U.S. patent number 3,831,585 [Application Number 05/273,016] was granted by the patent office on 1974-08-27 for retrograde renal biopsy device.
Invention is credited to Thomas L. Brondy, Andrew T. Cole.
United States Patent |
3,831,585 |
Brondy , et al. |
August 27, 1974 |
RETROGRADE RENAL BIOPSY DEVICE
Abstract
A medical instrument for use in renal biopsy is in the form of
an injector tube having a puncturing and scraping tool secured to
the end of an inner slide wire and a balloon surrounding the
injector tube at the distal end thereof. A second flexible tube is
mounted along the outside of the injector tube and connects to the
balloon for inflation thereof in the renal pelvis to hold the
distal end of the injector tube in fixed relation to the kidney to
permit penetration of the scraping tool into the kidney tissue
through the epithelium of the renal pelvis.
Inventors: |
Brondy; Thomas L. (Bartlett,
IL), Cole; Andrew T. (Chicago, IL) |
Family
ID: |
23042186 |
Appl.
No.: |
05/273,016 |
Filed: |
July 19, 1972 |
Current U.S.
Class: |
600/570; 606/185;
604/907; 604/915; 606/127; 606/192 |
Current CPC
Class: |
A61B
17/12099 (20130101); A61B 17/12022 (20130101); A61B
17/12136 (20130101); A61B 10/04 (20130101); A61M
25/10 (20130101) |
Current International
Class: |
A61B
17/12 (20060101); A61M 25/10 (20060101); A61B
10/00 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2B,2W,2M,349B,7,311,328,344 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Patnaude; Edmond T.
Claims
What is claimed is:
1. A biopsy instrument for obtaining a sample of kidney tissue,
comprising
an elongated flexible insertion tube for insertion through the
urethra, the bladder and the ureter into the renal pelvis of the
kidney,
a flexible slide wire slidably disposed in said insertion tube and
extending from both ends thereof,
a tissue removal tool fixedly secured to the foreward end portion
of said slide wire,
said tool having a scraping edge for insertion into the tissue of
said kidney and for removing therefrom a tissue sample,
an inflatable resilient balloon affixed to and surrounding the
foreward end of said insertion tube in proximity to said tool so as
to be positionable within the renal pelvis of said kidney and, when
inflated to hold the foreward end of said insertion tube in a
substantially fixed position in the renal pelvis, and
a passageway extending from the interior of said balloon to the
rearward portion of said instrument for use in inflating said
balloon after it is positioned within said renal pelvis,
whereby the inflated balloon holds the foreward end of said
insertion tube in a substantially fixed position within said renal
pelvis to permit the physician to cause said tool to penetrate the
epithelium by pushing the rearward end of said slide wire into said
insertion tube.
2. A biopsy instrument according to claim 1 wherein said balloon is
a tubular, resilient member surrounding said insertion tube.
3. A biopsy instrument according to claim 2 wherein said tool
comprises
a rearwardly extending finger for scraping tissue from an organ to
be examined.
4. A biopsy instrument according to claim 3 wherein said finger is
resilient.
5. A biopsy instrument according to claim 3 wherein said tool
comprises
a collar from which said finger and at least one additional finger
extend.
6. A biopsy instrument according to claim 1 wherein said tool
further comprises
a tubular member through which said slide wire slidably extends,
and
stop means mounted on said tubular member and on said slide wire
for limiting forward and rearward movement of said slide wire
relative to said tubular member.
7. A biopsy instrument according to claim 6 wherein said finger is
integral with said tubular member.
8. A biopsy instrument according to claim 7 wherein said tubular
member is provided with a slot through which said finger
extends.
9. A biopsy instrument according to claim 1 wherein said tool
comprises
a rearwardly extending tissue removal and collection finger on the
end of which said scraping edge is provided.
Description
The present invention relates in general to biopsy devices, and it
relates more particularly to such devices which are insertable into
a kidney through the urethra, the bladder and the associated
ureter.
BACKGROUND OF THE INVENTION
Heretofore, the only reliable method for obtaining a biopsy of
renal tissue has been percutaneous. Because of the dangers
inherently associated with the percutaneous method, attempts have
been made to obtain kidney tissue by insertion of a tissue removing
tool through the urinary tract to the bladder and through one of
the ureters to the kidney. Such attempts have thus far been
unsuccessful.
We believe that the principal reasons for such failures is the
inability of the prior art biopsy instruments to penetrate the
tough epithelium which lines the renal pelvis. In order to pass
through the urethra it is necessary that the tool carrier be
relatively flexible, but this flexibility has prevented the
application of a sufficient force on the scraping tool to puncture
the membrane lining. When the physician pushes on the tool carrier
in an effort to push the tool through the membrane-like epithelium,
the end portion of the carrier simply bends and curls up inside the
renal pelvis.
OBJECTS OF THE INVENTION
Therefore, an object of the present invention is to provide a new
and improved instrument for use in retrograde renal biopsies.
Another object of this invention is to provide a new and improved
instrument for use in obtaining renal tissue, which instrument
includes means enabling penetration of the epithelium which lines
the renal pelvis.
A further object of this invention is to provide an instrument for
obtaining sample renal tissue, which instrument is relatively easy
to use and reliable and safe in operation.
SUMMARY OF THE INVENTION
Briefly, the above and further objects may be realized in
accordance with the present invention by providing a thin, flexible
injector tube having a puncturing and scraping tool mounted to the
distal end portion of a slide wire disposed therein and further
having an inflatable balloon mounted at the end of the injector
tube for inflation in the renal pelvis to hold the end of the tube
in a fixed position in the renal pelvis whereby a sufficient axial
force may be applied to the puncturing and scraping tool to push it
through the membrane lining of the renal pelvis into the medulla
and cortical tissue for obtaining a specimen therefrom.
BRIEF DESCRIPTION OF THE DRAWING
Further objects and advantages and a better understanding of the
invention may be had from the following detailed description taken
in connection with the accompanying drawing, wherein:
FIG. 1 is a somewhat schematic illustration of a renal and urinary
system showing the instrument of the present invention disposed
therein;
FIG. 2 is a partially sectioned view of the forward end of an
instrument of the present invention particularly showing the
deflated balloon and the puncturing and scraping tool;
FIG. 3a is an elevational view of another puncturing and scraping
tool embodying the present invention showing the tool in the closed
position;
FIG. 3b is a view of the device of FIG. 3a showing the tool in an
open, tissue removal position;
FIG. 4 is an elevational view of still another puncturing and
scraping tool embodying the present invention;
FIG. 5 is an elevational view of yet another puncturing and
scraping tool of the present invention;
FIG. 6a is an elevational view of another embodiment of a
puncturing and scraping tool of the present invention; and
FIG. 6b is a partial, elevational view of the tool of FIG. 6a taken
from the line 6b--6b thereof.
DETAILED DESCRIPTION OF THE DRAWING
Referring now to the drawing and particularly to FIG. 1 thereof, a
retrograde renal biopsy instrument 10 embodying the present
invention is shown in a renal tissue specimen collecting position
within a urinary tract including the urethra, the bladder, the
ureter canal and the associated kidney. As shown in FIGS. 1 and 2,
the instrument 10 includes a flexible injector tube 11 in which a
flexible wire 12 is slidably mounted. A second tube 13, which is
also flexible and of substantially smaller diameter is secured to
the injector tube 11 and opens at its forward end into a balloon 14
which surrounds the injector tube 11 near its forward distal end
and which is hermetically sealed thereto. The balloon 14 is, when
in its deflated condition, a resilient, tubular member having an
internal diameter but slightly greater than the external diameter
of the injector tube 11. The other end of the tube 13 is connected
to an enlarged cylindrical member 15 of conventional construction
in catheters enabling the insertion therein of a hypodermic needle
to inflate the balloon 14 when it is disposed in the renal pelvis
of the kidney.
Fixedly mounted near the forward distal end of the slide wire 12,
as best shown in FIG. 2, is a scraping tool 16 having a collar
portion fixedly mounted to the wire 12 and a plurality of
rearwardly extending finger-like projections 17. The fingers 17 are
preferably resilient and inherently biased into the closed position
as illustrated in FIG. 2. The ends 18 of the fingers 17 have a
sharp outer edge which functions to scrape renal tissue from the
medulla or cortex portions of the kidney as the tool is moved
rearwardly through the kidney.
As shown, the distal end 19 of the slide wire 12 extends forwardly
beyond the end of the scraping tool 16 and, being relatively small
in diameter, is used for penetration of the epithelium of the renal
pelvis.
In use, the instrument 10 is inserted, with the aid of a cystoscope
through the urethra into the bladder and from the bladder into the
ureter canal leading to the kidney from which the biopsy specimen
is to be obtained. With the aid of a fluoroscope the instrument is
guided through the ureter canal into the renal pelvis of the kidney
until the end 19 of the slide wire engages the epithelial membrane.
The length of the scraping tool 16 and the balloon 14 is such that
the balloon 14 is located within the renal pelvis at this time. Air
is then injected through the tube 13 to inflate the balloon 14
which expands into the renal pelvis to fixedly lock the forward end
of the instrument in place therein at substantially right angles to
the adjacent portion of the epithelium. In FIG. 1 the balloon 14 is
shown in this inflated condition. The physician then pushes
inwardly on the slide wire 12 causing the end 19 thereof to
puncture and penetrate the epithelium layer and to be followed by
the scraping tool 16 into the medullary tissue of the kidney. It
will be apparent to those skilled in the art that if a specimen of
the cortical tissue is desired, the wire 12 is pushed farther
inwardly so that the cutting tool is disposed within the cortex
portion of the kidney. The physician then retracts the slide wire
12 which causes the rear edges 18 of the fingers 17 to scrape along
the adjacent portions of the kidney to remove small sliver-like
segments thereof which are collected and retained along the inside
surfaces of the fingers 18. When the fingers 17 abut the distal end
of the injector tube 11, a condition which is readily apparent to
the physician, the balloon 14 is deflated through the tube 13 and
the entire instrument can then be readily withdrawn from the
patient. After retraction from the patient the specimens may be
removed from the tool 16 with a small tweezer and placed in
specimen bottles in the normal manner.
Referring now to FIG. 3a, there is shown another puncturing and
scraping tool 21 which is secured to the injector tube 11 over the
end thereof. The tool 21 comprises a cylindrical tube having an
integral flap 22 of rectangular shape partially cut therefrom. The
outer edge 23 of the flap 22 is sharp and provides the scraping
edge of the tool. A puncturing head 24 is secured to the forward
end of the slide wire 12 and has a pointed conical end 25 for
puncturing and penetrating the epithelium membrane. A stop collar
26 is positioned around and secured to the rearward end of the head
24 for cooperation with a collar 27 fixed in the distal end of the
tool 21 so that when the forward shoulder on the collar 26 engages
the rearward shoulder on the collar 27, further projection of the
cutting head 24 is prevented. A transverse rod 28 is fixed in the
tool 21 to limit rearward movement of the puncturing head 24 within
the housing cylinder.
In use, the insertion tube 11 is used to feed the tool 21 and the
balloon 14 into the renal pelvis. In this embodiment of the
invention there is no sharp forward edge on the tool during such
insertion. Once the balloon 14 is within the renal pelvis with the
forward end of the tool abutting the renal pelvis the balloon 14 is
inflated and the slide wire 12 is then pushed forward to cause the
head 24 to puncture and penetrate the epithelium. Further pushing
of the wire 12 after engagement of the opposing shoulders on the
collars 26 and 27 moves the entire scraping tool 21 into the
medulla tissue of the kidney. Upon retraction of the tool 21, the
finger 22 scrapes the tissue and feeds a sliver of the removed
tissue along the inner surface of the finger 22. The tool cylinder
is made of a resilient material so that upon completion of the
scraping operation the finger 22 is self biased back into
substantial engagement with the adjacent edges of the cylinder so
as to provide a substantially flush outer surface to facilitate
withdrawal of the instrument from the patient.
Referring now to FIG. 4 there is shown another puncturing and
tissue removal tool 30 embodying the present invention. The tool 30
comprises a tube 31 fitted over and secured to the injector tube 11
just forward of the balloon 14. The slide wire 12 is provided with
a pointed forward end 32 and a centering collar 33 is fixed to the
wire 12 for engagement with a pair of transverse rods 34 and 35 to
limit the forward and rearward movement of the slide wire 12 in the
tube 31. A plurality of rods 36 are mounted in the forward end
portion of the tube 31 and extend in a rearward direction at an
angle of about 45.degree. into the tube 31. The ends of the rods
define an axial opening through which the slide wire 12 may be
moved.
In use, the instrument is inserted into the patient until the
forward end of the tube engages the epithelium of the renal pelvis.
The balloon 14 is then inflated and the slide wire 12 is then
pushed forward to puncture the epithelium. The wire 12 is then
retracted and the tube 11 is pushed forward into the kidney tissue
a sufficient distance to collect a cylinder of tissue in the end of
the tube 31. The inherent resiliency of the balloon 14 is
sufficient to permit this forward movement of the tube 31. The tube
11 is then retracted and the rods 36 hold the cylindrical specimen
in the end of the tube 31. The balloon 14 is then deflated and the
entire instrument is removed from the patient.
Referring to FIG. 5, there is shown another puncturing and tissue
removal tool 40 embodying the present invention. The tool 40
comprises a tube 41 fixedly connected to the insertion tube 11 just
forwardly of the balloon 14. A pair of longitudinal slots 42 and 43
are provided in the tube 41 for receiving a pair of flexible,
spring steel, scraping fingers 44 and 45 fixed by an integral
collar 46 to the slide wire 12. A collar 49 is fixed to the slide
wire 12 for cooperation with a stop collar 50 fixedly mounted in
the tube 41 between the collar 49 and a retainer rod 48. As shown,
the forward end 51 of the slide wire 12 is pointed to facilitate
puncturing of the epithelium of the renal pelvis.
In use, the instrument is inserted into the patient until the
forward end of the tool 40 abuts the wall of the renal pelvis. The
balloon 14 is then inflated and the slide wire is pushed forward to
puncture the epithelium and to push the entire tool into the renal
tissue. The slide wire 12 is then retracted and moves rearwardly in
the tube 41 until the collar 49 engages the rod 48. A short
distance before the collar 49 engages the retainer rod 48 the ends
of the fingers 44 and 45 emerge through the slots 42 and 43
spreading outward, due to spring tension, causing beyond the
envelope of the tube 41 to scrape a sliver of tissue from the
kidney. The slide wire 12 is then pushed forward to cam the fingers
44 and 45 inwardly so as not to interfere with the withdrawal of
the instrument from the patient and to hold the specimens during
withdrawal. The entire instrument is then withdrawn from the
patient.
Referring now to FIGS. 6a and 6b, a puncturing and scraping tool 55
includes a stainless steel tube 56 tightly fitted into the end of a
tube 63 slidable in the insertion tube and extending from both ends
thereof. The tube 56 is bonded to the tube 63 with a suitable
cement. The tube 56 has an end surface 57 cut on a bias relative to
the axis of the tube to provide a sharp cutting edge. A stainless
steel wire 58 is slidably mounted in the tube 63 and extends beyond
the rear end thereof for manipulation thereof by the physician. The
forward end portion of the wire 58 is flattened beginning at 59 and
the tube 56 is crimped at 60 to provide a stop for limiting forward
relative movement of the slide wire 58.
The wire 58 is provided with a reverse bend at the forward end
portion to provide a flat finger 62 lying parallel to the face 57
of the tube 56 and a camming surface 61 adapted to engage the
adjacent edge of the tube 56 when the slide wire 58 is pulled
downwardly as shown in FIGS. 6a and 6b.
In use the slide wire is retracted to withdraw the portion 61 into
the tube 56 a sufficient amount to move the finger 62 against the
surface 57 whereby the external diameter of the tool 55 is less
than the external diameter of the insertion tube and the tube 63 is
withdrawn into the insertion tube. The entire instrument is then
inserted into the patient until the tool enters the renal pelvis.
The balloon is then inflated and the tube 63 is pushed forward to
expose the tool which punctures the epithelium of the renal pelvis
and extends the desired distance into the renal tissue. The slide
wire is then pushed forward and retracted to cause the end to clip
off a piece of renal tissue and capture it in the end of the tube
56. The tube 63 is then withdrawn into the insertion tube, the
balloon is deflated and the entire instrument is then withdrawn
from the patient.
While the sizes and dimensions of the tools of the present
invention are not critical the following dimensions have been found
to provide satisfactory devices:
balloon 14 (deflated diameter) 0.156 inch slide wire 12 (diameter)
0.020 inch fingers 17 (maximum diameter) 0.1875 inch tube 21
(outside diameter) 0.069 inch tube 41 (outside diameter) 0.069 inch
tube 56 (outside diameter) 0.025 inch wire 58 (unflattened) 0.020
inch wire portions 60 and 61 0.013 .times. 0.023 inch
While the present invention has been described in connection with
particular embodiments thereof, it will be understood that those
skilled in the art may make many changes and modifications without
departing from the true spirit and scope thereof. Accordingly, the
appended claims are intended to cover all such changes and
modifications as fall within the true spirit and scope of the
present invention.
* * * * *