Patent Description:
The following paragraphs are not an admission that anything discussed in them is prior art or part of the knowledge of persons skilled in the art.

<CIT> describes systems and methods for left radial access, right room operation peripheral interventions that include left radial bases to stabilize a left arm of a cardiac patient across a midsagittal plane, transradiant right radial bases to position a right arm of the patient, and radiodense radiation reduction barriers located between the patient and a doctor.

<CIT> describes a medical apparatus for use in supporting a patient lying in a supine position during a radial cardiac catheterization procedure. More particularly, an arm board is described for use with a patient's arm during a radial cardiac catheterization procedure. The arm board has a base member having a substantially planar support surface on which the patient's arm can be stabilized during a catheterization procedure and at least one shield member affixed to the base member and extending away from the support surface. The base member has both a radiolucent portion and a radiopaque portion and the shield member is a radiopaque material, thereby reducing and/or eliminating a doctor's exposure to radiation during radial cardiac catheterization procedures without impairing the ability to obtain the necessary medical images.

According to the present invention there is provided an apparatus for supporting an arm of a human patient during a medical procedure as defined in the appended claim <NUM>. Further optional features are recited in the associated dependent claims.

The following summary is intended to introduce the reader to various aspects of the applicant's teaching, but not to define any invention.

Described is an apparatus that can include: a base; a first barrier mounted to the base for shielding scatter radiation, the first barrier extending upwardly from the base; a second barrier mounted to the base for shielding scatter radiation, the second barrier extending downwardly from the base; and an arm pad on the base positioned laterally intermediate the first and second barriers, the arm pad including a proximal portion for supporting an arm of a human patient, and a central portion for supporting a hand of the arm.

Also described is a method of supporting an arm of a human. The method can include: positioning a base to lie between the human patient and a table on which the human patient is supported, the base including a lateral portion that extends laterally from the table; placing the arm of the human patient on an arm pad that is positioned on the lateral portion of the base; shielding scatter radiation with a first barrier, the first barrier mounted to the base and positioned laterally intermediate the lateral portion and the human patient, the first barrier extending upwardly from the base to above the arm pad; and shielding scatter radiation with a second barrier, the second barrier mounted to the lateral portion of the base and extending downwardly therefrom.

Other aspects and features of the teachings disclosed herein will become apparent, to those ordinarily skilled in the art, upon review of the following description of the specific examples of the present disclosure.

The drawings included herewith are for illustrating various examples of apparatuses and methods of the present disclosure and are not intended to limit the scope of what is taught in any way. In the drawings:.

Various apparatuses or methods will be described below to provide an example of an apparatus or a method for supporting an arm of a human patient during a medical procedure.

When performing a cardiac catheterization using the radial artery for access, radiation exposure to the operating physician can be higher than during use of the femoral artery. In the context of increasing popularity of radial access, this greater radiation exposure for operating physicians performing cardiac catheterization is of concern, particularly given evidence suggesting a higher incidence of tumors among invasive cardiologists.

Current equipment, such as lead aprons and above-table shields, provide some protection, but it is desirable for operator radiation exposure to be reduced further, especially for cases using radial access. Existing cardiac catheterization labs can use non-specific arm support devices when gaining access to the radial artery. These devices can be clumsy, unprofessional, and uncomfortable for the patient and can provide little or no additional radiation protection. While more specific arm support devices have been created, they have many limitations, which can include: they can offer only modest, incremental radiation protection for the operating physician; they can increase patient and operator radiation dose and degrade the image quality due to the relative radiopacity and thickness of the materials used; and they can be inconvenient as they can require being removed between cases, or once the procedure begins, to avoid contaminating the sterile field.

The present disclosure relates to arm support apparatuses that are well suited for use in gaining access to a human patient's radial arteries during cardiac catheterization procedures.

Referring to <FIG> and <FIG>, an example of an apparatus for supporting an arm of a human patient during a medical procedure is shown generally at reference number <NUM>. The apparatus <NUM> as illustrated includes a base <NUM>, and arm pad <NUM>, a first barrier <NUM> and a second barrier <NUM>. In use, the arm pad supports the right arm of the human patient, and the first and second barriers <NUM>, <NUM> can shield an attending staff member from scatter radiation during the medical procedure.

In the example illustrated, the base <NUM> includes a medial portion <NUM> and a lateral portion <NUM>. The medial portion <NUM> is configured to lie between the human patient and a table on which the human patient is supported. The lateral portion <NUM> extends in a lateral direction <NUM> from the medial portion <NUM>. To aid with understanding, <FIG> includes a directional legend, in which a longitudinal direction <NUM>, the lateral direction <NUM>, and a vertical direction <NUM> are shown.

In the example illustrated, the arm pad <NUM> is positioned on the lateral portion <NUM> of the base <NUM>. The arm pad <NUM> extends in the longitudinal direction <NUM> between first and second ends <NUM>, <NUM>. In some examples, the arm pad <NUM> rests on the lateral portion <NUM>, without being attached. This can allow adjustment of the position of the arm pad <NUM> according to patient's arm length. Therefore, the apparatus <NUM> can be customized to the patient's size without needing to move the patient or the base <NUM> underneath them. In other examples, the arm pad <NUM> can be fixed to the lateral portion <NUM>.

In the example illustrated, the first barrier <NUM> is mounted to the base <NUM> and is positioned intermediate the medial and lateral portions <NUM>, <NUM> in the lateral direction <NUM>. The second barrier <NUM> is mounted to the lateral portion <NUM>. The first barrier <NUM> extends upwardly from the base <NUM> in the vertical direction <NUM> to above the arm pad <NUM>. The second barrier <NUM> extends downwardly from the base <NUM> in the vertical direction <NUM>.

In the example illustrated, the arm pad <NUM> includes a proximal portion <NUM> adjacent to the first end <NUM>, a distal portion <NUM> adjacent to the second end <NUM>, and a central portion <NUM> arranged between the proximal and distal portions <NUM>, <NUM>. In use, the proximal portion <NUM> supports the arm of the human patient, and the central portion <NUM> supports a hand of the arm. The portions <NUM>, <NUM>, <NUM> each include an upper surface <NUM>, <NUM>, <NUM>, respectively. In the example illustrated, each of the upper surfaces <NUM>, <NUM>, <NUM> is spaced above the lateral portion <NUM> of the base <NUM> in the vertical direction <NUM>.

Referring to <FIG>, the lateral portion <NUM> of the base <NUM> extends in the longitudinal direction <NUM> to support a length of the arm pad <NUM>. The first and second barriers <NUM>, <NUM> are each shown arranged longitudinally intermediate of the arm pad <NUM>. Furthermore, the central portion <NUM> of the arm pad <NUM> is shown arranged within a longitudinal extent of each of the first and second barriers <NUM>, <NUM>. With this arrangement, in use, the first and second barriers <NUM>, <NUM> provide shielding of radiation in the vicinity of the hand of the human patient.

As shown in <FIG>, the arm pad <NUM> further includes a radiopaque panel <NUM>. In the example illustrated, the panel <NUM> is arranged in the central and distal portions <NUM>, <NUM> of the arm pad <NUM>, horizontally and adjacent to the lateral portion <NUM> of the base <NUM>. In the example illustrated, the panel <NUM> can extend generally laterally between the first and second barriers <NUM>, <NUM> to provide shielding of radiation in the vicinity of the hand of the human patient.

Referring to <FIG>, the lateral portion <NUM> of the base <NUM> extends laterally to support a width of the arm pad <NUM>. In the example illustrated, the first barrier <NUM> is mounted to the base <NUM> and is positioned intermediate the medial and lateral portions <NUM>, <NUM> in the lateral direction <NUM>. The second barrier <NUM> is mounted to a lateral edge <NUM> of the lateral portion <NUM>, and the arm pad <NUM> is positioned laterally intermediate the first and second barriers <NUM>, <NUM>.

Referring to <FIG>, <FIG>, it can be seen that the upper surface <NUM> of the central portion <NUM> is substantially below the upper surface <NUM> of the proximal portion <NUM>. In the example illustrated, the upper surface <NUM> of the central portion <NUM> is concave in shape to position the hand generally below the arm. The upper surface <NUM> of the distal portion <NUM> is shown to be generally planar and horizontal, and can be used by the attending staff as a working surface.

Dimensions for the arm pad <NUM> are shown in <FIG> and provided in Table <NUM>. These dimensions are intended to be illustrative but non-limiting.

In some examples, the arm pad <NUM> can be formed of a foam material that is clad with marine grade vinyl. In some examples, the radiopaque panel <NUM> can be formed of a relatively thin layer of lead, which can be disposed in the arm pad <NUM> underneath a bottom outer vinyl layer. In some examples, the upper surface <NUM> of the distal portion <NUM> can be reinforced to create a stable working surface.

Referring to <FIG>, <FIG> and <FIG>, the base <NUM> is shown to be generally planar and arranged horizontally. The base <NUM> can be formed at least partially of a substantially radiolucent material. In some examples, the base <NUM> can be formed of a unitary piece of clear polycarbonate material.

In the example illustrated, the medial portion <NUM> of the base <NUM> includes a central aperture <NUM> that is positioned so that, in use, it is underneath an abdomen of the human patient. The lateral portion <NUM> is also shown to include a series of apertures <NUM>. The apertures <NUM>, <NUM> can be cutouts of the base <NUM> that reduce weight and decrease impedance during medical imaging.

As shown in <FIG>, the first barrier <NUM> can be mounted to the base <NUM> by a flexible and resilient connection <NUM> to permit adjustment of its position. In some examples, the connection <NUM> can be a curved bracket formed of spring steel, and fastened between the first barrier <NUM> and the base <NUM>.

Dimensions for the base <NUM> are shown in <FIG> and provided in Table <NUM>. These dimensions are intended to be illustrative but non-limiting.

It can be seen in <FIG> that each of the aperture <NUM>, the first barrier <NUM> and the second barrier <NUM> can be aligned with a transverse axis <NUM>.

Referring to <FIG> and <FIG>, the first and second barriers <NUM>, <NUM> are each shown to be generally planar and arranged vertically. The first and second barriers <NUM>, <NUM> can each be formed at least partially of a substantially radiopaque material. In some examples, the first and second barriers <NUM>, <NUM> can be formed of vinyl coated lead sheets.

In the example illustrated, the second barrier <NUM> includes first and second planar portions <NUM>, <NUM>. The planar portions <NUM>, <NUM> have outward vertical edges <NUM>, <NUM>. In the example illustrated, the second planar portion <NUM> is joined to the first planar portion <NUM> at an oblique angle, so that the vertical edge <NUM> is spaced apart laterally from the vertical edge <NUM> in a direction away from the rest of the apparatus <NUM>, which provides some clearance for a patient table.

Referring to <FIG>, the apparatus <NUM> is shown supporting an arm <NUM> of a human patient <NUM>. The human patient <NUM> is shown lying on a mattress <NUM> and a table <NUM>.

In the example illustrated, the medial portion of the base lies between the human patient <NUM> and the table <NUM>. It will be appreciated that, in other examples, the medial portion of the base can be omitted, and an alternative means of attaching the apparatus to the side of the table can be used.

There can be several advantages to the apparatus of the present disclosure over products currently on the market. These advantages relate to: increased radiation protection, improved visualization, greater operator convenience, and enhanced patient comfort.

In terms of increased radiation protection, the radiation barriers and panel can be substantially radiopaque, and can block significantly more radiation than existing shielding equipment. The apparatus can also be compatible with femoral access procedures, and provide radiation protection for such cases.

In terms of improved visualization, the polycarbonate base can be more radiolucent than existing devices, which can reduce the amount of radiation needed during medical imaging. Furthermore, the position of the base under the patient's abdomen is also outside of the typical field of view (the patient's chest), which can prevent both increases in radiation and image degradation. Moreover, the positioning of the radiation barriers and panel can allow clear fluoroscopic visualization of the patient's arm.

In terms of operator convenience, beyond the patient's hand, the working surface of the distal portion of the arm pad can be level with the patient's wrist and provide a convenient platform upon which the attending staff can manipulate equipment. Furthermore, the contoured shapes of the upper surfaces of the proximal and central portions of the arm pad can position the patient's wrist at a desirable angle, improving the attending staff's access to the patient's artery. Moreover, because the apparatus can be compatible with both radial and femoral access cases, the apparatus does not need to be removed between cases depending on the access site chosen.

Finally, the arm pad can be relatively large and include contoured foam padding to provide full arm support and enhance patient comfort. Furthermore, the flexibility of the first barrier allows for multiple positions to accommodate the patient, and because it is not rigidly attached it can deflect if it is knocked by the patient or the attending staff.

Referring to <FIG> and <FIG>, another example of an apparatus for supporting an arm of a human patient during a medical procedure is shown generally at reference number <NUM>. The apparatus <NUM> is shown to include a first barrier <NUM> and a second barrier <NUM>. In use, the primary arm pad (omitted for clarity of illustration) supports the right arm of the human patient, and the first and second barriers <NUM>, <NUM> can shield an attending staff member from scatter radiation during the medical procedure.

In the example illustrated, the apparatus <NUM> includes a base that includes a medial portion <NUM> and a lateral portion <NUM>. The medial portion <NUM> is configured to lie between the human patient and a table on which the human patient is supported. The lateral portion <NUM> extends in a lateral direction <NUM> from the medial portion <NUM>. To aid with understanding, a longitudinal direction <NUM>, the lateral direction <NUM>, and a vertical direction <NUM> are shown in <FIG>.

In the example illustrated, the first and second barriers <NUM>, <NUM> are each mounted to the lateral portion <NUM> and are spaced from one another in the lateral direction <NUM>. The first barrier <NUM> extends upwardly in the vertical direction <NUM>, and the second barrier <NUM> extends downwardly in the vertical direction <NUM>.

In the example illustrated, the apparatus <NUM> includes an additional support surface that is shown generally at reference numeral <NUM>, which can be referred to as the "left wing". The left wing <NUM> is shown coupled to the medial portion <NUM> opposite from the lateral portion <NUM>, and extends in the lateral direction <NUM> away from the medial portion <NUM>. In use, the left wing <NUM> can support the left arm of the human patient.

Referring to <FIG>, the lateral portion <NUM> extends laterally to support a width of the primary arm pad (not shown). In the example illustrated, the first barrier <NUM> is mounted adjacent to a first lateral edge of the lateral portion <NUM>, and the second barrier <NUM> is mounted to a second lateral edge of the lateral portion <NUM>.

In the example illustrated, the medial and lateral portions <NUM>, <NUM> of the base are separate components that are capable of disassembly. The medial portion <NUM> is arranged laterally intermediate the lateral portion <NUM> and the left wing <NUM>.

Referring to <FIG>, the left wing <NUM> is shown to include an adjustable support <NUM> that is coupled to a mounting bracket <NUM> by hinge mechanisms <NUM>, <NUM>. The support <NUM> is shown to be generally planar and includes a plurality of cutouts. In the example illustrated, the support <NUM> includes a central cutout, intended to reduce weight, and four peripheral cutouts, which are designed to accept straps to secure a secondary arm pad (not shown) to the support <NUM>. In the example illustrated, the support <NUM> has a relatively large upper portion, and a relatively narrow lower portion adjacent to the hinge mechanisms <NUM>, <NUM>, and is therefore shaped to be less intrusive when pivoted upwardly towards the patient.

Referring to <FIG>, the support <NUM> can be pivoted about a longitudinal axis <NUM> by actuating a tab <NUM>. The tab <NUM> disengages locks in the hinge mechanisms <NUM>, <NUM> to permit pivoting of the support <NUM> about the axis <NUM>. Releasing the tab <NUM> reengages the locks to fix the support <NUM> at a desired angle. In the example illustrated, the tab <NUM> is provided at the hinge mechanism <NUM>, and coordination between the hinge mechanisms <NUM>, <NUM> can be achieved via a shaft <NUM>. This can allow for one handed adjustment of the left wing <NUM>.

<FIG> shows disassembly of the lateral portion <NUM> and the left wing <NUM> from the medial portion <NUM>. In the example illustrated, the lateral portion <NUM> and the left wing <NUM> each includes pins that are arranged to engage keyhole slots in the medial portion <NUM>, permitting quick and easy assembly/disassembly.

In the example illustrated, the primary arm pad <NUM> can rest on the lateral portion <NUM>, and the secondary arm pad <NUM> is fixed to the left wing <NUM> by straps. Two straps are also shown attached to the medial portion <NUM>, for securing the medial portion <NUM> to a mattress (not shown).

Referring to <FIG> and <FIG>, the apparatus <NUM> is shown supporting arms <NUM>, <NUM> of a human patient <NUM> lying on a mattress <NUM> and a table <NUM>.

<FIG> shows the arm pad <NUM> and the left wing <NUM> in a generally horizontal position. In use, the arm pad <NUM> can support the left arm <NUM> of the human patient <NUM> during a medical procedure, in which the left radial artery of the human patient <NUM> can be accessed, for example. During the medical procedure, the attending staff member can remain along the right hand side relative to the human patient <NUM>, and the apparatus <NUM> can therefore continue to shield the attending staff member from scatter radiation.

<FIG> shows the left wing <NUM> in an upright position in which there is an acute angle between the support <NUM> and the medial portion <NUM>. This can be a more comfortable position for the human patient <NUM> to maintain, after the left radial artery has been accessed, and during which images can be taken using a C-arm camera, for example.

It will be appreciated that the subject matter of interest herein is not necessarily limited to implementation in cardiac catheterization labs, and can apply more broadly to other medical procedures.

Furthermore, it will be appreciated that terms used herein to convey geometrical or mathematical relationships need not be construed with absolute precision. For example, the terms 'concave' and 'convex' as used herein need not be interpreted to mean structures having a curved surface that is exactly circular. These terms and other terms herein may be interpreted with some flexibility, without strict adherence to mathematical definitions, as will be appreciated by persons skilled in the art. It will also be appreciated that terms used herein to connote orientation, including 'up', 'down', 'above', 'below', 'lateral', 'longitudinal', 'vertical' and 'horizontal', correspond to the arm board apparatus in use and are intended to aid with understanding, but need not refer to the orientation of various components during manufacture or when not in use.

Claim 1:
An apparatus (<NUM>) for supporting an arm of a human patient during a medical procedure, the apparatus (<NUM>) comprising:
a base (<NUM>) comprising a medial portion (<NUM>) that is configured to lie between the human patient and a table on which the human patient is supported, and a lateral portion (<NUM>) that extends laterally from the medial portion (<NUM>);
an arm pad (<NUM>) positioned on the lateral portion (<NUM>) of the base (<NUM>), the arm pad (<NUM>) extending longitudinally between first and second ends (<NUM>, <NUM>);
a first barrier (<NUM>) for shielding scatter radiation during the medical procedure, the first barrier (<NUM>) mounted to the base (<NUM>) and positioned laterally intermediate the medial and lateral portions (<NUM>, <NUM>) thereof, the first barrier (<NUM>) extending upwardly from the base (<NUM>) to above the arm pad (<NUM>); and
a second barrier (<NUM>) for shielding scatter radiation during the medical procedure, the second barrier (<NUM>) mounted to the lateral portion (<NUM>) of the base (<NUM>) and extending downwardly therefrom,
wherein the arm pad (<NUM>) comprises a radiopaque panel (<NUM>).