U.S. patent number 3,795,246 [Application Number 05/326,647] was granted by the patent office on 1974-03-05 for venocclusion device.
This patent grant is currently assigned to C. R. Bard, Inc.. Invention is credited to John F. Sturgeon.
United States Patent |
3,795,246 |
Sturgeon |
March 5, 1974 |
VENOCCLUSION DEVICE
Abstract
A device designed to be implanted in a blood vessel such as the
inferior vena cava, as a substitute for a tying or clamping
operation on such vessel, the device being inserted in deflated
condition through a simple incision, moved to the desired location,
inflated to engage securely the wall of the vessel and then
detached from the inserting means. The device comprises a generally
cylindrical core body containing one or more one-way valves and
having around its outer surface an inflatable balloon, the device
being initially mounted on and inserted by an elongated catheter
traversed by a needle through which inflation fluid is fed to the
balloon; withdrawal of the needle after inflation permits the valve
or valves to close and simultaneously separates the device from the
catheter.
Inventors: |
Sturgeon; John F. (Glens Falls,
NY) |
Assignee: |
C. R. Bard, Inc. (Murray Hill,
NJ)
|
Family
ID: |
23273109 |
Appl.
No.: |
05/326,647 |
Filed: |
January 26, 1973 |
Current U.S.
Class: |
606/195; 606/200;
604/907; 604/99.03 |
Current CPC
Class: |
A61B
17/12109 (20130101); A61B 17/12136 (20130101) |
Current International
Class: |
A61B
17/12 (20060101); A61b 017/12 (); A61m
025/02 () |
Field of
Search: |
;128/246,344,325,349B,349BV |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
hughes; Carl W., "Use of Intra-Aortic Balloon Catheter Tamponade
For Controlling Intra-Abdominal Hemorrhage In Man." Surg. 36
;65-68,1954. .
Hunter; James A. et al., "Experimental Balloon Obstruction of
Inferior Vena Cava," Annals of Surgery, 171 : 315-320,
1970..
|
Primary Examiner: Pace; Channing L.
Attorney, Agent or Firm: Martine, Jr.; Chester E.
Claims
What I claim is:
1. A blood vessel occluding device comprising, a rigid cylindrical
body having distal and proximal ends and an axial bore, means
closing the distal end of said bore, a valve seat spaced from said
closing means, to define a valve compartment between said closing
means and said seat, a valve movable in said compartment toward and
away from said seat, a passage extending outward from said
compartment through the body wall, resilient means urging said
valve toward engagement with said seat, a mass of self-sealing
material substantially filling said bore proximally of said valve
seat, means at the proximal end of said body for retaining said
mass in said bore, and a sheath of stretchable fluid-impervious
material sealed to said body distally and proximally of said
passage and adapted to be inflated to form a balloon around said
body.
2. A blood vessel occluding device according to claim 1 which
includes a ring engaging the distal end portion of the sheath to
hold it in sealing contact with the body surface.
3. A blood vessel occluding device according to claim 2 which
includes a smoothly rounded distal tip element adapted to hold the
ring in sheath engaging position.
4. A blood vessel occluding device according to claim 1 wherein the
valve seat and the mass retaining means are traversed axially by
openings to permit passage of an inflating needle.
5. In combination, the occluding device as claimed in claim 1 and a
positioning device comprising an elongated flexible catheter, a
fitting on the distal end of the catheter having a socket adapted
to receive the proximal end of the body and an axial opening, an
elongated needle having a bore and a distal end, the bore
terminating distally in an opening adjacent said distal end, and
means for moving said needle axially relative to said catheter, the
occluding device being associated with the positioning device with
the proximal end of the body seated in the socket and the needle
passing through the mass of material and projecting distally
therefrom sufficiently to hold the valve off its seat and provide
communication between the distal opening in the needle and the
outwardly extending passage.
6. The combination according to claim 5 wherein the outer surface
of the fitting forms a smooth continuation of the outer surface of
the catheter at the distal end of the latter.
7. The combination according to claim 5 wherein the outer surface
of the fitting forms a smooth continuation of the outer surface of
the balloon sheath at the proximal end of the latter.
8. The combination according to claim 5 wherein the needle moving
means includes a fitting on the proximal end of the catheter and a
separate base element, the needle having its proximal end connected
to said base element and passing through said proximal catheter
fitting, and said base element being adapted to rest against said
latter fitting.
9. The combination according to claim 8 which includes a flanged
bushing threaded to the proximal catheter fitting and adapted to be
positioned to determine the axial position of the separate base
element relative to said latter fitting.
10. The combination according to claim 8 which includes means
preventing rotation of said base element relative to said proximal
catheter fitting.
Description
The problem of migration of clots from veins in the legs toward the
heart has been met heretofore by a dangerous major operation in
which the inferior vena cava is tied, causing blood to return to
the heart by way of collateral circulation. The background of the
present invention is clearly set forth in Mobin-Uddin U. S. Pat.
No. 3,540,431, wherein an umbrella-like device is proposed, to
serve as a permanently implanted filter. That patent also suggests
that the "canopy" part of the umbrella may be impervious, for
complete occlusion, and it is known that the filter commonly
becomes clogged sooner or later so that the passageway is
completely blocked, either intentionally or otherwise. Other forms
of occlusion devices are shown in Hunter and Sessions application
Ser. No. 878,813, filed Nov. 21, 1969, (and continuation
application Ser. No. 232,323, filed Feb. 23, 1972) under which
applicant's assignee is licensed, and the present invention being
specifically an improvement on the Hunter and Sessions devices.
Objects of the present invention are the provision of an occlusion
device with a balloon assembly in which the balloon material is
practically impervious to the inflating fluid, in which a
spring-loaded mechanical valve is in series with a plug of
self-sealing material under compression, and in which the balloon
assembly is detachably secured to the end of the inserting catheter
only by means of the inflating needle. Additionally, the catheter
is provided with a passage, an inlet fitting and outlet holes for
feeding radiopaque dye to a point in the vessel, as an aid in the
precise location of the occlusion device.
A practical embodiment of the invention is shown in the drawings,
wherein:
FIG. 1 represents a longitudinal axial section of the occlusion
device, needle and distal end of the insertion catheter with valve
open;
FIG. 2 represents a similar longitudinal axial section with the
balloon inflated and valve closed;
FIG. 3 represents an elevation of the occlusion device and
insertion catheter, with fittings, part of the length being
indicated by a broken line;
FIG. 4 represents a detail elevation, on an enlarged scale, of the
proximal end of the catheter and its fitting, parts being in
section and parts being broken away.
Referring to the drawings, the occlusion device 10 is shown as
comprising cylindrical body portion 11 having a tapered distal end
12 and a proximally open axial bore 13, the distal portion 14 of
said bore having a smaller diameter than the proximal portion
thereof and said portions being defined by an annular shoulder 15
forming a proximally facing seat.
A distally recessed annular retainer 16 rests against the shoulder
15 and an O-ring 17 is seated in the recess. Proximally of the
retainer 16, the bore 13 is filled with a self-sealing rubber
compound 18 held in the bore 13 by a tight fitting plug 19 having a
small axial bore 20. A valve 21 having a beveled face 22 is
slidable in the portion 14 of the bore, constituting a valve
compartment, the valve being urged by a spring 23 under compression
toward engagement with the O-ring 17. One or more radial holes 24
extend outward from the portion 14 at points near the proximal end
of said portion.
The latex rubber balloon 25 is applied to the outer surface of the
body 10, preferably, by first stretching the end 26 of a
cylindrical rubber sleeve or sheath over the proximal end of said
body, wrapping said end tightly with thread (Dacron) 27, reversing
the sleeve to cover the thread, as shown, and securing the distal
end 28 of the sleeve against the tapered distal end 12 of the body
10 by means of an internally tapered ring 29 which is held in place
by a round-headed screw 30 threaded into the distal end of the body
10. The ring 29 and screw 30 are very precisely proportioned to
hold the sleeve end 28 securely in sealing contact with the tapered
end 12 of the body but without undue compression, and the diameters
of said ring and screw are the same so that a comparatively smooth
edge is formed at their juncture. In addition to the fastenings
just described the balloon sleeve or sheath may be cemented to the
body 10 at any desired areas in order to predetermine the size and
shape of the balloon when inflated.
The insertion catheter 35 is an elongated plastic tube having a
small bore 36, a simple adapter fitting 37 at its distal end and a
multi-purpose fitting 38 at its proximal end. The fitting 37 has a
plug portion 39 seated within the end of the catheter, a socket 40
(which may be slightly flaring) to receive the proximal end of the
body portion 10 and a cylindrical or slightly tapering outer
surface 41 which is flush, proximally, with the outer surface of
the catheter and distally with the wrapped proximal end 26 of the
rubber balloon 25.
The proximal fitting 38 is traversed by an axial bore 42 and has a
plug portion 43 seated within the end of the catheter, a Luer lock
44 on a separate base 45 at its proximal end with valve 46 and a
side-arm two-way Luer lock 47 with valve 48, communicating with the
bore 36. An annular flange 49 extends radially outward from the
bushing 50 which is threaded on the proximal end of the fitting
38.
The needle 31 has an outside diameter smaller than the bore 36 of
the catheter, and a lumen extending from the proximal end Luer lock
fitting 44 to a lateral opening 52 spaced from the distal tip 53,
the needle being securely fixed to the base 45. The length of the
needle is such that, when the base 45 is engaged against the
fitting 38 and bushing 50, the sharply pointed tip end 53 will
extend through and beyond the self-sealing material 18 to a
position within the valve bore 14 where it holds the valve 21 wide
open (FIG. 1), with the opening 52 in the bore 14 more or less
opposite the opening or openings 24. The base 45 is held
non-rotatably in its set position by means of pins 55 mounted in
the base and extending into holes in the fitting 38.
With the parts assembled in the position of FIG. 1, the occlusion
device 10 is introduced into a selected vessel and advanced to the
desired location, such as the inferior vena cava, the position and
progress of the device being monitored radioscopically, with or
without the injection of dye and/or heparin saline through the
side-arm 47, lumen 36 and radial passages 56 near the distal end of
the catheter 35. During introduction of the occlusion device the
body 10 is held firmly in the socket 40 on the end of the catheter
by the engagement of the needle 31 in the compressed mass of
self-sealing material 18, this engagement being secure enough to
permit the occlusion device to be adjusted in either direction to
its optimum position. Upon reaching that position, inflation of the
balloon 25 is effected by injecting an inflation fluid from a
syringe (not shown) through the luer lock fitting 44, the lumen of
the needle and the opening 52.
The fluid acts through the opening 24 to inflate the balloon 25 to
a diameter sufficient to engage securely the adjacent wall of the
vessel to be occluded, the size of said vessel being generally both
known and observable. When satisfactory engagement has been
effected, inflation is stopped, the base 45 is disengaged from the
fitting 38 and the needle is carefully withdrawn, as by screwing in
a proximal direction the bushing 50.
As the needle is withdrawn from the open position of FIG. 1 to the
closed position of FIG. 2 the valve 21 is moved proximally by the
spring 23 until the surface 22 comes to a rest on the O-ring 17,
creating a tight seal as the O-ring is compressed into the recess
of retainer 16. Further retraction of the needle eventually frees
its tip portion from the material 18, the hole made by original
insertion of the needle closing tightly in the wake of the needle
point to create a second seal, preventing leakage of the inflation
fluid in the event that any is able to pass the O-ring. The
cylindrical body of the valve 21 may be so proportioned that its
surface will, in the closed position, seal off the opening 24, as
an additional precaution against leakage.
For optimum results, the balloon has to be scientifically
compounded to reduce the effect of osmolarity imbalance, prevent
premature deflation, and transfer of liquid and salts from inside
the balloon to the surrounding tissue. The balloon must be of a
sufficient modulus to prevent premature rupture while under
tension.
The balloon shape is substantially spherical when unrestricted, but
becomes somewhat elongated when inflated against the wall of the
inferior vena cava. Its proportions can be designed for use in
occluding vessels from 4F through 22F.
It will be understood that various changes may be made in the form,
construction and arrangement of the several parts without departing
from the spirit and scope of the invention and hence I do not
intend to be limited to the details shown or described herein
except as the same are included in the claims or may be required by
disclosures of the prior art.
* * * * *