Catheter adapter with stabilization function

Abstract

The catheter adapter includes a body having a first end and a second end opposite the first end, the body including an inlet port disposed between the first end and the second end, the body defining a longitudinal axis extending between the first end and the second end of the body, a catheter configured to be inserted into a patient's vascular system, the catheter disposed at the first end of the body, and a stabilizer including a first wing member and a second wing member, a portion of the stabilizer extending beyond the inlet port of the body in a direction extending along the longitudinal axis from the first end of the body to the second end of the body.

Description

[Technical field]

[0001] The present invention relates to a catheter adapter with stabilizing features. [Background technology]

[0002] This application claims priority to U.S. Provisional Application No. 63 / 313,821, entitled "Catheter Adapter with Stabilizing Features," filed February 25, 2022, the entire disclosure of which is incorporated by reference herein in its entirety.

[0003] Catheters are frequently utilized for the administration of fluids into and out of the body. Patients in various settings, including hospitals and home care, receive fluids, medicines, and blood products through vascular access devices inserted into the patient's vascular system. Catheters of various types and sizes are widely used in a variety of procedures, including, but not limited to, treating infections, providing anesthesia or analgesia, providing nutritional support, treating cancerous tumors, maintaining blood pressure and heart rhythm, and many other clinical applications. A common vascular access device is a plastic catheter that is inserted into a patient's vein. The length of the catheter can vary from a few centimeters for peripheral access to several tens of centimeters for central access. Catheters are commonly incorporated into catheter adapters to increase the ease of use, accessibility, and utility of the catheter. The catheter adapter is adapted to accommodate one end of a catheter, which is supported by the catheter adapter, and the body and tip of the catheter extend beyond the first end of the catheter adapter. The catheter adapter typically further comprises a second end adapted to receive additional infusion components for use with the catheter. For example, the second end of the catheter adapter may include a series of threads for attaching an intravenous line or for connecting a syringe to the catheter adapter, thereby providing access to the patient's vascular system via an attached catheter.

[0004] Catheters may be inserted percutaneously. When inserted percutaneously, insertion of the catheter is generally assisted by an introducer needle. The introducer needle is usually housed within the lumen of the catheter such that the gauge of the needle approximates the inner diameter of the catheter. The needle is placed within the catheter such that the tip of the needle extends beyond the tip of the catheter, whereby the needle is used to penetrate the patient's vein and provide an opening for inserting the catheter.

[0005] During insertion into a patient, the needle and catheter typically approach the patient's vein at approximately a 30 degree angle so that the needle first pierces the patient's epidermis and then enters the vein. Once the tip of the needle and catheter is in the patient's vein, the needle and catheter are then positioned to position the needle and catheter approximately parallel to the patient's vein and insert the needle and catheter into the lumen of the patient's vein. When the catheter is properly positioned within the patient's vein, the needle is removed from the catheter lumen and a catheter adapter is secured to the patient to prevent premature removal of the catheter.

[0006] The catheter adapter may be secured to the patient by securing the catheter adapter to the patient's skin via tape, a fastening device, and / or a fastening bandage. When the catheter adapter is secured to the patient's skin, the root portion of the catheter immediately exiting the catheter adapter must be arched to accommodate the transition of the catheter from the generally parallel, fixed orientation of the catheter adapter to the insertion angle of the catheter. Summary of the Invention [Problem to be solved by the invention]

[0007] With reference to FIG. 1, an extended portion of the catheter may be left between the patient and the catheter adapter to allow for transitional arching of the catheter. This exposed arched length of the catheter deflects the catheter toward the patient's skin. The portion of the catheter that extends from the catheter adapter may be generally S-shaped. However, the catheter may twist slightly at the bend in the S-shaped profile such that it may occlude the catheter and / or prevent the passage of instruments through the catheter. For example, the S-shaped profile and / or twisting of the catheter may pose a challenge for line draw devices that use the catheter and pass through the catheter to open a fluid pathway for blood collection. [Means for solving the problem]

[0008] In one aspect or embodiment, a catheter adapter includes a body having a first end and a second end disposed opposite the first end, the body including an inlet port disposed between the first end and the second end, the body defining a longitudinal axis extending between the first end and the second end of the body, a catheter configured to be inserted into a patient's vasculature, the catheter disposed at the first end of the body, and a stabilizer including a first wing member and a second wing member, a portion of the stabilizer extending beyond the inlet port of the body in a direction extending along the longitudinal axis from the first end of the body to the second end of the body.

[0009] The bottom surface of the stabilizer is configured to contact a skin surface of the patient, and the bottom surface of the stabilizer defines a plane that forms an angle greater than zero with respect to a longitudinal axis of the body.

[0010] The stabilizer may be symmetric about the longitudinal axis. The stabilizer may be asymmetric about the longitudinal axis.

[0011] The first wing member has a first end and a second end, the first wing member defining a recess adjacent the inlet port of the body, the recess in the first wing member extending from the second end of the first wing member toward the first end of the first wing member.

[0012] The first and second wing members may define an opening disposed completely within the perimeter of the first and second wing members, respectively.

[0013] The stabilizer may include a first extension portion extending from the first wing toward the second end of the body and a second extension portion extending from the second wing toward the second end of the body.

[0014] The stabilizer may include a clip configured to attach the stabilizer to the body. The clip may be disposed on a base portion, the base portion forming a part of the stabilizer.

[0015] The portion of the stabilizer that extends beyond the entry port of the body may include a hinge portion. The hinge portion may include a living hinge.

[0016] The bottom surface of the stabilizer can be configured to contact a skin surface of the patient, the bottom surface of the stabilizer defining a recess configured to be aligned with a vein of the patient when the stabilizer is in contact with the skin surface of the patient.

[0017] The bottom surface of the stabilizer can be configured to contact a skin surface of a patient, the bottom surface of the stabilizer comprising a plurality of protrusions and / or a plurality of channels.

[0018] In a further aspect or embodiment, a vascular access device includes the catheter adapter of any of the above aspects or embodiments and a needle hub assembly connected to the body of the catheter adapter.

[0019] The stabilizer may be spaced from the needle hub assembly.

[0020] In a further aspect or embodiment, a catheter adapter includes a body having a first end and a second end disposed opposite the first end, the body including an inlet port disposed between the first end and the second end and defining a longitudinal axis extending between the first end and the second end of the body, and a catheter configured to be inserted into a patient's vascular system, the catheter including: a catheter disposed at the first end of the body; a first support member extending from the body; and a second support member extending from the body, the first and second support members configured to engage a skin surface of the patient and space the body from the skin surface of the patient when the catheter is inserted into the patient.

[0021] The first and second support members may each include a support surface spaced from a bottom surface of the body via a support arm. The first support member may be disposed on an opposite side of the body from the second support member. The support surfaces of each of the first and second support members may comprise an elastomeric material. [Brief description of the drawings]

[0022] The above and other features and advantages of the present disclosure, as well as the manner in which they are accomplished, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure in conjunction with the accompanying drawings.

[0023] [Figure 1] FIG. 1 is a partial cross-sectional view of a conventional catheter adapter and catheter, showing the catheter inserted into a patient's vein. [Diagram 2] FIG. 1 is a perspective view of a vascular access device according to an aspect or embodiment of the present application. [Diagram 3] FIG. 1 is a side view of a conventional catheter adapter. [Figure 4] FIG. 1 is a side view of a catheter adapter according to one aspect or embodiment of the present application. [Diagram 5] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 6] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 7] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 8] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 9] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 10] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 11] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 12] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 13] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 14] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 15] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 16] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 17] FIG. 1 is a side view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 18] FIG. 1 is a top view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 19] FIG. 1 is a perspective view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 20] FIG. 1 is a bottom view of a catheter adapter and needle hub according to one aspect or embodiment of the present application. [Figure 21] FIG. 1 is a bottom view of a catheter adapter according to one aspect or embodiment of the present invention. [Figure 22]FIG. 1 is a side view of a catheter adapter and stabilizer assembly according to one aspect or embodiment of the present invention. [Diagram 23] FIG. 23 is a perspective view of the stabilizer assembly of FIG. 22. [Figure 24] FIG. 1 is a side view of a catheter adapter according to one aspect or embodiment of the present invention. [Diagram 25] FIG. 25 is a side view of the catheter adapter of FIG. 24, showing the catheter adapter in contact with a patient's skin surface. [Figure 26] FIG. 25 is a side view of the catheter adapter of FIG. 24 illustrating the molding process of the stabilizer of the catheter adapter. [Figure 27] FIG. 1 is a bottom perspective view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 28] FIG. 1 is a perspective view of a catheter adapter according to one aspect or embodiment of the present application. [Figure 29] FIG. 1 is a perspective view of a catheter adapter according to one aspect or embodiment of the present application. [Diagram 30] FIG. 1 is a perspective view of a catheter adapter according to one aspect or embodiment of the present application.

[0024] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations set forth herein illustrate exemplary embodiments of the present disclosure, and such illustrations are not to be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Spatial or directional terminology such as "left", "right", "inside", "outside", "up" and "down" should not be considered limiting as the present invention can contemplate various alternative orientations.

[0026] In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "vertical", and derivatives thereof, refer to the invention as illustrated in the drawings. However, it should be understood that the invention may assume various alternative variations, 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 aspects of the invention.

[0027] Unless otherwise specified, all ranges or ratios disclosed herein are understood to include the starting and ending values, and all subranges or subratios contained therein. For example, a range or ratio "1 to 10" should be considered to include all subranges or subratios between the minimum value of 1 and the maximum value of 10, inclusive. That is, all subranges or subratios beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less.

[0028] The terms "first," "second," and the like do not refer to a particular order or chronology, but rather to different conditions, characteristics, or elements.

[0029] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any two or more of A, B, or C in combination. For example, "at least one of A, B, and C" includes one or more of A only, one or more of B only, one or more of C only, one or more of A and B, one or more of A and C, one or more of B and C, or one or more of all of A, B, and C.

[0030] 2 and 3, a vascular access device 10 according to one aspect or embodiment of the present application includes a catheter adapter 12 and a catheter 14. In a particular aspect or embodiment, the vascular access device 10 further includes a needle hub assembly 16, an extension tube 18, a clamp 20, and a luer access device 22. The catheter adapter 12 includes an inlet port 24 that receives an end of the extension tube 18 for establishing fluid communication between an intravenous fluid source and the catheter adapter 12, or the lumen of the catheter 14. In one aspect or embodiment, the needle hub assembly 16 is assembled with the catheter adapter 12 by inserting a needle into the lumen of the catheter 14. The needle hub assembly 16 is shown as including a finger grip 28 disposed on a side of the needle hub assembly 16 to facilitate various insertion techniques. In one aspect or embodiment, the needle hub assembly 16 includes a needle shield 30 configured to secure the tip of the needle within the shield after use. The needle shield 30 may be passively actuated. The needle hub assembly 16 includes a push tab 32 to facilitate advancement of the catheter during insertion. The push tab 32 may be advanced with one or two hands. The push tab 32 may be removed along with the needle shield 30. A clamp 20 is placed on the extension tube 18 to prevent blood flow if necessary.

[0031] 2, the Luer access device 22 of the vascular access device 10 includes a first Luer access 34 and a second Luer access 36 in fluid communication with the extension tube 18, a blood control dividing septum 38 associated with the first Luer access 34, and an air vent 40 associated with the second Luer access 36. The dividing septum 38 functions as the blood control septum 38, allowing for a reduction in catheter-related bloodstream infections (CRBSIs) while providing unrestricted flow and a straight fluid path. The air vent 40 allows air to escape from the system during insertion, preventing blood from leaking from the system during insertion while continually verifying vascular access. In one aspect or embodiment, the extension tube 18 is connected near a patient port configured to connect to a blood collection device, such as a PIVO™ blood collection device available from Velano Vascular.

[0032] 3, the conventional catheter adapter 42 includes a stabilizing platform 44 made of an elastomeric material and disposed on a bottom surface of the conventional catheter adapter 42. The stabilizing platform 44 forms a "belly" that contacts the patient's skin surface. During dressing of the conventional catheter adapter 42 and after placement of the catheter, the catheter may bend to impede flow through the catheter and / or prevent passage of instruments through the catheter.

[0033] 4-21, in one aspect or embodiment of the present application, the catheter adapter 12 of the vascular access device 10 includes a body 60 having a first end 62 and a second end 64 opposite the first end 62. The inlet port 24 is disposed between the first end 62 and the second end 64. The body 60 defines a longitudinal axis L extending between the first end 62 and the second end 64 of the body 60. The catheter 14 is configured to be inserted into the vascular system of a patient and is disposed at the first end 62 of the body 60. The catheter adapter 12 also includes a stabilizer 66 having a first wing member 68 and a second wing member 70. A portion of the stabilizer 66 extends beyond the inlet port 24 of the body 60 in a direction extending along the longitudinal axis L from the first end 62 of the body 60 to the second end 64 of the body 60. Having more material in the stabilizer 66 toward the second end 64 of the body 60 stabilizes the catheter adapter 12 and prevents it from rocking, which can cause the catheter 14 to kink or bend undesirably. The stabilizer 66 may be integrally molded of the same material as the body 60. The stabilizer 66 may be formed of an elastomeric material. In one aspect or embodiment, the stabilizer 66 is molded using a two-shot overmolding process.

[0034] 4, in one aspect or embodiment, the bottom surface 74 of the stabilizer 66 configured to contact the patient's skin surface defines a plane that forms an angle greater than zero with respect to the longitudinal axis L of the body 60. In one aspect or embodiment, the bottom surface 74 of the stabilizer 66 defines a plane that forms an angle between 3 and 10 degrees with respect to the longitudinal axis L of the body 60. The bottom surface 74 is configured to lift the second end 64 of the body 60 when engaged with the patient's skin surface to reduce kinking or undesired bending of the catheter 14.

[0035] 5, 6, 11, and 18, in certain aspects or embodiments, the first wing member 68 includes a first end 76 and a second end 78, and the first wing member 68 defines a recess 80 adjacent the inlet port 24 of the body 60. The recess 80 of the first wing member 68 extends from the second end 78 of the first wing member 68 toward the first end 76 of the first wing member 68. The recess 80 is configured to provide a gap around the inlet port 24. The stabilizer 66 may be symmetrical about the longitudinal axis L of the body 60, as shown in FIG. 5, or asymmetrical about the longitudinal axis L of the body 60, as shown in FIGS. 6 and 11.

[0036] With reference to FIG. 7, in one aspect or embodiment, the first and second wing members 68, 70 define an opening 84 disposed completely within the perimeter of the first and second wing members 68, 70, respectively.

[0037] Referring to FIG. 9 , in one aspect or embodiment, the stabilizer 66 includes a first extension portion 86 extending from the first wing member 68 toward the second end 64 of the body 60 and a second extension portion 88 extending from the second wing member 70 toward the second end 64 of the body 60.

[0038] 5-21, the stabilizer 66 may be symmetrical or asymmetrical with respect to the longitudinal axis L of the body 60. The stabilizer 66 may be triangular, elliptical, or various other shapes. The stabilizer 66 may include various curves, notches, and / or extensions. As shown more clearly in FIGS. 20 and 21, the stabilizer 66 is spaced apart from the needle hub assembly 16. In one aspect or embodiment, the stabilizer 66 is configured to provide clearance between the stabilizer 66 and the needle hub assembly 16 by extending the stabilizer 66 around the needle hub assembly 16.

[0039] 22 and 23 , in one aspect or embodiment, the stabilizer 66 includes a clip 92 configured to attach the stabilizer 66 to the body 60. The clip 92 is disposed on a base portion 94, which forms a part of the stabilizer 66. In one aspect or embodiment, the base portion 94 and the clip 92 are molded separately from the first and second wing members 68, 70.

[0040] 16, 19-21, and 24-26, in one aspect or embodiment, the portion of the stabilizer 66 that extends beyond the inlet port 24 of the body 60 includes a hinge portion 98. In one aspect or embodiment, the hinge portion 98 is a living hinge. A living hinge may be molded through an undercut. Alternatively, as shown in FIG. 26, in one aspect or embodiment, the hinge portion 98 may be formed using two separate mold pulls. Rather than forming the hinge portion 98 with an undercut, a second mold pull flexes the hinge portion 98 out of the way.

[0041] 27, in one aspect or embodiment, the bottom surface 102 of the stabilizer 66 configured to contact the patient's skin surface defines a recess 104 configured to be aligned with the patient's vein when the stabilizer 66 is in contact with the patient's skin surface. The width and height of the recess 104 may be optimized to achieve reduced force. In one aspect or embodiment, the recess 104 is configured to reduce the likelihood of occluding the vein, thereby increasing the likelihood of successful blood collection.

[0042] 28, in one aspect or embodiment, instead of providing the first and second wing members 68, 70, the catheter adapter 12 includes a first support member 110 extending from the body 60 and a second support member 112 extending from the body 60, the first and second support members 110, 112 being configured to engage a skin surface of a patient and space the body 60 from the skin surface of the patient when the catheter 14 is inserted into the patient. The first and second support members 110, 112 include support surfaces 114, 116 spaced from a bottom surface 118 of the body 60 via support arms 120, 122, respectively. The first support member 110 is disposed on an opposite side of the body 60 from the second support member 112. The support surfaces 114, 116 of the first and second support members 110, 112, respectively, may be molded from an elastomeric material. The first and second support members 110, 112 and their respective support arms 120, 122 are molded from a plastic material and the support surfaces 114, 116 are molded onto the first and second support members 110, 112 by an overmolding process. The first and second support members 110, 112 are configured to provide stability to the catheter adapter 12 and prevent the catheter adapter 12 from rocking, while thereby relieving pressure on the vein and reducing the chance of the vein becoming blocked, resulting in better blood collection results.

[0043] 29 and 30, in certain aspects or embodiments, the bottom surface 126 of the stabilizer 66 includes a plurality of protrusions 128 and / or a plurality of channels 130. The plurality of protrusions 128 and the plurality of channels 130 are configured to reduce force on the patient's veins while improving breathability of the skin beneath the stabilizer 66.

[0044] Although the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for this purpose only, and that the present invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention 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. a body having a first end and a second end disposed opposite the first end, the body defining a longitudinal axis extending between the first end and the second end, the body including an inlet port disposed between the first end and the second end; a catheter configured to be inserted into a patient's vascular system, the catheter disposed at the first end of the body; a stabilizer including a first wing member and a second wing member, a portion of the stabilizer extending beyond an inlet port of the body in a direction extending along the longitudinal axis from the first end of the body to the second end of the body; A catheter adapter comprising:

2. 10. The catheter adapter of claim 1, wherein a bottom surface of the stabilizer is configured to contact a skin surface of a patient, the bottom surface of the stabilizer defining a plane that forms an angle greater than zero with respect to the longitudinal axis of the body.

3. The catheter adapter of claim 1 , wherein the stabilizer is symmetrical about the longitudinal axis.

4. The catheter adapter of claim 1 , wherein the stabilizer is asymmetric with respect to the longitudinal axis.

5. 2. The catheter adapter of claim 1, wherein the first wing member includes a first end and a second end, the first wing member defining a recess adjacent the inlet port of the body, the recess of the first wing member extending from the second end of the first wing member toward the first end of the first wing member.

6. The catheter adapter of claim 1 , wherein the first and second wing members define an opening disposed completely within a perimeter of the first and second wing members, respectively.

7. 2. The catheter adapter of claim 1, wherein the stabilizer comprises a first extension extending from the first wing member toward the second end of the body and a second extension extending from the second wing member toward the second end of the body.

8. The catheter adapter of claim 1 , wherein the stabilizer comprises a clip configured to attach the stabilizer to the body.

9. The catheter adapter of claim 8 , wherein the clip is disposed on a base portion, the base portion forming part of the stabilizer.

10. The catheter adapter of claim 1 , wherein the portion of the stabilizer that extends beyond the entry port of the body comprises a hinge portion.

11. The catheter adapter of claim 10 , wherein the hinge portion comprises a living hinge.

12. 10. The catheter adapter of claim 1, wherein a bottom surface of the stabilizer is configured to contact a skin surface of a patient, the bottom surface of the stabilizer defining a recess configured to be aligned with a patient's vein when the stabilizer contacts the patient's skin surface.

13. 10. The catheter adapter of claim 1, wherein a bottom surface of the stabilizer is configured to contact a skin surface of a patient, the bottom surface of the stabilizer comprising a plurality of protrusions.

14. 10. The catheter adapter of claim 1, wherein a bottom surface of the stabilizer is configured to contact a skin surface of a patient, the bottom surface of the stabilizer comprising a plurality of channels.

15. The catheter adapter according to any one of claims 1 to 14, a needle hub assembly connected to the body of the catheter adapter; A vascular access device comprising:

16. The vascular access device of claim 15 , wherein the stabilizer is spaced from the needle hub assembly.

17. a body having a first end and a second end located opposite the first end, the body defining a longitudinal axis extending between the first end and the second end, the body including an inlet port located between the first end and the second end; a catheter configured to be inserted into a patient's vascular system, the catheter disposed at the first end of the body; a first support member extending from the body; a second support member extending from the body; Preparation, A catheter adapter configured such that when the catheter is inserted into the patient, the first and second support members engage a skin surface of the patient and space the body from the skin surface of the patient.

18. 18. The catheter adapter of claim 17, wherein the first and second support members each include a support surface spaced from a bottom surface of the body via a support arm.

19. 20. The catheter adapter of claim 18, wherein the first support member is disposed on an opposite side of the body from the second support member.

20. The catheter adapter of claim 19, wherein the support surface of each of the first and second support members comprises an elastomeric material.

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