SYSTEM AND METHODS FOR DECOMPRESSION OF SPINAL EPIDURAL SPACE

Abstract

A surgical tool for removing tissue from a body organ which includes an axially extending outer shell and an axially extending actuator. The outer shell includes a steerable region and the actuator is arranged to flex and extend the steerable region about at least two axes that are transverse to each other.

Claims

1. A surgical tool for removing tissue from a body organ and comprising a longitudinal extending outer shell and a longitudinal extending actuator, the outer shell comprising a steerable region and the actuator being arranged to flex and extend the steerable region about at least two non-parallel axes.

2. The surgical tool of claim 1, wherein the two axes are generally orthogonal one to the other.

3. The surgical tool of claim 1, wherein the outer shell comprising plurality of joints interconnected by hinge joints.

4. The surgical tool of claim 3, wherein adjacent joints are interconnected by a pair of hinge joints.

5. The surgical tool of claim 3, wherein at least one of the hinge joints is arranged to flex and extend adjacent joints it interconnects about a first axis and at least one other hinge joint is arranged to flex and extend adjacent joints it interconnects about a second axis that is non-parallel to the first axis.

6. The surgical tool of claim 1, wherein the actuator comprising a plurality of rod members for urging the flexing and extending in the steerable region.

7. The surgical tool of claim 6, wherein pairs of rod members are arranged to act together in push-pull relationship in order to urge flexing and extending in the steerable region.

8. The surgical tool of claim 6, wherein each rod member comprises a section that is flexible in the axial direction.

9. The surgical tool of claim 8, wherein flexibility in the axial direction is formed by meandering bellow-like interruptions in the rod member.

10. The surgical tool of claim 9 and comprising an axially extending rail located between adjacent rod members.

11. The surgical tool of claim 1 and comprising an inner tool extending through the actuator, wherein the inner tool comprises a cutting edge at its distal end.

12. The surgical tool of claim 11 and comprising a generally cylindrical shaped partition in between the actuator and the inner tool.

13. A surgical tool for removing tissue from a body organ and comprising an axially extending outer shell, an actuator extending axially through the outer shell and an inner tool extending axially through the actuator, wherein the outer shell comprises a steerable region that is bendable by the actuator and the inner tool comprises a cutting edge at a distal end and being rotatable for performing a cutting operation.

14. The surgical tool of claim 13, wherein the inner tool comprises at least one flexible region and the outer shell comprises at least one flexible region that is generally axially aligned with the flexible region of the inner tool.

15. The surgical tool of claim 14, wherein a flexible region is formed as a helical cut.

16. The surgical tool of claim 15, wherein aligned flexible regions of the outer shell and the inner tool comprise opposing right-hand and left-hand helical paths.

17. The surgical tool of claim 15, wherein adjacent flexible regions in the outer shell comprise opposing right-hand and left-hand helical paths and/or adjacent flexible regions in the inner tool comprise opposing right-hand and left-hand helical paths.

18. The surgical tool of claim 13, wherein the inner tool comprises a thorough going internal passage for removal of debris formed during cutting operations.

19. The surgical tool of claim 18 and comprising applying suction to the internal passage from a proximal side of the surgical tool in order to assist in debris removal.

20. The surgical tool of claim 19 and comprising providing an incoming flow of liquid from a proximal side of the tool that is channeled to flow substantially between the inner tool and outer shell in the distal direction towards the inner tool's cutting edge in order to assist in debris removal.

21. The surgical tool of claim 20 and comprising an outer tubing formed on an outer side of the outer shell, possibly a heat shrink tubing.

22. A tracking device for tracking magnetic material comprised in an invasive surgical tool within the human body, wherein the tracking device comprises an array of magnetic sensors suitable for tracking at least an X, Y location of the magnetic material.

23. The tracking device of claim 22, wherein the array of magnetic sensor are arranged in a matrix of rows and columns.

24. The tracking device of claim 23 and being arranged for use outside of the human body, possibly attached to the skin of the human body.

25. A method for tracking magnetic material within the human body comprising the steps of: providing a tracking device comprising an array of magnetic sensors, placing the tracking device outside of the human body adjacent the skin, and determining X, Y coordinates of the magnetic material in response to changes and/or disturbances in magnetic field picked up by at least some of the sensors.

26. The method of claim 25 and comprising a step of providing a 3D model of the anatomy of the body where the magnetic material can pass and computing a distance along a Z axis to the magnetic material based on the 3D model.

27. The method of claim 26, wherein the 3D model is reconstructed from data Obtained from CT or MRL

28. The method of claim 26 and comprising a step of transforming the X, Y coordinates of the tracked magnetic material onto a 3D model.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0058] Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative, rather than restrictive. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying figures, in which:

[0059] FIG. 1 schematically shows a human spinal cord;

[0060] FIG. 2 schematically shows a section of a lumbar curve of the human spine and a surgical device in accordance with an embodiment of the present invention located within a spinal canal of the lumbar curve;

[0061] FIG. 3 schematically shows an embodiment of a surgical device in accordance with the present invention;

[0062] FIG. 4 schematically shows an exploded view of the surgical device of FIG. 3;

[0063] FIG. 5A schematically shows an enlarged section of an outer shell of the surgical device;

[0064] FIG. 5B schematically shows enlarged views of an actuator of the surgical device;

[0065] FIG. 5C schematically shows an enlarged section of a partition of the surgical device;

[0066] FIG. 5D schematically shows an enlarged section of an inner tool of the surgical device;

[0067] FIGS. 6A and 6B schematically show a distal region of the outer shell assuming various curvatures;

[0068] FIG. 7 schematically shows an embodiment of a debris clearing mechanism possibly used with an embodiment of a surgical device of the present invention;

[0069] FIG. 8 schematically shows a lumbar curve of a human spine and a tracking device according to an embodiment of the present invention;

[0070] FIGS. 9A and 9B schematically show an exploded view of the tracking device and an embodiment of a sensor of the tracking device; and

[0071] FIG. 10 schematically shows a cross section of a human spine revealing the thecal sac, and possible use of a tracking device for tracking a surgical tool within either a posterior or anterior side of the thecal sac.

[0072] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated within the figures to indicate like elements.

DETAILED DESCRIPTION

[0073] Attention is first drawn to FIG. 1 illustrating a human spine. FIG. 2 shows a lumbar curve of the human spine and a surgical device 12 in accordance with an embodiment of the present invention located within a spinal canal of the lumbar curve. The surgical device may be arranged to include a base member 13 in this example formed as a manipulator at its proximal side for assisting in controlling/manipulating an actuator of the device (an embodiment of such actuator being described in detail further below).

[0074] The base member 13 in this example may be formed with two toggles T1, T2, each arranged to interact with a respective pair of rod members of the actuator (see 1221, 1222—described e.g. with respect to FIG. 5 below). Each one of the toggles in this example is arranged to pivot about a respective axis to urge a “swing” like actions (T11, T12) that can transmit push-pull movements to the rod members attached thereto. Base member 13 in this example is also shown formed with an optional pair of nozzles N1, N2 for assisting in debris removal that will be described in more detail herein below with respect e.g. to FIG. 7.

[0075] A distal cutting head 14 of the surgical device in this example is seen guided to a location between vertebrae bones L2 and L3 of the lumbar curve. Cutting head includes cutting blades 1241 and a shield 1211 defining a sector through which the cutting blades remain exposed for performing a cutting operation.

[0076] Attention is drawn to FIGS. 3 and 4 illustrating an embodiment of a surgical tool 12 in, respective, assembled and exploded states. Surgical tool 12 has a longitudinal axis L and can be urged to assume various curvatures along its extension to assist its passage through the spinal canal.

[0077] Surgical tool 12 in this embodiment can be seen including the following parts: an outer shell 121, an actuator 122, a partition 123 and an inner tool 124. FIGS. 5A to 5D provide detailed views of the various parts forming surgical tool 12, while it is noted that all these parts will be described with respect to the longitudinal axis L of the surgical tool, and hence in their assembled orientation within the tool.

[0078] Attention is drawn to FIG. 5A providing an enlarged view of a distal portion of outer shell 121. Shield 1211 is located here at the distal tip of outer shell and is arranged to include an axially extending opening 12111 that faces sideways away from axis L. In certain embodiments, shield 1211 may be formed from, or may be arranged to include, magnetic material to assist in tracking of the surgical tool during in use.

[0079] Outer shell 121 in this example includes a steerable region 1212 that includes several joints 12121, and shield 1211 is here shown being attached to the distal most joint. The joints 12121 in this example are shown interconnected by first 1 and second 2 pairs of hinge joint types. In FIG. 5A only one of the hinge joints of each pair can be fully viewed.

[0080] Each hinge joint 1 of the first type allows adjacent joints 1212 that it interconnects to flex and extend about a first axis P1 thereof, and each hinge joint 2 of the second type allows adjacent joints 1212 that it interconnects to flex and extend about a second axis P2 thereof that is generally orthogonal to the first axis P1.

[0081] Each one of the hinge joints 1, 2 in this example can be seen in the enlarged section at the right-hand side of the figure, being arranged to include a bearing member 17 positively engaged within a socket member 19. The socket member 19 may be integral with one of the joints (here a proximal joint) that is being hinged, and the bearing member 17 may be integral with the other joint (here a distal joint) being hinged, while as here seen also optionally remaining integrally joined also to the proximal joint via a flexible linking arm 15.

[0082] Facing ends 71, 72 of adjacent joints being hinged may be suitably cut in order to define a maximal angle ‘α’ that said joints may be pivoted one relative to the other about their respective first or second axes Y1, Y2—from a non-pivoted state and/or a straight section of axis L. In one example, angle ‘α’ may be about 30 degrees, however other values may be suitably chosen.

[0083] Outer shell 121 includes a shank region 1213 that extends in a proximal direction away from steerable region 1212 to a proximal end of the outer shell. Shank region 1213 may include axially spaced apart flexible regions 12131 in this example formed as helical cuts through the outer shell. At least some of the flexible regions 12131 may be formed having opposing right-hand and left-hand helical paths to assist in resisting twisting of the outer shell about axis L during use. The flexible regions 12131 are arranged to allow the shank region to assume curvatures along its axial extension to assist in its passage through the spiral canal.

[0084] Attention is drawn to FIG. 5B. Actuator 122 includes in this example a first pair of axially extending opposing rod (or wire like) members 1221 and a second pair of axially extending opposing rod (or wire like) members 1222. Thus, rod members in each pair are rotated by about 180 degrees one relative to the other about the actuator's axis. Each respective pair of rod members in this example may be designed to function in push-pull relationship, so that when pulling one rod member of a given pair, the other rod member of said given pair may be pushed to assist in intended actuation (and visa-versa).

[0085] Actuator 122 in addition includes four axially extending rails 1223, where each such rail 1223 is located in-between adjacent rod members 1221, 1222 of different pairs. Each one of the rod members and rails, in this example, extends generally un-interrupted along a proximal region 1214 of the actuator. In a distal region 1215 of the actuator, in this example substantially shorter than the proximal region, each one of the rod members and rails may be imparted with flexibility by extending axially with meandering bellow-like interruptions.

[0086] Each one of the rod members 1221 of the first pair may be arranged to extend up to and terminate at a respective first anchoring region 1216, while each Iii one of the rod members 1222 of the second pair may be arranged to extend up to and terminate at a respective second anchoring region 1217. In this example the anchoring regions 1217 of the second pair of rods 1222 are arranged to be distal to the anchoring regions 1217 of the first pair of rods 1221.

[0087] Attention is drawn to FIG. 5C schematically illustrating an optional partition 123 that may be included in the surgical tool in between actuator 122 and inner tool 124. Such partition 123 may be useful in providing a buffer between actuator 122 and e.g. its moving rods, and inner tool 124 that may be controlled to rotate when the surgical tool 12 performs a cutting action.

[0088] Partition 123 may include axially spaced apart flexible regions 1231 in this example formed as helical cuts through the partition. At least some of the flexible regions 1231 may be formed having opposing right-hand and left-hand helical paths to assist in resisting twisting of the partition about axis L during use. Possibly, flexible regions 1231 of the partition may be axially aligned in the surgical tool with flexible regions 12131 of the outer shell—in order to impart overall flexibility to the surgical tool in these regions so that it can flex and assume changing curvatures while being urged through the spinal canal.

[0089] The partition may also include a distal flexible region 1232 in this example also formed as a helical cut through the partition. Flexible region 1232 may be arranged to be overlaid by the steerable region 1212 of the outer shell in the assembled surgical tool, thus also with the aim of providing overall flexibility o the surgical tool in this region.

[0090] This overall flexibility may be useful, as with the former discussed aligned flexible regions 1231, 12131, in allowing the surgical tool to adjust in these regions to curvatures through which the tool may advance in the spinal canal. In addition, the flexibility imparted by flexible region 1232 may assist in permitting movements at the steerable region 1212, which may be controlled by the actuator 122.

[0091] Attention is drawn to FIG. 5D schematically illustrating the inner tool 124 that includes an axially extending through going passage 1244. Inner tool includes cutting blade(s) 1241 formed at its distal end. The cutting blades 1241 are here shown being formed generally along a helical route, however any cutting blade formation suitable for cutting intended tissue, e.g. along the spine, may be applicable.

[0092] In addition the inner tool includes a flexible region 1242 proximal to the cutting blades 1241, which in this example may be formed as a helical cut through the inner tool. The flexible region 1242 may be arranged to be aligned and overlaid by the flexible region 1232 of the possible partition, and by the steerable region 1212 of the outer shell. And thus, the inner tool's flexible region 1242 assists in imparting overall flexibility in this region of the surgical tool.

[0093] The inner tool in this example may also include spaced apart flexible regions 1243 here also possibly formed as helical cuts through the partition. At least some of the flexible regions 1243 may be formed having opposing right-hand and left-hand helical paths to assist in resisting twisting of the inner tool about axis L during use. Possibly, the flexible regions 1243 of the inner tool may be axially aligned in the surgical tool with flexible regions 1231 of the partition and with flexible regions 12131 of the outer shell—in order to impart overall flexibility to the surgical tool in these region so that it can flex and assume changing curvatures while passing through the spinal canal.

[0094] It is noted that at least some axially aligned helical cuts forming flexible regions in different tool parts (e.g. 12131 in outer shell, 1231 in partition, 1243 in inner tool)—may possibly be formed having opposing right-hand and left-hand helical paths, in order to further assist in resisting twisting of the surgical tool about axis L during use.

[0095] Attention is drawn to FIGS. 6A and 6B illustrating the steerable region 1212 of the outer shell in various possible steered states; while also drawing attention back to FIG. 5B to explain possible actuation of these steered states by actuator 122.

[0096] Actuator 122 in this example may be connected to the steerable region 1212 of the outer shell at two zones. One of the zones may be defined at the distal most hinge 12121 that is hinged in place by a hinge joint 1, where said distal hinge will be referred to from hereon also as an “actuated” hinge 11. The other zone may be defined at the distal most hinge 12121 that is hinged in place by a hinge joint 2, where said distal hinge will be referred to from hereon also as an “actuated” hinge 22.

[0097] The “actuated” hinge 11 may be arranged to include opposing ports 91, and may be designed at its inner side to attach at each port 91 to a respective one of the anchoring regions 1217 of the actuator. The “actuated” hinge 22 may be arranged to include opposing ports 92, and may be designed at its inner side to attach at each port 92 to a respective of the anchoring regions 1216 of the actuator. The ports 91 on “actuated” hinge 11 are rotated by about 90 degrees relative to the ports 92 “actuated” hinge 22, when the steerable region 1212 of the actuator is held straight.

[0098] By pulling and respectively pushing the first pair of rod members 1221 (as indicated e.g. by the ‘dotted’ arrows at the upper right-hand side of FIG. 5B), the rod members 1221 can be manipulated by a surgeon to urge the anchoring regions 1216 (that are fixed to “actuated” hinge 22) to rotate/pivot/twist generally about an axis P2′ (P2 prime). This in turn urges the “actuated” hinge 22 that is connected to the anchoring regions 1216 to also rotate about axis P2 of the hinge joints 7 linking it to the joint 12121 that is proximal thereto. This bending within the steerable region 1212 that is urged by the rod members 1221, can occur at all the hinge joints 2 proximal to the “actuated” hinge 22.

[0099] By pulling and respectively pushing the second pair of rod members 1222 (as indicated e.g. by the ‘dashed’ arrows at the upper left-hand side of FIG. 5B), the rod members 1222 can be manipulated by a surgeon to urge the anchoring regions 1217 (that are fixed to “actuated” hinge 11) to rotate/pivot/twist generally about an axis P1′ (P1 prime). This in turn urges the “actuated” hinge 11 that is connected to the anchoring regions 1217 to also rotate about axis P1 of the hinge joints 1 linking it to the joint 12121 that is proximal thereto. This bending within the steerable region 1212 that is urged by the rod members 1222, can occur at all the hinge joints 1 proximal to the “actuated” hinge 11.

[0100] In FIG. 6A, the joints 12121 hinged by hinge joints 2 were controlled by the rod members 1221 of actuator 122 to fully pivot about their receptive axes P2.

[0101] This may amount to about a 60 degree bending of the outer shell in this region assuming angle ‘α’ is about 30 degrees (while accordingly other bending values may be assumed e.g. by designing angle ‘α’ to have a different value).

[0102] In FIG. 6B, the joints 12121 hinged by hinge joints 1 were further controlled by the rod members 1222 of the actuator 122 to fully pivot about their receptive axes P1. This may amount to about a 90 degree bending of the outer shell in this region assuming angle ‘α’ is about 30 degrees (while accordingly other bending values may be assumed e.g. by designing angle ‘α’ to have a different value).

[0103] While performing a cutting action with the surgical tool, debris being cut away e.g. ligaments within the spinal canal may be flushed out of the tool. This may be performed e.g. by applying suction at the through going passage 1244 of the inner tool. In addition or alternatively, fluid being urged downstream in the distal direction may be used to flush debris back upstream out of the surgical tool via the passage 1244.

[0104] An aspect of the present invention may be defined as provision of a tracking ability of invasive surgical tools located within a human body. Devices performing such tacking may be external to the human body and arranged to remotely sense a location of at least a portion of a surgical tool advancing within an area of the body. This aspect can be considered as an independent inventive aspect not necessarily linked to the described surgical tool embodiments disclosed herein and to their intended therapeutic purpose. For example, tracking as disclosed herein may be used for tracking an endoscope within an intestine, a sinus canal (or the like), a gastroscope within the oesophagus, stomach, duodenum (or the like), otorhinolaryngology (or the like).

[0105] Attention is drawn to FIG. 7 for a view of a possible mechanism for debris removal that may be implemented with respect to at least certain surgical device embodiments. The lower side of the figure illustrates a cross sectional view of a base member possibly similar to base member 13 illustrated in FIG. 2. This base member may include a first nozzle N1 that may be arranged for creating suction (possibly zero pressure or slightly below) within the through going passage 1244 passing through inner tool 124. This suction may be useful in removing out of the tool debris that may be formed during cutting operations of the surgical tool.

[0106] Possibly, an optional second nozzle N2 may be formed in the base member for inputting an incoming flow of liquid (possibly at or slightly above atmospheric pressure) that may be channeled to flow in the distal direction within a gap formed between inner tool 124 and outer shell 121. The incoming flow of liquid in one example may be saline. Possibly the outer shell may be coated at its periphery by an outer thin tubing 777 such as a PET heat shrink tubing (or the like). Tubing 777 may be useful in channeling most of the liquid entering via nozzle N2 towards the distal region of the surgical tool where at least some of this liquid may enter through the cutting blades of the inner tool and flow back (e.g. due to applied suction at the nozzle N1) in the proximal direction through passage 1244 to assist in removal of debris.

[0107] Attention is drawn to FIG. 8 illustrating a curve of a lumbar human spine and a tracking device 50 according to an embodiment of the present invention. Tracking device 50 may be placed outside of the human body, here fitted to a skin region (here marked by dashed line S) of a patient adjacent to his lumbar curve.

[0108] Attention is drawn to FIG. 9A demonstrating that the tracking device 50 may include an outer casing 501, 502 and a sensor plate 503 located within the casing. In this example, casing 502 arranged to contact the patient's skin S may be lid fitted to the skin e.g. by adhesive tape (or the like) in order to substantially fix tracking device 50 to the patient while tracking takes place.

[0109] Attention is drawn to FIG. 9B for a closer view of a lower side of sensor plate 503. Sensor plate 503 as here seen may be fitted with an array 55 of magnetic sensors 5 arranged in a matrix of rows (extending alongside axis X) and columns (extending alongside axis Y).

[0110] Each sensor may be arranged to detect changes and disturbances in a magnetic field like flux, strength, direction (or the like). A controller receiving sensed signals from the sensors may be suitably programmed to detect X, Y coordinates of an object being tracked. Such coordinates may be determined e.g. by one or more sensor whose sensed signal(s) are maximal.

[0111] Attention is drawn to FIG. 10 schematically showing a cross section of a human spine revealing e.g. vertebral bodies or intervertebral discs 110 anterior to the thecal sac 100 and e.g. laminae and ligamentum flavum 120 posterior to the thecal sac 100. A tracking device 50 including a sensor plate 503 such as that shown in FIG. 9B may be arranged to track here X′, Y′ coordinates of an invasive surgical tool advancing along the spinal cord.

[0112] In an aspect of the present invention, determining a location of the tracked invasive surgical tool along the Z axis in a direction towards the anatomy where the invasive surgical tool is located may be assisted by transforming the X′, Y′ coordinates of the tracked tool onto a 3D model of the anatomy being treated. Such a computerized three dimensional (3D) model of e.g. the epidural space may be reconstructed from data obtained from e.g. CT or NMI examination of the patient (or the like).

[0113] Once mapping and aligning the X′, Y′ coordinates of the detected invasive tool onto a reconstructed 3D model of the treated anatomy; a surgeon may be provided with suggestions/options along axis Z where the tracked tool may be present. In FIG. 10, such suggestions/options are marked by numeral 77 here as possible locations of the surgical tool, either within an anterior spacing between e.g. a vertebral body and the thecal sac—or e.g. within a posterior spacing between e.g. ligamentum flavum and the thecal sac.

[0114] Since the surgeon is aware of the route along which he chose to advance the surgical tool along the spinal canal, i.e. a route anterior or posterior to the thecal sac—the correct location along the Z axis may be confirmed.

[0115] When using a tracking device 50 with an embodiment of the a surgical tool according to the present invention, the object being tracked may optionally be shield 1211 that may of or arranged to include magnetic material that can be picked up by the magnetic sensors 5 of array 55. It is noted however that other and/or additional elements of a surgical tool according to an embodiment of the present invention may be designed to be made of or include magnetic material in order to be detected by tracking device 50.

[0116] In the description and claims of the present application, each of the verbs, “comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.

[0117] Further more, while the present application or technology has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and non-restrictive; the technology is thus not limited to the disclosed embodiments. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed technology, from a study of the drawings, the technology; and the appended claims.

[0118] In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures can not be used to advantage.

[0119] The present technology is also understood to encompass the exact terms, features, numerical values or ranges etc., if in here such terms, features, numerical values or ranges etc. are referred to in connection with terms such as “about, ca., substantially, generally, at least” etc. In other words, “about 3” shall also comprise “3” or “substantially perpendicular” shall also comprise “perpendicular”. Any reference signs in the claims should not be considered as limiting the scope.

[0120] Although the present embodiments have been described to a certain degree of particularity; it should be understood that various alterations and modifications could be made without departing from the scope of the invention as hereinafter claimed.