The invention relates to retaining devices and, more specifically, retaining devices for securing medical wires, catheters, guidewires, electrical lines, cables, tubing and other elongated members during medical procedures.
Guidewires and catheters are used in a variety of different medical procedures, for example, during angiographic, endovascular, or surgical procedures. Guidewires arc typically used to position catheters in a body lumen, for example arteries, veins or natural orifices within a mammal. The leading end portion of the guidewire is typically introduced into the body through an incision or natural orifice and then advanced to the treatment area. A catheter can be threaded over the guidewire, and advanced over the guidewire to the treatment area. A single guidewire can be used to deliver multiple catheters to the treatment area within the body lumen. This is normally accomplished by withdrawing and removing the first catheter from the wire while leaving the leading edge of the wire in place within the body lumen, and then threading a second catheter over the wire and advancing down to the treatment site. Multiple guidewires and catheters can be inserted into the body lumen at the same time.
When the guidewire or a guidewire and catheter combination is placed within the body lumen, a loose trailing end portion extends out of the patient from the entry point. This trailing end portion can be difficult to manage and requires special attention from the medical staff to ensure it does not become contaminated, tangled or confused with other wires in the procedural area.
Therefore, a device and method for retaining the trailing end of guidewires and catheters is desired.
Accordingly, this invention is directed towards a retention device and method of using the same that substantially obviates one or more of the problems due to limitations and disadvantages of the related art.
An advantage of the invention is to provide an apparatus to securely retain a medical wire to a medical surface while providing ease of loading and removal of the medical wire from the apparatus.
Another advantage of the invention is to provide a simple and secure mechanism for attaching an apparatus to a medical surface.
Additional features and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described, an aspect of the invention is directed towards a retaining device for retaining at least one medical line adjacent a supporting surface. The retaining device includes a flexible body having a top and bottom surface with at least one nonlinear slot formed in top surface and extending to a depth greater than a diameter of the medical line that the retaining device is configured to be used with. An attachment mechanism is coupled to the body and secured to a supportive surface.
Yet another aspect of the invention is directed towards a retaining device for securing a medical line to a substrate, which includes a flexible body having a top surface, a bottom surface, a side surface, and at least one slot is formed in a top surface of the flexible body. The least one slot extends into the flexible body to a distance greater than a diameter of the medical line. An attachment mechanism is coupled to a bottom surface of the flexible body configured to secure the base portion to a substrate.
Still yet another aspect of the invention is directed towards a retaining device to secure a medical line to a substrate. This method includes attaching a retaining device to the substrate, deforming an opening of at least one slot, and arranging a portion of the medical line in this deformed slot to secure the portion of the medical line.
Yet another aspect of the invention is directed towards a medical kit. The medical kit includes a retaining device which has an attachment mechanism coupled to this retaining device and instructions for use. The kit may also include a secondary device, such as, catheter, stent, or other medical device.
It is to be understood that both the foregoing general description and the following detailed description arc exemplary and explanatory and arc intended to provide further explanation of the invention as claimed.
The accompanying drawings, which are included to provide further understanding of the invention, are incorporated in and constitute a part of this specification. They illustrate embodiments of the invention and together with the description serve to explain the principles of the invention.
In the drawings:
An aspect of the invention is directed towards retaining devices and, more specifically, to retaining devices for securing a medical line. The expression “medical line” is used herein to include all kinds of elongated members used during medical procedures, e.g., medical wires, catheters, guidewires, electrical lines, cables, tubing and other elongated members.
In one embodiment, the invention relates to a retaining device for retaining at least one medical line adjacent to a supporting surface. The retaining device includes a flexible body having a top and bottom surface with at least one nonlinear slot formed in the top surface and extending to a depth greater than a diameter of the medical line that the retaining device is configured to be used with. An attachment mechanism is coupled to the body to secure the body to a supportive surface.
In one embodiment, a retaining device for securing a medical line to a substrate includes a flexible body having a top surface, a bottom surface, a side surface, and at least one slot is formed in a top surface of the flexible body. This one slot extends into the flexible body to a distance greater than a diameter of the medical line. An attachment mechanism is coupled to a bottom surface of the flexible body configured to secure the base portion to a substrate.
In one embodiment, a method of using a retaining device to secure a medical line to a substrate includes attaching a retaining device to the substrate, deforming an opening of the at least one slot, and arranging a portion of the medical line in this deformed slot to secure the portion of the medical line.
In one embodiment, a medical kit includes a retaining device which has an attachment mechanism coupled to this retaining device and instructions for use. The kit may also include a secondary device, such as, catheter, stent, or other medical device.
In one embodiment, the flexible body includes a wedge-type shape, however, any geometric shape may be used, such as a square, rectangle, circle, partial sphere, sphere and/or combinations of the same may be used. The flexible body is deformable and constructed from polymer elastomers such as silicone rubber, natural rubber, thermoplastic elastomers and polymer foams such as silicone foams, polyurethane foams, neoprene, and polyolefin foams, and EVA foams.
In one embodiment, the at least one slot includes a plurality of slots. For example, 2 to 10 slots or more. The slot may have a nonlinear configuration to aid with securing the medical line, e.g., a sinusoidal, s-shape and the like. The slot may have constant or variable width as it extends into the flexible body. In a preferred embodiment, the width is configured to be larger than the diameter of the medical wire to be retained. In one embodiment, slot can be a cut slit having a smaller width than the slot may also be used, such as, about 0 inches to about 0.02 inches. In one embodiment, the slot has a “v” shaped opening at or near the top surface to aid in receiving the medical wire. The end portion of the slot may also be angled or curled compared to another portion of the slot, e.g., J shaped end portion.
The at least one slot or slit is configured to extend into the flexible body to a depth greater than a diameter of the medical line that the retaining device is configured to be used with. The slots or slits may also extend into the flexible body at different depths, e.g., a first slot may extend to a first depth and a second slot may extend to a second depth where the first depth is greater than the second depth. Any of the slots may have a tapered configuration, e.g., being wider at one end compared to the other end.
In one embodiment, the at least one slot extends into the flexible body at an angle in a range from about 5 degrees to about 90 degrees measured relative to the top surface. The angle of each slot may be the same or different then the angle of another slot. In a preferred embodiment, the angle is about 80 degrees to about 100 degrees.
In one embodiment, the flexible body includes at least one slot arranged in the side surface extending into the flexible body and in communication with the at least one slot extending from the top surface. In a preferred embodiment, the width of this side slot is greater than the width of the top slot. The side slot can be any geometric shape, e.g., square, rectangular, circular, elliptical, hook shaped, combinations of the same and the like.
In one embodiment, at least one of the slots has a distinguishing marking or color.
In one embodiment, a rigid or semi-rigid plate shaped device is attached to at least a side of the body and covers a portion of the at least one slot. This device is configured to secure the medical line in the at least one slot. The plate may also be able to rotate, thereby locking the medical wire into the slot.
In one embodiment, the attachment mechanism includes a pressure sensitive adhesive secured to the bottom surface of the flexible body.
In one embodiment, the attachment mechanism includes at least one plate shaped structure coupled to a bottom surface of the flexible body. The plate shape structure includes at least one movable tab cut out of a portion shaped structure. The at least one movable tab may include any type geometry, e.g., trapezoidal, square, triangle, angled edges, rectangle, pentagon, hexagon, and/or combinations of the same. In a preferred embodiment, the tab includes three sides. A void or cut out portion remains in the plate shaped structure.
In one embodiment, the attachment mechanism may include a slot mechanism as described with reference towards U.S. Pat. No. 7,229,051, which is hereby incorporated by reference as if fully set forth herein.
In one embodiment, the attachment mechanism may be a securing device as described in U.S. Pat. No. 1,389,304, which is hereby incorporated by reference as if fully set forth herein.
Reference will now be made in detail to an embodiment of the present invention, example of which is illustrated in the accompanying drawings.
As shown in the drawings, medical line retaining device 10 generally includes a flexible body with top and bottom surfaces containing at least one nonlinear slot 11 formed in the top surface. The device may include an attachment mechanism 12 coupled to the body for attaching the retaining device to a substrate. As shown in
The slots 11 are dimensioned smaller than the medical line 14 and in a preferred embodiment have a v-shaped opening where they meet the top surface to facilitate entry of the medical line 14 in the slot. In this embodiment the perimeter surface of the body is elliptical shaped and substantially perpendicular to the bottom surface. The perimeter surface may be any geometric configuration. The attachment mechanism 12 is a pressure sensitive adhesive attached to the bottom surface with a protective liner 13 over the adhesive. Other attachment mechanisms may be used. For example, retaining device 10 could be attached to a heavy, draping pad such as a mouse pad. Mouse pads are typically made with flexible, heavy polymers such as rubber, neoprene rubber, silicone, and silicone foam. A mouse pad holds to a surface without sliding due to weight, a large contacting surface area, a textured contacting surface area, and high coefficient of friction of the before mentioned materials. Alternatively, retaining device 10 could be a unitary structure with sufficient weight and surface area to hold it to the surface without sliding.
In use, a protective liner 13 is removed from pressure sensitive adhesive 12 and retaining device 10 is attached to a supportive substrate, such as a surgical drape, surgical table, bed sheet or the like, via the adhesive material. Medical line 14 is pressed into slot 11 by inserting it into the upper most section of the slot 11 first and then guiding and pulling slightly into the remainder of the slot. During insertion, the flexible material surrounding the slots moves or is deformed to accept the medical line 14, and then forms around the medical line 14 to retain it within the device 10. Retention occurs both by mechanical and/or frictional mechanisms. Mechanical mechanism is due to the body material physically surrounding the medical line 14 and preventing it from moving out of the slot 11. Frictional forces come from at least two sources, the body material pressing into the medical line 14, and the straightening force of the medical line 14 pressing into the curves of the slot 11. To remove, the medical line 14 is simply pulled upward at a force exceeding the mechanical and frictional forces holding the line in the medical slot 11.
In use, the medical line 14 is pressed into the slits 11 and moved to the bottom of the slits, the straightening force of the line 14 will cause the line to move into slots 15, thereby providing additional retention to secure line 14 into retaining device 10.
In this embodiment, the attachment mechanism 12 is attached to the bottom surface and extends out one side of the device 10. The attachment mechanism 12 is configured to secure the retaining device 10 to a substrate, e.g., table, bed sheet, a medical drape, gown and the like. The attachment mechanism 12 includes a plate shaped structure overlapping and attached to the bottom surface by an adhesive or other suitable fixing unit, e.g., screw, rivet, and the like. In this embodiment, it is configured to extend from a perimeter of the retaining device 10 and has an integral rectangular or square tab 16 removed from the plate shaped structure extending from the perimeter.
The tab 16 has three sides and a bend on the remaining side connected to attachment mechanism 12 and angled up from the plate structure top surface. Below the bent tab 12 is a rectangular or square orifice 17 in the attachment mechanism 12 approximately the same size as the tab. The tab may have at least one protrusion for aiding securement to the substrate, e.g., a barb. Other types of attachment mechanisms may also be used.
Referring now to
Referring to
The medical devices 14 shown in
Without intending to limit the scope of the invention, the following examples illustrate how various embodiments of invention may be made and/or used.
In this example, a retaining device similar to
The SolidWorks file was saved as a .STL file format and used by stereolithography software to generate information needed to produce 3D models on stereolithography machines. The file was sent to Morpheous Prototypes of Torrence, CA to create a mold by Stereolithography and casting the part. After forming, the mold surface was sanded and polished. A two-part RTV silicone rubber having a 25A durometer was mixed and poured into the mold, allowed to cure for 24 hours and then removed from the mold. The resulting device weighed 0.4 lbs and had a base surface area of 7.7 in.
The inventions and methods described herein can be viewed as a whole, or as a number of separate inventions that can be used independently or mixed and matched as desired. All inventions, steps, processes, devices, and methods described herein can be mixed and matched as desired. All previously described features, functions, or inventions described herein or by reference may be mixed and matched as desired.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover all of the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
This application is a divisional of U.S. patent application Ser. No. 13/367,206, filed Feb. 6, 2012, which claims the benefit under U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/447,219, filed on Feb. 28, 2011, each of these applications are incorporated by reference for all purposes as if fully set forth herein.
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20190275304 A1 | Sep 2019 | US |
Number | Date | Country | |
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61447219 | Feb 2011 | US |
Number | Date | Country | |
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Parent | 13367206 | Feb 2012 | US |
Child | 16422266 | US |