Catheter Systems for Pediatric Therapy

Abstract

A pediatric catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The lumen may include an upper surface and a lower surface, wherein an adhesive is coupled to the lower surface. The system may include a plurality of wings extending outwardly from the catheter adapter. The plurality of wings may be configured to be foldable 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 tubing. The proximal end of the introducer needle may be fixed within the needle hub.

Description

Background Art

[0001] Infusion therapy, a common medical procedure, can be facilitated by a vascular access device. Hospitalized, home care, and other patients receive fluids, medications, and blood products via a vascular access device inserted into the vascular system. Blood draws are another common medical procedure that can be facilitated by a vascular access device.

[0002] A vascular access device can access a patient's peripheral or central vasculature. A vascular access device can be left in place for a short-term (a few days), medium-term (a few weeks), or long-term (a few months to a few years). A vascular access device can be used for continuous infusion therapy or intermittent therapy.

[0003] A common type of vascular access device is an over-the-needle peripheral intravenous catheter (PIVC). As the name implies, an "over-the-needle" peripheral intravenous catheter can be placed over an introducer needle with a sharp distal tip. The sharp distal tip can be used to pierce the patient's skin and vasculature. Insertion of the peripheral intravenous catheter into the vasculature can be performed after piercing the vasculature with the needle. The needle and peripheral intravenous catheter are usually inserted through the skin into the patient's vasculature at a shallow angle, with the bevel of the needle facing away from the patient's skin.

[0004] In pediatric patients, including neonates, where veins may be smaller and therefore more difficult to access, catheter placement can be more difficult when attempting to position a peripheral intravenous catheter in a vein. As a result, in some cases, more fragile patients, including children, may experience more needle sticks, which can result in pain and other complications. Conventional vascular access devices have not adequately addressed these issues. Therefore, there is a need for a catheter system that can alleviate the difficulties that occur in pediatric care.

[0005] The subject matter claimed herein is not limited to implementations that solve all disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one example technology area in which some embodiments described herein may be practiced. Summary of the invention

[0006] The present disclosure relates to a catheter system configured to facilitate catheter insertion and related devices and methods. The catheter system can reduce complications that may be associated with inserting a catheter tube into a patient's vein. The catheter system can be particularly useful for pediatric patients, including neonates, to improve placement of catheters in smaller veins. It can also reduce the risk of unnecessary needle sticks for these more fragile patients.

[0007] In some embodiments, the catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The outer 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 extending through the catheter tubing. The proximal end of the introducer needle may be fixed in the needle hub.

[0008] In some embodiments, the catheter system may include a pediatric catheter system. In such a pediatric catheter system, the catheter tubing may be 24 gauge or 26 gauge. The length of the catheter tubing may be approximately 14 mm and the catheter cannula may include a peripheral intravenous catheter.

[0009] In some embodiments, the catheter adapter can include one or more wings that can extend outward from the catheter adapter. The wings can be configured to be folded upward. The one or more wings can include a first surface and a second surface, wherein the adhesive can be coupled to the second surface.

[0010] In some embodiments, the catheter system can include a housing that can be removably coupled to a catheter adapter. The housing can be assembled on the catheter adapter and fix the wings in an upward position. The housing can also include a finger grip that can extend outward from the distal end of the housing. The housing can be removed from the catheter adapter to extend the plurality of wings.

[0011] In some embodiments, the catheter adapter further comprises a push tab extending upward from an upper surface of the catheter adapter.The catheter adapter may comprise a first push tab and a second push tab extending upward from between the plurality of wings.

[0012] It should be understood that the foregoing overview and the following detailed description are exemplary and illustrative, rather than restrictive, of the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that the various embodiments may be combined or other embodiments may be utilized without departing from the scope of the various embodiments of the invention, and structural changes may be made (unless such requirements are present). Therefore, the following detailed description should not be considered restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Example embodiments will be described and illustrated with additional specificity and detail through the use of the accompanying drawings, in which:

[0014] Figure 1 is a top view of one embodiment of a catheter assembly;

[0015] Figure 2A is a side perspective view of one embodiment of a catheter system;

[0016] Figure 2B yes Figure 2A A top perspective view of a catheter system;

[0017] Figure 2C yes Figure 2A A bottom perspective view of a catheter system;

[0018] Figure 2D yes Figure 2A A side perspective view of a catheter system;

[0019] Figure 2E yes Figure 2A A front perspective view of a catheter system;

[0020] Figure 2F yes Figure 2A A cross-sectional view of a catheter system;

[0021] Figure 3 yes Figure 2A A front view of an example housing of a catheter system;

[0022] Figure 4 is a cross-sectional view of one embodiment of a catheter system showing a housing mounted on an example catheter adapter; and

[0023] Figure 5 yes Figure 2A Exploded view of the catheter system.

[0024] It should be understood that these drawings are for the purpose of illustrating the concepts of the present disclosure and may not be drawn to scale. In addition, these drawings illustrate example embodiments and are not intended to limit the scope of the present disclosure. DETAILED DESCRIPTION

[0025] The example embodiments of the present disclosure may be best understood by reference to the accompanying drawings, wherein similar parts are indicated by similar reference numerals throughout. It is readily understood that the components of the present disclosure may be arranged and designed in a variety of different configurations as generally described and illustrated in the drawings herein. Therefore, the following more detailed description of the embodiments of the devices and systems as shown in the drawings is not intended to limit the scope of the present disclosure as required by this application or any other application claiming priority to the present application, but merely represents an example embodiment of the present disclosure.

[0026] Now refer to Figure 1 , shows an embodiment of the catheter system 10. The catheter system 10 may be similar to the BD Neoflon TMIntravenous cannula system or other suitable catheter system.For pediatric use, particularly for neonatal patients with capillary fragility where atraumatic fine needles may be preferred, smaller gauge cannulas and catheters may be preferred for patient comfort during cannulation and / or indwelling.

[0027] 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 of a size suitable for use in pediatric patients (e.g., including neonatal patients). 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 (millimeter) and / or a length approximately equal to 14 mm. In some embodiments, the water flow rate through the catheter tubing 12 may be approximately 20 ml / min (milliliters / minute). 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 water flow rate through the catheter tubing 12 may be approximately 13 ml / min. Suitable needle gauges and lengths may be determined by many factors, including target body tissue, injection formulation and / or viscosity, and patient ratio.

[0028] In some embodiments, the catheter cannula 14 can be made of thermoplastic polyurethane ("TPU") or other suitable materials. The catheter cannula 14 can be made of TPU alone or in part. TPU or other suitable materials can facilitate the catheter cannula 14 to be smoothly inserted into the patient's vein, or can provide less resistance than standard catheter tubing when the user inserts the catheter cannula 14 into the vein. Standard catheter tubing can be made of polytetrafluoroethylene ("PTFE") or similar materials, which may be difficult to insert into the patient's vein, thereby providing resistance that may cause the standard catheter tubing to collapse. The catheter cannula 14 made of TPU or other suitable materials can be easily inserted into the patient's vein and help avoid the catheter cannula 14 from collapsing during insertion. In addition, the catheter cannula 14 made of TPU can reduce the risk of phlebitis and extend the indwelling time of the catheter cannula 14.

[0029] In some embodiments, the catheter adapter 12 can include a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. In some embodiments, the outer surface of the lumen can include an upper surface and a lower surface. The upper surface of the lumen can include a push tab 16 to withdraw the needle after insertion. In some embodiments, the upper surface of the lumen can include a second push tab 17. In some embodiments, the push tab 16 and / or the push tab 17 can enable a clinician to improve control of the catheter adapter 12 during use.

[0030] In some embodiments, the catheter adapter 12 can include one or more wings 18 that can extend outward from the catheter adapter 12 to hold the catheter in place. The wings 18 can extend from a lower portion of the catheter adapter 12. The catheter adapter 12 can be constructed of a relatively flexible plastic. In some embodiments, the wings 18 can include score lines 20 to facilitate folding the wings 18 into an upward and / or downward position.

[0031] Now refer to Figure 2A-2B , a catheter system 22 is shown. In some embodiments, the catheter system 22 may include one or more of the following: a catheter adapter 12, a catheter cannula 14, a housing 24, a needle hub 26, a needle 28, a flow control plug 30, and an end cap 32. The housing 24 may be removably coupled to the catheter adapter 12. The housing 24 may be gripped by a user, such as a clinician, during insertion of the catheter cannula 14 into a patient's vein. In addition, the housing 24 may provide a larger gripping surface area than the catheter adapter 12 itself. In some embodiments, the housing 24 may also include a finger grip 34 configured to assist in inserting and / or withdrawing the catheter system 10 from a patient's body. The housing finger grip 34 may extend outward from the distal end of the housing 24. The housing 24 may be generally square to fit over the wings and hold them in an upward position. The wings 18 may be disposed within the housing 24 in an upward position when the catheter system 20 is in an insertion position prior to inserting the catheter system 20 into a patient, as will be explained in further detail.

[0032] In some embodiments, the proximal end of the needle 28 can be fixed within the needle hub 26. The proximal end of the needle 28 can be press-fit within the needle hub 26. The needle 28 can include an introducer needle having a sharp distal tip to facilitate insertion of the catheter cannula 14 into a patient's vein. In some embodiments, the needle hub 26 can include a thumb grip 36 that can be configured to assist in removing the needle hub 26 and needle 28 from the catheter system 10 after the catheter cannula 14 is inserted into the patient's vein. The needle 28 can be made of stainless steel or other suitable materials.

[0033] In some embodiments, the flow control plug 30 can be configured to exhaust air, such as, for example, by a semipermeable membrane, a porous membrane, and / or microgrooves disposed within the flow control plug 30, but can contain blood. An end cap 32 can be coupled to the 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 can prevent the flow control plug 30 from exhausting. The end cap 32 and / or the proximal end of the flow control plug 30 can include a Luer adapter, such as a sliding or threaded male or female Luer adapter, or include other suitable connectors, which can facilitate the coupling of the end cap 32 and the flow control plug 30. In some embodiments, an extension tube can be coupled to the Luer adapter.

[0034] The lumen can 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 can include a Luer adapter, such as a sliding or threading male or female Luer adapter, or include other suitable connectors. The distal end of the needle hub 26 can include a connector configured to couple with a connector at the proximal end of the catheter adapter 12. For example, the distal end of the needle hub 26 can include a Luer adapter, such as a sliding or threading male or female Luer adapter, or include other suitable connectors.

[0035] Now refer to Figure 2C , Figures 2A-2C The catheter system 22 is shown in a position corresponding to after the catheter cannula 14 is inserted into the patient's vein but before the needle 28 is removed. In this position, the wing 18 can be set in a downward position so as to be fixed to the patient's skin by an adhesive 38. In some embodiments, the wing 18 includes a first surface and a second surface. The second surface of the wing 18 can be configured to contact the patient's skin when the wing is set in the downward position. An adhesive 38 can be applied to the second surface so that the wing 18 can be fixed to the skin. The adhesive 38 can be an integral tape strip. In some embodiments, the adhesive 38 can include a backing layer that is removable before the wing is fixed to the patient's skin. The catheter adapter 12 can include an upper surface and a lower surface. In some embodiments, the lower surface of the catheter adapter includes an adhesive 40 that fixes the catheter adapter 12 to the patient's skin. The adhesives 38, 40 can prevent the catheter from being displaced in the event of accidental movement of the patient.

[0036] Now refer to Figure 2D-2FIn some embodiments, the upper surface of the catheter adapter 12 can include a push tab 16. The push tab 16 can extend upward from the upper surface of the catheter adapter 12. The push tab 16 can be distal to the housing 24 so that it is more accessible to the user. In some embodiments, the push tab 16 can be a first push tab, and the catheter adapter 12 can include a second push tab 17 extending upward from between the plurality of wings. The second push tab 17 can not extend as far as the first push tab 16, so that the second push tab 17 fits under the housing 24. The first push tab 16 and / or the second push tab 17 can enable the clinician to control the catheter adapter 12 during removal and / or insertion.

[0037] The housing 24 may be removed prior to inserting the needle 28 and the catheter cannula 14 into the patient. When removed, the first push tab 16 and / or the second push tab 17 may enable the clinician to withdraw the needle 28 after insertion into the 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. In addition, the first push tab 16 and / or the second push tab 17 may enable the user to separate the needle hub 26 from the catheter adapter 12 with one hand.

[0038] Now refer to Figure 3 In some embodiments, the housing 24 may include a distal wall 42 that may include a first arched door 44 and a proximal wall 46 that may include a second arched door 48 (e.g., Figure 4 ). The first and second arched doors 44, 48 can each include a width slightly larger than the diameter of the catheter adapter 12 so that the housing 24 can be pushed by a sliding fit on the catheter adapter 12. The doors 44, 48 can embrace the catheter adapter 12 in front of and / or behind the wings 18. In addition, the height 50 of the housing 24 can be at least the same size as the length of the wings 18.

[0039] Now refer to Figure 4 In some embodiments, the wings 18 can be folded upward and then the housing 24 having at least an opening at the bottom can be pushed by a sliding fit on the catheter adapter 12 to secure the wings 18 within the housing 24. After or before conventional operations have been performed with the aid of the housing finger grip 34 and / or thumb grip 36, i.e., venipuncture, secure insertion of the catheter tubing 12 into the vein, and separation of the needle hub 26 from the catheter adapter 10, the housing 24 can be removed from the catheter adapter 10 and the wings 14 can be unfolded and then secured to the patient's skin.

[0040] Now refer to Figure 5, a wedge 52 is shown according to some embodiments. The wedge 52 can secure the catheter cannula 14 within the catheter adapter 12. The wedge 52 can be made of metal, plastic, or other suitable material.

[0041] References throughout this specification to "one embodiment" or "the embodiment" mean that a particular feature, structure, or characteristic described in conjunction with the embodiment is included in at least one embodiment. Thus, as described throughout this specification, referenced phrases or variations thereof do not necessarily all refer to the same embodiment. It should be understood that any embodiment of the disclosure or any portion of any embodiment of the disclosure may be combined together in any number of different ways.

[0042] Similarly, it should be understood that in the above description of the embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of simplifying the present disclosure. However, the format of the present disclosure should not be interpreted as reflecting the following intention: any claim requires more features than the features explicitly recited in the claim. On the contrary, as reflected in the attached claims, the inventive aspects lie in the combination of less than all the features of any single previously disclosed embodiment. Therefore, the claims following this embodiment description are hereby expressly incorporated into the present embodiment description, with each claim existing independently as an independent embodiment. The present disclosure includes all arrangements of independent claims and their dependent claims.

[0043] In the claims, use of the term "first" with respect to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be interpreted pursuant to 35 U.S.C. Section 112, paragraph 6. It will be apparent to those skilled in the art that changes may be made to the details of the above-described embodiments without departing from the basic principles set forth herein.

[0044] Standard medical guidelines, reference planes, and descriptive terms are used in this specification. For example, anterior refers to the front of the body. Posterior refers to the back of the body. Superior refers to the head. Inferior refers to the feet. Medial refers to the midline of the body. Lateral refers to the body away from the midline. Axial refers to the body's central axis. Abaxial refers to the body away from the body's central axis. Ipsilateral refers to the same side of the body. Contralateral refers to the opposite side of the body. The sagittal plane divides the body into left and right halves. The midsagittal plane divides the body into bilaterally symmetrical left and right halves. The coronal plane divides the body into anterior and posterior. The transverse plane divides the body into upper and lower parts. These descriptive terms can be applied to the living or inanimate body.

[0045] The phrases "connected to," "coupled to," "engaged with," and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluidic, and thermal interactions. Two components can be functionally coupled to one another even if they are not in direct contact with one another. The term "adjacent" refers to items that are in direct physical contact with one another, although the items are not necessarily attached together. The phrase "in fluid communication" refers to two features being connected so that a fluid in one feature can enter the other feature.

[0046] As defined herein, "substantially equal to" means "equal to" or within a relative deviation of approximately plus or minus 10% of each other.

[0047] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations. Although various aspects of the implementations are shown in the drawings, the drawings are not necessarily drawn to scale unless otherwise noted.

[0048] Although the specific embodiments and applications of the present disclosure have been illustrated and described, it should be understood that the scope of the appended claims is not limited to the precise configurations and components disclosed herein. Various modifications, changes and variations that are obvious to those skilled in the art may be made to the arrangement, operation and details of the devices and systems disclosed herein.

[0049] All examples and conditional language described herein are intended for teaching purposes to help readers understand the present invention and the concepts made by the inventors to further develop the art, and should be interpreted as not being limited to such specific examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions and modifications may 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 between the distal end and the proximal end, wherein an outer surface of the lumen comprises an upper surface and a lower surface, wherein the catheter adapter further comprises a first push sheet and a second push sheet, wherein the first push sheet is distal to the plurality of wings, and the second push sheet extends upward from between the plurality of wings; the plurality of wings extending outwardly from the catheter adapter, wherein the plurality of wings are configured to be foldable upwardly; a housing, wherein the housing is removably coupled to the catheter adapter and disposed on the catheter adapter to secure the plurality of wings in an upward position, wherein the first push tab is distal to the housing and separate from the second push tab, wherein the housing is positioned such that the second push tab is within the housing and fits beneath the housing, wherein when the housing is removed, the second push tab is exposed for access by a user, wherein when the housing is coupled to the catheter adapter, a finger grip of the housing is located between the first push tab and the second push tab; a catheter cannula extending distally from the catheter adapter; a needle hub removably coupled to the proximal end of the catheter adapter, wherein the needle hub includes a thumb grip, wherein the height of the thumb grip is greater than the height of the first push tab, the height of the second push tab, and the height of the finger grip, wherein when the plurality of wings are in an upward position, the height of the plurality of wings is greater than the height of the second push tab; and an introducer needle extending through the catheter cannula, wherein a proximal end of the introducer needle is secured within the needle hub, The thumb grip is configured to be gripped by a thumb, and the first push piece and / or the second push piece are configured to be pushed by a finger different from the thumb, so that a user can separate the needle hub from the catheter adapter with one hand.

2. The pediatric catheter system of claim 1, wherein: The catheter cannula was approximately 14 mm in length.

3. The pediatric catheter system of claim 1, wherein: Adhesive is coupled to a lower surface of the outer surface of the lumen, wherein the adhesive comprises an integral tape strip having a removable backing layer.

4. The pediatric catheter system of claim 1, wherein: The plurality of wings include an upper surface and a lower surface, wherein the lower surface includes an adhesive.

5. The pediatric catheter system of claim 1 further comprising a housing, wherein: The housing is configured to be removed to extend the plurality of wings.

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