Coded-sequence activation of surgical implants
Implants responsive to spatiotemporal signal sequences, and methods of operating implants by transmitting spatiotemporal signal sequences.
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The present application is related to and claims the benefit of the earliest available effective filing date(s) from the following listed application(s) (the “Related Applications”) (e.g., claims earliest available priority dates for other than provisional patent applications or claims benefits under 35 USC § 119(e) for provisional patent applications, for any and all parent, grandparent, great-grandparent, etc. applications of the Related Application(s)).
RELATED APPLICATIONS
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- For purposes of the USPTO extra-statutory requirements, the present application constitutes a continuation-in-part of U.S. patent application Ser. No. [To Be Assigned by USPTO], entitled CODED-SEQUENCE ACTIVATION OF SURGICAL IMPLANTS, attorney docket no. 0606-002-002B-000000, naming Edward S. Boyden, Roderick A. Hyde, Muriel Y. Ishikawa, Eric C. Leuthardt, Nathan P. Myhrvold, Dennis J. Rivet, Michael A. Smith, Thomas A. Weaver, and Lowell L. Wood, Jr. as inventors, filed 22 Feb. 2007, which is currently co-pending, or is an application of which a currently co-pending application is entitled to the benefit of the filing date.
The United States Patent Office (USPTO) has published a notice to the effect that the USPTO's computer programs require that patent applicants reference both a serial number and indicate whether an application is a continuation or continuation-in-part. Stephen G. Kunin, Benefit of Prior-Filed Application, USPTO Official Gazette Mar. 18, 2003, available at http://www.uspto.gov/web/offices/com/sol/og/2003/week11/patbene.htm. The present Applicant Entity (hereinafter “Applicant”) has provided above a specific reference to the application(s) from which priority is being claimed as recited by statute. Applicant understands that the statute is unambiguous in its specific reference language and does not require either a serial number or any characterization, such as “continuation” or “continuation-in-part,” for claiming priority to U.S. patent applications. Notwithstanding the foregoing, Applicant understands that the USPTO's computer programs have certain data entry requirements, and hence Applicant is designating the present application as a continuation-in-part of its parent applications as set forth above, but expressly points out that such designations are not to be construed in any way as any type of commentary and/or admission as to whether or not the present application contains any new matter in addition to the matter of its parent application(s).
All subject matter of the Related Applications and of any and all parent, grandparent, great-grandparent, etc. applications of the Related Applications is incorporated herein by reference to the extent such subject matter is not inconsistent herewith.
SUMMARYIn one aspect, a device for implantation in a body includes a receiver responsive to a selected spatiotemporal signal sequence to produce an activation signal and a member responsive to the activation signal to shift from a first mechanical configuration to a second mechanical configuration. The selected spatiotemporal signal sequence may include spatially separated and/or temporally separated signals, which may include, for example, magnetic fields, electric fields, acoustic signals, electromagnetic signals, and/or optical signals. The member may be configured to engage one or more vertebrae (e.g., a spinal screw), and the second mechanical configuration may provide more or less stress shielding to the vertebrae than the first mechanical configuration. The member may be configured to engage a bony structure (e.g., a tooth), and the second mechanical configuration may provide more or less stress shielding to the bony structure than the first mechanical configuration. The member may include a tissue expander, an intralumenal device (e.g., a stent such as an expandable stent, or a lumen-traversing device including a physiological sensor such as a gastrointestinal camera), a shunt (e.g., a cerebrospinal fluid shunt or a vascular conduit), a drug reservoir (e.g., a reservoir that is configured to dispense a drug by shifting from the first to the second mechanical configuration), an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, or a cosmetic implant (e.g., a lip, breast, pectoral, or deltoid augment). The member may be configured to accommodate growth of the body.
In another aspect, a device for providing a coded signal to an implant in a body includes a plurality of signaling units having a selected spatial arrangement. The signaling units are arranged to deliver a spatiotemporal signal sequence corresponding to the coded signal. The spatiotemporal signal sequence may include spatially separated and/or temporally separated signals, which may include, for example, magnetic fields, electric fields, acoustic signals, electromagnetic signals, and/or optical signals, and may include at least two different signal modes. The device may be configured to conform to a surface of the body, and/or may be configured to be secured to the body. The device may further include a receiving unit that is configured to receive a signal from the implant, such as a receiver that can receive a signal selected from the group consisting of magnetic fields, electric fields, acoustic signals, electromagnetic signals, and/or optical signals.
In yet another aspect, a method of treating a patient having a surgical implant of a type responsive to a spatiotemporal signal sequence to change from a first mechanical configuration to a second mechanical configuration includes directing a series of signals corresponding to the spatiotemporal sequence into the patient's body. The series of signals may include spatially separated and/or temporally separated signals, which may include, for example, magnetic fields, electric fields, acoustic signals, electromagnetic signals, and/or optical signals. The patient may have a plurality of surgical implants, and fewer than all of the implants (e.g., one implant) may be responsive to the spatiotemporal signal sequence. The method may further include measuring a physiological parameter of the patient (e.g., blood pressure, heart rhythm, breathing rhythm, neurological activity, blood flow, blood oxygenation, end tidal CO2, pressure, viscosity, joint angle, vertebral angle, spinal angle, mechanical stress, shear, torque, distance between selected reference points, mechanical strain, modulus, and/or compressibility), and directing the series of signals in response to the measured physiological parameter. The surgical implant may be configured to engage one or more vertebrae, and the first mechanical configuration may provide more or less stress shielding to the vertebrae than the second mechanical configuration, and/or the implant may change the relative position of the vertebrae. The surgical implant may be configured to engage a bony structure, and the first mechanical configuration may provide more or less stress shielding to the bony structure than the second mechanical configuration. The patient may be a human or an animal, and may be an adult or a juvenile. The surgical implant may be, for example, a tooth implant, a tissue expander, an intralumenal device, a stent, a shunt, a gastrointestinal camera, a drug reservoir, an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, a cosmetic implant, a lip augment, a breast augment, a pectoral augment, or a deltoid augment.
In still another aspect, a system for treating a patient includes a signaling unit configured to emit a spatiotemporal signal sequence into the patient, and an implant configured for implantation into the patient. The implant is configured to respond to the spatiotemporal signal sequence by shifting from a first mechanical configuration to a second mechanical configuration. The spatiotemporal signal sequence may include a spatial and/or a temporal arrangement of magnetic fields, electric fields, acoustic signals, electromagnetic signals, and/or optical signals. The implant may be, for example, a bone implant, a spinal implant, a tooth implant, a tissue expander, an intralumenal device, a stent, a shunt, a gastrointestinal camera, a drug reservoir, an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, a cosmetic implant, a lip augment, a breast augment, a pectoral augment, or a deltoid augment.
In a still yet another aspect, a device for implantation into a body includes a receiver responsive to a trigger signal, authentication circuitry coupled to the receiver and operative to distinguish an authentic trigger signal from a non-authentic trigger signal and responsive to an authentic trigger signal to generate an actuation signal, and an actuable member coupled to receive the actuation signal and responsive to the actuation signal to change configuration. The device may further include a physiological sensor configured to sense a physiological parameter in the body (e.g., a parameter indicative of an abnormal condition of the body such as loss of consciousness, altered consciousness, abnormal heart rhythm, abnormal breathing rhythm, abnormal blood pressure, abnormal blood chemistry, change in tissue perfusion, myocardial infarction, stroke, hypoglycemia, hyperglycemia, electrolyte disturbance, and/or hormone imbalance), and the authentication circuitry may use the sensed physiological parameter to determine whether to generate an actuation signal (e.g., only if the sensed physiological parameter is indicative of an abnormal condition of the body). The authentication circuitry may be configured to determine that the physiological parameter is indicative of an abnormal condition if it falls outside of a selected normal range, and it may be configured to accept a change in the selected normal range. The receiver may be configured to accept any one of a plurality of trigger signals, each associated with a respective permissions level, and may be configured to generate an actuation signal under different conditions for different permissions levels. The device may be, for example, a bone implant, a spinal implant, a tooth implant, a tissue expander, an intralumenal device, a stent, a shunt, a gastrointestinal camera, a drug reservoir, a pacemaker, a defibrillator, a cochlear implant, a brain stimulator, an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, a cosmetic implant, a lip augment, a breast augment, a pectoral augment, or a deltoid augment.
In a further aspect, a device for implantation in a body may include a receiver configured to receive a first signal, a transmitter configured to send a second signal, and an actuable member having a therapeutic function in the body. The actuable member is configured to be actuated after both receipt of the first signal and sending of the second signal. The transmitter may be configured to send the second signal in response to receipt of the first signal by the receiver. Actuation of the actuable member after both receipt of the first signal and sending of the second signal may include actuation in response to a third signal determined by both the first signal and the second signal. The transmitter configured to send the second signal may be a passive transmitter such as an RFID. The second signal may include identifying information for the device. The device may be, for example, a bone implant, a spinal implant, a tooth implant, a tissue expander, an intralumenal device, a stent, a shunt, a gastrointestinal camera, a drug reservoir, a pacemaker, a defibrillator, a cochlear implant, a brain stimulator, an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, a cosmetic implant, a lip augment, a breast augment, a pectoral augment, or a deltoid augment.
In yet a further aspect, a method of accessing an implant in a body includes identifying a spatiotemporal signal sequence corresponding to an access code for the implant and providing the identified spatiotemporal signal sequence to the implant without physically contacting the implant. The identified spatiotemporal signal sequence may be a command to the implant, such as a data retrieval command, an actuation command (e.g., to direct the implant to shift from a first to a second mechanical configuration, such as to a configuration that provides a different level of stress shielding to a bony structure), and/or a reconfiguration command (e.g., a command that modifies behavior of a logic circuit in the implant). The command may be a data retrieval command that directs the implant to return a parameter such as implant position, implant shape, implant identity, measurements of a physiological parameter (e.g., blood pressure, heart rhythm, breathing rhythm, neurological activity, blood flow, blood oxygenation, end tidal CO2, pressure, viscosity, joint angle, vertebral angle, spinal angle, mechanical stress, shear, torque, distance between selected reference points, mechanical strain, modulus, and/or compressibility), and/or measurements of an environmental parameter (e.g., temperature, pressure, chemical activity of a substance, chemical concentration of a substance, and acceleration). The implant may be, for example, a bone implant, a spinal implant, a tooth implant, a tissue expander, an intralumenal device, a stent, a shunt, a gastrointestinal camera, a drug reservoir, a pacemaker, a defibrillator, a cochlear implant, a brain stimulator, an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, a cosmetic implant, a lip augment, a breast augment, a pectoral augment, or a deltoid augment.
In still a further aspect, a method of accessing an implant in a patient includes receiving identifying information for the patient or for the implant, retrieving implant-specific data corresponding to the identifying information, generating a coded signal responsive to the retrieved implant-specific data, and transmitting the coded signal to the implant. Receiving the identifying information may include interrogating the implant in the patient, and/or accessing a compilation of identifying information. The implant-specific data may include an access code for the implant and/or a location for the implant. Generating the coded signal may include determining a signal operative to induce the implant to shift from a first to a second mechanical configuration, and/or determining a signal operative to induce the implant to transmit information out of the body. The implant may include logic circuitry, and generating the coded signal may include determining a signal operative to induce the implant to modify its logic circuitry.
In yet still a further aspect, a method of operating an implant in the body includes receiving an implant-correlated spatiotemporal signal sequence, and responding to the implant-correlated spatiotemporal signal sequence by performing an action. Responding to the implant-correlated spatiotemporal signal sequence may include determining whether the spatiotemporal signal sequence appears to originate from a sender having permission to actuate the implant. Performing an action may include shifting from a first to a second mechanical configuration, transmitting information out of the body (e.g., a physiological parameter, an environmental parameter, and/or identifying information for the implant), and/or determining a permission level for the implant-correlated spatiotemporal signal sequence. The implant may include logic circuitry that determines response to spatiotemporal signal sequences, and performing an action may also or alternatively include modifying that logic circuitry.
The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
In the following detailed description, reference is made to the accompanying drawings, which form a part hereof In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.
Connection of adjacent vertebrae or other bones via spinal screws (e.g., pedicle screws) or other mechanical structures is common in surgeries such as spinal fusions (which will typically involve removal of one or more intervertebral discs, and, often, filling of the intervertebral space with autologous or exogenous bone, or with a mechanical construct). However, implants may shift in an uncontrolled fashion over time, causing them to become less effective at maintaining alignment. In addition, when the implant structure is too strong, it may provide too much stress shielding to the spine, potentially resulting in bone loss.
Implants responsive to spatiotemporal signal sequences may take a wide variety of forms and respond to a wide variety of signal modes. Spatiotemporal signal sequences may include patterns in time and/or space of electric fields, magnetic fields, electromagnetic fields, acoustic signals, optical signals, or combinations of any of the above. For example, an implant may respond to an acoustic signal followed by a magnetic field (temporal sequence of differing signal modes), a set of magnetic poles in a defined spatial arrangement (spatial sequence of similar signal modes), or a pair of optical signals in a defined spatial arrangement followed by an electric field having defined characteristics (spatiotemporal sequence of differing signal modes). Implant types may include, for example, those that engage bony structures (e.g., the spinal support implant shown in
A wide variety of other implants may be actuated by means of spatiotemporal signal sequences. For example, some surgical weight loss treatments involve artificially constricting the stomach to deter overeating. In one embodiment, a gastric band or other bariatric implant may be adjusted via a spatiotemporal signal sequence (e.g., gradually loosening the band as the patient develops better eating habits). In another embodiment, an intralumenal device (e.g., a gastrointestinal camera) may be remotely controlled, for example to change the data rate or residence time when the camera passes through an area of interest. In a further embodiment, a shunt may be remotely adjustable (e.g., a CSF shunt may be adjusted via a spatiotemporal signal sequence to adjust the pressure of spinal fluid, or a vascular conduit may be adjusted in a pediatric patient to accommodate growth). In another embodiment, a drug reservoir may shift its mechanical configuration to dispense a drug in response to a signal sequence. In yet another embodiment, an orthodontic appliance (e.g., braces or a retainer) may be responsive to a signal sequence. In still another embodiment, a cosmetic implant (e.g., an augment for the lip, breast, pectoral muscle, or deltoid muscle) may respond to the signal sequence. For example, a breast implant could be gradually increased in size over a period of many days, allowing the skin to stretch gradually as described above in connection with the tissue expander. Cosmetic implants may also be configured for long-term reshaping, for example in response to social norms as an individual ages and/or moves from one social community to another.
In some embodiments, the implant may be partially placed under patient control. For example, for an orthodontic appliance, a progressive, stepwise shifting of the teeth may be accomplished by providing a patient with a signaling device and instructing him to actuate it when the teeth no longer ache from the previous shift. Similarly, a patient may be given (possibly limited) control over a gastric band, controlling the rate of a gradual loosening of the band.
In some embodiments, a handle (not shown) may be provided, or the device may include straps or other apparatus for securing the device to a body (e.g., the slots 136 for straps shown in
As shown in
In some embodiments, an implant also may include authentication circuitry. The authentication circuitry may be configured to determine the authenticity of a received trigger signal, and to actuate the implant only if the received signal is determined to be authentic. For example, an implant may require a code from the patient before it can be actuated, so that it cannot be actuated without the patient's consent. In other embodiments, the implant may require a code from a doctor (instead of or in addition to a code from the patient) in order to actuate the implant. For example, a pacemaker may be adjustable on a temporary basis by the patient (e.g., in anticipation of athletic activity), but may be semi-permanently adjusted by the doctor for therapeutic reasons. Similarly, a patient may be able to make limited short-term adjustments to a cochlear implant in order to respond to unusual ambient noises, while his audiologist may make other types of adjustments to the response of the implant to fit it to the patient's auditory profile.
The authentication circuitry may further use a sensed physiological parameter (e.g., loss of consciousness, altered consciousness, abnormal heart rhythm, abnormal breathing rhythm, abnormal blood pressure, abnormal blood chemistry, change in tissue perfusion, myocardial infarction, stroke, hypoglycemia, hyperglycemia, electrolyte disturbance, and/or hormone imbalance) to determine whether to send an actuation signal (e.g., to send an actuation signal only during an abnormal condition of the body). For example, an implanted defibrillator may be configured to be actuated only when an authentic signal is received and when the patient exhibits an abnormal heart rhythm. In some embodiments, the authentication circuitry may be configurable, either before or after implantation into a patient. For example, the circuitry may be configured to accept a range of blood pressures that can be considered to be normal for a particular patient. In some embodiments, this range can be adjusted after the implant has been placed.
The sensed physiological parameter may also be used to alter the permissions required to actuate the implant. For example, an implanted defibrillator may require codes from both doctor and patient for actuation when patient's sensed heart rhythm appears to be normal (or may not be actuatable at all during normal heart rhythm), may be actuated by the patient or the doctor when the heart appears to be beating with an abnormal rhythm, and may be actuated by anyone when the heart has stopped beating.
In embodiments in which the implant senses a physiological parameter and/or an environmental parameter (e.g., temperature, pressure, chemical activity and/or concentration of a substance, and/or acceleration), the implant may be configured to transmit such information in response to an authentication signal. The implant may be configured to transmit either instantaneous values of the parameter, and/or a historical record of past values of the parameter.
The patient to be treated according to the method illustrated in
While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.
Claims
1. A device for implantation in a body, comprising:
- a receiver responsive to a selected spatiotemporal signal sequence to produce an activation signal; and
- a member responsive to the activation signal to shift from a first mechanical configuration to a second mechanical configuration.
2. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a sequence of magnetic fields.
3. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a sequence of electric fields.
4. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a sequence of acoustic signals.
5. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a sequence of electromagnetic signals.
6. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a sequence of optical signals.
7. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a series of spatially separated input signals.
8. The device of claim 1, wherein the selected spatiotemporal signal sequence includes a series of temporally separated input signals.
9.-11. (canceled)
12. The device of claim 1, wherein the member is configured to engage a bony structure.
13.-14. (canceled)
15. The device of claim 12, wherein the member is configured to change the shape of the bony structure.
16. (canceled)
17. The device of claim 1, wherein the member includes a tissue expander.
18. The device of claim 1, wherein the member includes an intralumenal device.
19. The device of claim 18, wherein the intralumenal device includes a stent.
20. (canceled)
21. The device of claim 18, wherein the intralumenal device is configured to traverse a lumen and comprises a physiological sensor.
22. (canceled)
23. The device of claim 1, wherein the member includes a shunt.
24.-25. (canceled)
26. The device of claim 1, wherein the member includes a drug reservoir.
27. The device of claim 26, wherein the member is configured to dispense a drug from the drug reservoir by shifting from the first mechanical configuration to the second mechanical configuration.
28. The device of claim 1, wherein the member includes an artificial joint.
29. The device of claim 1, wherein the member includes a gastric band.
30. The device of claim 1, wherein the member includes an artificial sphincter.
31. The device of claim 1, wherein the member includes an orthodontic appliance.
32. The device of claim 1, wherein the member includes a cosmetic implant.
33. (canceled)
34. The device of claim 1, wherein the member is configured to accommodate growth of the body.
35. A device for providing a coded signal to an implant in a body, comprising:
- a plurality of signaling units having a selected spatial arrangement, wherein the signaling units are arranged to deliver a spatiotemporal signal sequence corresponding to the coded signal.
36. The device of claim 35, wherein the spatiotemporal signal sequence includes a spatial arrangement of magnetic fields.
37. The device of claim 35, wherein the spatiotemporal signal sequence includes a temporal arrangement of magnetic fields.
38. The device of claim 35, wherein the spatiotemporal signal sequence includes an arrangement of electromagnetic fields.
39. The device of claim 35, wherein the signaling units are arranged to deliver a plurality of different spatiotemporal signal sequences.
40. The device of claim 35, wherein the spatiotemporal signal sequence includes at least two different signal modes selected from the group consisting of magnetic fields, electric fields, electromagnetic fields, optical signals, and acoustic signals.
41. The device of claim 35, wherein the device is configured to conform to a surface of the body.
42. The device of claim 35, wherein the device is configured to be secured to the body.
43.-44. (canceled)
45. A method of treating a patient having a surgical implant in the patient's body of a type responsive to a spatiotemporal signal sequence to change from a first mechanical configuration to a second mechanical configuration, comprising:
- directing a series of signals corresponding to the spatiotemporal sequence into the patient's body.
46. The method of claim 45, wherein the series of signals includes a sequence of magnetic fields.
47. The method of claim 45, wherein the series of signals includes a sequence of electric fields.
48. The method of claim 45, wherein the series of signals includes a sequence of electromagnetic fields.
49. The method of claim 45, wherein the series of signals includes a sequence of acoustic signals.
50. The method of claim 45, wherein the series of signals includes a sequence of optical signals.
51. The method of claim 45, wherein the series of signals includes a series of spatially separated input signals.
52. The method of claim 45, wherein the series of signals includes a sequence of temporally separated input signals.
53. The method of claim 45, wherein there are a plurality of surgical implants in the patient's body, and wherein fewer than all of the surgical implants are responsive to the spatiotemporal signal sequence.
54. (canceled)
55. The method of claim 45, further comprising measuring a physiological parameter of the patient, wherein directing the series of signals into the patient's body includes directing the series of signals in response to the measured physiological parameter.
56. The method of claim 55, wherein the measured physiological parameter is selected from the group consisting of blood pressure, heart rhythm, breathing rhythm, neurological activity, blood flow, blood oxygenation, end tidal CO2, pressure, viscosity, joint angle, vertebral angle, spinal angle, mechanical stress, shear, torque, distance between selected reference points, mechanical strain, modulus, and compressibility.
57. The method of claim 45, wherein the surgical implant is configured to engage one or more vertebrae.
58.-59. (canceled)
60. The method of claim 57, wherein the surgical implant is configured to change the relative position of at least two vertebrae.
61. The method of claim 45, wherein the surgical implant is configured to engage a bony structure.
62.-63. (canceled)
64. The method of claim 45, wherein changing from the first mechanical configuration to the second mechanical configuration includes disengaging a retaining pin.
65. The method of claim 45, wherein the patient is human.
66. The method of claim 45, wherein the patient is an animal.
67. The method of claim 45, wherein the patient is an adult.
68. The method of claim 45, wherein the patient is a juvenile.
69. The method of claim 45, wherein the surgical implant is selected from the group consisting of a tooth implant, a tissue expander, an intralumenal device, a stent, a shunt, a gastrointestinal camera, a drug reservoir, an artificial joint, a gastric band, an artificial sphincter, an orthodontic appliance, a cosmetic implant, a lip augment, a breast augment, a pectoral augment, and a deltoid augment.
70.-81. (canceled)
Type: Application
Filed: Feb 22, 2007
Publication Date: Aug 28, 2008
Applicant:
Inventors: Edward S. Boyden (Cambridge, MA), Roderick A. Hyde (Redmond, WA), Muriel Y. Ishikawa (Livermore, CA), Eric C. Leuthardt (St. Louis, MO), Nathan P. Myhrvold (Medina, WA), Dennis J. Rivet (St. Louis, MO), Michael A. Smith (San Gabriel, CA), Thomas A. Weaver (San Mateo, CA), Lowell L. Wood (Bellevue, WA)
Application Number: 11/710,592
International Classification: A61F 2/48 (20060101);