US20040249335A1 - Implantable arteriovenous shunt device - Google Patents

Implantable arteriovenous shunt device Download PDF

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Publication number
US20040249335A1
US20040249335A1 US10/820,169 US82016904A US2004249335A1 US 20040249335 A1 US20040249335 A1 US 20040249335A1 US 82016904 A US82016904 A US 82016904A US 2004249335 A1 US2004249335 A1 US 2004249335A1
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United States
Prior art keywords
shunt device
set forth
flow rate
blood flow
blood
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Abandoned
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US10/820,169
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English (en)
Inventor
John Faul
Toshihiko Nishimura
Peter Kao
Ronald Pearl
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Leland Stanford Junior University
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Leland Stanford Junior University
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Priority to US10/820,169 priority Critical patent/US20040249335A1/en
Assigned to BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY, THE reassignment BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY, THE ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NISHIMURA, TOSHIKO, FAUL, JOHN L., KAO, PETER N., PEARL, RONALD G.
Priority to US10/961,731 priority patent/US7628768B2/en
Publication of US20040249335A1 publication Critical patent/US20040249335A1/en
Priority to US11/789,759 priority patent/US7967769B2/en
Priority to US12/378,438 priority patent/US8048016B2/en
Priority to US13/101,240 priority patent/US8574185B2/en
Priority to US13/241,497 priority patent/US20120010556A1/en
Priority to US13/654,273 priority patent/US8551032B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655—Arterio-venous shunts or fistulae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A61M2230/06—Heartbeat rate only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/202—Blood composition characteristics partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure

Definitions

  • the present invention relates generally to medical devices and methods. More particularly, the present invention relates to non-cardiac devices and methods that provide a fistula or lumen between the arterial system and venous system.
  • Lung reduction surgery has recently been proposed for treating patients with chronic obstructive pulmonary disease. Such surgery, however, is not a panacea. It can be used on only a small percentage of the total patient population, requires long recovery times, and does not always provide a clear patient benefit. Even when successful, patients often continue to require supplemental oxygen therapy.
  • the present invention is a long-term implantable arteriovenous shunt device that can be used as a therapeutic method.
  • the shunt device is implanted between an artery and a vein, preferably between the aorta and the inferior vena cava.
  • the shunt device is implanted for a long-term period of at least 6 weeks and the implantation could be established via an open surgical procedure, a minimally invasive surgical procedure, or an intravascular procedure.
  • the objective of the shunt device is to decrease the systemic vascular resistance and allow a blood flow rate through the lumen of the shunt device of at least 5 ml/min after the implantation.
  • the cross sectional area (or radius) and the length of the lumen of the shunt device are selected to having such a blood flow rate, with the cross sectional area in the range of about 19 mm 2 to about 750 mm 2 , the length in the range of about 2.5 mm to about 15 mm, and the radius in the range of about 2.5 mm to about 15 mm.
  • the inner wall of the shunt device has a coating to prevent clot formation or atheroma formation.
  • the present invention includes a control means to control the blood flow rate through the shunt at a desirable blood flow rate level or range.
  • the control means could be as simple as an on/off mechanism (or switch), or could be more sophisticated by regulating the rate of flow ranging from either an open loop control or a closed loop control with feedback provided by physiological parameters.
  • the control means could include a controller (ranging from a switch to a decision algorithm), one or more flow control elements that control the rate of flow through the lumen, and/or one or more sensors to provide feedback to a controller. Examples of physiological parameters that could be sensed or measure are blood pressure, heart rate, cardiac output, paO 2 , O 2 saturation, O 2 saturation, mean systemic arterial pressure or mean systemic venous pressure.
  • the shunt device could a self-adjustable shunt device to self-adjust its cross sectional area or its length, or both, as a function of the pressure difference across the shunt device.
  • the self-adjustable shunt could then automatically control the blood flow rate through the shunt at a predetermined blood flow rate level or range.
  • the material of such a self-adjustable shunt device would then have expansion and contraction features to change the cross sectional area or the length, or both.
  • the method could be a respiratory or cardio-respiratory therapy based on an increase of the partial pressure of O 2 dissolved in the arterial blood plasma, an increase of the hemoglobin O 2 saturation in arterial or venous blood, or an increase of the O 2 concentration in arterial or venous blood. Accordingly, patients with respiratory problems could benefit from the consequences as a respiratory or cardio-respiratory therapy.
  • the method could be is a cardiac therapy based on an increase of the cardiac output.
  • the method could be a circulatory therapy based on a decrease of the pulmonary arterial blood pressure, a decrease of the systemic arterial blood pressure, a decrease of the systemic systolic pressure or a decrease of the systemic diastolic pressure. Accordingly, patients with circulatory problems could benefit from the consequences as a circulatory therapy.
  • FIG. 1 shows the concept of decreasing systemic vascular resistance according to the present invention
  • FIG. 2 shows an example blood flowing, with or without a shunt device of the present invention, from a high resistance arterial system with a high oxygen concentration to the low resistance venous system with a low oxygen concentration;
  • FIG. 3 shows an example of shunt device positioned between the aorta and inferior vena cava according to the present invention
  • FIG. 4 shows examples of shunt devices according to the present invention
  • FIG. 5 shows an example of shunt device with a control means according to the present invention
  • FIG. 6 shows an example of shunt device with a controllable or self-adjustable mechanism according to the present invention
  • FIG. 7 shows an example of shunt device with a controllable mechanism based on a smart material according to the present invention
  • FIG. 8 shows an example of a self-adjustable shunt device according to the present invention
  • FIG. 9 shows an example of shunt device with a means to increase resistance to blood flow according to the present invention.
  • FIGS. 10-12 show additional information regarding some physiological effects of an aorto-caval fistula in rats according to the present invention.
  • Blood returning to the right side of the heart is pumped to the lungs where it binds oxygen (becomes oxygenated, or re-oxygenated) before returning to the left side of the heart to be pumped to the body's tissues via the arterial system.
  • SVR excludes the pulmonary vasculature but when these two are combined it is sometimes referred as total peripheral resistance (TPR).
  • SVR is determined by factors that influence vascular resistance in individual vascular beds. Mechanisms that cause vasoconstriction (reducing the caliber of a vessel) will increase SVR, and those that cause vasodilation (increasing the caliber of a vessel) will decrease SVR.
  • the actual change in SVR in response to neurohumoral activation will depend upon the degree of activation and vasoconstriction, the number of vascular beds involved, and the relative in-series and parallel arrangements of these vascular beds to each other.
  • SVR is primarily determined by changes in blood vessel diameters, changes in blood viscosity will also affect SVR.
  • the present invention decreases the SVR by having an arteriovenous shunt device 130 implanted to shunt and re-circulate blood from the arterial system AS to the venous system VS in system 120 as shown in FIG. 1.
  • the re-circulated blood through shunt device 130 bypasses the peripheral microcirculation and decreases the SVR when one would compare system 110 with SVR 0 to system 120 with SVR 1 ; i.e. SVR 1 is lower than SVR 0 .
  • a desired decrease of the SVR would be at least 5% after the implantation of shunt device 130 .
  • shunt device 110 could be implanted between a large (proximal) artery and a large (proximal) vein. The location is selected to shunt and (quickly) re-circulate blood from the high resistance arterial system with a high oxygen concentration to the low resistance venous system with a low oxygen concentration as shown by system 120 in FIG. 2.
  • implantation of shunt device 130 is between the aorta 310 and the inferior vena cava 320 , either proximal of the renal arteries, or more preferably distal of the renal arteries, as shown in FIG. 3.
  • Blood flow through a lumen 230 of the shunt device 130 typically results from a pressure gradient between the blood in the arterial system and the blood in the venous system, indicated by the large P and small p in FIG. 2 (note different font sizes).
  • the blood flow rate through shunt device 130 after implantation should be at least (about) 5 ml/min. While the pressure gradient between the arterial and venous sides of the vasculature will generally be sufficient to achieve and control the target volume of blood flow, in some instances it may be desirable to utilize a control means or self-adjustable mechanism to either maintain a level/range or increase/decrease the blood flow rate (see also infra).
  • CO cardiac output
  • MAP mean arterial pressure
  • CVP central venous pressure
  • Cardiac output is equivalent to the blood flow rate according to:
  • MAP decreases to a smaller degree.
  • the decrease in MAP is due to a small drop in systolic pressure (P systolic ) and a larger drop in diastolic pressure (P diastolic ).
  • P diastolic is dependent on the SVR whereby a drop in SVR results in a drop in P diastolic .
  • the pulse pressure (P systolic ⁇ P diastolic ) is then increased. For instance, before MAP could be 90 mmHg and SVR could be 18 dynes, which results in a CO of 5 liters per minute.
  • SVR of 18 dynes is determined by dividing an SVR of 1440 dynes by a conversion factor of 80.
  • MAP of 90 mmHg is determined by using: MAP ⁇ P diastolic + 1 3 ⁇ ( P systolic - P diastolic )
  • SVR could for instance drop from 1440 dynes to 1000 dynes and with the conversing factor of 80 drop from 18 to 12.5.
  • MAP is 70 mmHg; i.e. in this example the P systolic could have dropped by 10 mmHg, but the P diastolic could have dropped by 25 mmHg. Combining these exemplary numbers would result in a cardiac output of 5.6 liters per minute; i.e. 70 mmHg divided by 12.5.
  • O 2 concentration in the venous blood system leads to an increase in the O 2 concentration in the arterial blood in two ways, which is also illustrated by the different (font) sizes of O 2 in FIG. 2.
  • Cardiac therapies could benefit patients with cardiac failure or patients who suffer from a low cardiac output (congestive heart failure) by providing an increased cardiac output.
  • the shunt device of the present invention could benefit patients with pulmonary arterial hypertension to lower pulmonary arterial blood pressure, patients with heart and/or respiratory failure by increasing arterial oxygen concentration, patients with chronic obstructive pulmonary disease by increasing of blood oxygen concentration.
  • Circulatory therapies The shunt device of the present invention could benefit patients with hypertension to lower systemic arterial, systolic and/or diastolic blood pressure.
  • Other diseases or conditions that could benefit from the present invention are, for instance, hypotension (by increasing cardiac output), lung fibrosis, adult respiratory distress syndrome, and the like.
  • the blood flow rate through the shunt device is preferably at least 5 ml/min.
  • volume flow rate (BFR) is a function of a blood with viscosity ⁇ , the pressure difference ⁇ P across the lumen of the shunt device, length l of the lumen of the shunt device and radius r of the lumen of the shunt device as shown by shunt device 410 in FIG. 4.
  • ⁇ P volume flow rate
  • ⁇ P pressure difference across the lumen of the shunt device
  • length l of the lumen of the shunt device and radius r of the lumen of the shunt device as shown by shunt device 410 in FIG. 4.
  • CSA cross sectional area
  • the shape of the lumen could be a circle, an oval or any other shape as long as the requirement of blood flow is met.
  • ⁇ P could range from about 30 mmHg (in someone with a MAP of 40 mmHg and a venous pressure of 10 mmHg) to about 150 (in someone with a MAP of 160 mmHg and a venous pressure of 10 mmHg).
  • the blood viscosity could be determined in a variety of ways that could for instance be obtained from a paper by Johnston B M et al. (2004) entitled “ Non - Newtonian blood flow in human right coronary arteries: steady state simulations ” and published in J Biomechanics 37:709-720.
  • the length could range from about 2.5 mm to about 15 mm, and the radius could range from about 2.5 mm to about 15 mm.
  • the length one could determine a minimum length of e.g. 2.5 mm given an exemplary wall thickness of a human adult aorta of about 1.5 mm and an exemplary wall thickness of a human adult inferior vena cava of about 1 mm.
  • the shunt device is preferably made from any biocompatible material strong enough or sufficiently reinforced to maintain a lumen that meets the desired blood flow rate.
  • the shunt device is made of metal, preferably titanium, while in other embodiments the shunt device could be formed from conventional vascular graft materials, polytetrafluoroethylene (PTFE), nickel titanium memory, elastic material, or the like.
  • the inner surface of the shunt device is preferably coated in whole or in part to inhibit the formation of blood clots. The surface could be coated with for instance polytetrafluoroethylene (Teflon®), or similar coatings/products.
  • the shunt device might also be coated with antibiotic to prevent atheroma, infection, and/or anti-proliferative or anticoagulant agents to prevent clot formation in the lumen.
  • the shunt device could be formed with flared or flanged ends, such as the umbrella or funnel device 424 (shown in FIG. 4).
  • Umbrella ends 424 are placed at opposite ends of a tubular element 422 that form shunt device 420 .
  • Umbrella ends 424 are positioned respectively inside the artery and inside the vein, and the tubular element connects in between the artery and the vein.
  • umbrella ends 434 could be positioned more or less perpendicular with respect to tubular element 432 as shown in shunt device 430 .
  • the key idea is that the diameter of the securing (connection) elements is larger than the opening in the artery and vein thereby keeping the shunt device in place.
  • the securing elements could include a mechanism that unfolds when the shunt device is in place and implanted in the artery and vein.
  • the art teaches different techniques and securing type mechanisms that could be used in the present invention.
  • the shunt device(s) could be implanted in a variety of ways, including the open surgical procedures, the laparoscopic and other minimally invasive techniques, and the intravascular techniques (where all or a portion of the shunt device is introduced at least partially through the lumen of one of the blood vessels to be shunted).
  • the shunt device could also be implanted by, for instance, a surgical procedure such as an aortic surgery.
  • the shunt device could further be implanted through interventional procedures such as, for instance, by means of a catheter through the iliac artery and guided by fluoroscopy.
  • the shunt device could be deployed over a guidewire (e.g.
  • the Seldinger technique and assembled in the body through interventional radiology techniques like the opening of an umbrella. All such surgical and interventional techniques are well known in the art. It is preferred to leave the shunt device implanted in the person for a long-term period (at least 6 weeks, but most often for years).
  • a flow control element 520 could be placed in the shunt device 510 as shown in FIG. 5. It could be placed at either end of the shunt device or somewhere in between.
  • the function of the flow control element could be as simple as to have an electrically, magnetically or mechanically open/close mechanism such as a switch or one-way valve. Such an open/close element could also be a hook with a lever or a gearshift.
  • a controller 530 could be used to control the timing of opening/closing (e.g. frequency and duration) or to control changes in blood flow rate.
  • Controller 530 could control flow control element 510 such as one-way valve(s), pump(s) (positive displacement pump(s), rotary pump(s), peristaltic pump(s), and the like), controllable orifice(s) and the like.
  • the flow control element could be electrically charged using an internal battery (e.g. a lithium battery; not shown) or by external power (not shown) using a magnetic impeller, both of which are common techniques in the art.
  • Yet another advancement of the control means for the shunt device is to include one or more sensors 540 that provide feedback to the controller 530 .
  • the figures show two sensors, however, the present invention is not limited to two sensors and could be at least one sensor that is implanted inside the shunt device, near the shunt device, or inside or near the vasculature system.
  • the sensor(s) could also be placed outside the body.
  • Sensors 540 could sense (and/or measure) physiological parameter(s) in real time either periodically or continuously. The selection of one or more physiological parameters could be to reflect the condition of a person or patient who is being treated.
  • physiological parameters that could be sensed with one or more sensors are blood pressure, heart rate, cardiac output, paO 2 , O 2 saturation, O 2 saturation, mean systemic arterial pressure, and/or mean systemic venous pressure.
  • the controller could include a decision method to determine appropriate action on the flow control element.
  • the controller could either be a stand-alone implantable controller and/or could be operated from outside the body. It might be useful to update the controller or change the current controller settings; e.g. in cases when the controller controls a set-value, a particular range or critical boundaries (minima/maxima), or when the controller requires an upgrade of its code.
  • the controller may select different criteria that are e.g. dependent on the type of disease, condition and/or desired therapy.
  • the heart rate could be maintained at a reasonable physiological range and not exceed the person's maximum heart rate.
  • the controller could have a target heart rate range of, for instance, 80 to 140 beats per minute, more usually from 90 to 110 beats per minute.
  • these increases could be higher and on the order of 10% or 20% and up (5% and 10% for HbO 2 ).
  • the blood flow rate could increase from at least 5 ml/min compared to before implantation to a situation where the shunt is capable of carrying up to 5000 ml/min of blood at e.g. a pressure differential across the shunt device of 70 mmHg.
  • the description supra relates to a shunt device whereby the blood flow rate could be changed and controlled.
  • the structural parameters of the shunt device such as the length, cross section area and radius are fixed.
  • the shunt device could change its cross section area, radius and/or length. This could be accomplished either in a controlled fashion, like with a controller and sensor(s) as described supra, or in a self-adjustable fashion (i.e. self-organizing fashion).
  • FIG. 6 shows an example of a shunt device 610 , 620 with a mechanism of leaves 630 disposed in the lumen of the shunt device that could change the cross section area of the lumen.
  • Leaves 630 could be attached to a central axis or to the inner wall of shunt device 610 , 620 respectively. Two or more leaves could be used with the capability of changing their position from a closed position gradually to an open position (compare 610 and 612 , and 620 and 622 respectively).
  • the leaves in shunt devices 610 , 620 could be integrated with a controller 640 and/or sensor(s) 650 in a similar fashion as described supra.
  • Leaves 630 could also be included as a self-adjusting mechanism for opening and closing of the shunt device. When the blood flow increases or blood pressure increases, the flexible leaves automatically open up from a more or less closed position to a more or less open position, and vice versa.
  • FIG. 7 shows an example of a shunt device 710 that is made of a smart material such as a memory metal/alloy that can change its length and cross sectional area (radius).
  • shunt device 710 could be made longer as shown by 720 or wider as shown by 730 (larger cross sectional area).
  • Shunt devices 710 could be integrated with a controller 740 and/or sensor(s) 750 in a similar fashion as described supra.
  • Mechanisms of memory metals/alloys (including particular stent-graft materials) and their controls are known in the art.
  • Shunt device 810 should then be made of a material that is capable of increasing its length, but simultaneously decreasing its radius when ⁇ P increases, (indicated by changing from 810 and 820 ).
  • Examples of such materials are elastic materials with reinforced filaments or fibers arranged and distributed over (or within) the shunt device (not shown in 810 , 820 ) to ensure selected and directional changes, according to Poiseuille equation; i.e. (i) an increase in cross sectional area with a decrease in length, and (ii) a decrease in cross sectional area with an increase in length.
  • FIG. 11 shows the effect of the presence of an aorto-caval fistula in several groups of experimental animals.
  • Aorta-caval fistuala attenuates the development of pulmonary arterial hypertension.
  • the measurements shown in FIG. 11 are of mean pulmonary artery pressures (PAP).
  • FIG. 12 shows photomicrographs of small pulmonary arteries (A-D).
  • A shows an example that normal rat (group N) arterioles do not have evidence of neointimal formation (grade 0).
  • B shows an example of a grade 1 neointimal lesion ( ⁇ 50% occlusion) seen in rats that received monocrotaline alone (group M).
  • C shows an example of grade 1 neointimal lesion ( ⁇ 50% occlusion) seen in rats that underwent left pneumonectomy and the creation of an aortocaval fistula (ACF) and then received monocrotaline (group PMF).
  • ACF aortocaval fistula
  • (D) shows an example of a grade 2 neointimal lesion (>50% occlusion) seen in rats that underwent left pneumonectomy and received monocrotaline (group PM). All photomicrographs (X400), elastin van Gieson stain.
  • the present invention has now been described in accordance with several exemplary embodiments, which are intended to be illustrative in all aspects, rather than restrictive.
  • the present invention is capable of many variations in detailed implementation, which may be derived from the description contained herein by a person of ordinary skill in the art.
  • the individual shunts may be implanted in close proximity to each other or may be distributed at different regions of the vasculature.
  • the present invention could be used as preventative care or as a therapy for a condition or disease.
  • the long-term implantable shunt device could be beneficial to improve the performance in athletes, military service personnel, performance animals (e.g. dogs and horses).
  • the preferred location of the shunt device is between the aorta and inferior vena cava as described supra.
  • the shunt device could be positioned in the axilla and it would link the axillary artery and vein.
  • the device could be positioned close to the clavicle and link the subclavian artery and vein.
US10/820,169 2003-04-08 2004-04-06 Implantable arteriovenous shunt device Abandoned US20040249335A1 (en)

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US10/820,169 US20040249335A1 (en) 2003-04-08 2004-04-06 Implantable arteriovenous shunt device
US10/961,731 US7628768B2 (en) 2003-04-08 2004-10-07 Implantable arterio-venous shunt devices and methods for their use
US11/789,759 US7967769B2 (en) 2003-04-08 2007-04-24 Implantable arterio-venous shunt devices and methods for their use
US12/378,438 US8048016B2 (en) 2003-04-08 2009-02-12 Arterio-venous shunt devices
US13/101,240 US8574185B2 (en) 2003-04-08 2011-05-05 Implantable arterio-venous shunt devices and methods for their use
US13/241,497 US20120010556A1 (en) 2003-04-08 2011-09-23 Long-Term Implantable Arterio-Venous Shunt Device
US13/654,273 US8551032B2 (en) 2003-04-08 2012-10-17 Therapeutic method for treatment of hypertension

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US10/820,169 US20040249335A1 (en) 2003-04-08 2004-04-06 Implantable arteriovenous shunt device
US10/961,731 US7628768B2 (en) 2003-04-08 2004-10-07 Implantable arterio-venous shunt devices and methods for their use

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US10/961,731 Continuation-In-Part US7628768B2 (en) 2003-04-08 2004-10-07 Implantable arterio-venous shunt devices and methods for their use

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US10/961,731 Expired - Fee Related US7628768B2 (en) 2003-04-08 2004-10-07 Implantable arterio-venous shunt devices and methods for their use
US12/378,438 Expired - Fee Related US8048016B2 (en) 2003-04-08 2009-02-12 Arterio-venous shunt devices
US13/241,497 Abandoned US20120010556A1 (en) 2003-04-08 2011-09-23 Long-Term Implantable Arterio-Venous Shunt Device

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US12/378,438 Expired - Fee Related US8048016B2 (en) 2003-04-08 2009-02-12 Arterio-venous shunt devices
US13/241,497 Abandoned US20120010556A1 (en) 2003-04-08 2011-09-23 Long-Term Implantable Arterio-Venous Shunt Device

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WO2006041824A2 (fr) 2006-04-20
WO2004091696A1 (fr) 2004-10-28
US20090156978A1 (en) 2009-06-18
US7628768B2 (en) 2009-12-08
WO2006041824A3 (fr) 2007-05-03
EP1613373A4 (fr) 2008-09-10
US20050107733A1 (en) 2005-05-19
US8048016B2 (en) 2011-11-01
US20120010556A1 (en) 2012-01-12
EP1613373A1 (fr) 2006-01-11

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