JP4125339B2 - Portable assembly, system and method for providing functional or therapeutic neuromuscular stimulation - Google Patents

Description

(Field of Invention)
The present invention relates to systems and methods for providing neuromuscular stimulation.

(Background of the Invention)
Neuromuscular stimulation can have functional and / or therapeutic results. While existing systems and methods can provide significant benefits to individuals in need of neuromuscular stimulation, many quality of life issues still remain. For example, existing systems perform stimulation functions for a single application. Furthermore, these controllers are relatively large and cumbersome to operate and carry according to today's standards.

  A system and method for providing neuromuscular stimulation provides not only specific prosthetic and specific therapeutic purposes, but also neuromuscular stimulation (the ability to allow end users to operate this system via a wireless interface). It is also time to deal with the quality of life of individuals who need it.

(Summary of the Invention)
The present invention provides the following.
(Item 1)
A neuromuscular stimulation assembly, the assembly comprising:
At least one electrode sized and configured for implantation in a targeted neural tissue region or muscle tissue region;
A percutaneous lead comprising an exposed region electrically coupled to the electrode and projecting through an external skin surface;
A carrier sized and configured to be worn on the external skin surface; a circuit holding the carrier configured to emit stimulation pulses; and a circuit electrically coupled to the circuit; An electrode connection element holding the carrier on the substrate, the electrode connection element electrically engaging at least a portion of the exposed area of the conductor to electrically couple the electrode to the circuit An electrode connecting element sized and configured to percutaneously apply the stimulation pulse to the tissue region;
A neuromuscular stimulation assembly comprising:
(Item 2)
The assembly of claim 1, further comprising a power input bay holding the carrier electrically coupled to the circuit on a substrate, the power input bay being removable and replaceable. An assembly sized and configured to hold a power supply that can be.
(Item 3)
3. The assembly of item 2, wherein the assembly further comprises instructions to command the removal and replacement of the power source according to a preset schedule.
(Item 4)
The assembly of claim 2, wherein the power source comprises a battery.
(Item 5)
The assembly of claim 1, wherein the at least one electrode is sized and configured for implantation in peripheral motor nerves distributed in the triceps.
(Item 6)
A neuromuscular stimulation assembly, the assembly comprising:
At least one electrode,
A carrier sized and configured to be worn on an external skin surface;
A circuit holding on a substrate the carrier configured to emit a stimulation pulse to the electrode;
A power input bay holding the carrier electrically coupled to the circuit on a substrate, the power input bay sized to hold a power supply that can be removed and replaced; and Power input bay, configured as such
A neuromuscular stimulation assembly comprising: an instruction to command the removal and replacement of the power supply according to a preset schedule; and a power supply for recharging the circuit according to the preset schedule.
(Item 7)
The assembly of claim 6, wherein the power source comprises a battery.
(Item 8)
7. The assembly of item 6, wherein the electrode is sized and configured for implantation in a targeted nerve tissue region or muscle tissue region.
(Item 9)
The assembly of claim 6, wherein the electrode is sized and configured for placement on an external skin surface.
(Item 10)
7. The assembly of item 6, wherein the at least one electrode is sized and configured for placement in connection with peripheral motor nerves distributed in the triceps.
(Item 11)
A neuromuscular stimulation assembly, the assembly comprising:
At least one electrode,
A carrier sized and configured to be worn on an external skin surface;
A circuit holding the carrier configured to emit a stimulation pulse to the electrode on the substrate, and a communication bay holding the carrier electrically coupled to the circuit on the substrate, the communication bay comprising: A communication bay sized and configured to establish wireless communication between the circuit and an external device;
A neuromuscular stimulation assembly comprising:
(Item 12)
A neuromuscular stimulation assembly, the assembly comprising:
At least one surface-mounted electrode sized and configured for stimulation of a targeted neural tissue region or muscle tissue region;
A carrier sized and configured to be worn on an external skin surface;
A programmable circuit comprising on a substrate the carrier configured to emit stimulation pulses;
A power input bay holding the carrier electrically coupled to the circuit on the substrate, and an electrode connecting element holding the carrier electrically coupled to the circuit on the substrate, the electrode connecting element comprising: An electrode connecting element sized and configured to electrically couple at least one electrode to the circuit and apply the stimulation pulse to the tissue region;
A neuromuscular stimulation assembly comprising:
(Item 13)
13. The assembly of item 12, further comprising a surface mount return electrode.
(Item 14)
13. The assembly of item 12, further comprising a communication bay holding the carrier electrically coupled to the programmable circuit on a substrate, the communication bay being a wireless between the circuit and an external device. An assembly sized and configured to establish a communication link.
(Item 15)
An introducer for a percutaneous electrode, wherein the introducer is sized and configured to protect the percutaneous electrode from contact with tissue while it is advanced to a desired location within the tissue. A distal tissue piercing region comprising a body defining an internal lumen that includes a material that can be selectively deformed to advance the body along a selected patch, and manipulation of a remote actuator A mechanism coupled to the distal region to change the deformation of the distal region in response to
An introducer.
(Item 16)
Item 16. The introducer of item 15, wherein the mechanism comprises at least one linear motor assembly.
(Item 17)
A method for assessing C5-6 limb paralysis for treatment comprising at least one electrode, a carrier sized and configured to be worn on an external skin surface, and a stimulation pulse on the electrode Providing a neuromuscular stimulation assembly comprising circuitry that holds the carrier configured to emit on a substrate, placing the carrier on an external skin surface, and distributing the electrode to a peripheral motor nerve that distributes the triceps A method comprising: placing in association, and activating the circuit to determine whether the individual has a nerve-distributed triceps in response to electrical stimulation.
The present invention provides improved assemblies, systems and methods for providing prosthetic neuromuscular or therapeutic neuromuscular stimulation.

  One aspect of the present invention is a portable, transdermal device that provides an electrical connection between a muscle or nerve inside the body and a stimulus generator or recording device temporarily attached to the skin surface outside the body. Cutaneous or surface mounted neuromuscular stimulation assemblies, systems and methods are provided. These assemblies, systems and methods are, in use, coupled to an electrode by a percutaneous lead, which can be implanted beneath the skin surface, or alternatively, can be coupled to a conventional surface mounted electrode, It can be placed in the targeted tissue region. The neuromuscular stimulation assembly, system, and method provide a highly selective pattern of neuromuscular stimulation to achieve one or more highly selective therapeutic and / or diagnostic results only in a targeted area. Apply. The pattern may vary according to the desired therapeutic and / or diagnostic purpose. Indications include, for example, highly selective treatment of pain or muscle dysfunction, and / or highly selective promotion of tissue or bone healing, and / or devices that remain permanently implanted in the future. A highly selective diagnosis of the effectiveness of the expected functional electrical stimulation treatment may be mentioned. Further, the controller interface from the user to the neuromuscular stimulation assembly, system and method can be wireless.

  The neuromuscular stimulation assembly, system and method includes a patch or carrier attached to the skin. This carrier can be easily held, for example by using a pressure sensitive adhesive, without discomfort and without affecting the body shape of the individual's arms, legs or torso.

  The carrier comprises an electronic pod that generates the desired current pattern. The pod contains a microprocessor-based programmable circuit that generates stimulation current, time or sequence of stimulation pulses, logs, and monitor usage. The electronic pod can be configured to accept wireless RF-based commands for both wireless programming control and wireless patient control, if desired.

  The electronic pod also includes an electrode connection region for physically and electrically coupling the percutaneous electrode lead to the circuit of the electronic pod or to the surface-mounted electrode.

  The carrier further includes a power input bay to receive a small, lightweight primary cell battery that can be removed and replaced as commanded. This battery provides power to the electronic pod.

  In a typical regimen ordered using a neuromuscular stimulation assembly, system and method, an individual periodically removes and discards the battery (eg, about once a day or about once a week). It is contemplated that it will be instructed to replace it with a new battery. This arrangement makes it easy to meet the power requirements of the electronic pod. The use of this neuromuscular stimulation assembly, system, and method is thereby commanded in parallel with a normal automated dosing regimen, and this battery is similar to an individual receiving a dosing regimen in pill form. It is exchanged at a certain frequency.

  This power input bay may also serve as a communication interface. This communication interface may be fitted into a mating communication interface on the external device or may have a wireless interface to the external device. Via this link, the caregiver or clinician can individually program the operation of a given electronic pod. If necessary, the caregiver or clinician can adjust various stimulation parameters in real time.

  This assembly, system, and method enables, for example, many different results: (i) damage to the peripheral or central nervous system (eg, extremity trauma, stroke, by treatment of pain or muscle dysfunction) Alleviation of acute pain through the application of electrical stimulation to muscles (or nerves that are distributed therewith) that are under voluntary control due to, eg, central nervous system disease); and / or (ii) disease or injury Maintenance of muscle function after temporary disruption of function and prevention of inactive atrophy through temporary stimulation to maintain muscle strength, weight, peripheral blood flow, etc. and / or ( iii) A small amount of DC current (or very low frequency AC current) in the bone or tissue to aid or promote healing, such as bone healing, tissue regrowth, etc. ) Enhanced tissue and bone regeneration via supply; and / or (iv) treatment of pain or other conditions via application of neural stimulation to provide a neuromodulatory or inhibitory effect; and / or ( v) post-operative recovery to enhance muscle function and promote post-surgery strength recovery; and / or (vi) antithrombotic treatment (eg, to increase blood return by veins) And / or (vii) treatment of osteoporosis by periodic muscle stimulation; and / or (viii) assessing the efficacy of such treatment prior to more sustained implant implantation (eg, Short of electrical stimulation to assess whether an individual with C5-6 limb paralysis has a nerve-distributed triceps that can respond to treatment with electrical stimulation) And / or (ix) a brief recording of biopotential signals generated in the body to assist in the diagnosis of a medical condition or to assess the effectiveness of a treatment method; and / or (x) For functional benefits such as impaired or lost gait or restoration of upper limb function.

  Another aspect of the invention provides systems and methods for implanting transdermal electrodes. The system and method provide a percutaneous electrode with an anchor element to prevent movement of the percutaneous electrode within the tissue. This system and method inserts a percutaneous electrode contained within an introducer, which protects its anchor element from contact with tissue, through the skin and tissue. This system and method implants a percutaneous electrode while it is inserted in an introducer to place the percutaneous electrode at a desired location in the tissue, but without contacting the anchor element with the tissue. This system and method retracts the introducer to bring the anchor element into contact with the tissue, thereby preventing the percutaneous electrode from moving from the desired location.

  Another aspect of the invention provides systems and methods for implanting transdermal electrodes. The system and method provide an introducer that defines a lumen. The lumen is sized and configured to protect the percutaneous electrode from contact with the tissue while it is advanced to the desired location within the tissue. The region that penetrates the distal tissue of the introducer includes a material that can be selectively deflected to advance the body along a selected path toward the desired location. A mechanism for changing the deflection of the distal region in response to operation of the remote actuator is coupled to the distal region.

  Other features and advantages of the invention are set forth in the following specification and attached drawings.

  The present invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims rather than in the specific description that follows. Accordingly, all embodiments that come within the meaning and range of equivalency of the claims are to be construed as being encompassed by the claims.

(Description of Preferred Embodiment)
Various aspects of the invention are described in connection with providing functional neuromuscular stimulation for prosthetic or therapeutic purposes. This is because the features and advantages resulting from the present invention are well suited for this purpose. In addition, it should be understood that various aspects of the invention can be applied to accomplish other objectives as well.

(I. Neuromuscular stimulation assembly)
(A. Overview)
FIG. 1 shows a neuromuscular stimulation assembly 10. As shown in FIG. 2, the neuromuscular stimulation assembly 10 is sized and configured to be conveniently worn temporarily on an external skin surface in use. “Temporary” means that the presence of the neuromuscular stimulation assembly 10 can be well tolerated without discomfort over a period of several hours to a month or two months; Can be removed and discarded.

  As shown in FIG. 3, the neuromuscular stimulation assembly 10 is removably coupled in use to an electrode 14 (which is implanted under the skin surface in a targeted tissue region) by a percutaneous lead 12. The This tissue region is targeted prior to implantation of electrode 14 due to its muscular and / or neural morphology in view of desirable therapeutic and / or functional and / or diagnostic purposes.

  In use, the neuromuscular stimulation assembly 10 generates and distributes a current pattern to the electrode 14 via the percutaneous lead 12. In this way, the neuromuscular stimulation assembly 10 applies a highly selective neuromuscular stimulation pattern only to its targeted region to produce one or more highly selective treatment and / or diagnostic results. Achieve. As described in more detail later, the input / stimulation parameters may vary according to the desired therapeutic and / or diagnostic purposes. For example, the results may indicate the effectiveness of highly selective treatment of pain or muscle dysfunction and / or the promotion of highly selective healing of tissues or bones and / or future functional electrical stimulation treatments. May include highly selective diagnosis of sex.

(B. Career)
In its most basic form (see FIGS. 1 and 3), the neuromuscular stimulation assembly 10 comprises a patch or carrier 16. The carrier 16 is desirably sized and so like a small, lightweight housing, for example made from an inert, formed or machined plastic or metal material. Composed.

  In the preferred implementation, the carrier 16 is close to the shape of a watch dial, for example, about 1 inch in diameter, and weighs about 5 grams, for example. At this size, the carrier 16 can be easily worn in an uncomfortable and apparently acceptable manner (as shown in FIG. 2). The carrier 16 physically covers and protects the site where the percutaneous electrode lead 12 penetrates the skin. In its compact configuration, this carrier 16 comprises several functional components and will now be described.

(C. Adhesion area)
At least a portion of the lower surface of the carrier 16 (see FIGS. 1 and 3) includes an adhesive region 18. The function of the adhesive area 18 is to temporarily secure the carrier 16 to the external skin surface during use. For example, inert conventional pressure sensitive adhesives can be used. Desirably, the adhesive area includes a bacteriostatic sealant that prevents skin irritation or superficial infections, which can result in premature removal.

  The adhesive region 18 can also include a conductive material. In this arrangement, this adhesive region 18 can serve as a return electrode so that a unipolar electrode 14 can be embedded if desired. This adhesive region 18 can also serve as an active electrode if it can be used as a surface mount stimulation system. In this configuration, a second return electrode 19 is coupled to the stimulation system (see FIG. 19) or incorporated within a concentric ring (see FIG. 20).

(D. Electronic Pod)
The carrier 16 further comprises an electronic pod 20 that can generate a desired current pattern and communicate wirelessly with an external programming system or controller 46.

  As shown in FIG. 3, the electronic pod 20 may include components that can be inserted into and removed from the electronics bay 22 in the carrier 16. Having an electronic pod 20 that can be separated from the carrier 16 is desirable when there is a need to replace the carrier 16 during the course of treatment. If the expected duration of use of the neuromuscular stimulation assembly 10 is likely to be long enough to predict a decrease in the adhesive properties of the adhesive region 18, or as this adhesive region 18 serves and uses as a return electrode If the adhesive properties and / or conductivity can be deteriorated, for example, it is desirable to replace the carrier 16 without replacing the electronic pod 20.

  Alternatively, as shown in FIGS. 12A and 12B, the electronic pod 20 may include an integral non-removable portion of the carrier 16.

  Regardless of whether the electronic pod 20 is removed from its carrier 16 (FIGS. 4A and 4B) and not removed (FIGS. 12A and 12B), the pod 20 will receive the stimulation current, time or sequence of stimulation pulses, log And a microprocessor-based circuit 24 that generates monitor usage and can communicate wirelessly via an RF link to an external programmer or controller. This circuit 24 preferably comprises a flash memory device or EEPROM memory chip to hold embedded programmable code 26. This code 26 represents a pre-programmed rule or algorithm under which stimulus timing and command signals are emitted. This circuit 24 may be held at a single location on the pod 20 or at various locations.

(E. Electrode connection area)
As shown in FIGS. 4A / 4B and FIGS. 12A / 12B, the electronic pod 20 also includes an electrode connection region 28. The function of the electrode connection region 28 is to physically and electrically couple the end of the percutaneous electrode lead 12 to the circuit 24 of the electron pod 20 (as shown in FIG. 10). This electrode connection region 28 distributes the current pattern in the channels (each electrode 14 includes a channel) so that highly selective stimulation patterns can be applied through the electrodes 14. Four channels (numbered 1-4 on pod 20) are shown in FIGS. 4A / 4B and 12A / 12B.

  This electrode connection region 28 can be constructed in various ways. In the illustrated embodiment (FIGS. 4A / 4B and 12A / 12B), this electrode connection region 28 comprises a groove 30 formed in the electronic pod 20. Four grooves 30 are shown in FIGS. 4A / 4B and 12A / 12B, and each groove 30 is sized and so as to slidably receive the lead 12 of one electrode 12 with a tether. (See FIG. 10). Each groove 30 is labeled with a number or other indicia to record the channel of its electronics circuit 24 that is coupled to each groove 30.

  Each groove 30 routes the end of the electrode conductor 12 to a predetermined channel (see FIG. 7), allowing the conductor 12 to be pinched so as to be caught in the groove 30 by friction. To do. 4A / 4B, the groove 30 includes a mechanism 60 at its end that shifts the insulation of the conductor or penetrates the insulation and makes electrical contact with the conductive wire of the conductor 12. This mechanism secures the lead 12 and at the same time electrically couples the associated electrode 14 with the circuit 24 of the electronic pod 20.

  In the illustrated embodiment, to facilitate installation, the electronic pod 20 shown in FIGS. 4A and 4B is slidably coupled by rails 36 to mating left pod section 32 and right pod section 34. Is provided. The pod sections 32 and 34 can be separated by sliding along the rail 36 in the direction of opening away as shown in FIG. 4B. The pod sections 32 and 34 can be brought together by sliding along the rail 36 to a closed state, as shown in FIG. 4A. This electronics circuit 24 is held in one or both of the pod sections 32 and 34.

  When in the open state (see FIG. 6), its separate pod sections 32 and 34 expose an underlying skin region 38 where the electrode 14 can be implanted percutaneously. The implantation of this electrode 14 in this skin region 38 will be described in more detail below. Opening the pod sections 32 and 34 creates a groove 30 that can be readily used to determine the acceptance and path of the electrode lead 12 (through its exposed skin region 38 in the central direction) (see FIG. 8). See

When the pod sections 32 and 34 are closed (see FIG. 10), the electrode lead 12 is captured in a mechanism 60 that is electrically connected to the circuit 24 of the electronic pod 20. When in the closed state (as shown in FIG. 10), its pod sections 32 and 34 are mated, but visual inspection of the underlying skin region 38 through which the electrode lead 12 penetrates is still possible. As shown in FIG. 5, viewing the underlying skin region 28 through the pod 20 is still considered even after the carrier 16 has merged into the pod 20 (through the empty power input bay 40 of the carrier 16). By looking).

  Desirably, closing the pod sections 32 and 34 also cuts excess conductor wire at its ends. Otherwise, the excess lead can be cut manually. At this time (see FIG. 11), the carrier 16 can be placed over the electronic pod 20 by snap-fitting its electronics pod 20 into the electronics bay 22 of the carrier 16. An electrical connection region or contact 62 on the pod 20 electrically couples to a mating connection region or contact on the carrier 16 to couple the circuit 24 on that pod 20 to a power source 42 held by the carrier 16. To do.

  In an arrangement where the electronic pod 20 is an integral part of the carrier 16 (as shown in FIGS. 12A and 12B), it should be understood that the carrier 16 itself may comprise separable sections 32 and 34. . In this arrangement, one retained section 34 can comprise an adhesive region 18 that can adhere to the skin with the carrier 16 open to determine the path of the electrode lead 12. . In closing the carrier sections 32 and 34, the pull-off strip 60 on the other carrier section 32 can be removed to expose another adhesive area in order to fully secure the carrier 16 to the skin.

  Alternative embodiments are possible. For example, a locking action, coupling the electrode lead 12 to the electronic pod 20 may be accomplished by a button, lever arm, or other drive that is pushed, slid, pulled or rotated.

(F. Power input / communication bay)
Returning to FIG. 3, the carrier 16 may further comprise a power input bay 40. One function of the power input bay 40 is to removably receive a replaceable and (desirably) disposable battery 42 (eg, an alkaline battery or a lithium battery). The battery 42 provides power to the electronic pod 20. If desired (see FIG. 3), the power input bay 40 may include a hinged cover 44. FIG. 12B also shows the presence of a power input bay 40 that receives the battery. Alternatively, the battery 42 may form its cover without a hinge using a snap fit mechanism to secure the battery to the power input bay 40.

  In a typical regimen ordered using neuromuscular stimulation assembly 10, an individual is instructed to remove and discard battery 42 and replace it with a new battery 42 approximately once a day. Is contemplated. This arrangement simplifies meeting the power demand of the electronic pod 20. The use of the neuromuscular stimulation assembly 10 thereby makes a normal automated dosing regimen in parallel, with the battery 42 being replaced at the same frequency that the individual administers the drug in pill form. The battery 42 can be provided in an overmolded housing for easy installation and removal.

  The power input bay 40 can also serve as a communication interface. As shown in FIG. 13A, in the absence of battery 42, its bay 40 can be used to snap into external programming device 46 or computer with cable 58. This will also be described later. This allows the electronic pod 20 to be linked to an external programming device 46 or a computer. Via this link, information and programming inputs can be exchanged and data can be downloaded from the electronic pod 20.

  In this way, the neuromuscular stimulation assembly 10 allows a caregiver or clinician to individually program the operation of a given electronic pod 20 to the extent permitted by the embedded programmable code 26. . Of course, instead of using a cable interface, as shown, wireless link 59 (eg, magnetically coupled RF, infrared, or RF) connects electronic pod 20 to external programming device 46 or a computer. It should be understood that can be used to communicate with (see FIG. 13B).

  As also shown in FIG. 5, with the battery 42 removed and the cover (if any) open, the underlying skin region 38 (through which the percutaneous electrode leads penetrate) is the power input. It can be easily seen through the bay 40.

(G. Electrode and its embedding)
The configuration of electrode 14 and the manner in which the battery is embedded can vary. Exemplary embodiments are described with reference to FIGS.

  In the exemplary embodiment, each electrode 14 and lead 12 may comprise a thin flexible component made from a metal and / or polymer material. By “thin” is intended that the electrode 14 should be about 0.5 mm (0.020 inches) in diameter or less.

  The electrode 14 and the lead 12 may comprise one or more coiled metal wires with, for example, an open core or a flexible elastomer core. The wire can be insulated with, for example, a biocompatible polymer film (eg, polyfluorocarbon, polyimide, or parylene). The electrodes 14 and the leads 12 are preferably coated with a textured bacteriostatic material. This helps to stabilize the electrode in a manner that still allows easy removal at a later date and increases tolerance.

  This electrode 14 and lead 12 are electrically connected everywhere except for one (unipolar), two (bipolar), or three (tripolar) conductive locations near their distal end. Insulated. Each of these conductive locations is connected to a conductor over the length of the electrode and conductor to provide an electrical continuity from the conductive location to the electronic pod 20. This conductive location may include uninsulated regions of other insulated conductors that span the length of the totally insulated electrode. The uninsulated conductive regions of this conductor can be formed differently, for example, can be wound at different pitches, can be wound at larger or smaller diameters, or can be shaped to different dimensions. The conductive location of the electrode may include a separate material (metal or conductive polymer) that is exposed to the body tissue to which the wire conductor is bound.

  The electrode 14 and the lead 12 desirably have mechanical properties in terms of flexibility and fatigue life. This property takes into account the dynamics of the surrounding tissue (ie stretching, bending, pushing, pulling, crushing, etc.) and provides an operational life without mechanical and / or electrical failures. The electrode material desirably prevents connective tissue ingrowth along its length so as not to inhibit withdrawal at the end of its use. However, it is desirable to promote connective tissue ingrowth at the distal end of the electrode to enhance anchoring in the tissue.

  Further, the desired electrode 14 includes an anchor element 48 at its distal end (see FIGS. 15 and 16). In the exemplary embodiment, the anchor element 48 takes the form of a simple barb. The anchor element 48 is sized and configured so that when in contact with the tissue, it works erratically in the tissue so that the electrode is not displaced or moved out of the exact location in the surrounding tissue. Is done. Desirably, the anchor element 48 is not fully engaged with body tissue until after the electrode has been placed. This electrode is not deployed until it is correctly positioned during the implantation (attachment) process, as described in more detail below.

  In one embodiment, the electrode 14 and the lead 12 may comprise a metal style within its core. The needle movement of the electrode and / or associated introducer (if used) relative to the body is used to position the electrode by exposing the anchor element 48 to body tissue. In this arrangement, the needle is removed once the electrode 14 is located in the desired area.

  In the illustrated embodiment (see FIGS. 14 and 15), each electrode 14 housed within the electrode introducer 50 is implanted percutaneously. The electrode introducer 50 comprises a shaft shaped at the needle-like distal end. The shaft penetrates the skin and tissue and leads to the targeted tissue region. The electrode 14 and the lead 12 are positioned in the lumen of the introducer 50, and the anchor element 48 protects complete tissue contact within the shaft of the introducer 50 (see FIG. 14). In this way, the introducer locates the desired final electrode implantation site before placing the electrode (see FIG. 15) and retracting the introducer 50 (see FIG. 16). It can be manipulated freely in the tissue (FIG. 14).

  The electrode introducer 50 is insulated along the length of the shaft, except in a region that coincides with the exposed conductive surface of the electrode 14 housed inside the introducer 50. These surfaces outside the introducer 50 are electrically isolated from each other and from the shaft of the introducer 50. These surfaces are electrically connected to the connector 64 at the end of the introducer body (see FIGS. 14 and 15). This allows connection to the stimulation circuit 66 (FIG. 14) during the implantation process. Application of the stimulation current through the outer surface of introducer 50 provides a very close response to the response that electrode 14 provides when electrode 14 is positioned at the current location of introducer 50.

  The electrode introducer 50 is sized and configured to be bent by hand before it is inserted into the skin. This allows the doctor to place the electrode 14 at a position that is in line with an unobstructed straight line. The construction and material of the electrode introducer 50 allows it to bend without interfering with the placement of the electrode 14 and withdrawing the electrode introducer 50 and leaving the electrode 14 in the tissue.

  In an alternative embodiment (see FIGS. 17A, 17B and 17C), the electrode introducer 50 comprises a distal needle region 70, which is operated by a remote steering actuator 72, Can be deflected or steered. This bending of the needle region 70 by remote control is another way of facilitating guiding the electrode 14 to a position that is not aligned with an unobstructed straight line with the insertion site.

  The creation of the bendable needle region 70 that can be deflected remotely can be accomplished in various ways. In the illustrated embodiment, the needle region 70 includes a semi-flexible, conductive needle extension 74. The needle extension 74 is telescoped into the distal end of the introducer 50, which means that the extension 74 can slide into the introducer 50. The semi-flexible needle extension 74 includes a lumen 78 that communicates with the lumen of the introducer 50 through which the electrode 14 passes. Thus, the electrode 14 can penetrate the lumen 78 of the needle extension 74 for placement.

  For example, small linear motors 76L and 76R employing conventional microelectromechanical (MEMS) system technology couple the proximal end of their needle extension 74 to introducer 50. The motors 76L and 76R are desirably mounted in a 180 ° spaced relationship in the illustrated embodiment.

  When the motors 76L and 76R are driven forward or backward at the same speed, the flexible extension 74 extends and contracts from the introducer 50 through a straight path. Driving motors 76L and 76R at different speeds and / or in different directions imparts bending torque on needle extension 74 and causes deflection. For example, when the left motor 76L is driven at a forward speed faster than the right motor 76R (or when the left motor 76L is driven at the same time as the right motor 76R is driven in the reverse direction), as shown in FIG. 74 deflects to the right. In contrast, when the left motor 76L is driven at a slower speed than the right motor 76R (or when the right motor 76R is driven forward and at the same time the left motor 76L is driven in the reverse direction), as shown in FIG. The extension 74 is deflected to the left.

  In this arrangement, the steering actuator 72 may include a conventional joystick device, for example. By manipulating this joystick device 72, as shown in FIGS. 17B and 17C, varying drive speeds / directions are applied to motors 76L and 76R to deflect or advance the needle extension 74 in the desired direction. Is done. The path that the introducer 50 takes through the tissue can thereby be indicated. While leading the introducer 50 in this manner, a stimulation current can be applied through the outer surface of the needle extension 74 until a position with the desired stimulation response is found. This electrode 14 is placed through the needle extension 74 (which fully engages the electrode anchor element 48 with body tissue) in the manner previously described, after which the introducer 50 is retracted.

  Instead of the MEMS linear motors 76L and 76R, a conventional push-pull steering wire can pass through the lumen in the introducer 50 and can be coupled to the needle extension 74. The operation of the actuator 72 is pushed or pulled with a wire to take the bend of the extension 74 in the manner described immediately above.

(II. Installation of neuromuscular stimulation assembly)
Prior to attachment, the clinician identifies a specific muscle region and / or nerve region, and the treatment ordered using the neuromuscular stimulation assembly 10 is applied to this region. This particular type of treatment possible using the neuromuscular stimulation assembly 10 will be described later. Once a specific muscle region and / or tissue volume region is identified, an electronic pod 20 (or carrier 16 integrated with the electronic pod 20) is placed on the skin over this region (see FIG. 6). And the bottom of one half of the pod / carrier is fixed in place with a pressure sensitive adhesive. As previously mentioned, this adhesive region desirably includes a bacteriostatic sealant that prevents skin irritation or superficial infections, which can result in premature removal.

  As shown in FIG. 6, the electronic pod 20 (or carrier 16 integrated with the electronic pod 20) is used to expose a skin area 38 between the pod (or carrier 16) sections 32 and 34. Placed on the skin in an open state.

  As shown in FIGS. 7-10, the clinician proceeds to percutaneously implant the electrodes 14 and leads 12 one by one through the desired skin region 38. Each electrode 14 is implanted sequentially, but the electrode introducer 50 applies a stimulation signal until the desired response is achieved, at which point the electrode 14 is placed and the introducer 50 is placed. Withdraw.

  As each electrode is implanted (see FIG. 7), the clinician routes each electrode lead 12 to a predetermined groove 30. The clinician notes which electrode 14 is coupled to which channel.

  After all of the electrodes 14 have been implanted and the path of each lead 12 has been determined (see FIG. 9), the clinician closes the electronic pod 20 (or carrier 16 with integrated electronic pod 20) (see FIG. 9). 10). In the former situation, the clinician snaps the carrier 16 onto the electronic pod 20 as shown in FIG. The adhesive area 18 on the carrier 16 fixes the carrier 16 to the skin. A battery 42 is disposed in the power input bay 40. The neuromuscular stimulation assembly 10 is ready for use.

  Typically, as shown in FIG. 18, a container 52 containing a commanded number of replacement batteries 42 is provided in the neuromuscular stimulation assembly 10 to form a neuromuscular stimulation system 54. Instructions for use 56 may accompany this neuromuscular stimulation system 54. The instructions 56 direct use of the neuromuscular stimulation assembly 10 including periodically removing and replacing the battery 42 with a new battery 42. Thus, this instruction 56 provides for the pill-based dosing regimen through battery replacement of the neuromuscular stimulation assembly 10 in the same manner that directs periodic “refilling” of the drug by taking the pill. Direct neuromuscular stimulation regimen, including periodic recharging. In the context of the neuromuscular stimulation system 54, the battery 42 becomes the therapeutic equivalent of a pill (ie, is part of the user's behavior taken to prolong the treatment).

  As shown in FIGS. 13A and 13B, an external desktop or portable (preferably charged) pre-programmed device 46 programs the stimulation regimen and parameters into the neuromuscular stimulation assembly 10; Alternatively, it can be used to download recording data from the neuromuscular stimulation assembly 10 for display and further processing. This device 46 may communicate with the neuromuscular stimulation assembly 10, for example, by cable connection 58, by radio frequency magnetic field coupling, by infrared, or by RF wireless 59. As previously described, the power input bay 40 may further comprise a communication interface that is coupled to a communication cable 58 connected to the device 46. The communication cable 58 provides power to the neuromuscular stimulation assembly 10 during programming and during communication with the circuit 24 of the neuromuscular stimulation assembly 10. This external programming device 46 may also be a general purpose personal computer or personal digital device, fitted with a suitable custom program and an interface box for connection to a suitable cable or communication cable 58.

  This programming device 46 allows the clinician to modify the programmable code 26 present on the individual neuromuscular stimulation assembly 10 to suit the particular needs of the user and the clinician's treatment objectives. Once modified, the neuromuscular stimulation assembly 10 can be separated from the programming system, allowing for portable, skin-operated operation as previously described.

(III. Typical Applications of Neuromuscular Stimulation Assembly / System)
(A. Overview)
The neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54, as described, is between a muscle or nerve inside the body and a stimulus generator or recording device attached to the skin surface outside the body. By providing an electrical connection, it is possible to provide a short-term treatment or diagnostic test. The neuromuscular stimulation assembly 10 and / or the programmable code 26 of the neuromuscular stimulation system 54 can be programmed to perform a number of neuromuscular stimulation functions. A representative example of its function is described for illustrative purposes.

(B. Continuous active operation (CAM))
A CAM using the neuromuscular stimulation assembly 10 and / or the neuromuscular stimulation system 54 provides the necessary stimulation to improve cardiovascular durability, muscle strength, and neurological coordination. This assisted movement (active-assisted excerci) via CAM
se) is a technique used to assist the target limb activity, voluntary movement, thereby reducing the amount of muscle force required to move the joint. This technique has been found to be effective in increasing an individual's muscle strength starting at a very low level. The therapeutic benefits include reduced inflammation of the affected joint, improved range of motion, pain relief, and enhanced functioning mobility. CAM is distinguished from continuous passive movement (CPM), which is movement of a joint or limb over a range of movement without voluntary movement of the limb.

(C. Anti-scarring treatment after trauma)
Post-surgical scarring (eg, later spines) is a problem with most orthopedic or neurosurgical procedures. Scarring or adhesion is a fibrous zone of scar tissue that usually joins together with a distinct anatomy during the healing process, and is one of the most common reasons for surgical “failure” of patients It is one of. Surgery performed successfully and successfully by a talented surgeon takes only a short time due to the tendency of the body to scar during post-operative healing. By applying this neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 to muscles or nerves in a particular surgical wound area, scarring is prevented while tissue is healing with relatively little movement. Can be done.

(D. Temporary non-surgical diagnostic evaluation)
This neuromuscular stimulation assembly 10 and / or before applying certain permanently implanted neuromodulation or stimulation systems (eg, urinary incontinence, vagus nerve stimulation for acupuncture, spinal cord stimulation for pain relief) The neuromuscular stimulation system 54 can be applied to provide clinicians and their patients with some assurance that the treatment is realistic through temporary stimulation of the end organs. This means that the clinician will screen patients who are not candidates for permanent treatment or otherwise may not find a treatment effect worthy of surgical implantation of a permanent system. enable.

  A specific example relates to the treatment of C5-6 limb paralysis. C5-6 limb paralysis cannot extend the elbow. Because they cannot stretch their elbows, they are restricted to being able to contact only the area just in front of their bodies and require assistance in many of their actions in daily life. They rely on using biceps to do most of their upper limb work. If hand function is limited or not functioning, they rely on adaptive equipment to perform many self-care activities such as grooming and hygiene and eating It will be.

  An existing surgical procedure to restore elbow extension is to transfer a portion of the deltoid muscle to the triceps. This irreversible surgical procedure requires thorough surgical intervention, long-term postoperative fixation and long-term rehabilitation. Furthermore, the time frame for achieving useful results after surgery is at least 3 months once an individual recovers from surgery, and it can take up to a year before the elbow can be fully extended.

  As an alternative to transplanting the deltoid muscles to the triceps, the pulse generator is implanted in a minimally invasive manner in association with the leads / electrodes in conductive contact with the peripheral motor nerves distributed in the triceps Can be. The pulse generator can be programmed to provide a single channel electrical stimulation to peripheral motor nerves distributed in the triceps to stretch the elbow. Adding the ability to stretch the elbows can allow greater independence as it can significantly expand the reachable and working space. The ability to stretch above the elbow and the ability to extend the arms laterally outward when the elbows stretch greatly expands this workspace, thereby allowing much greater freedom to finish the work that would otherwise be difficult. Enable. The ability to stretch also provides better control of the object as it provides joint contraction of the elbow flexor and extensor at the same time.

  The first phase of the treatment or evaluation period is desirably performed to identify whether the individual has a neurodistributed triceps muscle that responds to electrical stimulation. If the muscle is nerve-distributed and functioning, the clinician will determine that the stimulus for this muscle is appropriate in both the horizontal plane to extend sideways and the vertical plane to extend upward, for example. Identify whether elbow extension can be provided. Individuals must also be able to surpass the power of triceps stimulation by demonstrating that their elbows can be further extended during triceps stimulation. Usually this can be tested by asking an individual to take their hand to their mouth.

  This evaluation process can be accomplished with a transcutaneous stimulation device or surface neuromuscular stimulation device of the type described herein. The stimulation device includes an electronic pod on a substrate that generates a desired current pattern to cause electrical stimulation to distribute the radial nerve to the triceps. The pod contains a microprocessor-based programmable circuit that generates the stimulation current, time or sequence of stimulation pulses, logs, and monitor usage. As described above, a wireless user interface / programmer may be used.

  When a percutaneous electrode is used, the electronic pod circuit is physically and electrically coupled to the percutaneous lead of the electrode. One week after placing the percutaneous lead, the stimulator settings can be programmed either by direct coupling to the programmer or by a wireless link. Stimulation is applied using a 0-200 microsecond pulse at 20 Hz. The power of triceps activation can be determined by the strength of their biceps. The subject must maintain the ability to stretch their elbows comfortably during triceps stimulation. A stronger biceps allows more intense stimulation to the triceps. The subject may require an adjustment phase of 1 to 2 weeks after initial setup to increase triceps endurance. The subject must demonstrate the ability to stretch the elbow while stimulation to the triceps is provided. Therefore, when the biceps are relaxed, the elbow can be extended.

  If electrical stimulation to the radial nerve distributed in the triceps using a surface stimulation program or a percutaneous stimulation program provided active elbow extension beyond the individual's previous workspace, A second stage of treatment is scheduled.

  The second stage of treatment involves the placement of a first layer stimulation device by implantation of an implantable pulse generator and associated conductors / electrodes.

(E. Neuroplasticity treatment)
Individuals with neurological deficits (eg, those who survive a stroke or have multiple sclerosis) may have lost control of certain bodily functions. The brain recovers functionally through a process called “neural plasticity” by reconstructing the cortical map or spinal cord-root boundary and assisting in increasing blood flow (which contributes to nerve recovery). Can do. By applying the neuromuscular stimulation assembly 10 and / or the neuromuscular stimulation system 54 to the affected area of the body and providing the brain with excitement and input, a neuroplastic effect can occur, Will be able to re-learn and re-acquire control of lost functions.

(F. Anticonvulsant treatment)
The use of temporary neurotoxins (eg, Botox) is severe due to cerebral palsy, head injury, multiple sclerosis, and spinal cord injury to assist in walking, maintaining posture and improving daily activities Widely spread in treating muscle spasms. Botox can also be used to treat eye conditions where the line of sight intersects or blinks continuously. It also means eliminating wrinkles by limiting the aging process. This neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 can be used as an alternative to alleviating convulsions without the need to temporarily numb the nerves and muscles. This neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 may also be useful in treating TMJ (temporomandibular joint) disorders. This disorder is manifested by pain in the jaw region and associated muscle spasms and limitations in the ability to perform normal speech movements, facial expressions, eating, chewing, and swallowing.

(G. Treatment of chronic or temporary pain)
Local pain in any region of the body can be treated with this assembly and / or system by applying the neuromuscular stimulation assembly 10 and / or the neuromuscular stimulation system 54 directly to the area to be performed. This neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 works by blocking or blocking the pain signal from reaching the brain.

(H. Postoperative recovery)
Post-surgical recovery of physical strength and muscle function may be facilitated using the neuromuscular stimulation assembly 10 and / or the neuromuscular stimulation system 54. The assembly 10 and / or system 54 provides a temporary regimen of muscle stimulation, alone or in conjunction with an active exercise program, to restore post-operative muscle tone, function and tone. In order to assist the individual in this regard, it can be directed and attached post-operatively in association with the appropriate muscle area.

(I. Prevention of thromboembolism)
The neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 may provide antithrombotic treatment by stimulating leg muscles, which increases venous return and is associated with visible blood retention. To prevent clots. Conventional post-operative treatment is now using a pneumatic compression cuff that patients are wearing on their calves while on the floor. The compression band compresses the calf muscles periodically and mechanically, thereby stimulating venous flow. Patients dislike it, but now there is this unit attached to every surgical bed in the hospital. This same effect can be reproduced by attaching the neuromuscular stimulation assembly 10. Prevention is most effective when initiated during surgery, and as much, otherwise a clot is formed during the majority of the surgery. Accordingly, it is desirable to install the neuromuscular stimulation assembly 10 and begin using the neuromuscular stimulation system 54 at the beginning of the surgery.

(J. Treatment of osteoporosis)
Periodic muscle contraction stresses the bone enough to prevent and (probably) improve osteoporosis. It is known that the effectiveness of such treatment is frequency dependent. The neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 can be programmed to stimulate muscles at an appropriate frequency to prevent / ameliorate osteoporosis.

(K. Neuroprosthesis)
Recovery of movement lost due to paralytic disease or injury can be achieved. The neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 may be controlled wirelessly in real time via an external control source (eg, a heel switch that monitors gait). This external control source triggers a neuromuscular stimulation system to activate during the preset period, allowing functional exercise in the individual's lower limb or upper limb, thereby causing paralysis that was not previously functioning Recover the limbs.

(L. Body sculpting)
The muscle characteristics of the human anatomy can be enhanced and its overall muscle contour can be altered by neuromuscular stimulation of specific groups of muscles. An example is stimulation of the abdominal region, which increases muscle strength and improves muscle tone and contours. The neuromuscular stimulation assembly 10 and / or neuromuscular stimulation system 54 can be programmed to stimulate muscles at an appropriate frequency to change body size and assist in the effects of active exercise.

  Various features of the invention are set forth in the appended claims.

FIG. 1 is a perspective view of a neuromuscular stimulation assembly that provides an electrical connection between muscles or nerves within the body and a stimulus generator temporarily attached to the skin surface outside the body. 2 is a diagram of the neuromuscular stimulation assembly shown in FIG. 1 temporarily attached to the external skin surface of the arm. FIG. 3 is an exploded side view of the neuromuscular stimulation assembly shown in FIG. 1 showing the coupling from the percutaneous lead to the electrode, which is implanted beneath the skin surface in the targeted tissue region. . 4A and 4B are perspective views of an electronic pod associated with the neuromuscular stimulation assembly shown in FIG. This electronic pod can be combined for use in an electronics bay in a neuromuscular stimulation assembly. FIG. 4A shows the pod in the closed state for mating with the neuromuscular stimulation assembly. FIG. 4B shows the pod in an open state for receiving electrode leads prior to incorporation with the neuromuscular stimulation assembly. FIG. 5 is a perspective view of the electronic pod shown in FIG. 4A. This electronic pod is coalesced for use in an electronics bay in the neuromuscular stimulation assembly. This figure shows an open and empty power input bay to allow visual inspection of the underlying skin. FIG. 6 is a perspective view of the electronic pod shown in FIG. 4B in an open state on the skin surface prior to placement of the percutaneous electrode. FIG. 7 shows the implantation of the first percutaneous electrode. FIG. 8 illustrates routing the percutaneous electrode lead of the first percutaneous electrode to the electrode connection area on the pod. FIG. 9 shows the presence of the second, third, and fourth percutaneous electrodes (these electrodes are embedded in sequence), and their percutaneous electrode leads as electrodes on the pod. Indicates routing to the connection area (while the pod remains open). FIG. 10 shows the pod shown in FIG. 9 after being placed in a closed state ready for use. FIG. 11 shows the pod shown in FIG. 10 after being combined for use in an electronics bay in a neuromuscular stimulation assembly. 12A and 12B are perspective views of an alternative embodiment of a neuromuscular stimulation assembly comprising an integrated electronic pod. FIG. 12A shows the neuromuscular stimulation assembly in a closed state for use. FIG. 12B shows the neuromuscular stimulation assembly in an open state for receiving electrode leads prior to use. FIG. 13A is a perspective view of a neuromuscular stimulation assembly of the type shown in FIG. 1 coupled to an external programming device. FIG. 13B is a perspective view of a neuromuscular stimulation assembly of the type shown in FIG. 1 associated with an external programming and control device that relies on a wireless communication link. FIGS. 14-16 illustrate using an electrode introducer to percutaneously implant an electrode in the manner shown in FIGS. 6 and 7 to connect to the neuromuscular stimulation assembly shown in FIG. FIGS. 14-16 illustrate using an electrode introducer to percutaneously implant an electrode in the manner shown in FIGS. 6 and 7 to connect to the neuromuscular stimulation assembly shown in FIG. FIGS. 14-16 illustrate using an electrode introducer to percutaneously implant an electrode in the manner shown in FIGS. 6 and 7 to connect to the neuromuscular stimulation assembly shown in FIG. FIG. 17A is an electrode introducer with a distal needle region that can be remotely altered to advance the electrode percutaneously to the desired implantation position prior to connection to the neuromuscular stimulation assembly shown in FIG. Indicates. FIG. 17B is an electrode introducer with a distal needle region that can be remotely altered to advance the electrode percutaneously to the desired implantation position prior to connection to the neuromuscular stimulation assembly shown in FIG. Indicates. FIG. 17C is an electrode introducer with a distal needle region that can be remotely altered to advance the electrode percutaneously to the desired implantation position prior to connection to the neuromuscular stimulation assembly shown in FIG. Indicates. FIG. 18 shows the recharging of neuromuscular stimulation treatment by inserting a new battery so that the individual just involved in the dosing regimen “recharges” the individual's medications by taking the pills. 2 is a perspective view of a neuromuscular stimulation system comprising a neuromuscular stimulation assembly of the type shown in FIG. 1 associated with an ordered supply of replacement batteries and instructions for using the neuromuscular stimulation assembly. FIG. 19 is a perspective view of a neuromuscular stimulation system assembly of the type shown in FIG. 1 showing a second return electrode connected to the stimulation system. FIG. 20 is a bottom view of a neuromuscular stimulation system assembly of the type shown in FIG. 1, showing an adhesive region that includes both an active electrode portion and a return electrode portion.

Claims (9)

A neuromuscular stimulation system comprising:
A carrier sized and configured to be worn by an individual, the carrier comprising:
(A) a circuit configured to emit a stimulation pulse;
(B) a power input bay sized and configured to hold a disposable battery for the circuit that can be removed and replaced to operate the circuit; And (c) electrically connecting an electrode lead for an electrode percutaneously implanted in the targeted tissue region so as to apply the stimulation pulse percutaneously to the targeted tissue region. An electrode connecting element sized and configured to engage
Comprising a carrier,
Accordance battery replacement regimens formulated prescribe removal and replacement of batteries of the disposable, a instructions provided by the clinician or caregiver or physician, battery replacement regimen is the formulation repeated formulated Instructions, including replacement of the disposable battery in a manner as described, and a source of disposable batteries, each battery having a fixed amount for the circuit for administration according to the prescribed battery replacement regimen. A neuromuscular stimulation system comprising a source including power. The system of claim 1, wherein the carrier is sized and configured to be attached to an external skin surface at or near a targeted nerve or muscle region. The system of claim 1, wherein the neuromuscular stimulation is:
(I) maintenance of muscle function;
(Ii) tissue or bone regeneration;
(Iii) continuous active motion therapy;
(Iv) anti-scarring treatment;
(V) diagnostic evaluation;
(Vi) neuroplasticity treatment;
(Vii) anticonvulsant treatment;
(Viii) treatment of pain;
(Ix) postoperative recovery;
(X) antithrombotic therapy, and (xi) treatment of osteoporosis,
Providing a function selected from the group comprising: The system of claim 1, wherein the circuit comprises programmable code that controls the generation of the stimulation pulse. The system of claim 1, wherein the carrier comprises means for allowing a user to program programmable code. The system of claim 1, wherein the prescribed battery replacement regimen comprises a disposable battery replacement that is repeated on a basis at least about once a day. The system of claim 1, wherein the prescribed battery replacement regimen includes a disposable battery replacement that is repeated on a basis at least about once a week. The carrier further comprises (d) an area sized and configured to adhere the carrier to an external skin surface and allow removal of the carrier from the external skin surface; The system of claim 1. The system of claim 1, wherein the carrier further comprises: (d) a removable and replaceable electronic pod sized and configured to hold the circuit and the power input bay.

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