Catheter securement device with energy dissipating body

Abstract

To provide a device for securing the position of a small catheter, such as an epidural pain block catheter, and preventing migration of the catheter while it is inserted in a patient.SOLUTION: A catheter securement device includes a base 120 defining a slot, and at least one inertial damper 130 attached to the base 120 and extending above the slot. The slot and the at least one inertial damper 130 can be relatively positioned such that, when the slot is aligned over a catheter insertion site, a catheter tube exiting the catheter insertion site is receivable through the slot and coilable around at least a portion of the at least one inertial damper 130.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present disclosure relates generally to catheter devices, and more particularly to devices for maintaining the position of small catheters, such as epidural pain block catheters, and preventing migration of the catheter while inserted into a patient. [Background technology]

[0002] Catheter tubes / lines are often inserted into a patient's body and left there for long periods of time. Depending on the medical condition, the patient may be able to move around with the catheter in place. In such cases, the catheter must remain in place even as the patient moves. Furthermore, the catheter insertion site must be protected from infection at all times.

[0003] Retention devices have been developed in an attempt to secure the position of the catheter and prevent undesired movement. Many such retention devices are designed for larger catheters that have a hub or tube connector near the insertion site. These types of catheters are relatively easy to secure because the hub or tube connector is rigid and has a surface that can be gripped or otherwise held by the retention device.

[0004] However, catheter types that do not have a rigid hub or connector near the insertion site are more difficult to retain. For example, epidural pain block catheters generally do not have a rigid hub or connector near the insertion site. Furthermore, typical epidural pain block catheters feature very thin tubing, approximately 2 mm or less in diameter. Such tubing is difficult to secure for a variety of reasons. For example, retention devices designed to retain the catheter hub are too large and bulky to secure small tubing. Also, many retention devices have rigid parts with edges that can pinch small tubing. Furthermore, many retention devices have flat rigid surfaces that allow small tubing to easily slip off. This can encourage the catheter to gradually migrate over time. For these reasons, conventional catheter retention devices are not suitable in all situations in which a catheter tube is used. Summary of the Invention [Means for solving the problem]

[0005] This disclosure describes a catheter retention device or "CSD" that is applicable to many types of catheters, particularly catheters that do not have a hub or connector near the insertion site, are small in diameter, and / or are difficult to secure with existing retention devices.

[0006] In one aspect of the disclosure, a catheter retention device includes a base defining a slot and at least one inertial damper attached to the base and extending over the slot. The slot and the at least one inertial damper are relatively positioned such that the slot is aligned over a catheter insertion site. A catheter tube exiting the catheter insertion site is received through the slot and is coilable around at least a portion of the at least one inertial damper.

[0007] In another aspect of the disclosure, the slot and the at least one inertial damper are relatively positioned such that the catheter tube can be coiled around the at least one inertial damper to completely surround the at least one inertial damper.

[0008] In another aspect of the present disclosure, the at least one inertial damper includes a peripheral sidewall configured to frictionally engage the catheter tube.

[0009] In another aspect of the present disclosure, the sidewall is compressible under stored energy.

[0010] In another aspect of the present disclosure, the slot and the peripheral sidewall are positioned relative to one another such that when the slot is aligned over a catheter insertion site, a catheter tube exiting the catheter insertion site is receivable through the slot and coilable around at least a portion of the peripheral sidewall.

[0011] In another aspect of the present disclosure, the peripheral sidewall includes a plurality of sidewall sections.

[0012] In another aspect of the present disclosure, the slot and the peripheral sidewall are positioned relative to one another such that when the slot is aligned over a catheter insertion site, a catheter tube exiting the catheter insertion site is receivable through the slot and coilable around some or all of the multiple sidewall sections.

[0013] In another aspect of the present disclosure, a catheter retention device includes at least two coil retention members configured to retain a catheter tube in a coiled state around at least one inertial damper.

[0014] In another aspect of the present disclosure, each of the at least two coil retaining members is configured to limit movement of the catheter tube away from the sidewall after the catheter tube is coiled around the at least one inertial damper.

[0015] In another embodiment of the present disclosure, the at least two retaining members include at least two posts.

[0016] In another aspect of the present disclosure, the catheter retention device includes a cover, and at least one inertial damper is included between the base and the cover.

[0017] In another aspect of the present disclosure, the at least one inertial damper separates the base from the cover by a gap surrounding the at least one inertial damper, the gap configured to receive the catheter tube when the catheter tube is coiled around the at least one inertial damper.

[0018] In another aspect of the disclosure, the cover is tiltable relative to the base to increase the size of the gap on one side of the at least one inertia damper.

[0019] In another aspect of the present disclosure, each post is configured to limit tilt of the cover relative to the base.

[0020] In another aspect of the disclosure, the at least one inertia damper includes a first side inertia damper, a second side inertia damper, and at least one inner inertia damper between the first side inertia damper and the second side inertia damper.

[0021] In another aspect of the present disclosure, the at least two coil retaining members include a first side inertia damper and a second side inertia damper.

[0022] In another aspect of the present disclosure, the first side inertia damper and the at least one inner inertia damper are separated by a first channel.

[0023] In another aspect of the present disclosure, the second side inertia damper and the at least one inner inertia damper are separated by a second channel.

[0024] In another aspect of the present disclosure, the first channel and the second channel are configured such that a catheter tube can be coiled around the at least one inner inertial damper through the first channel and the second channel, respectively.

[0025] In another aspect of the present disclosure, the at least one inner inertia damper includes the first inner inertia damper and the second inner inertia damper.

[0026] In another aspect of the present disclosure, the first inner inertial damper and the second inner inertial damper are separated by a third channel.

[0027] In another aspect of the disclosure, the first channel, the second channel, and the third channel are configured such that a catheter tube can be coiled around the first inner inertia damper and the second inner inertia damper via the first channel, the second channel, and the third channel, respectively.

[0028] In another embodiment of the present disclosure, the first channel, the second channel and the third channel are parallel.

[0029] In another embodiment of the disclosure, the slot intersects with said third channel. In another aspect of the disclosure, the catheter retention device includes a transparent dressing configured to cover the base, the at least one inertial damper, and the slot. [Brief description of the drawings]

[0030] The drawings illustrate one or more embodiments by way of example only, and not by way of limitation, in which like reference numbers indicate the same or similar elements. [Figure 1] FIG. 1 is a schematic top view of a CSD according to the present disclosure, showing the CSD securing a catheter tube to a patient. [Diagram 2] FIG. 2 is a front view of the CSD of FIG. [Diagram 3]FIG. 3 is an exploded front view of the CSD of FIG. [Figure 4] FIG. 4 is a top view of the first component of the CSD of FIG. [Diagram 5] FIG. 5 is a top view of a second component of the CSD of FIG. [Figure 6] FIG. 6 is a bottom view of the third component of the CSD of FIG. [Figure 7] FIG. 7 is a schematic top view of the CSD of FIG. 1 illustrating one technique for securing the catheter tube to the CSD. [Figure 8] FIG. 8 is a block diagram illustrating a method of using a CSD in accordance with the present disclosure. [Figure 9] FIG. 9 is a schematic top view of another CSD according to the present disclosure, the CSD shown in a closed state, securing a catheter tube to a patient. [Figure 10] FIG. 10 is a cutaway perspective view of the components of the CSD of FIG. [Figure 11] FIG. 11 is an exploded front view of the CSD of FIG. [Figure 12] FIG. 12 is a cutaway top view of the components of the CSD of FIG. [Figure 13] FIG. 13 is a schematic top view of the CSD of FIG. 9, with the CSD shown in an open state and with the catheter tube secured to the patient. [Figure 14] FIG. 14 is a cutaway top view of components of another CSD illustrating another channel configuration according to the present disclosure. [Figure 15] FIG. 15 is a cutaway top view of components of another CSD illustrating another channel configuration according to the present disclosure. [Figure 16] FIG. 16 is a top view of components of another CSD illustrating another slot configuration in accordance with the present disclosure. [Figure 17] FIG. 17 is a schematic top view of another channel configuration according to the present disclosure. [Figure 18] FIG. 18 is a schematic top view of another channel configuration according to the present disclosure. [Figure 19] FIG. 19 is a schematic top view of another channel configuration according to the present disclosure. [Figure 20] FIG. 20 is a top view of components of another CSD illustrating another channel configuration and another slot configuration in accordance with the present disclosure. [Figure 21] FIG. 21 is a block diagram illustrating another method of using a CSD according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] In the following detailed description, numerous specific details are shown by way of example in order to provide a thorough understanding of the relevant teachings. It is understood that such examples are non-limiting. Without departing from the scope of the present disclosure and its teachings, those skilled in the art can make numerous variations, modifications, substitutions and combinations, which are part of this disclosure. This includes replacing a feature shown in one embodiment with a feature shown in another embodiment, or combining a feature shown in one embodiment with a feature shown in another embodiment. All substitutions and combinations are considered part of this description.

[0032] CSDs according to the present disclosure feature one or more inertial dampers to fix the position of the catheter tubes and prevent them from sliding or moving over time. As used herein, the phrase "inertial damper" refers to a body that redirects kinetic energy from a force applied to the catheter tube and (1) converts that kinetic energy into thermal energy through friction and (2) absorbs at least a portion of that force through plastic or elastic deformation of the body. As used herein, the phrase "inertial damper" refers to a process that redirects kinetic energy from a force applied to the catheter tube and (1) converts that kinetic energy into thermal energy through friction and (2) absorbs at least a portion of that force through plastic or elastic deformation of the body.

[0033] The inertial damper according to the present disclosure can secure the catheter tube against movement without pinching the catheter tube. The inertial damper can be formed from or include components formed from a resilient material that is plastically or elastically deformable. Suitable resilient materials can include, but are not limited to, polyethylene foam, thermoplastic elastomers, and silicone.

[0034] 1-3, a CSD 100 is shown as an example, with a catheter tube CT secured to the CSD. The CSD 100 includes a pad 110 having a bottom surface 111 for attachment to a patient's skin around a catheter insertion site S. The pad 110 also has a top surface 112 opposite the bottom surface 111, which faces away from the patient's skin when the CSD is attached to the patient. A first adhesive 113 is applied to the bottom surface 111 to secure the pad 110 to the patient's skin. A peelable cover or liner 114 is removably attached to the bottom surface 111 to cover the first adhesive 113 until the CSD is attached to the patient. The liner 114 includes a first liner portion 115 and a second liner portion 116 that are separately removable from the bottom surface 111 to partially expose the first adhesive 113. Pads according to the present disclosure may be formed of any suitable material. In this non-limiting example, pad 110 is formed from 1 / 32 inch thick polyethylene foam with a single coat of adhesive.

[0035] Pads according to the present disclosure can have a variety of shapes and geometries. In this example, pad 110 has a perimeter 117 that conforms to the shape of a circle C. A portion of perimeter 117 is cut away to form a notch 118 that extends radially from the perimeter of circle C toward the center of the circle, as shown. The arc segment of circle C that intersects with the peripheral opening formed by notch 118 is shown in dashed lines in FIG.

[0036] The base 120 is attached to the top surface 112 of the pad 110. The base 120 has a bottom surface 121 and a top surface 122 opposite the bottom surface. The bottom surface 121 of the base 120 can be attached to the top surface 112 of the pad 110 using a second adhesive 123, which can be applied to the bottom surface of the base, the top surface of the pad, or both. Referring to FIG. 4, the top surface 122 has a flat portion 123 and a raised portion 124 separated from the flat portion by a slope 125. The thickness of the flat portion 123 is significantly less than the raised portion 124. An elongated slot 126 is defined by the base 120 of the flat portion 123. The slot 126 has a first rounded end 126a and a second rounded end 126b, each enclosed within the flat portion 123. An intermediate portion 126c of the slot 126 connects to the outermost periphery 127 of the base 120 through a catheter tube guide opening 128. The guide opening 128 has a rounded end 128a with no sharp angles that forms a smooth, continuous transition between the outer periphery 127 and the inner wall 126d of the slot 126.

[0037] The raised portion 124 and the angled portion 125 define a first receptacle 129. The first receptacle 129 is generally rectangular with two opposing side walls 129a, an end wall 129b, and rounded corners 129c connecting the side walls and the end wall. The first receptacle 129 also defines a first bearing surface 129d. The opposing side walls 129a are separated by a width W1, which is equal to or substantially equal to the width W2 of the slot 126. The raised portion 124 extends upwardly from the bottom surface 121 and has a curved shoulder portion 124a that is leveled to form a flat top deck 124b. The top deck 124b surrounds the first receptacle 129 on three sides to abut the side walls 129a and the end wall 129b.

[0038] The base 120 can be attached to the pad 110 such that the slot 126 and guide opening 128 are aligned with a portion of the notch 118. This allows the CSD 100 to be manipulated around the catheter tube CT while guiding the catheter tube into the slot 126 where it exits the insertion site S. A base according to the present disclosure can be formed of any suitable material. In this non-limiting example, the base 120 is an injection molded part made of nylon.

[0039] The inertia damper 130 sits in the first receptacle 129 on the first bearing surface 129d. In this example, the inertia damper 130 consists of a block 131 made of a resilient foam material and having a generally rectangular geometric shape. With reference to FIG. 5, the foam block 131 has a first side wall 131a, a second side wall 131b opposite the first side wall, a first end wall 131c, and a second end wall 131d opposite the first end wall. The first side wall 131a connects to the first end wall 131c at a first rounded corner 131e and connects to the second end wall 131d at a second rounded corner 131f. The second side wall 131b connects to the first end wall 131c at a third rounded corner 131g and connects to the fourth end wall 131d at a fourth rounded corner 131h. In this arrangement, the first and second side walls 131a, 131b, the first and second end walls 131c, 131d, and the rounded corners 131e-131h form a smooth, continuous peripheral wall 131i without any sharp corners. The first and third rounded corners 131e, 131g have a first radius of curvature R1, and the second and fourth rounded corners 131f, 131h have a second radius of curvature R2. R1 is twice as large as R2. Foam blocks according to the present disclosure can be formed from any suitable foam material. In a non-limiting example of the present invention, the foam block 131 is a 1 / 8 inch thick polyethylene foam block.

[0040] 2 and 3, the cover 140 rests on the foam block 131. The foam block 131 is sandwiched between the base 120 and the cover 140, supporting the cover in a floating state above the base. The cover 140 has a bottom surface 141 and a top surface 142 opposite the bottom surface. Referring to FIG. 6, the bottom surface 141 defines a second receptacle 143. The second receptacle 143 is rectangular having two opposing side walls 143a, an end wall 143b, and rounded corners 143c. The second receptacle 143 also defines a second bearing surface 143d. The opposing side walls 143a are spaced apart by a width W3 that is equal to or substantially equal to the width W1 of the first receptacle 129. Foam block 131 has a width W4 that is equal to or slightly less than the width W1 of first receptacle 129 and the width W3 of second receptacle 143. These dimensional relationships allow a lower portion 136 of foam block 131 to fit snugly within first receptacle 129 and an upper portion 137 of the foam block to fit snugly within second receptacle 143. Covers according to the present disclosure can be formed of any suitable material. In this non-limiting example, cover 140 is an injection molded part made of nylon, like base 120.

[0041] The foam block according to the present disclosure can have a shape that corresponds to the shape of the receptacles in the base and cover. In this example, the rounded corner 129c of the first receptacle 129 and the rounded corner 143c of the second receptacle 143 have a radius of curvature R3. R3 is equal to or slightly greater than the first radius of curvature R1 of the foam block 131. That is, R3 is equal to or slightly greater than the radius of the first and third rounded corners 131e, 131g. This dimensional relationship further enables the foam block 131 to fit snugly into the first and second receptacles 129, 143.

[0042] A foam block according to the present disclosure can be secured between the base and the cover in a number of ways. Returning to FIG. 3, foam block 131 has a bottom surface 132 that is attached to the first bearing surface 129d by a third adhesive 133. Foam block 131 also has a top surface 134 that is attached to the second bearing surface 143d by a fourth adhesive 135. The third adhesive 133 and the fourth adhesive 135 are applied as coatings to the bottom surface 132 and the top surface 134 of foam block 131, respectively. Here, the third adhesive 133 and the fourth adhesive 135 can be applied as coatings to the first bearing surface 129d and the second bearing surface 143d, respectively, which can be done as an alternative to or in addition to coating foam block 131.

[0043] Foam block 131 is sandwiched between base 120 and cover 140 with a lower portion 136 received and seated in first receptacle 129 and an upper portion 137 received and seated in second receptacle 143. With reference to Figures 2 and 3, first receptacle 129 has a first depth D1 and second receptacle 143 has a second depth D2. Foam block 131 has a height H that is greater than the sum of first depth D1 and second depth D2. Thus, foam block 131 separates base 120 and cover 140 by a small gap G.

[0044] The first portion 136 seats in the first receptacle 129 with a snug fit between the side walls 129a, and the second portion 137 seats in the second receptacle 143 with a snug fit between the side walls 143a. The side walls 129a, 143a, the third adhesive 133, and the fourth adhesive 135 prevent the foam block 131 from translating in the first and second receptacles 129, 143. That is, the bottom surface 132 remains fixed relative to the first bearing surface 129d, and the top surface 134 remains fixed relative to the second bearing surface 143d. Despite these fixations, the base 120 and the cover 140 can translate laterally relative to one another due to the deformability of the foam block 131. The deformability of the foam block 131 also allows the cover 140 to tilt in multiple directions relative to the base 120. 2 shows two possible directions of translation by arrow T1 and two possible directions of tilt by arrow T2. Arrows T1 and T2 indicate the direction of translation in the plane of the drawing and the direction of tilt relative to an axis perpendicular to the plane of the drawing. Cover 104 can also be translated and tilted relative to other planes and axes.

[0045] A CSD according to the present disclosure can have one or more retaining members that serve multiple functions. The retaining members are useful for limiting tilt of the cover relative to the base and maintaining a minimum clearance between the bottom surface 141 of the cover 140 and the top surface 122 of the base 120. This reduces the possibility of pinching of the catheter tube CT between the bottom surface 141 of the cover and the top surface 122 of the base 120. The retaining members also provide a coil management structure that tightly wraps the catheter tube CT around the inertial damper 130, as described below. The retaining members can have various configurations and arrangements between the base and the cover. Additionally, the retaining members can be located on only the base, only the cover, or on both the base and the cover.

[0046] In this example, as shown in Figs. 2, 3 and 6, two retaining members are provided in the form of a first post 144 and a second post 145. The first and second posts 144, 145 protrude from the bottom surface 141 of the cover 140 toward the top surface 122 of the base 120 when the parts are assembled. The first post 144 is arranged to align and abut the top deck 124b on one side of the first receptacle 129, and the second post 145 is arranged to align and abut the top deck on the opposite side of the first receptacle. The first post 144 and the second post 145 each limit the extent to which the cover 140 can be tilted laterally so as to maintain a minimum spacing between the bottom surface 141 and the top surface 122. The minimum spacing can be selected to be larger than the diameter of the largest catheter tube CT commercially available, allowing for safety considerations to prevent catheter tube collisions in all applications.

[0047] When the CSD 100 is assembled, the first post 144 is spaced from the foam block 131 by a first lateral clearance 152. The second post 145 is spaced from the foam block 131 by a second lateral clearance 154. The first and second lateral clearances 152, 154 provide a small space between the first and second posts 144, 145 and the foam block 131.

[0048] When the CSD 100 is placed over the catheter insertion site S, the gap G is configured to receive a portion of the catheter tube CT that extends out of the insertion site from the slot 126. The gap G is configured to receive a portion of the catheter tube CT between the base 120 and the cover 140 so that the catheter tube is wrapped around the foam block 131. Another top view of the CSD 100 is shown in FIG. 7, which illustrates how the catheter tube CT is wrapped under the cover 104. Hidden parts such as the foam block 131, the first and second posts 144, 145, and a portion of the catheter tube CT are shown in dashed lines. The two arrows on the CT indicate the winding direction starting at the insertion site S and ending at the bottom right of the figure.

[0049] The CSD 100 is symmetrical about an axis Y that bisects the slot 126. Thus, the slot 126, the first and second posts 144, 145, the foam block 131, and the first and second clearances 152, 154 are symmetrically positioned about the axis Y. This symmetry allows a user to position the CSD 100 over the catheter insertion site S with the catheter tube CT positioned at either the first rounded end 126a or the second rounded end 126b of the slot 126. This symmetry also allows the catheter tube CT to enter the gap G on either side of the axis Y. Furthermore, this symmetry allows a user to wind the catheter tube CT around the foam block 131 in either a clockwise or counterclockwise direction. Thus, the symmetrical positioning allows a user to select the relative position of the CSD 100 over the insertion site S according to preference, and to select the winding direction according to preference.

[0050] The CSD 100 shown in FIG. 7 is positioned over the insertion site S with the catheter tube CT positioned at the first rounded end 126a of the slot 126. From this position, the catheter tube CT enters the gap G to the left of the axis Y and is fed through the first clearance 152. The catheter tube CT further extends through the gap G extending along the first side wall 131a. The catheter tube CT then continues around the first rounded corner 131e, the first end wall 131c, the third rounded corner 131g, and the second side wall 131b before entering the second clearance 154. From the second clearance 154, the catheter tube CT further extends along the fourth rounded corner 131h, the second end wall 131d, and the second rounded corner 131f until it returns to the first side wall 131a. In this manner, the catheter tube CT is wrapped clockwise around the foam block 131, forming a complete loop around the circumference of the foam block 131. The catheter tube CT then loops again around the first side wall 131a, the first rounded corner 131e, the first end wall 131c, the third rounded corner 131g, the second side wall 131b and the second clearance 154, before exiting gap G on the right side of axis Y.

[0051] The catheter tube CT is loaded and frictionally engaged against some or all of the side walls 131a, 131b, end walls 131c, 131d, and rounded corners 131e-131h as the catheter tube is wrapped around the foam block 131. The frictional engagement between the catheter tube CT and the foam block 131 allows the foam block to convert kinetic energy in the catheter tube CT (i.e., energy from a tensile force applied to the catheter tube) into thermal energy through frictional resistance. The foam block 131 also absorbs a portion of the force applied to the catheter tube CT by plastically or elastically deforming. For example, the foam block 131 can buckle, bend, and / or twist in response to a force applied to the catheter tube CT, absorbing a portion of the kinetic energy as the shape of the foam changes.

[0052] The CSD according to the present disclosure is configured to be covered with a bio-occlusive dressing to reduce the risk of infection at the catheter site. The components of the CSD have a geometry that allows the dressing to be easily applied over the device and adhere securely to the patient. The cover and base can have a very low height-to-width ratio, resulting in a low profile on the patient's skin. The low profile limits the amount that the device protrudes above the skin surface, thereby reducing the required size of the dressing. With reference to FIG. 2, for example, the base 120, block 131 and cover 140 have a height-to-width ratio of about 1:5 when assembled. It will be appreciated that a higher ratio, such as 1:4 or 1:3, can also be used, but in this case the device may protrude further from the patient and require a larger dressing.

[0053] The CSD according to the present disclosure also has a shape that allows the dressing to lie flat against the device components and the patient. In this embodiment, the base 120 and cover 140 form a pyramidal shape when assembled, with a rectangular base and sloping sides that taper inward as the sides extend from the base to the cover. The sloping surfaces on the base 120 are generally aligned with the sloping surfaces on the cover 140. Furthermore, the contour changes along the sloping surfaces are rounded, defining a smooth compound curvature. This shape allows the dressing to be easily applied onto the CSD 100 and pressed flat against the cover and base without catching on sharp edges.

[0054] A variety of dressings can be applied over the CSD 100. The dressings can be provided in a kit with the CSD 100. Or, the CSD 100 can be packaged as a stand-alone device and the dressings provided separately. FIGS. 1 and 3 show a kit 50 including a CSD 100 and a bio-occlusive dressing 80 packaged with a CSD. The dressing 80 includes a foam border 82 and a transparent window 84. The foam border 82 is formed from 1 / 16 inch thick medical grade polyethylene foam. The window 84 is made from a medical grade polyurethane film. The foam border 82 is attached to the window 84 by a fifth adhesive 83 applied to the patient-facing side 82a of the foam border. The window 84 has a sixth adhesive 85 applied to the patient-facing side 84a of the window to attach the dressing 80 to the CSD 100 and to the patient. Dressing 80 also has a release liner 86 applied to the patient-facing side 84a of window 84 to cover sixth adhesive 85 until the dressing is ready for use. The total area of ​​dressing 80 is larger than the top surface area of ​​CSD 100, allowing window 84 to cover the entire footprint of the CSD along with all components visible through the window, as shown.

[0055] 8 illustrates one possible method 1000 for using a CSD according to the present disclosure. The following sections describe the steps of method 1000 assuming that CSD 100 is used. It will be understood that the following steps may be used with other CSDs having a similar design to CSD 100 and are not limited to CSD 100. The following sections further assume that the catheter insertion site S is prepared according to an appropriate protocol prior to performing the described steps.

[0056] In step 1100, the first and second liner sections 115, 116 are removed from the pad 110, exposing the first adhesive 113 on the bottom surface 111 of the pad.

[0057] In step 1200, the CSD 100 is placed over the insertion site S and rotated into the appropriate orientation. The user grasps one side of the pad 110 with a first hand (either the left or right hand) and holds the CSD 100 so that the notch 118 faces toward the user. This orientation is shown in Figure 1. The CSD 100 is then moved into a position where the notch 118 is adjacent to the catheter tube CT.

[0058] In step 1300, the catheter tube CT is carefully guided into the slot 126 of the CSD 100. This step is preferably performed without the bottom surface 111 of the pad 110 and the first adhesive 113 touching the patient. With the first hand still gripping the pad 110, the user grasps the catheter tube CT with the other hand and raises the catheter tube as necessary to prevent the catheter tube from lying flat on the patient. The user manipulates the CSD 100 around the catheter tube so that it is received within the notch 118. The user then further manipulates the CSD 100 to align a section of the catheter tube CT with the guide opening 128. Once alignment is achieved, the user adjusts the position of the CSD 100, the catheter tube CT, or both to guide the catheter tube CT into the slot 126. The base 120 has a smooth leading end 120a without sharp corners extending on each side of the guide opening 128. If the catheter tube CT misses the guide opening 128 and contacts the front end 120a of the base 120 during the manipulation process, the catheter tube will slide along the front end until it reaches one of the rounded ends of the guide opening. The rounded end 128a is configured to pull the catheter tube CT into the slot 126 without encountering any sharp edges or obstacles. Once the catheter tube CT enters the slot 126, the user can fine-tune the relative position of the CSD 100 and the catheter tube CT so that the catheter tube is located at the first rounded end 126a or the second rounded end 126b, depending on the user's preference. For example, if the user prefers to wrap the catheter tube CT clockwise around the foam block 131 as shown in FIG. 6, the user can place the catheter tube at the first rounded end 126a so that the wrapping starts on the left side of the axis Y. If the user prefers to wrap the catheter tube CT around the foam block 131 counterclockwise, the user can position the catheter tube at the second rounded end 126b so that the wrapping begins on the right side of the axis Y.

[0059] In step 1400, the user applies the CSD 100 to the patient around the insertion site S. The user tilts the pad 110, if necessary, so that the bottom surface 111 of the pad 110 is perpendicular to an imaginary line extending perpendicularly from the insertion site S. The user then lowers the pad 110 onto the patient's skin and presses the pad down around the insertion site S so that the first adhesive 113 forms a bond with the patient's skin.

[0060] In step 1500, the user feeds the catheter tube CT into the CSD 100. The user grasps a section of the catheter tube CT proximate the insertion site S and carefully inserts the tube section into the gap G between the base 120 and the cover 140. The user can do this by gently pulling on the catheter tube CT to apply a small amount of tension so that the catheter tube section straightens out. The straight length of the tube is then positioned on either the left or right side (depending on preference) of the base 120 and cover 140 such that the straight length of the tube approximately matches the gap G. Once this alignment is achieved, the user guides the catheter tube CT into the gap G. The user continues to apply a small amount of tension to the catheter tube CT so that the catheter tube CT snaps into the gap G and bears against the foam block 131. Depending on design preferences and dimensions, the first post 144 or the second post 145 may create a small obstruction that partially blocks the path of the catheter tube CT when the catheter tube CT snaps into the first clearance 152 or the second clearance 154, respectively. Therefore, the first post 144 and the second post 145 preferably have rounded ends that allow the catheter tube CT to slide smoothly around the ends of the posts. Upon reaching the foam block 131, the catheter tube CT is positioned in the first clearance 152 if entering from the left side, or in the second clearance 154 if entering from the right side.

[0061] In step 1600, the user wraps the catheter tube CT around the foam block 131. The catheter tube CT can be wrapped in a clockwise direction in the manner previously described. For example, the user can insert the catheter tube CT from the left side of the base 120 and cover 140 into the gap G, and then wrap it around the top, right side, and bottom of the base and cover, as shown in FIG. 7. Alternatively, the catheter tube CT can be wrapped in a counterclockwise direction, in which case the user inserts the catheter tube CT from the right side of the base 120 and cover 140 into the gap G, and then wrap it around the top, left side, and bottom of the base and cover. The user should gently tug on the catheter tube CT each time it enters the left and right sides and hits the first post 144 and the second post 145, so that the catheter tube slides under the posts and snaps into the first and second clearances 152, 154. The catheter tube CT can be wrapped around the foam block 131 one or more times to secure the catheter tube to the CSD 100. A small amount of tension can be maintained on the catheter tube CT throughout the winding process to keep the catheter tube CT snugly fitted around the foam block 131. If some tension is lost in the catheter tube CT, the coil can slacken a small amount such that one or more sections of the loop move away from the foam block 131. In such a case, the first and second posts 144, 145 act as coil retaining members that limit the amount of unwinding of the coil, and the coil is maintained in partial engagement with and close proximity to the foam block 131.

[0062] During the wrapping process, the cover 140 can be tilted left or right or sideways to increase the height of the gap G on one side of the CSD 100. This may be desirable to facilitate fitting the catheter tube CT into the gap G. For example, to increase the height of the gap G on the left side of the CSD 100, the user gently presses the right side of the cover 140 to raise the left side of the cover relative to the base. To increase the height of the gap G on the right side of the CSD 100, the user gently presses the left side of the cover 140 to raise the right side of the cover relative to the base. When tilting the cover 140 to the right, the second strut 145 limits how much the cover can tilt to reduce the possibility of pinching the catheter tube CT. Similarly, when tilting the cover 140 to the left, the first strut 144 limits how much the cover can tilt to reduce the possibility of pinching the catheter tube CT.

[0063] Once the catheter tube CT is wrapped around the foam block 131, the catheter tube is secured against movement by inertial damping. The catheter tube CT is loaded against and frictionally engages at least a portion of the side walls 131a, 131b, end walls 131c, 131d, and rounded corners 131e-131h of the foam block 131. This allows the foam block 131 to convert kinetic energy from forces applied to the catheter tube CT into thermal energy as a result of frictional resistance between the catheter tube and the foam block. The foam block 131 also absorbs a portion of the forces applied to the catheter tube CT by plastically or elastically deforming.

[0064] Inertial damping can be further explained with reference to FIG. 7, where a hypothetical tensile force F is applied to the catheter tube CT. The force F can be caused by accidental contact between the catheter tube CT and its surroundings, for example, clothing or clothing pulling on the catheter tube as the patient moves. The force F is transmitted along the length of the catheter tube CT to the coiled portion of the tube around the foam block 131, which places the coiled portion under higher tension. During this period of increased tension, at least some of the coils are tightened and pressed against the foam block 131, creating additional frictional resistance. The frictional resistance limits or prevents the catheter tube CT from sliding against the foam block 131. The side walls, end walls and rounded corners of the foam block 131 are radially compressible in response to the tightening of the coils, causing plastic or elastic deformation that absorbs some of the energy and stores some of the energy as potential energy in the foam. When the tension is released, i.e., when the tensioned portion of the catheter is released from the exterior portion that is pulling the tube, some or all of the tension in the coils may also be released. In such a case, the energy stored in the foam block 131 is released, causing the foam block 131 to expand and return to its original shape or be able to return to its original shape. The tensile forces along the length of the tube are dissipated by a combination of energy transformation and absorption by the foam block 131. As a result, the foam block 131 is configured to transform and absorb energy applied to a section of the catheter tube CT that is external to the patient such that the energy does not displace a section of the catheter tube CT that is internal to the patient.

[0065] Referring again to FIG. 8, the method may further include applying a bio-occlusive dressing in step 1700. For example, the dressing 80 described above may be applied over the CSD 100. A user may hold the dressing 80 over the CSD 100 with one hand, with the patient-facing side 84a and the release liner 86 facing towards the CSD. The user then removes the release liner 86 with the other hand. After removing the release liner 86, the user places the window 84 over the CSD 100, with the center of the CSD at the center of the window. The user then applies the dressing 80 to the patient by pressing down the edges of the dressing so that the sixth adhesive 85 adheres to the patient. The window 84 may also be pressed over the CSD 100 and the catheter tube CT so that the sixth adhesive 85 adheres to the CSD and the catheter tube. Dressing 80 covers the entire footprint of CSD 100 and provides a protective seal around the periphery of the CSD, sealing the insertion site S from moisture and reducing the risk of infection at the insertion site.

[0066] 9-11, another example CSD 200 is shown with a catheter tube CT' secured to the CSD. The CSD 200 includes a base in the form of a pad 210 having a bottom surface 211 for attachment to a patient's skin surrounding a catheter insertion site S'. The pad 210 also has a top surface 212 opposite the bottom surface 211 that faces away from the patient's skin when the CSD is attached to the patient. A first adhesive 213 is applied to the bottom surface 211 to secure the pad 210 to the patient's skin. A peelable cover or liner 214 is removably attached to the bottom surface 211 to cover the first adhesive 213 until the CSD is to be used. The liner 214 is removable from the bottom surface 211 to expose the first adhesive 213. Pads according to the present disclosure may be formed of any suitable material. In this non-limiting example, the pad 210 is formed from 1 / 32 inch thick polyethylene foam and is provided with a single coat of adhesive as in the previous example.

[0067] Pads according to the present disclosure can have a variety of shapes and geometries. With reference to FIG. 12, pad 210 has a perimeter 217 that conforms to the shape of a circle C'. A portion of perimeter 217 is cut away to form a notch 218 that extends radially from the perimeter of the circle toward the center of the circle, as shown. The arc segment of circle C' that intersects with the peripheral opening formed by notch 218 is shown in dashed lines. Pad 210 also includes an extension portion 219 that protrudes from perimeter 217.

[0068] The inertial damper 220 is attached to the top surface 212 of the pad 210. The inertial damper 220 has a foam body 221 having a bottom surface 221a and a top surface 221b opposite the bottom surface. The bottom surface 221a of the foam body 221 is attachable to the top surface 212 of the pad 210 with a second adhesive 223, which may be applied to the bottom surface of the base, the top surface of the pad, or both. The foam body 221 has a perimeter 227 that conforms to the shape of a circle C''. The arc segment of the circle C'' that intersects with the peripheral opening formed by the notch 218 is shown in dashed lines in FIG. 12.

[0069] An elongated slot 226 is defined through the foam body 221. The slot 226 has a first end 226a located adjacent the center of the circle C'' and a second end 226b opening through the perimeter 227. The first end 226a has a semicircular or rounded shape without sharp angles and is configured to guide the catheter tube CT' from the insertion site S' into the inertial damper 220. The second end 226b forms a catheter tube guide opening 228 having a rounded edge 228a without sharp angles and forming a smooth continuous transition between the perimeter 227 and the inner wall 226d of the slot 226. The catheter tube guide opening 228 and the rounded edge 228a assist the catheter tube CT' in being received in the slot 226 when the CSD 200 is positioned around the catheter tube and insertion site S'.

[0070] The foam body 221 is attached to the pad 210 so that the slot 226 and guide opening 228 are aligned with the notch 218. This alignment allows the CSD 200 to be manipulated around the catheter tube CT' while guiding the catheter tube into the slot 226 where it exits the insertion site S'. The notch 218 and slot 226 also form an unobstructed viewing opening 229 that allows the caregiver to view the insertion site S' during and after placement of the CSD 200.

[0071] The foam body 221 is attached to the pad 210 with the circle C'' concentrically disposed with the circle C' and the slot 226 aligned with the notch 218 as shown. A base according to the present disclosure may be formed of any suitable material. Additionally, a base according to the present disclosure may be formed in one or more sections. In this non-limiting example, the foam body 221 is formed of thick polyethylene foam having a thickness of 1 / 8 inch, coated with a second adhesive 223, and divided into four separate sections.

[0072] The four sections of the foam body 221 are positioned relative to one another on the pad 210 to collectively fit within a circle C″, and each section is attached to the pad with a second adhesive 223. The sections are spaced apart from one another to allow the catheter tube CT′ to be wound around the foam body 221 and looped through the foam body. The inertial damper according to this embodiment can feature any number of sections to facilitate winding and looping of the catheter tube. Additionally, the inertial damper sections can have geometric shapes and relative spacing to create a symmetrical arrangement of the inertial damper sections or an asymmetrical arrangement of the inertial damper sections. For example, the inertial damper can have at least two outer or “side” damper sections having the same shape and top surface area arranged in a mirrored arrangement, or at least two side damper sections having different shapes and top surface areas. Additionally or alternatively, the inertial damper can have at least two inner or “inner” damper sections having the same shape and top surface area arranged in a mirrored arrangement, or at least two inner damper sections having different shapes and top surface areas. A symmetrical arrangement of the damper portions may distribute forces more evenly across the foam body 221, while an asymmetrical arrangement may allow more foam material to be placed on certain sides or in certain areas that are expected to receive more forces from the catheter tube CT' than other areas.

[0073] In this example, the inertia damper 220 consists of an inner inertia damper 220a spanning the inner area of ​​the circle C'' and a side inertia damper 220b spanning two side areas of the circle C''. The inner inertia damper 220a consists of a first inner inertia damper 220a1 shown to the left of the slot 226 and a second inner inertia damper 220a2 shown to the right of the slot. The side inertia damper 220b consists of a first side inertia damper 220b1 shown to the left of the first inner inertia damper 220a1 and a second side inertia damper 220b2 shown to the right of the second inner inertia damper 220a2. The first inner inertia damper 220a1 and the second inner inertia damper 220a2 are arranged symmetrically about an axis Y' that intersects the diameter of the circle C'' and bisects the slot 226. Similarly, the first side inertia damper 220a1 and the second side inertia damper 220a2 are arranged symmetrically about the axis Y'.

[0074] The first side inertia damper 220b1 and the first inner inertia damper 220a1 are separated by a first flow passage 252. The second side inertia damper 220b2 and the second inner inertia damper 220a2 are separated by a second flow passage 253. The first inner inertia damper 220a1 and the second inner inertia damper 220a2 are separated by a third flow passage 254. The first flow passage 252, the second flow passage 253 and the third flow passage 254 extend parallel to one another through the foam body 221.

[0075] The first channel 252, the second channel 253, and the third channel 254 each have a channel width W' adapted to receive a portion of the catheter tube CT' in one or more passes. Referring again to FIG. 9, the first channel 252 has a first end 252a and a second end 252b opposite the first end. The first end 252a and the second end 252b each open to the periphery 227 of the foam body 221. Similarly, the second channel 253 has a first end 253a and a second end 253b each opening to the periphery 227. With this configuration, the catheter tube CT' can be inserted into the first channel 252 from two different peripheral positions of the foam body 221 and / or into the second channel 253 from two different peripheral positions of the foam body.

[0076] The third channel 254 has a first end 254a that opens to the periphery 227 and a second end 254b that intersects with the slot 226. With this configuration, a portion of the catheter tube CT' protruding from the insertion point S' can be fed through the second end 254b into the third channel 254. As a result, the first channel 252, the second channel 253 and the third channel 254 allow the catheter tube CT' to be fed from the insertion point S' into the third channel 254, looped around the outside of one or more of the inner inertia dampers 220a1, 220a2 and the lateral inertia dampers 220b1, 220b2, inserted around the outside of one or more of the inner and lateral inertia dampers of the first and second channels 252, 253, and looped again as needed.

[0077] 10, the first channel 252 is spaced apart from the third channel 254 by a first distance X1, and the second channel 253 is spaced apart from the third channel 254 by a second distance X2. Since the first distance X1 is equal to the second distance X2, the first channel 252 and the second channel 253 are equidistant to the third channel 254. The first, second and third channels 252-254 open towards the periphery 227 at five locations around the periphery to form openings 258a-258e arranged in a circular pattern that fits the circle C''. The distribution of the openings 258a-258e around the periphery allows the user to wrap the catheter tube CT' around the outside of the foam body 221 in a clockwise or counterclockwise direction, depending on preference. The distribution of the openings 258a-258e also allows a user to wrap the tube partially or completely around any of the inner inertia dampers 220a1, 220a2 and / or the lateral inertia dampers 220b1, 220b2, depending on preference. The catheter tube CT' can be coiled around any one of the inner inertia dampers 220a1, 220a2 and / or the lateral inertia dampers 220b1, 220b2, and / or can be coiled around a combination of two or more of the inner inertia dampers 220a1, 220a2 and / or the lateral inertia dampers 220b1, 220b2.

[0078] With reference to FIG. 13, the catheter tube CT' is shown extending convolutedly from the insertion point S' through the foam body 221. The catheter tube CT' is first passed through the third channel 254 so that the tube exits the third channel at opening 258b. The catheter tube CT' is then wound clockwise around the outer edge of the second inner inertial damper 220a2 and through the second channel 253 so that the tube exits the second channel at opening 258d. From opening 258d, the catheter tube CT' is further wound clockwise around the outer edge of the second inner insert damper 220a2, the outer edge of the first inner inertial damper 220a1 and through the first channel 252 so that the tube exits the first channel at opening 258a. From there, the catheter tube CT' extends to a source of fluid to be administered to the patient. In FIG. 13, the source is shown diagrammatically as an infusion pump P connected to the catheter tube CT'. The first side inertia damper 220b1 and the second side inertia damper 220b2 act as coil retaining members, similar to the posts 144, 145 in the first embodiment, so that the loop remains tightly wound around the first and second inner inertia dampers 220a1, 220a2.

[0079] The tube fixation channel according to the present disclosure can have one or more sidewall configurations to stabilize and fixate the catheter tube within the inertial damper. Thus, the foam body according to the present disclosure can be cut in a number of ways to form different sidewall configurations. For example, one or more channels can have flat continuous sidewalls with a uniform width between the sidewalls that is smaller than the diameter of the tube to be fixed. Flat sidewalls provide a simple geometry, but can create difficulties when inserting the tube into the inertial damper. The flat sidewalls tend to engage all or substantially all of the catheter tube. If the diameter of the catheter tube is significantly larger than the width of the channel, the sidewalls can create a significant amount of frictional resistance along the entire length of the tube segment, making insertion and removal of the tube difficult.

[0080] Applicant has discovered that sidewall discontinuities in the form of undulations strike an appropriate balance between (1) providing sufficient surface area to secure the catheter tube against undesired movement, and (2) limiting the amount of frictional resistance encountered when inserting the tube into the channel so as to facilitate insertion. The undulations can be spaced at regular or irregular intervals along the length of the channel and have a variety of shapes. Suitable shapes include, but are not limited to, zigzag edges, sawtooth, sawtooth and wave patterns. The undulations can form a series of narrow or constricted sections and wider sections, the narrow sections having a channel width slightly less than the diameter of the catheter tube CT' to frictionally engage the outer region of the catheter tube.

[0081] 10 and 12, each of the channels 252-254 has a pair of wavy side walls 257. Each side wall 257 has a series of undulations 257a that extend in a sinusoidal or wavy manner. The undulations 257a are comprised of peaks or ridges 251 and valleys or recesses 259. The undulations 257a are provided in a mirror arrangement on both sides of the channel. That is, the peaks 251 are aligned and facing each other on both sides of each channel, and the recesses 259 are aligned and facing each other on both sides of each channel. In this arrangement, the peaks 251 form a narrow constriction 257b, and the recesses 259 form a wider non-constriction 257c. The channel width at the narrow constriction 257b is smaller than the diameter of a typical catheter tube. For example, the channel width at the narrow constriction 257b can be between about 0.0125 and 0.0250 inches. The channel width at the wide non-constricted portion 257c is larger than the diameter of a typical catheter tube. For example, the channel width at the non-constricted portion 257c can be between about 0.100 inches and 0.130 inches. The channels 252-254 have a universal channel width at the narrow waist portion 257b to accommodate 18G-24G tubing.

[0082] The softness of the foam body 221 allows the side walls 257 to be pushed outward and expand under the stored energy as the catheter tube CT' is inserted into each channel. As the catheter tube CT' is inserted into the channel, the expansion of the side walls 257 creates a reaction force in the foam that resists the catheter tube. The reaction force gently squeezes or resists loads from outside the catheter tube CT' to secure the position of the tube without pinching the tube walls or changing the size or shape of the tube passage. The convex portion 251 occupies only a small portion of the total side wall length. Thus, the side walls 257 only resist loads from a small portion of the outer surface area of ​​the catheter tube CT'. As a result, the reaction force only creates a slight to moderate amount of frictional resistance that is sufficient to prevent accidental dislodging of the catheter tube CT, but not so great as to make it difficult or cumbersome to insert the catheter tube into the channel.

[0083] In this embodiment, the side walls 257 in each channel do not contact one another. However, it will be understood that opposing side walls of a channel can contact one another without departing from this disclosure and its intended purpose. For example, the waist portions of the channels can contact one another such that the channel width W' between the side walls of the waist portions is 0 mm. This may be desirable for very small catheter tubes or applications where more frictional engagement is desired.

[0084] The ratio of the thickness of pad 210 to the diameter of circle C' is relatively small. The ratio of the thickness of foam body 221 to the diameter of circle C'' is also relatively small. These ratios can be as small as, for example, 1:16 to 1:20 or less. This configuration allows CSD 200 to have a very low profile, such that the CSD is more comfortable to wear and less likely to snag on clothing than CSD designs with higher profiles. The small ratio and the presence of multiple channels also provide an efficient fixed geometry that allocates a large surface area within inertial damper 220 for transforming and absorbing kinetic energy while taking up little space above insertion point S'.

[0085] The present disclosure contemplates other configurations having less than four inertia damper sections, as well as configurations having more than four inertia damper sections. For example, the inertia damper can have as few as two dampers, one on the left side of axis Y' and the other on the right side of axis Y'. Alternatively, the inertia damper can have six dampers, three on the left side of axis Y' and the other three on the right side of axis Y'.

[0086] FIG. 14 shows another configuration of an inertial damper 220′ featuring two symmetrically positioned damper sections 220a′ and 220b′. The damper sections 220a′ and 220b′ are semicircular dampers separated by a single channel 252′. In this configuration, the catheter tube can be passed from an insertion point S″ through the channel 252′ and wrapped around one or both damper sections 220a′ and 220b′. After completing one turn or loop around one or both damper sections 220a′, 220b′, the catheter tube can be fed through the channel 252′ in one or more subsequent passes.

[0087] FIG. 15 shows another configuration of an inertial damper 220'' featuring six symmetrically arranged damper sections 220a'', 220b'', 220c'', 220d'', 220e'', and 220f''. The damper sections 220a''-220f'' are separated by five channels 252''-256''. In this configuration, the catheter tube can be passed through the foam body in a convoluted manner from the insertion point S''''. For example, the catheter tube may be threaded from insertion site S''' through third channel 254'', pulled clockwise around the outer edge of damper portion 220d'', looped through fourth channel 255'', pulled clockwise again around the outer edges of damper portions 220d'' and 220c'', looped through second channel 253'', pulled clockwise again around the outer edges of damper portions 220c''-220e'', looped through fifth channel 256'', pulled clockwise again around the outer edges of damper portions 220b''-220e'', and finally looped through first channel 252''. The catheter tube may then be extended and connected to an infusion pump or other source. Alternatively, the catheter tube may be rewound around one or more of damper portions 220a''-220f'' and reinserted through one or more of channels 252''-256'' to further secure the tube.

[0088] FIG. 16 shows a pad 210''' and inertia damper 220''' according to an alternative configuration. Pad 210''' has a keyhole shaped notch 218''' and inertia damper 220''' has a keyhole shaped slot 226'''. The keyhole shape of notch 218''' and slot 226''' provides a spherical opening 290'''' towards the center of pad 210''' and inertia damper 220'''. Opening 290''' provides a larger opening above the insertion point compared to the previous example.

[0089] 17-19 show examples of alternative channel geometries that can be used. FIG. 17 shows a channel 352 having corrugated sidewalls 357 with rectangular shaped peaks 351 and rectangular shaped valleys 359. FIG. 18 shows a channel 452 having corrugated sidewalls 457 with peaks 451 and valleys 459 conforming to an equilateral triangle. FIG. 19 shows a channel 552 having corrugated sidewalls 557 with peaks 551 and valleys 559 conforming to a right triangle. It will be appreciated that other geometries according to the present disclosure can be used to strike a balance between providing sufficient frictional resistance to secure the catheter tube against undesired movement and allowing the catheter tube to be easily inserted into the channel.

[0090] FIG. 20 illustrates an inertial damper 220'''' according to another configuration. The inertial damper 220'''' has first, second and third channels 252''''-254'''' with three different wall shapes. The first channel 252'''' has a rectangular pattern of undulations, the second channel 253'''' has a polygonal pattern of undulations, and the third channel 254'''' has a sinusoidal pattern of undulations. Each channel provides a different amount of frictional resistance based on the amount of surface area in contact with the catheter tube. An inertial damper with multiple channels with different wall shapes and widths, such as the inertial damper 220'''', provides versatility to accommodate a wide range of tube sizes. Multiple channels with different wall shapes and / or widths also allow a user to test different channels and determine which channel provides the best fit for securing a particular catheter tube.

[0091] A CSD according to the present disclosure, as described above, is configured to be covered with a bio-occlusive dressing, which may be supplied with the CSD as a kit or packaged separately. Referring back to Figures 9, 11 and 13, the CSD 200 includes an integrated bio-occlusive dressing 80'. The dressing 80' is attached to the pad 210 via a hinge portion 215. The hinge portion 215 is attached to the pad 210 by double-sided tape 233. In use, the bio-occlusive dressing 80' is pivotable relative to the pad 210 between an open position in which the dressing does not cover the pad and foam body 220, and a closed position in which the dressing is folded over so that it covers the entire pad and foam body. Figure 9 shows the dressing 80' in the closed position, and Figure 13 shows the dressing in the open position.

[0092] The dressing 80' includes a foam border 82' and a transparent window 84'. The foam border 82' is a thick piece of 1 / 16 inch formed medical grade polyethylene foam and includes a patient facing side 82a' and a gripping portion 82b'. The window 84' is made of a medical grade polyurethane film. The foam border 82' is attached to the window 84' by a third adhesive 83' applied to the patient facing side 82a' of the foam border. The window 84' has a fourth adhesive 85' applied to the patient facing side 84a' to attach the dressing 80' to the foam body 220, pad 210 and catheter tube CT' as shown. The dressing 80' also has a release liner 86' applied to the patient facing side 84a' of the window 84' to cover the fourth adhesive 85' until the dressing is ready to be used. The total area of ​​the dressing 80' is greater than the top surface area of ​​the pad 210, allowing the window 84' to cover the entire footprint of the pad and foam body 220, allowing all components to be seen through the window as shown.

[0093] A CSD according to the present disclosure can have an integrated or attached dressing, as in the example of FIG. 13, or can work with a separate dressing. Referring again to FIG. 16, pad 210''' and inertia damper 220''' do not have lateral extensions for attaching the hinge portion of a dressing. Pad 210''' and inertia damper 220''' are not connected to an integrated dressing, but instead are part of a stand-alone CSD that can be used with a separately packaged dressing.

[0094] 21 illustrates another possible method 2000 for using a CSD according to the present disclosure. The following sections describe the steps of method 2000 assuming that a CSD 200 with dressing 80' in an open position is used. It will be understood that the following steps may be used with other CSDs having a similar design to CSD 200 and are not limited to CSD 200. The following sections further assume that the catheter insertion site S' is prepared according to an appropriate protocol prior to performing the described steps.

[0095] In step 2100, the liner 214 is removed from the pad 210, exposing the first adhesive 213 on the bottom surface 211 of the pad. In step 2200, the CSD 200 is placed over the insertion site S' and rotated to the appropriate orientation. The user grasps one side of the pad 210 with their first hand (either left or right) and holds the CSD 200 so that the notch 218 is open or facing towards the user. This orientation is shown in Figure 12. The CSD 200 is then moved into a position where the notch 218 is adjacent to the catheter tube CT'.

[0096] In step 2300, the catheter tube CT' is carefully guided into the notch 218 and slot 226. This step is preferably performed without the bottom surface 211 of the pad 210 and the first adhesive 213 touching the patient. With the first hand still gripping the pad 210, the user grasps the catheter tube CT' with the other hand and raises the catheter tube as necessary to prevent the catheter tube from lying flat on the patient. Holding the catheter tube CT' in a raised position, the user manipulates the CSD 200 around the catheter tube such that the catheter tube is received within the notch 218 and slot 226. The user then further manipulates the CSD 200 to align the first end 226a of the slot 226 over the insertion site S' such that the section of the catheter tube CT' exiting the insertion site is located at the first end.

[0097] In step 2400, the user attaches the CSD 200 to the patient around the insertion site S'. The user tilts the pad 210, if necessary, so that the bottom surface 211 of the pad 210 is perpendicular to an imaginary line extending perpendicularly from the insertion site S'. The user then lowers the pad 210 onto the patient's skin and presses the pad down around the insertion site S' so that the first adhesive 213 bonds with the patient's skin.

[0098] In step 2500, the user provides the catheter tube CT' to the CSD 200. The user grasps a section of the catheter tube CT' proximate the insertion site S' and carefully inserts the tube section into the foam body 221. More specifically, the user inserts the catheter tube CT' into the first end 254a of the third channel 254. The user can do this by gently pulling on the catheter tube CT' to apply a small amount of tension so that the catheter tube section straightens out. The user then places the straight length of tube over the third channel 254 and lowers it into the channel until the tube section is between the wavy sidewalls 257 of the channel. At this stage, at least the top 251 of the sidewalls 257 frictionally engages a portion of the catheter tube section in the third channel 254.

[0099] In step 2600, the user wraps the catheter tube CT' around and through the foam body 221. The catheter tube CT' can be wrapped around the foam body 221 and the individual inertial dampers in either a clockwise or counterclockwise direction. Additionally, the catheter tube CT' can be inserted one or more times through one or more channels. With reference to FIG. 13, for example, the user can first wind the catheter tube CT' in a clockwise direction and actuate the tube around the second inner inertial damper 220a2 as previously described. The catheter tube CT' is then wound in a clockwise direction through the second channel 253, around the outer edge of the second inner inertial damper 220a1, across the notch 218, and around the outer edge of the first inner inertial damper 220a1. The catheter tube CT' is then inserted through the first channel 252. From there, the catheter tube CT' extends from the first channel 252 to an infusion pump or other source of fluid to be administered to the patient. As mentioned above, a small amount of tension can be maintained on the catheter tube CT′ throughout the winding process to keep the catheter tube straight for insertion into each channel and to allow the catheter tube to be tightly wound around 227 of the foam body 221.

[0100] Once the catheter tube CT' is wound around and through the foam body 221, the catheter tube is secured against movement by inertial damping, similar to how the catheter CT is secured to the CSD 100. The catheter tube CT' is pressed against and frictionally engages at least a portion of the side walls 257 of the first, second and third channels 252-254. Additionally, the catheter tube CT' frictionally engages at least a portion of the peripheral side walls of the inertial dampers that constitute the periphery of the foam body 221. This allows the foam body 221 to convert kinetic energy from forces applied to the catheter tube CT' into thermal energy as a result of frictional resistance between the catheter tube and the foam body. The foam body 221 also absorbs a portion of the forces applied to the catheter tube CT' by plastically or elastically deforming. The first and second side inertial dampers 220b1, 220b2 act as coil retention members, keeping the CT' tightly wound around the inner inertial dampers during and after the winding process.

[0101] At step 2700, the user applies the integrated bio-occlusive dressing 80'. The user may do so by holding the gripping portion 82b' of the foam border 82' when the dressing 80' is in the open position and removing the release liner 86' from the window 84' to expose the fourth adhesive 85'. The user then rotates or turns the dressing 80' about the hinge portion 215 until the dressing is inverted about the window 84' and over the foam body 221. Once the window 84' is over the foam body 221, the user presses the edge of the dressing 80' against the patient so that the fourth adhesive 85' adheres to the patient, the foam body 221 and the catheter tube CT' (see FIG. 9). The dressing 80' covers the entire footprint of the CSD 200 and provides a protective seal around the CSD to seal the insertion site S' from moisture and reduce the risk of infection at the insertion site.

Claims

1. The catheter holding device a base forming a slot; at least one inertia damper attached to the base and extending above the slot; A catheter retention device, wherein the slot and the at least one inertial damper are positioned relative to one another such that when the slot is aligned over a catheter insertion site, a catheter tube exiting the catheter insertion site can be received through the slot and coiled around at least a portion of the at least one inertial damper.

2. 2. The catheter retention device of claim 1, wherein the slot and the at least one inertial damper are positioned relative to one another such that the catheter tube can be coiled around the at least one inertial damper to completely surround the at least one inertial damper.

3. The catheter retention device of claim 1 , wherein the at least one inertial damper comprises a peripheral sidewall configured to frictionally engage the catheter tube.

4. The catheter retention device of claim 3 , wherein the peripheral sidewall is compressible under stored energy.

5. The slot and the peripheral sidewall are 4. The catheter retention device of claim 3, wherein the slot is relatively positioned such that when the slot is aligned over the catheter insertion site, a catheter tube exiting the catheter insertion site can be received through the slot and coiled around at least a portion of the peripheral sidewall.

6. The catheter retention device of claim 3 , wherein the peripheral sidewall includes a plurality of sidewall sections.

7. The slot and the peripheral sidewall are 7. The catheter retention device of claim 6, wherein the catheter retention device is relatively positioned such that when the slot is aligned over the catheter insertion site, a catheter tube exiting the catheter insertion site can be received through the slot and coiled around some or all of the plurality of sidewall sections.

8. The catheter retention device of claim 3 , further comprising at least two coil retention members configured to retain the catheter tube in a coil around the at least one inertial damper.

9. 9. The catheter retention device of claim 8, wherein each of the at least two coil retention members is configured to limit movement of the catheter tube away from the peripheral sidewall after the catheter tube is coiled and retained around the at least one inertial damper.

10. The catheter retention device of claim 8 , wherein the at least two retention members include at least two posts.

11. The catheter retention device includes a cover; The catheter retention device of claim 10 , wherein the at least one inertial damper is included between the base and the cover.

12. 12. The catheter retention device of claim 11, wherein the at least one inertial damper separates the base and the cover by a gap that surrounds the at least one inertial damper, the gap being configured to receive the catheter tube when the catheter tube is coiled around the at least one inertial damper.

13. The catheter retention device of claim 12 , wherein the cover is tiltable relative to the base to increase the size of a gap on one side of the at least one inertial damper.

14. The catheter retention device of claim 13 , wherein each post is configured to limit tilt of the cover relative to the base.

15. 9. The catheter retention device of claim 8, the at least one inertia damper comprises a first side inertia damper, a second side inertia damper, and at least one inner inertia damper between the first side inertia damper and the second side inertia damper; The at least two coil retention members include the first side inertia damper and the second side inertia damper.

16. 16. The catheter retention device of claim 15, the first side inertia damper and the at least one inner inertia damper are separated by a first flow path; the second side inertia damper and the at least one inner inertia damper are separated by a second flow path; a catheter retention device, the catheter tube being configured to be coiled around the at least one inner inertial damper via the first flow path and the second flow path;

17. 16. The catheter retention device of claim 15, the at least one inner inertia damper comprises a first inner inertia damper and a second inner inertia damper; the first inner inertial damper and the second inner inertial damper are separated by a third channel; a catheter retention device, the first channel, the second channel and the third channel being configured such that the catheter tube can be coiled around the first inner inertial damper and the second inner inertial damper via the first channel, the second channel and the third channel, respectively.

18. The catheter retention device of claim 17 , wherein the first channel, the second channel, and the third channel are parallel.

19. The catheter retention device of claim 17 , wherein the slot intersects the third channel.

20. The catheter retention device of claim 1 , further comprising a transparent dressing configured to cover the base, the at least one inertial damper, and the slot.

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