Method for improving kidney function with extracorporeal shockwaves

Abstract

A method for treating the kidney with focused extracorporeal shockwaves in a noninvasive manner. The method configured to restore blood flow velocity in the interlobular renal arteries, the method using non-invasive focused extracorporeal shockwave therapy (‘ESWT’), the method comprising applying between 1 and 2400 non-invasive focused shockwaves having a repetition rate above one shockwave per second, and energy density of about 0.02 to 0.18 mJ/mm.sup.2. The non-invasive shockwave treatment is applied to various focal zones encompassing renal structures.

Claims

1. A non-invasive method for restoring blood flow velocity in an interlobular renal artery, the method provided in the form of non-invasive focused extracorporeal shockwave therapy (‘ESWT’), the method comprising applying between 1 and 2400 focused shockwaves having a repetition rate above one shockwave per second, and energy density of about 0.02 to 0.18 mJ/mm.sup.2, to at least one of a plurality of renal structure treatment zones selected from: nephron, glomerulus, Bowman's capsule, tubules, medulla, renal artery, renal vein, renal pelvis, papilla, adrenal glands, adrenal cortex, adrenal medulla, phrenic arteries, and adrenal vein, neural tissue directly or indirectly innervating a kidney and renal structures, kidney neural system including renal sympathetic and renal para-sympathetic nerves, and renal sympathetic nerves that lie within and immediately adjacent a wall of a renal artery, or any combination thereof; wherein each of the plurality of treatment zones are provided with at least 100 shockwaves; and, wherein the shockwaves are delivered to the plurality of treatment zones during at least one session per week for up to about 20 sessions within a time frame of up to about 18 weeks.

2. The method of claim 1, wherein the shockwaves are applied to from about 5 and up to about 15 treatment zones.

3. The method of claim 1, wherein at least one of the plurality of renal structure treatment zones is the glomerulus so as to bring about a reduction of intra-glomerular hypertension.

4. A non-invasive method for improving renal blood flow, the method comprising: applying focused extracorporeal shockwave therapy (‘ESWT’) to at least one treatment zone of at least one renal structure selected from renal sympathetic and renal para-sympathetic nerves or renal sympathetic nerves that lie within and immediately adjacent to a wall of a renal artery; the focused shockwave treatment protocol being applied at at least one session per week for up to 20 sessions within a period of up to about 18 weeks, the treatment protocol per session comprising delivery of at between 100 and 2400 shockwaves focused at the at least one treatment zone, the shockwaves having a repetition rate above 1 shockwave per second, and an energy density between 0.02 to 0.18 mJ/mm.sup.2.

5. The method of claim 4, wherein at least one of the shockwaves having a repetition rate between 2-4 shockwaves per second and an energy density of between 0.9-1.1 mJ/mm.sup.2.

6. The method of claim 4, wherein at least 1800 shockwaves are applied during one of the treatment sessions.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the Drawings:

(2) FIG. 1 is a schematic illustrative diagram of the kidney showing the kidney structures including the adrenal gland; and optional treatment zones comprising the nervous system innervating the kidney and the renal artery;

(3) FIG. 2 is a schematic illustrative diagram of a Gantt chart of an optional treatment protocol according to the present invention; and

(4) FIG. 3 is a flowchart of an exemplary method according to the present invention for ESWT of kidney structures.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(5) The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description.

(6) FIG. 1 provides an illustrative schematic diagram of the kidney structures including kidney 100, adrenal gland 110, nephron and glomerulus 102, and renal artery 50. FIG. 1 further provides a schematic illustration of a plurality of optional focal zones and/or treatment zones 104 depicted about the kidney 100 and kidney structures associated with the kidney.

(7) A preferred embodiment of the present invention provides for applying non-destructive and non-invasive ESWT to such kidney structures and in particular to glomerulus 102, adrenal gland, 110 and renal artery 50, and the neural tissue associated with and/or innervating the kidney structures. Most preferably the non-invasive ESWT applied improves overall kidney function. Optionally and preferably the ESWT treatment is provided to treat and/or maintain kidney function at its current level therein reducing kidney degradation due to chronic diseases such as hypertension, diabetes, and/or reduced kidney function. Optionally and preferably the ESWT of the kidney according to the present invention further leads to an overall improvement in kidney function and/or conditions associated with the kidney and/or renal structures.

(8) Optionally the ESWT treatment according to the present invention may be provided to treat chronic kidney disease (‘CKD’) at any stage.

(9) Optionally the ESWT treatment according to the present invention may be provided to treat hypertension.

(10) Most preferably the applied shockwaves are provided in a noninvasive, nondestructive manner, and do not cause tissue temperature elevation while utilizing low pressure amplitude, low energy shockwaves to bring about the treatment to the kidney structures.

(11) Most preferably the ESWT according to the present invention is provided under the visual guidance of an imaging device for example including but not limited to an ultrasound, CT, MRI or the like imaging technology and/or devices as is known and practiced in the art.

(12) Most preferably imaging device and/or technology provides for aiding in defining the ESWT focal zone where treatment is to be applied for example including but not limited to the glomerulus 102, and/or adrenal gland 110, renal artery 50.

(13) Optionally and preferably the shockwave treatment protocol may be focused on the glomerulus to bring about improved blood flow therethrough and associated kidney structures. Optionally the treatment according to the present invention may optionally further provide for removing glomerular calci.

(14) Optionally the ESWT treatment protocol according to the present invention may provide for the treatment of neural tissue and/or neural function of tissue associated with the kidney and kidney structures via optional pathways for example including but not limited to regenerating neural tissue and/or normalization of neural function and/or normalization of neural activity and/or modification of neural function and/or modification of neural activity and/or regulating neural activity and/or regulating neural functions and/or inhibiting neural activity and/or inhibiting neural function and/or promoting neural activity and/or promoting neural function, the like, or any combination thereof.

(15) Optionally and preferably ESWT treatment according to the present invention provides for a cascade of molecular activity that brings about improved renal blood flow through the glomerulus and/or other renal structures and/or restored blood flow velocity in interlobular renal arteries.

(16) Optionally a cascade of molecular activity may for example, involve but is not limited to at least one or more of the following regulatory factors selected from the group consisting of: vascular endothelial growth factor (VEGF), fibroblast growth factors (FGF), angiopoietins (Ang), platelet-derived growth factor, angiogenin, angiotropin, hepatocyte growth factor, platelet endothelial cell adhesion molecule, angiostatin, endostatin, thrombospondin, CXC chemokines, Nitric oxide synthesis, NFkapaB activation, TNF-alpha mRNA expression, decreases the expression of MCP1, decrease expression of CD3 mRNA, and pigment epithelium.

(17) Optionally the shockwave parameters utilized may be: a frequency of about 2 Hz and energy density from about 0.02 to about 0.18 mJ/mm.sup.2.

(18) Most preferably the shockwave parameters utilized are energy density of about 0.09 to about 0.1 mJ/mm.sup.2; at a frequency of about 2 Hz.

(19) Optionally each treatment session may comprise up to about 5000 shockwaves. Most preferably each treatment comprises about 2400 shockwave that are delivered to the kidney structure. Optionally the number of shockwaves per treatment session may be applied to at least one and more preferably a plurality of treatment zones 104 about the kidney structures. Optionally and more preferably a plurality of zones from about 5 up to about 15 zones may be treated during a treatment session. Optionally each zone may be treated with about 100 shockwaves to about 500 shockwaves, that may distributed amongst a plurality of zones from about 5 zones to about 15 zones forming the kidney structures.

(20) Optionally treatment may be provided at a particular structure or about a plurality of structures within one treatment session.

(21) Optionally treatment may be provided from different approaches to the kidney structures.

(22) FIG. 2 shows a schematic non-limiting treatment protocol according to the present invention where non-invasive ESWT treatment is provided to a kidney structure where treatment is provided over a span of 9 weeks, as shown. The optional treatment protocol calls for 2 active treatment sessions per week during weeks 1, 2, 3, 7, 8, and 9, while no treatment is provided during weeks 4-6.

(23) FIG. 3 shows a flowchart of an optional method of treatment of the kidney structures according to an optional embodiment of the present invention. First in stage 300 the kidney structure to be treated is located with an imaging device, for example including but not limited to ultrasound. Optionally and preferably the kidney structure to be treated is identified from the prone approach. Next in stage 302, the shockwave regimen is selected, treatment protocol adjusted and applied. Most preferably treatment protocol comprises 1800 shockwaves with shockwave frequency of 2 Hz, and energy density of about 0.1 mJ/mm.sup.2. Optionally either one or both kidneys are treated; optionally each kidney may be treated in turn, with shockwave regimen including 900 shockwaves with shockwave frequency of 2 Hz, and energy density of about 0.1 mJ/mm.sup.2.

(24) Optionally treatment of 2400 shockwaves is distributed amongst various kidney structures forming a plurality of treatment zones, for example from about 5 zones up to about 15 zones, therein providing from about 100 to about 500 shockwaves per treatment zones.

(25) Optionally the shock treatment may be applied to kidney structures from a plurality of optional approaches for example including but not limited to prone (back), lateral (side), supine (stomach) any combination thereof providing for appropriate non-invasive access to the kidney structures to be treated. For example, an optional treatment protocol may call for 900 shockwaves to be provided from the lateral position and 900 from the prone position.

(26) For example, an optional treatment protocol may for example call for 1800 shockwaves delivered at a frequency of 2 Hz, with energy density of about 0.1 mJ/mm.sup.2. Optionally the 2400 shockwaves may be distributed about both kidneys amongst a plurality of treatment zones, from a plurality of zones for example:

(27) 100 shockwaves from the prone position targeting a kidney structure forming a single treatment zone of the left kidney, with frequency of 3 Hz with energy density of 0.06 mJ/mm.sup.2;

(28) Next the right kidney is treated with 1650 shockwaves with frequency of 2 Hz with energy density of 0.1 mJ/mm.sup.2 distributed about a plurality of treatment zones and kidney structures from a plurality of approaches (position) as follows;

(29) 100 shockwaves from the prone position targeting a first kidney structure forming a first treatment zone of the right kidney;

(30) next 650 shockwaves from the lateral position dispersed about a plurality of treatment zones comprising a second treatment zone provided with 300 shockwaves, a third zones provided with about 100 shockwaves and a fourth treatment zone provided with about 250 shockwaves;
next a further 900 shockwaves from the prone position delivered to a plurality of treatment zones, a fifth zone provided with 300 shockwaves and finally a sixth zone provides with 600 shockwaves.

(31) Optionally and preferably treatment is repeated as necessary about at least one or more focal zones 104.

(32) Lastly, in stage 304 following treatment of all renal structures and/or zones a follow up period applied based on the structure treated.

(33) While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.