The present disclosure relates to medical devices and methods, particularly for the storage of guidewires suitable for use in various medical procedures and for the introduction of these guidewires into the proximal hubs of catheters.
The following references may be of interest: U.S. Publication Nos. 2014/0259821, 2014/0171833, 2013/0292365, and 2012/0227751 and U.S. Pat. Nos. 8,679,065, 8,480,597, 7,886,906, 7,144,402, 6,047,825, 5,830,183, 5,279,573, 4,707,906, and D329698.
The present disclosure relates to medical devices and methods, particularly for the storage of guidewires suitable for use in various medical procedures. During a medical procedure, for example, guidewires may be coiled and temporarily stored in one or more fluid-filled bowls. In many medical procedures, a single guidewire is used or multiple guidewires may be used concurrently. In such procedures, one or multiple guidewires may be stored between re-use during the same procedure in a coiled configuration where the stiff end of the guidewire is looped under the coiled guidewire loops to secure the loops. However, this technique may often fail as the loops can uncoil spontaneously or can be uncoiled when a medical practitioner attempts to identify and retrieve a specific guidewire from the bowl. With one or more of the coiled wires becoming uncoiled, the guidewire(s) may unravel, straighten, and spontaneously spring out of the sterile fluid filled bowl, becoming potentially contaminated and contaminating the sterile environment. In at least some cases, particularly in a small and crowded fluid filled storage bowl, a medical practitioner may confuse one guidewire with another. Such confusion may be problematic where one guidewire suitable for one application becomes used in a different application. Disclosed herein are devices and methods to temporarily store guidewires in an improved manner so as to address some of these disadvantages.
Aspects of the present disclosure provide color-coded and markable clamps for maintaining a guidewire in a coiled configuration when placed in a storage bowl. Clamps with different coloring and/or different markings made thereon may be used with different guidewires of various diameters and/or design or performance characteristics. The different clamps can help a medical practitioner quickly and easily identify and differentiate between different guidewires in a multi-wire environment.
Aspects of the present disclosure may provide a method of storing one or more guidewires. A guidewire may be wrapped into a coiled configuration. In the coiled configuration, the guidewire may have a coiled portion and a free end portion. The free end portion may comprise a stiff end of the guidewire. The free end portion may be wrapped under the coiled portion. A color-coded, markable clamp may be placed over the free end portions and/or a part of the coiled portion. The clamp may maintain the guidewire in the coiled configuration. The guidewire and clamp placed thereover may be placed in a fluid-filled storage bowl. The method may be repeated for a second or further guidewire to be placed in the same or different storage bowl. To distinguish the guidewires, the second or further clamp may have a different color than the first guidewire or may be marked in a different manner. In some embodiments, the first and/or second portion or jaw of the clamp may comprise an introducer shaped as a funnel. The funnel may lead to a straight guidewire lumen which leads to a tip tapered on the outside. The tip may be coupled to the hub of a catheter for the introduction of shaped tipped or other guidewires into the inner lumen of the catheter. The first, second, or other guidewire may have a diameter matching the color coding, marking, or labelling of the clamp; and, the lumen of the funnel of the clamp may have a diameter matching that of the guidewire. In this manner, a guidewire of a preselected size can be stored and introduced to a catheter with the same clamp or clamp structure. Further, a grasping mechanism may be actuated to secure the first guidewire relative to the funnel structure of the first clamp to allow the entire structure to function as a guidewire torque device or torquer.
Aspects of the present disclosure may also provide a clamp for facilitating guidewire storage. The clamp may comprise a first portion, a second portion, and a pivotable portion therebetween. The first and second portions may be folded or pivoted relative to one another about the pivotable portion to open or close the clamp. The first and second portions may comprise upper surfaces which may approximate or come into contact with one another when the clamp is closed. The upper surface of one or more of the first or second portions may comprise surface features to facilitate the capture of the guidewire. For example, the upper surfaces may comprise teeth or be ridged. Alternatively or in combination, the upper surfaces may comprise a high friction material or coating such as rubber, latex, teflon, silicone, or other polymer. The material or coating may be compliant to minimize any damage that may occur to the guidewire as it is clamped. The material and/or coating may be colored and/or may be markable such as with a pen or marker. Where a coating is used, the clamp upper or lower portions may comprise a core made of a harder material such as hardened rubber, silicone, or other polymer. Alternatively, the clamp may be in a single, integral piece made of the high friction and/or compliant material.
The clamp may further comprise a first end coupled to the first portion and a second end opposite the first end and coupled to the second portion. The first and second ends may be removably coupled to one another. For example, the first and second ends may form a latch mechanism. The first end may comprise one or more teeth to capture the second end when the first and second portions are folded or pivoted relative to one another to close the clamp. These teeth may be de-coupled from the second end so that the first and second portions can be folded or pivoted relative to one another to open the clamp. Alternatively or in combination, the first end may have a series of apertures or openings to capture the second end.
The clamp may further comprise a guidewire introducer coupled to one or more of the first or second portions. The guidewire introducer may be removably coupled to a main body of the clamp. The guidewire introducer may have a guidewire lumen, an open proximal funnel end to receive a guidewire and direct it into the guidewire lumen, and a distal tapered tip to couple with a proximal hub of a catheter. The guidewire introducer may further comprise a grasping mechanism to secure the guidewire received in the guidewire lumen.
Aspects of the present disclosure may also provide a kit for facilitating guidewire storage. The kit may include a first clamp and a second clamp. The clamps may be as described as above. The first clamp may have a first color and the second clamp may have a second color different from the first color. One or more of the first or second clamps may be markable. The kit may further include a storage bowl for the guidewires and a set of instructions. One or more of the first or second clamps may comprise a funnel structure integral with its first or second portion or jaw. The funnel structure may have a tip configured to be coupled to a hub of a catheter of the same internal diameter as marked or indicated by the respective clamp. The funnel structure may further comprise a grasper mechanism to secure a guidewire received in the funnel structure. Alternatively or in combination, the funnel structure may be a separate device to be removably coupled to the main body of the one or more clamps.
All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the present disclosure are set forth with particularity in the appended claims. It should be noted that the drawings are not to scale and are intended only as an aid in conjunction with the explanations in the following detailed description. In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which:
In some embodiments, the guidewire clamp 100 may lack teeth for the top and/or bottom jaw. The guidewire clamp 100 may be made of various materials, such as a soft rubber, teflon, or other polymers. The entire guidewire clamp 100 may be made of a single material or of a combination of various materials. The guidewire clamp 100 may be color coded and/or comprise a markable surface for identification. A plurality of the guidwire clamps 100 may be provided in a kit, where different guidewire clamps of the kit for different diameter guidewires may have different colors. In some embodiments, the clamp 100 may further comprise an integral guidewire introducer lumen or funnel with a diameter matching that of the guidewire the clamp 100 is color coded or marked to identify. In some embodiments, the clamp 100 may further comprise an integral guidewire torque device or torquer as a part of the guidewire introducer lumen or funnel.
The guidewire clamp 100 as in
The individual introducer and introducer/torquer components can be an integral part of the guidewire clamp device 100 (
Also provided may be assemblies and components to grasp a guidewire GW in the introducer devices 300, allowing them to also function as a torquer. Various assemblies and components in various combinations are described below. Such components may include: a screw assembly to compress the jaws, jaws compressible by a screw mechanism, a slider compression assembly which may press against a thin walled compressible elastic memory dilator or an elastic memory membrane (either or both of which may be a metal or a synthetic plastic) to grab the guidewire, by a slider compression assembly, or a thin walled compressible elastic memory dilator which may be pressed against the guidewire by a slider compression assembly. This dilator may be packaged already inserted into the funnel component of the guidewire clamp device, or packaged separately to be better protected until use, when it is slipped into the guidewire lumen of the guidewire clamp device. It may be held securely in place by a ridge that snaps into a corresponding grove in the introducer body. The introducer device 300 may have various cross-sectional shapes such as circular, ovoid, rectangular, square, or triangular, to name a few.
Referring now to
Referring to
Referring to
While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit of the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application is a divisional of U.S. application Ser. No. 15/005,210, filed Jan. 25, 2016, which claims the benefit of U.S. Provisional Application Nos. 62/140,138, filed Mar. 30, 2015, 62/121,695, filed Feb. 27, 2015 and 62/107,962, filed Jan. 26, 2015, the contents of which are fully incorporated herein by reference.
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Number | Date | Country | |
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Parent | 15005210 | Jan 2016 | US |
Child | 15632805 | US |