U.S. patent application number 11/671548 was filed with the patent office on 2007-09-13 for system and method for irrigation and tissue evacuation and collection.
This patent application is currently assigned to CIVCO Medical Instruments Co., Inc.. Invention is credited to Winston E. Barzell, Willet F. III Whitmore.
Application Number | 20070213666 11/671548 |
Document ID | / |
Family ID | 56290560 |
Filed Date | 2007-09-13 |
United States Patent
Application |
20070213666 |
Kind Code |
A1 |
Barzell; Winston E. ; et
al. |
September 13, 2007 |
SYSTEM AND METHOD FOR IRRIGATION AND TISSUE EVACUATION AND
COLLECTION
Abstract
The present invention provides a system and method for
irrigating and collecting tissue from a body cavity in a patient.
The system includes an irrigation and collection device for
injecting an irrigation fluid into the body cavity. The irrigation
device injects fluid into the body cavity by creating a positive
pressure within the device to expel the irrigation fluid from the
device into the body cavity. The irrigation fluid is evacuated from
the body cavity by the resulting negative pressure within the
device, drawing the irrigation fluid and any loose tissue or
particulate material into the device. The irrigation fluid is
filtered, collecting the evacuated tissue and particulate material
in a collection receptacle thereby isolating the evacuated tissue
and particulate material within the irrigation fluid.
Inventors: |
Barzell; Winston E.;
(Sarasota, FL) ; Whitmore; Willet F. III;
(Longboat Key, FL) |
Correspondence
Address: |
STEPTOE & JOHNSON LLP
1330 CONNECTICUT AVENUE, N.W.
WASHINGTON
DC
20036
US
|
Assignee: |
CIVCO Medical Instruments Co.,
Inc.
|
Family ID: |
56290560 |
Appl. No.: |
11/671548 |
Filed: |
February 6, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10841074 |
May 7, 2004 |
7172579 |
|
|
11671548 |
Feb 6, 2007 |
|
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|
60501263 |
Sep 9, 2003 |
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60553067 |
Mar 15, 2004 |
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Current U.S.
Class: |
604/131 ;
604/132; 604/133 |
Current CPC
Class: |
A61M 2210/1085 20130101;
A61M 1/0056 20130101; A61M 2205/075 20130101; A61M 1/0062 20130101;
A61M 3/0262 20130101; A61M 3/0229 20130101; A61M 3/0204 20140204;
A61M 3/0212 20140204; A61M 1/0011 20130101 |
Class at
Publication: |
604/131 ;
604/132; 604/133 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Claims
1. A medical irrigation and tissue collection system for
introducing fluid into and withdrawing fluid from a body cavity via
a fluid line, the system comprising: a container having an interior
for holding fluid; a pump bulb in fluid communication with the
container; a tube having a first end portion connected with the
fluid line and a second end portion in fluid communication with the
interior of the container; and a collection receptacle for
collecting particulate material, the collection receptacle located
within the interior of the container and removably connected to the
second end portion of the fluid line, wherein the collection
receptacle is provided with a plurality of openings allowing the
passage of fluid and particulate material smaller than a
predetermined size.
2. The medical irrigation and tissue collection system of claim 1
wherein the second end portion has a perforated section with a
plurality of pores allowing the passage of fluid and particulate
material of a given size.
3. The medical irrigation and tissue collection system of claim 2
wherein the plurality of openings has an average opening size and
the plurality of pores has an average pore size, the average pore
size area being smaller than the average opening size.
4. The medical irrigation and tissue collection system of claim 2
further comprising a one-way valve operatively associated with the
tube allowing fluid and particulate material to flow through the
tube and pass into the collection receptacle.
5. The medical irrigation and tissue collection system of claim 4
wherein the one-way valve is coupled to the second end portion of
the tube and includes a length of tubing collapsible under a
pressure differential generated by the pump bulb.
6. The medical irrigation and tissue collection system of claim 5
wherein the collection receptacle is a mesh bag.
7. The medical irrigation and tissue collection system of claim 6
wherein the mesh bag is collapsible under a pressure differential
generated by the pump bulb.
8. The medical irrigation and tissue collection system of claim 2
wherein the collection receptacle is a mesh bag.
9. The medical irrigation and tissue collection system of claim 8
wherein the mesh bag is collapsible under a pressure differential
generated by the pump bulb.
10. The medical irrigation and tissue collection system of claim 9
further comprising a flow restrictor positioned above the mesh
bag.
11. The medical irrigation and tissue collection system of claim 10
wherein the flow restrictor is a restrictor plate radially
extending from the tube.
12. The medical irrigation and tissue collection system of claim 2
further comprising a cap removably coupled to the container.
13. The medical irrigation and tissue collection system of claim 12
further comprising a pump conduit having a first end portion
extending from the cap and a second end portion coupled to the pump
bulb.
14. The medical irrigation and tissue collection system of claim 13
wherein the pump bulb is threadably mounted to the pump
conduit.
15. The medical irrigation and tissue collection system of claim 13
wherein the pump conduit extends downwardly from the cap.
16. The medical irrigation and tissue collection system of claim 15
wherein the collection receptacle is a basket made of a rigid
polymeric material.
17. The medical irrigation and tissue collection system of claim 13
wherein the container has upper and lower portions with the cap
removably coupled to the upper portion.
18. The medical irrigation and tissue collection system of claim 17
wherein the collection receptacle is located within the lower
portion of the container.
19. The medical irrigation and tissue collection system of claim 18
wherein the upper and lower portions of the container are
configured and dimensioned such that turbulent flow resulting from
the pressure generated by compressing the pump bulb is higher in
the upper portion of the container compared to the lower portion of
the container.
20. The medical irrigation and tissue collection system of claim 19
wherein the collection receptacle is a basket made of a rigid
polymeric material.
21. The medical irrigation and tissue collection system of claim 20
wherein a bottom of the basket experiences substantially no
turbulent flow from the pressure generated by compressing the pump
bulb.
22. The medical irrigation and tissue collection system of claim 17
wherein the cap defines a cap interior and turbulent flow resulting
from the pressure generated by compressing the pump bulb is
substantially limited to the cap interior.
23. The medical irrigation and tissue collection system of claim 22
further comprising a flow restrictor located between the cap
interior and the upper portion of the container.
24. The medical irrigation and tissue collection system of claim 23
wherein the flow restrictor is a lipped portion of the cap.
25. The medical irrigation and tissue collection system of claim 23
wherein the flow restrictor is a restrictor plate radially
extending from the tube.
26. A medical irrigation and tissue collection system for
introducing fluid into and withdrawing fluid from a body cavity via
a fluid line, the system comprising: a container defining a
container interior for holding a fluid; a pump bulb in fluid
communication with the container interior; a tube having a first
end portion connected with the fluid line and a second end portion
positioned in the container interior; and a collection receptacle
positioned in the container interior and connected to the second
end portion of the tube, the collection receptacle including a
plurality of openings allowing passage of fluid and particulate
material smaller than a predetermined size therethrough, wherein
the container interior has upper and lower portions, the upper and
lower portions configured and dimensioned and arranged with respect
to the pump bulb such that turbulent flow generated by the pump
bulb is substantially limited to the upper portion and the lower
portion is substantially free of turbulence.
27. The medical irrigation and tissue collection system of claim 26
further comprising a pump conduit having a first end portion
extending from the container in fluid communication with the upper
portion of the container interior and a second end portion coupled
to the pump bulb.
28. The medical irrigation and tissue collection system of claim
27, wherein the pump conduit is configured to position the pump
bulb below the upper portion of the container interior.
29. The medical irrigation and tissue collection system of claim 26
further comprising a cap removably coupled to the container.
30. The medical irrigation and tissue collection system of claim 29
wherein the tube includes a perforated section having a plurality
of pores allowing the passage of the fluid and particulate material
of a given size therethrough.
31. The medical irrigation and tissue collection system of claim 30
further comprising a flow restrictor located between the cap
interior and the upper portion of the container.
32. The medical irrigation and tissue collection system of claim 31
wherein the flow restrictor is a lipped portion of the cap.
33. The medical irrigation and tissue collection system of claim 31
wherein the flow restrictor is a restrictor plate radially
extending from the tube.
34. A method of collecting tissue and particulate material from a
body cavity in a patient, the method comprising: positioning a
medical irrigation and tissue collection device in fluid
communication with the body cavity; injecting an irrigation fluid
from the medical irrigation and tissue collection device into the
body cavity; evacuating the irrigation fluid from the body cavity
into the medical irrigation and tissue collection device, wherein
the evacuated irrigation fluid includes tissue and particulate
material from the body cavity; and filtering the evacuated
irrigation fluid to isolate tissue and particulate material within
the irrigation fluid such that the tissue and particulate material
is collected in a collection receptacle located within the medical
irrigation and tissue collection device.
35. The method of claim 34 wherein injecting an irrigation fluid
from the medical irrigation and tissue collection device into the
body cavity comprises creating a positive pressure within the
irrigation and tissue collection device into the body cavity,
including creating a turbulent flow in an upper portion of the
medical irrigation and tissue collection device, while maintaining
a substantially turbulent free flow in a lower portion of the
medical irrigation and tissue collection device.
36. The method of claim 34 wherein filtering the evacuated
irrigation fluid to isolate tissue and particulate material within
the irrigation fluid includes collecting tissue and particulate
material in the lower portion of the medical irrigation and tissue
collection device.
37. A method of collecting tissue and particulate material from a
body cavity in a patient, the method comprising: coupling a bulb to
a neck portion of a container for medical irrigation and tissue
collection so that mechanical advantage resists decoupling of the
bulb, the container being formed of a material to permit inspection
of contents therein; positioning the container in fluid
communication with the body cavity, the container forming an
enclosed space; injecting an irrigation fluid from the container
into the body cavity by applying pressure to the bulb to compress
the bulb; evacuating the irrigation fluid from the body cavity into
the container by releasing the pressure applied to the bulb,
wherein evacuated irrigation fluid includes tissue and particulate
material from the body cavity; inspecting the tissue and
particulate material through the container while the container is
in fluid communication with the body cavity.
38. The method of claim 37, wherein the mechanical advantage
comprises threads.
39. The method of claim 38, wherein the threads are disposed on the
bulb.
40. The method of claim 37, further comprising: collecting the
tissue and particulate material in a receptacle disposed within the
container.
41. The method of claim 40, wherein the receptacle comprises a
basket with openings therein to permit passage of irrigation fluid
therefrom.
42. The method of claim 40, wherein irrigation fluid in the
enclosed space flows in a first region having a first
cross-sectional area disposed proximate the neck portion of the
container and in a second region having a second cross-sectional
area disposed proximate the receptacle, the container being
configured and dimensioned with the first cross-sectional area
being less than the second cross-sectional area so that flow of the
irrigation fluid is more turbulent in the first cross-sectional
area than in the second cross-sectional area.
43. The method of claim 37, further comprising: filtering the
evacuated irrigation fluid to isolate the tissue and particulate
material.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of prior U.S. patent
application Ser. No. 10/841,074 filed May 7, 2004 and entitled
SYSTEM AND METHOD FOR IRRIGATION AND TISSUE EVACUATION AND
COLLECTION, which in turn claims the benefit under 35 U.S.C
.sctn.119(e) of U.S. Provisional Patent Application No. 60/501,263,
filed Sep. 9, 2003 and entitled SYSTEM FOR IRRIGATION AND TISSUE
EVACUATION AND COLLECTION, and U.S. Provisional Patent Application
No. 60/553,067, filed Mar. 15, 2004 and also entitled SYSTEM FOR
IRRIGATION AND TISSUE EVACUATION AND COLLECTION, the entirety of
which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to an irrigation and tissue
evacuation and collection system and method for use in medical
procedures.
BACKGROUND OF THE INVENTION
[0003] A number of medical procedures involve the irrigation of a
body cavity. For example, it is necessary to irrigate the urinary
bladder during many endoscopic urologic procedures to flush out
(and in some cases collect) blood clots, pieces of tissue, and the
like. The general approach to accomplish this is to introduce a
sterile saline solution or water into the bladder and then withdraw
the fluid which has mixed and suspended material to be removed.
This process needs to be repeated until the withdrawn fluid becomes
clear and satisfactorily free of particulate material.
[0004] Presently, the most common device used for bladder
irrigation is the Ellik evacuator. The Ellik evacuator consists of
a clear hourglass-shaped bowl with rubber bulb and nozzle fitted to
the upper bowl for circulating solution through the urethra and the
bladder. The bulb is opaque and oriented at a right angle to the
axis of the hourglass. Because of this, one problem with the Ellik
evacuator is the difficulty in fluid filling and air purging.
Tissue found in the return flow of solution ideally is collected in
the lower chamber. Tissue collects there due to the effects of
gravity. Thus, another limitation of the Ellik evacuator is that
the entrained tissue must settle by gravity into the lower chamber.
As a result, only the particulate and tissue of a specific gravity
greater than that of the sterile solution will settle into the
lower chamber. The particulate in suspension in the upper chamber
tends to be reintroduced into the bladder when the bulb is again
compressed. Also, tissue or particulate matter is often sucked into
the bulb regardless of specific gravity and because of the opacity
of the bulb, tissue caught there cannot be visualized and may
become lost. In order to prevent the recirculation of contaminated
solution created by the initial irrigation with the Ellik
evacuator, the surgeon must empty and refill the Ellik repeatedly
until the final irrigation remains clear. In addition to this
repetitive exercise, each time the Ellik evacuator is emptied and
refilled, the tissue that has accumulated in the irrigant must be
filtered and removed from the basin by hand at the conclusion of
the irrigation. During this step, tissue is occasionally lost on
the table or floor and there are significant blood and tissue
exposure risks to operating room personnel. A final problem with
the Ellik is that the rubber bulb is plugged like a stopper into a
smooth glass tubular port. Since the neck of the bulb is smooth and
cylindrical, there is only friction without mechanical advantage to
hold them together. Consequently, the bulb may easily detach from
the glass container inadvertently during handling with the result
that the glass container can crash to the floor and shatter.
[0005] A number of attempts have been made to improve upon the
Ellik evacuator. These efforts include the devices described in
U.S. Pat. Nos. 3,892,226; 4,282,873; 4,729,764, 4,801,292;
5,338,294; and 5,421,824. In addition to their own unique
limitations, all of the devices taught by these patents fail to
duplicate the ideal degree and velocity of fluid turbulence that is
generated with the Ellik evacuator. Furthermore, none of these
devices have a readily transferable tissue collecting mechanism.
For example, in U.S. Pat. No. 5,421,824, a squeezable portion of
the container forces fluid from the container into the body cavity
and by releasing the compressional forces allows the squeezable
portion to expand and withdraw the fluid. Unfortunately, the fluid
turbulence generated by this squeezable portion, and specifically
the negative pressure generated when releasing the compressional
forces, is inadequate and does not match those of the Ellik
evacuator. Moreover, there is often leakage of fluid at the
juncture of the container and its cap. Additionally, while this
patent prevents particulate tissue from reentering the body cavity,
it does not have a readily tansferable tissue collecting mechanism
and thus suffers from the same limitation as the Ellik evacuator in
that the tissue collected by the device must be filtered and
removed from the basin by hand at the conclusion of the irrigation.
During this step, tissue is occasionally lost on the table and
floor and there is significant blood and tissue exposure risk to
operating room personnel in this maneuver.
[0006] Thus, there remains a need for an improved irrigation and
tissue evacuation and collection system.
SUMMARY OF THE INVENTION
[0007] The present invention relates to a medical irrigation and
tissue collection system for introducing fluid into and withdrawing
fluid from a body cavity via a fluid line. The system includes a
container having an interior for holding fluid; a pump bulb in
fluid communication with the container that may be securely
attached using means other than pure friction; a tube having a
first end portion connected with the fluid line and a second end
portion in fluid communication with the interior of the container;
and a collection receptacle for collecting particulate material.
The collection receptacle is located within the interior of the
container and removably connected to the second end portion of the
fluid line. The collection receptacle is provided with a plurality
of openings allowing the passage of fluid and particulate material
smaller than a predetermined size.
[0008] In one embodiment, the second end portion has a perforated
section with a plurality of pores allowing the passage of fluid and
particulate material of a given size. The relative sizes of the
pores and opening can be selected as desired. For example, the size
of the opening, on average, can be larger than the size of the
pores, on average. Thus, smaller and intermediate sized particles
can more readily move freely in and out of collection receptacle
than through the second end portion of the tube, allowing for the
collection of the larger size particles in the collection
receptacle.
[0009] A one-way valve can be operatively associated with the tube
allowing fluid and particulate material to flow through the tube
and pass into the collection receptacle. The one-way valve can be
coupled to the second end portion of the tube and include a length
of tubing collapsible under a pressure differential generated by
the pump bulb.
[0010] The collection receptacle can be a basket made of a rigid
polymeric material. Alternatively, the collection receptacle can be
a mesh bag. As an alternative to the use of a one-way valve or as a
supplement thereto, the mesh bag can be collapsible under a
pressure differential generated by the pump bulb.
[0011] A cap can be removably coupled to the container with a pump
conduit having a first end portion extending from the cap and a
second end portion coupled to the pump bulb. The pump conduit can
extend from the cap at a right angle or downwardly from the cap at
a non-orthogonal angle. In an exemplary embodiment, the container
has upper and lower portions with the cap removably coupled to the
upper portion and the collection receptacle located within the
lower portion of the container.
[0012] The upper and lower portions of the container can be
configured and dimensioned such that turbulent flow resulting from
the pressure generated by compressing the pump bulb is greater in
the upper portion of the container compared to the lower portion of
the container. Furthermore, the basket can be positioned to
experience substantially no turbulent flow from the pressure
generated by compressing the pump bulb. The cap can define a cap
interior such that turbulent flow resulting from the pressure
generated by compressing the pump bulb is substantially limited to
the cap interior.
[0013] A flow restrictor can be located between the cap interior
and the upper portion of the container. In one embodiment, the flow
restrictor is a lipped portion of the cap. In a second embodiment
the flow restrictor is an external flange attached to the interior
tube.
[0014] The present invention also relates to a method of collecting
tissue and particulate material from a body cavity in a patient.
The method comprises positioning a medical irrigation and tissue
collection device in fluid communication with the body cavity;
injecting an irrigation fluid from the medical irrigation and
tissue collection device into the body cavity and evacuating the
irrigation fluid from the body cavity into the medical irrigation
and tissue collection device. As the evacuated irrigation fluid
includes tissue and particulate material from the body cavity, the
evacuated irrigation fluid is filtered to isolate the tissue and
particulate material within the irrigation fluid. The filtering is
performed such that the tissue and particulate material of a
minimum chosen size is collected in a collection receptacle within
the medical irrigation and tissue collection device.
[0015] The injection of the irrigation fluid from the medical
irrigation and tissue collection device into the body cavity can
include creating a positive pressure within the irrigation and
tissue collection device into the body cavity. This creates a
turbulent flow in an upper portion of the medical irrigation and
tissue collection device while maintaining a substantially
turbulent free flow in a lower portion of the medical irrigation
and tissue collection device. The filtering of the evacuated
irrigation fluid to isolate the tissue and particulate material
within the irrigation fluid can include collecting the tissue and
particulate material in the lower portion of the medical irrigation
and tissue collection device. The steps can be repeated as
desired.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] A more complete understanding of the present invention, and
the attendant advantages and features thereof, will be more readily
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings
wherein:
[0017] FIG. 1 is a perspective view of an embodiment of the system
according to the present invention;
[0018] FIG. 2 is a side view of the system of FIG. 1 with the cap
disconnected from the fluid vessel and the pump bulb removed;
[0019] FIG. 3 is a sectional view of a flow limiter of the present
invention;
[0020] FIG. 4 is a schematic representation of the configuration of
the mesh bag during fluid in flow;
[0021] FIG. 5 is a schematic representation of the configuration of
the mesh bag during fluid out flow;
[0022] FIG. 6 is a perspective view of another embodiment of the
system according to the present invention;
[0023] FIG. 7 is first exploded view of the system of FIG. 6;
[0024] FIG. 8 is a second exploded view of the system of FIG.
6;
[0025] FIG. 9 is a cross-sectional view of the system of FIG. 6
showing fluid flow patterns;
[0026] FIG. 10 is a perspective view of another embodiment of the
system according to the present invention;
[0027] FIG. 11 is an alternative embodiment of the system of FIG.
10;
[0028] FIG. 12 is a perspective view of another embodiment of the
system according to the present invention;
[0029] FIG. 13 is a perspective view of another embodiment of the
system according to the present invention;
[0030] FIG. 14 is an alternative embodiment of the system of FIG.
13; and
[0031] FIG. 15 is an exploded view showing a pump bulb threadably
coupled to a pump conduit.
DETAILED DESCRIPTION OF THE INVENTION
[0032] The present invention provides a system and method for
irrigating and collecting tissue from a body cavity in a patient.
The system includes an irrigation and collection device for
injecting an irrigation fluid into the body cavity. The irrigation
device injects fluid into the body cavity by creating a positive
pressure within the device to expel the irrigation fluid from the
device into the body cavity. The irrigation fluid is evacuated from
the body cavity by the resulting negative pressure within the
device, drawing the irrigation fluid and any loose tissue or
particulate material into the device. The irrigation fluid is
filtered to collect the evacuated tissue and particulate material
in a collection receptacle.
[0033] To repeat the process, the positive pressure is created
within the device, expelling the irrigation fluid from the device
into the body cavity. During the expulsion of the irrigation fluid,
the previously collected tissue and particulate material are
retained within the collection receptacle, such that they do not
re-enter the body cavity with the expelled irrigation fluid. The
irrigation fluid is again evacuated from the body cavity by the
resulting negative pressure within the device, drawing the
irrigation fluid and any loose tissue or particulate material into
the device. The irrigation fluid is filtered to collect the
additional evacuated tissue and particulate material in the
collection receptacle. The process can be repeated as desired to
remove substantially all of the loose tissue and particulate
material from the body cavity.
[0034] Referring now to the drawing figures in which like reference
numerals refer to like elements, there is shown in FIGS. 1 and 2 an
irrigation and tissue evacuation and collection system 10 of the
present invention. The irrigation and tissue evacuation and
collection system 10 includes a container 12 for holding irrigation
fluid. The irrigation fluid can be any fluid used for irrigation or
lavage, such as a sterile normal saline solution or a sterile water
solution. A pump bulb 14 is coupled to container 12 via a pump
conduit 16. Although pump conduit 16 is shown as attached to
container 12, pump conduit 16 could be connected to a removable cap
18. Cap 18 is shown as connected to container 12 by threads, but
other coupling mechanisms could be used.
[0035] Pump bulb 14 is made of a resilient material such that as
pump bulb 14 is squeezed, positive pressure is created to force
irrigation fluid from container 12. When the squeezing force is
removed, pump bulb 14 returns to its non-compressed state, thereby
creating negative pressure to draw irrigation fluid into container
12. Although pump bulb 14 is shown frictionally connected to the
pump conduit 16, other coupling mechanism could be used. For
example, the pump conduit 16 can be internally (or externally)
threaded, for threadably receiving the pump bulb 14, which would
have corresponding threads. The mating threads may provide a more
secure connection than a simple friction fit. This is beneficial
since the pump bulb may be the only portion of the device held by
the clinician. It should be noted that any suitable pump member
could be used as an alternative to pump bulb 14.
[0036] A tube 20 provides the pathway for the irrigation fluid into
and out of container 12. Tube 20 has a first end coupled to a fluid
line (not shown) that is insertable into the patient body cavity
that is being treated (for example through the working channel of
an endoscope), e.g. a bladder to remove prostatic tissue chips
after a transurethral resectioning (TUR) procedure. The second end
of tube 20 is in fluid communication with the interior of container
12. In this embodiment, the second end is coupled to a collection
bag 22 via a releasable connector 24 (e.g. an o-ring) so that
collection bag 22 can be removed.
[0037] In use, collection bag 22 is located within the interior of
container 12 and is used to obtain samples of particulate
materials. Collection bag 22 is provided with a plurality of
openings allowing the passage of fluid and particulate material of
a given size. The openings in the collection bag 22 have a size to
restrict throughflow of particulate material of a predetermined
size. As collection bag 22 can be made of a mesh type material,
such as a mesh fabric bag, different bags having a range of mesh
size openings can be used to suit a particular application. For
example, if large tissue particles are desired to be collected, a
collection bag having relatively large mesh size openings would be
used. Also, a series of collection bags 22 could be used so that
samples containing particles of different sizes could be
obtained.
[0038] In the manufacture of collection bag 22, the size and shape
of the openings may not necessarily be uniform. This may result in
a variety of shapes of the openings and a range of sizes of the
openings (for example the cross sectional opening areas).
Accordingly and as is customary in the art, the openings in
collection bag 22 can be referred to as having an average size.
[0039] Tube 20 also includes a filter 28 such as a fenestrated
portion that allows fluid, but not particulate material, to
circulate in and out of container 12. Filter 28 is provided with a
plurality of pores allowing the passage of fluid and particulate
material of a given size. The pores in filter 28 have a size to
restrict throughflow of particulate material of a predetermined
size. Similar to collection bag 22, in the manufacture of filter
28, the size and shape of the pores may not necessarily be uniform.
This may result in a variety of shapes of the pores and a range of
sizes of the pores (for example the cross sectional pore area).
Accordingly and as is customary in the art, the pores of filter 28
can be referred to as having an average size.
[0040] The relative sizes of the openings (in collection bag 22)
and the pores (in filter 28) can be adjusted as desired to a
particular clinical situation. For example, the pores on filter 28
can be made to have an average size that is smaller than the
average size of the openings on collection bag 22. Thus, smaller
and intermediate sized particles can move more freely in and out of
collection bag 22 than through filter 28, allowing for the
collection of the larger size particles in collection bag 22.
[0041] The second end of tube 20 terminates in a flow limiter 26
that allows fluid (including any particulate material) to pass into
collection bag 22, but not back out into tube 20. One example of a
flow limiter 26 that can be used is a valve such as a check valve.
Another flow limiter that can be used is a Penrose drain or other
type of pliable length of tubing. Although a check valve may be
more restrictive in preventing flow out of collection bag 22, the
use of a pliable length of tubing may be beneficial in that the
tubing would have no moving parts and is more cost efficient.
[0042] Referring to FIG. 3, tube 20 includes a pliable tubing 29.
When positive pressure is created within container 12 to force
irrigation fluid from container 12 (for example, by squeezing pump
bulb 14), a pressure differential is created between the irrigation
fluid within pliable tubing 29 and the irrigation fluid surrounding
pliable tubing 29. The irrigation fluid surrounding pliable tubing
29 has greater pressure then the irrigation fluid within pliable
tubing 29, causing pliable tubing 29 to collapse within,
effectively sealing off collection bag 22 and preventing the
collected tissue and particulate material from re-entering the body
cavity with the re-circulated irrigation fluid. Pliable tubing 29
can be provided with slits to facilitate the opening and closing of
its lumen.
[0043] When the squeezing force is removed from pump bulb 14,
creating negative pressure, the fluid is drawn from the body cavity
into container 12 through tube 20. The drawing of the irrigation
fluid through tube 20 into container 12 creates a pressure
differential between the irrigation fluid within pliable tubing 29
and the irrigation fluid surrounding pliable tubing 29. The
irrigation fluid within pliable tubing 29 has a greater pressure
then the irrigation fluid surrounding pliable tubing 29 causing
pliable tubing 29 to expand, providing access to collection bag 22
to collect and isolate the evacuated tissue and particulate
material from the irrigation fluid.
[0044] Collection bag 22 of the present invention can also be made
of a pliable material (or as an alternate to pliable tubing). When
the positive pressure is created to force irrigation fluid from
container 12 as shown by the arrows of FIG. 5, a pressure
differential is created between the irrigation fluid within
collection bag 22 and the irrigation fluid surrounding collection
bag 22. The irrigation fluid surrounding collection bag 22 has a
greater pressure then the irrigation fluid within collection bag 22
causing collection bag 22 to collapse in on itself, preventing the
collected tissue and particulate material 25 from re-entering the
body cavity.
[0045] When the squeezing force is removed from pump bulb 14,
creating negative pressure, the fluid is drawn into collection bag
22 through tube 20 as shown by the arrows of FIG. 4. The drawing of
the irrigation fluid into collection bag 22 creates a pressure
differential between the irrigation fluid within collection bag 22
and the irrigation fluid surrounding pliable collection bag 22. The
irrigation fluid within collection bag 22 has a greater pressure
then the irrigation fluid surrounding collection bag 22 causing
collection bag 22 to expand, providing access to collection bag 22
to collect and isolate the evacuated tissue and particulate
material 25 from the irrigation fluid.
[0046] In use, system 10 provides a system for irrigation and
tissue evacuation and collection for any body cavity, such as the
bladder. Container 12 can be filled with irrigation fluid and the
entire system can be purged of air. As is well known in the art,
purging can be accomplished, for example, by submerging the opened
device in a fluid filled basin and repeatedly compressing the bulb,
or by repeatedly dipping the nozzle of a closed device into
irrigating fluid and aspirating with the bulb until full. An
endoscope can be used to advance the fluid line to the body cavity
(connected to tube 20) of interest.
[0047] By compressing pump bulb 14, irrigation fluid in container
12 is forced through filter 28 out through tube 20 which is
connected to the body cavity via the fluid line. On relieving
pressure on pump bulb 14, fluid is sucked back in from the body
cavity through the fluid line and through tube 20. Particulate
tissue and other material will be trapped in collection bag 22
while the rest of the fluid will refill container 12 and pump bulb
14. When desired, collection bag 22 can be disconnected and dropped
in a specimen jar. In this way, separate specimens can be
accurately collected and submitted without the potential for
specimen tissue loss or mix-up. In this regard, container 12 or a
portion thereof can be made transparent or translucent so that the
turbidity of the fluid can be visually examined.
[0048] Referring to FIGS. 6-8, another embodiment of an irrigation
and tissue evacuation and collection system 30 according to the
present invention is shown. In general, most of the structure and
function of system 30 is like or comparable to the structure of
system 10 and, accordingly the same name and an analogous reference
numeral are used for like components and discussion of those like
components is not believed necessary.
[0049] System 30 includes a container 32 for holding irrigation
fluid. A pump bulb 34 is coupled to a removable cap 38 via a pump
conduit 36. Alternatively, pump conduit 36 is attached to container
32. In contrast to conduit 16, conduit 36 extends downwardly at a
non-orthogonal angle from cap 38. In addition to improved feel and
handling, this configuration also facilitates purging of air with
pump bulb 34.
[0050] A tube 40 provides the pathway for the irrigation fluid into
and out of container 32. One end of tube 40 is removably coupled to
a collection basket 42 via a connecting tube 44. As collection
basket 42 can be made of a mesh type material or be perforated to
have an array of openings 43, different baskets having a range of
mesh size openings can be used to suit a particular application. If
desired, collection basket 42 can be made of a rigid material, such
as a suitable polymer.
[0051] Connecting tube 44 flares outwardly to form a flange 46.
Although flange 46 is shown as threaded to mate with threads on
collection basket 42, other coupling mechanisms could be used. Like
collection basket 42, connecting tube 44 is provided with pores 45
to restrict throughflow of particulate material above a certain
size. As was the case for system 10, the relative sizes (average
cross sectional areas) of openings 43 and pores 45 can be varied to
suit a particular application.
[0052] Connecting tube 44 is configured and dimensioned and
arranged with respect to conduit 36 such that the portion of
connecting tube 44 located within and in close proximity to cap 38
experiences higher turbulence and flow compared to other portions
(i.e. portions closer to flange 46). As a result, fluid near the
base of container 32 in the vicinity of the bottom of collection
basket 42 remains substantially undisturbed and substantially free
of turbulent flow. This tends to allow material to settle in
collection basket 42, while still providing for adequate
circulation of fluid.
[0053] Referring to FIG. 9, container 32 includes an upper portion
48 and a lower portion 50. Container 32 may be configured and
dimensioned such that the cross sectional area of lower portion 50
is larger then the cross sectional area of upper portion 48. For
example and as generally shown, container 32 can have a
substantially frusto-conical shape. The configuration and dimension
of container 32 disperses the turbulent flow as the fluid travels
from upper portion 48 to lower portion 50 of container 32. As
described above, by compressing pump bulb 34, irrigation fluid is
forced into container 32, creating highly turbulent flow (HT) in
upper portion 48 of container 32. As the irrigation fluid is forced
into lower portion 50 of container 32, the increasing cross section
of container 32 disperses the turbulent flow, creating a lower
turbulent flow (LT). As a result, fluid in lower portion 50 of
container 32, in the vicinity of the bottom of collection basket
42, remains substantially undisturbed and substantially free of
turbulent flow (NT). This tends to allow material to settle in
collection basket 42, while still providing for adequate
circulation of fluid.
[0054] In one embodiment, removable cap 38 defines a cap interior
52. Cap interior 52 is removably attached to container 32 and
defines a fluid interface 54 between upper portion 48 of container
32 and cap interior 52. By compressing pump bulb 34, irrigation
fluid is forced into cap interior 52, creating highly turbulent
flow (HT) in cap interior 52 and upper portion 48 of container 32.
As the irrigation fluid is forced into lower portion 50 of
container 32, the increasing distance, flow restriction and, in
some embodiments, the increasing cross sectional area of container
32 disperses the turbulent flow, creating a lower turbulent flow
(LT). As a result, fluid in lower portion 50 of container 32, in
the vicinity of the bottom of collection basket 42, remains
substantially undisturbed and substantially free of turbulent flow
(NT). This tends to allow material to settle in collection basket
42, while still providing for adequate circulation of fluid.
[0055] System 30 optionally includes a flow restrictor 56, which
partially segregates cap interior 52 from upper portion 48 of
container 32. Flow restrictor 56 can be part of removable cap 38.
For example, flow restrictor 56 can be a lip circumferentially
extending from cap 38 to partially segregate cap interior 52 from
upper portion 48 of the container 32. Alternatively, flow
restrictor 52 can be positioned within upper portion 48 of
container 32.
[0056] Flow restrictor 56 acts to decrease the cross sectional area
of fluid interface 54 between cap interior 52 and upper portion 48
of container 32. The restricted fluid interface 54 acts to limit
the propagation of the highly turbulent flow (HT), caused by
compressing pump bulb 34, from cap interior 52 into lower portion
50 of container 32.
[0057] As noted above, compressing pump bulb 34 creates highly
turbulent flow (HT) in cap interior 52. As the irrigation fluid is
forced into upper portion 48 of container 32, the restricted fluid
interface 54 limits the propagation of the highly turbulent flow
into upper portion 48 of container 32. Furthermore, the increasing
cross sectional area of container 32 further disperses the
remaining turbulent flow, creating a lower turbulent flow (LT). As
a result, fluid in lower portion 50 of container 32, in the
vicinity of the bottom of collection basket 42, remains
substantially undisturbed and substantially free of turbulent flow
(NT). This tends to allow material to settle in collection basket
42, while still providing for adequate circulation of fluid.
[0058] Referring to FIG. 10, another embodiment of an irrigation
and tissue evacuation and collection system 60 according to the
present invention is shown. In general, most of the structure and
function of system 60 is like or comparable to the structure of the
prior systems and, accordingly the same name and an analogous
reference numeral are used for like components and discussion of
those like components is not believed necessary.
[0059] System 60 includes a container 62 for holding irrigation
fluid. A pump bulb 64 is coupled to a removable cap 68 via a pump
conduit 66. Alternatively, pump conduit 66 is attached to container
62. In contrast to conduit 16, conduit 66 extends downwardly at an
angle from cap 68. In addition to improved feel and handling, this
configuration also facilitates purging of air with pump bulb 64.
Pump bulb 64 is frictional connected to pump conduit 66, by
inserting a portion of pump bulb 64 in conduit 66. Alternatively,
pump bulb 64 is threadably connected to pump conduit 66.
[0060] A tube 70 provides the pathway for the irrigation fluid into
and out of container 62. One end of tube 70 is removably coupled to
a collection basket 72 via a connecting tube 74. As collection
basket 72 can be made of a mesh type material or be perforated to
have an array of openings 73, different baskets having a range of
mesh size openings can be used to suit a particular application. If
desired, collection basket 72 can be made of a rigid material, such
as a suitable polymer.
[0061] Connecting tube 74 flares outwardly to form a flange 76. A
flange skirt 78 extends from the flange 76. Although flange skirt
78 is shown as threaded to mate with threads on collection basket
72, other coupling mechanisms could be used. Like collection basket
72, connecting tube 74 is provided with pores 75 to restrict
throughflow of particulate material above a certain size. As was
the case for the prior systems the relative sizes (average cross
sectional areas) of openings 73 and pores 75 can be varied to suit
a particular application.
[0062] Connecting tube 74 is configured and dimensioned and
arranged with respect to conduit 66 such that the portion of
connecting tube 74 located within and in close proximity to cap 68
experiences higher turbulence and flow compared to other portions
(i.e. portions closer to flange 76). As a result, fluid near the
base of container 62 in the vicinity of the bottom of collection
basket 72 remains substantially undisturbed and substantially free
of turbulent flow. This tends to allow material to settle in
collection basket 72, while still providing for adequate
circulation of fluid.
[0063] The container 62 includes an upper portion 80 and a lower
portion 82. The configuration and dimension of container 62, flange
76, and the flange skirt 78 limit the propagation of the turbulent
flow as the fluid travels from upper portion 80 to lower portion 82
of container 62. As described above, by compressing pump bulb 64,
irrigation fluid is forced into container 62, creating highly
turbulent flow (HT) in upper portion 80 of container 62. As the
irrigation fluid is forced into lower portion 82 of container 62,
the restricted spacing between the inner wall of the container 62
and the flange 76 and the flange skirt limit the propagation of the
turbulent flow, creating a lower turbulent flow (LT). Turbulence is
also reduced in lower portion 82 by increasing the distance from
pump conduit 66 (i.e. increasing the length of container 62). As a
result, fluid in lower portion 82 of container 62, in the vicinity
of the collection basket 72 (and in particular near the bottom of
collection basket 72), remains substantially undisturbed and
substantially free of turbulent flow (NT). This tends to allow
material to settle in collection basket 72, while still providing
for adequate circulation of fluid.
[0064] In one embodiment, removable cap 68 defines a cap interior
84. Cap interior 84 is removably attached to container 62 and
defines a fluid interface 86 between upper portion 80 of container
62 and cap interior 84. By compressing pump bulb 64, irrigation
fluid is forced into cap interior 84, creating highly turbulent
flow (HT) in cap interior 84 and upper portion 80 of container 62.
As the irrigation fluid is forced into lower portion 82 of
container 62, the increasing distance and flow restriction
disperses the turbulent flow, creating a lower turbulent flow (LT).
As a result, fluid in lower portion 82 of container 62, in the
vicinity of the collection basket 72 (and in particular near the
bottom of collection basket 72), remains substantially undisturbed
and substantially free of turbulent flow (NT). This tends to allow
material to settle in collection basket 72, while still providing
for adequate circulation of fluid.
[0065] As shown in FIG. 11, the flange 76 optionally includes a lip
portion 88, radially extending from the flange 76. The lip portion
88 acts to further limit the propagation of the turbulent flow to
the bottom portion of the container 72.
[0066] Referring to FIG. 12, another embodiment of an irrigation
and tissue evacuation and collection system 90 according to the
present invention is shown. In general, most of the structure and
function of system 90 is like or comparable to the structure of
systems 10, 30, and 60 and, accordingly the same name and an
analogous reference numeral are used for like components and
discussion of those like components is not believed necessary.
[0067] System 90 includes a container 92 for holding irrigation
fluid. A pump bulb 94 is coupled to a removable cap 98 via a pump
conduit 96. Alternatively, pump conduit 96 is attached to container
92.
[0068] A tube 100 provides the pathway for the irrigation fluid
into and out of container 92. One end of tube 100 is removably
coupled to a collection basket 102 via a connecting tube 104. As
collection basket 102 can be made of a mesh type material or be
perforated to have an array of openings 103, different baskets
having a range of mesh size openings can be used to suit a
particular application. If desired, collection basket 102 can be
made of a rigid material, such as a suitable polymer.
[0069] Connecting tube 104 flares outwardly to form a flange 106.
Although flange 106 is shown as threaded to mate with threads on
collection basket 102, other coupling mechanisms could be used.
Like collection basket 102, connecting tube 104 is provided with
pores 105 to restrict throughflow of particulate material above a
certain size. A restrictor plate 108 radially extends from
connection tube 104 and is interposed between the flange 106 and
the cap 98.
[0070] Connecting tube 104, flange 106, and restrictor plate 108
are configured, dimensioned and arranged with respect to conduit 96
such that the portion of connecting tube 104 located within and in
close proximity to cap 98 experiences higher turbulence and flow
compared to other portions (i.e. portions closer to flange 106). As
a result, fluid near the base of container 92 in the vicinity of
the collection basket 102 (and in particular near the bottom of
collection basket 102) remains substantially undisturbed and
substantially free of turbulent flow. In particular, restrictor
plate 108 acts like a shield, directing fluid from pump conduit 96
toward tube 100. The combined effect of these features tends to
allow material to settle in collection basket 102, while still
providing for adequate circulation of fluid.
[0071] The container 92 includes an upper portion 110 and a lower
portion 112. The configuration and dimension of container 92,
flange 106, and the restrictor plate 108 limit the propagation of
the turbulent flow as the fluid travels from upper portion 110 to
lower portion 112 of container 92. As described above, by
compressing pump bulb 94, irrigation fluid is forced into container
92, creating highly turbulent flow (HT) in upper portion 110 of
container 92. As the irrigation fluid is forced into lower portion
112 of container 92, the restrictor plate 108 and the flange 106
limit the propagation of the turbulent flow, creating a lower
turbulent flow (LT). As a result, fluid in lower portion 112 of
container 92, in the vicinity of the collection basket 102 (and in
particular near the bottom of collection basket 102), remains
substantially undisturbed and substantially free of turbulent flow
(NT). This tends to allow material to settle in collection basket
102, while still providing for adequate circulation of fluid.
[0072] In one embodiment, removable cap 98 defines a cap interior
114. Cap interior 114 is removably attached to container 92 and
defines a fluid interface 116 between upper portion 110 of
container 92 and cap interior 114. By compressing pump bulb 94,
irrigation fluid is forced into cap interior 114, creating highly
turbulent flow (HT) in cap interior 114 and upper portion 110 of
container 92. As the irrigation fluid is forced into lower portion
112 of container 92, the increasing distance and flow restriction
disperses the turbulent flow, creating a lower turbulent flow (LT).
As a result, fluid in lower portion 112 of container 92, in the
vicinity of the collection basket 102 (and in particular near the
bottom of collection basket 102), remains substantially undisturbed
and substantially free of turbulent flow (NT). This tends to allow
material to settle in collection basket 102, while still providing
for adequate circulation of fluid.
[0073] Referring to FIG. 13, another embodiment of an irrigation
and tissue evacuation and collection system 120 according to the
present invention is shown. In general, most of the structure and
function of system 120 is like or comparable to the structure of
the prior systems and, accordingly the same name and an analogous
reference numeral are used for like components and discussion of
those like components is not believed necessary.
[0074] System 120 includes a container 122 for holding irrigation
fluid. A pump bulb 124 is coupled to a removable cap 128 via a pump
conduit 126. Alternatively, pump conduit 126 is attached to
container 122. As has previously been discussed and is shown in
FIG. 15, pump bulb 124 is threadably connected to pump conduit
126.
[0075] A tube 130 provides the pathway for the irrigation fluid
into and out of container 122. A lower end portion 132 of the tube
130 is removably coupled to a collection bag (not shown) via a
connecting tube 134. As the collection bag can be made of a mesh
type material or be perforated to have an array of openings,
different bags having a range of mesh size openings can be used to
suit a particular application.
[0076] Like the collection bag, connecting tube 134 is provided
with pores 136 to restrict throughflow of particulate material
above a certain size. As was the case for the prior systems, the
relative sizes (average cross sectional areas) of the collection
bag openings and pores 136 can be varied to suit a particular
application.
[0077] Connecting tube 134 is configured, dimensioned and arranged
with respect to conduit 126 such that the portion of connecting
tube 134 located within and in close proximity to cap 128
experiences higher turbulence and flow compared to other portions.
As a result, fluid near the base of container 122 in the vicinity
of the collection bag (and in particular near the bottom of the
collection bag) remains substantially undisturbed and substantially
free of turbulent flow. This tends to allow material to settle in
collection bag, while still providing for adequate circulation of
fluid.
[0078] Referring to FIG. 14, connecting tube 134 includes a
restrictor plate 138 radially extending out there from. Restrictor
plate 138 is interposed between the lower end portion 134 of tube
130 and cap 128, and acts like a shield directing fluid from pump
conduit 126 toward tube 130. If desired, restrictor plate 138 can
snugly fit against the edge of cap 128 to be fluid-tight, thereby
serving as a bulkhead so that fluid must pass through connecting
tube 134 to reach the lower section of container 122.
[0079] Container 122 includes an upper portion 140 and a lower
portion 142. The configuration and dimension of container 122 and
restrictor plate 138 limits the propagation of the turbulent flow
as the fluid travels from upper portion 140 to lower portion 142 of
container 122. As described above, by compressing pump bulb 124,
irrigation fluid is forced into container 122, creating highly
turbulent flow (HT) in upper portion 140 of container 122. As the
irrigation fluid is forced into lower portion 142 of container 122,
restrictor plate 138 limits the propagation of the turbulent flow,
creating a lower turbulent flow (LT). As a result, fluid in lower
portion 142 of container 122, in the vicinity of the collection bag
(and in particular near the bottom of the collection bag), remains
substantially undisturbed and substantially free of turbulent flow
(NT). This tends to allow material to settle in the collection bag,
while still providing for adequate circulation of fluid.
[0080] In one embodiment, removable cap 128 defines a cap interior
144. Cap interior 144 is removably attached to container 122 and
defines a fluid interface 146 between upper portion 140 of
container 122 and cap interior 144. By compressing pump bulb 124,
irrigation fluid is forced into cap interior 144, creating highly
turbulent flow (HT) in cap interior 144 and upper portion 140 of
container 122. As the irrigation fluid is forced into lower portion
142 of container 122, the increasing distance and flow restriction
disperses the turbulent flow, creating a lower turbulent flow (LT).
As a result, fluid in lower portion 142 of container 122, in the
vicinity of the collection bag (and in particular near the bottom
of the collection bag), remains substantially undisturbed and
substantially free of turbulent flow (NT). This tends to allow
material to settle in collection bag, while still providing for
adequate circulation of fluid.
[0081] All references cited herein are expressly incorporated by
reference in their entirety. In addition, unless mention was made
above to the contrary, it should be noted that all of the
accompanying drawings are not to scale.
[0082] There are many different features to the present invention
and it is contemplated that these features may be used together or
separately. Thus, the invention should not be limited to any
particular combination of features or to a particular application
of the invention. For example, although flow limiter 26 is
discussed as part of system 10, it is also contemplated by the
present invention that flow limiter 26, or a similar mechanism,
could be used in conjunction with any of the other embodiments.
Further, it should be understood that variations and modifications
within the spirit and scope of the invention might occur to those
skilled in the art to which the invention pertains. Accordingly,
all expedient modifications readily attainable by one versed in the
art from the disclosure set forth herein that are within scope and
spirit of the present invention are to be included as further
embodiments of the present invention. The scope of the present
invention is accordingly defined as set forth in the appended
claims.
* * * * *