Bandage-integrated tube occlusion

Abstract

Provided herein is an intravascular catheter assembly having a distal end, a proximal end, a lumen disposed between and in fluid communication with the distal and proximal ends, a catheter disposed at a distal end of the catheter adapter and in fluid communication with the lumen, and a side port in fluid communication with the lumen. The assembly further includes a fluid conduit having a distal end and a proximal end, a distal end of the fluid conduit coupled to the side port, a connector disposed at the proximal end of the fluid conduit, and an occlusion device configured to stop flow through the fluid conduit.

Description

[Technical field]

[0001] The present disclosure relates generally to intravenous (IV) catheter assemblies, and more particularly to IV catheter assemblies with occlusion devices that stop flow through a catheter adapter and allow for exchange of various components.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 321,938, entitled "BANDAGE-INTEGRATED TUBE OCCLUSION," filed March 21, 2022, the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.

[0004] A common type of intravenous (IV) catheter device includes a catheter that is over-the-needle. As the name suggests, an over-the-needle catheter may be attached over an introducer needle with a sharp distal tip. The IV catheter device may include a catheter adapter, a catheter extending distally from the catheter adapter, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system.

[0005] An IV catheter device may include an extension set with multiple ports and / or connectors for administering or withdrawing fluids from a patient and / or flushing the catheter device. One or more of these ports and / or connectors may be replaceable, but there is currently no way to occlude the extension set during such a replacement procedure. Thus, there is a need in the art for an IV catheter device that allows for simple occlusion of its associated tubing. Summary of the Invention

[0006] Provided herein is an intravascular catheter assembly having a distal end, a proximal end, a lumen disposed between and in fluid communication with the distal and proximal ends, a catheter disposed at a distal end of the catheter adapter and in fluid communication with the lumen, and a side port in fluid communication with the lumen. The assembly further includes a fluid conduit having a distal end and a proximal end, a distal end of the fluid conduit coupled to the side port, a connector disposed at the proximal end of the fluid conduit, and an occlusion device configured to stop flow through the fluid conduit.

[0007] In a particular configuration, the intravascular catheter assembly includes a dressing having a bottom surface configured to contact the patient's skin and a top surface. The occlusion device may be coupled to the top surface of the dressing. Optionally, the occlusion device is a clamp including a base and first and second arms extending substantially perpendicularly from the base, the base and the first and second arms defining a channel configured to receive a fluid conduit. The clamp may be formed of an elastomeric material.

[0008] In certain configurations, the first arm and the second arm are resiliently biased toward the channel. The diameter of the channel may be smaller than the diameter of the fluid conduit such that when the fluid conduit is received by the channel, fluid flow through the fluid conduit is slowed and / or stopped.

[0009] The occlusion device may be a clamp including a base and a button defining a channel therebetween, the channel configured to receive a fluid conduit, the button configured to be movable within the channel, and moving the button into the channel causes the clamp to occlude the fluid conduit, thereby slowing and / or stopping fluid flow through the fluid conduit. The button may be biased away from the channel. Optionally, the button may be biased away from the channel by a spring.

[0010] In other configurations, the occlusion device is a clamp including a base having a first end and a second end, a cover having a first end and a second end, the cover having a first end hingedly connected to the first end of the base, and a latch mechanism configured to secure the second end of the base to the second end of the cover. The second end of the base can be secured to the second end of the cover, and the cover and base define a channel configured to hold a fluid conduit therein. The diameter of the channel can be smaller than the diameter of the fluid conduit such that when the fluid conduit is held by the channel, fluid flow through the fluid conduit is slowed and / or stopped.

[0011] In yet another configuration, the occlusion device is a slide clamp that includes a channel having at least one portion having a diameter less than the diameter of the fluid conduit and at least one other portion having a diameter equal to or greater than the diameter of the fluid conduit. The occlusion device may be disposed between the side port and the connector.

[0012] In yet another configuration, the occlusion device is a valve. The valve may be disposed within the connector. Optionally, the valve includes a manual actuator. The connector may be a t-connector or a y-connector.

[0013] In certain configurations, the intravascular catheter assembly further includes a needleless access connector coupled to the connector. The needleless access connector may be releasably coupled to the connector.

[0014] Also provided herein is an intravascular catheter assembly having a distal end, a proximal end, a lumen disposed between and in fluid communication with the distal and proximal ends, a catheter disposed at a distal end of the catheter adapter and in fluid communication with the lumen, and a side port in fluid communication with the lumen. The assembly further includes a fluid conduit having a distal end and a proximal end, a distal end of the fluid conduit coupled to the side port, a connector disposed at the proximal end of the fluid conduit, and a stabilization device configured to receive the fluid conduit therein.

[0015] The intravascular catheter assembly may further include a bandage having a bottom surface configured to contact the patient's skin and an upper surface. The stabilizing mechanism may be coupled to the upper surface of the bandage. Optionally, the stabilizing mechanism may include a base and first and second arms extending substantially perpendicularly from the base, the base and the first and second arms defining a channel configured to receive a fluid conduit.

[0016] In certain configurations, the clamp is formed of an elastomeric material. Optionally, the first arm and the second arm are resiliently biased toward the channel. In certain configurations, the stabilization device includes a base and first and second arms extending substantially perpendicularly from the base, each arm including a flange at an opposite end of the base, and the flange, the first arm, the second arm, and the base define a channel configured to receive a fluid conduit. [Brief description of the drawings]

[0017] Exemplary embodiments will be described and explained with additional specificity and detail through the use of accompanying drawings. [Figure 1A] FIG. 1A is a top perspective view of an exemplary catheter assembly according to some non-limiting embodiments or aspects. [Figure 1B]FIG. 1B is a cross-sectional view of the catheter assembly of FIG. 1A according to some non-limiting embodiments or aspects. [Diagram 2] FIG. 2 is a top perspective view of another exemplary catheter assembly, according to some non-limiting embodiments or aspects. [Diagram 3] FIG. 3 is a top perspective view of another exemplary catheter assembly, according to some non-limiting embodiments or aspects. [Figure 4] FIG. 4 is a top perspective view of another exemplary catheter assembly, according to some non-limiting embodiments or aspects. [Figure 5A] FIG. 5A is a side view of an occlusion device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. [Figure 5B] FIG. 5B is a side view of an occlusion device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. [Figure 5C] FIG. 5C is a side view of an occlusion device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. [Figure 5D] FIG. 5D is a side view of an occlusion device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. [Figure 5E] FIG. 5E is a side view of an occlusion device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. [Figure 5F] FIG. 5F is a side view and a top view of an occlusion device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. [Figure 6] FIG. 6 is a side view of a stabilization device for use with a catheter assembly described herein, according to some non-limiting embodiments or aspects. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The following description is provided to enable those skilled in the art to make and use the described embodiments that are intended to practice the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0019] For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives refer to the present invention as oriented in the drawings. However, it will be understood 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 attached drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0020] It should be understood that any numerical range recited herein is intended to include all subranges subsumed therein. For example, a range "from 1 to 10" is intended to include all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., ranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0021] 1A and 1B, a non-limiting embodiment of a catheter assembly 10 is shown, which can include a catheter adapter 12 including a distal end 14 and a proximal end 16. In some embodiments, the catheter adapter 12 can include a side port 18 disposed between the distal end 14 and the proximal end 16. In some embodiments, the first catheter adapter 12 can include a lumen 20 extending through the distal end 14 and the proximal end 16. FIG. 1B shows a cross-sectional view illustrating the needle hub and introducer needle removed, according to some embodiments or aspects, and such that the lumen 20 is visible.

[0022] In some non-limiting embodiments or aspects, the first catheter assembly 10 may include a first catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral intravenous 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 first catheter assembly 10 may include a fluid conduit 24 extending from the side port 18. The 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 fluid conduit may be coupled at its distal end 26 to the side port 18. In some non-limiting embodiments or aspects, a connector 30 may be coupled to the proximal end 28 of the fluid conduit 24.

[0023] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set that includes an extension line 34. Extension sets are known to those of skill in the art and are commercially available, for example, from Becton, Dickinson and Company under the trade names MAXPLUS, MAXZERO, NEUTRACLEAR, Q-SYTE, and SmartSite. In some non-limiting embodiments or aspects, the extension line 34 may include a luer connection 36 at its end. In some non-limiting embodiments or aspects, the extension set may include a clamp 40 to allow for occlusion of the extension line 34. The clamp 40 and the extension line 34 may be formed of any suitable material known to those of skill in the art.

[0024] With continued reference to FIGS. 1A and 1B and 2, the catheter assembly 10 may include an occlusion device 32 for slowing and / or stopping the flow of fluid through the fluid conduit 24. As used herein, "occlude" or "occlusion" means at least a slowing down of the flow of fluid through a conduit, such as the fluid conduit 24, and includes within its scope a complete cessation of flow through an occluded portion of the conduit. Various placements of the occlusion device 32 are described below and illustrated in the accompanying drawings. Placement of the occlusion device 32 along the fluid conduit 24 can allow for the cessation of the flow of fluid, such as blood, from the lumen 20 to the connector 30. Such an occlusion device can allow a user, such as a medical professional, to replace one or more components of the catheter assembly 10, such as the needleless access connector 38, as shown in FIG. 2. Needleless access connectors 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.

[0025] In some non-limiting embodiments or aspects, the catheter assembly 110 including the catheter adapter 112, the side port 118, the catheter 122, the fluid conduit 124, the connector 130, the extension set including the extension line 134, the needleless access connector 138, and / or the occlusion device 132 may be secured to the patient at the insertion site of the catheter 122 using a bandage 142, as shown, for example, in FIG. 3 . Suitable bandages are known to those skilled in the art and may include, for example, a gauze component as well as a transparent film component to cover the insertion site, protect against punctures from microorganisms in the surrounding environment, and / or secure the catheter assembly 110 in place to prevent the patient from removing the catheter 122. In some non-limiting embodiments or aspects, the occlusion device 132 may be coupled to the bandage 142, as shown, for example, in FIG. 4 , and in some embodiments, the bandage may cover some or all of the catheter assembly 110. In some non-limiting embodiments or aspects, the occlusion device 132 may be coupled to either the gauze component and / or the transparent film component of the bandage. In some non-limiting embodiments or aspects, the bandage 142 may be configured with slits or other types of openings in the gauze and / or transparent film components to allow fluid conduits to pass through the bandage, and an occlusive device 232 as described herein may be disposed on a surface of the bandage opposite the patient-contacting surface. In non-limiting embodiments, the occlusive device may be coupled to a separate bandage, for example, as shown in FIG.

[0026] Referring to FIG. 4, a non-limiting embodiment or aspect of a catheter assembly 110 is shown according to a non-limiting embodiment or aspect. As previously described, the catheter assembly 110 including the catheter adapter 112, the side port 118, the catheter 122, the fluid conduit 124, the connector 130, the extension set including the extension line 134, the needleless access connector 138, and / or the occlusion device 132 can be secured to the patient at the insertion site of the catheter 122 with a dressing 142. In the non-limiting embodiment or aspect shown in FIG. 4, the occlusion device 132 is a clamp, such as a slide clamp, having a channel 146 through which the fluid conduit 124 is received. In some non-limiting embodiments or aspects, the channel 146 is not of uniform diameter along its entire length, so that the fluid conduit 124 can be occluded by sliding the fluid conduit 124 into a narrow portion of the channel 146, which can impact the wall of the fluid conduit 124 and occlude flow therethrough. In non-limiting embodiments or aspects, an occlusion device 132 in the form of a clamp is coupled to a bandage 142, which in some non-limiting embodiments or aspects can stabilize the clamp and make occlusion of the fluid conduit 124 easier to achieve (e.g., with only one hand).

[0027] 5A-5F, various non-limiting embodiments or aspects of an occlusion device useful in a catheter assembly as described herein are shown. With reference to FIG. 5A, a non-limiting embodiment or aspect of an occlusion device 232 is shown in which a fluid conduit 224 is retained via an interference fit. In the illustrated embodiment or aspect, the occlusion device 232 can include a base 240 and first and second arms 242, 244 extending from the base 240. In some non-limiting embodiments or aspects, the first and second arms 242, 244 can extend substantially perpendicularly from the base 240, optionally substantially parallel to one another. The base 240 and the first and second arms 242, 244 define a channel 246 configured to retain the fluid conduit 224, for example, via an interference fit. 5A may be formed of any useful material, and in some non-limiting embodiments or aspects, may be formed of a resilient material, such as, for example, an elastomeric material, to allow separation of the arms 242, 244 (e.g., moving radially outwardly away from the channel 246) to allow the fluid conduit 224 to be introduced into and removed from the channel 246. In some non-limiting embodiments or aspects, the channel 246 may have a diameter along at least a portion of its length that is smaller than the diameter of the fluid conduit 224, such that when the fluid conduit 224 is received within the channel 246, the base 240 and one or more of the arms 242, 244 impinge on the walls of the fluid conduit 224 and block flow therethrough.

[0028] 5B and 5C, a non-limiting embodiment or aspect of occlusion device 232 is shown in which fluid conduit 224 is occluded by being compressed by button 248. In the illustrated non-limiting embodiment or aspect, occlusion device 232 includes base 240, first arm 242, and button 248 and is resiliently biased away from channel 246 formed by base 240, first arm 242, and button 248. Button 248 may be biased by resilient biasing element 250, which may be an elastomeric component, a spring, or other similar mechanism that exerts a force on button 248 in a direction away from first arm 242. FIG. 5B shows a first state in which button 248 is maintained out of channel 246 by resilient biasing element 250. In some non-limiting embodiments or aspects, the channel 246 is configured such that the fluid conduit 224 can be retained within the channel, for example, by an interference fit (tight fit), even when the button 248 is in the first state (non-depressed state).

[0029] Referring to FIG. 5C, a second state of non-limiting embodiments or aspects of the occlusion device 232 in the second state in FIG. 5B is shown. In such second state, the force exerted by the resilient biasing element 250 may be overcome by a user pressing a button 248, which in non-limiting embodiments may be a push button latch, such button 248 may be reversibly held against the force of the resilient biasing element 250 in a depressed position, such button 248 causing the channel 246 to narrow. In some non-limiting embodiments or aspects, in the depressed position (e.g., the second state), the button 248 may impinge on a wall of the fluid conduit 224 and block flow therethrough. In some non-limiting embodiments or aspects, the occlusion device 232 may be coupled to a dressing as described herein.

[0030] 5D and 5E, non-limiting embodiments or aspects of an occlusion device 232 are shown in which the fluid conduit 224 is occluded by being compressed within a channel 246 formed by a base 240 and a cover 252. In non-limiting embodiments or aspects, the occlusion device 232 includes a base 240, a cover 252 that may be connected at its ends to the base 240, and a channel 246 defined by the base 240 and the cover 252. In some non-limiting embodiments or aspects, the fluid conduit 224 may be held within a portion of the channel 246 disposed in the base 240 by an interference fit prior to closing the cover 252. In some non-limiting embodiments or aspects, the cover 252 is hingedly connected to the base 240, for example, with a hinge 254. In some non-limiting embodiments or aspects, the channel 246 has a diameter along at least a portion of its length that is smaller than the diameter of the fluid conduit 224, such that when the fluid conduit 224 is received within the channel 246, one or more of the base 240 and the cover 252 impinge on the walls of the fluid conduit 224 and block flow therethrough. To secure the cover 252 to the base 240 and block flow through the fluid conduit 224, one or both of the base 240 and the cover 252 may include a latching mechanism 256. One of ordinary skill in the art will appreciate that the type of latching mechanism 256 used is not limited, so long as the latching mechanism 256 is capable of securing the cover 252 to the base 240 in a reversible manner. In some non-limiting embodiments or aspects, the occlusion device 232 may be coupled to a dressing as described herein.

[0031] Referring to FIG. 5F, a non-limiting embodiment or aspect of the occlusion device 232 is shown in which the fluid conduit 224 is occluded by a valve 258. The valve 258 may be formed from any useful material and may include a valve body 260 capable of reversibly stopping flow through the fluid conduit 224. In some non-limiting embodiments or aspects, the connector (e.g., the connector 30 as shown in FIGS. 1A and 1B) may include or be replaced by the valve 258. In some non-limiting embodiments or aspects, the valve 258 may divert flow to the extension line 234. In some non-limiting embodiments or aspects, the valve body 260 may include an actuator 262 to allow for manual actuation of the valve 258. In some non-limiting embodiments or aspects, the valve 258 may be a stopcock with a rotatable actuator 262 that allows for control of the fluid flow through the valve body 260. In some non-limiting embodiments or aspects, the valve 258 is coupled to a dressing as described herein.

[0032] 6, a non-limiting embodiment or aspect of a stabilization device 370 is shown. The stabilization device may be similar to the occlusion device 232 described herein, but may be configured such that the fluid conduit 324 is retained within, but not occluded by, a channel 346, for example, by an interference fit. In the illustrated embodiment or aspect, the stabilization device 370 includes a base 340 and first and second arms 342, 344 extending from the base 340. In some non-limiting embodiments or aspects, the first and second arms 342, 344 may extend substantially perpendicularly from the base 340, optionally substantially parallel to one another. The base 340 and the first and second arms 342, 344 define a channel 346 configured to retain the fluid conduit 324, for example, by an interference fit. The stabilization device 370 as shown in FIG. 6 may be formed of any useful material, and in some non-limiting embodiments or aspects, may be formed of a resilient material, such as, for example, an elastomeric material, to allow separation of the arms 342, 344 (e.g., radially outwardly away from the channel 346) to allow the fluid conduit 324 to be introduced into and removed from the channel 346. In some non-limiting embodiments or aspects, the first arm 342 and the second arm 344 include one or more flanges 343, 345 at the ends separated from the base 340. In some non-limiting embodiments or aspects, the flanges 343, 345 project radially inwardly toward one another, as shown in FIG. 6, and together with the arms 342 and 344 and the base 340, provide a surface that retains the fluid conduit 324 within the channel 346. In some non-limiting embodiments or aspects, the stabilization device 370 is coupled to a dressing as described herein.

[0033] While the present disclosure has been described in detail for purposes of illustration based on what are currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is 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 may be combined with one or more features of any other embodiment.

Claims

1. A catheter adapter comprising: 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; a catheter disposed at the distal end of the catheter adapter and in fluid communication with the lumen; a side port in fluid communication with the lumen; a fluid conduit having a distal end and a proximal end, the distal end of the fluid conduit being coupled to the side port; a connector disposed at the proximal end of the fluid conduit; an occlusion device configured to stop flow through the fluid conduit; The catheter adapter comprising:

1. An intravascular catheter assembly comprising:

2. The intravascular catheter assembly of claim 1 , further comprising a dressing having a bottom surface configured to contact the skin and upper surface of a patient.

3. The intravascular catheter assembly of claim 2 , wherein the occlusion device is coupled to the upper surface of the dressing.

4. 2. The intravascular catheter assembly of claim 1, wherein the occlusion device is a clamp comprising a base and first and second arms extending substantially perpendicularly from the base, the base and the first and second arms defining a channel configured to receive the fluid conduit.

5. The intravascular catheter assembly of claim 4 , wherein the clamp is formed from an elastomeric material.

6. The intravascular catheter assembly of claim 4 , wherein the first arm and the second arm are resiliently biased toward the channel.

7. 5. The intravascular catheter assembly of claim 4, wherein a diameter of the channel is less than a diameter of the fluid conduit, and fluid flow through the fluid conduit slows and / or stops when the fluid conduit is received by the channel.

8. 2. The intravascular catheter assembly of claim 1, wherein the occlusion device is a clamp comprising a base and a button defining a channel therebetween, the channel configured to receive the fluid conduit, the button configured to be movable within the channel, and wherein moving the button into the channel causes the clamp to occlude the fluid conduit, thereby slowing and / or stopping fluid flow through the fluid conduit.

9. The intravascular catheter assembly of claim 8 , wherein the button is biased away from the channel.

10. The intravascular catheter assembly of claim 9 , wherein the button is biased away from the channel by a spring.

11. The occlusion device comprises: a base having a first end and a second end; a cover having a first end and a second end, the first end of the cover hingedly connected to the first end of the base; a latch mechanism configured to secure the second end of the base to the second end of the cover; Including, 2. The intravascular catheter assembly of claim 1, wherein when the second end of the base is secured to the second end of the cover, the cover and the base define a channel configured to retain the fluid conduit therein.

12. 12. The intravascular catheter assembly of claim 11, wherein a diameter of the channel is less than a diameter of the fluid conduit such that when the fluid conduit is retained within the channel, fluid flow through the fluid conduit slows and / or stops.

13. 2. The intravascular catheter assembly of claim 1, wherein the occlusion device is a slide clamp comprising a channel having at least one portion having a diameter less than a diameter of the fluid conduit and at least one other portion having a diameter equal to or greater than the diameter of the fluid conduit.

14. The intravascular catheter assembly of claim 1 , wherein the occlusion device is disposed between the side port and the connector.

15. The intravascular catheter assembly of claim 1 , wherein the occlusion device is a valve.

16. The intravascular catheter assembly of claim 15 , wherein the valve is disposed in the connector.

17. The intravascular catheter assembly of claim 15 , wherein the valve comprises a manual actuator.

18. The intravascular catheter assembly of claim 1 , wherein the connector is a t-connector or a y-connector.

19. The intravascular catheter assembly of claim 1 , further comprising a needleless access connector coupled to the connector.

20. The intravascular catheter assembly of claim 19 , wherein the needleless access connector is releasably coupled to the connector.

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