Abstract:
A method for draining autologeous biological fluid includes positioning a catheter to receive the autologeous biological fluid from a selected site in a mammalian body with the end of the catheter adapted to receive such fluid. An output end of the catheter is positioned into the intraosseus space. The fluid is transmitted through the catheter to intraosseus space thereby draining the selected site from the autologous biological fluid.

Description:
CROSS REFERENCE TO RELATED APPLICATION(S) 
       [0001]    The present application is a continuation-in-part of and claims priority of U.S. patent application Ser. No. 12/868,329, filed Aug. 25, 2010, now abandoned, which is a continuation-in-part of application Ser. No. 12/775,111, filed May 6, 2010, which is a continuation-in-part of application Ser. No. 11/656,341, filed Jan. 22, 2007, now U.S. Pat. No. 7,753,903, granted Jul. 13, 2010 which claims priority from Provisional Application No. 60/764,854, filed on Feb. 2, 2006, which is hereby incorporated by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to draining autologous biological fluids into the intraosseus space, and it also relates to apparatuses for monitoring biological fluids in the intraosseus space and in some instances for delivery of drugs or other substances into the intraosseal bone marrow. 
       BACKGROUND OF THE INVENTION 
       [0003]    Currently, there are a large number of methods and devices designed to detect blood glucose levels and particularly hypoglycemia in human beings with diabetes mellitus. The traditional method for monitoring glucose levels is by “finger sticking” and measuring the glucose level from the blood expressed. Avoiding the pain and discomfort of “finger sticking” has promoted the development of the non-invasive techniques such as measuring glucose concentration using the absorption of light in the infrared spectrum. Another approach has been subcutaneous fluid testing using either a disposable subcutaneous glucose monitor or the relatively permanent implantation of glucose sensors. Additionally, a noninvasive method has been developed in which impedance spectroscopy or similar methods are used to measure glucose concentrations. These various methods and devices have suffered in the reliability of the test results and the survivability of the devices. The most accurate present means of repeatedly and accurately monitoring blood substances is by an indwelling intravascular catheter. The problem with these is that their useful time is limited by tissue breakdown and infection. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention relates to the development of a stable and reliable implanted device designed to utilize the intra-osseal bone barrow for the delivery of autologous biological fluids from a selected site within the body to transfer the autologous biological fluid to the intraosseus space. Specifically, this includes a method for draining autologeous biological fluid includes positioning a catheter to receive the autologeous biological fluid from a selected site in a mammalian body with the end of the catheter adapted to receive such fluid. An output end of the catheter is positioned into the intraosseus space. The fluid is transmitted through the catheter to intraosseus space thereby draining the selected site from the autologeous biological fluid. 
         [0005]    This invention also relates to chronic and long-term testing for, and delivery of substances into this body compartment within a mammal, particularly in a human being, to monitor biological substances in the blood stream, particularly the level of glucose, and the delivery of drugs, particularly insulin into the compartment as well as the integration of the foregoing, and related and ancillary matters and the methods respecting the foregoing. 
         [0006]    In a further aspect, the present invention includes an apparatus for monitoring and controlling biological substance concentrations in a bloodstream. The apparatus includes a monitoring device comprising a pedestal and a sensor for implantation into a human body. The sensor is mounted within the pedestal when implanted into a patient and the sensor extends through the bone into bone marrow and is capable of detecting the concentration of a biological substance and transmitting signals that correlate to the concentration of the biological substance in the blood stream. The apparatus also includes a receiver in communication with the sensor wherein the sensor relates information relating to the biological substance concentration in the bloodstream to the receiver and a drug delivery device for implantation into a human body and having a drug delivery end for positioning through the bone and into bone marrow wherein the drug delivery device is in communication with the receiver and delivers a selected dose of a drug into the bone marrow based upon the information received by the receiver from the sensor regarding the biological substance concentration in the bloodstream. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  is a schematic representation of the implanted monitoring device. 
           [0008]      FIG. 2  is a schematic representation of the implanted drug delivery device. 
           [0009]      FIG. 3  is a schematic view of the implanted drug delivery device and the drug monitoring device implanted within the body. 
           [0010]      FIG. 4  is a view of the human body illustrating insertion points for the drug delivery device and the monitoring device. 
           [0011]      FIG. 5  is a view of the interrogation device placed over the implanted monitoring device. 
           [0012]      FIG. 6  is a schematic representation of the pelvic bone region of a human body indicating insertion points for the implanted drug monitoring device and the implanted drug delivery device. 
           [0013]      FIG. 7  is a perspective view of a pedestal. 
           [0014]      FIG. 8  is a sectional view of an implanted pedestal with both a monitoring and a transmission device. 
       
    
    
     DETAILED DESCRIPTION 
       [0015]    The present invention includes an apparatus for the chronic, long-term monitoring and controlling biological substance concentrations in the bloodstream of a patient. The apparatus includes an implantable monitoring device for monitoring the concentration of the biological substance. The monitoring device can utilize the relationship between the bone marrow and the intravascular system with respect to levels of similar substances in the blood stream by implanting a monitoring device having a pedestal and a sensing device into the bone, particularly the iliac crest. Alternatively, the monitoring device may also be placed in other areas with sufficient mass of intra-osseal bone marrow material. An external interrogation device can be used to communicate with the monitoring device. 
         [0016]    The present invention also utilizes the reliable relationship between bone marrow and the intravascular system to provide drug delivery into the intra-osseal bone marrow compartment by implanting a drug delivery device into the surrounding bone, particularly the iliac crest, but alternatively in other areas with sufficient mass of bone marrow material and in a manner as to not inhibit the contemporaneous monitoring of levels of substances, particularly glucose or cerebrospinal fluid, in the blood stream. 
         [0017]    The present invention includes devices and communication methods that can integrate the monitoring apparatus and the drug delivery apparatus with wired or wireless connections. Methods to monitor the biological substances and deliver the appropriate drugs to control the concentration of the biological substance are also included in the present invention. In particular, methods to monitor the glucose concentration in a patient and delivering the appropriate amounts of insulin in response to the glucose concentration are described herein. 
         [0018]      FIG. 1  is a schematic representation of the implanted monitoring device  1 . In one application, the dermis  8  is populated with conductive material and electrical contact is direct. In another application the electrical contact is indirect (i.e., by radio frequency  4 ). A sensor  2  acts as a transmitter and receiver. It is either powered with a battery encased in a substance such as titanium or is powered externally be electrical emanations from the external interrogation device  5 , which is also the transmitter and receiver  6  of the data generated by the implanted monitoring device  1 . The internally placed sensor unit  2  includes a substance sensor end  2   a  and is implanted in the osseous exterior of the ilium  9  or a site of similar mass with access to a robust supply of blood marrow  10 . Monitoring device  1  includes pedestal  3 . Pedestal  3  is screwed into the ilium prior to insertion of sensor unit  2 . The sensor unit  2  is then screwed into the ilium within threaded pedestal  3 . In preferred embodiments, the monitoring device  1  is placed in the posterior iliac crest. The sensor  2  has a geodesic shape to permit interrogation from various angles. The substance sensor end  2   a  may function by detecting electronic, chemical, or photometric signals. The interrogation phase may be by transmission of radio frequency, infra red light, or other forms of energy transmission  4 . A communication link  7  is attached to the interrogation device  5 . Communication link  7  may connect to a variety of components including, for example, a implanted power supply, another interrogation device, another transmitter and/or receiver, a drug delivery device. 
         [0019]      FIG. 2  is a schematic representation of the implanted drug delivery device  11 . While the drug delivery device  11  is envisioned to be placed into the ilium  9  or similar osseous site of similar mass and access to a robust supply of blood marrow  10 , the drug supply pod could be located remotely. Alternatively, the drug delivery pod may be within the drug delivery device  11 . 
         [0020]    Drug delivery device  11  includes sensor  16  having perforated end  13  and pedestal  3 . Pedestal  3  is screwed into the ilium prior to sensor  16 . Sensor  16  is then inserted into the ilium within threaded pedestal  3 . Sensor  16  can be a receiver and/or a transmitter. The delivery of the drug could be occasioned by signals sent from the same external device  5  that interrogates monitor  1 . A hypodermic needle  12  may optionally be utilized to deliver the drug to the bone marrow through delivery device  11  containing a perforated end  13 . The drug is injected into device  11  with a hypodermic needle  12  that is forced through sensor  16  and perforated end  13  to deliver the drug to the bone marrow. An electrical cable  15  is attached to sensor  16 . Cable  15  may indicate to interrogation device  5  that the drug has been delivered. Alternatively, sensor  16  may indicate to interrogation device  5  that the drug has been delivered through a wireless connection. 
         [0021]      FIG. 3  is the preferred embodiment of the integration of the implanted monitoring device  1  and the implanted drug delivery device  11 . Here the implanted monitoring device  1  and the implanted drug delivery device  11  are placed on each ilium  9  and communication between the monitoring device and the drug delivery device is through a wired connection  15 . Alternatively, the monitoring device and the drug delivery device may communicate through a wireless connection. 
         [0022]      FIG. 4  indicates the preferred location of implantation of monitoring device  1  and drug delivery device  11  on the posterior crest of the ilium. Alternative locations may be appropriate. Additionally, the implanted monitor  1  and drug delivery device  11  could be integrated into a single apparatus or could remain separate but share a proximate location, provided the data generated by the monitor  1  does not become corrupted by the inflow of the substance, such as insulin, delivered by the drug delivery device  11 . 
         [0023]      FIG. 5  indicates the position of the interrogation device  5  placed over the implanted monitor  1  or drug delivery device  11 . 
         [0024]      FIG. 6  indicates the pelvic bone region of a human body and insertion points, in one exemplary embodiment, for drug monitoring device  1  and drug delivery device  11 . 
         [0025]    The monitoring devices and the drug delivery devices of the present invention can be placed in a variety of locations. Preferably, these devices are placed in the iliac crest, and more preferably in the posterior iliac crest of a patient. These devices may be placed surgically. However, alternative methods of placing the devices within the patient are also within the scope of this invention. The placement can be performed under supplemented local anesthesia or general anesthesia with the aid of image intensification, image guidance systems and monitors. Preferably, the devices may be placed using minimally invasive procedures using local anesthesia. Additional drugs may be administered to enable or aid in the placement of the devices and/or to comfort the patient. For example, image intensification combined with guidance systems can be used to accurately direct the placement of the devices in the patient. 
         [0026]    In one exemplary embodiment, a pedestal screw is first screwed into the pelvic ilium through a small drill hole under bi-plane image intensification control. Three dimensional guidance systems may also be used in addition to bi-plane fluoroscopy. Monitoring may be performed, for example, using fluorescence based monitoring systems. The sensor units can then be inserted through the pedestal. In another exemplary embodiment, the drug monitoring device may be placed in the posterior iliac crest and the drug delivery device may be placed in the contra-lateral posterior iliac crest of the patient. Alternatively, the monitoring device and the drug delivery device may be placed on the same posterior iliac crest. The drug monitoring device and the delivery device may be integrated into a single device. 
         [0027]    Communication between the components in the present invention can be using wired or wireless systems. There are a variety of wireless communication systems known such as radio frequency systems and the use of any wireless communication is within the scope of the invention. The monitoring device and the drug delivery device can communicate using wired connections or wireless connections. Communication from the monitoring device to the interrogation device may be wireless as illustrated in  FIG. 1 . Alternatively, the monitoring device may include a wired connection or a wireless connection that can communicate with the interrogation device or the drug delivery device. For example, the drug delivery device may communicate with the sensor in the monitoring device to indicate the amount of drug that has been delivered. The interrogation device may communicate over a wired or wireless connection with the drug delivery device to indicate that the delivery of the drug should either commence or cease. The implanted devices can be, for example, coordinated and/or optimized by wireless connection to a laptop computer. 
         [0028]    The sensors used in the monitoring devices can be based on a variety of methods that are amenable to long-term stability within the marrow of a patient. The methods may employ or detect electronic, chemical or photometric signals. In a preferred embodiment, the sensors are solid state implantable electronic biosensors. These sensors have long-term stability when inserted within the bone marrow of a patient. 
         [0029]    The monitoring devices and drug delivery devices described herein can be used to monitor a variety of biological substances and administer a variety of drugs. The drugs administered can be, for example, biological substances normally found in patients. By biological substances is meant substances such as insulin antibiotics, chemotherapeutic agents, analgesics, cerebrospinal fluid (CSF), lymph fluid and the like. An example of one type of pedestal that may be used is illustrated generally at  50  in  FIG. 7 . The exemplary pedestal  50  is made of titanium or other suitable metal and is cylindrical in shape having threads  52  around its cylindrical exterior  54 . A hole is drilled in the ilium and the pedestal  50  is then screwed into the hole. Typically, the hole is drilled at the crest of the ilium. 
         [0030]    The pedestal contains a cavity extending its entire length. A monitor  58  for monitoring a biological substance, such as insulin, lymph fluid or cerebrospinal fluid (CSF) is secured to a distal end portion  60  as best illustrated in  FIG. 8 . A communication device  62  is also positioned within the pedestal  50  at a proximal end portion  64 . The communication device  64  is used to transfer data collected by the monitor  58  transmitting such data to a receiver, exterior of the patient. 
         [0031]    In the case of monitoring glucose, an insulin delivery device is implanted in the other iliac crest. The delivery of insulin can be coordinated with the monitoring of glucose. 
         [0032]    The apparatus described herein may also be used to perform a variety of blood work including blood chemistry, blood counts and blood screening for abnormal blood cells such as cancer, sickle cell anemia and the like. In some embodiments, the biological substance monitored is the same as the substance that is administered to control the concentration of the biological substance. In other embodiments, the biological substance monitored can be different from the drug that is administered to control the concentration of the drug. The drug when administered to the patient can cause the concentration of the biological substance to change, thus the drug is administered to change the concentration of the biological substance. For example, in one preferred embodiment, the biological substance monitored is glucose and the drug administered is insulin. 
         [0033]    The intraosseus space may also be used as a depository area for autologous bodily fluids. For example, CSF may be deposited into the intraosseus space. It is desirable to drain CSF to treat hydrocephalus removing excess CSF. With this invention the CSF can be drained through the use of a long catheter, draining the excess CSF into the intraosseus space. Similarly, lymph fluid may also be drained into the intraosseus space when lymphatic obstruction occurs such as caused by lymphedema. The intraosseus space may also be used to drain other autologous fluids. 
         [0034]    Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.