The present invention relates to an upper extremity radial artery procedure support device, and associated warming sleeve, such as for use when performing a trans-radial cardiac catheterization process on a patient
Background of the Invention
The history of invasive cardiology dates back to 1711 when Stephen Hales placed catheters into the right and left ventricles of a living horse. Cardiac catheterization in a human however was first performed in 1929, when Werner Forssman catheterized himself by inserting a catheter through his left antecubital vein, advancing it all the way to his right atrium and confirming it under a chest X-ray. Over the following decades this procedure underwent a series of metamorphoses. In 1958, an interventional radiologist by the name of Dr. Charles Dotter devised methods to visualize the coronary anatomy.
Until the 1950's, access to an arterial or venous system for catheterization typically required a physical cut down. The percutaneous approach widely used today, was developed in 1953 by a radiologist Sven-Ivar Seldinger. Building on work previously done by Drs. Melvin Judkins and Charles Dotter, Dr. Andreas Gruentzig performed the first successful percutaneous trans-luminal coronary angioplasty (PTCA) on a human in Zurich on Sep. 16, 1977, by using a balloon-tipped catheter to dilate a severely narrowed coronary artery. His pioneering work ushered into the mainstream, the field of percutaneous coronary intervention or PCI.
Historically coronary angiography and intervention have been done via a percutaneous access of the femoral artery using the modified Seldinger technique (where the anterior wall of the artery is punctured by a hollow needle). Through this femoral access, a port with a one-way-valve, called a sheath, is placed, and through the sheath, a diagnostic or interventional catheter is advanced to cannulate the coronary arteries over a guide wire, with the patient laying very still in a supine position (lying flat on his/her back, horizontally with face and torso facing generally upwards). Although this route of accessing the femoral artery typically guarantees an ability to access a large caliber vessel, the femoral artery, it comes with potentially significant drawbacks, which includes, but are not limited to; a risk of significant bleeding, infection due to the close proximity to the groin/perineum, as well as significant discomfort to the patient since the patient may have to lay down for over four to six hours after the procedure, to prevent catastrophic bleeding. The time spent in a hospital bed also means that costs attributed to the procedure may also be much higher, to the patient and/or payor, who gets billed for the time the patient spends in the hospital. Hence different means of accessing arteries in order to reach and cannulate coronary arteries were investigated.
The trans-radial access to perform diagnostic cardiac catheterization was first introduced by Campeau in 1989, and later adapted by Kiemeneij and Laaman in 1997 for therapeutic procedures of coronary angioplasty. At the dawn of the 21st century, the trans-radial route gained in popularity, and now rivals the trans-femoral access especially in Europe and Asia. In the United States however, the shift to trans-radial artery access, has been relatively slow.
Advantages for performing a coronary artery angiography or intervention via the trans-radial route, include, but are not limited to, relatively short procedural time and reduced risk of vascular complication including bleeding, to mention a few. But perhaps the most important reason the trans-radial method has become so popular, is the comfort it provides the patient.
After a trans-radial procedure, the patient is usually able to sit up in bed and ambulate or walk around in approximately one hour, compared to the four to six hours in a supine position after a trans-femoral method. It is time-saving, and less costly to the patient and the insurance companies. Hospitals are able to free up a hospital bed. These advantages have led to the acceptance of the use of the trans-radial access as a method of coronary interventions, including during acute ST-Elevation myocardial infarction interventions.
To perform a trans-radial procedure, an interventional cardiologist uses the radial artery in the wrist (left or right) of a patient as the entry point for the catheter. The cardiologist (typically always standing on the right side of the patient on the operating table), threads a thin hollow catheter through the patient's network of arteries in the arm and into the chest in a retrograde fashion, eventually reaching the patient's aortic root. Accordingly the patient needs to be prepared and positioned in a supine position. The patient's arm needs to be immobilized in the anatomical position (arms to the sides of the body with the palms facing forward), and with the hand fully extended at the wrist, to expose the flat part of the forearm where the radial artery can be easily palpated and accessed. To achieve this, devices such as radial arm-boards have been proposed, and designed, to offer support for the patient's arm during the procedure. Most of these arm-supports are designed to only support the patients right arm. In certain cases however, the procedure needs to be done from the left arm, or through the left radial artery. Because the operator typically always stands on the right side of the patient who is laying supine on the operating table, if the procedure needs to be done via the left arm (the side opposite the operator), it requires the left arm to be presented in such a way that the arm comes across the abdomen, to place the left wrist at the patient's lower abdomen. That way, the operator doesn't have to strain him or herself to reach across the left wrist. For patient and physician comfort, as well as to provide the most optimal left arm support, there is a need for a paradigm shift in how a patient's left arm is supported.
Canulating the radial artery may also lead to vasoconstriction. As a result there is typically a need to infuse a systemic vasoactive drug through the sheath in the radial artery, to reduce such vasoconstriction. These vasoactive drugs may also cause systemic reduction in blood pressure, and would be contraindicated in a radial artery procedure of a critical patient with low blood pressure to begin with. The application or gentle warmth may be applied to the patient's arm to prevent such vasoconstriction.
A comprehensive look at the plethora of arm boards currently on the market, shows that most of them just create a flat surface for the arm to rest on, with a few accessories such as soft cushions, or even rolled cloths under the wrist. These flat boards or surfaces are typically hard, and hence are relatively uncomfortable, defeating the purpose of a trans-radial procedure, and most of them do not even offer a support mechanism for a left sided procedure. There is no device on the market known to the inventor which uses the application of gentle heat to the patient's arm to induce vasodilation of the radial artery during radial artery interventions.
Other devices such as a “radial access table” have tried to overcome the drawback of the flat surfaces by creating a separate table that can be set up to attach to the main procedure table. This radial table and the likes of it, touts its ability to swivel into many positions as its advantage. See for example Schaeffer, U.S. Pat. No. 6,821,288, and Neri, Published US Patent Application No. 2016/0008199. However this may not be particularly practical, since this table may be heavy and cumbersome to setup and disassemble, especially during acute coronary interventions, where an ability to quickly setup and get the patient re-vascularized is extremely vital. The radial table, and the likes of it, may also not overcome the flat surface disadvantage of the flat arm boards. As a result, Dr. Kwarteng conceived of, and invented the present radial arm support device, as well as an arm-warming sleeve to support both right-sided and left sided radial artery mediated coronary angiograms/interventions, as described below.
In accordance with one aspect of the invention, a multi-jointed radial arm support device is provided which functions like a human arm and is designed to support both right-sided and left sided interventions.
The multi-jointed radial arm support device may allow flexion and extension of a patient's arm at the patient's elbow.
The multi-jointed radial arm support device may allow flexion and extension of the wrist.
In accordance with another aspect of the invention, an arm-warming sleeve may be provided, which may apply gentle warmth to the patient's arm during a procedure to induce vasodilation of the radial artery, and eliminate a need for vasoactive drugs during radial artery procedures.
The arm-warming sleeve may be used together with the multi-jointed radial arm support device, or used independently.
Other features and advantages of the present invention should become apparent from the following description of the preferred embodiment, taken in conjunction with the accompanying drawings, which illustrate, by way of example, principles of the invention.
For a more complete understanding of the disclosure, reference should be made to the following detailed description and accompanying drawings, wherein:
While this invention is susceptible of embodiment in many different forms, there will be described herein in detail, specific embodiments thereof with the understanding that the present disclosure is to be considered exemplifications of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated.
Due to deficiencies and imperfections of previously known radial arm-boards and tables, and the likes of it, currently on the market, Dr. Collins Kwarteng, a practicing interventional cardiologist, conceived of the present invention, to provide a radial arm-board support system that overcomes the deficiencies of the previously known arm-boards. The radial arm-board support system, was born out of Dr. Kwarteng's dissatisfaction he experienced when he personally used some of the previously known arm-boards on the market. Performing 80% of his diagnostic and interventional cases via the trans-radial access, Dr. Kwarteng had become very familiar with many of the devices already on the market, and he had not liked any of them. Dr. Kwarteng had come to realize that not only were these flat-board devices uncomfortable for the patients, but they were also not optimal for the operator (the cardiologist or radiologist) performing the procedure. Therefore, with all the things he disliked about the other devices he had been using, Dr. Kwarteng decided to invent a unique, robotic radial arm-board support system that functions like the patient's own arm.
Dr. Kwarteng's radial arm-board support system is provided with six main objectives in mind: 1) to create a device that mimics the patient's own upper extremity anatomy in a natural position; 2) to provide relative comfort to the patient during the procedure; 3). To offer the operator a unique work environment in which to work; 4) to provide relatively easy setup and disassembly; 5) to offer durability so as to be able to withstand the rough handling of a typical Cath-lab environment; and 6) to use the application of gentle heat to the patient's arm through an arm-warming sleeve, to induce thermal-mediated vasodilation, and thereby reduce or eliminate the need for vasoactive drugs during radial artery interventions. Dr. Kwarteng's radial arm-board support system and arm-warming sleeve concept, simulates the patient's own anatomy, and uses joints similar to a robotic arm, and designed by a practicing interventionalist, to optimize arm support for both right as well as left radial procedures. The arm-warming sleeve provides thermal-mediated vasodilation.
In accordance with the present invention, a radial arm-board support system, generally designated 50, provides the look of a robotic arm, with a firm attachment to the procedure table, via a heavy-duty suction cup or a “vice grip” system (
The three joints are connected to each other through three durable rectangular carbon-fiber tubes (104), which may run down the backs of the “u”-shaped arm rests, providing it with unmatched support.
Because the conventional flat-board devices currently on the market are placed under the patients mat, and are not adjustable, such devices only support the patient's arm at a very low level relative to the hip/groin area where femoral access is obtained, which is the most ideal level where the hand is supposed to be. The articulated joints in the elbow of the present invention especially overcomes this disadvantage seen in the flat board supports, by allowing for flexion at the elbow to present the patient's arm to the hip area.
The heated sleeve helps vasodilate the arteries, and minimize the rate of arterial puncture-induced vasoconstriction. Ordinarily as part of the routine trans-radial procedure, an intra-arterial cocktail of vasoactive drugs (typically verapamil and nitroglycerine) are administered via a sheath in the artery, to keep the radial and brachial arteries vasodilated. By slowly and carefully warming up the arm through the heated sleeve, it is the expectation that, the arteries will remain relatively relaxed, and will be less likely to shrink-down in size during arterial puncture. This should reduce medication administration during trans-radial procedures as well as the number of aborted trans-radial procedures due to severe radial artery vasoconstriction.
The present radial arm-board support system is provided to be relatively light in weight, and relatively easy to setup and take down. It can be relatively effortlessly mounted and easily taken down by even the tiniest of personnel. The device may also be used from either the right (
Referring to
Attached to the right of the leftmost carbon fiber tube 104, is an adjustable, locking double armature joint 105, which moves along the axis 202, labeled as a circle inscribed with an “X”, that moves in the vertical plane only. The curved arrow describes the rotational movement 203 that the joint 105 permits which is along the plane of the page. Again, the rotational movement 203 is allowed when the button atop the joint 105 is pressed downwards so that the button is flush with the armature of the joint. Attached to the armature portion of the leftmost double armature joint 105 is another carbon fiber tube 104. At the end of this tube 104 exists another adjustable locking double armature joint 105, which may permit movement also in a vertical plane as the previous joint 105. The rightmost carbon fiber tube 104 connects to the rightmost double armature locking joint 105 on its left. A plug 106 may be located at the end of this carbon fiber tube 104 to prevent materials from entering the open end of the tube 104. Support structures 107 may rest around each carbon fiber tube 104. Each support structure 107 may be specially designed to support a patient's upper arm, lower arm and hand (left to right on figure). Each support structure 107 may move along the length of its respective carbon fiber tube 104 as desired until locked in place by screwing in each support structure's stopping mechanism 108. A spring-loaded button 109 may be provided so that all objects to the right of that release point can be removed from the leftmost carbon fiber tube 104 when pressed, while the device is pulled.
The left-sided support device is different from the right-sided arm support (
It is to be understood that this disclosure is not intended to limit the invention to any particular form described, but to the contrary, the invention is intended to include all modifications, alternatives and equivalents falling within the spirit and scope of the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/034668 | 5/26/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62341890 | May 2016 | US |