Medical Line Retaining Device and Method of Using the Same

Abstract

The invention is directed towards a retaining device for retaining at least one medical line. The retaining device includes a flexible body having a top and bottom surface with at least one slot formed in the top surface. The at least one slot extends to a depth greater than the largest medical line the retaining device is destined to be used with. An attachment mechanism is coupled to the flexible body for securing the flexible body to a supportive surface.

Claims

1.-20. (canceled)

21. A method of using a retaining device to secure a medical device to a substrate during a medical procedure, comprising the steps of: providing a retaining device wherein the retaining device comprises a flexible elliptical shaped body comprises a flexible material having a top surface, a bottom surface, a first side surface region substantially perpendicular to the bottom surface and the top surface, a second side surface region substantially perpendicular to the bottom surface and the top surface, the first side surface region spaced apart from the second side surface region, a first slot arranged in a top surface of the flexible elliptical shaped body extending from the first side surface region to the second side surface region, and a second slot arranged in a top surface of the flexible elliptical shaped body extending from the first side surface region to the second side surface region, wherein the first slot has a starting point and an end point relative to the top surface, the starting point starts on a top surface of the flexible elliptical shaped body and extends to the end point and the end point terminates directly adjacent to an interior portion of the flexible elliptical shaped body and the first slot extends from a first side surface region to the second side surface region, the first slot comprises a non-linear slot in an S type shape relative to the top surface, wherein the second slot has a starting point and an end point relative to the top surface, the starting point starts on a top surface of the flexible elliptical shaped body and extends to the end point and the end point terminates directly adjacent to an interior portion of the flexible elliptical shaped body and the second slot extends from a first side surface region to the second side surface region, the second slot comprises a non-linear slot in an S type shape relative to the top surface; attaching a retaining device to the substrate; deforming an opening of one or more of the first slot and the second slot; and arranging a portion of the medical line in the one or more of the deformed first slot or the deformed second slot in order to secure at least the portion of the medical device in the deformed first slot or the deformed second slot.

22. The method of claim 21, wherein the medical device comprises at least one of a medical wire, a guide wire, a catheter, an electrical line, a cable, and a medical tubing.

23. The method of claim 21, wherein the first side slot and the second slot each have a slot width that is smaller than the diameter of the medical device.

24. The method of claim 21, wherein the flexible elliptical shaped body comprises a material selected from the group consisting of a polymer material, an elastomer material, a foam material, a rubber material, and combinations thereof.

25. The method of claim 21, wherein at least one of the first slot and the second slot has an end portion comprising a J type shape.

26. The method of claim 21, wherein the substrate is selected from the group consisting of a table, a drape, a sheet, and a gown.

27. A method of using a retaining device to secure a medical device to a substrate, comprising the steps of: providing a retaining device, the retaining device comprising a flexible elliptical shaped body having a concave top surface, a flat bottom surface, a side surface substantially perpendicular to the bottom surface and the top surface, and at least two slots in a top surface of the flexible elliptical shaped body, wherein each of the two slots extend from the top surface towards a bottom surface and terminate at an end point within the flexible elliptical shaped body, wherein each of the two slots extend at an angle from about 80 degrees to about 100 degrees relative to the top surface and to a distance greater than a diameter of the medical device, and wherein each slot has a substantially constant width; deforming an opening of one or more of the first slot and the second slot; and arranging a portion of the medical device in the one or more of the deformed first slot or the deformed second slot in order to secure at least the portion of the medical device in the deformed first slot or the deformed second slot.

28. The method of claim 27, further comprising the step of attaching the retaining device to a substrate with an attachment mechanism.

29. The method of claim 28, wherein the attachment mechanism comprises a rectangular base plate coupled to a bottom surface of the flexible elliptical shaped body.

30. The method of claim 27, wherein the first slot and the second slot are color coded.

31. The method of claim 23, wherein the flexible elliptical shaped body comprises a weight greater than about 0.2 lbs.

32. The method of claim 23, wherein the medical device comprises at least one of a medical wire, a guide wire, a catheter, an electrical line, a cable, and a medical tubing.

33. A method of using a retaining device to secure a medical device to a substrate during a medical procedure, comprising the steps of: providing a retaining device, the retaining device comprising a flexible elliptical shaped body having a concave top surface, a flat bottom surface, a side surface substantially perpendicular to the bottom surface and the top surface, and at least two slots in a top surface of the flexible elliptical shaped body, wherein each of the two slots extend from the top surface towards a bottom surface and each of the two slots terminates at an end point within the flexible elliptical shaped body, wherein each of the two slots extend at an angle from about 80 degrees to about 100 degrees relative to the top surface, wherein each of the two slots has a substantially constant width, and wherein the width of each of the two slots is smaller than an external dimension of the medical device; attaching the retaining device to the substrate with an attachment mechanism; deforming an opening of one or more of the first slot and the second slot; and arranging a portion of the medical device in the one or more of the deformed first slot or the deformed second slot in order to secure at least the portion of the medical device in the deformed first slot or the deformed second slot.

34. The method of claim 33, wherein the attachment mechanism comprises a rectangular base plate coupled to a bottom surface of the flexible elliptical shaped body.

35. The method of claim 33, wherein the attachment mechanism comprises an adhesive material.

36. The method of claim 33, wherein the flexible elliptical shaped body comprises a material selected from the group consisting of a polymer material, an elastomer material, polymer foam material, a rubber material and combinations thereof.

37. The method of claim 36, wherein the substrate includes one of a table, a drape, a sheet, and a gown.

38. The method of claim 33, wherein the flexible elliptical shaped body comprises a weight greater than about 0.2 lbs.

39. The method of claim 33, wherein the flexible elliptical shaped body comprises a textured surface.

40. The method of claim 33, further comprising the steps of deforming an opening of one or more of the first slot and the second slot; and removing the medical device from the deformed first slot or the deformed second slot.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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.

[0016] In the drawings:

[0017] FIG. 1 is a perspective view of a retaining device according to an embodiment of the invention;

[0018] FIG. 2 is a cross-sectional view of the retaining device of FIG. 1 across line 1-1;

[0019] FIG. 3 is a perspective view of another embodiment of the invention;

[0020] FIG. 4 is a partial, perspective view of an attachment mechanism shown in FIG. 3;

[0021] FIG. 5 is a partial, perspective view of the attachment mechanism shown in FIG. 4;

[0022] FIG. 6 is an interior, partial, perspective view of the attachment mechanism shown in FIG. 5;

[0023] FIG. 7 is a perspective view of another embodiment of the invention;

[0024] FIG. 8 is a perspective view of another embodiment of the invention;

[0025] FIG. 9 is a front view of another embodiment of the invention; and

[0026] FIG. 10 is a perspective view of another embodiment of the invention

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] In one embodiment, at least one of the slots has a distinguishing marking or color.

[0038] 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.

[0039] In one embodiment, the attachment mechanism includes a pressure sensitive adhesive secured to the bottom surface of the flexible body.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] Reference will now be made in detail to an embodiment of the present invention, example of which is illustrated in the accompanying drawings.

[0044] FIG. 1 illustrates a retaining device according to an embodiment of the invention. Referring to FIG. 1, the retaining device 10 is configured to hold medical lines.

[0045] 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 FIGS. 1 and 2, the retaining device 10 includes a wedge shaped flexible body with 2 sinusoidal shaped slots 11 in the top surface and extending toward the bottom surface. The flexible body is composed of a flexible and compressible material such as a polymer elastomer or polymer foam. These materials flex to allow entry into the slot or slit where the medical line is larger than the slot width. They also allow for greater retention of the line as the material compresses around the line, particularly around the curves in the slot, and thus produce more holding friction due to the increased surface contact.

[0046] 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.

[0047] 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.

[0048] FIG. 3 illustrates another embodiment of the invention. Referring to FIG. 3, the retaining device 10 includes a wedge shaped body with a rectangular shaped perimeter and has two sinusoidal shaped slits 11 in the top surface and extending towards the bottom surface so that slit depth (from the top surface) is greater than the diameter of the medical device 14. The slits 11 are thin cuts made into the body and width to a distance in of about 0 inches to about 0.02 inches or greater. Two slots 15 extend from the front surface to the back surface. These slots 15 communicate with and are perpendicular with slits 11. Slot 15 height is preferably larger than the largest diameter medical line to be used and width is preferably aligned with and dimensioned the same as the maximum amplitude of the sinusoidal slots 11. Alternately, slot 15 could be a slit or a round orifice.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] Referring now to FIG. 4, an edge or folded edge of a sheet 18 may be placed partially over the orifice 17 and under the tab 16. To secure the retaining device 10 to the sheet 18, the tab 16 is pushed down and through the orifice 17 and slightly below the plane of the bottom portion of the attachment means 12, wedging the sheet 18 between the tab 16 and orifice 17.

[0053] FIGS. 5 and 6 illustrate a substrate 18 in the locked position as viewed from above and below. This embodiment provides a simple, secure means for securing the retaining device to a sheet, drape, or gown. To disengage the substrate 18, the tab 16 is moved back out in the other direction. Other advantages of this attachment mechanism is that it can be combined with an adhesive mechanism as shown in FIGS. 1 and 2 to provide increased utility to secure to many different supporting surfaces.

[0054] FIG. 7 illustrates another alternative embodiment of the invention. Referring to FIG. 7, the retaining device 10 includes markings 19 on the top surface next to slots 11 to help identify multiple medical lines 14. The slots could be color coded. Retaining device 10 contains j-shaped slots 20 on the front surface communicating with the sinusoidal slots 11 and they extend perpendicular toward the back surface. The end of the J slot is aligned with the top of the first curve in slot 11 such that the end of the J will enter slot 11 at the before mentioned point. This creates a finger shaped projection at the bottom of slot 11 where the line 14 can be manually placed to obtain maximum retention.

[0055] FIG. 8 illustrates another embodiment of the invention. Referring to FIG. 8, the retaining device 10 includes slots 11 formed in a deformable material. A plate structure 21, e.g., isosceles trapezoid shaped plate, is utilized with the retaining device 10 and adhesively mounted to the front of the retaining device 10 such that the ends extend across the slots 11. The top edge of the plate structure 21 where it crosses the slots 11 has an angled surface which allows a medical line to be easily pushed past ends of structure 11 during insertion of the line 14. The purpose of plate structure 21 is to provide increased retention of the wire 14 and removal of the line 14 is accomplished by manually pushing medical line 11 into the flexible material of the body in order move around ends of structure 21. The plate 21 may also be able to rotate to allow the medical line 11 to be more easily removed.

[0056] FIG. 9 illustrates another embodiment of the invention. Referring to FIG. 9, the retaining device 10 includes slots 11 in a nonlinear configuration. The slots 11 have a tapered cross section, e.g., the slot width is greater at the bottom than at the top.

[0057] FIG. 10 illustrates another embodiment of the invention.

[0058] Referring to FIG. 10, the retaining device 10 includes a wedge shaped body with an elliptical shaped perimeter and four sinusoidal shaped slots 11 in the top surface. Each of the four sinusoidal slots extend toward a bottom surface body. In a preferred, embodiment, this distance or slot depth from the top surface is greater than a diameter or portion of the medical device 14 to be retained and the slots 11 width are sized to be greater than a diameter or portion of a medical device 14 to be retained. In a preferred embodiment, each of the slots contain a V-shaped opening cut into the slots near the top portion of the wedge to aid in receiving a medical device 14. The V-shaped opening runs parallel to the bottom surface and are collinear with the slots. It is noted that the width and depth of each slot may be different with respect to each other.

[0059] The medical devices 14 shown in FIG. 10 include a coiled guidewire, a catheter, and a straight guidewire. The wider slots in this embodiment have the advantage of easier loading of the medical device as the material does not need to be deformed to insert the medical device. Retention is accomplished by the friction caused by the bending forces of the medical device against the sinusoidal shaped slot walls. The may also be slot in a sidewall of the shaped body.

EXAMPLES

[0060] Without intending to limit the scope of the invention, the following examples illustrate how various embodiments of invention may be made and/or used.

Example 1

[0061] In this example, a retaining device similar to FIG. 10 was designed using CAD software (SolidWorks) with the following characteristics. The device was formed as an elliptical shaped measuring 3.9 inches by 2.5 inches. The top surface was angled at 25 degrees to the bottom surface and height of 0.8 inches in the front and 1.9 inches in back. The top surface perimeter was rounded to a radius of 0.15 inches. Four sinusoidal slots, spaced 0.8 inches apart on the top surface, extended to a depth of 0.6 inches from the bottom surface. A slot width of 0.080 inches at the bottom and drafts outward at a 2 degree angle to top surface. The sinusoidal slots include S shaped slots including four connected curves having a 1.40 inch curve with 0.80 inch centerline aligned vertically. The slots lots are symmetrical across horizontal centerline and mirror images across vertical centerline. A 50 degree, horizontal chamfer is cut co-linear with the slots to a depth of 1.7 inch from a bottom surface for middle slots and 1.6 inches from a bottom surface for the edge slots.

[0062] 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, Calif. 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.

[0063] 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.

[0064] 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.