WO2021158802A1

WO2021158802A1 - Compression device and related methods for using the same

Info

Publication number: WO2021158802A1
Application number: PCT/US2021/016636
Authority: WO
Inventors: Douglas D. SILIN
Original assignee: Silin Douglas D
Priority date: 2020-02-04
Filing date: 2021-02-04
Publication date: 2021-08-12

Abstract

Compression devices and methods for compression assisted percutaneous procedures are described for use in conjunction with imaging and surgical procedures. The devices and methods, as taught herein, are particularly useful for displacing small or large bowel or other structures interfering with percutaneous procedure(s) in the abdominal or pelvic regions of a mammalian subject, which cannot be reliably performed using existing methods. The described devices and methods are a low-cost and clinically effective solution to the inadequate methods that currently exist.

Description

COMPRESSION DEVICE AND RELATED METHODS FOR USING THE SAME

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C § 119(e) to U.S. Provisional Application No. 62/969,819, filed February 04, 2020, which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

BACKGROUND

Percutaneous biopsy and drainage procedures have proven to be a low-risk and efficacious method for diagnosis and treatment of abdominal and pelvic lesions. In some cases, an intervening bowel precludes straight forward instrument or needle trajectory. In general, lesions in the abdomen present with unobstructed percutaneous access. However, even in these cases, there can be the risk of unintended damage due to the close proximity of various organs and vascular structures in the pelvis and abdominal cavity. Particularly, significant is the risk in performing these procedures in patients with anatomic, or imaging related complicating factors. Unintended damage can include hemorrhage, bowel perforation with resulting peritonitis, non-target organ injury, and pneumothorax.

In spite of advances in imaging, tissue samples obtained through biopsy continue to remain the mainstay in providing definitive diagnosis for lesions of various types. Although tissue samples can be obtained through fine-needle aspiration (FNA) techniques, core biopsies are preferred because of samples with better preservation of the tissue architecture for histologic assessment. Commonly performed in the hospital setting by interventional and diagnostic radiologists, image-guided percutaneous FNA and core-needle biopsy are the mainstay of obtaining tissue samples from solid organs, lesions within organs, and tumors. The success of the procedure in complicated cases where bowel or other structures intervene with the placement of a needle or instrument in the patient’s abdominal or peritoneal cavity depends directly on the radiologist’s ability to create a safe trajectory for the biopsy device from the skin to the lesion--commonly referred to as “the window.” This same issue arises for ablation procedures, in which a device is placed into a lesion and then activated to destroy a tumor without open surgery.

Some methods for access have been previously described and include, adjusting patient position, sedation or breath-hold, triangulation method, gantry tilt, hydro-dissection, trans-organ access, use of additional modalities and use of intravenous contrast. Hydro-dissection is the injection of a saline solution to displace structures, however, it is not reliable because it has a limited and transient effect. Electromagnetic navigation systems for CT-guided abdominal percutaneous biopsy have been developed, however, implementation will be limited to resource-rich settings given the significant cost associated with proprietary surgical devices. Each of these previously described techniques have only limited situational success and are not therefore widely applicable to procedures requiring an unobstructed window.

Therefore, there is a need for a general technique, devices, and methods to create a window for image-guided percutaneous techniques that are low-cost, effective, and easily-implemented in the clinical setting. The present disclosure describes a new compression assisted percutaneous procedure technique meeting these needs, namely, to displace bowel and allow for effective ‘window’ creation, and maintenance through the length of the image-guided percutaneous technique. The devices and methods, as taught herein, are generally useful for such a technique and other related medical or surgical techniques. SUMMARY

Embodiments of the present disclosure may be drawn to compression devices for compression-assisted percutaneous procedures. An exemplary compression device may include a bottom section having an inner and outer surface; a top section extending from the bottom section to form a sidewall, with said top section and inner surface of the bottom section defining a cavity; at least one securing mechanism attached to an outer surface of the top section; and at least one fenestration disposed within the bottom section, wherein the at least one fenestration extends through an entire thickness of the bottom section.

An exemplary compression device may include a top section sidewall is defined by a shape selected from the group consisting of round, square, rectangular, kidney, star, irregular, or combinations thereof.

An exemplary compression device may include a bottom section defined by a generally round shape.

An exemplary compression device may include a top section sidewall defined a round shape.

An exemplary compression device may include a top section sidewall which is generally curved.

An exemplary compression device may include an outer surface of a bottom section which is flat.

An exemplary compression device may include an outer surface of a bottom section which is rounded or curved.

An exemplary compression device may include an inner surface of a bottom section which is flat.

An exemplary compression device may include an inner surface of a bottom section which is rounded or curved.

An exemplary compression device may include two securing mechanisms extending longitudinally from the device and opposing each other on the outer perimeter of the top section.

An exemplary compression device may include two securing mechanisms extending longitudinally from the device and opposing each other on the outer perimeter of the top section, wherein the two securing mechanism are generally hook- shaped and configured in dimension to receive one or more straps from a medical imaging table.

An exemplary compression device may include straps to secure the compression device to the patient. In some embodiments, the straps may be permanently or releasably attached or fastened to the compression device and may be constructed from materials such as cloth, fabric, nylon, polymers, natural fibers, or any appropriate material. In some embodiments, the straps may further include a hook or mechanism to secure the device to the patient or to an imaging table.

An exemplary compression device may include from about 1 to about 30 fenestrations, or from about 5 to about 20 fenestrations, or from about 5 to about 15 fenestrations, or from about 9 to about 15 fenestrations.

An exemplary compression device may include 21 fenestrations.

An exemplary compression device may include 9 fenestrations.

An exemplary compression device may include fenestrations shaped as a square, a circle, an ellipse, or a star.

An exemplary compression device may include fenestrations shaped as a square.

An exemplary compression device may include fenestrations configured and dimensioned to receive a widest dimension of an insertable medical instrument.

An exemplary compression device may be constructed from a radiolucent material.

An exemplary compression device may be manufactured by a technique selected from the group consisting of 3D printing, machining, injection molding, or combinations thereof.

Embodiments of the present disclosure may be drawn to methods of performing compression-assisted percutaneous procedures using a device having a compression body with one or more fenestrations. An exemplary method may include identifying a skin region for the expected trajectory of the percutaneous procedure by medical imaging; placing the compression device onto the region for the expected trajectory of the percutaneous procedure such that at least one fenestration overlaps with said region; securing the compression device to the subject to apply pressure to said region; ascertaining whether a clear window for one or more percutaneous procedures is present by medical imaging; and performing one or more percutaneous procedures through one or more fenestrations of the compression device. An exemplary method may include releasing the compression device from the subject after the percutaneous procedure has been completed to release the pressure.

An exemplary method may include a method wherein the percutaneous procedure is a drainage procedure.

An exemplary method may include a method wherein the percutaneous procedure is a drainage procedure, and wherein performing the one or more percutaneous procedures includes placing a drainage catheter.

An exemplary method may include a method wherein the percutaneous procedure is a drainage procedure, wherein performing the one or more percutaneous procedures includes placing a drainage catheter, and wherein after performing one or more percutaneous process, the compression device is removed with the drainage catheter in place.

An exemplary method may include a method wherein the percutaneous procedure is a drainage procedure, wherein performing the one or more percutaneous procedures includes placing a drainage catheter, and wherein the method may further include connecting the drainage catheter to a drainage bag.

An exemplary method may include a method wherein an anesthetic is applied to the skin prior to performing the one or more percutaneous procedures.

An exemplary method may include a method wherein the medical imaging comprises obtaining radiographic images of a specimen selected for imaging.

An exemplary method may include a method wherein the steps prior to performing the one or more percutaneous procedures are repeated iteratively until it can be ascertained that a clear window for one or more percutaneous procedures is present by medical imaging.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an exemplary compression device;

FIG. 2 is a perspective view of the exemplary compression device of FIG.1 in use;

FIG. 3 is a perspective view of an alternative exemplary compression device;

FIG. 4 is a perspective view of the exemplary compression device of FIG. 3 in use; FIG. 5 is a perspective view of an alternative exemplary compression device;

FIG. 6 is a side view of the exemplary compression device of FIG. 5;

FIG. 7 is a bottom view of the exemplary compression device of FIG. 5;

FIG. 8 is a perspective view of an alternative exemplary compression device;

FIG. 9 is a side view of the exemplary compression device of FIG. 8;

FIG. 10 is a bottom view of the exemplary compression device of FIG. 8;

FIG. 11 is a cross-sectional view of the center of the exemplary compression device of FIG. 8;

FIG. 12 is an illustration of a radiographic image depicting an obstructed expected trajectory with the target structure visible;

FIG. 13 is an illustration of the radiographic image of FIG. 12 further including a secured compression device; and

FIG. 14 shows the illustration of FIG. 13 further comprising a medical device inserted through one of the fenestrations of the compression device.

DETAILED DESCRIPTION

The compression devices and methods described herein are generally useful for percutaneous techniques. Some exemplary techniques are biopsy, abscess fluid aspiration, ablation procedures, and drain-placement, or any other percutaneous technique which can be assisted by compression. The compression devices and methods are particularly useful for percutaneous techniques of the abdominal or pelvic region of a mammalian subject. The compression devices and methods are typically used in conjunction with a standard medical imaging technique in order to align and guide the procedure and it can be said that such procedures are image-guided. Such medical imaging techniques include, but are not limited to, CT (computerized tomography or CT), Magnetic Resonance (MR) Imaging, fluoroscopy, or any other technique useful for performing an image-guided technique in conjunction with the compression devices and methods described herein. Definitions

The term “compression device” as taught herein may refer to a device that is compressed against a mammalian subject or patient in order to assist in a percutaneous procedure. A compression device may include a compression body that is used to apply pressure to a region of a subject or patient and fenestrations through the region of the compression body that is in contact with the subject or patient during use. The fenestrations are useful for the insertion of needles or instruments for performing the percutaneous technique. A compression device may include a securing means for strapping the device to the subject or patient in order apply pressure. In some embodiments, such securing means may include hook members adapted for the straps typically present in clinical settings, such as on a CT table.

The term “fenestration” as taught herein may refer to apertures or holes through a compression device or compression body. The compression devices have one or more fenestrations typically through the bottom section, or base member, of the compression body that are useful for insertion of needles or instruments for performing a percutaneous technique. The fenestrations could be described as fenestration apertures or apertures, which are taken to be synonymous. The compression devices may include one or more fenestrations or apertures that are sized and shaped appropriately for the needles or medical instruments related to the percutaneous techniques.

The term “compression body” as taught herein is the portion of the compression device that is secured against the subject by the attached one or more securing mechanisms or hook members. In general, a compression device may include a compression body and securing mechanisms. In some embodiments, the compression body may include a bottom section having an inner and outer surface, wherein the bottom section is generally circular in shape, a top section extending outwardly from the bottom section to form a curved sidewall, with said top section and inner surface of the bottom section defining a cavity, and at least one fenestration disposed within the bottom section, wherein the at least one fenestration extends through an entire thickness of the bottom section.

The term “securing mechanism” as taught herein may define any securing means or means for securing the compression device to the subject. In some embodiments, the securing mechanism may be a hook-shaped mechanism or a hook member. In further embodiments, the securing mechanism may be any appropriate mechanism or securing means configured in dimension to receive straps from a standard medical imaging table. It can be appreciated that different medical imaging tables may have slightly or substantially different strap dimensions, and the securing mechanism can be configured in dimension to accept a wide range of strap dimensions.

The term “bowl” as taught herein is generally descriptive of the shape or form of a compression body. Such bowl-shaped compression bodies may include a base member, or bottom portion, and a top portion extending outwardly therefrom forming sidewalls. In some embodiments, the compression body has an overall rounded shape with slightly or substantially curved sidewalls and a flat or curved base member and/or bottom. In some embodiments, the compression body may have an overall square or rectangular shape with substantially flat sidewalls and a flat or curved base member and/or bottom. In further embodiments, the compression body may have one or more slightly or substantially curved sidewalls and one or more substantially flat sidewalls. In some embodiments, one or more of the sidewalls may be discontinuous provided that the structural rigidity is appropriate for use. The term “bowl” as used herein is a non-limiting term for the shape or form of such compression bodies.

The term “subject” as taught herein describes a mammalian subject or patient to which the compression device is applied. In some embodiments, the mammalian subject may be a human. In some embodiments the mammalian subject may be a canine or other mammal.

The term “procedure” as taught herein describes a procedure performed in conjunction with the compression devices, such as a percutaneous procedure. In some embodiments, the procedure is biopsy, abscess drainage, ablation, and/or drain- placement, or any other percutaneous technique which can be assisted by compression. The procedure typically involves one or more needles, instruments, tools, or medical devices which are inserted through one or more of the fenestrations of the compression device. The procedure is generally an image-guided technique and involves a medical imaging technique such as, but not limited to, CT (computerized tomography or CT scan), MR or fluoroscopy. The term “window” as taught herein is used to describe a largely unobstructed trajectory of a needle, instrument, tool, or medical device through the abdominal or pelvic cavity of a patient to the structure of interest. In some cases, small bowel, large bowel, or other structure may block an intended trajectory, in which case there is not an appropriate window for the percutaneous technique. In such cases, the use of a compression device is effective for creating a window by displacing obstructing bowel or other structures.

The term “radiolucent” is taught herein within the context of the material from which a compression device is constructed. A radiolucent material is partly or wholly permeable to radiation in the energy ranges typically employed in imaging techniques, such as CT, MR or fluoroscopy. In the context of X-ray imaging, a radiolucent material is partly or wholly invisible to the imaging technique. The term “radiolucent” may encompass materials that are either translucent or transparent. It can be appreciated that the term does not imply a continuous degree of translucency or transparency throughout the material or device. It can also be appreciated that the degree of translucency or transparency is dependent upon the geometry from which the material or device is imaged, viewed, or measured as well as its interaction with type or energy of radiation used for the imaging modality.

The term “obstruction” or “obstructing structures” are structures, organs, or bowel such as small bowel or large bowel that would interfere with the instrument or needle trajectory in a percutaneous procedure. Such obstructing structures can also be said to be “interfering” or “interfering structures”.

As taught through the present disclosure, the compression devices are generally useful for being pressed against the abdominal or pelvic cavity of a subject or patient in order to displace bowel or obstructing structures for the following procedure. In some embodiments, the devices may be generally bowl-shaped with a base member having one or more apertures for the insertion of needles, instruments, medical devices, or tools through the bottom member and into the abdominal or pelvic cavity of the patient or subject. In some embodiments, the shape or profile of the compression device and/or base member thereof may be designed to apply a focal pressure to the patient. In some embodiments, the compression devices may include a generally rounded profile with a flat, substantially flat, curved or rounded, or substantially curved or rounded bottom section, and said bottom section is thereby configured to apply an appropriate focal pressure. The focal pressure applied by the device is generally useful for displacing small bowel or other structures to create a window for a percutaneous procedure.

The devices, as taught herein through various exemplary embodiments, may include a bottom section with fenestrations, a top section forming a sidewall, and at least one securing mechanism or securing means. In some embodiments, the bottom section may be referred to as the base member. In some embodiments, the top section forming a sidewall may be referred to as a sidewall or sidewalls. The inner surface of the sidewall and inner surface of the bottom section may be formed to generally define a cavity. The sidewall may be considered to extend from the base member to form said cavity. In some embodiments, the sidewall may be considered to extend outwardly or radially outwardly from the center of the bottom section to form a cavity defined by the inner surface of the sidewall and the inner surface of the bottom section.

In some embodiments, the bottom section, when viewed from either or both of the top and bottom of the device, may define a generally round, elliptical, square, rectangular, triangular, polygonal, kidney-shaped, or irregular shape. That is, in some embodiments, either or both of the inner or outer surfaces of the bottom section may define a generally round, elliptical, square, rectangular, triangular, polygonal, kidney shaped, or irregular shape. In some embodiments, the bottom section may have generally the same shape as the shape defined by the sidewall. In some embodiments, the bottom section may be a slightly or substantially different shape from the shape defined by the sidewall.

In some embodiments, either or both of the inner and outer surfaces of the bottom section may be flat, concave, or convex. Concave or convex bottom sections and bottom section surfaces may be generally referred to as rounded or curved. In some embodiments, the concavity may be defined in one dimension. In some embodiments, the concavity may be defined in two dimensions. The property of the bottom section or the surfaces of the bottom sections being flat, concave, or convex may be described as the profile or contour of the bottom section. In some embodiments, the profile or contour of each of the top and bottom section surfaces may be the same. In some embodiments, the profile or contour of each of the top and bottom section surfaces may be different.

The profile or contour of the bottom section may be generally configured in dimension to match an appropriate section of the abdomen or pelvis to be compressed. It can be appreciated that different subjects or patients may have a different abdominal or pelvic shape dependent upon, including, among other factors, obesity or subject size. In such cases, the bottom section may generally be configured in dimension as appropriate for a given subject or patient. It can be appreciated that the profile or contour of the bottom section may also be generally configured in dimension as appropriate for non-human mammalian uses.

In some embodiments, the structure comprising the bottom section and the top section may be referred to as a compression body. In some embodiments, the one or more securing mechanisms may be secured, attached, or joined with the outer surface of the sidewall and extend longitudinally from the device. In some embodiments, the device may include two securing mechanisms which extend longitudinally from the device and oppose each other on the perimeter of the top section or sidewall. The devices may be generally configured in dimension to receive one or more straps from a medical imaging table. In some embodiments, the straps may have different shapes or dimensions and it can be appreciated that the securing mechanisms may be configured in dimension to receive any strap or strapping means.

Focal Pressure

One characteristic of the compression devices is the pressure that is exerted on the abdomen or pelvis of a patient or subject while in use. In use, the bottom section of the compression device (i.e. the bottom or bottom surface of the base member of the device) is pressed against the abdomen or pelvis of the patient or subject in order to displace bowel or any interfering structures for the following percutaneous procedure. It can be appreciated that compression devices with different shapes will have a different imprint on the abdomen or pelvis while pressed against it, and will therefore exert a different pressure in terms of both magnitude and spatial profile or area. In some instances, it may be advantageous to have constant pressure over a wider area, which could be accomplished with a larger compression device with a flat or slightly curved bottom. In other instances, it may be advantageous to have a more focused pressure in a smaller area, which could be accomplished with a smaller compression device with a rounded or curved bottom profile or contour. Such devices having a more focused pressure in a smaller area may be considered to have a higher focal pressure than a device exerting a less focused pressure over the same or a larger area. It can be appreciated that the overall pressure applied may be adjusted in practice as necessary by tightening or loosening the straps securing the device to the patient or subject.

Focal pressure is, in many aspects, an important characteristic to optimize. In some embodiments, a high focal pressure may be desired in order to most effectively displace bowel or interfering structures for the following procedure. In other embodiments, some degree of loss of focal pressure may be tolerated in order to have a larger spatial profile, if necessary, for a given procedure. In some embodiments, focal pressure may be applied by one rounded or curved region of the compression device. In some embodiments, focal pressure may be applied by one region of the compression device having at least one flat region. In some embodiments, focal pressure may be applied by one region of the device having both a curved or rounded region and a flat region. In further embodiments, focal pressure may be applied by an irregularly shaped region or a region not otherwise defined by a curved, round, or flat profile.

In further embodiments, focal pressure may be applied by two or more regions of the compression device. In some embodiments, each of the two or more regions of the compression device applying the focal pressure may have the same shape, size, and/or profile. In some embodiments, the two or more regions of the compression device applying the focal pressure may have a different shape, size, and/or profile. It can be appreciated that the compression devices described herein may have any suitable size, shape, or profile that is useful for applying pressure to a subject.

Materials and Methods of Construction

The compression devices may be constructed from any radiolucent material (i.e. a material transparent or translucent to X-rays). Non-limiting examples of appropriate radiolucent materials are polymers, copolymers, and plastics, such as ABS (acrylonitrile butadiene styrene), PLA (polylactic acid), PET (polyethylene terephthalate), nylon (polyamides), PEEK (polyether ether ketone), ECTFE (ethylene chlorotrifluoroethylene), ETFE (ethylene tetrafluoroethylene), FEP (fluorinated ethylene propylene), PCTFE (polychlorotrifluoroethylene), PFA (perfluoroalkoxy alkane), PPS (polyphenylene sulfide), PPSU (polyphenylsulfone), PSU (polysulfone), and resins. In further embodiments, a radiolucent polymer composite comprising one or more polymers and one or more type of reinforcing fibers may be used to produce the compression devices.

It can be appreciated that all or a portion of a compression device may be constructed from a particular material. In some embodiments, the compression device may be constructed from a single material. In further embodiments, the compression device may be constructed from one or more materials. In some embodiments, the securing mechanisms may be constructed from the same material as the compression body. In further embodiments, the securing mechanisms may be constructed from a material different from that of the compression body. In some embodiments, the base member may be constructed from a material that is the same as the remainder of the compression body. In further embodiments, the base member may be constructed from a material different from that of the compression body. In some embodiments, the securing mechanisms or other portion of the compression device that is not pressed into the abdominal or pelvic cavity of the patient, such as fasteners or fastening means, may incorporate or be constructed from materials that are not radiolucent.

The devices may be manufactured using any appropriate manufacturing technique or process. In some embodiments, the devices are manufactured using 3D printing, machining, or injection molding. In some embodiments, all or a portion of the device may be manufactured using a given manufacturing technique or process. In some embodiments, more than one manufacturing technique or process may be used to produce or manufacture a device. For example, in some embodiments, one or more machining steps may be performed after a device has been produced by 3D printing or injection molding. In further embodiments, portions, sections, or pieces of the device may be produced separately using the same or different manufacturing processes and then permanently or releasably joined to form a device. Fenestrations

According to various exemplary embodiments, as taught herein, the compression device(s) may include one or more fenestrations, i.e. at least one aperture, through the bottom or base member of the device. The fenestration(s) may extend through the entire thickness of the bottom or base member of the device. The number, dimension, arrangement, and shape characteristics of the fenestrations may be any such characteristics that are useful. In some embodiments, the fenestrations may be circular or square. In further embodiments, the fenestrations may be polygonal. In further embodiments, the fenestrations may be an 8-pointed star shape that has a perimeter defined by two overlaid squares rotated 45 degrees with respect to one another. In some embodiments, the shape and dimensions of the fenestrations may be configured in dimension or adapted for the dimensions of a portion of a cannula, needle, medical instrument, medical device, or tool.

In some embodiments, it may be advantageous for a cannula, needle, medical instrument, medical device, or tool to remain in place after a compression device has been released from a subject. In such cases, the compression device may be configured such that the smallest dimension of one or more fenestrations is larger than the largest dimension of the cannula, needle, medical instrument, medical device, or tool. In some embodiments, the medical instrument, medical device, or tool may have an insertable portion that may remain in place, as appropriate, while the compression devices is removed from the patient. In some embodiments, the cannula, needle, medical instrument, medical device, or tool may have a device hub, shank or fitting defining its largest dimension. In some embodiments, the shape and dimensions of the fenestrations may be slightly larger than the dimensions of a Luer fitting, device hub, other fitting, or shank of a cannula, needle, medical instrument, medical device, or tool in order to accommodate the largest outer dimension of said fitting within the fenestration.

In some embodiments, the fenestrations may be symmetrically arranged in a grid. In some embodiments, the fenestrations may be symmetrically arranged in one or more concentric circles with or without a central fenestration. In some embodiments, the fenestrations are not symmetrically arranged. In some embodiments, the fenestrations may comprise one or more apertures of the same shape and dimensions. In some embodiments, the fenestrations may comprise one or more apertures of different shape and/or dimensions. It can be appreciated that, in some embodiments, the spacing between the apertures may be any spacing that maintains the structural rigidity of the device while in use.

Exemplary Compression Devices

While some specific embodiments will be shown and described, it will be understood that such disclosure is not intended to be limiting, but rather, the disclosure is intended to cover all modifications and alternate constructions falling within the spirit and scope of the embodiments described herein.

Referring to Figures 1 and 2, an exemplary compression device 10 for placing continuous compression on the abdomen or pelvis during cross-sectional imaging (eg CT or MR) and needle access is provided. As explained above, percutaneous biopsy and drainage occasionally requires adjusting patient position, gantry tilt, hydro dissection, trans-organ access, and use of additional modalities. During CT or MR imaging-guided needle access, the application of continuous pressure as provided in accordance with the devices and methods described herein enhances the medical practitioner's ability to gain an unobstructed window to the target.

In accordance with an exemplary embodiment, the compression device 10 includes a compression body 12 that is bowl shaped. The compression body 12 includes a generally planar base member 14 having a sidewall 20 extending outwardly and upwardly therefrom. The disclosed planar base member 14 is substantially circular and includes a circumferential edge 16 from which the sidewall 20 extends upwardly. As the planar base member 14 is circular, the sidewall 20 maintains the circular shape and defines a generally cylindrical shape. The sidewall 20 therefore includes a first end 20a adjacent the upper surface 14u of the base member 14 at the juncture of the base member 14 and the sidewall 20. The sidewall 20 also includes a second end 20b remote from the base member 14 and defining the upper edge 17 of the compression body 12. As will be appreciated based upon the following disclosure, the upper edge 17 includes an outwardly face ledge 22 that helps prevent the patient straps from sliding over the opening 24 defined by the compression body 12 when the patient straps are positioned over hook members 26 extending from the sidewall. While a circular construction is disclosed above in accordance with a disclosed embodiment, the compression body may take a variety of shapes without departing from the spirit of the devices and methods described herein.

As it is desirable that the compression device 10 not obstruct imaging of the body, the majority of the compression device 10, in particular, the compression body 12, is preferably made from a rigid radiolucent material. For example, the compression body may be made of various plastics, for example, ABS, well known in the manufacture of medically related products.

The base member 14 includes an upper surface 14u and a lower surface 141 , and the sidewall 20 extends upwardly from the upper surface 14u of the base member 14. As such, the inner surface 20i of the sidewall 20 and the upper surface 14u of the base member 14 define a cavity 28.

The base member 14 is provided with a central fenestration or aperture 30 that allows for access to the patient. In particular, and as will be described below in detail, the central aperture 30 provides for needle access to the patient for performing various procedures. While a circular aperture 30 is disclosed in accordance with this embodiment, the aperture 30 may take a variety of forms. Further, and as discussed below with reference to the embodiment disclosed with reference to Figures 3 and 4, the aperture 30 may be integrated with a grid-like structure that may enhance the application of pressure, provide imaging advantages, and identify needle access locations.

It can be appreciated that the exemplary embodiment provides a sidewall 20 that increases slightly in its diameter as it extends upwardly from the base member 14 as this construction enhances the stability of the compression body 12 when it is pulled downwardly toward the patient's body during use. Further, the junction of the base member 14 and the sidewalls 20 is slightly curved so as to enhance patient comfort when the compression body 12 is pulled downwardly toward the patient's body during use.

Hook members 26 extend from and are secured to the sidewall. In accordance with the exemplary embodiment, the hook members 26 are diametrically oriented relative to the base member 14. When only two hook members 26 are disclosed in accordance with the embodiment shown with reference to Figures 1 and 2, it is appreciated various handle/hook member arrangements may be utilized within the spirit of the embodiments described herein.

Ultimately, the hook members 26 are oriented for ready engagement with patient straps extending across the patient support table. These straps are commonly found on CT tables. With this in mind, each of the disclosed hook members 26 includes a first end 26a secured to the sidewall 20 and a second up turned end 26b positioned remotely from the sidewall 20. More specifically, each of the hook members 26 includes an elongated first segment 32 including a first end 32a and a second end 32b and an elongated second segment 34 including a first end 34a and a second end 34b. The first end 32a of the first segment 32 is secured to the sidewall 20 such that the first segment 32 extends generally perpendicularly relative to the sidewall 20. The second end 32b of the first segment 32 is secured to the first end 34a of the second segment 34 such that the second segment 34 angular extends from the first segment 32 such that the second end 34b of the second segment 34 sits at a position above the first segment 32. This orientation provides a barrier for the patient strap when it is positioned on the hook members 26 and over the first segment 32 of the hook member 26.

However, it can be appreciated that the hook members 26 may take various forms and orientations relative to the sidewalls 20 so long as the hook members 26 allow for easy placement of CT table straps, are maintained out of the CT beam, and allowed for excellent downward force. As such, the hook members 26 may take various shapes and configurations so long as they allow a medical practitioner to maintain even pressure on the compression device 10 and, ultimately, the abdominal cavity positioned below the compression device 10.

In accordance with an exemplary embodiment, the compression body 12 exhibits the following dimensions: a diameter of the base member (14) — 4 inches — 6 inches depending upon the size of the patient and the area of interest; a diameter of an aperture within the base member (14) — 4 cm; and a depth of a compression body (that is, height of the sidewall 20) — 3 inches. It can be appreciated that different embodiments may have slightly or substantially different dimensions than those given depending on the particular application so long as the compression device is effective for its intended use.

The compression devices may take various forms. Such an alternative embodiment is disclosed with reference to Figures 3 and 4. In accordance with an exemplary embodiment, the compression device 110 includes a compression body 112 that is generally bowl shaped. The compression body 112 includes a generally planar base member 114 having a sidewall extending upwardly therefrom. The disclosed planar base member 114 is substantially rectangular and includes a perimeter edge 116 from which the sidewall 120a-d extends upwardly. As the planar base member 114 is rectangular, the sidewall 12a-d maintains the rectangular shape and defines a rectangular cavity 128 defined by first and second long sidewalls 120a, 120b and first and second short sidewalls 120c, 120d. Each of the first and second long sidewalls 120a, 120b and first and second short sidewalls 120c, 120d includes a first end 121 adjacent the upper surface 114u of the base member 114 at the juncture of the base member 114 and the sidewall 120a-d. Each of the first and second long sidewalls 120a, 120b and first and second short sidewalls 120c, 120d includes a second end 123 remote from the base member 114 and defining the upper edge 117 of the compression device 110. While the disclosure shows an upper edge without a ledge as disclosed in accordance with the embodiment of Figures 1 and 2, it is appreciated this embodiment could also include a ledge similar to that disclosed in the first embodiment to help prevent the patient straps from sliding over the opening defined by the compression body when the patient straps are positioned over hook members extending from the sidewall.

The base member 114 includes an upper surface 114u and a lower surface 1141 , and the sidewall 120a-d extends upwardly from the upper surface 114u of the base member 114. As such, the inner surface 125 of the sidewall 120a-d and the upper surface 114u of the base member 114 define a cavity 128.

The fenestrations or apertures 130 disposed within the base member 114 of this exemplary embodiment are integrated as a grid-like structure 131 that enhances the application of pressure, provides imaging advantages, and helps to identify needle access locations. In addition, the spacing within the grid should be sufficient for the passage of needles and other instruments therethrough, for example, approximately 1.5 cm. In addition, the grid like structure should be of sufficient rigidity to assist in applying pressure.

It can be appreciated that the disclosed embodiment provides a sidewall 120a- d that increases slightly in its diameter as it extends upwardly from the base member 114 as this constructions enhances the stability of the compression body 112 when it is pulled downwardly toward the patient's body during use. Further, the junction of the base member 114 and the sidewalls 120a-d is slightly curved so as to enhance patient comfort when the compression body 112 is pulled downwardly toward the patient's body during use.

Hook members 126a-f extend from and are secured to the first and second long sidewalls 120a, 120b. In accordance with a disclosed embodiment, three hook members 126a-f are positioned on each of the first and second long sidewalls 120a, 120b. Specifically, and as will be appreciated based upon the following disclosure, outer first and second hook members 126a, 126b, 126d, 126e are secured at positions adjacent to the respective first and second short sidewalls 120c, 120d and a central third handle/hook member 126c, 126f is positioned between the outer first and second hook members 126a, 126b, 126d, 126e. With this arrangement, the patient straps may be passed over the outer first and second hook members 126a, 126b, 126d, 126e and under the central third handle/hook member 126c, 126f. It is appreciated that such an arrangement could also be used in conjunction with the embodiment disclosed above with reference to Figures 1 and 2.

With the foregoing in mind, each of the disclosed hook members 126a, 126b, 126c, 126d, 126e, 126f includes a first end 127 secured to the sidewall 120a, 120b and a second up turned end 129 positioned remotely from the sidewall 120a-d. More specifically, each of the hook members 126a-f includes an elongated first segment 132 including a first end 132a and a second end 132b and an elongated second segment 134 including a first end 134a and a second end 134b. The first end 132a of the first segment 132 is secured to the sidewall 120a, 120b such that the first segment 132 extends generally perpendicularly relative to the sidewall 120a, 12b. In the case of the outer first and second hook members 126a, 126b, 126d, 126e, the second end 132b of the first segment 132 is secured to the first end 134a of the second segment 134 such that the second segment 134 angular extends from the first segment 132 such that the second end 134b of the second segment 134 sits at a position above the first segment 132. In the case of the central third handle/hook member 126c, 126f, the second end 132b of the first segment 132 is secured to the first end 134a of the second segment 134 such that the second segment 134 angular extends from the first segment 132 such that the second end 134b of the second segment 134 sits at a position below the first segment 132. This orientation provides a barrier for the patient strap when it is positioned on the hook members 126a-f and over the first segment 132 of the hook members 126a-f, while also providing for secure attachment between the patient strap and the compression device 110 in a manner that provides substantially even compression along the extend of the base member 114.

As with the prior embodiment, it is appreciated that the hook members 126a-f may take various forms and orientations relative to the sidewalls so long as the hook members 126a-f allow for easy placement of CT table straps, are maintained out of the CT beam, and allowed for excellent downward force. As such, the hook members 126a-f may take various shapes and configurations so long as they allow a medical practitioner to maintain even pressure on the compression device 110 and, ultimately, the abdominal cavity positioned below the compression device 110.

In accordance with an exemplary embodiment, the compression body 112 exhibits the following dimensions: width & length of base member (114) — 3 inches — 6 inches in either direction depending upon the size of the patient and the area of interest (wherein the aperture is of a size slightly small than the base member in consideration of the fact a grid is provided) depth of compression body (that is, height of sidewall 120a-d) — 3 inches

It can be appreciated that different embodiments may have slightly or substantially different dimensions than those given depending on the particular application so long as the compression device is effective for its intended use.

The compression device described below is an alternative exemplary embodiment and the specific details disclosed should not be construed as general limitations to the scope of the embodiments described herein. The compression device 210 as shown in FIGs 5-7 comprises a compression body 212 that is bowl shaped and hook members 226. The compression body 212 includes a generally planar base member 214 having a curved upper section or sidewall 220 extending generally outwardly or upwardly therefrom. The bottom section or base member 214 is substantially circular and includes an inner circumferential edge 216 from which the curved sidewall 220 extends generally upwardly. The base member has a flat interior surface 217 defined by the inner circumferential edge 216. The curved sidewall 220, which extends upwardly from the base member 214, maintains the hemispherical shape of a bowl. The sidewall has in inner surface 222 that includes a first end 222a joined with the circumferential edge of the base member 216 and a second end 222b located remotely from the base member 214. The second end of the sidewall 222b joins with the top rim of the curved sidewall 224 at its first inner circumferential edge 224a. The inner surface of the sidewall 222 and the inner surface of the bottom section or base member 214 generally define a cavity 228. The outer circumferential edge of the rim 224b joins with the second edge of the outer curved sidewall surface 223b and the outer curved sidewall surface 223b extend to the bottom of the base member generally maintaining the hemispherical bowl shape of the sidewall 220. The outer sidewall surface has a bottom first edge 223a that joins with the bottom circumferential edge of the base member 218. The base member has an outer or bottom surface 219 defined by the bottom circumferential edge of the base member 218. In particular, the bottom surface 219, may take various shapes and profiles to effectively produce the intended focal pressure on the abdomen of the subject or patient.

The base member 214 has fenestrations comprising apertures, or holes, extending through it to allow for the insertion of needles, instruments, medical devices, or tools through the device for access to the patient for performing various procedures. In the particular embodiment shown in FIG. 7, the fenestrations comprise square shaped apertures 230 are shown defined by a grid lattice 231. The fenestration apertures may take any shape or form, and any number of apertures may be incorporated into the compression devices described herein. In some embodiments, the number and shape or design of the apertures may be adapted for a specific tool or procedure in order to provide the appropriate aperture size. The apertures do not necessarily need to be arranged in any regular grid or pattern, and each of the apertures do not necessarily need to be the same shape or size. For instance, in some embodiments, a larger central aperture could be surrounded by several smaller apertures. In further embodiments, the device could comprise from 1 to about 30 apertures, or from about 5 to about 20 apertures, or from about 5 to about 15 apertures, or from about 10 to about 15 apertures.

In the flat-bottom (210) compression device as shown in FIG. 6, the hook members 226 extend from and are joined with the outer surface of the sidewall (223) at opposing positions on the circumference of the compression body (212) at their first end (227). Each hook member includes a second up turned end (229) positioned remotely from the sidewall (220). More specifically, each of the hook members 226includes an elongated first segment 232 including a first end 232a and a second end 232b and an elongated second segment 234 including a first end 234a and a second end 234b. The first end 232a of the first segment 232 is joined with the outer surface of the sidewall 223, such that the first segment 232 extends generally perpendicularly relative to the sidewall 220. For each of the hook members 226, the second end 232b of the first segment 232 is joined with the first end 234a of the second segment 234 such that the second segment 234 angularly extends upward from the first segment 232, and such that the second end 234b of the second segment 234 sits at a position above the first segment 232. This orientation of the first and second segments generally forms the shape of a hook and both holds and provides a barrier for the patient strap when it is positioned on the hook members 226, while also providing for secure attachment between the patient strap and the compression device 210. The hook members are generally oriented at opposing positions on the circumference of the compression body in a manner that provides substantially even compression at the base member (214). The vertical positioning of each hook with respect to the compression body (212) are typically the same and are at an appropriate distance from the bottom of the compression body such that the hook members interfere minimally with abdominal compression during use of the device.

Ultimately, the hook members 226 are oriented for ready engagement with patient straps extending across the patient support table. These straps are commonly found on CT tables. Flowever, it is appreciated that the hook members 226 may take various forms and orientations relative to the sidewalls 220 so long as the hook members 226 allow for placement of CT table straps, are maintained out of the CT beam, and allow for appropriate downward force. As such, the hook members 226 may take various shapes and configurations so long as they allow a medical practitioner to maintain even pressure on the compression device 210 and, ultimately, the abdominal cavity positioned below the compression device 210.

In a particular embodiment, the compression body 212 exhibits the following approximate dimensions:

4 - 5 cm tall (sidewall height)

8 - 10 cm outer diameter defined by circumference 224b

4 - 6 cm diameter of bottom circumferential edge of base member defined by

218

2 - 5 cm hook member (226) length

0.5 cm x 0.5 cm fenestration apertures (230)

The below describes an alternative exemplary embodiment shown wherein the bottom of the base member has a rounded or curved bottom section.

The compression device 310, as shown in FIGs. 8 - 10 comprises a compression body 312 that is bowl shaped and hook members 326. The compression body 312 includes a generally curved or rounded base member 314 having a curved upper section or sidewall 320 extending generally upwardly therefrom. A depiction of a center slice of the device is shown in FIG. 11 . In the specific embodiment depicted, the curvature of the inner surface portion of the curved base member 317 differs from the curvature from the outer surface portion of the curved bottom section or base member 319. The curvature may be defined generally by a radius of a hypothetical circle based upon the curvature of a particular element. An approximate representation of such hypothetical radii is shown in the sliced depiction of FIG. 11. In this particular embodiment, the radius of the inner surface of the curved sidewall 322c has a radius that is essentially equivalent to the radius of the inner surface of the curved base member 317a. In this particular embodiment, the radius of the outer surface of the curved sidewall 323c has a radius that is not essentially equivalent to the radius of the outer surface of the base member 319a. That is, the curvature of the inner surface of the base member is essentially equivalent to the curvature of the inner surface of the sidewalls whereas the curvature of the outer surface of the base member is different from the curvature of the outer surface of the sidewalls.

In some embodiments, the outer surface of the base member may have a curvature equivalent to that of the outer surface of the sidewall, in which case the combination of the sidewall and base member is best described as a hemispherical shape. In other embodiments, the curvature of the outer base member may be substantially different from that of the outer surface of the sidewall. In further embodiments, the sidewall or base member may each have two or more regions defined by sections with different curvatures. In some embodiments, the curvature of the outer base member and/or outer surface of the sidewall may be irregular or contain inflections or other features. It can be appreciated that any features, shapes, or variations thereof are encompassed as long as such embodiments are generally useful as a compression device.

In some embodiments, the curvature of the inner surface of the base member is different from the curvature of the inner surface of the sidewall. In some embodiments, the inner surface of the base member does not have curvature (i.e. it is substantially planar, irregular, or otherwise not described by a curved surface). In some embodiments, the inner surface of the sidewall does not have curvature (i.e. it is substantially planar, irregular, or otherwise not described by a curved surface). It can be appreciated that any features, shapes, or variations thereof are encompassed as long as such embodiments are generally useful as a compression device.

The curved sidewall 320, which extends upwardly from the base member 314, maintains the hemispherical shape of a bowl. The sidewall has in inner surface 322 that includes a first end 322a joined with the base member 314 and a second end 222b located remotely from the base member 314. The second end of the sidewall 322b joins with the top rim of the curved sidewall 324 at its first inner circumferential edge 324a. The inner surface of the sidewall 322 and the inner surface of the bottom section or base member 314 generally define a cavity 328. The outer circumferential edge of the rim 324b joins with the second edge of the outer curved sidewall surface 323b and the outer curved sidewall surface 323b extends to the bottom of the base member generally maintaining the hemispherical bowl shape of the sidewall 320. The outer sidewall surface has a bottom first edge 223a that joins with the bottom circumferential edge of the rounded base member 318.

The curved base member 314 has fenestrations comprising apertures, or holes, extending through it to allow for the insertion of needles, instruments, medical devices, and/or tools through the device for access to the patient for performing various procedures. In the particular embodiment shown in FIG. 10, generally square-shaped fenestration apertures 330 are shown defined by a grid lattice 331 . The fenestration apertures may take any shape or form, and any number of apertures may be incorporated into the compression devices described herein. In some embodiments, the fenestrations are generally square. In some embodiments, the number and shape or design of the fenestrations or apertures may be adapted for a specific medical instrument or procedure in order to provide the appropriate aperture size. The apertures do not necessarily need to be arranged in any regular grid or pattern, and each of the apertures do not necessarily need to be the same shape or size. For instance, in some embodiments, a larger central aperture could be surrounded by several smaller apertures. In further embodiments, the device could comprise from 1 to about 35 apertures, or from about 5 to about 30 apertures, or from about 15 to about 25 apertures, or from about 20 to about 25 apertures.

In the curved bottom compression device 310 as shown in FIG. 9, the hook members (326) extend from and are joined with the outer surface of the sidewall (323) at opposing positions on the circumference of the compression body (312) at their first end (327). Each hook member includes a second up turned end (329) positioned remotely from the sidewall (320). More specifically, each of the hook members 326 includes an elongated first segment 332 including a first end 332a and a second end 332b and an elongated second segment 334 including a first end 334a and a second end 334b. The first end 332a of the first segment 332 is joined with the outer surface of the sidewall 323, such that the first segment 332 extends generally perpendicularly relative to the sidewall 320. For each of the hook members 326, the second end 332b of the first segment 332 is joined with the first end 334a of the second segment 334 such that the second segment 334 angularly extends upward from the first segment 332, and such that the second end 334b of the second segment 334 sits at a position above the first segment 332. This orientation of the first and second segments generally forms the shape of a hook and both holds and provides a barrier for the patient strap when it is positioned on the hook members 326 while also providing for secure attachment between the patient strap and the compression device 310. The hook members are generally oriented at opposing positions on the circumference of the compression body in a manner that provides substantially even compression at the base member (314). The vertical positioning of each hook with respect to the compression body (312) are typically the same and are at an appropriate distance from the bottom of the compression body such that the hook members interfere minimally with abdominal compression during use of the device.

Ultimately, the hook members 326 are oriented for ready engagement with patient straps extending across the patient support table. These straps are commonly found on CT tables. However, it is appreciated that the hook members 326 may take various forms and orientations relative to the sidewalls 320 so long as the hook members 326 allow for placement of CT table straps, are maintained out of the CT beam, and allow for appropriate downward force. As such, the hook members 326 may take various shapes and configurations so long as they allow a medical practitioner to maintain even pressure on the compression device 310 and, ultimately, the abdominal cavity positioned below the compression device 310.

In a particular embodiment, the compression body 312 exhibits the following approximate dimensions:

4 - 5 cm tall (sidewall height)

8 - 10 cm outer diameter defined by circumference 324b

4 - 6 cm diameter of bottom circumferential edge of base member defined by

318

2 - 5 cm hook member (326) length

0.5 cm x 0.5 cm fenestration apertures (330)

0.3 - 0.5 cm compression body thickness (340) as defined by 324a and 324b 0.3 - 0.5 cm base member thickness (342) It can be appreciated that different embodiments may have slightly or substantially different dimensions than those given depending on the particular application so long as the compression device is effective for the methods described herein. In some embodiments, the base member thickness 342 is equivalent to that of the compression body 340. In further embodiments, the compression body and base member have different thicknesses. In further embodiments, the thickness may increase or taper by a linear or non-linear gradient between the compression body and base member. In further embodiments, the thickness of the compression body and base member may be irregular or discontinuous so long as the compression body remains rigid enough to be effective for the methods described herein.

A further alternative exemplary compression device may comprise a 3x3 grid of fenestrations with about 1 cm x 1 cm dimensions and about 0.5 cm spacing in- between the fenestration apertures. In such an exemplary embodiment, the substantially flat base member may have a 7 cm bottom diameter and a 6 cm inner diameter inside of the bowl device. The thickness of the base member in such a device may be about 0.5 cm and the total height from the bottom of the base member to the top rim of the bowl may be approximately 7 cm. The inner diameter at the top rim of the bowl device may be approximately 8 cm and the outer diameter may be approximately 9 cm. The radius of curvature from the flat bottom to the vertical dimension may be approximately 1 cm.

Thickness: 0.5 cm

Fenestrations: 1 cm x 1 cm (squares)

Inter-Fenestration spacing: 0.5 cm

Diameter Bottom section: inner 6 cm, outer 7 cm

Yields 3 x 3 grid of fenestrations on bottom

Height 7 cm outer to outer

Diameter at top: inner 8 cm, outer 9 cm

Radius of curvature from flat bottom to vertical: 1 cm

Exemplary Methods for Using the Devices

Also described are general methods of use of the compression devices. The compression devices may be used in conjunction with routine imaging techniques, such as CT, MR or fluoroscopy. Standard techniques may be used to locate the region for the expected trajectory of the percutaneous procedure by use of a radiopaque marker and obtaining radiographic images of the subject. Once the region for the expected trajectory has been identified, a skin mark is made and the skin is prepped and draped in a sterile fashion. FIG. 12 is an illustration of a radiographic image depicting an expected trajectory with the target structure visible. The window is obstructed by an obstructing structure in FIG. 12, and devices and methods, as taught herein, may be applied to create the necessary window for the percutaneous techniques.

The compression device is placed onto the subject in the region identified for the expected trajectory of the percutaneous procedure. In some embodiments, the compression device may be placed onto the subject so that the center-most fenestration overlaps with the center of said region. In some embodiments, the compression device may be placed onto the subject so that at least one fenestration overlaps with the region for the expected trajectory.

Once in place, the compression device is secured to the subject in order to apply pressure. The securing may be performed using standard CT table straps or any appropriate strap. In some embodiments, the straps are placed over the hook members while loose and then tightened to press the compression device onto the subject. In some embodiments, the straps securing the compression device to the patient may surround both the patient and the CT table. In some embodiments, the straps securing the compression device to the patient may surround only the patient. It can be appreciated that the straps may be configured or utilized in any appropriate manner to secure the compression device to the patient. After pressure has been applied, the subject may again be imaged to determine if the compression device is in the correct position, if more or less pressure is required, or if further adjustments need to be made prior to the percutaneous procedure. If further adjustments are needed or if the compression device needs to be moved, the straps can be loosened, the compression device may be placed in a new location or repositioned, and the device may be again secured to apply pressure. The decision of whether or not the compression device needs to be moved or repositioned may be by way of ascertaining whether a clear window for the percutaneous procedure is present by medical imaging. While repositioning, it may be appropriate or necessary to maintain sterility. Multiple iterations of repositioning may need to be performed and imaging may be used where appropriate to ascertain whether a clear window for the percutaneous procedure is present. FIG. 13 is an illustration of the radiographic image of FIG. 12 further including a secured compression device. The pressure applied by the compression device has pushed aside the obstruction so that there is a clear window for the percutaneous procedure. Because of the applied pressure, the skin is additionally pressed closer to the target structure. FIG. 13 shows straps (one strap on the hook member at the front of the device from this perspective is visible while the second strap on the hook member at the back of the device from this perspective is not visible) securing the compression device to the patient. The straps are shown with broken lines indicating that the strap continues beyond the shown portion in such a manner to secure the compression device to the patient. In some embodiments, the straps may continue and be connected or tightened around an imaging table. In some embodiments, the straps may continue and be connected or tightened directly around the patient. In further embodiments, the straps may continue or be configured in any manner to secure the compression device to the patient.

If necessary or appropriate, the skin may be anesthetized before beginning the procedure with the compression device in place and secured. One or more percutaneous procedures are then performed by passing the needle, instrument, medical device, or tool through one or more fenestrations. It can be appreciated that one or more procedures are typically performed sequentially but may be performed simultaneously if possible or advantageous to do so. For biopsies, the compression device may be left in place and secured until the biopsy is complete. For drainage procedures, the compression device may be removed after the initial access needle reaches the intended target or any time before connecting the drainage catheter to the drainage bag. In embodiments where the compression device is removed while a needle, instrument, medical device, or tool is in place, such removal may be achieved by releasing the pressure and orienting either the released compression device or the largest diameter of the needle, instrument, medical device, or tool such that the entire or insertable portion of the needle, instrument, medical device, or tool can pass through the fenestrations of the compression device as the compression device is lifted away from the subject. FIG. 14 shows the illustration of FIG. 13 further comprising a medical device inserted through one of the fenestrations of the compression device. The depicted embodiment shows a medical instrument that has been safely inserted into the target structure through the window created by the compression device. In some embodiments, the fenestrations are configured in dimension such that the hub, shank, or connector of the needle or cannula portion of the medical instrument can fit through the fenestration as depicted in FIG. 14.

In some embodiments the cannula, needle, instrument, or medical device first inserted through a fenestration of the compression device may be left in place while the pressure is released. In some embodiments, the cannula, needle, instrument, or medical device may be left in place while the compression device is removed from the patient. In some embodiments, a wire may be inserted through the cannula, needle, instrument, or medical device that is left in place after the compression device has been removed. In some embodiments, the inserted wire may be in contact with or inserted into a target structure or organ. In some embodiments, the cannula, needle, instrument, or medical device through which a wire has been inserted may be removed with the inserted wire remaining in place. In some embodiments, the wire may remain stationary (i.e. as a “stationary wire”) for the insertion of a further cannula, needle, instrument, or medical device over or around the stationary wire. In some embodiments, a further cannula, needle, instrument, or medical device may be inserted around the stationary wire such that the stationary wire passes through the further cannula, needle, instrument, or medical device as it is inserted into the patient. In such embodiments, the wire may act as a guide that allows for the further cannula, needle, instrument, or medical device to be inserted with a trajectory or window that avoids obstructing structures. In such embodiments, the wire may act as a guide that allows for the further cannula, needle, instrument, or medical device to be inserted such that it is guided around obstructing structures to avoid them or to safely push them aside. In some embodiments, the wire may be removed once the further cannula, needle, instrument, or medical device is in place or has reached the target structure or organ.

In some embodiments, such procedures where a further cannula, needle, instrument, or medical device is inserted around a stationary wire may be termed “over the wire” procedures. In some embodiments, the “over the wire” procedure is performed after the stationary wire has been placed but before the compression device has been removed from the patient. In such embodiments, the further cannula, needle, instrument, or medical device may be smaller in dimension than the fenestrations of the compression device such that it can pass through the fenestrations. In some embodiments, the “over the wire” procedure is performed after the stationary wire has been placed and after the compression device has been removed from the patient. In such embodiments, the further cannula, needle, instrument, or medical device may be larger than the fenestrations of the compression device such that the further cannula, needle, instrument, or medical device could not be inserted through the fenestrations of the compression device. In some embodiments, the further cannula, needle, instrument, or medical device may be an “over the wire device” configured to be inserted around a stationary wire. It can be appreciated that such “over the wire” procedures may be used in conjunction with any appropriate devices or methods as taught herein, and that such devices or methods can be adapted as appropriate to perform such “over the wire” procedures.

In further embodiments, the methods of use comprise using more than one compression device sequentially or concurrently to perform more than one procedure on a subject. In some embodiments, the compression device is a one-time use item. In further embodiments, the compression device is sterilizable and reusable.

EXAMPLES

The following examples further describe and demonstrate exemplary embodiments. The Examples are given solely for purpose of illustration and are not to be construed as limitations, as many variations thereof are possible without departing from the spirit and scope of the devices and methods described herein.

Example 1. Use of an Exemplary Embodiment

In practice, the compression device 10, shown in FIGs. 1 and 2, is used in conjunction with routine CT needle placement. In particular, a radiopaque marker is placed on the skin overlying the expected trajectory. Axial images are obtained. A skin mark is made and the skin is prepped and draped in sterile fashion. At this point the compression device 10 is placed such that the skin mark is visible within the fenestration 30 and with the hook members 26 are positioned toward the head and feet. The CT table straps are placed over the hook members 26 and tightened, causing the compression device 10, in particular, the base member 14, to apply compression to the abdomen or pelvis. This compression provides for stability and access in the situation when a non-perpendicular approach may be needed. A radiopaque marker is placed on the skin within the fenestration for confirmation on imaging. Repeat images are acquired. The straps are then loosened and the compression device 10 re-position while maintaining sterility if needed. The skin is anaesthetized and the usual process is resumed.

The access or guiding needle is placed through the fenestration 30 in the base member 14 of the compression device 10 and the procedure is carried out. For biopsies, the compression device 10 is left in place until the biopsy is complete. Final images are acquired after the compression device 10 is removed. For drainage procedures, the compression device 10 is removed after the access needle is in place but before connecting the drainage catheter to the drainage bag.

The present compression device 10 allows for advancement of current techniques used in other modalities such as ultrasound and fluoroscopy that could not be used in CT or MR. Once the bowel or intervening structure is displaced, the continued overlying compression should prevent re-interposition. The compression on the lesion may aid in hemostasis. We noted a decrease in skin to target distance and in conjunction with the deeper starting location, gantry clearance in large patients is improved. Ultimately, we find that the use of the present compression device 10 will result in decrease risk of injury to the patient. Use of the present compression device 10 also allows patients to have procedures who otherwise be unable to have them.

Example 2. Use of an Exemplary Embodiment

In practice, the exemplary compression device 110, shown in FIGs. 3 and 4, is used in conjunction with routine CT needle placement. In particular, a radiopaque marker is placed on the skin overlying the expected trajectory. Axial images are obtained. A skin mark is made and the skin is prepped and draped in sterile fashion. At this point the compression device 110 is placed such that the skin mark is visible within the fenestration 130 and with the hook members 126 across the patient’s body. The CT table straps are placed over the hook members 126 and tightened, causing the compression device 110, in particular, the base member 114, to apply compression to the abdomen or pelvis. A sterile radiopaque marker is placed on the skin within the fenestration for confirmation on imaging. Repeat images are acquired. The straps are then loosened and the compression device 110 reposition while maintaining sterility if needed. The skin is anaesthetized, and the usual process is resumed.

The access or guiding needle is placed through the fenestration 130 in the base member 114 of the compression device 110 and the procedure is carried out. For biopsies, the compression device 110 is left in place until the biopsy is complete. Final images are acquired after the compression device 110 is removed. For drainage procedures, the compression device 110 is removed after the access needle reaches the target but before connecting the drainage catheter to the drainage bag.

The present compression device 110 allows for advancement of current techniques used in other modalities such as ultrasound and fluoroscopy that could not be used available in CT scan. Once the compression bowel is displaced, the continued overlying compression should prevent re-interposition. The compression on the lesion may aid in hemostasis. A decrease in skin to target distance has been noted and, in conjunction with the deeper starting location, gantry clearance in large patients is improved. Ultimately, it has been found that the use of the present compression device 110 results in decrease risk of injury to the patient. Use of the present compression device 110 also allows patients to have procedures who otherwise be unable to have them.

Example 3. Use of an Exemplary Embodiment

In practice, the compression device 220, shown in FIGs. 5-7, is used in conjunction with routine CT needle placement. In particular, a radiopaque marker is placed on the skin overlying the expected trajectory. Axial images are obtained. A skin mark is made and the skin is prepped and draped in sterile fashion. At this point the compression device 210 is placed such that the skin mark is visible within the fenestration 230 and with the hook members 226 are positioned toward the head and feet. The CT skin table straps are placed over the hook members 226 and tightened, causing the compression device 210 and, in particular, the base member 214, to apply compression to the abdomen or pelvis. This compression provides for stability and access in the situation when a non-perpendicular approach may be needed. A radiopaque marker is placed on the skin within the fenestration for confirmation on imaging. Repeat images are acquired. The straps are then loosened and the compression device 210 is re-positioned while maintaining sterility if needed. The skin is anaesthetized and the usual process is resumed.

The access or guiding needle is placed through any one of the fenestrations 230 in the base member 214 of the compression device 210 and the procedure is carried out. For biopsies, the compression device 210 is left in place until the biopsy is complete. Final images are acquired after the compression device 210 is removed. For drainage procedures, the compression device 210 is removed after the access needle reaches the target but before connecting the drainage catheter to the drainage bag.

The present compression device 210 allows for advancement of current techniques used in other modalities such as ultrasound and fluoroscopy that could not be used in CT or MR. Once the bowel or intervening structure is displaced, the continued overlying compression should prevent re-interposition. The compression on the lesion may aid in hemostasis. There will be a decrease in skin to target distance and in conjunction with the deeper starting location, gantry clearance in large patients is improved. Ultimately, the use of the present compression device 210 will result in decrease risk of injury to the patient. Use of the present compression device 210 also allows patients to have procedures who otherwise be unable to have them.

Example 4. Use of an Exemplary Embodiment

In practice, the compression device 320, shown in FIGs. 8-11 is used in conjunction with routine CT needle placement. In particular, a radiopaque marker is placed on the skin overlying the expected trajectory. Axial images are obtained. A skin mark is made and the skin is prepped and draped in sterile fashion. At this point the compression device 310 is placed such that the skin mark is visible within the fenestration 330 and with the hook members 326 are positioned toward the head and feet. The CT skin table straps are placed over the hook members 326 and tightened, causing the compression device 310 and, in particular, the base member 314, to apply compression to the abdomen or pelvis. This compression provides for stability and access in the situation when a non-perpendicular approach may be needed. A radiopaque marker is placed on the skin within the fenestration for confirmation on imaging. Repeat images are acquired. The straps are then loosened and the compression device 310 is re-positioned while maintaining sterility if needed. The skin is anaesthetized and the usual process is resumed.

The access or guiding needle is placed through any one of the fenestrations 330 in the base member 314 of the compression device 310 and the procedure is carried out. For biopsies, the compression device 310 is left in place until the biopsy is complete. Final images are acquired after the compression device 310 is removed. For drainage procedures, the compression device 310 is removed after the access needle reaches the target but before connecting the drainage catheter to the drainage bag.

The present compression device 310 allows for advancement of current techniques used in other modalities such as ultrasound and fluoroscopy that could not be used in CT or MR. Once the bowel or intervening structure is displaced, the continued overlying compression should prevent re-interposition. The compression on the lesion may aid in hemostasis. There will be a decrease in skin to target distance and in conjunction with the deeper starting location, gantry clearance in large patients is improved. Ultimately, the use of the present compression device 310 will result in decrease risk of injury to the patient. Use of the present compression device 310 also allows patients to have procedures who otherwise be unable to have them.

Example 5. Clinical Results

Five cases were presented to us in which existing techniques would have been unsuitable for percutaneous access due to overlying small bowel. Therefore, the Compression-Assisted Percutaneous Procedure was performed using the devices and methods described herein. Lesions biopsied in this cohort were present in the kidney, adnexa, peritoneum (colonic-origin neuroendocrine tumor) and the retroperitoneum (leiomyosarcoma). In addition, one of the cases involved a CT-guided abscess drainage and catheter placement for a history of diverticulitis.

Following the imaging and alignment procedures of Example 1 , the exemplary embodiment shown in FIGs. 1 and 2 was compressed into each of the patients’ abdomens to displace overlying small bowel or obstructing structures. The percutaneous techniques were carried out by insertion of needles or instruments through the fenestration of Compression Device 1 while in-place on the patient. For drainage procedures, the compression device was removed after the drainage catheter is in place but before connecting to the drainage bag.

For the five cases, the success rate was 100%. These results demonstrate that the devices and methods, as taught herein, are safe, easy to apply to existing clinical and surgical techniques, and effective.

Incorporation by Reference

The entire disclosure of each of the patent documents, including certificates of correction, patent application documents, scientific articles, governmental reports, websites, and other references referred to herein is incorporated by reference herein in its entirety for all purposes. In case of a conflict in terminology, the present specification controls.

Equivalents

The invention can be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are to be considered in all respects illustrative rather than limiting on the invention described herein. In the various embodiments of the methods and systems of the present invention, where the term comprises is used with respect to the recited steps of the methods or components of the compositions, it is also contemplated that the methods and compositions consist essentially of, or consist of, the recited steps or components. Furthermore, it should be understood that the order of steps or order for performing certain actions is immaterial so long as the invention remains operable. Moreover, two or more steps or actions can be conducted simultaneously.

In the specification, the singular forms also include the plural forms, unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In the case of conflict, the present specification will control.

Furthermore, it should be recognized that in certain instances a composition can be described as being composed of the components prior to mixing, or prior to a further processing step such as drying, binder removal, heating, sintering, etc. It is recognized that certain components can further react or be transformed into new materials.

Claims

WHAT IS CLAIMED IS:

1. A device for compression-assisted percutaneous procedures, comprising: a bottom section having an inner and outer surface; a top section extending from the bottom section to form a sidewall, with said top section and inner surface of the bottom section defining a cavity; at least one securing mechanism attached to an outer surface of the top section; and at least one fenestration disposed within the bottom section, wherein the at least one fenestration extends through an entire thickness of the bottom section.

2. The device of claim 1 , wherein the top section sidewall is defined by a shape selected from the group consisting of round, square, rectangular, kidney, star, irregular, or combinations thereof.

3. The device of claim 1 , wherein the bottom section is defined by a generally round shape.

4. The device of claim 3, wherein the top section forming the sidewall defines a round shape.

5. The device of claim 1 , wherein the top section sidewall is generally curved.

6. The device of claim 1 , wherein the outer surface of the bottom section is flat.

7. The device of claim 1 , wherein the outer surface of the bottom section is rounded or curved.

8. The device of claim 1 , wherein the inner surface of the bottom section is flat.

9. The device of claim 1 , wherein the inner surface of the bottom section is rounded or curved.

10. The device of claim 1 , comprising two securing mechanisms extending longitudinally from the device and opposing each other on the outer perimeter of the top section.

11. The device of claim 10, wherein the two securing mechanism are generally hook-shaped and configured in dimension to receive one or more straps from a medical imaging table.

12. The device of claim 1 , wherein the at least one fenestration includes from about 1 to about 30 fenestrations, or from about 5 to about 20 fenestrations, or from about 5 to about 15 fenestrations, or from about 9 to about 15 fenestrations.

13. The device of claim 12, wherein the at least one fenestration includes 21 fenestrations.

14. The device of claim 12, wherein the at least one fenestration includes 9 fenestrations.

15. The device of claim 1 , wherein the at least one fenestration is shaped as a square, a circle, an ellipse, or a star.

16. The device of claim 1 , wherein the at least one fenestration is square in shape.

17. The device of claim 16, wherein the at least one fenestration is configured and dimensioned to receive a widest dimension of an insertable medical instrument.

18. The device of claim 1 , wherein the device is constructed from a radiolucent material.

19. The device of claim 1 , wherein the device is constructed by a manufacturing technique selected from the group consisting of 3D printing, machining, injection molding, or combinations thereof.

20. A method for performing compression-assisted percutaneous procedures using a compression device having a compression body with one or more fenestrations, the method comprising: identifying a skin region for the expected trajectory of the percutaneous procedure by medical imaging; placing the compression device onto the region for the expected trajectory of the percutaneous procedure such that at least one fenestration overlaps with said region; securing the compression device to the subject to apply pressure to said region; ascertaining whether a clear window for one or more percutaneous procedures is present by medical imaging; and performing one or more percutaneous procedures through one or more fenestrations of the compression device.

21. The method of claim 20, further comprising releasing the compression device from the subject after the percutaneous procedure has been completed to release the pressure.

22. The method of claim 20, wherein the percutaneous procedure is a drainage procedure.

23. The method of claim 22, wherein performing the one or more percutaneous procedures includes placing a drainage catheter.

24. The method of claim 23, further comprising, after performing one or more percutaneous process, removing the compression device with the drainage catheter in place.

25. The method of claim 23, further comprising connecting the drainage catheter to a drainage bag.

26. The method of claim 20, further comprising, prior to performing the one or more percutaneous procedures, applying an anesthetic to the skin.

27. The method of claim 20, wherein the medical imaging comprises obtaining radiographic images of a specimen selected for imaging.

28. The method of claim 20, wherein the steps prior to performing the one or more percutaneous procedures are repeated iteratively until it can be ascertained that a clear window for one or more percutaneous procedures is present by medical imaging.