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BR-112021018549-B1 - Stabilization device and method thereof for integrated catheters.

BR112021018549B1BR 112021018549 B1BR112021018549 B1BR 112021018549B1BR-112021018549-B1

Abstract

STABILIZATION DEVICE, SYSTEM, AND METHODS THEREOF FOR INTEGRATED CATHETERS. A stabilization device for integrated catheters may include a platform, a pair of catheter fixation devices on the platform, and a pair of stabilization wings extending from the platform. The platform may include a skin-facing side and a catheter fixation side of the platform. The pair of catheter fixation devices may be on the catheter fixation side of the platform. The catheter fixation devices may be configured to secure a hub of an integrated catheter having an extension port. The pair of stabilization wings may extend from a transverse axis of the platform. The stabilization wings may be configured to mitigate rotation of the integrated catheter around a longitudinal axis thereof when the integrated catheter is secured by the catheter fixation devices on the platform and the stabilization device is adhered to a patient. A method for stabilizing integrated catheters may include securing an integrated catheter and adhering the stabilization device to a patient's skin.

Inventors

  • JITHENDRA KUMAR SATHYANARAYANA NAIDU

Assignees

  • BECTON, DICKINSON AND COMPANY

Dates

Publication Date
20260310
Application Date
20200320
Priority Date
20190322

Claims (14)

  1. 1. Stabilization device (100) for integrated catheters (10), comprising: a platform (110) having a skin-facing side (102) and a catheter fixation side (104) of the platform (110); a pair of catheter fixation devices (120) on the catheter fixation side (104) of the platform (110) configured to hold a hub of an integrated catheter (10) having an extension port (16); a pair of stabilizing wings (130) extending from a transverse axis (412) of the platform (110) configured to mitigate rotation of the integrated catheter (10) around a longitudinal axis thereof when the integrated catheter (10) is secured by the catheter fasteners (120) on the platform (110) and the stabilizing device (100) is attached to a patient, CHARACTERIZED in that the catheter fasteners (120) are spaced and separated from each other to accommodate an extension port (16) of the integrated catheter (10) between the catheter fasteners (120) when the integrated catheter (10) is secured by the catheter fasteners (120) on the platform (110).
  2. 2. Stabilization device, according to claim 1, CHARACTERIZED in that the platform (110) is configured with a degree of flexibility allowing the platform to conform to a patient's contour at a stabilizing location thereof.
  3. 3. Stabilization device, according to claim 1 or 2, CHARACTERIZED in that the skin-facing side (102) of the platform (110) has an adhesive (140) configured thereon to adhere to the patient's skin.
  4. 4. Stabilization device, according to claim 1, CHARACTERIZED in that it further comprises a cushion (130) of a foam-like material having one side facing the skin and one side facing the cushion platform, the cushion configured with a degree of compressibility allowing the cushion to conform to the patient's contour at a stabilizing location thereof.
  5. 5. Stabilization device, according to claim 4, CHARACTERIZED in that the skin-facing side of the pad (130) has an adhesive configured on it to adhere to the patient's skin.
  6. 6. Stabilization device, according to any one of claims 1 to 5, CHARACTERIZED in that at least one catheter fixation device of the pair of catheter fixation devices (120) is a ‘C’ shaped clip (222) connected to the catheter fixation side of the platform.
  7. 7. Stabilization device, according to any one of claims 1 to 5, CHARACTERIZED in that at least one catheter fixation device of the pair of catheter fixation devices (120) is a clamp (322) having a first jaw (324) connected to the catheter fixation side of the platform and a second jaw (326) connected to the first jaw by a living hinge (325).
  8. 8. Stabilization device, according to any one of claims 1 to 7, CHARACTERIZED in that the platform includes a plurality of passage holes (612) configured to allow moisture between the stabilization device and the patient to escape through the passage holes when the stabilization device is attached to the patient.
  9. 9. Stabilizing device, according to any one of claims 1 to 8, CHARACTERIZED in that the transverse axis (412) of the platform is an axis of symmetry of the platform.
  10. 10. Stabilizing device, according to any one of claims 1 to 5 or 8, CHARACTERIZED in that the platform (110) is a polymer-based platform, the platform having two-fold symmetry around the transverse axis (412) of the platform.
  11. 11. Stabilization device, according to claim 10, CHARACTERIZED in that: at least one catheter fixation device of the pair of catheter fixation devices (120) is a ‘C’ shaped clip (222) connected to the catheter fixation side of the platform, and the ‘C’ shaped clip (222) is configured with a degree of flexibility allowing an opening of the ‘C’ shaped clip to initially expand when the integrated catheter hub is inserted into the opening and subsequently contract when the integrated catheter hub is inserted after the opening.
  12. 12. Stabilization device, according to any one of claims 10 or 11, CHARACTERIZED in that: at least one catheter fixation device of the pair of catheter fixation devices (120) is a clamp (322) having a first jaw (324) connected to the catheter fixation side of the platform and a second jaw (326) connected to the first jaw by a live hinge (325), and the clamp is configured with a fitting (328) between the first jaw and the second jaw configured to fit the first and second jaws together after the integrated catheter hub is inserted into the clamp.
  13. 13. Method for stabilizing integrated catheters, as defined in any one of claims 1 to 12, comprising: attaching a hub (14) of an integrated catheter (10) to a pair of catheter fasteners (120) on a catheter fixation side (104) of a platform (110) of a stabilization device (100), the catheter fasteners (120) spaced apart to accommodate an extension port (16) of the integrated catheter (10) between the catheter fasteners; removing an adhesive backing (140) from a skin-facing side of the stabilization device to expose an adhesive; adhering the stabilization device (100) to the skin at a stabilization site close to a patient's percutaneous insertion site, thereby stabilizing the integrated catheter (10) and decreasing the risk of mechanical phlebitis, CHARACTERIZED by the fact that the stabilization device (100) comprises a pair of stabilization wings (130) extending from a transverse axis (412) of the platform (110) configured to mitigate rotation of the integrated catheter (10) around a longitudinal axis thereof.
  14. 14. Method according to claim 13, CHARACTERIZED in that securing the hub (14) of the integrated catheter (10) to the pair of catheter fixation devices (120) includes expanding an opening of at least one C-shaped clip (222) of the pair of catheter fixation devices when inserting the hub (14) into the C-shaped clip (222) and allowing the opening of the C-shaped clip to contract when inserting the hub after the C-shaped clip opens, or in that securing the hub (14) of the integrated catheter to the pair of catheter fixation devices (120) includes enclosing the hub (14) within at least one clamp (322) of the pair of catheter fixation devices and fitting the clamp (322) closed around the hub (14), the clamp having a first jaw (324) connected to the catheter fixation side of the platform (110) and a second jaw (326) connected to the first jaw by a living hinge. (325).

Description

PRIORITY [001] This application claims the priority benefit of U.S. Provisional Application No. 62/822721, filed March 22, 2019. BACKGROUND [002] A peripheral intravenous catheter (“PIVC”) often needs to be removed prematurely from a patient before an intended IV therapy is completed. A primary factor contributing to the need for premature removal of a PIVC is mechanical phlebitis, which occurs when the PIVC moves and irritates the patient's internal anatomy. A secondary factor contributing to the need for premature removal of a PIVC is the potential introduction of microorganisms when the PIVC moves while inside the patient. Mechanical stabilization of PIVCs has been shown to decrease mechanical phlebitis and increase the dwell time of IV therapy. However, existing stabilization devices for such PIVCs are not compatible with integrated PIVCs. Thus, existing stabilization devices cannot provide the necessary mechanical stabilization to reduce mechanical phlebitis and increase the dwell time required to complete intended IV therapies with integrated PIVCs. A stabilization device and methods thereof for integrated catheters, such as integrated PIVCs, are disclosed herein. [003] WO 2015/134250 A1 discloses a chart for use with medical device fixation systems, medical device fixation systems comprising a chart, and methods of use thereof. The chart may include a representation of an anatomical figure, such that the chart provides a visual indication for attaching the medical device fixation system to a subject in a desired orientation relative to the subject. Medical device fixation systems comprising a chart may be configured to be attached to the subject and further configured to fix at least part of a medical device. Methods may include attaching the medical device fixation system to the subject in accordance with the chart. [004] US 2012/0029484 A1 discloses a device for securing metallic guidewires and balloon catheters for performing medical procedures involving percutaneous vascular surgery. [005] ES 2264219 T3 discloses medical line fastening devices. [006] US 2013/345639 A1 discloses a fastening device. [007] SUMMARY [008] A stabilization device for integrated catheters is disclosed here, including, in some embodiments, a platform, a pair of catheter fixation devices on the platform, and a pair of stabilization wings extending from the platform. The platform has a skin-facing side and a catheter fixation side of the platform. The pair of catheter fixation devices is on the catheter fixation side of the platform. The catheter fixation devices are configured to secure a hub of an integrated catheter with an extension port. The pair of stabilization wings extend from a transverse axis of the platform. The stabilization wings are configured to mitigate rotation of the integrated catheter around its longitudinal axis when the integrated catheter is secured by the catheter fixation devices on the platform and the stabilization device is attached to a patient. The catheter fixation devices are spaced and separated from each other to accommodate the extension port of the integrated catheter between the catheter fixation devices when the integrated catheter is secured by the catheter fixation devices on the platform. [009] In some modalities, the platform is configured with a degree of flexibility, allowing the platform to adapt to a patient's contour in a stabilizing location. [0010] In some modalities, the skin-facing side of the platform has an adhesive configured on it to adhere to the patient's skin. [0011] In some embodiments, the stabilization device also includes a cushion made of a foam-like material with one side facing the skin and one side facing the cushion platform. The cushion is configured with a degree of compressibility that allows the cushion to adapt to the patient's contour in a stabilizing location. [0012] In some embodiments, the skin-facing side of the pad has an adhesive configured on it to adhere to the patient's skin. [0013] In some embodiments, at least one catheter fixation device of the catheter fixation device pair is a ‘C’ shaped clip connected to the catheter fixation side of the platform. [0014] In some embodiments, at least one catheter fixation device of the catheter fixation device pair is a clamp having a first jaw connected to the catheter fixation side of the platform and a second jaw connected to the first jaw by a live hinge. [0015] In some embodiments, the platform includes a plurality of passage holes configured to allow moisture between the stabilization device and the patient to escape through the passage holes when the stabilization device is attached to the patient. [0016] In some forms, the transverse axis of the platform is an axis of symmetry of the platform. [0017] Also disclosed in this document is a stabilization device for integrated catheters, including, in some embodiments, a platform, a pair of catheter fixation devices on the platform, and a pair of sta