WO2002070039A2 - Intravascular device for treatment of hypertension - Google Patents

Intravascular device for treatment of hypertension Download PDF

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Publication number
WO2002070039A2
WO2002070039A2 PCT/US2002/006929 US0206929W WO02070039A2 WO 2002070039 A2 WO2002070039 A2 WO 2002070039A2 US 0206929 W US0206929 W US 0206929W WO 02070039 A2 WO02070039 A2 WO 02070039A2
Authority
WO
WIPO (PCT)
Prior art keywords
pump
blood pressure
artery
blood flow
producing
Prior art date
Application number
PCT/US2002/006929
Other languages
French (fr)
Other versions
WO2002070039A3 (en
WO2002070039A8 (en
Inventor
Richard Y. Lin
Gholam Reza Zadno-Azizi
Erica Rogers
Original Assignee
Three Arch Partners
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US27263401P priority Critical
Priority to US60/272,634 priority
Application filed by Three Arch Partners filed Critical Three Arch Partners
Publication of WO2002070039A2 publication Critical patent/WO2002070039A2/en
Publication of WO2002070039A3 publication Critical patent/WO2002070039A3/en
Publication of WO2002070039A8 publication Critical patent/WO2002070039A8/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/10Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps
    • A61M1/101Non-positive displacement pumps, e.g. impeller, centrifugal, vane pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/10Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps
    • A61M1/101Non-positive displacement pumps, e.g. impeller, centrifugal, vane pumps
    • A61M1/1012Constructional features thereof
    • A61M1/1018Constructional features thereof with occluders preventing backflow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/10Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps
    • A61M1/101Non-positive displacement pumps, e.g. impeller, centrifugal, vane pumps
    • A61M1/1029Drive systems therefor
    • A61M1/1031Drive systems therefor using a motor with canned rotor, i.e. a motor enclosed within a casing along with the rotor so that the motor bearings are lubricated by the blood that is being pumped
    • A61M1/1034Drive systems therefor using a motor with canned rotor, i.e. a motor enclosed within a casing along with the rotor so that the motor bearings are lubricated by the blood that is being pumped using rotating cables for driving
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/10Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps
    • A61M1/12Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps implantable into the body
    • A61M1/122Heart assist devices, i.e. for assisting an ailing heart, using additional pumping means in the blood circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/10Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps
    • A61M1/12Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps implantable into the body
    • A61M1/125Blood pumps; Artificial hearts; Devices for mechanical circulatory assistance, e.g. intra-aortic balloon pumps implantable into the body intravascular, i.e. introduced or implanted in an existing blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3507Communication with implanted devices, e.g. external control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1078Urinary tract
    • A61M2210/1082Kidney
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation

Abstract

Some aspects include a mechanical pump (3) which is placed in the renal artery (4) by means of a percutaneous catheter (6), surgical implantation, or other appropriate means. This pump increases blood flow through the renal artery to the kidney (12). This increased bloodflow is perceived at the level of the macula densa as increased sodium delivery to the macula densa and the juxtaglomerular apparatus, resulting in suppression of renin production from the juxtaglomerular apparatus, with consequent reduction in angiotensin II production and aldosterone levels. This decreased aldosterone and decreased angiotensin II production lead to a reduction in blood pressure.

Description

INTRAVASCULARDEVICE FOR TREATMENT OF HYPERTENSION

Background of the Invention The invention relates to devices used in the treatment of essential hypertension. More particularly, the invention relates to an intrarenal pump that produces a decrease in blood pressure via hormonal modulation.

High blood pressure, or hypertension, is a primary or contributing cause in more than 10% of deaths in the United States. Hypertension is a disease often overlooked and inefficiently managed. According to the American Heart Association, about 44% of men and women age 55-64 have hypertension. Sixty percent of men and women age 65-74 are hypertensive, and after age 75, 64% of men and 77% of women have hypertension. Men are at increased risk for development of hypertension prior to age 55. After age 55, women have a slightly increased risk, and after age 75, women are at a much greater risk of developing hypertension. Hypertension is generally defined as a systolic blood pressure of greater than 140 mm Hg, or a diastolic blood pressure of 90 mm Hg or more. Systolic blood pressure is the transmural pressure within arteries during the contraction of the left ventricle. Diastolic pressure is pressure within arteries during relaxation of the left ventricle. Elevated diastolic blood pressure reflects high continuous, static pressure on arterial walls, while an elevated systolic blood pressure intermittently stresses the arterial walls with increased pressure during each heart beat. Essential, or primary, hypertension accounts for approximately 90% of cases of hypertension, and the cause is unknown.

Hypertension is often called a "silent killer." Symptoms of elevated blood pressure are rare unless the pressure is extremely high. Target organ damage can be the first manifestation of hypertension and occurs primarily in the heart, brain, eyes, and kidney.

Organs can be damaged by labile and chronic hypertension, or by acute episodes of severe hypertension.

Hypertension is a major risk factor for the development of arteriosclerosis.

Vascular damage develops as a result of chronically elevated blood pressure. In early stages of arteriosclerosis, high blood pressure can contribute to the buildup of arteriosclerotic plaque within vessel walls. This plaque accumulation can hinder a vessel's ability to react to hormonal and neurogenic stimuli. Furthermore, elevated blood pressure can cause rupture of thin-walled vessels. The exposure of inflammatory material within the vessel walls to procoagulant factors in the blood leads to thrombus (clot) formation. This unstable environment provides a physiologic basis for angina (chest pain caused by inadequate oxygen delivery to the heart), myocardial infarction (heart attack), peripheral vascular disease, ischemic neuropathy, transient ischemic attacks (TIAs), and stroke.

Epidemiological and experimental data link increased sodium intake to development of hypertension in some patients. The presence of high intracellular sodium results in increased vascular tone. Restricting sodium intake can sometimes result in the lowering of blood pressure by decreasing vascular tone. Age is the strongest identifiable factor related to elevated blood pressure. Epithelial tissue declines in elasticity as people age. Blood vessels become less flexible, and their response to numerous regulatory substances is reduced. This suggests a decline in the effectiveness of endogenous mechanisms of blood pressure control with age.

Blood pressure is normally regulated by compensatory mechanisms that respond to changes in cardiac demand. Blood pressure is mathematically equivalent to the product of cardiac output and total peripheral resistance in the vasculature. Cardiac output, in turn, is the product of cardiac stroke volume and heart rate. An increase in cardiac output (i.e., the volume of blood expelled from the heart each minute) results in a compensatory decrease in total peripheral resistance, caused by dilation of arterioles (vasodilation). Conversely, a decreased cardiac output normally leads to a compensatory increase in total peripheral resistance through vasoconstriction. In normal circumstances, this compensation occurs to maintain a normal blood pressure.

A complex interplay exists in the body between mechanisms of blood pressure regulation. Baroreceptors and chemoreceptors located throughout the body react quickly, via the sympathetic and parasympathetic nervous systems, to produce changes in vascular tone and changes in the oxygenation of blood to maintain homeostasis. Hormonal and fluid balance systems in the body also maintain and control blood pressure. Such hormones include angiotensin π, vasopressin (antidiuretic hormone), bradykinin, endothelium-derived relaxing factor, epinephrine, norepinephrine, atrial natriuretic peptide, thyroid hormone, and the adrenal cortical hormones, such as aldosterone and cortisol.

Two systems closely involved with blood pressure control are the renin-angiotensin- aldosterone system and the sympathetic nervous system. The sympathetic nervous system can act on the heart and blood vessels by direct nerve transmission and through the release of catecholamine hormones, including epinephrine and norepinephrine. The catecholamines stimulate alpha and beta adrenergic receptors throughout the body. The most prevalent receptors are alpha- 1 receptors, located in blood vessels. Beta-1 receptors are similar to alpha- 1 receptors, except that beta-1 receptors are located primarily in the heart. Medications that block these adrenergic receptor sites decrease blood pressure. Alpha- 1 receptor blockade causes blood vessels to dilate. Beta-1 receptor blockade causes myocardial contractility and heart rate to decrease, thereby decreasing cardiac output. Alpha-2 receptors located in the brain stem can be stimulated to reduce catecholamine release as part of a negative feedback mechanism. Medications that bind to these receptors can cause a decrease in the amount of catecholamines released, thereby lowering blood pressure.

One of the major hormonal and fluid balance systems in the body that maintains blood pressure is the renin-angiotensin-aldosterone, a complex compensatory blood pressure system located principally in the kidney. Whenever blood pressure, blood volume, or arterial sodium concentration decreases, renin is released by the kidney to ensure adequate renal perfusion. The renin-angiotensin system is triggered when the granular cells of the juxtaglomerular apparatus release renin in response to various stimuli, including norepinephrine release from sympathetic innervation of the kidney, reduced stretch of juxtaglomerular cells, and reduced flow of sodium to the macula densa cells of the juxtaglomerular apparatus, located in the distal tubule of the nephron.

Renin is an enzyme that acts on angiotensinogen, also known as renin substrate, to produce angiotensin I. Angiotensin I is then converted to angiotensin π through the action of angiotensin converting enzyme (ACE). Angiotensin π is a potent vasoconstrictor that quickly increases total vascular resistance (total peripheral resistance) as a way of keeping vital organs adequately perfused. Angiotensin II also stimulates the production of the hormone aldosterone from the adrenal cortex.

Aldosterone, in turn, causes renal retention of sodium chloride at the level of the distal convoluted tubule and, to a lesser extent, the collecting duct, helping to maintain fluid balance and blood pressure homeostasis. Aldosterone also produces renal loss of hydrogen and potassium ions. In the presence of aldosterone, up to 99.5% of all ingested sodium is retained through renal tubular reabsorption. In the absence of aldosterone, a continued obligatory loss of approximately 20 mg of sodium per day occurs until blood pressure falls, and symptoms, such as fainting (syncope), may result.

It is well established that by reducing the activity of the renin-angiotensin system, blood pressure may be lowered. As a result of this knowledge, angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor blockers (ARBs) have become important and beneficial drugs in the treatment of hypertension.

Summary of the Invention

Some aspects of the invention include an apparatus for reducing blood pressure, comprising an intravascular pump configured to be placed within an artery. The pump is configured to increase antegrade blood flow in a renal artery, thereby producing a reduction in blood pressure. In some embodiments, the intravascular pump is placed in a renal artery.

In other embodiments, it can be placed in the aorta.

In some embodiments, the intravascular pump further comprises a control mechanism in communication with the pump, whereby a user can adjust the mechanism producing a change in the antegrade blood flow through the pump.

In yet other embodiments, the intravascular pump further comprises a radiofrequency transmitter, wherein the user can adjust the mechanism remotely via the radiofrequency transmitter, thereby producing a change in the antegrade blood flow through the pump. In another embodiment, the intravascular pump further comprises an inductive coupling controller, wherein the user can adjust the mechanism remotely via the inductive coupling controller, thereby producing a change in the antegrade blood flow through the pump.

Some aspects of the invention include a method for reducing blood pressure, comprising placing an intravascular pump in an artery. The pump is configured to increase antegrade blood flow in a renal artery, thereby producing a reduction in blood pressure. In some embodiments, the intravascular pump is placed in a renal artery. In other embodiments, it can be placed in the aorta.

In some embodiments, the method further comprises adjusting a control mechanism that is in communication with the pump, whereby said adjusting causes a change in the antegrade blood flow through the pump. In some embodiments, the method further comprises using a radiofrequency transmitter to adjust the mechanism remotely, thereby producing a change in the antegrade blood flow through the pump.

In some embodiments, the method further comprises using an inductive coupling controller to adjust the mechanism remotely, thereby producing a change in the antegrade blood flow through the pump.

Brief Description of the Drawings Figure 1 is a schematic frontal view of an intravascular pump placed within the renal artery. Figure 2 is a schematic frontal view of an intravascular pump with a balloon fixation member placed within the renal artery.

Detailed Description of Preferred Embodiments

Referring to Figure 1 , an intravascular pump 2 is shown, which may, for example, be placed within the renal artery or aorta or other suitable artery via percutaneous catheter 6 or via an open surgical procedure. Such a percutaneous catheter 6 may be placed via the femoral artery into the common iliac area artery 8, then fed up the aorta 10 and into a renal artery 4. The pump 2 may then be situated within the renal artery 4 by any suitable fixation method. Such methods include inflation of a balloon 14, as shown in Figure 2, as well as other fixation methods known to those skilled in the art. The pump 2 causes an increase in forward (downstream or antegrade) flow through the renal artery 4 and into the kidney 12. This increased flow is perceived at the level of the macula densa of the kidney 12 as increased volume and sodium delivery to the macula densa and the juxtaglomerular apparatus. This increased delivery of sodium to the macula densa results in suppression of renin production and release from the granular cells of the juxtaglomerular apparatus, with consequent reduction in angiotensin II and aldosterone levels. This decreased aldosterone and angiotensin TJ production leads to a reduction in blood pressure.

Alternatively, the intravascular pump 2 may be surgically placed directly or indirectly into the renal artery 4, the aorta 10, or other suitable artery, with or without the need for placement via a percutaneous catheter 6.

Figure 2 illustrates another embodiment. Again shown is the catheter 6 ascending from the aorta 10 into the renal artery 4. A balloon 14 or other appropriate expander may be located around the periphery of, or adjacent to, the pump 2. The balloon 14 can be inflated, or the expander otherwise expanded, to cause the pump 2 to be situated securely within the renal artery 4. This allows for minimal lateral and axial movement of the pump 2 within the renal artery 4. The pump 2 may be any suitable fluid pump known to those of skill in the art to produce an increase in blood flow in the renal artery 4 above the physiologic rate of flow. This pump 2 may have an internal rotary propeller, diagonal fan or propeller, or other suitable mechanism. The pump 2 may be powered at the proximal end of the catheter, and even outside the patient. A drive shaft for the pump 2 may be located within the body of the catheter 6, to which the pump 2 is attached. Alternatively, the power source may be self-contained within the pump 2 itself, or its housing, or adjacent thereto.

The pump 2 may operate continuously or in some embodiments, intermittently, as befits the need of the patient in optimally lowering blood pressure. The pump 2 may, in certain embodiments, be programmable to operate at various intervals and/or speeds. The programming of the pump 2 may be accomplished before and/or after implantation in the patient. In certain embodiments, the programming may be accomplished by an external electromagnetic coupling device (not shown) such as a hand-held radiofrequency transmitter that may be held by a physician over the patient's body during the programming of pump variables, such as on-off intervals and pump speed. In another aspect (not shown), a microelectrode, radiofrequency catheter, or other energy releasing device is placed within the renal artery 4 and into the substance of the kidney 12, with the tip of the microelectrode or other device in close proximity to the macula densa and juxtaglomerular apparatus. This device then stimulates the macula densa and juxtaglomerular apparatus with an electrical current or other type of energy transmission, such as radiofrequency transmission. This energy stimulation causes a suppression of renin release from the juxtaglomerular apparatus, leading to decreased sodium chloride and water retention by the kidney, and a consequent reduction in blood pressure.

This microelectrode or micro-RF transmitter may be powered outside the patient, with an electrical wire running through a catheter body and supplying electrical power to the microelectrode, or other suitable actuator or transducer at the distal end of the catheter 6. An appropriate power source, such as a battery, may also be located outside of the patient's body. Alternatively, the microelectrode or micro-RF transmitter may be powered by a battery, which may be located, for example, within the microelectrode or micro-RF transmitter device. In other embodiments, an appropriate power source, such as a battery; may also be located outside of the patient's body and power may be delivered to the device through inductive coupling, in any of various ways well known to those skilled in the art.

While certain aspects and embodiments of the invention have been described, these have been presented by way of example only, and are not intended to limit the scope of the invention. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms without departing from the spirit thereof. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the invention.

Claims

WHAT IS CLAIMED IS:
1. An apparatus for reducing blood pressure, comprising: an intravascular pump configured to be placed within an artery, the pump configured to increase antegrade blood flow in a renal artery, thereby producing a reduction in blood pressure.
2. The apparatus of Claim 1 , wherein the artery is a renal artery.
3. The apparatus of Claim 1 , wherein the artery is an aorta.
4. The apparatus of Claim 1, further comprising a control mechanism in communication with the pump, whereby a user can adjust the control mechanism producing a change in the antegrade blood flow through the pump.
5. The apparatus of Claim 4, further comprising a radiofrequency transmitter, wherein the user can adjust the control mechanism remotely via the radiofrequency transmitter, thereby producing a change in the antegrade blood flow through the pump.
6. The apparatus of Claim 4, further comprising a inductive coupling controller, wherein the user can adjust the mechanism remotely via the inductive coupling controller, thereby producing a change in the antegrade blood flow through the pump.
7. An method for reducing blood pressure, comprising: placing an intravascular pump in an artery, the pump configured to increase antegrade blood flow in a renal artery, thereby producing a reduction in blood pressure.
8. The method of Claim 7, further comprising adjusting a control mechanism that is in communication with the pump, whereby said adjusting causes a change in the antegrade blood flow through the pump.
9. The method of Claim 1, wherein the artery is a renal artery.
10. The method of Claim 7, wherein the artery is an aorta.
11. The method of Claim 8, further comprising using a radiofrequency transmitter to adjust the control mechanism remotely, thereby producing a change in the antegrade blood flow through the pump.
12. The method of Claim 8, further comprising using an inductive coupling controller to adjust the control mechanism remotely, thereby producing a change in the antegrade blood flow through the pump.
PCT/US2002/006929 2001-03-01 2002-03-01 Intravascular device for treatment of hypertension WO2002070039A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US27263401P true 2001-03-01 2001-03-01
US60/272,634 2001-03-01

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AU2002250250A AU2002250250A1 (en) 2001-03-01 2002-03-01 Intravascular device for treatment of hypertension

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WO2002070039A3 WO2002070039A3 (en) 2003-05-01
WO2002070039A8 WO2002070039A8 (en) 2003-10-30

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