阅读说明：本技术 硬脑膜修复设备 (Dura mater repair device ) 是由 约翰·雅克曼 于 2018-10-25 设计创作，主要内容包括：一种可单手操作的硬脑膜修复设备。设备包括手柄和外臂,外臂具有端部开口和用于将针固持在外臂内的机构。设备还包括内臂,内臂包括跟部、平台、端部开口和用于捕获针的机构。手柄是可激活的,以使得内臂和外臂联接,针被用于将针捕获在内臂内的机构捕获,并且当内臂和外臂分离时,针从外臂转移到内臂。(A dura mater repair device capable of being operated by one hand. The device includes a handle and an outer arm having an end opening and a mechanism for retaining the needle within the outer arm. The device also includes an inner arm including a heel, a platform, an end opening, and a mechanism for capturing the needle. The handle is activatable such that the inner and outer arms are coupled, the needle is captured by a mechanism for capturing the needle within the inner arm, and the needle is transferred from the outer arm to the inner arm when the inner and outer arms are separated.)

1. A single-handed dura mater repair device, the device comprising:

a handle;

an outer arm comprising an end opening and a mechanism for retaining a needle therein;

an inner arm comprising a heel, a platform, an end opening, and a mechanism for capturing the needle; and is

Wherein the handle is activatable such that the inner arm and the outer arm are coupled, the needle is captured by the mechanism for capturing the needle within the inner arm, and the needle is transferred from the outer arm to the inner arm when the inner arm and the outer arm are separated.

2. The apparatus of claim 1, wherein the platform has a length of from about 2mm to about 4 mm.

3. The device of claim 1, wherein a maximum distance between the end openings of the outer and inner arms is less than about 1cm prior to activation of the handle.

4. The device of claim 1, wherein the handle comprises opposable arms that are squeezable by a single hand, wherein squeezing the handle causes the outer arm and the inner arm to move toward a longitudinal centerline of the device.

5. The device of claim 1, wherein the handle, the outer arm, and the inner arm are formed from a single piece.

6. The apparatus of claim 1, wherein the handle comprises a shape memory alloy.

7. The apparatus of claim 1, further comprising a coupling between the handle and each arm.

8. The device of claim 1, wherein the needle is fully retained within the outer arm prior to activation of the handle and is fully retained within the inner arm after transfer of the needle to the inner arm, and no portion of the needle passes through the openings of the outer and inner arms prior to coupling of the outer and inner arms.

9. The device of claim 1, wherein the inner arm further comprises a tip extending out toward a longitudinal midline of the device, further than any portion of the platform or the heel, and wherein the tip, the platform, or the heel has at least one curved portion that can slide under an edge of dura mater and is configured to push a rootlet away from the device.

10. The apparatus of claim 1, wherein the heel and the platform comprise a continuous curve.

11. The method of claim 1, wherein the mechanism for capturing a needle within an inner arm is a groove within a wall of the inner arm, a ring extending away from the inner arm, or a magnet.

12. A single-handed dura mater repair device, the device comprising:

a top section comprising a handle comprising opposable arms that can be pressed by a single hand such that the opposable arms move toward each other and both move toward a longitudinal midline of the device;

a bottom section comprising opposed, couplable arms, wherein the arms comprise outer and inner arms opposed to each other, and upon squeezing the handle, the outer and inner arms move toward a longitudinal centerline of the device;

wherein:

the outer arm includes:

a bottom surface;

the end part is open; and

a mechanism for holding the needle therein;

the inner arm includes:

a heel section;

a platform having a length of from about 2mm to about 4mm slidable under an edge of the dura to push the rootlet off the needle;

the end part is open; and

a mechanism for capturing the needle therein; and is

When the handle is squeezed to couple the arms of the bottom section, a needle held within the outer arm is captured within the inner arm, such that when the handle is released, the needle moves from the outer arm to the inner arm and is protected from snagging the rootlet throughout the process of suturing via the device to repair the dura.

13. The device of claim 13, wherein the mechanism for capturing the needle within the inner arm is a groove within a wall of the inner arm.

14. The device of claim 13, wherein the inner arm further comprises a tip extending out toward a longitudinal midline of the device further than any portion of the platform or the heel, and wherein the tip, the platform, or the heel has at least one curved portion.

15. A method for dural repair, the method comprising:

providing an apparatus, the apparatus comprising:

a handle;

an outer arm comprising an end opening and a mechanism for retaining a needle therein;

an inner arm comprising a heel, a platform, an end opening, and a mechanism for capturing the needle;

positioning the outer and inner arms of the device such that the outer and inner arms straddle the torn dura mater, respectively;

pushing at least a portion of a nerve, rootlet, or spinal cord away from the device with a portion of the inner arm to prevent the nerve, rootlet, or spinal cord from being included in a suture or knot;

squeezing a handle of the device such that the inner and outer arms are coupled and the needle is captured by the mechanism for capturing the needle within the inner arm;

releasing the handle to separate the inner and outer arms and transfer the needle from the outer arm to the inner arm;

withdrawing the device from the dura mater, thereby pulling a suture coupled with the needle through the dura mater.

16. The method of claim 15, wherein the pushing away is performed with at least a portion of the platform.

17. The method of claim 15, wherein the torn dura mater comprises a partially torn dura mater, wherein cerebrospinal fluid does not leak out of the spinal canal, and wherein the step of pushing away comprises moving at least a portion of the nerve, rootlet, or spinal cord while the portion floats in cerebrospinal fluid.

18. The method of claim 15, wherein cerebrospinal fluid is not drained during the repair process.

19. The method of claim 15, wherein the torn dura mater includes a tear notch located on a bone sidewall of the spinal canal.

20. The method of claim 15, wherein the torn dura has been damaged due to direct injury of an instrument and/or during removal of adherent tissue including scar tissue, cysts, intervertebral discs, and/or ligamentum flavum.

Technical Field

The present invention relates to devices and methods for dural repair. More particularly, the present invention relates to a dural repair device that can be operated with one hand, wherein by activating a handle, an arm of the device can be moved to transfer a needle during suturing of a dural tear for repair without damaging nerves.

Background

The number and complexity of spinal surgery is increasing in the united states. The dynamics and trends that lead to surgical procedures with low morbidity and short healing times are becoming more and more common and are collectively referred to as minimally invasive procedures.

Spinal surgery typically involves working around the spinal cord and nerves contained in the spinal fluid. The spinal fluid is held in place by tissue known as the dura mater, which creates a dural sac in which the tissue "floats". Injury may result in tearing of the dura mater.

Repair of these lesions is usually accomplished by repairing the tissue directly by re-suturing the two sides of the torn dura mater together. However, these procedures are limited by the fact that the nerves within the capsule are lifted up through the lacerations, thereby complicating closure and increasing the likelihood of nerve damage. In addition, the tear may be located at a location that is difficult to pass through a needle, or at a location where a suture or repair or knot circumferentially entangles one or more nerves.

Current devices, suture types, and needles are often too large to work in the limited space required for minimally invasive surgery. This results in repair, including the step of increasing the size of the exposed area of tissue to ensure adequate closure. This undermines the intent of minimally invasive surgery.

There is a continuing need for improved devices and methods to achieve closure of dural lacerations while protecting nerves and spinal cord from suturing and knotting or from injury during closure. Such apparatus and methods are described herein.

Disclosure of Invention

The present invention generally relates to a dural repair device operable with one hand, the device comprising: a handle; an outer arm comprising an end opening and a mechanism for retaining a needle therein; an inner arm comprising a heel, a platform, an end opening, and a mechanism for capturing a needle; and wherein the handle is activatable such that the inner and outer arms are coupled, the needle is captured by a mechanism for capturing the needle within the inner arm, and the needle is transferred from the outer arm to the inner arm when the inner and outer arms are separated.

Additional embodiments relate to a single-handed operable dural repair device, the device comprising: a top section comprising a handle comprising opposable arms that can be pressed by a single hand such that the opposable arms move toward each other and both move toward a longitudinal midline of the device; a bottom section comprising opposed, couplable arms, wherein the arms comprise an outer arm and an inner arm that are opposed to each other, and the outer arm and the inner arm move towards a longitudinal centerline of the device when the handle is squeezed; wherein the outer arm includes: a bottom surface, an open end and a mechanism for holding a needle therein; the inner arm includes: a heel, a platform about 2mm to about 4mm in length that can slide under the edge of the dura to push the rootlet off the needle, an end opening, and a mechanism for capturing the needle therein; and when the handle is squeezed to couple the arms of the bottom section, the needle held within the outer arm is captured within the inner arm, such that when the handle is released, the needle moves from the outer arm to the inner arm and the protective needle does not catch on the rootlet throughout the process of suturing via the device to repair the dura mater.

Certain embodiments relate to a method for dural repair, the method comprising: providing an apparatus, the apparatus comprising: a handle; an outer arm comprising an end opening and a mechanism for retaining a needle therein; an inner arm comprising a heel, a platform, an end opening, and a mechanism for capturing a needle; positioning the outer and inner arms of the device such that the outer and inner arms straddle the torn dura mater, respectively; pushing at least a portion of the nerve, rootlet, or spinal cord away from the device with a portion of the inner arm to prevent the nerve, rootlet, or spinal cord from being included in the suture or knot; squeezing a handle of the device such that the inner and outer arms are coupled and the needle is captured by a mechanism for capturing the needle in the inner arm; releasing the handle to separate the inner and outer arms and transfer the needle from the outer arm to the inner arm; the device is withdrawn from the dura mater, pulling a suture coupled to the needle through the dura mater.

Other aspects and advantages of the invention will become apparent from the following description.

Drawings

The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the invention defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, wherein:

fig. 1 shows an embodiment of a dural repair device as detailed herein;

FIG. 2 shows the dural repair device of FIG. 1 in a closed position;

FIG. 3 shows the dural repair device of FIG. 1 with the needle transferred from the outer arm to the inner arm of the device;

FIG. 4 shows an area of dura mater to be repaired;

FIG. 5 shows a partially torn dura mater in which cerebrospinal fluid has not leaked from the spinal canal;

FIG. 6 shows a repair process of a partially torn dura mater;

FIG. 7 shows a sequential process of repair of the tear of FIG. 6, wherein the platform has successfully pushed the rootlets away from the region within the cerebrospinal fluid-containing space;

FIG. 8 shows a sequential process of repair of the tear of FIG. 7, wherein when the handle is released, the arms of the device are separated and a suture can be performed through the dura mater;

FIG. 9 illustrates a repair process of a torn dura mater at a bony sidewall of a spinal canal;

fig. 10 shows the outer arm and the mechanism for holding the needle: and is

Fig. 11 shows the inner arm and the mechanism for capturing the needle.

Detailed Description

Specific embodiments of the present disclosure will now be described. This invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to illustrate more specific features of certain aspects of the invention to those skilled in the art.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which embodiments of the invention belong. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in the specification and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

Unless otherwise indicated, all numbers expressing quantities of ingredients, properties (such as molecular weight, reaction conditions), and so forth, used in the specification and claims are to be understood as being modified in all instances by the term "about" which is intended to be indicative of at most ± 10% of the indicated value. In addition, disclosure of any range in the specification and claims should be understood to include the range itself as well as any ranges and endpoints contained therein. As used herein, a range of values is intended to include each and every number and subset of numbers within the range, whether or not specifically disclosed. Unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained in the examples of the present invention. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the errors found in their respective measurements.

Dura mater and surrounding tissue structures are known in the art. Lunatt Haimer written "human brain and spinal cord: such structures are described in detail in the functional neuroanatomical and anatomical guidelines literature, which is incorporated by reference herein in its entirety. This structure is described in detail in the "spine, spinal cord and ANS clinical anatomy" literature written by the neurologists of vertebralis, gregorid · crimer and susan · a · darby, which is also incorporated herein by reference in its entirety.

As used herein, unless otherwise indicated, the term "platform" refers to a portion of the inner arm that can be used to apply pressure to a portion of a nerve, rootlet, or spinal cord. In particular embodiments, the pressure is intended to induce movement of a nerve, rootlet, and/or a portion of the spinal cord. In particular embodiments, the platform may also be used to apply pressure to tissue surrounding a nerve, rootlet, or spinal cord. In particular embodiments, the platform may also be used to apply pressure on nerves, rootlets, and/or the spinal cord and/or on tissue surrounding the nerves, rootlets, or spinal cord without causing damage to the material being compressed.

As used herein, unless otherwise noted, the term "heel" refers to the location where the platform meets a portion of the inner arm that extends substantially longitudinally rearward toward the coupling at the central region of the device. In certain embodiments, the heel includes a sharp or otherwise angled region when the heel moves from the platform to the substantially longitudinally extending section of the inner arm. In certain embodiments, the heel and the platform form a continuous curve.

As used herein, unless otherwise noted, the term "handle" refers to a section of the device that may be used to move the inner and/or outer arms. In certain non-limiting embodiments, the apparatus has an embodiment with a top section comprising two opposing upper arms that together act as a handle. Various additional handle embodiments are described herein.

Unless otherwise indicated, the term "activate" as used herein with respect to the handle means to cause, directly or indirectly, movement of at least a portion of the handle, either mechanically or electronically, so as to move the inner and/or outer arms.

Fig. 1 shows a dural repair device 1. The apparatus has: a top section 2, the top section 2 having an exemplary length a-a; a bottom section 3, the bottom section 3 having an exemplary length B-B, and the bottom section 3 having an exemplary width C-C when the dural repair device is in the open position. The top section 2 comprises two opposing upper arms 4 and 5, which together the two opposing upper arms 4 and 5 may act as one embodiment of a handle and may be pressed by a single hand such that the arms 4 and 5 move towards each other and both move towards the longitudinal centre line E-E of the device 1. The bottom section 3 comprises two opposing arms, an inner arm 6 and an outer arm 7. The apparatus 1 may have a coupling 8 located substantially between the top and bottom sections 2, 3. Inner arm 6 has a heel 9, a platform 10 having an exemplary length D-D, a toe 11, and an end opening 12. In certain embodiments, the platform 10 may be formed from straight lines. In particular embodiments, the angle between the platform 10 and the inner arm 6 is about 45 degrees, or from about 25 degrees to about 65 degrees, or from about 30 degrees to about 60 degrees, or from about 40 degrees to about 50 degrees. The outer arm 7 has a bottom surface 13 and an end opening 14. In a particular embodiment, outer arm 7 includes a mechanism M for retaining needle 15 therein, and needle 15 may be coupled to suture 16. Particular embodiments of the mechanism M may comprise an attachment directly to the inner wall of the outer arm 7 or an attachment to an extension coupled to the inner wall of the inner arm. For example, the attachment may comprise an adhesive, or attachment via a frangible clip, or the needle 15 may be hooked via a loop or other attachment onto one or more protrusions extending upwardly from the inner wall of the outer arm 7. The one or more protrusions may be at any angle or series of angles with the inner wall of the outer arm 7, such as from about 0 degrees to about 90 degrees. The protrusion may extend from or between the inner top, bottom or inner side of the outer arm. Fig. 1 provides a non-limiting example of a mechanism M, and various other mechanisms M are described and illustrated herein.

In a particular embodiment, inner arm 6 includes a tip 11, tip 11 extending away toward a longitudinal centerline E-E of device 1, further than any portion of platform 10 or heel 9. In a particular embodiment, the tip 11, the platform 10 or the heel 11 has at least one curved portion that is slidable under the edge of the dura mater and is configured to push the rootlet away from the device 1. In certain embodiments, the platform 10 comprises a continuous curve.

In particular embodiments, the length of the platform 10 is less than 6mm, or less than about 5mm, or less than about 4mm, or less than about 3 mm. In particular embodiments, the length of the platform 10 is from about 1mm to about 5mm, or from about 2mm to about 4mm, or from about 2.5mm to about 3.5 mm.

In particular embodiments, the maximum distance between the end openings (14, 12) of the outer and inner arms 7, 6 is less than about 2cm, or less than about 1cm, or less than about 0.5 cm. In particular embodiments, the maximum distance between the end openings (14, 12) of the outer and inner arms 7, 6 is from about 0.25cm to about 2cm, or from about 0.5cm to about 1 cm.

Fig. 2 shows the dural repair device 1 of fig. 1 in a closed position. When moving the two opposing upper arms 4 and 5 (not shown in fig. 2) towards each other, the two opposing arms, respectively inner arm 6 and outer arm 7, move towards each other and towards the longitudinal midline E-E of the apparatus. The opposed upper arms 4 and 5 can be moved towards each other to move the inner arm 6 and the outer arm 7 for coupling. The needle 15 may be housed within the outer arm 7. For completeness, fig. 2 also shows the coupling 8, the heel 9 and the platform 10 of the inner arm 6, the underside 13 of the outer arm 7, the needle 15 and the suture 16.

Fig. 3 shows the dural repair device 1, wherein the upper arms 4 and 5 (not shown in fig. 3) are moved towards each other such that the inner arm 6 and the outer arm 7 are coupled and the needle 15 is transferred from the outer arm 7 to the inner arm 6. In a particular embodiment, upon activation of the handle, the needle 15 is transferred, and more particularly, in a particular embodiment, the needle 15 is initially held completely within the outer arm 7, and after the needle 15 is transferred to the inner arm 6, the needle 15 is held completely within the inner arm 6, and no portion of the needle 15 passes through the openings (14, 12) of the arms (7, 6) before the arms (7, 6) are coupled. In a particular embodiment, the inner arm 6 comprises a mechanism (not shown in fig. 3) for capturing the needle 15. The mechanism may be a recess in the wall of the inner arm 6. The recess may be a groove or a series of grooves. The mechanism may include a recess that matches at least a portion of the shape of the needle 15. The mechanism may also be one or more holes through the inner arm 6. The mechanism may also be a catch or series of catches extending upwardly from the inner wall of the inner arm at the same or mixed angle. The extended catch may be angled, such as from about 0 degrees to about 90 degrees (such as from about 25 degrees to about 75 degrees, and/or from about 40 degrees to about 60 degrees, and/or from about 75 degrees to about 90 degrees) relative to the inner surface of the inner arm 6. The extended catcher may also have a ring or adhesive for catching the needle 15. The extended catch may be formed by a ring extending away from the inner arm 6, or may be formed by a magnet. For completeness, fig. 3 also shows the coupling 8, the heel 9, the platform 10 and the tip 11 of the inner arm 6, the underside 13 of the outer arm 7 and the stitching 16.

In a particular embodiment, the outer arm 7 and the inner arm 6 are formed by a single piece. In other embodiments, the arms (7, 6) are formed separately. In either case, the coupling 8 may be used to bring together the single pieces of metal used to form the two arms (7, 6), and/or may be used to form a generally figure-8 configuration in which the metal arms (7, 6) overlap one another. The handle may comprise a shape memory alloy, such as nickel titanium (NiTi). The coupling 8 may comprise a slot through which portions of the arms (7, 6) and/or the handle 8 slide. The coupling 8 may include a ratchet mechanism therein or coupled thereto such that squeezing of the handle results in locking of the arms (7, 6) at a plurality of open positions; in this case the mechanism for ratchet release may comprise a side button on the device 1, but may also comprise a simple pressure mechanism, so that when the closed position where the arms (7, 6) are coupled is reached, further squeezing together of the upper arms 4 and 5 by squeezing the handles releases the ratchet to the open position.

Examples of the invention

The embodiments of the device outlined herein show surprising utility in the results of a method of repairing dural damage. Current techniques tend to cause additional damage or require cerebrospinal fluid drainage for local repair. The methods described herein may be used when the dura has been damaged due to direct injury of the instrument and/or during removal of adherent tissue including scar tissue, cysts, intervertebral discs and/or ligamentum flavum. Fig. 4 shows the area of the dura mater to be repaired. The dura mater 17 and the tear 18 of the dura mater 17 are shown. The small joint 19 and spinous process 20 are also shown for context. As shown, exemplary distances are denoted as F-F. In a particular embodiment, the length of F-F is less than 1 cm.

Example 1: and (4) loading the equipment. In a particular embodiment, the complete device 1 is pre-loaded withShaped suture 16 and needle 15. The needle 15 and platform 10 meet when the handle is squeezed, or the needle 15 may be free and then moved by a separate forceps or captured by a catch of the inner arm 6. At least a part of the inner arm 7 slides under the edge of the dura mater 17 to push the rootlet 21, and hasA groove that mates with and captures or accommodates the needle 15. The handle is squeezed and the two upper arms 4 and 5 are brought together. During repair, needle 15 is protected and rootlet 21 cannot be hooked by a portion of needle 15 and/or suture 16.

Sutures used in methods and devices as described herein may include one or a combination of one or more monofilament, multifilament synthetic, biological, absorbable, and/or non-bioabsorbable sutures. Non-limiting examples of monofilament sutures includeAnd/orII polydioxanone. Non-limiting examples of multifilament sutures includeSilk sutureVicrylVicrylSilk suture (such asSilk suture line),And/orNon-limiting examples of synthetic sutures includeVicrylVicryl And/orAnd II, performing treatment. A non-limiting example of a biological suture is a silk suture. Non-limiting examples of absorbable sutures includeVicrylVicrylAnd/or PDS II. Non-limiting examples of non-absorbable sutures includeSilk And/or polypropylene sutures. Non-limiting examples of suture material may include one or more of the following: stainless steel, polyester, polypropylene, nylon, and/or cotton. The needles used herein may be curved or straight.

The handle or other part of the device 1 may be made partly or entirely of one or more metals or of a composite material. In certain examples, some or all of the device includes a shape memory material. In a particular example, part or all of the device includes one or more of copper aluminum nickel (cupel), nickel titanium (NiTi), zinc, copper, gold, and/or iron.

Example 2: the dura mater is partially torn, but cerebrospinal fluid does not leak out of the spinal canal. The rootlets float and are beside the repair site. If cerebrospinal fluid is drained, the rootlets will sink and repair will be easier, but the methods provided herein can be used to repair the original partial tear, rather than completing the tear to then repair the tear. The methods provided herein can repair tears where cerebrospinal fluid is not drained during the repair process. At least a portion of the inner arm 6, such as the platform 10, may be used to safely push a nerve, rootlet, or portion of the spinal cord away from the device so that the suture 15 or needle 16 does not touch or otherwise damage them even when a nerve, rootlet, or portion of the spinal cord floats in the cerebrospinal fluid.

This is shown in fig. 5, which shows the dura mater 17, the laceration port 18, the small root 21 and the space containing the cerebrospinal fluid 22. Fig. 6 shows the placement of the device 1 such that the inner arm 6 and the outer arm 7 are on opposite sides of the dura mater 17 and there is a dural tear 18 without leakage of cerebrospinal fluid. In fig. 6, the platform 10 is used to remove the floating rootlet 21 from the device 1 in order to protect the rootlet 21 from the needle 15. Fig. 6 also shows the space containing cerebrospinal fluid 22 and the heel 9 of the inner arm 6. Although in fig. 6, the needle 15 is shown partially exposed from the end opening 14 of the outer arm 7, various embodiments contemplate retaining the needle 15 completely within the outer arm 7, partially within the outer arm 7 and/or beyond the end opening 14 of the outer arm 7. More specifically, needle 15 may be retained within outer arm 7 so as to prevent any interaction of the needle with rootlet 21; alternatively, the needle 15 may be held with a portion thereof exposed, and the needle 15 may be held with a portion within the outer arm 7 and a portion exposed toward the space containing the cerebrospinal fluid 22. Alternatively, an embodiment may include placing the needle 15 outside the end opening 14 of the outer arm 7. In particular embodiments, needle 15 may be held within outer arm 7, partially within outer arm 7, or outside outer arm 7 by a jaw.

Fig. 7 shows a continuous process of repair of the tear notch 18 of the dura mater 17 of fig. 6, wherein the rootlet 21 (not shown in fig. 7) has been pushed away by the platform 10 from the area within the space containing cerebrospinal fluid 22 and the needle 15 can be transferred from the outer arm 7 to the inner arm. As shown in FIG. 7, the platform 10 may be multi-segmented to achieve a platform shape having one or more than one curve, or a particular shape as desired for a given procedure. Fig. 8 shows a continuous process of repair of the tear opening 18 of the dura mater 17. Once the needle 15 is captured by the inner arm 6, the inner arm 6 and outer arm 7 separate and the wire can be pulled through the dura mater 17 when the handle is released. When this occurs, the rootlets 21 may float back to the dura mater 17 and repair site in the space containing the cerebrospinal fluid 22 without being damaged. The suturing process may then be repeated until complete closure of the dura mater 17 is achieved. The outer arm 7 is configured so that a needle 15 can be manually loaded, or it can be provided pre-loaded with a plurality of needles 15, and can be configured so that one needle 15 is released from within the outer arm 7 so as to be held in use once the needle 15 is used. The inner arm 6 may be configured to manually or electronically remove the needle 15 from the capture. In certain embodiments, one needle 15 is reused and is manually or mechanically moved back to the outer arm 7 for reuse.

Example 3: in the event that the needle is moved too hard and hooks the rootlet, repairing the dura may cause a tear at the edge of the anatomy. The methods described herein may be used when the torn dura mater includes a tear notch located on the bone sidewall of the spinal canal. This is shown in fig. 9, showing the tear 18 of the dura mater 17, the rootlet 21, the space containing the cerebrospinal fluid 22, and the bony sidewall 23 of the spinal canal. With current techniques, there is a risk of injury due to the small root being caught by the forceful movement of the needle. In the presently outlined embodiment, the rootlets will be protected, and cerebrospinal fluid drainage will not be required in some cases. It is contemplated that drainage of cerebrospinal fluid or removal of small amounts of cerebrospinal fluid may be performed during the repair described herein, but other embodiments are contemplated in which fluid removal is not required; in either case, less fluid removal will be required than in the comparative methods of the current art. In repairing the dura mater, the methods described herein can further include additional repair steps such as glue or staplers.

Example 4: a mechanism for holding the needle. Fig. 1 outlines various mechanisms M for holding a needle. Fig. 10 shows various additional mechanism M embodiments. More specifically, fig. 10 shows exemplary embodiments 24 to 28 of the outer arm 7 and the mechanism M for holding the needle 15. The needle 15 may be held at or outside the end opening 14 of the outer arm 7 as shown in example 24, or may be held directly against or otherwise attached to the inner wall of the outer arm 7 as shown in examples 25 and 26. The needle can be slid into a hole or recess in the inner wall of the outer arm 7. The needle may be held by an attachment or extension coupled to the inner wall of the inner arm 7. As shown in embodiments 27 and 28, needle 15 may be held by jaws 29. The jaws 29 may extend partially or completely from the end opening 14 of the outer arm as in embodiment 27, or part or all of the jaws 29 and/or the needle 15 may be held partially or completely within the outer arm 7 as in embodiment 28. In certain embodiments, the surface of jaw 29 facing needle 15 is smooth and holds needle 15 in a friction fit. In other embodiments, jaw 29 has ridges or teeth for holding needle 15. In other embodiments, needle 15 may be placed between jaws 29 held together by spring force. In particular embodiments, jaws 29 may be sized to correspond to various needle sizes, such as 1, 2, 3, 4, or 5 sizes, or from about 1 to about 10 sizes, and in particular embodiments, jaws 29 may be set to various positions and locked in place to act as a clamp. In certain embodiments, when acting as a clamp, the force of jaw 29 against needle 15 may be set to more closely fit needle 15, such as by electronic thrust of a rotating screw or button, thereby electrically moving jaw 29; in other cases, the settings are configured manually.

Example 5: a mechanism for capturing the needle. Fig. 11 shows an embodiment of the inner arm 6, the platform 10 and the end opening 12 as well as the means 30 to 35 for catching the needle 15. In certain embodiments, the needle 15 may be placed through the loop 36 or a partial loop where the needle 15 is captured to allow its translation, as shown in embodiment 30, with the inner arm 6 at a small angle to make the loop 36 clearly visible. Embodiment 31 is a longitudinal section of the inner arm 6. As in embodiment 31, the needle 15 may be captured by a flange 37 protruding from the inner surface of the inner arm 6. Particular embodiments include 1, 2, 3, 4, 5, or from about 1 to about 20, or from about 1 to about 10, or from about 3 to about 7, or from about 4 to about 6 flanges 37. In a particular embodiment, the ring 38 extends out from the inner surface of the inner arm 6, and as shown in embodiment 32, which shows the inner arm 6 at a small angle, the needle 15 can be captured at any point around the inner surface of the inner arm 6 via a portion of the capture ring 37. As the inner arm 6 slides into the outer arm 7, the needle 15 can slide over the ring 38 as the needle 15 slides into the inner arm 6, and since the diameter of the opening 12 of the inner arm 6 at the point of the ring 38 is smaller than the diameter of the end opening 14 of the inner arm, and smaller than when one needle moves into the opening 12 of the inner arm 6 beyond the ring 38, the needle 15 can be pulled back against a portion of the ring 38 as the inner arm 6 slides out of the outer arm 7. Embodiment 32 shows the inner arm 6 at a smaller angle, making the ring 38 clearly visible. In a particular embodiment, the ring 38 is continuous. Particular embodiment 33 shows an end view of inner arm 6 and ring 38 that includes hole 39, a plurality of holes 39, and/or a slot 40 or plurality of slots 40 that can capture needle 15. In particular embodiments, the plurality of holes 38 and/or the plurality of slots 40 in which the needles 15 may be placed are disposed at equal or irregular intervals from one another, and in particular embodiments, for example, there are, for example, about 1, 2, 3, 4, 5, or from about 1 to about 20, or from about 1 to about 10, or from about 3 to about 7, or from about 4 to about 6 holes 38 and/or slots 40. The ring 38 may be placed directly at the opening 12 of the inner arm 6 or disposed or partially disposed within the opening 12 of the inner arm 6. The ring 38 may be configured to be removable, reusable, or disposable. In particular embodiments, a single device 1 may use rings 38 of various sizes. In a particular embodiment, the ring 38 is formed as part of the inner arm 6 of the device 1. Embodiment 34 shows a longitudinal section of the inner arm 6 in which the needle 15 can be placed right into the extensions 41 to 42 of the inner arm 6, the extensions 41 and 42 forming an opening 43, the needle 15 can be placed right into the opening 43 by friction and/or engagement. Particular embodiments include about 1, 2, 3, 4, 5, or from about 1 to about 20, or from about 1 to about 10, or from about 3 to about 7, or from about 4 to about 6 extensions. Embodiment 35 shows a longitudinal section of the inner arm 6 in which the needle 15 can be displaced via a magnet 44 extending out from a portion of the inner arm 6. Any one or more of the embodiments for holding a needle and/or embodiments for capturing a needle 30-35 as shown in 24-28 may use one or more magnets to cause the needle to be held, captured and/or displaced. For example, in certain embodiments, extensions 41 and 42 may be formed from magnets, or each include 1 or more magnets. Non-limiting examples of embodiments of magnets include permanent magnets and/or electromagnets.