The present invention pertains to intravascular devices such as catheters and apparatuses and methods for visual and electronic identification thereof.
The present invention relates to the field of catheterization of lumens within the human body, particularly lumens in the cerebral, peripheral and heart vasculature. The invention has application to guide, diagnostic, drug delivery, balloon and other therapeutic catheters.
Many medical procedures involve the insertion of one or more catheters into a lumen of a living body. These catheters usually include a luer hub and/or a manifold at the proximal end for grasping and for providing interfaces with other devices. These luer hubs and manifolds can be transparent and clear to be able to see any undesirable air bubbles. This clarity along with necessary size restrictions makes it difficult to provide all the desired information on the luer hub or manifold in a manner that can be easily and efficiently read. Thus is there an ongoing need for alternative catheter designs and manufacturing processes.
One embodiment pertains to a catheter having a transparent catheter hub having wings at least a portion of which are substantially opaque. Information such as product information can be legibly marked on the substantially opaque portion with laser-marking or other technique. A radio-frequency identification (RFID) microchip may be disposed in the substantially opaque portion of the wings or other suitable part of the catheter hub.
Another embodiment pertains to a method of making such a catheter in which a transparent hub body portion is provided where the body portion extends at least partially into the hub wings and where a substantially opaque material is overmolded to form the hub wings or to snap-fit to the hub wings.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures and Detailed Description which follow more particularly exemplify these embodiments.
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
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.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
Catheter 10 is a simple single lumen catheter with a simple hub design; it should not be thought, however, that the invention is so limited to this example embodiment. Embodiments of the invention may be included in a wide variety of catheters including multi-lumen catheters and catheters having a hub with multiple ports and one or more wings or catheters having manifolds or other hub-likes structures. Features not specifically discussed herein such as shaft construction, strain relief or luer port design or methods of use should not be considered limiting. For example, a contemplated embodiment of the invention is a balloon catheter where a hub has an inflation port and a guidewire port, each connected by a separate hub lumen to a separate shaft lumen.
Hub body 16 has a lumen 24 extending therethrough fluidly connected to the lumen of shaft 12 and is transparent along substantially the whole length of lumen 24 to allow for visual inspection. Wings 18 extend along the longitudinal axis of the hub to permit orientation and identification of the catheter.
Wings 18 include an opaque portion to permit catheter information to be legibly marked thereon. Such information (not depicted in the Figure) may be printed, laser-marked or marked using some other suitable technique and may include product name, pertinent characteristics such as length or outer diameter, product part number, serial number, manufacturing or use-by date, one- or two-dimensional bar codes or other desired information. Further, the opaque portion may be made from a polymer of a particular color where the color is selected to correspond to a pertinent characteristic of the catheter such as length, outer diameter or lumen diameter.
In addition or as an alternative to the visual display of information on the hub, an RFID (radio frequency identification) microchip may be disposed in the hub. Such a chip can hold much more information about the catheter than could be legibly printed on the surface of the hub and can be easily read by an electronic device and displayed. The electronic device, by reading the RFID microchip, puts the information into an electronic form that can be leveraged by computer and interconnectivity technologies. For example, current information about the product, such as devices currently compatible with the catheter, product recall or warning information, or detailed instructions for use can be displayed in a timely manner for the user. The RFID information can also be easily added to the electronic record of the procedure.
One example method of making such a catheter is illustrated by reference to
Another example method of making such a catheter is illustrated by reference to
Other example methods of producing such a catheter include the following. An opaque identification insert may be affixed to a wing by adhesive or thermal bonding, heat staking, or other suitable technique. In another embodiment, two opaque portions may be joined by adhesion or a snap fit or the like over a body portion of a wing. In another embodiment, opaque wings may be produced separately from the catheter body and affixed by adhesive or thermal bonding methods.
An RFID chip may be installed into any of the above catheter configurations by any suitable technique. In one technique, illustrated in
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.