Information
-
Patent Grant
-
6699232
-
Patent Number
6,699,232
-
Date Filed
Thursday, March 1, 200125 years ago
-
Date Issued
Tuesday, March 2, 200422 years ago
-
Inventors
-
Original Assignees
-
Examiners
Agents
- Marshall, Gerstein & Borun LLP
-
CPC
-
US Classifications
Field of Search
US
- 604 6901
- 604 9701
- 604 9901
- 604 10102
- 604 10104
- 604 113
- 604 264
- 604 523
- 604 533
- 604 528
- 604 915
- 606 194
-
International Classifications
-
Abstract
An apparatus and method for manually injecting fluid into a patient with improved contrast visualization are disclosed. The apparatus includes a syringe having a cylinder in which a plunger is reciprocatingly mounted. The syringe is connected to a manifold which itself is connected to a source of radiopaque contrast. Retraction of the plunger within the cylinder draws contrast into the cylinder, and depression of the plunger forces the contrast through the manifold and into a patient through a catheter. In order to increase the speed of injection and thus the visualization of the contrast, an improved visualization device is provided which may be provided in the form of a heater or, alternatively, in the form of an expandible catheter. The heater may be positioned anywhere within the apparatus to elevate the temperature of the contrast material, which in turn reduces its viscosity and thereby increases the speed with which fluid may be injected. The expandible catheter, may be used to restrict blood flow through a vascular structure so that the contrast material may be injected into the patient with lessened resistance and dilution from blood flow.
Description
FIELD OF THE INVENTION
The invention generally relates to fluid injection apparatus and, more particularly, relates to manually operated syringes.
BACKGROUND OF THE INVENTION
Many medical procedures require the injection of fluid. One example is angiography. Angiography is a procedure used in the detection and treatment of abnormalities or restrictions in blood vessels. During angiography, a radiographic image of a vascular structure is obtained by injecting radiopaque fluid or contrast through a catheter into a vein or artery. Vascular structure fluidically connected with the vein or artery in which the injection occurs is filled with the contrast material. X-rays are then passed through the region of the body in which the contrast material was injected, with the x-rays being absorbed by the contrast material, creating a radiographic outline or image of the blood vessel containing the contrast material. The x-ray image of the blood vessels filled with the contrast material is usually recorded onto film or videotape and then displayed on a fluoroscope monitor.
The speed with which the injection of contrast occurs enhances the resulting radiographic image because the speed of injection counteracts the flow of blood through the vessels that continually carries or flushes the contrast away. The faster the injection of contrast means a higher concentration of the contrast during the x-ray imaging and therefore a higher radiopacity of the blood vessels. Due to the high viscosity of the contrast material, and the flow resistance in the catheter and other fluid channels, the force required for rapid injection of a contrast is relatively high.
An additional factor contributing to the high forces required for plunger depression is that as current technology has evolved, the catheters used for angiography have reduced in size. The outlet diameters of the catheters have been reduced to four or five French size catheters. As a result, the force required to inject into the arteries has increased significantly.
Currently, manual syringes are used to inject contrast into most arteries. When large flow rates of contrast are required, as is the case for ventrilography (injecting into the left ventricle), a power injector is typically used because manual syringes cannot be operated with sufficiently high flow rate due to the inability to apply enough manual force on the syringe plunger. The power injector is operated by first setting a flow rate and an injection volume. The operator then activates the system by pressing a button on a hand controller which actuates a motor or the like for injecting the contrast. Examples of such power injectors are disclosed in U.S. Pat. Nos. 5,515,851 and 5,916,165.
However, while such power injectors are preferable in certain applications, in other instances, it would be advantageous to use a manual syringe. One advantage of using a manual syringe is that the operator is provided with more direct control of the injection. For example, if resistance is encountered during the injection process, the operator can detect the resistance due to an increase in the pressure, and thus the force required to manually depress the plunger.
It would therefore be advantageous to provide a fluid injection apparatus which enables the injection to be performed manually, but which reduces the force required for such manual operation without employing a power injector.
SUMMARY OF THE INVENTION
In accordance with one aspect of the invention, a fluid injection apparatus adapted to inject fluid is provided which comprises an input device, a catheter, and an improved visualization device. The catheter is in fluid communication with the input device. The improved visualization device is adapted to increase the speed with which fluid may be injected.
In accordance with another aspect of the invention, a method of manually injecting fluid is provided which comprises the steps of retracting a plunger from a syringe cylinder and drawing fluid into the cylinder, depressing the plunger into the cylinder forcing the fluid out an outlet of the cylinder, increasing the speed with which fluid may be injected, and injecting the fluid into a patient.
In accordance with another aspect of the invention, a manually operated fluid injection apparatus is provided which comprises a syringe, a manifold, a fluid line, a catheter, a source of fluid, and a heater. The syringe includes a movable plunger, while the manifold includes a plurality of inlet ports in first and second ends. The syringe is connected to the first end of the manifold. The catheter is connected to the second end of the manifold. The source of fluid is in communication with one of the manifold inlet ports via the fluid line, while the heater is operatively associated with one of the syringe, manifold, fluid line, catheter, or source of fluid.
In accordance with another aspect of the invention, a manually operated fluid injection apparatus is provided which comprises a syringe, a manifold, a fluid line, a catheter, a source of fluid, and an expandable ring. The syringe includes a movable plunger, while the manifold includes a plurality of inlet ports in first and second ends. The syringe is connected to the first end of the manifold. The catheter is connected to the second end of the manifold. The source of fluid is in communication with one of the manifold inlet ports via the fluid line, while the expandable ring is associated with the catheter and is expandable after catheter insertion and prior to injection to constrict blood flow.
In accordance with another aspect of the invention a manually operated fluid injection system is provided which comprises a manipulable input device, and a heater associated with the input device and adapted to increase the temperature of fluid prior to injection.
In accordance with another aspect of the invention a manually operated fluid injection system is provided which comprises a manipulable input device, a catheter connected to the input device, and an expandable member associated with the catheter and adapted to expand after the catheter is inserted into a patient to restrict blood flow during injection.
These and other aspects and features of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1
is a schematic representation of a manual fluid injection apparatus constructed in accordance with the teachings of the invention;
FIG. 2
is a block diagram of an alternative embodiment of a fluid injection apparatus constructed in accordance with the teachings of the invention; and
FIG. 3
is a flow chart of a sample sequence of steps which may be taken by a fluid injection system constructed in accordance with the teachings of the invention.
While the invention is susceptible to various modifications and alternative constructions, certain illustrative embodiments thereof have been shown in the drawings and will be described below in detail. It should be understood, however, that there is no intention to limit the invention to the specific forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions and equivalents falling within the spirit and scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawings, and with specific reference to
FIG. 1
, a manually operated fluid injection apparatus constructed in accordance with the teachings of the invention is generally depicted by reference numeral
20
. The apparatus
20
is depicted in reference to a manually operated apparatus
20
for the injection of radiopaque contrast from a supply
22
to a patient (not shown). However, it is to be understood that the teachings of the invention can be used for the injection of other fluids as well, and in power-assisted, or automatic injection systems as well.
As shown in
FIG. 1
, the apparatus
20
includes a manually operated syringe
24
, a manifold
26
, a first fluid line
28
, a second fluid line
30
, a catheter
32
, and an improved visualization device
34
.
The syringe
24
includes a cylinder
36
in which a plunger
38
is disposed for translational movement. The plunger
38
includes a thumb ring
40
, as well as a rubber or otherwise elastomeric stopper
42
engaging an inner circumferential surface
44
of the cylinder
36
. First and second finger rings
46
and
48
extend from the cylinder
36
to facilitate operation of the syringe
24
in conjunction with the thumb ring
40
. The cylinder
36
includes a reduced diameter outlet
50
connected to a first end
52
of the manifold
26
. A threaded or other suitable coupling
54
is provided for attachment therebetween.
The manifold
26
includes the first end
52
, a second end
56
, and a plurality of valved inlet ports
58
a, b
, and
c
. As shown in
FIG. 1
, inlet port
58
c
is connected to the first fluid line
28
for receipt of contrast from the supply
22
. The second inlet port
58
b
, is connected to a source of saline
60
by way of the second fluid line
30
. The third inlet port
58
a
, is shown connected to a pressure transducer
64
. The second end
56
of the manifold
26
is connected to the catheter
32
.
The first fluid line
28
, connecting the source of contrast
22
to the manifold
26
, may include a valve
66
as well as a vent
68
. The valve
66
, which may be provided in the form of a stop cock, is provided to control flow of contrast from the source of contrast
22
to the manifold
26
. The vent
68
, is provided to aerate any air or gas within the first fluid line
28
.
The catheter
32
includes a proximal end
70
, and a distal end
72
. As shown in
FIG. 2
, in an alternative embodiment the distal end
72
of the catheter
32
may be provided with an expandable ring
74
, the importance of which will be discussed in further detail herein. The expandable ring
74
may be provided in the form of an elastomeric hollow ring which upon introduction of compressed air or the like, may expand to increase the diameter of the catheter
32
.
Referring again to
FIG. 1
, the improved visualization device
34
is shown proximate the catheter
32
. The improved visualization device
34
may be provided in the form of a heater, or may include the expandable ring
74
. The heater
76
can be provided in a variety of radiant, convective and conductive forms, including conventional heating coils which, upon electrical actuation, elevate temperature to thereby increase the temperature of the catheter
32
and thus the temperature of the contrast within the catheter
32
. Alternatively, the heater
76
may be provided in the form of conduits or tubes wrapped around the catheter
32
or other parts of the apparatus
20
and through which a relatively warm fluid is passed for heating of the contrast. In a still further alternative, the heater
76
may be embedded directly in the apparatus
20
. More specifically, resistor coils or other heating devices may be provided in the body of the syringe
24
, the manifold
26
, the first fluid line
28
, the second fluid line
30
, or the catheter
32
. However, the inventor has found that it is beneficial to provide the heater
76
as close to the end of the catheter
32
inserted into the patient as possible to lessen the cooling effects of traveling through the apparatus
20
.
The improved visualization devices
34
are provided to increase the speed with which the contrast may be injected to thereby minimize the effect of blood flow washing the contrast away and lessening the visual radiographic image generated. In the embodiment employing the heater
76
, the speed is increased by elevating the temperature of the contrast, which in turn decreases its density and decreases its viscosity. Accordingly, the contrast is more easily injected. In the embodiment employing expandable ring
74
, the size of the catheter
32
is increased after placement within the vascular structure of the patient. In so doing, blood flow is restricted through the vascular structure, momentarily, while the contrast is injected. The contrast therefore is injected with less mixing with blood flow and less dilution of the contrast. After injection of the contrast, the expandable ring can be deflated and the catheter
32
can be removed thereby allowing blood flow to return to normal. The heater
76
and the expandable ring
74
may be combined in the same system or apparatus
20
.
In operation, the apparatus
20
may be used to inject fluid into a patient with increased speed. As shown in
FIG. 3
, which is a sample depiction of steps which may be taken by the apparatus
20
, after the valve
66
is opened, the process is initiated by opening the valved port
58
c
, as indicated by step
78
. In so doing, fluid flow is communicated from the source of contrast
22
, through the manifold
26
and to the outlet
50
of the syringe
24
. The contrast
22
is able to enter the cylinder
36
of the syringe
24
upon retraction of the plunger
38
, as indicated by step
80
. More specifically, the retraction of the plunger
38
within the cylinder
36
creates a vacuum within the cylinder
36
, thereby drawing the contrast into the syringe
24
. The plunger
38
may be retracted a distance sufficient to fill the cylinder
36
to the appropriate volume. A series of indicia or graduations may be provided on the side of the cylinder to facilitate such operation.
Once the syringe
24
is filled to the appropriate volume, the plunger
38
is reciprocated back into the cylinder
36
as indicated by step
82
. In so doing, the contrast
22
is forced from the cylinder
36
into the manifold
26
, through the catheter
32
, and into the patient. While passing through the components of the apparatus
20
, the contrast fluid
22
is heated, as indicated by step
84
. In so doing, the density and viscosity of the contrast
22
are decreased, and the force required by the user to depress the plunger
38
is decreased, and the speed of injection is increased.
In an optional step
86
, the catheter
32
may be expanded in conjunction with the heating step
84
. In so doing, the catheter
32
restricts blood flow through the vascular structure in which the catheter
32
is placed. The contrast
22
can therefore be injected into the patient in step
88
with lessened interference and dilution from blood flow. Once the contrast
22
is fully injected, the catheter can be deflated and removed. It is to understood that the expansion of the catheter step
86
may be conducted in the absence of the heating step
84
, and similarly, that the heating of the contrast
84
can be conducted in the absence of the catheter expansion step
86
.
From the foregoing, it can be seen by one of ordinary skill in the art that the teachings of the invention may be utilized to provide a manual fluid injection apparatus and method which reduces the force required by an operator to manually inject fluid into a patient, increases the speed of injection, and improves the contrast visualization on the resulting radiographic image.
Claims
- 1. An angiography device, comprising:a catheter inserted into a blood vessel; a source of radiopaque fluid; an injector fluidically connected to the source of radiopaque fluid and the catheter, the injector driving the radiopaque fluid from the source to the catheter and into the blood vessel; a heater heating the radiopaque fluid, the heater reducing the viscosity of the radiopaque fluid thus increasing the speed with which the radiopaque fluid is introduced into the blood vessel; and an expandable ring provided on the catheter, the expandable ring constricting blood flow through the blood vessel when expanded thus decreasing the speed with which the radiopaque fluid is diluted in the blood vessel.
- 2. The angiography device of claim 1, wherein the injector is a syringe.
- 3. The angiography device of claim 2, wherein the syringe is manually operated.
- 4. The angiography device of claim 1, further including a manifold having a plurality of ports, the injector, the source, and the catheter each being connected to one of the ports.
- 5. The angiography device of claim 1, wherein the heater is integrated into one of the injector, catheter, and source.
- 6. The angiography device of claim 1, wherein the heater employs a form of heating selected from the group of heating forms consisting of radiant, convective, and conductive heating.
- 7. An angiographic device, comprising:a catheter inserted into a blood vessel; a source of radiopaque fluid; an injector fluidically connected to the source of radiopaque fluid and the catheter and driving the radiopaque fluid from the source to the catheter and into the blood vessel; and an expandable ring provided on the catheter, the expandable ring constricting blood flow through the blood vessel when expanded thus decreasing the speed with which the radiopaque fluid is diluted in the blood vessel.
- 8. The angiographic device of claim 7, wherein the injector is a syringe.
- 9. The angiographic device of claim 8, wherein the syringe is manually operated.
- 10. The angiographic device of claim 7, further including a manifold having a plurality of ports, the injector, source, and catheter each being connected to one of the ports.
US Referenced Citations (61)
Foreign Referenced Citations (4)
| Number |
Date |
Country |
| 0 702 966 |
Mar 1996 |
EP |
| 0 346 950 |
Sep 1997 |
EP |
| WO 9924094 |
May 1999 |
WO |
| WO 0059569 |
Oct 2000 |
WO |