Catheter systems for pediatric care

Abstract

The pediatric catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending therebetween. The lumen may include an upper surface and a lower surface, and an adhesive may be bonded to the lower surface. The system may include a plurality of wings extending outward from the catheter adapter. The plurality of wings may be configured to fold upward. The system may include a catheter cannula extending distally from the catheter adapter. The system may include a needle hub removably coupled to the proximal end of the catheter adapter and an introducer needle extending through the catheter tube. The proximal end of the introducer needle may be secured within the needle hub.

Description

[Technical field]

[0001] The present disclosure relates to catheter systems configured to facilitate catheter insertion, and related devices and methods. [Background technology]

[0002] Infusion therapy, a common medical procedure, can be facilitated by vascular access devices. Hospitalized, home care, and other patients receive fluids, medications, and blood products via vascular access devices inserted into the vascular system. Blood draws are another common medical procedure that can be facilitated by vascular access devices.

[0003] The vascular access device may access the patient's peripheral or central vascular system. The vascular access device may be left in place for short term (days), medium term (weeks), or long term (months to years). The vascular access device may be used for continuous infusion therapy or intermittent therapy.

[0004] A common type of vascular access device is the over-the-needle peripheral venous catheter (PIVC). As the name suggests, an "over-the-needle" PIVC may be mounted over an introducer needle that has a sharp distal tip. The sharp distal tip may be used to puncture the patient's skin and vasculature. Insertion of the PIVC into the vasculature may follow puncture of the vasculature with the needle. The needle and PIVC are generally inserted through the skin into the patient's vasculature at a shallow angle, with the bevel of the needle pointing away from the patient's skin. Summary of the Invention [Problem to be solved by the invention]

[0005] In pediatric patients, including neonates, catheter placement may be more difficult when attempting to place a PIVC in a vein, as the vein may be smaller and more difficult to access. Thus, in some cases, more vulnerable patients, including children, may experience more needle sticks, which may cause pain and other complications. Conventional vascular access devices do not adequately address these issues. Thus, a catheter system is needed that reduces the difficulties encountered in pediatric care. [Means for solving the problem]

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in such environments. Rather, this background is provided only to illustrate one example technology area in which some implementations described herein may be practiced.

[0007] The present disclosure relates to a catheter system, and related devices and methods, configured to facilitate catheter insertion. The catheter system may reduce complications that may be associated with the insertion of a catheter tube into a patient's veins. The catheter system may be particularly useful for pediatric patients, including neonates, to improve catheter placement in smaller veins. It may also reduce the risk that these more vulnerable patients will experience an unnecessary needlestick injury.

[0008] In some embodiments, the catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending therebetween. The exterior surface of the lumen may include an upper surface and a lower surface. The lower surface may include an adhesive. The adhesive may be an integral tape strip including a removable backing layer. The system may include a catheter cannula extending distally from the catheter adapter. A needle hub may also be included in the system, which may be removably coupled to the proximal end of the catheter adapter, and an introducer needle extends through the catheter tube. The proximal end of the introducer needle may be secured within the needle hub.

[0009] In some embodiments, the catheter system may include a pediatric catheter system. In such a pediatric catheter system, the catheter tube may be 24 gauge or 26 gauge. The length of the catheter tube may be about 14 mm, and the catheter cannula may include a peripheral intravenous catheter.

[0010] In some embodiments, the catheter adapter may include one or more wings that may extend outwardly from the catheter adapter. The wings may be configured to fold upward. The one or more wings may include a first surface and a second surface, and an adhesive may be bonded to the second surface.

[0011] In some embodiments, the catheter system can include a housing that can be removably coupled to the catheter adapter. The housing can fit over the catheter adapter and secure the wings in an upward position. The housing can also include a finger grip that can extend outward from a distal end of the housing. The housing can be removed from over the catheter adapter to extend the wings.

[0012] In some embodiments, the catheter adapter further includes a push tab extending upwardly from a top surface of the catheter adapter. The catheter adapter may include a first push tab and a second push tab extending upwardly from between the wings.

[0013] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Therefore, the following detailed description is not to be taken in a limiting sense.

[0014] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a top view of one embodiment of a catheter assembly. [Figure 2A] FIG. 1 is a side perspective view of one embodiment of a catheter system. [Figure 2B] FIG. 2B is a top perspective view of the catheter system of FIG. 2A. [Figure 2C] FIG. 2B is a bottom perspective view of the catheter system of FIG. 2A. [Figure 2D] FIG. 2B is a side perspective view of the catheter system of FIG. 2A. [Figure 2E] FIG. 2B is a front perspective view of the catheter system of FIG. 2A. [Figure 2F] FIG. 2B is a cross-sectional view of the catheter system of FIG. 2A. [Diagram 3] FIG. 2B is a front view of an exemplary housing of the catheter system of FIG. 2A. [Figure 4] FIG. 1 is a cross-sectional view of one embodiment of a catheter system showing a housing attached to an exemplary catheter adapter. [Diagram 5] FIG. 2B is an exploded view of the catheter system of FIG. 2A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] It should be understood that these figures are for purposes of illustrating the concepts of the disclosure and are not drawn to scale. Moreover, the figures depict example embodiments and are not intended to represent limitations on the scope of the disclosure.

[0017] Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, where like parts are designated with like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of device and system embodiments, as illustrated in the figures, is not intended to limit the scope of the disclosure, as claimed in this application or any other application claiming priority to this application, but is merely representative of exemplary embodiments of the disclosure.

[0018] 1, an embodiment of a catheter system 10 is shown. The catheter system 10 may be similar to the BD "Neoflon™" IV cannula system or another suitable catheter system. For pediatric use, particularly for neonatal patients with fragile capillaries, atraumatic and delicate needles may be selected, while smaller gauge cannulas and catheters may be selected for patient comfort during catheter insertion and / or placement.

[0019] In some embodiments, the catheter system 10 may include a catheter adapter 12 and a catheter cannula 14. The catheter cannula 14 may extend distally from the catheter adapter 12. In some embodiments, the catheter cannula 14 may include a small gauge catheter sized for a pediatric patient, which may include, for example, a neonatal patient. For example, the catheter cannula 14 may have a gauge size of 24 or less. In these and other embodiments, the catheter cannula 14 may include an outer diameter approximately equal to 0.7 mm and / or a length approximately equal to 14 mm. In some embodiments, the flow rate of water through the catheter tube may be approximately 20 ml / min. As another example, the catheter cannula 14 may have a gauge size of 26. In these and other embodiments, the catheter cannula 14 may include an outer diameter approximately equal to 0.6 mm and / or a length approximately equal to 14 mm. In some embodiments, the flow rate of water through the catheter tube may be approximately 13 ml / min. The appropriate needle gauge and length can be determined by many factors, including the target body tissue, the injection solution formulation and / or viscosity, and the proportions of the patient.

[0020] In some embodiments, the catheter cannula 14 may be constructed of thermoplastic polyurethane ("TPU") or another suitable material. The catheter cannula 14 may be constructed entirely or partially of TPU. The TPU or other suitable material may facilitate smooth insertion of the catheter cannula 14 into a patient's vein or may provide a user with less resistance to inserting the catheter cannula 14 into a vein than standard catheter tubing. Standard catheter tubing may be constructed of polytetrafluoroethylene ("PTFE") or a similar material, which may be difficult to insert into a patient's vein and provide resistance that may lead to standard catheter tubing fracturing. The catheter cannula 14 constructed of TPU or another suitable material may facilitate insertion into a patient's vein and help avoid fracturing the catheter cannula 14 during insertion. Additionally, the catheter cannula 14 constructed of TPU may reduce the risk of phlebitis and extend the duration of placement of the catheter cannula 14.

[0021] In some embodiments, the catheter adapter 12 may include a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, the exterior surface of the lumen may include an upper surface and a lower surface. The upper surface of the lumen may include a push tab 16 for withdrawing the needle after insertion. In some embodiments, the upper surface of the lumen may include a second push tab 17. In some embodiments, the push tab 16 and / or the push tab 17 may allow the clinician to improve control of the catheter adapter 12 during use.

[0022] In some embodiments, the catheter adapter 12 may include one or more wings 18 that may extend outwardly from the catheter adapter 12 to hold the catheter in place. The wings 18 may extend from a bottom portion of the catheter adapter 12. The catheter adapter 12 may be constructed of a relatively flexible plastic. In some embodiments, the wings 18 may include fold lines 20 to facilitate folding the wings 18 into an upward and / or downward position.

[0023] 2A-2B, a catheter system 22 is shown. In some embodiments, the catheter system 22 may include one or more of the catheter adapter 12, the catheter cannula 14, the housing 24, the needle hub 26, the needle 28, the flow control plug 30, and the end cap 32. The housing 24 may be removably coupled to the catheter adapter 12. The housing 24 may be useful for a user, such as a clinician, to grip while inserting the catheter cannula 14 into a patient's vein. The housing 24 may also provide a larger surface area for gripping as compared to the catheter adapter 12 itself. In some embodiments, the housing 24 may further include a finger grip 34 configured to aid in the insertion and / or withdrawal of the catheter system 10 into and / or from a patient. The housing finger grip 34 may extend outwardly from a distal end of the housing 24. The housing 24 may be generally square in shape to mount on the wings and hold them in an upward position. When the catheter system 22 is in an insertion position, prior to inserting the catheter system 22 into a patient, the wings 18 may be disposed in an upward position within the housing 24, as will be described in further detail.

[0024] In some embodiments, the proximal end of the needle 28 may be secured within the needle hub 26. The proximal end of the needle 28 may be press-fit within the needle hub 26. The needle 28 may include an introducer needle having a sharp distal tip to facilitate insertion of the catheter cannula 14 into the patient's vein. In some embodiments, the needle hub 26 may include a thumb grip 36, which may be configured to aid in removal of the needle hub 26 and needle 28 from the catheter system 10 after the catheter cannula 14 has been inserted into the patient's vein. The needle 28 may be constructed of stainless steel or another suitable material.

[0025] In some embodiments, the flow control plug 30 may be configured to vent air, but contain blood, for example, with a semi-permeable membrane, a porous membrane, and / or micro-channels disposed within the flow control plug 30. An end cap 32 may be coupled to a proximal end of the flow control plug 30. When the end cap 32 is secured to the flow control plug 30, the end cap 32 may prevent venting of the flow control plug 30. The end cap 32 and / or the proximal end of the flow control plug 30 may include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector, which may facilitate coupling of the end cap 32 and the flow control plug 30. In some embodiments, an extension tube may be coupled to the luer adapter.

[0026] The lumen may extend from the distal end of the catheter adapter 12 to the proximal end of the catheter adapter. The proximal end of the catheter adapter 12 may include a luer adapter, such as a slip or threaded, male or female luer adapter, or another suitable connector. The distal end of the needle hub 26 may include a connector configured to mate with the connector at the proximal end of the catheter adapter 12. For example, the distal end of the needle hub 26 may include a luer adapter, such as a slip or threaded, male or female luer adapter, or another suitable connector.

[0027] 2C, the catheter system 22 of FIGS. 2A-2C is shown in a corresponding position after insertion of the catheter cannula 14 into the patient's vein, but prior to removal of the needle 28. In this position, the wings 18 may be disposed in a downward position for fastening to the patient's skin via the adhesive 38. In some embodiments, the wings 18 include a first surface and a second surface. The second surface of the wings 18 may be configured to contact the patient's skin when the wings are disposed in the downward position. The adhesive 38 may be applied to the second surface to fasten the wings 18 to the skin. The adhesive 38 may be an integral tape strip. In some embodiments, the adhesive 38 may include a backing layer that is removable prior to fastening the wings to the patient's skin. The catheter adapter 12 may include an upper surface and a lower surface. In some embodiments, the lower surface of the catheter adapter includes an adhesive 40 that secures the catheter adapter 12 to the patient's skin. The adhesive 38, 40 may prevent dislodging of the catheter in the event of unexpected movement by the patient.

[0028] 2D-2F, in some embodiments, the top surface of the catheter adapter 12 may include a push tab 16. The push tab 16 may extend upward from the top surface of the catheter adapter 12. The push tab 16 may be distal to the housing 24 for greater accessibility to the user. In some embodiments, the push tab 16 may be a first push tab and the catheter adapter 12 may include a second push tab 17 extending upward from between the wings. The second push tab 17 may not extend to the first push tab 16 such that the second push tab 17 fits below the housing 24. The first push tab 16 and / or the second push tab 17 may allow the clinician to control the catheter adapter 12 during removal and / or insertion.

[0029] Prior to insertion of the needle 28 and catheter cannula 14 into a patient, the housing 24 may be removed. Once removed, the first push tab 16 and / or the second push tab 17 may allow a clinician to withdraw the needle 28 after insertion into a patient's vein. The first push tab 16 and / or the second push tab 17 may provide a surface or grip that the clinician uses to separate the needle hub 26 from the catheter adapter 12. Additionally, the first push tab 16 and / or the second push tab 17 may allow a user to separate the needle hub 26 from the catheter adapter 12 with one hand.

[0030] 3, in some embodiments, the housing 24 may include a distal wall 42, which may include a first arched gate 44, and a proximal wall 46 (e.g., as shown in FIG. 4), which may include a second arched gate 48. The first arched gate 44 and the second arched gate 48 may each include a width slightly greater than the diameter of the catheter adapter 12, such that the housing 24 may be pressed onto the catheter adapter 12 in a sliding fit. The gates 44, 48 may surround the catheter adapter 12 in front of and / or behind the wings 18. Also, the height 50 of the housing 24 may be at least as large as the length of the wings 18.

[0031] 4, in some embodiments, the wings 18 may be folded upward and then a housing 24 having at least an opening at the bottom may be pushed in a sliding fit onto the catheter adapter 12 to secure the wings within the housing. After or before normal manipulation, i.e., venipuncture, active insertion of the catheter tube into the vein, and separation of the needle hub 26 from the catheter adapter 12, is performed by the finger grips 34 and / or thumb grips 36 of the housing, the housing 24 may be removed from the catheter adapter 12 and the wings 18 may be spread and then secured to the patient's skin.

[0032] 5, there is shown, according to some embodiments, a wedge 52. The wedge 52 may secure the catheter cannula 14 within the catheter adapter 12. The wedge 52 may be constructed of metal, plastic, or another suitable material.

[0033] Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular aspect, structure, or feature described in connection with that embodiment is included in at least one embodiment. Thus, references or variations thereof appearing throughout this specification do not necessarily all refer to the same embodiment. It should be understood that any of the embodiments of the present disclosure, or any portion of any of the embodiments of the present disclosure, can be combined together in any number of different ways.

[0034] Similarly, in the description of the embodiments above, it should be understood that various aspects are often grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. However, this disclosure format should not be interpreted as reflecting an intention that any claim requires more aspects than are expressly expressed in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single, foregoing disclosed embodiment. Thus, the claims following this description of the embodiments are hereby expressly incorporated into this description of the embodiments, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of an independent claim with its dependent claims.

[0035] The use in a claim of the term "first" with respect to an aspect or element does not necessarily imply the presence of a second or additional such aspect or element. Elements expressed in means-plus-function form are intended to be construed in accordance with 35 U.S.C. §112, sixth paragraph. It will be apparent to those skilled in the art that changes can be made to the details of the above-described embodiments without departing from the underlying principles described herein.

[0036] Standard medical orientations, reference planes, and descriptive terminology are employed herein. For example, anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward the central axis of the body. Off-axis means away from the central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. A median plane divides the body into left and right. A midsagittal plane divides the body into right and left halves, symmetrically on both sides. A coronal plane divides the body into anterior and posterior portions. A transverse plane divides the body into upper and lower portions. These descriptive terms may be applied to animate or inanimate bodies.

[0037] The phrases "connected," "coupled," "engaged," and "in communication" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components can be functionally coupled even if they are not in direct contact with each other. The term "abutting" refers to units that are in direct physical contact with each other, even if the units are not necessarily attached together. The phrase "fluid communication" refers to two embodiments connected such that fluid in one embodiment can pass to the other embodiment.

[0038] As defined herein, "substantially equal" means "equal to" or within about +10% or about -10% relative variation from each other.

[0039] The term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While various aspects of the embodiments are illustrated in drawings, the drawings are not necessarily drawn to scale unless specifically noted.

[0040] Although particular embodiments and applications of the present disclosure have been illustrated and described, it should be understood that the appended claims are not limited to the precise structure and components disclosed herein.Various modifications, changes and variations may be made in the arrangement, operation and details of the devices and systems disclosed herein, as will be apparent to those skilled in the art.

[0041] All examples and conditional language expressed herein are intended as educational objects to assist the reader in understanding the invention and the concepts provided by the invention to advance the art, and should be construed as not being limited to such specifically expressed examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations could be made thereto without departing from the spirit and scope of the present disclosure.

Claims

1. A pediatric catheter system, comprising: a catheter adapter having a distal end, a proximal end, and a lumen extending therebetween, an outer surface of the lumen including an upper surface and a lower surface, the lower surface including an adhesive; a catheter cannula extending distally from the catheter adapter; a needle hub removably coupled to a proximal end of the catheter adapter; an introducer needle extending through the catheter cannula, the proximal end of the introducer needle being secured within the needle hub; and housing, Including, the catheter adapter further includes a plurality of wings extending outwardly from the catheter adapter, the plurality of wings being configured to fold upward; the housing fits over the catheter adapter and secures the wings in an upward position; the catheter adapter further comprising first and second push tabs extending upwardly from the top surface of the catheter adapter, the first push tab being distal to the housing and the second push tab being between the wings.

2. 2. The pediatric catheter system according to claim 1, wherein the catheter cannula is 24 gauge or 26 gauge.

3. 2. The pediatric catheter system of claim 1, wherein the catheter cannula has a length of about 14 mm.

4. 2. The pediatric catheter system of claim 1, wherein the housing includes a finger grip extending outwardly from a distal end of the housing, the housing being removed to extend the plurality of wings.

5. 2. The pediatric catheter system of claim 1, wherein the adhesive comprises an integral tape strip having a removable backing layer.

6. A pediatric catheter system, comprising: a catheter adapter having a distal end, a proximal end, and a lumen extending therebetween, an exterior surface of the lumen including an upper surface and a lower surface, and a first adhesive is bonded to the lower surface; a plurality of wings extending outwardly from the catheter adapter, the plurality of wings being configured to fold upwardly, the plurality of wings including a first surface and a second surface, a second adhesive being bonded to the second surface; a catheter cannula extending distally from the catheter adapter; first and second push tabs extending upwardly from the top surface of the catheter adapter; a needle hub removably coupled to a proximal end of the catheter adapter; an introducer needle extending through the catheter cannula, the proximal end of the introducer needle being secured within the needle hub; and housing, Including, the housing fits over the catheter adapter to secure the wings in an upward position, and the housing is removed to extend the wings; 11. A pediatric catheter system comprising: a first push tab located distally of the housing; and a second push tab located between the wings.

7. 7. The pediatric catheter system of claim 6, wherein the first adhesive and the second adhesive comprise integral tape strips having a removable backing layer.

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