Selective central nervous system treatment catheter and a method of using the same
11534336 ยท 2022-12-27
Inventors
Cpc classification
A61M3/0229
HUMAN NECESSITIES
A61M2205/3344
HUMAN NECESSITIES
A61M2025/0031
HUMAN NECESSITIES
A61M1/85
HUMAN NECESSITIES
A61M25/003
HUMAN NECESSITIES
A61M2027/004
HUMAN NECESSITIES
A61M25/0026
HUMAN NECESSITIES
A61M27/006
HUMAN NECESSITIES
A61F2007/126
HUMAN NECESSITIES
A61F7/12
HUMAN NECESSITIES
A61F7/123
HUMAN NECESSITIES
International classification
A61F7/00
HUMAN NECESSITIES
A61F7/12
HUMAN NECESSITIES
Abstract
An apparatus and method use a catheter for specific and discriminate treatment of central nervous system disease. With the catheter, selective hypothermia to the brain and/or the spinal cord for injury protection can be achieved without the need for systemic cooling. The catheter is also capable of draining excess cerebrospinal fluid.
Claims
1. A catheter for central nervous system treatment, the catheter comprising: an outside wall; a first inside wall; and a second inside wall, wherein the outside wall, the first inside wall, and the second inside wall define a first lumen, the first inside wall and the outside wall define a second lumen, the second inside wall and the outside wall define a third lumen, the first lumen and the second lumen communicate at a distal portion of the catheter, the first lumen and the second lumen being adapted to have a coolant circulated therethrough, and only a distal end portion of the outside wall defining the third lumen has one or more holes, the one or more holes allowing the third lumen to communicate with the outside environment.
2. The catheter of claim 1, wherein the outside wall is cylindrical.
3. The catheter of claim 1, wherein a distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable.
4. The catheter of claim 1, wherein a distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen comprises at least one balloon that is expandable.
5. The catheter of claim 3, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
6. The catheter of claim 3, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable in a peristaltic manner.
7. The catheter of claim 3, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable in a pulsating manner.
8. The catheter of claim 1, further comprising one or more of: a water sensor, a pressure sensor, an osmolarity sensor, a temperature sensor, an impedance sensor, an oxygenation sensor, a carbonation sensor, a metabolite sensor, a pH sensor, and a cerebrospinal fluid sensor.
9. A catheter of claim 1, wherein the second inside wall is straight, and the first inside wall and the second inside wall are connected.
10. The catheter of claim 9, wherein the third lumen is rectangular shaped.
11. A catheter for central nervous system treatment, the catheter comprising: an outside wall; a first inside wall; and a second inside wall, wherein the first inside wall is straight, the second inside wall is straight, the outside wall and the first inside wall define a first lumen, the outside wall, the first inside wall and the second inside wall define a second lumen, the outside wall and the second inside wall define a third lumen, the first lumen and the second lumen communicate at a distal portion of the catheter, the first lumen and the second lumen being adapted to circulate a coolant in a closed loop through an external flow regulator connected to the catheter, and only a distal end portion of the outside wall defining the third lumen has one or more holes, the one or more holes allowing the third lumen to communicate with the outside environment.
12. The catheter of claim 11, wherein a distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable.
13. The catheter of claim 11, wherein a distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen comprises at least one balloon that is expandable.
14. The catheter of claim 12, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
15. The catheter of claim 12, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable in a peristaltic manner.
16. The catheter of claim 12, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable in a pulsating manner.
17. The catheter of claim 11, further comprising one or more of: a water sensor, a pressure sensor, an osmolarity sensor, a temperature sensor, an impedance sensor, an oxygenation sensor, a carbonation sensor, a metabolite sensor, a pH sensor, and a cerebrospinal fluid sensor.
18. A catheter for central nervous system treatment, the catheter comprising: an outside wall; a first inside wall; and a second inside wall, wherein the outside wall, the first inside wall, and the second inside wall define a first lumen, the outside wall and the first inside wall define a second lumen, the second inside wall and the outside wall define a third lumen, the first inside wall and the second inside wall are parallel to each other, the first lumen and the second lumen communicate at a distal portion of the catheter, the first lumen and the second lumen being adapted to have a coolant circulated therethrough, and only a distal end portion of the outside wall defining the third lumen has one or more holes, the one or more holes allowing the third lumen to communicate with the outside environment.
19. The catheter of claim 18, wherein a distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable.
20. The catheter of claim 18, wherein a distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen comprises at least one balloon that is expandable.
21. The catheter of claim 19, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
22. The catheter of claim 19, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable in a peristaltic manner.
23. The catheter of claim 19, wherein the distal portion of the outside wall other than the distal end portion of the outside wall defining the third lumen is expandable in a pulsating manner.
24. The catheter of claim 18, further comprising one or more of: a water sensor, a pressure sensor, an osmolarity sensor, a temperature sensor, an impedance sensor, an oxygenation sensor, a carbonation sensor, a metabolite sensor, a pH sensor, and a cerebrospinal fluid sensor.
25. A method for treatment of a central nervous system, the method comprising: inserting a catheter into the central nervous system, the catheter including: an outside wall; a first inside wall; and a second inside wall, wherein the outside wall, the first inside wall, and the second inside wall define a first lumen, the first inside wall and the outside wall define a second lumen, the second inside wall and the outside wall define a third lumen, the first lumen and the second lumen communicate at a distal portion of the catheter, and only a distal end portion of the outside wall defining the third lumen has one or more holes, the one or more holes allowing the third lumen to communicate with the outside environment; and circulating a coolant through the first lumen and the second lumen.
26. The method of claim 25, wherein the treatment of the central nervous system addresses one or more of: traumatic brain injury, spine trauma, ischemia, hypoxia, seizure, hemorrhage, tumor, infection, cranial surgery, increased intracranial pressure, cerebral swelling, spinal cord injury, ischemia, hypoxia, swelling, aortic aneurysm surgery or endovascular treatment, aortic dissection surgery or endovascular treatment, cross clamping of aorta, tumor, infection, scoliosis surgery, and spine surgery.
27. The method of claim 25, wherein the inserting of the catheter is accomplished by one or more of: craniotomy, burr hole, twist-drill hole, laminectomy, laminotomy, percutaneously, endoscope assisted, stereotactic guidance, x-ray guided, fluoroscopy, intrathecal contrast agent, ultrasound guidance, and radio-opaque markers.
28. The method of claim 25, wherein the inserting of the catheter comprises inserting the catheter into one or more of: cerebrospinal fluid, intraventricular, lateral ventricle, cerebral subarachnoid, spinal subarachnoid, cerebral subdural, intrathecal, epidural, intracerebral, cisterna magna, third ventricle, and fourth ventricle.
29. The method of claim 25, further comprising at least one of draining cerebrospinal fluid via the third lumen or performing pressure monitoring of the central nervous system via the third lumen.
30. The method of claim 25, further comprising: draining cerebrospinal fluid via the third lumen; and regulating the draining of the cerebrospinal fluid by one or more of: a valve that opens at a set pressure, an anti-reflux valve, an automated collection chamber that allows fluid drainage at a set pressure, a drainage bag that allows fluid drainage at a set pressure based on location of a bag relative to anatomical landmarks.
31. The method of claim 25, further comprising performing selective hypothermia of the central nervous system with the circulating of the coolant.
32. The method of claim 31, wherein the performing of the selective hypothermia comprises adjusting a temperature of the coolant during the circulating of the coolant.
33. The method of claim 31, wherein the performing of the selective hypothermia comprises adjusting a flow rate of the coolant during the circulating of the coolant.
34. The catheter of claim 1, wherein one of the first inside wall and the second inside wall contacts the distal portion of the catheter, and the distal portion of the catheter and a terminal end of another of the first inside wall and the second inside wall have a gap formed therebetween.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(22) As shown in
(23) The catheter 1 can be inserted in the lateral ventricle of the brain similar to a ventriculostomy drain via, for example, a twist drill hole in the skull, a burr hole or during a craniotomy procedure. The option of a distal balloon increases the surface area to allow faster and more efficient heat exchange and selective cooling by convection to the CSF space, as well as the possibility of direct contact with the ventricle wall lining. An effective spinal cerebrospinal fluid space location of the catheter 1 is in the lumbar location, but can also include the cervical or thoracic spine. Alternatively, the catheter 1 can be inserted through the lumbar spine with the distal tip positioned in the thoracic spine. The catheter 1 cools the spinal cord by cooling the CSF, as well as by direct spinal cord surface contact. The catheter 1 can, for example, be inserted post-operatively after a laminectomy, discectomy, or corpectomy. The catheter 1 can also be inserted through a percutaneous technique similar to placement of a spinal drain or lumbar puncture. X-ray or fluoroscopy can also be used to locate the correct spinal placement of the catheter 1.
(24) As shown in
(25) The catheter distal end is placed inside the desired central nervous system location. The distal portion can also have one or more sensors (pressure, temperature, etc.). The distal portion of the inferior wall portion 9 can have one or more holes 10 that allow the lumen 12 to communicate with the outside environment, and allow for the drainage of cerebrospinal fluid, as well as the monitoring of the central nervous system (e.g., the intracranial pressure).
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(27) The distal portion of the outside coaxial wall superior portion 13 is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
(28) In a second embodiment, as shown in
(29) The distal end of the catheter 1 is placed inside the desired central nervous system location. A distal portion 23 of the catheter 1 can also have one or more sensors (pressure, temperature, etc.). The distal portion of the inferior wall portion 17 can have one or more holes 18 that allow the lumen 20 to communicate with the outside environment, and allow for the drainage of cerebrospinal fluid, as well as the monitoring of the central nervous system (e.g., the intracranial pressure).
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(31) The distal portion of the outside coaxial wall superior portion 15 is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
(32) In a third embodiment, as shown in
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(34) The distal portion of the outside coaxial wall superior portion 25 is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
(35) In a fourth embodiment of the catheter 1, as shown in
(36) The inside straight wall 75 and the inferior wall portion 66 define a lumen 71 which communicates with the outside environment through holes 72 at a distal end of the inferior wall portion 66. This allows for the drainage of cerebrospinal fluid, as well as the monitoring of the central nervous system (e.g., the intracranial pressure). The catheter distal end is placed inside the desired central nervous system location. The distal portion 70 can have one or more sensors (pressure, temperature, etc.).
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(38) The distal portion of the outside coaxial wall superior portion 67 is capable of expanding into one or more of the following: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the catheter, a shape of a portion of or an entire lateral ventricle, a shape of a frontal horn of a lateral ventricle, a shape of body of a lateral ventricle, a shape of an occipital horn of a lateral ventricle, a shape of a third ventricle, a shape of an operative area in a brain or spine, a shape of a cisterna magna, and a shape of a spinal canal.
(39) As shown in
(40) The catheter 1 also provides for drainage of cerebrospinal fluid and lowering the intracranial and spinal pressures via the other lumen of the catheter 1 that communicates with the outside environment through one or more holes in the catheter 1. The draining of the cerebrospinal fluid can be regulated by one or more of: a valve that opens at a set pressure, an anti-reflux valve, an automated collection chamber that allows fluid drainage at a set pressure, a drainage bag that allows fluid drainage at a set pressure based on location of a bag relative to anatomical landmarks.
(41) As shown in
(42) A spinal CSF location of the catheter 1 can be in the lumbar spine, but can also be the cervical or thoracic spine. Alternatively, the catheter 1 can be inserted through the lumbar spine with the distal tip positioned in the thoracic or cervical spine. The catheter 1 cools the spinal cord by cooling the CSF, as well as direct spinal cord surface contact. The catheter 1 can be placed post-operatively after either a laminectomy, discectomy, or corpectomy. The catheter 1 can also be placed through a percutaneous technique similar to placement of a spinal drain or lumbar puncture. X-ray or fluoroscopy can also be used to locate the correct spinal placement of the device.
(43) A cranial location of the catheter 1 can be the lateral ventricle of the brain. Other locations can include cerebral subdural space, cerebral subarachnoid space, spinal sabarachnoid space, cisterna magna, third ventricle, fourth ventricle, cerebral ventricles, intraventricular space, epidural space, and intracerebral space.
(44) For selective brain and/or spinal cooling, the catheter 1, as shown in
(45) As shown in
(46) The effects of the cooling provide for treatment of swelling, traumatic, hypoxic, and ischemic injuries. The catheter 1 is placed into the cerebrospinal fluid in the ventricle 43 of the brain 42. Typically a hole is drilled into the skull 45 to access the brain and the ventricles through a standard ventriculostomy approach.
(47) The methodology and device described provide for treatment of any central nervous system pathology including, but not limited to, treatment of increased intracranial pressure, brain swelling or edema, spinal cord edema, trauma, brain injury, skull fracture, stroke, ischemia, hypoxia following respiratory or cardiac arrest, tumors, hemorrhage, infection, seizure, spinal cord injury, spine fractures, arteriovenous malformations, aneurysms, aortic artery surgery related spinal cord ischemia protection, thoracic and/or abdominal aortic aneurysm or dissection surgical or endovascular repair, spinal stenosis, herniated disc, and scoliosis surgery.
(48) The catheter 1 can be inserted intracranially following the drilling of a hole in the skull via a twist drill, burr hole placement, or craniotomy/craniectomy. It can be inserted inside the spinal canal in the epidural, subdural or subarachnoid space through a percutaneous technique or following a laminotomy/laminectomy. Placement of the catheter 1 intracranially or intraspinally can be further facilitated by radiographic guidance (fluoroscopy), ventriculograms, cisternograms, myelogram with the injection of an intrathecal contrast agent through the catheter 1, ultrasound, frame based or frameless stereotactic navigation systems, or endoscopy. The catheter 1 can also comprise radio-opaque markers or be impregnated with barium to visualize correct placement in the central nervous system with x-rays.
(49) Examples of locations for inserting the catheter 1 are in the cerebrospinal fluid space in the lateral ventricle, the subarachnoid space of the brain surface, and adjacent to the thoracic spinal cord with entry through the lumbar intra-thecal space. Other locations include in the surgical resection bed following a craniotomy for the removal of a brain tumor or hemorrhage and the spinal epidural or intrathecal space following a laminectomy. The catheter 1 can also be secured to the skull by a hollow bolt. The closed loop cooling system of the catheter 1 selectively cools the central nervous system without serious side-effects of generalized body cooling and, in some embodiments, also provides for the drainage of fluid (cerebrospinal fluid or hemorrhage).
(50) Sensors can be placed in the distal portion of the catheter 1 to be positioned inside the central nervous system. These sensors can either be in one location or in multiple locations on the catheter wall. In an embodiment, the sensors monitor pressure and temperature. In other embodiments, water sensors can also be positioned on the catheter 1 to detect cerebrospinal fluid location inside the ventricle to confirm correct catheter location, since cerebrospinal fluid predominantly comprises water. Similarly, impedance sensors on the catheter 1 can also provide confirmation of the location as the impedance changes from brain to a cerebrospinal fluid location as the catheter 1 is advanced into the lateral ventricle during placement. Other sensors on the catheter 1 can comprise cerebrospinal fluid marker sensors (i.e., cerebrospinal fluid sensors), osmolarity sensors, oxygenation sensors, carbonation sensors, metabolite sensors, and pH sensors.
(51) The catheter 1 with the capabilities of cooling and circulating the cerebrospinal fluid provides for selective cooling of the brain and spinal cord. Since the cerebrospinal fluid is in communication from inside the brain to the outer surface of the brain and spinal cord, placement of the catheter 1 intracranially not only cools the brain but also the spinal cord. Similarly, cooling of the brain can also be achieved by placement of the catheter 1 inside the spinal canal. Alternatively, one catheter 1 can be placed intracranially and another catheter 1 in the spinal canal to increase the extent of selective central nervous system cooling.
(52) While the embodiments and methodology described herein along with the illustrations are specific examples of the present disclosure, it is understood that the disclosure is not limited to the embodiments described herein. Numerous modifications, rearrangements, and substitutions can be made by those skilled in the art without departing from the spirit of the disclosure as set forth and defined herein.