Patent Description:
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 one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.

<CIT> shows a medical device for accessing the central nervous system. The device includes an expandable access sheath having a proximal end region and a distal end region. The expandable access sheath is designed to shift between a first configuration and an expanded configuration. The expandable access sheath includes a tubular body having one or more axial support members disposed along the tubular body. The medical device also includes an expansion member designed to shift the expandable access sheath between the first configuration and the expanded configuration. <CIT> relates to a trocar especially designed for thoracic surgery. <CIT> shows a surgical access system including an access port device. <CIT> shows a radially expandable trocar, port or cannula system provided for use in minimally invasive surgeries. <CIT> discloses a retractor for percutaneous surgery in a patient.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An expandable access port is disclosed. The expandable access port comprises: a housing having a plurality of tines coupled thereto; a thrust washer disposed along the housing; and an actuation member coupled to the housing, the actuation member being designed to shift the plurality of tines between a first configuration and an expanded configuration.

Alternatively or additionally to any of the embodiments above, the plurality of tines include a first tine having a proximal end region with an angled surface.

The thrust washer includes a cutout region configured to engage the proximal end region.

Alternatively or additionally to any of the embodiments above, the actuation member includes an actuation surface designed to engage the angled surface.

Alternatively or additionally to any of the embodiments above, the thrust washer is disposed between the housing and the actuation member.

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

Alternatively or additionally to any of the embodiments above, the actuation member includes a nut threadably engaged with the threaded region.

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

Alternatively or additionally to any of the embodiments above, the sleeve includes a biocompatible elastomer.

Alternatively or additionally to any of the embodiments above, the sleeve is capable of elongating up to <NUM>-<NUM>%.

Alternatively or additionally to any of the embodiments above, the sleeve is capable of elongating up to <NUM>%.

An expandable access port is disclosed. The expandable access port comprises: a housing having a plurality of tines coupled thereto; a sleeve extending along at least some of the plurality of tines; wherein the sleeve includes a biocompatible elastomer; and an actuation member coupled to the housing, the actuation member being designed to shift the plurality of tines between a first configuration and an expanded configuration.

Alternatively or additionally to any of the embodiments above, further comprising a thrust washer disposed along the housing.

An expandable access port is disclosed. The expandable access port comprises: a housing having a plurality of tines coupled thereto and having a threaded region; an actuation nut coupled to the threaded region, the actuation nut being designed to shift the plurality of tines between a first configuration and an expanded configuration; a thrust washer disposed between the housing and the actuation nut; and a sleeve extending along at least some of the plurality of tines, the sleeve including a biocompatible elastomer.

Alternatively or additionally to any of the embodiments above, the actuation nut includes an actuation surface designed to engage the angled surface.

A system is disclosed. The system comprises an expandable access port including a housing having a plurality of tines coupled thereto, a thrust washer disposed along the housing, an actuation member coupled to the housing, the actuation member being designed to shift the plurality of tines between a first configuration and an expanded configuration. The system also includes an obturator including a shaft and nose cone, and a guide having a lumen configured to receive the obturator, the guide configured to mate with the housing.

On the contrary, the invention is defined by the appended claims.

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 the target side. For example, accessing a clot within the brain may require navigating a treatment device through regions of the brain. This may require relatively delicate traversal through brain tissue. It may be desirable to access regions of the brain in a manner that reduces trauma to the brain tissue, increases the ability to image/visualize regions of the brain, and/or otherwise provides better access to a target region. Disclosed herein are medical devices that are designed to provide improved access to body regions including regions along the central nervous system and/or the brain. Also disclosed are methods for making and using such devices.

<FIG> is a perspective view of a portion of an example expandable access port or sheath <NUM> for accessing the central nervous system. The expandable access port <NUM> may include a housing <NUM> and an expandable conduit <NUM> coupled to the housing <NUM>. In general, the expandable conduit <NUM> may be designed to be inserted into a body opening, cavity, or the like in order to provide access to a target region. For example, the expandable conduit <NUM> may be designed to be inserted through an opening in the head of a patient, through the skull, and into the brain so as to provide access to a target (e.g., a lesion, clot, tumor, or the like, etc.) within the brain. Furthermore, due to the expandable conduit <NUM> being "expandable", the expandable conduit 14can be placed near a target site (e.g., within the brain) and expanded. When doing so, the expandable conduit <NUM> may atraumatically push, move, and/or otherwise expand brain tissue adjacent to the target site, which may provide for better access, visualization (e.g. including direct visualization by a clinician through the expandable conduit <NUM>), etc. of the target site.

The expandable access port <NUM> may include a number of structural features. For example, the expandable conduit <NUM> may include a plurality of tines <NUM>. A sleeve <NUM> may be disposed along the tines <NUM>. In some instances, the sleeve <NUM> may include an elastomeric material and/or a biocompatible elastomer. For example, the sleeve <NUM> may include a thermoplastic rubber elastomer such as CHRONOPRENE (e.g., such as CHRONOPRENE 5A, commercially available from AdvanSource Biomaterials, Wilmington, MA). In some instances, the sleeve <NUM> may be capable of elongating up to about <NUM>-<NUM>%, or up to about <NUM>-<NUM>%, or up to about <NUM>%. Furthermore, in some instances the sleeve <NUM> may be substantially resistant to tearing or hole propagation. Thus, if the sleeve <NUM> is elongated up to about <NUM>%, a relatively small hole poked through the sleeve <NUM> will resist tearing at the hole and/or propagation at the hole.

The housing <NUM> may include a cap <NUM> and a distal opening <NUM>. An actuation member <NUM> may be coupled to the housing <NUM>. The actuation member <NUM> may be used to shift the expandable conduit <NUM> between a first configuration (e.g., as shown in <FIG>) and a second or expanded configuration (e.g., as shown in <FIG>). In this example, the actuation member <NUM> takes the form of a nut. The nut <NUM> can be rotated about threads along the housing <NUM>. When doing so, the nut <NUM> engages the tines <NUM> in order to shift the tines <NUM> (e.g., and the expandable conduit <NUM>) between the first and second configurations.

One or more adjustment mechanisms, for example a first adjustment mechanism 22a and a second adjustment mechanism 22b, may be coupled to the cap <NUM>. The form of the first adjustment mechanism 22a, the second adjustment mechanism 22b, or both may vary. For example, in some instances the first adjustment mechanism 22a may include a threaded leg <NUM> that may be used to adjust the position of the expandable access port <NUM> relative to the patient. The first adjustment mechanism 22a may also include a stabilizing bar <NUM>, which may be used to couple/secure the expandable access port <NUM> to a stabilizing system (not shown). Some example stabilizing systems that may be used with the stabilizing bar <NUM> may include those manufactured by INTEGRA, MIZUHO, TEDAN SURGICAL, as well as systems including GREENBERG, BUDDE, SUGITA, FUKUSHIMA, and the like. The second adjustment mechanism 22b may include one or more threaded legs <NUM> that may be used to adjust the position of the expandable access port <NUM> relative to the patient. Other adjustment mechanisms are contemplated that include a single threaded leg <NUM>, two or more threaded legs <NUM>, lack a threaded leg <NUM>, a single stabilizing bar <NUM>, two more stabilizing bars <NUM>, lack a stabilizing bar <NUM>, and the like.

<FIG> illustrates a portion of the expandable access port <NUM>. In this view, the actuation member <NUM> is removed so that the threaded region <NUM> of the housing <NUM> can be seen. In addition, <FIG> also illustrates that a thrust washer <NUM> may be disposed along the housing <NUM>. The thrust washer <NUM> is generally disposed between the actuation member <NUM> and the housing <NUM> and is designed to help reduce sliding forces so that the actuation member <NUM> can be rotated easily. The thrust washer <NUM> includes a cutout region <NUM>. A proximal end region <NUM> of the tines <NUM> (e.g., having an angled surface <NUM>) is disposed within and/or otherwise engaged with the cutout region <NUM>. A portion <NUM> of the cutout region <NUM> may also help to secure the thrust washer <NUM> in place by engaging a section <NUM> of the housing <NUM> between adjacent tines <NUM>.

<FIG> illustrates a cross-section of the actuation member <NUM> with the thrust washer <NUM>.

<FIG> illustrates a portion of the expandable access port <NUM>. Here it can be seen that at the distal ends <NUM> of the tines <NUM> may include a crimp region <NUM>. An end portion <NUM> of the sleeve <NUM> may engage the crimp region <NUM>. For example, the end portion <NUM> may be inserted into the crimp region <NUM> and the crimp region <NUM> may be crimped. This may help to secure the sleeve <NUM> to the tines <NUM>.

<FIG> illustrates the expandable access port <NUM> with the first adjustment mechanism 22a and the second adjustment mechanism 22b detached from the cap <NUM>. Here it can be seen that the cap <NUM> may include a first attachment region 83a and a second attachment region 83b. In at least some instances, the first attachment region 83a and the second attachment region 83b allow for a variety of adjustment mechanisms to be releasably coupled thereto. For example, the first attachment region 83a and/or the second attachment region 83b may take the form of a flange designed to have an adjustment mechanism (e.g., the first adjustment mechanism 22a, the second adjustment mechanism 22b, or both) releasably attached to the cap <NUM>. The adjustment mechanisms 22a/22b may include spring-release attachment/detachment mechanism including a spring or elastic member <NUM> and a lever member <NUM> as shown in <FIG>. In some instances, the elastic member <NUM> takes the form of an O-ring that is used as or like a spring to hold down the lever member <NUM> (e.g., so that adjustment mechanisms 22a/22b can be securely attached to the attachment regions 83a/83b). The lever member <NUM> can be depressed to enlarge or otherwise expand the elastic member <NUM>. This allows the adjustment mechanisms 22a/22b to easily be securely attached/detached from the attachment regions 83a/83b, as desired.

In use, a clinician may choose to attach a suitable number of adjustment mechanisms to the cap <NUM> (e.g., the first attachment region 83a and/or the second attachment region 83b). The form or type of adjustment mechanism may vary and, in at least some instances, the type of adjustment mechanism may be selected in order to best suit the needs of a particular intervention. For example, the first adjustment mechanism 22a may be attached to the first attachment region 83a as shown in <FIG>. In this example, an adjustment mechanism is not attached to the second attachment region 83b. Further illustrating the variability of the adjustment mechanisms contemplated, <FIG> illustrates another adjustment mechanism 22a' attached to the cap <NUM> (e.g., the first attachment region 83a) of the expandable access port <NUM>. In this example, the adjustment mechanism 22a' includes the stabilizing bar <NUM> but does not include a set screw. Other variations are contemplated.

<FIG> illustrates a system <NUM> that includes the expandable access port <NUM> along with a holder <NUM>. The holder <NUM> may include a tubular body <NUM> and a flange <NUM> disposed along the tubular body <NUM>. In some instances, a nut or grip region <NUM> may be disposed along the tubular body <NUM>. The holder <NUM> may include a shaft <NUM> extending from the tubular body <NUM> and a nose cone <NUM> may be coupled to the shaft <NUM>. The shaft <NUM> and the nose cone <NUM> may be designed so that the holder <NUM> can be inserted into the expandable access port <NUM> and, when fully inserted, the nose cone <NUM> may be disposed at the distal end of the expandable access port <NUM>. In some instances, the nose cone <NUM> may have a generally atraumatic shape. For example, the nose cone <NUM> may include a tapered proximal end region and/or a tapered distal end region. This may allow the nose cone <NUM> to more easily be inserted into and through the expandable access port <NUM> and/or more easily removed from the expandable access port <NUM>. When doing so, the expandable access port <NUM> may partially expand or flex while allowing the nose cone <NUM> to pass therethrough. Furthermore, the nose cone <NUM> (and/or the holder <NUM>, in general) can be inserted into or removed from the expandable access port <NUM> without having to shift the expandable conduit <NUM> to the expanded configuration.

<FIG> illustrate an alternate holder <NUM> that may be used with the expandable access port <NUM> described herein. As shown in <FIG>, the holder <NUM> may include an obturator <NUM> and guide <NUM>. The obturator <NUM> may include a lock <NUM> coupled to the proximal end. The lock <NUM> may have an opening <NUM> in its distal end face. The obturator <NUM> may have an opening or window <NUM> extending completely through the obturator <NUM> transverse to a longitudinal axis x-x. The window <NUM> may allow for a visual confirmation that a pointer tip (not shown) is fully seated within the obturator <NUM>. The obturator <NUM> may have a tapered distal shaft <NUM> and a nose cone <NUM>. In some examples, the obturator <NUM>, including the distal shaft <NUM> and nose cone <NUM>, may be a single monolithic element. As shown in <FIG>, the lock <NUM> may be coupled to the obturator <NUM> via a threaded connection. The proximal end of the obturator <NUM> may have external threading <NUM> that mates with internal threading (<NUM>; see <FIG>) on the lock <NUM>. The guide <NUM> and obturator <NUM> may be separate elements with the obturator <NUM> being insertable into a lumen in the guide <NUM>. The guide <NUM> may be configured to mate with the access port <NUM>. As shown in the cross-section in <FIG>, the opening <NUM> in the lock <NUM> is in communication with a lumen <NUM> extending partially through the obturator <NUM>, from the proximal end and connecting with the window <NUM>. In some examples, the window <NUM> is offset from the distal end of the nose cone <NUM> by about <NUM> to <NUM>, for example <NUM>. In some examples, an O-ring <NUM> may be positioned within the proximal end of the lumen <NUM> of the obturator <NUM>, to compress and secure a pointer shaft (not shown).

The shaft <NUM> and the nose cone <NUM> may be designed so that the holder <NUM> can be inserted into the expandable access port <NUM> and, when fully inserted, the nose cone <NUM> may be disposed at the distal end of the expandable access port <NUM>. In some instances, the nose cone <NUM> may have a generally atraumatic shape. For example, the nose cone <NUM> may include a tapered proximal end region and/or a tapered distal end region. In some examples, the nose cone <NUM> may have a diameter of <NUM> to <NUM>, for example <NUM>. This may allow the nose cone <NUM> to more easily be inserted into and through the expandable access port <NUM> and/or more easily removed from the expandable access port <NUM>. When doing so, the expandable access port <NUM> may partially expand or flex while allowing the nose cone <NUM> to pass therethrough. Furthermore, the nose cone <NUM> (and/or the holder <NUM>, in general) can be inserted into or removed from the expandable access port <NUM> without having to shift the expandable conduit <NUM> to the expanded configuration.

The materials that can be used for the various components of the expandable access port <NUM> may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the expandable access port <NUM>. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar medical devices and/or system disclosed herein.

The expandable access port <NUM> may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), 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, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

Claim 1:
An expandable access port (<NUM>), comprising:
a housing (<NUM>) having a plurality of tines (<NUM>) coupled thereto;
a thrust washer (<NUM>) disposed along the housing, the thrust washer having cutout regions (<NUM>), each cutout region (<NUM>) configured to engage a proximal end region (<NUM>) of one of each of the plurality of tines; and
an actuation member (<NUM>) coupled to the housing, the actuation member being designed to shift the plurality of tines between a first configuration and an expanded configuration.