Cerebrospinal fluid diverter

Abstract

A method includes introducing a shunt into a vascular system, where the shunt includes an inlet aperture in an inlet region and an outlet aperture in an outlet region; positioning the entrance region into an epidural vein or an intervertebral vein; puncturing the wall of the epidural vein or intervertebral vein, through the interstitial space, and puncturing the sheath capsule with a stylet, where the stylet includes a wire extending through a diverter; moving the diverter to extend the entrance region through the wall of the epidural vein or intervertebral vein; moving the diverter to extend the inlet region into the interstitial space; and moving the diverter to extend the inlet region through the sheath capsule such that the inlet region is positioned in the epidural lumen and such that the outlet region is positioned in the vein path.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 446,064, filed February 16, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0003] In general, this application relates to shunts for cerebrospinal fluid (CSF). Attached Figure Description

[0004] Figure 1 A cross-sectional view of the patient's anatomy is shown.

[0005] Figure 2 A cross-sectional view of the patient's anatomy and the delivery system for the CSF shunt, according to an embodiment, is shown.

[0006] Figure 3A , 3B Figures 3C and 3C show a cross-sectional view of the patient's anatomy and the sequence for locating the CSF shunt according to an embodiment.

[0007] Figure 4 A shows a longitudinal sectional view of a diverter and a portion of a diverter conveying system according to an embodiment.

[0008] Figure 5 A cross-sectional view is shown of a patient's anatomy and a portion of the CSF shunt in its final position, according to an embodiment.

[0009] Figure 6 A cross-sectional view of the patient's anatomy and the CSF shunt in its final position, according to an embodiment, is shown.

[0010] Figure 7A , 7B Figures 7C and 7D show axial cross-sectional views of different CSF splitter designs according to embodiments.

[0011] Figure 8A and 8B A cross-sectional view is shown of the patient's anatomy and the sequence for locating the CSF shunt in the patient's body, according to an embodiment.

[0012] Figure 9A and 9B Different cross-sectional views of a CSF shunt located inside a patient according to an embodiment are shown.

[0013] Figure 10A , 10B Figures 10C and 10C show a cross-sectional view of a CSF splitter with a flow regulator according to an embodiment.

[0014] Figure 11A and 11B A cross-sectional view of a portion of a CSF diverter with an anti-backflow valve according to an embodiment is shown.

[0015] Figure 12 A flowchart of a method for locating a CSF shunt in a patient's vein, according to an embodiment, is shown.

[0016] Figure 13A , Figure 13B , Figure 13C and Figure 14 The inner wire and core needle according to an embodiment are shown.

[0017] Figure 15 A portion of a diverter delivery system and a diverter according to an embodiment is shown.

[0018] Figure 16A , Figure 16B and Figure 16C The sequence of implanting a splitter using a splitter delivery system according to an embodiment is shown.

[0019] The foregoing summary of the invention and the following specific embodiments of certain technologies of this application will be better understood when read in conjunction with the accompanying drawings. Certain technologies are illustrated in the drawings for illustrative purposes. However, it should be understood that the claims are not limited to the arrangements and means shown in the drawings. Furthermore, the appearance shown in the drawings is one of many decorative appearances that can be used to achieve the said functions of the system. Summary of the Invention

[0020] According to an embodiment, a method for locating a cerebrospinal fluid (CSF) shunt within a vein in a patient includes: introducing the CSF shunt into the patient's vascular system, wherein the CSF shunt includes an inlet orifice in an inlet region and an outlet orifice in an outlet region, wherein the inlet orifice and the outlet orifice are in fluid communication with each other; locating the inlet region of the CSF shunt into an epidural vein or intervertebral vein; puncturing the wall of the epidural vein or intervertebral vein with a core needle, passing through the interstitial space, and puncturing the sheath, wherein the core needle includes a wire extending through the CSF shunt; and moving... A cerebrospinal fluid (CSF) shunt is used to extend the inlet region through the wall of an epidural vein or intervertebral vein; after moving the CSF shunt to extend the inlet region through the wall of the epidural vein or intervertebral vein, the CSF shunt is moved to extend the inlet region into the interstitial space; and after moving the CSF shunt to extend the inlet region into the interstitial space, the CSF shunt is moved to extend the inlet region through the sheath, such that the inlet region of the CSF shunt is located in the intradural lumen, and the outlet region of the CSF shunt is located in the venous pathway. The epidural vein or intervertebral vein may be located in the lumbar region of the patient. The epidural vein or intervertebral vein may be located in the thoracic region of the patient. The epidural vein or intervertebral vein may be located in the cervical region of the patient. The epidural vein or intervertebral vein may be located in the sacrum of the patient. The exit orifice of the cerebrospinal fluid shunt can be located in a venous pathway including at least one of the following: epidural vein, intervertebral vein, paravertebral vein, lumbar vein, iliac vein, femoral vein, azygos vein, hemiazygos vein, inferior vena cava, superior vena cava, right atrium of the heart, or a venous branch of the inferior vena cava or superior vena cava. The method may further include, after puncturing the sheath, deploying an anchor within the dural lumen to stabilize the inlet region of the cerebrospinal fluid shunt relative to the sheath. The method may also include, prior to puncturing the sheath, deploying a restrictor at least partially in the interstitial space, wherein the restrictor defines the maximum length of the cerebrospinal fluid shunt extending through the sheath and into the dural lumen. Deploying the restrictor may include expanding the restrictor such that its outer radius is greater than the outer radius of the lateral region of the cerebrospinal fluid shunt between the inlet and outlet regions. When the inlet region of the cerebrospinal fluid shunt can be located within the dural lumen, the outlet region of the cerebrospinal fluid shunt can be located in one of the epidural vein, intervertebral vein, lumbar vein, iliac vein, or perivertebral vein. The cerebrospinal fluid (CSF) shunt may include silicone resin. The CSF shunt may include polyurethane. The CSF shunt may include nitinol. The CSF shunt may include at least one radiopaque marker. The CSF shunt may include a material on at least one of the exterior or interior of the inlet region of the CSF shunt, the material being configured to reduce at least one of blood clotting, protein aggregation, or cell aggregation. The CSF shunt may include an anti-backflow mechanism between the inlet and outlet orifices, wherein the anti-backflow mechanism may be configured to reduce or prevent retrograde migration of blood.A cerebrospinal fluid (CSF) shunt may include a flow regulator between an inlet orifice and an outlet orifice, wherein the flow regulator may be configured to regulate the flow of CSF between the inlet and outlet orifices. The step of introducing a CSF shunt into a patient's vascular system may include introducing the CSF shunt into a vein in the leg, neck, or arm. The method may also include the step of removing the CSF shunt by engaging a shunt removal feature on the CSF shunt. The method may further include the step of temporarily enlarging at least one of the following at least one enlargement location: an orifice through the wall of an epidural vein or an intervertebral vein, an interstitial space region, or an orifice through a sheath, by positioning a balloon at at least one enlargement location and then inflating the balloon to perform enlargement before or during the passage of the shunt through at least one enlargement location.

[0021] According to an embodiment, a cerebrospinal fluid shunt for placement in a patient includes: an inlet region configured to pass through a hole in the wall of an epidural vein or an intervertebral vein, through a hole in a sheath, and through an interstitial space between the wall of the epidural vein or the intervertebral vein and the sheath; an inlet orifice in the inlet region, wherein the inlet orifice is configured to receive cerebrospinal fluid from the dural lumen; an outlet region configured to be located in a venous pathway; an outlet orifice in the outlet region, wherein the outlet orifice is in fluid communication with the inlet orifice, wherein the outlet orifice is configured to allow cerebrospinal fluid received by the inlet region to flow out of the cerebrospinal fluid shunt; a transverse region between the inlet region and the outlet region, wherein the transverse region includes a channel to achieve fluid communication between the inlet orifice and the outlet orifice; and an insertion limiting portion located in the transverse region, wherein the insertion limiting portion is configured to be located in the interstitial space between the wall of the epidural vein or the intervertebral vein and the sheath. The shunt may further include: at least one radiopaque marker at least partially located in the inlet region; at least one radiopaque marker at least partially located in the lateral region; and at least one radiopaque marker at least partially located in the outlet region. The inlet region may include a spherical head region. The insertion limiting portion may include a radially projecting portion, and wherein the spherical head region and the radially projecting portion may be integrated into a single piece. The single piece may be coupled to another portion of the cerebrospinal fluid shunt, including the outlet region.

[0022] According to an embodiment, a system for positioning a cerebrospinal fluid shunt in a patient includes: a guide catheter configured to slide over a proximal region of a guidewire located in the patient's venous system, wherein the guide catheter includes a proximal region and a distal region, wherein the guide catheter includes an anchor configured to anchor the distal region of the guide catheter at a location in the patient's venous system; an adapter coupled to the proximal region of the guide catheter, wherein the adapter is configured to selectively prevent fluid from flowing out of the patient and out of the adapter; a sheath including a proximal region and a distal region, wherein the sheath is at least partially located within the guide catheter; and a shunt at least partially located within the guide catheter. Between the shunt and the sheath, the shunt includes an inlet region having an inlet orifice, an outlet region having an outlet orifice, and a transverse region between the inlet and outlet regions, wherein the transverse region includes a channel such that the inlet and outlet orifices are in fluid communication, wherein the transverse region is configured to extend through the venous wall and through the interstitial space, wherein the inlet region is configured to extend through the sheath and into the dural lumen, and wherein the outlet region is configured to be positioned in the venous pathway; and a wire configured to extend through the shunt and at least partially extend out of the inlet orifice, wherein the wire includes a proximal region and a distal region, and wherein the distal region is configured to puncture the venous wall and the sheath. An anchor for the guiding catheter may include a balloon. The inlet region of the shunt may also include an anchor configured to stabilize the inlet region relative to the sheath. The sheath may include a retractable sheath. The transverse region may include a restrictor configured to limit the distance the shunt can be inserted into the patient.

[0023] According to an embodiment, a method for locating a cerebrospinal fluid (CSF) shunt within a vein in a patient includes: introducing the CSF shunt into the patient's vascular system, wherein the CSF shunt includes an inlet orifice in an inlet region and an outlet orifice in an outlet region, wherein the inlet orifice and the outlet orifice are in fluid communication with each other; locating the inlet region of the CSF shunt into an epidural vein or an intervertebral vein; after locating the inlet region of the CSF shunt into the epidural vein or an intervertebral vein, moving the CSF shunt to extend the inlet region into the interstitial space; and after moving the CSF shunt to extend the inlet region into the interstitial space, moving the CSF shunt to pass through a foramen of the sac sheath, such that the inlet region of the CSF shunt is at least partially located in the dural lumen, and such that the outlet region of the CSF shunt is located in the venous pathway.

[0024] According to an embodiment, a method for locating a cerebrospinal fluid (CSF) shunt within a vein in a patient includes: introducing the CSF shunt into the patient's vascular system, wherein the CSF shunt includes an inlet orifice in an inlet region and an outlet orifice in an outlet region, wherein the inlet orifice and the outlet orifice are in fluid communication with each other; locating the inlet region of the CSF shunt into an epidural vein or an intervertebral vein; moving the CSF shunt such that the inlet region passes through an orifice in the wall of the epidural vein or intervertebral vein; and after moving the CSF shunt such that the inlet region passes through the wall of the epidural vein or intervertebral vein, moving the CSF shunt such that the inlet region of the CSF shunt is at least partially located within the dural lumen, and such that the outlet region of the CSF shunt is located in the venous pathway.

[0025] According to an embodiment, a method for locating a cerebrospinal fluid (CSF) shunt within a vein in a patient includes: introducing the CSF shunt into the patient's vascular system, wherein the CSF shunt includes an inlet orifice in an inlet region and an outlet orifice in an outlet region, wherein the inlet orifice and the outlet orifice are in fluid communication with each other; locating the inlet region of the CSF shunt into an epidural vein or an intervertebral vein; moving the CSF shunt such that the inlet region extends through the wall of the epidural vein or the intervertebral vein; after moving the CSF shunt such that the inlet region extends through the wall of the epidural vein or the intervertebral vein, moving the CSF shunt such that the inlet region extends into the interstitial space; and after moving the CSF shunt such that the inlet region extends through the interstitial space, moving the CSF shunt such that the inlet region extends through the sheath, such that the inlet region of the CSF shunt is located in the dural lumen, and such that the outlet region of the CSF shunt is in fluid communication with at least one of a reservoir or transdermal port located under the patient's skin. The transdermal port can be configured to allow at least one of the following: delivery of medication to a patient, removal of CSF, or promotion of CSF pressure measurement. Detailed Implementation

[0026] The embodiments described herein relate to systems and methods for draining excess cerebrospinal fluid (CSF) from the dural space of a patient, particularly the subarachnoid space in the spinal canal. The embodiments of this document describe the placement of a CSF shunt within the patient using an endovenous approach via a vein within the spinal region.

[0027] Cerebrospinal fluid (CSF) is the ultrafiltrate of blood plasma. It is a generally clear liquid with a density close to that of water. CSF bathes the brain within the skull and the spine and spinal nerve roots within the vertebral canal. CSF is enclosed within the dura mater, or dura, a thick and relatively inelastic membrane that covers the inner surface of the skull and vertebral canal. In the spinal region, the dura mater is called the sac. CSF is secreted within the ventricles via the choroid plexus and circulates around the folds of the brain and around the spinal cord and nerve roots. CSF is reabsorbed into the venous blood by arachnoid granulations. Some arachnoid granules are located around the brain along the walls of the venous sinuses, in which case CSF is diverted into the venous sinuses. Other arachnoid granules are located along the nerve roots of the vertebral canal, in which case CSF is diverted into the veins around the nerve roots.

[0028] Hydrocephalus is a relatively neurological disorder in which pressure in the cerebrospinal fluid (CSF) increases due to various causes. Hydrocephalus can be communicating, where the CSF flow pathway is not interrupted, but there is a defect in the reabsorption of CSF by the arachnoid granulations. Hydrocephalus can also be caused by excessive production of CSF. Hydrocephalus can be secondary to CSF ​​circulatory disturbances, which is called non-communicating hydrocephalus. Some hydrocephalus conditions are congenital, while others may be acquired (e.g., after subarachnoid hemorrhage).

[0029] One treatment for hydrocephalus is CSF transfer. CSF transfer is often referred to as shunt and involves placing a permanent (or semi-permanent) shunt (e.g., a tube) that transfers the CSF from the subarachnoid space to another area of ​​the body where it can be reabsorbed. This procedure can be performed by a neurosurgeon.

[0030] Besides hydrocephalus, other conditions can also be treated with the techniques described in this article via CSF transfer. For example, in some patients, the ventricles may shrink, which is caused by conditions such as idiopathic intracranial hypertension (IIH). In some patients, the ventricles may enlarge without an increase in CSF pressure, leading to conditions such as normal pressure hydrocephalus (NPH).

[0031] Conventional shunts can be inserted into the CSF via locations within the skull. However, the neurosurgical procedures required for implanting such shunts can be relatively risky. For example, this procedure can be high-risk when the shunt is positioned in the inferior petrosal sinus, and failure can lead to neurological complications or even death. The embodiments disclosed herein describe delivery systems and CSF shunts for placement outside the cranial cavity. In particular, embodiments herein disclose placement of a CSF shunt in the spinal canal, for example, in the lumbar region. The lumbar region includes multiple sites that can be accessed via an intravenous catheter guided by X-ray fluoroscopy for delivery and positioning of the CSF shunt. In contrast to brain surgery, the spinal region (e.g., the lumbar region) can be a safer surgical area with lower risks.

[0032] It is worth noting that CSF shunts can fail at a relatively high rate (e.g., more than 50% within two years, and even higher percentages over longer periods). Furthermore, when a CSF shunt fails and additional removal and / or replacement is required, the spinal region may again be a safer area (compared to the cranial region) for performing procedures such as endovenous surgery.

[0033] According to the technique described herein, a cerebrospinal shunt has an inlet region and an outlet region. The inlet region is located within the dural space of the sheath. The outlet region is located within a venous pathway. The venous pathway can be any path along the venous system. One example of a venous pathway is along an intervertebral vein extending to the lumbar veins, iliac veins or paravertebral veins, vena cava (e.g., inferior vena cava or superior vena cava), and the right atrium of the heart. Another example of a venous pathway is along the epidural venous network of the spinal canal. Yet another example of a venous pathway is along the azygos vein or one of its tributaries, or a venous tributary of the inferior vena cava or superior vena cava.

[0034] According to the techniques described herein, an endovenous procedure is employed to implant a spinal-venous shunt for draining CSF from the dural lumen to a vein, such as an epidural vein (a vein in the spinal canal) or a vein surrounding the spine. The shunt may include a hollow tube having an inlet orifice in an inlet region within the dural lumen. The inlet orifice receives higher-pressure CSF. The shunt may also include an outlet orifice in an outlet region. The outlet orifice delivers the CSF received at the inlet orifice to a lower-pressure region. For example, the outlet orifice may be located in a venous pathway, such as in an epidural vein, intervertebral vein, lumbar vein, or a vein near or away from the spine. The shunt may also include a transverse region comprising a channel between the inlet and outlet regions. The channel may connect the inlet and outlet or otherwise enable fluid communication between the inlet and outlet. The shunt may include one or more anti-backflow features (e.g., valves and / or flow control elements) and / or flow restriction features.

[0035] According to the technology described herein, a method for placing a CSF shunt via an intravenous approach is provided. This method may include cannulating a vein near the sheath, orienting the catheter toward the sheath, perforating the vein wall, perforating the interstitial space, perforating the sheath, perforating the arachnoid membrane, and positioning the shunt through the perforations such that the inlet orifice is located within the dural lumen and the outlet orifice is located in the vein surrounding or away from the sheath.

[0036] According to the techniques described herein, for the implantation of a CSF shunt, the patient can be anesthetized or sedated and placed on an X-ray / fluorescence fluoroscopy system (hereinafter referred to as the fluoroscopy system) operating table. A surgeon or a member of the surgical team (hereinafter referred to as the surgeon) can insert a needle into a vein (e.g., a vein in the patient's leg, neck, or arm). The surgeon can then place an intubator over the needle and insert it into the vein, and then withdraw the needle. As another example, an intubator can be positioned with the needle such that the intubator is inserted simultaneously with the needle. The surgeon can inject a fluorescent contrast dye fluid into the patient. Using the fluoroscopy system, the surgeon can visualize the patient's venous system (or relevant portions thereof) on a monitor. The surgeon can determine the appropriate route for performing the intravenous delivery and implantation of the CSF shunt. This appropriate route can be via an epidural vein, an intervertebral vein, or a perivertebral vein.

[0037] Figure 1 The anatomical regions of a patient in the spinal region (e.g., the lumbar region) are shown. Examples of epidural veins and intervertebral veins are shown. The spinal region includes the spinal canal 10 (generally shown), bone 12, nerve 14, nerve root 16, fat and / or interstitial space 18, epidural vein 20, intervertebral vein 22, sac sheath 30, and cerebrospinal fluid 32. The interstitial space 18 includes fluid-filled and non-fluid-filled spaces (such as fat, which are represented by dotted areas). As shown, the interstitial space 18 is anatomically located at least between the veins and the patient's dura mater, which restricts the sac sheath 28. The interstitial space 18 is mainly composed of loose tissue and fat, as well as small blood vessels such as capillaries, arterioles, and venules.

[0038] Figure 2The distal portion of a shunt delivery system 100 (guide catheter 110, guidewire 120, and stabilizer 130, as shown) within a patient is illustrated. The guide catheter 110 is positioned such that its tip is suitably (for this example) located in the intervertebral vein 22 and the guidewire 120 is located in the epidural vein 20. The stabilizer 130 is further illustrated. The guide catheter 110, guidewire 120, and stabilizer 130 form part of the shunt delivery system 100 to deliver the CSF shunt 200 to the appropriate location, as will be described further. To position the guide catheter 110 and guidewire 120 appropriately, the surgeon may insert the guide catheter 110 together with the accompanying guidewire 120 into an introducer (not shown). The shunt 200 and the guide catheter 110 and / or other components of the shunt delivery system 100 may have one or more radiopaque or radiopaque markings 150 (RO markings). Figure 2 (Not shown in the image), as will be described further. The surgeon can easily visually inspect the radiopaque marker 150 via a fluoroscopic display, allowing the surgeon to visualize system components within the patient's contrast venous system. The radiopaque marker 150 may comprise one or more materials, such as platinum / iridium (90 / 10), gold, palladium, or substantially pure platinum (~99%).

[0039] One type of radiopaque marker 150 may be one or more filaments (e.g., platinum / iridium wire) extending along a given component (e.g., substantially longitudinally). Such filaments may be braided, implanted, embedded, or attached to the given component described herein, including one or more components of the shunt delivery system 100 and / or shunt 200. The radiopaque marker 150 discussed herein facilitates visualization of specific stages of surgery by the surgeon via a fluoroscopic display system monitor and does not need to be repeated each time the radiopaque marker 150 is described herein. The guiding catheter 110 may have a relatively flexible tip, which may be radiopaque or have radiopaque markers 150 (e.g., including platinum / iridium). Other portions of the guiding catheter 110 may be relatively rigid to allow manipulation of the guidewire 120 and its insertion into the patient. The surgeon may guide the guiding catheter 110 through a vein while simultaneously viewing the procedure in real time, for example, on a monitor. Once the tip of the guiding catheter 110 has been positioned in the appropriate location (e.g., an intervertebral vein, a perispinal vein, an epidural vein, or another appropriate location in the venous pathway), the surgeon can anchor the distal portion of the guiding catheter 110 in the appropriate location (e.g., an intervertebral vein, a perispinal vein, an epidural vein, or another appropriate location in the venous pathway).

[0040] Alternatively, catheter insertion can be performed using a catheter (not shown) with a guidewire 120, and the catheter can be replaced with a guiding catheter 110 on the guidewire 120. The guiding catheter 110 may have one or more radiopaque markers 150, and the surgeon can position the guiding catheter 110 while observing the procedure on a fluoroscopic monitor, ensuring the distal end of the guiding catheter 110 is in the appropriate location (e.g., an intervertebral vein, a perispinal vein, or an epidural vein). For example, depending on the size of the associated vein(s), the diameter of the guiding catheter 110 may range from approximately 3 Fr to 7 Fr. The guiding catheter can be relatively short (e.g., less than 50 cm) to relatively long (e.g., greater than 90 cm). The length of the guiding catheter 110 can be selected based on the surgical entry point. As an example, if the femoral vein is chosen for endovenous surgery and the implantation site is in the lumbar region, the guiding catheter 110 may be relatively short (e.g., 30-50 cm). If the brachial vein is used and the shunt 200 is to be implanted in the lumbar region, the guiding catheter 110 may be relatively long (e.g., 150 cm).

[0041] The guiding catheter 110 may include a guiding catheter stabilizer 130 (or stabilizer) in the distal region of the guiding catheter 110. This guiding catheter stabilizer 130 may include a balloon or mesh dilatation device, or a reinforcing element or component. The guiding catheter stabilizer 130 may have one or more radiopaque markers 150 for observation on a fluoroscopic display. The guiding catheter stabilizer 130 may include one or more different materials, including, for example, Pebax, polyurethane, and / or silicone elastic materials. When the guiding catheter stabilizer 130 includes a balloon, the balloon may be oriented substantially coaxially around the guiding catheter 130, or may be biased to one or more sides. Furthermore, two or more balloons may be present in the distal region of the guiding catheter 110 (e.g., each balloon is independently controlled). In this case, each stabilizer 130 may extend less than 360° around the guiding catheter 110 (e.g., one balloon at the top and one balloon at the bottom, each balloon extending 180° around the guiding catheter 110). If multiple balloons are used, each balloon may inflate individually. This expansion facilitates surgeon guidance and orientation of the distal region (e.g., the tip) of the guiding catheter 110. One or more balloons may be inflated via a Luer connector on the proximal handle or via a Luer connector on or within the guiding catheter 110.

[0042] Alternatively or additionally, the tip of the guide tube 110 may be oriented and secured using a mechanical system. For example, a mechanical system may eliminate the need for a stabilizer 130.

[0043] Once the guide catheter stabilizer 130 is properly positioned, the surgeon can deploy the guide catheter stabilizer 130 (e.g., inflate the balloon anchor) to stabilize the guide catheter 110 in the appropriate location within the vein and, if instructed, orient the guide catheter 110, for example, such that its long passage is centered or off-center along the main axis of the vein. After the guide catheter 110 has been properly positioned and / or stabilized, the surgeon can remove the guidewire 120 from the patient. Figure 2 An example of a guide catheter 110 that has been positioned and stabilized in the intervertebral vein 22 via a guide catheter stabilizer 130 (an inflatable balloon in this example) is shown. Stabilization can be performed before the guidewire 120 is withdrawn.

[0044] After positioning and stabilizing the guiding catheter 110, the surgeon may introduce an additional portion of the shunt delivery system 100 into the proximal end of the guiding catheter 110. Figure 4 A longitudinal sectional view of some additional components of an exemplary shunt delivery system 100 and shunt 200 is shown. The shunt 200 may include a shunt body 210, which may include an inlet region 212 and an inlet orifice 211, the inlet orifice 211 receiving CSF 32 from within the dural lumen 30. The inlet region 212 of the shunt body 210 may be located distally during implantation. The shunt body 210 may also include an outlet region 214 and an outlet orifice 213, which, once the shunt 200 has been implanted, allows the received CSF 32 to be delivered from the inlet orifice 211 to the patient's intravenous region. The shunt body 210 may also include a transverse region 215 between the inlet region 212 and the outlet region 214. The transverse region 215 may include a channel that allows fluid communication between the inlet orifice 211 and the outlet orifice 213, thereby allowing CSF 32 to flow through the shunt body 210 once implanted.

[0045] The shunt body 210 may include materials such as polyurethane, silicone, and / or nitinol. The shunt body 210 may include or be coated with materials that reduce blood clotting, protein aggregation, and / or cell aggregation on its external and / or internal regions. Such materials may be antithrombotic and may include materials or compounds such as Plavix or heparin.

[0046] like Figure 4 As shown, the diverter 200 may include an anchor 230, which facilitates the stabilization of the diverter 200 once it is fully installed. The anchor 230 may include multiple anchor fingers 231, which may have one or more transmissive markers 150. Anchor wires 232 may be included in or on one or more anchor fingers 231. The function, deployment, and operation of the anchor 230 will be further described.

[0047] like Figure 4 As shown, the diverter delivery system 100 may also include a limiter 140. The limiter 140 may also include one or more transmissive markers 150 (not shown). The function, deployment, and operation of the limiter 140 will be described further.

[0048] like Figure 4 As shown, the distributor delivery system 100 may further include a sheath 170 (e.g., a retractable sheath) outside some or all portions of the distributor 200. The sheath 170 may have one or more translucent markings 150 (…). Figure 4 Not shown in the image, but... Figure 8A and 8B (As shown in the diagram). Sheath 170 may include a distal region (away from the surgeon) and / or a distal tip, which is adapted for or facilitates piercing one or more portions of the patient's anatomy. Sheath 170 may be operated in conjunction with inner thread 160 for or to facilitate piercing. Sheath 170 may be coated with or may include a lubricating material, such as those described herein. For example, sheath 170 may have a laminated construction, wherein the inner layer of the laminate near the shunt 200 includes a lubricating material, such as PTFE. This lubricating material facilitates removal of sheath 170 from the shunt 200. The exterior of the lubricating material layer may be a stiffer layer and / or a braided fabric within the layer to improve stiffness, maneuverability, and / or trackability. The exterior of the stiffer layer may be one or more additional layers suitable for different purposes.

[0049] like Figure 4 As shown, the shunt delivery system 100 may further include an inner wire 160 extending through the shunt body 210 (e.g., through the outlet port 213, lateral channel 215, and inlet port 211). The inner wire 160 may include one or more radiopaque markers 150. The inner wire 160 may include a distal region and / or a tip 162 adapted or facilitating perforation of one or more portions of the patient's anatomy. The inner wire 160 may include a hollow tube extending through it, the hollow tube including an inlet port and an outlet port. The inner wire 160 may include biometal and / or bioplastic, and / or may internally contain a movable and / or removable core 165. The core 165 and / or the hollow tube may include nitinol (e.g., hyperelastic nitinol) to enhance flexibility or maneuverability.

[0050] Figure 13A and 13B Cross-sectional and top views are shown along the main axis of different embodiments of the inner wire 160 and the mandrel 165. Figure 13C A cross-sectional view along the main axis of the inner wire 160 and the mandrel 165 is shown according to an embodiment. Figure 14A cross-sectional view along the main axis and axial direction of the inner thread 160 and the mandrel 165, according to an embodiment, is shown. Figure 13A As shown, the distal region of the inner wire 160 may include a rounded or shovel-shaped area. One or more edges of the distal tip of the inner wire 160 may be sharp (e.g., razor-shaped). One or more edges of the distal tip of the inner wire 160 may include one or more bevels. Other configurations of the inner wire 160 and / or the mandrel 165 are shown in... Figure 13B (An irregular tip) and 13C (a tapered tip) are shown. After advancing the inner wire 160 through the sheath 28 (and / or advancing the inner wire 169 further forward into the dural lumen 30 to provide additional stability for deployment of the shunt 200), the core needle 165 can be removed, thereby clearing the internal hollow path and allowing the surgeon to retract the CSF 32 to confirm that the distal tip of the inner wire 160 is in the dural lumen. In this embodiment, the CSF 32 flows through the hollow tube in the inner wire 160. By removing the core needle 165, this also allows for drug delivery and / or contrast agent delivery for confirming position in the dural lumen 30 and / or pressure monitoring / reading via the hollow internal region of the inner wire 160.

[0051] The core needle 165 may include a distally sharp tip (e.g., razor-shaped). In this case, the inner wire 160 may (or may not) have a rounded edge (e.g., unlike a razor). The distal tip of the core needle 165 may be beveled, faceted, or semi-shovel-shaped. Figure 13B ) or conical ( Figure 13CThis creates a sharp tip, which may be advantageous for tissue penetration. In other embodiments, the needle 165 may have a distal tip in the shape of a cannula or a screw. When using a screw shape, the needle 165 and / or the inner wire 160 can be rotated to facilitate tissue puncture. The needle 165 may be coated or comprised of a material such as PTFE to enhance lubrication and facilitate movement. While the shunt 200 is positioned for puncture, the needle 165 may be retained, received, and locked (via a handle) in the inner wire 160. Once the inner wire 160 is positioned in the vein and before puncturing the vein wall, the needle 165 may be advanced to create holes, incisions, and / or openings in one or more tissues (e.g., the vein wall, interstitial space 18, and / or sheath 28) between the vein and the CSF 32. These holes, incisions, and / or openings facilitate the advance of the shunt 200 and / or other parts of the shunt delivery system 100. For example, they can facilitate the expansion of one or more portions of the shunt 200 to enlarge one or more portions of the hollow interior region of the shunt 200. This technique allows for the collapse of one or more portions of the shunt 200 (e.g., when encountering a region where the dimensions of one or more channels are smaller than the uncollapsed outer diameter of one or more of the shunt 200) while navigating the shunt 200 to its final implantation location. After puncture, the mandrel 165 can be partially or completely retracted.

[0052] Although the mandrel 165 is disclosed, the inner wire 160 can perform puncture without the mandrel 165. In such a configuration, the inner wire 160 can be one type of mandrel. In such an embodiment, the inner wire 160 may not be hollow, but solid, or at least may not have a hollow channel extending across its length. According to another embodiment, the inner wire 160 and the mandrel 165 can each provide puncture functionality.

[0053] The surgeon can navigate the shunt delivery system 100, which may also include a handle (not shown) outside the patient's body. The surgeon can interact with the handle to move the needle 165 forward (and / or backward) a controlled distance. The handle may also include a locking / unlocking engagement feature to ensure that the needle 165 can move forward / backward when engaged by the surgeon. The handle may further include a Luer connector for fluid connection with the inner thread 160. The handle may also include a mechanism (e.g., a locking / unlocking torsion mechanism) for removing the needle 165 from the shunt delivery system 100. Thus, the position of the needle 165 can be locked unless the surgeon intentionally engages it.

[0054] The inner wire 160 can be operated in conjunction with the sheath 170 and / or the distal region of the shunt to allow for perforation or perforation of patient anatomy (e.g., perforation of the vein wall, tissue in the interstitial space 18, or sheath 28). The inner wire 160 can be further used to position the shunt delivery system 100 in the appropriate location. Not shown, the inner wire 160 may include or be attached to a handle in a region proximal to the surgeon (e.g., not in the patient's body). The surgeon can engage the handle to move the inner wire 160 and the entire shunt delivery system 100 into the appropriate position. The handle may be the same handle described above in conjunction with the core needle 165.

[0055] like Figure 8A (As shown in the longitudinal sectional view of the shunt delivery system 100), the inner wire 160 may include a shoulder. When the surgeon moves the shunt delivery system 100 (e.g., via a handle) to the inner wire 160, the shoulder of the inner wire 160 may engage with the shunt body 210 (e.g., the outlet region 214 of the shunt body 210) and / or the intermediate spring 180 between the inner wire 160 and the shunt body 210 (which is not in...) Figure 8A As shown in the figure, although from Figure 4 (Understanding) engagement. In this way, the inner wire 160 shoulder allows the distributor delivery system 100 to be properly manipulated and positioned.

[0056] exist Figure 3A , Figure 3B and Figure 3C An exemplary sequence of the positioning diverter delivery system 100 is shown in the figure. Figure 3A After the guiding catheter 110 has been stabilized in the vein by the stabilizer 130, the surgeon at least partially withdraws the shunt delivery system 100 from the distal end of the guiding catheter 110. The outer surface of the shunt delivery system 100 includes a sheath 170 with radiopaque markings 150, allowing the surgeon to easily see the positioning of the shunt delivery system 100 within the patient. The exterior of the shunt delivery system 100 may also include the outer surface of a restrictor 140. The outer surface of the restrictor 140 may be integral with the sheath 170 or may be part of the sheath 170. The restrictor 140 may have radiopaque markings (not shown) 150.

[0057] exist Figure 3A Subsequently, the surgeon advances the shunt delivery system 100, causing the distal end of the shunt delivery system 100 (e.g., the inner wire 160 and / or the sheath 170) to perforate or move through the vein wall, thereby positioning the distal end within the interstitial space 18 of the patient near the sheath 28, as... Figure 3BAs shown. At this stage, the restrictor 140 can be deployed (e.g., expanded or inflated) by the surgeon. The restrictor 140 can be a structure or feature that prevents the shunt delivery system 100 from being over-inserted through the sheath 28 and into the dural lumen 30, or can otherwise adjust the distance the shunt delivery system 100 can be inserted into the subarachnoid space. The restrictor 140 can be an inflatable protrusion with an outer diameter greater than the outer diameter of the sheath 170. The restrictor 140 can include a wire cage / tube (e.g., flexible nitinol) or rubber material that expands in the middle when compressed.

[0058] The surgeon can remotely deploy the restrictor 140 from outside the patient's body. The surgeon may be able to remotely deploy the restrictor 140 via an actuator on a handle, such as a rotational mechanism (e.g., on the proximal end of the handle), which engages the restrictor 140 to expand upon rotation. As another example, the restrictor deployment mechanism may include a lever that engages the restrictor 140 to expand upon unidirectional movement (e.g., forward pushing) and disengages the restrictor 140 to contract upon movement in a different manner (e.g., reverse pulling). The restrictor deployment mechanism may include a clicker and may include a speed regulator to prevent over-expansion. The restrictor 140 can be deployed at least partially or fully when it is located in a vein and / or interstitial space 18.

[0059] exist Figure 3B Subsequently, the surgeon advances the shunt delivery system 100, causing the distal end of the shunt delivery system 100 (e.g., the inner wire 165 and / or the sheath and / or the shunt tip 200) to perforate or move through the vein wall and through the interstitial space 18, thereby positioning the distal end within the dural lumen 30, as... Figure 3C As shown. The limiter 140 can be fully deployed before the diverter delivery system 100 is fully positioned in the proper place. The limiter 140 can prevent over-insertion by having an outer diameter larger than the hole through the sheath 28 caused by the perforation from the diverter delivery system 100. Figure 4 A portion of a restrictor 140 positioned within the sheath 170 is shown. As illustrated, the restrictor 140 may be a balloon that can be selectively inflated (e.g., under the control of a surgeon). When the balloon inflates, it can cause the outer surface of the sheath 200 to expand to provide, for example, Figure 3B and 3C The effect shown.

[0060] Figure 8AThe stages of deploying the CSF shunt 200 using the shunt delivery system 100 are depicted. A limiter 140 is shown as a feature on the exterior of the sheath 170. This embodiment of the limiter 140 may differ from other limiters 140 shown herein. The limiter 140 may be a relatively small, inflatable balloon. As another example, the sheath 170 may be configured such that when advanced a predetermined distance (e.g., via a handle), the sheath 170 can buckle (e.g., small corrugated portions in the sheath may facilitate buckling) to create the limiter 140. As shown, the inner wire 160 may pierce the sheath 28 and, optionally with the aid of the sheath 200 (not shown), create a suitable hole in the sheath 28.

[0061] Different techniques may be used for implanting the shunt 200. According to one method, the sheath 170 is removed, exposing the shunt 200. For example, once the system has penetrated the sheath 28 (e.g., seen via live X-ray) and the shunt 200 is in place, the surgeon can loosen the connector (e.g., a groin loop) that allows the inner wire 160 and / or the shunt 200 to move independently of the sheath 170. The surgeon can then eliminate any looseness in the system, and with one hand locking the handle in place on the operating table (e.g., the handle is movable), and with the other hand on the Y-adapter, the surgeon can slide the Y-adapter back toward the handle (with the other hand) and move the sheath 170 away from the shunt 200, thereby exposing the shunt 200 (e.g., 10 to 20 mm). With this locking, the inner wire 160 can remain stationary.

[0062] According to another method, the shunt 200 can be moved forward out of the sheath 170. For example, once the system has penetrated the sheath 28, the surgeon can release the coupling (e.g., a groin loop) that allows the inner wire 160 and / or the shunt 200 to move independently relative to the sheath 170. The surgeon can then push the handle forward to position the shunt 200 in its final position. Once the shunt 200 is positioned, the surgeon can lock the handle in place and retract the remaining portion of the sheath 170 away from the shunt 200 and remove it from the patient.

[0063] like Figure 5As shown, the anchor 230 of the shunt 200 is deployed within the dura mater lumen 30. The anchor 230 may include a plurality of fingers 231. Each anchor finger 231 may be provided with at least one anchor wire 232 and may have one or more radiopaque markers 150. The anchor wire 232 may be formed of or include a material such as nitinol. The anchor wire 232 may be flexible and may have memory. The anchor wire 232 may function as a spring. When the anchor fingers 231 and anchor wire 232 therein or on them are covered by the sheath 170, they may store energy. When the anchor wires 232 are not covered, they may tend to relax, causing the anchor wires 232 (together with the anchor fingers 231) to spread away from the longitudinal axis of the shunt body 210. The anchor wires 232 may attempt to return to their original memory position, causing the anchor fingers 231 to unfold such that they at least partially abut the sheath 28. The force exerted by the anchor fingers 231 on the sheath 28 may tend to stabilize the shunt 200. Anchor wire 232 may not fully return to its original memory position, thereby facilitating relatively firm contact between anchor finger 231 and the inner surface of sheath 28. During (or before) completion of the insertion process, shunt inlet orifice 211 may be in fluid communication with the dura mater lumen 30. In this way, shunt inlet orifice 211 can receive CSF 32.

[0064] Figure 7A , 7B Figures 7C and 7D show axial views of various embodiments of the anchor finger 231. Figure 7A A generally circular finger 231 is shown, which may comprise a biopolymer (e.g., silicone, polyurethane, etc.) having an annular translucent marking 150 (e.g., shown as a loop) surrounding a circular anchor wire 232 (although other shapes are possible). The anchor wire 232 may be made of, for example, one or more elastic metals or biopolymers. The anchor wire 232 may have memory or may otherwise function as a spring. Figure 7B An anchor finger 231 with two anchor wires 232 is shown, but more anchor wires 232 are possible. The anchor wires 232 are shown as having a square or rectangular shape, but other shapes are also possible. The anchor finger 231 may include a non-transparent marking 150, which may be an embedded bead, a length, a line, or other arrangement. Figure 7C An anchor finger 231 with a flat anchor wire 232 and a non-transparent marking 150 are shown, which may be a bead or a length wire or another arrangement. Figure 7D The non-transmissive marking 150 is shown to be included inside the filament.

[0065] Figure 6An example of a shunt 200 in its final, in-situ position is shown. The shunt inlet region 212 can be positioned within the dural lumen 30 together with the anchor finger 231 (along with the accompanying anchor wire 232 and radiopaque marker 150). The shunt inlet orifice 211 can also optionally be positioned within or outside the dural lumen 28, for example, within an orifice passing through the sheath 28. The shunt lateral region 215 can extend through the interstitial space 18, the venous wall, and a portion of one or more veins. The shunt outlet region 214 and the shunt outlet orifice 213 can be positioned within the vein.

[0066] The shunt 200 can have various sizes. For example, the length of the shunt body 210 can be between 5 mm and 150 cm. According to an embodiment, the shunt body 210 can be less than 100 mm. Such a length may be advantageous because it reduces the length of the shunt body 210 in contact with blood, thereby reducing the risk of clotting. Furthermore, a shorter shunt 200 can reduce the residence time of a given portion of the CSF fluid 32 in the shunt 200, thereby potentially reducing protein buildup, which can narrow the inner hollow region of the shunt 200 and / or interfere with (e.g., block) the operation or structure of the anti-backflow valve 240 of the shunt 200. The length of the anchor finger 231 can be between 1 mm and 2 cm. The inner diameter of the lateral region of the shunt 215 can be between 0.05 mm and 1 mm. The portion of the shunt 200 extending through the sheath 28 can be between 270 μm and 100 mm. The portion of the shunt 200 extending through the interstitial space 18 can be between 0.1 mm and 10 mm. The portion of the shunt 200 extending through the venous wall can be between 0.1 mm and 0.5 mm. The portion of the shunt 200 extending through the intravenous space (along the venous path) can be up to 150 cm.

[0067] Figure 9A and Figure 9B Different views of an embodiment of the shunt 200 in its final, in-situ position are shown. In this embodiment, the anchor 230 may not have fingers. Instead, it can be operated by expanding into an annular or circular washer-like shape or a similar shape to anchor the shunt 200 into the interior of the dura mater lumen 28. According to this mechanism, the distal shunt region can be pre-shaped (e.g., as shown in the diagram) before the shunt 200 is loaded into the guide conduit 110. Figure 9B (As shown). Therefore, the anchor 230 can be compressed or deformed in the distal region of the guide conduit 110 and can be at least partially accommodated by the sheath 170 before deployment. Once the sheath 170 is retracted (or the shunt 200 is moved forward), the distal region of the shunt 200 can return to its original shape, as shown. Figure 9B As shown in the example. Figure 9BAs shown, the shunt 200 may further include a reinforcement 220 extending across an opening in the sheath 28. The reinforcement 220 may extend into the interstitial space 18 and / or the dura mater lumen 30. The reinforcement 220 may be embedded in or form part of the shunt body 210 or other parts of the shunt 200. The reinforcement 220 may be designed to prevent the shunt 200 (e.g., the shunt body 210 and, for example, pressure from the sheath 28) from collapsing or compressing. The reinforcement 220 may include a material having relatively high stiffness (e.g., higher than certain other parts of the shunt body). Examples of materials (one or more) included in the reinforcement may include PTFE, HDPE, braided tubing, non-transparent embedded metal tubing, and / or the like. The length of the reinforcing member 220 can be, for example, 1 to 20 mm, and can substantially keep the inner diameter (ID) of the splitter 200 (e.g., the splitter body 210) open, even when the sheath 28 is compressed.

[0068] like Figure 9B As further shown, the diverter 200 may include an external anchor 250, which may cooperate with the anchor 230 to promote the stability of the diverter 200. The external anchor 250 may be pre-formed (e.g., having a shape similar to...) before being loaded into the sheath 170. Figure 9B (as shown in the figure), and can be deployed in a manner similar to the anchor 230 described above.

[0069] Figure 10A , Figure 10B and Figure 10C Another embodiment of the splitter 200 with a flow regulator is described (particularly in...) Figure 10B and Figure 10C (As shown in the diagram). The shunt 200 may be similar to... Figure 9A and Figure 9B The shown is a splitter, but with an added flow regulator. Figure 10A The dashed area along the transverse region 215 of the splitter body 210 is shown. Figure 10B and 10C Roughly corresponding to Figure 10A The dashed area in the diagram. The lateral region 215 of the shunt body 210 includes one or more collapsible regions 216. The one or more collapsible regions 216 may be located within the venous and / or interstitial space 18. The one or more collapsible regions 216 may comprise a softer or more flexible material that is more sensitive to external (outside the shunt 200) and internal (inside the shunt 200) pressures. Exemplary pressures are indicated by the letter "P". When the pressure within the channel within the shunt 200 decreases and / or when the pressure from outside the shunt 200 increases, the one or more collapsible regions 216 may partially collapse. Figure 10BThis allows the inner diameter of the diverter 200 in the collapsible region 216 to have a minimum distance smaller than that of the other parts of the channel (either in the collapsible region 216 or in the other parts of the transverse region 215 of the diverter body 210). If the pressure is sufficient, the collapsible region 216 can completely collapse. Figure 10C This reduces the minimum inner diameter of the channel in the diverter 200 within the collapsible region 216 to approximately zero. As the inner diameter of the channel within the collapsible region 216 decreases, the amount of CSF32 flowing through the diverter 200 also decreases. In this way, the flow rate of the CSF32 can be regulated in response to changes in pressure in the CSF fluid 32 and / or the fluid in the vein and / or the fluid in the interstitial space 18.

[0070] Figure 11A and Figure 11B A cross-sectional view of a shunt 200 positioned in a venous pathway according to an embodiment is shown. The shunt includes an anti-backflow valve 240 located within a shunt body 210. The anti-backflow valve 240 can be located at any suitable location along the passage between an inlet port 211 and an outlet port 213, or optionally at the ports 211, 213 themselves. Figure 11A As shown, the shunt body 210 can be positioned within a venous pathway. CSF32 flows through channels in the shunt body 210, through the open valve 240, and out through the outlet orifice 213 into the vein. The flow of CSF32 is indicated by straight lines with arrows. Blood can flow within the vein to the outside of the shunt body 210. The flow of blood is indicated by wavy lines with arrows. Figure 11B As shown, valve 240 can be moved to the closed position to prevent or reduce retrograde flow of blood through the channels in the shunt body 210 toward the dural lumen 30. Valve 240 can be closed when the pressure of the CSF 32 flow is less than the pressure of the blood flow (e.g., if the CSF 32 flow pressure decreases and / or the blood flow pressure increases).

[0071] Valve 240 can be programmable or non-programmable. A non-programmable valve 240 can be in the open position when the pressure in the dural lumen 30 exceeds a certain level. This level can be determined by the valve 240 itself and may remain unchanged. A programmable valve 240 allows the surgeon to adjust the level. For example, the adjustment itself can be non-invasive, such as using a magnet (e.g., handheld), and can be performed in a clinical setting (e.g., outpatient setting). Furthermore, one or more anti-siphon devices or components (not shown) can be present to prevent or reduce excessive drainage of CSF 32 based on the patient's position in the space. Anti-siphon components can be built into valve 32 or placed in series along the path of the shunt body 210 within the channel.

[0072] Figure 15An embodiment of the diverter 200 and the diverter delivery system 100 is shown. Figures 16A to 16C A diagram showing implantation with Figure 15 An embodiment of the diverter 200 in the diverter conveying system 100. The diverter 200 and the diverter conveying system 100 may be similar to other embodiments described herein. Figure 15 As shown, the guide conduit 110 is fitted with a sheath 170. The sheath, in turn, covers at least a portion of the shunt body 210 (which is located in...). Figure 15 (Not visible in the image). One or more radially protruding portions 260 (three shown) and a spherical head region 270 may be present and connected to the splitter body 210. The spherical head region 270 may be located in the inlet region of the splitter 200. The spherical head region 270 and the radially protruding portions 260 may be formed from a single piece (e.g., machined from a single piece). This piece (or an assembly of different pieces) may be connected or coupled to the splitter body 210 or another part of the splitter 200 using standard joining techniques. This piece may resemble a plug or a plug-like component.

[0073] The shunt delivery system 100 may include an inner wire 160 (substantially occluded) having an inner wire tip 162. The inner wire 160 may pass through the shunt 200 and be exposed through an orifice in a spherical head region 270, which is the shunt inlet orifice 211. Alternatively, the inner wire 160 may be stopped before protruding from the spherical head region 270, and a mandrel 165 (not shown) may extend outward. A valley may be formed between the spherical head region 270 and one of the radial protrusions 260. Other valleys may be formed between the radial protrusions 260. When the sheath 28 is punctured by the mandrel 165 or the inner wire 160, the spherical head region 270 may be pushed through the orifice such that the valley between the spherical head region 270 and one of the radial protrusions 260 is positioned epidurally across the distance of the orifice in the sheath 28. Alternatively, the shunt 200 may be pushed further such that one of the other valleys is epidurally positioned. One of the (one or more) radially protruding portions 260 can be used as an external anchor outside the sheath 28 (e.g., similar to external anchor 250). The outer diameter of the shunt 200 at the valley (one or more) can be large enough that the sheath 28 around the puncture applies force to the given valley located via the dura mater to provide anchoring support for the shunt 200.

[0074] The spherical head region 270 can be used as an intradural anchor. According to one embodiment, the spherical head region 270 is recessed near the sheath 28.

[0075] exist Figures 16A to 16CIn the sequence shown, the shunt 200 can be implanted as follows. The guiding catheter 110 can be surgically positioned intravenously. The shunt 200 can be delivered through the venous system (e.g., to the intervertebral vein 22) via the guiding catheter 110 and the shunt delivery system 100. Once at the venous wall, the needle 165 can be advanced through the venous wall, interstitial space 18, and sheath 28. The bulbous head region 270 can be advanced through a foramen. Alternatively, the needle 165 can puncture only the venous wall, and then the bulbous head region 270 can be advanced through a foramen in the venous wall. Alternatively, once the needle 165 punctures the sheath 28, one or more areas in the puncture path (including the venous wall, interstitial space 18, and sheath 28) can be expanded by an inflatable balloon (not shown). The balloon can be independent of the needle 165 or can be part of the needle 165. Once the spherical head region 270 has moved through some or all of the interstitial space 18, the needle 165 can advance again to pierce the sheath 28. The spherical head region 270 can then advance through a hole in the sheath 28 and into the dural lumen 30. The spherical head region 270 and / or the radially protruding regions 260 can provide tactile feedback to the surgeon, allowing the surgeon to know that one or more of the spherical head region 270 and / or (one or more) radially protruding regions 260 have passed through the sheath 28. This tactile feedback, combined with radiopaque markers 150 (which may be located above or within the spherical head region 270, (one or more) radially protruding regions 260, and / or valleys therebetween), facilitates the surgeon's transdural implantation of the shunt 200 at the appropriate location. The (one or more) radially protruding regions 260 may also limit the insertion depth of the shunt into the dural lumen 30. Once the shunt 200 is properly positioned, the surgeon can remove the shunt delivery system 100 (including the needle 165 and the guide catheter 110) to leave the shunt 200 in place.

[0076] Figure 12A flowchart 400 of a method for intravenous implantation of a shunt 200 according to an embodiment is shown. This method can be performed by a surgeon or a surgical robot. Some steps may be omitted. For example, the shunt 200 may not be removed from the patient. In step 402, the shunt 200 may be introduced into the patient's vascular system, for example, into a vein in the leg, neck, or arm. In step 404, the inlet region 211 of the shunt 200 may be located in at least one of an epidural vein 20 or an intervertebral vein 22. These veins 20, 22 may be located in the lumbar region, chest region, cervical region, or sacrum. In step 406, the shunt 200 may be moved so that the inlet region 211 extends through the wall of the epidural vein 20 or the intervertebral vein 22. In step 408, the shunt 200 may be moved so that the inlet region 211 extends into the interstitial space 30. In step 410, the restrictor 140 may be at least partially deployed in the interstitial space 18, wherein the restrictor 140 determines the maximum length by which the shunt 200 can extend through the sheath 28 and into the dural lumen 30. Deploying the restrictor 140 may include expanding the restrictor 140 such that the outer radius of the restrictor 140 is greater than the outer radius of the lateral region 215 of the shunt 200 between the inlet region 212 and the outlet region 214. In step 412, the shunt 200 may be moved such that the inlet region 212 extends at least partially through the sheath 28 (including the arachnoid membrane). In step 414, an anchor 230 may be deployed within the dural lumen 30 to stabilize the inlet region 212 of the shunt 200 relative to the sheath 28. Once the shunt 200 is positioned in its final location, the outlet region 214 of the shunt 200 may be located at the epidural vein 18, the intervertebral vein 22, the perivertebral vein, or any suitable location along the venous pathway. The outlet region 214 can also be located in the vein wall, so that the outlet orifice 213 is in fluid communication with the vein path.

[0077] In step 416, the shunt 200 may be removed at a later time during a separate procedure, for example, if the shunt 200 has failed, is failing, or is no longer needed. The shunt 200 may be removed from the patient by engaging a shunt removal feature on the shunt 200. To facilitate removal of the shunt 200, the outward radial force on each finger 231 may be equal to or less than 90% of the tensile strength of the transverse stent body 215. This allows the shunt 200 to be retrieved via withdrawal through the sheath 28 or back into the catheter or sheath. As another embodiment, the tensile force required to collapse the finger 231 (or any other anchor 230 type) while simultaneously withdrawing it into the catheter or sheath or retrieving it from the sheath 28 may be equal to or less than 90% of the tensile strength of the transverse stent body 215. As another embodiment, the sheath may be pushed at the distal end of the shunt 200 to capture / cover the anchor 230 and partially or completely collapse it before retrieval.

[0078] In embodiments of the annular anchors 230, the radially outward force of each annular anchor 230 may be equal to or less than 90% of the tensile strength of the transverse support body 215, which facilitates the extraction of the shunt 200 via retraction through the sheath 28. As another embodiment, the tensile force may be equal to or less than 90% of the tensile force of the transverse shunt body 215, which is required to elongate the annular anchors 230 and subsequently collapse them upon retraction into the conduit or sheath or from the sheath 28.

[0079] According to an embodiment, the proximal shunt region residing in the vein may include a radiopaque marker 150 to allow for easy identification. The radiopaque marker 150 may be a material like platinum / iridium and / or may be incorporated into the shunt outlet 213. The shunt outlet region 214 may include features (e.g., snaps or hooks) that allow capture of the shunt 200 via a snare or a collapsible snare similar to a "Chinese finger cot". The radiopaque marker 150 may include a relatively soft material, such as gold, to allow it to be crushed and potentially seal the shunt 200. An external shunt anchor 250 (e.g., similar to the one shown in FIG. 9) may include features for identifying the radiopaque marker 150 and may include features for easy removal (e.g., snaps or hooks). A catheter that may include a snare or snap or hook mechanism with a sliding sheath may be advanced over the shunt body 210 (after being snare proximally) for retrieval. The lateral body 215 of the distributor may include features such as braided tubing to stop or reduce elongation of the distributor 200 during removal or sealing. The lateral body 215 of the distributor may include reinforcing plastic ribs in the tubing wall, also for stopping or reducing elongation. Such features can maintain flexibility and prevent kinking during extraction. The lateral body 215 of the distributor can be cut and removed from the distal distributor region, and thus removed if the distal distributor region is subsequently sealed.

[0080] In different embodiments, the shunt inlet region 212 is similarly located within the dural lumen 30, and the shunt body 210 is initially located within the venous pathway but ultimately passes through the venous wall, such that the shunt outlet region 214 exits the body, where it connects to the valve 240 or to a reservoir located under the skin. This embodiment may allow for direct drug delivery to the CSF32, enabling repeatable chemical and biological analysis of the CSF32, measurement of CSF32 pressure, and on-demand discharge of CSF32.

[0081] According to one embodiment, prior to implantation of the shunt 200, a balloon (not shown) can be used to dilate one or more puncture sites at the sheath 28 and / or the vein wall and / or interstitial space 18. Before advancing the shunt 200 through the shunt delivery system 100, the dilation system can be advanced closer to the implantation site via a guide catheter 110. A guide needle 165 can extend through the dilation system. Once the dilation system is positioned or before it is positioned, the guide needle 165 can puncture the sheath 28, the vein wall, and / or the interstitial space 18. After puncture, the constricted dilation balloon can be advanced through one or more puncture sites. The dilation balloon can be advanced through multiple puncture sites at once or through selected puncture sites individually. The dilation balloon may have one or more radiopaque markers 150 embedded or attached. Once the dilation balloon is properly positioned at one or more puncture sites, the surgeon can inflate the balloon to a suitable diameter to stretch the orifice at one or more puncture sites. After the tissue has been stretched, the inflatable balloon can be deflated again under the surgeon's control. The inflatable balloon and any other components of the inflatable system can be removed from the patient through the guide catheter 110. The shunt 200 can then be introduced onto the suture needle 165 and implanted as described herein.

[0082] In embodiments related to the foregoing embodiments, the dilating balloon may be part of the cardioid 165. This dilating balloon may have a length of 0.5 to 2 cm or may inflate over a length of 0.5 to 2 cm. The cardioid 165 may perforate the vein wall, then the interstitial space 18, and then the sheath 28. The dilating balloon on the cardioid 165 may then inflate and subsequently deflate. The shunt 200 may then be advanced over the cardioid 165. The cardioid 165 may then be removed while the shunt 200 remains in the appropriate position within the implantation site.

[0083] Partial List

[0084] part Figure Labels spinal canal 10 skeleton 12 nerve 14 nerve root 16 Fat, interstitial space 18 Epidural veins 20 Intervertebral vein 22 Lumbar vein 26 sac 28 Intradural lumen 30 Cerebrospinal fluid 32 Diverter Conveying System 100 Guiding catheter 110 guide wire 120 stabilizer 130 Limiter 140 Transmissive markers 150 inner silk 160 Inner silk shoulder 161 inner silk tip 162 Core needle 165 jacket 170 spring 180 Diverter 200 Shunt unit body 210 Diverter inlet port 211 Diverter inlet area 212 Diverter outlet port 213 Diverter outlet area 214 Lateral area of ​​the splitter 215 Collapsible area 216 Reinforcing components 220 Anchor (internal anchor of diaphragm) 230 Anchor finger 231 Anchor wire 232 Valve (yellow in Figure 11) 240 External (epidural) anchor 250 Radial protrusion area 260 spherical head region 270

[0085] Those skilled in the art will understand that various changes and equivalents can be made without departing from the scope of the novel technology disclosed herein. Furthermore, many modifications can be made to adapt a particular situation or material to the teachings of the novel technology without departing from its scope. Therefore, it is intended that the novel technology is not limited to the specific technology disclosed, but rather that it will include all technologies falling within the scope of the appended claims.

Claims

1. A method for locating a cerebrospinal fluid shunt intravenously in a patient, the method comprising: The cerebrospinal fluid shunt is introduced into the patient's vascular system, wherein the cerebrospinal fluid shunt includes an inlet port in an inlet region and an outlet port in an outlet region, wherein the inlet port and the outlet port are in fluid communication with each other; The inlet region of the cerebrospinal fluid shunt is located in the epidural vein or intervertebral vein; The core needle is used to puncture the wall of the epidural vein or the intervertebral vein, pass through the interstitial space, and puncture the sheath, wherein the core needle includes a wire extending through the cerebrospinal fluid shunt; Move the cerebrospinal fluid shunt so that the inlet area extends through the wall of the epidural vein or the intervertebral vein; After moving the cerebrospinal fluid shunt to extend the inlet region through the wall of the epidural vein or the intervertebral vein, the cerebrospinal fluid shunt is moved to extend the inlet region into the interstitial space; and After moving the cerebrospinal fluid shunt to extend the inlet region into the interstitial space, the cerebrospinal fluid shunt is moved to extend the inlet region through the sheath, such that the inlet region of the cerebrospinal fluid shunt is positioned in the dural lumen and the outlet region of the cerebrospinal fluid shunt is positioned in the venous pathway.

2. The method according to claim 1, wherein, The epidural vein or the intervertebral vein is located in the lumbar region of the patient.

3. The method according to claim 1, wherein, The epidural vein or the intervertebral vein is located in the patient's chest region.

4. The method according to claim 1, wherein, The epidural vein or the intervertebral vein is located in the patient's neck region.

5. The method according to claim 1, wherein, The epidural vein or the intervertebral vein is located in the patient's sacrum.

6. The method according to claim 1, wherein, The venous pathway in which the outlet orifice of the cerebrospinal fluid shunt is located includes at least one of the following: epidural vein, intervertebral vein, paravertebral vein, lumbar vein, iliac vein, femoral vein, azygos vein, hemiazygos vein, inferior vena cava, superior vena cava, the right atrium of the heart, or a venous branch of the inferior vena cava or superior vena cava.

7. The method according to claim 1, further comprising: After puncturing the sheath, an anchor is deployed within the dural lumen to stabilize the inlet region of the cerebrospinal fluid shunt relative to the sheath.

8. The method according to claim 1, further comprising: Prior to puncturing the sheath, a restrictor is deployed at least partially in the interstitial space, wherein the restrictor determines the maximum length of the cerebrospinal fluid shunt extending through the sheath and into the dural lumen.

9. The method according to claim 8, wherein, The deployment restrictor includes expanding the restrictor such that the outer radius of the restrictor is greater than the outer radius of the lateral region of the cerebrospinal fluid shunt between the inlet region and the outlet region.

10. The method according to claim 1, wherein, When the inlet region of the cerebrospinal fluid shunt is located in the dural lumen, the outlet region of the cerebrospinal fluid shunt is located in one of the epidural vein, intervertebral vein, lumbar vein, iliac vein, or perivertebral vein.

11. The method according to claim 1, wherein, The cerebrospinal fluid shunt comprises silicone resin.

12. The method according to claim 1, wherein, The cerebrospinal fluid shunt comprises polyurethane.

13. The method according to claim 1, wherein, The cerebrospinal fluid shunt includes nitinol.

14. The method according to claim 1, wherein, The cerebrospinal fluid shunt includes at least one non-transmissive marker.

15. The method according to claim 1, wherein, The cerebrospinal fluid shunt includes material on at least one of the exterior of the cerebrospinal fluid shunt or the interior of the inlet region, the material being configured to reduce at least one of blood clotting, protein aggregation, or cell aggregation.

16. The method according to claim 1, wherein, The cerebrospinal fluid diverter includes an anti-backflow mechanism between the inlet and outlet orifices, wherein the anti-backflow mechanism is configured to reduce or prevent retrograde migration of blood.

17. The method according to claim 1, wherein, The cerebrospinal fluid diverter includes a flow regulator between the inlet orifice and the outlet orifice, wherein the flow regulator is configured to regulate the flow rate of cerebrospinal fluid between the inlet orifice and the outlet orifice.

18. The method according to claim 1, wherein, The introduction of the cerebrospinal fluid shunt into the patient's vascular system includes introducing the cerebrospinal fluid shunt into a vein in the leg, neck, or arm.

19. The method of claim 1, further comprising removing the cerebrospinal fluid shunt by engaging a shunt removal feature on the shunt.

20. The method of claim 1, further comprising temporarily enlarging at least one of the foramen, interstitial space region, or foramen through the sheath at the at least one enlargement location by positioning the balloon at at least one enlargement location and then inflating the balloon to perform enlargement before or during the passage of the shunt through the at least one enlargement location.

21. A cerebrospinal fluid shunt for placement in a patient, the cerebrospinal fluid shunt comprising: The inlet region is configured to pass through a foramen in the wall of the epidural vein or the wall of the intervertebral vein, through a foramen in the sheath, and through the interstitial space between the sheath and one of the walls of the epidural vein or the intervertebral vein. An inlet orifice in the inlet region, wherein the inlet orifice is configured to receive cerebrospinal fluid from the dural lumen; The exit area is configured to be located within the venous pathway; An outlet orifice in the outlet region, wherein the outlet orifice is in fluid communication with the inlet orifice, wherein the outlet orifice is configured to allow the cerebrospinal fluid received by the inlet region to flow out of the cerebrospinal fluid diverter; A transverse region between the inlet region and the outlet region, wherein the transverse region includes a channel to achieve fluid communication between the inlet orifice and the outlet orifice; and An insertion restriction portion is located in the transverse region, wherein the insertion restriction portion is configured to be positioned in the interstitial space between the epidural vein wall or the intervertebral vein wall and the sheath.

22. The cerebrospinal fluid shunt of claim 21, further comprising: At least one non-transmissive marker is located at least partially in the entrance region; At least one non-transmissive marker, which is at least partially located in the lateral region; as well as At least one non-transmissive marker is located at least partially in the outlet region.

23. The cerebrospinal fluid shunt according to claim 22, wherein, The entrance area includes a spherical head region.

24. The cerebrospinal fluid shunt according to claim 23, wherein, The insertion limiting portion includes a radially protruding portion, wherein the spherical head region and the radially protruding portion are integrated as a single piece.

25. The cerebrospinal fluid shunt according to claim 24, wherein, The single component connected to the cerebrospinal fluid shunt includes another portion of the outlet region.

26. A system for positioning a cerebrospinal fluid shunt in a patient, the system comprising: A guiding catheter configured to slide over a proximal region of a guidewire located in the patient's venous system, wherein the guiding catheter includes a proximal region and a distal region, wherein the guiding catheter includes an anchor configured to anchor the distal region of the guiding catheter at a location in the patient's venous system; An adapter, which is connected to the proximal region of the guiding catheter, wherein the adapter is configured to selectively prevent fluid from flowing out of the patient and out of the adapter; A sheath, comprising a proximal region and a distal region, wherein the sheath is at least partially positioned within the guiding catheter; A shunt, at least partially positioned between the guiding catheter and the sheath, wherein the shunt includes an inlet region having an inlet orifice, an outlet region having an outlet orifice, and a transverse region between the inlet region and the outlet region, wherein the transverse region includes a channel such that the inlet orifice is in fluid communication with the outlet orifice, wherein the transverse region is configured to extend through the venous wall and through the interstitial space, wherein the inlet region is configured to extend through the sheath and into the dural lumen, and wherein the outlet region is configured to be positioned within the venous pathway; and A filament configured to extend through the shunt and at least partially out of the inlet orifice, wherein the filament includes a proximal region and a distal region, and wherein the distal region is configured to pierce the vein wall and the sheath.

27. The system according to claim 26, wherein, The anchor of the guiding catheter includes a balloon.

28. The system according to claim 26, wherein, The inlet region of the diverter also includes an anchor configured to stabilize the inlet region relative to the sheath.

29. The system according to claim 26, wherein, The sheath includes a retractable sheath.

30. The system according to claim 26, wherein, The lateral region includes a limiter configured to restrict the distance the shunt is inserted into the patient's body.

31. A method for locating a cerebrospinal fluid shunt intravenously in a patient, the method comprising: The cerebrospinal fluid shunt is introduced into the patient's vascular system, wherein the cerebrospinal fluid shunt includes an inlet port in an inlet region and an outlet port in an outlet region, wherein the inlet port and the outlet port are in fluid communication with each other; The inlet region of the cerebrospinal fluid shunt is located in the epidural vein or intervertebral vein; After positioning the inlet region of the cerebrospinal fluid shunt into the epidural vein or the intervertebral vein, the cerebrospinal fluid shunt is moved to extend the inlet region into the interstitial space; and After moving the cerebrospinal fluid shunt to extend the inlet region into the interstitial space, the cerebrospinal fluid shunt is moved to allow the inlet region to pass through the opening of the sheath, such that the inlet region of the cerebrospinal fluid shunt is at least partially located in the dural lumen, and the outlet region of the cerebrospinal fluid shunt is located in the venous pathway.

32. A method for locating a cerebrospinal fluid shunt intravenously in a patient, the method comprising: The cerebrospinal fluid shunt is introduced into the patient's vascular system, wherein the cerebrospinal fluid shunt includes an inlet port in an inlet region and an outlet port in an outlet region, wherein the inlet port and the outlet port are in fluid communication with each other; The inlet region of the cerebrospinal fluid shunt is located in the epidural vein or intervertebral vein; Move the cerebrospinal fluid shunt so that the inlet region passes through a foramen in the wall of the epidural vein or intervertebral vein; and After moving the cerebrospinal fluid shunt to allow the inlet region to pass through the wall of the epidural vein or the intervertebral vein, the cerebrospinal fluid shunt is moved to allow the inlet region to pass through a hole in the sheath, such that the inlet region of the cerebrospinal fluid shunt is at least partially located within the intradural lumen, and that the outlet region of the cerebrospinal fluid shunt is located in the venous pathway.

33. A method for locating a cerebrospinal fluid shunt intravenously in a patient, the method comprising: The cerebrospinal fluid shunt is introduced into the patient's vascular system, wherein the cerebrospinal fluid shunt includes an inlet port in an inlet region and an outlet port in an outlet region, wherein the inlet port and the outlet port are in fluid communication with each other; The inlet region of the cerebrospinal fluid shunt is located in the epidural vein or intervertebral vein; Move the cerebrospinal fluid shunt so that the inlet area extends through the wall of the epidural vein or the intervertebral vein; After moving the cerebrospinal fluid shunt to extend the inlet region through the wall of the epidural vein or the intervertebral vein, the cerebrospinal fluid shunt is moved to extend the inlet region into the interstitial space; and After moving the cerebrospinal fluid shunt to extend the inlet region into the interstitial space, the cerebrospinal fluid shunt is moved to extend the inlet region through the sheath, such that the inlet region of the cerebrospinal fluid shunt is positioned in the dural lumen, and the outlet region of the cerebrospinal fluid shunt is in fluid communication with at least one reservoir or transdermal port located under the patient's skin.

34. The method according to claim 33, wherein, The transdermal port is configured to allow at least one of the following: delivery of medication to the patient, removal of CSF, or promotion of CSF pressure measurement.

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