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JP-7857282-B2 - Medical connector with integrated adhesive backing

JP7857282B2JP 7857282 B2JP7857282 B2JP 7857282B2JP-7857282-B2

Inventors

  • ワイン、ジェイソン アンドリュー
  • ゾリンジャー、クリス ジェシー

Assignees

  • ケアフュージョン ３０３、インコーポレイテッド

Dates

Publication Date
20260512
Application Date
20210920
Priority Date
20200923

Claims (20)

  1. A holder for securing a venous access device to a patient, wherein the holder is A flexible substrate having an upper surface, a lower surface, and an outer peripheral surface; An adhesive layer covering the lower surface of the flexible substrate, wherein the adhesive layer has an adhesive for adhering to the patient's skin; A hydrophilic matrix integrated into at least a portion of the adhesive layer; Disposed on the upper surface of the flexible substrate and fluidly connected to the adhesive layer , the solvent reservoir is configured to contain a solvent for decomposing the adhesive ; A holder comprising a connector fixed to the outer surface, the connector comprising a first end including a Luer lock fitting for connection to a needle assembly, and a second end for connection to an IV fluid line.
  2. The holder according to claim 1, further comprising a removable barrier interposed between the hydrophilic matrix and the at least one solvent reservoir.
  3. The holder according to claim 1, wherein the flexible substrate comprises at least one of foam, silicone, soft plastic, rubber, or elastomer.
  4. The holder according to claim 1, wherein the solvent reservoir contains a solvent configured to dissolve at least a portion of the adhesive.
  5. The holder according to claim 4, wherein the hydrophilic matrix comprises a hydrophilic material capable of absorbing the solvent.
  6. The holder according to claim 4, wherein the solvent comprises isopropyl alcohol.
  7. The holder according to claim 1, wherein the lure lock fitting includes a spin lock collar.
  8. A method for assembling a holder for securing a venous access device to a patient, the method being: The steps include: selecting a flexible substrate containing a breathable material; Steps include: placing an adhesive layer on the lower surface of the flexible substrate, wherein the adhesive layer has an adhesive for adhering to the patient's skin; The steps include: fluidly connecting at least one solvent source to the adhesive layer; A method comprising the steps of fixing a connector to the outer peripheral surface of the flexible substrate, wherein the connector includes a first end having a Luer lock fitting for connection to a needle assembly, and a second end for connection to an IV fluid line.
  9. The method according to claim 8, further comprising the step of integrating a hydrophilic matrix into at least a portion of the adhesive layer.
  10. The step of fluidly connecting at least one solvent source to the adhesive layer is, The steps include positioning at least one solvent reservoir on the upper surface of the flexible substrate; The method according to claim 9, comprising the step of interposing a removable barrier between the at least one solvent reservoir and the upper surface of the flexible substrate.
  11. The method according to claim 8, further comprising the step of integrating a solvent pathway containing at least one aperture into at least a portion of the adhesive layer.
  12. The method according to claim 11, wherein the step of fluidly connecting at least one solvent source to the adhesive layer includes the step of fluidly connecting a solvent delivery line to the solvent path via at least one aperture, the solvent delivery line being disposed on the upper surface of the flexible substrate.
  13. The method according to claim 8, wherein the solvent of the at least one solvent source comprises isopropyl alcohol.
  14. A holder for securing a venous access device to a patient, wherein the holder is A flexible substrate having an upper surface and a lower surface; A solvent delivery line connected to the upper surface of the flexible substrate; An adhesive layer covering the lower surface of the flexible substrate, wherein the adhesive layer has an adhesive for adhering to the patient's skin; A solvent pathway integrated into at least a portion of the adhesive layer, wherein the solvent pathway includes the solvent delivery line and at least one aperture for fluid connection to the solvent pathway; A holder comprising a connector fixed to the upper surface, the connector having a first end including a Luer lock fitting for connection to a needle assembly, and a second end for connection to an IV fluid line.
  15. The holder according to claim 14, wherein the flexible substrate comprises at least one of foam, silicone, soft plastic, rubber, or elastomer.
  16. The holder according to claim 14, wherein the solvent delivery line includes a first end having a syringe connection portion and a second end connected to the at least one aperture.
  17. The holder according to claim 16, wherein the syringe connection portion includes a housing adapted to receive a syringe containing a solvent configured to dissolve and decompose at least a portion of the adhesive layer.
  18. The holder according to claim 17, wherein the solvent comprises isopropyl alcohol.
  19. The holder according to claim 14, wherein the solvent pathway is interposed between the patient's skin and the adhesive layer when the holder is adhered to the patient's skin.
  20. The holder according to claim 14, wherein the lure lock fitting includes a spin lock collar.

Description

This disclosure generally relates to fixation devices for stabilizing venous access devices, and more particularly to holders having an integrated adhesive backing material for fixing venous access devices, such as intravenous needles and their associated Luer fittings, to a patient's skin. Intravenous (IV) needles are frequently used in medical procedures. As with any invasive procedure, IV-related infections are a significant concern. When repeated access to the bloodstream is required, IV catheters are used. These catheters frequently utilize cylindrical Luer fittings and valves as an alternative to conventional needle-based injection ports. However, for effective use, catheters must not only avoid bloodstream and local infections but also prevent dislodgement. IV catheter fixation presents numerous challenges. To maximize dwell time, the IV catheter must be secured to prevent dislodgement or damage from unwanted movement. Furthermore, the insertion site should be readily inspected for contamination or infection and protected from such contamination or infection. Preferably, the catheter port should also be readily repairable. Conventional methods require securing the catheter insertion site with a gauze dressing with adhesive tape or a transparent film. Adhesive tape presents several problems, as it is difficult to maintain sterility and can easily irritate the patient's skin. The use of transparent film is preferable because it acts as a pathogen barrier and allows visualization of the insertion site. However, transparent film also presents several problems, as it can eventually loosen from everyday contact, allowing catheter migration. The difference in diameter between the IV needle and the Luer fitting further complicates the fixation problem. While adhesive strips can be applied over the Luer fitting to secure it to the skin, the opaque tape obstructs visual inspection of the fitting. Furthermore, securing the Luer fitting under a transparent film or adhesive tape presents several problems, as the larger diameter of the Luer fitting acts as a spacer, creating a gap between the film or tape and the patient's skin. This gap undermines the infection barrier purpose of the fixation. The descriptions provided in the background information chapter should not be considered prior art simply because they are mentioned in or associated with the background information chapter. The background information chapter may contain information describing one or more aspects of the subject matter. This is a perspective view of an IV set, including a holder for securing a venous access device, according to some embodiments of the present disclosure.This is a perspective view of a holder for securing a venous access device according to some embodiments of the present disclosure.This is a front view of the holder shown in Figure 2, according to some embodiments of the present disclosure.This is a bottom view of the holder shown in Figure 2, according to some embodiments of the present disclosure.This is a top view of the holder in Figure 2 according to some embodiments of the present disclosure.This is a bottom view of the holder connector shown in Figure 2, according to some embodiments of the present disclosure.This is a perspective top view of a holder for securing a venous access device according to some embodiments of the present disclosure.This is a bottom view of the holder shown in Figure 7, according to some embodiments of the present disclosure. The detailed description below illustrates various configurations of the subject art and is not intended to represent only the configurations in which the subject art can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject art. Therefore, dimensions may be provided as non-limiting examples with respect to certain embodiments. However, it will become apparent to those skilled in the art that the subject art can be practiced without these specific details. In some cases, to avoid ambiguity of the concepts of the subject art, well-known structures and components are shown in the form of block diagrams. It should be understood that this disclosure includes examples of the subject art and does not limit the scope of the appended claims. Here, various aspects of the subject art are disclosed in accordance with specific but non-limiting examples. The various embodiments described in this disclosure may be carried out in different ways and variations, and may be carried out according to the desired use or implementation. Various embodiments of this disclosure generally relate to fixation devices for stabilizing venous access devices, and more particularly to holders having an integrated adhesive backing for fixing venous access devices (e.g., intravenous needles and their associated Luer fittings, etc.) to the patient's skin. As used herein, the terms “medical connector,” “connector,” “fitting,” an