Hollow needle, kit and method for creating a void in tissue

Abstract

To provide a hollow needle configured to form a void in a membrane.SOLUTION: The hollow needle 110 includes a tube body extending along a tube axis between a first end and a second end, the first end defining a leading end of the tube body, and a hollow portion surrounded by the tube body, the hollow portion comprising an opening in the leading end. The tube body may comprise a sharpened portion provided at the tip and a suction cavity connected to the hollow portion that may be fluidly connected to a suction device, wherein the hollow portion is configured to cause negative pressure to be applied to the suction cavity to apply negative pressure through the aperture. Upon application of negative pressure through the opening, the membrane may be pulled against the tip such that the sharpened portion pierces the membrane.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE INVENTION This application relates generally to hollow needles, kits, and methods for forming voids in membranes. [Background technology]

[0002] Brain surgery can be performed for various medical purposes. The brain is surrounded by a thin membrane called the dura, which is approximately 0.3 mm thick. To access the surface of the brain, the dura is breached. Incisions in the dura may be necessary for purposes such as measuring electrophysiological brain activity, reducing abnormal intracranial hydrodynamic pressure, preventing bleeding, ablating brain tissue (e.g., cancer, arteriovenous malformations, traumatic brain energy, etc.), and sampling brain tissue. For example, for diagnostic procedures for epilepsy, an electrode array may be placed on the surface of the brain. To place these electrodes, a space must be created in the skull and dura. Traditional surgical procedures involve drilling a space in the skull to expose brain tissue and then using a scalpel to cut through the dura and make a straight or cross-shaped incision. Another approach involves piercing the skull and dura via a needle to access the subdural tissue. However, there is a need to reduce the size of such incisions to achieve more minimally invasive surgical procedures. Additionally, there is a need to reduce the likelihood of damaging the subdural tissue while forming a gap through the dura.

[0003] Minimally invasive surgical procedures typically require more specialized devices than conventional techniques. In minimally invasive brain surgery, access to organs is spatially limited, and traditional drill and scalpel techniques may not be suitable for safely exposing brain tissue. For example, traditional open skull surgery may require a skull cap as large as 10 cm to adequately expose brain tissue, while minimally invasive surgery may require examination of brain tissue by passing a fiberscope through a gap as small as 1 mm. Therefore, new instruments may be needed to safely and accurately access brain tissue at a scale several orders of magnitude smaller than conventional techniques. Summary of the Invention

[0004]

[0003] Embodiments of the present disclosure relate to hollow needles, hollow needle kits, and methods of using hollow needle kits. Exemplary hollow needles of the present disclosure include a tubular body extending along a tubular axis between a first end and a second end, the first end defining a tip of the tubular body, the tip including a sharpened portion, the second end defining a suction cavity configured to receive application of negative pressure from a suction device, and a hollow portion surrounded by the tubular body, the hollow portion extending through an opening in the tip and defining an opening, the hollow portion configured to apply negative pressure through the opening to suction a membrane to the tip, and the sharpened portion configured to cut the membrane via rotation of the tubular body.

[0005] In some embodiments, the tube body comprises a plurality of sharpened portions arranged annularly at the distal end. In some embodiments, the sharpened portions comprise protrusions, the protrusions comprising a sharpened tip configured to pierce the membrane and side edges configured to cut the membrane via rotation of the tube body. In some embodiments, the side edges are arranged substantially parallel to the tube axis. In some embodiments, the tube body further comprises a flat surface at the distal end, the flat surface being arranged substantially perpendicular to the tube axis, and the sharpened portions protruding from the flat surface. In some embodiments, the sharpened portions protrude from the flat surface by 0.2 mm to 4.0 mm. In some embodiments, the sharpened portions protrude from the flat surface by at least 0.3 mm.

[0006] In some embodiments, the hollow portion is closed within the second end, and a suction cavity is provided in a circumferential portion of the tubular body between the tip and the second end. In some embodiments, the tubular body further comprises an engagement shaft configured to connect a rotary instrument. In some embodiments, the engagement shaft is provided at the second end. In some embodiments, the engagement shaft comprises a solid flat portion configured to contact the tip and stop advancement of the tip into the membrane. In some embodiments, the diameter of the tubular body is 0.5 mm to 0.7 mm. In some embodiments, the membrane is the dura mater that surrounds the brain.

[0007] In various embodiments, a kit is provided that includes one or more hollow needles as described and illustrated herein. In some embodiments, the kit further includes a needle holder, the needle holder including a holder body with a connector configured to be fluidly connected to an aspiration device and a bearing configured to rotatably support the tube body, the needle holder configured to receive the aspiration cavity. In some embodiments, the bearing is further configured to provide an airtight seal between the holder body and the tube body.

[0008] In some embodiments, the tube body further comprises an engagement shaft configured to connect to the rotating instrument, the engagement shaft being provided at the second end of the tube body, the holder body comprising a needle holding portion and a connector portion, the tube body extending to the needle holding portion such that the tip and the second end extend from the needle holding portion, the connector portion comprising the connector. In some embodiments, the kit further comprises a suction device that can be fluidly connected to the connector. In some embodiments, the kit further comprises a sensor configured to measure negative pressure and an indicator configured to report the degree of negative pressure measured by the sensor. In some embodiments, the tube body further comprises an engagement shaft, and the kit further comprises a rotating instrument configured to hold the engagement shaft.

[0009] In various embodiments, methods of forming a void in a membrane are provided. In some embodiments, the method includes applying negative pressure at the tip with a suction device and advancing the tip toward the membrane, where the negative pressure pulls a portion of the membrane toward the tip such that the sharpened portion pierces the portion of the membrane. In some embodiments, the method further includes, in response to detecting an increase in negative pressure, ceasing advancement of the tip toward the membrane. In some embodiments, the method further includes rotating the tubular body such that the sharpened portion cuts the void into a portion of the membrane. In some embodiments, the method further includes ceasing rotation of the tubular body in response to detecting a decrease in negative pressure. In some embodiments, the method further includes aspirating a cut piece of the portion of the membrane into the hollow portion.

[0010] Having thus described embodiments of the present disclosure in general terms, reference is now made to the accompanying drawings, which are not necessarily drawn to scale, and in which: [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a perspective view of an exemplary kit according to some embodiments of the present disclosure. [Figure 2] FIG. 1 is a perspective view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 3A] FIG. 1 is a partial left perspective view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 3B] FIG. 1B is a partial right perspective view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 3C] FIG. 1B is a top view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 3D] FIG. 1 is a partial side view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 4] FIG. 10 is a perspective view of an exemplary needle holder cut in half along its axis, according to some embodiments of the present disclosure. [Figure 5] FIG. 1 is a perspective view of an exemplary bearing cut in half along an axis, according to some embodiments of the present disclosure. [Figure 6] FIG. 1 is a perspective view of an exemplary rotational instrument according to some embodiments of the present disclosure. [Figure 7] FIG. 1 is a perspective view of an exemplary kit according to some embodiments of the present disclosure. [Figure 8] FIG. 1 is a side view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 9] FIG. 1 is a partial perspective view of an exemplary hollow needle according to some embodiments of the present disclosure. [Figure 10A] 1A-1C are schematic diagrams of exemplary hollow needles according to some embodiments of the present disclosure. [Figure 10B] 1A-1C are schematic diagrams of exemplary hollow needles according to some embodiments of the present disclosure. [Figure 10C] 1A-1C are schematic diagrams of exemplary hollow needles according to some embodiments of the present disclosure. [Figure 10D] 1A-1C are schematic diagrams of exemplary hollow needles according to some embodiments of the present disclosure. [Figure 10E] 1A-1C are schematic diagrams of exemplary hollow needles according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] Certain embodiments of the present disclosure will now be described more fully with reference to the accompanying drawings, in which some, but not all, embodiments of the invention are shown. Like reference numerals refer to like elements throughout the drawings. Indeed, various embodiments of the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0013] As used herein, the term "or" is used in both the alternative and connective sense unless otherwise indicated. The term "along" and similarly used terms mean near or on the edge or other location referenced, but not necessarily directly on the edge or other location referenced. The terms "about," "generally," and "substantially" refer to within manufacturing and / or engineering design tolerances for corresponding materials and / or elements, unless otherwise indicated. Therefore, use of any such above-mentioned terms or similarly interchangeable terms should not be construed as limiting the spirit and scope of embodiments of the present invention.

[0014] As used herein, the term "hollow needle" refers to forming a gap in the dura mater. However, the present disclosure contemplates that the hollow needle of the present disclosure may be equally applicable to other applications in which a small gap is formed in the membrane. For example, the hollow needle may be used in other procedures, such as accessing the epicardium via a subxiphoid puncture.

[0015] overview Generally, various embodiments of the present disclosure provide improved designs for forming a void in the dura mater via a hollow needle. Specifically, the hollow needles described herein may be utilized to form a small-diameter void to support minimally invasive neurosurgical procedures. The various hollow needles described and illustrated herein may exhibit an efficient and safe design compared to conventional instruments for cutting the dura mater. In doing so, the needles of the present invention may overcome the difficulties associated with forming a reduced-diameter void compared to the incisions used in existing techniques. It is understood and appreciated that such context is provided by way of example, and that the use of hollow needles in additional contexts, such as in other medical procedures, is contemplated and within the scope of the present invention.

[0016] As explained above, existing instruments face challenges in minimizing voids within the dura. For example, it can be difficult for a surgeon to accurately and precisely cut the dura in small areas using a scalpel. Furthermore, using a scalpel or other conventional cutting instrument can increase the risk of damaging brain tissue.

[0017] To address these and other issues, exemplary implementations of the present application may provide a hollow needle including a tubular body with a sharpened tip and a hollow portion with an opening at the tip. The simple structure of the hollow needle may assist the surgeon in a simple procedure compared to using a traditional scalpel. The hollow needle may be configured to rotate to create a round gap in the dura. The sharpened tip of the hollow needle may enable an efficient cut of just the right size for a designated device (e.g., a sensor guidewire) to pass through. The round gap created by the hollow needle may minimize the size of the incision in the dura. The round gap may reduce the surface area of ​​the dura that needs to be removed to expose the subdural tissue. For example, compared to conventional techniques that utilize multiple linear cuts to remove portions of the dura, the hollow needles described herein may remove portions of the dura through a single circular cut. In some embodiments, the circular cut of the hollow needle reduces the likelihood of a tear propagating along the dura. For example, conventional techniques can create stress concentrations along linear cuts, which can increase the risk of fracture propagation along the cut path.

[0018] In some embodiments, the hollow needle has a flat surface at its tip. The structure of the tip of the hollow needle may reduce the risk of damaging brain tissue. In some embodiments, the flat surface is configured to contact the dura mater and prevent further progression of the sharp portion through the dura mater. Otherwise, there is a risk of the sharp portion penetrating into the subdural tissue. For example, when the flat surface contacts the dura mater, penetration of the sharp portion may be halted. In some embodiments, the height of the sharp portion protruding from the flat surface is 0.2 mm to 4.0 mm. For example, the height of the sharp portion may be 0.3 mm. As another example, the height of the sharp portion may be 2.0 mm. In some embodiments, the height of the sharp portion may be within a threshold range that is thinner than the thickness of the target membrane to be cut. For example, the height of the sharp portion may be 0.1 mm to 2.0 mm thinner than the thickness of the target section of the dura mater. In some embodiments, the appropriate height prevents the sharp portion from protruding behind the dura mater as it enters the dura mater. For example, a height to thickness ratio of the target membrane of less than 1:1 may reduce the likelihood of the sharp portion extending into the subdural tissue.

[0019] In some embodiments, the hollow needle comprises a hollow portion with an opening. In some embodiments, negative pressure is applied to the hollow portion. In such a context, negative pressure may further be applied to the dura mater. Applying negative pressure may displace the dura mater from the subdural brain tissue. In this way, the risk of perforating the subdural brain tissue while creating a gap may be reduced. For example, by pulling the dura mater away from the brain tissue, the hollow needle may more safely cut the dura mater without damaging the brain tissue. In some embodiments, the negative pressure causes the tip of the hollow needle to perforate the membrane. In some embodiments, while the negative pressure holds the membrane against the tip, the hollow needle rotates so that the tip cuts the membrane in a circular shape. In this way, a circular segment of material may be cut from the membrane, thereby forming a gap through the membrane.

[0020] In various embodiments, negative pressure may be applied continuously during the procedure to establish a void in the dura. In some embodiments, the constant application of negative pressure allows the surgeon to know when to stop moving the hollow needle toward the dura after contacting the dura and when to stop rotating after creating a void. In some embodiments, the negative pressure may be detected by a sensor, and the level of negative pressure may be displayed by an indicator. The steps of the procedure may be confirmed by monitoring changes in negative pressure. The indicator may help the surgeon identify important transition stages between procedural actions (e.g., advancement into the dura, rotation of the hollow needle, retraction from the dura, etc.). The negative pressure may increase when the hollow needle contacts the dura, indicating to the surgeon that the hollow needle has reached the target site for void creation, and advancement may be halted. The hollow needle may be rotated to cut the dura while the dura is aspirated against the tip, thereby creating a void. Once a void is created in the dura, the negative pressure may be decreased. A decrease in pressure may indicate to the surgeon that a void has formed in the dura.

[0021] In this way, the hollow needle described below improves the efficiency and safety of forming small-diameter gaps in the dura mater or other membrane tissue. The structure of the tip of the hollow needle may improve the accuracy of the surgical procedure and reduce the possibility of damaging the subdural tissue. Furthermore, the application of negative pressure to the tip may improve operation and reduce the risk of damage. This allows the hollow needle to achieve sufficient treatment to form a gap in the membrane, allowing the surgeon to easily, effectively, and safely form small gaps.

[0022] Exemplary Kits Including Hollow Needles Referring to FIG. 1 , a perspective view of an exemplary kit 100 for forming a void in a membrane such as the dura mater is shown. In some embodiments, the kit 100 includes a hollow needle 110, a needle holder 150, and a rotating instrument 170. In various embodiments, the hollow needle 110 is configured to cut a membrane such as the dura mater. For example, the tip of the hollow needle 110 may include a sharp-edged annular configuration such that a membrane held against the tip can be cut via rotation of the hollow needle 110. In some embodiments, the hollow needle 110 is rotatably supported by the needle holder 150. In some embodiments, the rotating instrument 170 is connected to the hollow needle 110 such that torque from the rotating instrument 170 can be transmitted to the hollow needle 110. Additionally or alternatively, the hollow needle 110 can be held and manipulated by the surgeon. In some embodiments, the kit 100 includes a suction device (e.g., a pump, etc.) that can be connected to the needle holder 150. In various embodiments, the suction device is configured to create a negative pressure within the needle holder 150 and the hollow needle 110. The hollow needle 110 may be positioned adjacent to the membrane, and the negative pressure may draw a portion of the membrane into the tip of the hollow needle 110. The hollow needle 110 may be rotated to create a circular incision that defines a gap through the membrane.

[0023] FIG. 2 shows a perspective view of an exemplary hollow needle 110. As shown, the hollow needle 110 may comprise a tubular body 111 with a hollow portion 113. The hollow portion 113 may be surrounded by the tubular body 111. In some embodiments, the tubular body 111 includes a first end defining a tip 115 and a second end 117 opposite the tip 115. The tubular body 111 may extend between the tip 115 and the second end 117. The terms tip 115 and second end 117 may refer to designated edges of the tubular body and regions of the tubular body 111 proximate the designated edges. In some embodiments, the tubular body 111 comprises a circular cross-section. In some embodiments, the tubular body 111 has a tubular axis 119, and the tubular body 111 extends longitudinally along the tubular axis 119. For example, the tube axis 119 may be the center of the circular cross section of the tube body 111. In some embodiments, the hollow needle 110 is rotatable about the tube axis 119.

[0024] In some embodiments, the tip 115 of the tube body 111 is configured to pierce and cut the membrane. The hollow portion 113 may include an opening in the tip 115. The hollow portion 113 may be closed at the second end 117. In various embodiments, the tube body 111 includes an engagement shaft that may be held by the rotation tool 170. The engagement shaft may include a solid flat portion. For example, the engagement shaft may be provided at the second end 117.

[0025] In some embodiments, the tube body 111 includes a suction cavity 121 connected to the hollow portion 113. The suction cavity 121 may be located around the circumference of the tube body 111 between the tip 115 and the second end 117. The suction cavity 121 may be located at a rear portion of the tube body 111, for example, near the second end 117. In some embodiments, the suction cavity 121 may be fluidly connected to a suction device such that a vacuum generated by the suction device is transmitted to the hollow portion 113. In various embodiments, the hollow portion 113 generates a negative pressure that is applied to the suction cavity 121, the negative pressure being configured to be applied through an opening in the tip 115. In various embodiments, the negative pressure is configured to pull the dura mater away from the brain tissue so that the sharp portion 131 penetrates the dura mater. In some embodiments, the negative pressure is between 0.1 atmospheres (atm) and 1.0 atm. For example, an electromechanical pump, syringe pump, or the like can be connected to hollow needle 110 and activated to generate a negative pressure of 1.0 atm within tube body 111 and at tip 115 .

[0026] In some embodiments, the tube body 111 comprises stainless steel, tungsten rhenium, titanium, tungsten carbide, etc. In various embodiments, the diameter of the tube body 111 is between 0.5 mm and 0.7 mm. For example, the diameter of the tube may be 0.6 mm.

[0027] 3A and 3B show partial left and right perspective views, respectively, of an exemplary hollow needle 110. In various embodiments, the distal end 115 of the tubular body 111 includes multiple pointed portions 131 for cutting a membrane. For example, the tubular body has four pointed portions. The pointed portions 131 may include a blade structure that forms a circular sawtooth on the distal end 115. In some embodiments, the pointed portions 131 are arranged in a ring configuration on the distal end 115. In some embodiments, the pointed portions 131 include identical structures to one another. In some embodiments, the identical structure of the pointed portions 131 distributes stress more evenly, thereby reducing the risk of fracture due to shearing, twisting, and the like. Alternatively, in some embodiments, one or more pointed portions 131 may exhibit varying heights, edge angles, and the like.

[0028] In some embodiments, the sharpened portion 131 comprises a protrusion having a sharpened tip 133 at its front end and side edges 135 extending toward the sharpened tip 133. The side edges 135 may comprise a sharpened portion that gradually tapers in the circumferential direction. For example, the side edges 135 may extend substantially parallel to the tube axis 119. In various embodiments, when cutting the membrane, the sharpened tip 133 first penetrates the membrane, and the side edges 135 further cut the membrane as the hollow needle 110 is rotated. In some embodiments, each sharpened portion 131 may comprise a single side edge 135 on one side in the circumferential direction such that the sharpened portion 131 can cut the membrane only when the hollow needle 110 is rotated in a predetermined direction (e.g., only clockwise or only counterclockwise). Alternatively, in some embodiments, each sharpened portion 131 may have two opposing side edges 135 (e.g., on either side of the circumference) so that the sharpened portion 131 can cut the membrane when the hollow needle 110 is rotated in a first direction or a second direction (e.g., clockwise or counterclockwise).

[0029] In some embodiments, the tube body 111 includes a flat surface 137 at the distal end 115. The flat surface 137 may be positioned substantially perpendicular to the tube axis 119. In some embodiments, the sharpened portion 131 protrudes from the flat surface. The flat surface 137 may be positioned between the side edges 135. In various embodiments, when the sharpened portion 131 penetrates the dura, the flat surface contacts the dura and prevents the sharpened portion 131 from penetrating into the brain tissue. In some embodiments, the height of the sharpened portion 131 protruding from the flat surface is 0.2 mm to 4.0 mm. For example, the height of the sharpened portion 131 may be 0.3 mm, which may be the thickness of the dura. The height of the sharpened portion may be within a threshold range of the thickness of the membrane to be cut. For example, the height of the sharpened portion may be equal to the thickness of the membrane. Alternatively, the height of the sharpened portion may be within a threshold range that is thinner than the thickness of the membrane. The appropriate height of the sharpened portion 131 may prevent the sharpened portion from protruding behind the dura mater when the sharpened portion 131 penetrates the dura mater.

[0030] In some embodiments, negative pressure applied through an opening in tip 115 pulls the membrane so that sharp portion 131 pierces the membrane, after which side edges 135 may cut the membrane with rotation of hollow needle 110, forming a rounded void in the membrane.

[0031] FIG. 3C shows a top view of an exemplary hollow needle 110 as viewed from the tip 115 side.

[0032] FIG. 3D shows a partial side view of an exemplary hollow needle 110.

[0033] 4 shows a perspective view of an exemplary needle holder 150 cut in half along the axis of the needle holder 150. The needle holder 150 may rotatably support the hollow needle 110 and fluidly connect the suction cavity 121 and the suction device. In some embodiments, the needle holder 150 may be coaxial with the tube axis 119 of the tube body 111 when the tube body 111 is supported by the needle holder 150.

[0034] In some embodiments, needle holder 150 comprises a needle holding portion 151 and a connector portion 153. Needle holding portion 151 may include a holder hollow 155 configured to receive tube body 111. In various embodiments, needle holder 150 comprises a bearing support 157 configured to hold bearing 159 (see FIG. 5 ). In some embodiments, the bearing support is configured as a recess in needle holding portion 151. Tube body 111 supported by needle holder 150 may pass through needle holding portion 151 such that tip portion 115 and second end 117 extend from needle holding portion 151.

[0035] In some embodiments, connector portion 153 includes a portion that extends perpendicularly from holding portion 151, which portion forms a T-shape with needle holding portion 151. Connector portion 153 may include connector 161 at one end. Connector 161 may be fluidly connected to a suction device. In various embodiments, connector portion 153 may be curved in any suitable direction.

[0036] 5 shows a perspective view of an exemplary bearing 159 cut in half along its axis. In some embodiments, the bearing 159 may be coaxial with the tube axis 119 of the tube body 111 when the tube body 111 is supported by the bearing 159. In some embodiments, the bearing 159 is configured to provide an airtight seal between the needle holding portion 151 and the tube body 111 so that suction forces can be effectively transferred to the hollow portion 113 of the tube body 111. For example, the bearing 159 may comprise a ring formed from an elastic material that fits tightly to the needle holding portion 151 and the tube body 111 to ensure an airtight seal. In some embodiments, the suction cavity 121 of the hollow needle 110 may be disposed between the bearing 159 within the needle holding portion 151. In various embodiments, the bearing maintains an airtight seal even while the tube body 111 rotates.

[0037] In some embodiments, kit 100 includes a sensor (not shown) that detects the negative pressure in hollow portion 113 created by the suction device. The sensor may be connected anywhere in the fluid pathway from the suction device to the opening in tip 115. In some embodiments, kit 100 includes an indicator (not shown) that displays the level of negative pressure detected by the sensor. In some embodiments, the suction device may include the sensor and indicator. Alternatively, or in addition, the sensor and / or indicator may be provided as a separate device from the suction device. In various embodiments, the indicator may be configured to indicate an increase in negative pressure as hollow needle 110 pulls the membrane with negative pressure. The indicator may be configured to indicate a decrease in negative pressure as hollow needle 110 cuts the membrane into a round shape and aspirates the round piece of membrane into hollow portion 113.

[0038] 6 shows a perspective view of an exemplary rotary tool 170. The rotary tool may be a drill that may be electrically powered to generate torque. In some embodiments, the rotary tool 170 includes a drive body 171 and a handle 173. In various embodiments, the drive body 171 includes a chuck 175 that is configured to connect to an engagement shaft located at the second end 117 of the tube body 111. The rotary tool 170 may be configured to transmit torque to the hollow needle 110 through the connection provided by the chuck 175.

[0039] 7 shows a perspective view of an exemplary kit 100. In some embodiments, the hollow needle 110 is rotatably supported by a bearing 159 of the needle holder 150. In some examples, the needle holder is configured as a T-shape. In some embodiments, a connector 161 is provided at the bottom of the needle holder in the T-shape. In some embodiments, the connector 161 is configured to connect to a first end of a hose 163, while a second end of the hose 163 may be connected to a suction device. In various embodiments, a chuck 175 of the rotating instrument 170 holds an engagement shaft at the second end 117 of the hollow needle 110.

[0040] 8 shows a perspective view of an exemplary hollow needle 110. As shown, the tubular body 111 may include a suction cavity 121 between the tip 115 and the second end 117.

[0041] 9 shows a partial perspective view of an exemplary hollow needle. In some embodiments, side edges 135 of pointed portion 131 may extend from surface 137 substantially perpendicular to surface 137.

[0042] 10A-10E show schematic diagrams of an exemplary hollow needle and a flow diagram of the use of hollow needle 110 to form a gap in the dura mater. In some examples, during the process of forming a gap in the dura mater, a burr hole is created in the skull to allow access to the dura mater through the burr hole (FIG. 10A). In some embodiments, the burr hole has a diameter of 1 mm to 2 mm. For example, a 1 mm burr hole may be created in the skull to allow access to the dura mater.

[0043] In some examples, negative pressure is applied to the tip 115 of the hollow needle 110 by a suction device, moving the tip 115 toward the dura (FIG. 10B). In some embodiments, the diameter of the hollow needle 110 is 0.5 mm to 0.7 mm. For example, the diameter of the hollow needle 110 may be 0.6 mm. The hollow needle 110 may be lowered while applying negative pressure (also referred to herein as "suction"). In some embodiments, the sensor may read a low level of negative pressure during a leak. The low negative pressure may indicate that the tip 115 of the hollow needle 110 is not in contact with the surface of the dura. Negative pressure by the suction device may be applied constantly while manipulating the hollow needle. In some embodiments, the negative pressure value is approximately 0.1 to 1.0 atm.

[0044] In some embodiments, suction may be applied to the dura mater through tip 115 by advancing tip 115 into sufficient proximity of the dura mater (FIG. 10C). In some embodiments, the suction causes sharp portion 131 to penetrate the dura mater by pulling the dura mater toward tip 115. In various embodiments, the pulling action pulls the dura mater away from the brain tissue. Flat surface 137 of tip 115 may contact the dura mater and prevent sharp portion 131 from penetrating further through the dura mater. Flat surface 137 may thereby reduce the likelihood of sharp portion 131 penetrating subdural brain tissue.

[0045] In various embodiments, contact between the hollow needle 110 and the dura mater causes an increase in negative pressure. For example, the negative pressure at the tip 115 may increase due to a more airtight seal between the hollow needle 110 and the dura mater. In some embodiments, a sensor may read the increase in negative pressure. In some embodiments, the increase in negative pressure may be reported to the surgeon, indicating contact between the tip 115 and the dura mater to the surgeon. For example, in response to a sensor reading an increased level of negative pressure, the surgeon may stop advancing the hollow needle 110 to avoid damage to the subdural tissue.

[0046] In some embodiments, the hollow needle 110 is rotated while the tip 115 contacts the dura mater to cut the membrane (FIG. 10D). As the hollow needle 110 rotates, the side edges 135 of the sharpened portion 131 slice the dura mater in a circular pattern. This allows the hollow needle 110 to form a round void extending through the dura mater. The rotational motion may be initiated after the piercing motion to ensure that the flat surface 137 stops the dura mater in instances where the hollow needle 110 unintentionally approaches the dura mater too quickly.

[0047] In some embodiments, rotation of hollow needle 110 is stopped after the circular void is formed. For example, hollow needle 110 may be rotated 360 degrees, 540 degrees, or another suitable value to ensure the formation of a void through the circular slice of dura. In some embodiments, as the dura is cut, a constant negative pressure draws the cut dural material into hollow portion 113. This may create a round void of a desired size in the dura to accommodate a designated sensor guidewire. In some embodiments, after the void is formed, tip 115 may be removed from contact with the dura. Additionally or alternatively, after the void is formed, the negative pressure within hollow needle 110 may decrease (e.g., as cut material, air, fluid, etc., traverses hollow portion 113). A sensor may read the decrease in pressure. The decrease in pressure may be reported to the surgeon, and this decrease in pressure may be interpreted as a signal that the dura has been cut. For example, the operator may cease rotation of hollow needle 110 in response to an indication of a decrease in pressure within hollow portion 113 at tip 115 or the like.

[0048] In some embodiments, the hollow needle 110 is removed from the burr hole in the skull ( FIG. 10E ). Negative pressure may be maintained throughout removal of the hollow needle 110 to ensure removal of the severed material from the target site. Alternatively, in some embodiments, the application of negative pressure is discontinued (or reduced) during removal of the hollow needle 110 from the target site. In some embodiments, the application of negative pressure is discontinued in response to detecting a decrease in negative pressure within the hollow needle. For example, aspirating the severed material into the hollow needle 110 may result in a decrease in negative pressure. The application of negative pressure may be discontinued or reduced in response to detecting the decrease in pressure, thereby reducing the aspirating of fluid into the hollow needle 110. In various embodiments, after removal of the hollow needle 110, one or more instruments may be inserted into the burr hole in the skull and advanced through the dural space to access the subdural tissue. For example, a sensor guidewire for epilepsy diagnosis may be inserted through the skull and dura, allowing sensor readings to be generated from the subdural tissue.

[0049] Conclusion Although some embodiments described herein relate to hollow needles, those skilled in the art will understand that the teachings herein may be applied to a wide range of medical procedures and devices. The embodiments described herein may be expandable to accommodate at least the applications described above. Various components of the embodiments described herein may be added, removed, rearranged, modified, duplicated, etc., as those skilled in the art may find advantageous and / or necessary to implement a particular application in conjunction with the teachings of the present disclosure. In some embodiments, specific features, characteristics, materials, components, and / or devices may be applied as those skilled in the art may find advantageous and / or necessary to implement a particular application in conjunction with the teachings of the present disclosure.

[0050] Moreover, numerous modifications and other embodiments of the present disclosure set forth herein will come to mind to those skilled in the art having the benefit of the teachings herein and presented in the foregoing description and the associated drawings. It is therefore to be understood that the present disclosure is not limited to the particular embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of any appended claims. Furthermore, while the foregoing description and associated drawings describe exemplary embodiments in the context of particular example combinations of elements and / or functions, it should be understood that alternative embodiments may provide various combinations of elements and / or functions without departing from the scope of any appended claims. In this regard, for example, different combinations of elements and / or functions than those expressly described above are also contemplated as being part of any appended claim. Although specific terms are employed herein, these terms are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. A hollow needle that forms a void in a membrane, the hollow needle comprising: a tube body extending along a tube axis between a first end and a second end, the first end defines a distal end of the tube body; The tip portion has a sharpened portion, the second end defining a suction cavity configured to receive application of negative pressure from a suction device; and a hollow portion surrounded by the pipe body; Equipped with the hollow portion extends through and defines an opening in the tip; the hollow portion is configured to apply the negative pressure through the opening to draw the membrane toward the tip; The sharpened portion is configured to cut the membrane via rotation of the tube body.

2. The hollow needle of claim 1 , wherein the tubular body includes a plurality of sharpened portions at the distal end, the sharpened portions being annular in configuration.

3. the pointed portion comprises a protrusion; The protrusion is a sharp tip configured to pierce the membrane; a side edge configured to cut the membrane via rotation of the tube body; Equipped with The hollow needle according to claim 1 or 2.

4. The hollow needle of claim 3 , wherein the side edges are disposed substantially parallel to the tube axis.

5. The tube body further includes a flat surface at the tip portion, the flat surface is disposed substantially perpendicular to the tube axis; The pointed portion protrudes from the flat surface. The hollow needle according to claim 1 or 2.

6. The hollow needle of claim 5 , wherein the pointed portion protrudes from the flat surface by 0.2 mm to 4.0 mm.

7. The hollow needle of claim 6, wherein the sharpened portion protrudes from the flat surface by at least 0.3 mm.

8. the hollow portion is closed within the second end; The suction gap is provided on a circumferential portion of the tube body between the tip end and the second end. The hollow needle according to claim 1 or 2.

9. The hollow needle of claim 1 or claim 2, wherein the tubular body further comprises an engagement shaft configured to connect a rotary instrument.

10. The hollow needle of claim 9 , wherein the engagement shaft is provided at the second end.

11. The hollow needle of claim 9 , wherein the engagement shaft comprises a solid flat portion configured to contact the tip and stop the tip from advancing toward the membrane.

12. 3. The hollow needle according to claim 1, wherein the diameter of the tube body is 0.5 mm to 0.7 mm.

13. 3. The hollow needle of claim 1 or claim 2, wherein the membrane is the dura mater that surrounds the brain.

14. A kit comprising the hollow needle according to claim 1 or 2, The kit further comprises a needle holder; The needle holder includes: a holder body including a connector configured to be fluidly connected to the suction device; a bearing configured to rotatably support the tube body; Equipped with The needle holder is configured to receive the aspiration cavity.

15. The kit of claim 14 , wherein the bearing is further configured to provide an airtight seal between the holder body and the tube body.

16. the tube body further comprises an engagement shaft configured to connect to a rotary instrument; the engagement shaft is provided at the second end of the tube body; the holder body includes a needle holding portion and a connector portion; the tube body extends into the needle holding portion such that the tip and the second end extend from the needle holding portion; The connector portion comprises the connector. The kit of claim 14.

17. The kit of claim 14 , further comprising the suction device capable of being fluidly connected to the connector.

18. The kit includes: a sensor configured to measure the negative pressure; an indicator configured to report the degree of negative pressure measured by the sensor; 15. The kit of claim 14, further comprising:

19. The tube body further comprises an engagement shaft; The kit of claim 14 , further comprising a rotation tool configured to hold the engagement shaft.

20. 3. A method for forming a void in a membrane using a hollow needle according to claim 1 or claim 2, said method comprising: applying negative pressure at the tip by the suction device; advancing the tip toward the membrane; Including, The method wherein the negative pressure pulls the portion of the membrane toward the tip such that the sharp portion pierces the portion of the membrane.

21. 21. The method of claim 20, further comprising ceasing advancement of the tip toward the membrane in response to detecting an increase in negative pressure.

22. 21. The method of claim 20, further comprising rotating the tube body such that the sharpened portion cuts a gap into the portion of the membrane.

23. 23. The method of claim 22, further comprising ceasing rotation of the tube body in response to detecting the increase in negative pressure.

24. 21. The method of claim 20, further comprising suctioning the cut pieces of the portion of the membrane into the hollow portion.

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