The present invention is related to medical implants, and more particularly, to electrical stimulation of nerves within a patient's extremities, for the treatment of intractable pain.
Intractable pain in a patient's limb, such as pain in the plantar surface of the foot, can be secondary to several conditions: plantar fasciitis, bunions, entrapped nerves, neuromas, nerve damage, diabetic neuropathy, to name a few. Millions of individuals in the USA suffer severe plantar foot pain which does not respond to conventional treatment modalities (medications, injections, surgical procedures, etc.).
A heel neuroma is basically a nerve entrapment that occurs amongst the inflammation that occurs in heel pain. Most patients will present with a complaint of heel pain on the bottom of the heel. After the interview, examination, x-rays and any other tests, the doctor may perform a diagnosis of plantar fasciitis or heel spur. There are other less common conditions that may also cause heel pain. It has been noticed that, in a substantial percentage of individuals where the diagnosis of plantar fasciitis or heel spur is made, there is also involvement of the “calcaneal nerve” which is a small branch that comes off the larger nerve. This nerve is located on the inside part of the heel and travels underneath the heel. The nerve can be traumatized from the constant pounding that the heel takes both in walking and exercise. This condition can also be accelerated by a degeneration of the fat pad on the bottom of the heel. In those cases where the heel pain gets worse as the patient ambulates, a diagnosis of heel neuroma has to be considered.
Interdigital neuroma, more commonly known as Mortons neuroma or “foot neuroma,” is an entrapment of a nerve that passes into the toes of the foot. The nerve becomes entrapped by the metatarsal bones. Typically this type of pain in the ball of the foot is the result of wearing shoes that are too narrow or with very flimsy soles, or in the case of women, high heel shoes. Other factors that will cause this condition can be the specific architecture of a person's foot structure, as well as occupational hazards such as those who work low to the ground forcing them to kneel down for long periods of time.
Complex Regional Pain Syndrome can be very painful. Typically, a person will be walking in shoes (although the condition can be painful out of shoes as well), and will develop a sharp pain just behind the third and fourth toes. Complex Regional Pain Syndrome is a still poorly understood neurological phenomenon that carries a number of names: Reflex Sympathetic Dystrophy (RSD), Sudecks Atrophy and causalgia. The condition is basically a short circuit of the nervous system where nerves misfire, thus sending constant pain signals to the brain. In other words, it is a completely abnormal response by the nervous system to normal external stimuli.
Metatarsal joint pain commonly results from misalignment of the joint surfaces, which puts pressure on the joint lining and destroys cartilage in the joints. Mild heat and swelling may develop pain in the ball of the foot (called metatarsalgia) and may have many different causes (including arthritis, poor circulation, pinching of the nerves between the toes, posture problems, and various disorders). However, most often the pain is caused by nerve damage or by an abnormality of the joints nearest the balls of the feet (metatarsal joints). Fat tissue, which helps cushion the joints when bearing weight can be pushed forward under the toes, resulting in a loss of cushioning. This loss of cushioning can also damage the nerves in the ball of the foot.
Often, developing one disorder that causes pain in the ball of the foot contributes to development of another disorder that causes pain in the same location.
Sesamoiditis is pain around a small bone (the sesamoid) below the metatarsal head where it adjoins the big toe (first metatarsal head). The cause of sesamoiditis is usually repeated injury. Sometimes the bone is fractured, or the bone or surrounding structures are inflamed. Sesamoiditis is particularly common among dancers, joggers, and those who have high-arched feet or wear high heels. The pain of sesamoiditis is felt beneath the ball of the foot at the big toe, is usually made worse by walking, and may be worse when wearing certain shoes. The area may be warm or swollen.
Plantar fasciitis is the most common condition of heel pain. This condition occurs when the long fibrous plantar fascia ligament along the bottom of the foot develops tears in the tissue resulting in pain and inflammation. The pain of plantar fasciitis is usually located close to where the fascia attaches to the calcaneous, also known as the heel bone. Plantar fasciitis causes the inflammation of the plantar fascia ligament that runs along the bottom of the foot. The plantar fascia ligament is made of fibrous bands of tissue and runs between the heel bone and the toes and stretches with every step. Inflammation develops when tears occur in the tissue.
The most common complaint from plantar fasciitis is a burning, stabbing, or aching pain in the heel of the foot. Most sufferers will be able to feel it in the morning because the fascia ligament tightens up during the night while we sleep, causing pain to diminish. In most cases, plantar fasciitis does not require surgery or invasive procedures to stop pain and reverse damage. Conservative treatments are usually all that is required. However, every person's body responds to plantar fasciitis treatment differently and recovery times may vary.
There are a number of plantar fasciitis causes. The plantar fascia ligament is like a rubber band and loosens and contracts with movement. It also absorbs significant weight and pressure. Because of this function, plantar fasciitis can easily occur from a number of reasons. Among the most common is an overload of physical activity or exercise. Athletes are particularly prone to plantar fasciitis and commonly suffer from it. Excessive running, jumping, or other activities can easily place repetitive or excessive stress on the tissue and lead to tears and inflammation, resulting in moderate to severe pain. Athletes who change or increase the difficulty of their exercise routines are also prone to overdoing it and causing damage.
A problem associated with treating the pain associated with the above-described conditions is the necessity to implant a pulse generator for providing the controls and power source for applying a stimulation signal to the appropriate nerve, such as the posterior tibial nerve. That is, for a relatively large implantable pulse generator, many patients do not have a calf of sufficient size to adequately serve as the implant location for the implantable pulse generator. As a result, the implantable pulse generator is positioned a significant distance from the electrode paddle, thereby requiring a lengthy wire that interconnects the implantable pulse generator to the electrode paddle. For example, the implantable pulse generator may be positioned in the patient's thigh or buttocks. The wire is therefore required to traverse the patient's knee, and is subject to bending and significant wear. This then leads to failure of the system causing one or more subsequent surgical events to become necessary to restore the system to working order. As a result, not only does the patient suffer when the system fails, but additional pain is endured because of the necessity for additional surgical procedures. In addition, higher health care costs are also incurred. Accordingly, there is a need for a system that address the shortcomings discussed above.
It is to be understood that the present invention includes a variety of different versions or embodiments, and this Summary is not meant to be limiting or all-inclusive. This Summary provides some general descriptions of some of the embodiments, but may also include some more specific descriptions of other embodiments.
A posterior tibial nerve stimulation system is provided for treating pain in the leg of a patient, such as pain in the foot of the patient. Thus, in at least one embodiment, a neurostimulation system is provided for treating pain in at least a portion of a leg of a patient, the system comprising:
In at least one embodiment the neurostimulation assembly further comprises a wearable appliance for recharging the implantable pulse generator. In at least one embodiment the wearable appliance is selected from a group consisting of a sock, wrap, and sleeve. In at least one embodiment of the neurostimulation assembly the shapeable housing comprises a bendable metal structure. In at least one embodiment of the neurostimulation assembly the bendable metal structure comprises a plurality of metallic strands such as separated wires. In at least one embodiment of the neurostimulation assembly the bendable metal structure comprises a wire mesh. In at least one embodiment of the neurostimulation assembly the implantable pulse generator comprises an arcuate shaped battery. In at least one embodiment of the neurostimulation assembly the implantable pulse generator comprises a plurality of batteries. In at least one embodiment of the neurostimulation assembly at least two batteries of the plurality of batteries are separated from each other by a hinge. In at least one embodiment of the neurostimulation assembly the hinge comprises a locking mechanism. In at least one embodiment of the neurostimulation assembly the shapeable housing comprises at least one hinge. In at least one embodiment of the neurostimulation assembly the at least one hinge comprises a locking mechanism.
A nerve stimulation system is provided for treating pain in a limb of a patient, such as by way of example and not limitation, pain in the foot, ankle, knee, leg, hand, wrist, elbow, and/or arm of the patient. Thus, in at least one embodiment, a neurostimulation system is provided for treating pain in a limb of a patient, the system comprising:
The present invention encompasses a variety of possible configurations for the implantable pulse generator. Accordingly, a neurostimulation assembly for implanting in the calf region of a patient is provided, the neurostimulation assembly for treating pain in the foot of a patient, the neurostimulation assembly comprising:
One or more embodiments described herein may be used to treat a variety of indications. Accordingly, a subcutaneously implantable neurostimulation system for treating pain in a limb of a patient is provided, the system comprising:
In at least one embodiment of the subcutaneously implantable neurostimulation system the first node comprises at least one planar surface. In at least one embodiment of the subcutaneously implantable neurostimulation system the implantable pulse generator further comprises a second node, wherein the second node comprises a battery. In at least one embodiment of the subcutaneously implantable neurostimulation system the implantable pulse generator comprises a hinge. In at least one embodiment of the subcutaneously implantable neurostimulation system the implantable pulse generator comprises a bendable member.
Various components are referred to herein as “operably associated.” As used herein, “operably associated” refers to components that are linked together in operable fashion, and encompasses embodiments in which components are linked directly, as well as embodiments in which additional components are placed between the two linked components.
As used herein, “at least one,” “one or more,” and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
Various embodiments of the present inventions are set forth in the attached figures and in the Detailed Description as provided herein and as embodied by the claims. It should be understood, however, that this Summary does not contain all of the aspects and embodiments of the one or more present inventions, is not meant to be limiting or restrictive in any manner, and that the invention(s) as disclosed herein is/are understood by those of ordinary skill in the art to encompass obvious improvements and modifications thereto.
Additional advantages of the present invention will become readily apparent from the following discussion, particularly when taken together with the accompanying drawings.
To further clarify the above and other advantages and features of the present invention, a more particular description of the invention is rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention is described and explained with additional specificity and detail through the use of the accompanying drawings in which:
a and 2b are perspective views of two appliances used to recharge a battery associated with the device illustrated in
a is a side elevation view of another embodiment of an implantable pulse generator;
b is a top plan view of the device shown in
c is a top plan view of an embodiment of an implantable pulse generator;
d is a side elevation view of the device shown in
e is a top plan view of the device shown in
The drawings are not necessarily to scale.
Intractable pain in the plantar surface of the foot can be secondary to several conditions: plantar fasciitis, bunions, entrapped nerves, neuromas, nerve damage, diabetic neuropathy, to name a few. One or more embodiments of the one or more present inventions include an implantable pulse generator comprising one or more structural features for accommodating the shape of a portion of the patient's leg, such as the shape of the patient's calf. Embodiments may further include features for improving the esthetics of the implant after it is implanted within the patient.
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In at least one embodiment, the implantable neurostimulation system 100 (including the implantable pulse generator 104, lead 112, and electrode paddle 108), as well as the other systems shown herein, are surgically positioned to reside subcutaneously, that is, entirely under the patient's skin after the implantation procedure is completed.
In at least one embodiment, the implantable pulse generator 104 is relatively thin, such as about 0.5 to 1.0 cm in thickness. The implantable pulse generator 104 may comprise a rechargeable battery. In addition, in at least one embodiment the battery within the implantable pulse generator 104 is approximately the same shape as the exterior housing of the implantable pulse generator 104. That is, the battery may also comprise an arcuate shape. In at least one embodiment, the implantable pulse generator provides a maximum amperage output of about 10 mAmps, about PW 10 to 200 msec at a frequency or rate of about 10 to 100 Hz.
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The implantable pulse generator 1200, therefore, includes features for reducing the profile of its various parts when implanted. The first node 1204 and second node 1208 are sized to accommodate one of either the control chip 1220 or battery 1224. Alternatively, depending upon the size of the control chip 1220 used, node 1204 or 1208 may include both a control chip 1220 and a battery 1224. The first node 1204 and second node 1208 serve to hold and protect the control chip 1220 associated with the implantable pulse generator 1200, and the arcuate-shaped bridge 1212 serves to distribute their location around a portion of the patient's leg while also serving as an electrical link.
In accordance with at least one embodiment, the arcuate-shaped bridge 1212 contains one or more batteries. By way of example and not limitation, at least a portion of a battery may reside within the arcuate-shaped bridge 1212, such that the battery itself is curved, and/or such that two or more relatively small batteries are used within the arcuate-shaped bridge 112.
In accordance with at least one embodiment, at least one node and/or the arcuate-shaped bridge 1212 may include a means for allowing the implantable pulse generator to be attached to the patient's internal tissue, such as tabs or apertures for receiving sutures, staples and/or similar anchoring materials.
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In accordance with at least one embodiment, an implantable pulse generator substantially comprises a curved bar, wherein neither of the right or left ends (that is, the medial and lateral ends) have a size that differs substantially from the height of the arcuate-shaped bridge 1212 residing between the ends. In addition, the horizontal length of the curved bar, that is, its arc length, is greater than a vertical height of the curved bar (as oriented when implanted). Thus, the curved bar is implanted below the patient's skin and it fits around the patient's leg, thereby distributing its profile to be similar to the lateral curvature of the patient's calf. Here, it is noted that in at least one embodiment, the curved bar is made of a substantially non-bendable material. Alternatively, at least portions of the curved bar may comprise bendable elements, such as those described above, that permit the surgeon to customize the fit of the implantable pulse generator.
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The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
The one or more present inventions, in various embodiments, include components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various embodiments, subcombinations, and subsets thereof. Those of skill in the art will understand how to make and use the present invention after understanding the present disclosure.
The present invention, in various embodiments, includes providing devices and processes in the absence of items not depicted and/or described herein or in various embodiments hereof, including in the absence of such items as may have been used in previous devices or processes (e.g., for improving performance, achieving ease and/or reducing cost of implementation).
The foregoing discussion of the invention has been presented for purposes of illustration and description. The foregoing is not intended to limit the invention to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the invention are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the invention.
Moreover, though the description of the invention has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the invention (e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure). It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
This application claims the benefit of U.S. Provisional Patent Application No. 61/231,837 filed on Aug. 6, 2009, the content of which is expressly incorporated herein by reference.
Number | Date | Country | |
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61231837 | Aug 2009 | US |
Number | Date | Country | |
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Parent | 12851882 | Aug 2010 | US |
Child | 13747293 | US |