Abstract
The invention relates to a method of central nervous system pathology treatment through selective hypothermia. Brain and spinal cord cooling is achieved through a closed loop catheter system inserted directly into the cerebrospinal fluid space. The catheter comprises of a portion that dilates in a pulsatile or peristaltic fashion and facilitates circulation of the cooled cerebrospinal fluid.
Claims
1-25. (canceled)
26. A device for treating a central nervous system, the device comprising: an elongated catheter including an outside wall having a first lumen formed therein, and an inside wall having a second lumen formed therein, wherein the inside wall divides the first lumen into two parts that communicate at a distal end of the elongated catheter, the two parts of the elongated catheter being adapted to allow a coolant to circulate therethrough, and wherein a distal portion of the outside wall includes a plurality of ports that communicate with the second lumen and the outside environment.
27. The device of claim 26, wherein the distal portion of the outside wall is capable of expansion.
28. The device of claim 26, the distal portion of the outside wall comprises at least one balloon that is expandable.
29. The device of claim 27, wherein the distal portion of the outside wall is capable of expanding into one or more of the following shapes: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the elongated 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.
30. The device of claim 27, wherein the distal portion of the outside wall is expandable in a peristaltic manner.
31. The device of claim 27, wherein the distal portion of the outside wall is expandable in a pulsating manner.
32. The device of claim 26, further comprising one or more of the following: 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.
33. The device of claim 26, wherein the first lumen and the second lumen are coaxial.
34. A device for treating a central nervous system, the device comprising: a first wall having an outer lumen formed therein; a second wall having an inner lumen formed therein; and a membrane connecting the second wall to the first wall and dividing the outer lumen into two parts, wherein the two parts of the outer lumen communicate at a distal end of the device, and wherein the first wall includes at least one port at the distal end that communicates with the inner lumen and not the outer lumen.
35. The device of claim 34, wherein the distal portion of the outside wall is capable of expansion.
36. The device of claim 34, the distal portion of the outside wall comprises at least one balloon that is expandable.
37. The device of claim 35, wherein the distal portion of the outside wall is capable of expanding into one or more of the following shapes: an oval shape, a round shape, a cylindrical shape, a triangular shape, a double balloon shape, a helical shape, at an angle to the elongated 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.
38. The device of claim 35, wherein the distal portion of the outside wall is expandable in a peristaltic manner.
39. The device of claim 38, wherein the inner lumen and the outer lumen are coaxial.
40. The device of claim 34, wherein the distal portion of the outside wall is expandable in a pulsating manner.
41. The device of claim 33, further comprising one or more of the following: 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.
42. A method of central nervous system treatment, the method comprising: inserting an elongated device into the central nervous system, the elongated device including an outside wall having a lumen formed therein, an inside wall dividing the lumen into two parts that communicate at a distal end of the elongated device, and another lumen with ports at the distal end of the elongated device that communicate with the outside environment; and circulating a coolant through the two parts of the lumen.
43. The method of claim 42, wherein the central nervous system comprises one or more of the following: an intracranial region, a spine, a brain, a spinal cord, a subdural region, a subarachnoid region, an epidural region, an intrathecal region, a cerebral spinal fluid, a lateral ventricle, brain ventricles, an operative area in a brain or spine, and a spinal canal.
44. The method of claim 42, wherein the central nervous system treatment comprises treating one or more of the following: hypothermia induction, increased intracranial pressure, trauma, brain injury, skull fracture, stroke, ischemia, hypoxia, hemorrhage, infection, seizure, edema, burr hole surgery, craniotomy, decompressive craniectomy, spinal cord injury, spine fracture, swelling, tumor, vascular malformation, stenosis, herniated disc, scoliosis surgery, and aortic aneurysm surgery.
45. The method of claim 42, wherein the inserting of the elongated device comprising performing one or more of the following techniques: craniotomy, burr hole, twist-drill hole, laminectomy, laminotomy, percutaneously, endoscope assisted, stereotactic guidance, and ultrasound guidance.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a schematic view of one embodiment the device in the brain lateral ventricle.
[0013] FIG. 2a is a schematic view of the central nervous system and cerebrospinal fluid.
[0014] FIG. 2b is a schematic view of the device in the spinal subarachnoid cerebrospinal fluid space.
[0015] FIG. 3a is a side view of the device.
[0016] FIG. 3b is a longitudinal cross-sectional view of the device.
[0017] FIG. 4 is a longitudinal cross-sectional view of the device with partially dilated balloon.
[0018] FIG. 5 is a longitudinal cross-sectional view of the device with fully dilated balloon.
[0019] FIG. 6 is a partial sectional view of the device.
[0020] FIG. 7 is a cross-sectional view of the device.
[0021] FIG. 8a is a longitudinal cross-sectional view of another embodiment of the device.
[0022] FIG. 8b is a longitudinal cross-sectional view of the device with the balloon in a contracted position.
[0023] FIG. 9a is a longitudinal cross-sectional view of the device with the balloon in a partially dilated position.
[0024] FIG. 9b is a longitudinal cross-sectional view of the device with the balloon in a fully dilated position.
[0025] FIG. 10 is a longitudinal cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0026] FIG. 11 is a longitudinal cross-sectional view of the device with the balloon in a partially dilated position.
[0027] FIG. 12 is a longitudinal cross-sectional view of the device with the balloon in a fully dilated position.
[0028] FIG. 13 is a cross-sectional view of another embodiment the device depicting direction of coolant flow.
[0029] FIG. 14 is a longitudinal cross-sectional view of another embodiment the device with the balloon in a partially dilated position.
[0030] FIG. 15 is a longitudinal cross-sectional view of the device with the balloon in a partially dilated position.
[0031] FIG. 16 is a longitudinal cross-sectional view of the device with the balloon in a fully dilated position.
[0032] FIG. 17 is a longitudinal cross-sectional view of another embodiment the device with the balloon in a partially dilated position.
[0033] FIG. 18 is a partial sectional view of the device.
[0034] FIG. 19 is a cross-sectional view of the device.
[0035] FIG. 20 is a longitudinal cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0036] FIG. 21 is a longitudinal cross-sectional view of the device with the balloon in a dilated position.
[0037] FIG. 22 is a cross-sectional view of the device with the balloon in a contracted position.
[0038] FIG. 23 is a cross-sectional view of the device with the balloon in a dilated position.
[0039] FIG. 24 is a side view of another embodiment of the device.
[0040] FIG. 25 is a side view of another embodiment of the device.
[0041] FIG. 26 is a side view of another embodiment of the device.
[0042] FIG. 27 is a longitudinal cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0043] FIG. 28 is a longitudinal cross-sectional view of the device with the balloon in a partially dilated position.
[0044] FIG. 29 is a longitudinal cross-sectional view of the device with the balloon in a fully dilated position.
[0045] FIG. 30 is a side view of another embodiment the device with the balloon in a contracted position.
[0046] FIG. 31 is a side view of the device with the balloon in a dilated position.
[0047] FIG. 32 is a cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0048] FIG. 33 is a cross-sectional view of the device with the balloon in a dilated position.
[0049] FIG. 34 is a cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0050] FIG. 35 is a cross-sectional view of the device with the balloon in a dilated position.
[0051] FIG. 36 is a cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0052] FIG. 37 is a cross-sectional view of the device with the balloon in a dilated position.
[0053] FIG. 38 is a cross-sectional view of another embodiment the device with the balloon in a contracted position.
[0054] FIG. 39 is a cross-sectional view of the device with the balloon in a dilated position.
[0055] FIG. 40 is a side view of another embodiment the device with the balloon in a dilated position.
[0056] FIG. 41 is a side view of another embodiment the device with the balloon in a dilated position.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0057] In one method of central nervous system pathology treatment, the device as shown in FIG. 1, is placed into the ventricle of the brain or the subarachnoid space of the spine. This allows for cooling of the cerebrospinal fluid and hence the brain and/or spinal cord selectively. The effects of the cooling provide for treatment of swelling, traumatic, hypoxic, and ischemic injuries. These devices can be placed in the lateral ventricles using the standard landmarks or can be precisely placed with stereotactic guidance or use of an endoscope or ultrasound. The device 1 is placed into the cerebrospinal fluid in the ventricle 2 of the brain 3. Typically a hole is drilled into the skull 4 to access the brain and the ventricles through a standard ventriculostomy approach. The device 1 distal end comprises a balloon placed in the cerebrospinal fluid that allows a greater surface area for heat exchange. The proximal end 5 of the device 1 is connected to a regulator that controls the extent of balloon dilation and circulation of the coolant through the device 1 closed loop cooling system. The regulator also monitors ICP and temperature through sensors positioned near the balloon end of the device 1. As shown in FIGS. 2a & 2b, the brain 6 contains cerebrospinal fluid inside the ventricles 8 and is also surrounded by cerebrospinal fluid 9 which is in communication with the cerebrospinal fluid 10 around the spinal cord. Cooling of the cerebrospinal provides for selective hypothermia of the brain and spinal cord. Facilitating circulation of the cooled cerebrospinal fluid provides for a faster brain and spinal cord cooling. The cerebrospinal fluid circulation can be facilitated by a device 1 placed in the cerebrospinal fluid 10 with a balloon that dilates and contracts in an alternating sequence or a peristaltic format as described in the current invention. This sequential dilation and contraction circulates the cerebrospinal fluid inside and outside the brain and spinal cord. It is also very prudent that the extent of the device balloon dilation placed inside the central nervous system be controlled so that the ICP is not increased in this process and also avoid compressive forces on the brain or spinal cord. A balloon that conforms to the shape of the space it has been placed inside the central nervous system allows for the best possible likelihood of not increasing the ICP with balloon dilation. The balloon shape can be round, oval, cylindrical or conform to the shape of the portion of the lateral ventricle it is placed in to avoid compression against the ventricle wall. The preferred spinal cerebrospinal fluid space location of the device is in the lumbar location but can also include cervical or thoracic spine. The device can be placed post-operatively after either a laminectomy, discectomy, or corpectomy. The device 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.
[0058] In one embodiment as shown in FIGS. 3-7, the device is in the contracted position of the balloon 16 as shown in FIGS. 3a & 3b and dilated balloon positions as shown in FIGS. 4 & 5. The device comprises an outside wall 11 and an inside wall 12. The inside wall divides the lumen of the device into two parts 15 that communicate at the distal end 14. The lumens circulate a coolant through a regulator/coolant placed external to the body. The device distal end is placed inside the desired central nervous system location. The distal end also comprises of one or more sensors 13 (pressure, temperature, etc). FIG. 4 shows the distal end 16 of the device in a partially dilated balloon position and FIG. 5 shows the distal balloon 16 completely dilated. The pulsating dilation and contraction of the balloon 16 circulates the cerebrospinal fluid outside the balloon and the circulating coolant in the lumens cools the cerebrospinal fluid. The increased surface area provided by the balloon expansion allows for a greater degree of heat exchange.
[0059] In another embodiment as shown in FIGS. 8 & 9, the device comprises a catheter with a wall 17 and a central lumen 20 surrounded by a lumen 18 and 19. The lumen 20 communicates with the lumen 18 and 19 through holes 21 at the distal end of the catheter and circulates a coolant with the arrows in FIG. 8a depicting the direction of the coolant flow. The catheter also contains sensors 22 at the distal portion. The contracted shape of the balloon is shown in FIGS. 8a & 8b and the expanded shape of the balloon 23 is shown in FIGS. 9a & 9b. The balloon 23 is partially dilated in FIG. 9a and completely dilated in FIG. 9b. The balloon 23 expands and contracts in a pulsating format with circulation of the coolant by an external coolant pump regulator. This pulsating expansion and contraction of the balloon creates a wave in the cerebrospinal fluid where the balloon tip is placed and facilitates circulation of the cooled cerebrospinal fluid throughout the central nervous system.
[0060] In another embodiment of the device as shown in FIGS. 10-12, the catheter comprises a wall 24 with a central lumen 27 that communicates with the lumen 25 and 26 surrounding the central lumen 27 through holes 28 and 29. The holes in the distal portion of the central lumen 27 are larger in diameter proximally 28 and decrease in diameter sequentially distally 29. The coolant is circulated through the lumen 27 and exits into lumen 25 and 26 through the holes 28 and 29 in a closed loop system. The distal catheter wall 31 can dilate if the pressure in the lumen is increased by an external coolant regulator. The larger holes 28 proximally and smaller holes 29 distally in the central lumen 27 allow larger coolant flow more proximally into lumen 25 and 26 thereby dilating the balloon in a peristaltic format as shown in FIGS. 11 & 12. In FIG. 11, the top portion of the balloon 31 is dilated more proximally and the dilation wave progresses more distally as seen with the bottom portion of the balloon 32. This peristaltic format of balloon dilation with circulation of the coolant moves the cooled cerebrospinal surrounding the balloon and facilitates central nervous system cooling.
[0061] In another embodiment of the catheter as shown in FIG. 13, the central lumen 27 is surrounded by lumen 25 with an outer wall 24. The central lumen 27 communicates with surrounding lumen 25 at the distal catheter end through holes 34 and 35 which enlarge circumferentially. This enables the wall 24 to dilate into a balloon in a peristaltic and spiraling format with circulation of the coolant 33 (arrows depicting flow direction). This balloon dilation format further facilitates circulation of the cooled cerebrospinal fluid surrounding the balloon.
[0062] In another embodiment of the catheter as shown in FIGS. 14-19, the central lumen 37 is surrounded by a lumen 39 and catheter wall 36. The central lumen is attached to the outer wall by a membrane 47. The central lumen 37 comprises holes 40 and 41 at the distal end. The holes are larger proximally 41 and taper to a smaller size 40 distally. The holes 41 and 40 also taper from a larger to smaller size in a spiraling format. With circulation of the coolant the outer catheter wall expands into a balloon from proximally to distally in a spiraling and peristaltic format. FIG. 14 shows the balloon 38 dilation in the initial phase, FIG. 15 shows circumferential balloon dilation 38, and FIG. 16 shows the peristaltic balloon dilation 38 moving from proximal to the distal end.
[0063] FIG. 17 illustrates another embodiment of the spiral peristaltic balloon dilation catheter. The central lumen 42 comprises holes 43 and 44 at the distal end surrounded by a lumen 46 and balloon wall 45. The lumen 42 holes enlarge from a smaller 43 to larger 44 sizes from proximal to distal end in a spiraling format. Circulation of the coolant dilates the balloon 45 in a spiral peristaltic manner from distally to proximally.
[0064] In another embodiment of the device as shown in FIGS. 20-23, the catheter also comprises a drainage lumen with ports at the distal end. The lumen 49 and 54 is contained between the catheter outer wall 48 and the inner wall 56. The inner lumen 50 is used for drainage of cerebrospinal fluid and/or hemorrhage through ports 51. This lumen can also be used to monitor intracranial pressure similar to a ventriculostomy drain. The lumen wall 56 is attached to the lumen wall 48 with membrane 55. A coolant is circulated in the lumens 49 and 54 which communicate at the distal end 53 with a closed loop system. A temperature and/or pressure sensor 52 is positioned at the tip or any other location on the catheter to monitor central nervous system temperature and/or pressure. The distal portion of the catheter is capable of dilating into a balloon with circulation of the coolant under controlled pressure with dilation of the lumen 49 and 54 spaces as shown in FIGS. 21 and 23.
[0065] The balloons located at the distal catheter ends can conform to the shape of the central nervous system space that they are placed in. The balloon walls are compliant and conform to the shape most amenable to not increasing the intracranial pressure. FIGS. 24-26 illustrate the various embodiments with different balloon shapes including but not limited to the shapes illustrated. FIG. 24 shows an inflow and outflow coolant circulation lumen 57 with a round balloon 58, FIG. 25 shows an inflow and outflow lumen 59 with an oval balloon 60, and FIG. 26 illustrates an inflow and outflow lumen 61 with a cylindrical balloon 62. Other balloon shapes can comprise of a shape of the lateral ventricle, post-surgical brain cavity, cisterna magna, subdural, epidural or subarachnoid space in the head or spine. The balloons can dilate parallel to the longitudinal catheter axis or at any other angle from 0 to 360 degrees.
[0066] In another embodiment of the device as shown in FIGS. 27-29, the catheter comprises double balloons at the distal heat exchange end. The catheter wall 63 encloses lumens 64 and 69 with a central lumen 70 and a temperature and ICP sensor 68. The central coolant inlet lumen comprises of holes 65 and 67 with a portion in between without holes 66. Pumping of the coolant through the inlet lumen 70 circulates the coolant through holes 65 and 67 with the coolant entering outlet lumens 64 and 69. The balloons 71 and 72 dilate depending on the pressure under which the coolant is pumped. FIG. 28 illustrates the partial dilation of balloon 71 and complete dilation of balloon 72. As more of the coolant is circulated under higher pressure, both the balloons dilate as shown in FIG. 29. This sequential balloon dilation creates a wave in the cerebrospinal fluid surrounding the balloons and facilitates circulation of the cooled cerebrospinal fluid.
[0067] In another embodiment of the device as shown in FIGS. 30 & 31, the catheter distal end comprises of thermal heat conductors 74 in the wall 75. The proximal portion 73 contains and inlet and outlet lumen for coolant circulation and the distal heat conductor portion of the wall 75 can dilate into a balloon as shown in FIG. 31 with the flow of the coolant under pressure. The thermal heat conductors 74 can also comprise of pressure sensors which gauge the extent of balloon dilation by maintaining the central nervous system pressure within a desired range and avoid undue pressure on the surrounding brain.
[0068] In another embodiment of the device as shown in FIGS. 32 and 33, the distal balloon end of the catheter wall 80 comprises of pressure sensors 75. The multiple balloons are arranged in a circumferential format and have an individual inlet 76 and 79 and outlet 77 and 78 ports for coolant circulation. The extent of each balloon 77, 78 dilation is dictated by the pressure on each balloon sensor 75 with the attempt to avoid pressure against the ventricle wall or central nervous system as would normally be undertaken with blind dilation in the prior art. In alternative embodiments, the pressure sensor 75 can also comprise a dual function as a thermal conductor to facilitate heat exchange. FIG. 32 shows the contracted position of the balloons 77 & 78 and FIG. 33 shows the dilated position of the balloons 77 & 78.
[0069] In another embodiment of the device as shown in FIGS. 34 and 35, the distal balloon end of the catheter comprises of balloons 85 and 86 each with a coolant inflow lumens 84 and 83 and outflow lumens 81 and 82. The outflow lumens 81 and 82 dilate into balloons once the coolant is circulated as shown in FIG. 35.
[0070] In another embodiment of the balloon catheter as shown in FIGS. 36 & 37, the central lumen 90 comprises a wall 91 and circulates a coolant into the multiple balloon lumens 87, 88, and 89 which dilate depending on the pressure of the coolant circulation as shown in FIG. 37. The balloon wall is compliant and adapts to the shape of the path of least resistance in the central nervous system. In alternative embodiments, as shown in FIGS. 38 and 39, the balloons 92, 94, and 96 have individual inflow 98, 95, 97 and outflow coolant lumens. The central lumen 93 communicates with cerebrospinal fluid through ports 99 for drainage and pressure monitoring. FIG. 38 shows the contracted position of the balloons 92, 94, and 96 and FIG. 39 shows the expanded position.
[0071] FIG. 40 illustrates double balloons 100 and 102 with drainage ports 104 in the catheter wall 101 between the balloons. A coolant is circulated through a closed loop system through the catheter proximal portion 103 connected to a cooler. FIG. 41 illustrates a balloon cooling catheter 108 with drainage ports 107. The drainage ports 107 can also be incorporated into the balloon wall 105.
[0072] The methodology and device described provides 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 ischemia protection, spinal stenosis, herniated disc, and scoliosis surgery. The device can be placed intracranial following drilling of a hole in the skull via a twist drill, burr hole placement, or craniotomy/craniectomy. It can be placed inside the spinal canal in the epidural, subdural or subarachnoid space through a percutaneous technique or following a laminotomy/laminectomy. Placement of the device intracranially or intraspinally can be further facilitated by radiographic guidance (fluoroscopy), ventriculograms, cisternograms, ultrasound, frame based or frameless stereotactic navigation systems, or endoscopy. The preferred location of the device is in the cerebrospinal fluid space in the lateral ventricle, subarachnoid space of the brain surface, and lumbar intra-thecal space. Other locations include in the surgical resection bed following craniotomy for removal of brain tumor or hemorrhage and spinal epidural or intrathecal space following a laminectomy. The catheter device can also be secured to the skull by a hollow bolt. The closed loop cooling system selectively cools the central nervous system without serious side-effects of generalized body cooling and in some embodiments also provides for drainage of fluid (cerebrospinal fluid or hemorrhage).
[0073] Sensors can be placed in the distal portion of the device positioned inside the central nervous system. These sensors can either be in one location or in multiple locations on the catheter wall. In the preferred embodiment, the sensors monitor pressure and temperature. In other embodiments water sensors can also be positioned to detect cerebrospinal fluid location inside the ventricle to confirm correct catheter location since cerebrospinal fluid predominantly comprises of water. Similarly, impedance sensors can also provide for confirmation of location as the impedance changes from brain to a cerebrospinal fluid location as the catheter is advanced into the lateral ventricle during placement. Other sensors can comprise of cerebrospinal fluid marker sensors, osmolarity sensors, oxygenation sensors, carbonation sensors, metabolite sensors, and pH sensors.
[0074] The device with the capability of cooling and circulation of 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 device intracranially not only cools the brain but also the spinal cord. Similarly, cooling of the brain can also be achieved by placement of the device inside the spinal canal. Alternatively, one device can be placed intracranially and another in the spinal canal to increase the extent of selective central nervous system cooling.
[0075] While the invention and methodology described herein along with the illustrations is specific, it is understood that the invention is not limited to the embodiments disclosed. Numerous modifications, rearrangements, and substitutions can be made with those skilled in the art without departing from the spirit of the invention as set forth and defined herein.
