Patent Grant
11800992
The present invention relates to the field of medical devices, in particular devices capable safely accessing bodily spaces or cavities.
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Fluids and other substances are infused into patients for a variety of reasons. For example, fluids may be given to a patient intravenously to hydrate the patient or to control overall blood volume.
It is often important to control infusion of fluid into patients in order to optimize the therapy being provided. Monitoring of patient parameters can consume precious health care time and resources, however. Fluid infusion into patients is therefore not always optimized.
Mantle US 2006/0161107 describes a system that extracts fluid from a body cavity, processes the fluid and then recirculates fluid back into the cavity. Mantle does not describe infusion of a fluid into a patient without extraction of the fluid from the patient, however. In addition, the parameters on which the Mantle system is controlled are limited.
One aspect of the invention provides an automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. In some embodiments, the sensor may be incorporated into the catheter, and in other embodiments, the sensor may be separate from the catheter. The sensor may be, e.g., an ECG sensor; an EEG sensor; a pulse oximetry sensor; a blood pressure sensor; a cardiac output sensor; a thermodilution cardiac output sensor; a cardiac stroke volume sensor; a heart rate sensor; a blood flow sensor; a pH sensor; a blood pO2 sensor; an intracranial pressure sensor; and/or a solute sensor.
In embodiments of the invention, the catheter may be a peripheral venous catheter; a central venous catheter; an arterial catheter; or a peritoneal catheter (possibly incorporating an intraperitoneal pressure sensor).
Another aspect of the invention provides a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient. In some embodiments, the method includes the step of monitoring cardiac output with the sensor and, possibly, adjusting fluid flow to the patient based on cardiac output monitored by the sensor. In embodiments of the invention, the patient parameter includes an electrocardiogram; an electroencephalogram; blood oxygen saturation; blood pressure; cardiac output; cardiac stroke volume; heart rate; blood flow; total circulating blood volume; whole body oxygen consumption; pH; blood pO2; osmolarity; peritoneal cavity compliance; intrathoracic pressure; bladder pressure; and/or rectal pressure.
In some embodiments, the adjusting step includes the step of adjusting fluid flow to achieve or maintain patient euvolumia; adjusting flow of a therapeutic agent (such as a chilled medium) to the patient; adjusting fluid flow to the patient through a peripheral venous catheter; adjusting fluid flow to the patient through a central venous catheter; adjusting fluid flow to the patient through an arterial catheter; and/or adjusting fluid flow to the patient's peritoneal cavity.
Yet another aspect of the invention provides a method of treating hypotension in a patient. The method includes the following steps: monitoring a patient parameter (such as blood pressure or cardiac output) with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.
Still another aspect of the invention provides a method of treating sepsis in a patient. The method includes the following steps: monitoring a patient parameter (such as blood pressure, central venous pressure, or cardiac output) with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient. Prevention of hypotension and/or hypovolemia is critical in the care of patients that have suffered severe hemorrhage or are septic. These patients are very difficult to monitor and treat, taking significant nursing time and still resulting in suboptimal therapy due to the intermittent nature of the blood pressure, central venous pressure and/or cardiac output checks. The present invention, then, will optimize fluid flow to the patient while also freeing up the already over-taxed nursing staff for other duties.
Yet another aspect of the invention provides a method of inducing and reversing therapeutic hypothermia in a patient. The method includes the steps of: monitoring intracranial pressure to generate a sensor signal; providing the sensor signal to a controller; and adjusting rate of hypothermia induction or rewarming based on intracranial pressure (such as by adjusting fluid flow to the patient), or depth of hypothermia, based on the sensor signal.
In some embodiments of the invention, irrigation and/or lavage of bodily tissues, cavities or spaces (or other patient interventions) may be optimized using a sensor or sensors to report electrical, chemical, acoustic, mechanical properties, pressure, temperature, pH or other parameters surrounding the access device in order to automate and optimize the irrigation/lavage.
Embodiments of the invention include a peritoneal catheter containing one or more sensors which may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, intraperitoneal pressure waveforms, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), pressure in veins (particularly the inferior vena cava or those that empty into the inferior vena cava, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), total circulating blood volume, blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO2 (or any other parameter that shows a measurable change with increased peritoneal pressure) to ensure safety of automated or manual peritoneal lavage. The invention also includes methods of performing peritoneal lavage using such devices.
Embodiments of the invention include an intravascular catheter containing one or more sensors which may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), partial pressure of oxygen or CO2, pH, temperature, blood pressure, central venous pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), total circulating blood volume, pressure in veins (particularly those that empty into the inferior vena cava, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO2 (or any other parameter that shows a measurable change with intravascular volume overload) to ensure safety of manual or automated intravascular infusion. The invention also includes methods of using such devices.
Other embodiments of the invention include control of the rate of infusion to minimize negative effects observed by the sensors. The invention may be used to induce and/or maintain hypothermia or hyperthermia; maximize hydration and/or intravascular volume in a patient receiving intravenous fluids (such as, e.g., post-operative patients, post-hemorrhage patients, septic patients or other intensive care patients).
Disclosed is a method and device for detection of intake and/or output in an individual. Fluid detection may be fully automated and the user may be alerted if volumes become too low or too high. The data may also be automatically routed to a centralized data collection server so that it may be collected and accessed without the requirement for nursing or other healthcare personnel to record the information manually. The output receptacle, in particular, may contain wireless technology, ie RFID, as well to optimize data collection and reduce nursing burden.
In reviewing the obstacles of urine output monitoring and data collection, then, it becomes clear that what is needed for widespread adoption is an easily implemented system capable of accurately measuring urine output wherein the use of the device reduces the nursing burden while reporting any issues with urine output in a timely manner. The present invention may also measure and report bladder temperature in real-time and this information may be used to alert the healthcare providers of changes in therapy and/or may be used to control and direct depth of therapeutic hypothermia. The reservoir/receptacle may also contain sensors capable of detecting other materials of interest within the fluid including, but not limited to: hemoglobin, blood, bacteria, leukocyte esterase, glucose, protein, particulate matter, etc. This information may also trigger an alert to provide real-time data monitoring of these parameters. Additionally, the present invention anticipates the use of wired or, ideally, wireless transmission of data to allow for centralized collection of data and centralized reporting. This is, once again, useful in reducing healthcare provider burden by allowing fewer personnel to monitor the data from all of the patients utilizing said system.
In addition, the system of the present invention anticipates the use of RFID technology within or attached to the reservoir itself which may be remotely queried and interrogated by one or more RFID readers. The data collected may be encrypted and specific to each receptacle such that the up.ne output reported may be securely associated with an individual patient. In its optimal embodiment, the reservoir may contain conducting channels connected to the RFID circuitry which determine the urine level by detection of the level of a simple short-circuit through the conducting fluid itself which may then be reported by the RFID chip to the reader. This cheap, easy-to-use system overcomes the obstacles of previous attempts to automate urine output monitoring.
In addition, information collected using the present invention may be used to automatically adjust therapeutic hypothermia, delivery of medicine or other interventions.
Disclosed is a method and device for safe access of a bodily tissues, spaces or cavities and automated therapy. The improved safety of the current invention is based, in part, on the ability of the access system to report entrance into the tissue/space/cavity via an integrated sensor. In its preferred embodiment, additional sensing capabilities may be incorporated, as well, to optimize the automated therapy delivered or intervention required.
In reviewing the obstacles of providing safe access to bodily cavities and spaces, it becomes clear that over- and under-insertion of invasive instrumentation is a major issue. During catheter placement in major vessels, for example, many of the complications that occur are due to over-insertion of the insertion needle or sliding of the catheter over the needle at a point when the needle is not appropriately positioned. The disclosed invention, then, is a method and device for safe access of a bodily tissues, spaces or cavities. The improved safety of the current invention is based, in part, on the ability of the access system to report entrance into the tissue, space, or cavity via a sensor integrated within, or inserted simultaneously with, the instrument itself. In its preferred embodiment, additional sensing capabilities may be incorporated, as well, to optimize the desired intervention or therapy to be delivered.
1) A device for accessing bodily tissues, spaces or cavities outside of the respiratory tree wherein; said access device or its insertion instrumentation incorporates a sensor and wherein said sensor may report access to the desired tissues, spaces or cavities.
2) The device of 1 wherein said sensor is capable of sensing optical, electrical, chemical, acoustic and/or mechanical properties to differentiate between tissues, spaces or cavities and indicate when said device is in the desired location.
3) The device of 1 wherein said access device may incorporate additional sensors in order to optimize therapy provided by said device.
4) The device of 2 wherein said access device sensor may report entrance into a cavity and wherein said additional sensor (or sensors) may report pressure, temperature, pH or other parameters in order to optimize therapy.
5) The device of 2 wherein said cavity to be accessed may be the peritoneal cavity, and wherein said sensor may directly or indirectly detect entry into this cavity.
6) The device of 4 wherein said additional sensors may directly or indirectly detect mechanical properties (such as pressure), chemical composition, thermal properties, electrical properties, acoustic properties or optical⋅properties to optimize filling of the peritoneal cavity with gases, liquids and/or solids.
7) The device of 2 wherein said cavity to be accessed may include peritoneal, pleural, cerebrospinal, biliary, gastrointestinal, gastric, intestinal, urinary cavities, or pathologic tissues, and wherein said sensor may directly or indirectly detect entry into this cavity.
8) The device of 2 wherein said space to be accessed may include the cardiovascular, venous, arterial, lymphatic, ureteral cerebrospinal ventricular spaces, or pathologic spaces and wherein said sensor may directly or indirectly detect entry into this space.
9) The device of 2 wherein said tissues to be accessed may include lung, liver, heart, bladder, brain, intestinal, pancreatic, splenic, vascular tissues, or pathologic spaces and wherein said sensor may directly or indirectly detect entry into these tissues.
10) The device of 1 wherein said sensor is incorporated into the device itself.
11) The device of 1 wherein said sensor is incorporated into the instrumentation required to insert said access device.
12) The device of 1 wherein said sensor may be introduced along with said access device and may be reversibly attached or contained within said device.
13) The device of 1 wherein said sensor may be physically connected to an external display.
14) The device of 1 wherein said sensor may be wirelessly connected to an external display.
15) The device of 13 wherein said display may be incorporated into said access device.
16) The device of 13 wherein said display may be reversibly or irreversibly attached to an external display.
17) The device of 14 wherein said display may be incorporated into said access device
18) The device of 1 wherein said sensor may be intermittently activated to detect the tissues surrounding the sensor.
19) The device of 18 wherein said sensor may be repeatedly activated to detect the tissues surrounding the sensor.
20) The device of 1 wherein said sensor continuously detects which tissues surround the sensor.
21) The device of 2 wherein said sensor detects optical transfer of wavelengths from a transmitter to a, receiver and wherein the wavelength conduction path includes the sensor incorporated within said device.
22) The device of 2 wherein said sensor detects electrical properties surrounding said sensor to detect unique electrical signatures of the surrounding tissues.
23) The device of 2 wherein said sensor detects chemical properties (ie albumin, pH, etc.) surrounding said sensor to detect unique chemical components, or concentrations of components, within the tissues/spaces.
24) The device of 2 wherein said sensor detects acoustic properties of the surrounding tissues/spaces to detect entrance into the desired tissue/space.
25) The device of 2 wherein said sensor detects mechanical properties (such as pressure, shear forces, etc.) surrounding said sensor to detect entrance into desired tissue/space.
26) The device of 2 wherein multiple sensors of any type are used to indicate exact positioning and the composition of the fluid surrounding said device.
27) The device of 26 wherein one or more sensors positively predict tissue/space access while one or more sensors negatively predict tissue/space access.
28) The device of 26 wherein one or more sensors positively predict tissue/space access while one or more sensors detect potential complicating factors, ie the presence of unexpected blood, etc.
29) The device of 3 wherein irrigation and/or lavage of bodily tissues, cavities or spaces is optimized by said additional sensors and wherein said access device contains a sensor to detect pressure, temperature, or other parameters to optimize the irrigation/lavage.
30) A method for accessing bodily tissues, spaces or cavities wherein; an access device or its insertion instrumentation incorporates a sensor and wherein said sensor may report access to the desired tissues, spaces or cavities.
31) The method of 30 wherein said sensor is capable of sensing optical, electrical, chemical, acoustic and/or mechanical properties to differentiate between tissues, spaces or cavities and indicate when said device is in the desired location.
32) The method of 30 wherein said access device may incorporate additional sensors in order to optimize therapy provided by said device.
33) The method of 31 wherein said access device sensor may report entrance into a cavity and wherein said additional sensor (or sensors) may report electrical, chemical, acoustic, mechanical properties, pressure, temperature, pH or other parameters in order to optimize therapy.
34) The method of 31 wherein said cavity to be accessed may be the peritoneal cavity, and wherein said sensor may directly or indirectly detect entry into this cavity
35) The method of 33 wherein said additional sensors may directly or indirectly detect mechanical properties (such as pressure), chemical composition, electrical properties, acoustic properties or optical properties to optimize filling of the peritoneal cavity with gases, liquids and/or solids.
36) The method of 31 wherein said cavity to be accessed may include peritoneal, pleural, cerebrospinal, biliary, gastrointestinal, gastric, intestinal, urinary cavities, or pathologic spaces and wherein said sensor may directly or indirectly detect entry into one or more of these cavities.
37) The method of 31 wherein said space to be accessed may include the cardiovascular, venous, arterial, lymphatic, ureteral cerebrospinal ventricular spaces, or pathologic spaces and wherein said sensor may directly or indirectly detect entry into one or more of these spaces.
38) The method of 31 wherein said tissues to be accessed may include lung, liver, heart, bladder, brain, intestinal, pancreatic, splenic, vascular tissues, or pathologic spaces and wherein said sensor may directly or indirectly detect entry into one or more of these tissues.
39) The method of 30 wherein said sensor is incorporated into the device itself.
40) The method of 30 wherein said sensor is incorporated into the instrumentation required to insert said access device.
41) The method of 30 wherein said sensor may be introduced along with said access device and may be reversibly attached or contained within said device.
42) The method of 30 wherein said sensor may be physically connected to an external display.
43) The method of 30 wherein said sensor may be wirelessly an external display.
44) The method of 42 wherein said display may be incorporated into said access device.
45) The method of 42 wherein said display may be reversibly or irreversibly attached to an external display.
46) The method of 43 wherein said display may be incorporated into said access device.
47) The method of 30 wherein said sensor may be intermittently activated to detect the tissues surrounding the sensor.
48) The method of 47 wherein said sensor may be repeatedly activated to detect the tissues surrounding the sensor.
49) The method of 30 wherein said sensor continuously detects which tissues surround the sensor.
50) The method of 31 wherein said sensor may detect optical transfer of wavelengths from a transmitter to a receiver and wherein the location of said device may be determined based on absorption or transmission of said wavelengths.
51) The method of 31 wherein said sensor detects electrical properties surrounding said sensor to detect and report unique electrical signatures of the surrounding tissues and allow for avoidance of undesirable tissues/spaces including conductance, impedance, resistance, capacitance, etc.
52) The method of 31 wherein said sensor detects chemical properties (ie albumin, pH, etc.) surrounding said sensor to detect unique chemical components, or concentrations of components, within the tissues/spaces and avoidance of undesirable tissues/spaces.
53) The method of 31 wherein said sensor detects acoustic properties of the surrounding tissues/spaces to detect entrance into the desired tissue/space and/or avoidance of undesirable tissues/spaces.
54) The method of 31 wherein said sensor detects mechanical properties (such as pressure, shear forces, etc.) surrounding said sensor to detect entrance into desired tissue/space and/or avoidance of undesirable tissues/spaces.
55) The method of 31 wherein said sensor detects thermal properties of the surrounding tissues/spaces to detect entrance into the desired tissue/space and/or avoidance of undesirable tissues/spaces.
55) The method of 31 wherein multiple sensors of any type may be used to indicate exact positioning and the composition of the fluid surrounding said device.
56) The method of 55 wherein one or more sensors may be used to positively predict tissue/space access while one or more sensors negatively predict tissue/space access.
57) The method of 55 wherein one or more sensors may be used to positively predict tissue/space access while one or more sensors detect potential complicating factors, ie the presence of unexpected blood, etc.
58) The method of 55 Wherein one or more sensors may be used to provide multiple data points to help determine the exact position of said sensor or sensors.
59) The method of 32 wherein irrigation and/or lavage of bodily tissues, cavities or spaces may be optimized by said additional sensors and wherein said access device contains a sensor or sensors to report electrical, chemical, acoustic, mechanical properties, pressure, temperature, pH or other parameters surrounding the access device in order to optimize said irrigation/lavage.
59) The method of 32 wherein an intervention performed in said tissues, cavities or spaces may be optimized by said additional sensors and wherein said access device contains a sensor or sensors to report electrical, chemical, acoustic, mechanical properties, pressure, temperature, pH or other parameters surrounding the access device in order to optimize said intervention.
60) A peritoneal catheter containing one or more sensors which may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (i.e. in superior mesenteric, celiac, renal or either arteries), pressure in veins (particularly those that empty into the IVC, i.e. femoral vein), pressure in arteries (particularly those distal to the aorta, i.e. the femoral artery), blood oxygenation (i.e. in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO2 (or any other parameter that shows a measurable change with increased peritoneal pressure) to ensure safety of automated or manual peritoneal lavage.
61) A method of performing peritoneal lavage wherein changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (i.e. in superior mesenteric, celiac, renal or other arteries), pressure in veins (particularly those that empty into the IVC, i.e. femoral vein), pressure in arteries (particularly those distal to the aorta, i.e. the femoral artery), blood oxygenation (i.e. in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO2 (or any other parameter that shows a measurable change with increased peritoneal pressure) are monitored and may be utilized to ensure safety of automated or manual peritoneal lavage.
62) An intravascular catheter containing one or more sensors which may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), partial pressure of oxygen or CO2, pH, temperature, blood pressure, central venous pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (i.e. in superior mesenteric, celiac, renal or other arteries), total circulating blood volume, pressure in veins (particularly those that empty into the IVC, i.e. femoral vein), pressure in arteries (particularly those distal to the aorta, i.e. the femoral artery), blood oxygenation (i.e. in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO2 (or any other parameter that shows a measurable change with intravascular volume overload) to ensure safety of manual or automated intravascular infusion.
63) A method of performing intravascular infusion wherein one or more sensors may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), partial pressure of oxygen or CO2, pH, temperature, blood pressure, central venous pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (i.e. in superior mesenteric, celiac, renal or other arteries), total circulating blood volume, pressure in veins (particularly those that empty into the IVC, i.e. femoral vein), pressure in arteries (particularly those distal to the aorta, i.e. the femoral artery), blood oxygenation (i.e. in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO2 (or arty other parameter that shows a measurable change with intravascular volume overload) which may be used to regulate the rate of infusion.
64) The method of 63 wherein said rate of infusion may be maximized in the absence of negative effects to the monitored parameters.
65) The method of 63 wherein said rate of infusion may be reduced or halted in the presence of negative effects to the monitored parameters.
66) The method of 63 wherein said intravascular infusion may be utilized to induce and/or maintain hypothermia or hyperthermia.
67) The method of 63 wherein said intravascular infusion may be utilized to optimize hydration and/or intravascular volume in any patient receiving intravenous fluids.
68) The method of 63 wherein said intravascular infusion may be utilized to optimize hydration and/or intravascular volume in post-operative patients.
69) The method of 63 wherein said intravascular infusion may be utilized to optimize hydration and/or intravascular volume in septic or other intensive care patients.
70) The method of 63 wherein said intravascular infusion may be utilized to optimize hydration and/or intravascular volume with additional inputs which may include sensor-based urine output detection.
71) The method of 70 wherein said monitored parameters and urine output information may be used, according to a hydration algorithm, to report issues with intake or output and automatically correct these issues via automated changes to the rate of infusion and/or addition of diuretics.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
In one embodiment, the infusion catheter also is used to detect the parameters used to optimize therapy.
As shown in
The sensor or sensors, whether cables/catheters or percutaneous monitoring technologies, and whether wired or wireless, may also be separate from the infusion line so long as the information from this sensor or sensors is transferred to the control unit in order to optimize fluid flow. Thus, as shown in
One example of such a device is a peripheral venous, central venous or arterial catheter that is capable of maintaining hydration without causing fluid overload. The catheter may incorporate a sensor that may detect central venous pressure, total circulating blood volume, peripheral venous pressure, cardiac output or osmolarity, and/or solute concentrations (e.g., chloride, sodium, etc.) in order to prevent fluid overload. The sensor may also be external to the catheter, so long as the output of said sensor is capable of controlling fluid flow through the catheter. In this embodiment, fluid flow is controlled by the output of the sensor, which is integrated by a fluid flow control unit which alters the rate of fluid flow based on this output. This embodiment may allow the user to bolus large volumes of fluids or solids into the vascular space in order to rehydrate, induce hypothermia or reverse hypothermia, or deliver a therapeutic agent or maintain blood pressure in sepsis.
In addition, this technology may provide a fully automated mechanism to optimize fluid flow into the vessel without fluid overloading the patient. Without this automated fluid delivery coupled to hemodynamic parameter monitoring, the patient is in danger of dehydration or fluid overload from infusion of fluid into any body cavity. This technology may also be applied to liquid or solid infusion into any body cavity or space in so long as the fluid flow is automated based on feedback from sensors within the body (possibly incorporated into the catheter itself) in order to optimize the volume of infusion.
This device and method of automating fluid flow based on hemodynamic sensor-based feedback may also be used to generate intravenous hypothermia. In its current state, IV hypothermia induction is limited due to concerns of fluid overload. If the hemodynamic parameters of the patient can be measured and fluid flow directly or indirectly controlled based on the output of these measurements, the volume of fluid can be maximized while ensuring hemodynamic instability. In this embodiment, the sensor may be incorporated within the catheter, and fluid flow into the vasculature may be tailored based on central venous pressure, total circulating blood volume, peripheral venous pressure, cardiac output or osmolarity, and/or solute concentrations (e.g., chloride, sodium, etc.) in order to prevent fluid overload.
In one embodiment, the fluid infusion catheter also may function as a thermodilution cardiac output sensor such that the same fluid that is used to generate hypothermia may also be used to detect cardiac output. This information may then be relayed, either directly or indirectly, back to the fluid infusion controller to increase, decrease or even halt fluid flow based on these parameters. For example, if cardiac output is low and venous pressure or total circulating volume is low, the patient has a low circulating volume and large volumes of fluid may be safely delivered. If the cardiac output is normal, fluid may also be safely delivered, but the cardiac output must be monitored to ensure that it does not begin to decrease (an indication of fluid overload). Blood flow, as detected by, for instance, thermodilution may be determined in a peripheral vessel as well. These data, while relatively useless on their own in a clinical setting due to variability in peripheral blood flow, may provide a baseline flow profile which may be rechecked over time in order to compare flow within that individual vessel to the baseline flow. Relatively improved flow may be correlated to improved cardiac output, while a relative reduction in flow may be correlated to fluid overload.
This same system may be used to infuse normal fluids or hypothermic fluids to sepsis patients or patients requiring intensive maintenance of their hemodynamic status. Sepsis patients that are aggressively monitored do much better than those that are not. Aggressive monitoring is very nurse-intensive, however. A system that provides automated optimal fluid infusion based on sensed parameters to ensure that fluid overload does not occur and that fluid infusion is not insufficient would be an improvement over current methods of treating sepsis patients. The devices and methods for automated sensor-based input to control fluid flow to a patient may be applicable to a wide range of conditions and should not be limited to the narrow scope of the conditions requiring fluid infusion described here.
The logic controller of the present invention may provide improved safety by monitoring for any of the deleterious changes expected with excess fluid flow, e.g., into the peritoneal cavity or vascular space. Examples of monitored parameters that may signal a warning or automatically result in an adjustment to rate of fluid infusion/extraction and/or fluid temperature include: electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, intraperitoneal pressure waveforms, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, total circulating blood volume, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), pressure in veins (particularly those that empty into the IVC, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and arterial pO2 and any other parameter that shows a measurable change once the peritoneal or vascular spaces have been overloaded.
These parameters in particular have been found to change with increases in peritoneal pressure, with significantly negative impact on each parameter found at 40 mmHg. Thus, monitoring for these changes in conjunction with a peritoneal infusion catheter of the present invention will allow for even greater safety with peritoneal infusion. These parameters may be measured a variety of ways and the data transmitted either wirelessly or via wires to the logic controller in order to alert the healthcare provider or to automatically adjust the fluid flow/temperature in order to optimize both the flow of the peritoneal fluid and patient safety.
In another embodiment, a urinary catheter capable of sensing physiologic parameters is envisioned. Additional sensing capabilities may include: blood pressure, oxygen saturation, pulse oximetry, heart rate, EKG, capillary fill pressure, etc. In particular, the incorporation of pulse oximetry technology to allow for blood oxygen concentration or saturation determination with a urinary catheter is envisioned. This device may function by incorporating pulse oximetry capabilities anywhere along the length of the catheter, but ideally the sensor or sensors will be contained within the tubing of the device to ensure approximation to the urethral mucosa. With this invention, the healthcare provider will be able to decompress the bladder with a urinary catheter and obtain pulse oximetry data in a repeatable and accurate manner. The power source for this device may be incorporated within the urinary drainage bag or within the catheter itself. Ideally, the pulse oximeter will be reusable and the catheter interface will be disposable wherein the pulse oximeter is simply reversibly attached to the disposable catheter and removed once measurements of oxygen are no longer desired. The urinary catheter, then, may contain an optically transparent, or sufficiently transparent, channel for the oximetry signal, ie a fiber-optic cable, transparent window, etc., and an interface for the reusable oximeter and otherwise be a standard urinary catheter. This method and device for urethral pulse oximetry may be used in conjunction with any of the other embodiments detailed herein or may be a stand-alone device in and of itself.
In its preferred embodiment, the novel access system involves the use of a puncturing instrument in conjunction with a sensor at, or near, the tip of the instrument. This sensor may be capable of detecting changes within its environment in order to report that it has passed from the subcutaneous tissues into the desired cavity, space or tissue. For example, a novel peritoneal access catheter is envisioned which is capable of detecting differences between the vascular, extraperitoneal, intestinal and intraperitoneal spaces. This sensor may detect 1) changes in the physical properties surrounding the instrument such as pressure, acceleration, forces or other physical properties, 2) chemical changes surrounding the instrument, ie the presence or absence of compounds such as albumin, hemoglobin, glucose or the pH or other chemical properties, or 3) changes in the electrical properties such as conductance, resistance, impedance, capacitance, etc. of the tissues 4) changes in the acoustic or vibratory properties of the tissues, 5) changes in optical properties such as refraction of light within the tissue, or 6) changes in any other parameter that is able to be sensed via a sensor placed on, in, within or otherwise attached to or in communication with said instrument.
In any of the embodiments, as well, the sensing element of said device may be incorporated in instrument itself, may be introduced along with the instrument or may be external to the instrument and communicate through a channel in said instrument. In the ideal embodiment, the sensor is incorporated into either in the instrument or its introducer and is able to provide immediate, definitive feedback that the correct body cavity has been accessed. For example, the electrical properties of blood are different from that of air, the epidermis, the subcutaneous space, the fascia and the adventia of the vessel. Thus, in accessing the femoral artery, for instance, one can slowly insert the arterial access device (ie a catheter with a sharp insertion trocar/needle) which incorporates a sensor in the catheter or insertion trocar/needle (in this case electrical) which will immediately report a change in the sensed parameter (in this case inductance, resistance, capacitance, etc.) indicating that the vessel has been entered. This same reading can then them be monitored continuously as the instrument is manipulated (ie the catheter is slid over the trocar/needle into the vessel) to ensure that the instrument does not migrate during manipulation and remains within the desired space.
Another embodiment comprises the use of heat differentials to guide a catheter/needle to the appropriate space/tissue. For example, by placing a cold pack on the skin over the femoral artery, a temperature differential will exist with the warmest location being in the intravascular space. A temperature sensing catheter can be guided to the warmest location which would be inside the vessel.
This sensing technique may be employed with virtually any invasive instrument to ensure correct placement via detection of changes in any of the aforementioned parameters (i.e. physical, chemical, thermal, electrical, acoustic/vibratory, optical or other parameter capable of being sensed) with the only requirement being that the target tissue or space within the body must have a sufficiently distinct sensor reading that it may be distinguished from its surrounding tissues. These invasive instruments may include, but are not limited to instruments, catheters or devices intended to access the following spaces/tissue: peritoneal cavity or fluid (ie paracentesis or peritoneal lavage), vascular fluid or space (arterial catheter, intravenous catheter, etc.), cerebrospinal fluid or space, pleural or pulmonary fluid or space (ie chest tubes), pericardial or cardiac space or tissue, urologic fluid or space (ie suprapubic catheters), gynecologic access (ie fallopian tubes or ovaries), gastrointestinal fluid or space (ie nasogastrostomy or gastrostomy tubes), ocular or bulbar tissues or spaces, neurological tissue or space (ie brain biopsy instruments), pathological tissue or space (ie abscess, hematoma, cyst, pseudocyst), bone marrow tissue or space, or any other tissues or spaces that may be accessed minimally invasively, percutaneously or through a natural orifice.
The sensing element may be disposable or reusable. The sensing element may be incorporated reversibly or irreversibly into the instrument itself, into the instrument's sheath, into the instrument's trocar, or kept external to said instrument with movement of gases, fluids or solids down the length of the instrument to the externally located sensor continuously or upon activation. Said sensor may also communicate wirelessly from the instrument to an external receiver removing the requirement for a tethering cord and allowing for a disposable and reusable component. The controller/reader may alert the user that access has been obtained through tactile, auditory, visual or any other _stimuli. The sensing may occur continuously or only upon command by the user (ie once they suspect that they are in the tissue or cavity).
One example of this embodiment is a peritoneal access catheter with an electrical inductance sensor at its tip. The subcutaneous space has a different inductance compared to the peritoneal space which also has a different inductance than the intestinal lumen. In accessing the peritoneal cavity, then, the catheter may be advanced until the subcutaneous tissue inductance readings change to the peritoneal cavity inductance levels. Once the peritoneal cavity is sensed, based on the change in electrical properties, the catheter then provides feedback that the cavity has been accessed. In the event that the catheter is over-inserted into the bowel, the inductance will be dramatically lower than that found in the subcutaneous tissue or peritoneal space and this complication can be rapidly reported. In addition, iron-rich blood has a higher inductance than any of the other tissues and exposure to concentrated blood can be quickly reported if the catheter experiences this fluid. The cutoff may be set, as well, so that dilute blood does not trigger the sensor since minor capillaries may be ruptured in the normal access procedure. This same technique may be used, in reverse, to purposefully access the vascular space. In fact, most tissues have characteristic electrical properties and virtually any tissue, cavity or space may be accessed through monitoring for this signal during instrument insertion. This is just one embodiment and the access device may be used to access any body tissue, space, or cavity and may do so with feedback from any of the sensors detailed above or any other sensing technology.
While this description has focused largely on the method and device for peritoneal insertion, this same procedure and method may be used to access any body cavity, tissue or space reliably and consistently with confidence. In using this technology, clinician's may be confident that their instrument resides in its desired space without the requirement for complex instrumentation or costly imaging techniques. For example, in its preferred embodiment this method and device may be used in conjunction with any access device that currently requires imaging to confirm placement, but without the need for ionizing radiation. Examples of such devices include nasogastric tubes, central venous lines, chest tubes, feeding tubes, etc.
Communications between the sensor and display or instrument control unit may also be done wirelessly, ie via RFID or Bluetooth. In the instance where the catheter is a dual lumen catheter, one lumen may be used for fluid delivery while the other may be used for fluid return and a temperature and/or pressure sensor may be incorporated along its length, ideally closer to the fluid return tubing than the fluid delivery tubing.
Furthermore, the logic controller of the present invention may provide improved safety by monitoring for any of the deleterious changes expected with excess fluid flow i.e. into the peritoneal cavity or vascular space. Examples of monitored parameters that may signal a warning or automatically result in an adjustment to rate of fluid infusion/extraction and/or fluid temperature include: electrocardiograph monitoring, electro-encephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (i.e. in superior mesenteric, celiac, renal or other arteries), pressure in veins (particularly those that empty into the IVC, i.e. femoral vein), pressure in arteries (particularly those distal to the aorta, i.e. the femoral artery), blood oxygenation (i.e. in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and arterial pO2 and any other parameter that shows a measurable change once the peritoneal or vascular spaces have been overloaded. These parameters, in particular, have been found to change with increases in peritoneal pressure with significantly negative impact on each parameter found at 40 mmHg, thus monitoring for these changes in conjunction with the peritoneal infusion catheter of the present invention will allow for even greater safety with peritoneal infusion. These parameters may be measured a variety of ways and the data transmitted either wirelessly or via wires to the logic controller in order to alert the healthcare provider or to automatically adjust the fluid flow/temperature in order to optimize both the flow of the peritoneal fluid and patient safety.
While most of these embodiments have been written focusing on certain embodiments, i.e. a catheter technology, the invention may be used with any instrument that demands precise access to tissues, body cavities or spaces and/or requires automated, sensor-based intervention or therapy.
This application is continuation of U.S. application Ser. No. 15/013,813, filed Feb. 2, 2016, which is a continuation of U.S. application Ser. No. 13/937,102, filed Jul. 8, 2013; which application is a continuation of U.S. application Ser. No. 13/354,210, filed Jan. 19, 2012, now U.S. Pat. No. 8,480,648; which application is a continuation of U.S. application Ser. No. 12/098,365, filed Apr. 4, 2008, now U.S. Pat. No. 8,100,880; which application claims the benefit of U.S. Provisional Patent Application No. 60/921,974, filed Apr. 5, 2007 to Burnett, entitled “Safety Access Device, Fluid Output Monitor & Peritoneal Organ Preservation”, all disclosures of which are incorporated by reference herein in their entirety.
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