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KR-102962288-B1 - Sensing catheter

KR102962288B1KR 102962288 B1KR102962288 B1KR 102962288B1KR-102962288-B1

Abstract

A catheter system may include a catheter lumen, first and second electrodes, and a sensor communicating with the first and second electrodes. The sensor may be configured to detect at least one of the bulk volume of blood within the blood vessel and the extravascular leakage of a drug from the blood vessel into the soft tissue adjacent to the blood vessel. Another catheter system may include a catheter lumen and a sensing chip coupled to the catheter lumen. The sensing chip may be configured to detect at least one of the bulk volume of blood within the blood vessel and the extravascular leakage of a drug from the blood vessel into the soft tissue adjacent to the blood vessel.

Inventors

  • 위 춘 키트
  • 쿠마 지텐드라

Assignees

  • 백톤 디킨슨 앤드 컴퍼니

Dates

Publication Date
20260512
Application Date
20200629
Priority Date
20200625

Claims (20)

  1. It is a catheter system, and As a catheter, the catheter is As a catheter lumen, Proximal end; Distal end; Inner lumen surface; and A catheter lumen including an outer lumen surface; A first electrode coupled to the catheter lumen and spaced apart from the distal end of the catheter; and A catheter comprising a second electrode coupled to a catheter lumen and spaced apart from a distal end of the catheter, wherein the distal end of the first electrode includes a first portion that extends perpendicularly to the proximal end of the first electrode to form an L-shape, and the distal end of the second electrode includes a second portion that extends perpendicularly to the proximal end of the second electrode to form another L-shape, and the first portion of the first electrode is spaced apart from the second portion of the second electrode and aligned with the second portion of the second electrode to create an electrode gap between the first portion of the first electrode and the second portion of the second electrode; and It includes a drug sensor that communicates with first and second electrodes coupled to the catheter lumen, and When the distal end of the catheter lumen is inserted into the patient's blood vessel: At least a portion of the first and second electrodes is embedded in the soft tissue of the patient adjacent to a blood vessel, and The first and second electrodes communicate with each other through the patient's soft tissue between the first and second electrodes, and A catheter system in which a drug sensor detects whether extravascular leakage of a drug has occurred from the patient's blood vessels into the soft tissue by detecting characteristics associated with the patient's soft tissue, wherein the characteristics include at least one of inductance, impedance, and capacitance.
  2. In paragraph 1, A catheter adapter coupled to a catheter, wherein the catheter adapter comprises an inner surface and an outer surface; A first attachment feature configured to electrically couple a drug sensor to a first electrode; and It further includes a second attachment feature configured to electrically couple a drug sensor to a second electrode, and A catheter system in which the first attachment feature and the second attachment feature traverse between the inner surface of the catheter adapter and the outer surface of the catheter adapter.
  3. In paragraph 1, The first electrode comprises an electrically conductive material deposited on the outer lumen surface; The second electrode comprises an electrically conductive material deposited on the outer lumen surface, and A catheter system in which the first and second electrodes are spaced apart from each other along the outer lumen surface.
  4. In paragraph 1, A catheter system in which the proximal portion of the first electrode adjacent to the first portion is parallel to the proximal portion of the second electrode adjacent to the second portion.
  5. It is a catheter system, and As a catheter, the catheter is As a catheter lumen, Proximal end; Distal end; Inner lumen surface; and A catheter comprising a catheter lumen, comprising an outer lumen surface; A first electrode coupled to the outer lumen surface; A second electrode coupled to the outer lumen surface; and It includes a drug sensor that communicates with first and second electrodes coupled to the catheter lumen, and The portions of the first and second electrodes extend toward each other to create an electrode gap located midway between the distal and proximal ends of the catheter lumen, and When the distal end of the catheter lumen is inserted into the patient's blood vessel, the electrode gap is embedded in the patient's soft tissue adjacent to the blood vessel so that the first and second electrodes communicate with each other through the patient's soft tissue between the first and second electrodes, and accordingly, the drug sensor is able to detect whether extravascular leakage of the drug has occurred from the patient's blood vessel into the soft tissue by sensing characteristics associated with the patient's soft tissue, and the characteristics include at least one of inductance, impedance, and capacitance. A catheter system in which the first and second electrodes extend along the length of the catheter and are spaced apart from each other along the outer lumen surface, and the distal portions of the first and second electrodes are electrically insulated from each other.
  6. In paragraph 5, A first attachment feature configured to electrically couple a drug sensor to a first electrode; and A catheter system further comprising a second attachment feature configured to electrically couple a drug sensor to a second electrode.
  7. In paragraph 5, The first electrode comprises an electrically conductive material deposited on the outer lumen surface; A catheter system comprising a second electrode including an electrically conductive material deposited on the outer lumen surface.
  8. In paragraph 7, the electrically conductive material comprises an electrically conductive ink, in a catheter system.
  9. In paragraph 6, A catheter system in which the first and second attachment features traverse between the outer and inner surfaces of a catheter adapter to which the proximal end of the catheter lumen is attached.
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Description

Sensing catheter Catheters are commonly used for various infusion therapies. For example, catheters may be used to infuse fluids into a patient, such as normal saline, various medications, and total parenteral nutrition. Catheters may also be used to draw blood from a patient. A common type of catheter is an over-the-needle peripheral venous catheter ("PIVC"). As the name implies, an over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may also be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC, with the bevel of the needle facing away from the patient's skin. The PIVC and the introducer needle are typically inserted through the skin into the patient's blood vessels, such as arteries, veins, or any other vascular structures, at a shallow angle. To verify the proper placement of the insertion needle and/or PIVC within the blood vessel, the clinician will typically observe for the presence of a blood "flashback" within the PIVC. A blood flashback occurs when blood moves proximally between the outer surface of the insertion needle and the inner surface of the PIVC, which may be transparent. Thus, the clinician may visualize the blood and confirm the placement of the insertion needle within the vascular structure. Once the placement of the needle is confirmed, the clinician may temporarily occlude the flow within the vein and remove the insertion needle, leaving the PIVC in place for future blood collection and/or fluid infusion. However, the blood flashback method can also cause false positives due to capillaries within the soft tissue surrounding the blood vessel. These capillaries may provide a false signal to the clinician before the insertion needle and/or PIVC are properly placed within the blood vessel. Furthermore, once the PIVC is placed within the blood vessel and the drug is delivered through the PIVC, extravasation of the drug into the extravascular space and adjacent soft tissue may occur. A sensor may be attached to the patient's skin near the catheter insertion site to monitor the patient for drug extravasation events. However, this detection method may only activate after a significant amount of drug has leaked out of the catheter/extravascular space and traveled close to the patient's skin. Moreover, a sensor placed on the patient's skin is an additional attachment (and cost) for the patient, as it must be periodically removed and reattached (e.g., when the patient needs to use the restroom). The subject matter claimed herein is not limited to embodiments that address any drawbacks or operate only in environments such as those described above. Rather, this background section is provided merely to describe an exemplary technical area in which some of the embodiments described herein may be implemented. The present disclosure generally relates to vascular access devices and related systems and methods. In some embodiments, the catheter system may include a catheter having a proximal end, a distal end, an inner lumen surface, and an outer lumen surface. The catheter may also include first and second electrodes coupled to the catheter lumen. A drug sensor may also electrically communicate with the first and second electrodes. The distal end of the catheter lumen may be inserted into a patient's blood vessel so that: (1) at least a portion of the first and second electrodes is embedded in the patient's soft tissue adjacent to the blood vessel; (2) the first and second electrodes electrically communicate with each other through the patient's soft tissue between the first and second electrodes; and (3) the drug sensor detects whether extravascular leakage of the drug has occurred from the patient's blood vessel into the soft tissue by sensing the impedance associated with the patient's soft tissue. In some embodiments, the catheter system may include a first attachment feature configured to electrically couple a drug sensor to a first electrode and a second attachment feature configured to electrically couple a drug sensor to a second electrode. In some embodiments, the first and second electrodes may comprise an electrically conductive material deposited on the outer lumen surface of the catheter, and the first and second electrodes may be spaced apart from each other along the outer lumen surface of the catheter. In some embodiments, the first electrode may include an electrically conductive material disposed within a first channel formed along the catheter lumen, and the second electrode may include an electrically conductive material disposed within a second channel formed along the catheter lumen, and the first and second electrodes may be spaced apart from each other along the outer lumen surface. In some embodiments, the first and second channels may include an open channel, and the distal portions of the first and second channels may include an electrically insulating cove