TITLE OF THE INVENTION

Vascular compression device with multi-axis degree of freedom for hemostasis management

FIELD OF THE INVENTION

The present invention relates generally to a vascular compression device with multi-axis degree of freedom in translational and rotational motion for achievement of hemostasis after an interventional procedure by application of compressive pressure on a patient’s vascular structure.
In several currently practiced clinical procedures, interventional catheterization is routinely involved. Once the interventional procedure is complete, the next task in the clinical workflow involves complete stoppage of bleeding from the incision site or hemostasis, so as to minimize the blood loss due to the interventional procedure, reduced bleeding induced complications, reduction in post-procedural nursing care requirements, increased patient throughput, quicker patient ambulation and increased patient comfort and satisfaction.
Although the manual compression method remains the gold standard and most widely practiced means for achieving hemostasis of vascular access site arteriotomies, the said technique has several disadvantages. The manual compression method involves application of pressure by a caregiver by pressing his / her hand or finger against a compressive bandage laid on the access site for period of 20 – 30 minutes. The manual method for hemostasis management is inconvenient for the patient and the care-giver, leads to wastage of valuable time of a care giver, difficult to maintain constant pressure at the access site and significant morbidity resulting from the access site complications due to improper compression. It is because of these reasons; there has been renewed interest in development of devices and technologies as an alternative to manual compression techniques for hemostasis management.
In the present invention, a manually operated device is described with multiple controls for translational and rotational motion for achievement of hemostasis after an interventional procedure. It comprises of measurable pressuring means to bear on vasculature at the access site, a base plate supporting the pressurizing means and is adaptable to differing patient body constitution.
The present invention enables the user to apply compressive pressure at the arterial access site with ease and comfort and reduce morbidity resulting from the access site complications due to improper compression significantly.

BACK GROUND OF THE INVENTION

Vascular compression devices of different types are being used in clinical settings over the last few years. The present invention is a mechanical compression device that comprises of measurable pressuring means for compressive bearing against a puncture or incision site of a patient. In addition to the pressure bearing devices, hemostatic pads are also employed for hemostasis management. However, the mode of operation of such pads and their background will not be discussed in this section as their principle of operation and area of application are completely different than those of pressurizing devices.
The existing pressure bearing compression devices are based on pre-set designs with fixed angle of approach between the measurable pressuring means and the surface area of the puncture site and hence have limited applications that require positioning of the measurable pressuring means to a variable angle with respect to the patient body surface with the access site.
It is well known that several patent applications have been submitted as femoral compression devices.
US 4770175 presents a device for occluding blood flow into a digit and not to regulate the same. The device is provided with a pressurizing means and a sensor sensing the pressure exerted by the means against the digit. The signal from the sensor is digitally processed and thereafter a signal goes to the pressurizing means in such a way that a constant occluding pressure always acts on the digit. The device does not comprise a sensor measuring blood flow.
In US 3625219 there is shown a device for hemostasis in which an inflatable balloon is used as pressurizing means. However, this device involves a complex and instable construction and does not allow patient movement. Like other devices, this embodiment does not comprise a feedback from the sensor to the pressurizing means.
The principle of these devices is the same, i.e., a pressure is applied on the incision site in the femoral artery for about 20 minutes post catheterization. The pressure is to be set as high as possible to stop bleeding but not as high so that the blood flow down to the leg and foot is cut off.
Following balloon dilation of the femoral artery in the leg, it is especially important not to apply too high pressure on the incision site as there is a risk that the dilated stenosis in the artery may contract is the blood pressure is too low. To avoid blood clots, the patients are given anti-coagulating agents, such as heparin, prior to the treatment. Administration of such agents extends the time requires to stop bleeding after completion of the procedure. For patients already on anti-coagulation agents for medical reasons, the time to stop bleeding may be as high as 1.5 hours. Hematoma is the most common side effect due to inadequate compression of the femoral artery.

OBJECTIVES OF THE INVENTION

It is a singularly important objective of the present invention is to provide an apparatus for hemostasis management with greater reliability and lowering of the disadvantages of the prior arts.
It is also an objective of the present invention is to provide an apparatus which is ergonomic, patient-friendly and provides greater degree of freedom of movement to the device for uses at multiple access sites.
It is also an objective of the present invention is to provide an apparatus for the specified functions as previously specified so as to minimize the cost of the material requirements and be devoid of expensive equipment for it’s functioning so as to keep the overall cost constraints to a minimum.

It is also an objective of the present invention is to provide an apparatus for the specified functions as previously specified so that the apparatus is stable during application and does not pose any safety related threats to the patient as well as the care giver.
It is also an objective of the present invention is to provide an apparatus for the specified functions as previously listed so that the functioning of the apparatus is simple and may be effected by personnel with minimal training.

SUMMARY OF THE INVENTION
The present invention relates generally to a vascular compression device with multi-axis degree of freedom in translational and rotational motion for achievement of hemostasis after an interventional procedure by application of compressive pressure on a patient’s vascular structure.

The said invention comprises of plurality of manually operable mechanical control modules with a pressurizing means having freedom for translational and rotational movement for vascular compression applications suitable for varying patient body constitution. The mechanical controls and the pressurizing means are supported on a sturdy base plate which is to be positioned below the patient body with its own weight as the supporting force for stability.

BRIEF DESCRIPTION OF THE DRAWING

The present invention will now be described with further details in the following section, with reference to the accompanying drawings, in which:
FIG.1 is a schematic view of the preferred embodiment illustrating the femoral compression device according to the invention.
FIG.2 is a schematic view illustrating the top slidable as well as rotatable pressurizing means of the present invention.
FIG.3 is a schematic front view illustrating the base platform, sliding height adjustable arm holder of the femoral compression device of the present invention.

FIG.4 is a schematic side view illustrating the height adjustable unit and Electronic control and 360 DEGREE Locking mechanism of the present invention.

7. DETAILED DESCRIPTION OF THE INVENTION

An apparatus and its essential components for pressurizing the femoral vascular structures are described in FIG.1 to FIG.4.
The apparatus shown in FIG.1 comprises of an apparatus base plate (A), which supports the vertical stand (V) derives the horizontal shaft holder (Y) in a screw and bolt relation intended to transmit motion to horizontal shaft (O) fixed with shaft holder (Y). The vertical stand comprises of lead screw (X) as shown in FIG.2 drives horizontal shaft (O) up and down converting the rotational motion of lead screw (X) into linear motion of (O) by rotating the affixed rotating clamp (B) of (X) screw functionally intended to carry the Dome (T) and holder (L) restricting any upward or downward load produced by the reaction force of human body. Dome (T) and holder (L) are in relation of hinge by Locking Hinge (N1) intended to rotational motion carrying reaction force from every angle applied by human body. Pressure sensor (N) on affixed with holder (M) placed between Dome (T) and Hinge (N1) intended to measure the any pressure exerted over pressure sensor within limit for protecting the device from rupture. A Dome holder consists of Compressive spring (R) and Lock Pin (K) functional to hold the dome (T), slides over the horizontal shaft (O) with positional restrictions on circular perforation (H) by compressive spring (R) loaded lock pin (K) as in Fig.3. A 360O angular Rotating shaft consists of rotating guide of lead screw (G) and lock hole (Q) as shown in FIG.1. A Base (A) consists of Grated Circular Wheel (R1) fixed with base in inseparable manner placed intended to guide and lock vertical stand (V) by bottom Lock pin manually placed through (Q) inserted to (R1) intended to fix rotation between vertical stand (V) and base plate (A) on same axis surrounding to Lead Screw (X). Base plate (A) also consists of Electronic circuit box (S) as in FiG.1 consists of Pressure monitoring screen (D), Power Button (E) for main power switching along with device power indicator (F) and battery reservoir (C) in a fixed manner as in FIG.4.
Horizontal Shaft (O) consists of Wiring Slot (W) intended to hold cables intended to shield the cable physically with non-sagging manner. Electronic circuit box (S) consists of Input Output wiring path (Z) intended to shield cables physically as in FIG. 2. Four Degrees of Freedom incorporated F1 as in FIG-1 for rotation of vertical stand (V) in order to aid positioning of dome (T) at the access site, F4 as in FIG.1 for sliding motion up and down in order to aid positioning of dome (T) at the access site, F2 as in FIG.3 for sliding motion of Dome holder (L) horizontally in order to aid positioning of Dome (T) at the access site, F3 as in FIG.3 for angular rotation of Dome (T) in order to aid positioning of dome (T) at the access site.

8. EXAMPLES

9. ADVANTAGES

The advantages of the present invention include its ability to assists users to accurately position the pressurizing means at the vascular access site for hemostasis management with low cost constraints. The apparatus is devoid of expensive equipment such as pressure measuring manometer and its simple design and methodology for operation that enables care giving personnel with minimal training to operate the apparatus. Additional advantages of the apparatus include its capability to level the apparatus horizontally by positioning the base plate below the patient body and its ability to ensure uniform compression force between the measurable pressuring means and the access site.

Claims:We Claim:

1. A vascular compression device functioning with four degrees of freedom F1, F2, F3, F4 that is useful for achievement of hemostasis after an interventional procedure by application of compressive pressure on a patient’s vascular structure, comprises of:
a. a base plate for holding and supporting the vertical stand, the pressurizing means and
b. a measurable pressuring means for compressive bearing at puncture site of a patient.
2. A vascular compression device as claimed in claim 1, wherein, the measurable pressuring means can be actuated manually or semi-automatically using multiple controls to position the means to the access site.
3. A vascular compression device as claimed in claim 1 to 2, wherein, the measurable pressuring means is in possession of FOUR DEGREES of freedom in translation motion in order to be positioned over the access site.
4. A vascular compression device as claimed in claim 1 to 3, wherein, the measuring pressuring means is rotatable with Four degrees of freedom in orthogonal axes in order to aid its positioning at the access site.
5. A vascular compression device as claimed in claim 1 to 4, wherein, the freedom in translational and rotational motion afforded to the pressuring means of the device enables the device to be versatile and adaptable to differing body constitution.
6. A vascular compression device as claimed in claim 1 to 5, wherein, the measurable pressuring means comprises of a semi-spherical dome attached to a dome holder. The spherical dome shaped pressuring means enables the device to apply compressive force at the access site without any risk to the subject.
7. A vascular compression device as claimed in claim 1 to 6, wherein, the measurable pressuring means is held to its desired position and orientation using locking pin arrangement on the vertical and horizontal shaft.
8. A vascular compression device as claimed in claim 1 to 7, wherein, the measurable pressuring means include electronic pressure gauges and timer modules to adjust the applied compressive force at the access site in a pre-determined manner that is suitable for achievement of hemostasis at the access site.