Medical line securement device

The present invention relates to a fixing device for fixing a medical line or device to a patient.

Medical care for a patient generally involves the use of a catheter that is inserted percutaneously to direct the fluid directly into the bloodstream, specific organs or areas within the patient's body, or to monitor the patient's biological function. .. For example, short arteriovenous catheters that are inserted peripherally are commonly used to direct fluids and / or medicines directly into the patient's bloodstream.

Liquids (eg, parenteral infusions, pharmaceuticals, etc.) are typically drained from a container located above the patient and fed under gravity or delivered by an IV pump. The liquid passes through the tubing and then flows into the indwelling catheter. Catheter and liquid tubing are generally detachably attached to each other by conventional luer-locking connectors.

In general practice, healthcare professionals use glue, foam or surgical tape to hold the catheter in place on the patient's skin. The healthcare professional wraps a thin piece of tape around the catheter hub, then uses the tape to form a "chevron" with the tip next to the indwelling catheter. The healthcare professional then places one piece of tape across the catheter hub, forming a loop in the tubing, placing another piece of tape beyond the tubing loop, and yet another piece of tape in the catheter. Place it above the hub and the tubing portion that is already looped and extends next to the indwelling catheter. The healthcare professional then typically covers the puncture site and indwelling catheter with a clear dressing.

It takes a few minutes from the valuable time of the healthcare professional to perform all the taping and dressing procedures. In addition, the catheterization process often requires fairly frequent interruptions and dressing changes between the catheter and the fluid supply. For example, intravenous catheterization is often maintained for several days, depending on the patient's condition. Tubing is generally changed every 48-72 hours to maintain the sterility of the liquid and the free flow of liquid through the tubing. Therefore, the healthcare professional must frequently replace the tubing and re-tap the connection. Healthcare professionals must also and frequently change the dressing by cleaning the insertion site around the indwelling catheter.

Thus, healthcare professionals spend a great deal of valuable time applying, removing, and reapplying tape. Frequent application and removal of tape also generally scrapes the skin around the patient's insertion site.

In addition, traditional methods for immobilizing intravenous catheters-using only surgical tape and clear dressings-have not necessarily prevented catheter movement and / or removal. Tapered intravenous catheters are also easily withdrawn during "routine" dressing changes, especially if the healthcare professional is inexperienced. In addition, if the catheter moves too far or is removed, the healthcare professional must replace the catheter, thus increasing the time and cost required to maintain an intravenous supply.

The prior fixation method also did not serve well for the patient. Surgical tape or foam strips are uncomfortable. If tape and dressing are the only things that hold the catheter in place, many patients will not be able to rest comfortably and are worried that movement may result in catheter removal.

The use of tape to secure the catheter presents some additional drawbacks. One of them is pollution. Healthcare professionals often tear the tape into small pieces and place them on the railing of the patient's bed. However, Clostridium and other bacteria are generally present on these surfaces and can migrate to the patient's skin near the insertion site.

In addition, nurses need to handle the tape while wearing protective latex gloves in order to secure the tape. Tearing the adhesive tape tends to create microscopic and / or visible holes in the glove, thus destroying the glove's barrier protection.

Numerous catheterization systems have been developed to improve catheter stability and eliminate the need for frequent application and removal of surgical tape. However, the precursor device has generally been held by a connector on the IV tubing that is fixed to the patient rather than the catheter fitting itself.

The present invention is an anatomical junction where (i) the catheter fixture secures the connector on the tubing rather than the catheter fixture, and (ii) the interconnect between the connector and the catheter fixture is flexible (eg, patient). If it occurs beyond the wrist), it includes the recognition that relative movement may occur between the indwelling catheter and the corresponding blood vessel (eg, vein). As a result of such exercise, the catheter under some circumstances may be removed, requiring reinsertion of the IV catheter, refixation of the catheter and redressing of the insertion site. Similarly, the movement and / or removal of such catheters results in an increase in time and cost associated with maintaining an intravenous supply.

This keeps the medical line in place on the patient's body, but keeps the medical line for dressing changes or other maintenance, even if the catheter-tubing connection crosses the anatomical junction. There is a need for a simple structure fixture that can be released. In addition, there is a need for a fixation device that incorporates a multipurpose medical line holding mechanism, i.e. a device that can be used to attach one of a variety of medical line attachments to an insertion site on the patient's body.

One aspect of the invention includes a fixation device system for fixing a medical line to the patient's body. The fixture includes a mounting surface that is at least partially covered by an adhesive layer to attach the fixture to the patient's body. A receiving surface is arranged distal to the mounting surface. The adhesive member is arranged to cover the receiving surface at least partially and contact at least one portion of the medical line secured by the fixture. The positioning mechanism interacts with the medical line and places the portion of the medical line relative to the adhesive member on the receiving surface.

A preferred method for manufacturing medical line fixtures is to apply a sheet of backing material to a sheet of backside adhesive foam material and then first pass the sheet of foam material through the sheet of backing material without cutting. Including cutting with a pattern, the first pattern at least partially defines the anchor pad. The second pattern is then cut through both the foam material sheet and the backing material sheet, where the second pattern exposes the adhesive back of the anchor pad before fixing it onto the patient's body on the backing material. Prescribes the peeling layer for. The retainer interacts with a portion of the medical line, thereby forming to include a suitable positioning mechanism to guide the medical line to a position relative to the retainer (eg, molding, or injection molding). Will be done. The retainer is attached to the surface of the anchor pad, and a patch of adhesive material is applied to the surface of the retainer. The peeling layer is applied above the adhesive patch, but can be removed to expose the adhesive patch during use.

Preferred methods for fixing the medical line to the patient include providing a fixation device with a first sticky member on one side, a second sticky member on the other side, and a positioning mechanism. The positioning mechanism meshes with a portion of the medical device so that the portion of the medical device can generally be located above the first adhesive member. The medical device is therefore meshed with the first adhesive member to secure the medical device to the fixation device. The second adhesive member is placed on the patient's body to secure the fixation device and thus the holding portion of the medical line to the patient.

Other aspects, features and advantages of the present invention will become apparent from the detailed description of the preferred embodiments below.

Illustrated embodiments of fixtures are intended to illustrate the invention without limitation and include the following drawings.<figref num="1">It is a perspective view of a medical line fixation device configured according to a preferred embodiment of the present invention, showing a typical catheter hub located above the fixation device.</figref><figref num="2">It is a top view of the fixing device of FIG.</figref><figref num="3">FIG. 5 is a perspective view of a fixture configured according to another preferred embodiment of the present invention.</figref><figref num="4">FIG. 5 is a perspective view of a fixture configured according to another preferred embodiment of the present invention.</figref><figref num="5">It is a perspective view of a fixture configured according to yet another preferred embodiment of the invention, illustrating a typical catheter hub in a holding position.</figref><figref num="6">FIG. 5 is a plan view of the fixture in FIG. 5 in an open position without a held catheter hub.</figref><figref num="7">FIG. 6 is a cross-sectional view of a portion of the fixture of FIG. 6 cut along line 7-7, illustrating the fixture in an open position with a catheter hub located above the fixture.</figref><figref num="8">FIG. 5 is a cross-sectional view of a portion of the fixture in Figure 5, cut along line 8-8, showing the fixture in a closed position receiving the catheter hub.</figref><figref num="9">It is a perspective view of the medical line fixing device configured according to another preferred embodiment of the present invention, and illustrates a catheter attachment arranged above the fixing device.</figref><figref num="10">It is sectional drawing of the fixture of FIG. 9 cut out along line 10-10.</figref><figref num="11">FIG. 10 is a cross-sectional view of the fixture according to FIG. 10 with the tongue shown in the open position.</figref><figref num="12">FIG. 10 is a cross-sectional view of the fixture according to FIG. 10 with a medical line attachment in the fastening position.</figref><figref num="13">FIG. 5 is a partial decomposition perspective view of a fixture configured according to yet another preferred embodiment of the present invention.</figref><figref num="14">FIG. 13 is a perspective view of the fixture in FIG. 13 in an assembled form, showing a catheter fitting located above the fixture.</figref><figref num="15">FIG. 5 is a partial decomposition perspective view of a fixture configured according to yet another preferred embodiment of the present invention.</figref><figref num="16">It is a perspective view of the fixture of FIG. 15 in the assembled shape, showing the catheter fitting placed above the fixture.</figref>

This embodiment of a medical line fixation device is disclosed in the context of using a typical intravenous (IV) catheter. However, the principles of the present invention are not limited to IV catheters. On the contrary, those skilled in the art will consider the invention and successfully utilize the fixtures and retainers disclosed herein in combination with other types of medical lines, including tubes for liquid communication and wire. You can understand what you can do. For example, but without limitation, the retention devices disclosed herein are CVCs, PICCs, Foley catheters, and hemodialysis catheters, surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes, endoscopes, and May be suitable for holding wires or cables connected to extracorporeal or implantable electronic devices or sensors. In addition, one of ordinary skill in the art may discover additional uses for the instruments disclosed herein. Therefore, the illustrations and descriptions of the fixation device coupled herein and disclosed herein are merely exemplary of one possible use of this device.

Each of the embodiments described herein uses the same basic concept characteristic of improved fixtures, namely the attachment of a medical line or device to a patient by using an adhesive member that adheres to the medical line or device. To do. The fixture also also has an interaction structure that functions between the fixture and a portion of the medical line or device (ie, detachably attached to or integrated with the medical line or device. Includes fixtures that are formed on the surface. The interaction structure between the retainer and the portion of the medical line or device generally impedes the degree of freedom of relative movement between the medical line and the fixture, at least in part. This interaction also places a portion of the medical line or device on the fixture and guides the portion of the medical line or device into contact with the adhesive member.

The following coordinate terms are used to assist in the description of the components of the fixture and holding device disclosed herein. The vertical axis is generally parallel to the portion of the medical line held by the fixation device and is generally in the plane of the base or pad of the fixation device (described below). The horizontal axis is generally perpendicular to the vertical axis in the plane of the base. The main axis extends across both the vertical and horizontal axes. In Figure 1, the coordinate system is shown on the side of the fixture. The illustrated coordinate system applies to the perspective views of each of the preferred embodiments illustrated herein. Further, as used herein, the "vertical direction" means a direction substantially parallel to the vertical axis. "Horizontal direction" means a direction substantially parallel to the horizontal axis. Further, the "spindle direction" means a direction substantially parallel to the spindle. These coordinates are used to illustrate the structure and movement of the fixture in each embodiment. A detailed description of each embodiment and related uses thereof are described below.

FIG. 1-2 shows a fixture 8 configured according to a preferred embodiment of the present invention. Fixture 8 is configured to hold the catheter 10 either directly or by a fitting as in the illustrated embodiment. Therefore, in the following description, a brief description of the catheter fitting 12 is first provided before the fixation device 8 is described to help the reader understand the present embodiment.

Figure 1 shows a typical short peripheral IV catheter of the type available, for example, from B. Braun Mesungen AG. The attachment 12 of the catheter 10 is screwed into a liquid tubing (not shown) for removable attachment to place a tubing that is in liquid contact with the catheter 10 and is in liquid contact with the catheter 10. Includes a conical receptacle 14 with a rim 16. The fixture 12 further includes a pair of lateral wings 18 extending roughly vertically from the lower portion of the fixture 12. Each wing 18 contains a through hole 20. The inner surface of the fixture 12, including the portion of the lateral wing 18, has a generally flat cross-shaped footprint.

Rather than holding one point in the medical line upstream of the catheter, the fixation device 8 accepts the catheter fitting 12 (eg, the connector between the catheter and the liquid supply tube) and secures it directly to the patient. To this end, the fixture 8 includes an adhesive member 24 on which the inner surface 22 of the catheter fitting 12 is located. Desirably, the shape of the adhesive member 24 generally matches the shape of the footprint of the catheter attachment, and the adhesive member 24 is the same size as or slightly smaller than the size of the footprint of the attachment. Therefore, in the illustrated embodiment, the adhesive member 24 generally has a cross shape.

The adhesive member 24 is preferably thick enough to secure and / or (at least to some extent) enclose the catheter attachment 12 to suppress relative movement between the fixation device 8 and the catheter attachment 12. And sticky. The adhesive member 24 can be applied to the fixture 8 by either a variety of conventional methods such as transfer technology (eg, thin film transfer tape) or sputtering. For example, in the illustrated embodiment, the adhesive member 24 is formed from a transfer adhesive available as product number 950 from the Minnesota Minning and Manufacturing Company (3M), Minneapolis, Minnesota.

As is clear from FIG. 1, the peeling layer 26 can initially cover the adhesive layer 24 before use. Alternatively, the packaging (not shown) for the fixture 8 can also function as the peeling layer 24. In either case, the appropriate material coats the adhesive member 24 prior to applying the fixation device to the patient. Such suitable materials include, for example, polycoated silicone-treated paper without limitation. The fixture 8 further includes a positioning mechanism for correctly placing the catheter fitting 12 on the adhesive member 24. For this, any of a wide range of positioning mechanisms can be used as illustrated by the various embodiments described below. For example, as is apparent from FIGS. 1 and 2, the fixture 8 preferably includes at least one post 28 that is associated with one of the holes 20 in the wing 18 of the catheter fitting.

In the illustrated embodiment, the fixture 8 preferably comprises a pair of posts 28; however, the fixture 8 can further include additional posts to suit a particular application. For example, if the fixture is designed to hold a significantly larger fixture, the fixture can include four posts arranged at the four corners of the rectangle for greater stability. .. As in another embodiment, three posts can be used to secure the Y site attachment.

Posts 28 can have different lengths and diameters and different distances between each other, depending on the particular application and the particular catheter fitting on which they must interact. For applications with known catheters, each post 28 has a length of preferably about 4 mm to 20 mm, and more specifically about 6 mm, but longer or shorter lengths are also possible. .. The diameter of the post is preferably slightly smaller than the corresponding hole 20 of the catheter fitting 12, but to prevent significant flexion of the post 28 under the normal forces experienced on the medical line. It's big enough. The post 28 is composed of a polymeric plastic material, preferably having a diameter of 0.5 mm to 3 mm, more preferably about 1.7 mm.

The post 28 is spaced laterally wide enough to accommodate at least a fixed medical line or device, and in the illustrated embodiment, preferably a hole 20 in the wing 18 of the catheter fitting. Corresponds to the interval between. For use with the most well-known catheters, the posts 28 are spaced about 5 mm to about 40 mm, and more specifically about 15 mm.

In the embodiments illustrated as apparent in FIGS. 1 and 2, the fixture 8 comprises a holding device mounted on a flexible anchor pad 32 and generally designated with reference number 30. The holding device 30 includes a positioning mechanism (eg, a post 28) and a base 34 that supports the adhesive member 24 of the holding device 30. The base 34 preferably has a planar shape that partially defines the range of the receiving surface (generally designated reference number 36) with respect to the catheter fitting 12. The posts 28 generally extend to the receiving surface 36 of the base 34 together with the adhesive member 24 arranged between the posts 28 on the receiving surface 36.

The base 34 and post 28 of the holding device 30 are preferably integrally formed as a single piece. This can be accomplished by any of a variety of methods well known to those of skill in the art. For example, the entire holding device 30 can be injection molded to reduce manufacturing costs. Suitable plastics for making post 28 and base 34 include, for example, polypropylene, polyethylene and others without limitation. In particular, acceptable materials include Tenite? 811 Low Density Polyethylene (LDPE) commercially available from Eastman Chemical Company (Kingsport, TN) and both commercially available from Huntsman Chemical (Salt Lake Tea, Utah). Polypropylene (# P6M5b-015) and polypropylene copolymer (# P6M5Z-036) are included.

As described above, the adhesive member 24 can be applied to the base 34 in a variety of ways, including transfer tape or sputtering, without limitation. If applied on a transfer tape, the application can be performed as part of the converter process described below.

The base 34 of the holding device 30 is attached to the anchor pad 34. The base 34 is preferably secured to the anchor pad 32 with a solvent-bound adhesive, such as cyanoacrylate or other adhesive material. One such adhesive is commercially available from 3M under product number 4693.

The anchor pad 32 contains a flexible structural layer to secure the retainer 30 to the patient's skin. The pad 32 preferably comprises a laminated structure with an upper foam layer (eg, closed cell polyethylene foam) and a bottom adhesive layer. The adhesive is this preferably a medical adhesive and can be either sweaty or non-perspirant depending on the particular application. The anchor pad 32 is preferably formed from a polyethylene foam tape (1/32 to 1/8 inch thick) with an acrylic adhesive having a density of 40 to 120 g per m3. Such foams with an adhesive layer are commercially available from New Dimensions in Medicine, Ohio, Columbus.

The top surface of the foam layer of the anchor pad 32 is roughened by corona treatment of the foam with a low charge. The rough or porous top surface of the anchor pad 32 improves the quality of the adhesive bond formed by the cyanoacrylate (or other type of adhesive or binding material) between the base 34 and the anchor pad 32. Alternatively, the flexible anchor pad 32 may include a bottom layer of medical adhesive, an intermediate foam layer and an upper paper layer or other woven or non-woven layer.

A removable paper or plastic backing or liner 38 covers the bottom adhesive surface before use. The peeling layer 38 is preferably split into pieces to resist tearing and facilitate pad attachment to the patient's skin. In the illustrated embodiment, the backing is a polycoated silicone treated paper.

The backing is preferably split along the centerline CL of the flexible anchor pad 32 to expose only half of the bottom layer adhesive at a time. The backing 38 further and beneficially extends beyond at least one end face of the anchor pad 32 as shown to facilitate removal of the backing 38 from the adhesive layer.

Although not shown, the retention device 30 and / or the anchor pad 32 can include a suture hole in addition to the adhesive layer to further secure the anchor pad to the patient's skin.

In the illustrated embodiment, the anchor pad 32 further comprises a pair of facing concave sections that are closer to the holding device base 34 and narrow the center of the anchor pad 32. As a result, the peripheral end face of the anchor pad 32 has a larger contact area that provides greater stability and adhesion to the patient's skin, while the retention device 30 located in the central section of the anchor pad 32. Can be placed adjacent to the catheter insertion site.

The anchor pad 32 and the peeling layer 38 (ie, backing) are formed using a converter process. First a sheet of backing material is applied on the adhesive surface of the foam material. (Forms are purchased with a backing; however, preferably a new backing is applied that includes a printed indicator that identifies the manufacturer of Fixture 8) The first pattern is cut multiple times into a sheet of backside adhesive foam material through the converter process. This may be done using a die punching method in which only the foam material is "kiss cut" in the first pattern without cutting the backing material. The cut of the first pattern preferably corresponds to at least one portion of the anchor pad 32. That is, the first pattern in which the foam material is cut defines the shape of the anchor pad 32 at least in part.

The second pattern is then cut multiple times into the backside adhesive material (ie, foam material) and backing material sheet. The second pattern defines the shape of the anchor pad and the balance of the exposed portion of the peeling layer 38. This process can also be performed by the die punching method.

The peeling liner 38 is also bisected without cutting into the foam layer. This process can be performed either before or after the second pattern is cut, as well as by die punching. Therefore, through this converter process, multiple anchor pads with a foam / adhesive / backing laminate structure are produced from a single sheet.

During use, the healthcare professional removes the protective sterile packaging (not shown) from the fixture and peels off the delamination layer 26 from the adhesive member 24 if prepared separately from the packaging. Otherwise, the adhesive member 24 will appear when the packaging is removed. The healthcare professional then aligns the post 28 with the suture hole 20 in the wing 18 of the catheter fitting and inserts the post 28 into the hole 20. The interaction between the hole 20 and the post 28 correctly positions the catheter fitting 12 on the retainer 30. The healthcare professional then moves the catheter attachment 12 into contact with the adhesive member 24 and holds the catheter attachment 12 so that the adhesive member 24 and the inner surface 22 of the catheter attachment 12 are in good contact with each other. Press against device 31. As a result of matching the shapes of the adhesive member 24 and the inner surface 22 of the catheter fitting 12, the inner surface 22 completely covers the adhesive member 24, thereby preventing the adhesive member 24 from being exposed. Minimizing such exposure reduces the risk of insertion site infections, as exposed adhesives can be sites of bacterial growth.

The healthcare professional secures the anchor pad to the patient, preferably after attaching the catheter fitting 12 to the holding device 31. This step can be performed prior to catheter attachment attachment, which requires the anchor pad 32 to be placed on the patient's body in a position that accurately aligns the retainer 30 under the catheter attachment 12. Occurs. Regardless of the order of these actions, the healthcare professional first removes half of the detachment layer and secures the anchor pad to the patient by pressing the anchor pad against the patient's skin with the adhesive side facing down. To do. The healthcare professional then removes the other half of the detachment layer and flattens the anchor pad 32 against the patient. The fixation device 8 in this position firmly secures the catheter attachment 12 to the patient.

FIG. 3 shows a medical line fixing device 8a according to another embodiment of the present invention. The above description relating to the embodiments of FIGS. 1 and 2 also applies to the embodiments of FIG. 3 unless otherwise specified. In addition, similar reference numbers have been used to indicate similar functions among all embodiments, with the addition of the letter "a" as a suffix to mean the features of this embodiment.

The fixture 8a includes a holding device 30a. The holding device 30a is illustrated in FIGS. 1-2, except that the base 34a of the holding device 30a includes a ridge 40 that extends upward from the base 34a and defines a portion of the receiving surface 36a. Similar to a holding device. The ridge 40, base 34a and post 28a are all integrally formed, preferably in a single holding device 30a.

The adhesive member 24a is formed on the upper surface of the ridge 40, and the peeling layer 26a covers the adhesive member 24a. Alternatively, the packaging (not shown) acts as a delamination as described above.

The ridge 40 of the holding device 30a preferably has a flat top surface on which the adhesive layer 24a is placed. Desirably, the plane generally defined by the top surface of the ridge 40 forms an acute angle with the plane of the base 34a. The slanted top surface provides tilting orientation to the catheter junction relative to the patient's skin. The resulting angle of incidence is preferably in the range of about 0-15-depending on the application of the catheter fixation device 8 as is known in the art.

The anchor pad 32a supports the holding device 30a. The delamination layer (not shown) covers the adhesive back surface of the anchor pad 32a prior to applying the anchor pad 32a to the patient as described above.

FIG. 4 shows a medical line fixture 8b according to another embodiment of the invention. The above description relating to the embodiments of FIGS. 1 and 2 also applies to the embodiments of FIG. 4 unless otherwise specified. In addition, similar reference numbers have been used to indicate similar functionality among all embodiments, with the addition of the letter "b" as a suffix to mean the features of this embodiment.

The holding device 30b is similar to the holding device of FIG. 1 except that the holding device 30b includes a cradle 42 that extends upward from the base 34B of the holding device 30b. The adhesive member 24b is preferably located within the pedestal 42 and covers at least one portion of the receiving surface 38b defined by the pedestal 42. The peeling layer 26b can initially cover the adhesive member 24b, or the packaging may perform this function as described above.

Further, the foam layer 46 is preferably inserted between the surface of the channel 44 and the adhesive layer 24b. The foam layer 46 provides good contact between the adhesive layer 24b and the surface of the catheter junction, even if there are ridges on the surface of the catheter junction. That is, the foam layer 46 allows the adhesive layer 24b to follow the contours of the surface of the catheter fittings in parallel.

The cradle 42 preferably has a concave arched upper surface that forms the channel 44 and serves as a receiving surface for the holding device 30b. Desirably, the surface of the channel 44 is substantially on one part of the conical surface so that the channel can easily engage with the conical catheter attachment, such as the attachment illustrated in FIG. Fits. The arched surface of channel 44 can be used to guide the catheter attachment to a position relative to the retainer 30b and onto the adhesive layer 34b, so in the present invention the post 28b (illustrated by a very thin line in FIG. 4). Is) is optional. Such posts 28b, in cooperation with corresponding suture holes such as hole 20 in the wing of the catheter attachment (see Figure 1), facilitates the placement of the catheter attachment relative to the retainer 10c. Therefore, it can be used if desired. In this embodiment, both the shapes of the channel 44 and the post 28b serve as a positioning mechanism for the holding device 30b when they are included.

The anchor pad 32b supports the holding device 30b. The delamination layer (not shown) preferably covers the adhesive back surface of the anchor pad 32b prior to applying the anchor pad 32b to the patient as described above.

Figures 5-8 show the medical line fixture 8c according to yet another embodiment of the present invention. The above description relating to the embodiments of FIGS. 1 and 2 also applies to the embodiments of FIGS. 5-8, unless otherwise specified. In addition, similar reference numbers have been used to indicate similar functionality among all embodiments, with the addition of the letter "c" as a suffix to mean the features of this embodiment.

The retainer 30c and anchor pad 32c of the fixture 8c are similar to those shown in FIG. 1, except that the positioning mechanism takes the form of a pedestal 48 with a movable wall 50. The adhesive member 24c is preferably located within the pedestal 48 and covers at least one portion of the receiving surface defined by the pedestal 48. The peeling layer (not shown) can initially cover the adhesive member 24c, or the packaging can perform this function as described above.

As best understood from FIGS. 6, 7 and 8, the cradle contains a tapered channel 52, which includes an arched surface that acts as a receiving surface for the holding device 30c. Desirably, the shape of the channel 52 is substantially adapted to one part of the cone (ie, having a truncated cone) so that the channel 52 can easily mesh with the conical section of the catheter attachment 12c. To do.

The channel 52 is partially defined by the opposing wall sections 50. Each wall section 50 has an arch shape with a curved radius that generally fits the catheter attachment 12c. Each wall section 50 further extends through an arc length generally greater than 90-so that the wall section 50 together surrounds the conical catheter fitting 12c by at least 180-.

The flexible coupler, generally identified by reference number 54, interconnects the wall sections 50 of the pedestal 48 and supports the pedestal 48 around the retainer base 34c. In the illustrated embodiment, the flexible binder 54 is integrally formed with the base 34c as well as the wall section 50. The flexible coupler 54 includes a pair of generally parallel rails 56. Each rail 56 includes a narrow neck section formed between the base 34c and the corresponding wall section 50. This neck section is flexible and allows the corresponding wall section 50 to move relative to the base 34c.

Thus wall sections 50 are movable relative to each other and relative to base 34C. Desirably, the flexible binder 54 normally holds the wall section 50 in the open position as shown in FIG. 7, in which case the top edge of the wall section 50 (distal to the base 34c) is spaced. Are separated. The flexible binder 54 allows the wall section 50 to move toward each other into a closed position as shown in FIG. In this position, the upper ends of the wall section 50 are close together and closely spaced, and the shape and size of the channels generally match the shape and size of the holding section of the catheter attachment 12c. Therefore, the cradle 48 in the closed position extends beyond 180-around the catheter attachment 12c.

The flexible connector 54 also includes an actuating mechanism for moving the wall section to the closed position when the channel 52 receives the catheter attachment 12c. In the illustrated embodiment, the actuating mechanism includes a pair of lugs 58 extending from the lower end of the wall section 50 between the rails 56. Each lug 58 generally has an arched inner surface (ie, a surface within channel 52) that matches the shape of the corresponding wall section 50. The lug 50 is further sized so that it has a slight upward orientation when the cradle 48 is in the open position, as is clear from FIG. However, when the catheter fitting 12c is pushed into the channel 52, the lug 58 moves downward. The downward movement of the lug 58 induces a rotational movement of the ancillary wall section 50 around the corresponding rail 56 along with the bending neck section of the rail 56, as is apparent from FIG.

A foam layer 60 is arranged within the channel 52 to align at least one portion of the channel surface. The foam layer 60 not only corrects for irregularities on the surface of the catheter fitting, but also acts as a substrate for the adhesive member 24c. In the illustrated embodiment, the foam layer 60 and the adhesive layer 24c align the entire inner surface of the cradle channel 52.

In use, the conical section of the catheter attachment 12c is inserted into the pedestal 48, while the flexible connector 54 holds the pedestal wall 50 in the open position. The facing wall 50 of the cradle 48 is then closed around the fixture 12c, bringing the adhesive member 24c into contact with the outer surface of the fixture 12c, thereby fixing the fixture 12c to the holding device 30c.

Figures 9-12 show the medical line fixture 8d according to yet another embodiment of the present invention. The above description relating to the embodiments of FIGS. 1 and 2 also applies to the embodiments of FIGS. 9-12, unless otherwise specified. In addition, similar reference numbers have been used to indicate similar functionality among all embodiments, with the addition of the letter "d" as a suffix to mean the features of this embodiment.

The holding device 30d includes a clamping mechanism formed by a pair of opposing latches 62. The latches 62 are spaced apart from each other on the base 34d, and an adhesive member 24d is placed between the latches 62. In the illustrated embodiment, the latch 62 and the base 34d are integrally formed together into the shape of the single holding device 30d, eg, by molding, extraction, or thermoforming without limitation; and the adhesive member 24 is described above. Applies in one of the methods.

Each latch 62 includes a tongue 64 protruding towards the other latch 62 and a generally upright support 66 that suspends the tongue 64 above the base 34d. At a point above the base 34d, a working device or lug 68 is attached to the support 66. The actuating device 68 preferably includes a rough top surface and / or a friction ridge to enhance frictional contact between the actuating device 68 and the user's fingertips. In the illustrated embodiment, each actuating device 68 is outside the corresponding tongue 64 at the top of the upright support 66. In this position, the movement of the actuator 68 towards the base 34d causes the support 66 to bend, as evidenced by FIG. 11, moving the tongue 64 farther from the other latch 66.

In the illustrated embodiment, the upright supports 66 have an elongated shape and are generally arranged parallel to each other on the base 34d. Support 66, along with base 34d, defines a range of channels 70 that are generally rectangular. The opposing tongue 64 of the latch 62 reduces the size of the upper opening of the channel. The floor of channel 70 defines the range of at least one portion of the receiving surface 36d of the holding device 30d.

The channel 70 is sized to accommodate the wing 18d of the catheter attachment, and latches 62 over the base 34d so that it snaps over the wing 34d to fasten the catheter attachment 12d within the channel 70. Is placed.

During operation, both activators 68 are pressed by acupressure and the support 66 is bent outwards, as shown schematicly in FIG. The outward flexion of the support 66 allows the lateral wing 18d of the catheter fitting to be placed between the supports 66, whereby the inner surface 22d of the fitting 12d is brought into contact with the sticky pads 24d. After inserting the catheter fitting wing 18d into the channel 70, the acupressure on the actuator 68 can be relaxed so that the tongue 64 can partially cover the top surface of the catheter fitting wing 18d. it can. Therefore, the fixture 12d is secured to the retainer 30d in two ways: first by the adhesive force of the adhesive member 24d to the inner surface 22d of the fixture 12d; and secondly by the wing of the fixture. By placing the tongue 64 on top of the 18d.

Figures 13-14 show the medical line fixture 8e according to yet another embodiment of the present invention. The above description relating to the embodiments of FIGS. 1 and 2 also applies to the embodiments of FIGS. 13-14, unless otherwise indicated. In addition, similar reference numbers have been used to indicate similar functionality among all embodiments, with the addition of the letter "e" as a suffix to mean the features of this embodiment.

The holding device 30e includes a plate with recesses or wells formed therein. The plate can be formed from any of a wide range of materials, including plastic polymers. However, in the illustrated embodiment, the holding device 30e includes a foam pad defining an opening 72 passing through it. As is clear from FIG. 14, the opening 72 has a shape that matches the shape of the footprint of the catheter fitting, thereby arranging the catheter fitting 12e relative to the holding device 30e.

The adhesive member 24e is generally centered on the pad 32e and is applied to the anchor pad 32e. The size and shape of the adhesive member 24e preferably fits the size and shape of the foam pad 30e. The adhesive member 24e preferably has a uniform thickness and covers the entire area within its perimeter. The peeling layer (not shown) or product packaging preferably covers the adhesive member 24e before use as described above.

The foam pad holding device 30e and its opening 72 can be formed during the converter process during the die punching process. The application of the adhesive member 24e and the attachment of the foam pad holding device 30e to the adhesive member 24e can also be performed as a step during the converter process.

Although not shown, the wells or recesses do not need to extend throughout the foam pad, but rather can take the form of embossing. In this shape, the adhesive member can be applied to the recessed floor so that it can be approached from one side of the anchor pad facing the patient's skin. Similarly, at least one portion of the recess is configured to correspond to the anchored portion of the wing of the catheter fitting in shape and size.

During operation, the catheter fixture 12e is moved into the recess 72 so that the inner surface 22e of the fixture 12e is located relative to the adhesive member 24e and is located therein. Therefore, the inner surface 22e is pushed into contact with the adhesive member 24e to secure the catheter attachment 12e to the fixture 8e. The anchor pad 32e is fixed to the patient's skin by the method described above.

Figures 15-16 show the medical line fixture 8f according to yet another embodiment of the present invention. The above description relating to the embodiments of FIGS. 1 and 2 also applies to the embodiments of FIGS. 15-16, unless otherwise specified. In addition, similar reference numbers have been used to indicate similar functions among all embodiments, with the addition of the letter "f" as a suffix to mean the features of this embodiment.

This embodiment is also similar to the embodiments shown in FIGS. 13-14, except that it is necessary for the holding device. The holding device shown in FIG. 13 has been excluded from this embodiment and the recess or well 74 is defined in the anchor pad 32f itself. In the illustrated embodiment, the recess 74 extends completely through the anchor pad 32f; however, the recess can take the form of a recess in the pad 32f. In either case, the recess 74 preferably has a shape and size similar to at least one portion of the catheter attachment 12f. More preferably, the recess 74 generally fits the footprint of the catheter fitting 12f in shape and size.

The adhesive member 24f is arranged at the bottom of the recess. However, in the illustrated embodiment, if the recess extends through the pad 32f, the substrate 76 supports the adhesive member 24f at this position. The adhesive member 76 preferably covers the entire substrate 76 and secures it to the side surface of an anchor pad on which an adhesive layer is formed. Therefore, the substrate can include an adhesive layer on both sides thereof.

The use of the fixture 8f of the present invention is similar to the use associated with the fixtures illustrated in FIGS. 13 and 14. The catheter fitting 12f is moved towards and placed in the recess 74 so that the inner surface 22f of the fitting 12f can be placed relative to the adhesive member 24f. The inner surface 22f is then pressed into contact with the adhesive member 24f to secure the catheter attachment 12f to the fixture 8f. The anchor pad 32f is fixed to the patient's skin by the method described above.

As is common to all of the above embodiments, the fixture includes an adhesive layer on two sides. One side attaches to the patient and the other side attaches to the medical line or equipment. Each of the above fixtures further includes a positioning mechanism to correctly position the medical line on the fixture and enhance the speed and ease of application of the fixture. Proper placement promotes good contact between the adhesive member and the medical line or device to enhance fixation, and ensures that the medical line or device completely covers the adhesive member. As a result, the adhesive does not tend to be a bacterial growth site. Positioning mechanisms also allow healthcare professionals to properly place medical lines or instruments on fixtures with minimal time and effort.

When used with a catheter-type device, the fixture above fixes the catheter fitting to the patient rather than fixing the connector on the tubing to the patient as in the preceding device. Therefore, the catheter does not move with the movement of the anatomical junction when the interconnect between the catheter and the tubing is separated beyond the junction.

Further, as is common to each of the above embodiments, the fixation device provides a sterile, stable and efficient method for fixing the medical line or device to the patient. The fixation device is quickly and easily applied to a medical line or device by using a positioning mechanism, and also to the patient's skin quickly and easily. During the application process, healthcare professionals do not need to touch the adhesive layer with their gloves. Therefore, the use of fixtures does not reduce the protection of the gloves. Once fixed, the fixation device stabilizes the catheter and also substantially prevents movement and movement of the catheter.

Although not shown, each of the above fixation devices can include one or more tube clips specifically for use with an intravenous catheter. A typical tube clip is disclosed and illustrated in US Pat. No. 5,578,013 issued to Steven F. Bierman and his designated agent on November 26, 1996, incorporated herein by reference. The tube clip can have a plate-like base that is attached to the anchor pad and placed on either side of the holding device to accommodate attachment to the left or right hand. The clip surrounds a substantial portion of the tubing, including the tubing placed within the channel.

During use, the healthcare professional loops the IV-supplied tubing from the insertion site and inserts a portion of the tubing into the tube clip. The looped section has sufficient slack to form a conventional safety loop. The safety loop absorbs any tension applied to the liquid supply to prevent withdrawal of the catheter.

A skilled technician will recognize the compatibility of different features from different embodiments. For example, the angle orientation of the receiving surface shown in FIG. 3 can be used with the cradle shown in FIGS. 4 and 5. Thus, various features of the embodiment can be combined to adapt the fixture to a particular application.

Although the present invention has been described with respect to certain preferred embodiments, it will be apparent to those skilled in the art that other embodiments are also within the scope of the invention. Therefore, the scope of the present invention is intended to be limited only by the claims.