Patent Application
20070156085
1. Field of the Invention
The present invention relates to implantable medical devices and more specifically to implantable medical devices having sensing capabilities.
2. Description of the Related Art
Peripheral Vascular Disease (PVD) refers to a number of conditions that occur within the vasculature generally outside of the heart and the brain. There are two broad categories of PVD including transient variants such as Raynaud's disease and structural variants resulting from occlusion, inflammation or tissue damage affecting a vascular structure. Peripheral artery disease (PAD) is an example of such a variant and is caused by partial or complete occlusion. PAD is similar to coronary artery disease (CAD), which occurs in and around the vasculature of the heart. When the occlusion becomes sufficient, ischemia results leading to an infarct if alternative delivery pathways are not available.
Transient varieties of PVD, such as Raynaud's disease relate to spasmic occlusion of a vessel, often induced by exposing an extremity to a cold source. The patient's reaction to the low temperature causes vasoconstriction that reduces or prevents blood flow. Stress and other factors may induce episodes.
Typically, the episodes are transient and upon vasodilation blood flow resumes without damage to the relevant tissue. In some cases, an infarct may occur that results in the loss of tissue or a digit of the extremities. The patient is particularly sensitive to cold and the phenomenon of vasoconstriction and subsequent dilation results in particular tonal changes to the skin that evidence Raynaud's disease. Treatment generally includes avoiding exposure to the cold and in severe cases drugs may be provided.
With PAD and similar variants, there is a wide variety of symptoms with many patients being completely unaware that any condition exists. Diabetic patients are at increased risk for the disease as well as for developing serious complications from the disease. As indicated, as many as half the patient population with PAD may be asymptomatic. Those patients experiencing symptoms may feel fatigue, pain, cramping, numbness, or a feeling of coldness. Arterial occlusions may lead to ischemia and infarct that result in the loss of a limb and may have fatal consequences.
Of note, PAD is similar to CAD. Furthermore, a finding of PAD may indicate CAD and cardiac disorders that cause emboli, such as atrial fibrillation, are a major cause of arterial embolisms resulting in PAD. Thus, patients having CAD, various cardiac disorders, and diabetes are at particular risk for PAD and may receive heightened scrutiny during a medical exam. Conversely, a determination of PAD may lead to testing for previously unknown CAD, cardiac disorders and diabetes.
When suspected, the patient's pulse is evaluated distal to the occlusion. If present, the pulse is reduced or absent. Pressure measurements are evaluated, such as with the ankle brachial index. Sequentially obtained (distally) measurements may be made to identify the location and the severity of the obstruction, when present in an extremity. MRI, Doppler measurement and other non-invasive techniques may be employed for further diagnosis.
Treatment will depend upon the severity of the disease and range from monitoring the status to providing medications, such as blood thinners, to more invasive techniques such as implanting a stent, atherectomy, bypass procedures and if necessary, amputation.
A partial occlusion 50 is illustrated at the proximal end of the deep femoral artery 24. Thus, blood flow through the deep femoral artery 24 and any dependent arteries will be reduced. A complete occlusion 52 is illustrated at the genicular artery; thus, blood flow is completely stopped beyond this point.
The occlusions 50, 52 may be formed in any number of ways. For example, a thrombus may be present, which is essentially a blood clot. Plaque or cholesterol deposits may also form occlusions. There may be a stricture, which is a scarring of the artery that forms as the result of some insult or injury. Alternatively, the occlusion 50, 52 is the result of external pressure or constriction, rather than a foreign body. Of course, there are a great many things that may result in the occlusions 50, 52 with the net result being either a reduction (which may or may not be significant) or cessation of blood flow beyond the occlusion.
Depending upon the nature and severity of the occlusion 50, 52, the patient 10 may or may not experience symptoms and if symptoms are present, they may be transient or of such a nature (e.g., numbness, tingling) that they are ignored. Alternatively, the patient's caregiver may identify the occlusions 50, 52 and provide an appropriate course of treatment.
In general, PVD is not well understood and despite the use of these treatments, recurrence is often likely. It is also difficult to gauge any degree of success or predict which patients are likely to develop subsequent, similar problems.
As tissue 80 is deprived of oxygen, the color of the tissue varies. Thus, the perfusion sensor 70 is able to determine how oxygenated the relevant tissue 80 is based upon any color or tonal changes. Of course, human physiology delivers oxygenated blood in a pulsitile manner, thus, there will be normal or expected variations. However, if the blood supply to the tissue is compromised a notable change will occur relatively rapidly. The degree to which the supply is compromised may also be determined; that is, perfusion may be minimally impacted or there may be tissue death, with a spectrum between.
Referring to
alternatively, the sensor 70 may be positioned such that the artery in question and more specifically the site of the occlusion is monitored. That is, light is directed to the selected location of the artery and the reflected light is indicative of oxygen saturation. With the monitoring of a specific occlusion, other techniques such as Doppler or acoustic techniques may be used to measure the dimensions of the artery.
Positioning a relatively small perfusion sensor 70a at exactly the location of the occlusion 50 and achieving proper orientation of the emitter 74 and detector 72 may be challenging. Thus, the present inventions also provides for implanting or injecting one or more perfusion sensors 70b into tissue (or monitoring the artery itself) distal to the occlusion site. Thus, if the occlusion 50 were to reform (or not have been completely removed in the first place), the effect will be apparent to such sensors 70b as the perfusion of tissue is affected. Similarly, sensor 70c is illustrated proximate the stent 65. While achieving exact placement may still be challenging, the sensor 70c may be implanted concurrent with the stent 65 thus making placement somewhat less difficult. Furthermore, the sensor 70c, in one embodiment may be incorporated into a portion of the stent 65. Sensors 70d and 70e are positioned to monitor tissue distal to the stent 65 such that if the stent fails and blood flow is occluded, the sensors 70 will determine this effect on tissue perfusion.
Sensor 70f represents another distal implant site. Thus far, the sensors 70 have been presented as a mechanism to monitor the success of a given treatment for a known occlusion. It should be appreciated that with the size and ease of implant of the perfusion sensor 70, such a sensor may be used to determine whether an occlusion is present, if so where, and to what extent the occlusion is impeding circulation. For example, sensor 70f may be used to determine the effectiveness of stent 65 or prior to such treatment, that sensor may have been implanted and identified that an occlusion was present proximal to the sensor 70f.
A single implanted sensor 70 may or may not be sufficient for either monitoring treatment or detecting circulation problems. That is, a single sensor 70 implanted at the correct location will identify variations in tissue perfusion.
However, the selected tissue may be supplied by multiple arteries or an artery not affected by a particular occlusion. In such a case, an array 90 of perfusion sensors 70 is implanted or injected. The number of such sensors 70 in a given array 90 will vary, but they are positioned to cover a larger area of a limb so that any circulation abnormalities will likely affect some area of tissue under surveillance. Thus, while illustrated as a single sensor 70f, an array 90 may be placed about the leg at one or more depths.
Even when a given occlusion is identified and treated, other occlusions may be present. Thus, a caregiver may remove a known occlusion and restore circulation; however, another occlusion may have escaped detection and either pose an immediate problem or worsen over time. The sensor 70 or an array 90 may be used to monitor the success of the given treatment and also may serve to identify the presence of additional occlusions.
With one or more sensors 70 so implanted, tissue perfusion is monitored for a given patient. Thus, the success of a given treatment can be evaluated and if necessary further or alternate treatments may be provided. Without such monitoring, an occlusion may worsen and lead to the loss of tissue, the amputation of a limb or potentially even death. Conversely, when a patient 10 has symptoms that are not readily explained, such monitoring may be provided to identify transient occlusions or static occlusions that were previously unknown or undetectable.
Variations in perfusion may indicate that the organ is being rejected. Treatment may include varying the patient's anti-rejection medication or determining that another transplant is necessary.
A communication bus 126 is provided to enable data transfer via interchip communication module 134. A microprocessor 130 is powered by the power source 102 via voltage regulator 132. The microprocessor 130 includes one or more analog to digital converters that receive the amplified output from the photodetectors, one or more memory devices and a clock. The signal from the photodetectors is processed and an output indicative of tissue color/perfusion or changes thereto is stored in the memory. While not limiting, in one embodiment sufficient memory is provided to collect data for about 100 days. The sensor 70 includes a transmission module 136 that permits the data within the memory to be telemetered to an external device wherein a caregiver may evaluate the data. Such transmission may occur on a real-time basis to an external device that is maintained proximate the patient 10 or on a periodic basis when the external device interrogates the sensor 70.
Due to the shape and the small size of the housing 200, tissue growth or encapsulation around the housing 200 will minimally interfere with the sensor 70's performance. That is, because the device has curved surfaces and is small compared with the track of the delivery mechanism (e.g., needled), the sensor 70 will be “ignored” by the surrounding tissue as it tends not to irritate that tissue.
Thus, whereas some sensors suffer from tissue growth around their implant which would hinder certain optical measurements, the present sensor 70 avoids such issues based upon size and configuration.
Another aspect of the housing 200 is that the sensor 70 may simply be left in place after its use has expired. That is, there is no particular need to extract the device. Furthermore, if monitoring on a longer term basis is required, one embodiment provides for a battery that is externally rechargeable. Alternatively, another device is simply injected proximate the expired device. As such sensors will be relatively inexpensive and may remain implanted, this provides for an effective protocol.
Alternatively, the patient 10 is ambulatory and the EMD 300 is carried with the patient 10 for continuous data collection or positioned in the patient's home for frequent data collection sessions. Of course, the patient 10 may simply visit a caregiver on a periodic basis to have data from the sensor 70 collected.
The perfusion sensor 70 may be utilized in a variety of ways. In one scenario, a patient may indicate that he has symptom such as pain in an extremity when exposed to cold. The caregiver may prescribe aspirin or other pain relievers to address the pain. Now the caregiver may also inject the wireless perfusion sensor 70. After one or more episodes, the caregiver may evaluate the data and determine whether a transient PVD is present and if so its severity. Furthermore, this disease may progress in severity over time and this is likewise tracked by the sensor 70. Thus, the patient 10 may take the pain medication and tolerate the symptoms and the caregiver can evaluate what is causing the symptoms and if more extensive treatment is required.
In another scenario high risk patients are implanted with one or more wireless perfusion sensors 70 or arrays of such sensors. High risk patients may include, but are not limited to those patients who have previously had an occlusion, including CAD; stroke patient, diabetic patients, and those who have become bedridden or otherwise immobilized. Here, perfusion is monitored and if changes are noted and occlusion or the formation of an occlusion may be detected early, potentially avoiding serious complication.
In another scenario, patients who are being treated for a PVD may be monitored to evaluate the effectiveness of the current treatment. Again, if the treatment is unsuccessful or symptoms redevelop, the sensors 70 will provide an early indication. Likewise, the use of the wireless perfusion sensor may identify the presence of other occlusions.
