Surgical catheter

Abstract

A surgical kit for removing a subdural hematoma is provided. The surgical kit includes a cranial access port that comprises a port body having a bend incorporated therein. The port body is configured to be disposed at least partially within a subdural space and the port body has at least one lumen formed therein, wherein the cranial access port has a catheter position indicator. A catheter is configured for insertion into the at least one lumen. The catheter comprises an elongated hollow body having a distal section, an intermediate section, and a proximal section. At least first and second markers are located along the intermediate section for indicating a degree of extension of the catheter from the access port.

Description

[0001] SURGICAL CATHETER

[0002] Cross-Reference to Related Application

[0003] The present application claims priority to and the benefit of U. S. patent application Serial No. 63 / 752,327, filed January 31, 2025, which is hereby expressly incorporated by reference in its entirety.

[0004] The present application is related to a PCT application that published as WO2024 / 249575, which is hereby expressly incorporated by reference in its entirety.

[0005] Technical Field

[0006] The present disclosure is directed to subdural hematoma evacuation devices and more particularly, to surgical catheters for use with cranial access ports for use in a subdural hematoma evacuation procedure and more particularly, to a surgical catheter configured for removal of a subdural hematoma and for use with cranial access ports that can be used in a minimally invasive procedure at the beside or in an angiography suite and are configured to permit delivery of one or more surgical tools to the subdural space, as well as providing a 360 degree real time view of the subdural space.

[0007] Background

[0008] A subdural hematoma (SDH) represents a blood collection, located between the dura and the middle layer of the meninges. This condition tends to have a compressive effect on the brain, which can lead to neurological effects and even death. When the blood is first collected, it has a viscous consistency. At this stage, the subdural hematoma is considered to be acute. As the hematoma progresses, the blood becomes thin, encapsulated, and liquified, at this stage, the hematoma is considered to be chronic (CSDH).

[0009] Subdural hematomas tend to develop after a traumatic event and are mostly produced due to falls from the same or another level. In a traumatic brain injury, the inertial movement that arises after the acceleration and deceleration of the skull and brain combo leads to a rupture of the bridging veins in the subdural space. Subdural hematomas are significantly more likely in older people. It is predicted given current trends, CSDH will surpass primary brain tumors and metastases as the most common cranial surgical condition in the U. S.

[0010] Without treatment, a subdural hematoma can be fatal. Approximately one-third of all chronic subdural hematoma patients die and another one-third become permanently disabled.If surgically removed, the hematoma capsule is usually reached and resolved with one of the two main treatments, a burr hole opening or a craniotomy. A craniotomy is generally reserved for an extensive hematoma and is considered a second-tier surgical option for most cases. It requires the surgeon to remove a relatively large piece of skull, evacuate the hematoma, and then reattach the flap back on the patient. A burr hole evacuation, in turn, is performed by suctioning and irrigating the blood out of the skull through a small hole; this procedure is generally preferred due to its low invasiveness.

[0011] However, compared to the craniotomy, a burr hole is not nearly as effective at evacuating the hematoma and is more likely to cause recurrence in patients. The recurrence occurs due to the small window the burr hole provides the surgeon with. Without complete access to the hematoma, the surgeon is rarely able to evacuate it properly, which leads to postoperative complications. Furthermore, clinical trials are currently ongoing to test the safety and efficacy of an up and coming technique called middle meningeal artery (MMA) embolization. MMA embolization is an intervention designed to occlude or restrict blood flow to these capillaries thereby preventing leakage. A downside to this technique, is that patients that undergo surgical evacuation and MMA embolization would need to receive two separate anesthesia sessions as one procedure is performed in the operating room, and the other in the angiography suite.

[0012] A third surgical option can be referred to as being a bedside procedure in that there are commercially available evacuation tools for subdural hematomas that are designed to be used at the bedside. These types of tools include equipment needed for burr hole drilling, insertion and blood drainage. If effective, bedside procedures are cheaper for both the hospital and the patient, less invasive, and faster. However, these commercially available tools fail to achieve the same effectiveness as a craniotomy or a burr hole evacuation. In particular, these types of tools tend to have a much higher likelihood to cause a recurrence than craniotomy.

[0013] It is also important to note that without any treatment, few chronic subdural hematomas have been reported to regress spontaneously, whereas 40% of all patients may recover without surgical intervention. However, 30% of patients undergoing conservative management require surgical intervention.

[0014] In order to create a successful catheter that allows for the removal of a subdural hematoma, multiple requirements must be met.

[0015] Summary

[0016] The present catheter device and surgical kit aim to aid physicians to maximizesubdural hematoma evacuation at the bedside table and in the angiography suite. Increased evacuation and efficacy will be achieved with an endoscopic system and a guided catheter that are inserted through an angled port and into the subdural space. The specialized catheter will allow the surgeon to navigate the subdural space, perform membranectomy and along with the endoscopic system, ensure that the subdural hematoma has been properly evacuated.

[0017] In one embodiment, a surgical kit for removing a subdural hematoma. The surgical kit includes a cranial access port that comprises a port body having a bend incorporated therein. The port body is configured to be disposed at least partially within a subdural space and the port body has at least one lumen formed therein, wherein the cranial access port has a catheter position indicator. A catheter is configured for insertion into the at least one lumen. The catheter comprises an elongated hollow body having a distal section, an intermediate section, and a proximal section. The elongated hollow body has a variable durometer throughout its length to allow for maneuverability and control. The distal section has a beveled shaped at a distal end thereof and the intermediate section comprises a braided or coiled section.

[0018] At least first and second markers are located along the intermediate section, the first marker indicating a retracted position of the catheter within the at least one lumen in which the distal tip has not exited the at least one lumen and the second marker indicating a fully deployed position of the catheter in which the distal section of the catheter is outside of the at least one lumen but a bottom portion of the intermediate section remains within the at least one lumen.

[0019] Brief Description of the Drawing Figures

[0020] Exemplary embodiments can be understood in more detail from the following description taken in conjunction with the accompanying drawings, in which:

[0021] Fig. 1 is a perspective view of an access port according to one embodiment;

[0022] Fig. 2 is a front elevation view of the access port along with first and second instruments inserted therein;

[0023] Fig. 3 is a cross-sectional view taken along the line A-A of Fig. 2;

[0024] Fig. 4 is a cross-sectional view taken along the line B-B of Fig. 2;

[0025] Fig. 5 is a perspective view of an access port according to another embodiment with a catheter inserted within a first lumen of the access port and being shown in a fully deployed position;

[0026] Fig. 6A is a breakaway side elevation view of a three-section catheter according to oneembodiment and shown a first suction state;

[0027] Fig. 6B is a breakaway side elevation view of the three-section catheter shown a second suction state;

[0028] Fig. 7 A is a breakaway side elevation view of a three-section catheter according to another embodiment and shown a first suction state;

[0029] Fig. 7B is a breakaway side elevation view of the three-section catheter shown a second suction state;

[0030] Fig. 8 is a perspective view of an access port with a catheter inserted within a first lumen of the access port and being shown in a fully deployed position with a torque device shown;

[0031] Fig. 9 is a perspective view of an access port with a catheter inserted within a first lumen of the access port and being shown in a retracted position with a first marker scheme being shown;

[0032] Fig. 10 is a perspective view of the access port with the catheter inserted within the first lumen of the access port and being shown in a fully deployed position with the first marker scheme being shown;

[0033] Fig. 11 A is a perspective view of an access port with a catheter inserted within a first lumen of the access port and being shown in a retracted position with a second marker scheme being shown;

[0034] Fig. 11 B is a perspective view of the access port with the catheter inserted within the first lumen of the access port and being shown in a fully deployed position with the second marker scheme being shown; and

[0035] Fig. 12 is a perspective view of an access port with a catheter inserted within a first lumen of the access port and being shown in a retracted position with a third marker scheme being shown.

[0036] Detailed Description of Certain Embodiments

[0037] The present surgical catheter device and surgical (instrument) kit aim to aid physicians to maximize subdural hematoma evacuation at the bedside table and in the angiography suite. Increased evacuation and efficacy will be achieved with an endoscopic system and a guided catheter that are inserted through an angled port and into the subdural space. Together, these various components form the surgical kit. The specialized catheter disclosed herein allows the surgeon to navigate the subdural space, perform membranectomy and along with the endoscopic system, ensure that the subdural hematoma has been properlyevacuated.

[0038] Selected surgical instruments of the surgical kit are described in more detail below.

[0039] Cranial Access Port 100

[0040] A cranial access port is disclosed and is configured to overcome the deficiencies noted above with respect to traditional subdural hematoma evacuations and provide an improved solution for subdural hematoma evacuations. As described herein, the cranial access ports disclosed herein provide a subdural hematoma evacuation solution that can be performed at bedside and in the angiography suite, thereby decreasing the number of anesthesia sessions necessary, which can be cumbersome for older patients. The present solution also provides active suction and a 360 degree view of the subdural space will provide the surgeon with the force necessary to remove viscous hematoma and the visual feedback to identify key structures and determine evacuation completion.

[0041] The cranial access port, according to one embodiment, comprises a port body having a bend incorporated therein and having an ellipse cross-section. The port body is configured to be disposed at least partially within a subdural space and the port body having at least one lumen formed therein. The at least one lumen is configured to receive at least one tool for performing at least one operation within the subdural space. The cranial access port is primarily discussed for use in the subdural space; however, other applications may be possible such as treatment of epidural and intraparenchymal hematoma.

[0042] In one embodiment, the at least one lumen comprises a first lumen and a second lumen and the at least one tool comprises a visualization device, such as an endoscope, and at least one other tool. The first or second lumen is configured to receive the endoscope and the other of the first or second lumen is configured to receive the at least one other tool. The visualization device, in combination with the 360 degree rotation, provides the surgeon with a 360 degree real time view of the subdural space.

[0043] The bend can be defined by an angle greater than 0 to 180 degrees, more particularly, by an angle greater than 0 to 90 degrees. For example, the bend can be a 90 degree bend.

[0044] The cranial access port also includes a stabilizing base that is configured to be fixedly attached to a patient’s scalp and includes an opening to permit the port body to pass therethrough. The stabilizing base thus permits anchoring of the access port 100 in a desired position.

[0045] More specifically and with reference to Figs. 1-4, a cranial access port 100 is illustrated and provides an improved solution for subdural hematoma evacuations. To successfully evacuate a subdural hematoma and provide an improved tool and surgical procedure, theevacuation tool must satisfy a number of requirements. Because subdural hematoma affects mainly older people, who tend to have a series of comorbidities, a minimally invasive evacuating surgery is highly beneficial. Additionally, creating a solution that can be performed at bedside and in the angiography suite will decrease the number of anesthesia sessions necessary, which can be cumbersome for older patients. Lastly, a solution that provides active suction and a 360 degree view of the subdural space will provide the surgeon with the force necessary to remove viscous hematoma and the visual feedback to identify key structures and determine evacuation completion.

[0046] As understood by one skilled in the art, the subdural space (or subdural cavity) is a potential space that can be opened by the separation of the arachnoid mater from the dura mater as the result of trauma. The dimensions of the subdural space will vary from patient to patient as a result anatomical differences, etc. A subdural hematoma is thus a buildup of blood on the surface of the brain. The blood builds up in a space (subdural space) between the protective layers that surround the brain.

[0047] The cranial access port 100 is defined by an access port body 110 that has a first end 112 and an opposite second end 114. Each of the first end 112 and the second end 114 can have a flat, planar surface. As shown in the figures, the access port body 110 comprises a bent structure in that there is a bend formed along a length of the access port body 110. The bend defines a bent section 120 that is located between an upper section 122 and a lower section 124. The bend in the access port body 110 can be defined by an angle that is greater than 0 and is 180 degrees or less and in one embodiment, the bend is defined by an angle that is greater than 0 and is 90 degrees or less. As shown, the bent section 120 is not formed as a sharp bend but instead has soft curvature within the bent section 120. In other words, there is a soft curve from the lower section 124 to the upper section 122.

[0048] In the illustrated embodiment, the angle of the bend is 90 degrees and therefore, a longitudinal axis of the upper section 122 that passes through a center of the upper section 122 at the first end 112 is perpendicular to a longitudinal axis of the lower section 124 that passes through a center of the lower section 124 at the second end 114. This results in the flat, planar surface at the first end 112 lying in a plane that is perpendicular to a plane that contains the flat, planar surface at the second end 114. The lengths of the upper section 122 and lower section 124 can be different, as shown, and more particularly, the upper section 122 can have a greater length than the lower section 124.

[0049] The cranial access port 100 can further include a retractor base 200 which is separate and removable from the combined access port body 110 and the collar 150. More particularly,the retractor base 200 is configured to engage the cranial access port 100 during the surgical procedure as discussed herein.

[0050] The retractor base 200 can be characterized as being an external stabilizing structure. It will also be understood that other stabilizing structures can be used so long as they can be fixed to the scalp and permit free rotation of the cranial access body 110. For example, a tripod structure can be provided as the stabilizing structure.

[0051] In addition, the stabilizing structure can contain a drainage mechanism, such as a number of holes to support drainage.

[0052] Intraluminal Tools

[0053] As mentioned, the cranial access ports disclosed herein have one or more lumens and in the case of the cranial access port 100, it has side-by-side first and second lumens 130, 140. These two lumens 130, 140 are designed to receive one or more intraluminal tool for use in the surgical procedure (i.e., the subdural hematoma evacuation).

[0054] Visualization Device

[0055] One of the intraluminal tools can be in the form of a visualization device that allows the surgeon a 360 degree view of the subdural space, and in particular, a view of the blood tissue mass to be evacuated. Direct visualization of the subdural space enables qualification of the percent of the hematoma that has been evacuated. Identification of septations and avoidance of structures that may cause secondary bleeds when tampered. The inclusion of visualization in the cranial access port 100 allows for increased evacuation rates and decreases the likelihood of excess surgical trauma that is undergone in more invasive procedures. In other words, inclusion of visuali zation in the cranial access port 100 allows for an evacuation procedure that provides the benefits of a craniotomy in a minimally invasive manner.

[0056] It will be appreciated that any number of different visualization devices can be used as part of the cranial access port 100. For example, the visualization can be achieved through the use of a camera system embedded at the top of the cranial access port; a rigid endoscope; or a flexible endoscope. Each of these devices is discussed below.

[0057] It will be appreciated that the visualization device can be designed to be received within one of the lumens, for example, the first lumen 130 or the second lumen 140. As such, the figures included herewith illustrate the visualization device contained within the first lumen 130 and alternatively, contained the second lumen 140. In the event that a camera system is used, the camera system is in communication with one of the first lumen 130 and the second lumen 140 which acts as a visualization lumen for visualization of the subdural space. The camera system is of a type suitable for inclusion in the cranial access port 100 and suitable forusing the selected lumen 130, 140 as a visualization pathway for visualizing the subdural space. The camera system can be a digital camera, such as a digital CCD camera. Other types of cameras are equally possible as well. In the event that the camera system is located at or near the top (first end 112) of the access port body 110, a mirror can be located within one lumen, in this case the second lumen 140. More particularly, the mirror is located within the bent section 120 of the access port body 110 and is positioned such that light traveling within the linear upper section 122 of the access port body 110 is reflected by the mirror into the lower section 124 of the access port body 110. The mirror can be disposed at a 45 degree angle within the second lumen 140 so as to reflect light at an angle of 90 degrees into the lower section 124. The mirror is illustrated in WO2024 / 249575.

[0058] The camera device is thus located above the mirror but the angle of the mirror allows for the camera device to image and visualize the subdural space. As a result, the camera device does not physically enter the subdural space and is in fact not located in the lower section 124. The distal end of the camera device can be located within the upper section 122 or can enter into the bent section 120.

[0059] As mentioned, alternatively, the visualization device can be in the form of a rigid endoscope 210 as shown in Fig. 9. Similar to the camera device described above, the rigid endoscope is disposed within the upper section 122 or can extend into the bent section 120 of the access port body 110 above the mirror (if present). As know, a rigid endoscope is one which cannot be bent to go around comers but instead has a fixed linear configuration. Much like the camera device, the rigid endoscope 210 utilizes the mirror to visualize the subdural space. The distal end of the rigid endoscope 210 can be located within the bent section 120 or it can terminate within the upper section 122.

[0060] The rigid endoscope 210 is thus inserted at least partially within one of the first lumen 130 and the second lumen 140. The access port body 110 can have an endoscope docking feature in that the construction of the endoscope and the access port body 110 are complementary and there can be a locating feature that ensures the endoscope is positioned at the desired location. In other words, not only does the docking feature ensure that the rigid endoscope is securely attached to the access port body 110 but also it ensures that the distal end of the rigid endoscope remains a desired distance from the mirror. This ensures optimal imaging occurs using mirror. The locating feature can be in the form of an inner stop formed within the selected lumen 130, 140 whereupon when the rigid endoscope is inserted into the lumen 130, 140, the rigid endoscope contacts the inner stop which prevents additional travel of the rigid endoscope within the lumen 130, 140 in the direction toward the mirror. Thelocating feature can also be of a keyed construction in that the lumen 130, 140 can include male or female features that mate with the opposite female or male features formed as part of the rigid endoscope. For example, along a length of the upper section 122, there can be one or more groove that receives one or more tabs that protrude outwardly from the body of the rigid endoscope. Reception of the one or more tabs within the one or more grooves locates and securely couples the rigid endoscope to the access port body 110. In addition, the bottom end of each groove can define the stop. The opposite is true in that is possible to construct the lumen 130, 140 to include one or more tabs that are received in one or more grooves formed in the body of the rigid endoscope. Other types of arrangements are equally possible.

[0061] The access port 100 can have the following characteristics, in one embodiment:

[0062] 1. a port body having a bend incorporated therein and having an ellipse cross-section, the port body being configured to be disposed at least partially within a subdural space and the port body having at least one lumen formed therein, the at least one lumen being configured to receive at least one tool for performing at least one operation within the subdural space.

[0063] 2. wherein the at least one lumen comprises a first lumen and a second lumen and the at least one tool comprises an endoscope and at least one other tool, the first lumen being configured to receive the endoscope and the second lumen being configured to receive the at least one other tool.

[0064] 3. wherein the first and second lumens are formed side-by-side.

[0065] 4. wherein the ellipse cross-section is defined by a major axis that extends end-to-end of the port body and a minor axis that extends side-to-side of the port body and is oriented perpendicular to the major axis, the lengths of the major axis and the minor axis permitting the port body to be received within a 1 cm sized subdural space.

[0066] 5. wherein the length of the major axis is at least 8 mm and the length of the minor axis is less than 8 mm.

[0067] 6. wherein the length of the minor axis is from 4 mm to 6 mm,

[0068] 7. wherein the port body has an upper section that is linear shaped and a lower section that is linear shaped with a bent section therebetween.

[0069] 8. wherein the upper section is defined by a first axis that is perpendicular to the first end of the port body and the lower section is defined by a second axis that is perpendicular to tlie second end of the port body, the first and second axes being perpendicular to one another.

[0070] 9. wherein the bend is defined by an angle greater than 0 to 180 degrees.

[0071] 10. wherein the bend is defined by an angle greater than 0 to 90 degrees.

[0072] 11. wherein the port body is formed of a rigid material and the bend comprises a fixedangle bend.

[0073] In the two lumen design shown in Fig. 1, one lumen, such as the second lumen 140, is intended to receive one or more other surgical tools. The second lumen 140 can be considered to be a tool lumen intended to receive one or more tools other than a visualization device. These tools are intended to perform the hematoma evacuation. Alternatively, the surgical tool is received within the first lumen 130 and the visualization device is in the second lumen 140.

[0074] For example, the at least one tool can be selected from the group consisting of: an irrigation tool, an aspiration tool, a coagulation tool, and a tissue grasping tool.

[0075] As known, an irrigation tool (instrument) is designed to deliver an irrigation solution to a target location, in this case the subdural space. Irrigation is a vital component of subdural hematoma evacuations. The constant introduction of saline solution into the subdural space allows for the resolution of clots and ultimate removal of the subdural hematoma. The irrigation tool thus includes a lumen through which the irrigation solution is delivered. The irrigation tool is formed of a flexible body to allow the irrigation tool to bend and pass along the bent section 120 and then exit the bottom end of the access port body 110 into the subdural space. However, it will be appreciated that the distal end of the irrigation tool does not have to extend beyond the bottom end of the access port body 110 to deliver the irrigation fluid. The irrigation tool is fluidly connected to a source of irrigation fluid and a fluid management system, such as a pump, can be used to controllably deliver the irrigation fluid.

[0076] The irrigation tool can thus have a tubular structure and can be part of an irrigation mechanism in which irrigation is provided through syringe infusion or it can be part of an irrigation mechanism in which irrigation is powered by a pump system.

[0077] An aspiration tool is designed to remove (evacuate) debris and fluid from the surgical site (i.e., the subdural space). In the case of evacuation of a subdural hematoma, the hematoma is gently removed using aspiration (suction) and irrigation, where it’s washed away with the irrigation fluid (saline solution). The aspiration tool is thus a tubular structure and is operatively connected to a suction source. The aspiration tool is formed of a flexible body to allow the aspiration tool to bend and pass along the bent section 120 and then exit the bottom end of the access port body 110 into the subdural space.

[0078] The aspiration tool can be part of a suction mechanism that is powered by wall suction or alternatively, the suction mechanism can be powered by a pump system.

[0079] The surgical tool can be a suction / irrigation catheter that has a center lumen through which irrigation fluid can flow to the surgical site when the catheter functions as an irrigation catheter and catheter can be operatively connected to suction when acting as an aspirationcatheter.

[0080] Irrigation Tool 300, 301

[0081] As mentioned herein, in one embodiment, the intraluminal tool can be in the form of a specially designed and constructed irrigation tool 300, 301 for use with the cranial access port 100.

[0082] In order to create a successful catheter 300, 301 that allows for the removal of a subdural hematoma, multiple requirements must be met. The clinical needs and technical requirements needed to accomplish a successful catheter 300, 301 for evacuation of subdural hematoma are outlined in Table 1, set forth below:

[0083] Key Clinical Needs / Technical Requirements

[0084] Soft Distal Tip (No Abrasion to the Brain)

[0085] Ability to perform Membranectomy

[0086] Ease of Use

[0087] Mechanical Navigation

[0088] Compatible with Wall Suction

[0089] Suction Regulating System

[0090] No Kinking Under Pressure

[0091]

[0092] Table 1: List of clinical needs / technical requirements for a subdural hematoma evacuation solution

[0093] Soft Distal Tip

[0094] The catheter 300, 301 must have a soft distal tip in order to slide through the angled cranial access port 100 and avoid any type of abrasion to the brain. The catheter 300, 301 must be gently navigated through the subdural space in order to avoid any type of interaction with the patient’s brain. However, it is important to ensure that in the scenario that the catheter 300, 301 collides or touches the brain, no harm is done.

[0095] Ability to Perform Membranectomy

[0096] The disruption and resection of membranes have been shown to lead to significantly lower recurrence rates. This is difficult to accomplish with the existing minimally invasive bedside systems. The catheter 300, 301 should be able to dissect membranes with the visual aid of the endoscopic system that will be inserted through the other lumen of the access port 100. The catheter 300, 301 has a 8< X<12F (French)diameter in order to be able to break down and aspirate the membranes. The membranes are broken down when a catheter with enough suction power pulls on them, which results in their collapse.

[0097] Ease of Use and Orientation

[0098] An ergonomic and easy to use catheter 300, 301 is necessary to ensure a safe procedure, which is vital at the bedside and in the angiography suite. The catheter 300, 301 is specifically design to be compatible with the access port 100 and be present on the field of view of the endoscopic system to ensure accurate navigation. The catheter 300, 301 also has the appropriate markers that inform the surgeon of catheter orientation.

[0099] Mechanical Navigation

[0100] The catheter 300, 301 must be able to be controlled while in the subdural space. Such control can be achieved with the proximal end of the catheter 300, 301 being more rigid than the distal end. Rotating the proximal rigid end results in the distal tip moving up and down, thus providing the surgeon maneuverability and control.

[0101] Compatible with Wall Suction

[0102] The catheter 300, 301 is capable to connect to wall suction in order to acquire its suction capabilities. The catheter’s midpoint has a higher rigidity to withstand wall suction force without kinking or compromising flexibility and the catheter’s proximal end has a lower rigidity to ease external control and enable a smooth interface with wall suction.

[0103] Suction Regulating System

[0104] The surgeon must have the ability to completely and partially stop the suction force without disconnecting the catheter 300, 301 to wall suction. In order to accomplish this, the catheter 300, 301 has a series of holes that can be covered / uncovered with a sliding block that is controlled with one hand. All holes must be covered to achieve full suction. In order to stop suction the surgeon must remove the sliding block and expose all the holes. In order to partially stop it, the surgeon may slightly move the block and expose only a few of the holes, letting only some air flow out.

[0105] No Kinking Under Pressure

[0106] The distal end of the catheter 300, 301 must have the appropriate stiffness to (flexible) in order to avoid any abrasion to the brain, but it must maintain rigidity so that it kinks when the suction force is turned on. The catheter 300, 301 must retain structural integrity when suction force is turned on, both at the tip and in the area that lays inside the access port 100.

[0107] The structure and features of the catheter 300, 301 are described in more detailbelow.

[0108] As will be appreciated with reference to the below embodiments, the catheter broadly speaking includes at least two discrete sections and preferably, three discrete sections, namely, a distal section, an intermediate section and a proximal section. The material properties and / or physical constructions of at least the distal section and the intermediate section differ from one another.

[0109] Figs. 5-8 illustrate catheter 300, 301 that comprises an elongated hollow structure having a distal end 302 and an opposing proximal end (not shown).

[0110] Braided Catheter

[0111] With reference to Figs. 6A-6B, the catheter 300 according to a first embodiment is shown. The catheter 300 is an elongated hollow structure having a distal end 302 and an opposing proximal end 304. The catheter 300 can be thought of as having three distinct sections, namely, a first section which can be referred to as being a distal section 310, a second section which can be referred to as being an intermediate section 320, and a third section which can be referred to as being a proximal section 330. As described herein, the three sections 310, 320, 330 have different material properties and / or have different constructions and perform different functions. As described below, the three sections 310, 320, 330 have different lengths and more particularly, the distal section 310 has a shorter length than the intermediate section 320, which itself has a length shorter than a length of the proximal section 330. In one embodiment, the length of the distal section 310 is about 225 mm, the length of the intermediate section 320 is about 600 mm and the proximal section 330 has a length that is typically greater than the length of the intermediate section 320 since the proximal section 330 will extend to the source of negative pressure (suction) which can be a pump.

[0112] In Fig. 5, the line 319 represents a transition line from the intermediate section to the proximal section of the catheter.

[0113] Turning first to the distal section 310, the distal section 310 itself has multiple different portions or sections. More specifically, the distal section 310 has three different portions, namely, a distal portion 312, an intermediate portion 314, and a proximal portion 316 (in Figs. 6A and 6B, broken lines are included to show the division of the portions and in particular, the differentiation of portion 314 from portions 312, 316). The distal portion 312 terminates in a distal tip (end) 311 which is constructed so as to have a bevel cut in that the distal tip 311 has an angled construction, such as a 45 degree cut. The distal portion 312 has a length that is greater than the lengths of both the intermediate portion314 and the proximal portion 316. For example, the length of the distal portion 312 can be about 200 mm, the length of the intermediate portion 314 can be about 10 mm and the length of the proximal portion 316 can be about 10 mm.

[0114] The portions 312, 314, 316 have different durometers. As is known, durometers measure the hardness and indentation resistance of polymers, elastomers, and rubbers using scales (00, A, D) ranging from 0 to 100, where higher numbers signify harder materials. Lower numbers indicate softer, more flexible materials, while higher numbers indicate stiffer, more durable ones.

[0115] As described herein, the catheter 300 has a variable durometer throughout the entire structure to allow for maneuverability and control. The catheter 300 has a soft distal tip (i.e., the distal section 310 with a bevel cut in one embodiment) to avoid any abrasion to the brain. Only the soft portion (distal section 310) of the catheter 300 should be advanced into the subdural space.

[0116] In the present embodiment, the distal portion 312 has a durometer of 35D and can be formed of a Pebax material. As is known, the Pebax is a high-performance thermoplastic elastomer (TPE) known for being exceptionally lightweight, flexible, and offering superior energy return. The intermediate portion 314 has a durometer of 45D and can be formed of a Pebax material and the proximal portion 316 has a durometer of 55D and can be formed of a Pebax material. Since the combined length of the intermediate portion 314 and the proximal portion 316 is substantially less than the length of the distal portion 312, the combined intermediate portion 314 and the proximal portion 316 can be considered to be transition region from the distal section 310 to the intermediate section 320.

[0117] The distal section 310 can comprise either a braided or coiled section with Figs. 6A and 6B illustrating the distal section 310 being a braided section. The distal section 310 can be a braided Pebax section that consists of a Pebax (polyether block amide) polymer reinforced with a metal (often stainless steel) or fiber braid layer. This structure provides superior torque response, kink resistance, and high-pressure resistance. A braided Pebax section typically includes an inner liner, a braided reinforcement layer, and an outer jacket, which are fused together. The material offers high lubricity, low friction, and variable flexibility based on the chosen Pebax durometer (hardness).

[0118] In one embodiment, the distal section 310 can be a diamond pattern braid (e.g.,.001 x.003 diamond pattern). In addition, the distal section 310 can be an 80 PPI braid. As is known, the PPI stands for picks per inch and refers to the density of the braided wirereinforcement embedded within the polymer layer. 80 PPI is a relatively high density, which provides a high degree of "pushability" (torque transmission) while still allowing the device to remain flexible enough to traverse tortuous paths.

[0119] The intermediate section 320 has similarly been reinforced to withstand pressure and avoid kinking or catheter collapse while inside the angled catheter lumen of the access port 100. The intermediate section 320 can also be a braided Pebax section that consists of a Pebax (polyether block amide) polymer reinforced with a metal (often stainless steel) or fiber braid layer. For example, the intermediate section 320 can be a diamond pattern braid (e.g.,.001 x.003 diamond pattern), such as a 30 PPI braid. The picks per inch of the intermediate section 320 is thus lower than the distal section 310 (i.e., 30 PPI vs 80 PPI).

[0120] The proximal section 330 can similarly be reinforced. The proximal section 330 can also be a braided Pebax section that consists of a Pebax (poly ether block

[0121] amide) polymer reinforced with a metal (often stainless steel) or fiber braid layer. For example, the proximal section 330 can be a diamond pattern braid (e.g.,.001 x.003 diamond pattern), such as a 30 PPI braid. The material of the proximal section 330 can thus be the same or similar to the material of the intermediate section 320.

[0122] As shown in Figs. 6A and 6B, one of the features of the proximal section 330 is the inclusion of a plurality of vent (aspiration) holes 335 spaced along a portion of the proximal section 330. For example, in the illustrated embodiment, there are five vent holes 335 that are spaced evenly apart from one another. For example, the vent holes 335 can be spaced 10 mm apart from one another. As previously mentioned, the vent holes 335 are to be covered and uncovered by an actuator 350 that is disposed along the proximal section 330. For example, the actuator 350 can be in the form of a sliding block that freely slides along the length of the proximal section 330 to provide the surgeon with suction control. By exposing all the vent holes 335, the surgeon can easily and quickly stop or reduce the suction. Partially covering or fully covering the vent holes 335 of the catheter 300 will provide the surgeon with different levels of suction, with full suction being achieved by covering all the vent holes 335 with the sliding block 350.

[0123] It will also be appreciated that markings in the form of indica or the like can be added along the exterior of the proximal section 330 at the location of the vent holes 335 to assist the surgeon in the use of the sliding block 350. For example, each vent hole 335 can be assigned a number that is printed on the exterior of the proximal section 330 to allow the surgeon to easily understand how many of the vent holes 335 have been covered and similarly, how many vent holes 335 remain uncovered. For example, the numberingcan be such that vent hole #1 represents the lowest level of suction and vent hole #5 represents the maximum level since when vent hole #5 is covered, ail five vent holes 335 are covered.

[0124] In yet another aspect, as shown in Fig. 8, an optional torque device 400 is shown. As is known, the torque device 400 is a device for selectively gripping an elongated structure, such as a guide wire or catheter as in the present application, and allows the surgeon to advance, rotate (torque) and grip the catheter 300, 301. Any number of commercially available torque devices can be used in the present application. The torque device is located along the proximal section 330 and preferably is located proximal to the sliding block 350. When the torque device 400 is manipulated, the catheter 300, 301 is torqued (rotated) and this is translated into rotation of the bevel cut open tip of the catheter 300, 301.

[0125] Coiled Catheter 301

[0126] As mentioned, the surgical catheter can have a slightly different construction than the one described above in that it can, at least partially, have a coiled construction as opposed to a braided construction. The coiled catheter 301 is illustrated in Figs. 5, 7A, 7B, which can be thought of as being a second embodiment. In this second embodiment, the reinforcement in at least one section is in coil form as opposed to being a braid reinforcement as in the catheter 300. For example, the coiled catheter 301 can be formed of a medical grade polymer tubing featuring a Pebax inner liner with stainless steel or nitinol coil reinforcement, providing exceptional kink resistance.

[0127] The catheter 301, like catheter 300, is an elongated hollow structure having a distal end and an opposing proximal end The catheter 301 can be thought of as having three distinct sections, namely, a first section which can be referred to as being a distal section 360, a second section which can be referred to as being an intermediate section 370, and a third section which can be referred to as being a proximal section 380. As described herein, the three sections 360, 370, 380 have different material properties and / or have different constructions and perform different functions. As described below, the three sections 360, 370, 380 have different lengths and more particularly, the distal section 360 has a shorter length than the intermediate section 370, which itself has a length shorter than a length of the proximal section 380. In one embodiment, the length of the distal section 360 is about 225 mm, the length of the intermediate section 370 is about 600 mm and the proximal section 380 has a greater length than the two other sections.

[0128] Turning first to the distal section 360, the distal section 360 itself has multipledifferent portions or sections. More specifically, the distal section 360 has three different portions, namely, a distal portion 362, an intermediate portion 364, and a proximal portion 366 (in Figs. 7A and 7B, broken lines are included to show the division of the portions and in particular, the differentiation of portion 364 from portions 362, 366). The distal portion 362 terminates in a distal tip (end) 361 which is constructed so as to have a bevel cut in that the distal tip 361 has an angled construction, such as a 45 degree cut. The distal portion 362 has a length that is greater than the lengths of both the intermediate portion 364 and the proximal portion 366. For example, the length of the distal portion 362 can be about 200 mm, the length of the intermediate portion 364 can be about 10 mm and the length of the proximal portion 366 can be about 10 mm.

[0129] In this embodiment, the distal section 360 comprises the coiled section of the catheter in the distal section 360 has an internal metal or polymer helical coil that reinforces the polymer shaft (e.g., Pebax shaft). In one embodiment, the coil is a.002 x.006 coil with a pitch of.014; however, other constructions are equally possible. Thus, in these embodiment, each of the portions 362, 364, 366 has a coiled construction.

[0130] The portions 362, 364, 366 have different durometers.

[0131] In the present embodiment, the distal portion 362 has a durometer of 35D and can be formed of a Pebax material. The intermediate portion 364 has a durometer of 45 D and can be formed of a Pebax material and the proximal portion 366 has a durometer of 55D and can be formed of a Pebax material.

[0132] In this embodiment, the intermediate section 370 comprises a braided section just like the catheter 300 construction. The intermediate section 370 has been reinforced to withstand pressure and avoid kinking or catheter collapse while inside the angled catheter lumen of the access port 100. The intermediate section 380 can be a braided Pebax section that consists of a Pebax (polyether block amide) polymer reinforced with a metal (often stainless steel) or fiber braid layer. For example, the intermediate section 370 can be a diamond pattern braid (e.g.,.001 x.003 diamond pattern), such as a 30 PPI braid. The picks per inch of the intermediate section 320 is thus lower than the distal section 310 (i.e., 30 PPI vs 80 PPI).

[0133] The proximal section 380 can similarly be reinforced. The proximal section 380 can also be a braided Pebax section that consists of a Pebax (polyether block

[0134] amide) polymer reinforced with a metal (often stainless steel) or fiber braid layer. For example, the proximal section 330 can be a diamond pattern braid (e.g.,.001 x.003 diamond pattern), such as a 30 PPI braid. The material of the proximal section 380 canthus be the same or similar to the material of the intermediate section 370.

[0135] As shown in Fig. 7A, one of the features of the proximal section 380 is the inclusion of a plurality of vent holes 335 spaced along a portion of the proximal section 380. The function of the vent holes 335 and sliding block 350 have been described above.

[0136] Markers

[0137] In another aspect of the present application, the catheters 300, 301 include markers or the like to provide the surgeon with guidance as to the location of the catheter 300, 301 relative to the access port 100 and more particularly, the extent of the catheter 300, 301 that is advanced beyond the access port 100 at the surgical site. As mentioned, herein, only the “soft” distal section 310, 360 is intended to be advanced into the brain by being advanced / extended beyond the lower section 124. The catheter 300, 301 is also designed so that the intermediate section 320, 370 remains within the access port 100 and does not extend out of the lower section into the surgical site (brain). Preferably, as shown, the intermediate section 320, 370 has a length such that during maximum deployment of the distal section 310, 360, the intermediate section 320, 370 extends above the top end of the access port 100.

[0138] Figs. 9 and 10 show a first type of markers in that the catheter 300, 301 includes a first marker 500 at a first location along the intermediate section 320, 370 and a second marker 510 at a second location along the intermediate section 320, 370 and spaced from the first location. The first marker 500 represents a retracted position of the catheter 300, 301 such that the distal tip thereof is at the bottom exit of the first lumen 130. In other words, the catheter 300, 301 has not yet been deployed into the brain. The second marker 510 represents the fully deployed position of the catheter 300, 301 and more particularly, the fully deployed position of the distal section 310, 360. In other words, in the fully deployed position, the maximum length of distal section 310, 360 is deployed and located outside of the first lumen at the lower section. As described above, in this fully deployed position, no length of the intermediate section 320, 370 is advanced beyond the lower section and thus, the intermediate section 320, 370 is purposely maintained in the access port 100 and not allowed to enter the surgical site.

[0139] The second marker 510 thus represents a warning marker to alert that the catheter 300, 301 should not be advanced further. The first and second markers 500, 510 are read with reference to a reference line or read line 515 that can be the top of the upper section of the access port 100. This reference line 515 can be considered to be a catheter position indicator.In the access port 100 of Figs. 5 and 9, the upper section is defined by a first conduit or first tube 520 and a second conduit or second tube 530. These conduits 520, 530 can represent extensions of the body of the access port 100. Each conduit 520, 530 is intended to carry a different instrument. The first conduit 520 aligns with and is continuous with the first lumen 130 and the second conduit 530 aligns with and is continuous with the second lumen 140. In this embodiment, the read line 515 is thus the top edge of the first conduit 520. The degree of advancement of the catheter 300, 301 is determined by observing the positions of the first and second markers 500, 510 relative to the top edge of the first conduit 520. For example, to place the catheter 300, 301 in the retracted position of Fig. 9, the catheter 300, 301 is advanced within the first conduit 520 until the first marker 500 aligns with the top edge of the first conduit 520. The catheter 300, 310 can safely be further advanced until the second marker 520 aligns with the top edge of the first conduit 520. Once this alignment occurs, the catheter 300, 301 cannot be further advanced.

[0140] The top edge of the first and second conduits 520, 530 can include graphic indicia to indicate the read line 515. For example, a colored band or the like can be used so that the user can easily understand the position of the catheter 300, 301.

[0141] In one embodiment, shown in Figs. 11 A and 11 B the first marker 500 can be a green colored band and the second marker 510 can be a red colored band and the area between the two markers 500, 510 can have a color gradient. For example, from the first marker 500 to a location close to but not yet at the second marker 510, the exterior of the catheter 300, 301 can have a green color to indicate safe positioning. Adjacent the second marker 510, there can be a third marker 535 which can be a yellow band indicating that caution should be exercised since the surgeon is approaching the second marker 510. The green colored area thus represents safe positioning of the catheter 300, 301, the yellow colored area represents a cautionary positioning of the catheter 300, 301 and the red represents a prohibited positioning of the catheter. In Fig. 11B, the yellow third markers 535 is at the read line indicating that the catheter advancement is approaching its end of safe travel. Once the read second marker 510 is the read line 515, advancement of the catheter should be immediately stopped.

[0142] In yet another embodiment, shown in Fig. 12, the intermediate section 320, 360 can include numerical markers that can indicate the retracted position and the fully deployed position and positions therebetween. For example, a number 0 can be printed on the catheter to represent the retracted position where the distal tip is just about to exit the port. The number 5 can be printed on the catheter to represent the fully deployed position. Betweenare numbers 1, 2, 3 and 4. When the distal section 310, 360 has a length of 225 mm, each number represents an increment of 45 mm. Thus, the surgeon can tell the general degree of advancement of the catheter 300, 301 by viewing which number is at the read line 515 (in Fig. 12, the 0 marker is at the read line 515). Instead of consecutive numbers, the graphic indicia can represent the exposed length of the distal section. For example, for the 225 mm length distal section, the markers can be the following numbers printed on the catheter: 0, 45, 90, 135, 180 and 225 (max position). Thus, when the 135 marker aligns with the read line, this means than 135 mm of the distal section is exposed and extended beyond the lower section of the access port 100. This scheme allows the user to immediately understand the degree of deployment. Since the 225 number is the maximum, it can be in a different color like red and / or can include graphic indicia around it such as one or more red bands indicating that the catheter should not be further advanced beyond this marking.

[0143] It will be appreciated that any number of other marking schemes can be used to guide the surgeon and indicate to the surgeon when the catheter is at the distal tip, as well as the maximum deployment position of the catheter.

[0144] It will also be appreciated that the locations of the markers depend on the type of access port 100 being used since the read line location depends on the construction of the access port, the length of the inner lumens, the height of any upper conduit for receiving the catheter, etc. Thus, there can be a coding between the catheter and access port to make it easy for the surgeon to match the catheter 300, 301 with the correct access port. For example, each of the catheter and access port can have matching numbers and / or letters or a combination thereof to identify the catheter and access port which are to be paired together. For example, an “A” type catheter can be paired to an “A” type access port.

[0145] Surgical Kit

[0146] It will also be appreciated that the components described herein, including the catheter, the access port, and the endoscope, as well as other components can be packaged as a surgical kit. It will also be appreciated that the ends of the endoscope and catheter includes connectors (not shown) to allow the instruments to be connected to a console or the like which includes working components of the endoscope and suction source (i.e., pump). For example, the connectors can allow the endoscope and the catheter to be plugged into the console.

[0147] Exemplay Surgical Procedure

[0148] Before inserting the base and the access port 100, the distal tip of the catheter 300, 301 can be used to evacuate any pooling blood inside the burr hole. After the pooling bloodis evacuated, the access port 100, including the base thereof, can be inserted. Once they have been positioned on the patient’s scalp, the endoscope 210 is inserted. After the endoscope’s visual display is up and running, the catheter 300, 301 can be safely inserted through the access port 100. The catheter 300, 301 should be pushed through the catheter lumen (e.g., first lumen 130) by the surgeon. The surgeon should utilize the visual guide (e.g., markers) to advance the catheter, evacuate hematoma and identify membranes. By rotating and advancing the portion of the catheter that extends outside the port, the surgeon is able to rotate the tip of the catheter and advance it forward.

[0149] Membranectomy can be performed by approaching the membrane and pulling on it with the catheter 300, 301until it collapses and the remains are aspirated by the catheter 300, 301 under the action of applied suction (e.g., as by a pump). The surgeon is free to adjust suction force with the sliding block 350 as they see fit during surgery. If there are any coagulated pieces of hematoma that might be difficult to aspirate, the surgeon can flush saline water through an irrigation channel (which can be the catheter or a separate instrument or structure) to ease its removal. Once the hematoma has been successfully evacuated, the catheter 300, 301 is removed. At last, the endoscope 210 is removed, along with the access port 100 and base. In the case that the catheter is clogged up, the surgeon can remove the catheter and unclog it with a small wire on a cup with saline water.

[0150] The catheter 300, 301 thus has the following features and provided the following advantages:

[0151] the catheter 300, 301 is specifically designed to evacuate subdural hematoma and perform membranectomy; and

[0152] the catheter 300, 301 has been specifically designed to work in conjunction with the access port 100, to allow for a safe and effective subdural hematoma evacuation.

[0153] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having," "containing," "involving," and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0154] The subject matter described above is provided by way of illustration only and should not be construed as limiting. Various modifications and changes can be made to the subject matter described herein without following the example embodiments and applications illustrated and described, and without departing from the true spirit and scope of the present invention, which is set forth in the following claims.

Claims

What is claimed is:

1. A surgical kit for removing a subdural hematoma comprising:a cranial access port comprising: a port body having a bend incorporated therein, the port body being configured to be disposed at least partially within a subdural space and the port body having at least one lumen formed therein, wherein the cranial access port has a catheter position indicator;a catheter configured for insertion into the at least one lumen, the catheter comprising an elongated hollow body having a distal section, an intermediate section, and a proximal section, wherein the elongated hollow body has a variable durometer throughout its length to allow for maneuverability and control, wherein the distal section has a beveled shaped at a distal end thereof and the intermediate section comprises a braided or coiled section; andat least first and second markers located along the intermediate section, the first marker indicating a retracted position of the catheter within the at least one lumen in which the distal tip has not exited the at least one lumen and the second marker indicating a fully deployed position of the catheter in which the distal section of the catheter is outside of the at least one lumen but a bottom portion of the intermediate section remains within the at least one lumen.

2. The surgical kit of claim 1, wherein the port body has an ellipse cross-section and the at least one lumen comprises a first lumen and a second lumen, the first lumen being configured to receive the catheter and the second lumen being configured to receive an endoscope.

3. The surgical kit of claim 2, wherein the first and second lumens are formed side-by- side.

4. The surgical kit of claim 2, wherein the ellipse cross-section is defined by a major axis that extends end-to-end of the port body and a minor axis that extends side-to-side of the port body and is oriented perpendicular to the major axis, the lengths of the major axis and the minor axis permitting the port body to be received within a 1 cm sized subdural space.

5. The surgical kit of claim 4, wherein the length of the major axis is at least 8 mm andthe length of the minor axis is less than 8 mm.

6. The surgical kit of claim 5, wherein the length of the minor axis is from 4 mm to 6 mm.

7. The surgical kit of claim 1, wherein the port body has an upper section that is linear shaped and a lower section that is linear shaped with a bent section therebetween.

8. The surgical kit of claim 7, wherein the upper section is defined by a first axis that is perpendicular to the first end of the port body and the lower section is defined by a second axis that is perpendicular to the second end of the port body, the first and second axes being perpendicular to one another.

9. The surgical kit of claim 1, wherein the bend is defined by an angle greater than 0 to 180 degrees.

10. The surgical kit of claim 1, wherein the bend is defined by an angle greater than 0 to 90 degrees.

11. The surgical kit of claim 1, wherein the port body is formed of a rigid material and the bend comprises a fixed angle bend.

12. The surgical kit of claim 1, wherein the catheter position indicator comprises a reference line on the port body.

13. The surgical kit of claim 12, wherein the port body has a first conduit extension and a second conduit extension along an upper section thereof, the catheter being received within the first conduit which is aligned and communicates with the at least one lumen, the catheter position indicator being located at a top edge of the first conduit.

14. The surgical kit of claim 1, wherein the distal section is defined by a distal portion, an intermediate portion and a proximal portion, the distal portion defined by a first durometer, the intermediate portion defined by a second durometer and the proximal portion defined by a third durometer, wherein the first durometer < the second durometer < the third durometer.

15. The surgical kit of claim 14, wherein a length of the distal portion is at least 10x to 20x a length of each of the intermediate portion and the proximal portion.

16. The surgical kit of claim 1, wherein the first marker comprises a first colored band and the second marker comprises a second colored band having a color that is different than a color of the first colored band.

17. The surgical kit of claim 16, wherein the first colored band comprises a green colored band and the second colored band comprises a red colored band.

18. The surgical kit of claim 17, wherein an exterior surface of the intermediate section between the green colored band and the red colored band is also green colored.

19. The surgical kit of claim 17, further including a third colored band in the form of a yellow band that is adjacent the red colored band.

20. The surgical kit of claim 19, wherein a distance between the first marker and the second marker is a first distance and the yellow colored band is at a location that is 90% of the first distance as measured in a direction from the first marker to the second marker.

21. The surgical kit of claim 1, wherein a distance between the first marker and the second marker is the same as a length of the distal section.

22. The surgical kit of claim 1, wherein the proximal section of the catheter includes a plurality of spaced apart vent holes and the surgical kit further includes an actuator for selectively covering and uncovering one or more of the vent holes for controlling aspiration.

23. The surgical kit of claim 22, wherein the actuator comprises a sliding block disposed exteriorly along the catheter.

24. The surgical kit of claim 1, further including a torque device disposed along the proximal section of the catheter for torquing the catheter.

25. The surgical kit of claim 1, wherein the distal section includes a coiled reinforcement, while the intermediate and proximal sections include a braided reinforcement.

26. A catheter configured to remove a subdural hematoma comprising:an elongated hollow body having a distal tip section, an intermediate section and a proximal section, wherein the elongated hollow body has a variable durometer throughout its length to allow for maneuverability and control;wherein the distal tip section has a beveled shaped at a distal end thereof; wherein the intermediate section comprises a braided or coiled section; and wherein the proximal section has a higher durometer than the distal end section.

27. The catheter of claim 26, wherein the intermediate section comprises a reinforced section to withstand pressure and avoid kinking or catheter collapse while inside an angled catheter lumen of a catheter port.

28. The catheter of claim 26, wherein the proximal section includes a plurality of aspiration holes formed therein and arranged in spaced apart orientation along a length of the proximal section.

29. The catheter of claim 26, further including an actuator for providing aspiration control.

30. The catheter of claim 29, wherein the actuator comprises a block that slides along the elongated hollow body to allow one or more holes to be either covered or opened.

31. The catheter of claim 30, wherein when: 1) the block is spaced from all of the plurality of holes, aspiration is minimized or stopped; 2) when the block partially covers or fully covers some but not all of the holes, a variable degree of aspiration is provided and 3) when the block fully covers all of the holes, maximum aspiration is provided.

32. The catheter of claim 26, wherein the catheter includes at least first and second markers located along the intermediate section, the first marker indicating a retracted position of the catheter within the at least one lumen in which the distal tip has not exited the at least one lumen and the second marker indicating a fully deployed position of the catheter in which the distal section of the catheter is outside of the at least one lumen but a bottom portion of the intermediate section remains within the at least one lumen.

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