Integrated catheter stabilization and fixation system with line suction optimization

Abstract

Provided herein is a stabilizing device for a catheter, the stabilizing device including: a base defining a base periphery, the base having a top surface and a bottom surface; a support surface disposed on the top surface of the base, the support surface having a wall extending away from the top surface of the base defining a support surface periphery, the support surface periphery having substantially the same shape as the catheter adapter; and a bandage defining a bandage periphery, the bandage configured to cover the base and the support surface.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 328,042, filed April 6, 2022, entitled “LINE Aspiration Optimized Integrated Catheter Stabilization and Fixation System,” the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] FIELD OF THEINVENTION Provided herein are devices and systems for use in vascular access, particularly stabilization devices and vascular access systems including such devices.

[0003] 2. Description of Related Art During placement, peripheral vascular catheters (PIVCs) can become occluded with thrombus or fibrin, preventing the ability to aspirate blood through the PIVC. A line aspiration device is meant to pass the catheter and open a fluid path for blood aspiration. One challenge with these devices is successfully passing the S-shape as the catheter enters the vessel. Sometimes the catheter tube can kink slightly at the bend of the S-curve (Figure 2), preventing the blood aspiration device from successfully passing through.

[0004] During insertion of a PIVC into a patient, the angle at which the catheter is inserted is typically approximately 30°, depending on many factors including the patient's vasculature, the depth of the vessel, and the practitioner's technique. Once the catheter is successfully inserted into the vessel, the catheter adapter is secured to the patient using adhesive tape or a bandage. When securing the catheter adapter, a bandage is placed over the catheter adapter and the surrounding skin, so that the catheter adapter is approximately parallel to the skin. Because the catheter is also inserted at a steeper angle to the skin, the tubing exiting the catheter adapter must transition from the plane of the adapter into the vessel, which can cause the tubing to twist or deform to the point that it cannot be passed by a line suction device.

[0005] Proper fixation of the PIVC is a critical step to ensure the success of line aspiration. Thus, there is a need in the art for a stabilization and fixation device and dressing system to provide improved overall blood aspiration success, line aspiration advancement reliability, and reduced risk of catheter complications due to the additional access and use of the PIVC for blood collection. Summary of the Invention

[0006] Provided herein is a stabilization device for a catheter, the stabilization device including: a base defining a base periphery, the base having a top surface and a bottom surface; a support surface disposed on the top surface of the base, the support surface having a wall extending away from the top surface of the base defining the support surface periphery, the support surface periphery having substantially the same shape as the catheter adapter; and a bandage defining a bandage periphery, the bandage configured to cover the base and the support surface.

[0007] Also provided herein is a stabilization catheter set including a catheter assembly having a catheter adapter having a distal end, a proximal end, a lumen disposed between the distal end and the proximal end and in fluid communication with the distal end and the proximal end, and a catheter disposed at the distal end of the catheter adapter and in fluid communication with the lumen, and a stabilization device as described herein. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view of a non-limiting embodiment of a catheter adapter useful with the stabilization device described herein. [Diagram 2] FIG. 2 is a partial cross-sectional view of a conventional catheter adapter and catheter, showing the catheter inserted into a patient's blood vessel. [Figure 3A] FIG. 3A is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 3B] FIG. 3B is a top view of a non-limiting embodiment of a stabilizing catheter set described herein. [Figure 4A] FIG. 4A is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 4B] FIG. 4B is a top view of a non-limiting embodiment of a stabilizing catheter set described herein. [Figure 5A] FIG. 5A is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 5B] FIG. 5B is a top view of a non-limiting embodiment of a stabilizing catheter set described herein. [Figure 6] FIG. 6 is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 7] FIG. 7 is a perspective view of a non-limiting embodiment of a stabilizing catheter set described herein. [Figure 8A] FIG. 8A is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 8B] FIG. 8B is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 9A] FIG. 9A is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. [Figure 9B] FIG. 9B is a perspective view of a non-limiting embodiment of a stabilization catheter set described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Description of the invention The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the invention.

[0010] In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof, refer to the present invention as oriented in the drawing figures. It should be understood, however, that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0011] It should be understood that the numerical ranges described herein are intended to include all values ​​and subranges subsumed therein. For example, a range "1 to 10" is intended to include all subranges between (and including) the stated minimum value of 1 and the stated maximum value of 10, i.e., having a minimum value of 1 or more and a maximum value of 10 or less.

[0012] Provided herein is a stabilization device for a catheter assembly. The stabilization device described herein may be used to provide a fixed position of a catheter adapter at a vascular puncture site, may provide an optimal entry angle of the catheter into the patient's vasculature, and may reduce or eliminate kinking of medical instruments passed through the catheter into the patient.

[0013] Referring now to FIG. 1, a non-limiting embodiment of a catheter assembly 10 useful with the stabilization device described herein below is shown. The catheter assembly 10 may include a catheter adapter 12, which may include a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 may include an additional port 18. In some embodiments, the port 18 may be located between the distal end 14 and the proximal end 16. In some embodiments, the port 18 may be located at the proximal end 16. In some embodiments, the first catheter adapter 12 may include a first lumen 20 extending through the distal end 14 and the proximal end 16. The first lumen 20 may be sealed at the proximal end 16 of the catheter adapter 12.

[0014] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral vascular catheter, a midline catheter, or a peripherally inserted central catheter. The catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art. In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 24 extending from the port 18. The first fluid conduit 24 may be formed of any suitable material known to those of skill in the art and may have a distal end 26 and a proximal end 28, and the first fluid conduit 24 may be coupled at its distal end 26 to the port 18. In some non-limiting embodiments or aspects, a connector 30 may be coupled to the proximal end 28 of the first fluid conduit 24. Connector 30 may be a t-connector (e.g., one side port positioned at a 90 degree angle relative to the longitudinal axis of connector 30), a y-connector (e.g., one side port positioned at a 25, 60, or 75 degree angle relative to the longitudinal axis of connector 30), or any other type of connector known in the art, and may include a second lumen therein having any number of branches appropriate to the type of connector.

[0015] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set (integral to or removably connectable to the catheter adapter 12, the connector 30, and / or the needleless access connector 32) that includes a second fluid conduit, such as the second fluid conduit 34. Extension sets are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, and NEUTRACLEAR. Needleless access connectors 32 are known to those skilled in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names SMARTSITE and Q-SYTE. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a luer connection 36 at its end. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a clamp 40 to allow for occlusion of the second fluid conduit 34. The clamp 40 and the second fluid conduit 34 may be formed of any suitable material known to those skilled in the art. In a non-limiting embodiment, the second lumen (eg, within connector 30) has an inner diameter substantially equal to the inner diameter of first fluid conduit 24 and / or second fluid conduit 34.

[0016] Turning to Figures 3A and 3B, a non-limiting embodiment of a stabilized catheter system 100 including a catheter assembly 10 and a stabilizer 110 is shown. Figure 3A shows a catheter adapter 12 with a port 18 as a side port that extends away from the catheter adapter 12 at an angle to a longitudinal axis defined by the distal end 14 and proximal end 16 of the catheter adapter 12. Figure 3B shows a catheter adapter 12 with a port 18 located at the proximal end 16. Those skilled in the art will appreciate that the stabilizer 110 described herein may be modified to accommodate catheter adapters having any arrangement of port(s). The stabilizer 110 may include a base bandage 120 having a top surface, a bottom surface configured to contact the skin of a patient to which the base bandage 120 is applied, and a periphery defining a base periphery. The base bandage 120 may be formed of any suitable material, such as woven and nonwoven fabrics, films, polymeric materials, and the like known to those skilled in the art. The base bandage 120 may include an adhesive on its bottom surface for reversibly adhering the base bandage 120 to the patient's skin. Suitable adhesives are known to those skilled in the art. As shown in the accompanying drawings, the base bandage 120 may include a cutout 140 for accommodating the catheter 22 at an insertion site into the patient's skin. The cutout 140 may accommodate additional adhesive or an antimicrobial composition that is applied to the insertion site of the catheter 22 into the patient's skin.

[0017] The base bandage 120 may further include a first support portion 130. The first support portion 130 may include a first support surface 132 configured to receive a catheter adapter thereon. The first support surface 132 may be defined by a wall 134 extending away from a top surface of the base bandage 120 (e.g., away from the patient's skin). The combination of the first support surface 132 and the wall 134 may define a pocket in which the catheter adapter 12, and / or other components of the catheter assembly 10, are received. The wall 134 may define a support surface perimeter that substantially matches the catheter adapter 12, and optionally one or more additional components of the catheter assembly 10. The wall 134 may, in embodiments, define a support surface perimeter that is smaller than the base perimeter. The first support surface 132 may be formed of any useful material. In a non-limiting embodiment, the first support surface 132 is formed of a foam, such as an open cell foam or a closed cell foam, or other resilient material that can be compressed. In a non-limiting embodiment, the first support surface 132 includes an adhesive thereon for securing the catheter adapter 12 in place. In a non-limiting embodiment, the first support surface 132 is configured such that the catheter adapter 12 received thereon is disposed at an angle relative to the skin of the patient to which the stabilization device 110 is applied. In a non-limiting embodiment, the first support surface 132 is configured such that the catheter adapter 12 is disposed at an angle of about 3 degrees to about 10 degrees (including all values ​​and ranges therebetween), optionally about 6 degrees to about 10 degrees, optionally about 6 degrees, relative to (away from) the skin of the patient to which the stabilization device 110 is applied. In a non-limiting embodiment, the support surface 132 may be adjustable to provide different angles of the catheter adapter 12 relative to the patient's skin depending on whether the catheter 22 is not in use, is being used to deliver a medicinal drug, and / or is being used to aspirate blood from the patient's vascular system.

[0018] The wall 134 may be formed of any suitable material, including rigid foam. The wall 134 may include one or more openings 136 therein to accommodate the catheter 22, any port(s) 18 included in the catheter adapter 12, and / or any fluid conduits 24, 34 extending from the catheter adapter 12. The one or more openings 136 in the wall 134 may include an adhesive for securing the components of the catheter assembly 10.

[0019] 3A and 3B, the base bandage 120 may include one or more alignment markers 145. The alignment marker(s) 145 may be any suitable indicia visible to a medical professional applying the stabilization device 110 to the patient's skin. The alignment marker(s) 145 may be located on one or both sides of the cutout 140. The alignment marker(s) 145 may indicate a location on the patient's skin where the catheter 22 is inserted and may be configured at a predetermined location on the base bandage 120 optimized to reduce and / or eliminate the s-curve of the catheter 22.

[0020] 4A-5B, the stabilizing device 110 may also include a top bandage 150. The top bandage 150 may be formed of any suitable material, such as polymeric materials known to those skilled in the art, such as polyurethane and polyethylene, woven and nonwoven fabrics, and / or combinations thereof, and may include adhesives (e.g., for releasably adhering the top bandage 150 to the base bandage 120 and / or the patient's skin), antimicrobial agents, and other suitable additives known to those skilled in the art. Suitable top bandages 150 are also commercially available, for example, from 3M Company (St. Paul, Minnesota) under the trade name TEGADERM. In a non-limiting embodiment, at least a portion 152 of the top bandage 150 is at least partially transparent to allow visualization of the catheter adapter 12 and / or other components of the catheter assembly 10. In a non-limiting embodiment, the top bandage 150 has a circumference that is greater than that of the base bandage 120. In a non-limiting embodiment, the top bandage 150 includes a fabric portion 155. In a non-limiting embodiment, the apical bandage 150 includes one or more openings and / or extensions 160 to allow the connectors 30, ports 18, and / or fluid conduits 24, 34 attached to or extending from the catheter adapter 12 to pass through the apical bandage 150 and / or to allow the apical bandage 150 to be wrapped around the connectors 30, ports 18, and / or fluid conduits 24, 34 attached to or extending from the catheter adapter 12.

[0021] Turning to FIG. 6, in a non-limiting embodiment, the stabilizing device 110 may include one or more additional markers on the base bandage 120. Such additional markers may be used in addition to or in place of the alignment markers 145 discussed herein. Such additional markers may include maximum 147 and minimum 149 distance markers, which may correspond to a maximum and minimum distance that the base bandage 120 may be positioned from the insertion site of the catheter 22 sufficient to maintain proper sterility, insertion depth / length, and / or s-curve of the catheter 22 to a minimum. The maximum and minimum 147, 149 distance markers may correspond to a distance between the distal end 14 of the catheter adapter 12 and the insertion site of the catheter 22. In a non-limiting embodiment, the minimum distance marker 149 indicates a distance of about 0.0 mm, optionally about 0.50 mm, and the maximum distance marker 147 indicates a distance of about 2.50 mm from the distal end 14 of the catheter adapter 12 and the insertion site of the catheter 22. The maximum and minimum distance markers 147 , 149 may be any suitable indicia, may be different colors or the same color, and may be located on one or both sides of the cutout 140 .

[0022] Turning to FIG. 7, in a non-limiting embodiment, such additional markers may include one or more displacement markers 146. The displacement marker(s) 146 may be any suitable indicator, may be different or the same color, and may be located on one or both sides of the notch 140. In a non-limiting embodiment, the displacement marker 146 is located relative to the alignment marker 145 and serves to provide the medical professional with the displacement of the stabilizing device 110, e.g., the displacement of the base dressing 120, relative to the insertion site of the catheter 22. This may assist the medical professional in determining if the stabilizing device 110 has moved an unacceptable difference (e.g., posing a continuing sterility issue or an unacceptable degree of s-curve issue for the catheter 22) so that it may be removed from and / or reapplied to the patient's skin.

[0023] Turning to Figures 8A and 8B, in a non-limiting embodiment, the stabilization device may further include a second support 170. The second support 170, like the first support 130, may be formed of any suitable material, such as a resilient material, a foam material, etc. The second support 170 may be configured to interact with a connector 30, such as a t-connector, a y-connector, and / or a needleless access connector 32, or other medical component included as part of or otherwise coupled to one or more components of the catheter assembly 10. For example, as shown in Figures 8A (t- or y-connector 30) and 8B (needleless access connector 32), may be supported by the second support 170, which may function to reduce pressure of the medical component against the patient's skin and / or to secure the component to the patient. The second support 170 may include any suitable feature for securing the connector 30 or other component, such as one or more pockets, ridges, etc. The second support 170 may include an adhesive on its bottom surface to releasably adhere the second support 170 to the patient's skin.

[0024] 9A and 9B, in a non-limiting embodiment, the stabilizing device 110 may include one or more positioning markers. In a non-limiting embodiment, the base bandage 120 may include one or more first positioning markers 180 disposed at one or more locations on the base bandage 120. As with other markers disclosed herein, the first positioning markers 180 may be any suitable indicator visible to a medical professional when the stabilizing device 110 is applied to the skin of a patient. The top bandage 150 may include one or more corresponding second positioning markers 190. As with other markers disclosed herein, the corresponding second positioning markers 190 may be any suitable indicator visible to a medical professional. In use, the medical professional may apply the top bandage 150 to the skin of a patient and align the corresponding second positioning markers 190 such that they overlap with the one or more first positioning markers 180 on the base bandage 120, allowing the medical user to be assured that the top bandage 150 is being applied correctly. Correct application of the apical bandage 150 may, in some embodiments, mean that one or more openings and / or extensions 160 of the apical bandage 150 are properly positioned to allow the connectors 30, ports 18, and / or fluid conduits 24, 34 attached to or extending from the catheter adapter 12 to pass through the apical bandage 150 and / or such that the apical bandage 150 is wrapped around the connectors 30, ports 18, and / or fluid conduits 24, 34 attached to or extending from the catheter adapter 12.

[0025] Also provided herein is a method of stabilizing the catheter assembly 10. The method may include inserting a catheter, such as the catheter 22 illustrated in FIG. 1, into a patient using any known process. Once the catheter 22 is inserted into the patient, any introducer(s) are removed or withdrawn from the catheter 22. A base bandage, such as the base bandage 120 described herein, may then be applied to the patient's skin, for example, by removing a peelable backing covering the adhesive-containing lower surface and pressing the base bandage 120 against the patient's skin. In non-limiting embodiments, a support, such as the support 130 described herein, may be provided as a separate element, and the top surface of the base bandage 120 may also include a peelable backing covering the adhesive-containing upper surface. In non-limiting embodiments, one or more markers, such as alignment marker(s) 145 and / or maximum and minimum distance markers 147, 149, may be used to align and / or position the base bandage 120 relative to the insertion site of the catheter 22. An adhesive or antimicrobial agent may then be applied to the insertion site and a top bandage, such as top bandage 150 described herein, may be applied to the base bandage 120 and / or the patient's skin, for example, by peeling off a removable backing covering the surface of the adhesive-containing top bandage 150 and pressing the top bandage 150 against the base bandage 120 and / or the patient's skin. In a non-limiting embodiment, the base bandage 120 includes one or more first positioning markers 180 as described herein and the top bandage 150 includes one or more corresponding second positioning markers 190, and application of the top bandage 150 includes aligning the corresponding second positioning markers 190 with the one or more first positioning markers 180 prior to pressing the top bandage 150 against the base bandage 120 and / or the patient's skin.

[0026] While the present disclosure has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such details are for this purpose only and that the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A stabilization device for a catheter, comprising: a base defining a base perimeter, said base having a top surface and a bottom surface; a support surface disposed on the top surface of the base, the support surface comprising a wall extending away from the top surface of the base defining a support surface perimeter, the support surface perimeter having substantially the same shape as a catheter adapter; and a dressing defining a dressing perimeter, said dressing configured to cover said base and said support surface; A stabilization device comprising:

2. The stabilization device of claim 1 , wherein the wall comprises a foam material.

3. 3. The stabilization device of claim 1 or claim 2, wherein the wall comprises a first opening configured to receive a component of a catheter adapter therein.

4. The stabilization device of claim 3 , wherein the wall includes a second opening configured to receive a component of the catheter adapter therein.

5. 5. The stabilization device of claim 4, wherein the second opening is disposed at an angle of 25 degrees, 45 degrees, 90 degrees, and / or 135 degrees relative to the first opening.

6. The stabilizing device of any of claims 1 to 5, wherein the bottom surface of the base comprises an adhesive configured to releasably attach the base to the skin of a patient to which the stabilizing device is applied.

7. 7. The stabilization device of claim 1, wherein the support surface is angled relative to the base such that the catheter adapter received within the support surface periphery is not parallel to the skin of a patient to which the stabilization device is applied.

8. The stabilization device of claim 7 , wherein the support surface comprises foam.

9. 9. The stabilization device of claim 7 or claim 8, wherein the support surface is angled at about 3 degrees to about 10 degrees with respect to the skin of the patient to which the stabilization device is applied.

10. The stabilizing device of any one of claims 1 to 9, wherein the dressing is substantially transparent.

11. The stabilization device of any of claims 1 to 10, wherein the base comprises a notch configured to receive the catheter therein.

12. The stabilizing device of claim 11 , wherein the base comprises one or more alignment markers.

13. The stabilizing device of claim 11 , wherein the base includes two alignment markers disposed on opposite sides of the notch.

14. The stabilization device of any one of claims 1 to 13, wherein the base comprises one or more distance markers representing the distance between an insertion site of the catheter and the catheter adapter received on the support surface.

15. 15. The stabilization device of any one of claims 1 to 14, wherein the base comprises one or more first positioning markers and the top bandage comprises one or more corresponding positioning markers, such that when the top bandage is applied, the one or more corresponding positioning markers overlap the one or more first positioning markers.

16. A stabilization device according to any preceding claim, wherein the base comprises one or more second support surfaces.

17. The stabilization device of claim 16 , wherein the one or more second support surfaces are positioned outside of the base perimeter.

18. A stabilizing catheter set 1. A catheter assembly comprising: A catheter adapter comprising: distal end, proximal end, a lumen disposed between and in fluid communication with the distal end and the proximal end; and a catheter disposed at the distal end of the catheter adapter and in fluid communication with the lumen; a catheter assembly comprising: A stabilizing device according to any one of claims 1 to 17, A stabilization catheter set comprising:

19. The stabilizing catheter set of claim 18 , wherein the catheter adapter further comprises a port in fluid communication with the lumen.

20. 20. The stabilizing catheter set of claim 19, further comprising a fluid conduit having a distal end and a proximal end, said distal end coupled to and in fluid communication with said port.

21. 21. The stabilizing catheter set of claim 19 or claim 20, wherein the port is located at a proximal end of the catheter adapter.

22. 21. The stabilizing catheter set of claim 19 or claim 20, wherein the port is disposed between the distal end and the proximal end of the catheter adapter.

23. The stabilizing catheter set of any one of claims 18 to 22, wherein the catheter assembly further comprises a needleless access connector in fluid communication with the lumen.

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