Insertion of medical devices through non-orthogonal and orthogonal trajectories within the cranium and methods of using

• US 9,179,875 B2
• Filed: 12/21/2010
• Issued: 11/10/2015
• Est. Priority Date: 12/21/2009
• Status: Active Grant

• Current Assignee: Sherwin Hua
• Original Assignee: Sherwin Hua
• Inventors: Hua, Sherwin
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): PIATESKI, ERIN M
• Application Number:
  US13/318,462
• Publication Number:
  US 20120046531A1
• Time in Patent Office: 1,785 Days
• Field of Search: 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1695 Trepans or craniotomes, i.e. specially adapted for drilling thin bones such as the skull
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6865 Access ports
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

The invention comprises an elongated device adapted for insertion, including self-insertion, through the body, especially the skull. The device has at least one effector or sensor and is configured to permit implantation of multiple functional components through a single entry site into the skull by directing the components at different angles. The device may be used to provide electrical, magnetic, and other stimulation therapy to a patient'"'"'s brain. The lengths of the effectors, sensors, and other components may completely traverse skull thickness (at a diagonal angle) to barely protrude through to the brain'"'"'s cortex. The components may directly contact the brain'"'"'s cortex, but from there their signals can be directed to targets deeper within the brain. Effector lengths are directly proportional to their battery size and ability to store charge. Therefore, longer angled electrode effectors not limited by skull thickness permit longer-lasting batteries which expand treatment options.

Claims

1. A device configured to create an effect on or gather data about a target site in a patient'"'"'s brain, comprising:

two or more shafts configured to be inserted through skin, muscle, tissue, bone, or skull at an entry site; and

at least one component, including an effector or a sensor, associated with each of said two or more shafts, each of said at least one component coupled to its associated shaft by one or more of;

being housed within, passing through, or being attached to each of said two or more shafts;

wherein the effectors are configured to communicate with one another either wirelessly or with a physical connector;

wherein each of said two or more shafts and its associated component are configured to be inserted at an angle, between and inclusive of parallel to a tangent of a surface at the entry site and perpendicular to a tangent of a surface at the entry site;

wherein each of said two or more shafts is configured to be inserted at the entry site at different trajectories from all other shafts;

wherein each of said two or more shafts is configured such that, when fully inserted along a trajectory, a proximal end of the shaft passes through the entry site, thereby allowing for another shaft to be inserted at a different trajectory through the entry site;

wherein the diameter of the entry site is less than the combined diameter of at least two of the effector shafts;

wherein a length of each shaft and its associated component is independent of other shafts and their associated components and is not limited to the thickness of the skin, muscle, tissue, bone, or skull at the entry site;

wherein the length of each shaft is selected such that, when fully inserted along the trajectory, the shaft does not pass into the patient'"'"'s brain and the length of at least one of the two or more shafts is greater than the thickness of the skull at the entry site; and

wherein the distal and proximal ends of the device are configured to be fully contained within the body when the device creates an effect on or gathers data about a target site in the patient'"'"'s brain.

2. The device of claim 1, wherein the components, including the effector or the sensor, are selected from the group consisting of:

a battery, an electrode, a recharger, a transmitter, a receiver, a transceiver, a sensor, a recorder, a capacitor, a transformer, a system control unit, a programmer, an address/positioning unit, a temperature sensor, a temperature adjuster, a thermogenerator, a thermoelectric generator, a mechanical power generator, a photo/light generator, an ultraviolet light generator, an infrared generator, an optical stimulator, a laser, a radiofrequency generator, a magnetic field generator, a mechanical vibration generator, an ultrasonic wave generator, an electrical field generator, a radiation generator, a fuel cell, a drug delivery unit, a gene therapy delivery unit, a reservoir for drugs and radioactive substances, and a reservoir for substances released into a body.

3. The device of claim 1, wherein each shaft is configured to be inserted through skin, tissue, or bone when a pre-made hole is not present, the shaft being self-drilling and/or self-tapping.

4. The device of claim 1, wherein the effector or the sensor communicates with the target site such that effects of the effector extend to the patient'"'"'s brain, or stimuli that activate the sensor are derived from the patient'"'"'s brain.

5. The device of claim 1, wherein the bone is a skull and a combined length, minus any overlap, of the shaft and its components, including effectors and/or sensors, results in a part of the device or its components, including effectors or sensors, being placed:

(i) superficial to the skull within skin, fat tissue, connective tissue, ligament, tendon, mucosa, or muscle,

(ii) within bone or skull or

(iii) epidurally (upon dura mater).

6. The device of claim 5, wherein the components, including effectors and/or sensors, are located on or are composed of a rigid, semi-rigid, or flexible housing that travels through the shaft;

wherein the housing is a metal, a plastic, a polymer, a mesh, a fabric, or a woven material, and

wherein the shaft and/or one or more components, on or within the flexible housing traveling through the shaft, is guided to the target location by one of the following or a combination of the following mechanisms;

i) mechanical steering of the housing such as an inner stylet that is steerable by having a bendable tip or that has a bend in a tip that is steerable by rotating, advancing, or withdrawing the housing and stylet;

ii) magnetic steering of the housing wherein a ferromagnetic, or electromagnetic tip of the housing or the tip of a removable stylet within the housing is guided, steered, or moved by a magnetic field induced by a magnetic or electromagnetic mechanism either inside or outside the body;

iii) stereotactic guidance to the target where stereotactic localization is based on one or a combination of the following techniques;

Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), Magnetic Resonance Spectroscopy (MRS), diffusion MRI (DWI), diffusion tensor MRI (DTI), electroencephalography (EEG), magnetoencephalography (MEG), nuclear neuroimaging, positron emission tomography (PET), single photon emission computed tomography (SPECT), Ictal-Interictal SPECT Analysis by Statistical Parametric Mapping (ISAS), Computed Tomography (CT), x-ray, fluoroscopy, angiography, ultrasonography, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial electrical stimulation (TES), motor evoked potential (MEP), somatosensory evoked potential (SSEP), phase reversal of somatosensory evoked potential, evoked potential, electrocorticography (ECoG), direct cortical electrical stimulation (DCES), microelectrode recording (MER), and local field potential recording (LFP);

iv) endoscopic visualization and guidance.

7. The device of claim 1, further comprising a head unit attached to or associated with an end of the first shaft,

wherein the head unit comprises one or more docking stations, each configured to receive at least one additional component or shaft housing the component;

wherein the docking station has one or more holes or couplings therein, through which one or more component(s) or shaft(s) housing these components is (are) inserted through, attached to, coupled with, or connected with the head unit;

wherein the docking stations are radially spaced around the head unit, in order that several components or shafts housing these components may be inserted at a single common entry site through the same head unit and directed perpendicularly downward, radially outward, or radially inward at different angles around the head unit.

8. The device of claim 7, wherein the head unit is a connector between multiple implanted components, shafts housing these components, or devices, and

wherein the head unit allows direct electrical contact between one or more additional component(s), or shaft(s) housing these components, and the first shaft of the device inserted through a common entry site, thereby allowing direct communication, connection, or power transfer between the additional component(s) or shaft(s) and the first shaft.

9. The device of claim 1, wherein said effect comprises one or more of the following:

electrical stimulation or electrical disruption of the target site;

mechanical stimulation or mechanical disruption of the target site;

changing temperature at the target site;

inducing a magnetic field at the target site;

photostimulation or photoinhibition of the target site, including photomodulation and use of laser to stimulate or inhibit a process at the target site;

ultrasonic stimulation or ultrasonic disruption of the target site;

inducing a vibration that is transmitted to the target site, including a sonic vibration that is transmitted to and activates auditory receptors;

creating and modulating an electrical field for ionophoresis or iontophoresis at the target site;

and irradiating the target site.

10. The device of claim 1, wherein said device is configured to gathers data by one or more of the following:

monitoring signals of single neurons and of populations of neurons;

monitoring intracranial pressure;

monitoring physiologic signals;

monitoring metabolic activity and other signals of tissues including neurons, glial cells, blood cells, immune cells, and other cells;

monitoring signals derived from cellular and sub-cellular components including proteins, DNA, RNA, molecules, neurotransmitters, hormones, and mitochondria;

measurement of components, states of components, or physical properties in a body including electrolytes, proteins, hormones, amino acids, molecules, carbohydrates, minerals, fatty acids, osmolarity, osmolality, pharmaceuticals, radioactive tracers, light, electromagnetic energy, fluorescence, radiation, and other measureable items;

monitoring optical, fluorescent, ultraviolet, infrared, and/or birefringence signals, and/or changes therein, emitted from tissues including neurons, glial cells, blood cells, other cells, blood and cerebral spinal fluid; and

/or

monitoring temperature of tissue and changes thereof.

11. The device of claim 1, wherein each said shaft has one or more of the following properties:

is straight;

is curved;

is curved to follow a contour curvature of bone or skull;

is curved in a spiral that skewers into the body or skull through the entry site;

can change shape during an insertion process as it is inserted;

is rigid;

is at least partially flexible;

changes between rigid and flexible states;

has a sharp tip;

has a blunt tip;

has a tip that is not sharp enough to puncture cortical bone;

has an atraumatic curved tip that can be easily inserted into a premade entry site;

is threaded and configured to be screwed into position;

is made of a selectively permeable material that differentially absorbs, transmits, repels, and elutes different molecules;

is made of a selectively permeable material that comprises cells embedded therein; and

/or

is made of a selectively permeable material that is a nanoporous mesh.

12. The device of claim 1, having at least one effector, wherein the effector is encased within a protective housing and capable of stimulating tissue by transmitting energy through the housing.

13. The device of claim 1, having at least one effector or sensor, wherein the effector or sensor protrudes out of an end of a shaft or is located on a surface of a shaft.

14. A method of providing electrical stimulation therapy to a patient'"'"'s brain using the device of claim 1, having at least one electrode, comprising:

implanting the device in the skull and generating a pulse from the electrode;

wherein an insertion angle of the device is related to device length such that when the device is fully inserted the length traverses entirely through the skull but does not penetrate into the brain.

15. A method of providing electrical stimulation therapy to the body using the device of claim 1, having at least one electrode, comprising:

implanting the device in the body and generating a pulse from the electrode(s);

wherein the insertion angle (θ

) is related to device length (l) such that;

sin θ

=x/l

wherein θ

is measured from an axial line perpendicular to a skin'"'"'s surface at the entry site; and

x is lateral displacement in a direction parallel to the skin'"'"'s surface at the entry site when the device is fully inserted.

16. A method of implanting the device of claim 1, having one or more additional shaft(s) housing additional components, comprising:

(i) inserting a head unit, with or without a shaft, perpendicularly to a skin'"'"'s surface;

(ii) inserting another shaft housing additional components through the head unit at any first angle between parallel and perpendicular to the skin'"'"'s surface and at any second radial angle around the head unit;

(iii) inserting one or more additional shafts, each shaft housing additional components, through the head unit, at any first angle between parallel and perpendicular to the skin'"'"'s surface and at any second radial angle around the head unit, wherein either the first angles or the second angles or both for any two shafts are different, such that each shaft occupies a unique position with respect to the other shafts.

17. A method of providing electrical stimulation therapy to a living body using the device of claim 1, having at least one electrode, comprising:

implanting the device in the body; and

generating one or more pulses from the electrode(s);

in order to provide therapy to a patient for treatment of a condition selected from the group consisting of;

epilepsy, stroke, movement disorders, Parkinson'"'"'s Disease, tremor, multiple sclerosis, dystonia, tics, Tourette'"'"'s Syndrome, stuttering, depression, pain, headache, migraine headache, trigeminal neuralgia, facial pain, insomnia, narcolepsy, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), autism, obesity, paralysis, blindness, deafness, benign tumors of brain and body, malignant tumors of brain and body, neurodegenerative disorders, alopecia, dementia, altered consciousness states, psychiatric disorders (including obsessive compulsive disease, bipolar depression, anxiety, schizophrenia, neuroses, and psychoses), criminal behavior, sexual dysfunction, erectile dysfunction, and addictions related to brain activity including addictions to the following;

drugs (including narcotics, pain medications, sedatives, stimulants), illicit drugs (including cocaine, marijuana, heroin, methamphetamine), prescription drugs, muscle relaxants, tobacco (smoking), alcohol, food, sex, pornography, pedophilia, gambling, thrill seeking, television, video games, and the internet.

18. A method of enabling communication between two or more entities, at least one entity being a living organism, comprising:

implanting the device of claim 1, in a first entity, said first entity being part of a living organism.

19. The method of claim 18, wherein the communication includes the following forms:

electromagnetic, acoustic, ultrasonic, and forms comprising frequencies outside a range of human hearing.

20. The method of claim 18, the device further comprising at least one component, such as a receiver or transceiver, and further comprising:

the receiver or transceiver receiving input from at least one other entity;

wherein said receiving input includes, but is not limited to, indirectly receiving input through one or more intermediary devices that relays, modulates, and/or processes one or more signals between the entities.

21. The method of claim 20, wherein the other entity is a radio, radio transmitter, musical player, cell phone, personal digital assistant, computer, or internet.

22. The method of claim 18, the device further comprising at least one component adapted to transmit, communicate, or broadcast, such as a transmitter or transceiver, and further comprising:

the transmitter or transceiver transmitting, communicating, or broadcasting information to at least one other entity;

wherein said transmitting, communicating, or broadcasting includes, but is not limited to, transmitting, communicating, or broadcasting through one or more intermediary devices that relays, modulates, and/or processes one or more signals between the entities.

23. The method of claim 18, the device further comprising at least one component adapted to receive, such as a receiver or transceiver, and/or at least one component adapted to transmit, such as a transmitter or transceiver, and further comprising:

implanting at least one additional component or identifying a receiver capability in a second entity;

gathering data or signals in the first entity with a sensor of the device;

transmitting these data or signals to the second entity; and

receiving these data or signals from the first entity in the second entity through the additional component or through an already present receiver capability in the second entity.

24. The method of claim 23, further comprising:

a second entity communicating or responding to the first entity by transmitting data/signals to the first entity, resulting in the effector of a device in the first entity generating a signal in the first entity, including when the device in the first entity that receives the data/signals from the second entity is a different device in a different location than the device in the first entity that transmits data or signals to the second entity, wherein this form of communication between two or more entities is two-way, recurrent, reciprocal, or closed-loop communication.

25. The method of claim 24, the device in the first entity further comprising at least one feedback component, and further comprising:

upon the first entity transmitting data or signals to the second entity;

the second entity verifying receipt of the data or signals transmission by sending a response, feedback, or verification signal to the first entity and thereby facilitating closed loop communication between two or more entities.

26. The method of claim 25, wherein the verification step, involving the second entity

sending a feedback signal to the first entity, is contingent on an effect in the second entity, such as generation or induction of a specific signal/response or completion of a desired task.

27. The method of claim 18, further comprising:

gathering data by a sensor on the device in the first entity; and

communicating the data to one or more second entities;

wherein the data relates to neuronal activity or physiological parameters.

28. The method of claim 23, further comprising:

initiating the transmission, from the first entity to the second entity, through a signal in the first entity;

wherein the signal is induced by;

activation of an effector of a device, electrode stimulation, vibrations, alterations in temperature/pressure/light, patterns of neural activity, and/or changes in cellular activity.

29. The method of claim 23, further comprising:

at least one component in the second entity recognizing specific signals as being from certain other entities.

30. The method of claim 23, further comprising:

at least one component in the second entity interpreting specific signals as indicating certain conditions.

31. The method of claim 23, wherein the second entity is a different part of the same living organism of which the first entity is a part.

32. The method of claim 18, wherein a second entity involved in the communication is also a living organism.

33. The method of claim 18, wherein a second entity involved in the communication is a machine.

34. The method of claim 33, wherein the machine is selected from the group consisting of one or more of the following:

a computer, a cell phone, a phone, a personal digital assistant, a muscle stimulator, a wheelchair, a motorized vehicle, a robot, and an electronic circuit.

35. A method of providing electrical stimulation therapy using at least two of the devices of claim 1, each device having at least one electrode as the effector, comprising:

implanting a first device through the skull at a first entry site;

implanting a second device through the skull at a second entry site;

generating a pulse from at least one electrode on the first device; and

generating a pulse from at least one electrode on the second device;

wherein the target site is in a brain of a patient between a center of the brain and the skull, and an orientation of at least one electrode on the first device and at least one electrode on the second device are selected so that at least one electrode from each device is directed at the target site.

36. The device of claim 1, wherein at least one of the components is disposed on or comprises a semi-rigid or flexible housing configured to travel through the shaft and slide within an epidural or subdural space.

37. The device of claim 36, wherein the housing is configured to be guided to the target location via mechanical steering, magnetic steering via a ferromagnetic or electromagnetic tip of the housing, stereotactic guidance, or endoscopic visualization and guidance.

38. The device of claim 1, wherein at least one of the shafts is semi-flexible and configured to slide within the cancellous space of the skull.

39. The device of claim 1, wherein each of the two or more shafts is configured to be directly embedded within and in contact with the skull.

40. The device of claim 39, wherein the two or more shafts are configured to be inserted at divergent angles from the entry site within the skull.

41. The device of claim 39, wherein a diameter of each of the two or more shafts is less than the thickness of the skull.

42. The device of claim 39, wherein a diameter of each of the two or more shafts is less than 5 mm.

43. The device of claim 1, wherein an area of the target site is greater than an area of the entry site.