Implantable device with sensors for differential monitoring of internal condition

This application is a continuation of U.S. patent application Ser. No. 10/789,492, filed Feb. 26, 2004, entitled “Implantable Device with Sensors for Differential Monitoring of Internal Condition,” the content of which is incorporated herein by reference in its entirety. U.S. patent application Ser. No. 10/789,492 claims priority to U.S. Provisional Patent Application 60/449,963, filed Feb. 26, 2003, and U.S. patent application Ser. No. 10/776,022, filed Feb. 9, 2004, “Surgical Drain with Sensors for Differential Monitoring of Internal Condition,” which issued as U.S. Pat. No. 7,244,251 on Jul. 17, 2007. U.S. patent application Ser. No. 10/776,022 claims priority to U.S. Provisional Patent Applications 60/445,714, filed Feb. 7, 2003, and 60/453,009, filed Mar. 6, 2003. The entire contents of all of the above-referenced patent and patent applications is incorporated by reference in their entirety.

1. Field

The present invention is directed to devices and methods of using devices to monitor internal tissue condition, and more particularly to an implantable device or system having at least two sensors for differential monitoring the condition of a tissue or fluid proximate to the sensors.

2. Description of Related Art

It is desirable for a physician to know the condition of organs, or more generally tissues within the patient\'s body particularly after trauma or surgical manipulation. Since such tissues may reside under the skin or within a body cavity, a physician must invasively inspect the tissue (such as by surgery, including laparoscopy), or use indirect measures to assess a tissue\'s condition (such as radiology, blood testing and patient accounts of sensations of illness or pain). However, these methods can be disadvantageous. An invasive examination may cause discomfort and risk of infection to the patient, and the information obtained either through direct inspection or indirectly via blood or radiological analysis, may be relevant only to the time at which the procedure is performed, and examination may render only indirect information about the physiological condition of the tissue.

Monitoring of tissue function can be important after surgeries such as organ transplantation, resection, cryosurgery and alcohol injection. Surgical complications, including tissue rejection, infection, non-specific inflammation, and vascular complications should be monitored. For example, vascular complications, may disrupt adequate oxygen circulation to the tissue, which is critical to organ function and survival. Following liver surgery, for example, a physician may draw patient blood to determine the condition of the organ by measuring liver enzymes (such as transaminases) and clotting factors (such as prothrombin). Unfortunately, these blood tests reflect liver condition only at the time the blood sample is drawn, and changes in these laboratory values can often be detected only after significant organ damage has already occurred, permitting a limited opportunity for intervention by the physician to improve the condition of the organ or find a replacement organ in case of transplantation for the patient.

Early access to information regarding complications would allow early intervention and avoid the need for more invasive procedures such as biopsy, angiogram, nephrogram, etc. and further associated complications. Both early diagnosis of complications and early intervention may improve the chances of therapeutic intervention prior to irreversible damage, tissue survival and decrease the risk of mortality and morbidity in patients, and may also play an important role in reducing the organ shortage and the extra cost and risk of retransplantation.

By further example, intra-abdominal pressure following major surgery or trauma (such as a car accident, gun shot wounds, combat, or earthquake injuries) may rise to extremely high levels due to tissue edema secondary to the injury, especially following multiple blood transfusions, severe shock or inflammatory responses.

An increase in pressure may lead to severe organ dysfunction, such as kidney failure and acute respiratory failure due to lung compression through the diaphragm. The increased pressure in the abdomen may also lead to a decrease in the venous returns to the heart, therefore, affecting the cardiac output and the perfusion to all organs/tissues leading to a decrease in oxygen delivery.

Early detection of critical intra-abdominal pressure may be corrected by several interventions, including sedating the patient or opening of the abdomen. Prompt restoration of proper intra-abdominal pressure can reverse the consequences described above. However, once a critical point is reached, organs may suddenly fail, which may be irreversible in certain conditions and lead to rapid deterioration of multiple organs and potentially death.

One method of monitoring intra-abdominal pressure following major surgery or trauma relies on indirect measurement of intra-organ pressure such as the bladder or the stomach pressure. These methods require direct operator intervention and are done only intermittently at a specific timing, such as every 1 to 4 hours, or if the patient shows signs of deterioration.

Current methods of measuring abdominal pressure may carry significant errors due to direct personal intervention, lack of reproducibility and challenges related to the injury itself. For example, a large hematoma or pelvic fracture may affect the bladder pressure directly without relation to the overall intra-abdominal pressure.

As discussed above, current methods of internal tissue monitoring have significant disadvantages. Therefore, it is desirable to have a device and methods to aid physicians in predicting problems and complications associated with internal trauma or surgery. It is desirable to have a device which is positionable and removable with relatively minimal effort, minimally invasive and causes minimal discomfort for the patient, provides continuous current information about tissue or organ condition, provides direct information about tissue or organ condition, and/or provides feedback on the effects of interventions, such as medications or other procedures to improve tissue or organ condition.

In one embodiment of the invention, a device may be used for intraoperative and/or postoperative monitoring of the condition of a tissue.

In one embodiment of the invention, a device having at least two sensors may be used to provide continuous differential measurements relating to the physiological condition of a tissue or fluids proximate to a tissue.

In one embodiment, an implantable device may be configured for ease of application by a physician, as well as ease of removal when monitoring is no longer required.

These, as well as other objects, features and benefits will now become clear from a review of the following detailed description of illustrative embodiments and the accompanying drawings.