Inventors:
Nozick, Jerome (Watchung, NJ)
Barr, Alvin (Clark, NJ)
Field of Search:
128/348,349B,349BV,35R,351,241,246,325,344,328
Description:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to embolectomy catheters and particularly to embolectomy catheters having separate passages therein, one for inflating a sleeve on the external surface on the distal end of the catheter, and the other for discharging a fluid behind an embolus so as to drive it toward a point of discharge.
2. Prior Art
The formation of an embolus in a blood vessel is a continuous threat to the security of the person wherein the embolus is formed. Numerous means have been devised for removing the embolus, because if it is not attended to, it may move to a critical site where it will deprive the body of blood and cause severe damage to that portion of the body. The problem has been dealt with in various ways as for example the embolectomy catheter of Klieman, U.S. Pat. No. 3,635,223 issued Jan. 18, 1972; Fogarty, U.S. Pat. No. 3,467,102 of Sept. 16, 1969; Fogarty, U.S. Pat. No. 3,435,826 of Apr. 1, 1969. The use of many devices has been attended with the possibility of damage to the blood vessels, difficulty of use, and failure to accomplish the objective of removal of the embolus. There are other disadvantages.
SUMMARY OF THE INVENTION
It has been found that an embolectomy catheter can be devised which is easy to use, which does not drag the embolus through the blood vessel, that does not require the user to drag a ballon through the blood vessel, that readily deflates, and surely moves the embolus toward discharge. In this embolectomy catheter, there is a first discrete passage with is entirely separate from a second passage; the first passage inflates an inflatable sleeve; the second passage discharges a liquid behind the embolus so as to exert pressure upon it and move it toward a discharge point.
THE DRAWINGS
These objects and advantages as well as other objects and advantages are achieved by the device shown by way of illustration in the drawings in which:
FIG. 1 is a vertical sectional view of the embolectomy catheter showing the separate discrete fluid passages therein and the connections for separately inserting fluid therein;
FIG. 2 is a vertical sectional view of the embolectomy catheter inserted in a blood vessel with the sleeve inflated; and
FIG. 3 is a cross-sectional view taken on the line 3--3 in FIG. 1 looking in the direction of the arrows.
PREFERRED EMBODIMENT
Referring now to the drawings in detail, our embolectomy catheter provides a thin flexible body 11, which is externally smooth so that it may easily be inserted into a blood vessel and move through it. It has a generally circular cross-section. Near the sealed distal end 12 of this body 11, a generally tubular sleeve 13 is applied and sealed thereto at both ends 14. This sleeve 13 is made of thin, light material which is elastic and capable of being inflated like a balloon. The body 11 has two separate and distinct passages thereto which do not communicate with each other. The first passage 15 has an orifice 16 which communicates with the interior of the sleeve. The second passage 17 has a plurality of orifices 18 immediately adjacent to the sleeve. Thus, fluid injected into the first passage 15 will cause the inflation of the sleeve in the manner of a balloon as shown by the dotted line in FIG. 1. Liquid injected into the second passage 17 will pass out of the several orifices 18 immediately behind the sleeve 13. The sleeve 13 is located immediately adjacent to the distal end 12 of the body 11.
At the ventral end 19 of the body 11, the body 11 is bifurcated to separate the first and second passages 15, 17. The first passage terminates in a valve 20 which a syringe may be applied for the introduction of fluid; the valve 20 will capture and hold fluid in the first passage 15. A sealing deflectable plug 21 will retain the fluid in the first passage 15. The plug 21 is seated on an O-ring 10, being urged into such engagement by a spring 9. The fluid in the first passage 15 will cause the sleeve 13 to be distended and remain distended until the plug 21 is unseated sufficiently to allow entrapped fluid in the first passage 15 to flow out. When fluid in the first passage 15 inflates the sleeve 13 as a balloon, it blocks the passage in a blood vessel in which the catheter is inserted. Such valves 20 are well known in the surgical appliance industry and readily available. The second passage 17 terminates in a standard tip 22 wherein a syringe may be inserted for the purpose of injecting fluid into the second passage 17, to flow out of the orifices 18 into a blood vessel 23.
The use of the embolectomy catheter is as follows:
The flexible body 11 is inserted into a slit in a blood vessel 23 and is moved toward an embolus. A clamp is applied to the blood vessel at an appropriate position to cut off the flow of blood to the blood vessel. The distal end of the flexible body 11 will be urged through the blood vessel and will pass around the embolus 24 or may pierce the embolus 24 and proceed to a position wherein the sleeve is beyond the embolus. The sleeve 12 may then be inflated by the injection of fluid into the first passage 15, thereby to inflate the sleeve 13 behind the embolus 24. The valve 20 retains the fluid in the first passage 15 so that the sleeve 13 stays in an inflated state, so that the inflated sleeve 13 will dam or block fluid injected behind the embolus flowing out of the second passage 17. Fluid is then injected into the second passage 17 and the fluid passes out of the orifices 18 behind the embolus 24. The fluid propels the embolus toward the point of insertion of the catheter into the blood vessel where the embolus 24 is discharged from the blood vessel 23. The body 11 is flexible; the sleeve 13 is soft and it has sufficient resiliency so that it will collapse when fluid pressure in the second passage 17 is relieved, but nevertheless will sustain tension against the walls of the blood vessel 23 when the sleeve 13 is inflated, and it will also close off any flow of blood or any flow of fluid until the embolus 24 has been removed.
In cases where a person has a shunt installed in his body to enable the frequent periodic attachment to a dialysis apparatus, the present catheter is particularly useful to remove an embolus that may form at the site of the shunt. If perchance, a catheter with hooked enlargements were to be used at the site of the shunt to remove an embolus, the enlargements might disconnect the shunt from the blood vessel. The present catheter being moved, does not present this kind of problem. The risk of such an occurrence is vastly reduced by the use of our smooth embolectomy catheter, which does not append upon hooking the embolus to remove it, but functions to flush an embolus out of a blood vessel.