MEDICAL PROCEDURES

CROSS-REFERENCE TO RELATED APPLICATIONS

[1] This application claims the benefit of U.S. Provisional Application. No.

62/789,277, filed January 7, 2019, which is incorporated by reference herein for all purposes.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to the field of medical equipment used during medical procedures. More particularly, the present invention relates to devices including a support and placement block for use with medical equipment used during medical procedures. Specifically, a preferred embodiment of the present invention relates to a support and placement block that holds and supports a piece of medical equipment in place in an outward direction away from a patient’s body during the medical procedure when a user is no longer supporting the piece of medical equipment. The present invention thus relates to a support and placement block that allows a user to have improved freedom of movement while the piece of medical equipment is held in place.

2. Discussion of the Related Art

Many medical procedures require various medical equipment to be inserted into a patient’s body and left in place for extended periods of time. For instance, there are many imaging procedures that require a needle or other device to be inserted into a patient’s body. In many instances, the specific location of the needle can be suboptimal. This can be due to a number of different factors, including the location of a lesion in the patient’s body that needs to be tested, the patient’s body habits, and the positioning of the patient relative to the operating table. In addition to having undesirable location of the needle due to these factors, the use of additional equipment, including biopsy guns, wires, and the like, can further exacerbate issues with proper location of the needle and maintenance of that location thereafter. Further still, the weight of a given piece of medical equipment in combination with gravitational forces can cause the piece of medical equipment to move or sag in a downward direction. For instance, the undesirable sagging of a coaxial needle device can occur, which can be further exacerbated once a biopsy gun is inserted into the needle due to the weight of the biopsy gun. Any unintentional movement of the piece of medical equipment is undesirable for the purposes of the medical procedure. These issues can be minimized when a physician is physically holding the needle and/or other medical equipment in place. However, many of these procedures require the physician to use both hands to complete other tasks. While additional physicians can be employed to hold the piece of medical equipment in place, this can crowd the operating room and result in unnecessary costs.

What is therefore needed is a device, that is relatively compact in size and simple in operation, that can be used to secure a piece of medical equipment, such as a needle, in place for extended periods of time. What is further needed is a device that securely holds the piece of medical equipment in place in an outward direction away from a patient’s body when a physician is no longer holding the piece of medical equipment. What is further still needed is a device that only allows the piece of medical equipment to be moved when a physician physically manipulates the piece of medical equipment. What is also needed is a method of using such a device that is capable of holding a piece of medical equipment in place in an outward direction away from the patient’s body.

SUMMARY AND OBJECTS OF THE INVENTION

By way of summary, the present invention is directed to a support and placement device having a block that is used during medical procedures. More specifically, the block is configured to hold a piece of medical equipment in place in an outward direction away from a patient’s body during a medical procedure. In accordance with a first aspect of the invention, the block includes a top surface, a bottom surface, and at least one side surface. Additionally, the block may have a slit extending from the at least one side surface. The device may also have a base that is mounted to the bottom surface of the block. Further still, the device may have an adhesive mounted to an undersurface of the base.

In accordance to another aspect of the invention, the block may further comprise a first side surface, a second side surface, a third side surface, and a fourth side surface. The first side surface may be opposite the third side surface, and the second side surface may be opposite the fourth side surface. Additionally, the block may be cube-shaped. Furthermore, a midway point may be located between the first side surface and the third side surface. The slit may extend from the second side surface to the midway point.

In accordance to yet another aspect of the invention, the block may have a density so that the piece of medical equipment is confined and can only move based on physical manipulation by a user. For instance, the block may be made of a high-density, lightweight foam.

In accordance to another aspect of the invention, the device may further include a strap that is configured to wrap around at least a portion of the block. For instance, the strap may include a first end, a second end, and a fastener located on the second end. The second end of the strap may be configured to be removably attached to the at least one side surface of the block. The strap may be configured to press opposite ends of the block together, which in turn helps to further secure the piece of medical equipment in place. The first end of the strap may be permanently secured to the at least one side surface of the block. Alternatively, a second fastener may be located at the first end of the strap. Where this occurs, both the first end and the second end can be removed from the block, which allows the strap to be completely separated from the block. For instance, the first end may be releasably secured to the first side surface and the second end may be releasably secured to the third side surface. Where this occurs, the strap brings the first side surface and the third side surface together to prevent movement of the piece of medical equipment.

In accordance to another aspect of the invention, a method of using the device for secure placement of a piece of medical equipment is provided. Initially, a piece of medical equipment is located. Next, a release layer configured to cover an adhesive located on an underside of a base that is mounted to a bottom side of a block of the device is removed. Thereafter, the adhesive is pressed against a skin surface of a patient that is located adjacent to an operation location. Next, the piece of medical equipment is located about a slit formed in the block. After that, the piece of medical equipment is held in place by the block. Once this occurs, the piece of medical equipment may be used during a medical procedure. After this movement occurs, the block continues to hold the piece of medical equipment in place in an outward direction away from the patient’s body. Additionally, a strap having a first end that is affixed to the block may be wrapped around the block. Once the strap is wrapped around the block, a second end of the strap may be secured to the at least one side surface. Alternatively, a strap may be affixed to the block, where a first end of the strap may be releasably secured to the at least one side surface and a second end of the strap may be releasably secured to the at least one side surface.

According to yet another aspect of the invention, a kit for medical procedures may be provided. The kit may include a block configured to hold a piece of medical equipment in place in an outward direction away from a patient’s body, a pair of sterile gloves, a disinfectant, and a piece of medical equipment. For instance, the piece of medical equipment could include a coaxial needle and a biopsy gun. The kit may also include a strap having first and second ends opposite one another, with a first fastener on the first end and a second fastener on the second end. The first end and second are configured to be releasably attached to the at least one side surface to hold the block together about the slit. These, and other aspects and objects of the present invention will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments of the present invention, is given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

A clear conception of the advantages and features constituting the present invention, and of the construction and operation of typical mechanisms provided with the present invention, will become more readily apparent by referring to the exemplary, and therefore non-limiting, embodiments illustrated in the drawings accompanying and forming a part of this specification, wherein like reference numerals designate the same elements in the several views, and in which:

FIG. 1 illustrates a perspective view of an inventive device for use during a medical procedure to support a piece of equipment, as shown a needle;

FIG. 2 illustrates a perspective view of the inventive device for use during a medical procedure to support a piece of equipment, as shown a biopsy gun;

FIG. 3 is a top, side isometric view of a medical equipment support and placement block for medical procedures;

FIG. 4 is a top plan view of the medical equipment support and placement block for medical procedures of FIG. 3;

FIG. 5 is a front side elevation view of the medical equipment support and placement block for medical procedures of FIGS. 3 and 4;

FIG. 6 is a rear side elevation view of the medical equipment support and placement block for medical procedures of FIGS. 3-5;

FIG. 7 is a side elevation view of the medical equipment support and placement block for medical procedures of FIGS. 3-6; FIG. 8 is a perspective view of the medical equipment support and placement block for medical procedures of FIGS. 3-7 including a piece of medical equipment that is a biopsy gun held in place by the support and placement block;

FIG. 9 illustrates a perspective view of the inventive device once a piece of medical equipment, as shown a coaxial needle system, is located about a slot formed in the inventive device but before a strap is secured in place;

FIG. 10 is a perspective view of the medical equipment support and placement block for medical procedures of FIG. 9 once the strap is wrapped around at least one side of the device to further secure the medical device about the inventive device;

FIG. 11 is a perspective view of the medical equipment support and placement block for medical procedures of FIG. 10, where an inner stylet is removed from the coaxial needle system;

FIG. 12 is a perspective view of the medical equipment support and placement block for medical procedures of FIGS. 10 and 11, where a biopsy gun is inserted into the needle system;

FIG. 13 illustrates a perspective of a kit containing the inventive device; and

FIG. 14 illustrates a simplified cross-sectional view of the inventive device where it may be used to collect a sample of a lesion.

In describing the preferred embodiment of the invention which is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. For example, the word connected, attached, or terms similar thereto are often used. They are not limited to direct connection but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art. DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments described in detail in the following description.

1. System Overview

The present invention is directed to a support and placement block having a variety of different sizes and shapes with an adhesive along an undersurface that enables it to be secured to a patient’s body. The support and placement block also has a thin slot that extends partially through the block to allow for support of a piece of medical equipment, while also allowing for appropriate placement of the piece of medical equipment, while enabling the future manipulation of the piece of medical equipment, such as a needle, during various medical procedures, including image guided procedures. The support and placement block has a simple design that is easy and cheap to produce. Additionally, the support and placement block can be easily modified for a specific medical procedure or patient. Such a support and placement block provides a number of benefits.

First, the block allows for greater control of the medical equipment, such as a needle, by the physician. This allows for increased precision and efficiency while directing the needle to the target. Additionally, this allows for increased safety for both the physician and the patient. More specifically, the support and placement block decreases the risk of inadvertent needle sticks. Additionally, the support and placement block decreases the chances of the patient injury due to an undesired needle trajectory. Further still, the support and placement block prevents undesired movement of the needle after it has been inserted.

Another major benefit to use of the support and placement block is that freedom of movement of the physician is substantially improved. This in turn results in the increased efficiency of the physician during operations. Where the physician need not worry about the stability, location, and position of the piece of medical equipment/needle, he or she can concentrate on the use of additional pieces of medical equipment and/or wires necessary for the medical procedure. This can also lead to increased efficiency of a given procedure while simultaneously reducing the overall time of procedure. In doing so, more medical procedures can be completed in a timely manner to generate additional revenue while also ensuring appropriate patient safety.

Further still, the support and placement block effectively serves as a second set of hands to ensure secure placement of the piece of medical equipment. This provides a number of benefits, including the elimination of an additional individual responsible for holding the piece of medical equipment in place in a position away from the patient’s body to enable ongoing use of the piece of medical equipment. The presence of an additional individual responsible for holding the piece of medical equipment in place can clutter the operating room and drive up the cost of a given procedure.

2. Detailed Description of Preferred Embodiments

As shown in the figures, the present invention is directed to a device 30 used during medical procedures to secure a piece of medical equipment 32 in place. By way of example and not limitation, as described herein the piece of medical equipment 32 may be a needle 34 used in image guided procedures, as well as wires and equipment associated therewith. While use of the device 30 will be described herein in connection with use of a needle 34, of course, the device 30 could similarly be used with any medical equipment 32 that is held in close proximity to a patient’s body 36. The device 30 is simple and affordable to manufacture, while also being easy to use to allow for increased procedural efficiency and increased physician and patient safety. This allows for increased department throughput, which in turn increases revenue, while also potentially resulting in cost savings to patients.

The illustrated device 30 includes a support and placement block 38 having a top surface 40, a bottom surface 42, and at least one side surface, as well as a slit 44 that extends at least partially from the at least one side surface. As shown in the figures, the block 38 is substantially cube shaped, with a first side surface 46, a second side surface 48, a third side surface 50, and a fourth side surface 52. The illustrated cube is similar in size to a closed fist. The cube could be larger or smaller depending on any number of factors, including the size of the patient, the medical procedure being performed, the equipment associated therewith, an operator’s preference, and any other relevant factors. For instance, the block 38 could be approximately a 2 inch by 2 inch by 2 inch cube. The block 38 could similarly be approximately a 4 inch by 4 inch by 4 inch cube. Further still, the block 38 could be approximately a 6 inch by 6 inch by 6 inch cube. Additionally, the block 38 may be specifically designed to be easily modified depending on the nature of the procedure, the patient in question, or any other relevant factors. For instance, the block 38 could be easily cut or trimmed using scissors, a scalpel, or any other sharp object. While a cube-shaped block 38 is shown in the figures, of course the block 38 could be any number of other shapes, including circular in shape, oval in shape, triangular in shape, or any other shape as desired.

When the device 30 is mounted in place, the piece of medical equipment 32, as shown a coaxial needle 34, is located within the slit 44. In doing so, movement of the needle 34 in any direction can be minimized due to the size and material of the block 38. As shown, the slit 44 extends from the second side surface 48 substantially midway towards the fourth side surface 52. Additionally, the slit 44 extends substantially midway between the first side surface 46 and the third side surface 50. By having a slit 44 that extends midway from the second side surface 48 towards the fourth side surface 52, and midway between the first side surface 46 and the third side surface 50, the block 38 provides a maximum amount of support to the needle 34 and helps to prevent movement of the needle 34 in any direction. The block 38 also helps to ensure appropriate placement of the needle 34 or other medical device.

The block 38 may be made of a foam material. For instance, the block 38 may be made of a lightweight foam material having a high density to result in resilience. Of course, as the foam will be used in a hospital or other operating room, it will preferably be made of medical grade foam. On a related note, the foam may be manufactured in a clean room fabrication facility. The block 38 could be made of any number of different foams, including polyethylene foam, cross-linked polyethylene foam, polyurethane foam, and other open cell foam. Of course, specific foam materials can be selected depending on the medical operation being performed, the equipment associated therewith, potential allergies of the patient, and any other relevant factors. Additionally, while the described device 30 may be made of affordable material enabling it to be a one-use product that is thereafter disposed of, it could also include various coatings that would enable repeated uses while minimizing stains, absorption of fluids, and abrasions, while also being anti-microbial and easy to clean. Similarly, the block 38 could be made of a closed cell foam to result in similar characteristics. Additionally, as the device 30 will oftentimes be used during image-guided procedures, it will preferably be radiolucent.

The block 38 can be made of a foam material that holds the needle 34 in place even once the physician has released the needle 34. More specifically, the block 38 holds the needle 34 in an outward direction from the patient’s body. As shown in the figures, the block 38 is used to hold the needle 34 or other equipment in an upward direction at an angle of approximately 90 degrees relative to the patient’s body. Of course, the specific position of the needle 34 or other equipment could vary, but it will generally extend in a direction away from the patient to enable ongoing access to the equipment. By way of example, where the needle 34 is inserted into the side of a patient’s body 36, without the presence of the block 38, the weight of any additional components 54 associated with the needle 34, as well as gravitational forces, can cause the needle 34 to be moved in a downward direction. The heavier the additional equipment 54, the further the movement and sagging will be in the downward direction. However, the foam material of the block 38 has sufficient rigidity to maintain the needle 34 in the original position until the physician physically moves the needle 34. Even where the needle 34 is inserted into a top surface of the patient’s body 36, it is helpful to a physician to have the needle 34 secured by the block 38 in a desired location to prevent movement. At the same time, because the block 38 is made of a foam material, it has a certain amount of compressibility and give. This allows a physician to manipulate and move the needle 34 relative to the block 38, when desired. That said, the device 30 is preferably configured to only allow for manipulation and movement of the needle 34 when a physician manually moves the needle 34.

Additionally, as shown the device 30 includes a base 56 that is mounted to the bottom surface 42 of the block 38. While the device 30 need not have the base 56 as shown in FIGS. 3 and 5-7, the base 56 does provide added stability to the device 30 once it is installed onto a patient’s body 36. The base 56 may be made of a stiffer material than the block 38, such as a semiflexible or semipliable layer of wax. This is particularly appealing as it helps to ensure a stable connection of the base 56, and by extension the overall device 30, to the patient’s skin. The base 56 may be attached to the block 38 using any attachments, including durable adhesive. Alternatively, the base 56 and the block 38 can be manufactured together.

For embodiments including the base 56, adhesive 58 is mounted to the under side of the base 56 and is covered by release layers (not shown), which can be peeled away to expose the adhesive 58. For embodiments that do not include the base 56, adhesive 58 is mounted directly to the bottom surface 42 of the block 38, again where the adhesive 58 is covered by release layers that can be peeled away to expose the adhesive 58. In either embodiment, the adhesive 58 is of sufficient strength to both hold the block 38 in place relative to the patient’s body 36, and to also support the weight of the needle 34 and any other medical equipment 54 or wires associated therewith as they extend away from the patient’s body. In addition to having sufficient strength, the adhesive 58 should also be selected to minimize risk of irritation to a patient’s skin.

Another optional feature that can be included with the device 30 is a strap 60. For instance, as shown in FIGS. 3-9, the strap 60 has a first end 62 and a second end 64. Additionally, the strap 60 may include a fastener 66 mounted to one or both of the ends 62, 64. As shown, a Velcro hook-and-loop material is used, although any other fasteners could similarly be used. The material of the block 38 may have qualities that would allow the fastener 66 to be mounted directly thereto. Alternatively, a pad 68 could be affixed to at least one of the side surfaces, where the pad is made of a Velcro hook-and-loop material compatible with the fastener 66 as shown in FIG. 4. Where fasteners 66 mount to both the first end 62 and the second end 64, the strap 60 can be completely removed from the block 38 if it is not needed. Otherwise, the first end 62 can be permanently attached to the block 38, whereas the second end 64 can be releasably secured to the block 38 using the fastener 66.

The strap 60 is configured to wrap around at least a portion of the block 38 and pull different side surfaces together about the slit 44. In doing so, the strap 60 helps to provide even further security of the needle 34 in place. As shown, the first end 62 of the strap 60 is secured to the third side surface 50 and the second end 64 is secured to the first side surface 46. Additionally, as described above while the illustrated embodiments include a separate Velcro hook-and-loop material on a pad 68 attached to the side of the block 38, the block 38 could also be made of a material to which the Velcro hook-and-loop fastener 66 of the strap 60 can be releasably attached.

Additionally, the present invention is directed to a method of using the device 30 described above to secure a piece of medical equipment 32 in place. By way of example, the piece of medical equipment 32 could be a needle 34 or biopsy gun 54 associated therewith. Initially, the piece of medical equipment 32 is identified and located. Thereafter, a release layer that is configured to cover an adhesive 58 located on an underside of a base 56 mounted to a bottom surface 42 of the block 38 associated with the device 30 is removed. This exposes the adhesive 58. Next, the adhesive 58 is pressed against a skin surface of a patient located adjacent to an operation location. Thereafter, the piece of medical equipment 32 can be located about a slit 44 formed in the block 38. Alternatively, the piece of medical equipment 32 may be initially located about a patient’s body, after which the device 30 is installed such that the slit 44 surrounds the piece of medical equipment 32. Once the device 30 and the piece of medical equipment 32 are properly located, the piece of medical equipment 32 is held in place by the block 38 until moved by a physician. Thereafter, the piece of medical equipment 32 can be used during a medical procedure, and the piece of medical equipment 32 can be held in place by the block 38 absent movement of the equipment 32 by the physician. Additional steps may include the wrapping of a strap 60 around the block 38. For instance, a first end 62 of the strap 60 may be secured to the block 38, and a second end 64 of the strap 60 may be wrapped around and secured to the at least one side surface of the block 38. Alternatively, a first end 62 of the strap 60 may be releasably secured to the at least one side surface, and a second end 64 of the strap 60 may also be releasably secured to the at least one side surface.

In addition to the device 30 being distributed by itself, it could also be distributed in a kit 70. Such a kit 70 would simplify the process of preparing the operating room or to simplify the installation and use of the device 30. The kit 70 could contain the block 38, as well as a variety of other equipment depending on the medical procedure being performed, including the specific medical equipment associated therewith. For instance, the kit could include a pair of sterile gloves 72 that can be used by a given physician. Additionally, the kit could include a disinfectant solution or wipe 74 that can be used to clean the patient’s skin before the block 38 is affixed to the patient’s body 36. Also, the piece of medical equipment 32 could be provided directly within the kit 70. For instance, as shown in the figures, the kit 70 could include a coaxial needle system 34, as well as a biopsy gun 54. The kit 70 may also include an optional strap 60, that can be used to further secure the piece of medical equipment 32 in place relative to the block 38. This strap 60 may have first and second ends 62, 64 with fasteners 66 that can be releasably attached to the block 38. Of course, any number of other items may be included within the kit 70.

While the device 30 may be used with many different types of medical equipment 32, as shown, the device 30 is used with a coaxial needle system 34. While the coaxial needle system 34 is well known in the art, it will briefly be described here. The coaxial needle system 34 includes an outer needle 76 and an inner stylet 78 having a trocar tip. Once the coaxial needle system 34 is inserted into a patient’s body 36, the inner stylet 78 can thereafter be removed. When this occurs, other devices can be inserted into the outer needle 76. For instance, a biopsy gun 54 may be inserted into the outer needle 76. The biopsy gun 54 is then advanced through the outer needle 76 and into the patient’s body 36. When the handle of the biopsy gun 54 is fired, it can collect specimen from lesions found within the patient’s body 36 in a trough. See FIG. 14, which shows a cross- sectional view of the device 30 relative to a lesion 80. These pieces of medical equipment can specifically be used during x-ray, CT (computed tomography), and MR (magnetic resonance) scanning procedures. The biopsy gun 54 can repeatedly be inserted and removed into the outer needle 76 to collect multiple samples from the same location, as required by a given medical procedure. Where the block 38 is used, the biopsy gun 54 can be repeatedly inserted and removed with a single hand without worrying about the displacement of the outer needle 76. While the device 30 can certainly be used to support the coaxial needle system 34, it is even more helpful where other devices, such as the biopsy gun 54 or other wires and devices are used that can present significant weight to the coaxial needle system 34.

Although the best mode contemplated by the inventors of carrying out the present invention is disclosed above, practice of the present invention is not limited thereto. It will be manifest that various additions, modifications and rearrangements of the features of the present invention may be made without deviating from the spirit and scope of the underlying inventive concept.

For example, the device could include additional features to improve the functionality, stability, and removal of the device. In addition, the individual components need not be fabricated from the disclosed materials but could be fabricated from virtually any suitable materials.

Moreover, the individual components need not be formed in the disclosed shapes, or assembled in the disclosed configuration, but could be provided in virtually any shape, and assembled in virtually any configuration. Additionally, any of the components shown herein could come assembled with one another, or they could be separate modules that are assembled depending on the preference of a given user. Furthermore, all the disclosed features of each disclosed embodiment can be combined with, or substituted for, the disclosed features of every other disclosed embodiment except where such features are mutually exclusive.

It is intended that the appended claims cover all such additions, modifications and rearrangements. Expedient embodiments of the present invention are differentiated by the appended claims.