阅读说明：本技术 穿刺装置、包括该穿刺装置的穿刺系统及其方法 (Puncture device, puncture system comprising same and method thereof ) 是由 S·梅瑟利 于 2020-04-22 设计创作，主要内容包括：本文公开了穿刺装置和包括穿刺装置的穿刺系统。此类穿刺装置和穿刺系统包括根据血氧、阻抗或血压来感测静脉血与静脉血之间的差异。因此,穿刺装置和穿刺系统能够区分静脉穿刺与动脉穿刺。还公开了用于区分静脉穿刺与动脉穿刺的穿刺装置和穿刺系统的方法。(Puncturing devices and puncturing systems including puncturing devices are disclosed herein. Such lancing devices and systems include sensing of differences between venous blood and venous blood based on blood oxygen, impedance, or blood pressure. Thus, the puncture device and puncture system are able to distinguish venipuncture from arterial puncture. Methods of a puncture device and puncture system for distinguishing venipuncture from arterial puncture are also disclosed.)

1. A puncture device configured to distinguish venipuncture from arterial puncture, comprising:

a needle comprising a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft;

a hub disposed over a proximal portion of the shaft, the hub including a blood flashback chamber in fluid communication with the lumen of the needle, the blood flashback chamber configured to collect an aliquot of blood in the blood flashback chamber upon entry of a vein or artery of a patient by puncture with the needle; and

an oxygen sensor integral with the liner, the oxygen sensor configured to measure oxygen in any collected blood in the blood flashback chamber to subsequently determine a concentration of oxygen in the collected blood, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

2. The lancing device of claim 1, wherein the oxygen sensor is an electrochemical sensor comprising an anode and a cathode disposed in an electrolyte, the electrolyte being separated from the blood flashback chamber by a semi-permeable membrane.

3. The lancing device of claim 2, wherein the semi-permeable membrane is configured to allow oxygen in the collected blood to permeate through the semi-permeable membrane for electrochemical reduction of the oxygen at the cathode, which produces a measurable current proportional to the partial pressure of oxygen in the collected blood.

4. The lancing device of claim 3, wherein the electrochemical sensor is coupled to an external meter configured to determine a concentration of oxygen in the collected blood from the measurable current, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venous and arterial puncture, respectively.

5. A puncture system configured to distinguish venipuncture from arterial puncture, comprising:

a lancing device, the lancing device comprising:

a needle having a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft; and

a hub disposed over a proximal portion of the shaft, the hub including a blood flashback chamber in fluid communication with the lumen of the needle, the blood flashback chamber configured to collect an aliquot of blood in the blood flashback chamber upon entry of a vein or artery of a patient by puncture with the needle; and

an external meter, the external meter comprising:

an oxygen sensor configured for placement around the blood flashback chamber of the lancing device, the oxygen sensor configured to measure oxygen in any collected blood in the blood flashback chamber in order to subsequently determine a concentration of oxygen in the collected blood, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venous and arterial punctures, respectively.

6. The lancing system of claim 5, wherein the oxygen sensor is an optical sensor including a red light emitting diode ("LED") disposed in an LED housing of the meter, an infrared LED disposed in the LED housing, and a photodetector disposed in a photodetector housing of the meter opposite the LED housing.

7. The lancing system of claim 5 or 6, wherein the meter is configured to determine a concentration of oxygen in the collected blood from a look-up table using red and infrared light absorption measurements, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venous and arterial punctures, respectively.

8. A puncture device configured to distinguish venipuncture from arterial puncture, comprising:

a needle comprising a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft;

a hub disposed over a proximal portion of the shaft, the hub including a blood flashback chamber in fluid communication with the lumen of the needle, the blood flashback chamber configured to collect an aliquot of blood in the blood flashback chamber upon entry of a vein or artery of a patient by puncture with the needle; and

an oxygen sensor integral with the liner, the oxygen sensor configured to indicate a concentration of oxygen in any collected blood in the blood flashback chamber for subsequent determination of whether the concentration of oxygen in the collected blood is consistent with venous blood or arterial blood to distinguish venipuncture from arterial puncture, respectively.

9. The lancing device of claim 8, wherein the oxygen sensor is a chemical disposed in the flashback chamber, the chemical configured to colorimetrically indicate a concentration of oxygen in the collected blood.

10. The lancing device of claim 9, wherein the formulation comprises at least a buffer and a chromogenic reagent.

11. The lancing device of claim 10, wherein the buffer is an alkaline buffer and the chromogenic reagent is indigo carmine.

12. A lancing device according to any one of claims 9 to 11, wherein said hub includes a simple comparator thereon for colorimetrically determining whether the concentration of oxygen in the collected blood corresponds to venous or arterial blood.

13. A puncture system configured to distinguish venipuncture from arterial puncture, comprising:

a lancing device, the lancing device comprising:

a needle comprising a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft;

a bushing disposed over a proximal end portion of the shaft; and

a pair of electrodes disposed in a shaft of the needle, the pair of electrodes configured to apply and detect a small current in order to measure an impedance of any blood in the shaft; and

an external meter coupled to the pair of electrodes, the external meter configured to determine an impedance as a function of a resistivity of any blood in the shaft, compare the impedance to an expected impedance of venous or arterial blood, and indicate whether the impedance is consistent with venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

14. A puncture system configured to distinguish venipuncture from arterial puncture, comprising:

a lancing device, the lancing device comprising:

a needle comprising a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft;

a bushing disposed over a proximal end portion of the shaft; and

a pressure sensor disposed in the shaft of the needle, the pressure sensor configured to respond to pressure changes caused by any blood entering the shaft; and

an external meter coupled to the pressure sensor, the external meter configured to determine a mean blood pressure from pressure changes received from the pressure sensor, compare the mean blood pressure to an expected mean blood pressure of venous or arterial blood, and indicate whether the mean blood pressure is consistent with venous or arterial blood pressure to distinguish between venipuncture and arterial puncture, respectively.

15. The lancing system of claim 14, wherein the pressure sensor is a micro-electromechanical system having a deformable diaphragm over a non-deformable substrate forming a capacitor responsive to the pressure change, and wherein the pressure sensor is configured to transmit a change in capacitance corresponding to the pressure change to the gauge concomitant with the pressure change.

16. A method for distinguishing venipuncture from arterial puncture, comprising:

accessing a vein or artery of a patient by puncturing with a puncturing device, the puncturing device comprising:

a needle comprising a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft;

a hub disposed over a proximal portion of the shaft, the hub including a blood flashback chamber in fluid communication with the lumen of the needle, the blood flashback chamber configured to collect an aliquot of blood in the blood flashback chamber upon entry of a vein or artery of a patient by puncture with the needle; and

a blood flashback chamber in fluid communication with the lumen of the needle, the blood flashback chamber configured to collect an aliquot of blood in the blood flashback chamber upon entry into a vein or artery of the patient; and

interrogating a puncture differentiating means for differentiating between venipuncture and arterial puncture, said puncture differentiating means comprising an oxygen sensor for measuring oxygen in any blood collected in said blood flashback chamber, an electrode pair for measuring impedance of any blood in said shaft, or a pressure sensor for measuring pressure changes caused by any blood entering said shaft.

17. The method of claim 16, further comprising:

determining, by the puncture differentiating tool, a concentration of oxygen in the collected blood using a measurement of a current generated by electrochemical reduction of oxygen at a cathode of the electrochemical sensor with the electrochemical sensor;

comparing the concentration of oxygen in the collected blood with an expected oxygen concentration of venous or arterial blood by using the puncture distinguishing means; and

the puncture distinguishing tool indicates whether the collected blood is venous blood or arterial blood, so that venous puncture and arterial puncture are distinguished respectively.

18. The method of claim 16, further comprising:

determining, by the puncture distinguishing tool, a concentration of oxygen in the collected blood using an optical sensor using red and infrared absorption measurements by a photodetector of the optical sensor;

comparing, by the puncture differentiating tool, the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood; and

the puncture distinguishing tool indicates whether the collected blood is venous blood or arterial blood, so that venous puncture and arterial puncture are distinguished respectively.

19. The method of claim 16, further comprising:

determining, by the puncture differentiating tool, an impedance as a function of a resistivity of any blood between a pair of electrodes disposed in a shaft of the needle;

comparing, by the puncture differentiating tool, the impedance to an expected impedance of venous or arterial blood; and

by means of the puncture distinguishing means, it is indicated whether the impedance coincides with venous blood or arterial blood, thereby distinguishing venous puncture from arterial puncture, respectively.

20. The method of claim 16, further comprising:

determining, by the puncture differentiating tool, a mean blood pressure from a change in capacitance of a micromechanical electronic pressure sensor disposed in a shaft of the needle caused by any blood entering the shaft;

comparing, by the puncture differentiating means, the mean blood pressure to a desired mean blood pressure of venous or arterial blood; and

indicating, by the puncture distinguishing tool, whether the mean blood pressure coincides with venous blood or arterial blood, thereby distinguishing venous puncture from arterial puncture, respectively.

Background

It is important to distinguish between veins and arteries prior to placement of the catheter because arterial cannulation is undesirable. Disclosed herein are puncture devices for distinguishing venipuncture from arterial puncture, puncture systems including the puncture devices, and methods thereof.

Disclosure of Invention

A puncture device configured to distinguish venipuncture from arterial puncture by a first type of oxygen sensor is disclosed herein. In some embodiments, the lancing device includes a needle, a hub disposed over the needle, and an oxygen sensor integral with the hub. The needle includes a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft. The bushing is disposed over the proximal end portion of the shaft. The hub includes a blood-flashback (blood-flashback) chamber in fluid communication with the lumen of the needle. The blood flashback chamber is configured to collect an aliquot of blood therein upon entry into a vein or artery of a patient by puncture with a needle. The oxygen sensor is configured to measure oxygen in any collected blood in the blood flashback chamber to subsequently determine a concentration of oxygen in the collected blood, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

In some embodiments, the oxygen sensor is an electrochemical sensor comprising an anode and a cathode disposed in an electrolyte separated from the blood return chamber by a semi-permeable membrane.

In some embodiments, the semi-permeable membrane is configured to allow oxygen in the collected blood to permeate through the semi-permeable membrane for electrochemical reduction of oxygen at the cathode. The reduction of oxygen at the cathode produces a measurable current proportional to the partial pressure of oxygen in the collected blood.

In some embodiments, the electrochemical sensor is coupled to an external meter. The meter is configured to determine a concentration of oxygen in the collected blood from the measurable current, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous blood or arterial blood, and indicate whether the collected blood is venous blood or arterial blood to distinguish venipuncture from arterial puncture, respectively.

Also disclosed herein is a puncture system configured to distinguish venipuncture from arterial puncture by a second type of oxygen sensor. In some embodiments, the lancing system includes a lancing device and an external meter. The puncture device includes a needle and a hub disposed over the needle. The needle includes a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft. The bushing is disposed over the proximal end portion of the shaft. The hub includes a blood flashback chamber in fluid communication with the lumen of the needle. The blood flashback chamber is configured to collect an aliquot of blood therein upon entry into a vein or artery of a patient by puncture with a needle. The meter includes an oxygen sensor configured for placement around the blood flashback chamber of the lancing device. The oxygen sensor is configured to measure oxygen in any collected blood in the blood flashback chamber to subsequently determine a concentration of oxygen in the collected blood, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

In some embodiments, the oxygen sensor is an optical sensor comprising a red light emitting diode ("LED") disposed in an LED housing of the meter, an infrared LED disposed in the LED housing, and a photodetector disposed in a photodetector housing of the meter opposite the LED housing.

In some embodiments, the meter is configured to determine a concentration of oxygen in the collected blood from a look-up table using the red and infrared light absorption measurements, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish between venipuncture and arterial puncture, respectively.

Also disclosed herein is a puncture device configured to distinguish venipuncture from arterial puncture by a third type of oxygen sensor. In some embodiments, the lancing device includes a needle, a hub disposed over the needle, and an oxygen sensor integral with the hub. The needle includes a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft. The bushing is disposed over the proximal end portion of the shaft. The hub includes a blood flashback chamber in fluid communication with the lumen of the needle. The blood flashback chamber is configured to collect an aliquot of blood therein upon entry into a vein or artery of a patient by puncture with a needle. The oxygen sensor is configured to indicate the concentration of oxygen in any collected blood in the blood flashback chamber for subsequent determination of whether the concentration of oxygen in the collected blood is consistent with venous blood or arterial blood to distinguish venipuncture from arterial puncture, respectively.

In some embodiments, the oxygen sensor is a chemical disposed in the blood flashback chamber. The formulation is configured to colorimetrically indicate the concentration of oxygen in the collected blood.

In some embodiments, the formulation includes at least a buffer and a chromogenic reagent.

In some embodiments, the buffer is an alkaline buffer and the chromogenic reagent is indigo carmine.

In some embodiments, the liner includes a simple comparator(s) thereon for colorimetrically determining whether the concentration of oxygen in the collected blood is consistent with venous or arterial blood.

Also disclosed herein is a puncture system configured to distinguish venipuncture from arterial puncture by impedance. In some embodiments, the lancing system includes a lancing device and an external meter. The puncture device includes a needle, a hub disposed over the needle, and at least one electrode pair disposed in the needle. The needle includes a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft. The bushing is disposed over the proximal end portion of the shaft. An electrode pair is disposed within the shaft, configured to apply and detect a small current for measuring the impedance of any blood in the shaft. A meter is coupled to the pair of electrodes. The meter is configured to determine an impedance from the resistivity of any blood in the shaft, compare the impedance to an expected impedance of venous or arterial blood, and indicate whether the impedance is consistent with venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

Also disclosed herein is a puncture system configured to distinguish venipuncture from arterial puncture by a pressure sensor. In some embodiments, the lancing system includes a lancing device and an external meter. The puncture device comprises a needle, a hub arranged above the needle, and a pressure sensor arranged in the needle. The needle includes a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft. The bushing is disposed over the proximal end portion of the shaft. A pressure sensor is disposed within the shaft and is configured to respond to pressure changes caused by any blood entering the shaft. The gauge is coupled to the pressure sensor. The meter is configured to determine a mean blood pressure from pressure changes received from the pressure sensor, compare the mean blood pressure to an expected mean blood pressure of venous or arterial blood, and indicate whether the mean blood pressure is consistent with venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

In some embodiments, the pressure sensor is a micro-mechanical electronic system having a deformable diaphragm over a non-deformable substrate, forming a capacitor responsive to pressure changes. The pressure sensor is configured to transmit a change in capacitance corresponding to the change in pressure to the gauge with the change in pressure.

A method for distinguishing venipuncture from arterial puncture is also disclosed herein. In some embodiments, the method comprises: accessing a vein or artery of a patient by puncturing with a puncturing device; and querying a puncture differentiating tool for differentiating between venipuncture and arterial puncture, the puncture differentiating tool comprising an oxygen sensor for measuring oxygen in any blood collected in the blood flashback chamber of the puncturing device, an electrode pair for measuring impedance of any blood in the needle of the puncturing device, or a pressure sensor for measuring pressure changes caused by any blood entering the needle. The puncture device includes a needle and a hub disposed over the needle. The needle includes a shaft, a lumen defined by an inner diameter of the shaft, and a tip in a distal portion of the shaft. The bushing is disposed over the proximal end portion of the shaft. The hub includes a blood return chamber in fluid communication with the lumen of the needle, the blood return chamber configured to collect an aliquot of blood in the blood return chamber upon entry into a vein or artery of a patient by puncture with the needle.

In some embodiments, the method further comprises: determining, by the puncture distinguishing tool, a concentration of oxygen in the collected blood using a measurement of a current generated by electrochemical reduction of oxygen at a cathode of the electrochemical sensor with the electrochemical sensor; comparing the concentration of oxygen in the collected blood with an expected oxygen concentration of venous or arterial blood by using a puncture differentiating means; and indicating whether the collected blood is venous blood or arterial blood by the puncture distinguishing tool, thereby distinguishing venipuncture from arterial puncture respectively.

In some embodiments, the method further comprises: determining, by the puncture distinguishing tool, a concentration of oxygen in the collected blood using the red and infrared light absorption measurements of the light detector of the optical sensor, using the optical sensor; comparing, by the puncture differentiating tool, the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood; and indicating whether the collected blood is venous blood or arterial blood by the puncture distinguishing tool, thereby distinguishing venipuncture from arterial puncture respectively.

In some embodiments, the method further comprises: determining, by the puncture differentiating tool, an impedance as a function of a resistivity of any blood between a pair of electrodes disposed in a shaft of the needle; comparing, by the puncture differentiating tool, the impedance to an expected impedance of venous or arterial blood; and indicating by the puncture distinguishing tool whether the impedance is consistent with venous blood or arterial blood, thereby distinguishing venous puncture from arterial puncture, respectively.

In some embodiments, the method further comprises: determining, by the puncture differentiating tool, a mean blood pressure from a change in capacitance of a micromechanical electronic pressure sensor disposed in the shaft caused by any blood entering the shaft of the needle; comparing, by the puncture differentiating tool, the mean blood pressure to an expected mean blood pressure of venous or arterial blood; and indicating by the puncture distinguishing tool whether the mean blood pressure is consistent with venous blood or arterial blood, thereby distinguishing venous puncture from arterial puncture, respectively.

These and other features of the concepts provided herein will become more readily apparent to those skilled in the art based upon the following description and the accompanying drawings, which disclose in greater detail specific embodiments of such concepts.

Drawings

Fig. 1 illustrates a puncture device and catheter according to some embodiments.

Fig. 2 illustrates the catheter of fig. 1 disposed over a puncture device, according to some embodiments.

Fig. 3 illustrates a lancing device including a first type of oxygen sensor according to some embodiments.

Fig. 4 illustrates a lancing device including a second type of oxygen sensor according to some embodiments.

Fig. 5 illustrates a lancing device including a third type of oxygen sensor according to some embodiments.

Fig. 6 illustrates an impedance-based puncture system according to some embodiments.

Fig. 7 illustrates a blood pressure sensing lancing system according to some embodiments.

Fig. 8 illustrates mean blood pressure as the sum of diastolic pressure and one-third systolic pressure, according to some embodiments.

Detailed Description

Before disclosing in greater detail some specific embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that particular embodiments disclosed herein may have features that are readily separable from the specific embodiments, and optionally may be combined with or substituted for the features of any of the several other embodiments disclosed herein.

With respect to the terminology used herein, it is also to be understood that these terminology is for the purpose of describing some particular embodiments, and that these terminology is not intended to limit the scope of the concepts provided herein. Ordinal words (e.g., first, second, third, etc.) are used generally to distinguish or identify different features or steps in a group of features or steps, and do not provide sequence or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily need to be present in order, and particular embodiments that include such features or steps do not necessarily need to be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back", and the like are used for convenience and are not intended to imply any particular fixed position, orientation, or direction, for example. Rather, such tags may be used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.

With respect to "proximal", for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of the catheter may comprise the proximal end of the catheter; however, the proximal portion, or proximal length of the catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, or proximal length of the catheter is not the distal portion or end length of the catheter.

With respect to "distal", for example, a "distal portion" or "distal portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used on the patient. Likewise, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within a patient when the catheter is used on the patient. For example, the "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used on the patient. The distal portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, or distal length of the catheter is not the tip portion or end length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

Fig. 1 illustrates a puncture device 100 and a catheter 199 according to some embodiments. Fig. 2 illustrates a conduit 199 disposed above the puncturing device 100, according to some embodiments.

As shown, the puncturing device 100 includes a needle 110 and a hub 120. The needle 110 includes a shaft 112, a lumen 114 defined by an inner diameter of the shaft 112, and a tip 116 in a distal portion of the shaft 112. A bushing 120 is disposed over the proximal portion of the shaft 112. The hub 120 includes a blood flashback chamber 122 in fluid communication with the lumen 114 of the needle 110, the blood flashback chamber being configured to collect an aliquot of blood in the blood flashback chamber 122 when a vein or artery of a patient is accessed by puncture with the needle. The flashback chamber 112 is configured to be transparent so that any collected blood in the flashback chamber can be seen by the clinician. When present, the collected blood indicates successful access of the puncturing device 100 into the patient's blood vessel; however, the type of vessel, e.g., vein or artery, is not solely indicated by the collected blood in the blood return chamber 122. For this reason, a puncture device, a puncture system including the puncture device, and methods thereof are described below for distinguishing a punctured vein (i.e., venipuncture) from an artery (i.e., arterial puncture). Such puncture devices are configured to allow a catheter, such as catheter 199, to be disposed thereover without interference.

Blood oxygen sensing device and system

Since the blood oxygen difference between venous blood and arterial blood is relatively large, blood oxygen sensing devices and systems including such devices are useful for distinguishing venipuncture from arterial puncture.

Fig. 3 illustrates a lancing device 300 that includes a first type of oxygen sensor according to some embodiments. The puncture device 300 is configured to distinguish venipuncture from arterial puncture by a first type of oxygen sensor as set forth below.

As shown, the puncturing device 300 includes a needle (e.g., needle 110), a hub 320 disposed over the needle, and an oxygen sensor 330 integral with the hub 320. The needle includes a shaft 312, a lumen 314 defined by an inner diameter of the shaft 312, and a tip, such as tip 116, of the needle 110 in a distal portion of the shaft 312. A bushing 320 is disposed over the proximal portion of the shaft 312. The hub 320 includes a blood return chamber 322 in fluid communication with the needle lumen 314. The blood return chamber 322 is configured to collect an aliquot of blood therein as it enters a vein or artery of a patient through a puncture with a needle. The oxygen sensor 330 is configured to measure oxygen in any collected blood in the blood return chamber 322 to subsequently determine the concentration of oxygen in the collected blood, compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and indicate whether the collected blood is venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

The oxygen sensor 330 is an electrochemical sensor comprising an anode 332 and a cathode 334 disposed in an electrolyte separated from the blood return chamber 322 by a semi-permeable membrane 336. If the oxygen sensor 330 is configured as a polarographic oxygen sensor, the anode 332 is silver, the cathode 334 is a noble metal such as gold or platinum, and the electrolyte is aqueous potassium chloride. If the oxygen sensor 330 is configured as a galvanic oxygen sensor, the anode 332 is zinc, lead, or another active metal, the cathode 334 is nickel or a noble metal such as silver, and the electrolyte is aqueous sodium chloride or sodium hydroxide. Whether the oxygen sensor 330 is a polarographic oxygen sensor or a amperometric oxygen sensor, the semi-permeable membrane 336 is configured to allow oxygen in the collected blood to permeate through the semi-permeable membrane 336 for electrochemical reduction of oxygen at the cathode 334. The reduction of oxygen at cathode 334 produces a measurable current proportional to the partial pressure of oxygen in the collected blood.

The electrochemical sensor may be coupled to an external meter 302, which may optionally be integrated with the ultrasound transducer, thereby forming a lancing system including the lancing device 300. The meter 302 may be configured with an algorithm in its memory to determine the concentration of oxygen in the collected blood from the aforementioned measurable current. The meter 302 may be configured with another algorithm in memory to compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood. Meter 302 may be configured with a display (not shown) to indicate whether the collected blood is venous or arterial blood to distinguish venipuncture from arterial puncture, respectively. At least for a polarographic oxygen sensor, the meter 302 may also be configured to supply an electrical current to the electrochemical sensor 330 for maintaining a constant potential across the anode 332 and cathode 334 for electrochemical reduction of oxygen at the cathode 334.

Fig. 4 illustrates a lancing system including a second type of oxygen sensor according to some embodiments. The puncture system is configured to distinguish venipuncture from arterial puncture with the puncture device 400 by a second type of oxygen sensor as set forth below.

As shown, the lancing system includes a lancing device 400 and an external meter 402. The puncture device 400 includes a needle, such as the needle 110, and a hub 420 disposed over the needle. The needle includes a shaft 412, a lumen 414 defined by an inner diameter of the shaft 412, and a tip, such as tip 116, of the needle 110 in a distal portion of the shaft 412. Bushing 420 is disposed over a proximal portion of shaft 412. The hub 420 includes a blood return chamber 422 in fluid communication with the needle lumen 414. The blood return chamber 422 is configured to collect an aliquot of blood therein upon entry into a vein or artery of a patient by puncture with a needle. The meter 402 includes an oxygen sensor 430 configured for placement around the blood flashback chamber 422 of the lancing device 400. The oxygen sensor 430 is configured to measure oxygen in any collected blood in the blood flashback chamber 422, to subsequently determine a concentration of oxygen in the collected blood, to compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood, and to indicate whether the collected blood is venous or arterial blood, to distinguish between venipuncture and arterial puncture, respectively.

The oxygen sensor 430 is an optical sensor that includes a red LED 432 disposed in an LED housing 435 of the meter 402, an infrared LED 434 disposed in the LED housing 435, and a photodetector 436 disposed in a photodetector housing 437 of the meter opposite the LED housing. Optionally, the LED housing 435 and the light detector housing 437 are the same housing configured with a "C" shape for supporting the blood flashback chamber 422 of the lancing device 400. Oxyhemoglobin in blood (e.g., collected blood) absorbs more infrared light and allows more red light to pass through than deoxyhemoglobin (or reduced hemoglobin), which absorbs more red light and allows more infrared light to pass through. Thus, LED 432 is configured to emit optimized 600-750nm wavelength red light, while LED 434 is configured to emit optimized 850-1000nm wavelength infrared light. Optionally, the functionality of LED 432 and LED 434 is embodied in a single LED configured to emit red and infrared light at different times.

The meter 402, which may optionally be integral with the ultrasound transducer, may be configured in its memory with an algorithm configured to determine the concentration of oxygen in the collected blood from a look-up table in the memory using the red and infrared light absorption measurements provided by the light detector 436. Meter 402 may be configured with another algorithm in memory to compare the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood. Meter 302 may be configured with a display (not shown) to indicate whether the collected blood is venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

Fig. 5 illustrates a lancing device 500 including a third type of oxygen sensor according to some embodiments. The puncture device 500 is configured to distinguish venipuncture from arterial puncture by a third type of oxygen sensor as set forth below.

As shown, the lancing device includes a needle (e.g., needle 110), a hub 520 disposed over the needle, and an oxygen sensor integral with the hub 520. The needle includes a shaft 512, a lumen 514 defined by an inner diameter of the shaft 514, and a tip, such as tip 116, of the needle 110 in a distal portion of the shaft 512. Bushing 520 is disposed over the proximal portion of shaft 512. The hub 520 includes a blood return chamber 522 in fluid communication with the needle lumen 514. The blood return chamber 522 is configured to collect an aliquot of blood therein as it enters a vein or artery of a patient through a puncture with a needle. The oxygen sensor is configured to indicate the concentration of oxygen in any collected blood in the blood flashback chamber 520 for a user, such as a clinician, to subsequently determine whether the concentration of oxygen in the collected blood is consistent with venous blood or arterial blood to distinguish venipuncture from arterial puncture, respectively.

The oxygen sensor is a chemical disposed in the blood flashback chamber 520. The formulation is configured to colorimetrically indicate the concentration of oxygen in the collected blood. The formulation includes at least a chromogenic reagent and a buffer configured to maintain the chromogenic reagent within a particular pH range in which the chromogenic reagent is operable. The chromogenic reagent may be indigo carmine, and the buffer may be an alkaline buffer configured to maintain the indigo carmine at a pH between about 8 and about 9.

The liner 520 may include a simple comparator 524 printed thereon for the user to determine colorimetrically whether the concentration of oxygen in the collected blood corresponds to venous or arterial blood. Optionally, a simple comparator 524 is provided on a piece of paper or cardboard provided with the puncturing device 500.

Impedance-based apparatus and system

While the impedance difference between venous and arterial blood may be relatively small, impedance-based devices and systems including such devices are useful for distinguishing between venipuncture and arterial puncture.

Fig. 6 illustrates an impedance-based puncture system according to some embodiments. The puncture system is configured to distinguish venipuncture from arterial puncture using the puncture device 600 by impedance as set forth below.

As shown, the lancing system includes a lancing device 600 and an external meter 602. The lancing device 600 includes a needle 610, a hub 620 disposed over the needle 610, and at least one electrode pair 630 disposed in the needle 610. The needle 610 includes a shaft 612, a lumen 614 defined by an inner diameter of the shaft 612, and a tip 616 of the needle 610 in a distal portion of the shaft 612. A bushing 620 is disposed over the proximal portion of the shaft 612. Optionally, the hub 620 includes a blood flashback chamber 622 in fluid communication with the lumen 614 of the needle 610, the blood flashback chamber 622 configured to collect an aliquot of blood therein upon entry into a vein or artery of a patient by puncture with the needle 610. Disposed in the shaft 612 is an electrode pair 630 configured to apply and detect a small current for measuring the impedance of any blood in the shaft 612. When the blood flashback chamber 622 is present, an electrode pair 630 may alternatively be disposed in the blood flashback chamber 622, the electrode pair configured to apply and detect a small current for measuring the impedance of any blood in the blood flashback chamber 622. A gauge 602, which may optionally be integral with the ultrasound transducer, is coupled to the electrode pair 630. The meter 602 may be configured with an algorithm in its memory to determine the impedance from the resistivity of any blood in the shaft 612 (or the flashback chamber 622). The meter 602 may be configured with another algorithm in memory to compare the impedance to an expected impedance in venous or arterial blood. The meter 602 may be configured with a display (not shown) to indicate whether the impedance is consistent with venous or arterial blood to distinguish venipuncture from arterial puncture, respectively.

Blood pressure sensing device and system

Due to the relatively large blood pressure difference P between venous blood and arterial blood, as shown in FIG. 8, the blood pressure P is measured through the veins_VeinIn comparison to the average arterial blood pressure MAP, blood pressure sensing devices and systems including such devices are useful for distinguishing venipuncture from arterial puncture.

Fig. 7 illustrates a blood pressure sensing lancing system according to some embodiments. The puncture system is configured to distinguish venipuncture from arterial puncture by blood pressure as set forth below using the puncture device 700.

As shown, the lancing system includes a lancing device 700 and an external meter 702. The lancing device 700 includes a needle 710, a hub 720 disposed over the needle 710, and a pressure sensor 730 disposed in the needle 710. The needle 710 includes a shaft 712, a lumen 714 defined by an inner diameter of the shaft 712, and a tip 716 in a distal portion of the shaft 712. A bushing 720 is disposed over the proximal portion of the shaft 712. Optionally, the hub 720 includes a blood flashback chamber 722 in fluid communication with the lumen 714 of the needle 710, the blood flashback chamber 722 being configured to collect an aliquot of blood therein upon entry into a vein or artery of a patient by puncture with the needle 710. A pressure sensor 730 is disposed in the shaft 712 and is configured to respond to pressure changes caused by any blood entering the shaft 712. A gauge 702, which may optionally be integral with the ultrasound transducer, is coupled to the pressure sensor 730. The meter 702 may be configured with an algorithm in its memory to determine an average blood pressure from the pressure changes received from the pressure sensor 730. The meter 702 may be configured with another algorithm in memory to compare the average blood pressure to a desired average blood pressure of venous or arterial blood. The meter 702 may be configured with a display (not shown) to indicate whether the average blood pressure is consistent with venous or arterial blood, to distinguish venipuncture from arterial puncture, respectively.

Pressure sensor 730 may be a micro-electromechanical system having a deformable diaphragm on a non-deformable substrate, forming a capacitor responsive to pressure changes. The pressure sensor 730 is configured to transmit a change in capacitance corresponding to the change in pressure to the gauge 702 with the change in pressure.

Method

Based on the aforementioned puncture device and the puncture system comprising the puncture device, a method for distinguishing venipuncture from arterial puncture is also provided.

A method for distinguishing venipuncture from arterial puncture comprising: accessing a vein or artery of a patient by puncturing with the puncturing device 300, 400, 500, 600, or 700; and querying a puncture differentiating tool for differentiating between venipuncture and arterial puncture, the puncture differentiating tool comprising an oxygen sensor 330, 430, etc. for measuring oxygen in any blood collected in the blood flashback chamber 322, 433, or 522 of the puncturing device 300, 400, or 500, an electrode pair 630 for measuring impedance of any blood in the needle 610 of the puncturing device 600, or a pressure sensor 730 for measuring pressure changes caused by any blood entering the needle 710 of the puncturing device 700. The puncture distinguishing tool comprises an assembly of any one of the puncture devices 300, 400, 500, 600 or 700 or a system comprising the aforementioned puncture devices for distinguishing venipuncture from arterial puncture.

The method may further comprise: determining, by an algorithm in the memory of meter 302, a concentration of oxygen in the collected blood using a measurement of a current produced by electrochemical reduction of oxygen at cathode 334 of the electrochemical sensor with oxygen sensor 330 configured as an electrochemical sensor; comparing, by another algorithm in the memory of meter 302, the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood; and indicating on the display of meter 302 whether the collected blood is venous or arterial blood, thereby distinguishing venipuncture from arterial puncture, respectively.

The method may further comprise: determining, by an algorithm in the memory of the meter 402, a concentration of oxygen in the collected blood using the red and infrared light absorption measurements of the light detector 436 of the optical sensor with the oxygen sensor 430 configured as an optical sensor; comparing, by another algorithm in the memory of meter 402, the concentration of oxygen in the collected blood to an expected oxygen concentration of venous or arterial blood; and indicating on the display of meter 402 whether the collected blood is venous or arterial blood, thereby distinguishing venipuncture from arterial puncture, respectively.

The method may further comprise: determining, by an algorithm in the memory of the meter 602, an impedance from the resistivity of any blood between the pair of electrodes 630 disposed in the shaft 612 of the needle 610; comparing, by another algorithm in the memory of the meter 602, the impedance to an expected impedance of venous or arterial blood; and indicating on the display of meter 602 whether the impedance is consistent with venous or arterial blood, thereby distinguishing venipuncture from arterial puncture, respectively.

The method may further comprise: determining, by an algorithm in the memory of the meter 702, a mean blood pressure from the change in capacitance of the micromachined electronic pressure sensor 730 disposed in the shaft 712 caused by any blood entering the shaft 712 of the needle 710; comparing, by another algorithm of the meter 702, the average blood pressure to an expected average blood pressure of venous or arterial blood; and indicating on a display of the meter 702 whether the average blood pressure is consistent with venous or arterial blood, thereby distinguishing venipuncture from arterial puncture, respectively.

Although specific embodiments have been disclosed herein, and although details of these specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and/or modifications may occur to those skilled in the art and are intended to be covered in a broader sense. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.