Patent Application
20120193255
The embodiments presented herein relate generally to medical devices with elongate shafts, and more particularly, to packaging that facilitates flushing of the elongate shaft.
A catheter is a medical device that may be inserted into a body structure to deliver fluids from an external source to an internal body structure. A catheter generally comprises a flexible shaft extending longitudinally from a proximal end to a distal end and often includes a hub at the proximal end for the connection of other devices or fluid conduits. Catheters, such as microcatheters, designed to thread deep into smaller body structures (e.g., the vascular system, the biliary tree, etc.) are often especially long to enable them to pass through other devices and a succession of vessels to reach target smaller vessels. Such smaller catheters are often more delicate and must be carefully packaged to prevent damage thereto.
Catheter packaging may includes a long tubular structure designed to house a length of the catheter shaft therein. The tubular structure may take a variety of different shapes such as for example, straight, curved or hooped. Portions of the tubular structure may be fixed to one another such that the tubular element is retained in a particular shape, which may be determined, for example, by the length of the catheter. Some catheters may require hydration and/or activation of a coating prior to use which necessitates flushing the catheter with fluid. For example, the catheter may be treated with a hydrophillic coating which provides lubrication to facilitate insertion when activated by water, saline or body fluid. However, current catheter packaging often does not facilitate effective flushing of fluid along an entire packaged length of the catheter.
The embodiments described herein are directed to packaging for a medical device such as a catheter that facilitates flushing of the packaged length of the catheter. The packaging comprises a longitudinal element defining a first lumen sized and shaped to receive therein a shaft of an elongate medical device such as a catheter with a desired clearance around an outer diameter of the shaft of the medical device. The length of the longitudinal element can be selected to receive a preferred packaged length of the shaft of the elongate medical device extending distally from a hub at a proximal end thereof. The packaging further comprises a connector attached to the proximal end of the longitudinal element. The connector, which may be a Y- or T-shaped connector, a manifold, or the like, includes a first branch defining therein a second lumen open to a proximal end of the first lumen and extending substantially along a longitudinal axis of the longitudinal element and a second branch defining therein a third lumen open to the second lumen and extending away from the longitudinal axis at a predetermined angle. A proximal end of the first branch including a structure configured to mate with a corresponding feature on a distal end of a housing or hub of the medical device to be received in the packaging to form a substantially fluid tight connection therebetween such that fluid introduced into the third lumen is prevented from exiting the proximal end of the second lumen and is forced move distally through the first lumen to the distal end of the longitudinal element without exiting from the distal end.
In one embodiment, the hub may act as a handle for maneuvering the elongate shaft of the medical device. The hub includes laterally extending wings with opposing contours. The contours of the wings allow operator fingers to interface with the wings to facilitate handling and rotation in the clockwise or counterclockwise directions.
In another embodiment, the medical device includes a strain relief member coupled to the elongate shaft and the hub. The strain relief member comprises a helical coil or spring that is covered by a polymeric tube. The tube is formed over the coil in a way that fills in the spaces between the coils resulting in the formation of multiple hinge points.
Other systems, methods, features and advantages will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the devices, systems and methods described herein, and be protected by the accompanying claims.
The figures provided herein are not necessarily drawn to scale, with some components and features being exaggerated for clarity. Each of the figures diagrammatically illustrates aspects of the embodiments.
a and 4b show opposing side views of the hub of
a show partial detail views of the medical device in
It should be noted that elements of similar structures or functions are generally represented by like reference numerals for illustrative purpose throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the preferred embodiments.
The embodiments provided herein may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The embodiments provided herein relate to medical device packaging. In particular, exemplary embodiments described herein include a catheter and a packaging interface which allows fluid to be flushed along an enclosed length of the catheter within the packaging. Specifically, exemplary embodiments described herein include a connector attached to a packaging that is coupleable with a hub of a catheter and creates a fluid path through the packaging that is biased by flow dynamics.
As shown in
The longitudinal element 106 of the packaging 102 is also preferably flexible permitting the longitudinal element 106 to be maintained in any of a variety of shapes and/or configurations. For example, in the embodiment shown, the longitudinal element 106 is maintained in a hoop configuration with a length of the longitudinal element 106 coiled upon itself permitting a greater length of the longitudinal element 106 to be accommodated in a reduced space facilitating storage and/or transport. It will also be understood by those of skill in the art that the longitudinal element 106 may be maintained in any configuration, so long as the longitudinal element 106 accommodates a predetermined packaged length of the flexible shaft 116. In instances where the flexible shaft 116 does not include a curved distal end, the packaged length may include the entire length of the flexible shaft 116. In instances where the flexible shaft 116 includes a curved distal end, the packaged length may include a predetermined length that is less than the entire length of the flexible shaft 116.
The Y-connector 108, which is attached to the proximal end 110 of the longitudinal element 106, includes, as shown in
It will be understood by those of skill in the art that the flexible shaft 116 may be of a variety of lengths and diameters so long as the flexible shaft 116 is insertable into the body. The length and the diameter or cross-sectional dimensions of the flexible shaft 116 may be selected depending on a purpose of the catheter 104 and a target location to which the flexible shaft 116 will be inserted. For example, where catheter 104 is a microcatheter, the flexible shaft 116 may be very long and of a small diameter in order to intravascularly access the target location. It will also be understood by those of skill in the art that the lumen 122 of the flexible shaft 116 may be sized to track over a guidewire for insertion into the body of a patient.
As shown in
In an exemplary embodiment, a configuration of the body 148 of the catheter hub 118 facilitates handling, tracking and manipulation of the device during clinical procedure. The body 148 preferably includes contoured wings 147 and 149 extending outwardly from the channel 124. As depicted in
The hub 118 further includes a mating element 130 at a distal end 150 of the body 148, coupleable with the Y-connector 108 to form an at least partially fluid tight connection. The distal mating element 130 may include, for example, a protrusion insertable into the proximal end 136 of the Y-connector 108. Thus, it will be understood by those of skill in the art that the diameter of the distal mating element 130 may be substantially similar to or only slightly smaller than a diameter of the lumen 140 at the distal end 136 of the Y-connector 108 so that when the hub 118 and the Y-connector 108 are coupled, the coupling produces a tight fit. It will also be understood by those of skill in the art that the distal mating element 130 may further include a feature facilitating removable coupling of the distal mating element 130 with the proximal end 136 of the Y-connector 108. For example, the distal mating element 130 may further include a protrusion 144 extending around at least a portion of a perimeter of the distal element 130 which snaps into a correspondingly shaped recess or groove 146 in the lumen 140 of the Y-connector 108. The distal element 130 may be removed from the Y-connector 108 by exerting a pulling force on either the hub 118 and/or the Y-connector 108. It will be understood by those of skill in the art, however, that the hub 118 and the Y-connector 108 may include any mating mechanism so long as the hub 118 and the Y-connector 108 are detachably coupleable in an at least partially or near fluid tight connection.
This connection forms an obstruction or “choke” preventing fluid from leaking out of the Y-connector 108 proximally toward the proximal end 120 of the shaft 116, urging fluid inserted into the port 135 through the Y-connector 108 distally along a length of the longitudinal element 106. Thus, once the hub 118 and the Y-connector 108 have been coupled, a user may inject fluid (e.g., water or saline) into the Y-connector via the port 135 of the second portion 134 passing the fluid through the lumen 142 into the lumen 140 and distally into the lumen 114 along the length of the longitudinal element 106 flushing the full length of the enclosed flexible shaft 116.
According to a further embodiment, as shown in
An o-ring 162 or other compressible protrusion may be positioned distally about the periphery of the second portion 134 along the first portion 132 such that the second element 160 abuts the O-ring 162. Additionally, the o-ring 162 ensures compression of the hub 118 and the Y-connector 108 while allowing for tolerance ranges between the hub 118, the Y-connector 108 and the retention clip 152. A length of the retention clip 152 is preferably selected to be substantially similar to a distance from the proximal end 128 of the body 148 of the hub 118 to a point distal of the second portion 134 of the Y-connector 108 when the hub 118 and the Y-connector are in the coupled configuration. Thus, it will be understood by those of skill in the art that the o-ring 162 may be positioned according to the length of the retention clip 152 to achieve a desired compression between the hub 118 and the Y-connector 108. The compression between the hub 118 and the Y-connector 108, formed by the retention clip 152 prevents the coupling between the hub 118 and the Y-connector 108 from becoming unintentionally detached during the flushing process.
Turning to
Once the jacket 216 is formed over the coil 220, the strain relief member or sub-assembly 210 is placed over the proximal end of the catheter shaft 202. A proximal end 212 of the strain relief sub-assembly 210 is coupled to the catheter shaft 202 and the distal element 207 of the hub 204 and the distal end 214 of the strain relief sub-assembly 210 is coupled to the catheter shaft 202. Coupling of the proximal end 212 of the strain relief sub-assembly 210 to the catheter shaft 202 and distal element 207 of the hub 204 is preferably done either through insert molding or adhesive bonding. Transfer of the rotational force from the hub 204 to the shaft 202 is enabled by attaching both ends 212 and 214 of the strain relief sub-assembly 210, and the transfer of rotation is further enhanced by the presence of the coil 220 in the jacket 216.
The primary function of relieving stress at the point of attachment of the shaft 202 to the hub 204 is maintained by the configuration of the strain relief sub-assembly 210. Stress relief is enhanced by the formation of the “hinge points” 212 between the coils of the coil 220.
In alternative embodiments shown in
Alternatively, the entire length of the strain relief sub-assembly 210 could be attached to the outside of the catheter shaft 202 by thermally melting the materials together or via adhesive bonding.
It will be apparent to those skilled in the art that various modifications and variations can be made in the structure and the methodology of the present invention, without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
