US-12616815-B1 - Intravenous catheter reinforced to maintain volumetric integrity

Abstract

An intravenous (IV) catheter having a cannula with a length of tubing with sidewalls reinforced by a radial force element. The radial force element is formed by a material different from a uniform material that forms the exposed external surface of the tubing and the interior surface of the tubing through which fluids flow. The radial force element distributes a perpendicular external force applied to a point of the length of tubing across a surface area of the tubing, which minimizes decreases in the interior diameter of the tubing at the point compared to a substantially equivalent tubing lacking the radial force element.

Inventors

• Akash R. Prashad
• Garen Manoogian

Assignees

• Akash R. Prashad
• Garen Manoogian

Dates

Publication Date

20260505

Application Date

20200110

Claims (20)

1. 1 . A medical device comprising: an intravenous (IV) catheter comprising cannula structures consistent with cannula conventions having a cannula formed from cannula materials, said cannula comprising: a tubing with sidewalls including an inner surface wall, the tubing comprising: a radial force element configured to reinforce an interior of the tubing, wherein the radial force element is positioned between a first attachment point and a second attachment point, wherein the first attachment point is configured to be positioned outside the skin of the human body when the tubing is inserted into the human body, and the second attachment point is configured to be positioned beyond the skin of the human body when the tubing is inserted into the human body and is located inside a blood vessel of the human body, the radial force element secured to the inner surface wall only at the first and second attachment points and no other affixation points, said radial force element distributing a perpendicular external force, which minimizes decreases in the interior diameter of the tubing to prevent kinks from occurring as a result of simple patient movement.
2. 2 . The medical device of claim 1 , wherein the radial force element is a helical coil.
3. 3 . The medical device of claim 1 , the sidewall of the tubing having a uniform exterior diameter and a uniform interior diameter.
4. 4 . The medical device of claim 1 , wherein the radial force element is metal.
5. 5 . The medical device of claim 1 , wherein the radial force element is formed from a cannula material different from that that forms an exposed external surface and an interior surface of the tubing.
6. 6 . The medical device of claim 1 , wherein an exterior diameter of the tubing is configured so that it is not uniform across its entire length and at least a portion of the radial force element is within an insertion section of the tubing.
7. 7 . The medical device of claim 1 , further comprising an expansion section, wherein the expansion section is longitudinally more compressive and expansive than a terminal section.
8. 8 . The medical device of claim 7 , wherein the expansion section has an exterior diameter greater than an exterior diameter of the terminal section.
9. 9 . The medical device of claim 7 , wherein the radial force element is a helical coil, and wherein the helical coil is contained within the expansion section and does not protrude out of an end of the catheter.
10. 10 . The medical device of claim 1 , wherein the radial force element reinforces a subsection of the tubing where potential kinking problems resulting from patient movement are most prevalent.
11. 11 . The medical device of claim 1 , wherein the radial force element prevents kinks resulting from motion of environmental items pulling on an exposed portion of the tubing.
12. 12 . The medical device of claim 1 , wherein the radial force element increases a longitudinal elasticity of the tubing.
13. 13 . A medical device comprising: a cannula formed from cannula materials, said cannula comprising tubing with sidewalls reinforced by a helical coil, the helical coil situated along substantially an entire length of the tubing and secured to the inner sidewall only at first and second attachment points and no other affixation points, which has a uniform exterior diameter and a uniform interior diameter, wherein the helical coil minimizes kinking of the tubing resulting from simple patient movements pulling at the tubing, wherein the helical coil is positioned between a first attachment point and a second attachment point, wherein the first attachment point is configured to be positioned outside the skin of the human body when the tubing is inserted into the human body, and the second attachment point is configured to be positioned beyond the skin of the human body when the tubing is inserted into the human body, and is located inside a blood vessel of the human body.
14. 14 . The medical device of claim 13 , wherein the helical coil is metal, wherein other than the helical coil, the tubing is made from a uniform, non-metal cannula material.
15. 15 . The medical device of claim 13 , wherein the helical coil is a first uniform non-metal cannula material, wherein other than the helical coil, the tubing is made from a second uniform non-metal cannula material.
16. 16 . The medical device of claim 13 , wherein an external diameter of the tubing is not uniform across its entire length and at least a portion of the helical coil is within an insertion section of the tubing.
17. 17 . A medical catheter comprising: a tubing made from a medical grade material, which is a cannula material, of a predetermined gauge and wall thickness consistent with cannula conventions commensurate with an intended medical purpose, the tubing having sidewalls including an inner surface wall; a hub component coupled to one end of the length of tubing to facilitate attachment to ancillary elements; a radial force element configured to reinforce an interior of the tubing; and a dynamic reinforcing member positioned along the inner surface wall, wherein the dynamic reinforcing member is configured to resist kinking, wherein the dynamic reinforcing member is positioned between a first attachment point and a second attachment point, wherein the first attachment point is configured to be positioned outside the skin of the human body when the tubing is at least partially inside the human body, and the second attachment point is configured to be positioned beyond the skin of the human body when the tubing is at least partially inside the human body and is located inside a blood vessel of the human body, wherein said reinforcing member provides sufficient outwards radial force to minimize kinking resulting from the external forces, wherein the reinforcing member is coupled to an interior wall of the length of tubing proximate to each end at a specified attachment point, wherein the reinforcing member is able to dynamically adjust its position within the interior space between the first and second attachment points in response to the external forces applied proximate to a skin boundary at an insertion point decreasing a likelihood that the external forces cause the tubing to kink.
18. 18 . The medical catheter of claim 17 , wherein the radial force element is one of a spring, a helical frame, and a mesh frame.
19. 19 . The medical catheter of claim 17 , wherein the sidewall of the tubing having a substantially uniform interior and exterior diameter.
20. 20 . The medical catheter of claim 17 , wherein the dynamic reinforcing member is a discrete section of the medical catheter positioned between the first attachment point and the second attachment point that is not coupled to a discrete actuatable controlling mechanism able to independently control an expansion or contraction of the dynamic reinforcing member, which inherently dynamically adjusts based on its structural integrity in response to application of external forces.

Description

BACKGROUND The present invention relates to the field of medical supplies, and more particularly to an intravascular (IV) catheter reinforced to maintain volumetric integrity. An intravascular (IV) catheter 125 is a crucial medical device for patient care. FIG. 1A illustrates the two primary components of a typical IV catheter 125, prior to insertion into a patient. The first component is a needle assembly comprised of an introducer needle 105 coupled to a needle hub 110. The second component is a catheter assembly comprised of the catheter 115 coupled to a catheter hub 120. The catheter 115 and catheter hub 120 are of a gauge to fit snuggly over the needle 105 and needle hub 110 to produce the assembled IV catheter 125. The introducer needle 105 extends past the length of the catheter 115 in order to pierce a patient's skin 135, subcutaneous tissue 140, and vessel 145 wall at a determined insertion point 155, creating a pathway for the catheter 115, as shown in FIG. 1A. The needle 105 is retracted, leaving the catheter 115 embedded in the vessel 145. Depending on the apparatus attached to the hub 110, fluids are then pushed directly into the vessel 145 or blood is drawn directly from the vessel 145. Despite its high usage, over one-third of the IV catheters 125 administered (in the United States) will fail in some manner before the end of its required dwell time (normal dwell time 72-96 hours), resulting in its removal and the insertion of a new IV catheter 125. Typical failures include phlebitis, infiltration, occlusion/mechanical failure, dislodgment, infection, and/or various combinations thereof. Therefore, the longer a patient needs an IV catheter 125, the more likely a failure will occur. Medical costs and complications resulting from the need to reinsert IV catheters greatly exceed the costs of the IV catheters themselves and given the relatively large anticipated failure rates of conventional IV catheters 125 minimization of failure rates through catheter improvements represents a significant cost savings overall and significant health improvement returns for patients. Historically, catheter designers were limited to single material options along the length of the catheter. Reinforced catheters in production occasionally lack the required flexibility at the distal end, while unreinforced catheters sometimes lack the necessary uniformity of rigidity from the proximal end. Nonetheless over the years, a few improvements to the design of the IV catheter 125 have been implemented to reduce failure rates. For example, stabilization apparatuses have been externally attached to address failures due to dislodgement (i.e., prevent the catheter 115 from being removed when pulled upon) or patient movements (i.e., bending or kinking the catheter 115). However, these stabilization apparatuses are not widely used due to their cumbersome nature. Most other attempted improvements have also been external attachments, such as an adhesive dressing 150 to stick the catheter 115 to the proximate skin 135, and not to the catheter 115 itself, save for advances in medical grade materials upon which the tubing is uniformly constructed. What is needed is a solution that allows the catheter 115 to retain its volumetric integrity in light of external forces, as well as improved cutability, torque transmission, and deformation upon insertion and during patient dwell time. Such a solution would dynamically reinforce the interior of the catheter 115 in response to external mechanical and fluidic forces. It should be understood that FIG. 1B as with other drawings presented herein are for illustrative purposes to demonstrate the concepts expressed herein. As such, one of ordinary skill can understand that some simplifications for expression are denoted. For example, in practice, dressings (150) are applied over the cannula, hub, and line even though they are shown as a horizontal plain in FIG. 1B to ensure visibility of significant drawing elements. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS FIG. 1A (PRIOR ART) depicts the basic components of a safety intravenous (IV) catheter. FIG. 1B (PRIOR ART) illustrates the general placement of a safety IV catheter in use. FIGS. 2A and 2B is a collection of illustrations that emphasize the benefit of a dynamically-reinforced IV catheter in accordance with embodiments of the inventive arrangements disclosed herein. FIG. 3A is a block diagram that presents an enlarged longitudinal cross-section of the dynamically-reinforced IV catheter in accordance with embodiments of the inventive arrangements disclosed herein. FIG. 3B depicts an example embodiment of the dynamically-reinforced IV catheter having a spiral or spring as the reinforcing member in accordance with embodiments of the inventive arrangements disclosed herein. FIG. 3C depicts an example embodiment of the dynamically-reinforced IV catheter having a spine with radial ribs as the reinforcing member in accordance with embodime