Magnetic targeting system and method of using the same
RE046282 ยท 2017-01-24
Assignee
Inventors
Cpc classification
A61B17/7083
HUMAN NECESSITIES
A61B2017/00199
HUMAN NECESSITIES
A61B34/70
HUMAN NECESSITIES
A61B17/7088
HUMAN NECESSITIES
A61B17/7032
HUMAN NECESSITIES
A61B17/7085
HUMAN NECESSITIES
International classification
A61B17/70
HUMAN NECESSITIES
Abstract
The present invention describes a magnetic targeting system suitable for guiding a biocompatible device to a target area within the body (in vivo) and method of using the same. The system includes a targeting member having a steering material and is attached to the biocompatible device. The system also includes at least one anchoring member constructed and arranged for the inclusion of a magnetic material effective for influencing the traversal of the steering material, in vivo. The magnetically influenced anchoring member interacts with the targeting member such that the biocompatible device is positionable relative to the target area.
Claims
.[.1. A method for facilitating navigation to a target area in vivo, comprising: providing a targeting member having a first end and a second end, said second end attached to a biocompatible device by a tether, wherein said first end includes a steering material influenced by a magnetic field; attaching to said target area in vivo at least two anchoring members, each said anchoring member having a proximal end and a distal end, wherein each said anchoring member is attached to said target area at its distal end; an extender coupled to each said anchoring member, said extender having an open top at said proximal end and an aperture juxtaposed to a bottom of said extender at said distal end; introducing a magnetic material into said proximal end of said anchoring member capable of influencing the traversal of said steering material, thereby positioning said biocompatible device relative to said target area; said targeting member is of a size which enables said targeting member to pass into said extender through said top of said extender, through said extender and out of said extender through said aperture of said extender, said targeting member is also of a size which enables said targeting member to pass into said extender through said aperture, through said extender and out of said extender through said open top; passing said targeting member through said open top of first extender, through said first extender and out of said first extender through said aperture of said first extender, also passing said targeting member into second extender through said aperture, through said second extender and out of said second extender through said open top of said second extender..].
.[.2. The method as set forth in claim 1, wherein said system includes a real-time feedback mechanism to verify location in vivo of said biocompatible device..].
.[.3. The method as set forth in claim 2, wherein said real-time feedback mechanism includes tactile feedback to verify location in vivo of said biocompatible device..].
.[.4. The method as set forth in claim 1, wherein said magnetic material is an electromagnet..].
.[.5. The method as set forth in claim 1, wherein said magnetic material is a permanent magnet..].
.[.6. The method as set forth in claim 1 wherein said biocompatible device is an implant or surgical instrument..].
.[.7. The method as set forth in claim 1 wherein said biocompatible device is formed from a material selected from the group consisting of rigid, semi-rigid, or flexible..].
.[.8. The method as set forth in claim 1, wherein said anchor member is a fastening means for attaching to a bony structure and said biocompatible device is an interconnecting means..].
.[.9. The method as set forth in claim 1, wherein said targeting member is formed from a material selected from the group consisting of rigid, semi-rigid, or flexible..].
.Iadd.10. A method for facilitating navigation of a biocompatible device to a target position connecting anchoring members secured in vivo, comprising: securing first and second anchor members to a body structure located in vivo, said first and second anchoring members each having a distal end configured to secure to a body structure located in vivo and a proximal end including a connector with a transverse passage configured to receive a portion of a biocompatible device, the biocompatible device being lockable to the first and second anchoring member connectors with locking members that engage the connectors, the first connector releasably coupled to a first extender and the second connector releasably coupled to a second extender, each of said first extender and said second extender having an interior passage that extends along the length of the extender between a proximal end opening and a distal end opening, the interior passage sized to receive a locking members therethrough and a driver associated with the locking members, each of the first extender and second extender also having an aperture in connection with the distal end opening and extending transversely through the interior passage, and a slot in connection with the aperture and extending towards the proximal end along a length of the extender; advancing a targeting member to a first position proximate the aperture of the first extender, the targeting member having a first end and a second end, said second end attached to the biocompatible device by a tether and said first end including a steering material configured to be influenced by a magnetic field; positioning the distal end of a magnetic device in a second position proximate the aperture of the second extender, the distal end of the magnetic device including a magnetic material configured to influence the steering material of the targeting member, and influencing the targeting member to move from the first position to the second position thereby creating a pathway through the tissue between the first connector and the second connector; withdrawing the targeting member along the second extender to pull the attached biocompatible device along the pathway into the target position connecting the first and second anchor members; and advancing a first locking member through the interior passage of the first extender and advancing a second locking member through the interior passage of the second extender to lock the biocompatible member to the first and second anchoring members..Iaddend.
.Iadd.11. The method of claim 10, wherein said magnetic material is an electromagnet and including the additional step of turning on the electromagnet after the distal end of the magnetic device is situated in the second position..Iaddend.
.Iadd.12. The method of claim 11, wherein the magnetic device includes a handle at a proximal end and the handle includes a switch for turning on the electromagnet..Iaddend.
.Iadd.13. The method of claim 12, wherein the handle also includes controls for increasing and decreasing the strength of the electromagnet..Iaddend.
.Iadd.14. The method of claim 10, wherein the magnetic material is a permanent magnet..Iaddend.
.Iadd.15. The method of claim 10, wherein the targeting member is semi-rigid with a portion of the targeting member proximate the first end being made of flexible material..Iaddend.
.Iadd.16. The method of claim 10, wherein the targeting member is rigid..Iaddend.
.Iadd.17. The method of claim 10, wherein the first and second anchoring members are pedicle screws and the step of securing the first and second anchor members to a body structure located in vivo include securing the first pedicle screw to a first vertebra of the spine and securing the second pedicle screw to a second vertebra of the spine..Iaddend.
.Iadd.18. The method of claim 17, wherein the first and second pedicle screws are multi-axis pedicle screws..Iaddend.
.Iadd.19. A method for facilitating navigation of a biocompatible device to a target position connecting anchoring members secured in vivo, comprising: securing anchor members to a body structure located in vivo, said anchor members including a first end anchor member, a second end anchor member, and a middle anchor member said first end, second end, and middle anchor members each having a having a proximal end including a connector with a transverse passage configured to receive a portion of a biocompatible device, the biocompatible device being lockable to the first end, second end, and middle anchor member connectors with locking members that engage the connectors, the first connector releasably coupled to a first extender, the second connector releasably coupled to a second extender, and the middle connector releasably coupled to a middle extender, each of said first extender, second extender and said middle extender having an interior passage that extends along the length of the extender between a proximal end opening and a distal end opening, the interior passage sized to receive locking members therethrough and a driver associated with the locking members, each of the first extender, second extender, and middle extender also having an aperture in connection with the distal end opening and extending transversely through the interior passage, and a slot in connection with the aperture and extending towards the proximal end along a length of the extender; advancing a targeting member to a first position proximate the aperture of the first extender, the targeting member having a first end and a second end, said second end attached to the biocompatible device by a tether and said first end including a steering material configured to be influenced by a magnetic field; positioning the distal end of a magnetic device in a second position proximate the aperture of the middle extender, the distal end of the magnetic device including a magnetic material configured to influence the steering material of the targeting member, and influencing the targeting member to move from the first position to the second position thereby creating a pathway through the tissue between the first connector and the middle connector; positioning the distal end of the magnetic device in a third position proximate the aperture of the second extender and influencing the targeting member to move from the second position to the third position thereby extending the pathway through tissue to the second connector; withdrawing the targeting member along the second extender to pull the attached biocompatible device along the pathway into the target position connecting the first end, second end, and middle anchor members; and advancing locking members through the interior passages of each of the first extender, second extender, and middle extender to lock the biocompatible member to the first end, second end, and middle anchor members..Iaddend.
.Iadd.20. The method of claim 19, further comprising multiple middle anchor members secured between the first end anchor member and the second end anchor member, each including a releasably coupled middle extender and wherein the magnetic device is used through each additional middle extender in sequence to move the targeting member to the coupled middle connector from the previous middle connector..Iaddend.
Description
BRIEF DESCRIPTION OF THE FIGURES
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DETAILED DESCRIPTION OF THE INVENTION
(10) Detailed embodiments of the instant invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific functional and structural details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representation basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.
(11) Referring now to
(12) The screw shown here is a multi-axial screw where the proximal end of the screw may include a connector 28 rotatably connected to the head portion 24 of the screw. That is, the connector is capable of 360 degree rotation relative to the threaded shank 27 of the screw along the axis L of the shank and angular motion defined by the angle (
(13) As shown in
(14) As discussed above, the distal end 34 of each of the hollow extenders 12a, 12b, 12c are removably attached to the screws by any appropriate means known in the art. For example, the extender may include a depressible member (not shown) located at the proximal end 33 of the extender that is operatively connected to an internal clamping member located that the distal thereof. The clamping member is capable of engaging and disengaging the connector portion of the screw. One example of a suitable extender which could be used in the present invention is disclosed in U.S. Pat. No. 7,011,660, herein incorporated by reference. The extender may also be able to rotate the connector of a multi-axial screw relative to the shank to facilitate the threading of the interconnecting rod therethrough.
(15) The extenders should be made of a substantially rigid biocompatible material and have a length dimension (along its longitudinal axis 50) that allows the proximal end 33 to protrude a distance outside of the percutaneous exposure 22 created through the outer skin S of the patient. According to a preferred embodiment, at least the first extender should have a c-shape, as seen along an axis transverse its longitudinal axis, thereby defining a slot 63 that extends along its longitudinal axis 50 and into the patient when attached to the screw. The slot should be sized to allow the targeting member to exit, so that it is able to be delivered percutaneously, as shown in
(16) Referring again to
(17) As shown in non-limiting embodiments of
(18) The tethering means 42 may be made of any flexible or semi-flexible biocompatible material capable of allowing the device to navigate around neural and bony obstructions without damaging them. Examples of suitable tethering means may be in the form of a cable, cord or ligament. Moreover, the tethering means may be formed of a cannulated or solid member. As discussed above, the first end 92 of the tethering means is attached to the second end 54 of the targeting member by any means of attachment known in the art. Similarly, the second end 94 of the tethering means is attached to the biocompatible device 44 by any means of removable connection known in the art. For example, the biocompatible device and tethering means could include corresponding threads that the surgeon can rotate to disconnect the tethering means from the biocompatible device.
(19) According to a preferred embodiment, the biocompatible device is shown as an implantable interconnecting rod. The rod may be rigid, semi-rigid or flexible. Rigid rods are usually preferred for providing the necessary stability during the healing process and arthrodesis, however, flexible rods have been found to provide for arthrodesis while allowing some movement between bony structures that have been interconnected to preserve some motion. Moreover, like the tethering means the biocompatible device may also be solid or cannulated.
(20) Although the interconnecting rod is shown in
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(22) As shown in
(23) The magnetic material 62 as used herein refers to either a permanent magnet (as shown in
(24) The steering material in the target member, as used herein, refers to any material capable of being influenced by the magnetic material 62. For example, the steering material may include any magnetically attractive material or alloy, (e.g. steel, iron, etc). The steering material may be the same or different than that used for magnetic material 62 so long as it is capable of being influenced, e.g., attracted or repelled. Moreover, either or both the magnetic material and the steering material may be coated with any suitable biocompatible element, such as plastic. The type, shape, and size of the magnetic material and steering material should be suitable for internal use in patients and provide the optimal magnetic field. Magnetic fields are used herein for navigating in vivo since these fields can penetrate human tissue and bone without being distorted similar to x-rays, but without the danger of radiation and physiologic damage.
(25) According to a preferred embodiment shown in
(26) The method of using the magnetic targeting system 10 of the present invention is described in accordance with the embodiment depicted in
(27) As a result of the attractive magnetic field, the steering material in the targeting member is pulled through the extender slot 63. The strength of the magnetic field generated by the magnetic material should be capable of pulling the targeting member (including attached tethering mean) toward the magnetic member such that the pointed first end penetrates the tissue and creates a pathway through the tissues as the targeting member is advanced toward the magnetic material. The use of the magnetic field to guide the targeting member, as compared to forcibly pushing the targeting member, as disclosed in the prior art, reduces the probability of damaging neural structures or breaking bony obstructions encountered along its path.
(28) Once the targeting member has reached the magnetic material 62 positioned inside the connector portion of the screw, the surgeon removes it from the anchoring member and places it into the next anchoring member (extender and screw), shown here as 12c attached to vertebra V3. The aforementioned procedure is then repeated inside anchoring member 12c. If an electromagnet is used, the electricity along the magnetic member is turned on and the strength of the magnetic field generated pulls the targeting member through the passageway 30 of the screw secured to V2 and toward the magnetic member located inside the screw secured to V3, see
(29) As described before, the pointed first end of the target member penetrates the tissue and creates a pathway through the tissues as it moves toward the magnetic material. This technique of threading through the screw does not require the surgeon to try to align multiple pedicle screws along the fixed path of the rod. Moreover, the continuous magnetic attraction of the targeting member toward the pedicle screw reduces the possibility that the target member will be diverted by structures in the anatomical topography that may cause it to penetrate unintended areas. In addition, the present invention allows the surgeon to avoid a given anchor member. In such a circumstance the surgeon can insert the magnetic material into that extender connected to the anchor member that is to be avoided. The magnetic material maybe either a permanent magnet or electromagnet having the same polarity as that of the targeting member. This will repel the steering material of the target member from that target area.
(30) Once the final vertebra is reached, the magnetic member is used to pull the targeting member through the slot in the upper opening 43 of the pedicle screw and along the interior length of the extender until it reaches the proximal end protruding out of the incision. The surgeon can then grasp the targeting member and attached tethering means, see
(31) If the tethering means and interconnecting rod are hollow, the user can disconnect the targeting member and releasably attach an injection means 96 thereto. The injecting means can be used into supply any suitable any flowable, biocompatible material inside the rod. One example of a suitable biocompatible material includes at least one a hardening material that will cause the rod to become rigid.
(32) Otherwise, the rod might be filled prior to the introduction of a hardening material. For example, the rod might contain ferroelectric material that allows the rod to remain flexible during insertion process until exposed to an electric current. This is particularly suitable if used in conjunction with the electromagnet embodiment previously described. Once the flexible rod is positioned at the final desired location (secured to pedicle screws), the rod may then be exposed to electric current in the electromagnet by inserting the magnetic means into the extenders. The electric current causes the ferroelectric material to harden to make a substantially rigid rod. Thus, the contour of the rod corresponds to the natural curvature of the surrounding anatomy.
(33) As discussed above, the connector portion of the screw is constructed and arranged to receive a set screw 32 therein. The set screw is inserted into each of the extenders and threadably attached by the driving tool (not shown) positioned in the extender and inserted in tool opening in the screw. The interconnecting rod 44 is sandwiched between the upper portion of the head and the set screw. This acts to secure the rod onto the screws. The extenders are then removed from the connector portion of the screw and the exposures closed.
(34) Referring to an alternative embodiment shown in
(35) Any of the aforementioned embodiments of the system and techniques of the present invention can employ any type of known imaging system to determine and locate placement of any of the aforementioned structures in vivo. For example, insertion of the anchor member into the bony structure can be pre-planned by CT scan, x-ray, or the imaging means known in the art.
(36) The present system may also include a feedback system having at least one detection element 120 (two are shown in
(37) Although the invention is described with reference to stabilization and fusion of adjacent spinal vertebrae, it is hereby contemplated that devices and methods disclosed herein could be used in all types of joints (ankle, interdigital, etc) found in the human or animal body. Although a rod-like member is exemplified herein, other such biocompatible devices known to one skilled in the art are also contemplated, for example, plates, clamps, etc.
(38) All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.
(39) It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.
(40) One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.