Sensing catheter

Abstract

The present disclosure relates to sensing catheters. A catheter system can include a catheter lumen, a first electrode and a second electrode, and a sensor in communication with the first electrode and the second electrode. The sensor can be configured to detect at least one of: an extravasation of a bolus of blood within a blood vessel and a drug from the blood vessel into soft tissue near the blood vessel. Other catheter systems can include a catheter lumen and a sensing chip coupled to the catheter lumen. The sensing chip can be configured to detect at least one of: an extravasation of a bolus of blood within a blood vessel and a drug from the blood vessel into soft tissue near the blood vessel.

Description

[0001] This application is a divisional application of the application filed on July 3, 2020, with application number 202010630773.3 and invention title "Sensing Conduit". Background Technology

[0002] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as saline solutions, various medications, and total parenteral nutrition, into patients. Catheters can also be used to draw blood from patients.

[0003] One common type of catheter is the peripherally inserted venous catheter (“PIVC”). As the name suggests, a PIVC can be mounted on a guide needle with a sharp distal end. The PIVC and guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the PIVC, with the bevel of the needle facing away from the patient's skin. The PIVC and guide needle are typically inserted into the patient's blood vessel, such as an artery, vein, or any other vascular system, through the skin at a small angle.

[0004] To verify proper placement of the guide needle and / or PIVC within the vessel, clinicians will typically observe a blood "flashback" occurring within the PIVC. This flashback occurs when blood flows proximally between the outer surface of the guide needle and the inner surface of the PIVC, during which time the PIVC may be transparent. This allows clinicians to observe the blood and confirm the guide needle's placement within the vascular system. Once placement is confirmed, the clinician may temporarily occlude flow in the vein and remove the guide needle, leaving the PIVC in place for future blood draws and / or fluid infusions.

[0005] However, the blood flashback method can also lead to false positives due to capillary blood within the soft tissue surrounding the blood vessel. This capillary blood may provide incorrect signals to the clinician before the guide needle and / or PIVC have been correctly placed within the blood vessel.

[0006] Furthermore, once a PIVC has been placed inside a blood vessel and the drug is delivered via the PIVC, extravasation of the drug from the vessel into the surrounding soft tissue can occur. Sensors can be attached to the patient's skin near the catheter insertion site to monitor for extravasation events. However, this detection method only works after a significant amount of drug has leaked from the catheter / vessel and migrated to the patient's skin. Additionally, sensors placed on the patient's skin are an additional accessory (and cost) that must be periodically removed and reattached (e.g., when the patient needs to use the restroom).

[0007] The subject matter claimed herein is not limited to addressing any of the drawbacks described above or to embodiments that operate only in environments such as those described. Rather, this background is provided merely to illustrate an example technical field in which some of the implementations described herein can be practiced. Summary of the Invention

[0008] This disclosure generally relates to vascular access devices and related systems and methods.

[0009] In some embodiments, the catheter system may include a catheter having a lumen having a proximal end, a distal end, an inner lumen surface, and an outer lumen surface. The catheter may also include a first electrode and a second electrode coupled to the lumen. A drug sensor may also be electrically connected to the first and second electrodes. The distal end of the lumen may be inserted into a patient's blood vessel such 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 are electrically connected to each other via the patient's soft tissue between the first and second electrodes; and (3) the drug sensor detects whether extravasation of a drug from the blood vessel into the patient's soft tissue has occurred by sensing impedance associated with the patient's soft tissue.

[0010] 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.

[0011] In some embodiments, the first electrode and the second electrode may comprise a conductive material deposited on the outer surface of the catheter, and the first electrode and the second electrode may be spaced apart from each other along the outer surface of the catheter.

[0012] In some embodiments, the first electrode may include conductive material placed in a first channel formed along the lumen of the catheter, the second electrode may include conductive material placed in a second channel formed along the lumen of the catheter, and the first electrode and the second electrode may be spaced apart from each other along the outer surface of the lumen.

[0013] In some embodiments, the first channel and the second channel may include an open channel, and the distal portions of the first channel and the second channel may include an electrically insulating cap configured to electrically isolate portions of the first electrode and the second electrode residing in the patient's blood vessels when the distal end of the catheter lumen is inserted into the patient's blood vessel.

[0014] In some embodiments, the first channel and the second channel may include closed channels, and the first channel and the second channel are at least partially cut to allow the first electrode and the second electrode to be electrically connected to each other via soft tissue between the first electrode and the second electrode.

[0015] In some embodiments, the catheter system may include a third electrode comprising conductive material placed within a third channel formed along the catheter lumen, and the first, second, and third electrodes may be spaced apart from each other along the outer surface of the lumen.

[0016] In some embodiments, the catheter system may include a catheter including a catheter lumen having a proximal end, a distal end, an inner lumen surface, and an outer lumen surface. The catheter may also include a first electrode and a second electrode. A blood sensor may be in communication with the first and second electrodes. The distal end of the catheter lumen may be inserted into a patient's blood vessel such that: (1) at least a portion of the first and second electrodes is embedded within the patient's blood vessel; (2) the first and second electrodes are in communication with each other via blood residing within the patient's blood vessel; and (3) the blood sensor detects insertion of the distal end of the catheter lumen into the patient's blood vessel by sensing at least one characteristic associated with the blood residing within the patient's blood vessel.

[0017] In some embodiments, at least one characteristic associated with blood residing in a patient's blood vessels includes at least one of the following: impedance, capacitance, pressure, and electromagnetic signal.

[0018] In some embodiments, the catheter system may include a first attachment feature configured to electrically couple a blood sensor to a first electrode and a second attachment feature configured to electrically couple a blood sensor to a second electrode.

[0019] In some embodiments, the first electrode and the second electrode comprise conductive material deposited on the outer surface of the lumen, at least a portion of the first electrode and the second electrode are located near the distal end of the catheter lumen, and the first electrode and the second electrode are spaced apart from each other on the outer surface of the catheter lumen.

[0020] In some embodiments, the conductive material includes conductive ink.

[0021] In some embodiments, the catheter lumen is made of conductive plastic, the catheter lumen includes a first electrode, the catheter system also includes a guide needle, and the guide needle includes a second electrode.

[0022] In some embodiments, the blood sensor is configured to detect when the distal end of the catheter lumen is inserted into the patient's blood vessel by sensing the electrical properties associated with blood residing between the catheter lumen and the guide needle.

[0023] In some embodiments, the inner surface of the catheter lumen further includes an electrically insulating layer, and the blood sensor is configured to detect when the distal end of the catheter lumen is inserted into the patient's blood vessel by sensing the electrical properties associated with blood residing between the distal end of the catheter lumen and the distal portion of the guide needle.

[0024] In some embodiments, the catheter system may include a catheter having a lumen having a proximal end, a distal end, an inner lumen surface, and an outer lumen surface. The catheter may also include a drug sensing chip coupled to the lumen. When the distal end of the lumen is inserted into a patient's blood vessel: (1) at least a portion of the drug sensing chip may be embedded in the soft tissue adjacent to the patient's blood vessel; and (2) the drug sensing chip may detect whether extravasation of a drug from the blood vessel into the patient's soft tissue has occurred.

[0025] In some embodiments, the drug sensing chip is configured to detect extravasation of a drug from blood vessels into the patient's soft tissue by sensing impedance associated with the patient's soft tissue.

[0026] In some embodiments, the drug sensing chip is configured to detect extravasation of a drug from blood vessels into the patient's soft tissue by sensing at least one of the following: pressure associated with the patient's soft tissue, capacitance associated with the patient's soft tissue, and infrared signals associated with the patient's soft tissue.

[0027] In some embodiments, the drug sensing chip includes an output configured to provide an indication when extravasation of a drug from a blood vessel into the patient's soft tissue is detected. In some embodiments, the output includes an LED.

[0028] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and not intended to limit the claimed embodiments of this disclosure. It should be understood that the various embodiments of this disclosure are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that embodiments of this disclosure can be combined, or other embodiments can be utilized, and structural changes can be made without departing from the scope of the various embodiments of this disclosure unless so required. Therefore, the following detailed description should not be construed as limiting. Attached Figure Description

[0029] Example embodiments will be described and explained with additional features and details using the accompanying drawings, in which:

[0030] Figure 1A This is a top perspective view of an example catheter system 10 according to some embodiments;

[0031] Figure 1B According to some embodiments Figure 1A A top-view cross-section of the conduit system 10;

[0032] Figure 2 This is a partial cross-sectional side view of an exemplary catheter system 200 inserted into tissue according to some embodiments;

[0033] Figure 3This is a cross-sectional side view of an exemplary catheter system 300 inserted into tissue according to some embodiments;

[0034] Figure 4 This is a partial cross-sectional side view of an exemplary catheter system 400 inserted into tissue according to some embodiments;

[0035] Figure 5 This is a perspective side view of an example catheter 500 according to some embodiments;

[0036] Figure 6 This is a perspective side view of an example catheter 600 according to some embodiments;

[0037] Figure 7 According to some embodiments, this includes insertion into tissue. Figure 6 A partial cross-sectional side view of an example catheter system 700, including catheter 600; and

[0038] Figure 8 An exemplary catheter system 800 for insertion into tissue is shown according to some embodiments.

[0039] It should be understood that the accompanying drawings are for illustrative purposes and may not be drawn to scale. Furthermore, the drawings illustrate exemplary embodiments and do not represent a limitation on the scope of this disclosure. Detailed Implementation

[0040] Exemplary embodiments of this disclosure will be best understood by referring to the accompanying drawings, wherein like components are always designated by like reference numerals. It will be readily understood that the components of this disclosure, as generally described and illustrated in the accompanying drawings, can be arranged and designed in a variety of different configurations. Therefore, the following more detailed description of embodiments of apparatus, systems, and methods as illustrated in the drawings is not intended to limit the scope of this disclosure as claimed in this application or any other application claiming priority to this application, but merely represents exemplary embodiments of this disclosure.

[0041] Reference Figure 1A and Figure 1B In some embodiments, the catheter system 10 may include a needle assembly 12 and a catheter assembly 14. Figure 1A and Figure 1BA catheter system 10 in an insertion position, prepared for insertion into a patient's vein (not shown), is illustrated according to some embodiments. In some embodiments, catheter assembly 14 may include a catheter adapter 16, which may include a distal end 18, a proximal end 20, and a catheter assembly lumen 21 extending through the distal end 18 and the proximal end 20. In some embodiments, catheter assembly 14 may include a catheter 22, which may include a distal end 24 and a proximal end 26. In some embodiments, catheter 22 may include a peripheral intravenous catheter (“PIVC”). In some embodiments, the proximal end 26 of catheter 22 may be secured within catheter adapter 16.

[0042] In some embodiments, the needle assembly 12 may include a needle hub 28 that can be removably coupled to the catheter adapter 16. In some embodiments, the needle assembly 12 may include a guide needle 30. In some embodiments, the proximal end of the guide needle 30 may be secured within the needle hub 28. In some embodiments, when the catheter system 10 is in an insertion position ready for insertion into a patient's vein, the guide needle 30 may extend through the catheter 22, for example as... Figure 1A and Figure 1B As shown in the image.

[0043] In some embodiments, the needle assembly 12 may include a needle grip 32, which a clinician can hold and move proximally to withdraw the guide needle 30 from the vein once the catheter 22 is confirmed to be placed in the vein. In some embodiments, the catheter system 10 may include an extension tube 34. In some embodiments, the distal end of the extension tube 34 may be coupled to a catheter adapter 16, and the proximal end of the extension tube 34 may be coupled to an adapter 36.

[0044] In some embodiments, once the guide needle 30 is removed from the catheter system 10, a fluid infusion device (not shown) can be coupled to the adapter 36 to deliver fluid to the patient via a catheter 22 inserted into a vein. In some embodiments, a blood collection device (not shown) can be coupled to the adapter 36 to draw blood from the patient via a catheter 22 inserted into a vein.

[0045] In some embodiments, the catheter system 10 may be integrated, having an extension tube 34 integrated within the catheter adapter 16, such as BD NEXIVA. TM Closed IV catheter system, BD NEXIVA TM DIFFUSICS TM Closed IV catheter system, BDPEGASUS TM A secure closed IV catheter system or another integrated catheter system. Figure 1A and Figure 1B An example of an integrated catheter system 10 is shown. In some embodiments, the catheter system 10 may be non-integrated and may not have an extension tube 34.

[0046] In some embodiments, the catheter system 10 may be vented to visualize blood and facilitate proximal blood flow within the guide needle 30 and / or catheter 22. In some embodiments, the catheter system 10 may be vented in any manner. For example, during insertion of the catheter assembly 14 into the patient, a vent plug 38 may be coupled to an adapter 36. In some embodiments, the vent plug 38 may be air-permeable but blood-impermeable. In some embodiments, the catheter 22, catheter adapter 16, extension tube 34, adapter 36, and vent plug 38 may be in fluid communication. As another example, in some embodiments, the needle hub 28 may include a flash chamber.

[0047] Figure 2 A partial cross-sectional side view of an exemplary catheter system 200 inserted into soft tissue according to some embodiments is shown. The catheter system 200 typically includes a catheter 223, a catheter adapter 216, a guide needle 230, and a sensor 250. Figure 2 As shown, catheter 223 can be inserted through skin 81 and into soft tissue 80 until the distal portion of catheter 223 enters blood vessel 70.

[0048] The catheter 223 may include a catheter lumen 222 having a proximal end 226, a distal end 224, an inner lumen surface 225, and an outer lumen surface 227. Although Figure 2 Not shown in the diagram, but in some embodiments, the distal end 224 of the catheter 223 may also be tapered, similar to... Figure 1A and Figure 1B The conical distal end 24 of the catheter 22 shown.

[0049] The catheter system 200 may further include a first electrode 241 and a second electrode 242. Figure 2In the illustrated embodiment, the first electrode 241 and the second electrode 242 may be coupled to the outer lumen surface 227 of the catheter 223 and extend along the length of the catheter 223. However, it will also be understood that in other embodiments (not shown), the first electrode 241 and the second electrode 242 may alternatively or additionally be coupled to the inner lumen surface 225 of the catheter 223. The first electrode 241 and the second electrode 242 may also be spaced apart from each other along the outer lumen surface 227 and / or along the inner lumen surface 225. In some embodiments, at least a portion of the first electrode 241 and a portion of the second electrode 242 may be located near the distal end 224 of the catheter 223. In some embodiments, the portions of the first electrode 241 and the second electrode 242 located near the distal end 224 of the catheter 223 may extend toward each other to form an electrode gap 243 near the distal end 224 of the catheter 223. In some embodiments, the orientation, direction, or distance of the electrode gap 243 may vary. In some embodiments, the first electrode 241 and the second electrode 242 may include a conductive material deposited on the surface of the conduit 223, such as the outer lumen surface 227 and / or the inner lumen surface 225. In some embodiments, the conductive material may include conductive ink.

[0050] The catheter system 200 may further include a first attachment feature 291 configured to couple a first electrode 241 to a sensor 250, and a second attachment feature 292 configured to couple a second electrode 242 to the sensor 250. The first attachment feature 291 and the second attachment feature 292 may be coupled to and / or integrated with a catheter adapter 216. However, in other embodiments (not shown), the first attachment feature 291 and the second attachment feature 292 may be directly coupled to and / or integrated with a catheter 223. In some embodiments, the first attachment feature 291 and the second attachment feature 292 may traverse between the outer surface and the inner surface of the catheter adapter 216. In some embodiments, the first attachment feature 291 may directly or indirectly contact the first electrode 241, and the second attachment feature 292 may directly or indirectly contact the second electrode 242. In some embodiments, the first attachment feature 291 and the second attachment feature 292 may be configured to electrically couple the first electrode 241 and the second electrode 242 to the sensor 250.

[0051] In some embodiments, sensor 250 may be a blood sensor 250 configured to sense a large volume of blood within blood vessel 70. In this way, blood sensor 250 can detect when the distal end 224 of catheter 223 has been successfully inserted into blood vessel 70, and an indication of successful insertion can be provided to a clinician via any suitable output device known in the art. For example, a large volume of blood within blood vessel 70 may exhibit different electrical, chemical, and / or physical properties compared to capillary blood dispersed within soft tissue 80 adjacent to blood vessel 70. These differences in electrical, chemical, and / or physical properties can be used to indicate whether catheter 223 has been properly inserted into blood vessel 70, resulting in fewer false positives indicating successful insertion compared to using the blood flashback method alone.

[0052] In some embodiments, the blood sensor 250 may be in communication with the first electrode 241 and the second electrode 242 such that when the distal end 224 of the catheter lumen 222 is successfully inserted into the blood vessel 70: (1) at least a portion of the first electrode 241 and the second electrode 242 is embedded in the blood vessel 70; (2) the first electrode 241 and the second electrode 242 are in communication with each other via blood residing in the blood vessel 70; and (3) the blood sensor 250 detects that the distal end 224 of the catheter lumen 222 has been successfully inserted into the blood vessel 70 by sensing at least one characteristic associated with the blood residing in the blood vessel 70.

[0053] In some embodiments, at least one characteristic associated with blood residing within the vessel 70 includes at least one of the following: impedance, capacitance, conductance, inductance, electromagnetic signal, pressure, and temperature. In some embodiments, at least one characteristic may be measured directly or indirectly. In some embodiments, successful insertion may be determined based on a threshold associated with at least one characteristic, a change detected in at least one characteristic when the distal end 224 of the catheter lumen 222 is inserted into the vessel 70, and / or a relative difference detected in at least one characteristic when the distal end 224 of the catheter lumen 222 is inserted into the vessel 70.

[0054] Figure 3 A cross-sectional side view of an exemplary catheter system 300 inserted into soft tissue 80 according to some embodiments is shown. The catheter system 300 typically includes a catheter 323, a catheter adapter 316, a guide needle 330, and a sensor 350. Figure 3 As shown, catheter 323 can be inserted through skin 81 and into soft tissue 80 until the distal portion of catheter 323 enters blood vessel 70.

[0055] The catheter 323 may include a catheter lumen 322 having a proximal end 326, a distal end 324, an inner lumen surface 325, and an outer lumen surface 327. Although Figure 3 Not shown in the diagram, but in some embodiments, the distal end 324 of the catheter 323 may also be tapered, similar to... Figure 1A and Figure 1B The distal tapered end 24 of the catheter 22 shown.

[0056] The catheter system 300 may further include a first electrode 341 and a second electrode 342. Figure 3 In the illustrated embodiments, the catheter lumen 322 may include a first electrode 341, and the guide needle 330 may include a second electrode 342. For example, in some embodiments, the catheter lumen 322 may be made of a conductive material. In some embodiments, the conductive material of the catheter lumen 322 may include a conductive plastic. In some embodiments, the catheter lumen 322 may also include a radiopaque material. Additionally, in some embodiments, the guide needle 330 may include a conductive material. In some embodiments, the conductive material of the guide needle 330 may include a conductive metal. In some embodiments, at least a portion of the first electrode 341 and a portion of the second electrode 342 may be located near the distal end 324 of the catheter 323.

[0057] In some embodiments, the inner lumen surface 325 of the catheter lumen 322 may include an electrically insulating layer 329 or a material. The electrically insulating layer 329 may be configured to electrically insulate the first electrode 341 (e.g., catheter 323) from the second electrode 342 (e.g., guide needle 330). In some embodiments, the electrically insulating layer 329 may be coupled to the inner lumen surface 325 of the catheter lumen 322 via a coating process. In some embodiments, the electrically insulating layer 329 may be integrated with the catheter 323 via a co-extrusion process.

[0058] The catheter system 300 may further include a first attachment feature 391 configured to couple a first electrode 341 to a sensor 350 and a second attachment feature 392 configured to couple a second electrode 342 to the sensor 350. The first attachment feature 391 and the second attachment feature 392 may be coupled to a catheter adapter 316 and / or a needle assembly / hub. Figure 3 (Not shown) and / or integrated therewith. However, in other embodiments (not shown), the first attachment feature 391 and the second attachment feature 392 may be directly coupled to and / or integrated to the catheter 323 and the guide needle 330. In some embodiments, the first attachment feature 391 and the second attachment feature 392 may traverse between the outer surface of the catheter adapter 316 (and / or the needle assembly / hub) and the inner surface of the catheter adapter 316 (and / or the needle assembly / hub). In some embodiments, the first attachment feature 391 may directly or indirectly contact the first electrode 341, and the second attachment feature 392 may directly or indirectly contact the second electrode 342. In some embodiments, the first attachment feature 391 and the second attachment feature 392 may be configured to electrically couple the first electrode 341 and the second electrode 342 to the sensor 350.

[0059] In some embodiments, sensor 350 may be a blood sensor 350 configured to sense a large volume of blood within blood vessel 70. In this way, blood sensor 350 can detect when the distal end 324 of catheter 323 has been successfully inserted into blood vessel 70, and an indication of successful insertion can be provided to a clinician via any suitable output device known in the art. As previously described, a large volume of blood within blood vessel 70 can exhibit different electrical, chemical, and / or physical properties compared to capillary blood dispersed within the soft tissue 80 adjacent to blood vessel 70. These differences in electrical, chemical, and / or physical properties can be used to indicate whether catheter 323 has been correctly inserted into blood vessel 70, resulting in fewer false positives indicating successful insertion compared to using the blood flashback method alone.

[0060] In some embodiments, the blood sensor 350 may be in communication with the first electrode 341 and the second electrode 342 such that when the distal end 324 of the catheter lumen 322 is successfully inserted into the blood vessel 70: (1) at least a portion of the first electrode 341 and the second electrode 342 is embedded in the blood vessel 70; (2) the first electrode 341 and the second electrode 342 are in communication with each other via blood residing in the blood vessel 70; and (3) the blood sensor 350 detects that the distal end 324 of the catheter lumen 322 has been successfully inserted into the blood vessel 70 by sensing at least one characteristic associated with the blood residing in the blood vessel 70.

[0061] In some embodiments, at least one characteristic associated with blood residing within the vessel 70 includes at least one of the following: impedance, capacitance, conductance, inductance, electromagnetic signal, pressure, and temperature. In some embodiments, at least one characteristic may be measured directly or indirectly. In some embodiments, successful insertion may be determined based on a threshold associated with at least one characteristic, a change detected in at least one characteristic when the distal end 324 of the catheter lumen 322 is inserted into the vessel 70, and / or a relative difference detected in at least one characteristic when the distal end 324 of the catheter lumen 322 is inserted into the vessel 70.

[0062] In some embodiments, the blood sensor 350 is configured to detect when the distal end of the catheter lumen 322 is inserted into the blood vessel 70 by sensing the electrical properties associated with blood residing within the blood vessel 70 between the catheter lumen 322 and the guide needle 330.

[0063] In some embodiments, the blood sensor 350 is configured to detect when the distal end 324 of the catheter lumen 322 is inserted into the blood vessel 70 by sensing electrical properties associated with blood residing within the blood vessel 70 between the distal end 324 of the catheter lumen 322 and the distal portion of the guide needle 330.

[0064] Figure 4A partial cross-sectional side view of an exemplary catheter system 400 for insertion into soft tissue, according to some embodiments, is shown. The catheter system 400 typically includes a catheter 423, a catheter adapter 416, and a sensor 460. Figure 4 As shown, catheter 423 can be inserted through skin 81 and into soft tissue 80 until the distal portion of catheter 423 enters blood vessel 70.

[0065] Catheter 423 may include a catheter lumen 422 having a proximal end 426, a distal end 424, an inner lumen surface 425, and an outer lumen surface 427. Although in Figure 4 Not shown in the diagram, but in some embodiments, the distal end 424 of the catheter 423 may also be tapered, similar to... Figure 1A and Figure 1B The distal tapered end 24 of the catheter 22 shown.

[0066] The catheter system 400 may further include a first electrode 441 and a second electrode 442. Figure 4 In the illustrated embodiment, the first electrode 441 and the second electrode 442 may be coupled to the outer lumen surface 427 of the catheter 423, extending along the length of the catheter 423. However, it should also be understood that in other embodiments (not shown), the first electrode 441 and the second electrode 442 may alternatively or otherwise be coupled to the inner lumen surface 425 of the catheter 423. The first electrode 441 and the second electrode 442 may also be spaced apart from each other at one or more distances along the outer lumen surface 427 and / or along the inner lumen surface 425.

[0067] In some embodiments, when the distal end 424 of the catheter lumen 422 is inserted into the blood vessel 70, at least a portion of the first electrode 441 and a portion of the second electrode 442 may be embedded within the soft tissue 80 adjacent to the blood vessel 70. In some embodiments, portions of the first electrode 441 and the second electrode 442 may extend toward each other to form an electrode gap 443 located between the proximal end 426 and the distal end 424 of the catheter 423. In some embodiments, the orientation, direction, or distance of the electrode gap 443 may vary. In some embodiments, the first electrode 441 and the second electrode 442 may include a conductive material deposited on the surface of the catheter 423, such as an outer lumen surface 427 and / or an inner lumen surface 425. In some embodiments, the conductive material may include conductive ink.

[0068] The catheter system 400 may further include a first attachment feature 491 configured to couple a first electrode 441 to a sensor 460, and a second attachment feature 492 configured to couple a second electrode 442 to the sensor 460. The first attachment feature 491 and the second attachment feature 492 may be coupled to and / or integrated with a catheter adapter 416. However, in other embodiments (not shown), the first attachment feature 491 and the second attachment feature 492 may be directly coupled to and / or integrated with a catheter 423. In some embodiments, the first attachment feature 491 and the second attachment feature 492 may traverse between the outer surface and the inner surface of the catheter adapter 416. In some embodiments, the first attachment feature 491 may directly or indirectly contact the first electrode 441, and the second attachment feature 492 may directly or indirectly contact the second electrode 442. In some embodiments, the first attachment feature 491 and the second attachment feature 492 may be configured to electrically couple the first electrode 441 and the second electrode 442 to the sensor 460.

[0069] In some embodiments, sensor 460 may be a drug sensor 460 configured to sense when drug 85 has leaked from blood vessel 70 and entered soft tissue 80 adjacent to blood vessel 70 via an extravasation process. In this way, drug sensor 460 can detect when extravasation of drug 85 has occurred and can provide an indication of drug extravasation to a clinician via any suitable output device known in the art. For example, soft tissue containing extravasated drug may exhibit different electrical, chemical, and / or physical properties compared to soft tissue without extravasated drug. These differences in electrical, chemical, and / or physical properties can be used to indicate whether soft tissue contains extravasated drug to warn a clinician of a potential dangerous situation.

[0070] In some embodiments, the drug sensor 460 may be in communication with a first electrode 441 and a second electrode 442 coupled to a catheter lumen 422 such that when the distal end 424 of the catheter lumen 422 is successfully inserted into a blood vessel 70: (1) at least a portion of the first electrode 441 and the second electrode 442 is embedded in soft tissue 80 adjacent to the blood vessel 70; (2) the first electrode 441 and the second electrode 442 are in communication with each other through the soft tissue 80 between the first electrode 441 and the second electrode 442; and (3) the drug sensor 460 detects whether extravasation of drug 85 from the blood vessel 70 into the soft tissue 80 has occurred by sensing properties associated with the soft tissue 80.

[0071] In some embodiments, at least one characteristic associated with the soft tissue 80 containing the extravasated drug 85 includes at least one of the following: impedance, capacitance, conductance, inductance, electromagnetic signal, pressure, and temperature. In some embodiments, at least one characteristic may be measured directly or indirectly. In some embodiments, the determination of drug extravasation may be based on a threshold associated with at least one characteristic, a change detected in at least one characteristic when the soft tissue 80 is infused with drug 85, and / or a relative difference detected in at least one characteristic when the soft tissue 80 is infused with drug 85.

[0072] Figure 5 A perspective side view of an example catheter 500, which can be used to detect drug extravasation according to some embodiments, is shown. The catheter 500 may include a catheter lumen 522 having a proximal end 526, a distal end 524, an inner lumen surface 525, and an outer lumen surface 527. Although Figure 5 Not shown in the diagram, but in some embodiments, the distal end 524 of the catheter 500 may also be tapered, similar to... Figure 1A and Figure 1B The conical distal end 24 of the catheter 22 shown.

[0073] The catheter 500 may include a first electrode 541, a second electrode 542, and a third electrode 543. However, in other embodiments (not shown), the catheter 500 may include only two electrodes. In yet another embodiment (not shown), the catheter 500 may include more than three electrodes.

[0074] In some embodiments, the first electrode 541, the second electrode 542, and the third electrode 543 may comprise a conductive material. In some embodiments, the conductive material may comprise a conductive metal. The first electrode 541, the second electrode 542, and the third electrode 543 may also be spaced apart from each other along the conduit 500 and / or the outer surface 527.

[0075] exist Figure 5 In the illustrated embodiment, each of the first electrode 541, the second electrode 542, and the third electrode 543 can be coupled to the catheter within the first channel 561, the second channel 562, and the third channel 563, respectively. The first channel 561, the second channel 562, and the third channel 563 can also extend along the length of the catheter 500. The first channel 561, the second channel 562, and the third channel 563 can include closed channels formed within the body of the catheter lumen 522 to electrically insulate the first electrode 541, the second electrode 542, and the third electrode 543 from each other.

[0076] The first electrode 541, second electrode 542, and third electrode 543 / first channel 561, second channel 562, and third channel 563 can be formed by co-extruding the first electrode 541, second electrode 542, and third electrode 543 with the conduit 500. In some embodiments, the first channel 561, second channel 562, and third channel 563 may subsequently undergo a thinning process to expose portions of the first electrode 541, second electrode 542, and third electrode 543. This thinning process may include removing conduit material above the first electrode 541, second electrode 542, and third electrode 543 to expose them and allow the first electrode 541, second electrode 542, and third electrode 543 to be electrically connected to each other via soft tissue 80 between the first electrode 541, second electrode 542, and third electrode 543. In some embodiments, the distal portion of the conduit 500 may not be thinned to maintain electrical isolation between the first electrode 541, second electrode 542, and third electrode 543 at the distal portion of the conduit 500. In this way, the first electrode 541, the second electrode 542, and the third electrode 543 at the distal portion of the catheter 500 (where it enters the blood vessel) will not sense the drug in the blood vessel and will not produce a false positive indication of drug extravasation.

[0077] Figure 6 A perspective side view of an example catheter 600, which can be used to detect drug extravasation according to some embodiments, is shown. The catheter 600 may include a lumen 622 having a proximal end 626, a distal end 624, an inner lumen surface 625, and an outer lumen surface 627. Although in Figure 6 Not shown in the diagram, but in some embodiments, the distal end 624 of the catheter 600 may also be tapered, similar to... Figure 1A and Figure 1B The conical distal end 24 of the catheter 22 shown.

[0078] The catheter 600 may include a first electrode 641, a second electrode 642, and a third electrode 643. However, in other embodiments (not shown), the catheter 600 may include only two electrodes. In yet another embodiment (not shown), the catheter 600 may include more than three electrodes.

[0079] In some embodiments, the first electrode 641, the second electrode 642, and the third electrode 643 may comprise a conductive material. In some embodiments, the conductive material may comprise a conductive metal. The first electrode 641, the second electrode 642, and the third electrode 643 may also be spaced apart from each other at any distance along the conduit 600 and / or the outer surface 627.

[0080] exist Figure 6In the illustrated embodiment, the first electrode 641, the second electrode 642, and the third electrode 643 can each be coupled to the catheter within the first channel 661, the second channel 662, and the third channel 663, respectively. The first channel 661, the second channel 662, and the third channel 663 can also extend along the length of the catheter 600. The first channel 661, the second channel 662, and the third channel 663 may include open channels formed within the body of the catheter lumen 622, which are open to the external lumen surface 627 to allow electrical communication between the first electrode 641, the second electrode 642, and the third electrode 643 via soft tissue.

[0081] The first electrode 641, second electrode 642, and third electrode 643 / first channel 661, second channel 662, and third channel 663 can also be formed via a co-extrusion process or by any other suitable manufacturing process. In some embodiments, the distal portions of the first electrode 641, second electrode 642, and third electrode 643 may be electrically insulated from each other by a cap, coating, sleeve, or visor. For example, in some embodiments, a cover 665 may be coupled to the distal end 624 of the catheter 600. The cap 665 may be configured to electrically isolate the intravascular portions of the first electrode 641, second electrode 642, and third electrode 643 from each other. In this way, the first electrode 641, second electrode 642, and third electrode 643 at the distal portion of the catheter 600 (which may enter the blood vessel) will not sense intravascular drug and will not produce a false positive indication of drug extravasation.

[0082] Figure 7 According to some embodiments, this includes insertion into tissue. Figure 6 A partial cross-sectional side view of an example catheter system 700, including catheter 600. Catheter system 700 typically includes catheter 600, catheter adapter 716, and sensor 760. Figure 7 As shown, the catheter 600 can be inserted through the skin 81 and into the soft tissue 80 until the distal portion of the catheter 600 enters the blood vessel 70.

[0083] The catheter system 700 may further include a first attachment feature 791 configured to couple a first electrode 641 to a sensor 760, and a second attachment feature 792 configured to couple a second electrode 642 to the sensor 760. The first attachment feature 791 and the second attachment feature 792 may be coupled to and / or integrated with a catheter adapter 716. However, in other embodiments (not shown), the first attachment feature 791 and the second attachment feature 792 may be directly coupled to and / or integrated with the catheter 600. In some embodiments, the first attachment feature 791 and the second attachment feature 792 may traverse between the outer surface and the inner surface of the catheter adapter 716. In some embodiments, the first attachment feature 791 may directly or indirectly contact the first electrode 641, and the second attachment feature 792 may directly or indirectly contact the second electrode 642. In some embodiments, the first attachment feature 791 and the second attachment feature 792 may be configured to electrically couple the first electrode 641 and the second electrode 642 to the sensor 760.

[0084] In some embodiments, sensor 760 may be a drug sensor 760 configured to sense when drug 85 has leaked from blood vessel 70 and entered soft tissue 80 adjacent to blood vessel 70 via extravasation. In this way, drug sensor 760 can detect when extravasation of drug 85 has occurred and can provide an indication of drug extravasation to a clinician via any suitable output device known in the art. As previously described, soft tissue containing extravasated drug may exhibit different electrical, chemical, and / or physical properties compared to soft tissue without extravasated drug. These differences in electrical, chemical, and / or physical properties can be used to indicate whether soft tissue contains extravasated drug to warn clinicians of potential dangers.

[0085] In some embodiments, the drug sensor 760 may be in communication with the first electrode 641 and the second electrode 642 such that when the distal end 624 of the catheter lumen 622 is successfully inserted into the blood vessel 70: (1) at least a portion of the first electrode 641 and the second electrode 642 is embedded in the soft tissue 80 adjacent to the blood vessel 70; (2) the first electrode 641 and the second electrode 642 are in communication with each other through the soft tissue 80 between the first electrode 641 and the second electrode 642; and (3) the drug sensor 760 detects whether extravasation of drug 85 from the blood vessel 70 into the soft tissue 80 has occurred by sensing characteristics associated with the soft tissue 80.

[0086] In some embodiments, at least one characteristic associated with the soft tissue 80 containing the extravasated drug 85 includes at least one of the following: impedance, capacitance, conductance, inductance, electromagnetic signal, pressure, and temperature. In some embodiments, at least one characteristic may be measured directly or indirectly. In some embodiments, the determination of drug extravasation may be based on a threshold associated with at least one characteristic, a change detected in at least one characteristic when the soft tissue 80 is infused with drug 85, and / or a relative difference detected in at least one characteristic when the soft tissue 80 is infused with drug 85.

[0087] Figure 8 An exemplary catheter system 800 inserted into tissue is shown according to some embodiments. The catheter system 800 typically includes a catheter 823 and a sensor 860. Figure 8 As shown, catheter 823 can be inserted through skin 81 and into soft tissue 80 until the distal portion of catheter 823 enters blood vessel 70.

[0088] The catheter 823 may include a catheter lumen 822 having a proximal end 826, a distal end 824, an inner lumen surface 825, and an outer lumen surface 827. Although in Figure 8 Not shown in the diagram, but in some embodiments, the distal end 824 of the catheter 823 may also be tapered, similar to... Figure 1A and Figure 1B The conical distal end 24 of the catheter 22 shown.

[0089] In some embodiments, sensor 860 may include a drug sensing chip 860 coupled to an external cavity surface 827. The drug sensing chip 860 may include one or more sensors and / or one or more electrodes (not shown) disposed along its surface, which may be spaced apart from each other at one or more distances.

[0090] In some embodiments, when the distal end 824 of the catheter lumen 822 is inserted into the blood vessel 70, at least a portion of the drug sensing chip 860 may be embedded within the soft tissue 80 adjacent to the blood vessel 70. In this manner, the drug sensing chip 860 can detect when extravasation of drug 85 from the blood vessel 70 into the soft tissue 80 has occurred by sensing characteristics associated with the soft tissue 80. If extravasation of drug 85 has been detected, an indication of the extravasation event can be provided to a clinician via any suitable output device known in the art. In some embodiments, the output device may include an LED 868, which may be configured to indicate the presence and / or absence of drug 85 extravasated into the soft tissue 80.

[0091] As previously described, if the soft tissue 80 near the drug sensing chip 860 contains extravasated drug 85, the soft tissue 80 may exhibit different electrical, chemical, and / or physical properties compared to soft tissue without drug. These differences in electrical, chemical, and / or physical properties can be used to determine whether the soft tissue 80 contains extravasated drug 85, thereby alerting clinicians to potential dangerous situations.

[0092] In some embodiments, at least one characteristic associated with the soft tissue 80 containing the extravasated drug 85 includes at least one of the following: impedance, capacitance, conductance, inductance, electromagnetic signal (e.g., infrared signal), pressure, and temperature. In some embodiments, at least one characteristic may be measured directly or indirectly. In some embodiments, the determination of drug extravasation may be based on a threshold associated with at least one characteristic, a change detected in at least one characteristic when the soft tissue 80 is infused with drug 85, and / or a relative difference detected in at least one characteristic when the soft tissue 80 is infused with drug 85.

[0093] It should be understood that any embodiment of this disclosure can be combined in any number of different ways. As a non-limiting example, Figure 2 The embodiments can be related to Figure 1A-1B Combined with any (or any combination of) the embodiments in 3-8. As another non-limiting example, Figure 3 The embodiments can be compared with Figure 1A-2 Combining with any one (or any combination thereof) of the embodiments in 4-8, etc.

[0094] Throughout this specification, references to "embodiment" or "this embodiment" mean that a particular feature, structure, or characteristic described in association with that embodiment is included in at least one embodiment. Therefore, not all phrases or variations thereof referenced throughout this specification necessarily refer to the same embodiment.

[0095] Similarly, it should be understood that in the above description of the embodiments, various features are sometimes grouped together in a single embodiment, drawing, or description thereof to make this disclosure flow smoothly. However, the approach of this disclosure should not be construed as reflecting an intention in any claim to require more features than those expressly recited in that claim. Rather, as reflected in the appended claims, the inventive aspect lies in a combination of fewer features than all the features of any single foregoing disclosed embodiment. Therefore, the claims following this detailed description are thus expressly incorporated into this detailed description, wherein each claim is independently presented as a separate embodiment. This disclosure includes all substitutions of the independent claims and their dependent claims.

[0096] The use of the term "first" in the claims relating to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements described in the device-plus-function format are intended to be interpreted according to paragraph 6 of 35 U.S. Patent §112. It will be apparent to those skilled in the art that changes can be made to the details of the above embodiments without departing from the basic principles set forth herein.

[0097] This instruction manual uses standard medical guidance, reference planes, and descriptive terminology. For example, "anterior" means facing the front of the body. "Posterior" means facing the back of the body. "Upward" means facing the head. "Lower" means facing the feet. "Middle" means facing the midline of the body. "Lateral" means away from the midline of the body. "Axial" means facing the central axis of the body. "Off-axis" means away from the central axis of the body. "Ipsilateral" means on the same side of the body. "Contralateral" means on opposite sides of the body. The sagittal plane divides the body into right and left parts. The median sagittal plane divides the body into two symmetrical halves. The coronal plane divides the body into anterior and posterior parts. The transverse plane divides the body into upper and lower parts. These descriptive terms can be applied to living or non-living bodies.

[0098] The phrases “connected to,” “coupled to,” “joined to,” and “connected to” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be functionally coupled to each other even if they are not in direct contact. The term “adjacent” refers to items that are in direct physical contact with each other, although these items may not necessarily be attached together. The phrase “fluid connectivity” means that two features are connected such that fluid within one feature can enter the other feature.

[0099] The term "exemplary" as used herein means "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. Although various aspects of embodiments are presented in the accompanying drawings, the drawings are not necessarily drawn to scale unless specifically indicated otherwise.

[0100] While specific embodiments and applications of this disclosure have been illustrated and described, it should be understood that the scope of the appended claims is not limited to the precise configurations and components disclosed herein. Various modifications, alterations, and variations can be made to the arrangement, operation, and details of the apparatuses, systems, and methods disclosed herein, which will be clear to those skilled in the art.

[0101] All examples and conditional language cited herein are for illustrative purposes and are intended to help the reader understand the invention and the concepts contributed by the inventors to advance the prior art, and should be construed as not being limited to these specifically cited examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of this disclosure.

Claims

1. A catheter system, comprising: The catheter includes: The distal end forms the farthest surface of the catheter; A catheter lumen extending proximally from the distal end of the catheter, the catheter lumen comprising: Proximal end; remote; The inner surface of the cavity; and External cavity surface; A guide needle extends through the catheter, wherein the guide needle includes a distal tip of a sharp point; A blood flashback pathway is placed between the inner lumen surface and the guide needle; The first electrode is located near the farthest surface of the conduit; The second electrode, wherein the guide needle includes the second electrode; An electrically insulating layer is located adjacent to the blood flashback pathway, wherein the electrically insulating layer is configured to electrically insulate the first electrode from the second electrode; and A blood sensor, connected to the first electrode and the second electrode, 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 patient's blood vessels. The first and second electrodes are connected to each other via blood residing in the patient's blood vessels, and The blood sensor detects that the distal end of the catheter lumen has been inserted into the patient's blood vessel by sensing at least one characteristic associated with the blood residing in the patient's blood vessel.

2. The catheter system according to claim 1, wherein, The at least one characteristic associated with blood residing in the patient's blood vessels includes at least one of the following: impedance; inductance; capacitance; Pressure; and Electromagnetic signals.

3. The catheter system according to claim 1, further comprising: A first attachment feature is configured to couple the blood sensor to the first electrode; as well as A second attachment feature is configured to couple the blood sensor to the second electrode.

4. The catheter system according to claim 1, wherein: The first electrode comprises a conductive material deposited on the surface of the outer cavity; and The second electrode comprises a conductive material deposited on the surface of the outer cavity. Wherein, at least a portion of the first electrode and the second electrode are located near the distal end of the catheter lumen, and The first electrode and the second electrode are spaced apart from each other on the surface of the outer cavity.

5. The catheter system according to claim 4, wherein, The conductive material includes conductive ink.

6. The catheter system according to claim 1, wherein: The catheter lumen is made of conductive plastic to form the first electrode; and The catheter lumen includes the first electrode.

7. The catheter system according to claim 6, wherein, The blood sensor is configured to detect when the distal end of the catheter lumen is inserted into the patient's blood vessel by sensing the electrical properties associated with the blood residing between the catheter lumen and the guide needle.

8. The catheter system according to claim 7, wherein: The blood sensor is configured to detect when the distal end of the catheter lumen is inserted into the patient's blood vessel by sensing the electrical properties associated with the blood residing between the distal end of the catheter lumen and the distal portion of the guide needle.

9. The catheter system according to claim 1, wherein, The first electrode is placed at least on top of the distal surface, which is configured to be the portion of the distal surface closest to the patient's skin when the catheter is inserted into the patient's blood vessel.

10. The catheter system according to claim 1, wherein, The distal surface of the catheter includes a circle, wherein the first electrode is placed at least at the top of the circle, the top of the circle being the portion of the distal surface closest to the patient's skin when the catheter is inserted into the patient's blood vessel.

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