Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-08-09
2001-02-20
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06190330
ABSTRACT:
TECHNICAL FIELD
The invention relates to surgical, therapeutic and diagnostic equipment and, more particularly, to endoscopes and endoscopic accessories.
BACKGROUND OF THE INVENTION
The use of intrabody medical equipment, such as endoscopes, catheters, and the like, for surgical, diagnostic and therapeutic purposes is rapidly expanding. To improve performance, the equipment has been optimized to best accomplish selected purposes. For example, endoscopes have been optimized and refined to provide upper endoscopes for examination of the esophagus, stomach, and duodenum; colonoscopes for the colon; angioscopes for blood vessels; bronchoscopes for the bronchi; laparoscopes for the peritoneal cavity; arthroscopes for joint spaces; nasopharyngoscopes for nasal passages and the pharynx; and intubation scopes for a person's airway.
A conventional endoscopic system
10
, shown in
FIG. 1
, has an insertion tube
12
that is connected at a proximal end
14
to a handle or headpiece
16
. The insertion tube
12
is adapted to be inserted into a patient's body to perform a selected surgical, therapeutic or diagnostic procedure. The endoscopic system
10
is generally manufactured with either a rigid or flexible insertion tube
12
. The rigid insertion tube
12
maintains its shape to allow the operator to change the position of the portion of the insertion tube
12
that is within the body by applying torque to the portion of the endoscopic system
10
that is outside the body. The flexible insertion tube
12
, on the other hand, cannot be controlled in such a manner. Instead, control wheels
24
are mounted on the headpiece
16
and connected to the insertion tube's distal end
20
by control cables (not shown). The control wheels
24
are manipulated to bend the insertion tube's distal end
20
to move the distal end
20
up, down, left, or right. Accordingly, the distal end
20
can be controlled to allow improved visibility or positioning of working tools within the patient's body.
The insertion tube
12
often contains an imaging system
18
having optical fibers or the like extending along the length of the insertion tube and terminating at a viewing window
19
in the insertion tube's distal end
20
. The imaging system
18
conveys an image from the viewing window
19
to an eyepiece
22
on the headpiece
16
, or to a monitor (not shown), so the user can see into a selected body cavity during an endoscopic procedure. Through manipulation of the control wheels
24
, an operator can cause the distal end
20
of the insertion tube
12
to become substantially linear, or to take a curved shape to selectively position the viewing window
19
.
The endoscopic system
10
also has an elongated working channel
32
extending from the proximal end
14
to the distal end
20
of the insertion tube
12
. The working channel
32
is hollow along its length, and terminates in an opening
30
at the distal end
20
of the insertion tube
12
. A working tool, such as a biopsy needle (not shown), to be used in a particular procedure is inserted into the working channel
32
from the proximal end
14
of the insertion tube
12
and threaded through the working channel
32
. The working tool is manipulated at the headpiece
16
external to the patient to selectively project from the working channel's opening
30
in the patient during a procedure, such as when collecting samples of tissue. The working channel
32
can also be used to inject fluid into the patient or to create suction during a procedure. The endoscopic system
10
is described in greater detail in U.S. Pat. No. Re 34,110 and U.S. Pat. No. 4,646,722, which are incorporated herein by reference.
The illustrated endoscopic system
10
, however, may not be suitable for all types of procedures. A cardiac catheter, for example, may be too narrow to contain both the working channel and imaging system, and may consequently be designed without an imaging system. The operator using such a cardiac catheter typically performs the procedure without direct visualization. The operator instead performs the procedure while the patient undergoes fluoroscopy, or with the help of an assistant, such as a cytologist, who performs cell assays on site to help determine whether the operator has located the desired area for the procedure.
Miniature location sensors have been developed to attach to the distal end of cardiac catheters and neuro probes to provide the operator with indirect visualization to determine the location of the distal end of the device inside the patient during the procedure. In indirect visualization, real time location information from the sensor is superimposed over a previously acquired CT or MRI model to illustrate to the operator the location of the distal end of the insertion tube with respect to the patient. Examples of such indirect visualization systems are described in more detail in U.S. Pat. Nos. 5,546,951 and 5,568,809, which are incorporated herein by reference.
SUMMARY OF THE INVENTION
The present invention is directed to an endoscopic assembly and methods of using the endoscopic assembly that overcome deficiencies experienced in the prior art. The endoscopic assembly is adapted to assist an operator having a first position indicator component in accurately monitoring the location of a distal end of an accessory within a patient and to create a partial vacuum at or collect a sample from a specific, identified location in the patient during an endoscopic procedure.
The endoscopic assembly has an elongated member and a second position indicator component, such as a sensor, transmitter or other homing device. The second position indicator component communicates with the first position indicator component external to the patient to aid the user in positioning the distal end of the assembly within the patient. The elongated member has a distal end insertable into the patient and a proximal end portion configured to remain external to the patient during the procedure. A bore extends from the proximal end portion of the elongated member to its distal end. The second position indicator component is sized to slidably engage the bore of the elongated member. The second position indicator component can be manipulated by the operator from the proximal end portion of the elongated member to move within the bore between first and second positions. In the first position, the second position indicator component is substantially adjacent to the distal end of the elongated member and is adapted to aid the operator in identifying and monitoring the position of the distal end of the elongated member inside the patient to facilitate placement of the distal tip near the desired location. In the second position, the second position indicator component is proximally spaced from the distal end of the elongated member to create a void between the second position indicator component and the distal end of the elongated member. The second position indicator component is conformed to the internal surface of the bore such that, when the second position indicator component is moved from the first position to the second position, the partial vacuum is generated in the bore near the distal end of the elongated member at the desired location. When the distal end of the elongated member is at the desired location in the patient and the partial vacuum is generated, samples such as liquid or solid material can be drawn into and retained in the elongated member's bore.
The endoscopic assembly can alternatively be used to collect multiple samples from one or more locations in the patient by collecting a first sample in the manner described above, then collecting an additional sample by moving the second position indicator component from the second position proximally to a third position to create a partial vacuum at the open distal end of the elongated member and draw the additional sample into the open distal end. The endoscopic assembly can further collect additional samples by sequentially moving the second position i
Dorsey & Whitney LLP
Hindenburg Max
Szmal Brian
Vision-Sciences, Inc.
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