This invention relates to a method for obtaining a biopsy of tissues of an internal organ of a patient. This invention also relates to an associated device for obtaining a biopsy by the method of the invention. A method and device in accordance with the invention are particularly, but not exclusively, useful in obtaining a biopsy of the liver or the spleen.
A biopsy device currently exists for obtaining tissue samples from internal organs. The device includes a rigid shaft in the form of a rigid tubular member having a sharp distal tip. An elongate rigid rod is inserted through the tubular member, the rod having a sharp distal tip and a recess juxtaposed to the sharp distal tip. An actuator handle is operatively connected to the rod at a proximal end thereof for moving rod relative to the tubular member to insert organic tissues into the recess and subsequently to shear the inserted organic tissues and retain the sheared tissues in the recess.
This biopsy device is marketed under the trademark TRU-CUT and is used by inserting a distal end portion of the device directly into an organ from outside the organ. This insertion can be implemented through overlying tissues. For example, a liver biopsy can be obtained by piercing the abdominal wall of a patient with the sharp distal end of the tubular member, pushing the biopsy device so that the distal end portion of the device passes through the abdominal wall and underlying connective tissues and enters the liver. The rod is then moved in the distal direction relative to the tubular member to thereby expose the recess for receiving liver tissue. Subsequently, the tubular member is shifted distally to cover the recess and thereby shear liver tissues to capture a tissue sample in the recess. Upon capture of the sample, the biopsy device is withdrawn from the patient.
This method for obtaining a tissue sample from the liver has been largely successful but nevertheless suffers from some serious complications or disadvantages. For example, the technique is painful to patients. Moreover, there is a substantial morbidity in the conventional TRU-CUT liver biopsy. The patient can bleed into the abdomen. Usually, liver biopsies are performed on patients who have liver disease including associated coagulation disorders. The liver controls coagulation, particularly with vitamin K and proteins which are essential. Accordingly, a bleeding liver frequently fails to form a clot.
If patient bleeds into the abdomen as a result of a liver biopsy, a transfusion may be required, or even an operation. Operating is dangerous because of the liver disease.
More recently, liver biopsies are taken during a laparoscopic procedure. A laparoscope is used to guide a liver biopsy under direct view. If bleeding occurs, it is controlled by inserting a coagulation device through another laparoscopic trocar sleeve.
If there is bleeding as a result of a liver biopsy in accordance with the present invention, the blood flows directly into the venous system.
Splenic biopsies not possible now. Percutaneous biopsy has a 1% chance of bleeding requiring a splenectomy, which is unacceptable for routine biopsy.
USPTO Backgrounds
USPTO Backgrounds