Abstract:
The present invention provides a intravascular nano-bubbling oxygenator comprises a catheter, capable of being inserted into a blood vessel to transport normal pressure to hyperbaric gas, comprising: a tube wall with one or two lumens, and an opening end, wherein the tube wall partially comprises a plurality of pores; a connector; a gas transporting apparatus, and a control panel with on-line data sensors connections.

Description:
CROSS REFERENCE OF RELATED APPLICATION 
       [0001]    This is a Continuation application that claims priority to U.S. non-provisional application, application Ser. No. 11/868,528, filed Oct. 7, 2007, the entire contents of each of which are expressly incorporated herein by reference. 
     
    
     NOTICE OF COPYRIGHT 
       [0002]    A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to any reproduction by anyone of the patent disclosure, as it appears in the United States Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever. 
       BACKGROUND OF THE PRESENT INVENTION 
       [0003]    The annual mortality rate for all lung diseases is estimated to be approximately 250,000 in the US in 2000. About 150,000 patients were related to acute, potentially reversible respiratory failure and 100,000 patients related to chronic respiratory failure due to chronic obstructive lung disease (COPD) or chronic irreversible respiratory failure due to other illness. The estimated economic burden of these diseases is in the range of 72 billion dollars per year. The rate of death related to COPD has increased by 54%, and the World Health Organization (WHO) estimated that COPD will affect 5-15% of all adults in industrialized countries and accounting for 3 million deaths worldwide in 2020, as the 5 th  most prevalent disease and the 3 rd  leading cause of mortality. 
         [0004]    The primary purpose of this design is to replace the oxygenation function of the diseased lung during acute or chronic lung function and ventilatory impairment. Because the exchange rate of CO 2  by the lungs is about 200 times more than that of oxygen, the oxygenation problem is the first and most serious clinical problem for us to face. Most of the clinical problems of CO 2  retention can be solved simply by the patients themselves or by the mechanical ventilation to increase the minute ventilation. So we simply focus on the resolutions for the main problem of acute, moderate to severe hypoxemia and chronic respiratory failure with long-term hypoxemia. Due to the improvement of biomaterial, the possibility to use normal pressure to hyperbaric nano-sized pure oxygen bubbles to improve oxygenation of the intracaval deoxygenated hemoglobin is reachable. In patients with acute respiratory failure, the normal pressure to hyperbaric nano-bubbling intracaval oxygenator can replace the conventional mechanical ventilator, IVOX, IMO, and ECMO, to facilitate the oxygen demand of the patients. In patients of chronic respiratory failure, a low-flow intravenous oxygenator can replace conventional oxygen therapy system, improving the power and the motivation of patient activities. 
         [0005]    The invention is directed at the intravascular nano-bubbling oxygenator that utilizes an intravascular catheter with numerous nano-porous surface, in order to facilitate oxygen bubbles binding with the deoxygenated hemoglobin of the red cells in cardiovascular system. The inventions were designed to improve the clinical hypoxic patients with any kinds of acute or chronic reasons. 
       FIELD OF INVENTION 
       [0006]    The invention relates to the normal pressure to hyperbaric intravascular oxygenator, and more particularly to the different design of one lumen and multi lumens catheters with numerous nano-porous surface to facilitate nano-sized pure oxygen bubbles to the cardiovascular system. 
         [0007]    Description of Related Arts 
         [0008]    The primary purpose of the ventilation is to bring the air into and out the lungs, therefore oxygen can be added into the lungs and carbon dioxide can be removed. The volume of the pulmonary capillary circulation is about 150 ml, spreading over a surface area of approximately 750 square feet. This capillary surface area surrounds 300 million air sacs called alveoli. The deoxygenated venous return is oxygenated in less than one second in the pulmonary circulation due to huge capillary surface and extremely thin blood-alveolar barrier approximately one micrometer in distance. This allows the blood to be replenished with oxygen and for the excess carbon dioxide to be removed. 
         [0009]    There have been numerous efforts in the past 40 years to achieve artificial ventilation function, such as negative pressure and positive pressure mechanical ventilator, and extracorporeal membrane oxygenator (ECMO). 
         [0010]    Positive-pressure mechanical ventilation is a somewhat efficient and safe means for improving gas exchange in the patients with acute respiratory failure. However, serious adverse effects may occur with prolonged duration of intensive respiratory support or high oxygen fraction. These hazardous effects, including oxygen toxicity, barotraumas, altered hormone and enzyme systems, mechanical ventilation induced lung injury (VILI), disuse atrophy of skeleton muscles, and added to the morbidity and mortality rates for these patients. 
         [0011]    Another approach to artificial lung function, extracorporeal membrane oxygenation (ECMO) constitutes a mechanism for prolonged pulmonary bypass, which has been developed and optimized over several decades but has limited clinical utility today as a state-of-the-art artificial lung. The ECMO system includes an extra-corporeal pump and membrane system that performs a gas transfer across membranes. Despite the numerous advances in the implementation of ECMO over the years, its core technology is unchanged and continues to face important limitations. The limitations of ECMO include the requirement for a large and complex blood pump and oxygenator system, the necessity for a surgical procedure for cannulation, the need for systemic anticoagulation, the labor intensive implementation, the exceeding high cost, and a high rate of complications, including bleeding and infection, protein absorption, and platelet adhesion on the surface of the oxygenator membrane. As a result of these limitations, the ECMO has become limited in its utility to select cases of neonatal respiratory failure, where reversibility is considered to be highly likely. 
         [0012]    One approach to artificial lung functions has been by gas sparing or diffusion of gas across the membrane surface of hollow fibers placed within the blood supply. Previous efforts have achieved some success, and have taught much to pulmonary physiologists, but gas sparing or diffusion has not yet achieved the degree of gas exchanges optimally desired. The development of the intravenous membrane oxygenator (IVOX) presented a natural extension in the artificial lung art, since it was capable of performing intracorporeal gas exchange across an array of hollow fiber membranes situated within the inferior vena cava but did not require any form of blood pump. The insertion of the IVOX effectively introduced a large amount of gas transfer surface area (up to 600 cm 2 ) without alternation of systemic hemodynamics; unfortunately, as with ECMO, the IVOX system has numerous limitations including a moderate rate of achievable gas exchange, difficulty in device implantation, a relatively high rate of adverse events, and a significant rate of device malfunctions, including blood-to-gas leaks due to broken hollow fibers. 
         [0013]    Clinically, there is still a long way to go for us to achieve perfect artificial oxygenation whether in acute patients or long-term care. Therefore, a serious need exists for new technology and therapeutic approaches that have the potential to provide acute, intermediate to chronic, and long-term respiratory support for patients suffering from severe pulmonary failure. There also remains a paramount need for an efficient and inexpensive technology to achieve sustained oxygen concentration in the blood, thereby bypassing the diseased lung without resorting to further damage. 
       SUMMARY OF THE PRESENT INVENTION 
       [0014]    The present invention is to provide a normal pressure to hyperbaric nano-bubbling intravascular oxygenation system comprising a catheter with single or multiple lumens, a tube wall with numerous nano-sized pores on its surface, capable of being inserted into a blood vessel to transport gas. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1A ,  1 B, it is an embodiment of the present invention to illustrate the normal pressure to hyperbaric intravascular nano-bubbling oxygenator of one lumen type. 
           [0016]      FIG. 2A ,  2 B, it is an embodiment of the present invention to illustrate the normal pressure to hyperbaric intravascular nano-bubbling oxygenator of multi lumens type. 
           [0017]      FIG. 3 , it is the flowchart to illustrates the method for oxygenation. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0018]    Referring to  FIGS. 1A and 1B , it is an embodiment of the present invention to illustrate a normal pressure to hyperbaric intravascular nano-bubbling oxygenator of one lumen type. A partial porous catheter  110  comprises a tube wall  111  having lots of pores  112 . The catheter  110  is capable of being inserted into a blood vessel. The cross-section area of the catheter  110  is less than three fourths (¾) of the cross-section area of the blood vessel. The length of the catheter  110  in a blood vessel varies from person to person depending on patient&#39;s body size. The catheter  110  comprises the biomaterial, such as, polymer, or ceramic, or metal, or composites. The tube wall  111  is hydrophobic and able to prevent bacterial colonization and thrombogenesis. The porous area portion of the tube wall  111  is five(5)% to ninety-five(95)% of the entire catheter in the blood vessel. The sizes of the pores are ranged from 0.3 nanometer to five hundred (500) micrometer. 
         [0019]    The catheter  110  includes one closed end and one opening end. The opening end is connected to a connector  120 . 
         [0020]    The connector  120  connects the catheter  110  and the gas transporting apparatus  130 . The gas transporting apparatus  130  comprises a couple with or without an extended tube and a filter (not shown) for the connection with the connector  120 . The gas transporting apparatus  130  comprises a flow adjustor  131  with a flow sensor (not shown), a pressure adjustor  132  with a barometer (not shown), a thermo adjustor  133  with a thermometer (not shown) for these range parameters. 
         [0021]    A pipe  140  connects the gas transporting apparatus  130  and a high pressure gas tank or any other container  142  with a regulator  141 . In an embodiment, the gas is oxygen. The regulator  141  works as one of the main switches to allow the oxygen to be transported into the normal pressure to hyperbaric intravascular nano-bubbling oxygenator. The thermo adjustor  133  warms or cools the oxygen to a proper temperature, the pressure adjuster  132  adjusts the pressure of the oxygen, and the flow adjustor  131  controls the flow rate of the oxygen. The oxygen passes the connector  120  to the tube  110 , and then distributes through the pores  112  to the blood. The pores  112  help produce bubbles in a range of nanometer to micrometer scale for range parameters when transporting gas. 
         [0022]    The control panel  150  calculates the feedback of the measurement of the blood oxygen concentration, vena caval pressure, heart rate, and temperature by one or one more detectors (not shown) and controls the gas transporting apparatus  130  for transporting gas at the specific range of temperature, pressure, and flowrate to the catheter  110  through the connector  120 . 
         [0023]    Referring to  FIG. 2A and 2B , it is an embodiment of the present invention to illustrate a normal pressure to hyperbaric intravascular nano-bubbling oxygenator of multiple lumens type. A partial porous catheter  210  comprises two lumens, one lumen tube wall  211  having lots of pores  212 , the other lumen tube wall  213  with or without pores, and a separating wall  214  to separate the tube  210  into the gas lumen  215  with pores on outer tube wall and the liquid lumen  216  with or without pores on the outer tube wall. Each of the gas lumen  215  and the liquid lumen  216  has an opening end with a removable cap (not shown) and the gas lumen  215  connects to a connector  220 . The other end of the liquid lumen  216  comprises an opening end to allow the guide wire or liquid passing through it. The other end of the gas lumen  215  comprises a closed end. The catheter  210  is capable of being inserted into a blood vessel. The cross-section area of the catheter  210  is less than three fourths (¾) of the cross-section area of the blood vessel. The length of the catheter  210  in a blood vessel varies from person to person depending on patient&#39;s body size. The catheter  210  comprises the biomaterial, such as, polymer, or ceramic, or metal, or composites. The tube wall  211  and tube wall  213  are hydrophobic and able to prevent bacterial colonization and thrombogenesis. The porous area portion of the tube wall  211  or tube wall  213  is five(5) % or zero(0)% to ninety-five(95)% of the entire tube in the blood vessel. The sizes of the pores are ranged from 0.3 nanometer to five hundred (500) micrometer. 
         [0024]    The connector  220  connects the gas lumen  215  of the catheter  210  and the gas transporting apparatus  230 . The gas transporting apparatus  230  comprises a couple with or without an extended tube and a filter (not shown) for the connection with the connector  220 . The gas transporting apparatus  230  comprises a flow adjustor  231  with a flow sensor (not shown), a pressure adjustor  232  with a barometer (not shown), a thermo adjustor  233  with a thermometer (not shown) for range parameters. 
         [0025]    A pipe  240  connects the gas transporting apparatus  230  and a high pressure gas tank or any other container  242  with a regulator  241 . In an embodiment, the gas is oxygen. The regulator  241  works as one of the main switches to allow the oxygen to be transported into the normal pressure to hyperbaric intravascular nano-bubbling oxygenator. The thermo adjustor  233  warms or cools the oxygen to a proper temperature, the pressure adjuster  232  adjusts the pressure of the oxygen, and the flow adjustor  231  controls the flow rate of the oxygen for range parameters. The oxygen passes the connector  220  to the gas lumen  215  of the catheter  210 , and then distributes through the pores  212  to the blood. The pores  212  help produce bubbles in a range of nanometer to micrometer scale when transporting gas. 
         [0026]    The control panel  250  calculates the feedback of the measurement of the blood oxygen concentration, vena caval pressure, heart rate, or temperature by one or one more detectors (not shown) and controls the gas transporting apparatus  230  for transporting gas at the specific range of temperature, pressure, and flowrate to the gas lumen  215  of the catheter  210  through the connector  220 . 
         [0027]    Referring to  FIG. 3 , it is the flowchart to illustrates the method for oxygenation. At step  310 , a pressurized pure oxygen source is prepared. The oxygen source may be tank containing pressurized pure or high concentration oxygen. At step  320 , a gas transporting apparatus, including a flow adjuster, a pressure adjuster, and a thermal adjuster to control the range parameters of the gas flow, temperature, and pressure of the oxygen, is connected to a gas lumen of a porous catheter with nano to micro-meter sized pores. At step  330 , the porous catheter is inserted into a blood vessel of a living body. At step  340 , the oxygen source is connected to the gas transporting apparatus. At step  350 , the gas transporting apparatus controls the distribution of the oxygen to the vascular system through the porous catheter. At step  360 , a blood oxygen concentration, a vena caval pressure, a heart rate, and a temperature of the living body are measured to as the control signals to feedback to the computer in a panel. At step  370 , The control signals are compared with the predetermined ranges set in the computer, and the panel sends commands to the gas transporting apparatus, and then back to the step  350 . 
         [0028]    One skilled in the art will understand that the embodiment of the present invention as shown in the drawings and described above is exemplary only and not intended to be limiting. 
         [0029]    The foregoing description of the preferred embodiment of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form or to exemplary embodiments disclosed. Accordingly, the foregoing description should be regarded as illustrative rather than restrictive. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. The embodiments are chosen and described in order to best explain the principles of the invention and its best mode practical application, thereby to enable persons skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use or implementation contemplated. It is intended that the scope of the invention be defined by the claims appended hereto and their equivalents in which all terms are meant in their broadest reasonable sense unless otherwise indicated. It should be appreciated that variations may be made in the embodiments described by persons skilled in the art without departing from the scope of the present invention as defined by the following claims. Moreover, no element and component in the present disclosure is intended to be dedicated to the public regardless of whether the element or component is explicitly recited in the following claims.