Multipurpose medical device

Surgery – Instruments – Suture – ligature – elastic band or clip applier

Reexamination Certificate

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Details

C606S144000

Reexamination Certificate

active

06238404

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a multipurpose medical device, more particularly, a singular device configured for use as a vascular dilator, calibrator, occluder, suture guide and perfusion device.
BACKGROUND OF THE INVENTION
Numerous medical devices used for vascular dilation, calibration, suturing or perfusion are in existence. However, most devices are designed for providing a singular function. Designing a multipurpose medical device is a significant challenge in that the device must be cost effective to produce, reliable and the structures which provide each function must be complimentary rather than interfere with each other. Some existing devices do provide more than one function however none perform all of the functions that are accomplished by the present invention.
One example of a multipurpose device is the Fogarty® Flexible Calibrator manufactured by American Edwards Laboratories. This device is used as a dilator and calibrator, however it is not and can not be used for suturing or perfusion. Also, this device can only calibrate a single size, since the device has a uniform diameter. This is not cost effective since surgeons on average require 2.5 devices per patient per procedure to properly calibrate the size. At approximately $75 per device, which are single use only (i.e., disposed of after use in a patient), this is a significant cost. Another device which is sometimes used in place of the Fogarty® Flexible Calibrator is the metal olive tip probe. Although this device is reuseable, it is very traumatic to vessels as it is very hard and inflexible.
Other devices exist for performing singular functions. The Coronary Artery Occluder manufactured by DLP is a typical device that is used to occlude the coronary artery. This is done by inserting the device into the artery and suturing the device in place. Every 15 minutes the sutures and the device must be removed to allow for perfusion of fluids or blood to the artery. This is time consuming and must be performed by the surgeon.
The Fogarty® Bi-pass Shunt is used to bi-pass an artery from one end of a diseased segment to another in order to maintain blood flow. Catheter are known in the art for use as perfusion devices. On example of such a catheter is found in U.S. Pat. No. 5,364,344, which discloses a dual lumen catheter.
The lack of a multipurpose medical device that functions as a dilator, calibrator, occluder, suture guide and perfusion device is an important problem in the medical field. Currently, multiple devices must be used to perform these functions. This results in higher surgical costs since additional instruments must be used during surgery. Also, time is lost since a surgeon must switch from one instrument to another in order to perform these different functions, rather than smoothly transitioning from one function to the next with a single instrument. Additionally, time is lost every time the surgeon must remove an occluder and sutures to perfuse an artery and then re-insert the occluder and sutures. This means time that the surgeon must spend in the operating room and the patient is anesthetized. Switching from one instrument to another is also problematic in that the surgeons attention shifts from the hand off of the instrument from the nurse and away from the patient.
The present invention provides a multipurpose medical device that helps solves these problems by packaging a multitude of functions into a singular medical device. In particular, the present invention is intended to replace the Fogarty® Flexible Calibrator (or the metal olive tip probe), the DLP Coronary Artery Occluder, the Fogarty® Bi-pass Shunt and perfusion catheters with a singular device that provides these functions and more.
SUMMARY OF THE INVENTION
The present invention is a multipurpose medical device which functions as a vascular dilator, calibrator, suture guide and perfusion device. All of these functions are provided in a singular device
An object of the invention is to combine multiple medical functions into a singular device.
Another object of the invention is to provide a multipurpose medical device where the structures which provide each function are complimentary and do not interfere with each other.
A further object of the invention is to provide a cost effective medical device where multiple functions are combined in a singular device.
It is also an object of the invention to provide a medical device which saves time normally lost when a surgeon must switch from one instrument to another in order to perform different functions.
Also, it is an object of the invention to provide a multipurpose medical device that allows smooth transitioning from one function to the next with a single instrument.
Additionally, it is also an object of the invention to provide a medical device which saves time normally lost every time the surgeon must remove an occluder and sutures to perfuse an artery and then re-insert the occluder and sutures.
Moreover, it is an object of the invention to provide a multipurpose medical device which reduces the time that the surgeon must spend in the operating room and the patient is anesthetized.
An additional object of the invention is to provide a multipurpose medical device which helps surgeons maintain attention on the patient rather than on the hand off of multiple instruments from the nurse.
Also, it is an object of the invention to provide a multipurpose medical device that reduces the risk of danger to vessels.
Another object of the invention is to provide a multipurpose medical device that is reliable and simple in construction.
The present invention is a multipurpose medical device for use as a dilator, calibrator, suture guide and perfusion device. The device has an tapered, elongated tube; a valve having an opening coupled to the proximal end of the elongated tube; a connecting tube disengagably coupled to a second opening of the valve; a cylindrical sleeve slidably mounted on a portion of the elongated tubular member and having at least one radial groove configured for guiding a suture needle; and a plurality of diameter indicia marks located on the elongated tubular member. The cylindrical sleeve slides between a use position towards the distal end of the elongated tubular member and a park position towards the proximal end of the elongated tubular member.
The present invention has other objects and advantages which are set forth in the description of the Best Mode of Carrying Out the Invention. The features and advantages described in the specification, however, are not all inclusive, and particularly, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims herein.


REFERENCES:
patent: 4623327 (1986-11-01), Mahurkar
patent: 4643194 (1987-02-01), Fogarty
patent: 4804365 (1989-02-01), Lizie et al.
patent: 5074846 (1991-12-01), Clegg et al.
patent: 5352198 (1994-10-01), Goldenberg et al.
patent: 5364344 (1994-11-01), Beattie et al.
patent: 5364374 (1994-11-01), Morrison et al.
patent: 5366471 (1994-11-01), Jones et al.
patent: 5478326 (1995-12-01), Shiu
patent: 5807326 (1998-09-01), O'Neill et al.
patent: 5810867 (1998-09-01), Zarbatany et al.
patent: 5830196 (1998-11-01), Hicks
patent: 5860992 (1999-01-01), Daniel et al.
Fogarty Flexible Catheter (photographs).
Fogarty Bi-Pass Shunt (photograph).
DLP Coronary Artery Occluder (photograph) date: May 1991.

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