and others. Also, in this example, the expandable access port 710 can be without a nose cone. Reference Fig. 9 Some additional discussion regarding expandable access port 710 may be found herein.

[0257] The system 700 may also include a retainer 756. The retainer 756 may include a tubular body 758 and a flange 760 disposed along the tubular body 758. In some cases, a set screw 780 may be disposed along the tubular body 758. As described above, the expandable access port 710 may lack a nose cone. In this case, the retainer 756 may include a shaft 776 extending from the tubular body 758; and a nose cone 778, which may be coupled to the shaft 776. The shaft 776 and the nose cone 778 may be designed so that the retainer 756 can be inserted into the expandable access port 710, and when fully inserted, the nose cone 778 can be disposed at the distal end of the expandable access sheath 710. In some cases, the nose cone 778 may have a generally non-invasive shape. For example, the nose cone 778 may include a tapered proximal region and / or a tapered distal region. This can allow the nose cone 778 to be more easily inserted into and through the expandable access sheath 710 and / or more easily removed from the expandable access sheath 710. When doing so, the expandable access sheath 710 can be partially expanded or bent when allowing the nose cone 778 to pass therethrough. In addition, the nose cone 778 (and / or the retainer 756, generally) can be inserted into or removed from the expandable access sheath 710 without the need to shift the expandable catheter 714 to an expanded configuration.

[0258] 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 the shaft 770 may include one or more visualization members 772. The visual navigation probe 762 may be inserted into the retainer 756, and the retainer 756 may be inserted into the expandable access port 710. The system 700 may then be placed along the patient 774 and / or otherwise guided toward a target area, such as a. Figure 8B The retainer 756 and the visual navigation probe 762 can be removed. The actuation member 726 can be actuated to displace the expandable catheter 714 to the expanded configuration, as shown in FIG. Figure 8C as shown in .

[0259] Fig. 9An expandable access port 710 is shown. The expandable access port 710 can include many of the structural features of the expandable access port 610. For example, the expandable access port 710 can include a housing 712 and an expandable catheter 714 coupled to the housing 712. The expandable catheter 714 can include a plurality of tines 716. A sleeve 718 can be disposed along the tines 716. The housing 712 can include a flange area 728 and a distal opening 730. An actuation member 726 can be coupled to the housing 712 and can function similarly to the actuation member 626. An adjustment mechanism 722 can be coupled to the housing 712.

[0260] As described above, the expandable access port 710 can lack a nose cone and, in at least some cases, can be used with another device, such as a retainer 756 (e.g., which includes a nose cone 778). Because the expandable access port 710 can lack a nose cone, all of the tines 716 can be substantially similar. Alternatively, one or more of the tines 716 can be different from other tines in the tines 716.

[0261] In some cases, the housing may lack a first adjustment mechanism (e.g., set screw 620) coupled to a stabilizing member (e.g., stabilizing member 624), and / or lack a stabilizing member similar to stabilizing member 624. Instead, a stabilizing rod 752 may be coupled to the housing 712 and radially protrude from it. Stabilizing rod 752 may be used to fix the expandable access port 710 to the stabilizing system. Some example stabilizing systems that can be used with stabilizing rod 752 may include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, and systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, etc. The form of stabilizing rod 752 may vary. In some cases, a stabilizing rod similar to stabilizing rod 752 may be used with the expandable access port 610.

[0262] Figures 10 to 15 An expandable access port 810 is shown that may be similar in form and function to other access ports / sheaths disclosed herein (e.g., expandable access port 810 may also be described as expandable access sheath 810). Expandable access port 810 may include a housing 812 and an expandable catheter 814 coupled to the housing 812. Expandable catheter 814 may include a plurality of tines 816. A sleeve 818 may be disposed along the tines 816. The housing 812 may include a cap 828 and a distal opening 830. An actuation member 826 may be coupled to the housing 812 and may function similarly to other actuation members disclosed herein to cause the expandable catheter to be in a first configuration (e.g., as Fig.10 ) and a second or expanded configuration (e.g., as Fig.11 ) between the two.

[0263] One or more adjustment mechanisms, for example, a first adjustment mechanism 822a and a second adjustment mechanism 822b can be coupled to the cap 828. The form of the first adjustment mechanism 822a, the second adjustment mechanism 822b, or both can vary. For example, in some cases, the first adjustment mechanism 822a can include a threaded leg 882, which can be used to adjust the position of the expandable access port 810 relative to the patient. The first adjustment mechanism 822a can also include a stabilizing rod 852, which can be used to connect / fix the expandable access port 810 to a stabilizing system (not shown). Some example stabilizing systems that can be used with the stabilizing rod 852 can include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, and systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, etc. The second adjustment mechanism 822b can include one or more threaded legs 882, which can be 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 legs 882, a single stabilizing rod 852, two or more stabilizing rods 852, no stabilizing rod 852, and the like.

[0264] Figures 12 to 13 An expandable access port 810 is shown having a first adjustment mechanism 822a and a second adjustment mechanism 822b that are separate from a cap 828. Here, it can be seen that the cap 828 may include a first attachment area 883a and a second attachment area 883b. In at least some cases, the first attachment area 883a and the second attachment area 883b allow various adjustment mechanisms to be releasably coupled thereto. For example, the first attachment area 883a and / or the second attachment area 883b can take the form of a flange that is designed to have an adjustment mechanism (e.g., the first adjustment mechanism 822a, the second adjustment mechanism 822b, or both) that is releasably attached to the cap 828. The adjustment mechanism 822a / 822b may include a spring release attachment / detachment mechanism that includes a spring or elastic member 833 and a lever member 835, such as Fig.14A . In some cases, the resilient member 833 can take the form of an O-ring that acts as or is similar to a spring to depress the lever member 835 (e.g., so that the adjustment mechanism 822a / 822b can be fixedly attached to the attachment 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 to or detached from the attachment area 883a / 883b as needed.

[0265] 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 cases, the type of adjustment mechanism can be selected to best suit the needs of a particular intervention. For example, the first adjustment mechanism 822a can be attached to the first attachment area 883a, such as Fig.14 In this example, the adjustment mechanism is not attached to the second attachment area 883b. Further illustrating the variability of the adjustment mechanism that can be envisioned, Fig.15 Another adjustment mechanism 822a' is shown attached to the cap 828 (eg, the first attachment area 883a) of the expandable access port 810. In this example, the adjustment mechanism 822a' includes a stabilizing rod 852 but does not include a set screw. Other variations are contemplated.

[0266] Figures 16 to 17 A system 800 is shown that includes an expandable access port 810 with a retainer 856. The retainer 856 can include a tubular body 858 and a flange 860 disposed along the tubular body 858. In some cases, a nut or clamping area 880 can be disposed along the tubular body 858. The retainer 856 can include a shaft 876 that extends from the tubular body 858; and a nose cone 878 that can be coupled to the shaft 876. The shaft 876 and the nose cone 878 can be designed so that the retainer 856 can be inserted into the expandable access port 810, and when fully inserted, the nose cone 878 can be disposed at the distal end of the expandable access port 810. In some cases, the nose cone 878 can have a generally non-invasive shape. For example, the nose cone 878 can include a tapered proximal region and / or a tapered distal region. This can allow the nose cone 878 to be more easily inserted into and through the expandable access port 810 and / or more easily removed from the expandable access port 810. When doing so, the expandable access port 810 can be partially expanded or bent when allowing the nose cone 878 to pass therethrough. In addition, the nose cone 878 (and / or the retainer 856, generally) can be inserted into or removed from the expandable access port 810 without the need to shift the expandable catheter 814 to the expanded configuration.

[0267] Materials that can be used for the various components of the medical device 10 (and / or other medical devices / systems disclosed herein) may include those associated with the medical device. For simplicity, the following discussion refers to the medical device 10. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other similar medical devices and / or systems disclosed herein.

[0268] The medical device 10 can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those commercially available from DuPont ), polyamide (e.g., available from Bayer Or available from Elf Atochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, available under the trade name commercially available), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS)), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc., thereof. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0269] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0270] In at least some embodiments, some or all of the medical device 10 may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopic screen or with another imaging technique during a medical procedure. This relatively bright image helps the user of the medical device 10 determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device 10 to achieve the same results.

[0271] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device 10. For example, the medical device 10 or portions thereof may be made of a material that does not substantially distort the image and create a number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in the MRI image. The medical device 10 or portions thereof may also be made of a material that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g. UNS: R30035, such as etc.), Nitinol, etc.

[0272] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly matters of shape, size, and arrangement of steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. An expandable access port comprising: a housing having an expandable catheter coupled thereto, the expandable catheter comprising a plurality of tines and a cannula coupled to the plurality of tines; an actuation member coupled to the housing, the actuation member configured to transition the expandable catheter between a first configuration and an expanded configuration; a cap coupled to the housing, the cap including an attachment region designed to have an adjustment mechanism releasably attached thereto; An adjustment mechanism releasably coupled to the attachment region is configured to adjust a position of the expandable access port relative to a patient, the adjustment mechanism comprising a resilient member and a lever member for releasably coupling the adjustment mechanism directly to one of the one or more attachment regions.

2. The expandable access port of claim 1, wherein the adjustment mechanism comprises threaded legs.

3. The expandable access port of claim 1, wherein the adjustment mechanism comprises a stabilization rod.

4. The expandable access port of any one of claims 1 to 3, wherein the cap further comprises a second attachment region, and further comprising a second adjustment mechanism releasably attached to the second attachment region.

5. A system for accessing the central nervous system, the system comprising: An expandable access port, the expandable access port comprising: a housing having a plurality of tines coupled thereto, the plurality of tines including a first tine, the housing further comprising a cap having an attachment area, and an actuation member coupled to the housing, the actuation member configured to transition the plurality of tines between a first configuration and an expanded configuration; an adjustment mechanism releasably coupled to the attachment region, comprising a resilient member and a lever member, the adjustment mechanism configured to adjust a position of the expandable access port relative to a patient; and A retainer, the retainer being designed to extend through the housing, the retainer comprising: Tubular base, a shaft extending from the tubular base, and Attach to the shaft is a nose cone. The system of claim 5 , wherein the housing includes a threaded region.

7. The system of claim 6, wherein the actuation member comprises a nut threadably engaged with the threaded region.

8. The system of any one of claims 5 to 7, wherein at least one of the plurality of tines is secured to the housing with a pivot member.

9. The system of claim 8, wherein the pivot member comprises a pivot pin.

10. The system of any one of claims 5 to 7, wherein at least one of the plurality of tines comprises a proximal region having an angled surface.

11. The system of claim 10, wherein the actuation member includes an actuation surface designed to engage the angled surface.

12. The system of any one of claims 5 to 7, further comprising a sleeve extending along at least some of the plurality of tines.

13. The system of any one of claims 5 to 7, wherein the housing defines a central axis and wherein the nose cone is aligned with the central axis when the plurality of tines are in the first configuration.

14. The system of any one of claims 5 to 7, further comprising one or more stabilizing members coupled to the housing.

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