DEVICES FOR EFFECTIVE AND UNIFORM DENERVATION OF NERVES AND UNIQUE METHODS OF USE THEREOF

• US 20140088575A1
• Filed: 09/27/2013
• Published: 03/27/2014
• Est. Priority Date: 09/27/2012
• Status: Abandoned Application

• Current Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Original Assignee: Trimedyne Incorporated (InnovaQuartz, LLC)
• Inventors: Loeb, Marvin P.
• Application Number:
  US14/039,800
• Publication Number:
  US 20140088575A1
• Time in Patent Office: Days
• US Class Current: 606/7
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence
• CPC Class Codes: A61B 2018/2288 the optical fibre cable having a curved distal end

Abstract

Apparatus for delivering laser energy suitable for denervation, such as renal denervation and the like, comprises an optical fiber inside a cannula and defining a channel therebetween for delivery of a liquid to cool and clean the tip of the optical fiber and to cool tissue subjected to laser irradiation, while the apparatus is Stationed, Moved, Rotated and or Swept during the emission of laser energy.

Claims

1. An apparatus for delivering laser energy to a Target Nerve Tissue comprised of an optical fiber inside a cannula and defining a confined flow passageway for delivery of a sterile, biocompatible liquid to cool and clean debris from a distal end portion of the optical fiber and to cool the Target Nerve Tissue.

2. The apparatus in accordance with claim 1 wherein distal end portion of the cannula is bendable to an angle of up to 90 degrees with respect to the rest of the cannula.

3. The apparatus in accordance with claim 1 wherein distal end portion of the cannula is pliant.

4. The apparatus in accordance with claim 1 wherein distal end portion of the cannula is flexible.

5. The apparatus in accordance with claim 1 wherein the cannula is made of a nickel titanium alloy.

6. The apparatus in accordance with claim 1 wherein the optical fiber has a core diameter of no more than 350 microns and has a beveled distal end portion.

7. A side firing optical fiber device which comprises

a cannula defining a side port;

an optical fiber within the cannula and defining therebetween a confined flow passageway for delivery of a biocompatible cooling liquid to irradiated tissue;

the optical fiber having an end portion encased in a closed-ended capillary tube and beveled for emission of laser energy laterally relative to the longitudinal axis of the optical fiber and through said side port of the cannula;

the device being sized for use through one of;

an endoscope, a laparoscope and a surgically created passageway to treat malfunctioning S/PS/SN nerves within a blood vessel from the outside of the blood vessel, and through an introducer catheter into the lumen of a blood vessel to treat malfunctioning S/PS/SN nerves from the inside of the lumen of the blood vessel.

8. The side firing optical fiber device of claim 7, wherein a double-walled, multi-channel plastic tube is attached to the cannula for delivery of a sterile, biocompatible fluid to a least one of:

(a) cool and clean debris from the tip of the side firing device and cool the Target Nerve Tissue;

(b) inflate a balloon to close the lumen of a blood vessel;

(c) inflate a balloon to press the laser energy emitting surface of the side firing optical fiber device close to the Target Nerve Tissue; and

(d) enable excess fluid to flow from the balloon to one of;

a drain and a collection bottle.

9. The side firing optical fiber device of claim 7, wherein said balloon is capable of venting excess fluid from the balloon.

10. A side firing optical fiber device sized for directing laser energy onto a Target Nerve Tissue to Treat a Medical Condition which comprises an optical fiber having core diameter of no more than 350 microns and a beveled end portion enveloped by a pliant sheath provided with a side port in alignment with laser energy emitted by the optical fiber.

11. The side firing optical fiber device of claim 10 defining a cooling fluid channel between the optical fiber and the sheath.

12. The side firing optical fiber device of claim 10 having a distal end of the optical fiber beveled at an angle in the range of about 35 degrees to about 45 degrees from the longitudinal axis of the optical fiber.

13. The side firing optical fiber device of claim 10 having a distal end of the optical fiber beveled at an angle in the range of about 40 degrees to about 41 degrees with respect to the longitudinal axis of the optical fiber.

14. The side firing optical fiber device of claim 10 wherein the beveled end portion comprises a pair of opposed beveled end surfaces each at an angle of 40 to 41 degrees from the longitudinal axis of the optical fiber.

15. The side firing optical fiber device of claim 10 wherein the beveled end portion is encased within a closed-ended capillary tube.

16. The side firing optical fiber device of claim 10 wherein the sheath is memory metal.

17. The side firing optical fiber device of claim 10 wherein the sheath is plastic.

18. A flexible optical fiber device bendable up to about 60 degrees from the longitudinal axis thereof and adapted to direct laser energy onto a Target Nerve Tissue to treat a Medical Condition and defining a channel between the optical fiber and a surrounding cannula for infusion of a biocompatible fluid for cooling the Target Nerve Tissue.

19. A method for Treating a Medical Condition of a Patient comprising of at least one of:

Stationing, Moving, Rotating and Sweeping onto a Target Nerve Tissue a Thermal Energy in an amount sufficient to interrupt S/PS/SN nerves, including at least one of;

(a) the vagus and splanchnic nerves, within at least one of;

(i) the esophagus, as well as the esophageal artery and vein of the esophagus;

(ii) the hepatic artery and veins of the liver;

(iii) the pancreas, as well as the pancreatic and pancreaticoduodenal arteries and their respective veins of the pancreas;

(iv) the stomach, as well as the abdominal celiac and gastroepiploic arteries and their respective veins of the stomach;

(v) the duodenum, as well as the celiac, gastroduodenal and pancreaticoduodenal arteries, their respective veins, and the portal vein of the duodenum; and

(vi) the intestines, as well as the mesenteric, colic and sigmoid arteries and their respective veins of the intestines, the Medical Condition of the patient being at least one of;

type II diabetes mellitus, insulin resistance, atherosclerosis (by changing the manner in which fat from the diet and fat released from stored fat is metabolized), obesity by at least one of;

affecting the sensation of satiety, the manner in which fat from the diet and fat released from stored fat is metabolized and the means by which the volume of fat stored is controlled, ulcers, irritable bowel syndrome, celiac disease and other S/PS/SN nerve-affected, digestive system-related disorders;

(b) the S/PS/SN nerves within at least one of;

the major arteries of the heart, the major veins of the heart and at least one of the fat pads of the heart and their associated ganglia, preferably the last 50 mm of the right pulmonary veins at their junction with the left atrium and the three fat pads of the heart located (i) on the posteroinferior surface of the heart beneath the left atrium containing the SA ganglion, (ii) on the posteroinferior surface of the heart beneath the right atrium containing the PA ganglion and (iii) on the anterior inferior surface of the heart beneath the left and right atria containing the AA ganglion, the Medical Condition of the patient being at least one of;

arrhythmia, paroxysmal arrhythmia, bradyarrythmia, bradycardia, reduced myocardial contractibility, atrial fibrillation, ventricular fibrillation, cardiac arrest, chronic hear failure, acute heart failure, acute myocardial infarction, stroke, sleep apnea and other S/PS/SN nerve-affected, cardiac-related disorders;

(c) the vagus and splanchnic nerves, within at least one of;

the popliteal, tibial, ilium, sacral and peroneal arteries and their respective veins and the saphenous vein of at least one of;

hip, legs, and feet, the Medical Condition of the patient being at least one of;

peripheral neuropathy, chronic leg cramps, claudication, edema, gangrene, restless leg syndrome and other S/PS/SN nerve-affected, peripheral (below the waist) artery-related disorders;

(d) the carotid, vagus and cervical nerves, within at least one of;

the carotid and vertebral arteries and their respective veins of the brain, the Medical Condition of the patient being at least one of;

epilepsy, seizures, convulsions, fragile X syndrome, autism, multiple sclerosis, amyotrophic lateral sclerosis (ALS), myasthenia gravis, severe depression, migraine headaches, schizophrenia, psychosis, anxiety, Parkinson'"'"'s disease, Huntington'"'"'s disease, senile dementia, Alzheimer'"'"'s disease and other S/PS/SN nerve-affected, central nervous system-related disorders;

(e) the carotid, vagus and cervical nerves, within at least one of;

the basilar, carotid, cerebral and caudate arteries and their respective veins and the thalomostrate vein of the thalamus, the Medical Condition of the patient being at least one of;

insomnia, narcolepsy, multiple sclerosis, amyotrophic lateral sclerosis (ALS), myasthenia gravis, the need to at least one of;

attract stem cells to repair tissue, attract killer white cells to attack at least one of bacteria, a virus or cancer cells (by affecting the means by which the volume, rate of maturism and release of stem cells and white cells is controlled) and other S/PS/SN nerve-affected. thalamus-related disorders;

(f) the cervical, carotid and vagus nerves, within at least one of;

the basilar, cerebral, hypothalamic, carotid and caudate arteries and their respective veins of the hypothalamus and the pituitary and hypophyseal arteries and their respective veins of the pituitary gland, the Medical Condition of the patient being at least one of;

hypogonadism, hypothyroxinemia (low concentration of thryroxine in the blood stream), hyperthyroidism (high concentration of thyroxin in the blood stream), infertility, irregular menorrhagia, Type II diabetes mellitus and other S/PS/SN nerve-affected hypothalamus and pituitary gland-related disorders;

(g) the vagus, cervical, spinous and sciatic nerves of the vertebra, the nerve endings in the capsule of the facets, dorsal primary ramus nerves of the facets and the sacral and sinu-vertebral nerves of the sacrum, within at least one of;

(i) the vertebra, a spinal disc, the sacrum, the hips, the long bones of the arms and legs and the small bones of the ankles, feet, toes, wrists, hands and fingers;

(ii) the vertebral, spinal and intercostal arteries, their respective veins and the vena cava vein of the vertebra;

(iii) the vertebral and sacral arteries and their respective veins of the sacrum;

(iv) the subclavian, brachial, humeral and scapular arteries and their respective veins of the joints of the shoulders;

(v) the radial and ulnar arteries and their respective veins of the joints of the elbows;

(vi) the palmar and digital arteries and their respective veins of the joints of at least one of;

the wrists, hands and fingers;

(vii) the femoral artery and vein and saphenous vein of the joints of the hips;

(viii) the femoral, ilium and popliteal arteries and their respective veins and the saphenous vein of the joints of the knees; and

(ix) the popliteal, tibial and peroneal arteries and their respective veins and the saphenous vein of the joints of at least one of;

the ankles, feet and toes, the Medical Condition of the patient being pain arising from at least one of;

arthritis, avascular necrosis, osteonecrosis, osteocarcoma and physical damage of at least one of;

the vertebra, spinal discs and bones; and

pain arising from the joints of at least one of;

the vertebra, facets, the joint of the sacrum and ilium, shoulders, elbows, wrists, hands, fingers, hips, knees, ankles, feet and toe and other S/PS/SN nerve-affected, joint-related disorders;

(h) the vagus and splanchnic nerves, within at least one of;

the splenic arteries and veins of the spleen, the Medical Condition of the patient being one of;

hypohemoglobia (anemia) and hyperhemoglobia (by affecting the means by which the volume and rate of destruction of red cells is controlled) and other S/PS/SN nerve-affected, spleen-related blood disorders;

(i) the vagus and splanchnic nerves, within at least one of;

the uterine arteries and veins of the uterus, the Medical Condition of the patient being at least one of;

uterine cramps, hot flashes, amenorrhea, dysmenorrhea and infertility (to affect the means by which the volume, type and rate of production of reproductive hormones are controlled) and other S/PS/SN nerve-affected, uterine-related disorders;

(j) the vagus and splanchnic nerves, within at least one of;

the ilium, uterine and ovarian arteries and their respective veins of the ovaries, the Medical Condition of the patient being infertility by affecting the means by which the maturity of eggs, the number of eggs released and their rate of release is controlled, menopause by affecting the means by which the type, volume and rate of production of reproductive hormones is controlled and other S/PS/SN nerve-affected, ovarian-related disorders;

(k) the pelvic and splanchnic nerves, within at least one of;

the ilium, epigastric and testicular arteries and their respective veins of the testes, the Medical Condition of the patient being at least one of;

aspermia (male infertility), by affecting the means by which the volume and maturity of sperm produced and released is controlled and hypogonadism by affecting the means by which the volume and rate of production of testosterone and its release is controlled and other S/PS/SN nerve-affected, testis-related disorders;

(l) the pelvic and splanchnic nerves, within at least one of;

the pudental arteries and veins of the penis, the Medical Condition of the patient being at least one of male impotence by affecting the means by which blood flow to cause erection of the penis is controlled and maintained and other S/PS/SN nerve-affected, penile-related disorders;

(m) the pelvic and splanchnic nerves, within at least one of;

the rectal artery and vein of the rectum and anus, the Medical Condition of the patient being fecal incontinence and other S/PS/SN nerve-affected, rectal and anal-related conditions;

(n) the frontal and parietal branches of the superficial arteries and veins of the scalp, the Medical Condition of the patient being at least one of;

alopecia (baldness), by affecting the means by which at least one of;

the type and volume of testosterone is produced and its rate of release is controlled, and dandruff, by affecting the means by which the volume of blood delivered to the scalp and its rate of flow is controlled, and other S/PS/SN nerve-affected, scalp-related disorders; and

(o) the S/PS/SN nerve endings in the capsule and the medial branches of the primary dorsal ramus nerve of the facet joints and the vertebral, sinu-vertebral, vagus and splanchnic nerves of the sacroiliac joint of the sacrum and ilium, preferably the sine-vertebral nerves, and their branches in the joints of at least the two vertebra above the sacrum;

the Medical Condition of the patient being at least one of;

neck, shoulder, back, hip and leg pain originating in the facets of the vertebra and the sacroiliac joint of the sacrum and ilium and their branches in the joints of at least the two vertebra above the sacrum; and

other S/PS/SN nerve-affected, facet and sacroiliac joint-related disorders.

20. The method of claim 19, wherein the Source of Thermal Energy is preferably a CTH:

YAG laser, which interrupts S/PS/SN nerves, tissues containing S/PS/SN nerves, and other Target Nerve Tissues, with less damage to adjacent tissues;

as it allows significant time between pulses of laser energy for the tissue to cool.

21. The method of claim 19, wherein the laser energy is delivered to a Target Nerve Tissue by one of:

(a) multiple beams of laser energy focused to intersect at a desired point and (b) a beam of laser energy focused to converge at a desired point, the point being about 2 mm to 5 mm from the laser energy emitting surface of the device, to shrink a Target Tissue.

22. A method for Treating a Medical Condition of a Patient comprising of at least one of:

Stationing, Moving, Rotating and Sweeping Onto a Target Nerve Tissue a Source of one of;

pulsed laser energy and continuous wave laser energy, delivered at a desired angle of one of;

an angle of 0°

, 1°

to 60°

, and 61°

to 90°

from the axis of laser beam exiting the Source of laser energy, through at least one needle containing an optical fiber to a desired depth within a Target Nerve Tissue and multiple beams of at least one of;

laser, x-ray, proton, RF, MW and US energy, focused to intersect at a desired point, to interrupt S/PS/SN nerves within the renal arteries of the kidneys, preferably the left and right main renal arteries, the Medical Condition of the patient being at least one of;

hypertension (systolic blood pressure equal to or greater than 140 mm of mercury), chronic heart failure, acute heart failure, acute myocardial infarction, stroke, insulin resistance, type II diabetes mellitus, sleep apnea and other S/PS/SN nerve-affected, kidney-related disorders.

23. A method for Treating a Medical Condition of a Patient comprising of at least one of:

Stationing, Moving, Rotating and Sweeping Onto a Target Nerve Tissue a Source of one of;

pulsed laser energy and continuous wave laser energy, delivered at one of;

a desired angle of at least one of;

0°

, 1°

to 60°

, and 61°

to 90°

from the axis of laser beam exiting the source of laser energy, through at least one needle, containing an optical fiber to a desired depth within a Target Nerve Tissue and multiple beams of at least one of;

laser, x-ray, proton, RF, MW and US energy, focused to intersect at a desired point, to at least one of;

interrupt S/PS/SN nerves, including the lower trachea and branches of the bronchi, as well as the vagus nerve, and after a layer of muscle cells within the bronchi of the lungs, the Medical Condition of the patient being at least one of;

asthma, chronic obstructive pulmonary disease and other S/PS/SN nerve and muscle cell-affected, pulmonary-related disorders.