Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1998-06-22
2001-08-28
Dawson, Glenn K. (Department: 3761)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S151000, C606S139000
Reexamination Certificate
active
06280452
ABSTRACT:
BACKGROUND OF THE INVENTION
Ligation is a medical procedure in which, for example, an elastic ligating band, is placed about tissue to prevent fluid flow therethrough. Where a ligating band is placed about, for example, a ballooning varix, polyp, hemorrhoid, or pre-cancerous lesion, a contracted ligating band induces fusion and healing in the base tissue and subjects the ligated tissue to necrosis. The necrotic tissue eventually separates from the surrounding tissue and passes into the human system. Alternatively, ligation may also be used for purposes of sterilization, wherein a ligating band may be placed over a folded loop portion of a Fallopian tube or a vas deferens to prevent the passage of internal reproductive fluids.
Means for delivering ligating bands, or ligating band dispensers, take various forms. One such form is a dedicated ligating band dispenser instrument which has a dispensing portion at a distal end, an actuating mechanism at a proximal end, and a typically rigid shaft therebetween. These instruments are useful for ligating tissue in which the user has access to the tissue to be ligated, e.g., tissue exposed through an invasive surgical procedure.
In contrast, ligating band dispensers may be positioned on the distal tip of an endoscope or a laparoscope. An endoscope is a conventional medical device used for viewing, exploring, and delivering therapies to internal regions of a patient. A laparoscope is a specialized endoscope for viewing a patient's peritoneal cavity. Unlike dedicated ligating band dispensing instruments, an endoscope allows minimally invasive exploration of regions which would otherwise require more significant surgical procedures.
FIGS. 1 and 2
illustrate a conventional endoscope. Endoscope
10
has a control portion
12
and an insertion portion
14
terminating at insertion tip
16
. Insertion portion
14
is of such a length to permit access to internal regions of a patient.
FIG. 2
illustrates the face of insertion tip
16
. A number of channels extend from the control portion
12
to the insertion tip
16
, where the channels terminate in functional outlets
18
-
26
. For the purposes of this example, outlet
18
is a light source; outlet
20
is a wide-field image sensing device, which transmits a video or fiber optic signal to a coupled monitor or eyepiece (not shown) at control portion
12
; outlet
22
enables the delivery of a stream of water or air for clearing the image receiving device or flushing an internal bodily region; and outlet
24
is an outlet to a working (or biopsy) channel. Inlet
28
of the working channel can be coupled to a suction device or a lavage fluid source (not shown) or can receive various medical instrumentation (not shown) for passage through the working channel and outlet
24
. Optional outlet
26
, for larger diameter endoscopes, is an outlet for a second working channel. A second working channel allows additional operations in a manner consistent with the working channel described above.
For a ligation procedure, a ligating band dispenser, mounted on insertion tip
16
of a hosting endoscope
10
, is inserted into a patient, for example, through the mouth, to observe certain internal regions. A user navigates the insertion tip
16
in accordance with images produced by the image-sensing device of outlet
20
. Once tissue has been targeted for ligation, the distal end of the dispenser is positioned adjacent to the targeted tissue. The user applies a vacuum to the appropriate outlet of insertion tip
16
(e.g., outlet
24
), or passes instrumentation (e.g., forceps) through the work channel and outlet
24
, to draw the targeted tissue into a volume defined by the inner periphery of the dispenser.
The user then dispenses a ligating band (two dispensers and their dispensing mechanisms are discussed in greater detail below). Upon dispensing a ligating band, the dispensed ligating band attempts to assume its non-expanded dimensions. As the subject tissue is positioned within the inner periphery of the ligating band, constriction of the band effectively ligates the subject tissue. The applied suction is ceased, and the insertion tip
16
is moved away from the ligated tissue and further exploration may be undertaken, if necessary.
Conventional endoscope ligating band dispensers commonly employ dispensing mechanisms which unnecessarily complicate a ligating procedure. Two examples of conventional mechanisms include a dispenser having a plurality of draw strings
1002
which are individually coupled to each of the stored ligating bands
1000
(FIG.
3
), and a dispenser having a mechanically actuated housing which engages and requires movement of all stored ligating bands
1000
for each dispensing operation (FIG.
4
).
In reference to
FIG. 3
, draw strings
1002
extend from each ligating band
1000
and around the distal end of the dispenser before extending proximally through the work channel of a receiving endoscope
10
. Application of a proximally-directed force to a single draw string
1002
effects distal movement and dispensing of a coupled ligating band
1000
.
As shown, each ligating band
1000
must be individually and properly coupled to at least one draw string
1002
to allow band control. As the number of stored ligating bands
1000
increase, the number of draw strings
1002
, and the criticality of their placement, increases. The draw strings
1002
must be optimally positioned to ensure reliable dispensing of a distal-most ligating band, to avoid obstruction of the image sensing device of the hosting endoscope, and to avoid filling the volume defined by the dispenser and effectively decreasing the tissue capacity of the dispenser. Understandably, the construction of this dispenser requires considerable care and is necessarily labor intensive.
Referring to
FIG. 4
, another conventional dispenser example includes a mechanically actuated housing having a movable inner element
1008
and a fixed outer element
1010
. Outer element
1010
carries a plurality of expanded ligating bands
1000
, excepting the distal-most ligating band
1000
a,
which is carried by inner element
1008
. For dispensing ligating band
1000
a,
element
1008
is drawn proximally, causing the distal-most ligating band
1000
a
to be released when inner element
1008
is pulled within outer element
1010
. During such movement, the remaining ligating bands
1000
are displaced by shoulders
1012
so that when inner element
1008
returns distally, ligating bands
1000
are distally advanced.
This dispenser requires an applied dispensing force having a magnitude sufficient to not only dispense a single ligating band but also distally displace the remaining stored ligating bands in preparation for a next ligation. As the number of stored ligating bands increase, the force necessary to move the ligating bands as a group also increases. Consequently, a user may experience some level of awkwardness during a procedure due to the force which may be necessary to dispense one or more ligating bands. Of further concern, this dispenser requires a number of working components to effect the dispensing of a ligating band, thus likely increasing the costs of the dispenser (i.e., assembly and materials) and functionally increasing the opportunity for a device malfunction.
Consequently, a need exists for a simple ligating band dispenser which offers safe, reliable, cost effective delivery of multiple ligating bands.
SUMMARY OF THE INVENTION
The present invention is directed to a ligating band dispenser. According to one aspect of the present invention, a ligating band dispenser is provided with an inner member and a flexible member receiving and at least partially encompassing the inner member. The relative positioning of the inner member to the flexible member defines a space therebetween. The dispenser further includes at least one fluid lumen which has an outlet in fluid communication with the space.
Accordingly to another aspect of the present invention, the above dispenser includes a valve mechanism. The valve mechanism en
Dawson Glenn K.
Ensurg, Inc.
Sidley Austin Brown & Wood
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